SRL Company Contacts
Rosetta Genomics Company Contact:		Subhranshu Neogi
Ron Kamienchick		Director        –         Brand and Corporate Communications
(646)509-1893		M – 011 -  9910993925
investors@rosettagenomics.com		Email: subhranshu.neogi@religare.in
Investor Contacts:
Lippert/Heilshorn & Associates		Varun Soni
Kim Sutton Golodetz		Vice-President            –            Corporate Communications
(212) 838-3777		M – 011 - 9650148885
		Email: soni.varun@religare.in
kgolodetz@lhai.com
or
Bruce Voss		Sagarika Mamik Gupta
(310) 691-7100		Sr. Manager – Corporate Communications
bvoss@lhai.com		M – 011 - 9910021712
		Email: sagarika.mamikgupta@religare.in

EXHIBIT 99.2

News Release

AXA Diagnostics Named Exclusive Distributor for Rosetta’s microRNA-based Assays in Italy

·

AXA Diagnostics will distribute Rosetta Genomics’ three recently launched miRview™ tests in Italy

·

By leveraging unique biomarkers called microRNAs, Rosetta’s miRview™ tests can offer patients and physicians new insights on cancer

Rehovot, Israel; Philadelphia; Rome, Italy (September 8, 2009 ) – Rosetta Genomics, Ltd. (NASDQ: ROSG), a leading developer of microRNA-based molecular diagnostics, and AXA Diagnostics, a privately owned company that markets specialized diagnostic tests , announced today the signing of an exclusive distribution agreement in Italy for Rosetta Genomics’ three currently available diagnostic tests. Under the terms of the agreement, AXA will market Rosetta Genomics’ miRview™ tests in Italy. Samples will be sent from Italy to Rosetta Genomics’ CLIA-laboratory in Philadelphia for analysis. The terms of the deal were not disclosed.

“This latest distribution agreement with AXA Diagnostics marks Rosetta Genomics’ entry into Europe, and we are excited to have AXA as our first partner in this region,” noted Ronen Tamir, Chief Commercialization Officer at Rosetta Genomics. “We believe that there is significant need for our miRview™ tests in Italy, as well as worldwide, and that AXA is the right partner to bring these tests to cancer patients in Italy. As we have previously mentioned, we are continuously expanding our global distribution network, and believe that by the end of the year our tests will be available in other regions as well.”

Silvio Furino, President of AXA Diagnostics, said “We are excited about our new relationship with Rosetta Genomics. We expect that these novel molecular diagnostic tests will provide improved diagnoses for cancer patients in Italy and that physicians will now be able to provide personalized medicine and customized treatment. This new era of high-quality healthcare has the potential to make better medical outcomes possible.”

The following tests will be distributed by AXA Diagnostics:

·

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

·

miRview™ squamous – Using a single microRNA, miRview™ squamous differentiates squamous from non-squamous, non-small cell lung cancer (NSCLC) patients. When administered targeted therapy, whether currently available or under development, patients with squamous cell carcinoma of the lung have demonstrated varying response patterns ranging from a high incidence of severe or fatal internal bleeding in the lungs to overall poor response to treatment. Current methods for differentiating squamous from non-squamous non-small cell lung cancer are not standardized, are difficult to reproduce and have low accuracy. miRview squamous produces a single score that indicates whether a sample is squamous or non squamous NSCLC.

·

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

About microRNAs

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

About AXA Diagnostics

AXA Diagnostics is a private company located in Pomezia, Italy that markets specialized diagnostic tests. AXA Diagnostics sells over 300 diagnostic products on a direct basis in Italy and through a network of distributors in Europe. AXA Diagnostics has obtained certification for the management of its quality system according to the requirements of UNI EN ISO 13485:2004. More information on AXA Diagnostics is available at www.axadiagnostics.com

About Rosetta Genomics

Rosetta Genomics (Nasdaq: ROSG) is a leading developer of microRNA-based molecular diagnostics. Founded in 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 IP 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 first three microRNA-based tests, miRview™ squamous, miRview™ mets, and miRview™ meso, are commercially available through its Philadelphia-based CLIA-certified lab. Rosetta Genomics is the 2008 winner of Wall Street Journal’s Technology Innovation Awards in the medical/biotech category.

Forward-Looking Statement Disclaimer

Various statements in this release concerning Rosetta’s future expectations, plans and prospects, including without limitation, statements relating to the role of microRNAs in human physiology and disease, the potential of microRNAs in the diagnosis and treatment of disease, and Rosetta’s expected expansion of its global distribution network constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including risks related to: Rosetta’s approach to discover microRNA technology and to work on the application of this technology in the development of novel diagnostics and therapeutic tools, which may never lead to commercially accepted products or services; Rosetta’s ability to obtain, maintain and protect its intellectual property; Rosetta’s ability to enforce its patents against infringers and to defend its patent portfolio against challenges from third parties; Rosetta’s need and ability to obtain additional funding to support its business activities; Rosetta’s dependence on third parties for development, manufacture, marketing, sales, and distribution of products; Rosetta’s ability to successfully develop its candidate tools, products and services; Rosetta’s ability to obtain regulatory clearances or approvals that may be required for its products and services; the ability to obtain coverage and adequate payment from health insurers for the products and services comprising Rosetta’s technology; competition from others using technology similar to Rosetta’s and others developing products for similar uses; Rosetta’s dependence on collaborators; and Rosetta’s short operating history; as well as those risks more fully discussed in the "Risk Factors" section of Rosetta’s Annual Report on Form 20-F for the year ended December 31, 2008 as filed with the Securities and Exchange Commission. In addition, any forward-looking statements represent Rosetta’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Rosetta does not assume any obligation to update any forward-looking statements unless required by law.

EXHIBIT 99.3

Rosetta Genomics Reports Second Quarter Financial Results, Provides

Business Update

Conference Call Begins at 4:30 p.m. Eastern Time Today

PHILADELPHIA and REHOVOT, Israel (September 8, 2009) – Rosetta Genomics, Ltd. (NASDAQ: ROSG), a leading developer of microRNA-based molecular diagnostics, today reported financial results for the three and six months ended June 30, 2009.  Highlights of the second quarter of 2009 and subsequent weeks include:

·

Entering into exclusive distribution agreements with Warnex Laboratories, Super Religare Laboratories and AXA Diagnostics for our first three cancer diagnostic tests, miRview™ mets, miRview™ squamous and miRview™ meso

·

Receiving clearance from the states of California, Maryland and Rhode Island for our CLIA-certified laboratory, bringing the total to 48 U.S. states

·

Continuing development of  our colon cancer screening test

·

Selling Parkway Clinical Laboratories for up to $2.5 million

·

Announcing plans for Amir Avniel to step down as chief executive officer of Rosetta Genomics once a successor is in place in order to lead Rosetta Green, the company’s early stage, cleantech division

Management Commentary

“Building on distribution agreements covering the U.S., Israel and Turkey, we continued to build commercial momentum by signing three additional agreements for our first microRNA tests, which diagnose cancer metastases and differentiate between two types of lung cancer,” said Amir Avniel, chief executive officer of Rosetta Genomics.  “Through an agreement with Warnex Medical Laboratories our products are now available in Canada; through an agreement with Super Religare Laboratories we added India and other countries; and through an agreement with AXA Diagnostics we added Italy, marking our entrée into Europe.  All of these agreements call for samples to be sent to Rosetta Laboratories for analysis.  Our goal is through distribution agreements to provide access to our products to 1.5 billion people around the globe by the end of this year.

“We are continuing the development of miRscreen™ colon, a minimally-invasive, serum-based test for colon cancer,” Mr. Avniel added.  “Since reporting in January initial results that showed that two microRNA biomarkers, obtained from a simple blood draw, differentiated colon cancer patients from healthy individuals with 91% sensitivity and 72% specificity in a study of 120 patients, we have continued our efforts to improve the technology.  Our goal is to be able to quantify cancer-related microRNA in body fluid samples in a more sensitive and reproducible manner.  We expect to spend the rest of this year and the first half of 2010 on additional discovery and validation, and that in the second and third quarters of 2010 we will work with a number of hospitals in the United States to screen approximately 1,000 samples in our lab in Philadelphia. If we are successful in developing and validating this test in this timeframe, we would expect to have the test ready for commercial sale around mid-2010.”

Rosetta Genomics is also announcing that Amir Avniel plans to step down as chief executive officer of the company as soon as a successor is in place, and will subsequently lead Rosetta Green, the company’s early-stage cleantech division that is utilizing its microRNA technology in energy and agriculture. Research conducted at Rosetta Green has been used to develop algae with increased oil content, and Rosetta scientists have also discovered a promising relationship between certain microRNAs and drought tolerance in corn.  Future plans call for this division to be developed into a commercial entity to be spun off or sold.

Financial Overview

Revenues from continuing operations, which derived from the company’s core technology, for the second quarter of 2009 were $14,000 as the company began processing samples for its three miRview molecular diagnostics tests at its CLIA-certified laboratory.  The company recorded no revenues in the second quarter of 2008. Revenue previously reported from Parkway Clinical Laboratories is now classified in discontinued operations.

Research and development expenses were $1.4 million for the second quarter of 2009, compared with $2.2 million for the second quarter of 2008.  R&D expenses decreased mainly due to expense reimbursement for projects in the current quarter and steps taken by the company to reduce costs.

Marketing and business development expenses were $1.4 million for the second quarter of 2009, compared with $434,000 for the second quarter of 2008.  The increase resulted primarily from expenses related to the transaction with Prometheus Laboratories.

General and administrative expenses were $749,000 in the second quarter of 2009, compared with $896,000 in the second quarter of 2008.

The operating loss for the second quarter of 2009 was $3.8 million, including $268,000 of non-cash stock based compensation expense.  This compares with an operating loss of $3.5 million, including $295,000 of non-cash stock based compensation expense, for the corresponding quarter of 2008.

The company’s net loss from continuing operations in the second quarter of 2009 was $3.8 million or $0.27 per ordinary share, compared with a net loss from continuing operations of $3.7 million or $0.31 per ordinary share in the same period of 2008.

In May 2009, the company sold Parkway Clinical Laboratories in a management buy-out for up to $2.5 million, which will be paid as a fixed percentage of revenues over six years.  Rosetta Genomics recorded a net loss from discontinued operation of $2.2 million related to this transaction in the second quarter of 2009, and future payments by Parkway’s current owners will be recorded as a discontinued operation.

On a non-GAAP basis, excluding stock-compensation expense, the net loss for the 2009 second quarter was $5.7 million, or $0.42 per ordinary share. This compares with the comparable figures for the 2008 second quarter of $3.1 million, or $0.26 per ordinary share.

On a GAAP basis, the net loss for the 2009 second quarter was $6.0 million, or $0.44 per ordinary share.  This compares with the GAAP net loss for the 2008 second quarter of $3.7 million or $0.31 per ordinary share.

For the six months ended June 30, 2009 the company reported revenues from continuing operations, of $31,000, compared with no revenues, in the prior year’s period. The company’s net loss from continuing operations in the first half of 2009 was $7.2 million or $0.55 per ordinary share, compared with a net loss from continuing operations of $7.6 million, or $0.63 per ordinary share in the same period of 2008.

As of June 30, 2009, the company had $16.7 million in cash, cash equivalents, short and long term bank deposits and marketable securities.  Cash includes the $8 million received from Prometheus Laboratories, upon the purchase of 2 million of our ordinary shares at a purchase price of $4 per ordinary share.

Details reconciling non-GAAP amounts with GAAP amounts including specified items are provided in the table attached.

2009 Financial Guidance

The company affirms its previous guidance and continues to expect its cash burn from operations for 2009 to be approximately $10 million, exclusive of the potential beneficial impact from any new distribution partnerships.

Conference Call Information

Rosetta Genomics will host a conference call beginning at 4:30 pm. Eastern time today to discuss second quarter results and recent corporate developments.  To access the live conference call, U.S. and Canadian participants may dial (866) 239-5859; international participants may dial (702) 495-1913. To access the 24-hour audio replay, U.S. and Canadian participants may dial (800) 642-1687; international participants may dial (706) 645-9291. The access code for the replay is 26563562. The replay will be available through September 10, 2009.

A live audio webcast of the call will also be available on the "Investors" section of the company's website www.rosettagenomics.com .  An archived webcast will be available on the company's website approximately two hours after the event, and will be archived for 30 days thereafter.

About microRNAs

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

About Rosetta Genomics

Rosetta Genomics (NASDAQ: ROSG) is a leading developer of microRNA-based molecular diagnostics. Founded in 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 IP 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 first three microRNA-based tests, miRview™ squamous, miRview™ mets, and miRview™ meso, are commercially available through its Philadelphia-based CLIA-certified lab. Rosetta Genomics is the 2008 winner of Wall Street Journal’s Technology Innovation Awards in the medical/biotech category.

Forward-Looking Statements

Various statements in this release concerning Rosetta’s future expectations, plans and prospects, including without limitation, statements relating to our ability to successfully develop and validate the miRscreen™ colon screening test in the timeframe we have provided, or at all; our expected expansion of distribution arrangements; our future plans for Rosetta Green; and our financial guidance for 2009, the development of early detection cancer screening products, including a non-invasive colon cancer screening test, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those risks more fully discussed under “Key Information - Risk Factors” in Rosetta’s Annual Report on Form 20-F for the year ended December 31, 2008 on file with the Securities and Exchange Commission. In addition, any forward-looking statements represent Rosetta’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Rosetta does not assume any obligation to update any forward-looking statements unless required by law.

Use of Non-GAAP Financial Measures

This press release contains certain non-GAAP financial measures.  A “non-GAAP financial measure” refers to a numerical measure of historical or future financial performance, financial position, or cash flows that excludes (or includes) amounts that are included in (or excluded from) the most directly comparable measure calculated and presented in accordance with GAAP in the financial statements.  In this release, Rosetta provides non-GAAP net loss and non-GAAP net loss per share data as additional information relating to its operating results.  The presentation of this additional information is not meant to be considered in isolation or as a substitute for net loss or net loss per share prepared in accordance with GAAP.

Pursuant to the requirements of Regulation G promulgated by the SEC, the company has provided a reconciliation of each non-GAAP financial measure used in this earnings release and related conference call or webcast to the most directly comparable financial measure prepared in accordance with GAAP. This reconciliation is presented in a table below under the heading “Reconciliation of GAAP to Non-GAAP Consolidated Statement of Operation.” Investors are encouraged to review these reconciliations to ensure they have a thorough understanding of the reported non-GAAP financial measures and their most directly comparable GAAP financial measures.

Management uses these non-GAAP measures for internal reporting and forecasting purposes.  The company has provided these non-GAAP financial measures in addition to GAAP financial results because it believes that these non-GAAP financial measures provide useful information to certain investors and financial analysts for comparison across accounting periods not influenced by certain non-cash items that are not used by management when evaluating the company's historical and prospective financial performance.

[Tables to follow]

CONFIDENTIAL

 

AMENDED AND RESTATED

 

LICENSE AGREEMENT

 

by and between

 

Max-Planck-Innovation GmbH

a German corporation having a principal place of business at

Marstallstraße 8, 80539 Muenchen, Germany

-hereinafter called "MI"-

 

and

 

Rosetta Genomics Ltd.

an Israeli corporation having a principal place of business at

10 Plaut Street, Science Park, Rehovot 76706, Israel

-hereinafter called "COMPANY"-

 

-MI and COMPANY hereinafter also individually called a "Party", or collectively called the "Parties"-.

 

PREAMBLE

 

At the Max-Planck-Institute for Biophysical Chemistry in Goettingen, an institute of the Max-Planck-Gesellschaft zur Foerderung der Wissenschaften e.V.. (hereinafter "MPG"), a German non-profit scientific research organisation, Dr. Thomas Tuschl and other scientists of MPG have discovered certain microRNA sequences (internal MI file No. MI 2916 ZJE). MPG has filed certain MPG Patent Rights (as later defined herein) relating thereto.

 

MI (formerly known as Garching Innovation GmbH or "GI") has already granted a co-exclusive license under the MPG Patent Rights to develop and commercialize products for Therapeutic Purposes (as later defined herein) to Alnylam Pharmaceuticals, Inc., and to Isis Pharmaceuticals, Inc. (hereinafter the "Therapeutic Licenses", or the "Therapeutic Licensees", as applicable). In addition, MI has already granted, and will grant in the future, non-exclusive licenses under the MPG Patent Rights to develop and commercialize products for Research Purposes (as later defined herein) to various companies.

 

COMPANY is focused on the development, manufacture and sale of products, and the performance and sale of services, for Diagnostic Purposes (as later defined herein). COMPANY desires to obtain one of four co-exclusive licenses under the MPG Patent Rights to develop and commercialize products and services for Diagnostic Purposes.

 

MPG has authorized MI, its technology transfer agency, to act as its sole agent for patenting and licensing the MPG Patent Rights, and to sign this Agreement in MI's own name.

 

CONFIDENTIAL

 

MI and COMPANY entered into a license agreement on June 30, 2006, and wish to amend and restate such license agreement in its entirety by means of this Amended and Restated License Agreement (the “Agreement”).

 

Now, therefore, COMPANY and MI agree as follows:

 

ARTICLE 1 - DEFINITIONS

 

1.1	“Affiliates"

shall mean any legal entity (including, without limitation, a corporation, partnership, or limited liability company) that controls, is controlled by, or is under common control with COMPANY. For the purpose of this definition, the term "control" or "controlled by" means (i) direct or indirect ownership of at least fifty percent (50%) of the voting securities of a legal entity, or (ii) a fifty percent (50%) or greater interest in the net assets or profits of a legal entity, or (iii) possession, directly or indirectly, of the power to elect or direct the management of a legal entity.

 

1.2	"Agreement"

shall mean the present agreement between MI and COMPANY, including all of its Annexes.

 

1.3	"Analyte Specific Reagents" (or "ASRs ")

shall mean antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens. ASR's that otherwise fall within this definition shall not fall within this definition when they are sold to (i) in vitro diagnostic manufacturers for the purpose of manufacturing in vitro diagnostic products, or (ii) organizations that use the reagents to make tests for purposes other than providing diagnostic information to patients and practitioners, e.g., forensic, academic, research, and other non-clinical laboratories.

 

1.4	"Confidential Information"

shall mean any information which is of a confidential and proprietary nature, including without limitation information in relation to the business of a Party to which this Agreement relates, and information in relation to patents, patent applications or other intellectual property rights Controlled by a Party.

Confidential Information will not include any information that the receiving Party can prove by written records (i) was known by the receiving Party prior to the receipt of Confidential Information from the disclosing Party, (ii) was disclosed to the receiving Party by a Third Party having the right to do so, (iii) was, or subsequently became, part of the public domain through no fault of the receiving Party, or (iv) was subsequently and independently developed by personnel of the receiving Party without having had access to or making use of the disclosing Party's Confidential Information.

 

 

 

1.5	"Control" or "Controlled"

shall mean, with respect to any patents, patent applications, or other intellectual property rights, possession of the right (whether by ownership, license or otherwise), to assign, or grant a license to, such patents, patent applications, or other intellectual property rights without violating the terms of any agreement with any Third Party, or any applicable law or governmental regulation.

 

1.6	"Diagnostic Purposes"

shall mean use

a)

where the medical management of a human is involved, for (aa) the measurement, observation or determination of (i) the presence of a human disease, (ii) the stage, progression or severity of a human disease, (iii) the risk of contracting a disease, or (iv) the effect of a particular treatment on a human disease; and/or (bb) the selection of patients for a particular treatment with respect to a human disease; and/or

b)	in clinical laboratory for tracking, testing or quality controlling of human body fluids or tissue samples, and/or

c)	designated and regulated by the FDA as a diagnostic test or ASR, to the extent used according to (a) and/or (b) above.

 

1.7	"Effective Date"

shall mean June 30, 2006.

 

1.8

"FDA"

shall mean (i) the United States Food and Drug Administration or any successor agency thereto, and (ii) any non-United States agency or commission performing comparable functions (e.g. the European Medicines Agency EMEA) or any successor agency thereto.

 

1.9

"Field"

shall mean sale and use of Licensed Products, or performance and sale of Licensed Services, for

a)	COMPANY'S internal and collaborative research and development purposes, and

b)	Diagnostic Purposes,

specifically excluding any sale and use of Licensed Products, or performance and sale of Licensed Services, for Research Purposes or for Therapeutic Purposes.

1.10	"Licensed Products"

shall mean any product (i) that, or the development, manufacture, use or sale of which, absent the license granted hereunder, would infringe one or more Pending Claims or Valid Claims of the MPG Patent Rights, or (ii) which is developed or manufactured by using a Licensed Process or that, when used, practices a Licensed Process.

For the purpose of this Agreement, diagnostic kits shall be considered as Licensed Products, and Net Sales of diagnostic kits shall be considered as Net Sales of Licensed Products, if and to the extent such diagnostic kits contain Licensed Products as a   diagnostically active product component, together with other diagnostically non-active product components (including without limitation buffers, purification components, or hardware such as tubes, plates, glassware).

 

 

 

1.11	"Licensed Process"

shall mean any process (i) that, absent the license granted hereunder, would infringe one or more Pending Claims or Valid Claims of the MPG Patent Rights, or (ii) which uses a Licensed Product.

 

1.12	"Licensed Service"

shall mean any service (i) that, or the performance or sale of which, absent the license granted hereunder, would infringe one or more Pending Claims or Valid Claims of the MPG Patent Rights, or (ii) which, when performed, uses a Licensed Process or a Licensed Product.

 

1.13	"MPG Patent Rights"

shall mean:

a)	the patent applications filed by MPG listed in Annex 1, and the resulting patents,

b)

any subsequent patent applications in any jurisdiction claiming the same priority date and directed to the same subject matter as the patent application listed in Annex 1, and any divisionals, continuations, continuation-in-part applications, and continued prosecution applications (and their relevant international equivalents) of the patent applications listed in Annex 1, and the resulting patents, and

c)	any patents resulting from reissues, reexaminations (and their relevant international equivalents) of the patents described in (a) and (b) above.

 

1.14	"Net Sales"

 

a)

shall mean the gross amount invoiced by each of COMPANY, Affiliates, and Sales Partners to independent Third Parties for the sale, use, lease, transfer or other disposition of Licensed Products (including the amounts invoiced for diagnostic kits) and Licensed Services in a first commercial sale at arm's length transaction, less the following: (i) to the extent separately stated on the document of sale, any taxes or duties imposed on the sale or import of Licensed Products and Licensed Services which are actually paid, (ii) to the extent separately stated on the document of sale, any outbound transportation costs and costs of insurance in transit, (iii) customary trade, cash or quantity discounts or rebates, to the extent actually allowed and taken, (iv) amounts repaid or credited by reason of rejection or return.

 

b)

COMPANY, Affiliates, and Sales Partners will be treated as having sold Licensed Products and Licensed Services for an amount equal to the fair market value of such Licensed Products if (i) Licensed Products and Licensed Services are internally used by each of COMPANY, Affiliates, or Sales Partners (excluding Licensed Products used by COMPANY for COMPANY'S internal and collaborative research and development purposes) without charge or provision of invoice, or (ii) Licensed Products and Licensed Services are provided to a Third Party by each of COMPANY, Affiliates or Sales Partners without charge or provision of invoice and used by such Third Party, except in the case of reasonable amounts of Licensed Products and Licensed Services used as promotional free samples, free goods, or other marketing programs to induce sales.

 

 

 

c)

If COMPANY, Affiliates or Sales Partners sell a Licensed Product to a Third Party in a first commercial sale at arm's length transaction for further resale, and if the relation between COMPANY and such Third Party is a pure seller-buyer relationship (i.e. if the agreement between COMPANY, Affiliates or Sales Partners and such Third Party does not provide for any obligation to share costs or revenues, or a reporting obligation, or responsibility for sales and/or marketing efforts in a country), then the gross amount to be included in the calculation of Net Sales shall be the amount invoiced by COMPANY, Affiliates, or Sales Partners to such Third Party, not the amount invoiced by such Third Party upon resale.

 

d)

No deductions shall be made for commissions paid to individuals or entities, or for cost of collections. Net Sales shall occur on the date of invoice for a Licensed Product or a Licensed Service.

 

e)

Sales of Licensed Products between COMPANY and its Affiliates or Sales Partners, or among such Affiliates and Sales Partners, for a subsequent resale of such Licensed Product to a Third Party, shall not be included in the calculation of Net Sales, but in such cases the Net Sales shall be calculated on the amount invoiced by such Affiliates or Sales Partners to a Third Party upon resale.

 

1.15	"Pending Claim"

shall mean any claim in a pending patent application in the country in question within the MPG Patent Rights that (i) has not been pending for more than 8 years after the Effective Date (provided, however, that if the Parties agree on a joint patent strategy which sets forth that certain patent applications (e.g. divisionals, continuations-in-part) within the MPG Patent Rights will be prosecuted with a certain delay, such 8-years-period will be prolonged accordingly), and (ii) has not been abandoned by MPG, or finally rejected by a competent administrative agency or court of competent jurisdiction from which no appeal can be or is taken.

 

1.16	“ Platform Technologies ”

shall mean any technology for qualitative and/or quantitative detection or quantification of nucleic acids and genotyping used in the performance of a Licensed Service or offered as part of a Licensed Product, including, without limitation, RNA extraction and/or PCR technologies, including, without limitation, realtime based, microarray technologies, or any current or future technology providing substantially similar results by any means.

 

1.17	"Research Purposes"

shall mean use as a research reagent for basic or applied research purposes only, specifically excluding (i) any use for Diagnostic Purposes or Therapeutic Purposes, whether said uses are in vivo or in vitro, and (ii) any use in humans for whatever purpose. Specifically excluded from Research Purposes are ASR products, to the extent the ASR products are used for Diagnostic Purposes.

 

 

 

1.18	"Sales Partners"

shall mean any person or legal entity that is authorized by COMPANY or its Affiliates by any kind of agreement to market, promote, distribute or sell, or otherwise dispose of, Licensed Products and/or Licensed Services to a Third Party and that is contractually required to (at least) share the revenues from sales with COMPANY or its Affiliates. Sales Partner shall not include distributors who purchase Licensed Products from COMPANY or its Affiliates in a first commercial sale at arm's length transaction for further resale, and who have no obligation to (at least) share revenues with COMPANY or its Affiliates.

 

1.19	"Sublicense Consideration"

shall mean any consideration, whether in cash (including, without limitation, initial or upfront payments, technology access fees, annual fixed payments, and running royalties on net sales of products sold by the Sublicensee or its sublicensees) or in kind (including, without limitation, devices, services, licenses or any other use rights, shares, options, warrants or any other kind of securities), received by COMPANY from Sublicensees as consideration for or otherwise in connection with the sublicense granted. Sublicense Consideration specifically excludes (i) payments made by the Sublicensee to COMPANY as consideration for COMPANY's equity (shares, options, warrants or any other kind of securities) at fair market value, (ii) equity (shares, options, warrants or any other kind of securities) of the Sublicensee purchased by COMPANY at fair market value, (iii) equity investments made by, or loans granted by, Sublicensee to COMPANY in the course of the further financing of COMPANY, (iv) payments made by the Sublicensee to COMPANY specifically committed and allocated to reimburse COMPANY for its actually spent prosecution and maintenance costs of the MPG Patent Rights ,   and (v) payments made by the Sublicensee to COMPANY specifically committed and allocated to reimburse COMPANY for its actually spent costs of actually performed research and development activities under a research agreement with the Sublicensee specifically and directly in connection with the sublicense granted.

 

1.20	"Sublicensee"

shall mean any Third Party that is granted a sublicense to the MPG Patent Rights in accordance with Section 2.2.

 

1.21

"Term"

shall have the meaning set forth in Section 9.1 of this Agreement.

 

1.22	"Therapeutic Purposes"

shall mean all prophylactic and therapeutic uses in human diseases, in particular to treat and/or prevent the cause and/or symptoms of human diseases.

 

1.23	"Third Party"

shall mean any person or entity other than MI and COMPANY and their respective Affiliates.

 

 

1.24	"Valid Claim"

shall mean any claim in an issued patent in the country in question within the MPG Patent Rights that (i) has not lapsed, or (ii) has not been held invalid by a final judgment of a competent administrative agency or a court of competent jurisdiction from which no appeal can be or is taken, or (iii) has not been abandoned by MPG.

 

ARTICLE 2 - GRANT OF RIGHTS

 

2.1	License Grant

 

 

 

2.2	Sublicenses

 

 

i)  also includes a license to substantial intellectual property rights (e.g. pending or issued patents that are dominant or subordinate to the MPG Patent Rights) solely or co-owned by COMPANY in the field of "microRNAs"

 

ii)  is for specific products or indications, and would, absent the license granted under Subsection (i) above, neither legally nor factually allow the Sublicensee to manufacture, use and sell such products;

 

iii)  permits no more than one further tier of sublicensing (which further sublicense shall comply with this Section 2.2(a), mutatis mutandis , and shall contain financial terms that result in no less Sublicense Revenue being payable to MI than would be due if the initial Sublicensee sold the Licensed Products or Licensed Services directly).

 

iv)  contains provisions substantially equivalent (mutatis mutandis) to Sections 2.3, 2.4, 3.2, 3.3, 4.4, 5.10, 9.5, and 10.4 and Articles 7 and 8;

 

v)  complies with Sections 4.2, 4.3, 4.5, 4.6, 5.5; and

 

 

vi)   is otherwise consistent with this Agreement.

 

Any such sublicense that complies with this Section 2.2(a) shall be deemed to have received the approval of MI.   Any intended sublicense that fails to comply with this Section 2.2(a) shall have no effect unless and until approved in writing by MI.

 

 

 

2.3	Retained Rights

 

MPG (including each and all of its Max-Planck-Institutes and other scientific research organisations affiliated with MPG) retains the right to practice under the MPG Patent Rights for non-commercial scientific research, teaching, education, non-commercial collaboration (including scientific collaborations with and/or sponsored by industry) and publication purposes.

 

2.4	No Additional Rights

 

Nothing in this Agreement shall be construed to confer any rights upon COMPANY, by implication, estoppel, or otherwise, as to any intellectual property rights, including without limitation patents and patent applications, trademarks, copyrights and know-how, of MPG other than the MPG Patent Rights.

 

2.5	Most Favored Licensee

 

If, before or after the Effective Date, MI grants an Other Diagnostic License under substantially more favorable economic terms as a whole than those in this Agreement, then MI will notify COMPANY of such Other Diagnostic License granted. The notice will include all material terms and conditions of such Other Diagnostic License, including degree of co-exclusivity, duration, field, territory, audit rights, right to sublicense, right to administer, prosecute and enforce patents, and all license fees (e.g. initial payment, maintenance fees, royalty rates, sublicense fees). Whether the economic terms of the Other Diagnostic License are substantially more favorable or not shall be mutually determined by COMPANY and MI. In the event that COMPANY elects to take all fees and royalty rates, and all material terms and conditions of such Other Diagnostic License, all fees and royalty rates, and all material terms and conditions of such Other Diagnostic License shall apply as a whole to COMPANY upon the date COMPANY provides MI with its written notice of such election.

 

 

 

COMPANY acknowledges and agrees that MI may provide a copy of this Agreement to any Other Diagnostic Licensee upon request of such Other Diagnostic Licensee.

 

This Section 2.5 shall not apply to (i) the settlement of a lawsuit or other dispute between MI and a Third Party (including Other Diagnostic Licensees) with respect to past infringements of the MPG Patent Rights, and (ii) any license granted by MI to any scientific or other non-profit research organisations.

 

ARTICLE 3 - REPRESENTATIONS AND WARRANTIES

 

3.1

MI and COMPANY each represent that, to the best of their knowledge as of the Effective Date, they have the legal right and authority to enter into this Agreement, and to perform all obligations hereunder. MI further represents that, to the best of its knowledge as of the Effective Date, the MPG Patent Rights listed in Annex 1 have been assigned to MPG by the inventors named therein, and MI is the exclusive licensor of the entire right, title and interest in and to the MPG Patent Rights, and MI has the full right to grant to COMPANY rights under the MPG Patent Rights as set forth in this Agreement.

 

3.2

COMPANY is informed of the MPG Patent Rights, and that it might need additional licenses from Third Parties to practice the rights granted herein. OTHER THAN AS EXPRESSLY PROVIDED HEREIN, MI AND MPG MAKE NO REPRESENTATIONS OR WARRANTIES OF ANY KIND CONCERNING THE MPG PATENT RIGHTS AND LICENSED PRODUCTS, EXPRESS OR IMPLIED, AND THE ABSENCE OF ANY LEGAL OR ACTUAL DEFECTS, WHETHER OR NOT DISCOVERABLE. Specifically, and not to limit the foregoing, MI and MPG make no warranty or representation (i) regarding the merchantability or fitness for a particular purpose of the MPG Patent Rights, (ii) regarding the patentability, validity or scope of the MPG Patent Rights, (iii) that the commercialization of the MPG Patent Rights, or any Licensed Product or Licensed Service, will not infringe any patents or other intellectual property rights of MPG or of a Third Party, and (iv) that the commercialization of the MPG Patent Rights, or any Licensed Product or Licensed Service, will not cause any damages of any kind to COMPANY or to a Third Party.

 

3.3

TO THE EXTENT LEGALLY PERMISSIBLE, IN NO EVENT SHALL MI, MPG, THEIR TRUSTEES, DIRECTORS, OFFICERS AND EMPLOYEES BE LIABLE FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND, INCLUDING ECONOMIC DAMAGES OR INJURY TO PROPERTY AND LOST PROFITS, REGARDLESS OF WHETHER MI OR MPG SHALL BE ADVISED, SHALL HAVE OTHER REASON TO KNOW, OR IN FACT SHALL KNOW OF THE POSSIBILITY OF THE FOREGOING.

 

ARTICLE 4 - COMPANY DILIGENCE OBLIGATIONS AND REPORTS

 

4.1	Development and Commercialization Responsibilities and Due Diligence

 

a)

COMPANY shall have full responsibility to use commercially reasonable efforts to develop and commercialize, solely or jointly with or through its Sublicensees, Licensed Products and Licensed Services in the Field.

 

 

b)

In particular, COMPANY shall use commercially reasonable efforts, and shall oblige its Sublicensees to use commercially reasonable efforts, to obtain all regulatory registrations or approvals necessary to manufacture, market and sell Licensed Products worldwide, and to manufacture, or have manufactured, Licensed Products, and to sell, or have sold, Licensed Products in the Field worldwide, following receipt, on a country-by-country basis, of all required regulatory registrations or approvals.

 

4.2	Development and Commercialization Reports

 

COMPANY shall furnish to MI, and shall oblige its Affiliates and Sublicensees to furnish to COMPANY for inclusion in its reports to MI, in writing semi-annually, within 30 (thirty) days after the end of each calendar half year, with a development and commercialization report, stating in reasonable detail the activities and the progress of its efforts (including the efforts of its Affiliates and Sublicensees) during the immediately preceding calendar half year to develop and commercialize Licensed Products and Licensed Services, on a product-by-product and country-by-country basis. The report shall also contain a discussion of intended development and commercialization efforts for the calendar half year in which the report is submitted. The first report shall be provided to MI for the second calendar half of 2006.

 

Any reports furnished to MI under this Section 4.2 shall constitute Confidential Information, and shall be treated by MI according to Article 8.

 

4.3	Compliance with Laws

 

COMPANY shall use best efforts to comply with, and shall use best efforts to oblige its Affiliates and Sublicensees to comply with, all local, state, federal, and international laws and regulations relating to the development, manufacture, use and sale of Licensed Products, and the performance and sale of Licensed Services.

 

4.4	Non-Use of Names

 

Neither COMPANY nor its Affiliates and Sublicensees may use the name of "Max Planck Institute", "Max Planck Society", "Max-Planck-Innovation" or any variation, adaptation, or abbreviation thereof, or of any of its trustees, officers, faculty, students, employees, or agents, or any trademark owned by any of the aforementioned, in any promotional material or other public announcement or disclosure without the prior written consent of MI or, in the case of an individual, the consent of that individual. Provided, however, that this section 4.4 shall not apply in the event that the use of the name of "Max Planck Institute", "Max Planck Society", or "Max-Planck-Innovation" is required by law or regulation (including without limitation by rules or regulations of any securities exchange), provided that prior to such disclosure, COMPANY promptly notifies MI of such requirement.

 

4.5	Liability for Affiliates and Sublicensees

 

If Affiliates or Sublicensees of COMPANY develop, manufacture, use and/or sell Licensed Products or Licensed Services, COMPANY warrants and is liable towards MI that its Affiliates and Sublicensees perform their rights and obligations in accordance with the terms and conditions of this Agreement, and COMPANY shall be responsible and liable for any acts and omissions, e.g. payments and reports, of its Affiliates and Sublicensees.

 

 

The grant of any such sublicense hereunder will not relieve COMPANY of its obligations under this Agreement. In the event that COMPANY becomes aware of a material default by any Sublicensee, COMPANY shall inform MI and take commercially reasonable efforts to cause the Sublicensee to cure the default; in the event of non-cure, COMPANY will terminate the agreement with its Sublicense.

 

4.6	Effect of Failure

 

In the event that COMPANY or any of its Affiliates and Sublicensees have failed to fulfill any of their obligations under this Article 4, then MI may treat such failure as a material breach of COMPANY in accordance with Section 9.6.

 

ARTICLE 5 - FINANCIAL PROVISIONS

 

5.1	Initial Payment

 

COMPANY shall pay to MI, within 30 days after the Effective Date, an initial payment of EUR [***] (Euro [***]).

 

5.2	Maintenance Fees

 

COMPANY shall pay to MI license maintenance fees as set forth in the table below. The respective maintenance fees are due on each January 1 st of the respective calendar year.

 

 

COMPANY's actual earned royalties payable to MI under Section 5.3 for a certain calendar year may be credited against the respective maintenance fee for the same calendar year.

 

5.3	Running Royalties

 

 

i)  [***]% ([***] percent) in the event of a sale by COMPANY (or its Affiliates or Sales Partners) to end users, and

 

ii)  [***]% ([***] percent) in the event of a sale by COMPANY (or its Affiliates or Sales Partners) to distributors (that are not Sales Partners)

 

 

5.4	Reduction of Running Royalties

 

 

If COMPANY is a party to one or more license agreements with one or more Third Parties, which license is employed in connection with the MPG Patent Rights for the manufacture, use and/or sale of a Licensed Products, or the performance and/or sale of a Licensed Services, and, in the aggregate, COMPANY owes running royalties of more than [***]% ([***] percent) of Net Sales to MI and such Third Parties, the running royalties set forth in Section 5.3 (a) will be reduced, on a country-by-country and product-by-product basis, from the date running royalties have to be actually paid to such Third Party, by MI’s share in the total royalties payable by COMPANY multiplied by the difference between the total royalties due to all Third Parties and MI and [***]% ([***] percent); provided, however, that the running royalties due to MI will not be reduced to less than [***]% of the royalty rate set forth in Section 5.3(a), and provided further that the initial royalty owed to all other Third Parties (excluding licensors of Platform Technologies) will also be reduced pursuant to the agreement between COMPANY and such Third Parties.

 

For the purpose of illustration, if COMPANY owed aggregate royalties of [***]%, then the royalties owed to MI under Section 5.3(a) would be reduced by [***], for a reduced royalty due under Section 5.3(a) of [***]%).

 

For the avoidance of doubt, in no event shall the royalty rate due to MI according to Section 5.3 (a) be reduced by the application of this Section 5.4 (a) to less than [***]% ([***] percent) in the event Section 5.3 (a) (i) applies, or [***]% ([***] percent) in the event Section 5.3 (a) (ii) applies.

 

5.5	Sublicense Revenues

 

 

In the event that COMPANY grants a sublicense to a Third Party pursuant to Section 2.2, COMPANY shall, within thirty (30) days after its respective receipt by COMPANY, pay to MI (i) with respect to royalty components of Sublicense Consideration, the greater of [***]% ([***] percent) of such royalty components of Sublicense Consideration received by COMPANY, or [***]% ([***] percent) of the Sublicensee’s net sales of Licensed Products and Licensed Services; MI agrees that for ease of administration, net sales by Sublicensees may be calculated using the deductions set forth in the applicable sublicense agreement instead of the deductions set forth in the definition of Net Sales used herein, so long as such deductions are commercially reasonable, and (ii) with respect to non-royalty components of Sublicense Consideration, [***]% ([***] percent) of such non-royalty components of Sublicense Consideration received by COMPANY; provided, however, that MI shall in any event receive a minimum participation in such non-royalty components of Sublicense Consideration of [***]% ([***] percent) as set forth in Subsection (c) below.

 

 

If COMPANY receives any non-cash Sublicense Consideration, COMPANY shall pay MI, at MI's election, either (i) a cash payment equal to the fair market value of the Sublicense Consideration, or (ii) the in-kind portion, if practicable, of the Sublicense Consideration.

 

If COMPANY is a party to one or more license agreements with one or more Third Parties, which license is employed in connection with the MPG Patent Rights for the manufacture, use and/or sale of a Licensed Products, or the performance and/or sale of a Licensed Service, and, in the aggregate, COMPANY owes more than [***]% ([***] percent) of the total Sublicense Consideration to MI and such Third Parties, the share of MI in the Sublicense Consideration set forth in Section 5.5(a) will be reduced, on a country-by-country and product-by-product basis, from the date any such share of Sublicense Consideration must be actually paid to such Third Parties, by MI’s share in the total Sublicense Consideration payable by COMPANY multiplied by the difference between the total percentage of Sublicense Consideration  due to all Third Parties and MI, and [***]% ([***] percent); provided, however, that in no event, MI shall receive (i) regarding royalty components of Sublicense Consideration, less than [***]% ([***] percent) of the Sublicensee’s net sales of Licensed Products and Licensed Services (as set forth in Section 5.5 (a) (i) above), and (ii) regarding non-royalty components of Sublicense Consideration, less than in total [***]% ([***] percent) of the non-royalty components of Sublicense Consideration.  For the purpose of illustration, if COMPANY owed [***]% in aggregate for the non-royalty components of the Sublicense Consideration to MI and to Third Parties, then the percentage owed to MI under Section 5.5(a) (ii) for such non-royalty components would be reduced by [***], for a reduced percentage due under Section 5.5(a) (ii) of [***] %.

 

5.6	Fair Market Value Determination

 

In the event that, according to this Agreement, a "fair market value" has to be determined, the Party obliged to suggest such fair market value shall provide the other Party in due time with a good faith determination of the fair market value, together with any information necessary or useful to support such determination. The other Party shall have the right to provide the suggesting Party in due time with a counter-determination of the fair market value, which shall include any information necessary or useful to support such counter-determination. If the Parties are unable to agree on a fair market value determination within 30 days after receipt of such counter-determination, Section 10.3 applies

 

 

5.7

Reports

 

Commencing with the first commercial sale of a Licensed Product or a Licensed Service, within 30 (thirty) days of the end of each calendar half year, COMPANY shall deliver a detailed report to MI for the immediately preceding calendar half year showing at least, on a product-by-product and country-by-country basis, (i) the kind and number of Licensed Products and Licensed Services sold by COMPANY, Affiliates, Sublicensees and Sales Partner, (ii) the gross price charged, (iii) the calculation of Net Sales, and (iv) the resulting running royalties or Sublicense Consideration due to MI according to those figures. If no running royalties or Sublicense Consideration are due to MI, the report shall so state.

 

5.8

Payments

 

 

Running royalties shall be payable for each calendar half year, and shall be due to MI within 30 (thirty) days of the end of each calendar half year.

 

 

All payments under this Agreement shall be made to "Max-Planck-Innovation GmbH" to the following account:

 

[***]

 

Each payment shall reference this Agreement and the obligation under this Agreement that the payment satisfies.

 

 

Unless otherwise expressly stated in this Agreement, all payments due under this Agreement shall be payable in Euro and, if legally required, shall be paid with the additional value added tax. Conversion of foreign currency to Euro shall be made at the official conversion rate existing in Germany (as reported in the Wall Street Journal on the last working day of the relevant calendar half year. Such payments shall be without deduction of exchange, collection, or other charges, except for deduction of withholding or similar taxes. The Parties shall use all reasonable and legal efforts to reduce tax withholding on payments made to MI hereunder. Notwithstanding such efforts, if COMPANY concludes that tax with holdings under the laws of any country are required with respect to payments to MI, COMPANY shall withhold the required amount and pay it to the appropriate governmental authority. In such a case, COMPANY will promptly provide MI with original receipts or other evidence reasonably desirable and sufficient to allow MI to document such tax withholdings adequately for purposes of claiming foreign tax credits and similar benefits.

 

 

Any payments that are not paid on or before the date such payments are due under this Agreement shall bear interest on arrears at [***]% ([***] percent) per year.

 

 

5.9	Bookkeeping and Auditing

 

COMPANY is obliged to keep, and shall oblige its Affiliates and Sublicensees and Sales Partners to keep, complete and accurate books on any reports and payments due to MI under this Agreement, which books shall contain sufficient information to permit MI to confirm the accuracy of any reports and payments made to MI. MI is authorized to check the books of COMPANY by an independent certified public accountant (the "CPA") appointed by MI, and, upon MI's request, COMPANY or the CPA appointed by MI for COMPANY and reasonably acceptable to the Affiliate, Sublicensee or Sales Partner, shall check the books of its Affiliates and Sublicensees and Sales Partners for MI, once a year. The charges for such a check shall be borne by MI. In the event that such check reveals an underpayment in excess of [***]% ([***] percent), COMPANY shall bear the full cost of such check, and shall remit any amounts due to MI within thirty days of receiving notice thereof from MI, together with interest calculated in the manner provided in Section 5.8 (d). Any information acquired by the CPA may only be used to confirm whether or not COMPANY (or its Affiliates, Sublicensees and Sales Partners) is in compliance with the obligations set forth in this Agreement.

 

The right of auditing by MI under this Section shall expire [***] ([***]) years after each report or payment has been made. Sublicenses granted by COMPANY shall provide that COMPANY shall have the right to check the books of its Sublicensees according to this Section 5.9. The same shall apply in respect of Sales Partners.

 

5.10

No Refund

 

All payments made by COMPANY (or, as the case may be, by Affiliates and Sublicensees and Sales Partners) under this Agreement are non-refundable and, except as set forth in Section 5.2, non-creditable against each other. This Section 5.10 shall apply, without limitation, in the event this Agreement is terminated prematurely in accordance with Article 9.

 

ARTICLE 6 - PATENT PROSECUTION AND INFRINGEMENT

 

6.1	Responsibility for MPG Patent Rights

 

 

 

 

 

 

6.2	Patent Costs

 

COMPANY shall pay [***]% ([***] percent) of all fees and costs, including attorneys fees, relating to the filing, prosecution, and maintenance of the MPG Patent Rights, which incur during the Term in accordance with Section 6.1.

 

MI will decide, in its sole discretion, if the fees and costs due pursuant to this Section 6.2 shall be paid directly by COMPANY to the creditor, or if COMPANY shall reimburse MI for all amounts due pursuant to this Section 6.2 within 30 (thirty) days after receiving MI's respective invoice.

 

6.3	Abandonment of MPG Patent Rights

 

In the event that COMPANY wishes not to file or wishes to abandon (e.g. by non-payment of fees) any of the MPG Patent Rights, COMPANY shall notify MI thereof in writing in due time, at least 3 months prior to any deadline. MI shall have the right, but not the obligation, to file or to continue payment for such MPG Patent Rights in its own discretion and at its own expense. In any event, such MPG Patent Rights shall no longer be covered by this Agreement after three months from the date COMPANY informs MI of its non-filing or its abandonment, and COMPANY shall be obliged to pay [***]% of all fees and costs that incur during such 3-months-period.

 

6.4	Infringement of MPG Patent Rights by Third Party and Third Party Objections

 

COMPANY shall promptly inform MI in writing if it becomes aware of any suspected or actual infringement of the MPG Patent Rights by any Third Party, and of any available evidence thereof. The same shall apply in the case of an opposition, revocation action or any other Third Party objection against the MPG Patent Rights.

 

MI shall have the right, but not the obligation, to prosecute (whether judicially or extra-judicially) in its own discretion and at its own expense, any and all infringements of the MPG Patent Rights, and to defend the MPG Patent Rights against any Third Party objection.

 

 

 

MI, COMPANY, and the Other Diagnostic Licensees shall cooperate in good faith, if necessary and appropriate, with each other, and shall use reasonable efforts to agree upon a joint strategy relating to the prosecution of any infringement of the MPG Patent Rights by any Third Party, and the defense of the MPG Patent Rights against any Third Party objection. MI shall use reasonable efforts to induce the Therapeutic Licensees to participate in such joint strategy.

 

ARTICLE 7 - INDEMNIFICATION AND INSURANCE

 

7.1	Indemnification

 

COMPANY shall indemnify, defend, and hold harmless MI, MPG and their trustees, officers, faculty, students, employees, and agents and their respective successors, heirs and assigns (collectively, the "Indemnitees"), against any and all claims, suits, actions (including without limitation actions in the form of tort, warranty, or strict liability and regardless of whether such action has any factual basis), demands, judgments, liabilities, losses, damages, costs, fees or expenses (collectively, the "Claims") incurred by or imposed upon any of the Indemnitees by a Third Party, to the extent resulting from or arising out of (i) any use of the MPG Patent Rights by COMPANY, its Affiliates, Sublicensees and Sales Partners, or (ii) any product, process, or service that is developed, made, used, sold, or performed by COMPANY, its Affiliates, Sublicensees or Sales Partners pursuant to any right or license granted under this Agreement, or (iii) any Third Party use of any products, processes or services sold by COMPANY, its Affiliates, Sublicensees or Sales Partners to such Third Party.

 

7.2	Procedures

 

The Indemnitees agree to provide COMPANY with written notice of any Claims for which indemnification is sought under this Agreement within 30 days after the Indemnitees have knowledge of such Claims.

 

COMPANY agrees, at its own expense, to provide attorneys reasonably acceptable to MI to defend the Indemnitees against any such Claims; provided, however, that any Indemnitee shall have the right to retain its own counsel, at its own expense, if representation of such Indemnitee by the counsel retained by COMPANY would be inappropriate because of actual or potential differences in the interests of such Indemnitee and any other party represented by such counsel.

 

The Indemnitees shall (i) permit COMPANY to assume full responsibility to investigate, prepare for and defend against any such Claims (including all decisions relative to litigation, appeal, and settlement), and (ii) assist COMPANY at the expense of COMPANY in the investigation, preparation and defense of any such Claims, and (iii) not compromise or settle such Claims without the prior consent of COMPANY.

 

COMPANY shall keep MI informed of the progress in the defense and disposition of such Claims, and COMPANY shall consult with MI with regard to any proposed settlement. COMPANY shall not compromise or settle such Claims without the prior written consent of MI.

 

 

7.3

Insurance

 

COMPANY shall obtain and carry in full force and effect commercial general liability insurance, including product liability and errors and omissions insurance, which shall protect COMPANY and the Indemnitees with respect to events covered by Section 7.1 above. The limit of insurance shall not be less than [***] USD ([***] US Dollar) per incident. COMPANY shall provide MI with certificates of insurance evidencing compliance with this Section 7.3.

 

ARTICLE 8 - CONFIDENTIALITY

 

8.1	Confidentiality Obligation

 

This Agreement and any Confidential Information disclosed to a Party under this Agreement by the other Party shall be treated confidential by the receiving Party during the Term and for 5 (five) years thereafter. The receiving Party shall not use the Confidential Information for any purposes other than those necessary to directly further the purpose of this Agreement.

 

8.2	Permitted Disclosures

 

A Party may disclose Confidential Information received from a disclosing Party under this Agreement:

 

 

 

 

Regarding the disclosure of this Agreement, (i) COMPANY may disclose a mutually agreed upon redacted copy of this Agreement on a confidential basis to prospective investors and collaborators, and (ii) MI may disclose a copy of this Agreement on a confidential basis to MPG and to the Other Co-Exclusive Licensees as set forth in Sec. 2.5.

 

ARTICLE 9 - TERM AND TERMINATION

 

9.1

Term

 

This Agreement shall come into effect on the Effective Date. It shall remain in effect until the expiration or abandonment of all issued patents and filed patent applications within the MPG Patent Rights, unless it is earlier terminated in accordance with the provisions of this Agreement.

 

 

 

9.2	Voluntary Termination by COMPANY

 

COMPANY shall have the right to terminate this Agreement, for any reason, (i) upon at least 3 (three) months prior written notice to MI, such notice to state the date at least 3 (three) months in the future upon which termination is to be effective, and (ii) upon payment of all amounts due to MI accrued until such termination effective date.

 

9.3	Cessation of Business

 

If COMPANY ceases to carry on its business related to this Agreement, COMPANY has to inform MI thereof immediately. COMPANY and MI shall each have the right to terminate this Agreement upon three months prior written notice to each other.

 

9.4	Change of Ownership

 

In the event that at least [***]% ([***] percent) of issued and outstanding securities of COMPANY are assigned or transferred to a Third Party, COMPANY shall provide MI, upon Gl's request, with written reports in reasonable detail on the actual and intended future activities of COMPANY to develop and commercialize Licensed Products. If COMPANY does not maintain a program to develop and commercialize Licensed Products that is substantially similar or greater in scope to the program of COMPANY prior to the change of ownership, then MI has the right to limit the scope and exclusivity of the license granted under this Agreement to such Licensed Products actually covered by the program of COMPANY. COMPANY shall inform MI promptly of the implementation of any such change of ownership.

 

9.5	Attack on MPG Patent Rights

 

MI shall have the right to terminate this Agreement upon 30 days prior written notice to COMPANY, if COMPANY attacks (e.g. by opposition, revocation or nullity actions), or have attacked or supports an attack through a Third Party, the validity of any of the MPG Patent Rights. For the avoidance of doubt, participation of COMPANY in an interference proceeding between the MPG Patent Rights and patents owned by COMPANY shall not be deemed as an attack of MPG Patent Rights under this Section 9.5; provided that such interference proceeding is initiated by the patent office, and not by, or induced or triggered by, COMPANY.

 

9.6	Termination for Default

 

In the event COMPANY fails to pay any amounts due and payable to MI hereunder, and fails to make such payments within 30 (thirty) days after receiving written notice of such failure, MI may terminate this Agreement immediately upon written notice to COMPANY. Notwithstanding the foregoing, in the event COMPANY commits a material breach of its obligations under this Agreement, and fails to cure that breach within 60 (sixty) days after receiving written notice thereof, MI may terminate this Agreement immediately upon written notice to COMPANY.

 

 

 

9.7	Effect of Termination

 

The following provisions shall survive the expiration or termination of this Agreement: Articles 1, 3, 5.7, 5.8, 5.9, 5.10, 7, 8, 10 and Section 9.7. In no event shall termination of this Agreement release COMPANY (including its Affiliates and Sublicensees) from the obligation to pay any amounts that became due on or before the effective date of termination.

 

In the event that any license granted by MI to COMPANY under this Agreement is terminated, any sublicense granted by COMPANY to a Sublicensee prior to termination of this Agreement shall remain in full force and effect, provided that (i) the Sublicensee is not then in breach of its sublicense agreement, and (ii) the Sublicensee agrees in writing, within thirty (30) days after the effective date of termination, to be bound to MI as licensor under the terms and conditions of the sublicense agreement, provided that MI shall have no other obligation than to leave the sublicense granted by COMPANY in place.

 

9.8	Insolvency

 

This Agreement shall terminate automatically upon (i) the filing or institution of bankruptcy, reorganization, liquidation, insolvency or receivership proceedings by or against COMPANY, or (ii) the assignment of all or a substantial portion of the assets of COMPANY for the benefit of creditors.

 

ARTICLE 10 - MISCELLANEOUS

 

10.1

Notice

 

Any notices required or permitted under this Agreement shall be in English and in writing, shall specifically refer to this Agreement, and shall be sent to the following addresses or facsimile numbers of the Parties:

 

If to MI:

Max-Planck-Innovation GmbH

Marstallstrasse 8

0-80539 Muenchen/Germany

Fax: +49/89/290919-99

If to COMPANY:

Rosetta Genomics Ltd.

10 Plaut Street Rehovot 76706,

Israel

Fax +97289484766

A Party may change its contact information immediately upon written notice to the other Party in the manner provided in this Section.

 

10.2	Governing Law

 

This Agreement and all disputes arising out of or related to this Agreement, or the performance, enforcement, breach or termination hereof, and any remedies relating thereto, shall be construed, governed, interpreted and applied in accordance with the laws of the Federal Republic of Germany, except that questions affecting the construction and effect of any patent shall be determined by the law of the country in which the patent shall have been granted.

 

 

 

10.3	Dispute Resolution

 

 

 

 

c)

In the event of a dispute relating to

 

i)  whether a Licensed Product would, absent the license granted hereunder, infringe the MPG Patent Rights, or

 

ii)  the determination of a MPG Patent Rights Value in the event of sublicenses for pooled technologies, or

 

iii)  the determination of a fair market value,

 

the disputing Party shall, in connection with its attempt according to Subsection (a) above to resolve such disputes, include or involve experienced Third Parties appointed by them (e.g. certified public accountants, patent attorneys, lawyers) in their good faith negotiations, and in rendering judgment, the arbitrators will be instructed by the Parties that they can only select from between the proposals for resolution of the relevant issue presented by each Party, and not any other proposal.

 

 

 

 

 

10.4	Assignment and Transfer

 

This Agreement is personal to COMPANY, and neither this Agreement nor any rights or obligations may be assigned or otherwise transferred by COMPANY to a Third Party without the prior written consent of MI. Notwithstanding the foregoing, COMPANY may assign this Agreement to a Third Party in connection with the merger, consolidation, or sale of all or substantially all of its assets or that portion of their business to which this Agreement relates; provided, however, that this Agreement shall immediately terminate if the proposed Third Party assignee fails to agree in writing to be bound by the terms and conditions of this Agreement on or before the effective date of assignment. After the effective date of assignment, the Third Party assignee shall provide MI, upon MI's request, with written reports in reasonable detail on the actual and intended future activities of the Third Party assignee to develop and commercialize Licensed Products. If the Third Party assignee does not maintain a program to develop and commercialize Licensed Products that is substantially similar or greater in scope to the program of COMPANY after the effective date of assignment, then MI has the right to limit the scope of the exclusive license granted under this Agreement to such Licensed Products actually covered by the program of the Third Party assignee.

 

10.5	Amendment and Waiver

 

This Agreement amends and restates the original license agreement dated June 30, 2006 by and between MI and COMPANY, which amendment and restatement shall be deemed to be effective as of the original Effective Date.  This Agreement may be amended, supplemented, or otherwise modified only by means of a written instrument signed by all Parties. Any waiver of any rights or failure to act in a specific instance shall relate only to such instance and shall not be construed as an agreement to waive any rights or fail to act in any other instance, whether or not similar.

 

10.6	Severability

 

Should one ore more of the provisions of this Agreement be held void, invalid or unenforceable under applicable law, the remaining provisions of this Agreement will not cease to be effective. The Parties shall negotiate in good faith to replace such void, invalid or unenforceable provision by a new provision which reflects, to the extent possible, the original intent of the Parties.

 

10.7

Headings

 

All headings are for convenience only and shall not affect the meaning of any provision of this Agreement.

 

10.8	Entire Agreement

 

This Agreement contains the entire understanding of the Parties with respect to the subject matter hereof, and any previous agreements and understandings, whether oral or written, made by the Parties on the same subject matter are expressly superseded by this Agreement.

 

 

 

 

10.9	Force Majeure

 

Neither Party will be deemed to be in default of this Agreement for failure or delay of the performance of its obligations or attempts to cure any breach of this Agreement, when such failure or delay is caused by or results from causes beyond the reasonable control of or not reasonably avoidable by the affected Party, including, without limitation, embargoes, acts of war, strikes, lockouts or other labour disturbances. The affected Party will notify the other Party of such force majeure circumstances as soon as reasonably practical and will make every reasonable effort to mitigate the effects of such force majeure circumstances. In case of such a force majeure event, the time for performance or cure will be extended for the period equal to the duration of such force majeure event. Should the duration of the force majeure event exceed more than three (3) months, each party shall be entitled to terminate this Agreement upon three (3) months prior written notice.

 

10.10

Relationship of the Parties

 

It is expressly agreed that MI and COMPANY will be independent contractors and that the relationship among the Parties will not constitute a partnership, joint venture or agency.

 

10.11

Press release

 

Each Party may make public announcements with respect to the execution, nature and general subject matter of this Agreement. The Party which intends to make such public announcement shall provide to the other Party a copy thereof as soon as reasonably practicable under the circumstances, but not less than one week, prior to its scheduled release, requesting the approval of the other Party, which shall not be unreasonably withheld.

 

In witness whereof, the Parties have caused this Agreement to be executed by their duly authorized representatives.

 

 

 

Annex 1

 

MPG Patent Rights

 

Patent applications filed by MPG entitled "Small expressed RNA molecules (MicroRNA molecules )":