Rosetta Genomics Ltd. (Form: 20-F, Received: 03/23/2016 16:32:52)

As filed with the Securities and Exchange Commission on March 23, 2016

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

x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2015

¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

¨ 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, Israel

(Address of principal executive offices)

Kenneth A. Berlin, CEO and President

3711 Market Street, Suite 740

Philadelphia, Pennsylvania 19104

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 0.6 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, 2015, the issuer had 20,515,536 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 x

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 x

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 x 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 x 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 x

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:

x 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 x

TABLE OF CONTENTS

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	23
ITEM 4A	UNRESOLVED STAFF COMMENTS	51
ITEM 5	OPERATING AND FINANCIAL REVIEW AND PROSPECTS	52
ITEM 6	DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES	62
ITEM 7	MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS	80
ITEM 8	FINANCIAL INFORMATION	81
ITEM 9	THE OFFER AND LISTING	82
ITEM 10	ADDITIONAL INFORMATION	83
ITEM 11	QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK	101
ITEM 12	DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES	102
PART II		102
ITEM 13	DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES	102
ITEM 14	MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS	102
ITEM 15	CONTROLS AND PROCEDURES	102
ITEM 16	RESERVED	103
ITEM 16A	AUDIT COMMITTEE FINANCIAL EXPERT	103
ITEM 16B	CODE OF ETHICS	103
ITEM 16C	PRINCIPAL ACCOUNTANT FEES AND SERVICES	104
ITEM 16D	EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES	104
ITEM 16E	PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS	104
ITEM 16F	CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT	104
ITEM 16G	CORPORATE GOVERNANCE	104
ITEM 16H	MINE SAFETY DISCLOSURE	105
PART III		105
ITEM 17	FINANCIAL STATEMENTS	105
ITEM 18	FINANCIAL STATEMENTS	105
ITEM 19	EXHIBITS	105
SIGNATURE		109
INDEX TO FINANCIAL STATEMENTS		F-1

INTRODUCTION

As used in this Annual Report on Form 20-F (hereinafter referred to as this “Annual Report”), unless the context requires otherwise, 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 subsidiary.

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.

All information in this Annual Report on Form 20-F relating to shares or price per share reflect (i) the 1-for-4 reverse stock split effected by Rosetta on July 6, 2011 and (ii) the 1-for-15 reverse stock split effected by Rosetta on May 14, 2012.

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.

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

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, 2013, 2014 and 2015, and as of December 31, 2014 and 2015 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, 2011 and 2012 and as of December 31, 2011, 2012 and 2013 have been derived from our audited financial statements which are not included in this Annual Report. For the year ended December 31, 2015, we have included the results of CynoGen, Inc. as of April 13, 2015, the acquisition date. Further details on the acquisition of CynoGen, Inc. can be found in Section 4.B. below. In July 2008, through our wholly owned subsidiary Rosetta Genomics Inc., we purchased Parkway Clinical Laboratories, Inc., a privately held Pennsylvania corporation owning a CLIA-certified laboratory. Parkway remained an indirect wholly owned subsidiary until we sold it in May 2009. On April 18, 2013, we signed a settlement agreement with Sanra Laboratories (“Sanra”) in connection with our sale of Parkway to Sanra. Under the terms of the agreement, on April 20, 2013 and on May 10, 2013, Sanra and Parkway paid us a total of $625,000. Operating results for Parkway have been classified as discontinued operations for all presented periods.

	Year Ended December 31,
	2015			2014			2013			2012			2011
	(In thousands, except share and per share data)
Consolidated Statement of Comprehensive Loss:
Clinical testing revenues	$	6,668		$	1,099		$	405		$	201		$	103
Licensing revenues		1,600			228			-			-			-
Total revenues	$	8,268		$	1,327		$	405		$	201		$	103

Cost of clinical testing revenues		6,192			1,310			709			258			324
Cost of licensing revenues		80			-			-			-			-
Total cost of revenues		6,272			1,310			709			258			324

Gross profit (loss)		1,996			(17	)		304			57			221

Consolidated Statements of Operations:
Operating expenses:
Research and development, net		2,956			1,927			1,744			1,247			3,386
Marketing and business development		7,350			6,848			7,002			3,938			2,633
General and administrative		7,566			5,494			4,297			3,025			2,537
Gain from bargain purchase related to acquisition of CynoGen, Inc.		(155	)		-			-			-			-
Total operating expenses		17,717			14,269			13,043			8,210			8,556

Operating loss		15,721			14,252			13,347			8,267			8,777
Financial expenses (income), net		1,605			259			(177	)		2,429			(1,984	)
Loss before taxes		17,326			14,511			13,170			10,696			7,393
Tax expense		19			15			-			-			-

Loss from continuing operations		17,345			14,526			13,170			10,696			7,393
Other comprehensive income attributed to marketable securities		-			-			-			-			7
Net loss (income) from discontinued operations		-			-			(273	)		(239	)		1,444
Net loss after discontinued operations		17,345			14,526			12,897			10,457			8,830

Net loss attributable to Rosetta Genomics	$	17,345		$	14,526		$	12,897		$	10,457		$	8,830
Basic and diluted net loss per ordinary share from continuing operations	$	1.15		$	1.29		$	1.37		$	2.40		$	14.55
Basic and diluted net loss (income) per ordinary share from discontinued operations attributable to Rosetta Genomics	$	-		$	-		$	(0.028	)	$	(0.054	)	$	2.85
Basic and diluted net loss per ordinary share attributable to Rosetta Genomics	$	1.15		$	1.29		$	1.34		$	2.35		$	17.4
Weighted average number of ordinary shares used to compute basic and diluted net loss per ordinary share attributable to Rosetta Genomics		15,092,679			11,239,892			9,593,952			4,448,449			507,622

	As of December 31,
	2015		2014		2013		2012		2011
	(In thousands)
Consolidated Balance Sheet Data:
Cash and cash equivalents	$	12,447	$	7,929	$	16,744	$	30,978	$	735
Short-term bank deposits and restricted cash		1,098		7,702		7,702		164		149
Trade receivable		3,633		338		224		88		11
Working capital (deficiency)		16,567		14,241		23,060		30,487		(638	)
Total assets		19,370		16,452		24,998		32,530		2,044
Long-term liabilities		-		2		309		364		552
Total shareholders’ equity (deficiency)		19,620		15,065		23,633		30,900		(356	)
Capital stock		159,890		137,990		132,032		126,402		84,689

CAPITALIZATION AND INDEBTEDNESS

Not applicable.

REASONS FOR THE OFFER AND USE OF PROCEEDS

Not applicable.

RISK FACTORS

If any of the following risks occur, 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

We will require substantial additional funds to continue our operations 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, commercialize and protect our microRNA tests and technologies and will require substantial additional funds to continue our operations. Following our acquisition of PersonalizeDx in 2015, we have incurred and expect to continue to incur increased costs that may adversely affect our current results of operations and liquidity in 2016 and beyond. As of December 31, 2015, we had cash, cash equivalents, short-term bank deposits and restricted cash of $13.5 million, compared to $15.6 million as of December 31, 2014. Our current operating plan includes various assumptions concerning the level and timing of cash receipts from sales and cash outlays for operating expenses and capital expenditures. Our ability to successfully carry out our business plan is primarily dependent upon our ability to (1) obtain sufficient additional capital, (2) attract and retain knowledgeable employees, (3) increase our cash collections and (4) generate significant additional revenues. We believe that our existing operating plan, which includes a cost-reduction plan should we be unable to raise sufficient additional capital, will be sufficient to fund our operations for at least the next 12 months. We may seek additional funding through collaborative arrangements and public or private equity offerings and debt financings, and we may elect to raise additional funds even before we need them if the conditions for raising capital are favorable. 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. Our failure to raise capital when needed will materially harm our business, financial condition and results of operations.

The approach we are taking to discover and develop novel microRNA-based diagnostics and therapeutics is new and may never lead to commercially accepted products.

We have concentrated our research and development efforts on diagnostics and therapeutics in the relatively new field of microRNAs. We are currently marketing and selling the following four diagnostic tests based on our proprietary microRNA technologies: RosettaGX Cancer Origin ^™ , mi-LUNG ^™ , mi-KIDNEY ^™ and RosettaGx Reveal ^™ . 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, and the scientific evidence to support the feasibility of developing products based on these discoveries is limited. Further, our focus 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. If we or a collaborative partner are not successful in commercializing our existing diagnostic tests or developing and commercializing additional microRNA-based tests or products, our business may fail.

Successful integration of PersonalizeDx with us and successful operation of the combined company are not assured. Also, integrating our business with that of PersonalizeDx may divert the attention of management away from operations.

In April 2015, we acquired CynoGen, Inc., which does business as PersonalizeDx (“CynoGen” or “PersonalizeDx”).

There can be no assurance that we will be able to maintain and grow the acquired business and operations of PersonalizeDx. In addition, the market segments in which PersonalizeDx operates may experience declines in demand and/or new competitors. Integrating and coordinating certain aspects of the operations, portfolio of products and personnel of PersonalizeDx with ours have involved and will continue to involve complex operational, technological and personnel-related challenges. This process will be time-consuming and expensive, may disrupt the businesses of either or both of the companies and may not result in the full benefits expected by us and PersonalizeDx, including cost synergies expected to arise from supply chain efficiencies and overlapping general and administrative functions. The potential difficulties, and resulting costs and delays, include:

managing a larger combined company;

consolidating corporate and administrative infrastructures;

issues in integrating research and development, commercial and sales forces;

difficulties attracting and retaining key personnel;

loss of customers and suppliers and inability to attract new customers and suppliers;

unanticipated issues in integrating information technology, communications and other systems;

incompatibility of purchasing, logistics, marketing, administration and other systems and processes;

unforeseen and unexpected liabilities related to the acquisition or PersonalizeDx’s business; and

potential costs of relocating employees to PersonalizeDx’s facilities or our other facilities.

Additionally, the integration of our and PersonalizeDx’s operations, products and personnel may place a significant burden on management and other internal resources. The diversion of management’s attention, and any difficulties encountered in the transition and integration process, could harm the combined company’s business, financial condition and operating results.

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 a company providing relatively new diagnostic services, 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:

maintain and further build our strong intellectual property portfolio;

execute development activities using an unproven technology;

execute sales, marketing and distribution activities;

continue to develop and maintain successful strategic relationships;

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 commercial and, if applicable, regulatory acceptance of our tests and products.

If we are unsuccessful in accomplishing these objectives, we may not be able to raise capital, develop additional tests or products, successfully commercialize our existing tests, 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, 2015, we had an accumulated deficit of $140 million. We had net loss of $17.3 million for the year ended December 31, 2015. We anticipate that the majority of any revenues we generate over the next several years will be from sales of our currently marketed products in the United States and from existing and future collaborations and licensing arrangements and the sale of future products we develop or acquire. We cannot be certain, however, that our sales efforts 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 be successfully commercialized. If we are unable to secure significant revenues from our current selling efforts or through 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.

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. We enter from time to time into foreign currency hedge transactions in order to mitigate some of this risk, however, we are unlikely to offset the entire currency exchange risk.

Fluctuations in our share price may have a significant impact on our reported liabilities and reported results of financial income or expenses.

Fluctuations in our share price may have a significant impact on our reported liabilities because certain outstanding warrants are classified as liabilities measured at fair value each reporting period until they are exercised or expire, with changes in the fair values being recognized in our statement of operations as financial income or expense. In periods when share price is ascending, the reported liability and the reported results of financial expense are adversely affected.

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 could 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 United States, Israel and other countries, so that we can prevent others from unlawfully using our inventions and proprietary information. As of March 1, 2016, our patent portfolio included a total of 44 issued U.S. patents, two issued Australian patents, two issued European patents, both validated in UK, Germany and France, two issued Israeli patents, one issued Japanese patent, 42 pending patent applications worldwide, consisting of 22 U.S. patent applications, two of which received notice of allowance, six applications that are pending in Europe, one of which received a notice of allowance, three applications pending in Israel, one application pending in Japan, two applications pending in Canada, three applications pending in China, two applications pending in Brazil, one application pending in Korea, and two PCT applications. 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, and, therefore, validity and enforceability cannot be predicted with certainty. Patents may be challenged, deemed unenforceable, invalidated, or circumvented.

Furthermore, the standards that the U.S. Patent and Trademark Office, or USPTO, 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. Currently, there is an opposition proceeding pending against one of our patents in Europe. This opposition relates to a patent granted by the European Patent Office that claims the use of miR-34a for the preparation of a pharmaceutical composition for treating cancer, wherein the cancer is p53 negative. Even if this opposition is successful, we do not anticipate that the result will have an adverse effect on our business.

Even if our other 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, and because certain applications 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.

From time to time, the U.S. Supreme Court, other federal courts, the U.S. Congress or the USPTO may change the standards of patentability and any such changes could have a negative impact on our business. There have been several cases involving “gene patents” and diagnostic claims that have been considered by the U.S. Supreme Court. On June 13, 2013, in Association for Molecular Pathology v. Myriad Genetics, Inc. the Court held that claims to isolated genomic DNA were not patentable subject matter, but claims to complementary DNA (cDNA) molecules were patentable subject matter. The effect of the decision on patents for other isolated natural products is uncertain, and this uncertainty includes microRNAs, which have a different chemical composition, differ in size, and have a more complicated discovery process than DNA. On March 20, 2012, in Mayo Collaborative Services, DBA Mayo Medical Laboratories, et al. v. Prometheus Laboratories, Inc., the Court held that several claims drawn to measuring drug metabolite levels from patient samples and correlating them to drug doses were not patentable subject matter. Although the decision relates to biomarker method patents, relating to simple methods, for affecting treatment decisions, the decision has created uncertainty around the ability to patent certain biomarker-related method patents. On June 12, 2015, the United States Court of Appeals for the Federal Circuit (CAFC) issued a decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc. The decision dealt with the subject matter eligibility of a non-invasive method for detecting paternally inherited cell-free fetal DNA from a blood sample of the pregnant woman carrying a fetus. The district court ruled that the method claims were patent ineligible and the Federal Circuit agreed. In December 2015, the CAFC denied an en banc hearing of this case. These decisions have increased the uncertainty with regard to our ability to obtain patents in the future as well as the value of current and future patents, once obtained. Depending on decisions by the U.S. federal courts and the Patent Office, the interpretation of laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents, all of which could have a material adverse effect on our business.

On March 4, 2014, the USPTO issued a memorandum to patent examiners titled 2014 Procedure For Subject Matter Eligibility Of Claims Reciting Or Involving Laws Of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products. These guidelines instruct USPTO examiners on the ramifications of the Prometheus and Myriad rulings. In addition, these guidelines reflect the USPTO’s interpretation of Supreme Court case law addressing patent subject matter eligibility. As such, the guidelines are subject to challenge in a court proceeding and are subject to modification by future court or USPTO decisions.

On December 15th, 2014, the USPTO released the revised subject matter eligibility examination guidance to patent examiners entitled " 2014 Interim Guidance on Patent Subject Matter Eligibility " (the "Interim Guidance"). The Interim Guidance intends to assist USPTO patent examiners to evaluate inventions that may be related to law of nature, natural phenomena, and/or an abstract idea. The Interim Guidance addresses the concerns raised by the public against the guidance issued in March of 2014 – namely that the USPTO applied with too broad a brush the recent Supreme Court decisions regarding the judicial exceptions (law of nature, natural phenomena, and/or an abstract idea). The USPTO’s new analysis, focusing on the claims as a whole and an analysis of the “markedly different” properties of the claimed subject matter (as compared to the natural counterpart product) is a balanced approach. The Interim Guidance also appears to indicate that a claim that recites a natural phenomenon, such as a diagnostic process or method, will satisfy Section 101 if the claim sufficiently limits the practical application of the natural phenomenon. The USPTO issued another update in July 2015 to provide additional information for subject matter eligibility. While we believe our patents and pending patent applications include claims that are patentable under current US law, as well as in foreign jurisdictions, no assurances can be given that a federal district court or the USPTO would agree.

In addition, Congress has directed the USPTO to study effective ways to provide independent, confirming genetic diagnostic test activity where gene patents and exclusive licensing for primary genetic diagnostic tests exist. This study will examine the impact that independent second opinion testing has on providing medical care to patients; the effect that providing independent second opinion genetic diagnostic testing would have on the existing patent and license holders of an exclusive genetic test; the impact of current practices on testing results and performance; and the role of insurance coverage on the provision of genetic diagnostic tests. The USPTO was directed to report the findings of the study to Congress and provide recommendations for establishing the availability of independent confirming genetic diagnostic test activity by June 16, 2012. On August 28, 2012, the Department of Commerce sent a letter to the House and Senate Judiciary Committee leadership updating them on the status of the genetic testing report. The letter stated in part: “Given the complexity and diversity of the opinions, comments, and suggestions provided by interested parties, and the important policy considerations involved, we believe that further review, discussion, and analysis are required before a final report can be submitted to Congress.” The USPTO issued a Request for Comments and Notice of Public Hearing on Genetic Diagnostic Testing on January 25, 2012, and held additional public hearings in February and March 2013. In September 2015, the USPTO submitted a report to Congress pursuant to Section 27 of the Leahy Smith America Invents Act. The report stated that in view of the altered legal landscape, the USPTO’s recommendations to Congress are limited in scope. The report provided three recommendations. The first recommendation was to proceed cautiously, monitoring changes in the actual availability of gene-based diagnostic tests from multiple providers. The second recommendation was to consider creating mechanisms to facilitate sharing data on diagnostic correlations in order to build robust databases of the relationships between genetic mutations and the presence, absence, or likelihood of acquiring the relevant medical condition. The third recommendation was to consider the role of cost and insurance. It is unclear whether the recommendations of this study will be acted upon by Congress to change the law or process in a manner that could negatively impact our patent portfolio or our future research and development efforts.

It may be more difficult to adequately protect or enforce the intellectual property rights of our company as a result of the acquisition of PersonalizeDx, which could harm our competitive position.

Our success and future revenue growth depends in part, on our ability to protect our intellectual property. We primarily rely on patent, copyright, trademark and trade secret laws, as well as nondisclosure agreements and other methods, to protect our proprietary technologies and processes. It is possible that competitors or other unauthorized third parties may obtain, copy, use or disclose proprietary technologies and processes, despite efforts by us to protect our proprietary technologies and processes. While we hold and have access to a significant number of patents, there can be no assurances that any additional patents will be issued. Even if new patents are issued, the claims allowed may not be sufficiently broad to protect our technology. In addition, any of our existing patents, and any future patents issued to us, may be challenged, invalidated or circumvented. As such, any rights granted under these patents may not provide us with meaningful protection. We may not have foreign patents or pending applications corresponding to its U.S. patents and applications. Even if foreign patents are granted, effective enforcement in foreign countries may not be available. If our patents do not adequately protect our technology, competitors may be able to offer products similar to our products. Our competitors may also be able to develop similar technology independently or design around our patents.

In addition, as a result of the acquisition of PersonalizeDx, after twelve months from the date of the acquisition, we will be required to renegotiate the terms of certain agreements under which PersonalizeDx had in-licensed proprietary markers from Abbott Molecular, Inc. We cannot be sure that we will be able to renegotiate these license agreements on acceptable terms or at all. If we are unable to do so, we may lose the ability to commercialize the products that rely on these licenses.

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. 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.

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 expect 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 or co-exclusive rights. Our licensors may not successfully prosecute the patent applications which we have licensed. Even if patents are issued 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.

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 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 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 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

If we fail to comply with the complex federal, state, local and foreign laws and regulations that apply to our business, we could suffer severe consequences that could materially and adversely affect our operating results and financial condition.

Our operations are subject to extensive federal, state, local and foreign laws and regulations, all of which are subject to change. These laws and regulations currently include, among other things:

CLIA, which requires that laboratories obtain certification from the federal government;

FDA laws and regulations;

Health Insurance Portability and Accountability Act of 1996 (HIPAA), which established comprehensive federal standards with respect to the privacy and security of protected health information and requirements for the use of certain standardized electronic transactions; amendments to HIPAA under the Health Information Technology for Economic and Clinical Health Act, or HITECH, which strengthen and expand HIPAA privacy and security compliance requirements, increase penalties for violators, extend enforcement authority to state attorneys general and impose requirements for breach notification;

state laws regulating genetic testing and protecting the privacy of genetic test results, as well as state laws protecting the privacy and security of health information and personal data and mandating reporting of breaches to affected individuals and state regulators;

the federal anti-kickback law, or the Anti-Kickback Statute, which prohibits knowingly and willfully offering, paying, soliciting, receiving, or providing remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual, or the furnishing, arranging for, or recommending of an item or service that is reimbursable, in whole or in part, by a federal health care program;

the federal False Claims Act, which imposes liability on any person or entity that, among other things, knowingly presents, or causes to be presented, a false or fraudulent claim for payment to the federal government;

the federal Civil Monetary Penalties Law, which prohibits, among other things, the offering or transfer of remuneration to a Medicare or state health care program beneficiary if the person knows or should know it is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of services reimbursable by Medicare or a state health care program, unless an exception applies;

other federal and state fraud and abuse laws, such as anti-kickback laws, prohibitions on self-referral, and false claims acts, which may extend to services reimbursable by any third-party payor, including private insurers; and

similar foreign laws and regulations that apply to us in the countries in which we operate.

These laws and regulations are complex and are subject to interpretation by the courts and by government agencies. Our failure to comply could lead to civil or criminal penalties, exclusion from participation in government health care programs, or prohibitions or restrictions on our laboratories’ ability to provide services. We believe that we are in material compliance with all statutory and regulatory requirements, but there is a risk that one or more government agencies could take a contrary position, or that a private party could file suit under the qui tam provisions of the federal False Claims Act or a similar state law. Such occurrences, regardless of their outcome, could damage our reputation and adversely affect important business relationships with third parties, including managed care organizations, and other private third-party payors.

If we do not comply with governmental regulations applicable to our CLIA-certified laboratories, we may not be able to continue our operations.

The operations of our laboratories in Philadelphia, Pennsylvania and Lake Forest, California are subject to regulation by numerous federal, state and local governmental authorities in the United States. Both laboratories are CLIA-certified and are accredited by the College of American Pathologists, or CAP. The CAP Laboratory Accreditation Program is an internationally recognized program that utilizes teams of practicing laboratory professionals as inspectors, and accreditation by CAP can also be used to meet CLIA and state certification requirements. In addition, our laboratories have obtained certain state licenses as required, including from California, Florida, Maryland, New York, Pennsylvania, and Rhode Island, and we plan to obtain licenses from other states if and as required.

CLIA is a federal law that regulates clinical laboratories that perform testing on human specimens for the purpose of providing information for the diagnosis, prevention or treatment of disease. CLIA imposes quality standards for laboratory testing to ensure the accuracy, reliability and timeliness of reporting patient test results. CLIA-certified 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, or if they were limited in scope, we would no longer be able to continue our testing operations, which would have a material adverse effect on our business.

From time to time, we may become aware of states other than California, Florida, Maryland, New York, Pennsylvania, and Rhode Island that require out-of-state laboratories to obtain a license in order to accept specimens from the state, and it is possible that other states already have such requirements or will have such requirements in the future. If we identify any other state with such requirements or if we are contacted by any other state advising us of such requirements, we intend to follow instructions from the state regulators as to how we should comply with such requirements. If we learn that we were accepting specimens from a state that requires licensure, we may be required to cease accepting specimens from that state while obtaining licensure, and we may be subject to monetary and other penalties for accepting specimens without a license.

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.

Although the FDA has consistently stated that it has the authority to regulate clinical laboratory tests as medical devices, it generally exercised enforcement discretion in not otherwise regulating most tests such as ours that are designed, manufactured and used within the high complexity CLIA-certified laboratory at which the test was performed. These tests are known as laboratory developed tests or LDTs. However, after many years of promising that it would be providing guidance on the regulation of LDTs, the FDA issued draft guidance entitled, “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and an accompanying draft guidance document, or Draft Guidance, entitled, “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)” on October 3 2014. If the Draft Guidance is finalized, the FDA may phase-in a risk-based approach to the regulation of LDTs in a manner that is consistent with the FDA’s current regulation of in vitro diagnostics, or IVDs, which means that new LDTs could be subject to requirements for premarket review. We cannot predict when or whether the Draft Guidance will be finalized, but we are monitoring this development carefully. Although we intend to continue to launch new clinical tests as LDTs in our CLIA-certified laboratory, we cannot provide any assurance that FDA regulations, including pre-market clearance or approval, will not be required in the future for LDTs applying our microRNA technology. If pre-market clearance or approval, or additional legal requirements such as implementing additional quality controls, are required, our business could be negatively impacted because we would have to obtain the data required to support the requirements of new FDA regulations and because our CLIA-certified laboratory may be required to stop offering our tests until they are cleared or approved by the FDA.

Diagnostic tests based on our microRNA technology may require the performance of clinical trials, which can be lengthy, costly and burdensome.

If the FDA decides to require pre-market clearance or approval of our current tests, or the tests that we are developing, it may require us to perform clinical trials prior to submitting a marketing application. If we are required to conduct 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 our inability to obtain a sufficient number of patient samples, which is a function of many factors, including the size of the relevant 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 increase the time to completion.

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 including those relating to development, clinical trials, manufacturing and commercialization. Rigorous preclinical testing, the performance of 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 approval 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 among other things. 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 required performance standards or expected deadlines, we might be required to replace them or the data that they provide could be rejected, all of which may result in a delay of the affected trial.

Failure to comply with government laws and regulations related to submission of claims for our services could result in significant monetary damages and penalties and exclusion from the Medicare and Medicaid programs and corresponding foreign reimbursement programs.

We are subject to laws and regulations governing the submission of claims for payment for our services, such as those relating to: coverage of our services under Medicare, Medicaid and other state, federal and foreign health care programs; the amounts that we may bill for our services; and the party to which we must submit claims. Our failure to comply with applicable laws and regulations could result in our inability to receive payment for our services or in attempts by government healthcare programs, such as Medicare and Medicaid, to recover payments already made. Submission of claims in violation of these laws and regulations can result in recoupment of payments already received, substantial civil monetary penalties, and exclusion from government health care programs, and can subject us to liability under the federal False Claims Act and similar laws. The failure to report and return an overpayment to the Medicare or Medicaid program within 60 days of identifying its existence can give rise to liability under the False Claims Act. Further, a government agency could attempt to hold us liable for causing the improper submission of claims by another entity for services that we performed if we were found to have knowingly participated in the arrangement at issue.

If we are found to have violated laws protecting the privacy or security of patient health information, we could be subject to civil or criminal penalties, which could increase our liabilities and harm our reputation or our business.

There are a number of U.S. federal and state laws and foreign laws protecting the privacy and security of identifiable health information, or “protected health information” as defined under HIPAA, and restricting the use and disclosure of that protected health information that we are subject to. In the United States, the U.S. Department of Health and Human Services promulgated health information privacy and security rules under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and then significantly strengthened and broadened the applicability of HIPAA under the Health Information Technology for Economic and Clinical Health Act (HITECH). HIPAA and HITECH and their implementing regulations and guidance will be collectively referred to herein as “HIPAA”. HIPAA applies to health care providers engaging in certain standard transactions electronically; health plans and health care clearing houses. These entities are referred to as “covered entities.” Certain HIPAA provisions also apply to “business associates” of covered entities, or third party providers of services to covered entities that involve the use or disclosure of protected health information. HIPAA’s privacy rules protect medical records and protected health information in all forms by limiting its use and disclosure, giving individuals the right to access, amend and seek accounting of their own health information and limiting, in some circumstances, the use and disclosure of protected health information to the minimum amount reasonably necessary to accomplish the intended purpose of the use or disclosure. HIPAA’s security standards require both covered entities and business associates to implement administrative, physical and technical security measures to maintain the security of protected health information in electronic form. Covered entities and business associates must conduct initial and ongoing risk assessments to ensure the ongoing effectiveness of security measures and maintain a written information security plan. HITECH amended HIPAA to require the reporting of breaches of protected health information to affected individuals, the federal government and in some cases, to the media. We are a covered entity and as such, we must comply with HIPAA and ensure that all aspects of our operations comply with relevant HIPAA standards. For example, we must take steps to ensure that our sales team does not inappropriately access or use protected health information in providing services and support to customers. We are subject to random audit by federal authorities, and enforcement by both state and federal regulators. We are also subject to investigation in response to complaints. If we are found to be in violation of the privacy rules security standards, breach notification rules or other HIPAA requirements, we could be subject to civil or criminal penalties as well as fines, which could increase our liabilities and harm our reputation or our business. Large breaches of protected health information could lead to class action lawsuits and other litigation. Any publicly reported breach could cause significant reputational harm to our business and significant expense for reporting, mitigation of harm and implementation of corrective actions mandated by regulators. HITECH expanded HIPAA enforcement authority to state attorneys general, so we are subject to additional enforcement and penalties from each state where individuals affected by a HIPAA violation may reside. Allegations that we have violated individuals’ privacy or security rights, even if we are not found liable, could be expensive and time-consuming to defend and could result in adverse publicity that could harm our business. Beyond HIPAA, most states have adopted data security laws protecting the personal data of state residents. Personal data subject to protection typically includes name coupled with social security number, state-issued identification number, or financial account number. Most states require specific, technical security measures for the protection of all personal data, including employee data, and impose their own breach notification requirements in the event of a loss of personal data. Many states have also adopted genetic testing and privacy laws. These laws typically require a specific, written consent for genetic testing, as well as consent for the disclosure of genetic test results, and otherwise limit uses and disclosures of genetic testing results. A few states have adopted laws that give their residents property rights in their genetic information. State privacy and data security laws generally overlap and apply simultaneously with HIPAA. In the event of a data breach affecting individuals from more than one state, we must comply with all relevant state notification requirements as well as HIPAA and are subject to enforcement by all relevant state and federal authorities as well as fines and penalties imposed by each state. Non-U.S. privacy protection requirements such as the European Union’s Data Protection Directive governing the processing of personal data, may be stricter than U.S. law and violations could result in claims for damages, fines or orders to stop or change the processing of the personal data. The European Union’s final draft General Data Protection Regulation, which is likely to be formally adopted, imposes extensive new legal obligations and substantially increases the risk of fines, with upper limits based on a corporate group’s global turnover. Privacy and data security laws, including those relating to health information, are complex, overlapping and rapidly evolving. All of these laws impact our business either directly or indirectly. Our failure to comply with applicable privacy or security laws, or significant changes in these laws, could significantly impact our business and future business plans.

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 chemical 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.

If we do not comply with laws regulating the use of human tissues, our business could be adversely affected.

We use human tissue samples for the purpose of development and validation of our tests. Our access and use of these samples is subjected to government regulation, in the United States, Israel and elsewhere and may become subject to further regulation. For example, the Israeli Ministry of Health requires compliance with the principles of the Helsinki Declaration, the Public Health Regulations (Clinical Trials in Human Subjects) 1980, the provisions of the Guidelines for Clinical Trials in Human Subjects and the provisions of the current Harmonized Tripartite Guideline for Good Clinical Practice. Our failure to comply with these or similar regulations could impact our business and results of operations. In the United States, we must comply with 45 C.F.R. 46, Federal Policy for the Protected of Human Subjects, or the “Common Rule” as well as HIPAA with respect to the use of clinical data associated with tissue samples. Failure to comply with these laws may result in federal or state enforcement, fines and/or civil penalties, reputational harm and inability to use data for test validation, research or other purposes.

Risks Related to Competition and Commercialization

If we are unable to expand sales of our diagnostic tests in the United States, it would have a material adverse effect on our business and financial condition.

In November 2010, we reacquired the U.S. commercial rights to our microRNA-based diagnostic tests, and in May 2011, we established our own internal oncology sales team consisting of four oncology sales specialists, which has since been increased and as of the date of this report stands at 12 sales specialists, two Regional Managers and an Executive Vice President. To date, this team has had moderate success in commercializing our diagnostic tests. In addition, in July 2012 (as amended in October 2012), we entered into a co-marketing agreement with Precision Therapeutics, pursuant to which we granted Precision Therapeutics the co-exclusive right, along with us, to market the RosettaGX Cancer Origin ^TM Test in the United States. Precision Therapeutics launched its marketing effort in October 2012, but had limited success and this agreement terminated on February 28, 2014. If we are unable to establish adequate sales, marketing and distribution capabilities to successfully commercialize our tests in the United States, whether independently or with third parties, it will have a material adverse effect on our business and financial condition.

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 and others who may develop products based on our technologies are targeting or may 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 and others who may develop products based on our technologies may also 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 will also face competition from other companies working to develop novel tests and products using technology that competes more directly with our technologies. We are aware of several other companies that are working to develop microRNA-based diagnostics and therapeutics, including HTG Molecular, Alnylam Pharmaceuticals, Inc., Asuragen Inc., Exiqon A/S, Life Technologies Corporation, Isis Pharmaceuticals, Mirna Therapeutics, Merck & Co., Inc., Santaris Pharma A/S, Regulus Therapeutics, Interpace Diagnostics, Inc. and others. In addition, we face competition from companies that have developed or are developing diagnostic tests based on other non-microRNA technologies such as Cancer Genetics, Inc., NeoGenomics Inc., Biotheranostics, Inc., Foundation Medicine, and Veracyte Inc. We are also aware of several other companies that provide tests and services that are competitive with those provided by our recently acquired PersonalizeDx business, including Cancer Genetics, NeoGenomics, Miraca, Bostwick and Healthtronics. If we are unable to compete effectively with existing tests and products, new treatment methods and new technologies, we and others who may develop products based on our technologies 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.

Health insurers and other third-party payors may decide not to cover our diagnostic products or may provide inadequate reimbursement, which could jeopardize our commercial prospects.

In the United States, private and government payors decide whether to cover a new diagnostic test, the amount that they will pay for a covered test and the specific conditions for reimbursement. In May 2012, we announced that the designated Medicare Administrative Contractor, or MAC, with jurisdiction for the RosettaGX Cancer Origin ^TM Test had informed us that it plans to cover this test for Medicare beneficiaries, and in June 2012, we announced that the MAC had established a reimbursement rate for the test. We then announced that this MAC had formalized their coverage decision in a Local Coverage Determination (LCD) effective August 1, 2013. Each third-party payor, however, makes its own decision about which tests it will cover and how much it will pay. While many third-party payors will follow the lead of Medicare, we cannot provide any assurance that other payors will cover this test or any of our other tests. The coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of each of our tests to each payor separately, with no assurance that approval will be obtained. Furthermore, reimbursement from third party payors depends upon whether a service is covered under the patient’s policy and if payment practices for the service have been established. If third-party payors decide not to cover our diagnostic tests or if Medicare or other payors offer inadequate payment amounts, our ability to generate revenue from our diagnostic tests could be limited. Third-party payors that decide to reimburse for our tests may stop or lower payment at any time, which would reduce revenue. We cannot predict whether third-party payors will cover our tests or offer adequate payments. We also cannot predict the timing of such decisions. In addition, physicians or patients may decide not to order our tests if third-party payments are inadequate, especially if ordering the test could result in financial liability for the patient.

In the United States, the American Medical Association, or AMA, assigns specific Current Procedural Terminology, or CPT, codes, which are a medical nomenclature used to report medical procedures and services under public and private health insurance plans. Once the CPT code is established, the Centers for Medicare and Medicaid Services, or CMS, establishes reimbursement payment levels and coverage rules for Medicare, and private payors establish rates and coverage rules independently. While we have been assigned a CPT code for the RosettaGX Cancer Origin ^TM Test , we cannot guarantee that any of our other tests will be assigned a CPT code and will be approved for reimbursement by Medicare or other third-party payors. Additionally, any or all of our diagnostic tests developed in the future may not be approved for reimbursement or may be approved at a level that limits our commercial success.

In addition, payment for diagnostic tests furnished to Medicare beneficiaries in most instances is made based on a fee schedule set by CMS. In recent years, payments under these fee schedules have decreased and may decrease more, which could jeopardize our commercial prospects. Reimbursement decisions in the European Union and in other jurisdictions outside of the United States vary by country and regions and there can be no assurance that we will be successful obtaining adequate reimbursement.

Recent and future changes to policies and pricing from the MolDx molecular diagnostics program utilized by Noridian Healthcare Solutions, our Medicare Administrative Carrier, could have positive or negative effects on our Medicare billing. This relates primarily to our high complexity laboratory in Lake Forest, California which is under Noridian and MolDx jurisdiction. MolDx changes to coding and reimbursement over the past three years for Fluorescence In Situ Hybridization, or FISH, is indicative of the MolDx impact. In 2013, MolDx reduced FISH reimbursement in an attempt to reduce overutilization causing substantive losses for many laboratories. In 2016, MolDx revised pricing for FISH upward after implementing better utilization controls in the form of revised code and billing guidance.

Because of Medicare billing rules, we may not receive reimbursement for all tests provided to Medicare patients.

Under current Medicare billing rules, the bundled payment for inpatient services includes clinical laboratory testing performed for a Medicare beneficiary who was a hospital inpatient at the time the tumor tissue sample was obtained and whose testing was ordered less than 14 days after discharge. Medicare billing rules also require hospitals to bill for our testing if it is ordered for a hospital outpatient under the same circumstances. Accordingly, we must bill hospitals for such testing. Because we generally do not have written agreements in place obligating these hospitals to pay for our testing, we may not be paid or may have to pursue payment from the hospital on a case-by-case basis. We cannot ensure that hospitals will pay us for tests performed on patients falling under these rules.

Changes in healthcare policy could increase our costs, decrease our revenues and impact sales of and reimbursement for our tests.

In March 2010, the President of the United States signed the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, or the ACA. This law substantially changed the way healthcare will be financed by both governmental healthcare programs and private insurers, and has significantly impacted our industry. The ACA contains a number of provisions that affect and will continue to affect our business and operations, including those governing enrollment in state and federal healthcare programs, Medicare reimbursement, and healthcare fraud and abuse.

The Protecting Access to Medicare Act of 2014, or PAMA, which was signed into law on April 1, 2014, significantly altered the current payment methodology for clinical diagnostic laboratory services covered by the Medicare Part B program and paid according to the Clinical Laboratory Fee Schedule, or CLFS. Under PAMA, applicable laboratories must report rates paid by private payors (i.e., health insurance issuers, group health plans, Medicare Advantage plans, and Medicaid managed care organizations) for each clinical diagnostic laboratory test, or CDLT, that it furnished during the data collection period. The reported data must include payment rates (reflecting all discounts, rebates, coupons and other price concessions), Healthcare Common Procedure Coding System codes, and the volume of tests associated with each rate. The CLFS payment rate for each CDLT (with some exceptions) will be equal to the weighted median, as calculated based on the data submitted by applicable laboratories. Every three years new data will be submitted, and new rates for CDLTs will be established based on that data. Significant reductions in reimbursement would be phased in over time. CMS would limit the maximum reimbursement reduction for a particular CDLT to no more than 10% each year in 2017 through 2019 and no more than 15% each year in 2020 through 2022. PAMA required publication of a final rule by June 15, 2015, submission of initial payment data on January 1, 2016, and implementation of new CLFS payment rates as of January 1, 2017. CMS did not publish a proposed rule until October 1, 2015, and has yet to issue a final rule. Whether CMS will implement new payment rates as of January 1, 2017, as required by PAMA, is therefore unknown at this time.

Diagnostic tests furnished to Medicare inpatients generally are included in the bundled payment made to the hospital under Medicare Part A’s Inpatient Prospective Payment System. Further, in 2014, CMS began to bundle payment for clinical laboratory tests together with other services performed during hospital outpatient visits under the Hospital Outpatient Prospective Payment System. While CMS exempted molecular diagnostic tests from this packaging provision, it is possible that CMS could propose to bundle payment for such tests in the future. Our tests are generally not paid in the hospital outpatient setting, and insofar as they are paid in that setting they likely would be considered molecular tests if billed under specific procedure codes, but it is possible that payment for our tests could be bundled if furnished in a hospital outpatient setting in the future.

On several occasions Congress has considered various cost reduction alternatives, including imposing a 20% co-insurance amount on clinical laboratory services (which would require beneficiaries to pay a portion of the cost of their clinical laboratory testing). Although these changes have not been enacted at this time, Congress could decide to impose these or other fee reductions or taxes at some point in the future. If so, these additional coinsurance payments for our tests could be difficult to collect and any new fee reductions or taxes would impact our revenues

We expect that there will continue to be proposals by legislators at both the federal and state levels, regulators and third-party payors to keep healthcare costs down. Some of these changes could impose additional limitations on the prices we will be able to charge for our tests or the amounts of payment available for our tests from governmental healthcare programs or third-party payors. Current and future healthcare reform legislation and policies could have a material adverse effect on our business and financial condition.

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 our distributors for the success of commercialization of our current diagnostic tests.

We currently have distribution agreements with respect to some of our tests covering Australia, Canada, Greece, India, Israel, New Zealand, Qatar, Romania, Saudi Arabia, Singapore, Turkey and the United Arab Emirates. All of these distribution agreements call for samples to be sent to our CLIA-certified laboratory in Philadelphia for analysis, but we are largely dependent upon these distributors for the commercial success of our tests outside of the United States. The potential revenues from these agreements are based on the sale of our products by these distributors and will depend upon our distributors’ ability to devote the necessary resources to successfully commercialize these tests. In addition, if any of our current or potential future distributors 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. If any of our distributors or co-marketers does not devote sufficient time and resources to the collaboration or if a 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 contract with a single manufacturer for the purchase of microarray chips for certain tests, including the RosettaGX Cancer Origin™ Test and miKIDNEY ^™ . The failure of this manufacturer to supply sufficient quantities on a timely basis could have a material adverse effect on our business.

We use a single manufacturer for the supply of microarray chips for certain tests, including the RosettaGX Cancer Origin™ Test and miKIDNEY ^™ . While we believe that there are a number of manufacturers from whom we could obtain such chips, we have not screened or approved any such manufacturers as potential back-up manufacturers for these chips, and it could take a significant amount of time and would be costly to do so. Accordingly, if this manufacturer is unable or unwilling to supply sufficient quantities of chips on a timely basis, it could have a material adverse effect on our business.

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. 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 could 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.

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 in the future depend significantly on third parties to commercialize microRNA-based diagnostic tests or therapeutic products we may develop.

We currently have a U.S. sales and marketing team that covers the appropriate markets for our current product offerings, however, we may need to expand our sales team as we introduce diagnostic tests to new markets. In the future, we may rely on collaborators or other third parties to commercialize certain future tests we may develop in the United States in the event such tests that don’t align with current call points. 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 expand our internal sales, distribution and marketing capabilities, we will have to invest financial and management resources, and we will face a number of additional risks, including:

our inability to develop and launch new tests that focus on larger potential markets;

we may not be able to attract and grow a 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.

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 product liability insurance covering our current commercial tests, and clinical trial insurance for certain trials and cancer programs requiring insurance 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 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.

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 our CLIA-certified and CAP-accredited laboratories in Philadelphia, Pennsylvania and Lake Forest, California 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 could limit the number of foreign employees 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.

Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Rule 13a-15(f) of the Exchange Act. Our management conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework). Based on this evaluation, management concluded that our internal control over financial reporting was effective as of December 31, 2015. Management reviewed the results of its assessment with our Audit Committee. 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 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 regarding the effectiveness of our internal control over financial reporting.

Risks Related to Israeli Law and Our Operations in Israel

For certain calendar years, we were a passive foreign investment company, or PFIC, for U.S. federal income tax purposes. 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 believe we may be a PFIC for the year ended December 31, 2015. The determination of whether or not we are a PFIC is made on an annual basis and will depend on the composition of our income and assets from time to time. Specifically, for U.S. federal income tax purposes, we will generally be classified as a PFIC for any taxable year in which either: (i) 75% or more of our gross income is passive income or (ii) at least 50% of the average value (determined on a quarterly basis) of our total assets for the taxable year (including cash) produce or are held for the production of passive income. The calculation of the value of our assets will be based, in part, on the quarterly market value of our ordinary shares. It is difficult to make accurate predictions of our future income, assets, activities and market capitalization, all of which are relevant to the PFIC determination. For years in which we are determined to be a PFIC for U.S. federal income tax purposes, U.S. holders of our ordinary shares may become subject to increased tax liabilities under U.S. tax laws and regulations and will become subject to burdensome reporting requirements. Accordingly, our treatment as a PFIC could therefore result in a reduction in the after-tax return of U.S. holders of our ordinary shares and may cause a reduction in the value of our shares. For more information please see “Item 10. Additional Information – E. Taxation - Certain Material U.S. Federal Income Tax Considerations – Passive Foreign Investment Company.”

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 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. Although Israel has entered in the past 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. In addition, tension among the different Palestinian factions may create additional unrest and uncertainty. In recent years, Israel was engaged in several rounds of armed conflicts with Hamas in the Gaza Strip. These conflicts involved missile strikes against civilian targets in parts of Israel that resulted in economic losses.

During 2011, riots and uprisings in several countries in the Middle East led to severe political instability and to a decline in the regional security situation. Such instability may affect the global economy and marketplace, could negatively affect business conditions and therefore could adversely affect our operations and make it more difficult for us to raise capital.

In addition, during the months of July and August 2014, Israel was engaged in an armed conflict in the Gaza Strip, a military operation given the name “Protective Edge”, and was subject to missile attacks against civilian targets in several areas of the country. While the fighting has currently ended, this fighting has contributed to the political and security instability in Israel, which could negatively affect business conditions, and could potentially have an adverse effect on our operations.

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 restrictions 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 commonly 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 are obligated to perform military reserve duty annually for extended periods of time through the age of 40 (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. 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 Economy that resulted in our currently being eligible for tax benefits under the Israeli Law for Encouragement of Capital Investments, 1959, as amended. 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 corporate tax at a rate of 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 and we may be required to refund the amount of the benefits already received, in whole or in part, with the addition of linkage differentials to the Israeli consumer price index and interest, or other monetary penalty. 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.

We participate in programs supported by the Israeli Chief Scientist, which may restrict the transfer of know-how that we develop.

We are currently participating in the consortium “Rimonim,” which is supported by the Office of the Chief Scientist at the Ministry of Economy of the State of Israel, or the OCS. The aim of this consortium is to develop technologies for the use of siRNA and microRNA mimetics for therapeutics. The consortium includes three companies and three academic groups. In addition, we are participating in a joint research program with Tel Aviv University that is jointly funded by the OCS, the aim of which is to develop a delivery system for microRNA mimetics for the treatment of cancer. The transfer of know-how developed in the framework of these programs or rights to manufacture based on and/or incorporating such know-how to third parties which are not members of the programs requires the consent of the OCS.

In the past two years, we participated in the Magneton Project. This two-year project was also supported by the OCS and was conducted in collaboration with Prof. Ronit Satchi-Fainaro (Department of Physiology and Pharmacology, Sackler School of Medicine, Tel Aviv University). It was aimed at developing a nano-carrier delivery system for microRNA mimetics for the treatment of cancer. In December 2015, we completed this project. Project activity included in vivo studies, pre-clinical toxicity studies and in vivo efficacy studies in an animal model of glioblastoma. The results have shown limited efficacy. The transfer of knowledge discovered in this project is subject to limitations specified in the Israeli R&D law.

The OCS, under special circumstances, may approve the transfer of the know-how developed in these supported projects outside of Israel, provided that the grant recipient pays to the OCS a portion of the sale price paid in consideration for such know-how, which portion will not exceed six times the amount of the grants received plus interest (or three times the amount of the grant received plus interest, in the event that the recipient of the know-how has committed to retain the R&D activities of the grant recipient in Israel after the transfer).

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, if the target company's shares are divided into classes, the approval of a majority of each class of shares 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 may be 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.

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 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, under NASDAQ’s rules, each of (1) the private placement completed in December 2010, (2) the concurrent private placement and registered direct offering completed in February 2011, (3) the private placement completed in October 2011, (4) the Debenture transaction completed in January 2012, (5) the registered direct offering completed in April 2012, (6) the registered direct offerings completed in May 2012 and (7) the private placement completed in October 2015, would have required shareholder approval because these offerings represented the issuance (or potential issuance) of more than 20% of our outstanding ordinary shares at a price per share below the greater of book value per share or market value per share. However, we chose to follow our home country practice, which did not require shareholder approval of these offerings. 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. See also “Item 16G Corporate Governance.”

Risks Related to our Ordinary Shares

Our stock price has been and is likely to continue to be volatile and the market price of our ordinary shares may drop.

Prior to our February 2007 initial public offering, there was not a public market for our ordinary shares. Since our ordinary shares began trading on NASDAQ on February 27, 2007 through March 22, 2016, our stock price has fluctuated from a low of $0.71 to a high of $619.77 (after giving effect to the reverse stock splits effected in July 2011 and May 2012). Furthermore, the stock market has recently experienced significant volatility, particularly with respect to pharmaceutical, biotechnology, and other life sciences company stocks. The volatility of pharmaceutical, biotechnology, and other life sciences company stocks often does not relate to the operating performance of the companies represented by the stock. Some of the factors that may cause the market price of our ordinary shares to fluctuate include:

failure of any of our diagnostic tests to achieve commercial success;

failure to successfully maintain and grow the acquired business and operations of PersonalizeDx;

introduction of technological innovations or new commercial products by us or our competitors;

our entry into new, or termination or other developments relating to our existing, collaboration, distribution and licensing agreements;

developments relating to our efforts to commercialize our tests in the United States;

regulatory developments in the United States and foreign countries;

developments or disputes concerning patents or other proprietary rights;

failure to secure adequate capital to fund our operations, or the issuance of equity securities at prices below fair market price;

changes in estimates or recommendations by securities analysts, if any cover our securities;

litigation;

future sales of our ordinary shares;

general market conditions;

changes in the structure of healthcare payment systems;

economic and other external factors or other disasters or crises;

period-to-period fluctuations in our financial results; and

overall fluctuations in U.S. equity markets.

These and other external factors may cause the market price and demand for our ordinary shares to fluctuate substantially, which may limit or prevent investors from readily selling their shares and may otherwise negatively affect the liquidity of our ordinary shares. In addition, in the past, when the market price of a stock has been volatile, holders of that stock have instituted securities class action litigation against the company that issued the stock. If any of our stockholders brought a lawsuit against us, we could incur substantial costs defending the lawsuit. Such a lawsuit could also divert the time and attention of our management.

We do not intend to pay any cash dividends in the foreseeable future and, therefore, any return on an investment in our ordinary shares must come from increases in the fair market value and trading price of our ordinary shares.

ITEM 4.

INFORMATION ON THE COMPANY

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, or the Companies Law. 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 3711 Market Street, Suite 740, Philadelphia, Pennsylvania 19104, and its telephone number is (215) 382-9000. Rosetta Genomics Inc. serves as our agent for service of process in the United States. In April 2015, we acquired CynoGen Inc. (d/b/a PersonalizeDx), a Delaware corporation with principal offices located at 25901 Commercentre Drive, Lake Forest, CA 92630. Our web site address is www.rosettagx.com . The information on our web site is not incorporated by reference into this prospectus and should not be considered to be a part of this annual report.

Principal Capital Expenditures

We had net capital expenditures and repayment of capital lease of $273,000 in 2015, $247,000 in 2014, and $626,000 in 2013. Our capital expenditures during 2015, 2014, and 2013 consisted primarily of laboratory equipment, computer equipment and leasehold improvements. We have financed our capital expenditures with cash generated from financing activities.

BUSINESS OVERVIEW

Overview

We are seeking to develop and commercialize new diagnostic tests based on various genomics markers, including DNA, microRNA and protein biomarkers and using various technologies, including, qPCR, microarrays, Next Generation Sequencing (NGS) and Fluorescence In Situ Hybridization (FISH). We have two CLIA-certified, CAP-accredited, laboratories in Philadelphia, PA, and Lake Forest, CA which enable us to commercialize our own diagnostic tests applying our microRNA technology.

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 and other diseases. We are currently marketing and selling the following four diagnostic tests based on our proprietary microRNA technologies:

RosettaGX Cancer Origin ^™ (formerly “miRview ^® mets ² ”) – This test is our second-generation microRNA-based diagnostic for the identification of the primary site of metastatic cancer, specifically metastatic cancer of unknown or uncertain primary (CUP). RosettaGX Cancer Origin ^™ has replaced miRview ^® mets as our primary CUP assay.

mi-LUNG ^™ (formerly “Rosetta Lung Cancer Test”) – This test is a microRNA-based lung cancer classification test for cytology samples, mainly fine-needle aspirate, or FNA, samples as well as pathology samples, such as small biopsies and resections. This test classifies primary lung cancers into Neuroendocrine vs. non-small cell lung cancer , or NSCLC, and then further classifies NSCLC into squamous vs. non-squamous and Neuroendocrine into small cell lung cancer, or SCLC, vs. carcinoid.

mi-KIDNEY ^™ (formerly “Rosetta Kidney Cancer Test”) – This test is a microRNA-based kidney tumor classification test for pathology samples. This test was designed to classify primary kidney tumors into one of the four most common types: the malignant renal cell carcinomas clear cell (conventional), papillary and chromophobe as well as the benign oncocytoma.

RosettaGX Reveal ™– This is a microRNA-based assay for the diagnosis of indeterminate thyroid fine-needle aspirate, or FNA, samples. The test utilizes routinely prepared FNA smears to diagnose a cytologically indeterminate thyroid nodule as “benign” or “suspicious for malignancy by microRNA”. The test also measures a microRNA biomarker for medullary carcinoma.

We currently have distribution agreements with respect to some of these tests covering Australia, Canada, Greece, India, Israel, New Zealand, Qatar, Romania, Saudi Arabia, Singapore, Turkey and the United Arab Emirates. All of these distribution agreements call for samples to be sent to our CLIA-certified laboratory in Philadelphia for analysis.

In general, we are generating demand for our testing services, primarily RosettaGX Cancer Origin and RosettaGX Reveal through our direct selling effort in the United States and are successfully fulfilling that demand in our lab in Philadelphia, Pennsylvania. We are working with our Vice President of Reimbursement and Managed Care to gain more consistent payment from commercial payors, as well as to secure reimbursement coverage from Medicare. We are increasing our activity to establish policy-level reimbursement, which could improve our ability to receive prompt payment from commercial payors. We announced in May 2012 that the designated Medicare Administrative Contractor, or MAC, for RosettaGX Cancer Origin is covering this test for all Medicare beneficiaries, and we are receiving approved payments for claims submitted.

On April 13, 2015, we acquired CynoGen, Inc., which does business as PersonalizeDx (“CynoGen” or “PersonalizeDx”). PersonalizeDx is a molecular diagnostics and services company serving community-based pathologists, urologists, oncologists and other reference laboratories across the United States. PersonalizeDx is focused on the detection of genomic changes through FISH technology, which helps to detect cancer, measure the potential aggressiveness of the disease and identify patients most likely to respond to targeted therapies.

PersonalizeDx offers its clients a virtual ‘tech only’ platform in which such clients can collaborate with the company to perform and bill for the ‘professional component’ of FISH molecular testing services for lung, breast, bladder, prostate and hematologic cancers. PersonalizeDx also performs PCR, IHC and histology testing services for its clients in its 30,000 square foot laboratory facility located in Lake Forest, CA. PersonalizeDx was initially founded by Abbott Laboratories and PersonalizeDx performed several clinical trial studies for Abbott and Abbott’s research partners. PersonalizeDx is currently performing testing for one clinical trial for Abbott in bladder cancer. There is no guarantee that PersonalizeDx will be granted additional clinical trial business from Abbott moving forward.

We have entered into an agreement to sell and market products for Admera Health, offering products to oncology physicians that are key call points for our sales force. By entering into this agreement, we believe we could gain additional opportunities to meet with oncologists and discuss new products that may improve the patients’ diagnostic experience.

In addition, we have a number of projects in our diagnostics pipelines including the research and development of product line extensions to, and next generation versions of, our thyroid assay. In addition, we are in the discovery stage for one diagnostic assay.

Bladder cancer risk stratification - We are seeking to discover tissue-based microRNA biomarkers for the purpose of developing a new assay for the risk stratification of patients with non-muscle-invasive bladder cancer. We have so far completed and published two studies that demonstrate the role of microRNAs for risk stratification of bladder cancer (Rosenberg et al., 2013 and Segersten et al., 2013). We plan to initiate an additional study this year and expect to launch this new assay in the first quarter of 2018.

MicroRNAs also represent potential targets for the development of novel drugs. We are participating in the Rimonim Consortium, which is supported by the Office of the Chief Scientist at the Ministry of Economy of the State of Israel, or the OCS. The aim of this consortium is to develop novel technologies for the use of short interfering RNA, or siRNA, and microRNA mimetics or anti-microRNAs for therapeutics. In this consortium we are attempting to: (1) develop novel RNA molecules that contain chemical modifications or conjugations for therapeutic purposes; and (2) develop novel delivery systems for microRNAs that will enable targeted delivery to desired cells. In 2015, the consortium included three companies and three academic groups. The transfer of know-how developed in the framework of the consortium or rights to manufacture based on and/or incorporating such know-how to third parties which are not members of the consortium requires the consent of the OCS.

As of December 31, 2015, we had received from the OCS total grants of $827,227 for our development under the Rimonim Consortium and $167,230 for our development under the Magneton Project.

The Encouragement of Industrial Research and Development Law, 5744-1984 (R&D law) was amended effective as of January 1, 2016. Pursuant to the amendment, a new National Authority for Technological Innovation will be established and replace the OCS. Pursuant to the amendment, the current restrictions under the R&D Law will be replaced by new arrangements to be determined by the National Authority for Technological Innovation, however, until the National Authority for Technological Innovation is established and the new arrangements are determined, the existing arrangements of the R&D Law shall remain effective. According to the amendment to the R&D Law, the National Authority for Technological Innovation should be established by July 28, 2018, and the new arrangements should be determined no later than one year thereafter.

Background

Rosetta Genomics was founded in 2000 with the belief that what was known as “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 thus have significant potential as a 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 Genetic , 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, some of which have been issued.

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 a number of diagnostic tests based on our platforms and have published several papers demonstrating how our methods can be used to develop such diagnostics (e.g. Rosenwald et al., Modern Pathology , 2010; Benjamin et al., Journal of Molecular Diagnostics , 2010). Moreover, we were able to demonstrate the utility of our developed tests in post-market studies with collaborators from leading medical centers in the United States and Europe (Bishop et al. Clinical Cancer Research , 2010; Muller et al., The Oncologist , 2010).

We believe that microRNAs are stable, sensitive and specific markers, and we are advancing diagnostic development programs in cancer and other areas, 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 and other genomics-based, diagnostic tests. Our key business strategies to achieve this goal are as follows:

Leverage our knowledge and experience . We plan to leverage our extensive microRNA and Fluorescence in situ Hybridization, or FISH, know-how and experience to potentially develop additional tissue-based as well as body fluid-based diagnostic tests.

Maximize sales of our current commercial tests through geographic partners and our own commercial efforts . We plan to maximize revenues from our current commercial tests via corporate relationships and through our own targeted commercial efforts. To date we have entered into distribution agreements with five distributors, pursuant to which these distributors have the right to commercialize these tests in their territories. Furthermore, during 2015 we expanded our sales force from ten to 12 territory managers and from one to two Regional Managers.

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, co-exclusively, or non-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. We have also filed, and intend to continue to file, patent applications that claim our technical platforms and method-of-use for specific diagnostic and therapeutic 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.

Selectively pursue opportunities to expand our business and enhance our product offerings. We plan to selectively pursue opportunities to acquire, license, or invest in complementary businesses, products, technologies and assets teams that will allow us to expand our portfolio of diagnostic tests and therapeutics, accelerate the pace of our innovation, and expand into additional markets beyond what we can achieve organically.

Our MicroRNA-Based 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; or

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. We believe microRNA-based tests have the potential to be 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 level 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. 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 the development and clinical validation of diagnostic products, evaluation of clinical samples is critical. Accordingly, we have entered into collaborations with several institutions in Israel, Europe and the United States that provide us high quality clinical samples. These relationships provide us the opportunity to study thousands of well-characterized samples relevant to different disease areas such as cancer, cardiovascular indications, women’s health, and neurodegenerative diseases. The sample collections include solid tumor samples and various body fluids such as blood, 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.

RNA extraction . We utilize both commercial and our proprietary technologies to extract microRNAs 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 MicroRNA-Based Commercial Tests

We are currently marketing and selling the following diagnostic tests based on our proprietary microRNA technologies:

RosettaGX Cancer Origin ^™ (formerly “miRview ^® mets ² ”) – This test is our second-generation microRNA-based diagnostic for the identification of the primary site of metastatic cancer, specifically metastatic cancer of unknown primary (CUP). CUP is a heterogeneous group of cancers that constitutes approximately 3-5% of all cancers with a poor median survival of six to ten months. It is estimated that over 50,000 patients in the United States are diagnosed with CUP each year. A patient is typically diagnosed with CUP only after undergoing a wide range of tests, including various imaging tests such as x-ray, CT, MRI, and PET, which have failed to identify the origin of the cancer. Presently, the choice of treatment for metastatic cancer is largely dependent on the nature of the primary tumor. Patients with CUP pose a therapeutic dilemma and treatment is often empiric with a “one treatment fits all” approach. In the era of rapidly growing effective cytotoxic and targeted therapies for known cancers, quicker and more accurate methods to identify the tissue of origin of CUP cancers would permit the use of these therapies, thereby improving the chances of achieving a response and possibly extending the patient’s survival. RosettaGX Cancer Origin ^™ is able to identify 49 tumor types that include carcinomas, soft tissue tumors, lymphoma and other malignancies with very high accuracy.

RosettaGX Reveal – This is a microRNA-based assay for the diagnosis of indeterminate thyroid fine-needle aspirate, or FNA, samples. The test utilizes routinely prepared FNA smears to diagnose a cytologically indeterminate thyroid nodule as “benign” or “suspicious for malignancy by microRNA”. The test also measures a microRNA biomarker for medullary carcinoma. The test targets patients with a cytologically indeterminate FNA biopsy result estimated to be up to 200,000 people annually in the United States alone. FNA biopsy is the most widely used method for diagnosis of thyroid nodules. FNA biopsy allows a definitive benign or malignant diagnosis of the majority of tumors, however, 10-40% of FNAs are classified as cytologically indeterminate. Most patients with cytologically indeterminate nodules are referred for partial or complete thyroidectomy, though up to 70% of these nodules prove to be benign on final surgical pathology.

mi-LUNG (formerly “Rosetta Lung Cancer Test”) - This test is a microRNA-based lung cancer classification test for cytology samples, mainly fine-needle aspirate, or FNA, samples as well as pathology samples, such as small biopsies and resections. The test targets all newly diagnosed lung cancer patients, estimated to be more than 220,000 people annually in the United States alone. The test classifies primary lung cancers into Neuroendocrine vs. NSCLC and then further classifies NSCLC into squamous vs. non-squamous and Neuroendocrine into Small Cell Lung Cancer (SCLC) vs. carcinoid. The microRNA-based assay that we have developed is performed by measuring microRNA biomarkers in a sample from the tumor, where the sample can be either a cytology sample or a pathology sample. The assay measures the expression of 8 microRNAs and using that expression accurately identifies the lung cancer subtype.

Lung cancer is the leading cause of cancer-related death in both men and women worldwide and in the United States. It is estimated that in the United States alone, there will be were 221,200 new cases of lung cancer diagnosed in 2015 and that approximately 158,040 people will die of the disease this year.

For patients with lung carcinoma, the accurate determination of tumor type significantly influences treatment decision. In general, SCLC, the main sub-type of Neuroendocrine tumors, is much more responsive to chemotherapy and consequently this comprises the mainstay of treatment. This is in contrast to NSCLC, which is relatively chemoresistant and thus primarily treated with surgical resection for local disease. In addition, the recent emergence of novel biological therapies that effectively target specific cellular alterations now demands the most precise classification possible for non-small cell carcinomas. For example, lung adenocarcinomas are more likely to respond to EGFR tyrosine kinase inhibitors (e.g. erlotinib). Similarly, antibody therapy (bevacizumab) directed against vascular endothelial growth factor (VEGF) is more effective in the treatment of adenocarcinomas. Not only is bevacizumab less effective in treating squamous cell lung cancers, but the squamous phenotype is also associated with much higher rates of life-threatening pulmonary hemorrhage. Thus, the distinction of squamous from non-squamous carcinomas is becoming increasingly important. 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.

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mi-KIDNEY (formerly “Rosetta Kidney Cancer Test”) - In May 2012 we launched this microRNA-based kidney tumor classification test for pathology samples. This test targets newly diagnosed kidney tumor patients, estimated to be 61,560 people in the United States in 2015. Renal cancers account for more than 3% of adult malignancies and cause more than 14,000 deaths per year in the United States. The test was designed to classify primary kidney tumors into one of the four most common types: the malignant renal cell carcinomas clear cell (conventional), papillary and chromophobe as well as the benign oncocytoma. These histological subtypes vary in their clinical course and their prognosis, and different clinical strategies have been developed for their management. In some of the kidney tumor cases it is difficult for the pathologist to distinguish between tumor types on the basis of morphology. The microRNA-based assay that we have developed is performed by measuring microRNA biomarkers in a sample from the tumor. The assay uses the expression of 24 microRNAs to accurately identify the kidney tumor subtype.

We currently have agreements for distribution of certain of our microRNA-based diagnostic tests in Australia, Greece, Israel, New Zealand, Qatar, Romania, Saudi Arabia, Singapore, Turkey and the United Arab Emirates. All of these distribution agreements call for samples to be sent to our CLIA-certified, CAP-accredited, laboratory in Philadelphia, Pennsylvania for analysis.

Our Long-Term MicroRNA-Based Diagnostic Test Pipeline

We are currently working on the development of the following diagnostic tests, based on microRNAs

RosettaGX Reveal V2 - We are seeking to develop a second version of RosettaGX Reveal, a microRNA-based assay for the differential diagnosis of indeterminate thyroid FNAs that utilizes routinely prepared FNA smears. This second version will combine RosettaGx Reveal’s current microRNA biomarkers with a panel of DNA-based biomarkers providing prognostic information (e.g. BRAF and TERT mutations). Four to seven percent of the general population develops nodules in the thyroid that can be felt on examination though fewer than 10% are malignant. An FNA to obtain tissue for analysis is the standard technique for detecting cancer. Interpretation of FNA samples is not always straightforward, leading to an indeterminate result in up to 30% of the samples. Currently, many patients with indeterminate results are sent to surgery as a precaution, though the majority are benign, exposing patients to unnecessary surgical risk and costing the system hundreds of millions of dollars. In patients with a malignant nodule, the presence of certain mutations in the BRAF and TERT genes could offer prognostic information and influence the course of treatment. We anticipating launching this assay by the end of 2016.

Bladder cancer risk stratification- We are seeking to discover tissue-based microRNA biomarkers for the purpose of developing a new assay for the risk stratification of patients with non-muscle-invasive bladder cancer. An estimated 74,000 new cases of bladder cancer are expected to occur in 2015 in the United States. At diagnosis, 70-80% of bladder tumors are non-muscle invasive, of which 50-80% will have one or several recurrences and 15-25% will progress to invasive tumors. Recurrence and progression prediction is currently based on clinical and pathological factors including tumor grade and stage and presence of concomitant carcinoma in situ (CIS). Since follow-up and treatment regimens depend on prognosis, there is a need for accurate stratification of these patients. The assay we are seeking to develop has the potential to influence clinical management in a cost effective manner, by refining risk stratification and guiding therapy. We have so far completed and published two studies that demonstrate the role of microRNAs for risk stratification of bladder cancer (Rosenberg et al., 2013 and Segersten et al., 2013). We plan to initiate an additional study this year and expect to launch this new assay by the first quarter of 2018.

In addition, in December 2015, we announced the successful completion of feasibility studies under our collaboration with Biocept, Inc. to evaluate the use of Biocept's patented microfluidic channel technology to extract circulating tumor cells, or CTCs, from blood and our technical expertise and proprietary qRT-PCR platform to characterize microRNAs isolated from those CTCs. In the next phase of the collaboration, we and Biocept will test for markers currently offered by us, as well as pursue new markers. This joint proof-of-concept study will initially seek to determine whether lung cancer CTCs provide microRNA signatures similar to those from tissue biopsy as previously demonstrated by us and in clinical use today. Biocept’s technology may allow for the study of tumor cells from a simple blood draw starting with the point-of-diagnosis and continuing throughout treatment. This has potential to provide valuable insights when a patient's disease progresses while on therapy due to emerging resistance, thus allowing the clinician to plot the optimal next course of treatment. MicroRNA analysis can provide unique insight into the biomarker profiles of these cells. We believe that combining current and new microRNA profiles through the use of CTC capture has the potential to expand the role and utility of microRNA signatures in various solid tumor diseases.

Our PersonalizeDx Business

PersonalizeDx is a CAP-accredited, CLIA-certified commercial laboratory that performs testing services on three primary platforms: FISH, PCR and IHC. FISH and PCR are considered molecular tests that query specific chromosomes regions and genes in order to provide diagnostic, prognostic and predictive information to clients in order to assist with patient treatment decisions. The majority of the company’s test volume and revenues are derived from the following tests in bladder, prostate and lung cancers:

UroVysion ® - UroVysion is a urine-based FISH assay intended for use in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer. UroVysion was the first test launched by CynoGen/PersonalizeDx in 2009 and remains a top volume and revenue producer for the company. UroVysion is currently a covered service by Medicare and the majority of private third party payers for the FDA approved clinical indications. PersonalizeDx provides a ‘tech only’ service option for UroVysion that allows Pathologists throughout the United States to partner with the lab through its ‘virtual’ portal.

ERG/PTEN - ERG and PTEN are FISH-based prognostic tests in prostate cancer that help urologists with the important decision point of whether or not to initiate surgery with their lower risk prostate cancer patients. ERG and PTEN have both been proven to be key biomarkers in the progression of prostate cancer, and abnormal results specific to these genes may indicate the need for more aggressive treatment. ERG and PTEN testing is performed on the same tumor tissue that is taken from the patient’s initial core needle biopsy procedure. PersonalizeDx also offers a ‘tech only, virtual’ service for ERG and PTEN testing.

ALK/ROS1 - ALK and ROS1 are FISH-based predictive tests indicated for patients that are diagnosed with late stage lung cancer. Patients that test positive for either ALK or ROS1 rearrangements are considered candidates for ALK-inhibitor therapy such as XALKORI® (crizotinib). Both ALK and ROS1 are listed in the FDA label for such therapy, and these tests have been recommended for routine testing by the National Comprehensive Cancer Institute’s (NCCN) guidelines. Again, PersonalizeDx offers its ‘tech only’ platform for ALK/ROS1 testing to its clients.

PCR Gene Mutation Analysis - PersonalizeDx has launched several PCR-based tests for bladder, lung, colon and melanoma patients since 2014. FGFR3, EGFR, KRAS, BRAF and NRAS are additional assays that support the core test offerings in urological disease and solid tumor analysis, and allow for an expanded breadth of testing services which may attract new customers that demand a more complete offering.

Therapeutic Products

MicroRNAs are important regulators of protein expression, and as such, they represent potential targets for the development of drugs. Expression studies indicate significant changes in microRNA expression in different disease states in comparison to normal tissue. Inhibition or replacement of one microRNA can extensively effect a cell internally and significantly alter the cellular phenotype since it can change a number of genes that are direct targets of the microRNA, as well as genes influenced by those direct targets, therefore influencing whole pathways. Accordingly, microRNA inhibition or replacement has the potential to be a key factor in the treatment of various disease conditions. MicroRNA replacement will strive to mimic the natural effect of a down-regulated microRNA in a specific indication. This will result in silencing the natural targets to reverse the phenotypic changes the cell experienced after the de-regulation of this specific microRNA.

Because microRNAs are natural regulators of protein expression, 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 a 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.

We have demonstrated this in liver cancer, ovarian cancer and pancreatic cancer, where differential microRNAs that were shown in tissues of patients were used to find drug candidates that could inhibit those cancers through either microRNA inhibition or mimetics. In ovarian cancer we selected microRNAs that were over-expressed in ovarian tissues (both tumor and normal) comparing to other normal tissues, and in liver and pancreatic cancer we chose microRNAs that are over expressed in the cancerous tissue comparing to adjacent healthy tissue. Those microRNAs served to help us design modified oligonucleotides with anti-sense sequences that were used in vitro in proliferation assays. We specifically wanted to see microRNA inhibition that can lead to reduction in proliferation of cancer cell lines. The anti-microRNAs with the strongest effect over cell proliferation were selected as the drug candidates with most potential.

Our therapeutic pipeline consists of the following projects:

Rimonim Consortium - In January 2011, we joined the Rimonim Consortium, which is supported by the Office of the Chief Scientist at the Ministry of Economy of the State of Israel, or the OCS. The aim of the consortium is to develop novel technologies for the use of short interfering RNA, or siRNA, and microRNA mimetics or anti-microRNAs for therapeutics. As a member of the consortium, we are entitled to certain grants to support our research and development activities. Under the terms applicable to members of the consortium, so long as we continue to meet the criteria for receiving these grants, which criteria include the payment by us of part of the expenses for the activities funded by the grants and the timely delivery to OCS of written reports regarding those activities, then we are not required to repay the grants. If we cease to meet these and other criteria, then the grant amounts for the year in which we ceased to meet the criteria become immediately due and payable to OCS. As of December 31, 2015, we had received total grants of $827,227 from the OCS for our development within the consortium and continued to meet the criteria to receive grants such that we are not obligated to repay those funds. The vision of the consortium is to develop new advanced technologies that are expected to help in solving some of the key problems and deficiencies that the industry is facing in developing RNAi-based therapeutics and create a significant RNAi-based industry in Israel by using breakthrough technologies and producing RNAi therapeutics and a range of additional products (diagnostics, chemical and biological services). Since discovery, the development of RNAi as first, a powerful research tool and, more recently, as a promising therapeutic approach, has occurred very rapidly. The ability to specifically silence virtually every gene including previously non-druggable (non-amenable for development of small molecule inhibitors) targets has made RNAi-based therapeutics a very attractive approach for treating diseases in many therapeutic areas.

The main challenges in the development of siRNA/microRNA therapeutics addressed by the consortium are:

1. siRNA/microRNA drug substance: Only a very limited number of non-toxic chemical modifications to the basic structures that are suitable to make the drug active and with the desirable properties are available.

2. siRNA/microRNA drug delivery to target tissues/cells: This is the major problem in the field. Practically all RNAi drugs in development are currently delivered only locally, and even the local delivery is not optimized. Efficient and productive systemic siRNA delivery has been demonstrated only to the kidney (non-formulated) and to the liver (formulated), whereas systemic delivery is needed for many serious diseases. In addition, most formulations currently available are highly toxic, thus allowing only very narrow therapeutic windows.

In 2015, the consortium included three companies and three academic groups. Members of the consortium are established representatives of the industry and academia in Israel that will share their expertise and experience in various fields of the technological challenges: biology, toxicology, physical and structural chemistry, formulation, and others, to establish a meaningful scientific/technological basis for what has the potential to be one of the most promising technical breakthroughs in biological research in the last decade.

The transfer of know-how developed in the framework of the consortium or rights to manufacture based on and/or incorporating such know-how to third parties which are not members of the consortium requires the consent of the OCS.

Magneton Project – In the past two years, we participated in the Magneton Project. This two-year project was also supported by the OCS and is conducted in collaboration with Prof. Ronit Satchi-Fainaro (Department of Physiology and Pharmacology, Sackler School of Medicine, Tel Aviv University). It was aimed at developing a nano-carrier delivery system for microRNA mimetics for the treatment of cancer. In December 2015, we completed this project. As of December 31, 2015, we had received $167,230 for our development under the Magneton Project. Project activity included in vivo studies, pre-clinical toxicity studies and in vivo efficacy studies in an animal model of glioblastoma. The results have shown limited efficacy. The transfer of knowledge discovered in this project is subject to limitations specified in the Israeli R&D law.

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;

navigate the changing legal patent landscape;

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. 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 March 1, 2016, our patent portfolio included a total of 44 issued U.S. patents, two issued Australian patents, two issued European patents, both validated in UK, Germany and France, two issued Israeli patents, one issued Japanese patent, 42 pending patent applications worldwide, consisting of 22 U.S. patent applications, two of which received notice of allowance, six applications that are pending in Europe, one of which received a notice of allowance, three applications pending in Israel, one application pending in Japan, two applications pending in Canada, three applications pending in China, two applications pending in Brazil, one application pending in Korea, and two PCT applications. Of these patent applications, 37 relate to human microRNAs and their uses, three claim viral microRNAs and their uses, and two contain claims related to our discovery process. Twenty-four applications contain claims directed to microRNA-based diagnostics in Heart Failure, Alzheimer’s disease, Cancer of Unknown Origin (CUP), thyroid, lung, mesothelioma and other cancers; and 9 contain claims directed to microRNA-based therapeutics. The issued patents expire between 2022 and 2031. To date, patent protection related to numerous human genes has been obtained in the United States and elsewhere. Although recent rulings from the U.S. Supreme Court, as well as guidelines recently issued by the USPTO expanding these, have caused uncertainty relating to the patentability of naturally occurring nucleic acid sequences, our patents and pending applications include claims to non-naturally occurring derivatives of microRNAs, which we believe are patentable under U.S. and foreign patent laws. For additional information, see “Item 3. Key Information—D. Risk Factors— 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.” for a description of recent U.S. case law that could affect the patentability of genes and genetic material.

In order to obtain maximum patent protection for composition of matter of microRNAs in the U.S. and foreign jurisdictions, our patent applications:

provide for utility, function and disease targets for each microRNA sequence; and

claim specific microRNA sequences, having modified nucleotides.

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 Patent applications on Biologically Validated MicroRNAs

We have filed a first 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, the 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. Our patent portfolio includes 32 issued patents and seven patent applications with composition-of-matter claims.

Second Tier: Technologies to detect MicroRNAs

We have filed a second tier of patent applications claiming patent coverage for our proprietary discovery process technologies for microRNA detection, including qRT-PCR methods, microarray, in-situ hybridization and extraction methods from all body fluids. Our patent portfolio includes one issued patent and two patent applications related to discovery process technologies.

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. This tier of patent applications includes applications which we have filed ourselves and those that we have filed jointly with academic, medical and commercial partners with whom we collaborate. Our patent portfolio includes 33 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.

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 $960,000 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.

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 $690,000 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 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 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.

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, 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 $440,000 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. This agreement was amended and restated in March 2009. 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 into sublicense agreements, only in the event that the granted sublicense includes a license to intellectual property rights owned or co-owned by us as well, is reasonably necessary for sublicensee in order to further develop and/or commercialize or manufacture products and permits no more than one tier of sublicensing.

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 $424,462 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 have 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.

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 $261,208 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. This agreement was amended and restated in August 2011. Under the restated agreement, we have licensed from Johns Hopkins the rights to its proprietary microRNAs for all fields and applications on a non-exclusive basis. The agreement covers approximately 130 biologically validated microRNAs. We also have the right to further sublicense these rights, provided that such sublicense includes a license to substantial intellectual property rights owned or co-owned by us and is consistent with the terms of our license agreement. In consideration for the restated license we paid an amendment 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.

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.

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 $320,000 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-day notice.

Master Research Collaboration Agreement with H. Lee Moffitt Cancer Center and Research Institute

In August 2014, we signed a 3 year Master Research Collaboration Agreement with H. Lee Moffitt Cancer Center and Research Institute, Inc. (“Moffitt”). Under the Agreement we will collaborate with Moffitt to discover and develop a variety of microRNA-based cancer diagnostics, which we could then have the right to commercialize. We will be providing funding for certain pilot studies, as agreed with Moffitt, and Moffitt has granted Rosetta an option to negotiate for a royalty-bearing, sublicensable, exclusive, worldwide license in Moffitt’s pilot study inventions, Moffitt’s interest in any pilot study inventions jointly owned with us, and any other intellectual property rights owned by or licensed to Moffitt (with a right of sublicense) that are necessary or useful for the exploitation of Moffitt’s pilot study inventions or Moffitt’s interest in jointly-owned pilot study inventions (to the extent reasonably available), for territories as we may request. Moffitt further granted us and our affiliates a perpetual, royalty-free, world-wide, non-exclusive license to use the results of each pilot study and to practice any pilot study invention owned by Moffitt for any and all purposes, which license shall be sublicensable only to our licensees or collaborators that are involved in researching or developing products licensed from us. We have granted Moffitt a royalty-free, non-sublicensable, worldwide, non-transferable, perpetual, non-exclusive license to use and practice any of our solely-owned pilot study inventions for Moffitt’s internal research, educational and/or non-commercial purposes. We also have the right to enter into one or more sponsored research agreements with Moffitt.

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. We face competition for our micro-RNA-based test and products from non-microRNA-based competing tests and products from companies such as Cancer Genetics, Inc., Biotheranostics, Inc., Foundation Medicine and Veracyte, Inc. that have developed or are developing diagnostic tests based on other non-microRNA technologies, and 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 Alnylam Pharmaceuticals, Inc., Asuragen Inc., HTG Molecular Diagnostics Inc., Interpace Diagnostics, Exiqon A/S, Life Technologies Corporation, Isis Pharmaceuticals, Mirna Therapeutics, Merck & Co., Inc., Santaris Pharma A/S, Regulus Therapeutics and others. We are also aware of several other companies that provide tests and services that are competitive with those provided by our recently acquired PersonalizeDx business, including Cancer Genetics, NeoGenomics, Miraca, Bostwick and Healthtronics

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, if required, for these tests and products;

the availability and cost of manufacturing, marketing and sales capabilities;

providing economic healthcare benefits, by either possibly directing better clinical treatment, or potentially reducing unnecessary surgical procedures;

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 and include waived tests, tests of moderate complexity, and tests of high complexity. Laboratories performing moderate or high-complexity testing must meet the CLIA 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 categories of testing they perform and to comply with standards covering, among other things, 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 other federal, state and local licenses, certifications and permits. A clinical laboratory may be licensed by the state in which it is located, but not all states require licensure. California and Pennsylvania require state licensure, and our laboratories located in those states each hold the appropriate state license. In addition, some states (California, Florida, Maryland, New York, Pennsylvania, and Rhode Island) require any clinical laboratory that analyzes samples taken from residents of or physicians located in that state to also be licensed by it. Many 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 be used to meet the CLIA requirements.

Food and Drug Administration

Laboratory Developed Tests

Although the FDA has consistently stated that it has the authority to regulate clinical laboratory tests as medical devices, it generally exercised enforcement discretion in not otherwise regulating most tests designed, manufactured and used within the high complexity CLIA-certified laboratory at which the test was performed. These tests are known as LDTs. After many years of promising that it would be providing guidance on the regulation of LDTs, the FDA provided notice to Congress on July 31, 2014, that it intended to issue a draft guidance document entitled, “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and an accompanying draft guidance document entitled, “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs).” The notice included the anticipated details of the draft guidance documents (“Draft Guidance”). In the Draft Guidance, the FDA describes its proposed regulatory framework as a phased-in risk-based approach to the regulation of LDTs in a manner that is consistent with the FDA’s current regulation of in vitro diagnostics, or IVDs. This means that new LDTs or currently available LDTs could be subject to requirements for premarket review of higher-risk LDTs that have the same intended uses as IVDs that were (i) cleared for marketing by the FDA under section 510(k) of the Food, Drug and Cosmetic Act, or (ii) approved for marketing after submission, review and FDA approval of a premarket approval application, or PMA.

For high-risk or Class III devices, the FDA has indicated that registration and listing requirements (with a notice option) and adverse event reporting will begin 6 months after the Draft Guidance is finalized with premarket review requirements (PMAs for Class III devices) beginning 12 months after the Draft Guidance is finalized for the highest risk devices. A 4-year phase-in will apply to the remaining high-risk devices. Devices that are already on the market would be allowed to remain on the market during FDA’s review and consideration of applications. The FDA’s initial focus will likely be on (i) LDTs that act like already cleared or approved companion diagnostics, (ii) LDTs with the same intended use as an FDA-approved Class III medical device, and (iii) certain LDTs for determining the safety or efficacy of blood or blood products.

For moderate-risk or Class II devices, FDA registration and listing requirements (with a notice option) and adverse event reporting will begin 6 months after the Draft Guidance is finalized. Premarket notice requirements (510(k)s for Class II devices) will begin after the high-risk LDTs are completed (or 5 years after the Draft Guidance is finalized) with a 4-year phase in.

There will be a 12-month phase-in period for LDTs on the market at the time that the Draft Guidance is finalized which may be extended if an appropriate premarket application is made during that period.

For some manufacturers of LDTs, notification to FDA that they are developing LDTs 6 months after the Draft Guidance becomes finalized may take the place of registration and listing, although they will still be required to begin reporting significant adverse events.

The FDA indicated that it will continue to exercise enforcement discretion for LDTs used solely for forensic purposes, certain LDTs for transplantation, low-risk LDTs, as well as LDTs intended for rare diseases and unmet needs where there is no FDA-cleared or approved alternative. However, the FDA may require compliance with certain non-review requirements such as registration, listing and adverse event reporting.

On October 3, 2014, the FDA published notices in the Federal Register formally announcing the release of the Draft Guidance and the beginning of a 120-day public comment period, and held a public workshop on the Draft Guidance on January 8 and 9, 2015, in order to obtain feedback from all stakeholders. The comment period ended February 2, 2015, and it is not clear when or whether the Draft Guidance will be finalized.

In Vitro Diagnostics

The type of regulation to which our tests and diagnostics may 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 are subject to review by the FDA as medical devices and must be cleared or approved before they can be marketed. Most tests that are offered as LDTs by a CLIA-certified laboratory have generally not been subject to regulation by the FDA, however, this will likely change after the FDA finalizes the Draft Guidance and announces the new requirements that will apply to LDTs.

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. Nearly all Class I devices are exempt from premarket review; most Class II devices require 510(k) clearance and all Class III devices must receive premarket approval before they can be sold in the United States. The payment of a fee is usually required when a 510(k) notice or premarket approval application is submitted.

510(k) Premarket Notification . A 510(k) notification requires the sponsor to demonstrate that a medical device is substantially equivalent to another marketed device, termed a “predicate device”, that is legally marketed in the United States and for which a PMA was not required. 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 is supposed to issue a decision letter within 90 days of receipt of the 510(k) if it has no additional questions or send a first action letter requesting additional information within 75 days. However, in 2012, the FDA issued a guidance document in which it indicated that it will conduct a preliminary review of a 510(k) based on an acceptance checklist within 15 business days of the submission of the 510(k). If the FDA determines that the 510(k) is not administratively complete, it will refuse to accept the application until a complete response is submitted in response to the refuse to accept, or RTA, notification. Most 510(k)s do not require clinical data for clearance, but a minority will. Requests for additional data, including clinical data, will increase the time necessary to review the notice. If the FDA believes that the device is not substantially equivalent to a predicate device, it will issue a “Not Substantially Equivalent” letter and designate the device as a Class III device, which will require the submission and approval of a PMA before the new device may be marketed. Under certain circumstances, the sponsor may petition the FDA to make a risk-based determination of the new device and reclassify the new device as a Class I or Class II device. The FDA continues to reevaluate the 510(k) review process, and we cannot predict what if any changes will occur.

Premarket Approval . The PMA process is more complex, costly and time consuming than the 510(k) process. A PMA must be supported by more detailed and comprehensive scientific evidence, including clinical data, to demonstrate the safety and efficacy of the medical device for its intended purpose. If the device is determined to present a “significant risk,” the sponsor may not begin a clinical trial until it submits an investigational device exemption, or IDE, to the FDA and obtains approval from the FDA to begin the trial.

After the PMA is submitted, the FDA has 45 days to make a threshold determination that the PMA is sufficiently complete to permit a substantive review. If the PMA is complete, the FDA will file the PMA. The FDA is subject to a performance goal review time for a PMA that is 180 days from the date of filing, although in practice this review time is longer. Questions from the FDA, requests for additional data and referrals to advisory committees may delay the process considerably. The total process may take several years and there is no guarantee that the PMA will ever be approved. Even if approved, the FDA may limit the indications for 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. Any changes to the medical device may require a supplemental PMA to be submitted and approved.

Any products sold by us pursuant to FDA clearances or approvals will be subject to pervasive and continuing regulation by the FDA, including record keeping requirements, reporting of adverse experiences with the use of the device and restrictions on the advertising and promotion of our products. Device manufacturers are required to register their establishments and list their devices with the FDA and are subject to periodic inspections by the FDA and certain state agencies. Noncompliance with applicable FDA requirements can result in, among other things, warning letters, fines, injunctions, civil penalties, recalls or seizures of products, total or partial suspension of production, refusal of the FDA to grant 510(k) clearance or PMA approval for devices, withdrawal of 510(k) clearances and/or PMA approvals and criminal prosecution.

European Regulations

In the European Union, IVD medical devices have been regulated under EU-Directive 98/79/EC, or the IVD Directive, and corresponding national provisions. The IVD Directive requires that medical devices meet the essential requirements set out in an annex of the directive. These requirements include the safety and efficacy of the devices. According to the IVD Directive, the Member States presume compliance with these essential requirements in respect of devices which are in conformity with the relevant national standards transposing the harmonized standards of which the reference numbers have been published in the Official Journal of the European Communities. These harmonized standards include ISO 13485:2003, the quality standard for medical device manufacturers. IVDs are not subject to pre-market authorization by a regulatory authority but to a conformity assessment which is often performed by the manufacturer. Certain specified high-risk devices and devices for self-testing require that the conformity assessment be performed by an independent third party known as a “notified body.” Notified bodies are designated and monitored by the Member States and act under the control of the national authorities. Once certified, devices bear the CE marking which allows them to circulate freely in the EU/EFTA countries and Turkey.

In 2012, the EU published a revision to the current Directive in the form of a proposed Regulation. Unlike a Directive, a Regulation minimizes the likelihood of divergent transposition by Member States by ensuring that the legal requirements are implemented in the same way and at the same time. The proposed Regulation will introduce a new risk-based classification system based on the Global Harmonization Task Force classification rules. Depending on the level of risk associated with an IVD, IVD manufacturers will be required to include a notified body in the conformity assessment process. In addition, clinical evidence will be required for some IVDs. The new regulatory process is expected to replace the current one and will be phased in over a 5-year period.

IVD medical devices, other than devices for performance evaluation, must bear the CE marking of conformity when they are placed on the market. The CE mark is a declaration by the manufacturer that the product meets all the appropriate provisions of the relevant legislation implementing the relevant European Directive. As a general rule, the manufacturer must follow the procedure of the EC Declaration of conformity to obtain this CE marking.

Each European country must adopt its own laws, regulations and administrative provisions necessary to comply with the IVD Directive. Member States may not create any obstacle to the placing on the market or the putting into service within their territory of devices bearing the CE marking according to the conformity assessment procedures. In September 2012, the European Commission adopted a proposal for a regulation which if adopted will change the way that most medical devices are regulated in the European Union, and may subject our products to additional requirements.

Therapeutics

In the United States, 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 preclinical testing stage. Preclinical tests include laboratory evaluations of product chemistry, toxicity and formulation, as well as animal studies. An IND sponsor must submit the results of the preclinical 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.

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, preclinical 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.

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.

Non-U.S. Regulations

In addition to regulations in the United States, we are 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.

HIPAA and Other Privacy and Security 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 safeguards to guard against the misuse of protected health information. Specifically, Title II of HIPAA, the administrative Simplification Act, contains four provisions that address the privacy of health data, the security of health data, the standardization of identifying numbers used in the healthcare system and the standardization of data content, codes and formats used in healthcare transactions. The privacy regulations protect identifiable health information or “protected health information” by limiting its use and release and giving patients the right to access and amend their protected health information. The HIPAA security standards require the adoption of administrative, physical and technical safeguards and the adoption of written security policies and procedures. Additionally, some state laws impose privacy protections more stringent than HIPAA and many impose security standards and breach notification requirements that apply in addition to 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 that must comply with HIPAA standards, such as obtaining proper authorization and consent from their patients for the subsequent use of those samples and associated clinical information. We are a Covered Entity to the extent that our U.S. operations involve standard transactions conducted electronically (such as billing) in connection with clinical testing. Accordingly, we have implemented privacy and security policies and procedures consistent with HIPAA standards and taken other steps to comply.

In 2009, Congress enacted Subtitle D of the Health Information Technology for Economic and Clinical Health Act, or HITECH, provisions of the American Recovery and Reinvestment Act of 2009. Final HITECH regulations were published in January, 2013. HITECH amends HIPAA and, among other things, creates significant new regulatory compliance obligations for “business associates” or organizations that provide services to Covered Entities involving the use or disclosure of protected health information and downstream entities providing services to business associates. Additionally, HITECH expands and strengthens HIPAA enforcement, imposes new penalties for noncompliance and establishes new breach notification requirements for Covered Entities and business associates. Under HITECH’s new breach notification requirements, Covered Entities must, as soon as possible but not later than 60 days following discovery, notify each individual whose information has been or is reasonably believed to have been, accessed, acquired or disclosed as a result of a breach. Covered Entities must also report breaches to the U.S. Department of Health and Human Services, or HHS, and in some cases, publish information about the breach in local or prominent media outlets. Consequently, it is important that breaches of PHI are promptly detected and reported within the company, so that we can make all required notifications. Most states have adopted data security laws protecting the personal data of state residents. Personal data subject to protection typically includes an individual’s name coupled with social security number, state-issued identification number, or financial account number. Most states require specific, technical security measures for the protection of all personal data, including employee data, and impose their own breach notification requirements in the event of a loss of personal data. Many states have also adopted genetic testing and privacy laws. These laws typically require a specific, written consent for genetic testing as well as consent for the disclosure of genetic test results, and otherwise limit uses and disclosures of genetic testing results. A few states have adopted laws that give their residents property rights in their genetic information. State privacy and data security laws generally overlap and apply simultaneously with HIPAA. In the event of a data breach affecting individuals from more than one state, we must comply with all relevant state notification requirements as well as HIPAA and are subject to enforcement by all relevant state and federal authorities as well as fines and penalties imposed by each state.

We are currently subject to the HIPAA regulations and maintain an active program designed to address regulatory compliance issues. Regulations and guidance in this area are evolving so we must regularly evaluate and update our regulatory compliance measures to remain in compliance with the law. We are subject to audit by federal authorities and subject to prosecution or administrative enforcement and increased civil and criminal penalties for non-compliance, including monetary penalties. We are also subject to enforcement by state attorneys general who were given authority to enforce HIPAA under HITECH and who also enforce state data security laws.

Our activities must also comply with other applicable privacy laws. For example, there are international privacy laws that impose restrictions on the access, use, and disclosure of health and other personal information. Non-U.S. privacy protection requirements, such as the European Union’s Data Protection Directive governing the processing of personal data, may be stricter than U.S. law and violations could result in claims for damages, fines, or orders to stop or change the processing of the personal data. The European Union’s final draft General Data Protection Regulation, which is likely to be formally adopted, imposes extensive new legal obligations and substantially increases the risk of fines, with upper limits based on a corporate group’s global turnover. Privacy and data security laws, including those relating to health information, are complex, overlapping and rapidly evolving. 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 or to conduct clinical testing could significantly impact our business and our future business plans.

Compliance with Fraud and Abuse Laws

We have to comply with various U.S. federal and state laws, rules and regulations pertaining to healthcare fraud and abuse, including anti-kickback and physician self-referral laws, rules and regulations. Violations of the fraud and abuse laws are punishable by criminal and civil sanctions, including, in some instances, exclusion from participation in federal and state healthcare programs, including Medicare and Medicaid.

Anti-Kickback Statute

The federal Anti-Kickback Statute prohibits persons from knowingly or willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce:

the referral of an individual for a service or product for which payment may be made by Medicare, Medicaid or other federal healthcare program; or

purchasing, ordering, arranging for, or recommending the ordering of, any service or product for which payment may be made by a federal healthcare program.

The definition of “remuneration” has been broadly interpreted to include anything of value, including such items as gifts, certain discounts, waiver of payments, and providing anything at less than its fair market value. In addition, several courts have interpreted the law to mean that if “one purpose” of an arrangement is intended to induce referrals, the statute is violated.

The Anti-Kickback Statute is broad and prohibits many arrangements and practices that are lawful in businesses outside of the healthcare industry. Recognizing that the Anti-Kickback Statute is broad and may technically prohibit many innocuous or beneficial arrangements, the Office of Inspector General for the Department of Health and Human Services, or OIG, has issued regulations, commonly known as “safe harbors.” These safe harbors set forth certain requirements that, if fully met, will assure healthcare providers, including clinical laboratories, that they will not be prosecuted under the Anti-Kickback Statute. Although full compliance with these safe harbor provisions ensures against prosecution under the Anti-Kickback Statute, full compliance is often difficult and the failure of a transaction or arrangement to fit within a specific safe harbor does not necessarily mean that the transaction or arrangement is illegal or that prosecution under the Anti-Kickback Statute will be pursued. However, conduct and business arrangements that do not fully satisfy each applicable safe harbor may result in increased scrutiny by government enforcement authorities such as the OIG.

The statutory penalties for violating the Anti-Kickback Statute include imprisonment for up to five years and criminal fines of up to $25,000 per violation. In addition, through application of other laws, conduct that violates the Anti-Kickback Statute can also give rise to False Claims Act lawsuits, civil monetary penalties and possible exclusion from Medicare and Medicaid and other federal healthcare programs.

Although the federal Anti-Kickback Statute applies only to federal health care programs, a number of states in which we operate have their own kickback laws. Often, these laws closely follow the language of the federal law, although they do not always have the same scope, exceptions, safe harbors or sanctions. In some states, these anti-kickback laws apply not only to payment made by a state or federal health care program but also by other payors, including commercial insurance companies.

Physician Self-Referral Laws

The federal ban on physician self-referrals, commonly known as the “Stark Law,” prohibits, subject to certain exceptions, a physician from referring of Medicare and Medicaid patients to an entity providing certain “designated health services” for which payment would otherwise be made by Medicare if the physician or an immediate family member of the physician has any financial relationship with the entity. The Stark Law also prohibits the entity receiving the referral from billing Medicare for any good or service furnished pursuant to an unlawful referral, and any person collecting any amounts in connection with an unlawful referral is obligated to refund such amounts. A person who engages in a scheme to circumvent the Stark Law’s referral prohibition may be fined up to $100,000 for each such arrangement or scheme. The penalties for violating the Stark Law also include civil monetary penalties of up to $15,000 per service and possible exclusion from federal healthcare programs. In addition, through application of other laws, conduct that violates the Stark Law can also give rise to False Claims Act lawsuits.

Many states have their own self-referral laws. Often, these laws closely follow the language of the federal law, although they do not always have the same scope, exceptions, safe harbors or sanctions. In some states these anti-referral laws apply not only to payment made by a federal health care program but also with respect to other payors, including commercial insurance companies. In addition, some state laws require physicians to disclose any financial interest they may have with a healthcare provider to their patients when referring patients to that provider even if the referral itself is not prohibited.

The False Claims Act and Other Fraud and Abuse Laws

The federal False Claims Act, or FCA, prohibits any person from knowingly presenting, or causing to be presented, a false claim or knowingly making, or causing to be made, a false statement to obtain payment from the federal government. Those found in violation of the FCA can be subject to fines and penalties of three times the damages sustained by the government, plus mandatory civil penalties of between $5,500 and $11,000 for each separate false claim. Actions filed under the FCA can be brought by any individual with the requisite level of knowledge on behalf of the government, a “qui tam” action, and such individual, known as a “relator” or, more commonly, as a “whistleblower,” may share in any amounts paid by the entity to the government in damages and penalties or by way of settlement. In addition, certain states have enacted laws modeled after the FCA, and this legislative activity is expected to increase. Qui tam actions have increased significantly in recent years, causing greater numbers of healthcare companies, including clinical laboratories, to defend false claim actions, pay damages and penalties or be excluded from Medicare, Medicaid or other federal or state healthcare programs as a result of investigations arising out of such actions.

The OIG also has authority to bring administrative actions to impose civil monetary penalties or exclusion from the Medicare, Medicaid and other federal health care programs. The federal Civil Monetary Penalties Law, or the CMP Law, prohibits, among other things (1) the offering or transfer of remuneration to a Medicare or state health care program beneficiary if the person knows or should know it is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of services reimbursable by Medicare or a state health care program, unless an exception applies; (2) employing or contracting with an individual or entity that the provider knows or should know is excluded from participation in a federal health care program; (3) billing for services requested by an unlicensed physician or an excluded provider; and (4) billing for medically unnecessary services. The penalties for violating the CMP Law include exclusion, substantial fines, and payment of up to three times the amount billed, depending on the nature of the offense.

Federal Prohibitions on Health Care Fraud and False Statements Related to Health Care Matters

The administrative simplification provisions of the Health Insurance Portability and Accountability Act, or HIPAA, created new federal crimes: health care fraud, false statements relating to health care matters, theft or embezzlement in connection with a health benefit program and obstruction of criminal investigation of health care offenses. The health care fraud statute prohibits knowingly and willfully executing a scheme to defraud any health care benefit program, including a private insurer. The false statements statute prohibits knowingly and willfully falsifying, concealing, or covering up a material fact or making any materially false, fictitious, or fraudulent statement in connection with the delivery of or payment for health care benefits, items, or services. The theft or embezzlement statute prohibits knowingly and willfully embezzling, stealing or otherwise converting or misapplying the money or property of a health care benefit program. The obstruction of criminal investigations of health care offenses statute prohibits willfully preventing, obstructing, misleading or delaying the communication of information and records relating to a violation of a federal health care offense to a criminal investigator. A violation of any of these laws is a felony and may result in fines, imprisonment, or exclusion from the federal health care programs.

Reimbursement

United States

Recent and future changes to policies and pricing from the MolDx molecular diagnostics program utilized by Noridian Healthcare Solutions, our Medicare Administrative Carrier, could have positive or negative effects on our Medicare billing. This relates primarily to our high complexity laboratory in Lake Forest, California which is under Noridian and MolDx jurisdiction. MolDx changes to FISH coding and reimbursement over the past 3 years is indicative of the MolDx impact. In 2013, MolDx revised FISH reimbursement in an attempt to reduce overutilization causing substantive losses for many laboratories. In 2016, MolDx revised pricing for FISH upward after implementing better utilization controls in the form of revised code and billing guidance.

In the United States, payments for diagnostic tests come from several sources, including third party payors such as insurance companies and health maintenance organizations; government health programs such as Medicare and Medicaid; patients; and, in certain circumstances, hospitals or referring laboratories (who then bill health third-party payors for testing).

Reimbursement of our tests by third-party payors is essential to our commercial success. Where there is a payor coverage policy, contract, or agreement in place, we bill the third party payor, the hospital, or referring laboratory as well as the patient (for deductibles and coinsurance or copayments, where applicable) in accordance with established policy, contract, or agreement terms. Where there is no payor policy in place, we pursue third party reimbursement on behalf of each patient on a case-by-case basis. Our efforts on behalf of these patients take a substantial amount of time and expense, and bills may not be paid for many months, if at all. Furthermore, if a third party payor denies coverage after final appeal, it may take a substantial amount of time to collect from the patient, if we are able to collect at all.

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 one or more existing, non-specific CPT codes. A clinical laboratory 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.

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 diagnosis or 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, particularly 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 contractors 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. Private third-party payors may negotiate contractual rates with participating providers, set rates as a percentage of the billed charge, or pay a set amount based on a fee schedule. Payment for diagnostic tests furnished to Medicare Part B beneficiaries is made based on the Clinical Laboratory Fee Schedule, or CLFS, under which a payment amount is assigned to each covered CPT code. Payment for a clinical laboratory test is based on the lesser of the actual charge, the local fee, or the National Limitation Amount (NLA). The law technically requires local 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 in certain years. For calendar year 2016, the NLA is 74% of the median of all local contractor fee schedule amounts for tests for which NLAs were established before January 1, 2001, and 100% for tests for which NLAs were first established on or after January 1, 2001. Medicaid programs generally pay for diagnostic tests based on a fee schedule, but reimbursement varies by state.

The Protecting Access to Medicare Act of 2014, or PAMA, which was signed into law on April 1, 2014, significantly altered the current payment methodology for clinical diagnostic laboratory services covered by the Medicare Part B program and paid according to the CLFS. Under PAMA, applicable laboratories must report rates paid by private payors (i.e., health insurance issuers, group health plans, Medicare Advantage plans, and Medicaid managed care organizations) for each clinical diagnostic laboratory test (CDLT) that it furnished during the data collection period. The reported data must include payment rates (reflecting all discounts, rebates, coupons and other price concessions), Healthcare Common Procedure Coding System codes, and the volume of tests associated with each rate. The CLFS payment rate for each CDLT (with some exceptions) will be equal to the weighted median, as calculated based on the data submitted by applicable laboratories. Every three years new data will be submitted, and new rates for CDLTs will be established based on that data. Significant reductions in reimbursement would be phased in over time. CMS would limit the maximum reimbursement reduction for a particular CDLT to no more than 10% each year in 2017 through 2019 and no more than 15% each year in 2020 through 2022. PAMA required publication of a final rule by June 15, 2015, submission of initial payment data on January 1, 2016, and implementation of new CLFS payment rates as of January 1, 2017. CMS did not publish a proposed rule until October 1, 2015, and has yet to issue a final rule. Whether CMS will implement new payment rates as of January 1, 2017, as required by PAMA, is therefore unknown at this time.

Although CMS has not yet finalized regulations to implement PAMA, we believe some of our tests would be considered “advanced diagnostic laboratory tests,” or ADLTs, rather than CDLTs. For existing ADLTs, new data will be submitted and new rates will be established based on that data annually. The initial payment rate (for a period not to exceed nine months) for a new ADLT will be set at the “actual list charge” for the test as reported by the laboratory. Insofar as the actual list charge substantially exceeds private payer rates (by more than 30%), CMS will have the ability to recoup excess payments made during the initial nine-month payment period.

Finally, State Medicaid agencies may assign a reimbursement rate equal to or less than the prevailing Medicare rate, often times determined by state law (e.g., a percentage of the Medicare reimbursement rate).

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 healthcare system. Acceptance for reimbursement comes with cost, use and often volume restrictions, which again can vary by country.

C. ORGANIZATIONAL STRUCTURE

Rosetta Genomics Ltd. is organized under the laws of the State of Israel and has a direct wholly owned subsidiary, Rosetta Genomics Inc., which is a Delaware corporation. Rosetta Genomics Ltd. also has two indirect wholly owned subsidiaries, Minuet Diagnostics, Inc., a Delaware corporation (which is wholly owned by Rosetta Genomics Inc.), and CynoGen, Inc., a Delaware corporation (which is wholly owned by Minuet Diagnostics, Inc.).

D. PROPERTY, PLANTS AND EQUIPMENT

We currently rent approximately 6,437 square feet of office and laboratory space in Rehovot, Israel, under a lease that expires in October 2017. Our wholly-owned subsidiary, Rosetta Genomics Inc., rents approximately 3,651 square feet of office space in Princeton, New Jersey under a lease that expires in September 30, 2018. The Princeton, New Jersey premises have been sub-leased under an agreement that expires on September 29, 2018. In addition, Rosetta Genomics, Inc., rents approximately 7,349 square feet of laboratory space in Philadelphia, Pennsylvania under a lease that expires in December 2018. Rosetta Genomics, Inc.’s wholly-owned subsidiary, Cynogen, Inc., rents approximately 28,700 square feet of laboratory and office space in Lake Forest, California under a lease that expires in November 2018. If our business grows we may need additional space, but expect that alternate facilities will be available on reasonable terms as and when needed.

ITEM 4A.

UNRESOLVED STAFF COMMENTS

None.

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, 2015, we had an accumulated deficit of $140 million. We funded our operations through December 31, 2015 primarily through proceeds received from the sale of equity securities to investors:

On March 22, 2013, we entered into a Controlled Equity Offering ^SM Sales Agreement (the “2013 Cantor Sales Agreement”) with Cantor Fitzgerald & Co., as sales agent (“Cantor”), pursuant to which we could offer and sell, from time to time through Cantor, our ordinary shares. We terminated the 2013 Cantor Sales Agreement on October 13, 2014. Between March 22, 2013 and October 13, 2014, we sold through the 2013 Cantor Sales Agreement an aggregate of 2,532,090 of our ordinary shares and received gross proceeds of $10.1 million, including 1,234,207 ordinary shares sold in 2014 for gross proceeds of $5.1 million.

On February 18, 2015, we entered into a Controlled Equity Offering ^SM Sales Agreement (the “2015 Cantor Sales Agreement” and, collectively with the 2013 Cantor Sales Agreement, the “Cantor Sales Agreements”) with Cantor and filed a prospectus supplement with the SEC relating to the sale, from time to time through Cantor, of up to $14.4 million of our ordinary shares. Between February 18, 2015, and the time of the filing of this Annual Report on Form 20-F, we sold through the 2015 Cantor Sales Agreement an aggregate of 2,424,358 of our ordinary shares, and received gross proceeds of $10.5 million.

Sales of our ordinary shares under the Cantor Sales Agreements are made in sales deemed to be “at-the-market” equity offerings as defined in Rule 415 promulgated under the Securities Act of 1933, as amended.

On October 13, 2015, we entered into a Securities Purchase Agreement (the "Securities Purchase Agreement"), pursuant to which we agreed to sell securities to various accredited investors (the "Purchasers") in a private placement transaction (the "Private Placement"). The Private Placement closed on October 16, 2015 (the "Closing Date").

Under the terms of the Private Placement, we issued an aggregate of 3,333,333 units and at a purchase price of $2.40 per unit for gross proceeds of approximately $8 million, Each unit consisted of (i) one ordinary share (collectively, the "Shares"), (ii) a Series A Warrant to purchase one-half of an ordinary share at an exercise price of $2.75 per ordinary share (subject to adjustment), exercisable for a period of five years from the Closing Date, and (iii) a partially pre-funded Series B Warrant (collectively and together with the Series A Warrants, the "Warrants"). The Series B Warrants had an exercise price of NIS 0.6 (which has been prepaid) plus $0.0001 per share. The Series B Warrants were intended to reset the price of the units, and became exercisable for an aggregate of 2,666,667 shares based on 85% of the arithmetic average of the five lowest weighted average prices calculated during the ten trading days following the effective date of the Resale Registration Statement registering the shares sold in the Private Placement. The Series A Warrant exercise price has been adjusted to $1.646 per share, and all of the Series B Warrants have been exercised on a cashless basis, resulting in the issuance of 2,666,489 of our ordinary shares.

We have focused our efforts since inception primarily on research and development, building and maintaining our intellectual property, business planning and commercializing our products. We have not achieved profitability and we expect to incur significant additional losses over the next several years. We expect our net losses to continue primarily due to research and development activities relating to our internal product development, collaborations, business development, commercialization, 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 and cash equivalents, as well as product revenues, additional equity and/or debt financings, funded research and development payments, and license fees and/or milestone payments under potential future collaborative arrangements.

Research and development expenses represented 17%, 14% and 13% of our total operating expenses for the years ended December 31, 2015, 2014 and 2013, 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 $2,956,000 in research and development expenses for the year ended December 31, 2015 included payroll and related expenses, research materials and related expenses, and sample acquisition costs.

In July 2008, through our wholly owned subsidiary 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 a purchase price of up to $2,500,000, to be paid as a fixed percentage of revenues over six years. During the years 2010-2012, we received an amount of $178,000. Operating results for Parkway have been classified as discontinued operations for all presented periods.

On April 18, 2013 we signed a settlement agreement with Sanra Laboratories (“Sanra”) in connection with the sale of Parkway to Sanra. Under the terms of the agreement, on April 20, 2013 and on May 10, 2013, Sanra paid us a total of $625,000. As a result of this settlement, the Parkway asset has been removed from the balance sheets and the corresponding gain in the amount of $273,000 was recorded in the consolidated statements of comprehensive loss as income from discontinued operations.

On April 13, 2015, we acquired CynoGen, Inc. (“CynoGen” or “PersonalizeDx”) from Prelude Corporation, a Fjord Ventures portfolio company. The purchase price included $2.1 million in cash, 500,000 of our ordinary shares and the provision of certain assets and services to Prelude Corporation. On July 22, 2015, we issued an additional 120,000 of our ordinary shares in lieu of services that were to be provided to an affiliate of PersonalizeDx. PersonalizeDx is a molecular diagnostics and services company serving community-based pathologists, urologists, oncologists and other reference laboratories across the United States. PersonalizeDx is focused on the detection of genomic changes through FISH technology, which helps to detect cancer, measure the potential aggressiveness of the disease and identify patients most likely to respond to targeted therapies.

Financial Operations Overview

Revenues

Revenues from continuing operations consist of revenues from sales of our diagnostic tests processed in either our laboratory in Philadelphia, Pennsylvania or in our laboratory in Lake Forest, California. Our first diagnostic products applying our microRNA technology that were launched in late 2008 began generating revenues in 2009. We have generated revenues from continuing operations for the years ended December 31, 2015, 2014, and 2013, in the amounts of $8.3 million, $1.3 million and $405,000, respectively.

Cost of Revenues

Cost of revenues related to our products consist primarily of salaries and employee benefits of our lab personnel as well as material costs and costs related to rent and maintenance of our lab in Philadelphia and Lake Forest.

Research and Development Expenses, net

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 we will continue such studies in 2016. 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 are expensed as incurred.

Marketing and Business Development Expenses

Marketing and business development expenses consist primarily of salaries and related expenses as well as expenses related to advertising, marketing campaigns, and our commercialization. As we continue to market our own products as well as explore new collaborations to develop and commercialize diagnostic and therapeutic products, we anticipate that these expenses will increase.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and related expenses, patent expenses, professional fees and expenses related to general corporate activities. We anticipate that general and administrative expenses will continue to grow in 2016 due to the continued growth and activities of our business.

Financial Expenses (Income)

Financial expenses for the year ended December 31, 2015, consisted primarily of revaluation of warrants related to share purchase agreements, partially offset by interest from bank deposits and foreign currency adjustment gains.

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 annual report, we believe the following accounting policies to be the most critical in understanding our consolidated financial statements and the assumptions management used.

Fair Value Measurements and Disclosures

The carrying amounts of our financial instruments, including cash and cash equivalents, short-term bank deposits, accounts receivable, accounts payable and accrued liabilities, approximate fair value because of their generally short-term maturities.

We apply ASC 820, “Fair Value Measurements and Disclosures”. Under this standard, fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (i.e., the “exit price”) in an orderly transaction between market participants at the measurement date.

In determining fair value, we use various valuation approaches. ASC 820 establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability developed based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect our assumptions about the assumptions market participants would use in pricing the asset or liability developed based on the best information available in the circumstances.

The hierarchy is broken down into three levels based on the inputs as follows:

Level 1 - Valuations based on quoted prices in active markets for identical assets that we have the ability to access. Valuation adjustments and block discounts are not applied to Level 1 instruments. Since valuations are based on quoted prices that are readily and regularly available in an active market, valuation of these products does not entail a significant degree of judgment.

Level 2 - Valuations based on one or more quoted prices in markets that are not active or for which all significant inputs are observable, either directly or indirectly.

Level 3 - Valuations based on inputs that are unobservable and significant to the overall fair value measurement.

The availability of observable inputs can vary from investment to investment and is affected by a wide variety of factors, including, for example, the type of investment, the liquidity of markets and other characteristics particular to the transaction. To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment and the investments are categorized as Level 3.

Revenue Recognition

The Company generates its revenues mainly from diagnosing patient tissue received from private patients or third-party distributors. The Company performs the diagnostic testing in its labs in the U.S. Additionally, the Company generates revenues from research and development services provided to, and licensing agreement with, third parties.

Revenues from sales of our diagnostic services are recognized in accordance with ASC 605, "Revenue Recognition", when (1) persuasive evidence of an agreement exists, (2) delivery of the test result has occurred or services have been rendered, (3) the vendor's fee is fixed or determinable, and (4) no further obligation exists and collectability is probable.

Criterion (1) is satisfied upon receiving a test requisition form which is evidence of medical necessity of the test ordered for the patients in order to bill the various relevant payers. Criterion (2) is satisfied when we perform the test and deliver a report to the physician, or make the patient report available to the patient. Determinations of criteria (3) and (4) are based on our judgments regarding whether the fee charged for products or services delivered is fixed or determinable, and the collectability of those fees under any contract or arrangement is probable. We assess whether the fee is fixed or determinable based on the nature of the fee charged for the services delivered and existing contractual arrangements.

Our specialized diagnostic services are performed based on a written test requisition form or electronic equivalent and revenues are recognized once the diagnostic services have been performed, and the results have been delivered to the ordering physician. These diagnostic services are billed to various payers, including Medicare, commercial insurance companies, other directly billed healthcare institutions such as hospitals and clinics, and individuals. We report revenues from contracted payers, including Medicare, certain insurance companies and certain healthcare institutions, based on the contractual rate, or in the case of Medicare, published fee schedules. We report revenues from non-contracted payers, including certain insurance companies and individuals, based on the amount expected to be collected. The difference between the amount billed and the amount estimated to be collected from non-contracted payers is recorded as a contractual allowance to arrive at the reported net revenues. The expected revenues from non-contracted payers are based on the historical collection data which is readily available and reliable of each payer or payer group, as appropriate, and used for estimating the amount of reduction in gross revenues. We regularly review our historical collection experience for non-contracted payers and adjusts our expected revenues for current and subsequent periods accordingly.

Revenues from licensed technology are recorded in accordance with the contract terms, when revenues can be reliably measured and collection of the funds is reasonably assured.

The additional potential milestones payments and royalties will be recognized upon the achievement of future events by Mirna, in accordance with ASC 450-30-25, "Gain Contingencies". As of December 31, 2015, no milestones were achieved, or royalty payments were made, by Mirna.

Revenues from research and development services to third parties are recognized in accordance with ASC topic 605-10, "Revenue recognition", when delivery has occurred, persuasive evidence of an arrangement exists, the vendor's fee is fixed or determinable, no future obligation exists and collectability is probable.

Deferred revenue includes unearned amounts received in its arrangements, and amounts received from customers but not recognized as revenues due to the fact that these transactions did not meet the revenue recognition criteria. During 2014, we recognized our deferred revenue since no further performance obligation existed.

Accounting for Stock-Based Compensation

We account for stock-based compensation in accordance with ASC 718 “Compensation- Stock Compensation”. ASC 718 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 our consolidated income statements.

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. ASC 718 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 future expected forfeitures, that approximately 90% of our options will actually vest, and therefore have applied an annual forfeiture rate of 10% to all options that are not vested as of December 31, 2015. 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 stock-option awards and value 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 of our stock starting from the IPO date. As a result of the above-mentioned calculations, the volatility used for the twelve months ended December 31, 2015 and 2014 was 123% and 120%, 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 our options. We determined the expected life of the options based on realized historical share price volatility of our share, average of vesting, and the contractual term of the options.

We apply ASC 718 and ASC 505-50 “Equity-Based Payments to Non-Employees”, with respect to options and warrants issued to non-employees. ASC 718 requires the use of option valuation models to measure the fair value of the options and warrants at the measurement date.

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, 2015, 2014, and 2013 may not be indicative of future compensation charges.

A. OPERATING RESULTS

Years Ended December 31, 2015 and 2014 - Continuing Operations

Revenues. In the years ended December 31, 2015 and December 31, 2014, we recognized $8.3 million and $1.3 million, respectively, as revenues from continuing operations. This increase resulted primarily from our acquisition of PersonalizeDx in April 2015.

Cost of revenues. Cost of revenues were $6.3 million for the year ended December 31, 2015, including $37,000 of non-cash stock-based compensation, compared to $1.3 million for the year ended December 31, 2014, which included $34,000 of non-cash stock-based compensation. This increase resulted primarily from the additional volume generated by the acquired PersonalizeDx business.

Research and development expense, net. Research and development expenses were $2.9 million for the year ended December 31, 2015, including $100,000 of non-cash stock-based compensation, compared to $1.9 million for the year ended December 31, 2014, including $73,000 of non-cash stock-based compensation. Research and development expenses for the year ended December 31, 2015 increased as we invested in launching our new thyroid assay, RosettaGX Reveal ^TM , in late 2015.

Royalty bearing grants from the Office of the Chief Scientist at the Ministry of Industry, Trade and Labor of the State of Israel, or the OCS, for funding approved research and development projects are presented as a reduction from the research and development expenses. We recognized grants in an amount of $197,000 and $292,000, for the years ended December 31, 2015 and 2014, respectively.

Marketing and business development expenses. Marketing and business development expenses were $7.3 million for the year ended December 31, 2015, including $281,000 of non-cash stock-based compensation, as compared to $6.8 million for the year ended December 31, 2014, including $226,000 of non-cash stock-based compensation. This increase resulted primarily from increased commercial activities, as a result of the acquisition of the PersonalizeDx business.

General and administrative expenses. General and administrative expenses were $7.6 million for the year ended December 31, 2015, including $598,000 of non-cash stock-based compensation, as compared to $5.5 million for the year ended December 31, 2014, including $590,000 of non-cash stock-based compensation. This increase is a result of increased corporate activities due to the acquisition of the PersonalizeDx business.

Financial expenses (income), net . Net financial expense was $1.6 million for the year ended December 31, 2015, as compared to a net financial expense of $259,000 for the year ended December 31, 2014. Financial expenses for 2015 consisted primarily of revaluation of warrants, interest from bank deposits and foreign currency adjustment losses. Financial expenses for 2014 primarily consisted primarily of interest from bank deposits and foreign currency adjustment losses.

Years Ended December 31, 2014 and 2013 - Continuing Operations

Revenues. In the years ended December 31, 2014 and December 31, 2013, we recognized $1.3 million and $405,000, respectively, as revenues from continuing operations. This increase resulted primarily from our increased commercial activities, including the expansion of our team of sales reps, as well as further investments in our commercial infrastructure.

Cost of revenues. Cost of revenues were $1.3 million for the year ended December 31, 2014, including $34,000 of non-cash stock-based compensation, compared to $709,000 for the year ended December 31, 2013, which included $16,000 of non-cash stock-based compensation. This increase resulted primarily from a ramp up of resources to meet anticipated demand.

Research and development expense, net. Research and development expenses were $1.9 million for the year ended December 31, 2014, including $73,000 of non-cash stock-based compensation, compared to $1.7 million for the year ended December 31, 2013, including $83,000 of non-cash stock-based compensation. Research and development expenses for the year ended December 31, 2013 increased as we further grew our R&D activities and advanced our pipeline.

Royalty bearing grants from the Office of the Chief Scientist at the Ministry of Industry, Trade and Labor of the State of Israel, or the OCS, for funding approved research and development projects are presented as a reduction from the research and development expenses. We recognized grants in an amount of $292,000 and $206,000, for the years ended December 31, 2014 and 2013, respectively.

Marketing and business development expenses. Marketing and business development expenses were $6.8 million for the year ended December 31, 2014, including $226,000 of non-cash stock-based compensation, as compared to $7.0 million for the year ended December 31, 2013, including $191,000 of non-cash stock-based compensation. This decrease resulted from maintaining a steady level of investment in our commercial infrastructure.

General and administrative expenses. General and administrative expenses were $5.5 million for the year ended December 31, 2014, including $590,000 of non-cash stock-based compensation, as compared to $4.3 million for the year ended December 31, 2013, including $603,000 of non-cash stock-based compensation. This increase is a result of increased corporate activities due to the growth and expansion of the business.

Financial expenses (income), net . Net financial expense was $259,000 for the year ended December 31, 2014, as compared to a net financial income of $177,000 for the year ended December 31, 2013. Financial expenses for 2014 consisted primarily of foreign currency adjustment loss, partially offset by interest from bank deposits and revaluation of warrants related to share purchase agreements. Financial income for 2013 primarily consisted primarily of interest from bank deposits and revaluation of warrants related to share purchase agreements.

Years Ended December 31, 2015, 2014 and 2013 - Discontinuing Operations

According to ASC 360, “Property, Plant, and Equipment” / ASC 205, “Presentation of Financial Statements” when a component of an entity, as defined in ASC 360, has been disposed of, the results of its operations, including the gain or loss on its disposal should be classified as discontinued operations when the operations and cash flows of the component have been eliminated from the company's consolidated operations and the company will no longer have any significant continuing involvement in the operations of the component.

The sale of Parkway met the criteria for reporting as discontinued operations and, therefore, the results of operations of the business and the loss on the sale have been classified as discontinued operations in the statement of operations and prior periods results have been reclassified accordingly. In addition, the comparative data of the assets and liabilities have been reclassified as assets and liabilities attributed to discontinued operations in the balance sheets.

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, 2015, we had an accumulated deficit of $140.3 million. We have funded our operations primarily through the proceeds from the sales of our equity securities. As of December 31, 2015, we had cash, cash equivalents and short-term bank deposit of $13.5 million, compared to $15.6 million as of December 31, 2014.

The aggregate gross amount of equity capital that was raised during 2015 was $18.5 million, and consisted of:

On February 18, 2015, we entered into the 2015 Cantor Sales Agreement with Cantor and filed a prospectus supplement with the SEC relating to the sale, from time to time through Cantor, of up to $14.4 million of our ordinary shares. Between February 18, 2015, and the time of the filing of this Annual Report on Form 20-F, we sold through the 2015 Cantor Sales Agreement an aggregate of 2,424,358 of our ordinary shares, and received gross proceeds of $10.5 million. Sales of our ordinary shares under the Cantor Sales Agreements are made in sales deemed to be “at-the-market” equity offerings as defined in Rule 415 promulgated under the Securities Act of 1933, as amended.

On October 16, 2015, we closed the Private Placement. Under the terms of the Private Placement, we issued an aggregate of 3,333,333 units at a purchase price of $2.40 per unit for gross proceeds of approximately $8 million. Each unit consisted of (i) one ordinary share, (ii) a Series A Warrant to purchase one-half of an ordinary share at an exercise price of $2.75 per ordinary share (subject to adjustment), exercisable for a period of five years from the Closing Date, and (iii) a partially pre-funded Series B Warrant. The Series B Warrants had an exercise price of NIS 0.6 (which has been prepaid) plus $0.0001 per share. The Series B Warrants were intended to reset the price of the units, and became exercisable for an aggregate of 2,666,667 shares based on 85% of the arithmetic average of the five lowest weighted average prices calculated during the ten trading days following the effective date of a resale registration statement registering the shares sold in the Private Placement for resale. The Series A Warrant exercise price has been adjusted to $1.646 per share, and all of the Series B Warrants have been exercised on a cashless basis, resulting in the issuance of 2,666,489 of our ordinary shares.

Cash Flows

Net cash used in operating activities. Net cash used in operating activities from continuing operations was $16.9 million in 2015, compared to $13.6 million in 2014, and $11.2 million in 2013. These amounts were used to fund our commercial, corporate, and R&D activities for these periods, adjusted for non-cash expenses and changes in operating assets and liabilities. Net cash provided by (used in) operating activities from discontinued operations for the years ended 2015, 2014 and 2013 were $0, $0 and $625,000, respectively.

Net cash provided by (used in) investing activities. Net cash used in investing activities from continuing operations was $4.1 million in 2015, compared to $258,000 in 2014 and $8.2 million in 2013. Net cash provided by investing activities during 2015 primarily relates to bank deposits and restricted cash. Net cash used in investing activities during 2014 primarily relates to the purchase of property and equipment. Net cash used in investing activities during 2013 primarily relates to deposit of bank.

Net cash provided by financing activities. Net cash provided by financing activities from continuing operations was $17.3 million in 2015, compared to $5.0 million in 2014 and $4.7 million in 2013. In 2015, 2014 and 2013, net cash provided by financing activities consisted primarily of proceeds from the issuance of shares and warrants. Net cash provided by financing activities from discontinued operations in 2015, 2014 and 2013 was $0.

Funding Requirements

We expect to incur continuing and increasing losses from operations for at least the next several years. In particular, we expect to incur significant marketing and business development expenses, research and 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, together with our existing operating plan, which includes a cost-reduction plan should we be unable to raise sufficient additional capital, are sufficient for us to meet our obligations as they come due at least for a period of twelve months from the date of this filing. However, our funding requirements may change and will depend upon numerous factors, including but not limited to:

the timing, receipt and amount of sales of our products;

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; and

costs necessary to protect our intellectual property.

We will likely 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. We plan to file a new shelf registration statement on Form F-3 with the SEC for the issuance of ordinary shares, various series of debt securities and/or warrants to purchase any such securities, either individually or in units, with a total value of up to $75 million, from time to time at prices and on terms to be determined at the time of such offering. The U.S. dollar value of our securities that we could issue under such new shelf registration statement will be subject to limitations imposed by the SEC for companies with a public float of less than $75 million. If we need additional funding, 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 needed and not available, we may be required to:

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;

monetizing certain of our assets;

pursue merger or acquisition strategies; or

seek protection under the bankruptcy laws of Israel and the United States.

RESEARCH AND DEVELOPMENT, PATENTS AND LICENSES, ETC.

Our research and development expenditures were $2.9 million, $1.9 million and $1.7 million in the years ended December 31, 2015, 2014 and 2013, respectively. See also “Item 5. Operating and Financial Review and Prospects - Financial Operations Overview - Research and Development Expenses.”

TREND INFORMATION

See “Item 5. Operating and Financial Review and Prospects.”

OFF-BALANCE SHEET ARRANGEMENTS

We are not party to any material off-balance-sheet arrangements.

TABULAR DISCLOSURE OF CONTRACTUAL OBLIGATIONS

Set forth below is a description of our contractual cash obligations as of December 31, 2015. 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.

(In thousands)	Total		2016		2017		2018		2019		2020		Thereafter
Operating and capital lease obligations	$	1,934	$	711	$	668	$	555	$	-	$	-	$	-
Other long-term liabilities	$	1,773	$	149	$	149	$	149	$	149	$	149	$	1,028

Total	$	3,707	$	860	$	817	$	704	$	149	$	149	$	1,028

Under our license agreements as of December 31, 2015, we are obligated to pay an aggregate amount of approximately $149,000 annually after 2020 and until 2022, $100,000 annually after 2022 and until 2029 and $10,000 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 2020 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.

ITEM 6.

DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES

DIRECTORS AND SENIOR MANAGEMENT

The following table sets forth information regarding our corporate and executive officers and directors:

Name	Age	Position
Kenneth A. Berlin	51	Chief Executive Officer and President
Ron Kalfus	41	Chief Financial Officer
Dganit Bar, Ph.D.	47	Chief Scientific Officer
Eti Meiri, Ph.D.	47	Vice President, Research
Sigal Russo-Gueta	38	Company Controller
Brian Markison (3)	56	Chairman of the Board of Directors
Roy N. Davis (4)	69	Director
Yitzhak Peterburg, M.D., Ph.D. (3) (4)	65	Director
Joshua Rosensweig, Ph.D. (2) (3)	63	Director
Dr. David Sidransky, M.D. (1) (4)	55	Director
Gerald Dogon (1)(2)	76	External Director
Tali Yaron-Eldar (1)(2)	52	External Director

(1) Member of our Audit Committee

(2) Member of our Compensation Committee

(3) Member of our Nominating and Corporate Governance Committee

(4) Member of our Research and Development Committee

Kenneth A. Berlin joined us in November 2009 as our President and Chief Executive Officer. He was later appointed by our shareholders in December 2009 as a member of our board of directors, and resigned as a director in March 2011. Prior to joining us, Mr. Berlin, served as Worldwide General Manager at cellular and molecular cancer diagnostics developer Veridex, LLC, a Johnson & Johnson company. Under his leadership the organization grew to over 100 employees, and he spearheaded the launch of three cancer diagnostic products, the acquisition of its cellular diagnostics partner, and delivered significant growth in sales as Veridex transitioned from a research and development entity to a commercial provider of oncology diagnostic products and services. During Mr. Berlin’s tenure, Veridex received numerous awards including recognition from the Cleveland Clinic and Prix Galien for the use of its innovative CellSearch® technology in the fight against cancer. Mr. Berlin joined Johnson & Johnson in 1994 and served as corporate counsel for six years. He then held positions of increasing responsibility within Johnson & Johnson and a number of its subsidiary companies. From 2001 until 2004, he served as Vice President, licensing and new business development in the pharmaceuticals group, and from 2004 until 2007 was Worldwide Vice President, franchise development, Ortho-Clinical Diagnostics. Mr. Berlin holds an A.B. degree from Princeton University and a J.D. from the University of California, Los Angeles School of Law.

Ron Kalfus joined us in May 2012 as our Chief Financial Officer. Prior to joining Rosetta, Mr. Kalfus served as the Chief Financial Officer and Treasurer of MabCure Inc., a publicly-traded biotechnology startup company in the field of early cancer detection using antibodies, from 2008 to 2012. From 2003 to 2007, Mr. Kalfus held various positions with Toys “R” Us, Inc., being responsible for the company’s financial reporting to the Securities and Exchange Commission and being responsible for the Toys “R” Us division’s annual budget. Prior to joining Toys “R” Us, Inc., Mr. Kalfus worked as an auditor for two large public accounting firms, specializing in audits of medium-sized enterprises as well as public companies. Mr. Kalfus holds an M.Sc. in Accounting from Fairleigh Dickinson University and a BBA in Finance from the University of Georgia, and is a Certified Public Accountant licensed in New Jersey.

Dganit Bar, Ph.D . joined us in October 2012, as our Chief Scientific Officer. Dr. Bar joined Rosetta with more than 10 years of experience in drug development. Prior to joining Rosetta, from 2004 to 2012 she served in various positions, including Executive Director Science & Technology at BioLineRx, Ltd, a biopharmaceutical company, where she led the development and out-licensing of several drug candidates spanning different therapeutic areas, including oncology, cardiovascular and CNS. From 2000 to 2004, Dr. Bar was with QBI Enterprises, Ltd, where she held several positions including Head of Cancer Research working on the company’s oncology pipeline. Dr. Bar received her B.Sc. in Life Science from The Hebrew University, Jerusalem. She holds an M.Sc. in Biotechnology and a Ph.D. in Biotechnology Engineering from Ben-Gurion University of the Negev.

Eti Meiri, Ph.D. has served as our Vice President, Research since May 2012. She previously served as our Senior Scientist, Molecular Biology since 2003. She has been contributing to our science and was extremely instrumental in all of the R&D activities throughout the years. Her contributions include the development of our microRNA array platform as well as the development of RNA extraction protocols suitable for microRNA extraction from clinical samples. Prior to joining us, from 2001 to 2002, Dr. Meiri served as Senior Scientist in ViroGene Ltd. She is the author of 20 papers published in peer reviewed journals. Dr. Meiri earned her Ph.D. from the Department of Plant Sciences in the Weizmann Institute of Science in Rehovot, her M.Sc. from The Hebrew university of Jerusalem, and her B.Sc. from the Faculty of life sciences, in Tel Aviv University.

Sigal Russo-Gueta joined us in September 2008 as our controller. Prior to joining Rosetta, Ms. Russo worked as an audit manager at Ernst & Young in Israel, specializing in audits of companies from various fields, both publicly traded and privately owned American and Israeli entities, from 2004 to 2008. Ms. Russo holds a BA in Economics and accounting, from the Ruppin Academic College, and is a Certified Public Accountant licensed in Israel.

Brian Markison has served as a member of our board of directors since March 2011. Mr. Markison was appointed by our board of directors to fill the vacancy created by the resignation of Mr. Berlin. Mr. Markison’s appointment was approved by the general meeting dated July 6, 2011. Mr. Markison was appointed as chairman of the board on April 12, 2011. Mr. Markison is a healthcare Industry Executive at Avista Capital Partners since September 2012, prior to which he served as President, Chief Executive Officer and a member of the Board of Directors of Fougera Pharmaceuticals Inc., from July 2011, until it was sold to the generics division of Novartis in July 2012. Previously, he had been with King Pharmaceuticals since 2004 and led the company through its acquisition by Pfizer for $3.6 billion in 2010. Previously Mr. Markison was with Bristol-Myers Squibb from 1982 to 2004, where he served in various commercial and executive positions rising from an oncology sales representative to become President, BMS Oncology/Virology and Oncology Therapeutics Network. Mr. Markison serves on the board of directors of Immunomedics, Inc., Lantheus Medical Imaging and Alere Inc, and is the Chairman and Chief Executive Officer of Osmotica Pharmaceuticals, Mr. Markison received a B.S. from Iona College in New Rochelle, New York and serves as a Trustee for The College of New Jersey.

Roy N. Davis has served as a member of our board of directors since June 2012. Mr. Davis joined Johnson & Johnson (J&J) in 1984, where he moved through leadership positions of increasing responsibility in the organization in the U.S., Europe and Asia for 27 years prior to his retirement in January 2012. Most recently, from January 2008 through January 2012 Mr. Davis was President, J&J Development Corporation, J&J’s wholly owned venture group, and Vice President of Corporate Development for all of J&J. In these roles Mr. Davis was responsible for acquisition and licensing in areas outside of current J&J business sectors, venture capital investing on behalf of J&J and management of J&J’s wholly owned ventures. These efforts focused on developing new companies for J&J that offer transformational health care solutions. From 2003 to 2007, Mr. Davis held the positions of Company Group Chairman, J&J and Worldwide Franchise Chairman, Ortho Clinical Diagnostics with responsibilities for Ortho Clinical Diagnostics, Inc., Veridex LLC and Therakos, Inc. Mr. Davis received a Bachelor of Science from the State University of New York and a Master of Science from Rensselaer Polytechnic Institute. He served as a member of the Innovations Advisory Board for the Cleveland Clinic during 2008-2014 and is currently a member of the Advisory Board for the Wake Forest Institute for Regenerative Medicine and in March 2012 was named to the Board of Directors of Innosight, an innovation consulting firm.

Prof. Yitzhak Peterburg has served as a member of our board of directors since December 2012. Prof. Peterburg became Teva's Chairman of the Board of Directors on January 1, 2015, after rejoining Teva’s Board of Directors in 2012. Prof. Peterburg was Teva’s Group Vice President—Global Branded Products from October 2010 until October 2011, after serving on Teva’s Board of Directors from 2009 until July 2010. Previously, he served as President and CEO of Cellcom Israel Ltd. from 2003 to 2005, Director General of Clalit Health Services, the leading healthcare provider in Israel, from 1997 to 2002 and CEO of Soroka University Medical Center, Beer-Sheva, from 1995 to 1997. Prof. Peterburg currently serves as the Chairman of Regenera Pharma. Prof. Peterburg received an M.D. degree from Hadassah Medical School in 1977 and is board-certified in Pediatrics and Health Services Management. Prof. Peterburg received a doctoral degree in Health Administration from Columbia University in 1987 and an M.Sc. degree in Information Systems from the London School of Economics in 1990. He is a professor at the School of Business, Ben-Gurion University.

Joshua Rosensweig has served as a member of our board of directors since May 2004. Since November 2010, he has served as a member of the board of directors of Bezeq Israel Telecommunication Corp. Ltd. (Israel’s leading communications group) and of Alrov Real Estate and Hotels Ltd., a publicly-traded property development company. From September 2003 to September 2006, Dr. Rosensweig served as the Chairman of the Board of Directors of the First International Bank of Israel. 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. 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. Dr. Rosensweig is currently a partner at the law firm of Rosensweig & Aviram, Attorneys.

David Sidransky, M.D. , has served as a member of our board of directors since December 22, 2009. 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 serves as the Director of the Head and Neck Cancer Research Program at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University. He is a Professor of Oncology, Otolaryngology, Cellular & Molecular Medicine, Urology, Genetics, and Pathology at John Hopkins University and Hospital. Dr. Sidransky has written over 500 peer-reviewed publications, and has contributed to more than 65 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 of ImClone. He is Chairman of the Board of Champions Oncology, Advaxis, and Tamir Biotechnology and is on the Board of Directors of Galmed, Celsus, and Orgenesis. He is serving and has served on scientific advisory boards of corporations and institutions, including Amgen, MedImmune, Roche and Veridex, LLC (a Johnson & Johnson diagnostic company), among others. In Addition, Dr. Sidransky served as Director of American Association for Cancer Research from 2005 to 2008. Dr. Sidransky received his B.A. from Brandeis University and his M.D. from the Baylor College of Medicine.

Gerald Dogon has served as a member of our board of directors since February 2007. 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 a 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. Mr. Dogon has also served as a member of the board of directors of Fundtech Ltd. and was a member of its audit and nominating committees. From 1994 to 1998, Mr. Dogon served as Executive Vice President and Chief Financial Officer of DSPC Inc., and in addition, from November 1997 until December 1999, as a member of its board of directors. Mr. Dogon holds a B.Comm. in Economics from the University of Cape Town.

Tali Yaron-Eldar has served as a member of our board of directors since February 2007. From January 2013, Ms. Yaron-Eldar has served as a partner and founder of Yetax law offices. Between March 2007 and December 2012, Ms. Yaron-Eldar had been a partner with the law firm of Tadmor & Co. From January 2004 to March 2007, she was a partner at the law firm of Cohen, Yaron-Eldar & Co. From January 2004 to January 2008, Ms. Yaron-Eldar served as the Chief Executive Officer of Arazim Investment Company. She 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 M.B.A. specializing in finance and an LL.M. from Tel Aviv University and is a member of the Israeli Bar Association.

COMPENSATION

Compensation-Related Requirements of the Israeli Companies Law

The term “office holder,” is defined in the Israeli Companies Law, 1999 (the “Israeli Companies Law”), as a general manager, general business manager, vice general manager, deputy general manager, any other person fulfilling or assuming any of the foregoing positions even if such person’s title is different, as well as director, or a manager who is directly subordinated to the general manager. Prior to amendment 20 to the Israeli Companies Law that came into effect on December 12, 2012 (“Amendment 20”), the compensation of our office holders required the approval of our audit committee and our Board of Directors, in that order. In addition, all compensation awarded to directors, also required the approval of our shareholders by a simple majority. Following Amendment 20, we were required to form a Compensation Committee, whose members need to comply with certain criteria, as well as to adopt a compensation policy regarding the compensation terms of our Office Holders, which includes direct and indirect compensation, including equity-based awards, exemption from liability, indemnification and insurance, severance and other benefits (“Compensation Terms”).

The compensation policy must be approved by the company's board of directors after considering the recommendations of the compensation committee. The compensation policy also requires the approval of the general meeting of shareholders, which approval must satisfy either of the following: (i) the majority of the votes for the approval should include a majority of the votes of the voting shareholders who are non-controlling shareholders or have no personal interest in the approval of the compensation policy (the votes of abstaining shareholders not included in the number of the said total votes) or (ii) the total number of votes against the proposed compensation policy among the shareholders mentioned in paragraph (i) does not exceed 2% of the aggregate voting power in the company. Under certain circumstances and subject to certain exceptions, the board of directors may approve the compensation policy despite the objection of the shareholders, provided that the compensation committee and the board of directors determines that it is for the benefit of the company, following an additional discussion and based on detailed arguments.

The compensation policy must be re-approved every three years, in the manner described above and in addition the board of directors has to review from time to time the compensation policy and whether there are any material changes to the circumstances since the approval of the compensation policy that requires an adjustment of the policy.

Amendment 20 details the considerations that should be taken into account in determining the Compensation Policy and certain issues and provisions which should be included in the Compensation Policy.

Our Compensation Policy for Executive Officers and Directors (the “Compensation Policy”) was approved by our shareholders at the 2013 annual general meeting of shareholders, held on August 5, 2013, following the favorable recommendation of the Compensation Committee and approval by the Board of Directors, and took effect thereafter.

Our Compensation Policy is designed to encourage pay for performance and align our executive officers’ interests with those of the Company and our shareholders. Its structure allows us to provide meaningful incentives that reflect both our short and long-term goals and performance, as well as the executive officer’s individual performance and impact on shareholder value, while providing compensation that is competitive in the global marketplace in which we recruit talent and providing for measures designed to reduce incentives to take excessive risks.

Pursuant to Amendment 20, any arrangement between the Company and its office holders regarding Compensation Terms must be consistent with the Compensation Policy. However, under certain circumstances, the Company may approve an arrangement that is not consistent with the Compensation Policy, if such arrangement is approved by a majority of the Company’s shareholders, provided that (i) the majority voting for the approval of the arrangement includes a majority of the votes cast by shareholders who are not controlling shareholders and who do not have a personal interest in the matter, (abstentions are disregarded), or (ii) the votes cast by shareholders who are not controlling shareholders and who do not have a personal interest in the matter who voted against the arrangement do not exceed two percent of the voting power of the company.

In addition, pursuant to Amendment 20, the Compensation Terms of our office holders require the approval of the Compensation Committee and the Board of Directors. The Compensation Terms of directors further require the approval of the shareholders by a simple majority; with respect to a chief executive officer who is not a director, the approval of our shareholders by the special majority mentioned above is also required. Under certain circumstances, if the Compensation Terms of office holders who are not directors are not approved by the shareholders, the Compensation Committee and the Board of Directors may nonetheless approve such terms.

Executive Officers’ Remuneration

The aggregate direct compensation we paid to our corporate and executive officers as a group (6 persons) for the year ended December 31, 2015 was approximately $2.04 million of which approximately $114,000 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.

In 2015, we paid bonuses to certain of our executive officers in an aggregate amount of $547,000 for performance during the year. Other employee’s bonuses for service in 2015 had not yet been determined or awarded. During 2015, we granted to our executive officers:

Options to purchase an aggregate amount of 220,000 ordinary shares, at an exercise price of $1.167 per share with an expiration date of December 3, 2022, of which 0 were vested as of December 31, 2015.

Options to purchase an aggregate amount of 100,000 ordinary shares, at an exercise price of $2.79 per share with an expiration date of November 11, 2024, of which 0 were vested as of December 31, 2014.

45,000 restricted stock units, of which 0 were vested as of December 31, 2015.

Additional Disclosure Required Under Israeli Law

According to section 4(d) of the Companies Regulations (Notification of general assemblies and by-type assemblies in a public company and adding an item to the agenda), 2000, the following table presents information regarding compensation actually received by our five most highly paid executive officers during the year ended December 31, 2015 (in USD):

Name and position	Salary		Employer 401K*		Vehicle Expenses		Pension**		Bonus paid		Equity***		Total
Mr. Ken Berlin Chief Executive Officer		500,000		15,000		18,000				375,000		335,782		1,243,782
Dr. Robert Wassman Chief Medical Officer		212,000		7,000		-						4,638		223,638
Mr. Oded Biran Chief Legal Officer		225,000		6,750		12,000				62,775		18,281		324,806
Mr. Ron Kalfus Chief Financial Officer		187,851		3,118		9,763		11,000		29,625		23,564		265,564
Ms. Dganit Bar Chief Science Officer		185,278		-		9,732		21,000		37,203		40,140		293,140

401K — in the U.S., this is the tax-qualified, defined-contribution pension account defined in subsection 401(k) of the Internal Revenue Code.

Pension is provided for Israel based employees only.

***

Equity is calculated as the value of options awarded, at the time of grant.

⁺

Dr. Wassman resigned as our Chief Medical Officer effective September 18, 2015.

⁺⁺

Mr. Biran resigned as our Chief Legal Officer effective March 6, 2016.

Directors’ Remuneration

Under the directors’ compensation package approved by our board of directors and shareholders (at its meeting held on July 12, 2006), as of our initial public offering, (i) each member of the board of directors was entitled to receive an annual fee of $10,000, payable in equal quarterly installments (ii) each member of our board of directors, other than the external directors, who served on board committees received an additional annual fee of $10,000, payable in equal quarterly installments. On October 12, 2012, our shareholders approved the following remuneration to our directors who are not external directors: (i) the chairman of our board is entitled to (a) an annual fee of $25,000, (b) an annual fee of $10,000 for every committee on which he serves, and (c) a participation fee of $250 for attendance of every meeting of the board or of a committee on which he serves and (ii) all other directors who are not external directors are entitled to (a) an annual fee of $20,000, (b) an annual fee of $7,500 for every committee on which such director serves, and (c) a participation fee of $250 for attendance of every meeting of the board or of a committee on which such director serves. On August 5, 2013, our shareholders approved an amendment to the compensation of our directors, so that the annual fee and the participation fee paid to each of the Company’s directors, shall not be less than the minimal annual fee and participation fee applying with respect to our external directors under the prevailing laws and regulations, which vary based on the company’s equity. Our directors do not receive any additional benefits upon termination.

The Companies Law and the regulations promulgated pursuant thereto governing the terms of compensation payable to external directors require that external directors receive annual payment as well as payment for participation in meetings as set forth in the regulations, and further provides that such remuneration may generally be determined relative to that of “other directors” (as such term is defined in the Companies Law). Our Compensation committee, Board and shareholders, in their meeting held on August 5, 2013 approved that the external directors of the Company shall receive remuneration that is equal to the remuneration paid to the “other directors” (as such term is defined in the Companies Law).

We paid an aggregate of $279,000 in direct compensation to our directors for their services as directors for the year ended December 31, 2015, including $66,000 paid in 2016 for service during the fourth quarter of 2015.

During 2015, we granted to our directors:

Options to purchase an aggregate amount of 24,000 ordinary shares, at an exercise price of $1.16 per share with an expiration date of December 12, 2022.

As of March 1, 2016, there were outstanding options to purchase 1,001,280 ordinary shares that were granted to our 13 directors and officers, at a weighted average exercise price of $5.02 per share.

BOARD PRACTICES

We are incorporated in Israel, and, therefore, subject to various corporate governance practices under Israeli law relating to such matters as external directors, independent directors, the audit committee, the compensation committee, independent auditor and the internal auditor. These matters are in addition to the requirements of The NASDAQ Capital Market and other relevant provisions of U.S. securities laws. Under The NASDAQ Capital Market rules, a foreign private issuer may generally follow its home country rules of corporate governance in lieu of the comparable NASDAQ Capital 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 Capital 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 committees. In addition, under the Companies Law, we are required to appoint at least two external directors. Gerald Dogon and Tali Yaron-Eldar were appointed as our external directors, each of whom is also independent under the rules of The NASDAQ Capital Market. Mr. Dogon and Ms. Yaron-Eldar were re-elected as external directors by a general meeting on August 5, 2013 for three-year terms that expire on August 4, 2016.

Board of Directors

Our board of directors currently consists of seven directors, including two external directors. Our directors, apart from the external directors, are elected at an annual meeting or an extraordinary meeting, as stated in our Articles of Association (the “Articles”) 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. The Articles provide that we may have no less than two and no more than seven directors.

In accordance with our Articles, our board of directors, apart from our external directors, is divided into three classes of directors, with one class being elected each year for a term of approximately three years. At each annual general meeting of shareholders, the successors to directors whose term then expires will be elected to serve from the time of election and qualification until the third annual meeting of shareholders following election. Our directors are divided among the three classes as follows:

the Class I directors are Brian A. Markison and Dr. Yitzhak Peterburg, and their terms expire at the annual general meeting of shareholders to be held in 2017;

the Class II directors are Dr. David Sidransky and Dr. Joshua Rosensweig, and their terms expire at the annual general meeting of shareholders to be held in 2018; and

the Class III director is Roy N. Davis, and his term expires at the annual general meeting of shareholders to be held in 2016.

In accordance with our Articles, 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, elect directors instead of directors so removed or fill any vacancy created in our board of directors. In addition, in case of vacancies on the board of directors, the continuing directors may generally continue to act in every matter and may appoint directors to temporarily fill any such vacancy. See “—External Directors” below for a description of the procedure for election of external directors.

In addition, our two external directors, Gerald Dogon and Tali Yaron-Eldar, were re-elected on August 5, 2013 for three-year terms that expire on August 4, 2016. 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. For that matter, external directors are excluded.

Our Articles provide, as allowed by Israeli law, that any director may, by written notice to us, appoint another natural person to serve as an alternate director (subject to the consent of the board of directors) and may cancel such appointment. Unless the appointing director limits such appointment to a specified period of time or restricts it to a specified meeting or action of the board of directors, or otherwise restricts its scope, the appointment shall be for all purposes and for a period of time concurrent with the term of the appointing director. Currently, no alternate directors have been appointed. 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, which are not relevant to our company. An alternate director has the same responsibilities as a director. Under the Companies Law, and our Articles, a director that is a member of a committee of the board of directors, may appoint as his alternate director on such committee of the board of directors another member of the board of directors, provided that such director is not already a member of such committee, and provided that if such person is appointed as an alternate director for an external director, such alternate director shall be an external director with the same accounting and financial expertise or other professional expertise as possessed by the appointing director. In addition, an independent director cannot appoint as his alternate director a person who is not qualified to be appointed as an independent 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 Capital Market, are required to appoint at least two natural persons as “external directors”. We have appointed Gerald Dogon and Tali Yaron-Eldar, who qualify as external directors under the Companies Law. Our external directors were re-elected on August 5, 2013 for three-year terms that expire on August 4, 2016. The Companies Law provides that no person may be appointed as an external director if such person is (i) a controlling shareholder or a relative of a controlling shareholder, or (ii) if such person, a relative, partner or employer of such person, or anyone to whom such person is directly or indirectly subordinate, or any entity under such person’s control, has or had, on or within the two years preceding the date of such person’s appointment to serve as an external director, any affiliation with the company to whose board such external director is proposed to be appointed or any other entity, with the controlling shareholder of the company, with a relative of such controlling shareholder, at the date of appointment, or with any entity controlled, on or within two years preceding the date of such appointment, by the company or by a controlling shareholder of the company, or, (iii) if the company has no controlling shareholder or a shareholder holding 25% or more of the company’s voting rights, any affiliation with anyone who is, at the time of the appointment, the chairman of the board of directors, the chief executive officer, the most senior financial officer of the company, or a shareholder holding 5% or more of the outstanding shares or voting rights of the company. 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.

In addition, no person may serve as an external director if: (a) the person’s position or other business activities create, or may create, a conflict of interest with the person’s duties as a director or may interfere with the person’s ability to serve as an external director; (b) such person serves as a non-external director of another company on whose board of directors a director of the reciprocal company serves as an external director; (c) the person is an employee of the Israel Securities Authority or of an Israeli stock exchange; (d) such person or such person’s relative, partner, employer or anyone to whom such person is directly or indirectly subordinate, or any entity under such person’s control, has business or professional relations with any person or entity he or she should not be affiliated with, as described above, even if such affiliation is not on a regular basis, unless such relations are negligible; or (e) such person received compensation, directly or indirectly, in connection with such person’s services as an external director, other than as permitted under the Companies Law and the regulations promulgated thereunder. If, at the time of election of an external director, all other directors, who are not controlling shareholders of such company or their relatives, are of the same gender, the external director to be elected must be of the other gender.

Under the Companies Law, a person may only be appointed as an external director if he or she has professional qualifications or if he or she has accounting and financial expertise, provided that at least one of the external directors must have accounting and financial expertise. However, according to regulations promulgated pursuant to the Companies Law, which were amended on and effective as of January 2013, companies whose shares are listed for trading on specified exchanges outside of Israel, including the NASDAQ Capital Market, may appoint external directors who have professional qualifications only (and not accounting and financial expertise) provided that an existing member of the board of directors has accounting and financial expertise and is considered as an independent director under the relevant non-Israeli rules, relating to independence standards for audit committee membership. In addition, the board of directors of publicly traded companies, such as us, are required to make a determination as to the minimum number of directors who must have financial and accounting expertise, based among other things, on the type and size of the company and the scope and complexity of its operations, and subject to the number of directors that may be appointed by the company as set forth in its articles of associations.

The conditions and criteria for possessing accounting and financial expertise or professional qualifications were determined in regulations promulgated by the Israeli Minister of Justice in consultation with the Israeli Securities Authority. The regulations mandate that a person is deemed to have “expertise in finance and accounting” if his or her education, experience and qualifications provide him or her with expertise and understanding in business matters, accounting and financial statements, in a way that allows him or her to understand, in depth, the company’s financial statements and to encourage discussion about the manner in which the financial data is presented.

The company’s board of directors must evaluate the proposed external director’s expertise in finance and accounting, by considering, among other things, his or her education, experience and knowledge in the following: (i) accounting and auditing issues typical to the field in which the company operates and to companies of a size and complexity similar to such company; (ii) a company’s external public accountant’s duties and obligations; and (iii) preparing company financial statements and their approval in accordance with the Companies Law and the Israeli Securities Law.

A director is deemed to be “professionally qualified” if he or she meets any of the following criteria: (i) has an academic degree in any of the following professions: economics, business administration, accounting, law or public administration; (ii) has a different academic degree or has completed higher education in a field that is the company’s main field of operations, or a field relevant to his or her position; or (iii) has at least five years of experience in any of the following, or has a total of five years of experience in at least two of the following: (A) a senior position in the business management of a corporation with significant operations, (B) a senior public position or a senior position in public service, or (C) a senior position in the company’s main field of operations. The board of directors here too must evaluate the proposed external director’s “professional qualification” in accordance with the criteria set forth above.

The board of directors has determined that other than one external director no other directors are required to have financial and accounting expertise. Our board of directors further determined that our external director, Mr. Dogon, possesses the requisite financial and accounting expertise and that both of our external directors possess the requisite professional qualifications.

Following termination of service as an external director, a public company, a controlling shareholder thereof and any entity controlled by a controlling shareholder, may not grant any benefit, directly or indirectly, to any person who served as an external director of such public company, or to his or her spouse or child, including, not appointing such person, or his or her spouse or child, as an Office Holder of such public company or of an entity controlled by a controlling shareholder of such public company, not employing such person and not receiving professional services for pay from such person, either directly or indirectly, including through a corporation controlled by such person, or his or her relative, all until the lapse of two years from termination of office with respect to the external director, his or her spouse or child and until the lapse of one year from termination of office with respect to other relatives besides spouse or child of the former external director.

Election of External Directors

External directors are elected at the general meeting of shareholders by a simple majority, provided that:

the majority includes a majority of the votes of shareholders who are not controlling shareholders and who do not have a personal interest in the matter (other than a personal interest which is not the result of an affiliation with a controlling shareholder), who voted on the matter of the election of the external director (disregarding abstentions); or

the votes of the non-controlling shareholders or shareholders that do not have a personal interest in the matter (other than a personal interest which is not the result of an affiliation with a controlling shareholder), who voted against the election of the external director do not exceed two percent of the voting rights in the company.

External directors are elected for a term of three years and may be re-elected for two additional terms of three years each, provided that with respect to the appointment for each such additional three-year term, one of the following has occurred:

(a) the reappointment of the external director has been proposed by one or more shareholders holding together one percent or more of the aggregate voting rights in the company and the appointment was approved at the general meeting of the shareholders by a simple majority, provided that all of the following conditions are met (“Voting Conditions”): (i) in calculating the majority, votes of controlling shareholders or shareholders having a personal interest in the appointment (other than a personal interest which is not the result of an affiliation with a controlling shareholder) and abstentions are disregarded; (ii) the total number of votes in favor of the appointment, by shareholders who are not controlling shareholders or who do not have a personal interest in the appointment (other than a personal interest which is not the result of an affiliation with a controlling shareholder), exceed two percent of the aggregate voting rights in the company; (iii) the external director is not a Related or Competitor Shareholder (as defined below) or a relative of such Related or Competitor Shareholder at the time of appointment, and is not an affiliate (as defined with regards to External Director's qualifications - please see above) of a Related or Competitor Shareholder at the time of appointment or two years preceding the appointment;

For this matter –

“Related or Competitor Shareholder” – is a shareholder that proposed the appointment of the external shareholder or a shareholder who holds 5% or more of the company’s outstanding share capital or voting rights, provided that at the time of appointment such shareholder, its controlling shareholder or a company controlled by such shareholder (or its controlling shareholder): (1) has business relationship with the company, or (2) is the company's competitor.

(b) the reappointment of the external director has been proposed by the board of directors and the appointment was approved by the majority required for the initial appointment of an external director.

(c) the external director has proposed its own appointment and the appointment was approved according to the Voting Conditions, as set above.

However, under regulations promulgated pursuant to the Companies Law, companies whose shares are listed for trading on specified exchanges outside of Israel, including The NASDAQ Global Market, The NASDAQ Global Select Market, and, as of January 14, 2013, The NASDAQ Capital Market, may elect external directors for additional terms that do not exceed three years each, beyond the three three-year terms generally applicable, provided that, if an external director is being re-elected for an additional term or terms beyond three three-year terms: (i) the audit committee and board of directors must determine that, in light of the external director’s expertise and special contribution to the board of directors and its committees, the reelection for an additional term is for the benefit of the company; (ii) the external director must be re-elected by the required majority of shareholders and subject to the terms specified in the Companies Law; and (iii) the term during which the nominee has served as an external director and the reasons given by the audit committee and board of directors for extending his or her term of office must be presented to the shareholders at the shareholder’s meeting prior to their approval.

An external director cannot be removed from office unless: (i) the board of directors determines that the external director no longer meets any of the statutory requirements for holding the office, or that the external director is in breach of his or her fiduciary duty to the company, and the shareholders vote, by the same majority of shareholders as is required for his or her appointment, to remove the external director after the external director has been given the reasonable opportunity to present his or her position; (ii) a court determines, upon a request of a director or a shareholder, that the external director ceases to meet the statutory requirements for his or her appointment or that the external director is in breach of his or her fiduciary duties to the company; or (iii) a court determines, upon a request of the company or a director, shareholder or creditor of the company, that the external director is unable to fulfill his or her duty on a regular basis, or has been convicted of specified offenses. If an external directorship becomes vacant and the number of external directors serving in the company is less than two, then the 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 cannot include any person who is not a director, and is required to include at least one external director except for the audit committee and compensation committee which are required to include all 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. For this matter, the term “compensation” shall not include the grant of an exemption, an undertaking to indemnify, indemnification or insurance.

Independent Directors

In addition to the concept of “external” directors, the Companies Law also includes the concept of ‘independent’ directors. An independent director is either an external director or a director appointed or classified as such who meets the same non-affiliation criteria as an external director, as determined by the subject company’s audit committee, and who has not served as a director of the company for more than nine consecutive years. For this purpose, ceasing to serve as a director for a period of two years or less would not be deemed to sever the consecutive nature of such director’s service. An independent director may be removed from office in the same manner that an external director may be removed.

Pursuant to the Companies Law, a public company, such as us, may include in its articles of association a provision providing that a specified number of its directors be independent directors or may adopt a standard provision providing that a majority of its directors be independent directors or, if there is a controlling shareholder or a 25% or more shareholder, that at least one-third of its directors be independent directors.

Regulations promulgated pursuant to the Companies Law provide that a director in a company whose shares are listed for trading on specified exchanges outside of Israel, including The NASDAQ Global Market, The NASDAQ Global Select Market, and as of January 14, 2013, The NASDAQ Capital Market, who qualifies as an independent director under the relevant non-Israeli rules relating to independence standards, may be deemed an “independent” director for purposes of the Companies Law, according to a decision made by the audit committee, provided that he or she meets certain non-affiliation criteria, and he or she has not served as a director for more than nine consecutive years. For these purposes, ceasing to serve as a director for a period of two years or less would not be deemed to sever the consecutive nature of such director’s service. Furthermore, pursuant to these regulations, such company may re-appoint a person as an independent director for additional terms, beyond nine years, which do not exceed three years each, inter alia, if the audit committee and the board of directors determine that in light of the independent director’s expertise and special contribution to the board of directors and its committees, the re-appointment for an additional term is for the benefit of the company.

Although the Company has not included such a provision in its Articles, it believes that David Sidransky, Gerald Dogon, Tali Yaron-Eldar, Roy Davis and Yitzhak Peterburg could qualify as independent directors under the Companies Law. In addition, the Company believes that all of its current directors qualify as ‘‘independent directors’’ as defined by The NASDAQ Stock Market.

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. For this matter, the term “compensation” shall not include the grant of an exemption from liability, an undertaking to indemnify, indemnification or insurance.

Board Committees

Our board of directors has established an audit committee, a compensation committee, a nominating and governance committee and a research and development committee.

Audit Committee

Under the listing requirements of The NASDAQ Capital Market, a foreign private issuer is required to maintain an audit committee that 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 Capital 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 Capital Market and the SEC.

The Companies Law requires public companies to appoint an audit committee comprised of at least three directors, including all of the external directors, and further stipulates that the majority of the members of the audit committee must be independent directors under the Companies Law.

The following may not be members of the audit committee: (a) the chairman of the board (b) a director employed by or providing services on an ongoing basis to the company, to a controlling shareholder or to an entity controlled by a controlling shareholder; (c) a director whose livelihood depends on a controlling shareholder, and (d) a controlling shareholder and his relative (as defined in the Companies law). The Companies Law further requires that (i) the chairperson of the audit committee be an external director; (ii) generally, any person who is not entitled to be a member of the audit committee may not attend the audit committee meetings; and (iii) the quorum required for the convening of meetings of the audit committee and for adopting resolutions by the audit committee be a majority of the members of the audit committee provided that the majority of the members present are independent directors and at least one of them is an external director.

Our audit committee provides assistance to the board of directors in fulfilling its responsibility to our shareholders relating to our accounting, financial reporting practices, and the quality and integrity of our financial reports. The audit committee also oversees consultants and experts providing the company with consulting services concerning risk management and internal control structure, pre-approves the services performed by our independent auditors and oversees that management has established and maintains processes to assure compliance by the Company with all applicable laws, regulations and corporate policies. The audit committee also oversees and ensures the independence of our independent auditors.

The responsibilities of the audit committee under the Companies Law include: (a) identifying deficiencies in the management of a company’s business, including by consulting with the internal auditor or with the independent auditor (and in case that the deficiency is a significant one – the committee shall convene), and making recommendations to the board of directors as to how to modify them; (b) decide for the purpose of the approval of actions involving fiduciary duties of the company's office holders, whether such actions are material or non-material actions and for the purpose of the approval of certain related party transactions, whether such transactions are extraordinary transactions or non-extraordinary transactions; (c) with respect to transactions with controlling shareholders, to determine the obligation to perform a competitive process that shall be supervised by the audit committee; (d) to decide whether to approve related parties transactions and actions involving fiduciary duties of the company’s office holders; (e) to determine the process in which non-negligible transactions with a controlling shareholder shall be approved and to determine the type and kind of such transactions that shall require the approval of the audit committee; (f) to review the internal auditor’s work program before it is brought for the approval of the board; (g) to examine the company’s internal control structure and processes, the performance of the internal auditor and whether the internal auditor has at his or her disposal the tools and resources required to perform his or her duties, considering, inter alia, the special needs of the company and its size; (h) to examine the independent auditor’s scope of work as well as the independent auditor’s fees and to provide the corporate organ responsible for determining the independent auditor’s fees with its recommendations; (i) be responsible for providing for arrangements as to the manner in which the Company will deal with employee complaints with respect to deficiencies in the administration of the Company’s business and the protection to be provided to such employees.

Gerald Dogon, Tali Yaron-Eldar and Dr. David Sidransky are the current members of our audit committee. Each of these persons is an ‘independent director’ in accordance with the NASDAQ listing standards.

Compensation Committee

Our compensation committee reviews and provides our board of directors with recommendations relating to compensation and benefits of our officers and key employees and assists the board of directors with establishing, overseeing and/or administering incentive compensation and equity based plans. The compensation committee reviews corporate goals and objectives set by our board that are relevant to compensation of the Chief Executive Officer, evaluates the performance of the Chief Executive Officer in light of those goals and objectives, and recommends to the board of directors the Chief Executive Officer’s compensation based on such evaluations, subject to additional approvals, to the extent required pursuant to the Companies Law. The compensation committee also reviews and makes recommendations for approvals to the board of directors, subject to additional approvals, to the extent required pursuant to the Companies Law, with respect to the compensation of directors, executive officers other than the Chief Executive Officer and key employees. The members of our compensation committee are, Gerald Dogon, Tali Yaron Eldar and Joshua Rosensweig

Amendment 20 to the Companies Law was published on November 12, 2012 and became effective on December 12, 2012 (“Amendment 20”). In general, Amendment 20 requires public companies to appoint a compensation committee and to adopt a compensation policy with respect to its officers (the “Compensation Policy”). In addition, Amendment 20 addresses the corporate approval process required for a public company’s engagement with its officers (with specific reference to a director, a non-director officer, a Chief Executive Officer and controlling shareholders and their relatives who are employed by the company).

According to Amendment 20, the compensation committee shall be nominated by the board of directors and be comprised of board members. The compensation committee must consist of at least three members. All of the external directors must serve on the compensation committee and constitute a majority of its members (in some cases, a company whose shares are listed for trading on specified exchanges outside of Israel, including The NASDAQ Capital Market, may appoint a compensation committee in which the external directors do not constitute a majority). The remaining members of the compensation committee must be directors whose compensation should be identical to the compensation paid to the external directors of the company.

The roles of the compensation committee under the Companies Law are, to: (1) recommend to the board of directors on the Compensation Policy for office holders, and recommend to the board once every three years regarding the extension of a Compensation Policy that had been approved for a period of more than three years; (2) recommend to the board of directors on periodic updates to the Compensation Policy, from time to time, and examine its implementation; (3) decide whether to approve the terms of office and of employment of office holders that require approval of the Compensation Committee; and (4) decide, in certain circumstances, and subject to certain terms whether to exempt the approval of terms of office of a proposed CEO from the requirements of shareholders’ approval.

The Compensation Policy generally requires the approval of the general meeting of shareholders with a Special Majority, as defined below.

Amendment 20 details the considerations that should be taken into account in determining the Compensation Policy and certain issues which the Compensation Policy should include.

Nominating and Governance Committee

The nominating and governance committee is responsible for making recommendations to the board of directors regarding candidates for directorships and the composition of our board of directors and its committees as well as to evaluate and consider matters relating to the qualifications of directors. In addition, the nominating and governance committee is responsible for reviewing and reassessing our corporate governance guidelines and making recommendations to the board of directors concerning governance matters. The members of our nominating and governance committee are Brian Markison, Dr. Joshua Rosensweig and Dr. Yitzhak Peterburg. Our board of directors has determined that the members of our nominating and governance committee are independent under the applicable NASDAQ Capital Market rules.

Pursuant to our Articles, nominations for the election of directors may be made by the board of directors or a committee appointed by the board of directors or by any shareholder holding at least 1% of the outstanding voting power in the Company. However, any such shareholder 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 delivered to us as required under our Articles.

Research and Development Committee

The research and development committee is responsible for liaising between the Company’s research and development team and the board of directors. This committee is also responsible for reviewing proposed research and development projects, as well as our research and development focus and making recommendations to the board of directors regarding the research and development projects which we intend to undertake as well as recommendations relating to our pipeline. The members of our research and development committee are Roy Davis, Dr. Yitzhak Peterburg and Dr. David Sidransky.

Internal Auditor

Under the Companies Law, the board of directors must appoint an internal auditor recommended 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, among other things, 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 a relative of an interested party or an office holder, nor may the internal auditor be the company’s independent auditor or anyone on his behalf. An interested party is defined in the Companies Law as a holder of 5% or more of the Company’s outstanding shares or voting rights, 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’s tenure cannot 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 the internal auditor the 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 — Additional Information — 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.

EMPLOYEES

We had 77 and 52 employees as of December 31, 2015 and 2014, respectively. Of the 77 employees as of December 31, 2015, 40 were engaged in research and development and in our CLIA lab activities and 37 were engaged in management, administration, business development, marketing and finance. 58 employees were located in the United States and 19 were located in Israel.

The Israeli labor laws govern the employment of employees located in Israel. These statutes cover a wide range of subjects and provide certain minimum employment standards including the length of the workday, minimum wage, hiring and dismissal procedures, determination of severance pay, annual leave, sick days and other terms of employment.

We contribute (usually following a trial period of three months) monthly amounts for the benefit and on behalf of all our employees located in Israel to a Managers Insurance plan and/or a pension fund. In General, according to the Israeli Severance Pay Law, the severance pay liability of the company to its Israeli employees is based upon the number of years of employment and the latest monthly salary. Nevertheless, since our contributions to the Managers Insurance plan and/or the pension fund are made pursuant to section 14 of the Israeli Severance Pay Law, our liability for severance pay is covered by our regular contributions to the Managers Insurance plan and the pension fund.

We have never experienced labor-related work stoppages and believe that our relations with our employees are good.

SHARE OWNERSHIP

The following table sets forth, as of March 1, 2016, the number of our ordinary shares beneficially owned by (i) each of our directors and corporate and executive officers and (ii) our current directors and corporate and executive officers as a group. The information in this table is based on 20,851,225 ordinary shares outstanding as of March 1, 2016. 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 March 1, 2016 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
Kenneth A. Berlin (1)		252,622		1.2%
Ron Kalfus (2)		15,843		*
Dganit Bar, Ph.D. (3)		27,864		*
E. Robert Wassman, M.D. (4)		8,370		*
Oded Biran (5)		16,093		*
Eti Meiri (6)		11,875		*
Sigal Russo-Gueta (7)		7,631
Brian Markison (8)		89,000		*
Yitzhak Peterburg, M.D., Ph.D. (9)		42,000		*
Roy N. Davis (10)		34,000		*
Joshua Rosensweig (11)		36,634		*
Dr. David Sidransky (12)		34,462		*
Gerald Dogon (13)		21,212		*
Tali Yaron-Eldar (14)		21,212		*
Current directors and executive officers as a group (14 persons) (16)		618,818		2.90%

* Less than 1%

(1)

Consists of (i) 1,084 ordinary shares, which were granted to Mr. Berlin upon the start of his employment with us, 9,878 shares, which were granted as RSUs and converted to shares in 2013, and 3,622 shares which were granted as RSUs and converted to shares in 2015 and (ii) options currently exercisable or exercisable within 60 days of March 1, 2016 to purchase 8,335 ordinary shares (which have an exercise price of $123.00 per share and expire in November 2019), 8,334 ordinary shares (which have an exercise price of $29.4 per share and expire in November 2019), 6,667 ordinary shares (which have an exercise price of $6.75 per share and expire in November 2021), 72,000 ordinary shares (which have an exercise price of $5.37 per share and expire in October 2022), 111,452 ordinary shares (which have an exercise price of $3.41 per share and expire in August 2023) and 31,250 ordinary shares (which have an exercise price of $2.79 per share and expire in November 2024). Does not include the following options that become exercisable after April 30, 2016: (i) options to purchase 24,000 ordinary shares (which have an exercise price of $5.37 per share and expire in October 2022), (ii) 66,872 ordinary shares (which have an exercise price of $3.41 per share and expire in August 2023), (iii) 68,750 ordinary shares (which have an exercise price of $2.79 per share and expire in November 2024), (iv) 220,000 ordinary shares (which have an exercise price of $1.16 per share and expire in December 2022), (v) 15,000 RSUs (which will vest in equal instalments annually over a period of four years and complete convert to shares in November 2018) and (vi) 45,000 RSUs (which will vest one year after the date of grant and complete convert to shares in December 2016).

(2)

Consists of (i) 3,000 shares, which were granted as RSUs and converted to shares in 2013, and 3,000 shares, which were granted as RSUs and converted to shares in 2015 and (ii) options currently exercisable or exercisable within 60 days of March 1, 2016 to purchase 7,500 ordinary shares (which have an exercise price of $5.37 per share and expire in October 2022), and 2,343 ordinary shares (which have an exercise price of $2.57 per share and expire in December 2024). Does not include the following options that become exercisable after April 30, 2016: (i) options to purchase 2,500 shares (which have an exercise price of $5.37 per share and expire in October 2022) (ii) options to purchase 5,157 shares (which have an exercise price of $2.57 per share and expire in December 2024).

(3)

Consists of (i) 5,000 shares, which were granted as RSUs and converted to shares in 2013 and 5,000 shares, which were granted as RSUs and converted to shares in 2015 and (ii) options currently exercisable or exercisable within 60 days of March 1, 2016 to purchase 15,000 ordinary shares (which have an exercise price of $5.21 per share and expire in October 2022), and 2,864 ordinary shares (which have an exercise price of $2.57 per share and expire in December 2024).Does not include the following options that become exercisable after April 30, 2016: (i) options to purchase 5,000 shares (which have an exercise price of $5.21 per share and expire in October 2022) and (ii) options to purchase 6,303 shares (which have an exercise price of $2.57 per share and expire in December 2024).

(4)

Consists of 3,370 shares, which were granted as RSUs and converted to shares in 2013 and 5,000 shares, which were granted as RSUs and converted to shares in 2015. Dr. Wassman resigned as our Chief Medical Officer effective September 18, 2015.

(5)

Consists of (i) 3,000 shares, which were granted as RSUs and converted to shares in 2013, and 3,000 shares, which were granted as RSUs and converted to shares in 2015 and (ii) options currently exercisable or exercisable within 60 days of March 1, 2016 to purchase 1,000 ordinary shares (which have an exercise price of $2.475 per share and expire in February 2022), 6,750 ordinary shares (which have an exercise price of $5.37 per share and expire in October 2022) and 2,343 ordinary shares (which have an exercise price of $2.57 per share and expire in December 2024). Does not include the following options that become exercisable after April 30, 2016: (i) options to purchase 2,250 shares (which have an exercise price of $5.37 per share and expire in October 2022) and (ii) 5,157 ordinary shares (which have an exercise price of $2.57 per share and expire in December 2024). Mr. Biran resigned as our Chief Legal Officer effective March 6, 2016.

(6)

Consists of (i) 1,875 shares, which were granted as RSUs and converted to shares in the years 2014 and 2015, (ii) 18 shares, which were granted as options and converted to shares in 2014 and (iii) options currently exercisable or exercisable within 60 days of March 1, 2016 to purchase 21 ordinary shares (which have an exercise price of $209.78 per share and expire in April 2016), 34 ordinary shares (which have an exercise price of $249.6 per share and expire in June 2018), 84 ordinary shares (which have an exercise price of $84 per share and expire in October 2020), 7,500 ordinary shares (which have an exercise price of $5.37 per share and expire in October 2022) and 2,343 ordinary shares (which have an exercise price of $2.57 per share and expire in December 2024). Does not include the following options that become exercisable after April 30, 2016: (i) options to purchase 2,500 shares (which have an exercise price of $5.37 per share and expire in October 2022) (ii) options to purchase 5,157 shares (which have an exercise price of $2.57 per share and expire in December 2024) and (iii) 4,125 RSUs (which will vest in equal installment quarterly over a period of 4 years and complete convert to shares in October 2018).

(7)

Consists of (i) 3,000 shares, which were granted as RSUs and converted to shares in 2015 and (ii) options currently exercisable or exercisable within 60 days of March 1, 2016 to purchase 100 ordinary shares (which have an exercise price of $133.80 per share and expire in March 2019), 3,750 ordinary shares (which have an exercise price of $4.27 per share and expire in December 2022), and 781 ordinary shares (which have an exercise price of $2.57 per share and expire in December 2024) . Does not include the following options that become exercisable after April 30, 2016: (i) options to purchase 1,250 shares (which have an exercise price of $4.27 per share and expire in December 2022) and (ii) options to purchase 1,719 shares (which have an exercise price of $2.57 per share and expire in December 2024).

(8)

Consists of (i) 20,000 shares, which were granted as RSUs and converted to shares in the years 2013 and 2014 and (ii) options currently exercisable or exercisable within 60 days of March 1, 2016 to purchase 5,000 ordinary shares (which have an exercise price of $16.2 per share and expire in July 2021), 48,000 ordinary shares (which have an exercise price of $5.37 per share and expire in October 2019), and 16,000 ordinary shares (which have an exercise price of $2.77 per share and expire in November 2021). Does not include the following options that become exercisable after April 30, 2016: 32,000 ordinary shares (which have an exercise price of $2.77 per share and expire in November 2021).

(9)

Consists of (i) 10,000 shares, which were granted as RSUs and converted to shares in the years 2013 and 2014 and (ii) options currently exercisable or exercisable within 60 days of March 1, 2016 to purchase 24,000 ordinary shares (which have an exercise price of $4.29 per share and expire in November 2019), and 8,000 ordinary shares (which have an exercise price of $2.77 per share and expire in November 2021). Does not include the following options that become exercisable after April 30, 2016: 16,000 ordinary shares (which have an exercise price of $2.77 per share and expire in December 2021).

(10)

(11)

Consists of (i) 2,306 ordinary shares held by Dr. Rosensweig, (ii) 10,000 shares, which were granted as RSUs and converted to shares in the years 2013 and 2015 and (iii) options currently exercisable or exercisable within 60 days of March 1, 2016 to purchase 212 ordinary shares (which have an exercise price of $368.67 per share and expire in July 2016), 116 ordinary shares (which have an exercise price of 209.78 per share and expire in July 2016) and 24,000 ordinary shares (which have an exercise price of 5.37 per share and expire in October 2019).

(12)

Consists of (i) 10,000 shares, which were granted as RSUs and converted to shares in the years 2013 and 2014 and (ii) options currently exercisable or exercisable within 60 days of March 1, 2016 to purchase 250 ordinary shares (which have an exercise price of $342 per share and expire in January 2018), 212 ordinary shares (which have an exercise price of $99 per share and expire in December 2019) and 24,000 shares (which have an exercise price of $5.37 per share and expire in October 2019).

(13)

Consists of (i) 5,000 shares, which were granted as RSUs and converted to shares in 2014 (ii) options currently exercisable or exercisable within 60 days of March 1, 2016 to purchase 212 ordinary shares (which have an exercise price of $528.01 per share and expire in March 2017), and 16,000 ordinary shares (which have an exercise price of $3.41 per share and expire in August 2020). Does not include the following (i) options that become exercisable after April 30, 2016: options to purchase 8,000 shares (which have an exercise price of $3.41 per share and expire in August 2020).

(14)

(15)

See notes 1 through 14 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 subsidiary 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 5,363 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 March 1, 2016, options to purchase 32 ordinary shares have been previously granted and remain outstanding under the 2003 Plan and 6,911 shares have been previously 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 8,333 shares under the 2006 Plan. In December 2009, our shareholders approved an additional 25,000 shares under the 2006 Plan. In October 2012, our shareholders approved an additional 853,770 shares under the 2006 Plan. In November 2014, our shareholders approved an additional 900,000 shares under the 2006 Plan. In December 2015, our shareholders approved an additional 765,000 shares under the 2006 Plan. As of March 1, 2016, there were 1,028,005 shares available for grant under the 2006 Plan, 165,277 shares have been issued pursuant to the exercise of options granted under the 2006 Plan and options to purchase 1,375,508 ordinary shares have been granted and are outstanding under the 2006 Plan. The 2006 Plan, and its appendices 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 office holders and those of our subsidiary and affiliates.

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 a minimum requisite period, which is currently two years from the date of grant. 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 generally subject to a capital gains tax of 25%, provided, however, that in accordance with Section 102(b)(3) of the Israel Income Tax Ordinance, if the exercise price of the options is lower than the average closing price of the shares in the 30 trading days preceding the grant, the difference between such average closing price and the exercise is taxed as ordinary employment income rates.

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 option holder holds more than 10% of our share capital.

Options granted under our employee benefit plans generally vest over three or four years, and they generally expire ten years from the date of grant. If we terminate the employment or engagement of a participant under the 2006 Plan for cause, all of such participant’s vested and unvested options expire immediately upon the date of such termination for cause unless specified otherwise in the award agreement. Upon termination of employment for any other reason, including due to death or disability of the participant, vested options may be exercised within three months of the date of termination, unless otherwise determined in the award agreement. Vested options not exercised within the prescribed period and options which have expired prior to vesting are available for future grants under the 2006 plan.

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 shares or assets, the options will be assumed or substituted by the acquiring entity, or if the acquiring party does not provide for such assumption or substitution, then the options shall be subject to acceleration.

ITEM 7.

MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS

MAJOR SHAREHOLDERS

On March 4, 2016, entities and individuals affiliated with Dolphin Offshore Partners, L.P. (collectively, “Dolphin”) filed a Schedule 13D with the SEC disclosing beneficial ownership of 1,114,738 of our ordinary shares (including 208,333 shares issuable upon exercise of warrants) as of February 24, 2016. This represents approximately 5.4% of our outstanding ordinary shares as of December 31, 2015. Based on a review of required SEC filings, we are not aware of any other person or entity that is the beneficial owner of more than 5% of our outstanding ordinary shares.

Our ordinary shares are traded on the NASDAQ Capital Market in the United States. 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

On November 23, 2015, entities and individuals affiliated with Sabby Management, LLC (collectively, “Sabby”) filed a Schedule 13G with the SEC disclosing beneficial ownership of 1,031,250 of our ordinary shares as of October 15, 2015, representing approximately 5.8% of our outstanding ordinary shares. On January 14, 2016, Sabby filed a Schedule 13G/A with the SEC disclosing beneficial ownership of 674,576 of our ordinary shares as of December 31, 2015, representing approximately 3.8% of our outstanding ordinary shares.

On November 23, 2015, entities and individuals affiliated with Empery Asset Management, LP (collectively, “Empery”) filed a Schedule 13G with the SEC disclosing beneficial ownership of 1,031,250 ordinary shares and 515,625 ordinary shares issuable upon exercise of warrants as of October 13, 2015, representing approximately 5.7% of our outstanding ordinary shares. On January 19, 2016, Empery filed a Schedule 13G/A with the SEC disclosing beneficial ownership of 386,136 ordinary shares and 515,625 ordinary shares issuable upon exercise of warrants as of December 31, 2015, representing approximately 4.8% of our outstanding ordinary shares.

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 March 1, 2016, our officers and directors as a group beneficially owned less than 2.9% of our outstanding ordinary shares.

RELATED PARTY TRANSACTIONS

Other than transactions related to compensation of our officers and directors as described under “Item 6. Directors, Senior Management and Employees—B. Compensation,” since January 1, 2015, we have not entered into any related party transactions.

Exemption, Indemnification and Insurance

Our Articles permit us to exempt from liability, indemnify and insure our directors and officers to the fullest extent permitted by the Companies Law. An undertaking provided in advance by an Israeli company to indemnify an office holder with respect to a financial liability imposed on or incurred by him or her in favor of another person pursuant to a judgment, settlement or arbitrator’s award approved by a court must be limited to events which in the opinion of the board of directors can be foreseen based on the company’s activities when the undertaking to indemnify is given, and to an amount or criteria determined by the board of directors as reasonable under the circumstances, and such undertaking shall detail the abovementioned events and amount or criteria. In addition, a company may indemnify an office holder against the following liabilities incurred for acts performed as an office holder:

reasonable litigation expenses, including attorneys’ fees, incurred by the office holder as a result of an investigation or proceeding instituted against him or her by an authority authorized to conduct such investigation or proceeding, provided that (i) no indictment was filed against such office holder as a result of such investigation or proceeding; and (ii) either (A) no financial liability was imposed upon him or her as a substitute for the criminal proceeding as a result of such investigation or proceeding or, (B) if such financial liability was imposed, it was imposed with respect to an offense that does not require proof of criminal intent or with respect to monetary sanction; and

reasonable litigation expenses, including attorneys’ fees, incurred by the office holder or imposed by a court in proceedings instituted against him or her by the company, on its behalf or by a third party or in connection with criminal proceedings in which the office holder was acquitted or criminal proceedings in which the office holder was convicted in an offense that does not require proof of criminal intent.

An Israeli company may insure an office holder against the following liabilities incurred for acts performed as an office holder:

a breach of duty of loyalty to the company, to the extent that the office holder acted in good faith and had a reasonable basis to believe that the act would not prejudice the company;

a breach of duty of care to the company or to a third party; and

a financial liability imposed on the office holder in favor of a third party.

An Israeli company may not indemnify or insure an office holder against any of the following:

a breach of duty of loyalty, except to the extent that the office holder acted in good faith and had a reasonable basis to believe that the act would not prejudice the company;

a breach of duty of care committed intentionally or recklessly, excluding a breach arising out of the negligent conduct of the office holder;

an act or omission committed with intent to derive illegal personal benefit; or

a fine, monetary sanction, forfeit or penalty levied against the office holder.

As of the effective date of Amendment 20 to the Companies Law, exemption of liability, indemnification and insurance of office holders are included in the definition of “terms of office and of employment” and as such must be approved in a specific manner, as noted below under “Item 10 – Additional Information – B. Memorandum and Articles of Association - Directors’ and Officers’ Compensation.”

Our directors and officers are currently covered by a directors’ and officers’ liability policy and our legal department is currently covered by a legal professional liability policy as well. We have also resolved to provide directors and certain other office holders with indemnification from any liability for damages caused as a result of a breach of duty of care and to provide such directors and other office holders with an exemption, to the fullest extent permitted by law, all in accordance with and pursuant to the terms set forth in our standard indemnification undertaking.

INTERESTS OF EXPERTS AND COUNSEL

Not applicable.

ITEM 8.

FINANCIAL INFORMATION

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 material 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.

SIGNIFICANT CHANGES

None

ITEM 9.

THE OFFER AND LISTING

OFFER AND LISTING DETAILS

Our ordinary shares began trading on The NASDAQ Global Market on February 27, 2007 under the symbol “ROSG.” On June 30, 2010, we transferred the listing of our ordinary shares from The NASDAQ Global Market to The NASDAQ Capital Market. Prior to February 27, 2007, there was no established public trading market for our ordinary shares. The high and low sales prices per share of our ordinary shares for the periods indicated are set forth below. This information reflects the 1-for-4 reverse stock split effected on July 6, 2011 and the 1-for 15 reverse stock split effected on May 14, 2012.

Year Ended	High		Low
December 31, 2011	$	61.80	$	1.95
December 31, 2012	$	23.43	$	1.40
December 31, 2013	$	5.98	$	2.35
December 31, 2014	$	6.69	$	2.07
December 31, 2015	$	4.48		1.05

Quarter Ended
March 31, 2014	$	6.69	$	2.87
June 30, 2014	$	5.40	$	3.43
September 30, 2014	$	4.37	$	3.25
December 31, 2014	$	3.53	$	2.07
March 31, 2015	$	3.55	$	2.29
June 30, 2015	$	4.48	$	2.90
September 30, 2015	$	3.44	$	2.20
December 31, 2015	$	2.68	$	1.05

Month Ended
September 30, 2015	$	3.10	$	2.35
October 31, 2015	$	2.68	$	2.11
November 30, 2015	$	2.32	$	1.33
December 31, 2015	$	1.40	$	1.05
January 31, 2016	$	1.30	$	0.71
February 29, 2016	$	1.29	$	0.75

PLAN OF DISTRIBUTION

Not applicable.

MARKETS

Our ordinary shares are traded only in the United States on The NASDAQ Capital Market.

SELLING SHAREHOLDERS

Not applicable.

DILUTION

Not applicable.

EXPENSES OF THE ISSUE

Not applicable.

ITEM 10.

ADDITIONAL INFORMATION

SHARE CAPITAL

Not applicable.

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 is to carry on any business and perform any act which is not prohibited by law.

Fiduciary Duties of Office Holders

An “office holder” is defined in the Companies Law as a general manager, general business manager, vice general manager, deputy general manager, or any other person fulfilling or assuming any of the foregoing positions without regard to such person’s title, as well as a director, or a manager directly subordinate to the managing director.

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 standard of skills with which a reasonable office holder in the same position would have acted under the same circumstances. The duty of care includes a duty to use reasonable means to obtain, considering the relevant circumstances:

information regarding the business advisability of a given action brought for his or her approval or performed by him or her by virtue of his or her position; and

all other information of importance pertaining to the aforesaid actions.

The duty of loyalty requires an office holder to act in good faith and for the benefit of the company and includes a duty to:

refrain from any act involving a conflict of interest between the fulfillment of his or her role in the company and the fulfillment of any other role or his or her personal affairs;

refrain from any activity that is competitive with the business of the company;

refrain from exploiting any business opportunity of the company with the aim of obtaining a personal gain for himself or herself or others; and

disclose to the company all information and provide it with all documents relating to the company’s affairs which the office holder has obtained due to his position in the company.

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 and documents 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”, is defined by the Companies Law, as a personal interest of a person in an act or transaction of the company, including a personal interest of his or her relative or of a corporate body in which that person or his relative holds 5% or more of the outstanding shares or voting rights, is a director or general manager, or in which either of them 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 term “personal interest” also includes the personal interest of a person voting under a proxy given by another person, even if such appointing person has no personal interest in the proposed act or transaction. In addition, the vote of a person voting under a proxy given by a person having a personal interest in the proposed act or transaction, even if the person voting under the proxy has no personal interest, shall be deemed as a vote made by a person having a personal interest in the proposed act or transaction. The Companies Law defines a “relative” as a person’s spouse, sibling, parent, grandparent or descendent, as well as the descendant, sibling or parent of a person’s spouse, or the spouse of any of the foregoing.

Notwithstanding the above, if the transaction is not an extraordinary transaction, the office holder is not required to disclose any personal interest that he or she has solely as a result of a personal interest of his or her relative in the transaction.

Transactions Requiring Special Approval

Under the Companies Law, an extraordinary transaction is a transaction:

not in the ordinary course of business of the company;

not on market terms; or

likely to have a material impact on the company’s profitability, assets or liabilities.

Under the Companies Law, certain transactions require special approvals, provided however that such transactions are for the benefit of the company. A transaction, between the company and an office holder, or between the company and a third party in which the office holder has a personal interest, must be approved by the board, subject to the provisions of the company’s articles of association. If the transaction is an extraordinary transaction, then it also must be approved by the audit committee, prior to the approval of the board of directors. Any engagement between a company and any one of its office holders with respect to terms of office and/or employment by the company, including with respect to the grant of exemption from liability, indemnification or insurance would generally require compensation committee and board of directors’ approval, and in some cases followed by approval of the general assembly, all as noted below under “Directors’ and Officers’ Compensation.” Generally, any person having a personal interest in the approval of a transaction which is considered at a meeting of the board of directors or the audit committee, may not be present at such meeting or participate in the vote on such transaction, provided however that an office holder having a personal interest in a transaction may be present in order to present such transaction, if the chairman of the audit committee or of the board of directors, as applicable, determine that the presence of such office holder is required for the presentation of the transaction. Notwithstanding the foregoing, a director may be present at such meeting and may participate in the vote on such transaction, if the majority of the board of directors or the audit committee, as applicable, has a personal interest in the transaction. If a majority of the directors have 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 activities of the company, including a shareholder holding 25% or more of the voting rights if no other shareholder owns more than 50% of the voting rights in the company, 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. If two or more shareholders are interested parties in the same transaction, their shareholdings are combined for the purposes of calculating percentages.

Under the Companies Law, extraordinary transactions of a public company with a controlling shareholder or in which a controlling shareholder has a personal interest, as well as any engagement between a public company and a controlling shareholder thereof or such controlling shareholder’s relative, whether directly or indirectly, including through a company controlled by such person with respect to the provision of services to the company, and if such person is also an office holder of such company - with respect to such person’s terms of service and employment as an office holder, and if such person is an employee of the company but not an office holder with respect to such person’s employment by the company (“a Controlling Shareholders Transaction”), generally requires the approval of the audit committee, (or if the transaction is with respect to terms of employment and or office – the compensation committee), the board of directors and the shareholders of the company. If such shareholder approval is required, it must satisfy either of the following criteria (“Special Majority”):

the majority of the votes for the approval includes a majority of the votes of voting shareholders 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 of the transaction, among the shareholders who have no personal interest in the transaction shall not exceed 2% of the aggregate voting rights in the company.

Such transactions with a controlling shareholder or in which a controlling shareholder has a personal interest, that are for a period of more than three years generally need to be brought for approval in accordance with this above procedure every three years.

In those circumstances in which shareholders’ approval is required, shareholders have the right to review any documents in the company’s possession related to the proposed transaction. However, the company may prohibit a shareholder from reviewing the documents if the company believes the request was made in bad faith, the documents include trade secrets or patents or their disclosure could otherwise harm the company’s interests.

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’ and Officers’ Compensation

As of the effective date of Amendment 20 to the Companies Law, directors’ and officers’ compensation, including exemption from liability, indemnification and insurance are included in the definition of “terms of employment and of office”, and as such must be approved in the following manner:

Office holder (or “Officer”) (except for director and the CEO) – generally, by the compensation committee, followed by the board of directors.

CEO – generally, by the compensation committee, followed by the board of directors and the general meeting with a Special Majority. Notwithstanding the above, the compensation committee may exempt the employment terms of a proposed CEO from the approval of the shareholders, provided that the proposed CEO is independent based on criteria set forth in the Companies Law, the compensation committee determined that bringing the transaction to the approval of the shareholders will prevent the transaction; and the proposed employment terms are consistent with the provisions of the company's compensation policy.

Director – generally, by the compensation committee, followed by the board of directors and the general meeting; if in accordance with the Compensation Policy –with a simple majority, if not in accordance with the Compensation Policy – with a Special Majority.

Controlling shareholder - generally, by the compensation committee, followed by the board of directors and the general meeting, with a Special Majority.

The terms of employment and office must be consistent with the company's compensation policy, provided that the compensation committee and the board of directors may, in special circumstances, approve terms of employment and office that are not in accordance with the compensation policy, subject to specific conditions regarding the consideration to be considered by the compensation committee and the board, mandatory provisions to be included in such employment terms and subject to the approval of the shareholders with a Special Majority.

Notwithstanding the above, with respect to the terms of employment of office holders or CEO who are not controlling shareholders or relatives of a controlling shareholder and do not serve as directors, the compensation committee and the board of directors may, in special circumstances and under specific terms determined in the Companies law, approve such employment terms even if the shareholders' meeting objected to their approval.

Under the Companies Law, non-material amendments to terms of employment of office holders (including the CEO), require only the approval of the compensation committee.

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.

Rights Attached to Our Shares

Dividend Rights . Our Articles 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, dividends, to the extent declared, are distributed according to the proportion of the nominal (par) value paid up on account of the shares held at the date so appointed by the Company, without regard to the premium paid in excess of the nominal (par) value, if any. Under the Companies Law, a company may only distribute a dividend which derives from its profits, as such term is defined under the Companies Law (the profit requirement), and provided that the distribution does not create a reasonable concern that the company will be unable to meet its existing and foreseeable obligations as they become due. A court may allow a company to distribute a dividend which does not comply with the profit requirement, as long as the court is convinced that there is no reasonable concern that such distribution might prevent the company from being able to meet its existing and foreseeable 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. 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. With respect to the election of external directors see Item 6. “Directors, Senior Management and Employees– C. Board Practices - External Directors.”

Liquidation Rights . In the event of our liquidation, subject to applicable law, 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 and to our Articles, issue redeemable preference shares and redeem the same.

Capital Calls . Under our Articles and the Companies Law, the liability of our shareholders is limited to the nominal (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, unless such transfer is restricted or prohibited by another instrument and subject to applicable securities laws.

Modification of Rights

Pursuant to our Articles, if at any time our share capital is divided into different classes of shares, the rights attached to any class, unless otherwise provided by our Articles, may be modified or abrogated by the Company, by a resolution of the shareholders, subject to the consent in writing of the holders of at least a majority of the issued shares of such class or the adoption of a resolution passed at a separate meeting of the holders of the shares of such class.

Shareholders’ Meetings and Resolutions

Pursuant to our Articles, the quorum required for an ordinary meeting of shareholders consists of at least two shareholders present in person or by proxy, who hold shares conferring in the aggregate more than 25% of the voting power of the Company. 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 meeting 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 or 35 days prior notice to the extent required under regulations promulgated under the Companies Law.

Under the Companies Law and our Articles, all resolutions of our shareholders require a simple majority of the shares present, in person or by proxy or by written ballot, and voting on the matter, subject to certain exceptions provided for in our Articles namely: (a) the amendment of the provisions of our Articles relating to the election of directors, which require the approval of the greater of (i) holders of not less than seventy-five percent (75%) of the voting power represented at a meeting in person or by proxy and voting thereon, or (ii) holders of a majority of the outstanding voting power of all shares of the Company voting on such matter at a general meeting; (b) the removal of any director from office, the election of a director in place of a director so removed or the filling of any vacancy, however created, on the board of directors, which require the vote of the holders of at least 75% of the voting power represented at the meeting; and (c) the consummation of a merger (as defined in the Companies Law) which requires the approval of the holders of at least a majority of the voting power of the Company.

Under the Companies Law, each and every shareholder has a duty to act in good faith and in customary manner in exercising his or her rights and fulfilling his or her obligations towards the company in which he or she holds shares and other shareholders, and refrain from abusing his or her power in the company, including 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 interested party transactions that require shareholder approval.

In addition, each and every shareholder has the general duty to refrain from discriminating against other shareholders. 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 of directors. All general meetings other than annual general meetings are called extraordinary general meetings.

Our board of directors may, in its discretion, convene additional meetings as “extraordinary general meetings.” In addition, the board of directors must convene an extraordinary general meeting upon the demand of (i) two of the directors or one fourth of the directors in office, (ii) one or more shareholders having at least 5% of the 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 shall preside at each of our general meetings, or if at any meeting the chairperson is not present within fifteen (15) minutes after the time fixed for holding the meeting or is unwilling to act as chairperson, then if there is a co-chairperson, such co-chairperson shall preside at the meeting, or in the absence of both or if both are unwilling to act as chairperson, the shareholders present shall choose someone of their number to be chairperson. 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

Our Articles and Israeli law do not restrict in any way the ownership or voting of ordinary shares by non-residents or persons who are not citizens of Israel, except with respect to subjects of nations which are in a state of war with Israel. We are members of the Rimonim Consortium, and a “Magneton” project which are supported by the OCS. According to the Encouragement of Industrial Research and Development Law, 5744-1984, a change of control of our company should be reported to the research committee at the Ministry of Economy (the Committee), and a change in the holding of the means of control in our company (means of control include the right to vote at a general meeting of a company or a corresponding body of another corporation or the right to appoint directors of the corporation or its general manager) which results in any person not being a citizen or resident of Israel or corporation incorporated in Israel holding 5% or more of the issued share capital or of the voting power of our company, should be reported to the committee, which (according to its internal proceedings) will notify us of its decision within seven days from the date thereof, and such person should sign an undertaking in the form published by the research committee.

Mergers and Acquisitions and Tender Offers under Israeli Law

The Companies Law includes provisions that allow a merger transaction and generally requires that each company that is a party to a merger have the transaction approved by its board of directors and shareholders (including the separate approval of each class of shares of the party to the merger which is not the surviving entity) at a shareholders’ meeting called on at least 35 days’ prior notice. In addition, under our Articles, approval of a merger transaction requires that holders of at least a majority of the voting power of the Company vote in favor of the merger transaction.

At a voting of the shareholders of a merging company whose shares are held by the other merging company, or by a person holding 25% or more of any means of control in the other merging company, the merger shall not be approved if the majority of the votes of the shareholders present and voting in such meeting (excluding abstentions not taking into consideration the votes of the other merging company, of the person holding 25% or more of any means of control in the other merging company or anyone acting on their behalf, including their relatives or entities under their control), objected to the merger (the " Special Majority Requirement "). If the general meeting of shareholders of a merging company approved the merger proposal, the court may, at the request of holders of at least 25% of the voting rights of the company, determine that the company approved the merger, even if the merger was not approved by all the classes of shares as set forth above or even if the Special Majority Requirement was not met. The court shall not approve a merger request unless the court was convinced that the merger proposal was fair and reasonable, while taking into account the value of the parties to the merger and the consideration offered to the shareholders. Notwithstanding the foregoing, a merger that is also an extraordinary transaction with a controlling shareholder or a transaction with another person in which a controlling shareholder has a personal interest, requires approval as an extraordinary transaction with a controlling shareholder (see “Transactions Requiring Special Approval”).

Under the Companies Law, each merging company must inform its creditors of the proposed merger. The court may, at the request of a creditor of a merging company delay or prevent the execution of the merger, if the court has concluded that there exists a reasonable concern that as a result of the merger, the surviving company will not be able to fulfill the obligations of the merged company and may further give instructions to secure the rights of creditors. 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 Israeli 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, subject to certain exceptions, an acquisition of shares of a public company must be made by means of a special tender offer if as a result of the acquisition the purchaser would become a holder of 25% or more of the voting rights in the company if at that time no other shareholder of the company holds 25% or more of the voting rights in the company. Similarly, the Companies Law provides that, subject to certain exceptions, an acquisition of shares in a public company must be made by means of a special tender offer if as a result of the acquisition the purchaser would become a holder of more than 45% of the voting rights in the company, if at that time there is no other shareholder of the company that holds more than 45% of the voting rights in the company.

Under the Companies Law, a person may not acquire shares of a public company or voting rights in such company if, following the acquisition, the acquirer will hold more than 90% of the company’s shares or more than 90% of any class of shares, other than by means of a tender offer to acquire all of the outstanding shares of the company or all of the shares of the particular class.

The Companies Law also provides that as long as a shareholder in a public company holds more than 90% of the company’s shares or of a class of shares, such shareholder shall be precluded from purchasing any additional shares of such company.

In the event that, either (i) the shareholders who did not accept the tender offer hold less than 5% of the company’s outstanding share capital or of the relevant class of shares and the majority of offerees who do not have a personal interest in accepting the tender offer, have accepted the offer, or (ii) the shareholders who did not accept the tender offer hold less than 2% of the company’s outstanding share capital or of the relevant class, then all of the shares that the acquirer offered to purchase will be transferred to the him by operation of law .

A shareholder that had its shares so transferred, whether he or she accepted the tender offer or not, has the right, within six months from the date of acceptance of the tender offer, to request the court to determine that the consideration for the shares under the tender offer was less than their fair value and that the fair value should be paid as shall be determined by the court. However, the acquirer may provide under the tender offer that shareholders who accepted the tender offer proposal will not be entitled to such remedy.

If the conditions set forth above are not met, the acquirer may not acquire additional shares of the company from shareholders who accepted the tender offer to the extent that following such acquisition the acquirer would own more than 90% of the company’s issued and outstanding share capital.

Any shares that were acquired in contradiction to the above conditions shall not provide any rights and shall be redeemed as long as they are held by the acquirer.

Notwithstanding the above, Israeli antitrust laws require that certain mergers be announced and receive approval of the Israeli Antitrust authority.

MATERIAL CONTRACTS

Please see “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.

EXCHANGE CONTROLS

There are currently no exchange controls in effect in Israel that restrict the repatriation by non-residents of Israel in non-Israeli currency of any dividends, if any are declared and paid, and liquidation distributions.

TAXATION

The following contains a description of material relevant provisions of the current Israeli income tax regime 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

In December 2010, the “Knesset” (Israeli Parliament) passed the Law for Economic Policy for 2011 and 2012 (Amended Legislation), 2011, which prescribes, among others, amendments to the Law. The amendment became effective as of January 6, 2011. According to the amendment, the benefit tracks in the Law were modified and a flat tax rate applies to the Company’s entire preferred income. The Company will be able to opt to apply (the waiver is non-recourse) the amendment and from then on it will be subject to the amended tax rates that are: 2011, 2012, and 2013 - 15% (in development area A - 10%), 2014 and 2015 - 16% (in development area A - 9%).

We examined the possible effect of the amendment on the financial statements, if at all, and at this time do not believe it will opt to apply the amendment.

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 and located in Israel. 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.

Special Provisions Relating to Taxation under Inflationary Conditions

According to the Income Tax law (Inflationary Adjustments), 1985, until 2007 (inclusive), the results for tax purposes were measured based on the changes in the Israeli CPI.

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 Company benefits from certain government programs and tax legislation, particularly as a result of the ‘Approved Enterprise’ or ‘Benefiting Enterprise’ status of substantially all of the Company’s existing production facilities in Israel under the Law for the Encouragement of Capital Investment, 1959 (an “Approved Enterprise”, a “Benefiting Enterprise” and the “ “Investment Law” respectively) 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 Economy (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.

The Investments Law also provides that an Approved Enterprise and a Benefiting Enterprise are entitled to accelerated depreciation on its property and equipment that are included in an Approved Enterprise program or in Benefiting Enterprise equipment, as the case may be, in the first five years of using the equipment, and up to the purchase price of those assets.

Tax Benefits for Income from Approved Enterprises Approved Before April 1, 2005

Before April 1, 2005 an Approved Enterprise was entitled to either receive investment grants and certain tax benefits 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.

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 tax is withheld 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% (as mentioned below) 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. However, 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.

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 “2005 Amendment”). The Investment Law provides that terms and benefits included in any certificate of approval that was granted before the 2005 Amendment came into effect will remain subject to the provisions of the Investment Law as they were on the date of such approval.

The 2005 Amendment changed certain provisions of the Law. As a result of the 2005 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 remained mandatory for companies seeking grants).

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 2005 Amendment states that the company must make an investment which meets all the conditions set out in the 2005 Amendment for tax benefits and exceeds a minimum amount specified in the Investment Law. Such investment allows the company to receive a “Benefiting 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 Benefiting 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 Benefiting 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 Benefiting 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 earliest of 7 (or 10 years) from the commencement year, or 12 years from the first day of the Year of Election. The tax benefits granted to a Benefiting 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 previous Alternative Benefits package, exemption from corporate tax on undistributed income for a period of two to ten years, depending on the geographic location of the Benefiting 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 or ten years, depending on the level of foreign investment in the company. If the company pays a dividend out of income derived from the Benefiting 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 Benefiting 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 Benefiting 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 which has a sufficiently high level of 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 extent of its income that is derived from exports.

Dividends paid out of income derived by a Benefiting 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 Benefiting Enterprise (or out of dividends received from a company whose income is derived from a Benefiting 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 Benefiting Enterprise during the benefits period. A company qualifying for tax benefits under the 2005 Amendment which pays a dividend out of income derived by its Benefiting 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 2005 Amendment changed the definition of “foreign investment” in the Investment 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.

As a result of the 2005 Amendment, tax-exempt income generated under the new provisions will subject us to taxes upon distribution of the tax-exempt income to shareholders or upon liquidation of the company, and we may be required to record a deferred tax liability with respect to such tax-exempt income.

Under the transitional provisions of the 2011 Tax Amendment, the Company may elect whether to irrevocably implement the 2011 Tax Amendment with respect to its existing Approved and Benefiting Enterprises while waiving benefits provided under the legislation prior to the 2011 Tax Amendment or keep implementing the legislation prior to the 2011 Tax Amendment during the next years.

We do not expect the 2011 Tax Amendment to have a material effect on the tax payable in respect of our Israeli operations.

As of December 31, 2013, we 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 require that all cross-border transactions carried out between related parties be conducted on an arm’s length basis and be taxed accordingly. The TP Regs are not expected to have a material effect on us.

Taxation of our Shareholders

To the extent that the following discussion is based on new or existing tax or other legislation that has not been subject to judicial or administrative interpretation, there can be no assurance that the views expressed herein will be accepted by the tax or other authorities in question. The summary below does not address all of the tax consequences that may be relevant to all purchasers of ordinary shares in light of each purchaser’s particular circumstances and specific tax treatment. For example, the summary below does not address the tax treatment of residents of Israel and traders in securities who are subject to specific tax regimes. As individual circumstances may differ, holders of ordinary shares should consult their own tax advisors as to United States, Israeli or other tax consequences of the purchase, ownership and disposition of ordinary shares. This discussion is not intended, nor should it be construed, as legal or professional tax advice and it is not exhaustive of all possible tax considerations. Each individual should consult his or her own tax or legal advisor.

(a) Israeli Taxation

(i) Taxation of Capital Gains Applicable to Non-Israeli Shareholders

Israeli law generally imposes a capital gains tax on the sale of securities and any other capital assets located in Israel. Pursuant to an amendment of the Tax Ordinance in 2005, effective as of January 1, 2006, the capital gains tax rate applicable to individuals upon the sale of securities acquired after that date is 20%. A 25% tax rate will apply to an individual who meets the definition of a ‘Substantial Shareholder’ on the date of the sale of the securities or at any time during the 12 months preceding such date. A ‘Substantial Shareholder’ is defined as a person who, either alone or together with any other person, holds, directly or indirectly, at least 10% of any of the means of control of a company (including, among other things, the right to receive profits of the company, voting rights, the right to receive the company’s liquidation proceeds and the right to appoint a director). Pursuant to an amendment of the Tax Ordinance in 2011, effective as of January 1, 2012, the capital gains tax rate applicable to individuals upon the sale of securities acquired after that date is 25% (instead of 20%), and a 30% tax rate will apply to an individual who meets the definition of a ‘Substantial Shareholder’ on the date of the sale of the securities or at any time during the 12 months preceding such date (instead of 25%). For sake of good order, securities acquired before January 1, 2012 and sold after that date, the profit received from such sale will be taxed as follows: from the purchase date until January 1, 2012 – 20% (or 25% - for Substantial Shareholder), and from January 1, 2012 until sales date – 25% (or 30% for Substantial Shareholder).

In addition, shareholders who bought their securities before January 1, 2003, will be taxed for the profit made from the purchase date until January 1, 2003 in accordance with their marginal rate of income.

With respect to corporate investors capital gain tax of 25% will be imposed on the sale of traded shares. This rate is subject to the provisions of any applicable bilateral double taxation treaty. The treaty concerning double taxation between the United States and Israel (the Convention between the Government of the State of Israel and the Government of the United States of America With Respect to Taxes on Income (the “Treaty”) is discussed below.

In addition, if the shares are traded on the Tel Aviv Stock Exchange, on an authorized stock exchange outside Israel or on a regulated market (which includes a system through which securities are traded pursuant to rules prescribed by the competent authority in the relevant jurisdiction) in or outside Israel, gains on the sale of shares held by non-Israeli tax resident investors will generally be exempt from Israeli capital gains tax. However, non-Israeli corporations will not be entitled to such exemption if Israeli residents (i) have controlling interest of 25% or more in such non-Israeli corporation, or (ii) are the beneficiaries of or are entitled to 25% or more of the revenues or profits of such non-Israeli corporation, whether directly or indirectly. Notwithstanding the foregoing, dealers in securities in Israel are taxed at regular tax rates applicable to business income. In addition, persons paying consideration for shares, including purchasers of shares, Israeli securities dealers effecting a transaction, or a financial institution through which securities being sold are held, are required, subject to any applicable exemptions and the demonstration of the selling shareholder of its non-Israeli residency, to withhold tax upon the sale of publicly traded securities at the applicable corporate tax rate (25% in 2013) for a corporation and 25% for an individual, subject to further conditions under the Israeli law.

Israeli law generally exempts non-resident individuals and entities, subject to the provision of the Israeli tax provision, from capital gains tax on the sale of securities of Israeli companies, provided that the securities were acquired on or after January 1, 2009.

(ii) Income Taxes on Dividend Distribution to Non-Israeli Shareholders

Non-Israeli residents (whether individuals or corporations) are generally subject to Israeli income tax on the receipt of dividends paid on the shares of companies that are not publicly traded at the rate of 25% (30% if the dividend recipient is a Substantial Shareholder, at the time of distribution or at any time during the preceding 12-month period), which tax is to be withheld at source, unless a different rate is provided under an applicable tax treaty. Dividends paid on the shares of companies that are publicly traded, like our ordinary shares, to non-Israeli residents, although generally subject to the same tax rates applicable to dividends paid on the shares of companies that are not publicly traded, are generally subject to Israeli withholding tax at a rate of 25% (whether or not the recipient is a Substantial Shareholder), unless a different rate is provided under an applicable tax treaty. The distribution of dividends to non-Israeli residents (either individuals or corporations) from income derived from an Approved Enterprise or a Benefiting Enterprise during the applicable benefits period or from Preferred Income is subject to withholding tax at a rate of 20% (as of January 1, 2014), unless a different tax rate is provided under an applicable tax treaty. In addition, non-Israeli residents may elect to obtain pre-approval from the Israeli Tax Authority for reduced or exempt withholding tax rate prior to distribution of dividends, under certain conditions.

A non-resident of Israel who has dividend income derived from or accrued in Israel, from which the full amount of tax was withheld at source, is generally exempt from the duty to file tax returns in Israel in respect of such income, provided that: (i) such income was not derived from a business conducted in Israel by the taxpayer; and (ii) the taxpayer has no other taxable sources of income in Israel with respect to which a tax return is required to be filed.

Residents of the United States generally will have withholding tax in Israel deducted at source. Such residents may be entitled to a credit or deduction for U.S. federal income tax purposes in the amount of the taxes withheld, subject to detailed rules contained in U.S. tax legislation.

(iii) U.S. - Israel Tax Treaty

The Treaty is generally effective as of January 1, 1995. Under the Treaty, the maximum Israeli withholding tax on dividends paid to a holder of shares who is a Treaty U.S. Resident (as defined below) is generally 25%. However, pursuant to the Investment Law, dividends distributed by an Israeli company and derived from income eligible for benefits under the Investment Law will generally be subject to a reduced 15% dividend withholding tax rate, subject to the conditions specified in the Treaty. The Treaty further provides that a 12.5% Israeli dividend withholding tax will apply to dividends paid to a U.S. corporation owning 10% or more of an Israeli company’s voting shares during, in general, the current and preceding tax year of the Israeli company. The lower 12.5% rate applies only on dividends distributed from income not derived from an Approved Enterprise or a Benefiting Enterprise in the applicable period or, presumably, from a Preferred Enterprise, and does not apply if the company has certain amounts of passive income.

Pursuant to the Treaty, the sale, exchange or disposition of shares in an Israeli company by a person who qualifies as a resident of the United States within the meaning of the Treaty and who is entitled to claim the benefits afforded to such residents under the Treaty (a “Treaty U.S. Resident”) generally will not be subject to the Israeli capital gains tax unless such Treaty U.S. Resident holds, directly or indirectly, shares representing 10% or more of the voting power of the company during any part of the 12-month period preceding such sale, exchange or disposition subject to certain conditions. A sale, exchange or disposition of shares in an Israeli Company by a Treaty U.S. Resident who holds, directly or indirectly, shares representing 10% or more of the voting power of the company at any time during such preceding 12-month period would not be exempt under the Treaty from such Israeli tax; however, under the Treaty, such Treaty U.S. Resident would be permitted to claim a credit for such taxes against U.S. federal income tax imposed on any gain from such sale, exchange or disposition, under the circumstances and subject to the limitations specified in the Treaty. In addition, in the event that (1) the capital gains arising from the sale of shares of an Israeli company will be attributable to a permanent establishment of the shareholder located in Israel, or (2) the shareholder, being an individual, is present in Israel for a period or periods aggregating 183 days or more during a taxable year, the aforesaid exemption shall not apply.

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. holders (as defined below) of purchasing, owning, and disposing of our ordinary shares. For this purpose, a U.S. holder 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 for U.S. federal income tax purposes) created or organized in or under the laws of the United States, any state thereof or the District of Columbia; (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. holders.

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. Except where noted, this summary deals only with ordinary shares held as capital assets (generally, property held for investment). 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, 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 ordinary shares in exchange for services.

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.

If a partnership holds our ordinary shares, the tax treatment of a partner will generally depend upon the status of the partner and the activities of the partnership. A partner of a partnership holding our ordinary shares should consult its tax advisors.

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, all as of the date hereof, and such authorities may be replaced, revoked or modified so as to result in U.S. federal income tax consequences different from those discussed below.. 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 summary 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

Subject to the discussion under “—Passive Foreign Investment Company” below, the gross amount of any distributions with respect to our ordinary shares (including any amounts withheld to reflect Israeli withholding taxes) will be taxable as dividends, to the extent paid out of our current or accumulated earnings and profits, as determined under U.S. federal income tax principles. Such income (including any withheld taxes) will be includable in a U.S. holder’s gross income as ordinary income on the day actually or constructively received. The dividends received deduction will not be available to a U.S. holder that is taxed as a corporation.

With respect to non-corporate U.S. holders, certain dividends received from a qualified foreign corporation may be subject to reduced rates of taxation. A qualified foreign corporation includes a foreign corporation that is eligible for the benefits of a comprehensive income tax treaty with the United States which the United States Treasury Department determines to be satisfactory for these purposes and which includes an exchange of information provision. The United States Treasury Department has determined that the Treaty meets these requirements. A foreign corporation is also treated as a qualified foreign corporation with respect to dividends paid by that corporation on shares that are readily tradable on an established securities market in the United States. Our ordinary shares are listed and readily tradeable on NASDAQ, which United States Treasury Department guidance treats as an established securities market in the United States. There can be no assurance that our ordinary shares will be considered readily tradable on an established securities market in later years. Non-corporate holders that do not meet a minimum holding period requirement during which they are not protected from the risk of loss or that elect to treat the dividend income as “investment income’’ pursuant to Section 163(d)(4) of the Code will not be eligible for the reduced rates of taxation regardless of our status as a qualified foreign corporation. In addition, the rate reduction will not apply to dividends if the recipient of a dividend is obligated to make related payments with respect to positions in substantially similar or related property. This disallowance applies even if the minimum holding period has been met.

Notwithstanding the above, dividends received by a non-corporate U.S. holder during a year in which the Company is a Passive Foreign Investment Company (a “PFIC Year”) or in a year following a PFIC Year generally will not be eligible for the reduced rates of taxation. Dividends will generally be from a non-U.S. source and treated as “passive income” for U.S. foreign tax credit purposes. U.S. holders should consult their own tax advisors regarding the application of these rules given their particular circumstances.

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 received as a dividend is converted into United States dollars on the date they are received, the U.S. holder generally will not be required to recognize foreign currency gain or loss in respect of the dividend income. 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.

Subject to certain conditions and limitations, Israeli withholding taxes on dividends may be treated as foreign taxes eligible for credit against a U.S. holder’s U.S. federal income tax liability. For purposes of calculating the foreign tax credit, dividends paid on our ordinary shares will be treated as income from sources outside the United States and will generally constitute passive category income. Further, in certain circumstances, if a U.S. holder has held ordinary shares for less than a specified minimum period during which the U.S. holder is not protected from risk of loss, or is obligated to make payments related to the dividends, such U.S. holder will not be allowed a foreign tax credit for foreign taxes imposed on dividends paid on our ordinary shares. The rules governing the foreign tax credit are complex. U.S. holders are urged to consult their tax advisors regarding the availability of the foreign tax credit under their particular circumstances. Instead of claiming a credit, a U.S. holder may, at its election, deduct such otherwise creditable Israeli withholding taxes in computing its taxable income, but only for a taxable year in which such holder elect to do so with respect to all foreign income taxes paid or accrued in such taxable year and subject to generally applicable limitations under U.S. law.

To the extent that the amount of any distribution (including amounts withheld to reflect Israeli withholding taxes) exceeds our current and accumulated earnings and profits for a taxable year, as determined under U.S. federal income tax principles, the distribution will first be treated as a tax-free return of capital, causing a reduction in the adjusted basis of the shares, and the balance in excess of 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. We do not expect to determine earnings and profits in accordance with U.S. federal income tax principles. Therefore, U.S. holders should expect that a distribution will generally be treated as a dividend (as discussed above).

Disposition of Ordinary Shares

In general, subject to the discussion under “—Passive Foreign Investment Company,”, a U.S. holder must treat any gain or loss recognized upon a taxable disposition of an ordinary share as capital gain or loss, long-term if the U.S. holder has held the share 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 in such share. A U.S. holder’s adjusted tax basis generally will equal the U.S. holder’s acquisition cost less any return of capital. Subject to certain exceptions (including but not limited to those described under “Passive Foreign Investment Company” below), long-term capital gain realized by a non-corporate U.S. holder generally will be eligible for reduced rates of tax. 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 Treaty. If such gain or loss is treated as U.S. source gain or loss, a U.S. holder may not be able to use the foreign tax credit arising from any Israeli tax imposed on the disposition of an ordinary share unless such credit can be applied (subject to applicable limitations) against tax due on other income treated as derived from foreign sources.. 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 Taxation, U.S. – Israel tax Treaty” 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.

Passive Foreign Investment Company

We believe we may be a PFIC for the year ended December 31, 2015.

In general, we will be a PFIC for any taxable year in which:

at least 75% of our gross income is passive income, or

at least 50% of the value (determined on a quarterly basis) of our assets is attributable to assets, that produce or are held for the production of passive income.

For this purpose, cash is a passive asset and passive income generally includes dividends, interest, royalties and rents (other than royalties and rents derived in the active conduct of a trade or business and not derived from a related person). If we own at least 25% (by value) of the stock of another corporation, we will be treated, for purposes of the PFIC tests, as owning our proportionate share of the other corporation’s assets and receiving our proportionate share of the other corporation’s income.

PFIC status is determined annually and cannot be definitively determined until the close of the year in question. Accordingly, it is possible that we may become a PFIC in the current or any future taxable year due to changes in our asset or income composition. Because we have valued our goodwill based on the market value of our equity, a decrease in the price of our ordinary shares may also result in our becoming a PFIC to the extent we are not already a PFIC. If we are a PFIC for any taxable year during which a U.S. holder holds our ordinary shares, such U.S. holder will be subject to special tax rules discussed below.

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 on the last day of the last taxable year in which the corporation was a PFIC. If a U.S. holder holds our ordinary shares in a PFIC Year, 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. Distributions received in a taxable year that are greater than 125.0% of the average annual distributions received during the shorter of the three preceding taxable years or the U.S. holder’s holding period for the shares will be treated as excess distributions. 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. Furthermore, non-corporate U.S. Holders will not be eligible for reduced rates of taxation on any dividends received from us in a PFIC Year or in the taxable year following a PFIC Year.

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. The adjusted tax basis of a U.S. holder’s ordinary shares is increased by the amount included in gross income under the mark-to-market regime, or is decreased by the amount of the deduction allowed under the regime. As with the QEF election, a U.S. holder who makes a mark-to-market election would not be subject to the general excess distribution rules and the denial of basis step-up at death described above. If a U.S. holder makes a mark-to-market election it will be effective for the taxable year for which the election is made and all subsequent taxable years unless the shares are no longer regularly traded on a qualified exchange or the Internal Revenue Service consents to the revocation of the election. U.S. holders are urged to consult their tax advisor about the availability of the mark-to-market election, and whether making the election would be advisable in such holder’s particular circumstances.

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 advisors regarding the issues raised by lower-tier PFICs.

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 ADVISORS ABOUT THE PFIC RULES IN CONNECTION WITH THEIR PURCHASING, HOLDING OR DISPOSING OF ORDINARY SHARES.

Backup Withholding and Information Reporting

In general, information reporting will apply to dividends in respect of our ordinary shares and the proceeds from the sale, exchange or redemption of our ordinary shares that are paid to a U.S. holder within the United States (and in certain cases, outside the United States), unless such holder is an exempt recipient. A backup withholding tax generally would apply to such payments if the U.S. holder fails to provide a taxpayer identification number or certification of other exempt status or, in the case of dividend payments, fails to report in full dividend and interest income.

Any amounts withheld under the backup withholding rules will be allowed as a refund or a credit against a U.S. holder’s U.S. federal income tax liability provided the required information is furnished to the Internal Revenue Service in a timely manner.

Under the Hiring Incentives to Restore Employment Act of 2010, individuals that own “specified foreign financial assets” with an aggregate value in excess of US$50,000 are required to file an information report with respect to such assets with their tax returns. “Specified foreign financial assets” include any financial accounts maintained by foreign financial institutions, as well as any of the following, but only if they are not held in accounts maintained by financial institutions: (i) stocks and securities issued by non-U.S. persons; (ii) financial instruments and contracts held for investment that have non-U.S. issuers or counterparties; and (iii) interests in foreign entities. U.S. holders that are individuals are urged to consult their tax advisors regarding the application of this legislation to their ownership of our ordinary shares.

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Tax on Net Investment Income

For tax years beginning after December 31, 2012, certain U.S. holders that are individuals, estates or trusts whose income exceeds certain thresholds will be required to pay an additional 3.8% tax on “net investment income”, which includes, among other things, dividends and net gain from the sale or other disposition of property (other than property held in a trade or business), which may include our ordinary shares. U.S. holders should consult their own tax advisors regarding the application of the tax on net investment income to their particular circumstances.

DIVIDENDS AND PAYING AGENTS

Not applicable.

STATEMENT BY EXPERTS

Not applicable.

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, N.E., 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, N.E., 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 at www.rosettagenomics.com as soon as reasonably practicable after such materials have been electronically filed with, or furnished to, the SEC.

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 Israeli mutual fund and Israeli government bonds, 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.

101

Exchange Rate Risk

We hold most of our cash, cash equivalents and short term bank deposits 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,
	2015				2014				2013
	Actual		At 2014 Exchange rates (1)		Actual		At 2013 Exchange rates (1)		Actual		At 2012 Exchange rates (1)
	(In thousands)
Operating loss	$	15,721		16,097	$	14,252	$	14,221	$	13,347	$	13,030

(1) Based on average exchange rates during the period.

ITEM 12.

DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES

Not applicable.

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

On December 3, 2015, our stockholders approved an increase to our registered (authorized) share capital by NIS 12,000,000, divided into 20,000,000 ordinary shares, nominal (par) value NIS 0.6 each, so that following such increase, the registered (authorized) share capital was NIS 36,000,000 divided into 60,000,000, ordinary shares nominal (par) value NIS 0.6 each.

The material provisions of our articles of association, as amended, are described under “Item 10. Additional Information — B. Memorandum and Articles of Association.”

Use of Proceeds

Not applicable.

ITEM 15.

CONTROLS AND PROCEDURES

DISCLOSURE CONTROLS AND PROCEDURES

Our principal executive officer and principal financial officer, after evaluating the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of the end of the period covered by this Annual Report on Form 20-F, have concluded that, based on such evaluation, our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms, and is accumulated and communicated to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.

102

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 conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework). Based on this evaluation, management concluded that our internal control over financial reporting was effective as of December 31, 2015. Management reviewed the results of its assessment with our Audit Committee.

ATTESTATION REPORT OF THE REGISTERED PUBLIC ACCOUNTING FIRM

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. Because we are neither an accelerated filer nor a large accelerated filer, management’s report was not subject to attestation by our registered public accounting firm pursuant to the rules of the SEC.

CHANGES IN INTERNAL CONTROL OVER FINANCIAL REPORTING

Based on the evaluation conducted by our management, 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 last fiscal year, 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), Dr. David Sidransky 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 corporate conduct and ethics that applies to all of our employees, officers and directors. The text of the code of corporate 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.

103

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, 2015 and December 31, 2014 and fees billed for other services rendered by Kost Forer Gabbay & Kasierer during those periods.

	2015		2014
Audit fees (1)	$	202,500	$	86,500
Audit-related fees (2)		71,150		23,990
Tax fees (3)		16,872		19,800
Total	$	290,522	$	130,290

(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) Audit related fees relate to assurance and associated services that traditionally performed by the independent auditor, including: due diligence investigations and audit services provided in connection with other statutory or regulatory filings.

(3) Tax services were comprised of tax compliance, tax advice and tax planning services.

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.

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:

104

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 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 more than 25% of the voting power of our issued share capital.

Under NASDAQ’s rules, (1) the private placement completed in December 2010, (2) the concurrent private placement and registered direct offering completed in February 2011, (3) the private placement completed in October 2011, (4) the convertible debt transaction completed in January 2012, (5) the registered direct offerings completed in April 2012 and May 2012, and (6) the private placement completed in October 2015 would have required shareholder approval because these offerings represented the issuance (or potential issuance) of more than 20% of our outstanding ordinary shares at a price per share below the greater of book value per share or market value per share. However, we chose to follow our home country practice, which exempts companies such as us from the requirement of shareholder approval of these offerings.

Under NASDAQ’s rules, the written charter of the Compensation Committee is required to specify certain details, including certain factors that must be considered when the Compensation Committee selects, or receives advice from, a compensation consultant, legal counsel or other advisor. However, we have chosen to follow our home country practice, which does not require such information to be specified in the Compensation Committee Charter.

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. See also “Item 3. Key Information — D. Risk Factors — Risks Related to Israeli Law and Our Operations in Israel — Being a foreign private issuer exempts us from certain SEC and NASDAQ requirements.”

ITEM 16H.

MINE SAFETY DISCLOSURE

Not applicable.

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*		Amended and Restated Articles of Association.

2.1(1)		Form of Share Certificate for Ordinary Shares.

2.2(6)		Registration Rights Agreement, dated November 29, 2010, by and between Rosetta Genomics Ltd. and the investors in the December 2010 private placement.

2.3(7)		Registration Rights Agreement, dated February 16, 2011, by and between Rosetta Genomics Ltd. and the investors in the February 2011 private placement.

2.4(8)		Form of Series A Warrant issued by Rosetta Genomics Ltd. to the investors and the placement agent in the October 2011 private placement.

105

2.5(8)		Registration Rights Agreement, dated October 13, 2011, by and between Rosetta Genomics Ltd. and the investors in the October 2011 private placement.

2.6(15)		Form of warrant issued to the placement agent in the January 2012 debt financing.

2.7(12)		Form of Purchase Option Agreement issued to Aegis Capital Corp as placement agent in the April 2012 Registered Direct Offering.

2.8(13)		Form of Purchase Option Agreement issued to Aegis Capital Corp as placement agent in the May 2012 Registered Direct Offering.

2.9(9)		Form of Purchase Option Agreement issued to Aegis Capital Corp as placement agent in the second May 2012 Registered Direct Offering.

2.10(15)		Form of Purchase Option Agreement issued to the underwriter in the August 2012 underwritten public offering.

2.11(16)		Form of Series A Warrant issued by Rosetta Genomics Ltd. to the investors and the placement agent in the October 2015 private placement.

2.12(16)		Form of Series B Warrant issued by Rosetta Genomics Ltd. to the investors in the October 2015 private placement.

2.12.1(17)		Form of Amendment to Series B Warrants issued by Rosetta Genomics Ltd. to the investors in the October 2015 private placement.

2.13(16)		Registration Rights Agreement, dated October 13, 2015, by and between Rosetta Genomics Ltd. and the investors in the October 2015 private placement.

2.14(16)		Controlled Equity Offering ^SM Sales Agreement, dated February 18, 2015, by and between Rosetta Genomics Ltd. and Cantor Fitzgerald & Co.

4.1(1)@		License Agreement, dated as of May 4, 2006, by and between Rosetta Genomics Ltd. and The Rockefeller University.

4.2(2)@		License Agreement, dated effective as of May 1, 2007, by and between Rosetta Genomics Ltd. and The Rockefeller University.

4.3*		Lease Agreement, dated December 31, 2008, by and between Rosetta Genomics Ltd., as tenant, and Rorberg Contracting and Investments (1963) Ltd. and Tazor Development Ltd., as landlords, as amended on August 15, 2012 (as translated from Hebrew).

4.4 *		Air Commercial Real Estate Association Standard Industrial/Commercial Single-Tenant Lease – Net, by and between Donna June Kitts Revocable Trust dated April 10, 2006 and CynoGen Inc., dated as of December 1, 2013, as amended.

4.5(4)		Lease Agreement from Wexford-UCSC II, L.P. to Rosetta Genomics Inc., dated July 7, 2008, and First Amendment thereto, dated August 11, 2008.

4.6(1)		2003 Israeli Share Option Plan.

4.7(11)		2006 Employee Incentive Plan (Global Share Incentive Plan).

4.8(1)		Form of Director and Officer Indemnification Agreement.

4.9(5)@		Amended and Restated License Agreement, dated as of March 3, 2009, by and between Rosetta Genomics Ltd. and Max Planck Innovation GmbH.

4.10(14)@		Amended and Restated License Agreement, dated August 14, 2011, by and between The Johns Hopkins University and Rosetta Genomics Ltd.

4.11(1)@		License Agreement, dated as of December 22, 2006, by and between Rosetta Genomics Ltd. and Max Planck Innovation GmbH.

106

4.12(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.

4.13(3)@		License Agreement, dated effective as of January 8, 2008, by and between Rosetta Genomics Ltd. and The Rockefeller University.

4.14*		Stock Purchase Agreement dated April 3 2015, by and between Prelude Corporation and Rosetta Genomics Inc. and Rosetta Genomics Ltd.

4.15(17)		Securities Purchase Agreement, dated October 13, 2015, by and between Rosetta Genomics Ltd. and the investors in the October 2015 private placement.

8.1*		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.

101*		The following materials from Rosetta Genomics Ltd.’s Annual Report on Form 20-F for the year ended December 31, 2015, formatted in XBRL (eXtensible Business Reporting Language): (i) the Consolidated Balance Sheets, (ii) the Consolidated Statements of Operations, (iii) the Consolidated Statements of Stockholders’ Equity (Deficit) and Comprehensive Income (Loss), (iv) the Consolidated Statements of Cash Flows, and (v) Notes to Consolidated Financial Statements

Filed herewith.

Confidential portions of these documents have been filed separately with the SEC pursuant to a request for confidential treatment.

(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 Form 6-K dated August 2, 2007 (Reg. No. 001-33042), filed with the SEC on August 3, 2007.

(3)

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.

(4)

Incorporated by reference from the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2008 (Reg. No. 001-33042), filed with the SEC on June 30, 2009.

(5)

Incorporated by reference from the Registrant’s Form 6-K dated August-September 2009 (Reg. No. 001-33042), filed with the SEC on September 9, 2009.

(6)

Incorporated by reference from the Registrant’s Form 6-K dated November 2010 (Reg. No. 001-33042), filed with the SEC on November 30, 2010.

(7)

Incorporated by reference from the Registrant’s Form 6-K dated February 2011 (Reg. No. 001-33042), filed with the SEC on February 18, 2011.

(8)

Incorporated by reference from the Registrant’s Form 6-K dated October 2011 (Reg. No. 001-33042), filed with the SEC on October 14, 2011.

(9)

Incorporated by reference from the Registrant’s Form 6-K dated May 2012 (Reg. No. 001-33042), filed with the SEC on May 25, 2012.

(10)

Incorporated by reference from the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2013 (Reg. No. 001-33042), filed with the SEC on March 31, 2014.

(11)

Incorporated by reference from the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2012 (Reg. No. 001-33042), filed with the SEC on March 22, 2013.

107

(12)

Incorporated by reference from the Registrant’s Form 6-K dated April 2012 (Reg. No. 001-33042), filed with the SEC on April 16, 2012.

(13)

Incorporated by reference from the Registrant’s Form 6-K dated April 2012 (Reg. No. 001-33042), filed with the SEC on May 17, 2012.

(14)

Incorporated by reference from the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2011 (Reg. No. 001-33042), filed with the SEC on April 2, 2012.

(15)

Incorporated by reference from the Registrant’s Registration Statement on Form F-1 (Reg. No. 333-182329), filed with the SEC on June 25, 2012, as amended on July 26, 2012 and August 2, 2012.

(16)

Incorporated by reference from the Registrant’s Form 6-K/A (Reg. No. 001-33042), filed with the SEC on February 18, 2015.

(17)

Incorporated by reference from the Registrant’s Form 6-K dated October 2015 (Reg. No. 001-33042), filed with the SEC on October 14, 2015.

(18)

Incorporated by reference from the Registrant’s Form 6-K dated December 2015 (Reg. No. 001-33042), filed with the SEC on December 3, 2015.

108

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: March 23, 2016	By:	/s/ Kenneth A. Berlin
	Kenneth A. Berlin, Chief Executive Officer and
	President

109

ROSETTA GENOMICS LTD. AND SUBSIDIARIES

CONSOLIDATED FINANCIAL STATEMENTS

AS OF DECEMBER 31, 2015

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 Comprehensive Loss	F-5

Consolidated Statements of Changes in Shareholders' Equity	F-6

Consolidated Statements of Cash Flows	F-7 - F-8

Notes to Consolidated Financial Statements	F-9 - F- 35

- - - - - - - - - - - - - - - - - - -

F- 1

Kost Forer Gabbay & Kasierer

3 Aminadav St.

Tel-Aviv 6706703, Israel

Tel: +972-3-6232525

Fax: +972-3-5622555

ey.com

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and Shareholders of Rosetta Genomics Ltd.

We have audited the accompanying consolidated balance sheets of Rosetta Genomics Ltd. (the "Company") and its subsidiaries as of December 31, 2015 and 2014, and the related consolidated statements of comprehensive loss, changes in shareholders’ equity and cash flows for each of the three years in the period ended December 31, 2015. 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, 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, 2015 and 2014, and the consolidated results of their operations and their cash flows for each of the three years in the period ended December 31, 2015, in conformity with U.S. generally accepted accounting principles.

Tel-Aviv, Israel	/s/ KOST FORER GABBAY & KASIERER
March 23, 2016	KOST FORER GABBAY & KASIERER
	A Member of Ernst & Young Global

F- 2

ROSETTA GENOMICS LTD. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

		December 31,
	Note	2015		2014

ASSETS

CURRENT ASSETS:
Cash and cash equivalents		$	12,447	$	7,929
Short-term bank deposits and restricted cash	4, 2e		1,098		7,702
Trade receivables			3,633		338
Other accounts receivable and prepaid expenses	5		2,192		483

Total current assets			19,370		16,452

LONG TERM ASSETS:

Property and equipment, net	6		2,975		822
Long-term bank deposits and other long-term receivables			78		4

Total long term assets			3,053		826

Total assets		$	22,423	$	17,278

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

F- 3

ROSETTA GENOMICS LTD. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

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

		December 31,
	Note	2015			2014

LIABILITIES AND SHAREHOLDERS EQUITY

CURRENT LIABILITIES:
Trade payables		$	1,070		$	563
Other accounts payables and accruals	7		1,733			1,648

Total current liabilities			2,803			2,211

LONG-TERM LIABILITIES:
Warrants related to share purchase agreements	9b		-			2

Total long-term liabilities			-			2

COMMITMENTS AND CONTINGENT LIABILITIES	8

SHAREHOLDERS EQUITY:
Share capital:	9
Ordinary Shares of NIS 0.6 par value: 60,000,000 and 40,000,000 shares authorized at December 31, 2015 and 2014, respectively; 20,518,794 and 11,765,678 shares issued at December 31, 2015 and 2014, respectively; 20,515,536 and 11,762,420 shares outstanding at December 31, 2015 and 2014, respectively			3,194			1,830
Additional paid-in capital			156,696			136,160
Accumulated deficit			(140,270	)		(122,925	)

Total shareholders' equity			19,620			15,065

Total liabilities and shareholders' equity		$	22,423		$	17,278

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

F- 4

ROSETTA GENOMICS LTD. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

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

		Year ended December 31,
	Note	2015			2014		2013

Clinical testing revenues		$	6,668		$	1,099	$	405
Licensing revenues			1,600			228		-
Total revenues		$	8,268		$	1,327	$	405

Cost of clinical testing revenues			6,192			1,310		709
Cost of licensing revenues			80			-		-
Total cost of revenues			6,272			1,310		709

Gross profit (loss)			1,996			17		(304	)

Operating expenses:

Research and development, net	2l		2,956			1,927		1,744
Sales, marketing and business development			7,350			6,848		7,002
General and administrative			7,566			5,494		4,297
Gain from bargain purchase related to acquisition of CynoGen, Inc.	1c		(155	)		-		-

Total operating expenses			17,717			14,269		13,043

Operating loss			15,721			14,252		13,347
Financial expense (income), net	11		1,605			259		(177	)

Loss before taxes			17,326			14,511		13,170
Income tax expense			19			15		-

Loss from continuing operations			17,345			14,526		13,170

Net comprehensive (income) from discontinued operations	1e		-			-		(273	)

Net comprehensive loss after discontinued operations		$	17,345		$	14,526	$	12,897

Basic and diluted net loss per Ordinary Share from continuing operations		$	1.15		$	1.29	$	1.37

Basic and diluted net (income) per Ordinary Share from discontinued operations		$	-		$	-	$	(0.03	)

Basic and diluted net loss per Ordinary Share		$	1.15		$	1.29	$	1.34

Weighted average number of Ordinary Shares used to compute basic and diluted net loss per Ordinary Share			15,092,679			11,239,892		9,593,952

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

F- 5

ROSETTA GENOMICS LTD. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS EQUITY

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

	Number of Ordinary Shares		Share capital			Additional paid- in capital			Accumulated deficit			Total equity (deficit)

Balance as of January 1, 2013		9,096,547	$	1,379		$	125,023		$	(95,502	)	$	30,900

Issuance of shares on May 2013, at 4.21 per share, net of $144 issuance expenses		628,245		103			2,397			-			2,500
Issuance of shares on June 2013, at 3.99 per share, net of $11 issuance expenses		94,015		16			348			-			364
Issuance of shares on September 2013, at 3.40 per share, net of $0.3 issuance expenses		2,950		(*	)		10			-			10
Issuance of shares on October 2013, at 3.28 per share, net of $24 issuance expenses		240,935		41			725			-			766
Issuance of shares on December 2013, at 3.40 per share, net of $34 issuance expenses		331,738		57			1,037			-			1,094
RSU's conversion		75,000		13			(13	)		-			-
Employee options exercised		800		(*	)		3			-			3
Share-based compensation relating to options and RSUs issued to employees and directors		-		-			893			-			893
Net loss		-		-			-			(12,897	)		(12,897	)

Balance as of December 31, 2013		10,470,230	$	1,609		$	130,423		$	(108,399	)	$	23,633

Issuance of shares in January 2014, at 3.64 per share, net of $33 issuance expenses		261,654		45			876			-			921
Issuance of shares in April 2014, at 5.09 per share, net of $9 issuance expenses		59,241		10			283			-			293
Issuance of shares in May 2014, at 4.03 per share, net of $8 issuance expenses		66,387		11			247			-			258
Issuance of shares in June 2014, at 4.23 per share, net of $45 issuance expenses		361,967		62			1,422			-			1,484
Issuance of shares in July 2014, at 4.52 per share, net of $48 issuance expenses		351,656		62			1,481			-			1,543
Issuance of shares in August 2014, at 3.82 per share, net of $6 issuance expenses		48,452		8			171			-			179
Issuance of shares in September 2014, at 3.81 per share, net of $10 issuance expenses		84,850		14			300			-			314
RSU's conversion		43,000		7			(7	)		-			-
Exercise of warrants		8,946		1			(1	)		-			-
Employee options exercised		37		(*	)		(*	)		-			-
Issuance of shares to a former employee		6,000		1			22			-			23
Share-based compensation relating to options and RSUs issued to employees and directors		-		-			943			-			943
Net loss		-		-			-			(14,526	)		(14,526	)

Balance as of December 31, 2014		11,762,420	$	1,830		$	136,160		$	(122,925	)	$	15,065

Issuance of shares in February 2015, at 4.46 per share, net of $491 issuance expenses		2,204,764		344			8,994			-			9,338
Issuance of shares related to acquisition (Note 1)		620,000		94			1,856			-			1,950
Issuance of shares in July 2015, at 3.27 per share, net of $18 issuance expenses		185,477		29			560			-			589
Issuance of shares in August 2015, at 3.04 per share, net of $3 issuance expenses		34,117		6			95			-			101
Issuance of shares and exercise of warrants B related to the October 2015 placement, at 1.33 per share, net of $331 issuance expenses		5,666,508		884			1,750			-			2,634
Reclassification of Warrants A and B to shareholders' equity		-		-			6,272			-			6,272
RSUs conversion		42,250		7			(7	)		-			-
Share-based compensation relating to options and RSUs issued to employees and directors		-		-			1,016			-			1,016
Net loss		-		-			-			(17,345	)		(17,345	)

Balance as of December 31, 2015		20,515,536	$	3,194		$	156,696		$	(140,270	)	$	19,620

* Less than $1

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

F- 6

ROSETTA GENOMICS LTD. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

U.S. dollars in thousands

	Year ended December 31,
	2015			2014			2013
Cash flows from operating activities:

Net loss	$	(17,345	)	$	(14,526	)	$	(12,897	)
Income from discontinued operations		-			-			273

Loss from continuing operations		(17,345	)		(14,526	)		(13,170	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation		748			299			298
Gain from bargain purchase related to acquisition of CynoGen, Inc.		(155	)		-			-
Foreign currency adjustments		-			-			6
Share-based compensation relating to options, RSUs, shares and warrants granted to employees, non-employees and directors		1,016			943			893
Issuance expenses of warrants classified as liabilities related to share purchase agreement		561			-			-
Revaluation of warrants related to share purchase agreements		1,051			(79	)		(55	)
Increase in trade receivables		(1,256	)		(114	)		(136	)
Decrease (increase) in other accounts receivable and prepaid expenses		(1,705	)		(170	)		259
Increase (decrease) in trade payables		101			(343	)		152
Decrease in deferred revenue		-			(228	)		-
Increase in other accounts payables and accruals		51			616			520

Net cash used in operating activities from continuing operations		(16,933	)		(13,602	)		(11,233	)
Net cash provided by operating activities from discontinued operations		-			-			625

Net cash used in operating activities		(16,933	)		(13,602	)		(10,608	)

Cash flows from investing activities:
Purchase of property and equipment		(273	)		(247	)		(626	)
Acquisition of CynoGen, Inc. (a)		(2,122	)		-			-
Decrease (increase) in bank deposits and restricted cash		6,526			(11	)		(7,527	)

Net cash provided by (used in) investing activities		4,131			(258	)		(8,153	)

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

F- 7

ROSETTA GENOMICS LTD. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

U.S. dollars in thousands

	Year ended December 31,
	2015			2014			2013
Cash flows from financing activities:

Issuance of shares and warrants and proceed from exercise of warrants, net		17,320			5,015			4,737

Net cash provided by financing activities		17,320			5,015			4,737

Increase (decrease) in cash and cash equivalents		4,518			(8,845	)		(14,024	)
Cash and cash equivalents at beginning of year		7,929			16,774			30,798

Cash and cash equivalents at end of year	$	12,447		$	7,929		$	16,774

Supplemental disclosure:

(a) Acquisition of CynoGen, Inc.

Fair value of assets acquired and liabilities assumed at the date of acquisition:
Working capital, net (excluding cash and cash equivalents)	$	1,599
Property and equipment		2,628
Gain from bargain purchase		(155	)
Issuance of shares		(1,950	)
	$	(2,122	)

(b) Supplemental disclosure of non-cash activities :

Share issuance for acquisition of CynoGen, Inc.	$	1,950
Reclassification of Warrants A and B to shareholders' equity	$	6,272

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

F- 8

ROSETTA GENOMICS LTD., AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

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

NOTE 1:-

GENERAL

Rosetta Genomics Ltd. (the "Company") commenced its operations on March 9, 2000. The Company's integrative research platform combining bioinformatics and state-of-the-art laboratory processes has led to the discovery of hundreds of biologically validated novel human microRNAs. Building on its strong patent position and proprietary platform technologies, Rosetta Genomics is working on the application of these technologies in the development of a full range of microRNA-based diagnostic tools. The Company's microRNA-based tests, RosettaGX Cancer Origin™, RosettaGX Reveal™, mi-LUNG™, and mi-KIDNEY™, are commercially available worldwide and all samples are processed in its Philadelphia-based CAP-accredited, Clinical Laboratories Improvement Amendments ("CLIA") certified lab. With the acquisition of CynoGen, Inc. (described in Note 1c below), the Company now offers a broader menu of molecular and other assays for bladder, lung, prostate and breast cancer patients through its new facility in Lake Forest, California.

The Company has three wholly-owned subsidiaries in the United States: (1), Rosetta Genomics, Inc. (“Rosetta Inc.”), (2) Minuet Diagnostics, Inc. (“Minuet”), and (3) CynoGen, Inc. (“CynoGen” or “PersonalizeDx” and collectively with Rosetta Inc. and Minuet, the “U.S. Subsidiaries”). The principal business activities of the U.S. Subsidiaries are to commercialize the Company's products, perform tests in its CLIA-approved laboratories and expand the business of the Company in the United States (see Note 1c).

Acquisition of CynoGen, Inc.

On April 13, 2015, the Company, through Rosetta Inc., acquired all of the outstanding shares of Minuet and CynoGen from Prelude Corporation, a Fjord Ventures portfolio company. CynoGen is a molecular diagnostics and services company serving community-based pathologists, urologists, oncologists and other reference laboratories across the United States. CynoGen is focused on the detection of genomic changes through Fluorescence in situ Hybridization ("FISH") technology, which helps to detect cancer, measure the potential aggressiveness of the disease and identify patients most likely to respond to targeted therapies.

The purchase price included $2,122 in cash, 500,000 of the Company’s Ordinary Shares, par value NIS 0.6 per share (“Ordinary Shares”) and the provision of certain assets and services at cost to Prelude Corporation. Prelude Corporation has accepted 120,000 of the Company’s Ordinary Shares in lieu of the provision of certain assets and services to it by the Company. The aggregate fair value of the 620,000 Ordinary Shares issued amounted to approximately $1,950.

The acquisition was accounted for under the purchase method of accounting, in accordance with Accounting Standard Codification ("ASC") 805, "Business Combinations", and accordingly the Company allocated the purchase price to assets acquired and liabilities assumed based on a preliminary purchase price allocation study. Following the purchase price allocation, the Company did not identify intangible assets to be recorded upon acquisition. As a result, the Company recognized a bargain purchased gain of approximately $155.

F- 9

ROSETTA GENOMICS LTD., AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

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

Acquisition costs in the amount of $707 consisted mainly of legal, tax and accounting fees and other external costs directly related to the acquisition and were included in operating expenses, as acquisition related costs.

The following represents the unaudited consolidated pro forma revenues and net loss for the years ended December 31, 2015 and 2014 assuming the acquisition of CynoGen occurred on January 1, 2014. The pro forma information is not necessarily indicative of the results of operations, which would have actually occurred, had the acquisition been consummated on that date, nor does it purport to represent the results of operations for future periods.

	Year ended December 31,
	2015		2014
	Unaudited		Unaudited

Total revenues	$	10,171	$	7,877

Net loss	$	19,370	$	22,577

Liquidity and Capital Resources

The Company incurred an accumulated deficit of approximately $140,270 since inception, and incurred recurring operating losses and negative cash flows from operating activities in each of the three years in the period ended December 31, 2015. As of December 31, 2015, the Company’s total shareholders’ equity amounted to $19,620.

On February 18, 2015, the Company entered into a Controlled Equity Offering ^SM Sales Agreement (the “2015 Cantor Sales Agreement”) with Cantor Fitzgerald & Co., as sales agent (“Cantor”), and filed a prospectus supplement with the SEC relating to the offer and sale of up to $14,400 of its Ordinary Shares. During 2015, the Company sold through the 2015 Cantor Sales Agreement an aggregate of 2,424,358 of its Ordinary Shares, and received gross proceeds of $10,540, before deducting issuance expenses in an amount of $512. The 2015 Cantor Sales Agreement was terminated on October 13, 2015.

In addition, on October 13, 2015, the Company entered into a Securities Purchase Agreement (the "2015 Securities Purchase Agreement"), pursuant to which the Company agreed to sell securities to various accredited investors (the "2015 Purchasers") in a private placement transaction (the "2015 Private Placement"). The Private Placement closed on October 16, 2015 (the "Closing Date").

F- 10

ROSETTA GENOMICS LTD., AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

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

Under the terms of the 2015 Private Placement, the Company issued an aggregate of 3,333,333 units at a purchase price of $2.40 per unit for gross proceeds of approximately $8,000. Each unit consisted of (i) one Ordinary Share (collectively, the "Shares"), (ii) a Series A Warrant to purchase one-half of an Ordinary Share at an exercise price of $2.75 per ordinary share (subject to adjustment), exercisable for a period of five years from the Closing Date (the “2015 Series A Warrants”), and (iii) a partially pre-funded 2015 Series B Warrant (collectively and together with the 2015 Series A Warrants, the "2015 Warrants"). The 2015 Series B Warrants had an exercise price of NIS 0.6 (which has been prepaid) plus $0.0001 per share. The 2015 Series B Warrants were intended to reset the price of the units, and became exercisable for an aggregate of 2,666,667 shares based on 85% of the arithmetic average of the five lowest weighted average prices calculated during the ten trading days following the effective date of a resale registration statement registering the shares sold in the 2015 Private Placement for resale. The 2015 Series A Warrant exercise price has been adjusted to $1.646 per share, and all of the 2015 Series B Warrants have been exercised on a cashless basis, resulting in the issuance of 2,666,489 of the Company’s Ordinary Shares. The net proceeds to the Company from the 2015 Private Placement, after deducting placement agent fees and expenses, the Company’s offering expenses and excluding the proceeds, if any, from the exercise of the 2015 Warrants, were approximately $7,293.

During 2014, the Company sold through the 2013 Cantor Sales Agreement (as defined in note 9.b.8) an aggregate of 1,234,207 of its Ordinary Shares (“Ordinary Shares”), and received gross proceeds of $5,151 before deducting issuance expenses in an amount of $159. Sales of the Company’s Ordinary Shares under the Cantor Sales Agreements were made in sales deemed to be “at-the-market” equity offerings as defined in Rule 415 promulgated under the Securities Act of 1933, as amended.

As of December 31, 2015, the Company's cash position (cash and cash equivalents and short-term bank deposits) totaled approximately $13,493. The Company’s current operating plan includes various assumptions concerning the level and timing of cash receipts from sales and cash outlays for operating expenses and capital expenditures. The Company’s ability to successfully carry out its business plan is primarily dependent upon its ability to (1) obtain sufficient additional capital, (2) attract and retain knowledgeable employees, (3) increase its cash collections and (4) generate significant additional revenues. Management believes that these funds, together with its existing operating plan, which includes a cost-reduction plan should it be unable to raise sufficient additional capital, are sufficient for the Company and its subsidiaries to meet its obligations as they come due at least for a period of twelve months from the date the consolidated financial statements.

Parkway Clinical Laboratories, Inc. ("Parkway")

Parkway was a national, full-service CLIA-certified clinical laboratory service that was owned by the Company. On April 18, 2013 the Company signed a settlement agreement with Sanra Laboratories ("Sanra") in connection with the Company's sale of Parkway to Sanra. Under the terms of the agreement, Sanra and Parkway paid to the Company a total of $625 in 2013. As a result of this settlement, the Parkway asset has been removed from the balance sheets and the corresponding gain in the amount of $273 was recorded in the Consolidated Statements of Comprehensive Loss as income from discontinued operations for the year ended December 31, 2013.

NOTE 2:-

SIGNIFICANT ACCOUNTING POLICIES

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

F- 11

ROSETTA GENOMICS LTD., AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

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

Use of estimates:

The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions. The Company's management believes that the estimates, judgments and assumptions used are reasonable based upon information available at the time they are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the dates of the financial statements, and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.

Financial statements in U.S. dollars:

All of the Company's revenues are generated in U.S. dollars ("Dollar"). In addition, the majority of the Company's costs and financing are in Dollars. The Company's management believes that the Dollar is the currency of the primary economic environment in which the Company and its subsidiaries have operated and expect to continue to operate in the foreseeable future. Therefore, the functional currency of the Company and its subsidiaries is the Dollar.

The Company and its subsidiaries' transactions and balances denominated in Dollars are presented at their original amounts. Non-Dollar transactions and balances have been remeasured to Dollars in accordance with ASC 830, "Foreign Currency Matters". All transaction gains and losses from remeasurement of monetary balance sheet items denominated in non-Dollar currencies are reflected in the Consolidated Statement of Comprehensive Loss as financial income or expenses, as appropriate.

Principles of consolidation:

The consolidated financial statements include the accounts of the Company and its wholly-owned U.S. Subsidiaries. Intercompany transactions and balances have been eliminated upon consolidation.

Cash equivalents:

Cash equivalents are short-term unrestricted, highly-liquid investments that are readily convertible to cash, with original maturities of three months or less at acquisition.

Restricted cash:

Restricted cash is invested in a bank deposit, which is pledged in favor of the bank that provides guarantees to the Company.

Short-term bank deposits:

Short-term bank deposits are deposits with maturities of more than three months at acquisition but less than one year at balance sheet date. The short-term bank deposits are presented at their cost which approximates its market value.

F- 12

ROSETTA GENOMICS LTD., AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

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

Business Combinations:

The Company applies ASC 805, “Business Combinations”. ASC 805 requires recognition of assets acquired, liabilities assumed, and non-controlling interest in the acquired entity at the acquisition date, measured at their fair values as of that date. This ASC also requires the fair value of acquired in-process research and development (“IPR&D”) to be recorded as intangibles with indefinite lives, contingent consideration to be recorded on the acquisition date, and restructuring and acquisition-related deal costs to be expensed as incurred. Any excess of the fair value of net assets acquired over purchase price and any subsequent changes in estimated contingencies are to be recorded in earnings. In addition, changes in valuation allowance related to acquired deferred tax assets and in acquired income tax position are to be recognized in earnings.

Property and equipment, net:

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 at the following annual rates:

		%
Computer equipment		33
Office furniture and laboratory equipment		7 - 20 (mainly 15)
Leasehold improvements		Over the shorter of the lease term or useful economic life

Impairment of long-lived assets:

The Company’s long-lived assets are reviewed for impairment in accordance with ASC 360, "Property, Plant and Equipment", 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, 2015 and 2014, no impairment losses have been identified.

Discontinued operations:

According to ASC 360, "Property, Plant, and Equipment" and ASC 205, "Presentation of Financial Statements" when a component of an entity, as defined in ASC 360, has been disposed of, the results of its operations, including the gain or loss on its disposal should be classified as discontinued operations when the operations and cash flows of the component have been eliminated from the Company's consolidated operations and the Company will no longer have any significant continuing involvement in the operations of the component.

F- 13

ROSETTA GENOMICS LTD., AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

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

Revenue recognition:

Revenues from sales of the Company's diagnostic services are recognized in accordance with ASC 605, "Revenue Recognition", when (1) persuasive evidence of an agreement exists, (2) delivery of the test result has occurred or services have been rendered, (3) the vendor's fee is fixed or determinable, and (4) no further obligation exists and collectability is probable.

Criterion (1) is satisfied upon receiving a test requisition form which is an evidence of medical necessity of the test ordered for the patients in order to bill the relevant payers. Criterion (2) is satisfied when the Company performs the test and delivers a report to the physician, or makes the patient report available to the patient. Determinations of criteria (3) and (4) are based on management’s judgments regarding whether the fee charged for products or services delivered is fixed or determinable, and the collectability of those fees under any contract or arrangement is probable. The Company assesses whether the fee is fixed or determinable based on the nature of the fee charged for the services delivered and existing contractual arrangements.

The Company’s specialized diagnostic services are performed based on a written test requisition form or electronic equivalent and revenues are recognized once the diagnostic services have been performed, and the results have been delivered to the ordering physician. These diagnostic services are billed to various payers, including Medicare, commercial insurance companies, other directly billed healthcare institutions such as hospitals and clinics, and individuals. The Company reports revenues from contracted payers, including Medicare, certain insurance companies and certain healthcare institutions, based on the contractual rate, or in the case of Medicare, published fee schedules. The Company reports revenues from non-contracted payers, including certain insurance companies and individuals, based on the amount expected to be collected. The difference between the amount billed and the amount estimated to be collected from non-contracted payers is recorded as a contractual allowance to arrive at the reported net revenues. The expected revenues from non-contracted payers are based on the historical collection data (which such historical collection data is readily available and reliable) of each payer or payer group, as appropriate, and used for estimating the amount of reduction in gross revenues. The Company regularly reviews its historical collection experience for non-contracted payers and adjusts its expected revenues for current and subsequent periods accordingly.

Revenues from licensed technology are recorded in accordance with the contract terms, when revenues can be reliably measured and collection of the funds is reasonably assured.

F- 14

ROSETTA GENOMICS LTD., AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

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

On December 31, 2015, the Company entered into a Patent License Agreement (the “Agreement”) with Mirna Therapeutics (“Mirna”) for a worldwide sublicense to the Company’s patents related to therapeutics uses of certain microRNA technologies (the “Licensed Patents”). Under the terms of the agreement, the Company received an upfront payment of $1,600 from Mirna, which was received on January 4, 2016, and the Company is eligible for low single-digit royalties on product sales and potential milestone payments (to be performed by Mirna) and sublicense fees. The sublicensed patents are jointly owned by YEDA Research and Development Company Ltd. (“YEDA”), the commercial arm of the Weizmann Institute of Science, and the Company. As such, YEDA is entitled to a portion of these and other proceeds the Company may receive under the agreement with Mirna. The term of the agreement is for the life of the licensed patents. Mirna may terminate the agreement without cause, and, in certain cases, may be subject to significant termination fees.

As of December 31, 2015, the effective date of the Agreement, Mirna has the right to use the Licensed Patents, and accordingly, revenues of $1,600 have been recorded in the Consolidated Statements of Comprehensive Loss associated with the above transaction. The Company has no continuing involvement or other obligations to Mirna regarding the Licensed Patents.

Deferred revenue includes unearned amounts received in its arrangements, and amounts received from customers but not recognized as revenues due to the fact that these transactions did not meet the revenue recognition criteria. During 2014, the Company recognized its deferred revenue since no further performance obligation existed.

Research and development expenses, net:

Research and development expenses consist of costs of salaries and related expenses, various activities related to intellectual property, research materials and supplies, and equipment depreciation. All such costs are expensed as incurred.

Royalty-bearing grants from the Bi-national Industrial Research and Development Foundation ("BIRD") and from the Chief Scientist of Israel's Ministry of Economy ("the OCS") for funding approved research and development projects, are recognized at the time the Company is entitled to such grants, on the basis of the research and development expenses incurred. Such Royalty-bearing grants arrangements are presented as a reduction from research and development expenses in the consolidated statements of comprehensive loss in an amount of $197, $292, and $206, in the years 2015, 2014 and 2013, respectively.

F- 15

ROSETTA GENOMICS LTD., AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

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

Accounting for share-based compensation:

The Company accounts for share-based compensation in accordance with ASC 718, "Compensation - Share Compensation", which requires the measurement and recognition of compensation expense based on estimated fair values for all share-based payment awards made to employees, directors and non-employees. ASC 505-50, "Equity-Based Payments to Non-Employees", 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 statement of comprehensive loss.

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. ASC 718 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 share-option awards and values restricted share units based on the market value of the underlying shares at the date of grant. The Company estimates the fair value of share options granted with the following assumptions:

	Year ended December 31,
	2015	2014	2013

Dividend yield	0%	0%	0%
Expected volatility	116-126%	113-125%	116-131%
Risk-free interest	1.74-1.96%	1.62-2.27%	1.13-1.75%
Expected life	4.5-6.25 years	4.5-6.25 years	4.5-6.25 years

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 cash dividends in the future.

The computation of expected volatility is based on realized historical share price volatility of the Company's share.

The risk-free interest rate assumption is the implied yield currently available on the U.S treasury yield 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 ASC 505 with respect to options and warrants issued to non-employees. ASC 505 requires the use of option valuation models to measure the fair value of the options and warrants at the measurement date.

F- 16

ROSETTA GENOMICS LTD., AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

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

Basic and diluted net loss per share:

Basic and diluted loss per Ordinary Share are presented in conformity with ASC 260 "Earnings Per Share", for all years presented. Basic loss per Ordinary Share is computed by dividing net loss for each reporting period by the weighted average number of Ordinary Shares outstanding during the period. Diluted loss per Ordinary Share is computed by dividing net loss for each reporting period by the weighted average number of Ordinary Shares outstanding during the period plus any additional Ordinary Shares that would have been outstanding if potentially dilutive securities had been exercised during the period, calculated under the treasury share method.

For the years ended December 31, 2015, 2014 and 2013, all outstanding options, RSUs, and warrants, if any, have been excluded from the calculation of the diluted net loss per share since their effect was anti-dilutive.

Income taxes:

The Company account for income taxes and uncertain tax positions in accordance with ASC 740, "Income Taxes" ("ASC 740"). ASC 740 prescribes the use of the liability method whereby deferred tax asset 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 provide a valuation allowance to reduce deferred tax assets to the amounts that are more likely-than-not to be realized.

The Company implements a two-step approach to recognizing and measuring uncertain tax positions accounted for in accordance with ASC 740. 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. As of December 31, 2015 and 2014, no liability for unrecognized tax benefits was recorded, as a result of the implementation of ASC 740.

Severance pay:

The Company's liability for severance pay for its Israeli employees is calculated pursuant to Israeli 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. After completing one full year of employment, the Company's Israeli employees are entitled to one month's salary for each year of employment or a portion thereof. The Company's liability is partially provided by monthly deposits with severance pay funds, insurance policies and by an accrual. The liability for employee severance pay benefits included on the balance sheet represents the total liability for such severance benefits, while the assets held for severance benefits included on the balance sheet represent the current redemption value of the Company's contributions made to severance pay funds and to insurance policies.

F- 17

ROSETTA GENOMICS LTD., AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

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

The carrying value of deposited funds includes profits (losses) accumulated up to the balance sheet date. The deposited funds may be withdrawn only upon the fulfillment of the obligation pursuant to Israeli severance pay law or labor agreements.

The Company's Israeli employees are included under Section 14 of the Israeli Severance Compensation Law ("Section 14"). Under Section 14, the Company's monthly deposits, at a rate of 8.33% of such employees' monthly salary, are made on their behalf with insurance companies on account of severance pay. Payments in accordance with Section 14 release the Israeli companies 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.

Severance expenses for the years ended December 31, 2015, 2014, and 2013 were $102, $116, and $107, respectively.

Rosetta Inc., and CynoGen have a 401(k) defined contribution plan covering certain employees in the U.S. All eligible employees may elect to contribute to the plan. The plan provides a 3% safe-harbor contribution up to the employee’s eligible compensation. In the years 2015, 2014 and 2013, the Company recorded an expense for matching contributions in the amount of $180, $112 and $65, respectively.

Concentrations of credit risk:

Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents, restricted cash, short-term bank deposits, trade receivables and other accounts receivable.

The Company’s cash and cash equivalents are deposited mainly in Dollars with major banks in Israel, the UK and the United States. Such deposits in the United States may be in excess of insured limits and are not insured in other jurisdictions. Management believes that the financial institutions that hold the Company's investments are institutions with high credit standing, and accordingly, minimal credit risk exists with respect to these investments.

Trade receivables are recorded from two primary payors: Medicare and third party/private payors (“Private Payors”), all located mainly in the United States. Trade receivables are recorded at contractual rates (or published rates for Medicare) less an allowance for contractual rates adjustment, based on reporting models utilizing historical cash collection percentages and updated for current effective reimbursement factors. Management performs ongoing valuations of trade receivable balances based on management’s evaluation of historical collection experience and industry trends. Concentration of credit risk with respect to trade receivables is also limited by credit limits, ongoing credit evaluation and account monitoring procedures.

The Company has no significant off balance sheet concentrations of credit risk.

F- 18

ROSETTA GENOMICS LTD., AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

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

Fair value of financial instruments:

The carrying amounts of the Company's financial instruments, including cash and cash equivalents, restricted cash, short-term bank deposits, accounts receivable, other accounts receivables, trade payables and other account payable and accruals, approximate fair value because of their generally short-term maturities.

The estimated fair value of financial instruments has been determined by the Company using available market information and valuation methodologies. Considerable judgment is required in estimating fair values. Accordingly, the estimates may not be indicative of the amounts the Company could realize in a current market exchange.

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, ASC 820, "Fair Value Measurements and Disclosures" establishes a three-tier value hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value:

Level 1 –	quoted prices in active markets for identical assets or liabilities;

Level 2 –	inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices in active markets for similar assets or liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; or

Level 3 –	unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

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 Company measures its warrants at fair value each reporting period until they will be exercised or expired, with changes in the fair values being recognized in the Company's Statement of Comprehensive Loss as financial income or expense.

F- 19

ROSETTA GENOMICS LTD., AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

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

Recent Accounting Pronouncements:

In May 2014, the Financial Accounting Standards Board (FASB) issued guidance on revenue from contracts with customers that will supersede most current revenue recognition guidance, including industry-specific guidance. The underlying principle is that an entity will recognize revenue upon the transfer of goods or services to customers in an amount that the entity expects to be entitled to in exchange for those goods or services. The guidance provides a five-step analysis of transactions to determine when and how revenue is recognized. Other major provisions include capitalization of certain contract costs, consideration of the time value of money in the transaction price, and allowing estimates of variable consideration to be recognized before contingencies are resolved in certain circumstances. The guidance also requires enhanced disclosures regarding the nature, amount, timing and uncertainty of revenue and cash flows arising from an entity’s contracts with customers. The guidance is effective for the interim and annual periods beginning on or after December 15, 2017 (early adoption is permitted for the interim and annual periods beginning on or after December 15, 2016). The guidance permits the use of either a retrospective or cumulative effect transition method. The Company is currently evaluating the impact of the guidance on its consolidated financial statements.

In September 2015, the FASB issued guidance on current accounting for measurement-period adjustments. The new guidance requires entities to recognize adjustments to provisional amounts that are identified during the measurement period in the reporting period in which the adjustment amounts are determined. Measurement period adjustments were previously required to be retrospectively adjusted as of the acquisition date. The provisions of this update are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2015 (early adoption is permitted), and should be applied prospectively. The Company is currently evaluating the impact of the guidance on its consolidated financial statements.

In November 2015, the FASB issued guidance on balance sheet classification of deferred taxes. The new guidance requires entities to present all deferred tax assets and liabilities, along with any related valuation allowance, as non-current on the balance sheet. The guidance is effective for interim and annual periods beginning after December 15, 2016 (early adoption is permitted).The Company believes this guidance will not have significant effect on its consolidated financial statements.

In February 2016, the FASB issued ASU 2016-02, “Leases (ASC 842)”, which sets out the principles for the recognition, measurement, presentation and disclosure of leases for both parties to a contract (i.e. lessees and lessors). The new standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight line basis over the term of the lease, respectively. A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greater than 12 months regardless of their classification. Leases with a term of 12 months or less will be accounted for similar to existing guidance for operating leases today. The new standard requires lessors to account for leases using an approach that is substantially equivalent to existing guidance for sales-type leases, direct financing leases and operating leases. The ASU is expected to impact the Company's consolidated financial statements as the Company has certain operating lease arrangements. ASC 842 supersedes the previous leases standard, ASC 840 Leases. The standard is effective on January 1, 2019, with early adoption permitted. The Company is in the process of evaluating the impact of this new guidance.

F- 20

ROSETTA GENOMICS LTD., AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

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

NOTE 3:-

FAIR VALUE MEASUREMENTS

In accordance with ASC 820, "Fair Value Measurements and Disclosures", the following methods and assumptions were used by the Company in estimating their fair value disclosures for financial instruments:

The carrying amounts of cash and cash equivalents, short-term bank deposits, trade receivables, trade payables and other accounts payable approximate their fair values due to the short-term maturities of such instruments.

The Company used an option pricing model (Black-Scholes-Merton) to determine the fair value of the warrants to purchase Ordinary Shares. Significant inputs included an estimate of the fair value of the Company’s Ordinary Shares as of December 31, 2015, the remaining contractual life of the warrant, a risk-free rate of interest, and an estimate of the Company’s share volatility. The fair value of the liability for warrants related to share purchase agreements classified within Level 3. The fair value of the warrants at December 31, 2015 and December 31, 2014 was $0 and $2, respectively. For the year ended December 31, 2015, the Company recognized a net loss of approximately $1,051 from the revaluation of warrants related to share purchase agreement which is recorded under Financial expense in the Consolidated Statements of Comprehensive Loss (refer to Note 9).

NOTE 4:-

SHORT-TERM BANK DEPOSITS AND RESTRICTED CASH

As of December 31, 2015 and 2014, the Company's bank deposits are as follows:

December 31, 2015
Amount*)		Maturity date	Annual interest

$	498	March 7, 2016		0.70	%
	600	December 31, 2016		1.04	%

$	1,098

December 31, 2014
Amount*)		Maturity date	Annual interest

$	5,050	Notice 95 days		0.75	%
	2,000	February 1, 2015		0.65	%
	600	May 28, 2015		0.4	%
	52	December 31, 2015

$	7,702

Includes restricted cash deposit. See Note 8a .

F- 21

ROSETTA GENOMICS LTD., AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

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

NOTE 5:-

OTHER ACCOUNTS RECEIVABLES AND PREPAID EXPENSES

	December 31,
	2015		2014

Prepaid expenses	$	322	$	258
Government authorities		47		61
Security deposits		65		65
Royalty-bearing grants		128		93
Amounts due from Patent License Agreement (Note 2k)		1,600		-
Other		30		6

	$	2,192	$	483

NOTE 6:-

PROPERTY AND EQUIPMENT, NET

	December 31,
	2015		2014
Cost:
Computer equipment	$	1,575	$	1,094
Office furniture and laboratory equipment		3,281		1,397
Leasehold improvements		1,196		660

		6,052		3,151
Accumulated depreciation:
Computer equipment		1,081		794
Office furniture and laboratory equipment		1,396		1,072
Leasehold improvements		600		463

		3,077		2,329

Depreciated cost	$	2,975	$	822

Depreciation expenses for the years ended December 31, 2015, 2014 and 2013 were $748, $299, and $298, respectively.

NOTE 7:-

OTHER ACCOUNTS PAYABLE AND ACCRUALS

	December 31,
	2015		2014

Employees' salaries and payroll accruals	$	1,216	$	1,258
Accrued expenses and other		517		390

	$	1,733	$	1,648

F- 22

ROSETTA GENOMICS LTD., AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

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

NOTE 8: -

COMMITMENTS AND CONTINGENT LIABILITIES

Restricted cash:

As of December 31, 2015 and 2014, restricted cash was primarily attributed to bank guarantees to the landlords of the Company and CynoGen’s premises for the fulfillment of their lease commitments in the amount of approximately $678 and $52, respectively. These restricted cash deposits are presented in short-term and long-term "Bank deposited and restricted cash".

The facilities of the Company and its subsidiaries are rented under various operating lease agreements, the latest of which ends in 2018. Aggregate annual minimum lease commitments under the non-cancelable operating lease agreements as of December 31, 2015, are as follows:

2016	$	711
2017		668
2018		555

Total	$	1,934

Total rent expenses for the years ended December 31, 2015, 2014 and 2013 were $725, $511, and $365, respectively.

The Company leases its motor vehicles under cancelable operating lease agreements . The minimum payment under these operating leases, upon cancellation of these lease agreements was $4 as of December 31, 2015 .

Lease expenses for motor vehicles for the years ended December 31, 2015, 2014, and 2013, were $39, $52, and $81, respectively.

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 until 2029 the minimum aggregate license maintenance fees over the term of this agreement will be approximately $960, of which $560 will be paid after December 31, 2015. During the years ended December, 31, 2015, 2014 and 2013, the Company paid fees in the amount of $47, $47 and $47, respectively, to the third party. The Company recorded the payments as research and development expenses.

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 until 2022 the minimum aggregate license maintenance fees over the term of this agreement should be approximately $424, of which $229 will be paid after December 31, 2015. During the years ended December 31, 2015, 2014 and 2013, the Company paid fees in the amount of $37, $41, and $40, respectively, to the third party. The Company recorded the payments as research and development expenses.

F- 23

ROSETTA GENOMICS LTD., AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

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

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. This agreement was amended and restated in August 2011 and is now on a non-exclusive basis. For the amendment, the Company paid an amendment fee. The Company estimates that until 2032 the aggregate minimum royalties over the term of this agreement should be approximately $320, of which $170 will be paid after December 31, 2015. During the years ended December 31, 2015, 2014, and 2013, the Company paid fees in the amount of $12, $10, and $12, respectively to the third party. The Company recorded the payments as research and development expenses.

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 paid 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 until 2022 the minimum aggregate license maintenance fees over the term of this agreement should be approximately $261, of which $114 will be paid after December 31, 2015. During the years ended December 31, 2015, 2014 and 2013, the Company paid fees in the amount of $18, $20, and $20, respectively under this agreement. The Company recorded the payments as research and development expenses.

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 until 2029 the minimum aggregate maintenance fees over the term of this agreement should be approximately $690, of which $420 will be paid after December 31, 2015. During the years ended December 31, 2015, 2014 and 2013, the Company paid fees in the amount of $35, $35 and $35, respectively, to the third party. The Company recorded the payments as research and development expenses.

F- 24

ROSETTA GENOMICS LTD., AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

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

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 until 2029 the minimum aggregate license maintenance fees over the term of this agreement should be approximately $440, of which $280 will be paid after December 31, 2015. During the years ended December, 31, 2015, 2014 and 2013, the Company paid fees in the amount of $24, $24 and $24, respectively, to the third party. The Company recorded the payments as research and development expenses.

In July 2014, the Company signed a royalty-bearing joint research and license agreement with a third party. Under this agreement, the Company and the third party engage in joint research and the Company was granted a non-exclusive, royalty bearing, non-transferable and non-sublicensable license to use the joint information, inventions and patents for the development, manufacture, commercialization, distribution and sale of products, while the third party was also granted a non-exclusive, sublicensable and a worldwide license. In consideration for this agreement, the Company will pay a fixed annual license maintenance fees and royalties based on net sales. During 2015, the Company paid $10 under this agreement and accrued $80 payable to YEDA following the license agreement with Mirna, as detailed in Note 2k.

Rimonim Consortium:

In January 2011, the Company joined the Rimonim Consortium, which is supported by the OCS. The purpose of the consortium is to develop RNA interference-based therapeutics. As a member of this consortium, the Company is entitled to certain grants to support its research and development activities. Under the terms applicable to members of the consortium, so long as the Company continues to meet the criteria for receiving these grants, which criteria include the payment by the Company of part of the expenses for the activities funded by the grants and the timely delivery to OCS of written reports regarding those activities, then the Company is not required to repay the grants. If the Company ceases to meet these and other criteria, then the grant amounts for the year in which the Company ceased to meet the criteria become immediately due and payable to OCS. During the year ended December 31, 2015 and 2014, the Company received total grants of $131 and $149, respectively, from the OCS for its development within the consortium and continued to meet the criteria to receive such grants.

Ramot:

In October 2013, the Company entered into a sponsored research agreement with Ramot at Tel Aviv University (“Ramot”), a Company organized under the laws of Israel and a wholly-owned subsidiary of Tel Aviv University, for the joint development of a nano-carrier system for miR mimetic technology to treat cancer. The parties will perform joint research in accordance with a plan approved, and jointly funded by the OCS and the Company, for an initial period of 12 months commencing on October 1, 2013 and an additional period of 12 months, subject to approval by OCS, which was approved in November 2014. During 2015 the Company received additional extension from the OCS which extended the plan to December 31, 2015. Under the applicable terms, so long as the Company continues to meet the criteria for receiving OCS grants, which criteria includes the payment by the Company of part of the expenses for the activities funded by the grants and the timely delivery to OCS of written reports regarding those activities, then the Company is not required to repay the grants. If the Company ceases to meet these and other criteria, then the grant amounts for the year in which the Company ceased to meet the criteria become immediately due and payable to OCS. During the year ended December 31, 2015 and 2014, the Company received total grants of $18 and $148, respectively, from the OCS for its development within the consortium and continued to meet the criteria to receive such grants. The obligation to pay these royalties is contingent upon actual sales of products of the Company and in the absence of such sales no payment is required.

F- 25

ROSETTA GENOMICS LTD., AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

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

NOTE 9:-

SHAREHOLDERS EQUITY

Ordinary Shares:

Ordinary Shares confer upon the holders the right to receive notice to participate and vote in the general meetings of the Company, and the right to receive dividends, if declared.

Investment agreements:

During the years 2010 through 2012, the Company completed several rounds of equity offerings which involved the issuance of warrants to purchase Ordinary Shares of the Company. As of December 31, 2015, 298,669 warrants remain outstanding with exercise prices ranging from $3.19 to $48. In February 2016, 104,178 warrants expired without exercise.

The Company accounts for the warrants in accordance with the provisions of ASC 815, "Derivatives and Hedging - Contracts in Entity's Own Equity", and based on certain terms of the warrants, classifies the Warrants as liabilities, measured at fair value in each reporting period until they are exercised or expired, with changes in the fair values being recognized in the Company's Statement of Comprehensive Loss as financial income or expense.

The fair value of the outstanding warrants as of December 31, 2015 and 2014, was $0 and $2, respectively. The fair value was measured using the Black-Scholes-Merton model. In estimating the warrants' fair value, the Company used the following assumptions:

	December 31,			December 31,
	2015			2014

Risk-free interest rate		0.14	%		0.67	%
Expected volatility		61	%		57	%
Expected life (in years)		1			2
Expected dividend yield		0			0
Fair value:
Warrants	$	0		$	2

F- 26

ROSETTA GENOMICS LTD., AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

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

On March 22, 2013, the Company entered into a Controlled Equity Offering ^SM Sales Agreement (the “2013 Cantor Sales Agreement”) with Cantor, pursuant to which the Company could offer and sell, from time to time through Cantor, its Ordinary Shares. From May 22, 2013 through December 31, 2013, the Company sold through the 2013 Cantor Sales Agreement an aggregate of 1,297,883 of its Ordinary Shares, and received gross proceeds of $4,947 before deducting issuance expenses in an amount of $213. During 2014, the Company sold through the 2013 Cantor Sales Agreement an aggregate of 1,234,207 of its Ordinary Shares, and received gross proceeds of $5,151 before deducting issuance expenses in an amount of $159. Sales of the Company’s Ordinary Shares under the 2013 Cantor Sales Agreement were made in sales deemed to be “at-the-market” equity offerings as defined in Rule 415 promulgated under the Securities Act of 1933, as amended.

On April 14, 2014, a cashless exercise of warrants that were issued in 2012 occurred resulting in the issuance of an aggregate of 8,946 Ordinary Shares to the warrant holders.

On September 18, 2014, the Company's Board of Directors approved the issuance of 6,000 Ordinary Shares to a former employee. Accordingly, the Company recorded $23 as marketing and business development expense.

On February 18, 2015, the Company entered into the 2015 Cantor Sales Agreement with Cantor, as sales agent, and filed a prospectus supplement with the SEC relating to the offer and sale of up to $14,400 of its Ordinary Shares. During 2015, the Company sold through the 2015 Cantor Sales Agreement an aggregate of 2,424,358 of its Ordinary Shares, and received gross proceeds of $10,540, before deducting issuance expenses in an amount of $512. The 2015 Cantor Sales Agreement was terminated on October 13, 2015. Sales of the Company’s Ordinary Shares under the 2015 Cantor Sales Agreement were made in sales deemed to be “at-the-market” equity offerings as defined in Rule 415 promulgated under the Securities Act of 1933, as amended.

On October 13, 2015, the Company entered into the Securities Purchase Agreement, pursuant to which the Company agreed to sell securities to the 2015 Purchasers in the 2015 Private Placement. The Private Placement closed on October 16, 2015 (the "Closing Date").

Under the terms of the 2015 Private Placement, the Company issued an aggregate of 3,333,333 units at a purchase price of $2.40 per unit for gross proceeds of approximately $8,000. Each unit consisted of (i) one Ordinary Share, (ii) a 2015 Series A Warrant to purchase one-half of an Ordinary Share at an exercise price of $2.75 per ordinary share (subject to adjustment), exercisable for a period of five years from the Closing Date, and (iii) a partially pre-funded 2015 Series B Warrant. The 2015 Series B Warrants had an exercise price of NIS 0.6 (which has been prepaid) plus $0.0001 per share. The 2015 Series B Warrants were intended to reset the price of the units, and became exercisable for an aggregate of 2,666,667 shares based on 85% of the arithmetic average of the five lowest weighted average prices calculated during the ten trading days following the effective date of a resale registration statement registering the shares sold in the 2015 Private Placement for resale. The 2015 Series A Warrant exercise price has been adjusted to $1.646 per share, and all of the 2015 Series B Warrants have been exercised on a cashless basis, resulting in the issuance of 2,666,489 of the Company's Ordinary Shares. The net proceeds to the Company from the 2015 Private Placement, after deducting placement agent fees and expenses, the Company’s offering expenses, and excluding the proceeds, if any, from the exercise of the 2015 Warrants, were approximately $7,293. For its services in the offering, the Company granted 100,000 Series A Warrants to the placement agent.

F- 27

ROSETTA GENOMICS LTD., AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

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

The Company accounted for the 2015 Series A and Series B Warrants according to the provisions of ASC 815 and based on certain terms of the warrants, classified them as liabilities, measured at fair value measured at fair value in each reporting period until they are exercised, expired or terms of the warrants become fixed, with changes in the fair values being recognized in the Company's Consolidated Statement of Comprehensive Loss as financial income or expense.

The fair value of the 2015 Series A and 2015 Series B Warrants was measured using the Black-Scholes-Merton model. In estimating the warrants' fair value, the Company used the following assumptions:

	December 31, 2015

Risk-free interest rate		0.08%-1.72%
Expected volatility		50%-123%
Expected life (in years)		0.16-4.9
Expected dividend yield		0
Fair value:
Warrants	$	1.25-1.52

For the year ended December 31, 2015, the Company recognized revaluation expenses of approximately $1,051 in the Consolidated Statement of Comprehensive Loss included in "Financial expenses (income), net".

During November 2015, following the tenth trading day of the effective date of the resale of the registration statement (as defined above), the exercise price was set and the terms of the 2015 Series A and B Warrants became fixed, resulting in the classification of the fair value of the 2015 Series A and B Warrants of $6,272 to shareholders' equity. In addition, 2,333,333 2015 Series B Warrants were exercised.

As of December 31, 2015, 1,766,667 2015 Series A Warrants and 333,333 2015 Series B Warrants are outstanding. In February 2016, the remaining 333,333 2015 Series B Warrants were exercised.

F- 28

ROSETTA GENOMICS LTD., AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

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

Share option plans:

In March 2003, the Company adopted a share option plan (the "2003 Plan"). The 2003 Plan provided for the grant of options to the Company's directors, employees, consultants and service providers. In July 2006, the Company adopted the 2006 Global Share Incentive Plan (the "2006 Plan"), pursuant to which options may be granted to the Company's directors, employees, consultants and service providers. Pursuant to the 2006 plan, the 2003 Plan was terminated and the 5,363 Ordinary Shares that were available for issuance under the 2003 Plan were transferred to the 2006 Plan. 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 December 31, 2015, 32 Ordinary Shares remain outstanding under the 2003 Plan.

Pursuant to the 2006 Plan, between July 2006 and October 2012, the Company approved an additional 903,739 Ordinary Shares for the 2006 Plan for any other share option plans that have previously been, or in the future may be, adopted by the Company.

On November 12, 2014, at the Company’s Annual Shareholder Meeting, the Company’s shareholders approved the addition of 900,000 Ordinary Shares to the shares authorized for issuance under the 2006 Plan.

On December 3, 2015, at the Company’s Annual Shareholder Meeting, the Company’s Shareholders approved the addition of 765,000 Ordinary Shares to the shares authorized for issuance under the 2006 plan, bringing the total number of Ordinary Shares authorized for issuance under the 2006 Plan to 2,576,674. As of December 31, 2015, a total of 1,017,397 Ordinary Shares remain available for future grants under the 2006 Plan.

Options granted under the 2006 Plan typically vest over four years, but are subject to each optionee's specific option agreement. Options are typically exercisable for ten years from the date of grant. Options which are forfeited or unexercised become available for future grants. The exercise price of the stock option equals the fair market value of the Company’s shares on the date of the grant.

During 2013, the Company's Board of Directors approved the grant of 3,000 RSUs to certain employees. Furthermore, during 2013, certain members of the Company’s Board of Directors were granted 40,000 RSUs under the approval of the Company’s shareholders at the 2012 and 2013 Shareholder meetings. During 2014, 43,000 RSUs became fully vested and were converted into Ordinary Shares of the Company. During 2015, 45,000 RSU and 244,000 options were granted to directors and officers of the Company.

F- 29

ROSETTA GENOMICS LTD., AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

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

The following is a summary of the Company's share options granted among the various plans:

	Number of options			Weighted- average exercise price			Weighted- average remaining contractual term (in years)		Aggregate intrinsic value

Outstanding at January 1, 2015		1,104,409		$	5.84
Granted		309,805		$	1.65
Exercised		-		$	-
Forfeited		(119,644	)	$	(3.74	)
Outstanding at the end of the year		1,294,570		$	5.03			7	$	17

Vested or expected to vest		1,262,976		$	4.8			6.98	$	17

Options exercisable at the end of the year		581,609		$	7.39			6.21	$	-

The weighted-average grant-date fair value of options granted during the twelve months ended December 31, 2015, 2014 and 2013 was $1.45, $2.62, and $2.46, respectively. The aggregate intrinsic value in the table above represents the total intrinsic value (the difference between the fair market value of the Company's Ordinary Shares on December 31, 2015 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, 2015. This amount changes based on the fair market value of the Company's shares.

The following table summarizes information about options to employees and non-employees outstanding at December 31, 2015 under the Plans:

	Exercise price	Options outstanding at December 31, 2015		Weighted average remaining contractual life (years)		Weighted average exercise price		Options exercisable at December 31, 2015		Average exercise price of options exercisable

$	1.16-2.86		566,061		7.58	$	2.01		90,859	$	2.71
$	3.26-3.57		253,324		7.08	$	3.41		143,896	$	3.41
$	3.62-4.69		100,146		7.24	$	4.04		39,780	$	4.34
$	5.16-99		365,373		5.85	$	6.15		297,408	$	6.35
$	123-528.01		9,666		3.53	$	155.45		9,666	$	155.45

			1,294,570						581,609

F- 30

ROSETTA GENOMICS LTD., AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

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

The following table summarizes information relating to RSUs, as well as changes to such awards during 2015:

	Number of RSUs

Outstanding at January 1, 2015		67,000
Granted		69,219
Converted		(42,250	)
Forfeited		-
Outstanding at December 31, 2015		93,969

As of December 31, 2015, there were $1,618 of total compensation cost related to unvested options and RSUs. This amount is expected to be recognized over a weighted-average period of 1.13 years.

The following table sets forth the total share-based compensation expense resulting from options and RSUs granted to employees, non-employees and directors included in the Company's Consolidated Statement of Comprehensive Loss:

	Year ended December 31,
	2015		2014

Cost of revenues	$	37	$	34
Research and development, net		100		73
Sales, marketing and business development		281		226
General and administrative		598		610

Total share-based compensation expense	$	1,016	$	943

The Company had accounted for its options to non-employees under the fair value method ASC 505-50.

Warrants issued to non-employees:

In October 2013, the Company’s Board of Directors approved the grant of 15,000 warrants to purchase 15,000 Ordinary Shares of the Company, nominal value NIS 0.6 per share, to a non-employee.

NOTE 10:-

INCOME TAXES

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.

Tax benefits under the Law for the Encouragement of Capital Investments, 1959 (the "Law"):

F- 31

ROSETTA GENOMICS LTD., AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

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

The Company's production facilities in Israel have been granted "Approved Enterprise" status under the Law currently under separate investment programs. Pursuant to the Law, the Company elected the "Alternative Benefits Track" and has waived Government grants in return for tax exemption.

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 during 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 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, 2015, 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 at the applicable rate in respect of the gross amount that the Company distributed. In addition, the Company is required to withhold tax at the source at a rate of 15% from any dividends distributed from income attributed to the exempted profits derived from the "Approved Enterprise

Income from sources other than the "Approved Enterprise" during the benefit period will be subject to tax at the regular corporate tax rate (26.5% in 2015).

On April 1, 2005, an amendment to the Law became effective (the "Amendment") and significantly changed the provisions of the 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 Law so that companies no longer require Investment Center approval in order to qualify for tax benefits.

F- 32

ROSETTA GENOMICS LTD., AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

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

If the Company pays a dividend out of income derived from the "Beneficiary Enterprise" during the tax exemption period, such income will be subject to corporate tax at the applicable rate 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 "Beneficiary Enterprise". Under the Amendment, the benefit period for the Company will be extended 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 a "Beneficiary Enterprise" owned by a "foreign investor's company" during all or part of the benefit period.

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, 2015, the Company did not generate income under the Law prior to and after the Amendment.

In December 2010, the "Knesset" (Israeli Parliament) passed the Law for Economic Policy for 2011 and 2012 (Amended Legislation), 2011, which prescribes, among others, amendments to the Law. The amendment became effective as of January 1, 2011. According to the amendment, the benefit tracks in the Law were modified and a flat tax rate applies to a company's entire preferred income. The Company will be able to opt to apply (the waiver is non-recourse) the amendment and from then on it will be subject to the amended tax rates.

Under the 2011 Amendment, a uniform corporate tax rate applies to all qualifying income of the Preferred Company, as opposed to the former law, which was limited to income from the Approved Enterprises and Benefited Enterprise during the benefits period. The uniform corporate tax rate was 9% in areas in Israel designated as Development Zone A and 16% elsewhere in Israel during 2014 and 2015, and it scheduled to remain at 9% and 16%, respectively, in 2016.

A dividend distributed from income which is attributed to a Preferred Enterprise/Special Preferred Enterprise will be subject to withholding tax at source at the following rates: (i) Israeli resident corporation –0%, (ii) Israeli resident individual – 20% in 2014 and onwards (iii) non-Israeli resident - 20% in 2014 and onwards, subject to a reduced tax rate under the provisions of an applicable double tax treaty

The Company examined the possible effect of the amendments on its consolidated financial statements, if at all, and at this time does not believe it will opt to apply the amendments.

Tax rates applicable to the income of the Company:

The Israeli corporate tax rate was 26.5% in 2015 and 2014 and 25% in 2013.

On January 4, 2016, the Israeli Parliament's Plenum approved by a second and third reading the Bill for Amending the Income Tax Ordinance (No. 217) (Reduction of Corporate Tax Rate), 2015, which includes a reduction of the corporate tax rate from 26.5% to 25%.

F- 33

ROSETTA GENOMICS LTD., AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

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

The Company estimates that the effect of the change in the tax rate will not have material effect on the Company's financial position or results of operations.

The tax rates applicable to Rosetta Genomics Inc., a Delaware corporation, is corporate (progressive) tax at the rate of up to 35%, excluding state tax and local tax if any, which rates depend on the state and city in which business is conducted.

Income tax on U.S. Subsidiaries:

The U.S. Subsidiaries are taxed under U.S. income tax laws. There are no significant provisions for U.S. federal, state or other taxes for any period, since no taxable income was generated in all periods since inception.

Deferred income taxes:

Deferred 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. The Company and its subsidiary's deferred tax assets are comprised of operating loss carryforward and other temporary differences. Significant components of the Company and its subsidiary’s deferred tax assets are as follows:

	December 31,
	2015			2014
Tax asset in respect of:
Operating loss carryforward and deductions	$	42,443		$	34,387
Reserves, allowances and other		27			22

Net deferred tax asset before valuation allowance		42,470			34,409
Valuation allowance		(42,470	)		(34,409	)

Net deferred tax asset	$	-		$	-

The Company and its subsidiaries have provided full valuation allowances in respect of deferred tax assets resulting from operating loss carryforward and other temporary differences. Management currently believes that since the Company and its subsidiaries have a history of losses it is more likely than not that the deferred tax regarding the loss carryforward and other temporary differences will not be realized in the foreseeable future.

Reconciliation of the theoretical tax expense (benefit) to the actual tax expense (benefit):

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" and few nondeductible expense.

F- 34

ROSETTA GENOMICS LTD., AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

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

Net operating losses carryforward:

The Company has estimated accumulated losses for tax purposes as of December 31, 2015, in the amount of approximately $109,146, which may be carried forward and offset against taxable income in the future for an indefinite period.

As of December 31, 2015, the U.S. Subsidiaries have estimated total available carryforward tax losses of approximately $33,499, to offset against future taxable income which expires in the years 2027 to 2034.

Utilization of U.S. net operating losses may be subject to substantial annual limitations due to the "change in ownership" provisions of the Internal Revenue Code of 1986 and similar state law provisions. The annual limitations may result in the expiration of net operating losses before utilization.

NOTE 11:-

FINANCIAL EXPENSE (INCOME), NET

	Year ended December 31,
	2015			2014			2013

Financial income:
Interest income on short-term deposits	$	(46	)	$	(111	)	$	(146	)
Foreign currency adjustments gains and other		(9	)		(3	)		-
Revaluation of warrants related to share purchase agreement		-			(79	)		(55	)

Total financial income:		(55	)		(193	)		(201	)
Financial expenses:
Bank and interest expenses		48			39			15
Foreign currency adjustments losses		-			408			6
Revaluation of warrants related to share purchase agreement, net		1,051			-			-
Issuance expenses of warrants classified as liabilities related to share purchase agreement		561			-			-
Foreign exchange futures transactions and others		-			5			3

Total financial expenses:		1,660			452			24

Financial expense (income), net	$	1,605		$	259		$	(177	)

F- 35

Exhibit 1.1

AMENDED AND RESTATED

ARTICLES OF ASSOCIATION

ROSETTA GENOMICS LTD.

A COMPANY LIMITED BY SHARES

PRELIMINARY

1.	COMPANY NAME

The name of the company is “Rosetta Genomics Ltd.” (the “Company”).

2.	INTERPRETATION

(a)

In these Articles, the following terms shall bear the meanings set forth below, unless inconsistent with the subject or context.

“Office Holder” shall mean every director and every other person included in the definition of “office holder” under the Companies Law, including the executive officers of the Company.

“External Directors” shall mean directors appointed and serving in accordance with Sections 239 through 249 of the Companies Law.

“Companies Law” shall mean the Israeli Companies Law, 5759-1999, as amended and as may be amended from time to time, and any regulations promulgated thereunder.

“Articles” shall mean these Amended and Restated Articles of Association as originally adopted or as amended from time to time.

“Office” shall mean the registered office of the Company.

“Year” and “Month” shall mean a Gregorian month or year.

(b)

Defined terms used herein, but not defined, shall have the meaning given them in the Companies Law.

(c)

Unless the subject or the context otherwise requires: words and expressions importing the masculine gender shall include the feminine gender; and words and expressions importing persons shall include bodies corporate.

3.	PUBLIC COMPANY; LIMITED LIABILITY AND COMPANY OBJECTIVES

(a)

The Company is a Public company, as such term is defined in the Companies Law.

(b)

The liability of the Company’s Shareholders is limited and, accordingly, the liability of each Shareholder for the Company’s obligations shall be limited to the payment of the nominal value of the shares held by such Shareholder, subject to the provisions of these Articles and the Companies Law.

(c)

The Company's objectives are to carry on any business and perform any act which is not prohibited by law. The Company may also make contributions of reasonable sums to worthy purposes even if such contributions are not made on the basis of business considerations.

SHARE CAPITAL

4.	SHARE CAPITAL

(a)

The registered (authorized) share capital of the Company is thirty six million New Israeli Shekels (NIS 36,000,000) divided into sixty million (60,000,000) Ordinary Shares, nominal (par) value NIS 0.6 per share.

(b)

The Ordinary Shares all rank pari passu in all respects.

5.	INCREASE OF AUTHORIZED SHARE CAPITAL

(a)

The Company may, from time to time, by resolution of its shareholders, whether or not all the shares then authorized have been issued and whether or not all the shares theretofore issued have been called up for payment, increase its authorized share capital by the creation of new shares. Any such increase shall be in such amount and shall be divided into shares of such nominal amounts, and such shares shall confer such rights and preferences, and shall be subject to such restrictions, as such resolution shall provide.

(b)

Except to the extent otherwise provided in such resolution, any new shares included in the authorized share capital increased as aforesaid shall be subject to all the provisions of these Articles which are applicable to shares of the same class included in the existing share capital.

6.	SPECIAL RIGHTS; MODIFICATION OF RIGHTS

(a)

Subject to the provisions of these Articles, and without prejudice to any special rights previously conferred upon the holders of existing shares in the Company, the Company may, from time to time, by resolution of its shareholders, provide for shares with such preferred or deferred rights or rights of redemption or other special rights and/or such restrictions, whether in regard to liquidation, dividends, voting, repayment of share capital or otherwise, as may be stipulated in such resolution provided that any resolution with respect to the issuance of shares will be made only by the Board of Directors.

(b)

(i)

If at any time the share capital is divided into different classes of shares, the rights attached to any class, unless otherwise provided by these Articles, may be modified or abrogated by the Company, by a resolution of the shareholders, subject to the consent in writing of the holders of at least a majority of the issued shares of such class or the adoption of a resolution passed at a separate General Meeting of the holders of the shares of such class.

(ii)

The provisions of these Articles relating to General Meetings shall, mutatis mutandis , apply to any separate General Meeting of the holders of the shares of a particular class, provided, however, that the requisite quorum at any such separate General Meeting shall be two or more members present in person or by proxy and holding not less than twenty-five percent (25%) of the issued shares of such class.

(iii)

Unless otherwise provided by these Articles, the enlargement of an authorized class of shares, or the issuance of additional shares thereof out of the authorized and unissued share capital, shall not be deemed, for purposes of this Article 6(b), to modify or abrogate the rights attached to previously issued shares of such class or of any other class.

7.	CONSOLIDATION, SUBDIVISION, CANCELLATION AND REDUCTION OF SHARE CAPITAL

(a)

The Company may, from time to time, by resolution of its shareholders (subject, however, to the provisions of Article 6(b) hereof and to applicable law):

(i)

consolidate and divide all or part of its issued or un-issued authorized share capital into shares of a per share nominal value which is larger than the per share nominal value of its existing shares;

(ii)

subdivide its shares (issued or un-issued) or any of them, into shares of smaller nominal value;

(iii)

cancel any shares which, at the date of the adoption of such resolution, have not been taken or agreed to be taken by any person, and diminish the amount of its share capital by the amount of the shares so canceled; or

(iv)

reduce its share capital in any manner, subject to any consent required by law.

(b)

With respect to any consolidation of issued shares into shares of a larger nominal value per share, and with respect to any other action which may result in fractional shares, the Board of Directors may settle any difficulty which may arise with regard thereto, as it deems fit, and, in connection with any such consolidation or other action which could result in fractional shares, may, without limiting its aforesaid power:

(i)

determine, as to the holder of shares so consolidated, which issued shares shall be consolidated into a share of a larger nominal value per share;

(ii)

allot, in contemplation of or subsequent to such consolidation or other action, shares or fractional shares sufficient to preclude or remove fractional share holdings;

(iii)

redeem, in the case of redeemable preference shares, and subject to applicable law, such shares or fractional shares sufficient to preclude or remove fractional share holdings; and/or

(iv)

cause the transfer of fractional shares by certain shareholders of the Company to other shareholders thereof so as to most expediently preclude or remove any fractional shareholdings, and cause the transferees of such fractional shares to pay the transferors thereof the fair value thereof, and the Board of Directors is hereby authorized to act in connection with such transfer, as agent for the transferors and transferees of any such fractional shares, with full power of substitution, for the purposes of implementing the provisions of this sub-Article 7(b)(iv).

SHARES

8.	ISSUANCE OF SHARE CERTIFICATES; REPLACEMENT OF LOST CERTIFICATES

(a)

Share Certificates shall be issued under the corporate seal of the Company and shall bear the signature of one Director, or of any other person or persons so authorized by the Board of Directors.

(b)

Each shareholder shall be entitled to one or several numbered certificates for all the shares of any class registered in his name, each for one or more of such shares. Each certificate shall specify the serial numbers of the shares represented thereby and may also specify the amount paid up thereon.

(c)

A share certificate registered in the names of two or more persons shall be delivered to the person first named in the Shareholder Register in respect of such co-ownership.

(d)

A share certificate which has been defaced, lost or destroyed, may be replaced, and the Company shall issue a new certificate to replace such defaced, lost or destroyed certificate upon payment of such fee, and upon the furnishing of such evidence of ownership and such indemnity, as the Board of Directors in its discretion deems fit.

9.	REGISTERED HOLDER

Except as otherwise provided in these Articles, the Company shall be entitled to treat the registered holder of each share as the absolute owner thereof, and accordingly, shall not, except as ordered by a court of competent jurisdiction, or as required by statute, be obligated to recognize any equitable or other claim to, or interest in, such share on the part of any other person.

10.

ALLOTMENT OF SHARES

The un-issued shares from time to time shall be under the sole control of the Board of Directors, who shall have the power to allot, issue or otherwise dispose of shares to such persons, on such terms and conditions (including inter alia terms relating to calls as set forth in Article 12(f) hereof), and either at par or at a premium, or, subject to the provisions of the Companies Law, at a discount and/or with payment of commission, and at such times, as the Board of Directors deems fit, and the power to give to any person the option to acquire from the Company any shares, either at par or at a premium, or, subject as aforesaid, at a discount and/or with payment of commission, during such time and for such consideration as the Board of Directors deems fit.

11.

PAYMENT IN INSTALLMENTS

If pursuant to the terms of allotment or issue of any share, all or any portion of the price thereof shall be payable in installments, every such installment shall be paid to the Company on the due date thereof by the then registered holder(s) of the share or the person(s) then entitled thereto.

12.

CALLS ON SHARES

(a)

The Board of Directors may, from time to time, as it, in its discretion, deems fit, make calls for payment upon shareholders in respect of any sum which has not been paid up in respect of shares held by such shareholders and which is not pursuant to the terms of allotment or issue of such shares or otherwise, payable at a fixed time, and each shareholder shall pay the amount of every call so made upon him or her (and of each installment thereof if the same is payable in installments), to the Company at the time(s) and place(s) designated by the Board of Directors, as any such time(s) may be thereafter extended or place(s) changed. Unless otherwise stipulated in the resolution of the Board of Directors (and in the notice hereafter referred to), each payment in response to a call shall be deemed to constitute a pro rata payment on account of all the shares in respect of which such call was made.

(b)

Notice of any call for payment by a shareholder shall be given in writing to such shareholder not less than fourteen (14) days prior to the time of payment fixed in such notice, and shall specify the time and place of payment. Prior to the time for any such payment fixed in a notice of a call given to a shareholder, the Board of Directors may in its absolute discretion, by notice in writing to such member, revoke such call in whole or in part, extend the time fixed for payment thereof, or designate a different place of payment. In the event of a call payable in installments, only one notice thereof need be given.

(c)

If pursuant to the terms of allotment or issue of a share or otherwise, an amount is made payable at a fixed time (whether on account of such share or by way of premium), such amount shall be payable at such time as if it were payable by virtue of a call made by the Board of Directors and for which notice was given in accordance with paragraphs (a) and (b) of this Article 12, and the provisions of these Articles with regard to calls (and the non-payment thereof) shall be applicable to such amount (and the non-payment thereof).

(d)

Joint holders of a share shall be jointly and severally liable to pay all calls for payment in respect of such share and all interest payable thereon.

(e)

Any amount called for payment which is not paid when due shall bear interest from the date fixed for payment until actual payment thereof, at such rate (not exceeding the then prevailing debitory rate charged by leading commercial banks in Israel), and payable at such time(s) as the Board of Directors may prescribe.

(f)

Upon the allotment of shares, the Board of Directors may provide for differences among the allottees of such shares as to the amounts and times for payment of calls in respect of such shares.

13.

PREPAYMENT

With the approval of the Board of Directors, any shareholder may pay to the Company any amount not yet payable in respect of his shares, and the Board of Directors may approve the payment by the Company of interest on any such amount until the same would be payable if it had not been paid in advance, at such rate and time(s) as may be approved by the Board of Directors. The Board of Directors may at any time cause the Company to repay all or any part of the money so advanced, without premium or penalty. Nothing in this Article 13 shall derogate from the right of the Board of Directors to make any call for payment before or after receipt by the Company of any such advance.

14.

FORFEITURE AND SURRENDER

(a)

If any shareholder fails to pay an amount payable by virtue of a call, or interest thereon as provided for in accordance herewith, on or before the day fixed for payment of the same, the Board of Directors may at any time after the day fixed for such payment, so long as such amount (or any portion thereof) or interest thereon (or any portion thereof) remains unpaid, resolve to forfeit all or any of the shares in respect of which such payment was called for. All expenses incurred by the Company in attempting to collect any such amount or interest thereon, including, without limitation, attorney’s fees and costs of legal proceedings, shall be added to, and shall, for all purposes (including the accrual of interest thereon), constitute a part of, the amount payable to the Company in respect of such call.

(b)

Upon the adoption of a resolution as to the forfeiture of a shareholder’s share, the Board of Directors shall cause notice thereof to be given to such shareholder, which notice shall state that, in the event of the failure to pay the entire amount so payable by a date specified in the notice (which date shall be not less than fourteen (14) days after the date such notice is given and which may be extended by the Board of Directors), such shares shall be ipso facto forfeited, provided, however, that, prior to such date, the Board of Directors may nullify such resolution of forfeiture, but no such nullification shall stop the Board of Directors from adopting a further resolution of forfeiture in respect of the non-payment of the same amount.

(c)

Without derogating from Articles 54 and 59 hereof, whenever shares are forfeited as herein provided, all dividends, if any, theretofore declared in respect thereof and not actually paid shall be deemed to have been forfeited at the same time.

(d)

The Company, by resolution of the Board of Directors, may accept the voluntary surrender of any share not fully paid for.

(e)

Any share forfeited or surrendered as provided herein, shall become the property of the Company, and the same, subject to the provisions of these Articles, may be sold, re-allotted or otherwise disposed of as the Board of Directors deems fit.

(f)

Any shareholder whose shares have been forfeited or surrendered shall cease to be a shareholder in respect of the forfeited or surrendered shares, but shall, notwithstanding, be liable to pay, and shall forthwith pay, to the Company, all calls, interest and expenses owing upon or in respect of such shares at the time of forfeiture or surrender, together with interest thereon from the time of forfeiture or surrender until actual payment, at the rate prescribed in Article 12(e) above, and the Board of Directors, in its discretion, may, but shall not be obligated to, enforce the payment of such moneys, or any part thereof. In the event of such forfeiture or surrender, the Company, by resolution of the Board of Directors, may accelerate the date(s) of payment of any or all amounts then owing to the Company by the shareholder in question (but not yet due) in respect of all shares owned by such shareholder, solely or jointly with another.

(g)

The Board of Directors may at any time, before any share so forfeited or surrendered shall have been sold, re-allotted or otherwise disposed of, nullify the forfeiture or surrender on such conditions as it deems fit, but no such nullification shall stop the Board of Directors from re-exercising its powers of forfeiture pursuant to this Article 14.

15.

LIEN

(a)

Except to the extent the same may be waived or subordinated in writing, the Company shall have a first and paramount lien upon all the shares registered in the name of each shareholder (without regard to any equitable or other claim or interest in such shares on the part of any other person), and upon the proceeds of the sale thereof, for his debts, liabilities and engagements to the Company arising from any amount payable by such shareholder in respect of any unpaid or partly paid share, whether or not such debt, liability or engagement has matured. Such lien shall extend to all dividends from time to time declared or paid in respect of such share. Unless otherwise provided, the registration by the Company of a transfer of shares shall be deemed to be a waiver on the part of the Company of the lien (if any) existing on such shares immediately prior to such transfer.

(b)

The Board of Directors may cause the Company to sell a share subject to such a lien when the debt, liability or engagement giving rise to such lien has matured, in such manner as the Board of Directors deems fit, but no such sale shall be made unless such debt, liability or engagement has not been satisfied within fourteen (14) days after written notice of the intention to sell shall have been served on such shareholder, his executors or administrators.

(c)

The net proceeds of any such sale, after payment of the costs thereof, shall be applied in or toward satisfaction of the debts, liabilities or engagements of such member in respect of such share (whether or not the same have matured), and the residue (if any) shall be paid to the shareholder, his executors, administrators or assigns.

16.

SALE AFTER FORFEITURE OR SURRENDER OR IN ENFORCEMENT OF LIEN

Upon any sale of a share after forfeiture or surrender or for enforcing a lien, the Board of Directors may appoint any person to execute an instrument of transfer of the share so sold and cause the purchaser’s name to be entered in the Shareholder Register in respect of such share. The purchaser shall be registered as the shareholder and shall not be bound to see to the regularity of the sale proceedings, or to the application of the proceeds of such sale, and after his name has been entered in the Shareholder Register in respect of such share, the validity of the sale shall not be impeached by any person, and the remedy of any person aggrieved by the sale shall be in damages only and against the Company exclusively.

17.

REDEEMABLE SHARES

The Company may, subject to applicable law, issue redeemable shares and redeem the same.

TRANSFER OF SHARES

18.

REGISTRATION OF TRANSFER

(a)

No transfer of shares shall be registered unless a proper writing or instrument of transfer (in any customary form or any other form satisfactory to the Board of Directors) has been submitted to the Company (or its transfer agent), together with the share certificate(s) and such other evidence of title as the Board of Directors may reasonably require. Until the transferee has been registered in the Shareholder Register (or with the transfer agent) in respect of the shares so transferred, the Company may continue to regard the transferor as the owner thereof. The Board of Directors, may, from time to time, prescribe a fee for the registration of a transfer.

(b)

The Board of Directors may, in its discretion to the extent it deems necessary, close the Shareholder Register for registrations of transfers of shares during any year for a period determined by the Board of Directors, and no registrations of transfers of shares shall be made by the Company during any such period during which the Shareholder Register is so closed.

19.

RECORD DATE FOR NOTICES OF GENERAL MEETINGS AND OTHER ACTION

(a)

Notwithstanding any provision of these Articles to the contrary, and to allow the Company to determine the shareholders entitled to notice of, or to vote at, any Annual or Extraordinary General Meeting or any adjournment thereof, or to express consent to or dissent from any corporate action in writing without a meeting, or entitled to receive payment of any dividend or other distribution or allotment of any rights, or entitled to exercise any rights in respect of, or to take or be the subject to, any other action, the Board of Directors may fix, a record date, which shall not be more than forty (40), or any longer period permitted under the Companies Law, nor less than four (4) days before the date of such meeting or other action. A determination of shareholders of record entitled to notice of or to vote at a meeting shall apply to any adjournment of the meeting: provided, however, that the Board of Directors may fix a new record date for the adjourned meeting.

(b)

Any shareholder or shareholders of the Company holding, at least one percent (1%) of the voting rights in the issued share capital of the Company may, pursuant to the Companies Law, request that the Board of Directors include a subject in the agenda of a General Meeting to be held in the future. Any such request must be in writing, must include all information related to subject matter and the reason that such subject is proposed to be brought before the General Meeting and must be signed by the shareholder or shareholders making such request. In addition, subject to the Companies Law and the provisions of Article 39, the Board of Directors may include such subject in the agenda of a General Meeting only if the request has been delivered to the Secretary of the Company not later than sixty (60) days and not more than one hundred and twenty (120) days prior to the General Meeting in which the subject is to be considered by the shareholders of the Company. Each such request shall also set forth: (a) the name and address of the shareholder making the request; (b) a representation that the shareholder is a holder of record of shares of the Company entitled to vote at such meeting and intends to appear in person or by proxy at the meeting; (c) a description of all arrangements or understandings between the shareholder and any other person or persons (naming such person or persons) in connection with the subject which is requested to be included in the agenda; and (d) a declaration that all the information that is required under the Companies Law and any other applicable law to be provided to the Company in connection with such subject, if any, has been provided. Furthermore, the Board of Directors, may, in its discretion to the extent it deems necessary, request that the shareholders making the request provide additional information necessary so as to include a subject in the agenda of a General Meeting, as the Board of Directors may reasonably require.

TRANSMISSION OF SHARES

20.

DECENDENTS’ SHARES

(a)

In case of death of a registered holder of a share registered in the names of two or more holders, the Company may recognize the survivor(s) as the sole owner(s) thereof unless and until the provisions of Article 20(b) have been effectively invoked.

(b)

Any person becoming entitled to a share in consequence of the death of any shareholder, upon producing evidence of the grant of probate or letters of administration or declaration of succession (or such other evidence as the Board of Directors may reasonably deem sufficient), shall be registered as a shareholder in respect of such share, or may, subject to the regulations as to transfer herein contained, transfer such share.

21.

RECEIVERS AND LIQUIDATORS

(a)

The Company may recognize any receiver, liquidator or similar official appointed to wind-up, dissolve or otherwise liquidate a corporate shareholder, and a trustee, manager, receiver, liquidator or similar official appointed in bankruptcy or in connection with the reorganization of, or similar proceeding with respect to a shareholder or its properties, as being entitled to the shares registered in the name of such member.

(b)

Such receiver, liquidator or similar official appointed to wind-up, dissolve or otherwise liquidate a corporate shareholder and such trustee, manager, receiver, liquidator or similar official appointed in bankruptcy or in connection with the reorganization of, or similar proceedings with respect to a shareholder or its properties, upon producing such evidence as the Board of Directors may deem sufficient as to his authority to act in such capacity or under this Article, shall with the consent of the Board of Directors (which the Board of Directors may grant or refuse in its absolute discretion), be registered as a shareholder in respect of such shares, or may, subject to the regulations as to transfer herein contained, transfer such shares.

GENERAL MEETINGS

22.

ANNUAL GENERAL MEETING

(a)

An Annual General Meeting shall be held once in every calendar year at such time (within a period of not more than fifteen (15) months after the last preceding Annual General Meeting) and at such place, either within or without the State of Israel, as may be determined by the Board of Directors.

(b)

Subject to the provisions of these Articles, the function of the Annual General Meeting shall be to elect the members of the Board of Directors; to receive the Financial Statements, to appoint the Company’s auditors and to fix their remuneration and to transact any other business which under these Articles or the Companies Law are to be transacted at a General Meeting.

23.

EXTRAORDINARY GENERAL MEETINGS

All General Meetings other than Annual General Meetings shall be called “Extraordinary General Meetings”. The Board of Directors may, whenever it thinks fit, convene an Extraordinary General Meeting, at such time and place, within or out of the State of Israel, as may be determined by the Board of Directors, and shall be obliged to do so upon a requisition in writing in accordance with Section 63 of the Companies Law.

24.

NOTICE OF GENERAL MEETINGS; OMISSION TO GIVE NOTICE

(a)

Not less than twenty-one (21) days’ prior notice, or thirty-five (35) days’ prior notice to the extent required under regulations promulgated under the Companies Law, shall be given of every General Meeting. Each such notice shall specify the place and the day and hour of the meeting and the general nature of each item to be acted upon thereat, said notice to be given to all members who would be entitled to attend and vote at such meeting. Anything therein to the contrary notwithstanding, with the consent of all members entitled to vote thereon, a resolution may be proposed and passed at such meeting although a lesser notice than hereinabove prescribed has been given.

(b)

The accidental omission to give notice of a meeting to any member, or the non-receipt of notice sent to such member, shall not invalidate the proceedings at such meeting.

(c)

Notwithstanding anything to the contrary in this Article 24, and subject to any applicable stock exchange rules or regulations, notice of general meetings does not have to be delivered to shareholders, and notice by the Company of a General Meeting which is published in one daily newspaper in New York, New York, USA or in one international wire service shall be deemed to have been duly given on the date of such publication to any shareholder whose address as registered in the Register of Shareholders (or as designated in writing for the receipt of notices and other documents) is located outside of Israel.

25.

MANNER OF MEETING

The Board may, in its absolute discretion, resolve to enable persons entitled to attend a general meeting to do so by simultaneous attendance and participation at the principal meeting place and a satellite meeting place or places anywhere in the world and the shareholders present in person, by proxy or by written ballot at satellite meeting places shall be counted in the quorum for and entitled to vote at the general meeting in question, and that meeting shall be duly constituted and its proceedings valid, provided that the chairman of the general meeting is satisfied that adequate facilities are available throughout the general meeting to ensure that shareholders attending at all the meeting places are able to:

(a)

participate in the business for which the meeting has been convened;

(b)

hear all persons who speak (whether by the use of microphones, loudspeakers audio-visual communications equipment or otherwise) in the principal meeting place and any satellite meeting place(s); and

(c)

be heard by all other persons so present in the same way.

PROCEEDINGS AT GENERAL MEETINGS

26.

QUORUM

(a)

No business shall be transacted at a General Meeting, or at any adjournment thereof, unless the quorum required under these Articles for such General Meeting or such adjourned meeting, as the case may be, is present when the meeting proceeds to business.

(b)

In the absence of contrary provisions in these Articles, two or more shareholders (not in default in payment of any sum referred to in Article 32(a) hereof), present in person or by proxy and holding shares conferring in the aggregate more than twenty-five (25 %) percent of the voting power of the Company, shall constitute a quorum of General Meetings.

(c)

If within half an hour from the time appointed for the meeting a quorum is not present, the meeting, if convened upon requisition under Sections 64 or 65 of the Companies Law, shall be dissolved, but in any other case it shall be adjourned to the same day in the next week, at the same time and place, or to such day and at such time and place as the Chairman may determine. No business shall be transacted at any adjourned meeting except business which might lawfully have been transacted at the meeting as originally called. At such adjourned meeting (other than an adjourned separate meeting of a particular class of shares as referred to in Article 6 of these Articles), any two (2) shareholders (not in default as aforesaid) present in person or by proxy, shall constitute a quorum.

(d)

The Board of Directors may determine, in its discretion, the matters that may be voted upon at the meeting by proxy in addition to the matters listed in Section 87(a) to the Companies Law.

27.

CHAIRMAN

The Chairman, if any, of the Board of Directors, shall preside as Chairman at every General Meeting of the Company. If at any meeting the Chairman is not present within fifteen (15) minutes after the time fixed for holding the meeting or is unwilling to act as Chairman, the Co-Chairman shall preside at the meeting. If at any such meeting both the Chairman and the Co-Chairman are not present or are unwilling to act as Chairman, the shareholders present shall choose someone of their number to be Chairman. The office of Chairman shall not, by itself, entitle the holder thereof to vote at any General Meeting nor shall it entitle such holder to a second or casting vote (without derogating, however, from the rights of such Chairman to vote as a shareholder or proxy of a shareholder if, in fact, he is also a shareholder or proxy).

28.

ADOPTION OF RESOLUTIONS AT GENERAL MEETINGS

(a)

A resolution shall be deemed adopted if approved by the holders of a majority of the voting power represented at the meeting in person or by proxy or by written ballot and voting thereon.

(b)

Every question submitted to a General Meeting shall be decided by a show of hands, but the Chairman of the Meeting may determine that a resolution shall be decided by a written ballot. A written ballot may be implemented before the proposed resolution is voted upon or immediately after the declaration by the Chairman of the results of the vote by a show of hands. If a vote by written ballot is taken after such declaration, the results of the vote by a show of hands shall be of no effect, and the proposed resolution shall be decided by such written ballot.

(c)

A declaration by the Chairman of the meeting that a resolution has been carried unanimously, or carried by a particular majority, or lost, and an entry to that effect in the minute book of the Company, shall be conclusive evidence of the fact without proof of the number or proportion of the votes recorded in favor of or against such resolution.

(d)

Notwithstanding any of the other provisions of these Articles, any resolution to consummate a Merger, as defined in Section 1 of the Law, shall require the approval of the holders of at least a majority of the voting power of the Company. For the avoidance of doubt, any amendment to this Article 28(d) shall require the approval of the holders of at least a majority of the voting power of the Company.

29.

RESOLUTIONS IN WRITING

A resolution in writing signed by all shareholders of the Company then entitled to attend and vote at General Meetings or to which all such shareholders have given their written consent (by letter, telegram, telex, facsimile, email or otherwise) shall be deemed to have been unanimously adopted by a General Meeting duly convened and held.

30.

POWER TO ADJOURN

(a)

The Chairman of a General Meeting at which a quorum is present may, with the consent of the holders of a majority of the voting power represented in person or by proxy and voting on the question of adjournment (and shall if so directed by the meeting), adjourn the meeting from time to time and from place to place, but no business shall be transacted at any adjourned meeting except business which might lawfully have been transacted at the meeting as originally called.

(b)

It shall not be necessary to give notice of an adjournment, whether pursuant to Article 26(c) or Article 30(a), unless the meeting is adjourned for twenty-one (21) days or more in which event notice thereof shall be given in the manner required for the meeting as originally called.

31.

VOTING POWER

Subject to the provisions of Article 32(a) and subject to any provision hereof conferring special rights as to voting, or restricting the right to vote, every shareholder shall have one vote for each share held by him of record, on every resolution, without regard to whether the vote thereon is conducted by a show of hands, by written ballot or by any other means.

32.

VOTING RIGHTS

(a)

No shareholder shall be entitled to vote at any General Meeting (or be counted as a part of the quorum thereat), unless all calls and other sums then payable by him in respect of his shares in the Company have been paid, but this Article 32(a) shall not apply to separate General Meetings of the holders of a particular class of shares pursuant to Article 6(b).

(b)

A company or other corporate body being a shareholder of the Company may duly authorize any person to be its representative at any meeting of the Company or to execute or deliver a proxy on its behalf. Any person so authorized shall be entitled to exercise on behalf of such shareholder all the power which the latter could have exercised if it were an individual shareholder. Upon the request of the Chairman of the meeting, written evidence of such authorization (in form acceptable to the Chairman) shall be delivered to him.

(c)

Any shareholder entitled to vote may vote either in person or by proxy (who need not be a shareholder of the Company), or, if the shareholder is a company or other corporate body, by a representative authorized pursuant to Article 32(b).

(d)

If two or more persons are registered as joint holders of any share, the vote of the senior who tenders a vote, in person or by proxy, shall be accepted to the exclusion of the vote(s) of the other joint holder(s). For the purpose of this Article 32(d), seniority shall be determined by the order of registration of the joint holders in the Shareholder Register.

PROXIES

33.

INSTRUMENT OF APPOINTMENTS

(a)

An instrument appointing a proxy shall be in writing and shall be substantially in the following form:

“I, [insert name of shareholder] of [insert address of shareholder], being a member of Rosetta Genomics Ltd. (the “Company”), hereby appoints [insert name of proxy] or [insert address of proxy] as my proxy to vote for me and on my behalf at the [Annual / Extraordinary] General Meeting of the Company to be held on the ___ day of _______, 20__ and at any adjournment(s) thereof.

Signed this ____ day of ___________, 20__.

(Signature of Appointer)”

or in any usual or common form or in such other form as may be approved by the Board of Directors. Such proxy shall be duly signed by the appointer or such person’s duly authorized attorney or, if such appointer is a company or other corporate body, under its common seal or stamp or the hand of its duly authorized agent(s) or attorney(s).

(b)

The instrument appointing a proxy (and the power of attorney or other authority, if any, under which such instrument has been signed) shall either be presented to the Chairman at the meeting at which the person named in the instrument proposes to vote or be delivered to the Company (at its Registered Office, at its principal place of business, or at the offices of its registrar or transfer agent, or at such place as the Board of Directors may specify) not less than two (2) hours before the time fixed for such meeting, except that the instrument shall be delivered (i) twenty-four (24) hours before the time fixed for the meeting where the meeting is to be held in the United States of America and the instrument is delivered to the Company at its Registered Office or principal place of business, or (ii) forty-eight (48) hours before the time fixed for the meeting where the meeting is to be held outside of the United States of America and Israel and the instrument is delivered to the Company’s registrar or transfer agent. Notwithstanding the above, the Chairman shall have the right to waive the time requirement provided above with respect to all instruments of proxies and to accept any and all instruments of proxy until the beginning of a General Meeting.

34.

EFFECT OF DEATH OF APPOINTOR OR TRANSFER OF SHARE OR REVOCATION OF APPOINTMENT

(a)

A vote cast in accordance with an instrument appointing a proxy shall be valid notwithstanding the prior death or bankruptcy of the appointing member (or of his attorney-in-fact, if any, who signed such instrument), or the transfer of the share in respect of which the vote is cast, unless written notice of such matters shall have been received by the Company or by the Chairman of such meeting prior to such vote being cast.

(b)

An instrument appointing a proxy shall be deemed revoked (i) upon receipt by the Company or the Chairman, subsequent to receipt by the Company of such instrument, of written notice signed by the person signing such instrument or by the member appointing such proxy canceling the appointment thereunder (or the authority pursuant to which such instrument was signed) or of an instrument appointing a different proxy (and such other documents, if any, required under Article 33(b) for such new appointment), provided such notice of cancellation or instrument appointing a different proxy were so received at the place and within the time for delivery of the instrument revoked thereby as referred to in Article 33(b) hereof, or (ii) if the appointing shareholder is present in person at the meeting for which such instrument of proxy was delivered, upon receipt by the Chairman of such meeting of written notice from such member of the revocation of such appointment, or if and when such shareholder votes at such meeting. A vote cast in accordance with an instrument appointing a proxy shall be valid notwithstanding the revocation or purported cancellation of the appointment, or the presence in person or vote of the appointing shareholder at a meeting for which it was rendered, unless such instrument of appointment was deemed revoked in accordance with the foregoing provisions of this Article 34(b) at or prior to the time such vote was cast.

BOARD OF DIRECTORS

35.

POWERS OF BOARD OF DIRECTORS

(a)

General . The management of the business of the Company shall be vested in the Board of Directors, which may exercise all such powers and do all such acts and things as the Company is authorized to exercise and do, and are not by these Articles or by law required to be exercised or done by the Company by action of its shareholders at a General Meeting. The authority conferred on the Board of Directors by this Article 35 shall be subject to the provisions of the Companies Law, these Articles and any regulation or resolution consistent with these Articles adopted from time to time by the Company by action of its shareholders at a General Meeting, provided, however, that no such regulation or resolution shall invalidate any prior act done by or pursuant to a decision of the Board of Directors which would have been valid if such regulation or resolution had not been adopted.

(b)

Borrowing Power . The Board of Directors may from time to time, at its discretion, cause the Company to borrow or secure the payment of any sum or sums of money for the purposes of the Company, and may secure or provide for the repayment of such sum or sums in such manner, at such times and upon such terms and conditions as it deems fit, and, in particular, by the issuance of bonds, perpetual or redeemable debentures, debenture stock, or any mortgages, charges, or other securities on the undertaking or the whole or any part of the property of the Company, both present and future, including its uncalled or called but unpaid capital for the time being.

(c)

Reserves . The Board of Directors may, from time to time, set aside any amount(s) out of the profits of the Company as a reserve or reserves for any purpose(s) which the Board of Directors, in its absolute discretion, shall deem fit, including without limitation, capitalization and distribution of bonus shares, and may invest any sum so set aside in any manner and from time to time deal with and vary such investments and dispose of all or any part thereof, and employ any such reserve or any part thereof in the business of the Company without being bound to keep the same separate from other assets of the Company, and may subdivide or redesignate any reserve or cancel the same or apply the funds therein for another purpose, all as the Board of Directors may from time to time think fit.

36.

EXERCISE OF POWERS OF BOARD OF DIRECTORS

(a)

A meeting of the Board of Directors at which a quorum is present shall be competent to exercise all the authorities, powers and discretion vested in or exercisable by the Board of Directors, whether in person or by any other means by which the Directors may hear each other simultaneously.

(b)

A resolution proposed at any meeting of the Board of Directors shall be deemed adopted if approved by a majority of the Directors present when such resolution is put to a vote and voting thereon.

(c)

The Board of Directors may adopt resolutions without holding a meeting of the Board of Directors, provided that all of the Directors then in office and lawfully entitled to vote thereon shall have agreed to vote on the matters underlying such resolutions without convening a meeting of the Board of Directors. If the Board of Directors adopts resolutions as set forth in the immediately preceding sentence, minutes including such resolutions, including a resolution to vote on such matters without convening a meeting of the Board of Directors, shall be prepared and the Chairman of the Board of Directors (or in his or her absence the Co-Chairman) will sign such minutes.

37.

DELEGATION OF POWERS

(a)

The Board of Directors may, subject to the provisions of the Companies Law, delegate any or all of its powers to committees, each consisting of one or more persons (who are Directors), and it may from time to time revoke such delegation or alter the composition of any such committee. Any Committee so formed (in these Articles referred to as a “Committee of the Board of Directors”), shall, in the exercise of the powers so delegated, conform to any regulations imposed on it by the Board of Directors. The meetings and proceedings of any such Committee of the Board of Directors shall, mutatis mutandis , be governed by the provisions herein contained for regulating the meetings of the Board of Directors, so far as not superseded by any regulations adopted by the Board of Directors under this Article. Unless otherwise expressly provided by the Board of Directors in delegating powers to a Committee of the Board of Directors, such Committee shall not be empowered to further delegate such powers.

(b)

Without derogating from the provisions of Article 50, the Board of Directors may from time to time appoint a Secretary to the Company, as well as officers, agents, employees and independent contractors, as the Board of Directors deems fit, and may terminate the service of any such person. The Board of Directors may, subject to the provisions of the Companies Law, determine the powers and duties, as well as the salaries and emoluments, of all such persons, and may require security in such cases and in such amounts as it deems fit.

(c)

The Board of Directors may from time to time, by power of attorney or otherwise, appoint any person, company, firm or body of persons to be the attorney or attorneys of the Company at law or in fact for such purpose(s) and with such powers, authorities and discretions, and for such period and subject to such conditions, as it deems fit, and any such power of attorney or other appointment may contain such provisions for the protection and convenience of persons dealing with any such attorney as the Board of Directors deems fit, and may also authorize any such attorney to delegate all or any of the powers, authorities and discretion vested in him.

38.

NUMBER OF DIRECTORS

The Board of Directors of the Company shall consist of not less than two (2) nor more than seven (7) Directors.

39.

ELECTION AND REMOVAL OF DIRECTORS

(a)

The Directors, except for External Directors, shall be classified, with respect to the time for which they severally hold office, into three classes, as nearly equal in number as possible, as determined by the Board of Directors, one class to hold office initially for a term expiring at the annual meeting of shareholders to be held in 2008, another class to hold office initially for a term expiring at the annual meeting of shareholders to be held in 2009, and another class to hold office initially for a term expiring at the annual meeting of shareholders to be held in 2010, with the members of each class to hold office until their successors are elected and qualified. At each annual meeting of the shareholders, the successors of the class of Directors whose term expires at that meeting shall be elected to hold office for a term expiring at the annual meeting of shareholders held in the third year following the year of their election. If the number of Directors constituting the Board is changed, any increase or decrease shall be apportioned among the classes so as to maintain the number of directors in each class as nearly as possible, and any additional directors of any class shall hold office for a term which shall coincide with the remaining term of such class, but in no case shall a decrease in the number of directors constituting the Board shorten the term of any incumbent director. Notwithstanding anything in these Articles to the contrary, the provisions of this Article 39(a) may not be amended without approval of the greater of (i) holders of not less than seventy-five percent (75%) of the voting power represented at a meeting in person or by proxy and voting thereon, or (ii) holders of a majority of the outstanding voting power of all shares of the Company voting on such matter at a General Meeting."

(b)

Directors shall be elected at the Annual General Meeting or an Extraordinary Meeting of the Company by the vote of the holders of a majority of the voting power represented at such meeting in person or by proxy and voting on the election of directors.

(c)

Nominations for the election of Directors may be made by the Board of Directors or a committee appointed by the Board of Directors or by any shareholder holding at least 1% of the outstanding voting power in the Company. However, and without limitation of Sections 63 or 64 of the Companies Law, any such shareholder 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 the Secretary of the Company not later than (i) with respect to an election to be held at an Annual General Meeting of shareholders, ninety (90) days prior to the anniversary date of the immediately preceding annual meeting, and (ii) with respect to an election to be held at a Extraordinary General Meeting of shareholders for the election of Directors, at least ninety (90) days prior to the date of such meeting. Each such notice shall set forth: (a) the name and address of the shareholder who intends to make the nomination and of the person or persons to be nominated; (b) a representation that the shareholder is a holder of record of shares of the Company entitled to vote at such meeting and intends to appear in person or by proxy at the meeting to nominate the person or persons specified in the notice; (c) a description of all arrangements or understandings between the shareholder and each nominee and any other person or persons (naming such person or persons) pursuant to which the nomination or nominations are to be made by the shareholder; and (d) the consent of each nominee to serve as a Director of the Company if so elected and a declaration signed by each of the nominees declaring that there is no limitation under the Companies Law for the appointment of such a nominee and that all the information that is required under the Companies Law to provided to the Company in connection with such an appointment has been provided. The Chairman of the meeting may refuse to acknowledge the nomination of any person not made in compliance with the foregoing procedure.

(d)

The General Meeting may, by a vote of the holders of at least 75% of the voting power represented at the meeting, remove any Director(s) from office, and elect Directors instead of Directors so removed or fill any Vacancy (as defined in Article 41), however created, in the Board of Directors unless such Vacancy was filled by the Board of Directors under Article 41.

(e)

Notwithstanding the provisions of this Article 39, External Directors shall be elected and hold office in accordance with the provisions of the Companies Law.

40.

QUALIFICATION OF DIRECTORS

No person shall be disqualified to serve as a Director by reason of his not holding shares in the Company or by reason of his having served as a Director in the past.

41.

CONTINUING DIRECTORS IN THE EVENT OF VACANCIES

In the event that one or more vacancies is created in the Board of Directors, including without limitation, a situation in which the number of Directors is less than the minimum number permitted under Article 38 (a “Vacancy”), the continuing Directors may continue to act in every matter, and, may appoint Directors to temporarily fill any such Vacancy, provided, however, that if the number of Directors is less than two (2), they may only act in (i) an emergency; or (ii) to fill the office of director which has become vacant; or (iii) in order to call a General Meeting of the Company for the purpose of electing Directors to fill any or all Vacancies, so that at least two (2) Directors are in office as a result of said meeting. Notwithstanding the foregoing, in the event of Vacancy of an External Director, the Company shall call a General Meeting to elect a new External Director or take such other action as required under the Companies Law.

42.

VACATION OF OFFICE

(a)

The office of a Director shall be vacated, ipso facto, upon his or her death, or if he or she be found lunatic or become of unsound mind, or if he or she becomes bankrupt, or if the Director is a company, upon its winding-up, or if he is found by a court guilty of any of the felonies listed in Section 226 of the Companies Law.

(b)

The office of a Director may also be vacated by the written resignation of the Director. Such resignation shall become effective on the date fixed therein, or upon the delivery thereof to the Company, whichever is later. Such written resignation shall include the reasons that lead the Director to resign from his office.

43.

REMUNERATION OF DIRECTORS

A Director shall be paid remuneration by the Company for his services as Director to the extent such remuneration shall have been approved by the Company in accordance with the Companies Law.

44.

CONFLICT OF INTEREST

Subject to the provisions of the Companies Law, no Director shall be disqualified by virtue of his office from holding any office or place of profit in the Company or in any company in which the Company shall be a shareholder or otherwise interested, or from contracting with the Company as vendor, purchaser or otherwise, nor shall any such contract, or any contract or arrangement entered into by or on behalf of the Company in which any Director shall be in any way interested, be voided, nor, other than as required under the Companies Law, shall any Director be liable to account to the Company for any profit arising from any such office or place of profit or realized by any such contract or arrangement by reason only of such Director’s holding that office or of the fiduciary relations thereby established, but the nature of his interest, as well as any material fact or document, must be disclosed by him at the meeting of the Board of Directors at which the contract or arrangement is first considered, if his interest then exists, or, in any other case, at no later than the first meeting of the Board of Directors after the acquisition of his interest.

45.

ALTERNATE DIRECTORS

(a)

A Director may, by written notice to the Company given in the manner set forth in Article 45(b) below, appoint any individual who is qualified to serve as a director (provided that such individual is not a member of the Board of Directors and is not already an Alternate Director) as an alternate for himself (in these Articles referred to as “Alternate Director”), remove such Alternate Director and appoint another Alternate Director in place of any Alternate Director appointed by him whose office has been vacated for any reason whatsoever. Notwithstanding the foregoing, a Director that is a member of a Committee of the Board of Directors may appoint as his Alternate Director on such Committee of the Board of Directors a member of the Board of Directors, but provided that such Director is not already a member of such Committee of the Board of Directors and further provided that if such person is appointed as an Alternate Director for an External Director, such Alternate Director shall have the same accounting and financial expertise or other professional expertise as possessed by the appointing Director (as such accounting, financial and professional expertise may be promulgated in applicable law and regulations and amended from time to time). An External Director may not appoint an Alternate Director for himself except as set forth in the immediately preceding sentence. The appointment of an Alternate Director shall be subject to the consent of the Board of Directors. Unless the appointing Director, by the instrument appointing an Alternate Director or by written notice to the Company, limits such appointment to a specified period of time or restricts it to a specified meeting or action of the Board of Directors, or otherwise restricts its scope, the appointment shall be for all purposes, and for a period of time concurrent with the term of the appointing Director.

(b)

Any notice to the Company pursuant to Article 45(a) above shall be given in person to, or by sending the same by mail to the attention of the General Manager of the Company at the principal office of the Company or to such other person or place as the Board of Directors shall have determined for such purpose, and shall become effective on the date fixed therein, or upon the receipt thereof by the Company (at the place as aforesaid), whichever is later, subject to the consent of the Board of Directors if the appointee is not then a member of the Board of Directors, in which case the notice will be effective as of the date of such consent.

(c)

An Alternate Director shall have all the rights and obligations of the Director who appointed him, provided however, that he or she (i) may not in turn appoint an alternate for himself or herself (unless the instrument appointing him otherwise expressly provides), and (ii) shall have no standing at any meeting of the Board of Directors or any committee thereof while the Director who appointed him is present, and (iii) is not entitled to remuneration.

(d)

An Alternate Director shall be responsible for his or her own acts and defaults.

(f)

The office of an Alternate Director shall be vacated under the circumstances, mutatis mutandis , set forth in Article 42 and Article 45(a), and such office shall ipso facto be vacated if the Director who appointed such Alternate Director ceased to be a Director.

PROCEEDINGS OF THE BOARD OF DIRECTORS

46.

MEETINGS

(a)

The Board of Directors may meet and adjourn its meetings and otherwise regulate such meetings and proceedings as the Directors think fit.

(b)

Any Director may at any time, and the Secretary, upon the request of such Director, shall, convene a meetings of the Board of Directors, but not less than two (2) days’ notice shall be given of any meetings so convened. Notice of any such meeting shall be given to all the Directors and may be given orally, by telephone, in writing or by mail, email or facsimile. Notwithstanding anything to the contrary herein, failure to deliver notice to a director of any such meeting in the manner required hereby may be waived by such Director, and a meeting shall be deemed to have been duly convened notwithstanding such defective notice if such failure or defect is waived prior to action being taken at such meeting, by all Directors entitled to participate at such meeting to whom notice was not duly given as aforesaid.

47.

QUORUM

Until otherwise unanimously decided by the Board of Directors, a quorum at a meeting of the Board of Directors shall be constituted by the presence in person or by telephone conference of half (50%) of the Directors then in office who are lawfully entitled to participate in the meeting. No business shall be transacted at a meeting of the Board of Directors unless the requisite quorum is present (in person or by telephone conference or by other means by which all directors may hear and be heard) when the meeting proceeds to business.

48.

CHAIRMAN OF THE BOARD OF DIRECTORS

The Board of Directors may from time to time, elect one of its members to be the Chairman of the Board of Directors, and another of its members as Co-Chairman, remove such Chairman and Co-Chairman from office and appoint others in their place. The Chairman of the Board of Directors shall preside at every meeting of the Board of Directors, but if there is no such Chairman, or if at any meeting he is not present within fifteen (15) minutes of the time fixed for the meeting or if he is unwilling to take the chair, the Co-Chairman shall preside. If both the Chairman and the Co-Chairman are not present within such fifteen (15) minutes or are unwilling to take the chair the Directors present shall choose one of their number to be the Chairman of such meeting.

49.

VALIDITY OF ACTS DESPITE DEFECTS

All acts done bona fide at any meeting of the Board of Directors, or of a Committee of the Board of Directors, or by any person(s) acting as Director(s), shall, notwithstanding that it may afterwards be discovered that there was some defect in the appointment of the participants in such meetings or any of them or any person(s) acting as aforesaid, or that they or any of them were disqualified, be as valid as if there were no such defect or disqualification.

CHIEF EXECUTIVE OFFICER AND PRESIDENT

50.

CHIEF EXECUTIVE OFFICER AND PRESIDENT

The Board of Directors may from time to time appoint one or more persons, whether or not Directors, as Chief Executive Officer or Officers, General Manager or Managers, or President of the Company and may confer upon such person(s), and from time to time modify or revoke, such title(s) and such duties and authorities of the Board of Directors as the Board of Directors may deem fit, subject to such limitations and restrictions as the Board of Directors may from time to time prescribe. Unless otherwise determined by the Board of Directors, the Chief Executive Officer shall have authority with respect of the management of the Company in the ordinary course of business. Such appointment(s) may be either for a fixed term or without any limitation of time, and the Board of Directors may from time to time (subject to the provisions of the Companies Law and of any contract between any such person and the Company) fix his or their salaries and emoluments, remove or dismiss him or them from office and appoint another or others in his or their place or places.

MINUTES

51.

MINUTES

(a)

Minutes of each General Meeting and of each meeting of the Board of Directors or of any Committee of the Board of Directors shall be recorded and duly entered in books provided for that purpose, and shall be held by the Company at its principal place of office or its Registered Office or such other place as shall have been determined by the Board of Directors. Such minutes shall, in all events, set forth the names of the persons present at the meeting and all resolutions adopted thereat.

(b)

Any minutes as aforesaid, if purporting to be signed by the chairman of the meeting or by the chairman of the next succeeding meeting, shall constitute prima facie evidence of the matters recorded therein.

DIVIDENDS

52.

DECLARATION OF DIVIDENDS

The Board of Directors may, subject to the applicable provisions of the Companies Law, from time to time declare, and cause the Company to pay, such dividend as may appear to the Board of Directors to be justified by the profits of the Company. The Board of Directors shall determine the time for payment of such dividends, both interim and final, and the record date for determining the shareholders entitled thereto.

53.

FUNDS AVAILABLE FOR PAYMENT OF DIVIDEND

No dividend shall be paid otherwise than out of the profits of the Company.

54.

AMOUNT PAYABLE BY WAY OF DIVIDENDS

Subject to the provisions of these Articles and subject to any rights or conditions attached at that time to any share in the capital of the Company granting preferential, special or deferred rights or not granting any rights with respect to dividends, the profits of the Company which shall be declared as dividends shall be distributed according to the proportion of the nominal value paid up on account of the shares held at the date so appointed by the Company, without regard to the premium paid in excess of the nominal value, if any. No amount paid or credited as paid on a share in advance of calls shall be treated for purposes of this Article as paid on a share.

55.

INTEREST

No dividend shall carry interest as against the Company.

56.

PAYMENT IN SPECIE

Upon the determination of the Board of Directors, the Company (i) may cause any monies, investments, or other assets forming part of the undivided profits of the Company, standing to the credit of a reserve fund, or to the credit of a reserve fund for the redemption of capital, or in the hands of the Company and available for dividends, or representing premiums received on the issuance of shares and standing to the credit of the share premium account, to be capitalized and distributed among such of the shareholders as would be entitled to receive the same if distributed by way of dividend and in the same proportion, on the footing that they become entitled thereto as capital, or may cause any part of such capitalized fund to be applied on behalf of such shareholders in paying up in full, either at par or at such premium as the resolution may provide, any unissued shares or debentures or debenture stock of the Company which shall be distributed accordingly or in payment, in full or in part, of the uncalled liability on all issued shares or debentures or debenture stock if such liability exists, on a pro rata basis; and (ii) may cause such distribution or payment to be accepted by such shareholders in full satisfaction of their interest in the said capitalized sum.

57.

IMPLEMENTATION OF POWERS U/NDER ARTICLE 56

For the purpose of giving full effect to any resolution under Article 56, and without derogating from the provisions of Article 7(b) hereof, the Board of Directors may settle any difficulty which may arise in regard to the distribution as it thinks expedient, and, in particular, may issue fractional certificates, and may fix the value for distribution of any specific assets, and may determine that cash payments shall be made to any members upon the footing of the value so fixed, or that fractions of less value than the nominal value of one share may be disregarded in order to adjust the rights of all parties, and may vest any such cash, shares, debentures, debenture stock or specific assets in trustees upon such trusts for the persons entitled to the dividend or capitalized fund as may seem expedient to the Board of Directors.

58.

DIVIDEND ON UNPAID SHARES

Without derogating from Article 54 hereof, the Board of Directors may give an instruction which shall prevent the distribution of a dividend to the registered holders of share the full nominal amount of which has not been paid up.

59.

RETENTION OF DIVIDENDS

(a)

The Board of Directors may retain any dividend or other monies payable or property distributable in respect of a share on which the Company has a lien, and may apply the same in or towards satisfaction of the debts, liabilities, or engagements in respect of which the lien exists.

(b)

The Board of Directors may retain any dividend or other monies payable or property distributable in respect of a share in respect of which any person is, under Article 20 or 21, entitled to become a member, or which any person, is, under said Articles, entitled to transfer, until such person shall become a member in respect of such share or shall transfer the same.

60.

UNCLAIMED DIVIDENDS

All unclaimed dividends or other moneys payable in respect of a share may be invested or otherwise made use of by the Board of Directors for the benefit of the Company until claimed. The payment by the Directors of any unclaimed dividend or such other moneys into a separate account shall not cause the Company to be a trustee in respect thereof. The principal (and only the principal) of an unclaimed dividend or such other moneys shall be, if claimed, paid to the person entitled thereto.

61.

MECHANICS OF PAYMENT

The Board of Directors may fix the mechanics for payment of dividends as it deems fit. However, if nothing to the contrary is provided in the resolution of the Board of Directors, than all dividends or other moneys payable in cash in respect of a share may be paid by check or warrant sent through the post to, or left at, the registered address of the person entitled thereto or by transfer to a bank account specified by such person (or, if two or more persons are registered as joint holders of such share or are entitled jointly thereto in consequence of the death or bankruptcy of the holder or otherwise, to the joint holder whose name is registered first in the Shareholder Register or his bank account or the person who the Company may then recognize as the owner thereof or entitled thereto under Article 20 or 21 hereof, as applicable, or such person’s bank account), or to such person and at such other address as the person entitled thereto may by writing direct. Every such check or warrant shall be made payable to the order of the person to whom it is sent, or to such person as the person entitled thereto as aforesaid may direct, and payment of the check or warrant by the banker upon whom it is drawn shall be a good discharge to the Company.

62.

RECEIPT FROM A JOINT HOLDER

If two or more persons are registered as joint holders of any share, or are entitled jointly thereto in consequence of the death or bankruptcy of the holder or otherwise, any one of them may give effectual receipts for any dividend or other moneys payable or property distributable in respect of such share.

ACCOUNTS

63.

BOOKS OF ACCOUNT

The Board of Directors shall cause accurate books of account to be kept in accordance with the provisions of the Companies Law and of any other applicable law. Such books of account shall be kept at the Registered Office of the Company, or at such other place or places as the Board of Directors may think fit, and they shall always be open to inspection by all Directors. No member, not being a Director, shall have any right to inspect any account or book or other similar document of the Company, except as conferred by law or authorized by the Board of Directors or by resolution of the shareholders of the Company.

64.

AUDIT

At least once in every fiscal year the accounts of the Company shall be audited and the correctness of the profit and loss account and balance sheet certified by one or more duly qualified auditors.

65.

AUDITORS

The appointment, authorities, rights and duties of the auditor(s) of the Company, shall be regulated by applicable law, provided, however, that in exercising its authority to fix the remuneration of the auditor(s), the shareholders by resolution in a General Meeting may act (and in the absence of any action in connection therewith shall be deemed to have so acted) to authorize the Board of Directors or a committee thereof to fix such remuneration subject to such criteria or standards, if any, as may be provided in such resolution, and if no such criteria or standards are so provided, such remuneration shall be fixed in an amount commensurate with the volume and nature of the services rendered by such auditor(s).

BRANCH REGISTERS

66.

BRANCH REGISTERS

Subject to and in accordance with the provisions of Sections 130 to 139, inclusive, of the Companies Law and to all orders and regulation issued thereunder, the Company may cause branch registers to be kept in any place outside Israel as the Board of Directors may think fit, and, subject to all applicable requirements of law, the Board of Directors may from time to time adopt such rules and procedures as it may think fit in connection with the keeping of such branch registers.

INSURANCE, INDEMNITY AND EXEMPTION

67.

INDEMNITY AND INSURANCE

(a)

Subject to the provisions of the Companies Law and to the fullest extent permitted under the Companies Law, as shall be in effect from time to time, the Company may:

(i)

enter into a contract for the insurance of the liability, in whole or in part, of any of its Office Holders;

(ii)

undertake in advance to indemnify an Office Holder, under any circumstances, in respect of which the Company may undertake in advance to indemnify an Office Holder under the Companies Law, subject to the limitations set forth in the Companies Law;

(iii)

indemnify an Office Holder as permitted under the Companies Law;

(iv)

release and exculpate, in advance, any Office Holder from any liability from damages arising out of a breach of a duty of care towards the Company.

(b)

Any amendment to the Companies Law adversely affecting the right of any Office Holder to be indemnified or insured pursuant to this Article 67 shall be prospective in effect, and shall not affect the Company’s obligation or ability to indemnify or insure an Office Holder for any act or omission occurring prior to such amendment, unless otherwise provided by the Companies Law.

(c)

The provisions of this Article 67 are not intended, and shall not be interpreted so as to restrict the Company, in any manner, in respect of the procurement of insurance and/or indemnification and/or exculpation, in favour of any person who is not an Office Holder, including, without limitation, any employee, agent, consultant or contractor of the Company who is not an Office Holder.

WINDING UP

68	WINDING UP

If the Company is wound up, then subject to applicable law and to the rights of the holders of shares with special rights upon winding up, the assets of the Company available for distribution among the shareholders shall be distributed to them in proportion to the respective holdings of the shares in respect of which such distribution is being made.

RIGHTS OF SIGNATURE, STAMP, AND SEAL

69	RIGHTS OF SIGNATURE, STAMP, AND SEAL

(a)

The Board of Directors shall be entitled to authorize any person or persons (who need not be Directors) to act and sign on behalf of the Company, and the acts and signature of such person (s) on behalf of the Company shall bind the Company insofar as such person (s) acted and signed within the scope of his or their authority.

(b)

The Board of Directors may provide for a seal. If the Board of Directors so provides, it shall also provide for the safe custody thereof. Such seal shall not be used except by the authority of the Board of Directors and in the presence of the person (s) authorized to sign on behalf of the Company, who shall sign every instrument to which such seal is affixed.

NOTICES

70	NOTICES

(a)

Any written notice or other document may be served by the Company upon any shareholder either personally or by sending it by prepaid mail (airmail if sent internationally) addressed to such member at his address as described in the Shareholder Register. Any written notice or other document may be served by any shareholder upon the Company by tendering the same in person to the Secretary or the General Manager or Chief Executive Officer of the Company at the principal office of the Company or by sending it by prepaid registered mail (airmail if posted outside Israel) to the Company at it Registered Address. Any such notice or other document shall be deemed to have been served two (2) business days after it has been posted (seven (7) business days if posted internationally), or when actually tendered in person, to such shareholder (or to the Secretary or the General Manager), whichever is earlier. Notice sent by email or facsimile shall be deemed to have been served two business days after the notice is sent to the addressee, or when in fact received, whichever is earlier, notwithstanding that if it was defectively addressed or failed, in some other respect, to comply with the provisions of this Article 70(a).

(b)

All notices to be given to the shareholders shall, with respect to any share to which persons are jointly entitled, be given to whichever of such persons is named first in the Shareholder Register, and any notice so given shall be sufficient notice to the holders of such share.

(c)

If requested by the Company, each shareholder shall provide the Company with the shareholder’s full street and mailing address, as well, if available with facsimile number and email address. Any shareholder whose address is not set out in the Shareholder Register, and who shall not have designated in writing delivered to the Company an address for the receipt of notices, shall not be entitled to receive any notice from the Company.

Exhibit 4.3

MADAI'IM 1

Contract of Lease

Prepared and signed in Tel Aviv on __ in the month of December 2008

- BETWEEN -

Rorberg Developers and Investors (1963) Ltd.

Private Registered Company Number 51 - 041126 - 7

Tazor Development Ltd.

Private Registered Company Number 51 - 196 01 -1

Whose address for the purpose of this Contract with

Rorberg Developers and Investors (1963) Ltd

Of 9, Bonei Hair Street, Tel Aviv 69373

(Hereinafter: “ The developer ” )

- AND BETWEEN -

Rosetta Genomics Ltd.

Private Registered Company 5 1-292138-8

Of 10, Flaut Street, Rabin Park, Rehovot.

(Hereinafter: “ The Lessee ”)

Sections of this contract and its appendices

Chapter A: Preamble and main points of the transaction
Preamble

The preamble, the headers and the appendices as per the law

Main principles of the transaction and declarations of the parties

Reservation of developer’s rights in respect of the project

Chapter B: Objectives of the lease; Lease period; Adaptation of the property and delivery to the Lessee

Objectives of the lease

Responsibility for licenses and permits

Lease period

Adaptation of the property for the lease purposes and additional works on the property

Cancelled

Chapter C: Rent and additional payments

10.

Rent

11.

Taxes, levies, expenses and various payments

Chapter D: Maintenance, insurance and management

12.

Maintenance of the property and repair of defects

13.

Liability and insurance

14.

Management contract

Chapter E: Breaches and securities

15.

Breaches and remedies

16.

Guarantees

Chapter F: General conditions

17.

Transfer of rights

18.

No waiver of rights

19.

Comprehensiveness of the contract and its validity

20.

Attorneys

21.

Jurisdiction and conflict of laws

22.

Notices

The appendices

Appendix A - Layout of the unit
Appendix B - Details of the parking space
Appendix C - Insurance appendix
Appendix D - Management contract

__________________________________________	_______________________
Rorberg Contractors and Developers (1963) Ltd.	Tazor Development Ltd.

Chapter A: Preamble and main points of the transaction

Preamble

Whereas the developer declares that:

He is exclusively entitled to be registered as the owner of the rights to the property, as defined below, located in the building known as the “Madai’im 1” building (Hereinafter – The structure of The project ) that he initiated and was constructed in the plot in an area of 5,948 m ² , known as plot 1009 in accordance with Town Building Plan RH/2005/A (Hereinafter: "The City building plan " ) located in Rehovot in the area of the Yitzhak Rabin T.M.R Park (Hereinafter: " The Land ").

A 1 .

The permitted uses of the Land in accordance with the City Building Plan are, inter alia , for office buildings and high tech industrial installations or for industrial research and development and/or for medical and/or biotechnical and/or agricultural, and all as specified in the Town Building Plan documents.

On the 3 ^rd floor (Level +12.95), the unit which is delineated with a red line in the plans attached as Appendix A of the Contract (hereinafter: " The Unit" )

The Unit area for the purpose of this Contract is 1,050 m2. The area of the unit for this purpose if the net area of the unit when multiplied by a factor of 1.2 for the common areas. The net area of the unit is the carpet area including areas below the pillars and walls included in the unit, including outer walls surrounding the unit; Notwithstanding the aforementioned, not brought into account except for half the areas under the dividing separators between the unit and the adjacent units.

In the courtyard of the structure a parking lot for vehicles has been established which includes, inter alia, the parking spots described in Appendix B to this contract (Hereinafter: Parking spaces ).

The unit, the relative part of the common property adjacent to it and the parking spaces shall be hereinafter named, inclusively – The property .

And Whereas:

The Lessee hold the property as a renter, and that is – by virtue of previous lease contracts that were signed between the parties (Hereinafter: The previous contracts ) whose lease period by their virtue ends on 31.12.2008;

The Lessee wishes to continue leasing the property from the developer and the developer’s wish to continue leasing to the Lessee, at an unprotected lease, all – under the conditions and considerations described in this contract;

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Rorberg Contractors and Developers (1963) Ltd.	Tazor Development Ltd.

And the parties have reached an agreement on the terms of engagement, all as described below in this contract;.

Therefore it is declared agreed and stipulated between the parties as follows:

The Preamble, Headings and Appendices as per the law

1.1

The preamble to this Contract and the declarations contained therein constitute an integral part hereof.

1.2

The appendices to this Contract constitute an integral part hereof.

1.3

The headings of this Contract are provided for the sake of convenience for reading and orientation only and no use is to be made thereof for the interpretation thereof.

The Main principles of the transaction and declarations of the parties

2.1

The developer undertakes to continue to lease out the Property to the Lessee and the Lessee undertakes to continue leasing the Property from the Developer and all - under the conditions and consideration as stipulated in this Contract.

The Lessee undertakes that the use he shall make of the property shall be in concordance with the characteristics of the project and its level, an according to the provisions of this contract and the management contract, aforementioned in this contract.

2.2

The Lessee hereby confirms that he has not paid and shall not pay and did not undertake to pay the developer any key money whatsoever in relation to leasing the property under this contract, but shall pay the developer rent for the lease period.

2.3

It is hereby expressly agreed and stipulated that the provisions of the Protected Tenancy (Consolidated Version), 5732 - 1972 and/or any other law replacing it and/or supplementing it and/or amending any of the said laws and/or regulations pursuant to those laws shall not apply to the leasing of the Property to the Lessee under this Contract and that the lease under this Contract shall not be protected pursuant to those provisions in any form whatsoever.

2.4

The Lessee hereby declares that he is familiar with the Project area and the Land and also that he has examined such and knows all the details, conditions and circumstances, vis-à-vis the physical, legal, surrounding, planning and permitted uses in relation with the Land, the City Building Plan, the project, the building, the Property and the unit and that they are suitable for its requirements and objectives in all aspects and without limitation and that it has done so in such a matter that it hereby waves any claim for unsuitability or any other similar claim with reference thereto, except for the right to repair defects, as stipulated in this contract.

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Rorberg Contractors and Developers (1963) Ltd.	Tazor Development Ltd.

Reservation of developer’s rights in respect of the project

Subject to it that the Lessee shall not be prevented from making reasonable use of the property (and the Lessee’s equipment in the property) for the lease purposes and that comfortable access to the property shall not be denied, the following rights are reserved to the developer as stipulated in this section below in relation to the project:

3.1

The provisions of this Contract do not restrict the developer in its use, utilization, designation and planning of the land and do not vest any right in the Lessee towards the developer and/or towards others regarding the nature of the land, the applicable limitations, utilization, designation and planning, except for the express undertaking of the developer towards the Lessee under this Contract.

3.2

The developer holds the right to further build on the additional presently existing areas, as of date, in the Building and also to further add and build in the presently existing areas in the Building, whether such is prior to the delivery of possession in the Property to the Lessee or thereafter and all - without any limitation whatsoever on the part of the Lessee regarding the type, shape, location, size and planning of the areas and unit in the project (except in the property). The Lessee undertakes not to make any claim in relation to the Building or non building of any part of the Project in any of its stages.

3.3

Without prejudicing as such to the generality of the aforesaid, the Lessee hereby expressly confirms that it is aware that not all the building rights in the land have been realized and also that the developer is likely to to act to change the City Building Plans and increase the building rights on the land.

The Lessee, by signing on this Contract, grants its consent such that the developer shall act at its own discretion with the competent authorities in order to request and obtain an amendment and/or modification in the CBP, including in a manner of increasing the building rights and/or expansion of the permitted use, and hereby undertakes not to object to any amendment as stated in the CBP and to refrain from any act and omission that may prevent, postpone, delay, interfere or disrupt the amendment processes as stated in the CBP and/or the construction as per the CBP and/or according to the CBP amendment

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Rorberg Contractors and Developers (1963) Ltd.	Tazor Development Ltd.

3.4

Without such prejudicing the generality of the above said, the Lessee hereby expressly confirms that it is aware that the developer is likely to continue building in the project even after the delivery of possession in the Property to the Lessee.
The Lessee, by signing on this Contract, grants its consent to the execution of the full construction works required by the developer for the purpose of realizing its full construction rights in the Land - those presently existing and those as shall exist in the future - and that is despite the noise, nuisance, inconvenience and damage involved with such and undertakes to refrain from any act and omission that may prevent, postpone, delay, interfere or disrupt the performance of the building works. The developer, on his part, undertakes to repair any damage caused to the property as a result of the construction stated above.

3.5

Without prejudice to the generality of the above said, the Lessee hereby expressly confirms that it is aware that the developer is likely to continue building in the project even after the delivery of possession in the Property to the Lessee.
The Lessee, by signing on this Contract, grants its consent to the execution of the full construction works required by the developer for the purpose of realizing its full construction rights in the Land - those presently existing and those as shall exist in the future - and that is despite the noise, nuisance, inconvenience and damage involved with such and undertakes to refrain from any act and omission that may prevent, postpone, delay, interfere or disrupt the performance of the building works. The developer, on his part, undertakes to repair any damage caused to the property as a result of the construction stated above.

3.6

The Developer and/or anyone on its behalf shall be entitled at any time whatsoever to install and/or move through any part of the Land, the Building and the property, various installations and systems, including water piping, heating, electricity, drainage, sewage, channeling of water, gas, telephone and communication cables, air conditioning system and also erect pillars, and this is regardless of whether the aforementioned installations serve the property or if it serves other properties, and solely provided that such is carried out at reasonable times and coordinated in advance with the Lessee.

3.7

The Lessee will allow the developer and/or anyone on its behalf to enter the property even after delivering possession to the Lessee – and to perform all the works and actions that it shall require for the purposes of the project and to secure the extended rights that the project areas entail, including maintenance works and/or repairs and/or moving pipes and/or cables in pipes designated for that purpose, once or in parts or at different dates, as necessary, and only upon being coordinated in advance with the Lessee, and all – subject to being coordinated in advance with the Lessee.

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Rorberg Contractors and Developers (1963) Ltd.	Tazor Development Ltd.

3.8

The developer may cause the registration of regulations for the condominium pursuant to Sections 62 and 63 of the Land Law and to include in it the same provisions designed to maintain the relations between unit owners in the building, engaging in the management agreement as mentioned in this Contract below, and the liabilities of unit holder in the project accordingly, and the arrangements and liabilities regarding maintenance and examination of the common property and the movement of piping and cables in the common property and determining the common property and the removal of parts from the common property and attaching it to the specific unit/s, easements, usage rights, parking, passages, reserving construction rights and henceforth, and all as required under the provisions of this contract and its appendices.

For the avoidance of doubt, the said regulations shall not impose any financial obligation and/or burden on the Lessee whatsoever which exceeds that as stipulated in this Contract and/or there under.

Chapter B: Objectives of the lease; Lease period; Adaptation of the property and delivery to the Lessee

Objectives of the lease

4.1

It is hereby agreed and stipulated between the parties that the property shall serve the Lessee for the purposes of managing his business in the field of biotechnology.

4.2

It is explicitly clarified that the Lessee is not allowed to make other and/or additional use for the lease purposes other than that stated above unless the developer agreed to this in advance and in writing.

Responsibility for licenses and permits

5.1

The Lessee undertakes to obtain all the required permits and licenses for the purposes stated in sub-section 4.1 above and the use that he is making of the property and to operate his business managed in the lease property for the leased purposes only and according to the conditions of the permits and licenses and subject to the provisions of any law.
For the avoidance of doubt, it is hereby agreed and declared that the full responsibility for the obtaining the licenses and permits, as stated above, is imposed upon the Lessee alone and the developer's consent to lease out the Property for the above said purposes shall not impose any obligation whatsoever on the developer towards the Lessee in this matter and the Lessee shall have no claim whatsoever against the developer in relation to this matter.
Notwithstanding the aforementioned, the parties have that agreed that is upon demand by the local authority from the developer, as owner of rights in the property, to sign on any document in order to allow the Lessee to get a business license, the developer shall sign on any document required as stated, on only that it shall not impose upon him responsibility, and/or any financial liability whatsoever beyond the required of him in this contract and/or respectively. In the event the developer signs on the document as stated, notwithstanding that this is required in writing by the Lessee, that non-issuance of the license as such shall not constitute a breach of the contract by the Lessee.

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Rorberg Contractors and Developers (1963) Ltd.	Tazor Development Ltd.

5.2

Without prejudice to the other remedies available to the developer pursuant to the provisions of this contract, pursuant to any law, it is hereby expressly agreed that if the Lessee does not obtain a license and/or a permit as is required under any law and/or if the Lessee has not acted pursuant to the conditions required by law for the management of the business in the property and/or use it is making in the property(not due to any breach whatsoever by the developer), and any third party, including a governmental, municipal or other authority, acts against the developer and/or any of its directors, whether by approaching the courts or by the imposition of fines or in any other way available to it by law, the Lessee shall indemnify the developer and/or any of its directors, respectively, for the full expenses, consequences and damages caused to it and sustained by it including fines and attorneys' fees, and shall do so in 14 days upon demand n acting.

5.3

Notwithstanding the stated in sub-sections5.1 and 5.2 above, it is agreed that in the event that the Lessee is prevented from obtaining a license and/or permit that are required by any law due to circumstances not in his control and the obstacle is not removed within 45 days from the date the developer was informed in writing of this by the Lessee, the Lessee shall be entitled, in a written notice delivered to the developer at least 90 days in advance, to stop the lease, and that is – without constituting any kind of breach of contract by him. If in the stated event neither of the parties shall have any complaint against the other for the stated obstacle and/or for stopping the lease.

Lease Period

6.1

The Lease period is hereby extended for another two years, i.e. commencing on 1.1.2009 until 31.12.2010 (Hereinafter: “The extended Lease period” ).

6.2

The Lessee is hereby given a choice (Option) to extend the extended lease period for an additional three years i.e. commencing on 1.1.2011 until 31.12.2013 (Hereinafter: “The option period” ).
The parties agree that extending the extended lease period as stated above shall be conducted automatically, unless the Lessee informs the developer in writing at least 120 days prior to this, according to which the Lessee is not interested in using the option right given to him.

6.3

The provisions of this contract shall apply on both the extended lease period and the option period and the term (lease period” in this contract means the extended lease period and/or the option period, respectively.

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Rorberg Contractors and Developers (1963) Ltd.	Tazor Development Ltd.

6.4

At the end of the Lease period, or upon the legal cancellation of this contract, the Lessee undertakes to vacate the property and to return possession thereof to the developer with the Property being in the physical state as received from the developer, subject to reasonable and normal wear and tear despite the careful use of the property, and after all the actions have been performed that the property shall be delivered as stated clean, tidy whitewashed, orderly and free of any person and object belonging to the Lessee.
Notwithstanding the aforementioned, it is agreed that:

(a)

The Lessee is entitled to take from the property any equipment movable by
nature and also furniture, even if affixed to the property and shall do so at his responsibility and expense and shall return the removal place to its normal state. The Lessee shall also be permitted to remove from the property all those changes and additions he made to the property and for which he received written consent from the developer to remove them at the end of the lease period, and only that he shall do so at his own responsibility and expense and return the removal place to its normal state.

(b)

If the developer is interested that the Lessee disposes of the additions and/or changes that the Lessee made to the property with written consent of the developer, the Lessee shall have to dispose of them and return it to its normal state at his own responsibility and expense.

6.5

The Lessee shall not be entitled to terminate the lease under this contract before the end of the Lease period. If the Lessee stops using the property and/or if it vacates the property before the end of the Lease period, the Lessee shall not be absolved from the fulfillment of its obligations under this contract, including its obligation to pay the developer the rental fees until the end of the lease period.

Adaptation of the property for the lease purposes and additional works on the property

7.1

The Lessee shall be entitled to perform, under his responsibility and at his expense further internal works in the unit if required by him to prepare the property for the purposes of the lease (Hereinafter: Preparation works ) and only if the developer agreed in advance and in writing to perform those works.
The Lessee undertakes that he shall perform the preparation works that the developer permitted him to perform in accordance and subject to regulations and requirements by the competent authority, including safety regulations, Civil Defense and fire department.
The developer shall refuse the implementation of works under the following conditions:

(a)

The Lessee shall provide the developer with the adaptation plans (Hereinafter: The adaptation plans) which shall correspond to the instructions provided by the project engineer and shall be at a suitable level that characterizes the project, all in a manner that shall ensuring that the performance of the works shall not harm the Building and/or its systems and/or the Building façade.

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Rorberg Contractors and Developers (1963) Ltd.	Tazor Development Ltd.

(b)

If necessary, the plans shall be drawn on the computer with a software appropriate for this purpose

The developer shall give his approval to the adaptation works (and/or shall explain his refusal to approve in the event they do not correlate the provisions of this contract) within 14 days from the day they are submitted by the Lessee. The adaptation works approved by the developer as stated will be attached as Appendix 4A to this contract, and the Lessee will be permitted to begin the adaptation works Upon completing the adaptation works, the Lessee shall provide the developer plans that entail the works performed (plans AS MADE)

Cancelled

Chapter C: Rent

10.

Rental fees

10.1

The monthly Rental fees for the lease period are hereby determined as per the following amounts:

(a)

For the extended lease period, i.e. 1.1.2009 until 31.12.2010 – sum of 63,152 NIS + VAT, when they are linked to the index on the day of signing the contract.

(b)

In the event the extended lease period was extended, the rental fees for the option period, i.e. 1.1.2011 until 31.12.2013 in the sum of 69,469 NIS + VAT, when they are linked to the index on the day of signing the contract.

“Index” - For the purpose of this Contract shall mean the - the price index known as the consumer price index published by the Central Bureau of the Statistics or any other official index replacing it.

“ Linked to the index on the date of the signing of the Main Contract ” for the purpose of this Contact shall mean - that if on the actual date of payment the known index (Hereinafter: “ The New Index ”) is higher than the November 2008 index that was published on 15.12.2008, (hereinafter: “ The Base Index ”), the amount for payment shall increase relative to the difference between the New Index and the Base Index.

10.2

The monthly rental fee shall be paid for each calendar quarter in advance - the first of the months of January, April, July or October, each year, respectively.

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Rorberg Contractors and Developers (1963) Ltd.	Tazor Development Ltd.

10.3

It is hereby agreed that the rental fees shall be paid at the developer’s address by 11 a.m. on the set payment date according to this contract, and only on a Banking day .If the agreed payment date is not a business day, as stated, then payment shall be postponed to the closest banking day.

10.4

It is hereby agreed that until another instruction is given by the developer, every payment under this Contract shall be made in two equal parts: One - in the favor of Rorberg Developers and Investors (1963) Ltd. into account no. 698001 at Bank Hapoalim Ltd., branch 609 and the second in favor of Tazor Development Ltd. Into account 13736 at Bank Hapoalim Ltd., branch 609.

10.5

In order to ease the collection of the rental fees, the Lessee shall deposit with the developer until 31.12.2008 checks for future rental fees for the year 2009 and shall also return and deposit adjacently before each calendar year thereafter (if he realized the option to extend the lease for the option period) , check for rental fees according to this contract for the following calendar year.

Once every quarter, or for a lengthier period, at the developer’s choice, an account shall be made of the difference for the Rental fees arising from changes to the Consumer Price Index from between the delivery date of the checks as stated above and the payment date and the said differences shall be paid to the developer within seven days of the developer’s demand.

For the avoidance of doubt, it is hereby clarified that the developer shall be entitled to present the checks mentioned at the heading of this sub-section for payment by the due dates, however only payment of the checks and the Rental fees differences, where required, as stipulated above, shall be considered as full payment of the Rental fees.

11.

Taxes, levies, expenses and various payments

11.1

In addition to the payment of Rental Payments and the other payments applicable to the Lessee under this Contract, the Lessee undertakes to pay the taxes, expenses and payments as follows:

(a)

All taxes, municipal rates and taxes, other mandatory payments and expenses applicable to the Property for the use and possession thereof including management fees, electricity, water, telephone payments and property taxes.

Insofar that the water and/or electricity connection to the unit is common with other units in the building, these cost will be divided among the various holders according to the common meters in such a manner that each holder shall pay part of the bill that correlates to the relative part of the inclusive area of the units as stated. If and when the developer acts and/or anyone on his behalf to install separate meters for this purpose, the Lessee undertakes to cooperate in this and with this rule to allow all actions required for this purpose in the unit.
It is explicitly agreed that the Lessee is not permitted to take advantage of an exemption from property tax for an empty property even if during the lease period he does not make use of the property and it remains empty, unless he received the developer’s approval in advance and in writing.

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Rorberg Contractors and Developers (1963) Ltd.	Tazor Development Ltd.

(b)

Management fee as mentioned in chapter D and appendix D to this contract.

(c)

Insurance fee as mentioned in chapter D and appendix D to this contract.

(d)

All the payments and expenses for permits and licenses for the Lessee’s use of the property as stated in chapter B to this contract.

(e)

A relative part, in accordance to the ratio of the unit to the collective area of the units on the floor and/or building, accordingly and according to the determined by the Management company or the competent authority, respectively, in payments of taxes, property tax and/or other expenses for the common property area, including the protection spaces on the floor and/or the building respectively that possession was not passed to a third party whosoever and/or for use of water in the common property and/or similarly, insofar as these payments and expenses are not included in the tax on the property and/or management fee and/or any other payment mentioned above.

(f)

Billboard expenses for the unit, in a general frame of the building.

(g)

Value added tax applicable to each payment applies to the Lessee according to this contract and at the rate by law on the payment date of each payment.

11.2

All other compulsory payments and/or applicable taxes and/or taxes to be applied in the future and which apply to and/or shall apply, by Law, or by the nature thereof, to the owners shall be paid by the Developer whilst those which apply and/or shall apply, by Law, or by the nature, to the holders of possession, shall be paid by the Lessee.

11.3

The payments indicated in this Section above, where no payment date has been stipulated, shall be paid to the Developer within 7 days from the demand date, to the competent authority, immediately upon first demand from that authority and/or at the date as determined under any Law; and to any other entity - at the time as demanded by it and/or by the Developer and/or pursuant to that agreed upon between them.
The Lessee shall provide the Developer, at the payment dates of the Rental fees, with copies of the receipts testifying to the execution of the above said payments.

11.4

The parties agree that the Developer may, but is not obligated to make the payments, fully or partially, instead of the Lessee and that is – if this about a debt whose non-payment may delay the developer from fulfilling his commitments or harm another righteous interest of the developer and/or the management company, and only if the developer gave the Lessee reasonable advance time under the circumstances an opportunity to himself pay, and if not paid it himself.
The Lessee shall repay the amount that the developer paid which he himself did not – immediately upon first demand, whilst bearing indexation differentials and interest by law, from the actual payment date by the developer and until the demand date.

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Rorberg Contractors and Developers (1963) Ltd.	Tazor Development Ltd.

Chapter D: maintenance, Insurance and Management

12.

Maintenance of the property and repair of defects

12.1

Subject to the provisions stipulated in this contract, the developer undertakes to repair any defect and irregularity resulting from defective construction and/or using defective materials during construction, and that were revealed during the lease period (Hereinafter: The defects ) and that is – under express condition that the Lessee informed the developer in writing upon discovering the above defect demanding their repair and gave the developer fair chance to repair them.
Repair of the stated defects shall be done within reasonable time (considering the nature of the defect, season in the year and the developer’s work plan) receives the Lessee’s written notice regarding the defect.
If the repair was not done as stated – the provisions of section 15.8 below shall apply.

12.2

The Lessee undertakes to allow the Developer, its workers and agents, including developers and sub-developers on behalf of the Developer to examine the faults, to carry out the repairs in the Property and/or other properties in the Building, and also to enter into the Property for the purpose of the installation and/or transfer of equipment to the holders of other properties in the Building. The Lessee hereby waives any claim and/or demand which it might have in connection with the time for the execution of the aforementioned actions or in connection with the inconvenience, if any has been caused to it as a result of such, even if such relates to another property in the Building and the execution thereof is done, fully or partially, from the Property or in the external walls of the Property, and provided that the Developer has executed the above work at reasonable times after prior coordination with the Lessee and without such harming the Lessee’s reasonable use of the Property and/or the Lessee’s use of the equipment in the Property and the Developer shall act to the best of its ability in order to limit the inconvenience which might be caused to the Lessee due to the execution of the above said actions.

12.3

The Lessee shall not be entitled to rely on a disparity, if any, if he has not provided the Developer with a fair opportunity to examine and repair such. Similarly, if the Lessee does not allow the execution of the repairs, such shall be considered as an absolute waiver on the part of the Lessee for the execution of the repairs and of any other legal measure regarding the disparity.

12.4

It is agreed that the Developer shall not be liable for the repairs of faults which have arisen from and/or have worsened due to an incorrect or careless or unacceptable or not in accordance with the Lessee’s obligations act and/or omission according to this contract in the property and/or common property, whether by the Lessee or by another who is not acting on behalf of the Developer including those caused as result of absence of performing maintenance work and/or inspection of the property and/or as a result of faulty maintenance work by the Lessee and/or other holders in the building and/or those on their behalf.

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Rorberg Contractors and Developers (1963) Ltd.	Tazor Development Ltd.

12.5

It is agreed that the Developer shall not be responsible for the quality of the additional work executed and/or to be executed in the Property unless the Developer has provided his written consent for the execution of the changes regarding the Additional Work and the Additional Work was carried out by the Developer.

12.6

Not to diminish from the developer’s full responsibility to repair faults as stated above, the developer is entitled to provide the Lessee or endorse in his favor and undertaking of repairs and/or warranty certificate, insofar as received from the contractors and/or suppliers and/or manufacturers and/or service providers regarding any work whatsoever performed in the building and/or property and/or an installation and/or any product supplied by them.
An irregularity was discovered for which the Lessee received a commitment for repair and/or warranty certificate, the Lessee shall approach the contractor or supplier or manufacturer or service provider, respectively, to repair it and shall send the developer a copy of each approach as stated.

12.7

Except for the stated in this contract, contractual responsibility and/or another liability whatsoever shall not apply to the developer according to this contract regarding any faults above and/or any other faults, and the less shall not have any rights regarding them.
In any event, the developer shall not be responsible for indirect damages incurred by the Lessee as a result of the irregularity and/or performance of repairs to conceal.

12.8

The Lessee undertakes to repair, upon first demand of the Developer, any breakdown or damage caused to the Property as a result of an action of the Lessee which exceeds the reasonable and cautious use on the Lessee’s behalf or an illegal omission on the Lessee’s part (including for that stipulated in subsection 12.4) but excluding as a result of wear and tear which is not due to reasonable use. Where no such claim has been made, then such repairs shall be carried out within a reasonable time before the vacating date in such a manner so that the repair is completed by no later than 7 days before the vacating date. If the repair is of the sort of repairs which must be executed urgently, then such shall be done by the Lessee immediately.
Where the said repair has not been executed, the Developer and/or anyone on its behalf may carry out the repair at the Lessee’s expense, without derogating from ny remedy which the Developer may request in such a case, in addition to the Repair expenses.

__________________________________________	_______________________
Rorberg Contractors and Developers (1963) Ltd.	Tazor Development Ltd.

12.9

The Lessee undertakes, throughout the Lease period, to comply with all provisions of any Law relating to the management of the business in the Property, not to hold any equipment, material or object in the Property or its surroundings which is likely to cause any damage whatsoever and/or which may be of tangible danger as well as to fulfill the provisions of any Law of any competent authority connected with the fire extinguishing arrangements and procedures, as well as those of the Home Front Command, safety and security procedures as well as hygiene procedures.

12.10

If the property area includes areas designated to serve as floor protection areas (Hereinafter: FPA ), during emergencies, the Lessee undertakes, without having to diminish from the remaining provisions of this contract, that he shall maintain the FPA in accordance with the instructions of the home front command / HFC, and will clear it os, as required and according to the instructions of the competent authorities, all movables, and that is – in order that he and the other holders in the building can make use of the FPA as designated during an emergency.

12.11

The Lessee shall manage its business and shall make use of the Property without disturbing the other neighbors in the building.

12.12

The Lessee undertakes to refrain from acting - or allowing others to act – or omitting in the Property anything which might impose any liability whatsoever on the Developer for damages towards a person and/or property.

12.13

The Developer and his proxies shall have the right, at reasonable times, to enter into the Property in order to ascertain that the Lessee is fulfilling its obligations pursuant to the terms and conditions of the Contract and/or in order to present the Property before potential tenants or buyers and/or in order to undertake those actions and those means as determined in this Contract or under any other Law and which require the said entry into the Property.
The entry into the Property shall be done with prior coordination with the Lessee and the Lessee undertakes not to prevent the Developer, or those acting on his behalf, to have the free access as stated.

13.

Liability and Insurance

13.1

The Lessee shall be responsible for any loss, harm or damage, of any kind whatsoever, to body and/or property that shall be caused to the developer and/or the management company and/or their employees and/or anyone on their behalf and/or any third party, that shall be caused to them as a result of an act and/or omission by the Lessee and/or his employees and/or anyone on his behalf and/or any of his customers and/or suppliers, including loss, harm or damage as stated that shall result from the state of the property insofar as the Lessee is responsible for it according to this contract and any law.
Without derogating from the aforesaid and the Lessee liabilities, the Lessee shall prepare insurances as stated below, the Lessee undertakes to take all the steps necessary to cancel any approach made to the developer and/or anyone on his behalf and any claim made against the developer and/or anyone on his behalf in relation to the damage that the Lessee is responsible for as stated above and to indemnify the developer upon his first demand for any damage caused to him and any amount that she shall expend for the demand and/or claim as stated, including – but without derogating for the aforementioned – legal fees and attorney fees.

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Rorberg Contractors and Developers (1963) Ltd.	Tazor Development Ltd.

13.2

The Lessee undertakes to act in accordance with the provisions of the Insurance Appendix of this Contract and to provide a required certificate there under by the Delivery of Possession Date and Delivery of Possession term.

14.

Managing Contract

14.1

The Lessee signs at the time of the signing this contract on the insurance appendix attached to this contract as Appendix C (Hereinafter: “The insurance appendix” ) and also with the Management Company contract attached to this contract as Appendix D (Hereinafter: “The Management contract” ) and undertakes to comply with their provisions, in a manner that breach of any of their provisions shall also constitute a breach of the lease contract.
The Lessee signature on the management contract shall be considered as a irrevocable offer on his part towards the Ramot-Mada’im maintenance and management Ltd management company that deals in providing management services for the project (Hereinafter: “The Management company” ) and that is – until the management contract is signed by the management company as well.

14.2

In the event that the engagement with the management company ceases, in accordance with the provisions of the management contract, the Lessee undertakes to sign the contract with the wording of the management company with the new management company that shall be appointed to provide services in the project (Hereinafter: “The new Management company” )

14.3

It is agreed that if the Lessee is required by the Management Company to provide the deposit as defined in the Management Contract, shall apply to the Developer, under the Lessee, the requirement to provide the deposit as stated to the Management Company – except in the event when the Lessee is in a status of breach of the management contract towards the Management Company.

Chapter E: breaches and securities

15.

Breaches and securities

__________________________________________	_______________________
Rorberg Contractors and Developers (1963) Ltd.	Tazor Development Ltd.

15.1

All the remedies and reliefs under this contract, unless explicitly noted otherwise, do not derogate from any right, grounds, remedy or relief that the harmed party is entitled to from the breach, by any law and they are accrued.

15.2

The provisions of sections 2, 3, 4, 6, 10, 11 and 16 to this contract are fundamental provisions whose breach or breach of any of them shall be considered as a fundamental breach of the contract.

15.3

The Lessee breached any of the obligations according to this contract and did not correct the breach within 30 days from the day that he was given notice to correct the breach, he shall be required to pay the developer agreed and pre-set compensation in the amount that equals monthly rental fees according to the provisions of chapter C to this contract.

15.4

The Lease period has ended, or in any event of the cancellation of this Contract by Law, due to the breach thereof by the Lessee and where the Lessee has not vacated and/or delivered possession of the Property to the Developer, free of any person and pursuant to the terms and conditions of this Contract, then in addition to the stated in sub-section 15.3 above, the Lessee shall pay the Developer for each day of arrears in the said vacating, arrears fees at the rate 200% of the relative daily Rental fees according to chapter C to this contract.
For the avoidance of doubt, it is clarified that the arrears as stated above are instead of the rental fees and do not have any rental fees added to it, that then the lease period ended.

15.5

Cancelled

15.6

The parties hereby declare that the compensation amount stipulated in sub-sections 15.3 and 15.4 above is based on a good faith evaluated estimation of the parties regarding the anticipated damage to the Developer during the normal course of affairs as a result of the breach of contract by the Lessee, whether by delay in returning possession on the due date or by shortening the lease period or any other manner, shall not prejudice any other or additional relief to which the Developer is entitled by any Law.
It is hereby agreed that the above said shall not release the Lessee from its undertakings to vacate the Property at the end of the Lease period and/or to grant any right to the Lessee to further hold the Property against the payment of the agreed compensation and/or in order to constitute a waiver on the part of the Developer on any of the Developer’s rights and/or to prejudice a right of the Developer to receive any additional remedy and relief including the eviction of the Lessee from the Property.

15.7

The developer was late in handing over possession to the Lessee, under circumstances which as stipulated in this contract constitutes a breach by the developer, the Lessee shall be entitled not to pay the rental fees for the delay period and also shall be entitled to receive from the developer, within 14 days of his written demand –as set, agreed and estimated in advance compensation – for every day’s delay (beyond the stated by law under this contract) compensation at the rate of 50% of the relative daily rental fee according to chapter C under this contract.
It is agreed that the Lessee shall not be entitled to any other and/or additional relief, for the delay in delivery of possession of the unit does not go beyond 90 days.

__________________________________________	_______________________
Rorberg Contractors and Developers (1963) Ltd.	Tazor Development Ltd.

15.8

Should any disparities be discovered in the Property that the developer is to repair under this contract, then the Lessee shall be entitled to relief for the breach, i.e. – repair of disparities, only, unless it is agreed between the parties to a monetary compensation.
If the Developer has done nothing to repair the disparity that he has to repair as stated in section 12 above, the Lessee shall be entitled, after informing the developer in writing, to repair it himself, and in such a situation, the developer shall have to repay the Lessee the reasonable costs of the repair as stated and that is – within 7 days from the Lessee’s written demand.
In any event, it is explicitly agreed that the developer shall not be responsible for indirect damages that shall be incurred by the Lessee from a physical fault whatsoever in the property and/or as a result of performing the repair to it.

15.9

It is explicitly agreed that the Lessee is not allowed to deduct any amount from the rental fee, the management fee and from any other monetary amount that he owes the developer and/or the management company under this contract, unless the developer agreed to it (and in the matter of management fees – also the consent of the management company) in advance and in writing.

15.10

Any amount which the Lessee owes and which the Lessee has not paid by the due date, shall bear linkage differences to the Index and linked interest during the arrears period at the rate of 9% per annum or arrears interest at a rate customary at Bank Discount Ltd. for approved overdraft facilities in current accounts (for an ordinary and not preferred customer) plus 4% per annum at the election of the Developer without diminishing any other remedy available to the Developer pursuant to the this Contract or under any Law.

It is hereby clarified that with respect of any payment for a debt which has been paid by the Lessee to the Developer in connection with this Contract, such shall be credited to the Lessee commencing with the expenses and afterwards the interest, linkage differences and agreed compensation (liquidated damages) and the balance shall be credited on account of the principal. If any balance remains of the principal, this shall also bear linkage and interest differences accordingly and the provisions of this section shall also apply with respect of the making of these payments and so on and so forth.

The provisions of this sub-section shall apply in the changes required under this, on the amounts that the developer has to pay the Lessee.

__________________________________________	_______________________
Rorberg Contractors and Developers (1963) Ltd.	Tazor Development Ltd.

16.

Guarantees

16.1

It is agreed that the guarantees given by the Lessee in order to guarantee its undertakings under the previous contracts shall also serve for the securing of its undertakings under this Contract.
At the Lessee’s request, the developer shall cooperate with the Lessee to convert all the bank guarantees that were delivered to the developer with a substitute bank guarantee of equivalent value.

16.2

It is explicitly agreed between the parties that the exercising and/or redemption of the note and/or its submission for execution at the execution office or its submission in a claim there under and/or the exercising of the bank guarantee shall not prejudice the Developer’s right to claim and to receive any other additional alternative relief of any sort whatsoever against the Lessee, for the collection of those amounts in excess of the amount to be realized as stated, and only that the developer shall not collect beyond what is due under the law.

16.3

The developer return the guarantee documents given to him as stated after the Lessee vacates the property and handing over possession to the developer in accordance with the provisions of this contract, and subject to it that the Lessee fulfilled all his obligations under this contract and delivered to the developer copies of the receipt for all the payments, that he has to bear for use and holding the property for the whole lease period.

In witness thereof the parties have signed on the aforementioned date:

[stamp and signature]	[stamps and signatures]

Rosetta Geonomics Ltd.	Tazor Development Ltd.

Private Company 512921388	Rorberg Contractors and

	Investments (1963) Ltd.


/s/ Signature illegible	/s/ Signature illegible
The Lessee	The Contractor

__________________________________________	_______________________
Rorberg Contractors and Developers (1963) Ltd.	Tazor Development Ltd.

Lease Contract

( unprotected tenancy)

Executed in Tel Aviv on the 15 ^th of August, 2012

- BETWEEN –

1. Rorberg Contractors and Investments (1963) Ltd.

Company number 51-041126-7

2. Tazor Development Ltd.

Company number 51-196201-1

Both, for the purposes of this contract, at the following address:

Rorberg Contractors and Investments (1963) Ltd., 9 Bonei Hair St., Tel Aviv (hereinafter: The Entrepreneur )

On one hand

- AND –

Rosetta Genomics Ltd.

Company number 51-292138-8

Of 10 Flaut St., Rabin Park, Rehovot

(hereinafter – The Lessee )

On the other hand

Whereas:

The parties have mutually engaged, on 31.12.2008, in an unprotected tenancy lease contract (hereinafter – The Original Contract ), according to which a unit was leased to the Lessee at the third floor, as well as parking spaces, in a building known as “Madaim 1 building” in Rabin Park, Rehovot (hereinafter, respectively – The Original Unit and The Building ), all as described in the Original Contract, its appendices and supplements;

The parties have also mutually engaged, on 23.1.2012, in an unprotected tenancy lease contract (hereinafter – The Preceding Contract ), according to which, instead of the Original Unit and parking spaces the Lessee had leased from the Contractor pursuant to the Original Contract, the Lessee had now leased from the Contractor a unit at the fourth floor of the Building, as marked in the scheme attached as appendix A to the Preceding Contract (hereinafter – the Preceding Unit ), as well as ten parking spaces, which were marked 37 to 46 in the scheme attached as appendix B to the Original Contract (hereinafter – The Original Parking Spaces );

The lease period, pursuant to the Preceding Contract, expires on 31.1.2013, subject to an option granted to the Lessee, to extend it for a further year;

The Lessee wishes to lease, instead of the Preceding Unit, the area at the second floor of the Building, which is outlined by an orange line in the scheme appended as Appendix A to this contract (hereinafter – The Alternative Unit ), as well as a floor protected space ( ממ"ק ) next to the Alternative Unit, which is painted yellow in the Appendix A scheme (hereinafter – the Floor Protected Space ). The Lessee further wishes to add to the property leased to him from the Entrepreneur, the parking spaces marked 128, 129, 130, 131 and 142 in the scheme attached as appendix B to the Original Contract (hereinafter – the Additional Parking Spaces ), in addition to the Original Parking Spaces. The Lessee further wishes to extend the term of the lease, as concerns the Alternative Unit, the Floor Protected Space, the Original Parking Spaces and the Additional Parking Spaces, to a period of about five years, as described in this contract below;

The area of the Alternative Unit (not including the Floor Protected Space, whose area is about 25 sqm.) is, for the purposes of this contract, 438 sqm. The area of the Alternative Unit for that matter is its net area, multiplied by a factor of 1.2 in respect of public areas. The net area of the Alternative Unit is its floor area, including under columns and walls which are included in the Alternative Areas, including external walls surrounding it; regardless of the aforementioned, only half of the areas under the separating partitions, which separate between the Alternative Unit and the units next to it, are taken into account.

The Contractor has answered the Lessee’s request favorably – subject and in keeping with the terms and conditions of this supplement;

The parties therefore agree as follows:

The introduction to this contract is a fundamental and inseparable part thereof.

Handing over the Alternative Unit, the Floor Protected Space and the Additional Parking Spaces; preparatory works

2.1

The Alternative Unit shall be handed over to the Lessee at its current condition, as of the signing of this contract (AS IS), subject to the provisions of subsections 2.1a-c below, and that no later than 2.9.2012. In addition, the Contractor shall allow the Lessee access to the Alternative Unit for planning purposes, as of the signing of this contract.

The Floor Protected Space shall be handed over to the Lessee no later than 12.9.2012.

The Additional Parking Spaces shall be handed over to the Lessee on 2.9.2012.

2.1a

Until 2.9.2012, the Contractor shall have the workstations located in a “clean room” in the Alternative Unit removed.

The Lessee shall demand in writing from the Entrepreneur, within 4 days of signing the contract, the removal of any movable equipment he finds in the apartment. The Contractor shall then see to its removal.

Should equipment as mentioned above fails to be removed by 2.9.2012, the Lessee shall be entitled to remove it on his own, and to charge the Contractor with the actual removal costs of that equipment, so long as he informs the Contractor of the fact in writing at least two business days beforehand.

2.1b

The Contractor shall have the management company install new smoke detectors in the apartment, in keeping with the applicable standard and according to specifications which would be included, for that matter, in the preparatory plans to be approved by the Contractor pursuant to the provisions of article 2.2 below, all – during the implementation period of the preparatory works as defined hereunder, in coordination between the Entrepreneur, the management company and the Lessee.

2.1c

The Contractor is responsible for verifying the serviceability of the automatic fire extinguisher in the main distribution board, and its compliance with the applicable standard, and in case of defective equipment and/or noncompliance with the standard – for repairing or replacing the fire extinguisher, so as to bring about compliance with the standard.

2.2

The Lessee shall carry out, at his own responsibility and expense, internal works in the Alternative Units, in order to prepare it to the purpose of the lease (hereinafter – The Preparatory Works ), provided that he receives the Entrepreneur’s prior written consent to the performance of these works, and has made construction works insurance for that matter, as indicated by the provisions of chapter A to appendix C of the Original Contract.

The Contractor shall not refuse the Preparatory Works by the Lessee, should the following conditions obtain:

(a)

The Lessee provides to the Contractor plans for the Preparatory Works (hereinafter – the Preparatory Plans ), at a standard which matches the character of the project, all, so as to guarantee that the Works would not harm the Buildings and/or its systems and/or its external appearance;

(b)

The Plans shall be drawn using a computer software adequate for this purpose;

(c)

The Plans shall include an architectural implementation plan: a safety plan approved by the fire brigades, as well as air conditioning, electricity, plumbing and communication implementation plans, which would be coordinated with the architectural plans (the Lessee would be responsible for the aforementioned coordination).

The Contractor shall approve the Preparatory Plans submitted to him (and/or shall explain his refusal to grant approval, in case the Plans do not comply with the provision of this supplement) within 10 days of having received them from the Lessee. The Preparatory Plans to be approved by the Contractor as mentioned above, shall be appended as Appendix B to this contract, and the Lessee will be entitled to commence implementation of the Preparatory Works upon approval of the Preparatory Plans.

Regardless of the aforementioned, the Contractor shall not delay his approval to the Preparatory Plans even in the absence of a safety plan approved by the fire brigades, subject to the Lessee’s pledge to provide a copy thereof to the Entrepreneur, no later than the starting date of the Lessee’s business activity at the Alternative Unit.

Inasmuch as the Lessee is precluded from presenting a safety plan, approved as mentioned above, by the fire brigades, because of missing sprinklers in the Building, this shall not be seen as breach of the contract by any of the parties towards its counterpart, so long as the Lessee will have provided the Contractor with a safety plan as mentioned above, signed by a safety consultant, with adequate clarification over this point.

Upon completion of the Preparatory Works, the Lessee shall provide the Contractor with plans presenting the works performed (plan AS MADE, edited using the AutoCAD software), both on paper and on disc.

2.3

It is clarified, for the avoidance of doubt, that the Entrepreneur’s approval as provided in subsection 2.2 above, does not constitute a confirmation to the effect that the plans are adequate to their purposes, or a confirmation that they meet the requirements set forth in standards and by the authorities. It certainly does not replace certification by consultants and/or experts, where such is required, in case it is required, by the authorities.

2.4

Subject to the aforementioned regarding the Preparatory Works to be conducted by the Lessee, the Lessee undertakes to refrain from introducing any changes or additional construction into the property or out of it throughout the lease period, except by the Entrepreneur’s prior written consent, and subject to receiving the required permits and licenses from the competent authorities.

2.5

For the avoidance of doubt, it is expressly clarified that the Preparatory Works mentioned above, to be implemented by the Lessee, shall not be seen as key money and will not entitle the Lessee to any payment from the Entrepreneur.

2.6

The Contractor shall not object to the Lessee connecting, at the Lessee’s own responsibility and according to the management company’s instruction, the Unit’s electricity infrastructures, including the infrastructure for the laboratory area, to the Building’s emergency generator, subject to the Lessee bearing the costs of the aforementioned connection, as well as a correct pro-rated part of the handling costs and of the generator usage, and that the required output does not exceed 30 KVA, all – according to the management company’s instructions.

Return of possession of the Preceding Unit

3.1

The Lessee undertakes to vacate the Preceding Unit and return possession thereof to the Entrepreneur, no later than 15.11.2012, free of any person or object belonging to the Lessee, and pursuant to the provisions of subsection 6.4 to the Original Contract and article 10 to the Preceding Contract.

3.2

Notwithstanding the provisions of subsection 3.1 above, it is agreed that the Lessee may delay in vacating the Preceding Unit, but not beyond 30.11.2012, without it being considered as breach of the contract towards the Entrepreneur, so long as the following cumulative conditions are met:

(a) The Lessee notifies the Contractor in writing, no later than 1.11.2012, of the delayed evacuation date, between the 16 ^th and the 30 ^th of November 2012 (hereinafter – The Delayed Evacuation Notice ) and return possession of the Preceding Unit to the Contractor at the delayed date, which would be indicated in the Delayed Evacuation Notice, at the condition described in subsection 3.1 above.

(b) The Lessee shall pay to the Entrepreneur, when delivering the Delayed Evacuation Notice, an amount in NIS equal to the number of delayed evacuation days multiplied by NIS 559 + VAT, linked to the index pursuant to the provisions of article 7 to the Preceding Contract (the base index – the October 2011 index), plus VAT.

Extending the lease period and updating the rental fees

4.1

The lease period between the parties is hereby extended for a period ending on 31.10.2017.

4.2

The monthly rental fees in respect of the lease period up to 1.9.2012 shall remain unchanged, that is to say – NIS 19,920 + VAT, linked to the index pursuant to the provisions of article 7 to the Preceding Contract (the base index – October 2011 Index).

4.3

The monthly rental fees in respect of the lease period from 2.9.2012 and until 14.11.2012, shall amount to NIS 21,655 (note: calculated as follows: the amount indicated in subsection 4.2, plus NIS 347 for an additional parking space, multiplied by 5 ) + VAT, linked to the index pursuant to the provision of article 7 to the Preceding Contract (the base index – the October 2011 index).

4.4

The monthly rental fees in respect of the lease period from 15.11.2012 onwards, shall be fixed at NIS 33,424 ( note: calculated as follows: NIS 63 per sqm. In respect of 438 sqm, plus NIS 945 in respect of the Floor Protected Space, plus NIS 315 per parking space, multiplied by 10, plus NIS 347 per additional parking space, multiplied by 5) + VAT, linked to the index pursuant to the provision of article 7 to the Preceding Contract (the base index – the October 2011 index).

Options to add a unit and parking spaces

5.1

The Lessee is hereby granted an option to add to the property being leased to him pursuant to this contract, as of 7.2.2014, the area at the Building’s second floor, which is outlined by a green line in the scheme attached as appendix A to this contract (hereinafter – the Additional Unit ), as well as three parking spaces, which are marked in the scheme attached as appendix B to the Original Contract as parking spaces 118, 119 and 120 (hereinafter – the Attached Parking Spaces ), which are leased at the signing of this contract to D. Schatz Engineers Ltd. (hereinafter – The Neighboring Lessee ), for a lease period which expires on 6.2.2014.

5.2

The Lessee, should he wish to exercise the aforementioned option, shall inform the Contractor of this fact by written notice (hereinafter, in this subsection – the Realization Notice ) to be delivered to the Contractor until and no later than 6.8.2013.

Should a Realization Notice be delivered as mentioned above, the Additional Unit and the Attached Parking Spaces shall be added to the property leased to the Lessee, at the date of evacuation by the Neighboring Lessee, at the AS IS condition as of that date.

The Lessee shall perform, at his own responsibility and expense, internal works in the Additional Units so as to prepare it for the purpose of the lease. The provisions of article 2 above shall apply to this, mutatis mutandis.

It is clarified for the avoidance of doubt, that in case of a delay as mentioned above, in evacuating the Neighboring Lessee, the Lessee shall be exempt for rental fees in respect of the Additional Units and the Attached Parking Spaces, for the duration of the aforementioned delay period.

5.3

The monthly rental fees described in article 4 above, shall be supplemented, in case the option mentioned in subsection 5.1 above is exercised, with rental fees in respect of the Additional Unit, amounting to NIS 11,121 (note: calculated as follows: NIS 63 per sqm. in respect of 160 sqm + 347 X 3 in respect of the parking spaces ) + VAT, linked to the index pursuant to the provision of article 7 to the Preceding Contract (the base index – the October 2011 index).

5.4

The Tenant is hereby granted an option to add to the property being leased to him pursuant to this contract, at any time, additional unroofed parking spaces at the Building yard, subject to the Contractor actually having such parking spaces, available to be leased.

The Lessee, should he wish to exercise the aforementioned option, should inform the Contractor of this fact by written notice (hereinafter, in this subsection – the Realization Notice ) to be delivered to the Contractor until and no later than the end of the calendar month preceding the calendar month preceding the month in which the Lessee wishes to receive additional parking spaces. Should a Realization Notice be delivered as mentioned above, the Contractor shall let the Lessee know whether he has parking spaces available for lease as mentioned above. In case and inasmuch as the Contractor has such available parking spaces for lease, he shall describe their location in a notification to be handed over to the Lessee within 30 days of having received the Realization Notice. The lease period in respect of these shall commence on the first day of the following calendar month.

5.5

The monthly rental fees described in article 4 above, shall be supplemented, in case the option described in subsection 5.4 above is exercised, by rental fees in respect of each aforementioned additional parking space, amounting to NIS 347 + VAT, linked to the index pursuant to the provision of article 7 to the Preceding Contract (the base index – the October 2011 index).

General provisions and update of amounts

6.1

The guarantees given by the Lessee, to warrant for his commitments pursuant to the main contract, shall also serve to warrant for his commitments pursuant to this supplement.

6.2

The Lessee additionally undertakes to furnish the Contractor with an additional bank guarantee, beyond the bank guarantee mentioned in article 9 to the Preceding Contract, which would amount to NIS 63,198 ( Note: respective of the monthly rental fee differential between subsections 4.2 and 4.4 above, in respect of four months of lease ), linked to the index pursuant to the provision of article 7 to the Preceding Contract (the base index – the October 2011 index), and that – within 14 days of the signing of this contract, and as a precondition to starting the Preparatory Works at the Alternative Unit.

6.3

In case the option mentioned in subsection 5.1 above is exercised, the Lessee shall increase the bank guarantee amount indicated in subsection 6.2 above, by an amount of NIS 52,046 ( Note: respective of the monthly rental fees in respect of the Additional Unit, for four months of lease ), linked to the index pursuant to the provision of article 7 to the Preceding Contract (the base index – the October 2011 index), and that – by 1.1.2014 and as a precondition to starting the Preparatory Works at the Additional Unit.

6.4

All of the provisions of the Original Contract, except for the changed indicated by the provisions of this contract, shall apply to the parties without exception, also for the lease of the Alternative Unit, the Floor Protected Space and the Additional Parking Spaces pursuant to this contract, and also to the lease of the Additional Unit, the Attached Parking Spaces and the parking spaces mentioned in subsection 5.4 above, in case the respective option(s) is (are) exercised pursuant to this contract.

In witness thereof the parties have signed on the aforementioned date:

[stamp and signature]	[stamps and signatures]

Rosetta Geonomics Ltd.	Tazor Development Ltd.

Private Company 512921388	Rorberg Contractors and

	Investments (1963) Ltd.


/s/ Signature illegible	/s/ Signature illegible
The Lessee	The Contractor

Second floor plan

[stamps and signatures]

Rosetta Geonomics Ltd. Private Company 512921388

Tazor Development Ltd.

Rorberg Contractors and Investments (1963) Ltd.

Exhibit 4.4

FIRST Amendment to air commercial real estate association
standard industrial/commercial single-tenant lease --net

This First Amendment to the AIR COMMERCIAL REAL ESTATE ASSOCIATION STANDARD INDUSTRIAL/COMMERCIAL SINGLE-TENANT LEASE - NET (this “ Amendment ”) is dated as of April 13, 2015 (the “ Effective Date ”) by and between Donna June Kitts Revocable Trust dated April 10, 2006 (" Lessor ") and Cynogen Inc., a Delaware corporation (“ Lessee ”).

RECITALS

WHEREAS , Lessor and Lessee are parties to that certain AIR COMMERCIAL REAL ESTATE ASSOCIATION STANDARD INDUSTRIAL/COMMERCIAL SINGLE-TENANT LEASE – NET (the “ Original Lease ”), dated December 1, 2013, as amended by that certain ADDENDUM TO AIR COMMERCIAL REAL ESTATE ASSOCIATION STANDARD INDUSTRIAL/COMMERCIAL SINGLE-TENANT LEASE – NET (the “ Addendum ”) dated December 1, 2013 (the Original Lease as amended by the Addendum shall hereinafter be referred to as the “ Lease ”) for the lease of certain space consisting of approximately 28,700 rentable square feet as more particularly described in the Lease;

WHEREAS , Abbott Laboratories executed and delivered to Landlord a certain AIR COMMERCIAL REAL ESTATE ASSOCIATION GUARANTY OF LEASE dated December 1, 2003 for the benefit of Landlord (the “ Guaranty ”);

WHEREAS , Rosetta Genomics Inc., a Delaware corporation (“ Rosetta ”) has agreed, under certain terms, to purchase the entity which owns one hundred percent (100%) of the issued and outstanding stock in Lessee, pursuant to a separate agreement;

WHEREAS , Lessee has requested, and Lessor has agreed, to release the Guaranty from Abbott Laboratories and replace the Guaranty with a letter of credit, and to amend certain other provisions of the Lease as further provided herein;

NOW, THEREFORE , for good and valuable consideration, the receipt and legal sufficiency of which are hereby acknowledged, Lessor and Lessee hereby agree to amend the Lease as follows.

AGREEMENT

1. Definitions . Capitalized terms used in this Amendment shall have the same meanings ascribed to such capitalized terms in the Lease, unless otherwise provided for herein.

2. Security Deposit . Within two weeks of the execution of this Amendment, Rosetta will cause a standby letter of credit to be issued for the beneficiary of Lessor in the amount of $625,365.76 (the “ Letter of Credit ”) in form and substance reasonably acceptable to Lessor. The Letter of Credit shall be reasonably reduced from time to time by the amount of Base Rent plus Common Area Maintenance charges under the Lease paid by Lessee to Lessor from and after the date that the Letter of Credit is initially issued, but in no event shall the Letter of Credit be reduced to less than $77,525.04. The Letter of Credit shall be issued by a bank reasonably acceptable to Lessor whose deposits are insured by the FDIC. The Letter of Credit shall be unconditional, irrevocable, transferable, and payable to Lessor or Lessor’s agent solely upon presentment by Lessor or Lessor’s agent of a sight draft in person, by courier, overnight mail, or by facsimile transmission in partial or full draws. Lessor may draw on the Letter or Credit in whole or in part and use, apply, or retain the whole or any part of such proceeds, as the case may be, to the extent required for the payment of any rent, additional rent, damages, or any other sum payable by Lessee under the Lease if Lessee defaults in observing or performing any of the terms, provisions or conditions of the Lease on Lessee’s part to be observed or performed, after the expiration of applicable notice and cure periods under the Lease. If the Letter of Credit is lost, stolen, or mutilated, Lessee shall cooperate with Lessor, promptly upon Lessor’s request, to replace such Letter of Credit. If Lessee shall fully and faithfully comply with all of the terms, provisions, covenants and conditions of the Lease, and delivers possession of the Premises to Lessor at the Expiration Date in the conditions required by the Lease, the Letter of Credit shall be returned to Lessee within 30 days after the Expiration Date. Lessor’s use of the Letter of Credit proceeds shall not be deemed a waiver of Lessee’s default or a waiver of any other rights and remedies to which Lessor may be entitled under the provisions of the Lease by reason of such default, it being intended that Lessor’s rights to use the whole or any part of the Letter of Credit proceeds shall be in addition to, but not in limitation of, any such other rights and remedies; and Lessor may exercise any of such other rights and remedies independent of or in conjunction with its rights hereunder.

3. Option to Terminate the Lease . Section 2 of the Addendum is hereby deleted and of no further force and effect. Commencing on the Effective Date, Lessee shall have no Termination Option relating to the Lease.

4. Installment Payments . As additional consideration for this Amendment, Lessee shall pay to Lessor, as additional Rent under the Lease, the sum of $150,000.00 in three installments as follows: (i) $50,000.00 on the Effective Date, (ii) $50,000.00 on or before the date which is 12 months from the Effective Date, and (iii) $50,000.00 on or before the date which is 24 months from the Effective Date, time being of the essence.

5. Sublease and Assignment .

A. Notwithstanding anything to the contrary set forth in Section 12 of the Original Lease and Section 4 of the Addendum, provided that Lessee is not then in default under the Lease after the expiration of applicable cure periods, Lessee shall have the right to sublet up to ten percent (10%) of the Premises without the consent of Lessor, provided that Lessee shall give not less than twenty (20) days prior written notice thereof to Lessor.

B. Commencing on the Effective Date, upon any assignment or transfer of all of Lessee’s interest in the Lease, whether a Permitted Transfer or done with the Lessor’s prior written consent in accordance with the Lease, Lessee shall have the right to substitute the Letter of Credit with a similar standby letter of credit or other comparable guaranty with terms at least equivalent to the Letter of Credit, in form and substance satisfactory to Lessor.

6. Security System . Lessor and Lessee agree to use commercially reasonable efforts to arrange for Lessee to (i) either contract directly with Landlord’s security system provider or install its own security system in and about the Building pursuant to Section 15 of the Addendum, in either event to provide that Lessee shall pay the costs thereof directly (rather than Lessor invoicing Lessee for the costs thereof), and (ii) incorporate the AT&T phone line currently dedicated for the security system into Lessee’s phone system.

7. Governing Law . This Amendment shall be governed by and construed in accordance with the laws of the State of California (without regard to conflicts of law).

8. Ratification of Lease . Except as modified hereby, all other terms and conditions of the Lease remain unchanged and in full force and effect and are hereby ratified and confirmed by the parties hereto.

9. Entire Agreement . This Amendment, in conjunction with the Lease, constitutes the entire agreement of Lessor and Lessee with respect to the subject matter hereof and supersedes all oral and written agreements and understandings made and entered into by the parties prior to the date hereof.

10. Multiple Counterparts . This Amendment may be executed in multiple counterparts, all of which, when taken together, shall constitute one and the same instrument.

[Signatures on the Following Page]

IN WITNESS WHEREOF, the parties hereto have executed this Amendment as of the Effective Date stated above.

	LESSOR:


	Donna June Kitts Revocable Trust dated April 10, 2006



	By:	/s/ Donna June Kitts
	Name:	Donna June Kitts
	Title:	Trustee


	LESSEE :


	Cynogen, Inc.



	By:	/s/ Olav Bergheim
	Name:
	Title:


	ACCEPTED AND AGREED TO:


	Rosetta Genomics Inc .



	By:	/s/ K.A. Berlin
	Name:	K.A. Berlin
	Title:	President

EXHIBIT 4.14

STOCK PURCHASE AGREEMENT

This STOCK PURCHASE AGREEMENT (this “ Agreement ”) is made and entered into as of April 3, 2015, by and between Prelude Corporation, a Delaware corporation (“ Seller ”), and Rosetta Genomics Inc., a Delaware corporation (“ Buyer ,”) and Rosetta Genomics Ltd., an Israeli corporation ("Buyer Parent")(together with Buyer and Seller, the “ Parties ”).

RECITALS

WHEREAS , Seller is the record and beneficial owner of all of the issued and outstanding shares of capital stock, consisting of 1,000 shares of common stock with a par value of $0.001 of Minuet Diagnostics, Inc., a Delaware corporation (“ MDI ,” and such shares of MDI’s capital stock, the “ Shares ”);

WHEREAS , MDI and Abbott Molecular, Inc., a Delaware corporation (“Abbott”), are parties to that certain Stock Purchase Agreement dated April 2, 2015 (the “Abbott Agreement”) pursuant to which MDI will acquire all of the issued and outstanding shares of capital stock, consisting of 1,000 shares of common stock without par value, of CynoGen, Inc., a Delaware corporation (the “ Company ,” and such shares of the Company’s capital stock, the “ CynoGen Shares ”) (the “ Abbott Transaction ”); and

WHEREAS , immediately following, and contingent upon, the closing of the Abbott Transaction, Seller desires to sell to Buyer, and Buyer desires to purchase from Seller, all of the Shares, as more fully described and upon the terms and subject to the conditions set forth herein.

NOW, THEREFORE , in consideration of the mutual agreements and covenants herein contained and intending to be legally bound hereby, the Parties hereby agree as follows:

ARTICLE I
DEFINITIONS

1.1 Definitions . As used in this Agreement, capitalized terms not otherwise defined herein shall have the respective meanings given to them in Exhibit A .

1.2 Other Definitional and Interpretive Matters .

(a) As used in this Agreement, except to the extent that the context otherwise requires, references:

(i) to the Recitals, Articles, Sections, Exhibits or Schedules, are references to the Recital, Article or Section of, or Exhibit or Schedule to, this Agreement unless otherwise indicated;

(ii) to any agreement (including this Agreement), Contract, statute or regulation are, unless specified otherwise, to the agreement, Contract, statute or regulation as amended, modified, supplemented or replaced from time to time, and to any section of any statute or regulation are to any successor to the section and all rules and regulations promulgated under the statute;

(iii) to this Agreement are to this Agreement and the Exhibits and Schedules to it, taken as a whole;

(iv) to a Person, include that Person and the permitted successors and assigns of that Person; and

(v) to gender, shall include all genders, and the definitions contained in this Agreement are applicable to the singular as well as the plural forms of such terms.

(b) The headings for this Agreement are for reference purposes only and do not limit or otherwise affect any of the provisions of this Agreement.

(c) Whenever the words “include,” “includes” or “including” (or similar terms) are used in this Agreement, they are deemed to be followed by the words “without limitation.”

(d) Whenever the words “hereof,” “herein” or “hereunder” (or similar terms) are used in this Agreement, they will be deemed to refer to this Agreement as a whole and not to any specific provision of this Agreement.

(e) The use of “or” is not intended to be exclusive unless expressly indicated otherwise.

(f) If any action is to be taken by any Party hereto pursuant to this Agreement on a day that is not a Business Day, such action shall be taken on the next Business Day following such day.

(g) It is understood and agreed that neither the specifications of any dollar amount in this Agreement nor the inclusion of any specific item in the Schedules or Exhibits is intended to imply that such amounts or higher or lower amounts, or the items so included or other items, are or are not material, and no Party will use the fact of setting of such amounts or the fact of the inclusion of such item in the Schedules or Exhibits in any dispute or controversy between or among the Parties as to whether any obligation, item or matter is or is not material for purposes hereof.

(h) No prior draft of this Agreement nor any course of performance or course of dealing will be used in the interpretation or construction hereof. No parol evidence will be introduced in the construction or interpretation of this Agreement unless the ambiguity or uncertainty in issue is plainly discernible from a reading of this Agreement without consideration of any extrinsic evidence.

(i) The Parties have participated jointly in the negotiation and drafting hereof; if any ambiguity or question of intent or interpretation arises, this Agreement will be construed as if drafted jointly by the Parties, and no presumption or burden of proof will arise favoring or disfavoring any Party by virtue of the authorship of any provision hereof.

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(j) All references to “$” or “dollars” herein will be deemed to be references to lawful currency of the United States of America.

(k) Unless otherwise defined in this Agreement, accounting terms will have the respective meanings assigned to them in accordance with GAAP consistently applied with the financial statements of the Company.

ARTICLE II
PURCHASE AND SALE OF SHARES

2.1 Purchase and Sale .

(a) At the Closing, upon the terms and subject to the conditions of this Agreement, Seller shall sell to Buyer, and Buyer shall purchase from Seller, all of Seller’s right, title and interest in the Shares, free and clear of all Encumbrances.

(b) Notwithstanding anything to the contrary in this Agreement, Buyer shall not purchase or otherwise acquire pursuant to this Agreement, any of the following:

(i) cash and cash equivalents, securities and negotiable instruments on hand, in lock boxes, in financial institutions or elsewhere, including any cash residing in any collateral cash account securing any obligation or contingent obligation;

(ii) Indebtedness of MDI, the Company or any of their Affiliates;

(iii) intercompany payables or receivables as between MDI and/or the Company, on the one hand, and Seller, MDI or any other Affiliate of Seller on the other hand;

(iv) the assets of the Company identified on Exhibit B hereto (the “ Retained Assets ”); or

(v) all rights or obligations under Section 2.3 (Working Capital Adjustment) of the Abbott Agreement, which rights and obligations shall be rights and obligations of Seller.

2.2 Consideration . Subject to the terms and conditions of this Agreement, in consideration of the sale of the Shares under Section 2.1 , Buyer shall:

(a) pay to Seller, at the Closing, $2,000,000, without deduction or withholding for or on account of any Taxes.

(b) Buyer Parent will issue to Seller 500,000 ordinary shares of Buyer Parent at closing (the “Buyer Parent Shares”) .

(c) provide Seller (including its successors and assigns) with the services set forth on Exhibit C hereto (the “ Support Services ”), following the Closing. The Support Services shall be provided (i) as reasonably requested by Prelude, (ii) pursuant to a Support Services Agreement to be entered into by and between Buyer and Prelude at the Closing (the “Support Services Agreement”), (iii) at cost and (iv) until the aggregate value of the Support Services provided is equal to $1,000,000, after which the Support Services Agreement will terminate.

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2.3 Closing . The Closing shall take place on the same Business Day as the closing of the Abbott Transaction, or at such other time and date as Seller and Buyer mutually agree in writing (the “ Closing Date ”), and shall be held at the offices of Seller located at 26051 Merit Circle, Suite 102, Laguna Hills, California 92653, or at such other place as Buyer and Seller mutually agree in writing; provided however, that Seller must give Buyer at least two (2) Business Day’s notice prior to the closing of the Abbott Transaction.

2.4 Closing Deliveries by Buyer . At the Closing, Buyer shall deliver or cause to be delivered to Seller:

(a) $2,000,000 in cash, by wire of immediately available funds to the account designated by Seller to Buyer;

(b) evidence of irrevocable instructions from Buyer Parent to the transfer agent for the ordinary shares of Buyer Parent with respect to the issuance and delivery of one or more certificates representing the Buyer Parent Shares;

(d) an officer’s certificate of Buyer attesting to the matters set forth in Sections 6.3(a) and 6.3(b) ; and

(e) such further instruments and documents as may be reasonably required to be delivered by Buyer or Buyer Parent pursuant to the terms of this Agreement or as may be reasonably requested by Seller prior to the Closing in connection with the Closing.

2.5 Closing Deliveries by Seller . At the Closing, Seller shall deliver or cause to be delivered to Buyer:

(a) certificates for the Shares issued in the name of Buyer or duly endorsed or accompanied by stock powers duly endorsed in blank, with any required transfer stamps affixed thereto;

(b) resignations from each director and officer of MDI and the Company in their capacity as such;

(d) a certificate in form and substance reasonably satisfactory to Buyer, duly executed and acknowledged, certifying any facts that would exempt the transactions contemplated hereby from withholding under Section 1445 of the Code; and

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(e) such further instruments and documents as may be reasonably required to be delivered by Seller pursuant to the terms of this Agreement or as may be reasonably requested by Buyer or Buyer Parent prior to the Closing in connection with the Closing.

ARTICLE III
REPRESENTATIONS AND WARRANTIES OF SELLER

Seller hereby represents and warrants to Buyer that, except as set forth in the disclosure schedules delivered by Seller to Buyer contemporaneously with or prior to the execution and delivery of this Agreement (the “ Disclosure Schedules ”) or may be set forth in an update to the Disclosure Schedules delivered by Seller to Buyer at least one Business Day prior to the Closing Date (which updated Disclosure Schedules will be deemed to be the Disclosure Schedules with respect to the representations and warranties of Seller at the Closing Date ) :

3.1 Title to Shares . All of the Shares are owned of record and beneficially by Seller free and clear of all Encumbrances created by Seller, MDI, their Affiliates or Abbott or its Affiliates. There is no restriction affecting the ability of such Seller to transfer the legal and beneficial title and ownership of such Shares to the Buyer pursuant to the terms of this Agreement, and upon transfer of such Shares to Buyer in accordance with the terms of Article II , Buyer will receive valid title to such Shares, free and clear of all Encumbrances created by Seller, MDI, their Affiliates, Abbott or its Affiliates. Other than Seller, no Person has any right to acquire or vote any Shares owned by Seller.

3.2 Organization; Authority; Non-Contravention; Proceedings . Each of Seller and MDI (collectively, the “Seller Parties”) is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware and is qualified to do business and in good standing in the State of California. Seller has all requisite corporate power and authority to execute and deliver this Agreement and to effect the transactions contemplated hereby, and the execution, delivery and performance of this Agreement has been duly authorized by all requisite corporate action of Seller. This Agreement has been duly executed and delivered by Seller, and, assuming due authorization, execution and delivery by Buyer and Buyer Parent (collectively, the “Buyer Parties”), this Agreement is a valid and legally binding obligation of Seller, enforceable against Seller in accordance with its terms except that the enforcement hereof or thereof may be limited by (i) bankruptcy, insolvency, reorganization, moratorium or other similar laws now or hereafter in effect relating to creditors’ rights generally, and (ii) general principles of equity (regardless of whether enforceability is considered in a proceeding at law or in equity). The execution, delivery and performance of this Agreement by Seller, and the consummation of the transactions contemplated hereby, does not (except as would not have a Material Adverse Effect): (i) result in a breach or violation of any provision of any Seller Party’s certificate of incorporation, bylaws or similar organizational documents, (ii) result in a breach of, or constitute a default under, or result in the creation of any Encumbrance on any of the assets or properties of MDI or the Company pursuant to, any Contract, or (iii) violate, in any respect, any Order from a Governmental Authority having jurisdiction over a Seller Party, the Shares or the CynoGen Shares. As of the date of this Agreement, to the Knowledge of Seller, there are no Proceedings pending or threatened against or affecting a Seller Party that, if adversely decided, would have a Material Adverse Effect. No consent, approval, order or authorization of, or registration, declaration or filing with any Person is required to be obtained by a Seller Party in connection with the execution and delivery of this Agreement or for the consummation of the transactions contemplated hereby by Seller.

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3.3 Capitalization; Subsidiaries . The authorized capital of MDI consists, as of the date of this Agreement, of 1,000,000 shares of common stock, par value $0.001 (“ Common Stock ”), 1,000 of which are issued and outstanding. All of the outstanding shares of Common Stock have been duly authorized, are fully paid and nonassessable and were issued in compliance with all applicable federal and state securities laws and are owned of record and beneficially by Seller. MDI holds no Common Stock in its treasury. As of the date of this Agreement, MDI does not have any Subsidiaries, and as of the Closing Date, the Company will be the only Subsidiary of MDI.

3.4 Corporate Documents . The certificate of incorporation and bylaws of MDI are in the form made available to Buyer. MDI is not in breach of its certificate of incorporation or bylaws.

3.5 Lack of Operating History . MDI was formed on March 23, 2015 for the sole purpose of acquiring the CynoGen Shares. MDI has no operations, no employees, and no Indebtedness or other liabilities. At the Closing, the only asset of MDI will be the CynoGen Shares.

3.6 Taxes . MDI has timely paid all Taxes required to be paid by it through the date of this Agreement. MDI has complied in all material respects with all applicable laws relating to the collection and withholding of Taxes (such as sales Taxes or withholding of Taxes from the wages of employees) and is not liable in any material amount for any Taxes for failure to comply with such laws.

3.7 Contracts .

(a) The only Contract to which MDI is a party as of the date of this Agreement is the Abbott Agreement.

(b) The Abbott Agreement is a valid, binding and enforceable obligation of MDI and, to the best knowledge of Seller, Abbott, in each case except as the enforcement thereof may be limited by (i) bankruptcy, insolvency, reorganization, moratorium or other similar laws now or hereafter in effect relating to creditors’ rights generally, and (ii) general principles of equity (regardless of whether enforceability is considered in a proceeding at law or in equity).

3.8 Title to CynoGen Shares . Following the closing of the Abbott Transaction, all of the CynoGen Shares will be owned of record and beneficially by MDI free and clear of all Encumbrances created by Seller, MDI or any of their respective Affiliates. Following the closing of the Abbott Transaction, other than MDI, no Person has any right to acquire or vote any CynoGen Shares owned by MDI.

3.9 Representations and Warranties of Abbott . Attached hereto as Exhibit D , are the representations and warranties made by Abbott in Article III of the Abbott Agreement. Seller has also provided to Buyer a true and correct copy of the disclosure schedules related to such representations and warranties. To the best knowledge of Seller, all such representations and warranties were true and correct as of the date of the Abbott Agreement, are true and correct as of the date hereof and will be true and correct as of the date of Closing.

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3.10 Compliance with Laws . Seller and MDI are in material compliance with all applicable Laws. Seller and MDI have not received any written notice to the effect that they are in material violation or default of any applicable Laws.

3.11 Brokers . No agent, broker, investment banker, financial advisor or other firm or Person is entitled to any brokerage, finder’s, financial advisor’s or other similar fee or commission for which Buyer or any of its Affiliates could become liable in connection with the transactions contemplated by this Agreement as a result of any action taken by or on behalf of Seller or any of its Affiliates.

3.12 Accredited Investor; Investment; No Reliance .

(a) At the time Seller was offered the Buyer Parent Shares, it was, and as of the date hereof it is an “accredited investor” as defined in Rule 501(a) under the Securities Act of 1933, as amended (the “Securities Act”).

(b) Seller has such knowledge and experience in financial and business matters that it is capable of evaluating the merits and risks of acquiring the Buyer Parent Shares. Seller confirms that Buyer Parent has made available to Seller the opportunity to ask questions of the officers and management of Buyer Parent and to acquire additional information about the Buyer Parent Shares and the business, assets, liabilities, revenues, costs, expenditures, cash flow, results of operations, financial condition, and prospects of Buyer Parent, and Seller has conducted, or has had an adequate opportunity to conduct, all necessary due diligence related to the Buyer Parent Shares and Buyer Parent, and all such other matters relating to or affecting any of the foregoing. Seller will acquire its interest in the Buyer Parent Shares not with a view toward or for sale in connection with any distribution thereof or with any present intention of distributing or selling any interest therein. Seller understands that the transactions contemplated hereby have not been, and will not be registered or qualified under the Securities Act, nor any state or any other applicable securities law, by reason of a specific exemption from the registration or qualification provisions of those laws, based in part upon Seller’s representations in this Agreement. Seller understands that no part of the interest in the Buyer Parent Shares which Buyer acquires may be resold unless such resale is registered under the Securities Act, and registered or qualified under applicable state securities laws or an exemption from such registration and qualification is available.

(c) Seller has not been induced by and has not relied upon any representations, warranties or statements, whether express or implied, made by Buyer or Buyer Parent (or their Affiliates, officers, directors, employees, agents and Representatives, as applicable) that are not expressly set forth herein, whether or not any such representations, warranties or statements were made in writing or orally.

(d) Seller acknowledges that neither Buyer, Buyer Parent nor any of their Affiliates makes, will make or has made any representation or warranty, express or implied, as to the prospects of Buyer Parent or its profitability to Seller, or with respect to any forecasts, projections or business plans made available to Seller in connection with Seller’s review of Buyer Parent.

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3.13 Disclaimer. EXCEPT AS SET FORTH IN THIS ARTICLE III , NONE OF SELLER, MDI OR ANY OF THEIR RESPECTIVE AFFILIATES (INCLUDING THE COMPANY), OFFICERS, DIRECTORS, EMPLOYEES OR REPRESENTATIVES MAKE OR HAVE MADE ANY OTHER REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, AT LAW OR IN EQUITY, IN RESPECT OF SELLER, MDI, THE COMPANY, THEIR RESPECTIVE AFFILIATES, THE SHARES OR THE COMPANY’S BUSINESS, ASSETS, LIABILITIES, REVENUES, COSTS, EXPENDITURES, CASH FLOW, RESULTS OF OPERATIONS, FINANCIAL CONDITION OR PROSPECTS, WHETHER HISTORICAL, CURRENT OR FUTURE, OR ANY OTHER INFORMATION OR DOCUMENTS MADE AVAILABLE TO BUYER OR ITS AFFILIATES, AGENTS OR REPRESENTATIVES. ANY SUCH OTHER REPRESENTATION OR WARRANTY IS HEREBY EXPRESSLY DISCLAIMED.

ARTICLE IV
REPRESENTATIONS AND WARRANTIES OF BUYER

Buyer hereby represents and warrants to Seller that:

4.1 Organization; Authority; Non-Contravention; Approvals .

(a) Buyer is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware. Buyer Parent is a corporation duly organized, validly existing and in good standing under the laws of the State of Israel.

(b) Each Buyer Party has all requisite corporate power and authority to execute and deliver this Agreement and to effect the transactions contemplated hereby, and the execution, delivery and performance of this Agreement have been duly authorized by all requisite corporate action.

(c) This Agreement has been duly executed and delivered by each Buyer Party and this Agreement is a valid and legally binding obligation of each Buyer Party, enforceable against such Buyer Party in accordance with its terms except that the enforcement hereof or thereof may be limited by (i) bankruptcy, insolvency, reorganization, moratorium or other similar laws now or hereafter in effect relating to creditors’ rights generally, and (ii) general principles of equity (regardless of whether enforceability is considered in a proceeding at law or in equity)

(d) The execution, delivery and performance of this Agreement by each Buyer Party, and the consummation of the transactions contemplated hereby, does not and will not: (i) result in a breach or violation of any provision of its charter, bylaws or similar organizational documents, (ii) violate or conflict with, in any material respects, or result in a material breach of or constitute an occurrence of material default under any provision of, any Contract to which such Buyer Party is a party or by which it is bound, or (iii) violate, in any material respect, any Order from a Governmental Authority having jurisdiction over such Buyer Party.

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(e) No consent, approval, order or authorization of, or registration, declaration or filing with, any Person is required to be obtained by a Buyer Party in connection with the execution and delivery of this Agreement or for the consummation of the transactions contemplated hereby by the Buyer Parties.

(f) As of the date of this Agreement, there are no Proceedings pending or, to the knowledge of the Buyer Parties, threatened against or affecting the Buyer Parties that, if adversely decided, would have a material adverse effect on the Buyer Partiesor prevent the consummation of the transactions contemplated by this Agreement.

4.2 Investment; No Reliance .

(a) Buyer has such knowledge and experience in financial and business matters that it is capable of evaluating the merits and risks of acquiring the Shares. Buyer confirms that Seller has made available to Buyer the opportunity to ask questions of the officers and management of Seller and the Company and to acquire additional information about the Shares and the business, assets, liabilities, revenues, costs, expenditures, cash flow, results of operations, financial condition, and prospects of the Company and MDI, and Buyer has conducted, or has had an adequate opportunity to conduct, all necessary due diligence related to the Shares, the Company and MDI, and all such other matters relating to or affecting any of the foregoing. Buyer will acquire its interest in MDI not with a view toward or for sale in connection with any distribution thereof or with any present intention of distributing or selling any interest therein. Buyer understands that the transactions contemplated hereby have not been, and will not be registered or qualified under the Securities Act, nor any state or any other applicable securities law, by reason of a specific exemption from the registration or qualification provisions of those laws, based in part upon Buyer’s representations in this Agreement. Buyer understands that no part of the interest in the Company which Buyer acquires may be resold unless such resale is registered under the Securities Act, and registered or qualified under applicable state securities laws or an exemption from such registration and qualification is available.

(b) Buyer has not been induced by and has not relied upon any representations, warranties or statements, whether express or implied, made by Seller (or its Affiliates, officers, directors, employees, agents and Representatives, as applicable) that are not expressly set forth herein, whether or not any such representations, warranties or statements were made in writing or orally.

(c) Buyer acknowledges that neither Seller nor any of its Affiliates makes, will make or has made any representation or warranty, express or implied, as to the prospects of the Company or its profitability to Buyer, or with respect to any forecasts, projections or business plans made available to Buyer in connection with Buyer’s review of the Company.

(d) UPON CLOSING, BUYER ACKNOWLEDGES THAT, EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN ARTICLE III , SELLER AND ITS AFFILIATES ARE SELLING AND CONVEYING THE SHARES ON AN “AS IS, WHERE IS” BASIS, WITHOUT RECOURSE, AND THAT (EXCEPT AS SPECIFICALLY SET FORTH IN ARTICLE III ), NONE OF SELLER, MDI OR ANY OF THEIR RESPECTIVE AFFILIATES (INCLUDING THE COMPANY) OR ANY OF THEIR RESPECTIVE AFFILIATES, OFFICERS, DIRECTORS, EMPLOYEES OR REPRESENTATIVES MAKE OR HAVE MADE ANY OTHER REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, AT LAW OR IN EQUITY, IN RESPECT OF SELLER, MDI AND THE COMPANY, THEIR RESPECTIVE AFFILIATES, THE SHARES OR MDI AND THE COMPANY’S BUSINESS, ASSETS, LIABILITIES, REVENUES, COSTS, EXPENDITURES, CASH FLOW, RESULTS OF OPERATIONS, FINANCIAL CONDITION OR PROSPECTS, WHETHER HISTORICAL, CURRENT OR FUTURE, OR ANY OTHER INFORMATION OR DOCUMENTS MADE AVAILABLE TO BUYER OR ITS AFFILIATES, AGENTS OR REPRESENTATIVES.

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4.3 Brokers . No agent, broker, investment banker, financial advisor or other firm or person is entitled to any brokerage, finder’s, financial advisor’s or other similar fee or commission for which Seller or any of its Affiliates could become liable in connection with the transactions contemplated by this Agreement as a result of any action taken by or on behalf of Buyer or any of its Affiliates.

ARTICLE V
COVENANTS

5.1 Further Assurances . From time to time after the Closing and until the date that is six months after the Closing, each of the Parties shall (or, if appropriate, cause their respective Affiliates to) execute and deliver such further instruments and documents, and take such other action as may be necessary under applicable Law to make effective the transactions contemplated by this Agreement and to vest in Buyer all of Seller’s right, title and interest in, to, and under the Shares, without Encumbrance of any kind, subject to Section 6.2 . If any Party (or any of its Affiliates) shall, following the Closing and until the date that is six months after the Closing, have in its possession any asset or right that under this Agreement should have been delivered to the other, such Party shall promptly deliver or cause to be delivered such asset or right to the other. Without limiting the foregoing, indefinitely following the Closing, (a) each Party shall promptly notify the other Party of any communication it or any of its Affiliates receives from any Governmental Authority relating to the matters that are the subject of this Agreement and shall permit the other Party to review in advance any proposed communication by such Party to any Governmental Authority relating to the matters that are the subject of this Agreement, (b) neither Party shall agree to participate in any meeting with any Governmental Authority in respect of any filings, investigation or other inquiry related to the transactions contemplated by this Agreement unless it consults with the other Party in advance and, to the extent permitted by such Governmental Authority, gives the other Party the opportunity to attend and participate at such meeting, (c) subject to the Confidentiality Agreement, the Parties shall coordinate and cooperate fully with each other in exchanging such information and providing such assistance as the other Party may reasonably request in connection with the foregoing, and (d) subject to the Confidentiality Agreement, the Parties shall provide each other with copies of all correspondence, filings or communications between them or any of their representatives, on the one hand, and any Governmental Authority or members of its staff, on the other hand, with respect to this Agreement and the transactions contemplated by this Agreement; provided, however, that clauses (a) through (d) of this sentence shall not apply so as to give Buyer any rights with respect to matters related to the Taxes of any affiliated, consolidated, combined, unitary or aggregate group of which Seller was a member at any time on or prior to the Closing Date. Notwithstanding the foregoing, such right to participate (or to review proposed communications and information) shall not apply when information that the other Party reasonably deems to be competitively sensitive is being discussed or provided.

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5.2 Tax Matters . Indefinitely, from and after the Closing:

(a) All transfer, registration, stamp, value added, documentary, sales, use and similar Taxes (including all applicable real estate transfer or gains Taxes and transfer Taxes), any penalties, interest and additions to Tax, and fees incurred in connection with this Agreement shall be the responsibility of and be timely paid by Buyer. Seller and Buyer shall reasonably cooperate in the timely making of all filings, returns, reports and forms as may be required in connection therewith.

(b) Buyer shall prepare or cause to be prepared and file or cause to be filed all Tax Returns for the MDI that are filed for taxable periods ending after the Closing Date.

(c) Buyer shall pay, indemnify and hold harmless Seller from and against any Taxes of Seller (or any affiliated, consolidated, combined, unitary or aggregate group of which Seller was a member at any time on or prior to the Closing Date) resulting from any actions outside of the ordinary course of business taken, or caused to be taken, by Buyer or any of its Affiliates (including MDI) following the Closing.

5.3 Public Announcements; Confidentiality . Buyer Parties and Seller will agree upon the form and substance of (i) a press release to be issued by Buyer Parent announcing the execution of this Agreement and the Closing of the transactions contemplated hereby, and (ii) a Report on Form 6-K to be filed by Buyer Parent with the Securities and Exchange Commission promptly following the Closing. Indefinitely following the Closing, Buyer Parties and Seller shall not issue any other press release, make any other public statement or schedule any press conference or conference call with investors or analysts, with respect to this Agreement or the transactions contemplated hereby, without the prior written consent of the other Party, except (A) to the extent that such communication contains only information that has been previously publicly disclosed pursuant to an agreed press release or the disclosure of which has otherwise previously been consented to pursuant to this section, or (B) as may be required by applicable Law, Order or any listing agreement with or rule of any applicable securities exchange or association.

5.4 Access to Books and Records . Buyer and Seller agree that Seller may maintain copies of any books, records and files of MDI after the Closing to comply with this Section 5.4. From and after the Closing and until the date that is seven years after the Closing, Buyer shall give (and shall cause its Affiliates to give) Seller and its Representatives reasonable access during normal business hours to officers of MDI and any properties, books and records and information relating to MDI or the Company related solely to periods prior to the Closing Date (and shall, and shall cause its Affiliates to, allow Seller and its Representatives to make copies of such books, records and information) for any reasonable purpose, including as may be necessary for: (a) preparation of Tax Returns and financial statements, (b) management and handling of any Tax audits and Tax disputes, (c) complying with any audit request, subpoena or other investigative demand by any Governmental Authority or for any civil litigation, (d) any dispute arising hereunder or (e) to enable Seller to satisfy its obligations and/or enforce its rights under Section 2.3 (Working Capital Adjustment) of the Abbott Agreement. For a period of seven years following the Closing, or such longer period as may be required by applicable Law or necessitated by applicable statutes of limitations, plus any additional time during which Buyer has been notified in writing by Seller that: (x) there is an ongoing Tax audit with respect to periods prior to the Closing or (y) any such period is otherwise open to assessment by a Tax authority (provided that only such books and records and information reasonably related to the appropriate Tax audit or period as notified by Seller shall be subject to such time extension), Buyer shall maintain all books and records of MDI and shall not destroy or dispose of any of such books and records.

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5.5 Notification of Certain Matters . Each Party agrees to give prompt notice to the other Party of (a) the occurrence, or failure to occur, of any event the occurrence or failure to occur of which would be likely to cause any of its representations or warranties contained in this Agreement to be untrue or inaccurate in any material respect at any time from the date of this Agreement to the Closing Date, (b) any failure on its part to comply with or satisfy any covenant or agreement to be complied with or satisfied by it hereunder in any material respect, and (c) the occurrence of any event that may make the satisfaction of the conditions in Article VI impossible or unlikely; provided that the delivery of any notice pursuant to this Section 5.7 , does not limit or otherwise affect the remedies available hereunder to the Parties.

5.6 License Agreement between Buyer and Prelude . Buyer and Prelude will negotiate in good faith a distribution agreement relating to the Prelude DCIS assay. Should the parties fail to finalize and execute such an agreement within 30 days after the Closing, then the parties will execute an agreement with substantially identical economics and for the same term as reflected in the Non-Exclusive License Agreement between Prelude and the Company, which agreement was terminated immediately following the closing of the Abbott Transaction.

5.7 Working Capital Adjustment . Within 75 Business Days of the Closing Date, Buyer will provide to Seller all necessary information relating to, and use commercially reasonable efforts to assist Seller in, the preparation of the Working Capital Statement as defined in Section 2.3 of the Abbott Agreement. Buyer will use commercially reasonable efforts to assist Seller in finalizing the Working Capital Statement and in fulfilling its obligations under Section 2.3 of the Abbott Agreement.

5.8 Collection of Accounts Receivable . Seller agrees that it shall forward promptly to Buyer any monies, checks or instruments received by Seller after the Closing with respect to the accounts receivable of the Company. Seller hereby authorizes Buyer to endorse and cash any checks or instruments payable or endorsed to Seller or its order which are received by Buyer and which relate to accounts receivable purchased by Buyer from Seller.

5.9 Provision of Information Related to the Company . Following the signing of the Agreement, Seller shall provide the Buyer Parties with all information, diligence materials and other information relating to the Company that has been provided to Seller by Abbott.

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ARTICLE VI
CLOSING CONDITIONS

6.1 Conditions to All Parties’ Obligations . The respective obligations of each Party hereunder are subject to the satisfaction or waiver by each Party (if permitted by applicable Law) at or prior to the Closing of each of the following conditions:

(a) No Proceedings will have been instituted or threatened to restrain, prohibit or delay any of the transactions contemplated by this Agreement.

(b) No Law or Order of any kind will have been enacted, entered, promulgated or enforced by any Governmental Authority that would prohibit or delay the consummation of the transactions contemplated by this Agreement or have the effect of making them illegal and no Proceeding seeking to impose such an Order is pending

6.2 Conditions to Buyer Parties’s Obligations . The obligations of the Buyer Parties are subject to the satisfaction or waiver at or prior to the Closing of each of the following conditions. The benefits of these conditions are for the Buyer Parties only and may be waived in writing by Buyer at any time in its sole discretion.

(a) The representations and warranties made by Seller in this Agreement, as qualified by the Disclosure Schedules (or any update thereto delivered by Seller pursuant to Article III ) shall have been accurate in all respects as of the Closing Date as if made on the Closing Date (except for such representations or warranties which address matters only as of a particular time, which shall have been accurate in all respects as of such particular time), except that any inaccuracies in such representations and warranties shall be disregarded if the circumstances giving rise to such inaccuracies (considered collectively) do not constitute a Material Adverse Effect, and Buyer will have received a certificate attesting thereto duly executed by Seller.

(b) Seller will have performed, satisfied and complied with all covenants and agreements required by this Agreement in all material respects and Buyer will have received a certificate attesting thereto executed by an officer of Seller.

(c) Seller shall have obtained the consent of each of Institut Curie, Centre national de la Recherche Scientifique and Assistance Publique – Hôpitaux de Paris to the sublicense granted to the Company pursuant to that certain Sublicense Agreement, to be dated as of the Closing Date, between Seller and the Company (the “Sublicense Agreement”).

(d) The closing deliveries set forth in Section 2.6 will have been delivered to Buyer.

(e) There shall be no information provided by Seller to the Buyer Parties in accordance with Section 5.9 or contained in any update to the Disclosure Schedules delivered by Seller pursuant to Article III, that is , in the reasonable judgment of the Buyer Parties, so material and adverse to the business, results of operations, financial condition, prospects and assets of the Company as to make it impracticable or inadvisable to proceed with the transactions contemplated by this Agreement.

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6.3 Conditions to Seller’s Obligations . The obligations of Seller are subject to the satisfaction or waiver at or prior to the Closing of each of the following conditions. The benefits of these conditions are for the benefit of Seller only and may be waived by Seller in writing at any time in its sole discretion.

(a) The representations and warranties made by Buyer in this Agreement shall be accurate in all respects as of the Closing Date as if made on and as of the Closing Date (except for such representations or warranties which address matters only as of a particular time, which shall have been accurate in all respects as of such particular time), and Seller will have received a certificate attesting thereto duly executed by an officer of Buyer.

(b) Buyer will have performed, satisfied and complied with all covenants and agreements required by this Agreement in all material respects and Seller will have received a certificate attesting thereto duly executed by an officer of Buyer.

(c) MDI shall have distributed to Seller all of its cash and cash equivalents and its securities and negotiable instruments on hand, in lock boxes, in financial institutions or elsewhere, including any cash residing in any collateral cash account securing any obligation or contingent obligation.

(d) Seller shall have assumed the Indebtedness of MDI.

(e) All intercompany payables and receivables as between MDI, on the one hand, and Seller or any Affiliate of Seller, on the other hand, shall have been settled or terminated .

(f) The Retained Assets shall have transferred to the Seller or an Affiliate of Seller by CynoGen.

(g) The Non-Exclusive License Agreement between Prelude and the Company shall have been terminated.

(h) The closing deliveries set forth in Section 2.5 will have been delivered to Seller.

ARTICLE VII
TERMINATION

7.1 Right to Terminate . Notwithstanding anything to the contrary set forth in this Agreement, this Agreement may be terminated and the transactions contemplated herein abandoned at any time prior to the Closing:

(a) by mutual written consent of Buyer Parties, on the one hand, and Seller, on the other hand;

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(b) by written notice of Buyer Parties or Seller to the other Party, if a Governmental Authority issues a final nonappealable Order restraining, enjoining or otherwise prohibiting the consummation of the transactions contemplated by this Agreement;

(c) by written notice of Buyer Parties or Seller, as the case may be, to the other Party, if the other Party has materially breached or failed to perform any of its representations, warranties, covenants or agreements contained herein, which breach or failure to perform is not cured within ten Business Days after the Party seeking to terminate has notified the other Party of its intention to terminate this Agreement pursuant to this clause, or if any condition that must be met by the other becomes impossible to fulfill;

(d) by written notice of Buyer Parties to Seller, if there has been an event, change, occurrence or circumstance since the date of this Agreement that has had or could reasonably be expected to have a Material Adverse Effect;

(e) by written notice of Buyer Parties to Seller, if Buyer Parties have determined in accordance with Section 6.2(e) that it is impracticable or inadvisable to proceed with the transactions contemplated by this Agreement;

(f) by written notice of Buyer or Seller to the other Party, at any time after three (3) Business Days following the closing of the Abbott Transaction or if the Abbott Transaction has not closed on or before May 8, 2015; or

(g) automatically if the Abbott Agreement is terminated prior to the closing of the Abbott Transaction

7.2 Effect of Termination . Each Party’s right of termination under Section 7.1 is in addition to any other rights it may have under this Agreement or otherwise and the exercise of a right of termination will not be an election of remedies. If this Agreement is terminated pursuant to Section 7.1 , written notice thereof must be given by the terminating Party to the other Party specifying the provision of Section 7.1 pursuant to which such termination is made, and this Agreement will terminate and become void and of no further force and effect and there will be no further liability or obligation on the part of any Party hereto, except that the provisions of Section 7.1 , this Section 7.2 , and Article IX will survive any termination of this Agreement. Nothing in this Section 7.2 will relieve any Party of liability for any breach of this Agreement.

ARTICLE VIII
SURVIVAL

8.1 Survival of Representations and Warranties . None of the representations and warranties of Seller or of Buyer made in this Agreement shall survive the Closing Date, and all such representations and warranties shall be extinguished by operation of the Closing. Unless otherwise specified, all covenants in this Agreement shall survive the Closing until the later of six months after the Closing Date or the date by which such covenant is to be performed.

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ARTICLE IX
MISCELLANEOUS

9.1 Notices . All notices required or permitted to be given hereunder shall be in writing and may be delivered by hand, facsimile, nationally recognized private courier, or United States mail. Notices delivered by mail shall be deemed given three Business Days after being deposited in the United States mail, postage prepaid, registered or certified mail. Notices delivered by hand or via facsimile, or by nationally recognized private carrier shall be deemed given on the first Business Day following receipt. All notices shall be addressed as follows:

if to Seller:

Prelude Corporation
26051 Merit Circle, Suite 102
Laguna Hills, CA 92653
Attention: Chief Executive Officer
Facsimile: (949) 348-1866

with a copy (which will not constitute notice) to:

Reed Smith
1901 Avenue of the Stars, Seventh Floor
Los Angeles, CA 90067
Attention: Michael Sanders
Facsimile: (310) 734-5299

if to Buyer:

Rosetta Genomics Inc.
3 Independence Way

Princeton, N.J. 08540

Attention: President

Fax: 1.609.419.9009

with a copy (which will not constitute notice) to:

Mintz Levin and Co.

One Financial Center, Boston, MA 02111

Attention: Brian Keane

with a copy (which will not constitute notice) to:

Rosetta Genomics Inc.
3 Independence Way

Princeton, N.J. 08540

Attention: Chief Legal Officer

Fax: 1.609.419.9009

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If to Buyer Parent:

Rosetta Genomics Ltd.
10 Plaut St.,

Rehovot, 7670609,

Israel

Attention: Legal Department

Fax: 972.73.222.0701

with a copy (which will not constitute notice) to:

Mintz Levin and Co.

One Financial Center, Boston, MA 02111

Attention: Brian Keane

and/or to such other respective addresses and/or addressees as may be designated by notice given in accordance with the provisions of this Section 9.1 .

9.2 Expenses . Except as otherwise provided herein, each Party hereto shall bear all fees and expenses incurred by such Party in connection with, relating to or arising out of the negotiation, preparation, execution, delivery and performance of this Agreement and the consummation of the transaction contemplated hereby, including, without limitation, attorneys’, accountants’ and other professional fees and expenses.

9.3 Entire Agreement; Amendment; Waiver . This Agreement and the other documents and instruments referred to herein and therein and all Exhibits and Schedules hereto and thereto, constitute the entire agreement among the Parties pertaining to the subject matter hereof and supersedes all prior agreements, understandings, negotiations and discussions, whether oral or written, of the Parties. This Agreement may be supplemented, modified or amended only by written agreement executed by each Party hereto. No supplement, modification or other amendment or waiver of this Agreement will be binding unless executed in writing by the Party to be bound thereby. No waiver of any of the provisions of this Agreement will be deemed or will constitute a waiver of any other provision hereof (whether or not similar), nor will such waiver constitute a continuing waiver unless otherwise expressly provided. The failure of any Party to enforce any condition or part of this Agreement at any time shall not be construed as a waiver of that condition or part, nor shall it forfeit any rights to future enforcement thereof. Any waiver hereunder shall be effective only if delivered to the other Party in writing by the Party making such waiver.

9.4 No Other Compensation . Each Party hereby agrees and acknowledges that the terms of this Agreement fully define all consideration, compensation and benefits, monetary or otherwise to be paid, granted or delivered to or by Seller or its Affiliates or to or by Buyer or its Affiliates in connection with the transactions contemplated by this Agreement.

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9.5 No Third Party Beneficiaries . This Agreement is for the sole benefit of the Parties and their permitted assigns and nothing herein, express or implied shall give or be construed to give to any Person, other than the Parties and such permitted assigns, any legal or equitable rights hereunder.

9.6 Counterparts . This Agreement may be executed in one or more counterparts, each of which when executed will be deemed to be an original, but all of which taken together will constitute one and the same agreement. In the event that any signature is delivered by facsimile transmission, or by e-mail delivery of a file in Adobe Portable Document Format or other format based on common standards, such signature will create a valid and binding obligation of the Party executing (or on whose behalf such signature is executed) with the same force and effect as if such signature page were an original thereof.

9.7 Severability . Any term or provision of this Agreement that is invalid or unenforceable in any situation in any jurisdiction will not affect the validity or enforceability of the remaining terms and provisions hereof or the validity or enforceability of the offending term or provision in any other situation or in any other jurisdiction. If the final judgment of a court of competent jurisdiction or other Governmental Authority declares that any term or provision of this Agreement is invalid or unenforceable, the Parties agree that the court or other Governmental Authority making such determination will have the power to limit the term or provision, to delete specific words or phrases, or to replace any invalid or unenforceable term or provision with a term or provision that is valid and enforceable and that comes closest to expressing the intention of the invalid or unenforceable term or provision, and this Agreement will be enforceable as so modified. In the event such court or other Governmental Authority does not exercise the power granted to it in the prior sentence, the Parties will use commercially reasonable efforts to replace such invalid or unenforceable term or provision with a valid and enforceable term or provision that will achieve, to the extent possible, the economic, business and other purposes of such invalid or unenforceable term.

9.8 Applicable Law . This Agreement shall be governed by, and construed in accordance with, the laws of the State of Delaware (including the applicable statute of limitations thereunder), regardless of the laws that might otherwise govern under applicable principles of conflicts of laws thereof.

9.9 Binding Effect; Benefit . This Agreement shall inure to the benefit of and be binding upon the Parties hereto, and their successors and permitted assigns. Nothing in this Agreement, express or implied, is intended to confer on any Person other than the Parties hereto, and their respective successors and permitted assigns any rights, remedies, obligations or liabilities under or by reason of this Agreement.

9.10 Specific Performance . The Parties hereto agree that irreparable damage would occur in the event any provision of this Agreement was not performed in accordance with the terms hereof and that the Parties will be entitled to seek specific performance of the terms hereof, in addition to any other remedy at law or equity without the necessity of demonstrating the inadequacy of monetary damages.

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9.11 Dispute Resolution . The Parties agree that any dispute (other than as set forth in Section 2.3(c) ) arising under this Agreement shall be resolved by the Alternative Dispute Resolution (“ ADR ”) provisions set forth in Schedule 9.11 .

9.12 Legal Representation . Buyer agrees that, as to all communications between all counsel for Seller, the Company, MDI and each of their Affiliates (including without limitation, Reed Smith LLP), and Seller and/or any of its respective Affiliates (including, prior to the Closing, the Company) that relate in any way to this Agreement or any agreement or matter contemplated hereby (collectively, the “ Privileged Communications ”), the attorney-client privilege and the expectation of client confidence with respect to the Privileged Communications belongs to Seller and may be controlled by Seller and will not pass to or be claimed by Buyer, MDI or the Company (after the Closing) or any of their respective Affiliates. The Privileged Communications are the property of Seller, and from and after the Closing none of MDI, the Company, its Affiliates or any Person purporting to act on behalf of or through MDI, the Company or its Affiliates will seek to obtain such communications, whether by seeking a waiver of the attorney-client privilege or through other means. Buyer, MDI, and the Company (after the Closing), and each of their respective Affiliates, successors or assigns further agree that no such Party may use or rely on any of the Privileged Communications in any action against or involving Seller or any of its Affiliates after the Closing. The Privileged Communications may be used by Seller and/or any of its Affiliates in connection with any dispute that relates to this Agreement or any agreement or matter contemplated hereby. Notwithstanding the foregoing, in the event that a dispute arises between Buyer, the Company or any of their respective Affiliates, on the one hand and a third party (other than a Party to this Agreement or any of their respective Affiliates), on the other hand, after the Closing, MDI, the Company and its Affiliates may assert the attorney-client privilege to prevent disclosure of confidential communications by counsel to such third party, provided that none of MDI, the Company or its Affiliates may waive such privilege without the prior written consent of Seller.

9.13 Assignability . Neither this Agreement nor any of the rights or obligations hereunder will be assigned by any Party, in whole or in part (whether by operation of law or otherwise), without the prior written consent of the other Party, and any attempt to make any such assignment without such consent will be null and void, except that each party may assign, in its sole discretion, any or all of its rights, interests and obligations under this Agreement to one or more of its Affiliates without the consent of the other party, provided that the assigning party remains fully liable for all of its obligations hereunder notwithstanding any such assignment and causes any such entity to observe and perform in all respects its obligations hereunder.

9.14 WAIVER OF JURY TRIAL . EACH PARTY HERETO HEREBY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN ANY LEGAL PROCEEDING DIRECTLY OR INDIRECTLY ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY (WHETHER BASED ON CONTRACT, TORT OR ANY OTHER THEORY). EACH PARTY HERETO (A) CERTIFIES THAT NO REPRESENTATIVE, AGENT OR ATTORNEY OF ANY OTHER PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT, IN THE EVENT OF LITIGATION, SEEK TO ENFORCE THE FOREGOING WAIVER AND (B) ACKNOWLEDGES THAT IT AND THE OTHER PARTIES HERETO HAVE BEEN INDUCED TO ENTER INTO THIS AGREEMENT BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION.

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9.15 Disclosure Schedules . The Disclosure Schedules have been arranged into separate Schedules corresponding to the Sections and Subsections of this Agreement setting forth certain exceptions to the representations and warranties contained in Article III and certain other information called for by this Agreement. Any such disclosure shall be deemed to be a disclosure against each of the other sections and subsections of Article III to the extent the applicability of such disclosure to such other sections and subsections is readily apparent on the face of such disclosure. No reference to or disclosure of any item or other matter in the Disclosure Schedules will be construed as an admission or indication that such item or other matter is material (nor will it establish a standard of materiality for any purpose whatsoever). The information set forth in the Disclosure Schedules is disclosed solely for the purposes of this Agreement, and no information set forth therein will be deemed to be an admission by any Party to any third party of any matter whatsoever, including of any violation of Law or breach of any Contract.

[Signatures begin on the next page.]

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IN WITNESS WHEREOF, each Party has caused this Stock Purchase Agreement to be duly executed on its behalf by its duly authorized officer as of the date first written above.

	SELLER:


	PRELUDE CORPORATION



	By:	/s/ Olav Bergheim
	Name:	Olav Bergheim
	Title:	CEO


	BUYER


	ROSETTA GENOMICS INC.



	By:	/s/ Kenneth A. Berlin
	Name:	Kenneth A. Berlin
	Title:	President


	BUYER PARENT


	ROSETTA GENOMICS LTD.



	By:	/s/ Kenneth A. Berlin
	Name:	Kenneth A. Berlin
	Title:	President and CEO

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List of Exhibits

Exhibit A Definitions

- 22 -

EXHIBIT A

DEFINITIONS

“ ADR ” has the meaning set forth in Section 9.11 .

“ Affiliate ” means, with respect to any Person, any other Person that directly or indirectly through one or more intermediaries, controls or is controlled by or is under common control with the Person specified. The term “control” (including the terms “controlling,” “controlled by” and “under common control with”) means possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a Person, whether through the ownership of voting securities, by contract or otherwise.

“ Agreement ” has the meaning set forth in the Preamble.

“ Business Day ” means any day other than a Saturday, Sunday or a statutory or civic holiday in the State of Illinois.

“ Buyer ” has the meaning set forth in the Preamble.

“ Closing ” means the closing of the transactions contemplated by this Agreement.

“ Closing Date ” has the meaning set forth in Section 2.4 .

“ Code ” means the United States Internal Revenue Code of 1986, as amended.

“ Common Stock ” has the meaning set forth in Section 3.3 .

“ Company ” has the meaning set forth in the Recitals.

“ Contracts ” means all legally binding contracts, agreements, leases, subleases, licenses, supply contracts, notes and other instruments, commitments, obligations, arrangements or understandings.

“ Disclosure Schedules ” has the meaning set forth in Article III .

“ Effect ” has the meaning set forth in the definition of Material Adverse Effect.

“ Encumbrances ” means any claim, mortgage, pledge, security interest, attachment, encumbrance, lien, charge, lease or restriction on transfer (such as a right of first refusal but excluding restrictions arising under securities Laws), option, conditional sale agreement, right of first refusal, first offer, termination, participation or purchase, and any other restriction or charge of any kind (including any restriction on voting, transfer, receipt of income and any agreement to grant any of the foregoing), in each case other than any license of Intellectual Property.

“ Governmental Authority ” means any international, supranational, national, provincial, federal, or state government, any court, tribunal or judicial body, any federal or state administrative or regulatory agency or commission, and any instrumentality of the foregoing.

Ex. A-1

“ Indebtedness ” of any Person means: either (i) any liability of any Person (A) for borrowed money (including the current portion thereof), (B) evidenced by a bond, note, debenture or similar instrument (including a purchase money obligation), (C) for the payment of money relating to leases that are required to be classified as a capital lease obligation in accordance with GAAP, (D) for all or any part of the deferred purchase price of property or services (other than trade payables), including any “earnout” or similar payments, or (E) under interest rate swap, hedging or similar agreements, (ii) any liability of others described in the preceding clause (i) that such Person has Guaranteed, that is recourse to such Person or any of its assets or that is otherwise its legal liability or that is secured in whole or in part by the assets of such Person.

“ Intellectual Property ” means (i) patents and patent applications, (ii) trademarks, service marks, trade names, trade dress and domain names, together with the goodwill associated exclusively therewith, (iii) copyrights, including copyrights in computer software, (iv) confidential and proprietary information, including trade secrets and know-how, and (v) registrations and applications for registration of the foregoing.

“ Law ” means the law of any jurisdiction, whether international, multilateral, multinational, national, federal, state, provincial, or local law, including a Order or act, statute, ordinance, regulation, rule, extension order or code promulgated by a Governmental Authority.

“ Material Adverse Effect ” means any event, occurrence, fact, condition or change (“ Effect ”) that, individually or together with all other Effects, is materially adverse to the business, results of operations, financial condition and assets of the Company, taken as a whole; provided, however, that “Material Adverse Effect” shall not include any Effect, directly or indirectly, arising out of or attributable to: (i) general economic or political conditions, (ii) conditions generally affecting the industries in which the Company operates, (iii) any changes in financial, banking or securities markets in general, including any disruption thereof and any decline in the price of any security or any market index or any change in prevailing interest rates, (iv) acts of war (whether or not declared), armed hostilities or terrorism, or the escalation or worsening thereof, (v) any action required or permitted by this Agreement or any action taken (or omitted to be taken) with the written consent of or at the written request of Buyer, (vi) any changes in applicable Laws or accounting rules (including GAAP) or the enforcement, implementation or interpretation thereof, (vii) the announcement, pendency or completion of the transactions contemplated by this Agreement, including losses or threatened losses of employees, customers, suppliers, distributors or others having relationships with the Company, (viii) any natural or man-made disaster or acts of God, or (ix) any failure by the Company to meet any internal or published projections, forecasts or revenue or earnings predictions (provided that the underlying causes of such failures (subject to the other provisions of this definition) shall not be excluded).

“ Order ” means any ruling, order, judgment, injunction or decree, issued, promulgated or entered by any Governmental Authority of competent jurisdiction.

“ Parties ” has the meaning set forth in the Preamble.

“ Permit ” means any license, franchise or permit issued by any Governmental Authority required by applicable Law in connection with the operation of the Company’s business.

“ Person ” means any natural person, corporation, general partnership, limited partnership, limited or unlimited liability company, proprietorship, joint venture, other business organization, trust, union, association or Governmental Authority.

Ex. A-2

“ Privileged Communications ” has the meaning set forth in Section 9.12 .

“ Proceeding ” means any criminal, judicial, administrative or arbitral action, proceeding or suit, whether civil, criminal, administrative or judicial commenced, brought, conducted or heard before any Governmental Authority.

“ Registered ” means issued by, registered with, renewed by or the subject of a pending application before any Governmental Authority or Internet domain name registrar.

“ Representative ” means, with respect to any Person, any officer, director, principal, attorney, agent, employee or other representative of such Person.

“ Seller ” has the meaning set forth in the Preamble.

“ Shares ” has the meaning set forth in the Recitals.

“ Subsidiary ” means with respect to any entity, that such entity shall be deemed to be a “Subsidiary” of another Person if such other Person directly or indirectly owns, beneficially or of record, (i) an amount of voting securities of other interests in such entity that is sufficient to enable such Person to elect at least a majority of the members of such entity’s board of directors or other governing body, or (ii) at least a majority of the outstanding equity interests of such entity.

“ Tax ” and “ Taxes ” means (a) any net income, corporate, capital gains, capital acquisitions, inheritance, gift, alternative minimum, add-on minimum, gross income, gross receipts, sales, use, ad valorem, transfer, franchise, profits, license, withholding, estimated, payroll, employment, excise, severance, stamp, occupation, property, environmental or windfall profit tax, custom duty or other tax, governmental fee or other like assessment or charge whatsoever, together with any interest or any penalty, addition to tax or additional amount, in each case imposed by any Governmental Authority (domestic or foreign) responsible for the imposition of any such tax or other amount, and (b) any liability for the payment of any amounts of the type described in clause (a) of this sentence as a result of being a member of an affiliated, consolidated, combined, unitary or aggregate group for any taxable period.

“ Tax Return ” means any return, statement, report or form (including information returns and reports) filed or required to be filed with respect to Taxes, including any schedules or other attachments thereto and any amendment thereof, and including TD F 90-22.1 or any successor form (relating to the reporting of foreign bank or financial accounts).

Ex. A-3

Exhibit 8.1

SUBSIDIARIES

Rosetta Genomics Inc., a Delaware corporation

Minuet Diagnostics, Inc., a Delaware Corporation

CynoGen, Inc., a Delaware Corporation

Exhibit 12.1

CERTIFICATIONS

I, Kenneth A. Berlin, certify that:

I have reviewed this Annual Report on Form 20-F of Rosetta Genomics Ltd.;

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;

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;

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:

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;

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;

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

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

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):

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

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: March 23, 2016	/s/ Kenneth A. Berlin
	Kenneth A. Berlin
	Chief Executive Officer and President
	(principal executive officer)

Exhibit 12.2

CERTIFICATIONS

I, Ron Kalfus, certify that:

I have reviewed this Annual Report on Form 20-F of Rosetta Genomics Ltd.;

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: March 23, 2016	/s/ Ron Kalfus
	Ron Kalfus
	Chief Financial Officer
	(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, 2015 (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: March 23, 2016	/s/ Kenneth A. Berlin
	Kenneth A. Berlin
	Chief Executive Officer and President
	(principal executive officer)

Dated: March 23, 2016	/s/ Ron Kalfus
	Ron Kalfus
	Chief Financial Officer
	(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. 333-163063, 333-171203, 333-172655, 333-177670, 333-185338 and 333-207697) and Form S-8 (Nos. 333-141525, 333-147805, 333-165722 and 333-191072) pertaining to the Rosetta Genomics Ltd. Global Share Incentive Plan (2006), as amended, of our report dated March 23, 2016, with respect to the consolidated financial statements of Rosetta Genomics Ltd., included in this Annual Report on Form 20-F for the year ended December 31, 2015.

Tel-Aviv, Israel	/s/ Kost Forer Gabbay & Kasierer
March 23, 2016	Kost Forer Gabbay & Kasierer
	A Member of Ernst & Young Global