UNITED STATES SECURITIES AND EXCHANGE
COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 21, 2011
 
Denali Concrete Management, Inc.
(Exact name of registrant as specified in its charter)
 
Nevada
 
000-52545
 
88-0445167
(State or other jurisdiction of
incorporation)
 
(Commission File Number)
 
(I.R.S. Employer
Identification No.)
 
123 West Nye Lane, Suite 129, Carson City,
NV
 
89706
(Address of principal executive offices)
 
(Zip Code)
 
Registrant’s telephone number, including area code:   +(972) 36133372
 
Former name or former address, if changed since last report

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 
 

 

Explanatory Note

This Current Report on Form 8-K is being filed in connection with a series of transactions consummated by the Registrant, and certain related events and actions taken by the Registrant.  This Current Report on Form 8-K includes the following items on Form 8-K:

Item 1.01.  Entry into a Material Definitive Agreement
Item 2.01.  Completion of Acquisition or Disposition of Assets
Item 3.02.  Unregistered Sales of Equity Securities
Item 5.01.  Changes in Control of Registrant
Item 5.02.  Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers;  Compensatory Arrangements of Certain Officers
Item 5.06.  Change in Shell Company Status
Item 9.01.  Financial Statements and Exhibits
 
 
2

 
 
Item 1.01.
Entry into a Material Definitive Agreement.

The disclosures set forth in Item 2.01 to this Current Report on Form 8-K are incorporated by reference into this Item 1.01.

Item 2.01.
Completion of Acquisition or Disposition of Assets.

On November 21, 2011 (the “ Closing Date ”), Denali Concrete Management, Inc., a Nevada corporation (“ Denali ”, the “ Company ,” “ we ”, “ our ” or “ us ”), consummated its acquisition (the “ Transaction ”) of all the outstanding interests in Eyefite Ltd., a private company incorporated on June 27, 2011 under the laws of the State of Israel (“ Eyefite ”), pursuant to an Agreement, dated November 21, 2011, (the “Agreement”) by and between the Company and Can-Fite BioPharma Ltd. (“ Can-Fite ”).

Stock Purchase Agreement

On November 21, 2011, in accordance with the terms of the Agreement, the Company entered into a stock purchase agreement (the “ Stock Purchase Agreement ”) with Can-Fite, whereby Can-Fite purchased 36,000,000 shares  of common stock of the Company in exchange for surrendering to the Company all of the issued and outstanding common stock of Eyefite. As a result of the consummation of the actions contemplated by the Stock Purchase Agreement, Eyefite became the Company’s wholly-owned subsidiary and Can-Fite became the Company’s majority shareholder. Prior to the date hereof, Eyefite has not commenced any operations.

License Agreement

In connection with consummation of the Transaction, Eyefite and Can-Fite entered into a License Agreement, effective November 21, 2011 (the “ License Agreement ”), pursuant to which Can-Fite granted to Eyefite a sole and exclusive worldwide license for the use of CF101, Can-Fite’s therapeutic drug candidate, solely in the field of ophthalmic diseases (“ CF101 ”).  The license granted to Eyefite allows Eyefite to sublicense to third parties, subject to the satisfaction of certain conditions.  Pursuant to the License, Eyefite has sole responsibility for preparing and maintaining all regulatory documentation with respect to approvals of CF101 in the field of ophthalmic diseases and all approvals and related regulatory documentation shall be Eyefite’s sole and exclusive property.  Eyefite is also required to assume responsibility for making payments to Can-Fite’s licensors (“ PHS ”) for certain patent rights relating to CF101 (the “ PHS Patents ) , including (i) a nonrefundable minimum annual royalty of $25,000, (ii) earned royalties of 4.0% to 5.5% on net sales in the territories in which PHS Patents exist and (iii) individual payments ranging from $25,000 to $500,000 upon the achievement of various development milestones for each indication.  Eyefite will also be required to make payments to PHS of 20% of sublicensing revenues, excluding royalties and net of the required milestone payments.    If Eyefite fails to make a required payment to PHS, Can-Fite will be entitled to terminate the license granted to Eyefite under the License Agreement upon 30 days’ prior written notice.  The License Agreement will remain in effect until the expiration of the last of the patents licensed thereunder, unless terminated sooner.  Can-Fite may terminate the License Agreement upon customary bankruptcy/insolvency events of Eyefite and upon Eyefite’s material breach of the License Agreement, upon 30 days’ prior written notice.  Eyefite may terminate the License Agreement upon three months’ prior written notice for any reason and upon 30 days’ prior written notice for Can-Fite’s material breach of the License Agreement.

Services Agreement

In connection with the transactions contemplated by the Agreement, the Company, Eyefite and Can-Fite entered into a Services Agreement that is effective as of November 21, 2011 (the “ Services Agreement ”).  In accordance with the Services Agreement, Can-Fite will manage, as an independent contractor, all activities relating to pre-clinical and clinical studies performed for the development of the ophthalmic indications of CF101.  The Services Agreement shall remain in force for an unlimited period of time unless earlier terminated as follows: (i) following the first anniversary of the Services Agreement, by either party upon six months’ prior written notice to the other party; or (ii) at any time for cause by either Eyefite (which includes breach of trust by Can-Fite, Can-Fite’s material breach of the Services Agreement or customary bankruptcy/insolvency events on the part of Can-Fite) or Can-Fite (which includes Eyefite’s material breach of the Services Agreement or the License Agreement, or customary bankruptcy/insolvency events on the part of Eyefite). As consideration for Can-Fite’s services pursuant to the Services Agreement, Eyefite shall pay to Can-Fite a services fee (consisting of all expenses and costs incurred by Can-Fite plus 15%) and an additional fee payment equal to 2.5% of any revenues received by the Company (or any affiliate of the Company including its wholly owned subsidiary, Eyefite) for rights to CF101 from third-party sublicenses including upfront payments, developmental or commercial milestones, royalties on net sales and any similar payments, but not including payments to support or reimburse the Company for research, development, manufacturing or commercial expenses or for equity) (the “ Additional Fee ”).  The Company must make such Additional Fee payment to Can-Fite within 30 days of receipt by the Company.
 
 
3

 

Warrant Agreement

Pursuant to a warrant agreement (the “ Warrant ”) issued by the Company to Can-Fite on November 21, 2011, in connection with consummation of the Transaction, Can-Fite shall have the right, at any time from November 21, 2011 until the earlier of (a) the 5th-year anniversary thereof and (b) the closing of the acquisition of the Company by another entity, resulting in the exchange of the outstanding shares of the Company’s capital stock such that the stockholders of the Company prior to such transaction own, directly or indirectly, less than 50% of the voting power of the surviving entity, to convert its right to the Additional Fee (mentioned above) into 2,160,102 shares of common stock of the Company (subject to adjustment in certain circumstances).  The per share purchase price for the shares will be as follows: (i) in the event that within 12 months of November 21, 2011, the Company or any of its affiliates completes any transaction which has a “bio-dollar” value of more than $100 million, then the par value of the shares of common stock, and (ii) at any other time, $1.144.  The Warrant may be exercised on either a cash or a cashless basis, provided that if the Warrant is exercised on a cashless basis, the Warrant must be exercised in whole, not in part.

Financings

Concurrent with the closing of the Transaction, Denali entered into subscription agreements with certain private investors (the “ Investors ”) pursuant to which Denali received an aggregate investment of $3.3 million in cash consideration for issuing an aggregate of 2,910,456 shares of common stock of Denali to the Investors in a private placement.  Also concurrent with closing of the Transaction, Denali issued 2,097,626 shares of its common stock to Can-Fite in exchange for 17,873,054 ordinary shares of Can-Fite, valued at $2.4 million (as determined by reference to the previous trading day’s closing price for Can-Fite shares on the Tel Aviv Stock Exchange) and 437,005 of common stock of Denali to Can-Fite in consideration for a cash investment of $500,000 (collectively, together with the shares issued to the Investors, the “ Financing ”), The stated price per each common stock of Denali in the Financing was $1.144. Furthermore, for each two (2) shares of Denali purchased in the Financing, Can-Fite and each Investor was issued, conditional on the increase of the share capital of Denali, if increased, one (1) warrant valid for a period of 5 years from the closing of the Financing, to acquire one (1) share of Denali for an exercise price of $1.72, which is 50% higher than the price per share in the Financing ($1.144).  Denali further agreed to apply a full-ratchet anti-dilution protective provisions for the benefit of Can-Fite and the Investors in the event that Denali enters into another financing during the 12 months following the closing of the Financing at a price which is lower than $1.144 per common stock of Denali. In connection with the Financing, Denali expects to pay cash commissions to third parties in the amount of approximately $330,000. Proceeds from the Financing are expected to be used to finance the operations of Denali and Eyefite post-Transaction

In connection with the closing of the Transaction, Denali also repurchased 7,750,000 outstanding shares of common stock of the Company from Mathew G. Rule, its sole officer and director, for $7,750 (the “ Recapitalization ”).  In addition, the Company issued 1,920,000 common shares to certain investors for an aggregate of $97,000, which funds were used solely to retire the outstanding shares in the Recapitalization and to pay outstanding payables of Denali as of closing.  These payments included satisfaction of a promissory note in the principal amount of $56,465 and payables to the transfer agent, accountants and Denali legal counsel.

Upon completion of the Transaction, after giving effect to the Financing, the Recapitalization, and the shares issued to raise funds to satisfy outstanding financial obligations existing prior to the Closing Date, the Company had an aggregate of 46,985,516 issued and outstanding shares of common stock.  Of these shares the Investors owned approximately 6.2 % of the Company, Can-Fite owned approximately 82% of the Company and the remaining shares are held by other Company stockholders (who held shares prior to the Financing or as a result of an issuance used solely pay outstanding payables of Denali as of closing) who owned 11.8% of the Company, on an issued and outstanding basis.
 
 
4

 

The Transaction will be accounted for as a reverse acquisition wherein Can-Fite will be treated as the acquirer for accounting purposes.

Board of Directors; Officers

Pursuant to the Agreement, upon consummation of the Transaction, the board of directors of the Company (the “ Board ”) was expanded from one to three members, the sole prior Denali director, Mathew G. Rule, resigned, and the following new directors were appointed: Pnina Fishman, Ilan Cohn and Guy Regev, each of whom is a current director of Can-Fite. Dr. Fishman will serve as Chairman. Pursuant to the terms of the Company’s agreement with the Investors , the Company will be required to appoint one additional director designated by the Investors in the period following closing of the transactions contemplated by the Agreement.  The Company intends to expand the Board from three directors to five directors, adding two independent directors (including the board member designated by the Investors ).

Each of the new directors will hold office until the earlier of the next annual meeting of stockholders and the election and qualification of their successors or their earlier death, resignation or removal. Additionally, effective upon consummation of the Transaction, Mathew G. Rule (the sole officer of Denali) resigned as President, Secretary, and Treasurer, and our Board appointed the following persons to serve in the offices set forth across from their names:
 
Name
 
Title(s)
Pnina Fishman
 
Interim Chief Executive Officer
Itay Weinstein
 
Interim Chief Financial Officer

The shares of common stock of Denali issued pursuant to the Stock Purchase Agreement to Can-Fite, the shares sold to the Investors in the Financing, and the shares issued to raise funds for satisfaction of Company debts, were not registered under the Securities Act of 1933, as amended (the “ Securities Act ”), or any state securities laws, in reliance upon the exemption from registration provided by Section 4(2) of the Securities Act and Regulation D promulgated under that section, which exempts transactions by an issuer not involving a public offering. None of these securities may be offered or sold in the United States absent registration or an applicable exemption from the registration requirements. No registration rights have been granted to Can-Fite or any other party.

The foregoing descriptions of the Agreement, Stock Purchase Agreement, License Agreement, Services Agreement, Warrant, and the transactions contemplated thereby are subject to the more detailed provisions set forth in the full text of these agreements, which are attached to this Current Report on Form 8-K as Exhibits 2.1, 4.1, 10.1, 10.2 and 10.3, respectively, and which are incorporated herein by reference.

FORM 10 DISCLOSURES

As disclosed elsewhere in this Current Report on Form 8-K, on November 21, 2011, we acquired Eyefite upon consummation of the Transaction. Item 2.01(f) of Form 8-K provides that if a registrant was a “shell company,” as such term is defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended (the “ Exchange Act ”), as we were immediately preceding the Transaction, then the registrant must disclose the information that would be required if the registrant were filing a general form for registration of securities on Form 10 under the Exchange Act (“ Form 10 ”).

Accordingly, set forth below is the information that would be included in Form 10. Please note that the information provided below relates to the combined company subsequent to the Transaction, except that information relating to periods before the Closing Date relates only to Denali, unless otherwise specifically indicated.
 
 
5

 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Current Report on Form 8-K, including the Form 10 disclosures, contain “forward-looking statements,” as that term is defined under the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements about our expectations, beliefs or intentions regarding our product offerings, business, financial condition, results of operations, strategies or prospects. You can identify forward-looking statements by the fact that these statements do not relate strictly to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These forward-looking statements are only predictions and reflect our views as of the date they are made with respect to future events and financial performance. We undertake no obligation to update, and we do not have a policy of updating or revising, these forward-looking statements.

* * * * *

Except where the context otherwise requires, the terms, “we,” “us,” “our” or “Denali” refer to the business of Denali Concrete Management, Inc. and its consolidated subsidiary, Eyefite. “Eyefite” refers to Eyefite Ltd., our wholly-owned subsidiary, which has been granted by Can-Fite BioPharma Ltd. a sole and exclusive worldwide license for the use of CF101, Can-Fite’s therapeutic drug candidate, solely in the field of ophthalmic diseases. Eyefite is our sole operating subsidiary, commenced its operations upon the closing of the Transaction and comprises all of our operations as of the date of this Current Report on Form 8-K.   Unless otherwise indicated, all references in this report are to U.S. Dollars.

Item 1.                   Business.

Historical Background

Denali was originally incorporated in the State of Nevada on December 10, 1999, under the name Bridge Capital.com, Inc.  Bridge Capital.com, Inc. was a nominally capitalized corporation that did not commence its operations until it changed its name to Denali Concrete Management in March 2001.  Denali was a concrete placement company specializing in providing concrete improvements in the road construction industry.  Denali operated primarily in Anchorage, Alaska, placing curb and gutter, sidewalks and retaining walls for state, municipal and military projects.

In December 2005, Denali ceased its principal business operations and focused its efforts on seeking a business opportunity.  Upon completion of the Transaction, Denali acquired Eyefite (which is now our wholly-owned subsidiary) and became a clinical-stage biopharmaceutical company focused on developing therapeutic products for the treatment of ophthalmic disorders.  Eyefite was incorporated in Israel on June 27, 2011, and commenced its operations upon the closing of the Transaction.  All references to Eyefite after the closing of the Transaction shall refer to Denali and Eyefite, collectively.

Subject to approval by Denali’s stockholders, Denali intends to change its name to Eyefite, increase its authorized common shares, and redomesticate from a corporation organized and existing under the laws of the State of Nevada to a corporation organized and existing under the laws of the State of Delaware.

Our principal executive offices are located at 123 West Nye Lane, Suite 129, Carson City, NV 89706.  The Company is planning to lease permanent office space during the near future.

You are advised to read this Current Report on Form 8-K in conjunction with other reports and documents that we file from time to time with the Securities and Exchange Commission (“ SEC ”).  In particular, please read our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and any Current Reports on Form 8-K that we may file from time to time.  You may obtain copies of these reports from the SEC at the SEC’s Public Reference Room at 100 F Street, N.E. Washington, D.C. 20549.  In addition, the SEC maintains information for electronic filers (including us) at its website at www.sec.gov.  The public may obtain information regarding the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330.
 
 
6

 

General
 
As a result of the Transaction, we are now an advanced clinical-stage biopharmaceutical company focused on developing therapeutic products for the treatment of ophthalmic disorders.  Our drug, CF101 (known generically as IB-MECA), is being developed to treat three ophthalmic indications: dry eye syndrome; glaucoma and uveitis.  We are currently: (i) initiating a Phase III trial with respect to the development of CF101 for dry eye syndrome, under an Investigational New Drug, or IND, application with the United States Food and Drug Administration, or FDA; (ii) conducting a Phase II trial with respect to the development of CF101 for the treatment of glaucoma; and (iii) preparing for Phase II study of the development of CF101 for uveitis.

CF101 is a highly-selective, orally bioavailable small molecule synthetic drug, which targets the A 3 adenosine receptor (A 3 AR).  We believe that CF101 has a favorable safety profile and a potent anti-inflammatory activity, mediated via its capability to inhibit the production of inflammatory cytokines, such as TNF-α, MMPs, IL-1, and IL-6.  This is mediated by activation of the A 3 AR, which is highly expressed in inflammatory tissues in contrast to normal tissues where expression levels of the receptor are very low.  We believe that the anti-inflammatory and neuroprotective effects of CF101 make it an attractive candidate for use in the treatment of a variety of ophthalmic diseases.

CF101

The information discussed below is based on the various studies conducted with CF101, including clinical studies in patients with diseases other than ophthalmic ones.  All the studies were conducted by Can-Fite or by Can-Fite’s partners.

Pre-Clinical Studies

The toxicity of CF101 has been evaluated following 28-day, 90-day, 6-month and 9-month good laboratory practice repeated-dose toxicity studies in male and female mice (28-day, 90-day and 6-month), dogs (single-dose only), and monkeys (28-day, 90-day and 9-month).  No toxic side effects were identified, even though the dose of CF101 in these studies was escalated to an exposure that is many folds higher than in the human clinical studies.

Effects on cardiovascular parameters were evaluated in conscious instrumented monkeys and anesthetized dogs.  These studies demonstrated no significant cardiovascular risk.

Genotoxicity studies were conducted in bacterial and mammalian mutation assays in vitro and in an in vivo mouse micronucleus assay; these studies were all negative.

Reproductive toxicology studies have been completed in mice and rabbits.  In mouse teratology studies, craniofacial and skeletal abnormalities were observed at doses > 10 mg/kg; however, no such effects were observed at 3 mg/kg. Teratogenicity was not observed in rabbits given doses ( > 13 mg/kg) that induced severe maternal toxicity.

Studies of P450 enzymes showed that CF101 caused no P450 enzyme inhibition or induction. Studies carried out with radiolabeled (C 14 ) CF101 in rats showed that the drug is excreted essentially unchanged. These studies also showed that the drug is widely distributed in all body parts except the central nervous system.
 
 
7

 

Clinical Studies

Phase I Clinical Studies:

CF101 has been studied comprehensively in normal volunteer trials to assess safety, pharmacokinetic metabolism and food interaction.  Two Phase I studies in 40 healthy volunteers, single dose and repeated dose, demonstrated that CF101 is rapidly absorbed (reaching a maximal concentration within 1-2 hours) with a half life of 8-9 hours. Some mild adverse events (principally increased heart rate) were observed at doses higher than those used in human clinical studies (single doses of 10 mg and twice-daily doses of 5 mg).  Such increase in heart rate was not accompanied by any change in QT intervals.  The drug showed linear kinetics and low inter-subject variability.  Based on the findings from Phase I clinical studies, 4 mg twice daily was selected as the upper limit for initial Phase II clinical trials in psoriasis. A fed-fast Phase I study demonstrated that food causes some attenuation in CF101 absorption; accordingly CF101 is given to patients on an empty stomach.  An additional Phase I study of the absorption, metabolism, excretion and mass balance of 4 mg of (C 14 ) CF101 was conducted in six healthy male subjects and demonstrated that CF101 was generally well tolerated in this group.

Based on the findings from Phase I clinical studies, 4 mg twice-daily was selected as the upper limit for the Phase II clinical trials.

Phase II Clinical Studies:

CF101 has completed five Phase II studies in 730 patients (527 patients treated with CF101 and 203 patients treated with placebo) for an aggregate exposure of about 150 patient years, and has demonstrated a favorable safety profile at doses up to 4 mg twice daily for up to 12 weeks.  In these Phase II studies, no dose-response relationship was evident between CF101 and adverse events.  Moreover, no clinically significant changes in vital signs, electrocardiograms, blood chemistry or hematology were observed.  CF101 given as a standalone therapy reached the primary endpoint in Phase II clinical study in dry eye syndrome.  In addition to the ophthalmic indications, positive data were observed utilizing CF101 as a standalone drug in two Phase II clinical studies in psoriasis and rheumatoid arthritis.  However, two Phase IIb studies in rheumatoid arthritis utilizing CF101 in combination with methotrexate failed to reach the primary endpoints.

Overall Ophthalmic Market

We estimate that the worldwide therapeutic ophthalmic market is a $12 billion market.  We believe that dry eye syndrome, or “ DES ”, is the most prevalent ophthalmic condition and that the glaucoma market generates the highest global sales.  We estimate that, in 2008, the DES market was $1.8 billion (based upon the global combined sales of Restasis® and leading artificial tear products) and that the glaucoma market was $5 billion.

Dry Eye Syndrome and its Market

We believe that DES is the most common problem of patients who seek eye care.  DES is characterized by eye irritation symptoms, blurred and fluctuating vision, tear film instability, increased tear osmolarity and ocular surface epithelial disease.  People with DES experience constant ocular discomfort and a decrease in visual function; in severe cases, DES may result in deterioration of vision.  We estimate that, as of 2010, 49.3 million people in the seven major markets (the United States, Japan, France, Germany, Italy, Spain and the United Kingdom) suffer from DES.  We expect that the number of people who suffer from DES will increase as the population in each of these countries ages.

A Phase II clinical trial for CF101 in the treatment of DES was completed and the study results were published in “Ophthalmology,” which is one of the leading journals in the field.  The Phase II CSR (Complete Study Report), demonstrated positive results in patients with moderate to severe DES and also served as the basis for an IND application with the FDA for a Phase III trial in the same patient population.  The FDA approved the IND in September 2010 and we will conduct our Phase III trial in the United States, Europe and Israel.

The primary endpoints of the Phase II trial were based on an improvement of more than 25% over baseline at week 12 in one of the following parameters: (1) tear break-up time, or BUT; (2) superficial punctate keratitis assessed by fluorescein staining results; and (3) Schirmer tear test 1 results.  Clinical laboratory safety tests included ophthalmic examinations, intraocular pressure, or IOP, measurements, electrocardiographic evaluations, vital sign measurements, and monitoring of adverse events.  The trial was a multicenter, randomized, double-masked, placebo-controlled, parallel-group study. 68 patients completed the study (35 patients in the placebo group and 33 patients in the CF101 group). Patients were treated orally with either 1 mg CF101 pills or matching vehicle-filled placebo pills, given twice daily for 12 weeks, followed by a two-week post-treatment observation . The results of the Phase II trial demonstrated the ability of CF101 to improve signs of ocular surface inflammation of the patients studied.  A statistically significant increase in the proportion of patients who achieved more than 25% improvement in the corneal staining and in the clearance of corneal staining was noted between the CF101-treated group and the placebo group. Treatment with CF101 resulted in a statistically significant improvement in the mean change from baseline at week 12 of the corneal staining, BUT, and tear meniscus height in the CF101-treated group. CF101 was well tolerated and exhibited an excellent safety profile with no serious adverse events. Moreover, a statistically significant decrease from baseline was observed in the IOP of the CF101-treated group in comparison with the baseline values. Additionally, there was a statistically significant difference in the clearing of corneal staining between the CF101 and the placebo-treated groups. Increases in the clearing of corneal staining is the primary endpoint of our Phase III clinical trials.
 
 
8

 

No serious adverse events were noted throughout the study.  Adverse events resulting in discontinuation of the study were observed in two patients: myalgias and recurrent corneal erosion.  The frequency of adverse events was comparable in both treated groups.  The most commonly reported adverse events included constipation, headache, palpitations, itching, abdominal pain, arthralgia, myalgia, fatigue and dry mouth.

Glaucoma and its Market

Glaucoma is a disease in which the optic nerve is damaged, leading to progressive, irreversible loss of vision.  Glaucoma is often associated with increased pressure of fluid in the eye and is usually diagnosed in advanced stages, making glaucoma the second leading cause of blindness worldwide.  The objective of treatment of glaucoma is to reduce IOP to avoid damage to the optic nerve and thereby preserve a person’s visual field.  We estimate that, as of 2010, 7 million people in the seven major markets suffer from glaucoma.  We expect that the number of people who suffer from glaucoma will increase as the population in each of the seven major markets ages.

Although the Phase II DES trial was not designed to assess the drug effect on IOP, the latter was tested as a safety parameter, showing that at week 12, the CF101-treated group had a 1.1-mmHg (6%) decrease from baseline, which was statistically significant (p = 0.048) when compared with the baseline values. This observation indicated that CF101 may also have potential as a treatment for glaucoma and lead to our current Phase II clinical trials in glaucoma.  The trial is randomized, double-masked, placebo-controlled, parallel-group study of the safety and efficacy of daily CF101 Administered Orally in Subjects with elevated IOP. The objectives of this study are to: determine the effects of oral CF101 in lowering IOP when administered twice daily for 16 weeks in subjects with elevated IOP; and determine the safety of oral CF101 in this subject population.   Effects on IOP will be measured by Tonometry, using a Haag-Streit Goldmann applanation tonometer or comparable instrument.   This trial will be performed in two segments. In Segment 1, subjects will be randomized to receive either CF101 1.0 mg, or matching placebo, given orally every 12 hours for 16 weeks. Segment 1 will enroll approximately 44 subjects, randomized in a 3:1 ratio to CF101 1.0 mg or to placebo. At the conclusion of Segment 1, a Data Review Committee, or DRC, will review safety and efficacy data and advise on progression of the trial to Segment 2. Segment 2 will enroll up to approximately 88 subjects in up to 3 dose groups (CF101 1.0 mg, CF101 2.0 mg, or placebo every 12 hours) randomized in a 3:3:2 ratio. At its discretion, the DRC may also recommend increasing enrollment in the CF101 1.0 mg group or other changes to the protocol design.

Uveitis and its Market

Uveitis is inflammation of the middle layer of the eye (the uvea, the layer of the eye between the sclera and the retina) caused by an immune reaction and is the third leading cause of blindness in developed countries.  Uveitis can be associated with auto-immune inflammatory diseases and with various eye infections.  The incidence of uveitis worldwide varies from 14 to 52.4 per 100,000 people, while the overall prevalence around the world is reported as 0.73%. In the United States, studies have estimated the disease prevalence is between 0.01% and 0.03%. Uveitis is estimated as the fifth or sixth leading cause of blindness in the United States. We estimate that fewer than 200,000 people in the United States suffer from uveitis, and therefore we recently submitted an orphan drug application to the FDA.
 
 
9

 

Former pre-clinical pharmacology studies conducted in collaboration with a research group from the U.S. National Institute of Health, or NIH, demonstrated that CF101 is effective in suppressing ocular inflammation in experimental murine model of uveitis.

Competition

The pharmaceutical industry is characterized by rapidly evolving technology and intense competition.  Other companies of various sizes engage in activities similar to ours.  Many of our competitors have substantially greater financial and other resources available to them.

CF101 for the Treatment of DES

The current products available to treat DES include Restasis®, Celluvisc, Hyalein, Vismed and Systane.  Restasis® is the only FDA approved prescription therapy indicated to treat DES and, as such, it dominates the U.S. market with respect to the treatment of DES.  Restasis® is not registered in Europe because of its severe side effects (eye irritation in particular).  There are several artificial tear products available to treat DES and such products are used either alone (in mild to moderate cases) or in combination with other treatments (in moderate to severe cases).  Eye drops are currently the most common method of treating DES and the most common practice is to have patients self-administer such drops several times daily.  Because of the self-administration of these eye drops, coupled with the fact that such administration is to occur several times each day, patients’ compliance with such a regimen poses a concern.

We believe that CF101, which is administered orally, represents a more attractive treatment option for patients suffering from DES because we believe that oral administration allows for increased patient compliance with self-administration, especially in light of the fact that many of the people who suffer from DES are aging and may have difficulty self-administering eye drops.  We also believe that there are needs with respect to the treatment of DES that are not being met by existing therapies, such as drugs that allow for less frequent administration than existing products, drugs that treat the underlying cause in addition to relieving the symptoms of DES and drugs that can act as anti-inflammatory agents.

CF101 for the Treatment of Glaucoma

The main drugs currently used to treat glaucoma include Xalatan®, Travatan® and Cosopt®.  Xalatan is recommended by the European Glaucoma Society and American Academy of Ophthalmologists as the first choice in the treatment of glaucoma.  Accordingly, Xalatan is the leading drug used to treat glaucoma, and had global sales of over $1.5 billion in 2008.  We anticipate that global sales of Xalatan will decrease in 2011 and after, upon the expiration of patents covering Xalatan.  Travatan was first launched in the U.S. in 2001 and then Europe and the rest of the world markets in 2002.  Travatan experienced sales of approximately $515 million in 2008 and was ranked third in the glaucoma market.  Travatan is administered once each day, which ophthalmologists cite as a significant advantage over other drugs used to treat glaucoma.  Cosopt is the oldest combination therapy in the glaucoma market.  Due to the expiration of patents covering Cosopt in 2008, some ophthalmologists have begun to look to other brands or generic drugs in the treatment of glaucoma.  Based on its toxicological profile, we believe that CF101 has the potential to have fewer side effects than the existing drugs.  CF101 is also potentially distinguishable given the evidence that it acts as a neuroprotective agent that could prevent the death of retinal cells.  In addition, the existing therapies, excluding Travatan, require more frequent administration than does CF101.

CF101 for the Treatment of Uveitis

The current treatments for uveitis include corticosteroids, anti-metabolites, T cell inhibitors, alkylating agents and biological drugs, which often involve serious adverse side effects and lack of efficacy.  We believe that a need exists for drugs used in the treatment of uveitis that are less toxic.
 
 
10

 

Intellectual Property

Pursuant to the License Agreement, Eyefite is the exclusive licensee of patent families covering both the composition and manufacture of CF101 and a portfolio of patent families established by Can-Fite covering the methods of use for treatment of DES, glaucoma and uveitis, using CF101 and other A 3 AR agonists.  Eyefite also holds exclusive rights for the use in the ophthalmic field of the patents granted to the NIH in the United States and Europe covering A 3 AR agonists including composition of matter claims to CF101 and its analogs.  Eyefite is not aware of any issued or pending patents that may block its freedom to operate.

The U.S. provisional and the Patent Cooperation Treaty patent applications that relate to the use of an A 3 AR agonist for the treatment of uveitis, are co-assigned to (and hence co-owned by) Can-Fite and the NIH. Can-Fite has licensed its share of this intellectual property to us and we and Can-Fite are currently in discussions with the NIH to obtain an exclusive license on the NIH’s share of this intellectual property.

Raw Materials and Suppliers

We believe that the raw materials that we require to manufacture CF101 are widely available from numerous suppliers and are generally considered to be generic industrial chemical supplies.  We do not rely on a single or unique supplier for the current production of any therapeutic small molecule in our pipeline.

Manufacturing, Marketing and Sales

We do not currently have any manufacturing or sales capabilities.  We may or may not manufacture the products we develop, if any.  We intend to license to, or enter into strategic alliances with, larger companies in the pharmaceutical businesses, which are equipped to manufacture, market and/or sell our products, if any, through their well-developed manufacturing capabilities and distribution networks.  We intend to license some or all of our worldwide patent rights to more than one third party to achieve the fullest development, marketing and distribution of any products we develop.

Government Regulation

The FDA and comparable regulatory agencies in foreign countries extensively regulate the manufacture and sale of the pharmaceutical products that we are currently developing.  The FDA has established guidelines and safety standards that are applicable to the nonclinical evaluation and clinical investigation of therapeutic products and stringent regulations that govern the manufacture and sale of these products.  The process of obtaining regulatory approval for a new therapeutic product usually requires a significant amount of time and substantial resources. The steps typically required before a product can be tested in humans include:
 
 
Animal pharmacology studies to obtain preliminary information on the safety and efficacy of a drug; and

 
Nonclinical evaluation in vitro and in vivo including extensive toxicology studies.

The results of these nonclinical studies may be submitted to the FDA as part of an IND application. The sponsor of an IND application may commence human testing of the compound 30 days after submission of the IND, unless notified to the contrary by the FDA.

The clinical testing program for a new drug typically involves three phases:

 
Phase I investigations are generally conducted in healthy subjects. In certain instances, subjects with a life-threatening disease, such as cancer, may participate in Phase I studies that determine the maximum tolerated dose and initial safety of the product;
 
 
11

 

 
Phase II studies are conducted in limited numbers of subjects with the disease or condition to be treated and are aimed at determining the most effective dose and schedule of administration, evaluating both safety and whether the product demonstrates therapeutic effectiveness against the disease; and

 
Phase III studies involve large, well-controlled investigations in diseased subjects and are aimed at verifying the safety and effectiveness of the drug.

Data from all clinical studies, as well as all nonclinical studies and evidence of product quality, typically are submitted to the FDA in a New Drug Application, or NDA.  Although the FDA’s requirements for clinical trials are well established and we believe that we have planned and conducted our clinical trials in accordance with the FDA’s applicable regulations and guidelines, these requirements, including requirements relating to testing the safety of drug candidates, may be subject to change or new interpretation.  Additionally, we could be required to conduct additional trials beyond what we had planned due to the FDA’s safety and/or efficacy concerns or due to differing interpretations of the meaning of our clinical data.

The FDA’s Center for Drug Evaluation and Research must approve an NDA for a drug before it may be marketed in the U.S.  If we begin to market our proposed products for commercial sale in the U.S., any manufacturing operations that may be established in or outside the U.S. will also be subject to rigorous regulation, including compliance with current good manufacturing practices. We also may be subject to regulation under the Occupational Safety and Health Act, the Environmental Protection Act, the Toxic Substance Control Act, the Export Control Act and other present and future laws of general application.

Regulatory obligations continue post-approval, and include the reporting of adverse events when a drug is utilized in the broader commercial population. Promotion and marketing of drugs is also strictly regulated, with penalties imposed for violations of FDA regulations, the Lanham Act (trademark statute), and other federal and state laws, including the federal anti-kickback statute.

We currently intend to seek, directly or through potential partners, approval to market our products and product candidates in foreign countries, which may have regulatory processes that differ materially from those of the FDA.  We anticipate that we will rely upon pharmaceutical or biotechnology companies to license our proposed products or independent consultants to seek approvals to market our proposed products in foreign countries.  We cannot assure you that approvals to market any of our proposed products can be obtained in any country.  Approval to market a product in any one foreign country does not necessarily indicate that approval can be obtained in other countries.

Employees

As of Nov 21, 2011, we did not have any employees and we had no consultants and advisors. There can be no assurance that we will be able to attract or retain the necessary qualified employees and/or consultants in the future.

Item 1A.
Risk Factors.

An investment in our company involves a significant level of risk. You should carefully consider the risks described below, together with all of the other information in this Current Report on Form 8-K, including all Form 10 information. The risks described below are not the only risks facing us. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial may also materially and adversely affect our business. If any of the following risks actually occur, our business, financial condition and results of operations could suffer, and the trading price of our common stock could decline.
 
 
12

 

Risks Related to Our Business

An investment in our common stock is very speculative and involves a very high degree of risk.

To date, we have not generated any revenue. Until Eyefite receives approval from the FDA and other regulatory authorities for its drug candidates, Eyefite cannot sell its drugs and will not generate product revenues. Therefore, for the foreseeable future, we will have to fund all of our operations and capital expenditures from the net proceeds of equity or debt offerings, cash on hand, licensing fees and grants. Although we plan to pursue additional financings, we may not be able to secure financing when needed or obtain financing on terms satisfactory to us. Our operations are subject to the risks and competition inherent in the establishment of a business enterprise. There can be no assurance that future operations will be profitable. We may not achieve our business objectives and the failure to achieve such goals would have an adverse impact on us.

We are not currently profitable and may never become profitable.

We expect to incur substantial losses for the foreseeable future and might never become profitable. We also expect to incur significant operating and capital expenditures and anticipate that our expenses will increase substantially in the foreseeable future as we:

 
initiate and manage pre-clinical development and clinical trials for our current and new drug candidates;

 
seek regulatory approvals for our drug candidates;

 
implement internal systems and infrastructure;

 
seek to license in additional technologies to develop; and

 
hire management and other personnel.

We expect to experience negative cash flow for the foreseeable future. As a result, we will need to generate significant revenues in order to achieve and maintain profitability. We may not be able to generate these revenues or achieve profitability in the future. Our failure to achieve or maintain profitability could negatively impact the value of our common stock. Eyefite has a limited operating history upon which to base an investment decision.

Eyefite has received an exclusive worldwide license for the use of CF101 in the field of ophthalmic diseases and commenced its operations upon the closing of the Transaction. These start-up operations provide a limited basis for investors to assess Eyefite’s ability to commercialize its drug candidates and the advisability of investing in our company.

We expect that we will require additional financing, and an inability to raise the necessary capital or to do so on acceptable terms would threaten the success of our business.

We believe that our current cash balances and cash equivalents, after giving effect to the Financing, will be sufficient to meet our operating and capital requirements, as currently being conducted, for at least twelve months, and will provide us the financial resources to continue to develop our product candidates. However, because of the uncertainties in our business, including the uncertainties discussed in this “Risk Factors” section, we cannot assure you that this will be the case. Our future capital requirements will depend on many factors, including:
 
 
the progress of the development of our product candidates;

 
the number of product candidates we pursue;

 
the time and costs involved in obtaining regulatory approvals;

 
the costs involved in filing and prosecuting patent applications and enforcing or defending patent claims;

 
whether or not we establish our own sales, marketing and/or manufacturing capabilities;

 
our ability to establish, enforce and maintain selected strategic alliances and activities required for product development and commercialization; and
 
 
13

 
 
 
our revenues, if any, from successful development and commercialization of any product candidates.
 
To carry out our business plan and implement our strategy, we anticipate that we will need to obtain additional financing from time to time and may choose to raise additional funds through strategic collaborations, licensing arrangements, public or private equity or debt financing, a bank line of credit, asset sales or other arrangements. We cannot be sure that any additional funding, if needed, will be available on terms favorable to us or at all. Furthermore, any additional equity or equity-related financing may be dilutive to our stockholders, and debt financing, if available, may subject us to restrictive covenants and significant interest costs. If we obtain funding through a strategic collaboration or licensing arrangement, we may be required to relinquish our rights to certain of our technologies, products or marketing territories. In addition, certain investors, including institutional investors, may be unwilling to invest in our securities since our common stock is quoted on the Over-the-Counter Bulletin Board and is not traded on a national securities exchange. Our inability to raise capital when needed would harm our business, financial condition and results of operations, and could cause our stock price to decline.

We may not obtain the necessary U.S. or worldwide regulatory approvals to commercialize our drug candidates, which would severely undermine our business by reducing the number of salable products and, therefore, corresponding product revenues.

We will need FDA approval to commercialize our drug candidates in the United States and approvals from foreign regulators to commercialize our drug candidates elsewhere. In order to obtain FDA approval of any of our drug candidates, we must submit to the FDA a New Drug Application, or NDA, demonstrating that the drug candidate is safe for humans and effective for its intended use. This demonstration requires significant research and animal tests, which are referred to as pre-clinical studies, as well as human tests, which are referred to as clinical trials. Satisfaction of the FDA’s regulatory requirements typically takes many years, and depends upon the type, complexity and novelty of the drug candidate and requires substantial resources for research, development and testing. Our research and clinical efforts may not result in drugs that the FDA considers safe for humans and effective for indicated uses. After clinical trials are completed, the FDA has substantial discretion in the drug approval process of the drug candidate and may require us to conduct additional pre-clinical and clinical testing or to perform post-marketing studies.

The approval process may also be delayed by changes in government regulation, future legislation or administrative action or changes in FDA policy that occur prior to or during its regulatory review. Delays in obtaining regulatory approvals may:

 
delay commercialization of, and our ability to derive product revenues from, our drug candidates;

 
impose costly procedures on us; and

 
diminish any competitive advantages that we may otherwise enjoy.

Even if we comply with all FDA requests, the FDA may ultimately reject one or more of our NDAs. We might not obtain regulatory clearance for our drug candidates in a timely manner, if at all. Failure to obtain FDA approval of any of our drug candidates in a timely manner or at all will severely undermine our business by reducing the number of salable products and, therefore, corresponding product revenues.

In foreign jurisdictions, we must receive approval from the appropriate regulatory authorities before we can commercialize our drug. Foreign regulatory approval processes generally include all of the risks associated with the FDA approval procedures described above. We might not be able to obtain the approvals necessary to commercialize our drug candidates for sale outside the United States in a timely manner, if at all.
 
 
14

 

We may be forced to abandon development altogether, which will significantly impair our ability to generate product revenues.

Upon the completion of any clinical trial, if at all, the results of these trials might not support the claims sought by us. Further, success in pre-clinical testing and early clinical trials does not ensure that later clinical trials will be successful, and the results of later clinical trials may not replicate the results of prior clinical trials and pre-clinical testing. The clinical trial process may fail to demonstrate that our drug candidates are safe for humans and effective for indicated uses. Any such failure may cause us to abandon a drug candidate and may delay development of other drug candidates. Any delay in, or termination of, our clinical trials will delay the filing of NDAs with the FDA and, ultimately, our ability to commercialize our drug candidates and generate product revenues. If the clinical trials do not support our drug product claims, the completion of development of such drug candidates may be significantly delayed or we may be forced to abandon development, which will significantly impair our ability to generate product revenues and will materially adversely affect our results of operations.

Even if we successfully complete clinical trials for our product candidates, there are no assurances that we will be able to submit, or obtain FDA approval of, an NDA, which would hinder or halt our ability to commercialize our products.

There can be no assurance that, if our clinical trials for any of our product candidates are successfully completed, we will be able to submit an NDA to the FDA or that any NDA we submit will be approved by the FDA in a timely manner, if at all. After completing clinical trials for a product candidate in humans, a drug dossier is prepared and submitted to the FDA as an NDA in order to allow the FDA to review such drug dossier and to consider a product candidate for approval for commercialization in the United States. If we are unable to submit an NDA with respect to any of our product candidates, or if any NDA we submit is not approved by the FDA, we will be unable to commercialize that product in the United States. The FDA can and does reject NDAs and requires additional clinical trials, even when drug candidates perform well or achieve favorable results in large-scale Phase III clinical trials. If we fail to commercialize any of our product candidates, we may be unable to generate sufficient revenues to continue operations or attain profitability and our reputation in the industry and our reputation in the investment community would likely be damaged, each of which could cause our stock price to significantly decrease.

Our product candidates will remain subject to ongoing regulatory requirements even if they receive marketing approval, and if we fail to comply with these requirements, we could lose these approvals, and the sales of any approved commercial products could be suspended.

Even if we receive regulatory approval to market a particular product candidate, the product will remain subject to extensive regulatory requirements, including requirements relating to manufacturing, labeling, packaging, adverse event reporting, storage, advertising, promotion, distribution and record keeping. Even if regulatory approval of a product is granted, the approval may be subject to limitations on the uses for which the product may be marketed or the conditions of approval, or may contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the product, which could negatively impact us or our collaboration partners by reducing revenues or increasing expenses, and cause the approved product candidate not to be commercially viable. In addition, as clinical experience with a drug expands after approval, typically because it is used by a greater number and more diverse group of patients after approval than during clinical trials, side effects and other problems may be observed after approval that were not seen or anticipated during pre-approval clinical trials or other studies. Any adverse effects observed after the approval and marketing of a product candidate could result in limitations on the use of or withdrawal of any approved products from the marketplace. Absence of long-term safety data may also limit the approved uses of our products, if any. If we fail to comply with the regulatory requirements of the FDA and other applicable United States and foreign regulatory authorities, or previously unknown problems with any approved commercial products, manufacturers or manufacturing processes are discovered, we could be subject to administrative or judicially imposed sanctions or other setbacks, including the following:

 
restrictions on the products, manufacturers or manufacturing processes;

 
warning letters;

 
civil or criminal penalties, fines and/or injunctions;
 
 
15

 
 
 
product seizures or detentions;

 
import or export bans or restrictions;

 
voluntary or mandatory product recalls and related publicity requirements;

 
suspension or withdrawal of regulatory approvals;

 
total or partial suspension of production; and

 
refusal to approve pending applications for marketing approval of new products or supplements to approved applications.

If we or our collaborators are slow to adapt, or are unable to adapt, to changes in existing regulatory requirements or adoption of new regulatory requirements or policies, marketing approval for our product candidates may be lost or cease to be achievable, resulting in decreased revenue from milestones, product sales or royalties, which would have a material adverse effect on our results of operations.

If physicians and patients do not accept and use our drugs, our ability to generate revenue from sales of our products will be materially impaired.

Even if the FDA approves our drug candidates for commercialization, physicians and patients may not accept and use such candidates. Future acceptance and use of our products will depend upon a number of factors including:

 
perceptions by members of the health care community, including physicians, about the safety and effectiveness of our drugs;

 
pharmacological benefit and cost-effectiveness of our products relative to competing products;

 
availability of reimbursement for our products from government or other healthcare payers;

 
effectiveness of marketing and distribution efforts by us and our licensees and distributors, if any; and

 
the price at which we sell our products.

Because we expect sales of our current drug candidates, if approved, to generate substantially all of our revenues for the foreseeable future, the failure of any of these drugs to find market acceptance would harm our business and could require us to seek additional financing.

We will initially be completely dependent upon Can-Fite to service our operations and development activities. If, at the time we seek to establish our own operations, we are unable to attract and retain key personnel, it could adversely affect our ability to develop and market our products.

Because we initially rely on Can-Fite to manage, as an independent contractor, all activities relating to pre-clinical and clinical studies for the development of the ophthalmic indications of CF101, we cannot assure you that we will ever be able to manage these operations and activities on our own. We do not currently have the capability of managing all activities relating to the development of the ophthalmic indications of CF101. Accordingly, if Can-Fite ceases to provide such services, our business would likely be materially adversely affected. In the future, we are planning to manage our own operations and take control of the development of the ophthalmic indications of CF101. In that event, our future success will depend in part on our ability to identify, hire, and retain key personnel that can manage our operations. While we intend to attempt to attract and retain key personnel to the best of our ability, some of our competitors are likely to have greater resources and more experience than we do, making it difficult for us to compete successfully for key personnel. If we are ultimately unable to attract and retain key personnel, we likely would not be able to develop and market our products and would have to continue to rely upon Can-Fite to provide the necessary services. If we are unable to manage our own operations and Can-Fite ceases to service our operations and development activities, our ability to develop and market our products, as well as our business, financial condition and results of operations, would be materially adversely affected.
 
 
16

 

The manufacture of our products is an exacting and complex process, and if we or one of our materials suppliers encounter problems manufacturing our products, our business could suffer.

The FDA and foreign regulators require manufacturers to register manufacturing facilities. The FDA and foreign regulators also inspect these facilities to confirm compliance with cGMP or similar requirements that the FDA or foreign regulators establish. We or our materials suppliers may face manufacturing or quality control problems causing product production and shipment delays or a situation where we or the supplier may not be able to maintain compliance with the FDA’s cGMP requirements, or those of foreign regulators, necessary to continue manufacturing our drug substance. Drug manufacturers are subject to ongoing periodic unannounced inspections by the FDA, the United States Drug Enforcement Agency and corresponding foreign standards to ensure strict compliance with cGMP requirements and other governmental regulations and corresponding foreign standards. Any failure to comply with cGMP requirements or other FDA or foreign regulatory requirements could adversely affect our clinical research activities and our ability to market and develop our products.

We have no experience selling, marketing, or distributing products, and, as a result, we might not be able to effectively market and sell our products, which would have a material adverse effect on us.

While we intend to have a role in the commercialization of our products, we currently have no sales, marketing or distribution capabilities. Our future success depends, in part, on our ability to enter into and maintain collaborative relationships with other companies having sales, marketing and distribution capabilities, the collaborator’s strategic interest in the products under development and such collaborator’s ability to successfully market and sell any such products. We intend to pursue additional collaborative arrangements regarding the sales and marketing of our products; however, we might not be able to establish or maintain such collaborative arrangements, or if such arrangements are made, our counterparties might not have effective sales and marketing forces. To the extent that we decide not to, or are unable to, enter into collaborative arrangements with respect to the sales and marketing of our proposed products, significant capital expenditures, management resources and time will be required to establish and develop an in-house marketing and sales force with technical expertise. We may not be able to establish or maintain relationships with third party collaborators or develop in-house sales and distribution capabilities. To the extent that we depend on third parties for marketing and distribution, any revenues we receive will depend upon the efforts of such third parties, as well as the terms of our agreements with such third parties, which cannot be predicted at this time. As a result, we might not be able to market and sell our products in the United States or overseas, which would have a material adverse effect on us.

Developments by competitors may render our products or technologies obsolete or non-competitive.

We will compete against fully integrated pharmaceutical companies and smaller companies that are collaborating with larger pharmaceutical companies, academic institutions, government agencies and other public and private research organizations. In addition, many of these competitors, either alone or together with their collaborative partners, operate larger research and development programs, and have substantially greater financial resources than we do, as well as significantly greater experience in:

 
developing drugs;

 
undertaking pre-clinical testing and human clinical trials;

 
obtaining FDA and other regulatory approvals of drugs;

 
formulating and manufacturing drugs; and
 
 
17

 

 
launching, marketing and selling drugs.

Many of these organizations have substantially greater capital resources, larger research and development staffs and facilities, longer drug development history, more experience in obtaining regulatory approvals, and greater manufacturing and marketing capabilities than we do. These organizations also compete with us to attract qualified personnel, parties for acquisitions, joint ventures, and other collaborations.

We may incur substantial liabilities and may be required to limit commercialization of our products in response to product liability lawsuits.

The clinical testing of, marketing, and use of our products exposes us to product liability claims in the event that the use or misuse of those products causes injury, disease or results in adverse effects. Use of our products in clinical trials, as well as commercial sale, could result in product liability claims. In addition, sales of our products through third-party arrangements could subject us to product liability claims. Any product liability claim, even one that is not in excess of our insurance coverage or one that is meritless and/or unsuccessful, could adversely affect our cash available for other purposes, such as research and development. In addition, the existence of a product liability claim could affect the market price of our common stock.

Risks Relating to Our Intellectual Property

Our ability to pursue the development of the ophthalmic indications of CF101 depends upon the continuation of our license from Can-Fite and Can-Fite’s license from PHS.

Our license agreement with Can-Fite provides us with a worldwide sole and exclusive license for the use of CF101 in the field of ophthalmic diseases. It includes licensed patents which are solely owned by Can-Fite and additional licensed patents which were sub-licensed to us according to Can-Fite agreement with the PHS.  The license agreement requires that we maintain sole responsibility for preparing and maintaining all regulatory documentation with respect to approvals of CF101 in the field of ophthalmic diseases and requires that we assume responsibility for making payments to Can-Fite’s licensor, PHS, for certain patent rights relating to CF101.  If we are unable to make the required payments to PHS under the license agreement, Can-Fite will be entitled to terminate the license granted to us upon 30 days’ prior written notice. Can-Fite may also terminate the license agreement upon 30 days’ prior written notice in the event of customary bankruptcy/insolvency events of ours or upon our material breach of the license agreement.  If the   license agreement were terminated, we would lose our rights to develop and commercialize CF101 for the treatment of ophthalmic conditions, which would materially and adversely affect our business, results of operations and future prospects.

If we fail to adequately protect or enforce our intellectual property rights or secure rights to patents of others, the value of our intellectual property rights would diminish and our business and competitive position would suffer.

Our success, competitive position, and future revenues, if any, depend in part on our ability to obtain and successfully leverage intellectual property covering our products and product candidates, know-how, methods, processes, and other technologies, to protect our trade secrets, to prevent others from using our intellectual property and to operate without infringing the intellectual property rights of third parties.

With respect to intellectual property rights, we cannot predict:
 
 
the degree and range of protection any patents will afford us against competitors, including whether third parties will find ways to invalidate or design around our own or licensed patents;

 
if and when patents will issue;
 
 
18

 

 
whether or not others will obtain patents claiming aspects similar to those covered by our own or licensed patents and patent applications; or

 
whether we will need to initiate litigation or administrative proceedings that may be costly whether we win or lose.

If patent rights covering our products and methods are not sufficiently broad, they may not provide us with any protection against competitors with similar products and technologies. Furthermore, if the United States Patent and Trademark Office or foreign patent offices issue patents to us or our licensors, others may challenge the patents or design around the patents, or the patent office or the courts may invalidate the patents. Thus, any patents we own or license from or to third parties may not provide any protection against our competitors.

Pursuant to our License Agreement with Can-Fite, Can-Fite has retained the right to prosecute and maintain the patents licensed to us.  While Can-Fite is contractually obligated to us to obtain and maintain protection for those patent rights, and is required to keep us informed of all patent-related activities, we will be dependent upon Can-Fite for the prosecution and maintenance of our licensed patents.

If we infringe the intellectual property rights of third parties, we could be prevented from selling products, forced to pay damages and defend against litigation.

If our products, methods, processes, and other technologies infringe the intellectual property rights of other parties, we could incur substantial costs and may have to:

 
obtain licenses, which may not be available on commercially reasonable terms, if at all;

 
redesign our products or processes to avoid infringement;

 
stop using the subject matter claimed in the patents held by others, which could cause us to lose the use of one or more of our drug candidates;

 
pay damages; or

 
defend litigation or administrative proceedings, which may be costly whether we win or lose, and which could result in a substantial diversion of our management resources.

Any claims of infringement asserted against us, whether or not successful, may have a material adverse effect on us.

Risks Relating to Our Operations in Israel

Potential political, economic and military instability in the State of Israel, where our senior management and our research and development facilities are located, may adversely affect our results of operations.

Our facilities and those of Can-Fite, upon whom we rely for our initial research and development activities, are located in the State of Israel. Political, economic and military conditions in Israel may directly affect our business. Since the State of Israel was established in 1948, a number of armed conflicts have occurred between Israel and its Arab neighbors. Any hostilities involving Israel or the interruption or curtailment of trade between Israel and its present trading partners, or a significant downturn in the economic or financial condition of Israel, could adversely affect our operations. Ongoing and revived hostilities or other Israeli political or economic factors could harm our operations and product development and cause our revenues to decrease. Furthermore, several countries, principally those in the Middle East, still restrict business with Israel and Israeli companies. These restrictive laws and policies may seriously limit our ability to sell our products in these countries.
 
 
19

 

Investors may have difficulties enforcing a U.S. judgment, including judgments based upon the civil liability provisions of the U.S. federal securities laws against Eyefite, its executive officers and directors or asserting U.S. securities laws claims in Israel.

Many of Eyefite’s directors and officers are not residents of the United States and some of their assets and Eyefite’s assets are located outside the United States. Service of process upon Eyefite’s non-U.S. resident directors and officers and enforcement of judgments obtained in the United States against Eyefite, some of its directors and executive officers may be difficult to obtain within the United States. Eyefite has been informed by its legal counsel in Israel that it may be difficult to assert claims under U.S. securities laws in original actions instituted in Israel or obtain a judgment based on the civil liability provisions of U.S. federal securities laws. Israeli courts may refuse to hear a claim based on a violation of U.S. securities laws against Eyefite or its officers and directors because Israel is not the most appropriate forum to bring such a claim. In addition, even if an Israeli court agrees to hear a claim, it may determine that Israeli law and not U.S. law is applicable to the claim. If U.S. law is found to be applicable, the content of applicable U.S. law must be proved as a fact, which can be a time-consuming and costly process. Certain matters of procedure will also be governed by Israeli law. There is little binding case law in Israel addressing the matters described above.

Israeli courts might not enforce judgments rendered outside Israel, which may make it difficult to collect on judgments rendered against Eyefite. Subject to certain time limitations, an Israeli court may declare a foreign civil judgment enforceable only if it finds that:

 
the judgment was rendered by a court which was, according to the laws of the state of the court, competent to render the judgment;

 
the judgment may no longer be appealed;

 
the obligation imposed by the judgment is enforceable according to the rules relating to the enforceability of judgments in Israel and the substance of the judgment is not contrary to public policy; and

 
the judgment is executory in the state in which it was given.

Even if these conditions are satisfied, an Israeli court will not enforce a foreign judgment if it was given in a state whose laws do not provide for the enforcement of judgments of Israeli courts (subject to exceptional cases) or if its enforcement is likely to prejudice the sovereignty or security of the State of Israel. An Israeli court also will not declare a foreign judgment enforceable if:

 
the judgment was obtained by fraud;

 
there is a finding of lack of due process;

 
the judgment was rendered by a court not competent to render it according to the laws of private international law in Israel;

 
the judgment is at variance with another judgment that was given in the same matter between the same parties and that is still valid; or

 
at the time the action was brought in the foreign court, a suit in the same matter and between the same parties was pending before a court or tribunal in Israel.

Risks Relating to Ownership of Our Common Stock

The market price of our common stock may fluctuate significantly.

The market price of our common stock may fluctuate significantly in response to numerous factors, some of which are beyond our control, such as:

 
the announcement of new products or product enhancements by us or our competitors;
 
 
20

 

 
developments concerning intellectual property rights and regulatory approvals;

 
variations in our and our competitors’ results of operations;

 
changes in earnings estimates or recommendations by securities analysts, if our common stock is covered by analysts;

 
developments in the biotechnology industry;

 
the results of product liability or intellectual property lawsuits;

 
future issuances of common stock or other securities;

 
the addition or departure of key personnel;

 
announcements by us or our competitors of acquisitions, investments or strategic alliances; and

 
general market conditions and other factors, including factors unrelated to our operating performance.

Further, the stock market in general, and the market for biotechnology companies in particular, has experienced extreme price and volume fluctuations in the past. Continued market fluctuations could result in extreme volatility in the price of our common stock, which could cause a decline in the value of our common stock. Price volatility of our common stock might be worse if the trading volume of our common stock is low. We have not paid, and do not expect to pay, any cash dividends on our common stock as any earnings generated from future operations will be used to finance our operations and as a result, investors will not realize any income from an investment in our common stock until and unless their shares are sold at a profit.

Some or all of the “restricted” shares of our common stock issued in connection with the Transaction and the Financing or held by other of our stockholders may be offered from time to time in the open market pursuant to an effective registration statement or Rule 144, and these sales may have a depressive effect on the market for our common stock.

Trading of our common stock is limited and trading restrictions imposed on us by regulatory authorities may further reduce our trading, making it difficult for our stockholders to sell their shares.

Trading of our common stock is currently conducted in the Over-the-Counter market and our common stock is quoted on the OTC Bulletin Board, or the OTCBB. The liquidity of our common stock is limited, not only in terms of the number of shares that can be bought and sold at a given price, but may also be adversely affected by delays in the timing of transactions and reduction in security analysts’ and the media’s coverage of us, if at all.

These factors may result in lower prices for our common stock than might otherwise be obtained and could also result in a larger spread between the bid and ask prices for our common stock. In addition, without a large float, our common stock is less liquid than the stock of companies with broader public ownership and, as a result, the trading prices of our common stock may be more volatile. In the absence of an active public trading market, an investor may be unable to liquidate his investment in our common stock. Trading of a relatively small volume of our common stock may have a greater impact on the trading price of our stock than would be the case if our public float were larger. We cannot predict the prices at which our common stock will trade in the future.
 
 
21

 

Rule 144 will not be available for the outstanding shares issued by the Company after December 2005 for a period of at least one year after the filing of this report on Form 8-K, which means that these shareholders may not be able to sell such shares in the open market during this period.

Rule 144 does not permit reliance upon such rule for the resale of shares sold after the issuer first became a shell company, until the issuer meets certain requirements, including ceasing to be a shell company, the filing of Form 10-type information, and the filing for a period of one year periodic reports required under the Exchange Act.  As a result, the holders of all of the restricted shares issued in the Transaction, including Can-Fite and the Investors, as well as of any of the outstanding shares issued by the Company after December 2005, will not be able to sell their shares in reliance upon Rule 144 during this waiting period except pursuant to a registration statement filed by us which includes these shares for resale.  We have not agreed to register any of these shares for resale.

Because our common stock may be a “penny stock,” it may be more difficult for investors to sell shares of our common stock, and the market price of our common stock may be adversely affected.

Our common stock may be a “penny stock” if, among other things, the stock price is below $5.00 per share, it is not listed on a national securities exchange or approved for quotation on the American Stock Exchange, the Nasdaq Stock Market or any other national stock exchange or it has not met certain net tangible asset or average revenue requirements. Broker-dealers who sell penny stocks must provide purchasers of these stocks with a standardized risk-disclosure document prepared by the SEC. This document provides information about penny stocks and the nature and level of risks involved in investing in the penny-stock market. A broker must also give a purchaser, orally or in writing, bid and offer quotations and information regarding broker and salesperson compensation, make a written determination that the penny stock is a suitable investment for the purchaser, and obtain the purchaser’s written agreement to the purchase. Broker-dealers must also provide customers that hold penny stock in their accounts with such broker-dealer a monthly statement containing price and market information relating to the penny stock. If a penny stock is sold to an investor in violation of the penny stock rules, the investor may be able to cancel its purchase and get its money back.

If applicable, the penny stock rules may make it difficult for investors to sell their shares of our common stock. Because of the rules and restrictions applicable to a penny stock, there is less trading in penny stocks and the market price of our common stock may be adversely affected. Also, many brokers choose not to participate in penny stock transactions. Accordingly, investors may not always be able to resell their shares of our common stock publicly at times and prices that they feel are appropriate.

Our management team, as in effect upon the consummation of the Transaction, has no experience in managing and operating a public U.S. company. Any failure to comply or adequately comply with federal securities laws, rules or regulations could subject us to fines or regulatory actions, which may materially adversely affect our business, results of operations and financial condition.
 
Our management team, as in effect upon the closing of the Transaction, has no experience managing and operating a public U.S. company.  Failure to comply or adequately comply with any laws, rules, or regulations applicable to our business may result in fines or regulatory actions, which may materially adversely affect our business, results of operation, or financial conditions and could result in delays in achieving the development of an active and liquid trading market for our stock.
 
Failure to achieve and maintain effective internal controls in accordance with Section 404 of the Sarbanes-Oxley Act could have a material adverse effect on our business and operating results. In addition, current and potential stockholders could lose confidence in our financial reporting, which could have a material adverse effect on the price of our common stock.

Effective internal controls are necessary for us to provide reliable financial reports and effectively prevent fraud. If we cannot provide reliable financial reports or prevent fraud, our operating results could be harmed.

We will be required to document and test our internal control procedures in order to satisfy the requirements of Section 404 of the Sarbanes-Oxley Act of 2002, which requires annual management assessments of the effectiveness of our internal controls over financial reporting and may include a report by our independent registered public accounting firm addressing these assessments. During the course of our testing, we may identify deficiencies and weaknesses that we may not be able to remediate in time to meet the deadline imposed by the Sarbanes-Oxley Act for compliance with the requirements of Section 404. In addition, if we fail to maintain the adequacy of our internal controls, as such standards are modified, supplemented or amended from time to time, we may not be able to ensure that we can conclude on an ongoing basis that we have effective internal controls over financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act. Disclosing deficiencies or weaknesses in our internal controls, failing to remediate these deficiencies or weaknesses in a timely fashion or failing to achieve and maintain an effective internal control environment may cause investors to lose confidence in our reported financial information, which could have a material adverse effect on the price of our common stock.
 
 
22

 

Item 2.
Financial Information.

The information required by this Item 2 of Form 10 for Denali was previously reported in its Annual Report on Form 10-K for the fiscal year ended December 31, 2010, filed with the SEC on March 3, 2011, and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2011, filed with the SEC on November 14, 2011.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
 
Overview

On November 21 2011, we acquired all the outstanding interests in Eyefite Ltd., a private company incorporated under the laws of the State of Israel (the “ Transaction ”).  As a result of the Transaction, we are now an advanced clinical-stage biopharmaceutical company focused on developing therapeutic products for the treatment of ophthalmic disorders.  Our drug candidate, CF101 (known generically as IB-MECA), is being developed to treat three ophthalmic indications: dry eye syndrome; glaucoma and uveitis.  We are currently: (i) initiating a Phase III trial with respect to the development of CF101 for dry eye syndrome, under an IND application with the FDA; (ii) conducting a Phase II trial with respect to the development of CF101 for the treatment of glaucoma; and (iii) preparing for Phase II study of the development of CF101 for uveitis.

Plan of Operations

We do not expect to generate any revenues over the next 12 months. Through our subsidiary, Eyefite, which holds all the intellectual property related to our technology, we hope to develop therapeutic products for the treatment of ophthalmic disorders.  As of November 21, 2011 we had approximately $3.5 million in cash and 17,873,054 ordinary shares of Can-Fite (traded on the Tel Aviv Stock exchange) valued at $2.4 million. We do not believe that such funds will be sufficient to effectuate our business. We will need to seek additional capital for the purpose of further testing our products and obtaining certifications necessary in order to market them. We expect to incur a minimum of $2,500,000 in expenses in order to effectuate our business for the next 12 months. We estimate that this will be comprised of $500,000 towards the development of our product, $250,000 towards medical consulting and the procurement of the CE and FDA certifications; $1,000,000 towards clinical trials, $750,000 for professional fees associated with being a public company and the balance for general and administrative expenses.

Results of Operations
 
As of September 30, 2011, we have no available cash on hand and have experienced losses since inception.  We did not generate any revenues from operations during the periods ended September 30 or September 30, 2011 and 2010.  Expenses during the nine-month period ended September 30, 2011 were $28,479 with interest expense of $4,365 compared to expenses of $7,241 with interest expense of $5,170 for the nine-month period ended September 30, 2010.  Expenses for both periods consisted entirely of general and administrative expenses.  These expenses were due to professional, legal and accounting fees relating to our reporting requirements .

We realized a net gain on the retention of a deposit of $50,000.  As a result of the foregoing factor, we realized net income of $17,156 for the nine-month period ended September 30, 2011, compared to a net loss of $12,411 for the nine-month period ended September 30, 2010.
 
 
23

 

Year Ended December 31, 2010 Compared to the Year Ended December 31, 2009

We have no available cash on hand, no assets, and have experienced losses since inception.  We did not generate any revenues from operations during the years ended December 31, 2010 and 2009.  Expenses during the year ended December 31, 2010 were $14,876 with interest expense of $7,101 for a net loss of $21,977 compared to expenses of $15,960 with interest expense of $5,395 for a net loss of $21,355 for the year ended December 31, 2009.  In 2009 we received a gain on retention of deposit in the amount of $25,000 which resulted in a net income of $3,645.  There was no corresponding gain for the year ended December 31, 2010.  Expenses for both years consisted entirely of general and administrative expenses.  These expenses were due to professional, legal and accounting fees relating to our reporting requirements .

As a result of the foregoing factors, we realized a net loss of $21,977 for the year ended December 31, 2010 compared to a net gain of $3,645 for the year ended December 31, 2009.

Liquidity and Capital Resources

There can be no assurance that additional capital will be available to the Company. The Company currently has no agreements, arrangements, or understandings with any person to obtain funds through bank loans, lines of credit, or any other sources. Since the Company has no such arrangements or plans currently in effect, its inability to raise funds for the above purposes will have a severe negative impact on its ability to remain a viable company.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources that are material to investors.

Item 3.
Properties.

The Company’s interim principal corporate office is located at 123 West Nye Lane, Suite 129, Carson City, NV 89706. The Company is planning to lease permanent office space during the next 12 months.

Item 4.
Security Ownership of Certain Beneficial Owners and Management.

The following table sets forth information regarding the beneficial ownership of our common stock, as of the closing date of the Transaction, by:

 
Our principal executive officer and our two most highly paid executive officers, including those persons who served as our principal executive officer during our fiscal year ended December 31, 2010 (collectively, the “ Named Executive Officers ”);

 
Each of our directors (including each person named to become a director on the closing date);

 
All of our directors (including each person named to become a director on the closing date) and executive officers as a group; and

 
Each person who is known by us to beneficially own more than 5% of our common stock.

Unless otherwise noted, we believe that all persons named in the table have sole voting and investment power with respect to all shares of our common stock beneficially owned by them. All percentages have been calculated based upon 46,985,516 shares of our common stock issued and outstanding as of the close of business on November 21, 2011, the closing date of the Transaction, after giving effect to the Financing (including warrants exercisable within 60 days from the date hereof).
 
 
24

 

Name and Address of
Beneficial Owner
 
Number of Shares Beneficially
Owned (1)
   
Percentage of  Outstanding
Common Shares
 
Greater than 5% Holders:
           
Can-Fite Biopharma Ltd. (2)
    40,694,733       82.8 %
Directors and Named Executive Officers:
               
Mathew Rule (Former Director, Former Chief Executive Officer and Former Chief Financial Officer)
    250,000       *  
Pnina Fishman (Chairman of the Board and Interim Chief Executive Officer)
    43,701       *  
Itay Weinstein (Interim Chief Financial Officer)
    -       -  
Ilan Cohn
    -       -  
Guy Regev
    223,463       *  
All Directors and Officers as a Group (including certain former officers) (5 persons)
    517,164       1.1 %

*           Less than one percent.

(1)         Represents shares of common stock and shares of common stock that may be acquired upon exercise of options, warrants and other rights exercisable within 60 days of the close of business on November 21, 2011, the closing date of the Transaction, after giving effect to the Financing.

(2)         Includes 2,160,102 shares of common stock issuable to Can-Fite upon the exercise of warrants issued to Can-Fite in connection with the Agreement described above. The beneficial owners of Can-Fite holding 5% or more of Can-Fite s outstanding ordinary shares are: Shaked Global 11.74%; Asend Technologies 6.12%; Giza Venture fund 5.94%.

Item 5.
Directors and Executive Officers.

The following table sets forth information concerning our executive officers and directors, each of whom was appointed on November 21, 2011, including their ages, as of November 21, 2011:

Name
 
Age
 
Title
Pnina Fishman, Ph.D.
 
62
 
Chairman of the Board, Interim Chief Executive Officer
Ilan Cohn, Ph.D.
 
56
 
Director
Guy Regev
 
42
 
Director
Itay Weinstein
 
40
 
Interim Chief Financial Officer

Pnina Fishman, Chairman of the Board.

Pnina Fishman, Ph.D. co-founded Can-Fite, has served as Chief Executive Officer of Can-Fite since September 2005 and is Can-Fite board member.  Dr. Fishman is the scientific founder of Can-Fite and was previously a professor of Life Sciences and headed the Laboratory of Clinical and Tumor Immunology at the Felsenstein Medical Research Institute, Rabin Medical Center, Israel. Dr. Fishman has authored or co-authored over 150 publications and presented the findings of her research at many major scientific meetings. Her past managerial experience included seven years as Chief Executive Officer of Mor Research Application, the technology transfer arm of Clalit Health Services, the largest healthcare provider in Israel. Mor Research Application was also the first clinical research organization in Israel. She was also involved in the establishment and served on the board of directors of several life sciences technology start-ups. Dr. Fishman is also a board member of F.D. Consulting Ltd.  Given Professor Fishman’s extensive scientific track record, biotechnology management expertise, preclinical and clinical trials management capabilities   and her deep acquaintance with Can-Fite and its technology, we have decided to appoint her as Chairman of the Board and Interim Chief Executive Officer.
 
 
25

 

Ilan Cohn, Director.

Ilan Cohn, Ph.D. is a Patent Attorney and Senior Partner at the patent attorney firm Reinhold Cohn & Partners. Dr. Cohn co-founded Can-Fite, served as its Chief Executive Officer until September 2004 and is currently Vice Chairman of the Can-Fite Board of Directors.  Dr. Cohn holds a Ph.D. in biology and is a patent attorney with many years of experience in the biopharmaceutical field.  He has served on the board of directors of a number of life science companies in Israel and in the United States.  He was also involved in the past in management of venture capital funds focused on investments in the life sciences industry.  Dr. Cohn served a number of years as a co-chairman of the Biotech Committee of the US-Israeli Science and Technology Commission. Dr. Cohn is a Director of I.C.R.C. Management Ltd a company wholly owned by him. Given Dr. Cohn’s expertise in intellectual property and licensing transactions, his business development experience and his deep acquaintance with Can-Fite and its technology, we have decided to appoint him as a director of the Board.

Guy Regev, Director.

Mr. Guy Regev is currently the Chief Executive Officer of Shaked Global Group, a privately-held equity investment firm that provides value added capital to environmental related companies and technologies.  Mr. Regev joined Shaked Global Group at the beginning of 2008.  Shaked Global Group is a major shareholder in Can-Fite and  Mr. Regev is a director of Can-Fite.  Mr. Regev has over 12 years of experience in accounting, financial management and control and general management of commercial enterprises. Prior to joining Shaked, Mr. Regev was Vice President, commercial business, at Housing & Construction Holding (“ HCH ”), Israel’s largest infrastructure company.  His duties included being responsible for the consolidation and financial recovery of various business units within HCH.  Prior to that, Mr. Regev carried several roles within the group including as a Chief Financial Officer and later the Chief Executive Officer of Blue-Green Ltd., the environmental services subsidiary of HCH.  Between 1999 and 2001, Mr. Regev was a manager at Deloitte & Touche, Israel.  Mr. Regev holds an LLB degree in Law (Israel) and is a licensed lawyer and has been a licensed CPA since 1999.  Mr. Regev is a director of Knollan Ltd, Lotus Bio, The Green Way Ltd, Yehuda Shtang Ltd, Raviv Revolution Ltd, Aeronautics Ltd, R.E.B.I. Ltd.  Given Mr. Regev’s financial background and experience in accounting, financial and general management, we have decided to appoint him as a director of our Board.

Itay Weinstein, Interim Chief Financial Officer.

Mr. Itay Weinstein is a Partner at Shimony C.P.A. and has been working there since 1999.  Mr. Weinstein is also Can-Fite’s controller and has served as Can-Fite’s controller since 2003.  Prior to that, Mr. Weinstein served as Auditor at Oren Horowitz.  Mr. Weinstein holds a B.A. in economics and accounting from the Tel Aviv University, Israel and has been a licensed CPA since 1999.  Mr. Weinstein is a board member of Uno Management and Consulting Ltd.

Item 6.
Executive Compensation.

The information required by Item 6 of Form 10 was previously reported by the Company in its Annual Report on Form 10-K for the fiscal year ended December 31, 2010, filed with the SEC on March 3, 2011. The foregoing previously reported information is supplemented as follows.

Employment Agreements

We do not have any employment agreements with any of our executive officers.
 
 
26

 

Benchmarking of Cash and Equity Compensation

We have not retained a compensation consultant to review our policies and procedures with respect to executive compensation. We may retain the services of third-party executive compensation specialists from time to time in connection with the establishment of cash and equity compensation and related policies and we intend to take into account input from other independent members of our Board and publicly available data relating to the compensation practices and policies of other companies within and outside our industry.

Elements of Compensation

We will evaluate individual executive performance with a goal of setting compensation at levels the Board or any applicable committee thereof believes are comparable with executives in other companies of similar size and stage of development while taking into account our relative performance and our own strategic goals. Post-Transaction, the compensation received by our executive officers is anticipated to consist of the following elements:

Base Salary . Base salaries for our executives are established based on the scope of their responsibilities and individual experience, taking into account competitive market compensation paid by other companies for similar positions within our industry.

Discretionary Annual Bonus . In addition to base salaries, our Board or any applicable committee thereof will have the authority to award discretionary annual bonuses to our executive officers. The annual incentive bonuses are intended to compensate officers for achieving corporate goals and value-creating milestones.

Director Compensation

We are currently considering the precise composition of our director compensation policy. We may adopt a policy of paying independent directors an annual retainer, stock options and a fee for attendance at Board and committee meetings. We anticipate reimbursing each director for reasonable travel expenses related to such director’s attendance at Board and committee meetings.

Item 7.
Certain Relationships and Related Transactions, and Director Independence.

Transactions with Related Persons

The information required by Item 7 of Form 10 was previously reported by the Company in its Annual Report on Form 10-K for the fiscal year ended December 31, 2010, filed with the SEC on March 3, 2011.

Item 8.
Legal Proceedings.

The Company is not currently party to any legal proceedings.

Item 9.
Market Price of and Dividends on the Registrant’s Common Equity and Related Stockholder Matters.

Our common stock is quoted on the OTCBB under the symbol “DCMG”.  Including the 36,000,000 shares of our common stock issued in the Transaction, the 5,445,087 shares of our common stock issued in the Financing, the 1,920,000 shares issued to raise funds to satisfy outstanding debts at closing, and the cancellation of the 7,750,000 shares by Mr. Rule in the Recapitalization, there are currently 46,985,516 shares of common stock issued and outstanding.  As of November 21, 2011, the last bid quoted for our common stock on the OTCBB was $0.26 per share.  All OTCBB quotations reproduced herein reflect inter-dealer prices, without retail mark-up, mark-down or commission and may not necessarily represent actual transactions.

The following table sets forth the range of high and low bid quotations for the Common Stock, as reported by the OTCBB, on a quarterly basis for the fiscal years ended December 31, 2010 and 2009 and the interim period ended November 20, 2011.
 
 
27

 

For the Fiscal Year Ended on December 31, 2009

   
CLOSING BID
   
CLOSING ASK
 
   
High
   
Low
   
High
   
Low
 
Quarter Ended March 31, 2009
  $ 1.65       1.65     $ 2.50       2.50  
Quarter Ended June 30, 2009
    1.65       0.51       2.50       2.50  
Quarter Ended September 30, 2009
    0.51       0.51       2.50       2.50  
Quarter Ended December 31, 2009
    0.51       0.51       2.50       2.50  

For the Fiscal Year Ended on December 31, 2010

   
CLOSING BID
   
CLOSING ASK
 
   
High
   
Low
   
High
   
Low
 
Quarter Ended March 31, 2010
  $ 0.51       0.51     $ 2.50       2.50  
Quarter Ended June 30, 2010
    0.51       0.51       2.50       2.50  
Quarter Ended September 30, 2010
    0.51       0.01       2.50       2.50  
Quarter Ended December 31, 2010
    0.01       0.01       2.50       2.50  

For the Interim Period Ended on November 20, 2011

   
CLOSING BID
   
CLOSING ASK
 
   
High
   
Low
   
High
   
Low
 
Quarter Ended March 31, 2011
  $ 1.65       1.65     $ 2.50       2.50  
Quarter Ended June 30, 2011
    1.65       1.65       2.50       2.50  
Quarter Ended September 30, 2011
    1.65       1.65       2.50       2.50  
October 1, 2011 through November 20, 2011
    0.26       0.25       2.50       2.50  

As of the close of business on November 18, 2011, there were approximately 17 holders of record of our common stock and an undetermined number of beneficial owners.

We paid no cash dividends in respect of our common stock during our two most recent fiscal years, and we have no plans to pay any dividends or make any other distributions in the foreseeable future.

The transfer agent for our common stock is Action Stock Transfer Corp.

Equity Compensation Plan Information

We do not currently have any equity compensation plans under which we would be authorized to issue our common stock, rights and/or stock options.

Item 10.
Recent Sales of Unregistered Securities.

On November 21, 2011, Denali issued an aggregate of 2,910,456 shares of common stock of Denali to certain Investors in a private placement for a cash investment of $3.3 million and 2,097,626 shares of common stock of Denali to Can-Fite in exchange for 17,873,054 ordinary shares of Can-Fite, valued at $2.4 million (as determined by reference to the previous trading day’s closing price for Can-Fite shares on the Tel Aviv Stock Exchange) and 437,005 of common stock of Denali to Can-Fite in exchange for investment of $500,000 .  Each of the investors was an accredited investor as defined in Regulation D.  The Company issued these shares pursuant to the exemption from registration provided by Section 4(2) of the Securities Act and/or Rule 506 of Regulation D promulgated thereunder.
 
 
28

 

On November 21, 2011, Denali issued an aggregate of 2,722,543 warrants to acquire 2,722,543 common stock of Denali to those Investors who participated in the Financing (including Can-Fite), conditional on the increase of the share capital of Denali, if increased, exercisable for a period of 5 years from the closing of the Financing, at an exercise price of $1.72, which is 50% higher than the price per share in the Financing ($1.144).  Each of the investors was an accredited investor as defined in Regulation D. The Company issued these warrants pursuant to the exemption from registration provided by Section 4(2) of the Securities Act and/or Rule 506 of Regulation D promulgated thereunder.

On November 21, 2011, Denali issued an aggregate of 36,000,000 shares of common stock to Can-Fite in consideration for the transfer to Denali by Can-Fite of all the outstanding interests in Eyefite.  Can-Fite is an accredited investor as defined in Regulation D.  The Company issued these shares pursuant to the exemption from registration provided by Section 4(2) of the Securities Act and/or Rule 506 of Regulation D promulgated thereunder.

On November 21, 2011, Denali issued an aggregate of 1,920,000 shares of common stock to certain Investors in a private placement for a cash investment of $97,000.  Each investor in the offering was an accredited investor as defined in Regulation D.  The Company issued these shares pursuant to the exemption from registration provided by Section 4(2) of the Securities Act and/or Rule 506 of Regulation D promulgated thereunder.

On November 21, 2011, Denali issued the Warrant to Can-Fite for the purchase of up to 2,160,102   shares of common stock of the Company (subject to adjustment in certain circumstances).  Can-Fite has the right, at any time from November  21, 2011 until the earlier of (a) the 5th-year anniversary thereof and (b) the closing of the acquisition of the Company by another entity, resulting in the exchange of the outstanding shares of the Company’s capital stock such that the stockholders of the Company prior to such transaction own, directly or indirectly, less than 50% of the voting power of the surviving entity to convert its right to Additional Fees (mentioned above) into 2,160,102   shares of common stock of the Company (subject to adjustment in certain circumstances).  The per share purchase price for the shares will be as follows: (i) in the event that within 12 months of November 21, 2011, the Company or any of its affiliates completes any transaction which has a “bio-dollar” value of more than US$100 million, then the exercise price shall be the par value of the shares of common stock, and (ii) at any other time, then the exercise price for all the shares shall be an aggregate of US$2.5 million, equal to a per share exercise price of $1.144.  The Warrant may be exercised on either a cash or a cashless basis, provided that if the warrant is exercised on a cashless basis, the Warrant must be exercised in whole, not in part.  The Company issued the warrant pursuant to the exemption from registration provided by Section 4(2) of the Securities Act and/or Rule 506 of Regulation D promulgated thereunder.

Denali further agreed to apply a full-ratchet anti-dilution protective provisions for the benefit of the investors in the Financing (including Can-Fite) in the event that Denali enters into another financing during the 12 months following the closing of the Financing at a price which is lower than $1.144 per common stock of Denali.

Item 11.
Description of Registrant’s Securities to be Registered.

The Articles of Incorporation of the Company (the “ Articles ”) authorize the issuance of 50,000,000 shares of common stock and 1,000,000 shares of preferred stock.

Each record holder of common stock of Denali is entitled to one vote for each share held on all matters properly submitted to the stockholders of the Company for their vote. In the event of liquidation, holders of common stock are entitled to share ratably in the distribution of assets remaining after payment of liabilities, if any.  Holders of common stock have no cumulative voting rights and the holders of a majority of the outstanding shares have the ability to elect all of the directors.  Holders of common stock have no preemptive or other rights to subscribe for shares.  Holders of common stock are entitled to such dividends as may be declared by the board of directors out of funds legally available for dividends.  The outstanding common stock is validly issued, fully paid and non-assessable.
 
 
29

 

Dividends, if any, will be contingent upon the Company’s revenues and earnings, if any, capital requirements and financial conditions. The payment of dividends, if any, will be within the discretion of the Company’s Board of Directors. The Company presently intends to retain all earnings, if any, for use in its business operations.
             
Item 12.
Indemnification of Directors and Officers.
             
Our Articles provide that no director or officer of the Company shall be personally liable to the Company or any of its stockholders for damages for breach of fiduciary duty as a director or officer involving any act of omission of any such director or officer.  The Nevada Revised Statutes provide that a corporation’s charter may include a provision that restricts or limits the liability of its directors or officers to the corporation or its stockholders for money damages except:  (1) to the extent that it is provided that the person actually received an improper benefit or profit in money, property or services, for the amount of the benefit or profit in money, property or services actually received, or (2) to the extent that a judgment or other final adjudication adverse to the person is entered in a proceeding based on a finding in the proceeding that the person’s action, or failure to act, was the result of active and deliberate dishonesty and was material to the cause of action adjudicated in the proceeding. Our Articles and bylaws provide that we shall indemnify and advance expenses to its currently acting and its former directors to the fullest extent permitted by the Nevada Revised Business Corporations Act and that the company shall indemnify and advance expenses to its officers to the same extent as its directors and to such further extent as is consistent with law.

The bylaws provide that we will indemnify our current and former directors and officers against liabilities and expenses incurred in connection with litigation in which they may be involved because of their offices with Denali. However, nothing in our Articles or bylaws protects or indemnifies a director, officer, employee or agent against any liability to which he would otherwise be subject by reason of willful misfeasance, bad faith, gross negligence or reckless disregard of the duties involved in the conduct of his office.  To the extent that a director has been successful in defense of any proceeding, the Nevada Revised Statutes provide that he shall be indemnified against reasonable expenses incurred in connection therewith.

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the Company pursuant to the foregoing provisions, or otherwise, the Company has been advised that, in the opinion of the SEC, such indemnification is against public policy and is, therefore, unenforceable.

Item 13.
Financial Statements and Supplementary Data.

The financial statements included in Item 9.01 of this Current Report on Form 8-K are incorporated by reference in this Item 13. Denali’s audited financial statements for its fiscal years ended December 31, 2010 and 2009 were previously reported by Denali in its Annual Report on Form 10-K for the fiscal year ended December 31, 2010, filed with the SEC on March 3, 2011.  Denali’s unaudited interim financial statements required by this Item 13 were previously reported in its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2011, and September 30, 2011, filed with the SEC on May 6, 2011, and November 14, 2011, respectively.

Item 14.
Changes in and Disagreements With Accountants on Accounting and Financial Disclosures.

We have had no disagreements with our independent and registered public accounting firm on accounting and financial disclosure.

Item 15.
Financial Statements and Exhibits.

The disclosures set forth in Item 9.01 of this Current Report on Form 8-K are incorporated by reference in this Item 15.  Denali’s audited financial statements for its fiscal years ended December 31, 2010 and 2009 were previously reported by Denali in its Annual Report on Form 10-K for the fiscal year ended December 31, 2010, filed with the SEC on March 3, 2011.  Denali’s unaudited interim financial statements required by this Item 15 were previously reported in its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2011, and September 30, 2011, filed with the SEC on May 6, 2011, and November 14, 2011, respectively.
 
*****End of Form 10 Disclosures*****
 
 
30

 
 
Item 3.02.
Unregistered Sales of Equity Securities.

The disclosure set forth in Item 2.01 of this Current Report on Form 8-K, including the Form 10 disclosures, is incorporated by reference in this Item 3.02.

Item 5.01.
Changes in Control of Registrant.

The disclosure set forth in Item 2.01 of this Current Report on Form 8-K, including the Form 10 disclosures, is incorporated by reference in this Item 5.01.

To the Company’s knowledge, there are no arrangements or understandings among pre-Transaction persons who controlled in excess of 50% of our then issued and outstanding voting securities nor among those post-Transaction persons who control in excess of 50% of our currently issued and outstanding voting securities. Additionally, to the Company’s knowledge, there are no arrangements, including any pledge by any person of securities of the Company, the operation of which may at a subsequent date result in a change of control of the Company.

Item 5.02.
Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

The disclosure set forth in Item 2.01 of this Current Report on Form 8-K, including the Form 10 disclosures, is incorporated by reference in this Item 5.02.

Effective upon consummation of the Transaction: (i) the Board increased the number of seats on the Board from one to three; (ii) Mathew G. Rule resigned as director; and (iii) three current directors of Can-Fite (including Pnina Fishman as Chairman of the Board, Ilan Cohn and Guy Regev) were appointed as directors to fill the vacancies created by the resignation of Mr. Rule and the increase in the number of seats on our Board. Pursuant to the terms of the Company’s agreement with the investors in the Financing (other than Can-Fite), the Company will be required to appoint one additional director designated by the investors in the period following closing of the transactions contemplated by the Agreement.  The identity of this additional director is unknown at this time and will be determined after such closing. We expect to increase the size of the Board from three directors to five directors, adding the two independent directors with relevant expertise (including the board member designated by the investors in the Financing in the period following closing of the transactions contemplated by the Agreement. Each of the new directors will hold office until the earlier of the next annual meeting of stockholders and the election and qualification of their successors or their earlier death, resignation or removal.

Additionally, effective upon consummation of the Transaction, Mathew G. Rule resigned as President, Secretary and Treasurer, and our Board appointed the following persons to serve in the offices set forth across from their names:

Name
 
Title(s)
Pnina Fishman
 
Interim Chief Executive Officer
Itay Weinstein
 
Interim Chief Financial Officer

All officers, whether executive or non-executive, serve at the discretion of our Board.

Item 5.06.
Change in Shell Company Status.

The disclosure set forth in Item 2.01 to this Current Report on Form 8-K, including the Form 10 disclosures, is incorporated by reference in this Item 5.06. As a result of the completion of the Transaction, we believe we are no longer a “shell company” as that term is defined in Rule 12b-2 of the Exchange Act.
 
 
31

 

Item 9.01.
Financial Statements and Exhibits.

(a) Financial statements of business acquired. The audited financial statements of EyeFite Ltd required to be filed pursuant to Items 9.01(a) of Form 8-K have been filed as Exhibit 99.1 to this Current Report.

(b) Pro forma financial information. The unaudited pro forma financial information required to be filed pursuant to Item 9.01(b) of Form 8-K is filed as Exhibit 99.2 to this Current Report.

(c) Exhibits.

Exhibit No.
 
Description
2.1
   
Agreement, dated November 21, 2011, between Denali Concrete Management, Inc. and Can-Fite Biopharma Ltd.
4.1
   
Warrant, dated November 21, 2011, by Denali Concrete Management, Inc. to Can-Fite Biopharma Ltd
10.1
   
Stock Purchase Agreement, dated November 21, 2011, between Denali Concrete Management, Inc. and Can-Fite Biopharma Ltd.
10.2
   
License Agreement, dated November 21, 2011, between Can-Fite Biopharma Ltd. and EyeFite Ltd.
10.3
   
Services Agreement, dated November 21, 2011, by and among Can-Fite Biopharma Ltd., EyeFite Ltd. and Denali Concrete Management, Inc.
21.1
   
Subsidiaries of Denali Concrete Management, Inc.
99.1
   
Audited financial statements of EyeFite Ltd.
99.2
   
Pro forma unaudited financial statements
 
 
32

 

*      *       *
 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: November 22, 2011
Denali Concrete Management, Inc.
 
By:
/s/Pnina Fishman
   
Pnina Fishman
   
Interim CEO
 
 
33

 

Exhibit Index

Exhibit No.
 
Description
2.1
   
Agreement, dated November 21, 2011, between Denali Concrete Management, Inc. and Can-Fite Biopharma Ltd.
4.1
   
Warrant, dated November 21, 2011, by Denali Concrete Management, Inc. to Can-Fite Biopharma Ltd
10.1
   
Stock Purchase Agreement, dated November 21, 2011, between Denali Concrete Management, Inc. and Can-Fite Biopharma Ltd.
10.2
   
License Agreement, dated November 21, 2011, between Can-Fite Biopharma Ltd. and EyeFite Ltd.
10.3
   
Services Agreement, dated November 21, 2011, by and among Can-Fite Biopharma Ltd., EyeFite Ltd. and Denali Concrete Management, Inc.
21.1
   
Subsidiaries of Denali Concrete Management, Inc.
99.1
   
Audited financial statements of EyeFite Ltd.
99.2
   
Pro forma unaudited financial statements
 
 
34

 
 
Exhibit 2.1
 
AGREEMENT

This Agreement (" Agreement ") is entered into and signed as of November 21, 2011, by and between Can-Fite Biopharma Ltd., an Israeli corporation, of 10 Bareket Street, Petach Tikva, Israel (" Can-Fite "), for the first part; and Denali Concrete Management, Inc., a Nevada corporation , of 123 W. Nye Lane, Suite 129 Carson City, NV 89706 (" Denali "), for the second part. Can-Fite and Denali may be referred to herein individually as a “Party” or collectively as the “ Parties ”.
 
WHEREAS, Can-Fite desires to grant to Denali a worldwide exclusive license over its therapeutic drug CF101 for the field of ophthalmic diseases (the " Field ") in exchange for the issuance to Can-Fite of shares and warrants of Denali representing 86.7% of the issued share capital of Denali (the “ Transaction ”); and
 
WHEREAS, the Board of Directors of each of Can-Fite and Denali has determined that it is desirable to effect the Transactions.
 
NOW THEREFORE, in consideration of the foregoing and the respective representations, warranties, covenants and agreements set forth herein, and intending to be legally bound hereby, the Parties agree as follows
 
1.       Grant of License . Subject to the terms and conditions contained herein, Can-Fite shall grant to Eyefite Ltd., an Israeli corporation and wholly owned subsidiary of Can-Fite (the " Sub ") an exclusive license to CF-101 for the Field (the " License "), in exchange for the issuance to Can-fite of 1,000 ordinary shares, nominal value NIS 0.01 each of the Sub, representing 100% of the issued and outstanding share capital of the Sub.  The License shall be granted pursuant to a mutually agreed upon license agreement (the " License Agreement "), which shall include customary provisions as are typically included in such license agreements, including timetables for the development and commercialization for CF 101 in the field, and shall be signed and executed by the relevant parties at the Closing (as defined below).
 
2.       Recapitalization . Prior to the completion of Closing, and as a condition thereto, Denali shall perform a recapitalization of its share capital so that of the 11,370,430 Common Stock, par value US$0.001 each (the " Common Stock ") issued and outstanding as of the date hereof, 7,750,000 shall be repurchased by Denali and returned to the authorized but unissued Common Stock of Denali and 1,920,000 shall be issued to certain investors in exchange for an investment the proceeds of which shall be allocated to pay for all the liabilities of  Denali prior to the Closing, so that immediately prior to completion of Closing the authorized share capital of Denali shall consist of 1,000,000 shares of Preferred Stock, none of which shall be issued and outstanding, and 50,000,000 shares of Common Stock, of which 5,540,430 shall be issued and outstanding (the " Recapitalization ").
 
3.       Transfer of Sub to Denali .  At Closing, Can-Fite shall transfer 1,000 ordinary shares of the Sub (representing 100% of the outstanding interests in the Sub) to Denali, free and clear of all liens and encumbrances, pursuant to such stock transfer and conveyance instruments as shall be reasonable and customary for similar transfers.
 
 
 

 
 
4.       Issuance of Shares and Warrants to Can-Fite . In consideration for the grant of the License to the Sub and the transfer of all (100%) of the issued shares of the Sub to Denali, Denali shall issue to Can-Fite thirty-six million (36,000,000) shares of Common Stock of Denali, representing 86.7% of the issued and outstanding share capital (on a fully diluted basis) as of the Closing (the " Transaction Shares "). The capitalization table of Denali immediately prior to and after the Closing shall be set out herein as Exhibit A .  In order to effect the transactions contemplated by Sections 3 and 4 hereof, the parties shall enter into a Stock Purchase Agreement which shall include customary provisions as are typically included in such agreements (the “ Stock Purchase Agreement ”).
 
5.       Financing . Concurrently with the Closing and as a condition thereto or prior thereto, Denali shall raise not less than US$6.2 Million from investors furnished by Can-Fite through a private placement, of which US$3.8 Million shall be in cash (of which US$500,000 will be invested by Can-Fite prior to the grant of the License) and US$2.4 Million will be in ordinary shares of Can-Fite, whose value at the date of their issuance to Denali shall be equal to US$2.4 Million, all for the issuance to the investors and Can-Fite of 5,445,086 shares of Common Stock of Denali at a price per share of US$1.144 per each such share, and an aggregate valuation, pre private placement, of US$50 Million . For each two (2) shares of Denali purchased in the Financing, each investor (including Can-Fite) will be issued, post Closing and conditional on the increase of the share capital of Denali, if increased, one (1) warrant valid for a period of 5 years from the closing of the Financing, to acquire one (1) share of Denali for an exercise price of $1.72, which is 50% higher than the price per share in the Financing ($1.144). Denali further agrees to apply a full-ratchet anti-dilution protective provisions for the benefit of the investors in the Financing (including Can-Fite) in the event that Denali enters into another financing during the 12 months following the closing of the Financing at a price which is lower than $1.144 per common stock of Denali. In connection with the Financing Denali expects to pay cash commissions to third parties in the amount of approximately $330,000 (the " Fundraising "). The proceeds of the Fundraising shall be used to continue the clinical development of CF101 in the Field, it being understood that additional future financing will probably be required to complete such clinical development. The investors will invest in the Fundraising through a mutually agreed upon subscription agreement which shall include customary terms and conditions for such transactions, which shall include that upon the Closing the investment amount placed in escrow prior to the Closing shall be released to Denali immediately after the Closing upon issuance of the investment shares (the " Investment Shares ") to such investors (the " Subscription Agreements "). For avoidance of doubt, if the valuation of the Fundraising won’t be approved by Can-Fite, at its sole discretion, then the Agreement will expire and cease to have any legal effect.
 
 
2

 

6.       Service Agreement . Concurrently with the Closing, Can-Fite shall enter into a service agreement with Denali or its affiliate for the management of all activities relating to pre-clinical and clinical studies performed for the development of the ophthalmic indications in the Field, including pre-clinical studies, drug manufacturing and supply, QT study in human beings, payments to consultants such as Dr. Bill Kerns and Dr. Mike Silverman for their role involved in the on-going clinical trials and all activities need to be conducted in order to launch CF101 to the market for the ophthalmic indications (the " Service Agreement "). The terms of the Service Agreement shall set out that Can-Fite shall invoice Denali for such services to be provided by Can-Fite at a rate of cost of such services + 15% (not including VAT, if applicable), and shall "pass through" any direct payments for intellectual property maintenance made to third parties. Furthermore, the Service Agreement shall include additional compensation for the services being performed under the Service Agreement in the form of a royalty to be paid to Can-Fite from any and all proceeds received by the Sub, Denali or any of its affiliates in relation to CF101 in the Field, of 2.5% of any such proceeds (the " Royalty "). In addition, the Service Agreement shall contain customary provisions as typically set out in similar agreements. Denali will undertake to be obligated to all current ongoing ophthalmic clinical trials’ agreements signed by Can Fite, and will pay all payments according to those agreements from the date of the Closing onwards. Denali shall also undertake to pay all other costs related to the ophthalmic indications such as IP maintenance, regulatory activities etc. Can-Fite will have the right, at any time until the expiry of 5 years from the Closing, to convert the Royalty into an additional 2,160,102 shares of Common Stock of Denali, which shall be equal to 5% of the issued and outstanding share capital (on a fully diluted as converted basis) as of the Closing (the " Warrants "). The exercise price of the Warrants shall be as follows: (a) in the event that within 12 months of the Closing, Denali or its affiliates complete any transaction which has a "bio-dollar" value of more than US$100 Million, then the exercise price shall be the par value of the shares of Common Stock, and (b) at any other time, then exercise price for ALL the Warrants shall be US$2.5 Million (which represents an assumed valuation as of the Closing of US$50 Million). Additional terms and conditions of the Warrants shall include anti-dilution, cashless exercise and other customary terms and conditions which shall be set out in a mutually agreed upon Warrant agreement (the " Warrant Agreement ").
 
7.       Closing . The Parties contemplate that a closing will take place as soon as practical following the execution and delivery of this Agreement, but no later than November 22, 2011 (the " Closing "), at which all of the following shall occur concurrently: (a) CanFite shall grant the License to the Sub, (b) all of the Sub's shares shall be transferred to Denali, (c) Denali shall issue to Can-Fite 36,000,000 shares of Common Stock representing 86.7% of the issued and outstanding share capital of Denali, (d) Denali shall issue to Can-Fite the Warrants, (e) Subscription Agreements in relation to not less than US$6.2 Million (including by way of receipt of Ordinary Shares of Can-Fite valued at US$2.4 Million) will have been signed and executed by investors with the respective investment amount placed in escrow to be released immediately following the Closing, and (f) all other Transaction Agreements shall be signed, executed and delivered by the parties thereto. “ Transaction Agreements ” shall mean this Agreement, the License Agreement, the Warrant Agreement, the Subscription Agreements, the Service Agreement and any additional agreements, documents or instruments required to complete the Transactions.
 
8.       Conditions to Closing .  The obligations of each Party hereto to satisfy its obligations hereunder at the Closing are subject to the fulfillment on or prior to the Closing of each of the following conditions; provided , that a Party may not assert a failure of a condition hereunder where such failure is due to its own failure to perform:
 
 
(i)
Recapitalization .  The Recapitalization shall have been completed;
 
 
(ii)
License Agreement .  The License Agreement shall have been duly executed by Can-Fite in favor of the Sub, including the obtaining of the consent of the NIH to the grant by Can-Fite of such License Agreement to the Sub;
 
 
3

 
 
 
(iii)
Transfer of Sub .  The Stock Purchase Agreement shall have been duly executed by Denali and Can-Fite, and all the outstanding interests in the Sub shall have been duly transferred and conveyed to Denali;
 
 
(iv)
Service Agreement .  The Service Agreement shall have been duly executed by Denali (or a designated affiliate) and Can-Fite;
 
 
(v)
Subscription Agreements .  The Subscription Agreements shall have been duly executed by investors representing subscriptions of not less than US$6.2 million(including by way of receipt of Ordinary Shares of Can-Fite valued at US$2.4 Million)  and the funds therefore of not less than US$3.8 Million are held in escrow pending the Closing;
 
 
(vi)
Tax Ruling . The receipt of a signed and executed tax ruling from the Israeli Tax Authorities to the grant of the License by Can-Fite to the Sub.
 
 
(vii)
Legal Opinion .  Can-Fite shall have received the legal opinion of Denali's legal counsel acceptable to Can-Fite, in the form set out in Exhibit B attached hereto;
 
 
(viii)
Representations and Warranties .  The representations and warranties made by each of the Parties herein shall be true and correct in all material respects as of the date hereof and as of the Closing with the same effect as if the representations and warranties were made as of the date hereof and as of the Closing;
 
 
(ix)
Covenants .  All covenants, agreements and conditions contained in this Agreement to be performed by either Party on or prior to the Closing shall have been performed or complied with in all material respects;
 
 
(x)
Satisfactory Completion of Due Diligence . Can-Fite shall have completed its legal, accounting and business due diligence and the results thereof shall be satisfactory to Can-fite in its sole and absolute discretion and Denali will have completed its legal, accounting and business due diligence of the Sub and the results thereof shall be satisfactory to Denali in its sole and absolute discretion.
 
 
(xi)
SEC Reports . Denali shall have filed all reports and other documents required to be filed by it under the U.S. federal securities laws through the Closing.
 
 
(xii)
OTCBB Quotation . Denali shall have maintained its status as a company whose common stock is quoted on the Over-the-Counter Bulletin Board and no reason shall exist as to why such status shall not continue immediately following the Closing.
 
 
(xiii)
No Suspensions of Trading in Denali Stock; Quotation . Trading in Denali’s Common Stock shall not have been suspended by federal regulators or any trading market at any time since the date of execution of this Agreement, and the Denali Common Stock shall have been at all times since such date quoted for trading on a trading market.
 
 
4

 
 
 
(xiv)
Secretary’s Certificate . Denali shall have delivered to Can-Fite a certificate, signed by its Secretary or other authorized officer, certifying that the attached copies of the Denali Articles of Incorporation, bylaws and resolutions of its board of directors approving this Agreement, the other Transaction Agreements and the transactions contemplated hereby and thereby are all true, complete and correct and remain in full force and effect.
 
 
(xv)
Good Standing Certificate . Denali shall have delivered to Can-Fite a certificate of good standing of Denali dated within two (2) business days of Closing issued by the Secretary of State of Nevada.
 
 
(xvi)
Resignations . Denali shall have delivered to Can-Fite letters of resignation from all officers of Denali, effective upon the Closing, and from all directors of Denali, effective upon appointment of new directors designated by Can-Fite.
 
 
(xvii)
No Injunctions .  No statute, rule, regulation, order, decree, ruling or injunction shall have been enacted, entered, promulgated, endorsed or threatened or is pending by or before any governmental authority of competent jurisdiction which in any material respect restricts, prohibits or threatens to restrict or prohibit the consummation of any of the transactions contemplated by the Transaction Agreements; and
 
 
(xviii)
No MAE .  As of the Closing, there shall have been no material adverse effect with respect to Denali or the Sub since the date hereof.
 
With respect to the closing conditions listed in (vii), (viii), (ix) and (x) above, the Parties shall deliver at the Closing an executed officer’s certificate to such effect.
 
9.       Representations and Warranties of Denali . Denali hereby makes the following representations and warranties as of the date hereof and as of the Closing to Can-Fite:
 
(a)     Organization and Qualification.   Denali is an entity duly organized, validly existing and in good standing under the laws of the State of Nevada, with the requisite corporate power and authority to own and use its properties and assets and to carry on its business as currently conducted. Denali is not in violation of any of the provisions of its Articles of Incorporation, bylaws, or other organizational documents.  Denali does not have any wholly or partially owned subsidiaries and does not own any economic, voting or management interests in any other entity or person .  Denali has no operating business activities and has no assets or properties.
 
(b)     Authorization; Enforcement.   Denali has the requisite corporate power and authority to enter into and to consummate the transactions contemplated by each of the Transaction Agreements and otherwise to carry out its obligations thereunder.  The execution and delivery of each of the Transaction Agreements to which it is a party by Denali and the consummation by it of the transactions contemplated thereby have been duly authorized by all necessary action on the part of Denali and no further action is required by Denali, its board of directors or its shareholders in connection therewith. Each Transaction Agreement to which Denali is a party has been (or, if executed after the date hereof, upon delivery will be) duly executed by Denali and, when delivered in accordance with the terms hereof, will constitute the valid and binding obligation of Denali enforceable against Denali in accordance with its terms except (i) as limited by applicable bankruptcy, insolvency, reorganization, moratorium and other laws of general application affecting enforcement of creditors’ rights generally and (ii) as limited by laws relating to the availability of specific performance, injunctive relief or other equitable remedies.
 

 
5

 
 
(c)     No Conflicts.   The execution, delivery and performance of the Transaction Agreements to which it is a party by Denali and the consummation by Denali of the transactions contemplated thereby do not and will not (i) conflict with or violate any provision of Denali’s Articles of Incorporation, bylaws or other organizational documents, or (ii) conflict with, or constitute a default (or an event that with notice or lapse of time or both would become a default) under, or give to others any rights of termination, amendment, acceleration or cancellation (with or without notice, lapse of time or both) of, any agreement or other understanding to which Denali is a party, or (iii) result in a violation of any law, rule, regulation, order, judgment, injunction, decree or other restriction of any court or governmental authority to which Denali is subject (including U.S. federal and state securities laws and regulations).
 
(d)     Filings, Consents and Approvals.   Denali is not required to obtain any consent, waiver, authorization or order of, give any notice to, or make any filing or registration with, any court or other U.S. federal, state, local or other governmental authority or other person in connection with the execution, delivery and performance by Denali of the Transaction Agreements, other than (i) the filing with the United States Securities and Exchange Commission (the “ Commission ”) of a current report on Form 8-K setting out the details of the Transactions hereunder, and (ii) such as have already been obtained or such exemptive filings as are required to be made under applicable state and federal securities laws.
 
(e)     Capitalization.   As of immediately prior to the Closing, the authorized capital stock of Denali consisted of 50,000,000 shares of Common Stock and 1,000,000 shares of Preferred Stock.  Of the authorized share capital, as of the Closing none of the Preferred Stock shall be issued and outstanding, and 5,540,430 shares of Common Stock shall be issued and outstanding.  All of such outstanding shares of Common Stock are, and all of the Transaction Shares and Investment Shares, when issued pursuant to the Transaction Documents, will be, duly authorized, validly issued, fully paid and nonassessable, and free and clear of all liens, and all such shares of Common Stock were, and the Transaction Shares and Investment Shares will be, issued in material compliance with all applicable U.S. federal and state securities laws, including available exemptions therefrom, and none of such issuances were, and the issuance of the Transaction Shares and Investment Shares will not be, made in violation of any pre-emptive or other rights.  The issuance of the Transaction Shares and Investment Shares will not trigger any anti-dilution rights of any existing securities of Denali.  Except as set forth herein, as of the Closing, there will be no rights, subscriptions, warrants, options, conversion rights, or agreements of any kind outstanding to purchase from Denali, or otherwise require Denali to issue, any shares of capital stock of Denali or securities or obligations of any kind convertible into or exchangeable for any shares of capital stock of Denali.
 
 
6

 

(f)      Reports and Financial Statements.   Denali has filed all reports required to be filed by it under the United States Securities Exchange Act of 1934, as amended (the “ Exchange Act ”), and the rules of the Commission promulgated thereunder, on a timely basis or has received a valid extension of such time of filing and has filed any such reports prior to the expiration of any such extension (as such documents have since the time of their filing been amended or supplemented, and together with all reports, documents and information filed on or after the date first written above through the date of Closing with the Commission, including all information incorporated therein by reference, collectively, the “ SEC Reports ”).  The SEC Reports (a) complied and will comply as to form in all material respects with the requirements of the Exchange Act, and (b) did not, at the time of their filing, contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading.  The financial statements included in the SEC Reports comply in all material respects with the applicable accounting requirements and the rules and regulations of the Commission with respect thereto as in effect at the time of filing.  The financial statements included in the SEC Reports have been prepared in accordance with generally accepted accounting principles in the United States applied on a consistent basis (“ GAAP ”), and fairly represent the financial position of Denali and as of and for the dates thereof and the results of operations and cash flows for the periods then ended, subject, in the case of unaudited statements, to normal, year-end audit adjustments and the omission of certain footnotes.  Except as set forth in the SEC Reports, Denali has no liabilities or obligations of any nature (whether accrued, absolute, contingent or otherwise) required by GAAP to be set forth on a balance sheet of Denali or in the notes thereto. There are no financial or contractual obligations and liabilities (including any obligations to issue capital stock or other securities) due after the date hereof. As of the Closing, all liabilities of Denali shall have been paid off and shall in no event remain liabilities of Denali or Can-Fite following the Closing.
 
(g)     No Material Change .  Since January 1, 2011, and except as disclosed in its SEC Reports, (i) Denali has not incurred any liabilities or obligations, indirect, or contingent, or entered into any oral or written agreement or other transaction which exceeds US$2,000; (ii) Denali has not sustained any loss or interference; (iii) Denali has not paid or declared any dividends or other distributions with respect to its capital stock, or redeemed or purchased or otherwise acquired any of its stock and Denali is not in default in the payment of principal or interest on any outstanding debt obligations, except as set forth herein; (iv) Denali has not initiated any compensation arrangement or agreement with any employee or executive officer; (v) Denali has not entered into any contract; (vi) there has not been any change in the capital stock of Denali; and (vii) there has not been any other event which has caused, or is likely to cause, a material adverse effect.
 
(h)     Litigation.   There is no action, suit, claim, proceeding, inquiry or investigation before or by any court, public board, government agency, self-regulatory organization or body pending against or, to the knowledge of Denali, threatened against Denali.  Denali is not subject to any order, writ, judgment, injunction, decree or award of any court or any governmental authority.
 
(i)      Compliance .  Denali has not been advised, nor does Denali have reason to believe, that it is not conducting its business in compliance with all applicable laws, rules and regulations of the jurisdictions in which it is conducting its business.
 
(j)      Material Agreements .  All material agreements (“ Material Agreements ”) to which Denali is a party are included as part of or specifically identified in the SEC Reports to the extent required by the rules and regulations of the Commission as in effect at the time of filing.  Except for the Material Agreements, Denali has no contracts.  Neither Denali nor, to Denali’s knowledge, any other party to the Material Agreements, is in breach of or default under any of such contracts.
 
 
7

 
 
(k)     Taxes .  Except as disclosed in the SEC Reports, Denali has filed all necessary federal, state and foreign income and franchise tax returns and has paid or accrued all taxes shown as due thereon, and Denali has no knowledge of a tax deficiency which has been or might be asserted or threatened against it.
 
(l)      Conformity of Descriptions.   The Transaction Shares and the Investment Shares, when issued, will conform in all material respects to the descriptions of Denali’s Common Stock contained in Denali’s SEC Reports and other filings with the Commission.
 
(m)    Statements True and Correct. No representation, warranty, statement, certificate, instrument, or other writing furnished or to be furnished by Denali to Can-Fite or its representatives pursuant to this Agreement, or any other Transaction Agreement contains or will contain any untrue statement of material fact or will omit to state a material fact necessary to make the statements therein not misleading.
 
(n)     Investment Company.   Denali is not, and is not an affiliate of, an “investment company” within the meaning of the Investment Company Act of 1940, as amended.
 
(o)     Sarbanes-Oxley; Internal Accounting Controls .  Denali is in material compliance with all provisions of the Sarbanes-Oxley Act of 2002 which are applicable to it as of the date hereof.  Denali has disclosure controls and procedures (as defined in Rule 13a-14 under the Exchange Act) that are designed to ensure that material information relating to Denali is made known to Denali’s principal executive officer and Denali’s principal financial officer or persons performing similar functions.
 
(p)     Disclosure.   All disclosure provided to Can-Fite regarding Denali, its business and the transactions contemplated hereby, including the Transaction Agreements and the Exhibits to this Agreement, furnished by or on behalf of Denali with respect to the representations and warranties made herein are true and correct with respect to such representations and warranties and do not contain any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements made therein, in light of the circumstances under which they were made, not misleading. Denali acknowledges and agrees that Can-Fite makes or has made no representations or warranties with respect to the transaction contemplated hereby other than those specifically set forth in Section 9 hereof.
 
10.     Representations and Warranties of Can-Fite . Can-Fite and the Sub, jointly, hereby make the following representations and warranties as of the date hereof and as of the Closing to Denali:
 
(a)     Organization and Qualification.   Can-Fite and the Sub are entities duly organized, validly existing and in good standing under the laws of the State of Israel, with the requisite corporate or other power and authority to own and use their properties and assets and to carry on their business as currently conducted. Neither Can-Fite nor the Sub are in violation of any of the provisions of their Articles of Organization or other organizational documents.
 
 
8

 
 
(b)     Authorization; Enforcement.   Can-Fite and the Sub have the requisite corporate or other power and authority to enter into and to consummate the transactions contemplated by each of the Transaction Agreements to which they are a party and otherwise to carry out their respective obligations thereunder.  The execution and delivery of each of the Transaction Agreements to which they are a party by Can-Fite or the Sub and the consummation by them of the transactions contemplated thereby have been duly authorized by all necessary action on the part of Can-Fite or the Sub and no further action is required by Can-Fite or the Sub, their board of directors, managers or their shareholders in connection therewith. Each Transaction Agreement has been (or, if executed after the date hereof, upon delivery will be) duly executed by Can-Fite and, when delivered in accordance with the terms hereof, will constitute the valid and binding obligation of Can-Fite enforceable against Can-Fite in accordance with its terms except (i) as limited by applicable bankruptcy, insolvency, reorganization, moratorium and other laws of general application affecting enforcement of creditors’ rights generally and (ii) as limited by laws relating to the availability of specific performance, injunctive relief or other equitable remedies.
 
(c)     No Conflicts.   The execution, delivery and performance of the Transaction Agreements by Can-Fite and the Sub and the consummation by Can-Fite and the Sub of the transactions contemplated thereby do not and will not (i) conflict with or violate any provision of Can-Fite or the Sub's Articles of Association or other organizational documents, or (ii) conflict with, or constitute a default (or an event that with notice or lapse of time or both would become a default) under, or give to others any rights of termination, amendment, acceleration or cancellation (with or without notice, lapse of time or both) of, any agreement or other understanding to which Can-Fite or the Sub is a party, or (iii) result in a violation of any law, rule, regulation, order, judgment, injunction, decree or other restriction of any court or governmental authority to which Can-Fite or the Sub is subject (including U.S. federal and state securities laws and regulations).
 
(d)     Filings, Consents and Approvals.   Can-Fite is not required to obtain any consent, waiver, authorization or order of, give any notice to, or make any filing or registration with, any court or other U.S. federal, state, local or other governmental authority or other person in connection with the execution, delivery and performance by Can-Fite or the Sub of the Transaction Agreements, other than the filing with the Tel-Aviv Stock Exchange of an immediate report setting out the details of the Transaction hereunder.
 
(e)     Capitalization.   As of immediately prior to the Closing, the authorized capital stock of the Sub consisted (or will consist) solely of 10,000 Ordinary Shares, nominal value NIS 0.01 each (the " Ordinary Shares "), of which 1,000 Ordinary Shares were issued and outstanding and owned by Can-Fite. All of such outstanding Ordinary Shares are, duly authorized, validly issued, fully paid and nonassessable, and free and clear of all liens created by Can-Fite or the Sub.  Except as set forth herein, as of the Closing, there will be no rights, subscriptions, warrants, options, conversion rights, or agreements of any kind outstanding to purchase from the Sub, or otherwise require the Sub to issue, any shares of capital stock of the Sub or securities or obligations of any kind convertible into or exchangeable for any shares of capital stock of the Sub.
 
 
9

 

(f)      Litigation.   There is no action, suit, claim, proceeding, inquiry or investigation before or by any court, public board, government agency, self-regulatory organization or body pending against or, to the knowledge of Can-Fite or the Sub, threatened against the Sub. The Sub is not subject to any order, writ, judgment, injunction, decree or award of any court or any governmental authority.
 
(g)     Compliance .  The Sub has not been advised, nor does the Sub have reason to believe, that it is not conducting its business in compliance with all applicable laws, rules and regulations of the jurisdictions in which it is conducting its business.
 
(h)     License Agreement . Can-Fite has the full authority and the power to executed the License Agreement in favor of the Sub. The execution of the License Agreement by Can-Fite in favor of the Sub will not violate or breach any other agreement to which Can-Fite is a party.
 
(i)      Taxes .  The Sub has no tax obligations nor any current requirement to file any tax returns.
 
(j)      Statements True and Correct. No representation, warranty, statement, certificate, instrument, or other writing furnished or to be furnished by Can-Fite to Denali or its representatives pursuant to this Agreement, or any other document, agreement, or instrument referred to herein contains or will contain any untrue statement of material fact or will omit to state a material fact necessary to make the statements therein not misleading.
 
11.     Pre-Closing Covenants . Can-Fite and Denali hereby agree that the following are pre-Closing obligations to be performed by the parties hereto:
 
(a)     Due Diligence . Denali will provide full access to Can-Fite and its advisors to conduct a reasonable investigation of information and materials relating to Denali's financial, business and legal condition and Can-fite will provide full access to Denali and its advisors to conduct a reasonable investigation of information and materials relating to the Sub's financial, business and legal condition. The due diligence period shall commence on the full execution of this Agreement by the Parties and shall terminate when the items listed above have been received and reviewed to the satisfaction of each Party (“ Due Diligence Period ”).
 
(b)     Standstill . From the date on which this Agreement is executed by the Parties through the closing date for the Transaction, but no later than November 30, 2011, Denali will not explore or pursue other transaction opportunities with any other individual or entity, including, without limitation (1) solicit, initiate, or encourage the submission of any proposal or offer from any person relating to the acquisition of any capital stock or other voting securities of Denali or any assets of Denali (including any acquisition structured as a merger, consolidation, share exchange or other business combination), or (2) participate in any discussions or negotiations regarding, furnish any information with respect to, assist or participate in, or facilitate in any other manner any effort or attempt by any person to do or seek any of the foregoing, in each case except as may be required on the reasonable advice of outside legal counsel pursuant to fiduciary duties under applicable law.
 
(c)     Board Approvals . Consistent with and subject to fiduciary duties imposed on their boards of directors, Denali and Can-Fite shall use commercially reasonable efforts to cause the Transaction Agreements to be approved and ratified by their respective boards of directors and, if required by law, by their respective stockholders.
 
 
10

 
 
12.     Post-Closing Covenants . Can-Fite and Denali hereby agree that the following are post-Closing obligations to be performed by the parties hereto:
 
(a)     Constitution of the Board of Denali . Immediately following the Closing, Can-Fite shall cause the enlargement of the Board of Denali so that it shall initially consist of 5 directors who shall be appointed by Can-Fite, of which 3 shall be current directors of Can-Fite and 2 shall be newly appointed independent directors who have an added value to the positioning of Denali on the US capital markets and the US biotech market. Prof. Pnina Fishman will be appointed as the Chairman of the Board of Denali.
 
(b)     Management . Denali shall seek to appoint a CEO and a CFO in order to commence the establishment of a management team to lead Denali following the Closing and during the clinical trials and future capital markets activity in the US.
 
(c)     Form 8-K .  Denali shall file, within four (4) business days of the Closing, a current report on Form 8-K with the Commission disclosing the terms of this Agreement and other requisite disclosure regarding the Transactions and including the requisite audited consolidated financial statements and requisite Form 10 disclosure.
 
13.     Miscellaneous
 
(a)     Expenses . It is understood that each Party shall pay its respective legal and accounting fees and other expenses incurred in connection with this Agreement and due diligence activities under Section 11(a) above, and in connection with the Transaction.
 
(b)     Announcements . Except to the extent the Parties believe that they are required by applicable law or regulation to do otherwise, prior to execution of Transaction Agreements, no Party shall issue any statement or communication to the public regarding the proposed Transaction without the consent of the other Party, which consent shall not be unreasonably withheld, and each Party shall keep the proposed Transaction and information obtained from the other Party confidential in accordance with the terms of this paragraph. To the extent a Party hereto believes it is required by law or regulation to disclose the proposed Transaction, it shall, if possible, immediately notify the other Party prior to such disclosure and give the other Party an opportunity to review and comment on the proposed disclosure.
 
(c)      Governing Law, Dispute Resolution, and Jurisdiction .  This Agreement shall be governed by and construed in accordance with the laws of the State of New York, without regard to the conflicts of laws principles thereof.  All disputes, controversies or claims arising out of or relating to this Agreement shall in the first instance be the subject of a meeting between a representative of each Party who has decision-making authority.
 
(d)     Access to Information and Confidentiality . In connection with the negotiation and preparation of the Transaction Agreements, each Party will make available to the other, and their respective representatives, all books, records, documents and other information that may reasonably be requested. Prior to the closing, each Party shall keep confidential any non-public information obtained from the other Party hereto. In the event of termination of negotiations, each Party will return or cause to be returned to the other all documents and other material obtained from the other in connection with the Transaction contemplated hereby and will use all reasonable efforts to keep confidential any such information, unless such information is ascertainable from public or published information or already known by the receiving Party.
 
 
11

 
 
(e)     Agreement Binding .  The provisions of this Agreement are intended to be binding on the Parties from the date hereof and shall cease to be binding on November 30, 2011 if the Closing is not completed by such time (or such other time if mutually extended in writing by the Parties).
 
(f)      Assignment .  Neither this Agreement nor any of the rights, interests or obligations under this Agreement shall be assigned, in whole or in part, by operation of law or otherwise by either of the Parties without the prior written consent of the other Party. Any purported assignment without such consent shall be void. Subject to the preceding sentences, this Agreement will be binding upon, inure to the benefit of, and be enforceable by, the Parties and their respective successors and assigns.
 
(g)     Remedies .  In addition to being entitled to exercise all rights provided herein or granted by law, including recovery of damages, Can-Fite shall be entitled to specific performance under this Agreement. The Parties agree that monetary damages may not be adequate compensation for any loss incurred by Can-Fite by reason of any breach of obligations described in the foregoing sentence and hereby agrees to waive in any action for specific performance of any such obligation the defense that a remedy at law would be adequate.
 
(h)     Amendment .  This Agreement may only be amended, modified or supplemented pursuant to a written agreement signed by each of the Parties hereto.
 
(i)      Survival of Representations and Warranties .  All covenants, representations and warranties made herein shall survive the making of this Agreement and shall continue in full force and effect until the Closing, at the end of which period no claim may be made with respect to any such covenant, representation, or warranty unless such claim shall have been asserted in writing to the indemnifying party during such period.

(j)      Notices .  Any notice, demand, request, waiver or other communication required or permitted to be given hereunder shall be in writing or electronic format, as applicable, and shall be effective (i) upon delivery in person (including by reputable express courier service) at the address set forth below; (ii) upon delivery by facsimile (as verified by a printout showing satisfactory transmission) at the facsimile number designated below (if sent on a business day during normal business hours where such notice is to be received and if not, on the first business day following such delivery where such notice is to be received); (iii) by electronic mail (as verified by a printout showing satisfactory transmission) at the electronic mail address set forth below (if sent on a business day during normal business hours where such notice is to be received and if not, on the first business day following such delivery where such notice is to be received); or (iv) upon three business days after mailing with the United States Postal Service if mailed from and to a location within the continental United States by registered or certified mail, return receipt requested, addressed to the address set forth below.  Any party hereto may from time to time change its physical or electronic address or facsimile number for notices by giving notice of such changed address or number to the other party hereto in accordance herewith.

 
12

 
 
If to Denali at:
 
123 West Nye Lane, Suite 129
   
Carson City, NV  89706
   
Attention:  Mathew G. Rule, President
   
Facsimile No.:
   
Email Address:  mathewrule@ymail.com
     
With a copy (which shall not
constitute notice) to:
 
 
Ronald N. Vance
   
Attorney at Law
   
1656 Reunion Avenue
   
Suite 250
   
South Jordan, UT  84095
   
Facsimile No.  (801) 446-8803
   
Email Address:   ron@vancelaw.us
     
If to Can-Fite at:
 
10 Bareket Street,
   
Petach Tikva, Israel
   
Attention: Prof. Pnina Fishman, CEO
   
Facsimile No.:
   
Email Address: pnina@canfite.com
     
With a copy (which shall not
constitute notice) to:
 
Kantor & Co.
12 Abba Hillel Street,
Ramat Gan, Israel
   
Attention:  Ronen Kantor, Adv.
   
Facsimile No.: +972-3-6133372
   
Email Address: rkantor@kantor-law.com
 
With a copy (which shall not
constitute notice) to:
 
 
Goodwin Procter LLP
4365 Executive Drive
Suite 300
San Diego, CA 92121
Attention:  Yoel Krantz
   
Facsimile No.: (212) 813-8831
Email Address: ykrantz@goodwinprocter.com
 
(k)     Waivers .   The failure of a party hereto at any time or times to require performance of any provision hereof shall in no manner affect the right of such party at a later time to enforce the same.  No waiver by a party of any condition or of any breach of any term, covenant, representation or warranty contained in this Agreement shall be effective unless in writing, and no waiver in any one or more instances shall be deemed to be a further or continuing waiver of any such condition or breach in other instances or a waiver of any other condition or breach of any other term, covenant, representation or warranty.
 
(l)      Interpretation .  The headings preceding the text of sections included in this Agreement are for convenience only and shall not be deemed part of this Agreement or be given any effect in interpreting this Agreement.  The use of the masculine, feminine or neuter gender herein shall not limit any provision of this Agreement.  The use of the terms “including” or “include” shall in all cases herein mean “including, without limitation” or “include, without limitation,” respectively.

 
13

 
 
(m)    Attorneys’ Fees .  If any legal action or other proceeding is brought for the enforcement of this Agreement, or because of an alleged dispute, breach, default, or misrepresentation in connection with any of the provisions of this Agreement, the successful or prevailing party or parties will be entitled to recover reasonable attorneys’ fees and other costs incurred in that action or proceeding, in addition to any other relief to which it or they may be entitled.
 
(n)     No Third Party Beneficiaries .  This Agreement is solely for the benefit of the parties hereto and, to the extent provided herein, their respective directors, officers, employees, agents and representatives, and no provision of this Agreement shall be deemed to confer upon other third parties any remedy, claim, liability, reimbursement, cause of action or other right.
 
(o)     Further Assurances .  Upon the reasonable request of a Party hereto, the other Party hereto shall, on and after the Closing, execute and deliver such other documents, releases, assignments and other instruments as may be required to effectuate completely the transactions contemplated by this Agreement.
 
(p)     Severability .  If any provision of this Agreement shall be held invalid, illegal or unenforceable, the validity, legality or enforceability of the other provisions hereof shall remain in full force and shall not be affected thereby, and there shall be deemed substituted for such invalid, illegal or unenforceable provision a valid, legal and enforceable provision as similar as possible to the provision at issue.
 
(q)     Remedies Cumulative .  The remedies provided in this Agreement shall be cumulative and shall not preclude the assertion or exercise of any other rights or remedies available by law, in equity or otherwise.
 
(r)      Entire Understanding .  This Agreement sets forth the entire agreement and understanding of the parties hereto and supersedes all prior agreements, letters of intent or understanding, arrangements and understandings between the parties. This Agreement replaces in full the Agreement of June 5, 2011 between the parties, as amended.
 
(s)      Exhibits and Schedules . Each of the exhibits, schedules, or similar attachments referenced in this Agreement is annexed hereto and is incorporated herein by this reference and expressly made a part hereof.
 
(t)      Counterparts .  This Agreement may be executed in counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.  Facsimile transmissions of any signed original document, or transmission of any signed facsimile document, shall constitute delivery of an executed original.  At the request of any of the parties, the parties shall confirm facsimile transmission signatures by signing and delivering an original document.

SIGNATURE PAGE FOLLOWS
 
 
14

 
 
SIGNATURE PAGE
 
IN WITNESS WHEREOF, each of the Parties has executed this Agreement on the day and year herein below written.

Can-Fite Biopharma Ltd.
 
Denali Concrete Management, Inc.,
BY:
Pnina Fishman Motti Farbstein  
BY:
Mathew G. Rule
TITLE:
CEO
COO
 
TITLE:
President
           
DATE:
November 21, 2011
   
DATE:
November 21, 2011
SIGNATURE: /s/ Pnina Fishman /s/Motti Farbstein   SIGNATURE: /s/ Mathew G. Rule
       
 
 
 
15

 
Exhibit 4.1

THIS WARRANT AND THE SECURITIES ISSUABLE UPON THE EXERCISE HEREOF HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933 AS AMENDED (THE “SECURITIES ACT”).  THEY MAY NOT BE SOLD, OFFERED FOR SALE, PLEDGED, HYPOTHECATED, OR OTHERWISE TRANSFERRED EXCEPT PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT, OR AN OPINION OF COUNSEL SATISFACTORY TO THE COMPANY THAT REGISTRATION IS NOT REQUIRED UNDER SUCH ACT OR UNLESS SOLD PURSUANT TO RULE 144 UNDER SUCH ACT.
 
WARRANT TO PURCHASE COMMON STOCK
 
OF
 
DENALI CONCRETE MANAGEMENT, INC.
 
This Warrant is issued to Can-Fite Biopharma Ltd. (the “Holder”) by DENALI CONCRETE MANAGEMENT, INC., a corporation formed under the laws of the State of Nevada (the “Company”), on November 21, 2011 (the “Warrant Issue Date”).  This Warrant shall expire and become void on the earlier of: (i) the date that is sixty (60) months from the Warrant Issue Date, or (ii) the closing of the acquisition of the Company by another entity by means of merger, consolidation or other transaction or series of related transactions, resulting in the exchange of the outstanding shares of the Company’s capital stock such that the stockholders of the Company prior to such transaction own, directly or indirectly, less than 50% of the voting power of the surviving entity (“Expiration Date”).
 
1.            Purchase of Shares .  Subject to the terms and conditions hereinafter set forth, the holder of this Warrant is entitled, upon surrender of this Warrant at the principal offices of the Company (or at such other place as the Company shall notify the holder hereof in writing), to purchase from the Company up to 2,160,102 fully paid and nonassessable shares of Common Stock, par value $0.01 per share, of the Company (the “Shares” or the “Warrant Shares”), as more fully described below. The number of Shares issuable pursuant to this Section 1 shall be subject to adjustment pursuant to Section 10 hereof.
 
2.            Purchase Price .  The per share purchase price (the “Exercise Price”) for the Shares shall be as follows: (i) in the event that within 12 months of the Warrant Issue Date, Company or its affiliates complete any transaction which has an aggregate value of more than US$100 Million (inclusive of any amounts that are held in escrow, subject to earn-outs, development or commercial milestone or any other contingencies and aggregate potential royalty payments based on market projections), then the par value of the shares of Common Stock, and (ii) at any other time, then $1.144.
 
3.            Exercise Period .  This Warrant may be exercised at the sole discretion of the Holder in whole or in part any time prior to the Expiration Date.
 
4.            Method of Exercise .  While this Warrant remains outstanding and exercisable in accordance with Section 3 above, the Holder may exercise, in whole or in part, the purchase rights evidenced hereby.  Such exercise shall be effected by:
 
(i)                      the surrender of this Warrant, together with a duly executed copy of the form of subscription attached hereto (“Notice of Exercise”), to the Secretary of the Company at its principal offices; and
 
(ii)                     the payment to the Company of an amount equal to the aggregate Exercise Price for the number of Shares being purchased.

 
1

 

5.            Net Exercise .  In lieu of the payment method set forth in Section 4 above, the Holder may elect, at anytime, to exchange the Warrant for a number of Warrant Shares equal to the increase in value of the Warrant Shares otherwise purchasable hereunder on the date of exchange.  If the Holder elects to exchange this Warrant as provided in this Section 5, the Holder shall tender to the Company, at the principal office of the Company, the Warrant along with the Notice of Exercise, and the Company shall issue to the Holder the number of Warrant Shares computed using the following formula:
 
X = Y (A-B)
A

Where X = the number of Warrant Shares to be issued to the Holder.

Y = the number of shares of Warrant Shares purchasable under the Warrant (as adjusted to the date of such calculation, but excluding those shares already issued under this Warrant).

A = the Fair Market Value (as defined below) of one share of the Warrant Shares.

B = Per Share Exercise Price (as adjusted to the date of such calculation).

“Fair Market Value” of a Warrant Share shall mean:

(i)           If the Company’s Ordinary Shares are listed on a national securities exchange or is quoted on the National Association of Securities Dealers, Inc. Automated Quotation/National Market System (NASDAQ/NMS), then the average closing or last sale price, respectively, reported for the five (5) trading days prior to the exercise date.

(ii)          If the Company’s Ordinary Shares are not listed on a national securities exchange or quoted on NASDAQ/NMS, but are traded in the over-the-counter market, then the average of the mean of the closing bid and asked prices as reported for the five (5) trading days prior to the exercise date.

(iii)        Except as set forth in sub-section 5 iv (below), if the Company’s Common Stock is not publicly traded, then as determined by the Company's Board of Directors in good faith.

(iv)        If the Exercise Date is the date of closing of a public offering of the Company's Common Stock pursuant to an effective registration statement under the Securities Act, as amended, then the public offering price (before deduction of discounts, commissions or expenses) in such offering.

In the event of a net exercise, the entire Warrant must be exercised and surrendered, and no new Warrant shall be issued.

6.            Certificates for Shares .  Upon the exercise of the purchase rights evidenced by this Warrant, one or more certificates for the number of Shares so purchased shall be issued as soon as practicable thereafter, and in any event within ten (10) days of the delivery of the Notice of Exercise.

 
2

 

7.            Issuance of Shares .  The Company covenants that the Shares, when issued pursuant to the exercise of this Warrant, will be duly and validly issued, fully paid and nonassessable and free from all taxes, liens, and charges with respect to the issuance thereof.
 
8.            Replacement of Warrant . On receipt of evidence reasonably satisfactory to the Company of the loss, theft, destruction or mutilation of this Warrant and, in the case of loss, theft or destruction, on delivery of an indemnity agreement reasonably satisfactory in form and substance to the Company or, in the case of mutilation, on surrender and cancellation of this Warrant, the Company at its expense shall execute and deliver, in lieu of this Warrant, a new warrant of like tenor and amount.
 
9.            Reservation of Stock .   The Company covenants that during the term this Warrant is exercisable, the Company will reserve from its authorized and unissued shares of Common Stock a sufficient number of shares to provide for the issuance of Common Stock upon the exercise of this Warrant and, from time to time, will take all steps necessary to amend its Certificate of Incorporation (the “Certificate”) to provide sufficient reserves of shares of Common Stock issuable upon exercise of this Warrant. The Company further covenants that all shares that may be issued upon the exercise of rights represented by this Warrant and payment of the Exercise Price, all as set forth herein, will be free from all liens and charges in respect of the issue thereof.  The Company agrees that its issuance of this Warrant shall constitute full authority to its officers who are charged with the duty of executing stock certificates to execute and issue the necessary certificates for shares of Common Stock upon the exercise of this Warrant.
 
10.          Adjustment of Exercise Price and Number of Shares . The Exercise Price and the number of shares purchasable hereunder are subject to adjustment from time to time as follows:
 
(a)            Reorganization, Sale of Assets, etc.   If at any time while this Warrant, or any portion thereof, is outstanding and unexpired there shall be (i) a reorganization (other than a combination, reclassification, exchange or subdivision of shares otherwise provided for herein),  (ii) a merger or consolidation of the Company with or into another corporation in which the Company is the surviving entity, or a reverse triangular merger in which the Company is the surviving entity but the shares of the Company’s capital stock outstanding immediately prior to the merger are converted by virtue of the merger into other property, whether in the form of securities, cash, or otherwise, or (ii) a sale or transfer of the Company’s properties and assets as, or substantially as, an entirety to any other person, then, as a part of such reorganization, sale or transfer, lawful provision shall be made so that the holder of this Warrant shall thereafter be entitled to receive upon exercise of this Warrant, during the period specified herein and upon payment of the Exercise Price then in effect, the number of shares of stock or other securities or property of the successor corporation resulting from such reorganization, sale or transfer that a holder of the shares deliverable upon exercise of this Warrant would have been entitled to receive in such reorganization, sale or transfer if this Warrant had been exercised immediately before such reorganization,  sale or transfer, all subject to further adjustment as provided in this Section 10. The foregoing provisions of this Section 10(a) shall similarly apply to successive reorganizations, sales and transfers and to the stock or securities of any other corporation that are at the time receivable upon the exercise of this Warrant. If the per share consideration payable to the Holder hereof for shares in connection with any such transaction is in a form other than cash of marketable securities, then the value of such consideration shall be determined in good faith by the Company’s Board of Directors. In all events, appropriate adjustment (as determined in good faith by the Company’s Board of Directors) shall be made in the application of the provisions of this Warrant with respect to the rights and interests of the Holder after the transaction, to the end that the provisions of this Warrant shall be applicable after that event, as near as reasonably may be, in relation to any shares or other property deliverable after that event upon exercise of this Warrant.

 
3

 

(b)            Reclassification, etc. If the Company, at any time while this Warrant, or any portion hereof, remains outstanding and unexpired by reclassification of securities or otherwise, shall change any of the securities as to which purchase rights under this Warrant exist into the same or a different number of securities of any other class or classes, this Warrant shall thereafter represent the right to acquire such number and kind of securities as would have been issuable as the result of such change with respect to the securities that were subject to the purchase rights under this Warrant immediately prior to such reclassification or other change and the Exercise Price therefor shall be appropriately adjusted, all subject to further adjustment as provided in this Section 10.
 
(c)            Split, Subdivision or Combination of Shares.   If the Company at any time while this Warrant, or any portion hereof, remains outstanding and unexpired shall split, subdivide or combine the securities as to which purchase rights under this Warrant exist, into a different number of securities of the same class, the Exercise Price for such securities shall be proportionately decreased in the case of a split or subdivision or proportionately increased in the case of a combination.
 
(d)            Adjustments for Dividends in Stock or Other Securities or Property. If while this Warrant, or any portion hereof, remains outstanding and unexpired, the holders of the securities as to which purchase rights under this Warrant exist at the time shall have received, or, on or after the record date fixed for the determination of eligible stockholders, shall have become entitled to receive, without payment therefor, other or additional stock or other securities or property (other than cash) of the Company by way of dividend, then and in each case, this Warrant shall represent the right to acquire, in addition to the number of shares of the security receivable upon exercise of this Warrant, and without payment of any additional consideration therefor, the amount of such other or additional stock or other securities or property (other than cash) of the Company that such holder would hold on the date of such exercise had it been the holder of record of the security receivable upon exercise of this Warrant on the date hereof and had thereafter, during the period from the date hereof to and including the date of such exercise, retained such shares and/or all other additional stock available by it as aforesaid during such period, giving effect to all adjustments called for during such period by the provisions of this Section 10.
 
(e)            Certificate as to Adjustments.   Upon the occurrence of each adjustment or readjustment pursuant to this Section 10, the Company at its expense shall promptly compute such adjustment or readjustment in accordance with the terms hereof and furnish to each Holder of this Warrant a certificate setting forth such adjustment or readjustment and showing in detail the facts upon which such adjustment or readjustment is based. The Company shall, upon the written request, at any time, of any such Holder, furnish or cause to be furnished to such Holder a like certificate setting forth: (i) such adjustment and readjustment; (ii) the Exercise Price at the time in effect; and (iii) the number of shares and the amount, if any, of other property that at the time would be received upon the exercise of the Warrant.

 
4

 

(f)            No Impairment. The Company will not, by any voluntary action, avoid or seek to avoid the observance or performance of any of the terms to be observed or performed hereunder by the Company, but will at all times in good faith assist in the carrying out of all the provisions of this Section 10 and in the taking of all such action as may be necessary or appropriate in order to protect the rights of the Holder of this Warrant against impairment.
 
11.          No Fractional Shares or Scrip .  No fractional shares or scrip representing fractional shares shall be issued upon the exercise of this Warrant, but in lieu of such fractional shares the Company shall make a cash payment therefor on the basis of the Exercise Price then in effect.
 
12.          No Shareholder Rights .  Prior to exercise of this Warrant, the Holder shall not be entitled to any rights of a shareholder with respect to the Shares, including (without limitation) the right to vote such Shares, receive dividends or other distributions thereon, exercise preemptive rights or be notified of shareholder meetings, and such holder shall not be entitled to any notice or other communication concerning the business or affairs of the Company.
 
13.          Tax Consequences .  All tax consequences and obligations regarding any other compulsory payments arising from the grant or exercise of this Warrant, from the payment for, or the subsequent disposition of the Warrant Shares or from any other event or act (of the Company or the Holder) hereunder, shall be borne solely by the Holder, and the Holder shall indemnify the Company and hold it harmless against and from any and all liability for any such tax or other compulsory payments or interest or penalty thereon, including without limitation, liabilities relating to the necessity to withhold, or to have withheld, any such tax or other compulsory payments.
 
14.          Successors and Assigns .  The terms and provisions of this Warrant shall inure to the benefit of, and be binding upon, the Company its successors and assigns.  This Warrant cannot be assigned or transferred by the Holder without the express written consent of the Company.  Notwithstanding the foregoing, this Warrant may, upon prior written notice to the Company, be assigned, sold or otherwise transferred (i) if the Holder is a Company, to any entity controlled by, controlling, or under common control with such Holder and (ii) if the Holder is a limited or general partnership, to its partners and to affiliated partnerships managed by the same management company or managing (general) partner or by an entity which controls, is controlled by, or is under common control with, such management company or managing (general) partner, provided, that such assignment, sale, or transfer complies with applicable laws, rules and regulations, provided, further, that the transferee agrees to be bound by the terms hereof and of the Investors’ Rights Agreement.
 
15.          Amendments and Waivers .  Any term of this Warrant may be amended and the observance of any term of this Warrant may be waived (either generally or in a particular instance and either retroactively or prospectively), with the written consent of the Company and the Holder.  Any waiver or amendment effected in accordance with this Section shall be binding upon the Holder, each holder of any Shares purchased under this Warrant at the time outstanding (including securities into which such Shares have been converted), each future holder of all such Shares, and the Company.
 
16.     Governing Law,   Jurisdiction .  This Warrant shall be governed by and construed according to the laws of the State of Delaware, without regard to the conflict of laws provisions thereof.  Any dispute arising under or in relation to this Warrant shall be resolved exclusively in the United States federal and state courts of the State of Delaware, and each of the parties hereby submits irrevocably to the exclusive jurisdiction of such court.

 
5

 

17.       Notices.   All notices required under this Warrant shall be in writing and shall be telecopied or mailed by registered or certified mail, postage prepaid, or otherwise delivered by hand or by messenger, addressed to such party's address as set forth below or at such other address as the party shall have furnished to each other party in writing in accordance with this provision:
 
if to the Holder:
Can-Fite Biopharma Ltd.
10 Barket Street,
Petach Tikva, Israel
Facsimile:

with a copy (which shall not constitute notice) to:
Ronen Kantor, Adv.
Kantor & Co.
Sasson Chugi House
12 Abba Hillel Street, Ramat Gan, Israel
Facsimile:  (972-3) 613-3372
 
if to the Company:
Denali Concrete Management Inc.
___________________
___________________
Facsimile:  _______________________

with a copy (which shall not constitute notice) to:
________________
________________
Facsimile:  ________________________

or such other address with respect to a party as such party shall notify each other party in writing as above provided.  Any notice sent in accordance with this Section 17 shall be effective (i) if mailed, seven (7) business days after mailing, (ii) if sent by messenger, upon delivery, and (iii) if sent via telecopier, upon transmission and electronic confirmation of receipt or (if transmitted and received on a non-business day) on the first business day following transmission and electronic confirmation of receipt (provided, however, that any notice of change of address shall only be valid upon receipt).

IN WITNESS WHEREOF, the Company has caused this Warrant to be executed by an officer thereunto duly authorized.

 
DENALI CONCRETE MANAGEMENT INC.
 
By:
/s/ Matthew G. Rule
 
Name:
Mathew G. Rule
 
Title:
President

 
6

 

NOTICE OF EXERCISE

DENALI CONCRETE MANAGEMENT INC.
[address]

The undersigned hereby elects to purchase, pursuant to the provisions of the Warrant to purchase shares of Common Stock issued by DENALI CONCRETE MANAGEMENT, INC. and held by the undersigned,   ___________ shares of Common Stock of DENALI CONCRETE MANAGEMENT, INC.

_______         Payment of the exercise price per share required under such Warrant is attached hereto; or

_______           Exercise of the Warrant is by way of Net Exercise in accordance with Section 5 of the Warrant.

Dated: ____________
Holder:
   
 
By:
   
 
Name:
   
 
Title:
   
 
Address:
   
       
       

Exercise Date:
   

Name in which shares should be registered: _____________________________

 
 

 
Exhibit 10.1

DENALI CONCRETE MANAGEMENT, INC.
STOCK PURCHASE AGREEMENT
 
This STOCK PURCHASE AGREEMENT (this “ Agreement ”) is made as of November 21, 2011 by and between Denali Concrete Management, Inc., a Nevada corporation (the “ Company ”) and Can-Fite Biopharma Ltd. (“ Can-Fite ”).
 
BACKGROUND
 
A.           Can-Fite currently holds an aggregate of 1,000 shares of common stock, par value NIS 0.01 per share (the “ Eye-Fite Common Stock ”), of Eye-Fite Ltd. (“ Eye-Fite ”).  Can-Fite is the sole holder of all issued and outstanding shares of the Eye-Fite Common Stock.
 
B.           In accordance with the terms of that certain agreement entered into between the Company and Can-Fite on November 21, 2011, (the “ Master Agreement ”) Can-Fite desires to surrender all 1,000 shares of Eye-Fite Common Stock that it holds in consideration for a total of 36,000,000 shares of common stock, par value $0.001 per share, of the Company (the “ Shares ”), and the Company desires to issue and sell the Shares to Can-Fite in consideration for the surrender hereunder of the Eye-Fite Common Stock.
 
AGREEMENT
 
NOW, THEREFORE, in consideration of the foregoing recitals and the mutual promises, representations, warranties and covenants hereinafter set forth and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereby agree as follows:
 
 
1.
Sale and Issuance of Shares .
 
1.1          Sale and Issuance of the Shares; Closing .  Subject to the terms and conditions of this Agreement, Can-Fite agrees to purchase the Shares at the Closing (as defined below), and the Company agrees to sell and issue the Shares to Can-Fite at the Closing.  The purchase and sale of the Shares shall take place remotely via the exchange of documents and signatures on the date hereof, or at such other time and place as the Company and Can-Fite mutually agree upon, orally or in writing (which time and place are designated as the “ Closing ”).
 
1.2          Delivery; Payment .  The stock certificates representing the Shares shall be issued in two certificates, one representing 31,000,000 of the Shares and the other for 5,000,000 of the Shares.  At the Closing, subject to the terms and conditions hereof, the Company will deliver to Can-Fite the first certificate representing 31,000,000 of the Shares against payment of the aggregate purchase price by surrender of a stock certificate representing the Eye-Fite Common Stock.  The second certificate representing 5,000,000 of the Shares shall be delivered to Can-Fite by overnight delivery service for delivery the day following Closing.  At Closing Denali shall deliver a copy of the certificate issued by the transfer agent representing the 5,000,000 Shares and tracking information for the overnight delivery of the physical certificate.  Such stock certificate surrendered by Can-Fite shall be accompanied by a stock power duly executed in favor of the Company and in a form reasonably acceptable to the Company, free from any charge, lien, encumbrance or adverse claim of any kind whatsoever.  The Shares issued to Can-Fite shall have all the rights and privileges attached to the shares of the Company’s common stock as set forth in the Company’s Articles of Incorporation, as in effect on the date hereof and as may be amended from time to time.

 
1

 

2.        Representations and Warranties of the Company .  The Company hereby represents and warrants to Can-Fite that, as of the date hereof:
 
2.1          Organization, Good Standing and Qualification .  The Company is a corporation duly organized, validly existing and in good standing under the laws of the State of Nevada.
 
2.2          Authorization .  All corporate action on the part of the Company, its officers, directors and stockholders necessary for the authorization, execution and delivery of this Agreement and the performance of all obligations of the Company hereunder, including the authorization, issuance, sale and delivery of the Shares has been taken or will be taken prior to the Closing.  This Agreement constitutes valid and legally binding obligations of the Company, enforceable against the Company in accordance with its terms, except (a) as limited by applicable bankruptcy, insolvency, reorganization, moratorium and other laws of general application affecting enforcement of creditors’ rights generally and (b) as limited by laws relating to the availability of specific performance, injunctive relief or other equitable remedies.
 
2.3          Valid Issuance of Common Stock .  The Shares, when issued, sold and delivered in accordance with the terms of this Agreement for the consideration expressed herein, will be duly and validly issued, fully paid and non-assessable.
 
3.        Representations, Warranties and Covenants of Can-Fite .  Can-Fite hereby represents and warrants to the Company that, as of the date hereof:
 
3.1          Authorization .  Can-Fite has full power and authority to enter into this Agreement.  This Agreement, when executed and delivered by Can-Fite, will constitute a valid and legally binding obligation of Can-Fite, enforceable in accordance with its terms, except as limited by applicable bankruptcy, insolvency, reorganization, moratorium, fraudulent conveyance, and any other laws of general application affecting enforcement of creditors’ rights generally, and as limited by laws relating to the availability of specific performance, injunctive relief, or other equitable remedies.
 
3.2          Purchase Entirely for Own Account .  This Agreement is made with Can-Fite in reliance upon Can-Fite’s representation to the Company, which by Can-Fite’s execution of this Agreement, Can-Fite hereby confirms that the Shares to be acquired by Can-Fite will be acquired for investment for Can-Fite’s own account, not as a nominee or agent, and not with a view to the resale or distribution of any part thereof, and that Can-Fite has no present intention of selling, granting any participation in, or otherwise distributing the same.  By executing this Agreement, Can-Fite further represents that Can-Fite does not presently have any contract, undertaking, agreement or arrangement with any Person (defined below) to sell, transfer or grant participations to such Person or to any third Person, with respect to any of the Shares.  For the purposes of this Agreement “ Person ” shall mean any individual, corporation, partnership, trust, limited liability company, association or other entity.

 
2

 

3.3          Restricted Securities .  Can-Fite understands that the Shares have not been, and will not be, registered under the Securities Act of 1933, as amended (the “ Securities Act ”), by reason of a specific exemption from the registration provisions of the Securities Act which depends upon, among other things, the bona fide nature of the investment intent and the accuracy of Can-Fite’s representations as expressed herein.  Can-Fite understands that the Shares are “restricted securities” under applicable U.S. federal and state securities laws and that, pursuant to these laws, Can-Fite must hold the   Shares indefinitely unless they are registered with the Securities and Exchange Commission and qualified by state authorities, or an exemption from such registration and qualification requirements is available.  Can-Fite acknowledges that the Company has no obligation to register or qualify the Shares for resale.  Can-Fite further acknowledges that if an exemption from registration or qualification is available, it may be conditioned on various requirements including, but not limited to, the time and manner of sale, the holding period for the Shares, and on requirements relating to the Company which are outside of Can-Fite’s control, and which the Company is under no obligation   and may not be able to satisfy.  Can-Fite represents and warrants that it is an “accredited investor” as defined in Rule 501(a) of Regulation D promulgated under the Securities Act.
 
3.4          Legends .  Can-Fite understands that the Shares may bear one or all of the following legends:
 
(a)           “THE SHARES REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AND HAVE BEEN ACQUIRED FOR INVESTMENT AND NOT WITH A VIEW TO, OR IN CONNECTION WITH, THE SALE OR DISTRIBUTION THEREOF.  NO SUCH TRANSFER MAY BE EFFECTED WITHOUT AN EFFECTIVE REGISTRATION STATEMENT RELATED THERETO OR AN OPINION OF COUNSEL IN A FORM SATISFACTORY TO THE COMPANY THAT SUCH REGISTRATION IS NOT REQUIRED UNDER THE SECURITIES ACT OF 1933.”
 
(b)           Any legend required by the securities laws of any state to the extent such laws are applicable to the Shares represented by the certificate so legended.
 
3.5          Accredited Investor and Financial Sophistication .  At the time Can-Fite was offered the Shares, it was, and at the date hereof it is, an “accredited investor” as defined in Rule 501(a) under the Securities Act.  Can-Fite, either alone or together with its representatives, has such knowledge, sophistication and experience in business and financial matters so as to be capable of evaluating the merits and risks of the prospective investment in the Shares, and has so evaluated the merits and risks of such investment.  Can-Fite is able to bear the economic risk of an investment in the Shares and, at the present time, is able to afford a complete loss of such investment.
 
3.6          Foreign Laws .  Can-Fite hereby represents that it has satisfied itself as to the full observance of the laws of its jurisdiction in connection with any invitation to subscribe for the Shares or any use of this Agreement, including (i) the legal requirements within its jurisdiction for the purchase of the Shares, (ii) any foreign exchange restrictions applicable to such purchase, (iii) any governmental or other consents that may need to be obtained, and (iv) the income tax and other tax consequences, if any, that may be relevant to the purchase, holding, redemption, sale, or transfer of the Shares.  Can-Fite’s subscription and payment for and continued beneficial ownership of the Shares will not violate any applicable securities or other laws of Can-Fite’s jurisdiction.

 
3

 

3.7          Title to Eye-Fite Common Stock .  Can-Fite has good and valid title to the Eye-Fite Common Stock being surrendered pursuant to this Agreement in consideration for the Shares and will deliver the Eye-Fite Common Stock to the Company free and clear of any security interests, liens, claims or encumbrances.  Can-Fite further represents to the Company that it has full legal right, power and capacity to tender for cancellation the Eye-Fite Common Stock as set forth herein.
 
3.8          Residence and Domicile .  The office of Can-Fite in which its principal place of business is identified in the address of Can-Fite set forth on the signature page hereto.
 
4.          Conditions to Closing .
 
4.1          Conditions to the Company’s Obligation to Close .  The obligations of the Company to consummate the Closing shall be subject to the following:
 
(a)           Can-Fite’s delivery and surrender to the Company of a stock certificate representing the Eye-Fite Common Stock.
 
(b)            A stock power duly executed in favor of the Company and in a form reasonably acceptable to the Company, free from any charge, lien, encumbrance or adverse claim of any kind whatsoever.
 
(c)           A true and correct copy of a resolution of the Board of Directors of Eye-Fite approving the transfer of the Eye-Fite Common Stock to the Company against issuance of the Shares to Can-Fite.
 
(d)           Any and all approvals and/or waivers and/or consents and/or permits or the like required for the consummation of this Agreement executed by Can-Fite or any other party.
 
4.2          Conditions to Can-Fite’s Obligation to Close .  The obligations of the Company to consummate the Closing shall be subject to the following:
 
(a)           Can-Fite shall have received a pre-ruling from the Israeli Tax Authority in relation to the tax treatment of Can-Fite’s surrender of the Eye-Fite Common Stock in return for the receipt of the Shares in accordance with Sections 104B(f) and 103 of the Income Tax Ordinance, 1961 (the “ Ordinance ”) (and not the personal tax status of each Shareholder as a result thereof).
 
(b)           The Company’s delivery to Can-Fite of certificates representing the Shares, registered in the name  of Can-Fite Biopharma Ltd., to be held by ______________, as trustee for and on behalf of Can-Fite (the “ Trustee ”).  The Trustee shall hold the Shares on behalf of Can-Fite for not less than 24 months from the end of the calendar year in which the issuance of the Shares to Can-Fite was concluded and for the purpose of fulfilling the requirements of Sections 104 and 103 of the Ordinance.
 

 
4

 

(c)           A true and correct copy of a resolution of the Board of Directors of the Company issuing the Shares to Can-Fite.
 
5.          Miscellaneous .
 
5.1          Survival of Representations, Warranties and Covenants .  The representations, warranties and covenants of the Company and Can-Fite contained in or made pursuant to this Agreement shall survive the execution and delivery of this Agreement.
 
5.2          Successors and Assigns .  Except as otherwise provided herein, the terms and conditions of this Agreement shall inure to the benefit of and be binding upon the respective successors and assigns of the parties (including transferees of any Shares).  Nothing in this Agreement, express or implied, is intended to confer upon any party other than the parties hereto or their respective successors and assigns any rights, remedies, obligations or liabilities under or by reason of this Agreement, except as expressly provided in this Agreement.
 
5.3          Governing Law .  This Agreement is to be construed in accordance with and governed by the internal laws of the State of Israel, without giving effect to any choice of law rule that would cause the application of the laws of any jurisdiction other than the internal laws of the State of Israel as to the rights and duties of the parties.  The parties hereto irrevocably submit to the exclusive jurisdiction of the courts in Tel-Aviv, Israel in respect of any dispute or matter arising out of or connected with this Agreement.
 
5.4          Counterparts .  This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
 
5.5          Notices . Except as may be otherwise provided herein, all notices, requests, waivers and other communications made pursuant to this Agreement shall be in writing and shall be deemed to have been duly given (a) when hand delivered to the other party; (b) the next business day when sent by facsimile; or (c) the next business day after deposit with an international express delivery service (e.g., DHL or Federal Express).  All communications shall be sent to the address or facsimile of a party appearing in its signature block hereto or at such address or facsimile as such party may designate.
 
5.6          Further Assurances .  Can-Fite and the Company shall from time to time and at all times hereafter make, do, execute, or cause or procure to be made, done and executed such further acts, deeds, conveyances, consents and assurances without further consideration, which may reasonably be required to effect the transactions contemplated by this Agreement.
 
5.7          Entire Agreement .  This Agreement and the documents referred to herein constitute the entire agreement among the parties with respect to the subject matter hereof and no party shall be liable or bound to any other party in any manner by any representations, warranties or covenants except as specifically set forth herein or therein.  Any term of this Agreement may be amended and the observance of any term of this Agreement may be waived (either generally or in a particular instance and either retroactively or prospectively), only with the written consent of the Company and Can-Fite.

 
5

 

5.8          Delays or Omissions .  No delay or omission to exercise any right, power, or remedy accruing to any party upon any breach or default under this Agreement shall be deemed a waiver of any other breach or default therefore or thereafter occurring. Any waiver, permit, consent, or approval of any kind or character on the part of any party of any breach or default under this Agreement, or any waiver on the part of any party of any provisions or conditions of this Agreement, must be in writing and shall be effective only to the extent specifically set forth in such writing. All remedies, either under this Agreement, or by law, or otherwise afforded to any of the parties, shall be cumulative and not alternative.
 
5.9          Severability .  If any provision of this Agreement is held by a court of competent jurisdiction to be unenforceable under applicable law, then such provision shall be excluded from this Agreement and the remainder of this Agreement shall be interpreted as if such provision were so excluded and shall be enforceable in accordance with its terms; provided, however , that in such event this Agreement shall be interpreted so as to give effect, to the greatest extent consistent with and permitted by applicable law, to the meaning and intention of the excluded provision as determined by such court of competent jurisdiction.
 
5.10 Headings .  The titles and subtitles used in this Agreement are used for convenience only and are not to be considered in construing or interpreting this Agreement.
 
( Signature Page Follows )

 
6

 

IN WITNESS WHEREOF, the parties have executed this Stock Purchase Agreement as of the date first written above.
 
 
DENALI CONCRETE MANAGEMENT, INC.
       
 
By:
/s/ Mathew G. Rule
 
 
Its:
Mathew G. Rule
 
 
Title:
President
 
 
Address:
123 W. NYE Lane, Ste 129
 
   
Carson City, NV 89706
 
 
 
CAN-FITE BIOPHARMA LTD.
 
         
 
By:
/s/ Pnina Fishman
 /s/Motti Farnstein
 
 
Its:
     
 
Title:
CEO
COO
 
 
 
Address:
10 Bareket St.
 
   
Petach-Tkva, Israel
 

 
 

 
Exhibit 10.2
LICENSE AGREEMENT
 
This License Agreement (this “ Agreement ”), dated November 21, 2011 (the “ Effective Date ”), is made by and between CAN-FITE Biopharma Ltd., a public company incorporated under the laws of the State of Israel (“ CANFITE ”), and Eye-Fite Ltd., a private company incorporated under the laws of the State of Israel (“ EYEFITE ”).  CANFITE and EYEFITE are sometimes hereinafter referred to each as a “Party” and collectively as the “Parties.”
 
WHEREAS, the Parties desire to enter into an agreement pursuant to which CANFITE will grant a  sole and exclusive license to EYEFITE under the CANFITE Patent Rights and CANFITE Know-How for EYEFITE to develop and commercialize the Licensed Compound and Licensed Product in the Field as defined below, and
 
WHEREAS, CANFITE and the PHS entered into that certain PHS Agreement by which CANFITE was granted exclusive license under certain PHS Patents relating, among other things, to CF101 (as such terms are defined below); and
 
WHEREAS, said PHS Patents are among the CANFITE Patent Rights licensed to EYEFITE, and
 
WHEREAS, the Parties acknowledge that the rights granted hereunder by CANFITE to EYEFITE are subject to the terms and conditions of the PHS Agreement.
 
NOW, THEREFORE, the Parties hereby agree as follows:
 
Section 1.   Definitions .
 
For the purpose of this Agreement, the following words and phrases shall have the meanings set forth below:
 
1.1            “ Affiliate ” means with respect to a party, any other business entity that directly controls, is controlled by, or is under common control with, such party.  A business entity or party shall be regarded as in control of another business entity if it owns, or controls, more than fifty percent (50%) of the voting stock or other voting ownership interest of the other business entity, or if it directly or indirectly possesses the power to direct or cause the direction of the management and policies of the other business entity by any means whatsoever.
 
1.2            “ Annual ” means from January 1 to December 31 of any given calendar year.
 
1.3            “ Approval ” means, with respect to any Licensed Product in any regulatory jurisdiction, approval from the applicable Regulatory Authority sufficient for the manufacture, offer for sale, sale, distribution, importation or use of the Licensed Product in such jurisdiction in accordance with applicable Laws.
 
1.4            “ CANFITE Know-How ” means all Technology owned, licensed or otherwise Controlled by CANFITE or any of its Affiliates as of the Effective Date, that is related to the Licensed Compound or Licensed Product, or that is essential, necessary or useful for the manufacture, use, sale, offer for sale, importation, research, development, commercialization or other exploitation of the Licensed Compound or Licensed Product in the Field.

 
 

 
LICENSE AGREEMENT
 
1.5            “ CANFITE Patent Rights ” means the PHS Patents and the patents and patent applications listed in Exhibit A attached hereto, as amended from time to time during the term of this Agreement by mutual agreement of the Parties (for example to incorporate patent rights relating to new inventions that EYEFITE may require for development or commercialization of the Licensed Product in the Field in the Territory), and (a) any foreign counterparts thereof, (b) all divisionals, continuations, continuations-in-part thereof or any other patent application claiming priority directly or indirectly to (i) any of the patents or patent applications identified in Exhibit A or (ii) any patent or patent application from which the patents or patent applications identified in Exhibit A claim direct or indirect priority, and (c) all patents issuing on any of the foregoing, and any foreign counterparts thereof, together with all registrations, reissues, re-examinations, renewals, supplemental protection certificates, or extensions of any of the foregoing, and any foreign counterparts thereof.  The parties shall update Exhibit A from time to time during the term of this Agreement as may be required.
 
1.6            “ CF101 ” means the adenosine A3 receptor agonist designated by CANFITE as CF101, and known generically as IB-MECA (Methyl 1-[N6-(3-iodobenzyl)-adenin-9-yl]- β-D-Ibofuronamid).
 
1.7            “ Clinical Data ” means the information with respect to the Licensed Product or the Licensed Compound made, collected or otherwise generated under or in connection with pre-clinical, clinical, or the post-Approval studies for the Licensed Compound or Licensed Product, including any data, reports and results with respect to any of the foregoing.
 
1.8            “ Commercially Reasonable Efforts ” means, with respect to Licensed Products, the carrying out of development and commercialization activities in a manner comparable to that which a company within the pharmaceutical industry that is similarly situated to EYEFITE and its Affiliates, taken collectively, would reasonably devote to a product of similar market potential based on conditions then prevailing and taking into account, without limitation, issues of safety and efficacy, product profile, the proprietary position, the then current competitive environment for such product and the timing of such product’s entry into the market, the regulatory environment and status of such product, and other relevant scientific, technical and commercial factors.
 
1.9            “ Confidential Information ” means all data or information received by a Party or its Affiliates (“ Receiving Party ”) that is of value to the Party or its Affiliates disclosing or providing such data or information (“ Disclosing Party ”) including, but not limited to, Technology; marketing plans or strategies; formulas; methods; techniques; drawings; processes; financial data; financial plans; product plans; lists of actual or potential customers, vendors and/or employees; potential packaging; advertising materials; trademarks, service marks and trade dress; price lists; pricing policies; and competitive strategies.  Confidential Information also includes any compilation or organization of information which, divided into individually segregated segments, may not be deemed confidential but in its organized completed format is unique, proprietary and confidential to the Disclosing Party.  Additionally, Confidential Information includes any information described in this provision which the Disclosing Party obtains from another party and which the Disclosing Party treats as proprietary or designates as confidential information, whether or not owned or developed by the Disclosing Party.  Confidential Information shall be treated as such regardless of whether it is marked “confidential” or “proprietary” or communicated by the Disclosing Party or its Affiliates in oral, written, graphic, or electronic form.
 
1.10          “ Controlled ” or “ Controls ”, means, when used in reference to intellectual property (including, but not limited to, patents, trademarks, know-how or Technology), the legal authority or right of a person or entity to license or sublicense such intellectual property to another person or entity, or to provide or disclose such intellectual property to such other person or entity, in each case, without breaching any contractual or fiduciary obligations.

 
2

 
LICENSE AGREEMENT
 
1.11          “ EMEA ” means the European Agency for the Evaluation of Medicinal Products, or any successor agency thereto.
 
1.12          “ EU ” means the European Union, as its membership may be altered from time to time, and any successor thereto, and which, as of the Effective Date, consists of Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom, and that certain portion of Cyprus included in such organization.
 
1.13          “ Europe ” means the countries comprising the EU as it may be constituted from time to time, together with those additional countries included in the European Economic Area as it may be constituted from time to time.
 
1.14          “ EYEFITE Patent Rights ” means the CANFITE Patent Rights that encompass within their scope the use of the Licensed Compound or the Licensed Product in the Field and that in the absence of a license would be infringed by the development of the Licensed Product in the Field in the Territory (and that are licensed to EYEFITE within the framework of this Agreement).
 
1.15          “ FDA ” means the United States Food and Drug Administration or any successor agency thereto.
 
1.16          “ Field ” means the treatment of any ophthalmic disease, disorder and conditions in humans.
 
1.17          “ First Commercial Sale ” means, with respect to any Licensed Product on a country-by-country basis, the first sale for use by the general public of such Licensed Product in such country after Approval of such Licensed Product has been granted, or marketing and sale of such Licensed Product is otherwise permitted, by the applicable Regulatory Authority of such country.
 
1.18          “ FTE ” means full-time equivalent.
 
1.19          “ Governmental Authority ” means any supranational, national, federal, state or local judicial, legislative, executive or regulatory authority or any arbitrator or arbitration tribunal.
 
1.20          “ IND ” means an investigational new drug application filed with a Regulatory Authority such as the FDA for authorization to commence clinical studies or post-Approval studies and its equivalent in other countries or regulatory jurisdictions.
 
1.21          “ Koseisho ” means the Japanese Ministry of Health and Welfare, or any successor agency thereto.
 
1.22          “ Laws ” means all laws, statutes, rules, regulations, ordinances and other pronouncements having the effect of law of any federal, national, multinational, state, provincial, county, city or other political subdivision, domestic or foreign.
 
1.23          “ Licensed Compound ” means CF101.

 
3

 
LICENSE AGREEMENT
 
1.24          “ Licensed Product ” means any pharmaceutical product in all forms, presentations, formulations and dosage forms containing a Licensed Compound, either alone or in combination with one or more other active ingredients, to be used solely for the Field.
 
1.25          “ NDA ” means a New Drug Application filed with a Regulatory Authority such as the FDA seeking approval to market a Licensed Product in the Territory.
 
1.26          “ NDA Filing ” means an NDA for a Licensed Product that has been accepted for filing by a Regulatory Authority such as the FDA.
 
1.27          “ Net Sales ” means the definition set out in Paragraph 2.10 of the PHS Agreement.
 
1.28          “ Phase III Trial ” means the Phase III Trial of CF101 in the dry eye syndrome indication as set forth in the Development Plan attached hereto as Exhibit B .
 
1.29          " PHS Agreement " means that that certain Patent License Agreement dated December 3, 2002 entered into between CANFITE and the PHS, a copy of which is attached hereto as Appendix A .
 
1.30          " PHS " means singly or collectively the National Institutes of Health, the Centers for Disease Control and Prevention, or the FDA.
 
1.31          " PHS Patents " means the patents exclusively licensed to CANFITE under the PHS Agreement and detailed in Exhibit C attached hereto.
 
1.32          “ Regulatory Authority ” means any national or supranational governmental authority, including, without limitation, the FDA, EMEA or Koseisho, that has responsibility in countries in the Territory over the development and/or commercialization of the Licensed Compound and Licensed Product.
 
1.33          “ Regulatory Documentation ” means all applications, registrations, licenses, authorizations and approvals (including all Approvals), all correspondence submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents and all preclinical and clinical studies and tests, relating to the Licensed Compound or the Licensed Product and all data contained in any of the foregoing, including all NDAs, regulatory drug lists, advertising and promotion documents, manufacturing data, Clinical Data, adverse event files and complaint files.
 
1.34          “ Technology ” means know-how, trade secrets, chemical and biological materials, formulations, information, documents, studies, results, data and regulatory approvals, filings and correspondence (including drug master files), including biological, chemical, pharmacological, toxicological, pre-clinical, clinical and assay data, manufacturing processes and data, specifications, sourcing information, assays, and quality control and testing procedures, whether or not patented or patentable, in each case, to the extent related to the Licensed Compound or Licensed Product.
 
1.35          “ Territory ” means all countries of the world.
 
1.36          “ Third Party ” means any person or entity other than EYEFITE or CANFITE or any of their Affiliates.

 
4

 
LICENSE AGREEMENT
 
1.37          “ Trademark ” means any word, name, symbol, color, designation or device or any combination thereof, including any trademark, trade dress, brand mark, service mark, trade name, brand name, logo or business symbol, whether or not registered.
 
Section 2.   License and Assignment Grants by CANFITE .
 
2.1          Exclusive Field of Use License .  CANFITE hereby grants to EYEFITE a non-transferable (except in accordance with Section  12.1), sole and exclusive (even as to CANFITE) license, with the right to sublicense in accordance with Section 2.1 (a), under the EYEFITE Patent Rights and CANFITE Know-How, to make, have made, use, sell, offer to sell, import, research, develop, commercialize and otherwise exploit the Licensed Compound and Licensed Product in the Field in the Territory.  The foregoing license grant includes the right to make reference to all regulatory approvals, filings and correspondence (including drug master files) contained within the CANFITE Know-How.  Each Affiliate of EYEFITE, if any, performing any obligations or exercising any rights hereunder shall be bound by the terms and conditions of this Agreement as and to the same extent as EYEFITE, and EYEFITE shall remain fully responsible for the performance of its Affiliates hereunder.
 
(a)             Right to Sublicense .  The licenses granted in Section  2.1 include the right to grant sublicenses (through multiple tiers) to Third Parties (each such Third Party sublicensee, a “ Sublicensee ”), provided that: (1) each such sublicense shall be subordinate to this Agreement, (2) no such sublicense shall impair EYEFITE (directly or with and through its Sublicensees) to perform its obligations hereunder, (3) no such sublicense shall limit or impair CANFITE’s rights hereunder,  (4) no such sublicense shall limit or impair PHS’s rights under the PHS Agreement, (5) EYEFITE shall remain responsible for its, its Affiliates and its Sublicensees conformity to the terms and conditions set forth herein, including without limitation, the obligation to use Commercially Reasonable Efforts to develop and commercialize the Licensed Compound and Licensed Product, the obligation to make payments as and when due hereunder, and the obligation to keep records and make reports hereunder, (6) the sublicense will require the approval of CANFITE, which will not be unreasonably withheld, and (7) as far as such sublicense includes also the PHS Patents, also the approval of PHS, as stipulated in the PHS Agreement.  EYEFITE shall provide CANFITE with a true, accurate and complete copy of each sublicense agreement with its Sublicensees promptly after execution. Each sublicense granted to a Sublicensee by EYEFITE to any rights licensed to it hereunder shall terminate immediately upon the termination of the license from CANFITE to EYEFITE with respect to such rights as of the effective date of such termination by CANFITE pursuant to Section  11.2(b), provided however, that if a Sublicensee is not in material default of its obligations to EYEFITE under its sublicense agreement, and within sixty (60) days of such termination   the Sublicensee agrees in writing to be bound directly to CANFITE under a license agreement substantially similar to this Agreement with respect to the rights sublicensed hereunder, substituting such Sublicensee for EYEFITE, then such sublicense shall not so terminate.
 
(b)             Restrictions on CANFITE .  For as long as the license grant set forth in Section  2.1 is in effect, CANFITE Know-How shall be treated as Confidential Information of both EYEFITE and CANFITE, and CANFITE and its Affiliates shall neither use CANFITE Know-How, nor shall CANFITE or its Affiliates disclose CANFITE Know-How, except as permitted by Section  8.1(b) or  8.2.
 
2.2         Assignment of INDs.   CANFITE, for itself and its Affiliates, hereby assigns and transfers to EYEFITE all of CANFITE’s right, title, and interest in and to any and all INDs relating to the Licensed Compound in the Field in the Territory

 
5

 
LICENSE AGREEMENT
 
2.3           Use of Trademarks .  As between the Parties, EYEFITE shall have the sole right to determine and own the Trademarks to be used with respect to the commercialization of the Licensed Product in the Field in the Territory.  EYEFITE and its Affiliates shall make reasonable efforts to avoid using in their Development and Commercialization activities any Trademark that is confusingly similar to, misleading or deceptive with respect to any trademark owned by CANFITE.
 
2.4           License Limitations .  All licenses and other rights are or shall be granted only as expressly provided in this Agreement, and no other licenses or other rights are or shall be created or granted hereunder by implication, estoppel or otherwise.
 
Section 3.   Regulatory Matters in the Territory .
 
3.1           Regulatory Responsibilities .  As between the Parties, EYEFITE shall have sole responsibility for preparing and maintaining all Regulatory Documentation with respect to (i) Approvals for the Licensed Product in the Field in the Territory and (ii) Development and Commercialization activities, as set forth in Section 5, for the Licensed Product in the Field in the Territory.  CANFITE shall provide, however, as may be requested by EYEFITE, any reasonable assistance to EYEFITE with respect to this Section 3.1.
 
3.2           Ownership .  All Approvals and related Regulatory Documentation for the Licensed Product in the Field in the Territory shall be the sole and exclusive property of EYEFITE and held in the name of EYEFITE (or in each such case EYEFITE’s Affiliate or Sublicensee).  Except as provided in this Section 3 and Section 11.4(b) below, CANFITE shall be entitled to receive copies of EYEFITE’s Regulatory Documentation, including Clinical Data, subject to the confidentiality provisions of Section 8.
 
3.3           Communications with Regulatory Authorities .  As between the Parties, EYEFITE shall be responsible for all communications with any Regulatory Authority relating to the Licensed Product or Licensed Compound in the Territory during the term of this Agreement.  As relating to the Licensed Product or Licensed Compound, EYEFITE (or its Affiliates or Sublicensees) shall promptly provide CANFITE with copies of all (i) material written communications to or from any Regulatory Authority,  and (ii) written meeting minutes or summaries of material meetings, conferences and discussions with Regulatory Authorities.  Except as necessary to comply with the Laws, CANFITE shall not initiate any communications with any Regulatory Authority concerning the Licensed Compound or the Licensed Product without first obtaining EYEFITE’s approval.
 
(a)            EYEFITE shall promptly inform CANFITE of any action, correspondence or reports to or from governmental authorities (other than Regulatory Authorities) that would reasonably be expected to materially affect the current or anticipated development or commercialization of the Licensed Product or Licensed Compound, and shall furnish CANFITE with copies of any relevant documents relating thereto.
 
3.4           Regulatory Records .  EYEFITE shall maintain, or cause to be maintained, records of the development and commercialization activities performed by EYEFITE, its Affiliates and Sublicensees with respect to the Licensed Product in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, which shall be reasonably complete and accurate and shall properly reflect all work done and results achieved in the performance of such development activities, and which shall be retained by or for EYEFITE for at least five (5) years after the termination of this Agreement, or for such longer period as may be required by Law.

 
6

 
LICENSE AGREEMENT
 
Section 4.   Performance of Duties .
 
4.1           Transition .  Within thirty (30) days following the Effective Date, CANFITE shall transfer or cause to have transferred to EYEFITE, or shall perform or cause to have performed, each item scheduled in Exhibit D hereto; provided that any copies of documents, data and other information shall be made available to EYEFITE and may be copied at EYEFITE’s expense.
 
4.2           Studies Completion .  For each deliverable identified in Exhibit D hereto, CANFITE shall complete or cause to have completed such deliverable in a manner comparable to that which a similarly situated company within the pharmaceutical industry would reasonably devote to a product of similar market potential within the time period for completion associated with such deliverable as specified in Exhibit D .  With respect to each such deliverable, EYEFITE shall reimburse CANFITE for its direct FTE costs and vendor costs subject to CANFITE’s completion of such deliverable within the specified time frame.
 
4.3           Sales of Licensed Compound or Licensed Product .  To the extent that such purchase is necessary for the Commercialization and Development of the Licensed Product, during the term of this Agreement EYEFITE shall purchase the Licensed Compound (as bulk drug substance) or the Licensed Product (as a finished formulated drug product, e.g. in the form of tablets, or in the form of a finished and packaged formulated drug product) in compliance with the applicable good manufacturing practice (GMP) from CANFITE’s at a price equal to CANFITE’s cost to manufacture or obtain the quantity of such material, plus 15% overhead charge. The form of the material to be purchased by EYEFITE from CANFITE (whether as a bulk drug substnace of the Licensed Compound or whether as a formulated drug product of the Licensed Product and in the latter cased whether non-packaged or packaged) will be as agreed from time to time between the parties. EYEFITE will forward purchase orders for said Licensed Compound or said Licensed Product at the earlier to occur of (i) as soon as possible after becoming aware of the need for supply of such material, and (ii) 6 months advanced notice prior to the date in which the need for supply of said material is anticipated.  In the case (and only in the case) that (i) Can-Fite is unable to provide said Licensed Compound or said Licensed Product at needed quantities or meeting the applicable GMP requirements, or (ii) upon decision by CANFITE to transfer manufacturing rights of Licensed Compound or said Licensed Product or the packaging of said Licensed Prodcutfrom it to EYEFITE, EYEFITE shall be entitled to purchase such material from another source.  Within fourteen days notice from EYEFITE of EYEFITE’s request to purchase a quantity of said Licensed Compound or said Licensed Product (each such request, a “ Purchase Request ”), CANFITE shall take all actions that may be reasonably necessary or desirable to fulfill the Purchase Request.  For each such Purchase Request, EYEFITE shall remit payment to CANFITE for the purchased quantity of Inventory within thirty (30) days of receipt of an invoice from CANFITE.
 
For a period of three (3) years following the Effective Date, CANFITE shall be responsible for and shall perform any necessary stability testing of the Inventory of samples of batches of supplied Licensed Compound and/or said Licensed Product.

 
7

 
LICENSE AGREEMENT

Section 5.   Development and Commercialization .
 
5.1           Clinical Trial .  EYEFITE shall use Commercially Reasonable Efforts to initiate (i.e., dosing of the first patient) a Phase III Trial of the Licensed Compound no later than the one (1) year  anniversary of the date of CANFITE’s compliance with Section 4.1.  If EYEFITE fails to initiate a Phase III Trial of the Licensed Compound by such anniversary, and provided that such failure is not due to a delay that is beyond EYEFITE’s reasonable control, including, without limitation, delays caused by Regulatory Authorities or by CANFITE, then EYEFITE may obtain a six (6) month extension of such period for a payment of one (1) million U.S. dollars (US$1,000,000), provided that EYEFITE may not obtain more than four extensions (each one requiring such payment).  Failure to initiate a Phase III Trial of the Licensed Compound within the two (2) year anniversary of the date of CANFITE’s compliance with Section 4.1 shall constitute a material breach of this Agreement, unless such failure is due to a delay that is beyond EYEFITE’s reasonable control, including, without limitation, delays caused by Regulatory Authorities or by CANFITE.
 
5.2           Responsibilities and Costs .   EYEFITE shall use Commercially Reasonable Efforts to develop and commercialize the Licensed Compound and Licensed Product.  Without limiting the foregoing requirement, EYEFITE shall have sole responsibility for, and shall bear all costs associated with, such commercialization and development activities.
 
5.3           Development Plan .  Attached hereto as Exhibit B is a summary of EYEFITE’s initial “Development Plan,” which summarizes EYEFITE’s plans for the development of Licensed Product.  The Development Plan may be revised from time-to-time by EYEFITE, after obtaining the approval of CANFITE, which will not be unreasonably withheld , but shall not be revised in a manner that would likely result in EYEFITE failing to initiate the Phase III Trial after the one (1) anniversary of the Effective Date.  Once each calendar quarter until the first Approval of the Licensed Product in a country is received, EYEFITE shall provide to CANFITE (i) any significant updates or revisions to the Development Plan, and (ii) a report presenting a meaningful summary of the development activities accomplished by EYEFITE through the end of the preceding quarterly period.
 
5.4           Markings .  All promotional materials, packaging and product labeling for the Licensed Product used by EYEFITE, its Affiliates, Sublicensees or distributors in connection with the Licensed Product shall contain (i) the applicable Trademark selected by EYEFITE for use in commercialization of the Licensed Product, (ii) if required by Law, the logo and corporate name of the manufacturer, and (iii) if appropriate, the applicable patent numbers.
 
Section 6.   EYEFITE Obligations .
 
6.1           Issuance of Shares .  EYEFITE shall issue to CANFITE 999 Ordinary Shares, nominal value NIS 0.01 each of EYEFITE, representing 100% of the issued and outstanding share capital of EYEFITE.
 
6.2           Royalties and Milestone Payments . EYEFITE shall be obligated to make to PHS, for as long as the PHS Agreement is in effect and obligates CANFITE to make any payments to PHS, the following Royalty, Milestone and Sublicensing payments to PHS under the PHS Agreement, as follows:
 
(a)             Annual Royalty Payment - EYEFITE agrees to pay to PHS a nonrefundable minimum annual royalty in the amount of twenty-five thousand dollars ($25,000), which is half of the nonrefundable minimum annual royalty payable to PHS of US$50,000 (the other half to be paid by CANFITE).
 
(b)             Royalties on Net Sales - EYEFITE agrees to pay PHS earned royalties on Net Sales by or on behalf of EYEFITE and its Sublicensees or Affiliates in those territories in which PHS Patents exist, calculated on an annual basis in each calendar year and graded as follows:

 
8

 
LICENSE AGREEMENT
 
(i)         Royalties of five and one half percent (5.5%) on an amount of annual Net Sales of Licensed Products in the Territory of up to and including twenty-five million U.S. dollars ($25,000,000);
 
(ii)        Royalties of four and one half percent (4.5%) on an amount of annual Net Sales of Licensed Products in the Territory between twenty five million U.S. dollars ($25,000,000) and one hundred million US Dollars ($100,000,000);
 
(iii)       Royalties of four percent (4.0%) on an amount of annual Net Sales of Licensed Products in the Territory of greater than and including one hundred million U.S. dollars ($100,000,000) .
 
In case sales are made in any calendar year by both  CANFITE and EYEFITE, EYEFITE will pay its pro-rated share of the aggregate sales of both Parties out of the payment Schedule listed under (i) – (iii) of this Sub-Section (b).
 
(c)           Milestone Payments EYEFITE agrees to pay PHS milestone payments as follows :
 
(i)             Twenty Five Thousand ($25,000) Dollars payable within sixty (60) days after the initiation of the first Phase I clinical trials (or its equivalent) per indication of the Licensed Product in the Field.
 
(ii)            Seventy Five Thousand ($75,000) Dollars payable within sixty (60) days after the initiation of the first Phase II clinical trials (or its equivalent) per indication of the Licensed Product in the Field.
 
(iii)           One Hundred Thousand ($100,000) Dollars payable within sixty (60) days after the initiation of the first Phase III clinical trials (or its equivalent) per indication of the Licensed Product in the Field.
 
(iv)           Five Hundred Thousand ($500,000) Dollars payable within ninety (90) days after each FDA (or its equivalent) approval in each major market area (U.S.A., Europe, or Japan) per indication of the Licensed Product in the Field.
 
(d)           Sublicensing Payments – EYEFITE agrees to pay PHS a sublicensing payment of twenty percent (20%) of any monetary consideration received from each sublicense, but not including royalties on Net Sales for which royalties will only be due under Sub-Section (b) above. EYEFITE may credit Milestone Payments due under Sub-Section (c) above against any sublicensing payments due on consideration received by EYEFITE from any Sublicensee for any milestones achieved by a Sublicensee when such milestones are substantially similar to the milestones described above for Sub-Section (c) .
 
(e)           Payment Term.   The payments to be made by EYEFITE to PHS under this Section 6.2 shall be payable only for so long as the PHS Agreement between CANFITE and the PHS is in effect and for as long as CANFITE is obligated to make such payments to the PHS under the PHS Agreement.

 
9

 
LICENSE AGREEMENT
 
(f)           Effect of Failure to Make any Payment . The failure of EYEFITE to make any of the aforesaid payments to PHS upon such payment becoming due shall be deemed a breach of this Agreement entitling CANFITE the right to terminate the license granted hereunder, provided that EYEFITE shall have a thirty (30) day period from receipt of a written letter from CANFITE of the occurrence of such breach during which to cure such breach and make such applicable payment.
 
(g)            The license of the CANFITE Patent Rights other than the PHS Patents will be free of any royalties and milestone payments .
 
6.3            Payment Terms .
 
(a)             Manner of Payment .  All payments to be made by EYEFITE hereunder shall be made in U.S. dollars by wire transfer to such bank account as PHS may designate, all in accordance with the terms and conditions of the PHS Agreement.
 
(b)             Reports and Royalty Payments .  For as long as royalties are due under Section  6.2, EYEFITE shall furnish to CANFITE a written report, within forty-five (45) days after the end of each calendar quarter, showing the amount of Net Sales of Licensed Products and   royalty due for such calendar quarter.  Royalty payments for each calendar quarter shall be due at the same time as such written report for the calendar quarter.  The report shall include, at a minimum, the following information for the applicable calendar quarter, each listed by product and by country of sale:  (i) the number of units of Licensed Products sold by EYEFITE and its Affiliates and Sublicensees on which royalties are owed CANFITE hereunder; (ii) the gross amount received for such sales; (iii) deductions taken from Net Sales as specified in the definition thereof; (iv) Net Sales; and (v)  the royalties and Milestone Payments owed to CANFITE, listed by category.  In addition to the foregoing, EYEFITE shall furnish to CANFITE a written report within ten (10) business days after the end of each calendar quarter estimating the total Net Sales for such calendar quarter by EYEFITE, its Affiliates and Sublicensees.
 
(c)             Records and Audits .  EYEFITE shall keep, and shall cause each of its Affiliates and Sublicensees, as applicable, to keep adequate books and records of accounting for the purpose of calculating all royalties payable to PHS hereunder and as set out in the PHS Agreement.
 
(d)             Currency Exchange .  Royalties shall accrue in the currency of the country in which the sale of the Licensed Product or Licensed Compound is made, and if different from U.S. dollars, shall be converted into U.S. dollars using the exchange rate of such domestic currency as quoted by the Wall Street Journal, for the business day immediately prior to the date of payment.
 
(e)             Tax Withholding .  The withholding tax, duties, and other levies (if any) applied by any government authority on payments made by EYEFITE to PHS hereunder shall be borne by EYEFITE.  PHS shall provide to EYEFITE a signed Form W-9 with its certified tax identification number within 30 days from the date hereof.
 
(f)             Other terms of the PHS Agreement . EYEFITE shall be bound by and subject to all other terms and conditions set out in the PHS Agreement which relate to the payment of any annual payments, royalties , milestone payments or sublicensing payments as set out herein.

 
10

 
LICENSE AGREEMENT

(g)             Payment to PHS. Attached as Exhibit E are payment options for paying royalties to PHS. EyeFite, in coordination with CanFite, will make payments as stipulated herein using one of these payment options.
 
Section 7.   Patent Prosecution, Infringement and Extensions .
 
7.1           Ownership of Inventions; Royalty-Free Licenses.
 
(a)            Inventorship of information, know-how, data, discoveries, developments, designs, inventions, methods, processes, techniques, materials, formulae, trade secrets, trademarks, copyrights, patents and patent applications and other proprietary information conceived and/or reduced to practice in connection with, or as a result of, EYEFITE’s activities hereunder (the “ Inventions ”) shall be determined in accordance with the patent laws of the country in which such invention occurred.
 
(b)            All Inventions relating to the Licensed Compound or the Licensed Product (whether invented solely by CANFITE or by EYEFITE or jointly by CANFITE and EYEFITE) shall belong to CANFITE (each a CANFITE Invention ”).   CANFITE hereby grants to EYEFITE a royalty-free, exclusive license to use and exploit CANFITE Inventions in connection with the Licensed Product in the Field in accordance with this Agreement.
 
7.2           Prosecution and Maintenance of CANFITE Patent Rights .
 
(a)            CANFITE shall be solely responsible for the preparation, prosecution (including any interferences, oppositions, reissue proceedings and reexaminations) and maintenance of the CANFITE Patent Rights.  CANFITE shall use Commercially Reasonable Efforts to obtain appropriate patent protection for the EYEFITE Patent Rights.   
 
(b)            Without limiting the foregoing, CANFITE shall not knowingly permit any of the CANFITE Patent Rights which may include EYEFITE Patent Rights to be abandoned in any country without EYEFITE first being given an opportunity to assume full responsibility and costs for the continued prosecution and maintenance of same.
 
(c)            CANFITE shall be responsible for the preparation, prosecution (including any interferences, oppositions, reissue proceedings and reexaminations) and maintenance of all EYEFITE Patent Rights, and all preparation, filing, prosecution, and maintenance decisions with respect to the EYEFITE Patent Rights shall be made by CANFITE with the goal and intention of obtaining appropriate patent protection for the Licensed Compound and Licensed Product for the Field in the Territory. CANFITE shall reasonably consult with EYEFITE with respect to the preparation, filing, prosecution and maintenance of the EYEFITE Patent Rights.  CANFITE shall keep EYEFITE advised of the status of such activities and shall also inform EYEFITE in a timely manner of any material communications CANFITE receives from the relevant patent office with respect to such activities, including providing EYEFITE with copies of any papers relating to the filing, prosecution or maintenance of the EYEFITE Patent Rights. EYEFITE shall forward to CANFITE copies of any papers relating to the filing, prosecution or maintenance of the CANFITE Patent Rights promptly upon receipt.  As of the Effective Date, EYEFITE shall be responsible for all its costs incurred for such preparation, filing, prosecution and maintenance of the EYEFITE Patent Rights and shall reimburse CANFITE for any such costs relating thereto.

 
11

 
LICENSE AGREEMENT

7.3           Enforcement and Defense of CANFITE Patent Rights .
 
(a)             Enforcement by EYEFITE .  In the event that CANFITE or EYEFITE becomes aware of a suspected infringement of any CANFITE Patent Right exclusively licensed to EYEFITE under this Agreement, or any such CANFITE Patent Right is challenged in any action or proceeding (other than any interferences, oppositions, reissue proceedings or reexaminations, which are addressed above), in each case, in the Field in the Territory, such Party shall notify the other Party promptly, and following such notification, the Parties shall confer.  EYEFITE shall have the right, but shall not be obligated, to bring an infringement action or defend any such action or proceeding at its own expense, in its own name and entirely under its own direction and control, or to settle any such action or proceeding by sublicense, subject to the following.  CANFITE shall reasonably assist EYEFITE (at EYEFITE’s expense) in any action or proceeding being defended or prosecuted if so requested, and shall lend its name to and join as a nominal party in such actions or proceedings if reasonably requested by EYEFITE or required by applicable Laws.  CANFITE shall have the right to participate and be represented in any such suit by its own counsel at its own expense.  No settlement of any such action or proceeding which restricts the scope, or adversely affects the enforceability, of a CANFITE Patent Right may be entered into by EYEFITE without the prior written consent of CANFITE, which consent shall not be unreasonably withheld, delayed or conditioned.
 
(b)             Enforcement by CANFITE .  If EYEFITE elects not to bring any action for infringement described in Section 7.2(a) and so notifies CANFITE, then CANFITE may bring such action at its own expense, in its own name and entirely under its own direction and control, subject to the following.  EYEFITE shall reasonably assist CANFITE (at CANFITE’s expense) in any action or proceeding being prosecuted if so requested, and shall lend its name to such actions or proceedings if requested by CANFITE or required by applicable Laws.  EYEFITE shall have the right to participate and be represented in any such suit by its own counsel and at its own expense. No settlement of any such action or proceeding which restricts the scope, or adversely affects the enforceability, of a CANFITE Patent Right may be entered into by CANFITE without the prior written consent of EYEFITE, which consent shall not be unreasonably withheld, delayed or conditioned.
 
(c)             Damages .  In the event that either Party exercises its rights under this Section  7.3 (the “ Exercising Party ”) and recovers any damages or other sums in such action or proceeding or in settlement thereof (“ Recovery ”), then after deducting the costs and expenses borne by such Exercising Party in prosecuting or defending such action, proceeding or settlement, and, in the event the other Party participated in the action, proceeding or settlement, after deducting the costs and expenses borne by such other Party in prosecuting or defending such action, proceeding or settlement, the Exercising Party shall be entitled to seventy-five percent (75%) of the remainder of such Recovery and the other Party, regardless of whether such other Party participated in the action, proceeding or settlement, shall be entitled to twenty-five percent (25%) of the remainder of such Recovery.
 
(d)             Withdrawal . If either Party brings an action or proceeding under this Section 7.3 and subsequently ceases to pursue or withdraws from such action or proceeding, it shall promptly notify the other Party and the other Party may substitute itself for the withdrawing Party under the terms of this Section 7.3.
 
7.4           Patent Extensions; Orange Book Listings; Patent Certifications .
 
(a)             Patent Term Extension .  CANFITE shall have the sole right to make any elections with respect to obtaining patent term extension or supplemental protection certificates or their equivalents in any country with respect to CANFITE Patent Rights.

 
12

 
LICENSE AGREEMENT

(b)           Data Exclusivity .  With respect to any data exclusivity periods, such as those periods listed in the FDA’s Orange Book (including any available pediatric exclusivities) or other exclusivity periods under national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 (and all equivalents in any country), CANFITE shall have the sole right to seek and maintain all such data exclusivity periods available for the Licensed Compound or Licensed Product.
 
(c)           Notification of Patent Certification .  CANFITE shall notify and provide EYEFITE with copies of any allegations of alleged patent invalidity, unenforceability or non-infringement of a CANFITE Patent Right pursuant to a Paragraph IV Patent Certification by a Third Party filing an Abbreviated New Drug Application, an application under §505(b)(2) or any other similar patent certification by a Third Party, and any foreign equivalent thereof.  Such notification and copies shall be provided to EYEFITE within five (5) business days after CANFITE receives such certification, and shall be sent to the address set forth in Section  12.6.
 
Section 8.   Confidential Information and Publicity .
 
8.1           Confidentiality .
 
(a)           Confidential Information .  Except as expressly provided herein, each of the Parties agrees that, for itself and its Affiliates, and for as long as this Agreement is in effect and for a period of five (5) years thereafter, a Receiving Party shall (i) not disclose such Confidential Information to any Third Party without the prior written consent of the Disclosing Party, except for disclosures expressly permitted below, and (ii) not use such Confidential Information for any purpose except those licensed or otherwise authorized or permitted by this Agreement.  For clarity, all Confidential Information of EYEFITE received by or disclosed to CANFITE hereunder shall be used by CANFITE only for ensuring that EYEFITE complies with its obligations hereunder and that CANFITE complies with its obligations under the PHS Agreement and for no other purposes.
 
(b)           Exceptions .  The obligations in Section  8.1(a) shall not apply with respect to any portion of the Confidential Information that the Receiving Party can show by competent proof:
 
(i)             is publicly disclosed by the Disclosing Party, either before or after it is disclosed to the Receiving Party hereunder;
 
(ii)             was known to the Receiving Party or any of its Affiliates, without any obligation to keep it confidential or any restriction on its use, prior to disclosure by the Disclosing Party;
 
(iii)           is subsequently disclosed to the Receiving Party or any of its Affiliates by a Third Party lawfully in possession thereof and without any obligation to keep it confidential or any restriction on its use;
 
(iv)           is published by a Third Party or otherwise becomes publicly available or enters the public domain, either before or after it is disclosed to the Receiving Party;
 
(v)            has been independently developed by employees or contractors of the Receiving Party or any of its Affiliates without the aid, application or use of Confidential Information of the Disclosing Party; or

 
13

 
LICENSE AGREEMENT

(vi)          Information provided or will be provided by CANFITE to third parties under a confidentiality disclosure agreement (“ CDA ”), which is relevant for the use of the License Product outside of the Field.
 
8.2           Authorized Disclosures .  The Parties may disclose Confidential Information belonging to either Party to the extent such disclosure is reasonably necessary, in order to comply with applicable Laws, in connection with prosecuting or defending litigation, making regulatory filings, and filing, prosecuting and enforcing patent applications and patents.  Other than the publishing of a press release and regulatory filings, prior to publishing any Clinical Data regarding the Licensed Compound, EYEFITE shall provide CANFITE with a reasonable opportunity to review and comment on the proposed publication (which notice shall be no less than one business day under any circumstances).  Prior to the Effective Date, CANFITE submitted certain articles for publication by various journals.  The Parties agree that the publication of such articles after the Effective Date shall not be a breach by CANFITE of its obligations under this Agreement.  EYEFITE shall, in connection with all publications regarding the Licensed Compound, indicate that the Licensed Compound is licensed by EYEFITE from CANFITE.
 
8.3           Terms of this Agreement; Publicity .  The Parties agree that the terms of this Agreement shall be treated as Confidential Information of both Parties.  Each Party agrees not to issue any press release or other public statement disclosing information relating to this Agreement or the transactions contemplated hereby or the terms hereof without the prior written consent of the other Party, except:
 
(a)            A mutually agreed upon press release detailing the transaction set out herein pre approved by both Parties;
 
(b)            CANFITE shall be permitted to disclose the terms hereof to PHS; and
 
(c)            The Parties shall each be permitted to disclose the terms of this Agreement and the PHS Agreement (i) in communication with investors, consultants, advisors or others on a need-to-know basis, in each case under appropriate confidentiality provisions substantially equivalent to those of this Agreement; (ii) as necessary to comply with applicable governmental Laws and regulations (including, without limitation, the rules and regulations of the Securities and Exchange Commission or any national securities exchange) and with judicial process; or (iii) to other parties under a written confidentiality agreement.
 
8.4           Relationship to the Confidentiality Agreement .  This Agreement supersedes the Confidentiality Agreement, provided that all “Confidential Information” disclosed or received by the Parties thereunder shall be deemed “Confidential Information” hereunder and shall be subject to the terms and conditions of this Agreement.
 
Section 9.   Adverse Experience .
 
9.1          As stated in Sections 9.2 and 9.3, EYEFITE shall keep (and EYEFITE shall cause its sublicensees to keep under terms and conditions equal to those set forth in this Section 9) CANFITE, during the term of this Agreement, promptly and fully informed of all pharmaceutical, toxicological and clinical findings relating to adverse experience of the Licensed Product or Licensed Compound.  CANFITE shall be permitted to share with PHS all data and information provided under this Article 9 by EYEFITE.

 
14

 
LICENSE AGREEMENT

9.2          EYEFITE undertakes to notify CANFITE promptly with written confirmation by immediate telecopy of any information concerning any serious adverse event as defined by C.I.O.M.S. or any Regulatory Authority, as applicable, reasonably associated with clinical studies or attributed to the use or application of the Licensed Product or Licensed Compound.  In any event the above notification shall be made within two (2) working days after Licensee first learns or is advised of relevant information with respect to such serious adverse event.
 
9.3          EYEFITE shall also forward regularly (and usually every six (6) months unless the Parties agree on another period) to CANFITE any information on all other adverse effects or any difficulty associated with the clinical use, studies, investigations, tests and prescription of the Licensed Product or Licensed Compound.
 
9.4          EYEFITE shall provide upon request the information on estimated patient days of exposure.
 
9.5          EYEFITE shall inform CANFITE, without delay, of any governmental action, correspondence or reports to or from governmental authorities that may affect the situation of the Licensed Product or Licensed Compound and furnish CANFITE with copies of any relevant documents relating thereto.
 
Section 10.   Warranties; Limitations of Liability; Indemnification ; Covenants.
 
10.1         Representations and Warranties of Both Parties .  Each Party represents and warrants to the other Party, as of the Effective Date, that:
 
(a)             Such Party is a corporation duly organized and validly existing under the Laws of the state in which it is incorporated , and it has full right and authority to enter into this Agreement and to accept the rights and licenses granted as herein described.
 
(b)             This Agreement has been duly authorized by all requisite corporate action, and when executed and delivered will become a valid and binding contract of such Party enforceable against it in accordance with its terms, subject to applicable bankruptcy, insolvency, reorganization, moratorium and other Laws affecting creditors’ rights generally from time to time if effect, and to general principles of equity.
 
(c)             The execution, delivery and performance of this Agreement does not conflict with any other agreement, contract , instrument or understanding, oral or written, to which such Party is bound, nor will it violate any law applicable to such Party.
 
(d)            All necessary consents, approvals and authorizations of all regulatory and governmental authorities and other persons or entities required to be obtained by such Party in connection with the execution and delivery of this Agreement and the performance of its obligations hereunder have been obtained.

 
15

 
LICENSE AGREEMENT

10.2         CANFITE Representations and Warranties .  CANFITE covenants, represents and warrants to EYEFITE that as of the Effective Date:
 
(a)            CANFITE, through in-licensing or ownership, controls the patents and patent applications that are included within the CANFITE Patent Rights as of the Effective Date and CANFITE Controls the CANFITE Know-How, in both cases, for use with the Licensed Compound within the Field;
 
(b)            To the best of its knowledge and belief, all of the issued patents within the CANFITE Patent Rights are in good standing;
 
(c)            To the best of its knowledge and belief, CANFITE is not aware of any notice from any Third Party asserting any ownership rights to any CANFITE Know-How for use with the Licensed Compound within the Field;
 
(d)            To the best of its knowledge and belief, CANFITE is not aware of any pending or threatened action, suit, proceeding or claim by a Third Party asserting that CANFITE is infringing or has misappropriated or otherwise is violating any patent, trade secret or other proprietary right of any Third Party as would reasonably be expected to result in CANFITE being unable to grant the rights and licenses to EYEFITE under this Agreement;
 
(e)            CANFITE has not granted any right or license or other encumbrance of any kind in the FIELD to any Third Party relating to the CANFITE Patent Rights and CANFITE Know-How that conflicts with any of the rights granted to EYEFITE hereunder;
 
(f)             There are no claims, actions, or proceedings pending or, to CANFITE’s knowledge, threatened; nor are there any formal inquiries or notices that may lead to the institution of such legal proceedings, against CANFITE or its Affiliates or PHS or its Affiliates, which if adversely decided, would, individually or in the aggregate, have a material adverse effect on, or prevent CANFITE’s ability to grant the licenses and assignments to EYEFITE contemplated hereunder; and
 
10.3         Disclaimer .  EXCEPT AS EXPRESSLY SET FORTH HEREIN, NEITHER CANFITE NOR EYEFITE MAKES ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
 
10.4         Limitation of Liability .  NOTWITHSTANDING ANYTHING IN THIS AGREEMENT OR OTHERWISE, NEITHER PARTY SHALL BE LIABLE TO THE OTHER OR ANY THIRD PARTY WITH RESPECT TO ANY SUBJECT MATTER OF THIS AGREEMENT FOR ANY INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES; PROVIDED, HOWEVER, THAT THIS SECTION  10.4 SHALL NOT APPLY TO THE PARTIES’ INDEMNIFICATION RIGHTS AND OBLIGATIONS UNDER SECTIONS 10.6(a) AND 10.6(b).
 
10.5         Performance by Affiliates .  The Parties recognize that each Party may perform some or all of its obligations under this Agreement through Affiliates and Third Party contractors provided, however, that each Party shall remain responsible and liable for the performance by its Affiliates and Third Party contractors and shall cause its Affiliates and Third Party contractors to comply with the provisions of this Agreement in connection therewith.

 
16

 
LICENSE AGREEMENT

10.6         Indemnification .
 
(a)             EYEFITE Indemnity .  EYEFITE hereby agrees to indemnify and hold CANFITE and its Affiliates, and their respective employees, directors, agents and contractors, and their respective successors, heirs and assigns   and representatives (“ CANFITE Indemnitees ”) harmless from and against all claims, liability, threatened claims, damages, expenses (including reasonable attorneys’ fees), suits, proceedings, losses or judgments, whether for money or equitable relief, of any kind, including death, personal injury, illness, product liability or property damage or the failure to comply with applicable law (collectively, “ Losses ”), arising from any Third Party claim due to the use, manufacture, sale, development or commercialization of any Licensed Compounds or Licensed Products by or for EYEFITE or any of its Affiliates, Sublicensees, agents and contractors, except to the extent that such Losses arise from (a) the negligence, recklessness or willful misconduct of any CANFITE Indemnitees or (b) any breach of this Agreement by CANFITE.
 
(b)             CANFITE Indemnity .  CANFITE hereby agrees to indemnify and hold EYEFITE, its Affiliates and Sublicensees, and their respective employees, directors, agents and contractors, and their respective successors, heirs and assigns   and representatives (“ EYEFITE Indemnitees ”) harmless from and against all Losses arising from any Third Party claim due to the use, manufacture, sale, development or commercialization of any Licensed Compounds or Licensed Products by or for CANFITE or any of its Affiliates, licensees (other than EYEFITE and its Affiliates and Sublicensees), agents and contractors, except to the extent that such Losses arise from (a) the negligence, recklessness or willful misconduct of any EYEFITE Indemnitees or (b) any breach of this Agreement by EYEFITE.
 
(c)             Indemnification Procedure .  A claim to which indemnification applies under Section 10.6(a) or Section 10.6(b) shall be referred to herein as a “Claim.”  If any person or entity (each, an “ Indemnitee ”) intends to claim indemnification under this Section  10.6, the Indemnitee shall notify the other Party (the “ Indemnitor ”) in writing promptly upon becoming aware of any claim that may be a Claim (it being understood and agreed, however, that the failure by an Indemnitee to give such notice shall not relieve the Indemnitor of its indemnification obligation under this Agreement except and only to the extent that the Indemnitor is actually prejudiced as a result of such failure to give notice).  The Indemnitor shall have the right to assume and control the defense of such Claim at its own expense with counsel selected by the Indemnitor and reasonably acceptable to the Indemnitee; provided, however, that an Indemnitee shall have the right to retain its own counsel, with the fees and expenses to be paid by the Indemnitee, if representation of such Indemnitee by the counsel retained by the Indemnitor would be inappropriate due to actual or potential differing interests between such Indemnitee and any other party represented by such counsel in such proceedings.  If the Indemnitor does not assume the defense of such Claim as aforesaid, the Indemnitee may defend such Claim but shall have no obligation to do so.  The Indemnitee shall not settle or compromise any Claim without the prior written consent of the Indemnitor, and the Indemnitor shall not settle or compromise any Claim in any manner which would have an adverse effect on the Indemnitee’s interests, without the prior written consent of the Indemnitee, which consent, in each case, shall not be unreasonably withheld.  The Indemnitee shall reasonably cooperate with the Indemnitor at the Indemnitor’s expense and shall make available to the Indemnitor all pertinent information under the control of the Indemnitee, which information shall be subject to Section  8.1.
 
10.7         Insurance .   EYEFITE shall, beginning with the initiation of the first clinical trial for a Licensed Product, maintain at all times during the development and commercialization of the Licensed Compound a commercial general liability insurance from a recognized, creditworthy insurance company, on a claims-made basis, with endorsements for contractual liability and clinical trials (prior to distribution or sale of the actual product, a product liability endorsement shall be added), and with coverage limits in such amounts as is customary in the industry.  EYEFITE cause CANFITE and PHS to be named as additional insureds on all such insurance policies, for their respective rights and interests.  Within ten (10) days following written request by CANFITE, EYEFITE shall furnish to CANFITE a certificate of insurance evidencing such coverage, and shall communicate to CANFITE during the term of this Agreement any modifications to such coverage.

 
17

 
LICENSE AGREEMENT

10.8         Covenants .
 
(a)          CANFITE shall not take any action, or omit to take any action, that would (i) encumber any of its right, title and interest in and to the Licensed Compounds or the Licensed Products in any way that would have a material adverse effect on the rights and licenses granted to EYEFITE hereunder, or (ii) cause CANFITE to be in breach under the PHS Agreement.
 
(b)          EYEFITE agrees to be bound by the following obligations towards PHS ( all capitalized terms in this Sub-Section 10.8(b) shall have the meaning ascribed to them in the PHS Agreement ):
 
(i)           PHS reserves on behalf of the Government an irrevocable, nonexclusive, nontransferable, royalty-free license for the practice of all inventions licensed under the Licensed Patent Rights throughout the world by or on behalf of the Government and on behalf of any foreign government or international organization pursuant to any existing or future treaty or agreement to which the Government is a signatory .
 
(ii)             Prior to the First Commercial Sale, EYEFITE agrees to provide PHS reasonable quantities of Licensed Products or materials made through the Licensed Processes for PHS research use.
 
(iii)            In the event that Licensed Patent Rights are Subject Inventions made under a Cooperative Research and Development Agreement (CRADA), EYEFITE grants to the Government, pursuant to 15 U.S.C. 3710a(b)(1)(A), a nonexclusive, nontransferable, irrevocable, paid-up license to practice Licensed Patent Rights or have Licensed Patent Rights practiced throughout the world by or on behalf of the Government. In the exercise of such license, the Government shall not publicly disclose trade secrets or commercial or financial information that is privileged or confidential within the meaning of 5 U.S.C. 552(b)(4) or which would be considered as such if it had been obtained from a non-Federal party. Prior to the First Commercial Sale, EYEFITE agrees to provide PHS reasonable quantities of Licensed Products or materials made through the Licensed Processes for PHS research use.
 
(iv)           EYEFITE agrees that products used or sold in the United States embodying Licensed Products or produced through use of Licensed Processes shall be manufactured substantially in the United States, unless a written waiver is obtained in advance from PHS.
 
(v)            EYEFITE acknowledges that PHS may enter into future Cooperative Research and Development Agreements (CRADAs) under the Federal Technology Transfer Act of 1986 that relate to the subject matter of this Agreement. EYEFITE agrees not to unreasonably deny requests for a Research License from such future collaborators with PHS when acquiring such rights is necessary in order to make a Cooperative Research and Development Agreement (CRADA) project feasible. EYEFITE may request an opportunity to join as a party to the proposed Cooperative Research and Development Agreement (CRADA).

 
18

 
LICENSE AGREEMENT

(vi)           (a) In addition to the reserved license of Paragraph 5.01 of the PHS Agreement, PHS reserves the right to grant nonexclusive Research Licenses directly or to require EYEFITE to grant nonexclusive Research Licenses on reasonable terms. The purpose of this Research License is to encourage basic research, whether conducted at an academic or corporate facility. In order to safeguard the Licensed Patent Rights, however, PHS shall consult with EYEFITE before granting to commercial entities a Research License or providing to them research samples of materials made through the Licensed Processes.
 
(vii)          (b) In exceptional circumstances, and in the event that Licensed Patent Rights are Subject Inventions made under a Cooperative Research and Development Agreement (CRADA), the Government, pursuant to 15 U.S.C. 3710a(b)(1)(B), retains the right to require the EYEFITE to grant to a responsible applicant a nonexclusive, partially exclusive, or exclusive sublicense to use Licensed Patent Rights in EYEFITE's field of use on terms that are reasonable under the circumstances; or if EYEFITE fails to grant such a license, the Government retains the right to grant the license itself. The exercise of such rights by the Government shall only be in exceptional circumstances and only if the Government determines (i) the action is necessary to meet health or safety needs that are not reasonably satisfied by EYEFITE; (ii) the action is necessary to meet requirements for public use specified by Federal regulations, and such requirements are not reasonably satisfied by the EYEFITE; or (iii) the EYEFITE has failed to comply with an agreement containing provisions described in 15 U.S.C. 3710a(c)(4)(B). The determination made by the Government under this Article is subject to administrative appeal and judicial review under 35 U.S.C. 203(2).
 
(viii)         EYEFITE agrees to keep accurate and correct records of Licensed Products made, used, sold, or imported and Licensed Processes practiced under this Agreement appropriate to determine the amount of royalties due PHS. Such records shall be retained for at least five (5) years following a given reporting period and shall be available during normal business hours for inspection at the expense of PHS by an accountant or other designated auditor selected by PHS for the sole purpose of verifying reports and payments hereunder. The accountant or auditor shall only disclose to PHS information relating to the accuracy of reports and payments made under this Agreement. If an inspection shows an underreporting or underpayment in excess of five percent (5%) for any twelve (12) month period, then EYEFITE shall reimburse PHS for the cost of the inspection at the time EYEFITE pays the unreported royalties, including any late charges as required by Paragraph 9.08 of the PHS Agreement. All payments required under this Paragraph shall be due within thirty (30) days of the date PHS provides EYEFITE notice of the payment due.

 
19

 
LICENSE AGREEMENT

(ix)            EYEFITE shall use its reasonable best efforts to bring the Licensed Products and Licensed Processes to Practical Application.
 
(x)             Upon the First Commercial Sale, until the expiration of this Agreement, EYEFITE shall use its reasonable best efforts to make Licensed Products and Licensed Processes reasonably accessible to the United States public .
 
(xi)            EYEFITE shall indemnify and hold PHS, its employees, students, fellows, agents, and consultants harmless from and against all liability, demands, damages, expenses, and losses, including but not limited to death, personal injury, illness, or property damage in connection with or arising out of: a) the use by or on behalf of EYEFITE, its sublicensees, directors, employees, or third parties of any Licensed Patent Rights; or b) the design, manufacture, distribution, or use of any Licensed Products, Licensed Processes or materials by EYEFITE, or other products or processes developed in connection with or arising out of the Licensed Patent Rights. EYEFITE agrees to maintain a liability insurance program consistent with sound business practice.
 
(xii)           PHS reserves the right according to 35 U.S.C. . 209(f)(4) to terminate or modify the terms of the PHS Agreement if it is determined that such action is necessary to meet requirements for public use specified by federal regulations issued after the date of the license and such requirements are not reasonably satisfied by EYEFITE.
 
(xiii)          Within thirty (30) days of receipt of written notice of PHS's unilateral decision to modify or terminate the PHS Agreement, EYEFITE may, consistent with the provisions of 37 CFR 404.11, appeal the decision by written submission to the designated PHS official. The decision of the designated PHS official shall be the final agency decision. EYEFITE may thereafter exercise any and all administrative or judicial remedies that may be available .
 
(xiv)          Within ninety (90) days of expiration or termination of the PHS Agreement under Article 13 of the PHS Agreement, a final report shall be submitted by EYEFITE. Any royalty payments, including those incurred but not yet paid (such as the full minimum annual royalty), and those related to patent expense, due to PHS shall become immediately due and payable upon termination or expiration. If terminated under Article 13 of the PHS Agreement, sublicensees may elect to convert their sublicenses to direct licenses with PHS pursuant to Paragraph 4.03 of the PHS Agreement. Unless otherwise specifically provided for under this Agreement, upon termination or expiration of this Agreement, EYEFITE shall return all Licensed Products or other materials included within the Licensed Patent Rights to PHS or provide PHS with certification of the destruction thereof.
 
(xv)           Any sublicenses granted by EYEFITE shall provide for the termination of the sublicense, or the conversion to a license directly between such sublicensees and PHS, at the option of the sublicensee, upon termination of the PHS Agreement under Article 13 of the PHS Agreement. Such conversion is subject to PHS approval and contingent upon acceptance by the sublicensee of the remaining provisions of the PHS Agreement .

 
20

 
LICENSE AGREEMENT

(xvi)         The non-compliance by EYEFITE of any of the aforesaid obligation in this Sub-section 10.8(b) shall be deemed a breach of this Agreement entitling CANFITE the right to terminate the license granted hereunder, provided that EYEFITE shall have a thirty (30) day period from receipt of a written letter from CANFITE of the occurrence of such breach during which to cure such breach and comply with such obligation..
 
Section 11.   Term and Termination .
 
11.1         Term .  This Agreement shall commence as of the Effective Date and, unless sooner terminated in accordance with the terms hereof or by mutual written consent, shall continue until the expiry of the last of the CANFITE Patent Rights (the "Term").  Notwithstanding the aforesaid, upon the expiry of the PHS Agreement, the obligations of EYEFITE to make the payments to PHS under Section 6 above shall cease to exist.
 
11.2         Termination By CANFITE .  CANFITE shall have the right to terminate this Agreement, in CANFITE’s sole discretion, as follows:
 
(a)             Insolvency .  CANFITE shall have the right to terminate this Agreement upon delivery of written notice to EYEFITE in the event that: (i) EYEFITE fails to or is unable to make payments to CANFITE or to PHS or to any third parties as and when they become due and payable in the ordinary course of business, (ii) a liquidation proceeding under any state or United States bankruptcy Law, receivership Law, or the like, as they now exist, or as they may be amended, is commenced by EYEFITE, (iii) if EYEFITE is served with an involuntary petition against it in any insolvency proceeding, upon the thirtieth (30th) day after such service if such involuntary petition has not previously been stayed or dismissed, or (iv) upon the making by EYEFITE of an assignment of substantially all of its assets for the benefit of its creditors.
 
(b)             Breach . Subject to Section 11.2(c) below, CANFITE shall have the right to terminate this Agreement, at CANFITE’s sole discretion, upon delivery of written notice to EYEFITE in the event of any material   breach by EYEFITE of any terms and conditions of this Agreement, provided that such breach has not been cured within thirty (30) days after written notice thereof is given by CANFITE to EYEFITE specifying the nature of the alleged breach, provided, however , that to the extent such material breach involves the failure to make a payment when due, such breach must be cured within thirty (30) days after written notice thereof is given by CANFITE to EYEFITE.
 
(c)             Disputed Breach .  If EYEFITE disputes in good faith the existence or materiality of a breach specified in a notice provided by CANFITE pursuant to Section  11.2(b) and EYEFITE provides notice to CANFITE of such dispute within the applicable thirty (30) day period, CANFITE shall not have the right to terminate this Agreement unless and until the existence of such material breach or failure by EYEFITE has been determined in accordance with Section  12.7 and EYEFITE fails to cure such breach within thirty (30) days following such determination (except to the extent such breach involves the failure to make a payment when due, which breach must be cured within ten (10) business days following such determination).  It is understood and acknowledged that during the pendency of such a dispute, all of the terms and conditions of this Agreement shall remain in effect and the Parties shall continue to perform all of their respective obligations hereunder; provided, however, that any payments that are made by one Party to the other Party pursuant to this Agreement pending resolution of the dispute shall be paid into escrow (such payments, the “ Escrow Funds ”) with an escrow agent mutually selected by the Parties according to an escrow agreement in form and substance reasonably satisfactory to the Parties.  The Parties further agree that any Escrow Funds shall be promptly refunded from the escrow if an arbitrator or court determines pursuant to Section  12.7 that such Escrow Funds are to be refunded by one Party to the other Party.

 
21

 
LICENSE AGREEMENT
 
(d)             Scope of Termination .  Except as otherwise expressly provided herein, termination of this Agreement shall be as to all countries in the Territory and all Licensed Products.
 
11.3         Termination by EYEFITE .
 
(a)            At EYEFITE’s discretion, effective upon three (3) months prior written notice, EYEFITE may terminate this Agreement for any reason.
 
(b)            In addition, EYEFITE may terminate this Agreement in the event of material breach by CANFITE, provided that such breach has not been cured within thirty (30) days after written notice thereof is given by EYEFITE to CANFITE.   If CANFITE disputes in good faith the existence or materiality of such breach and provides notice to EYEFITE of such dispute within such thirty (30) day period, EYEFITE shall not have the right to terminate this Agreement in accordance with this Section  11.3 (b) unless and until it has been determined in accordance with Section  12.7 that this Agreement was materially breached by CANFITE and CANFITE fails to cure such breach within thirty (30) days following such determination.  It is understood and acknowledged that during the pendency of such a dispute, all of the terms and conditions of this Agreement shall remain in effect and the Parties shall continue to perform all of their respective obligations hereunder.  The Parties further agree that any payments that are made by one Party to the other Party pursuant to this Agreement pending resolution of the dispute shall be promptly refunded if an arbitrator or court determines pursuant to Section  12.7 that such payments are to be refunded by one Party to the other Party.
 
11.4         Effect of Termination .  Upon termination (or, in the case of clauses (c) and (g) below, expiration) of this Agreement under Section 11.3(a) or Section 11.2,:
 
(a)            All rights and licenses granted to EYEFITE in Section 2 shall terminate, all rights of EYEFITE under the CANFITE Patent Rights and CANFITE Know-How shall revert to CANFITE, and EYEFITE shall cease all use of the CANFITE Patent Rights, CANFITE Know-How and Trademarks and Corporate Names of CANFITE and its Affiliates.
 
(b)            EYEFITE shall assign to CANFITE EYEFITE’s right, title and interest in all regulatory filings (including, without limitation, all NDAs) and Approvals and other documents relating to or necessary to further develop and commercialize Licensed Compounds and Licensed Products, as they exist as of the date of such termination, and  EYEFITE shall provide to CANFITE one (1) copy of the foregoing documents and filings and all documents and filings contained in or referenced in any such filings, together with the raw and summarized data for any preclinical and clinical studies of the Licensed Compounds and such Licensed Product (and where reasonably available, electronic copies thereof) at CANFITE’s cost.  In addition, upon request by CANFITE, EYEFITE shall grant to CANFITE the right to access and reference any other documents (including but not limited to regulatory filings) that are available to EYEFITE and reasonably necessary for CANFITE to further develop, manufacture and commercialize the Licensed Compounds and Licensed Product.

 
22

 
LICENSE AGREEMENT

(c)            All amounts due or payable to CANFITE, PHS or other third parties that were accrued, or that arise out of acts or events occurring, prior to the effective date of termination or expiration shall remain due and payable; but (except as otherwise expressly provided herein) no additional amounts shall be payable based on events occurring after the effective date of termination or expiration.
 
(d)            Should EYEFITE have any inventory of the Licensed Compound suitable for use, EYEFITE shall offer to sell such Licensed Compound to CANFITE at EYEFITE’s out-of-pocket cost (but CANFITE shall be under no obligation to purchase same unless it agrees to do so in writing at such time).
 
(e)            EYEFITE shall assign (or, if applicable, cause its Affiliate to assign) to CANFITE all of EYEFITE’s (and such Affiliates’) right, title and interest in and to any registered or unregistered trademark, trademark application, trade name or internet domain name that is specific to a Licensed Product (it being understood that the foregoing shall not include any trademarks or trade names that contain EYEFITE’s name).
 
(f)            EYEFITE shall grant to CANFITE a license, which license shall be exclusive, with the right to grant sublicenses, under all patent rights owned or Controlled by EYEFITE as of the Termination Date to make, use, import, sell and offer for sale and otherwise develop and commercialize the Licensed Product and Licensed Compound in the Field.  In consideration of the license granted by EYEFITE to CANFITE in accordance with this Section 11.4(f), CANFITE shall pay EYEFITE a royalty on a product-by-product basis at a rate equal to one percent (1%) of Net Sales (with the roles of CANFITE and EYEFITE reversed for purposes of the definition of Net Sales.  The maximum cumulative royalty payments under this Section 11.4(f) shall not exceed one hundred percent (100%) of the payments due and actually paid by EYEFITE to PHS under this Agreement prior to the time EYEFITE grants CANFITE a license in accordance with this Section 11.4(f).
 
(g)            Neither Party shall be relieved of any obligation that accrued prior to the effective date of such termination or expiration.
 
(h)            CANFITE shall have the right to retain all amounts previously paid to CANFITE by EYEFITE, subject to any applicable determination of an arbitrator or court pursuant to Section  12.7.
 
11.5         Survival .  The following provisions shall survive termination or expiration of this Agreement, as well as any other provision which by its terms or by the context thereof, is intended to survive such termination: Section 1 (as applicable), Section  2.1(a)(i), Section 5 (with respect to obligations arising prior to expiration or termination of this Agreement), Section 6 (with respect to obligations arising prior to expiration or termination of this Agreement).  Section  7.3(c) (with respect to an action, suit or proceeding commenced prior to termination), Section  7.4(c), Section 8, Section 10.3, Section 10.4, Section  10.6, Section  11.4, Section  11.5, and Section 12.  Termination or expiration of this Agreement shall not relieve the Parties of any liability or obligation which accrued hereunder prior to the effective date of such termination or expiration nor preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity, subject to Section  12.7, with respect to any breach of this Agreement nor prejudice either Party’s right to obtain performance of any obligation.  All other obligations shall terminate upon expiration of this Agreement.

 
23

 
LICENSE AGREEMENT

Section 12.   General Provisions .
 
12.1         Efforts to Consummate; Certain Governmental Matters .  Upon the terms and subject to the conditions herein provided, each of the Parties agrees to use its reasonable best efforts to take, or cause to be taken, all actions and to do, or cause to be done, all things necessary for it to do under applicable Laws to consummate and make effective the transactions contemplated by this Agreement, including all actions and all things necessary for it (i) to comply promptly with all legal requirements that may be imposed on it with respect to this Agreement and the transactions contemplated hereby (which actions shall include furnishing all information required by applicable Laws in connection with approvals of or filings with any Governmental Authority), (ii) to satisfy the conditions precedent to the obligations of such party hereto, and (iii) to obtain any consent, authorization, order or approval of, or any exemption by, any Governmental Authority or other Person required to be obtained or made by EYEFITE or CANFITE in connection with the grant of the license to the Licensed Compounds and Licensed Products to EYEFITE or the taking of any action contemplated by this Agreement.  Without limiting the generality of the undertakings pursuant to this Section 11.1, each of EYEFITE and CANFITE agree to provide or cause to be provided promptly to each Governmental Authority with regulatory jurisdiction over enforcement of any applicable Competition Laws (“ Governmental Antitrust Authority ”) information and documents requested by such Governmental Antitrust Authority or necessary, proper or advisable to permit consummation of the license of the Licensed Compounds and Licensed Products and the other transactions contemplated by this Agreement.  Subject to appropriate confidentiality protections, each of the parties hereto will furnish to the other parties such necessary information and reasonable assistance as such other parties may reasonably request in connection with the foregoing and will keep the other parties reasonably informed with respect to any consent, authorization, order or approval of, or exemption by, sought from any Governmental Authority in connection with this Agreement and the transactions contemplated hereby.  For purposes of this Section 11.1, “Competition Laws” shall mean statutes, rules, regulations, orders, decrees, administrative and judicial doctrines and other Laws of any jurisdiction that are designed or intended to prohibit, restrict or regulate actions that may have the purpose or effect of creating a monopoly, lessening competition or restraining trade.
 
12.2         Assignment .  Except as provided by Sections  2.1, 6.5 or  10.5, neither Party may assign this Agreement, delegate its obligations or otherwise transfer licenses or other rights created by this Agreement, without the prior written consent of the other Party, which consent shall not be unreasonably withheld; provided that each Party may assign this Agreement as a whole without such consent to an Affiliate or in connection with the acquisition (whether by merger, consolidation, sale or otherwise) of such Party or of that part of such Party’s business to which this Agreement relates.  Any assignment or transfer in violation of this Section  12.2 shall be void.  This Agreement shall inure to the benefit of, and be binding upon, the legal representatives, successors and permitted assigns of the Parties.
 
12.3         Force Majeure .  Neither Party shall be responsible for failure or delay in the performance of any of its obligations hereunder due to Force Majeure. Force Majeure shall mean any circumstance that, due to an event or a legal position beyond the Party’s reasonable control, renders impossible the fulfillment of any of the Party’s obligations hereunder, such as, but not limited to, acts of God, acts, regulations, or Laws of any government, war, civil commotion, destruction of facilities or materials by fires, earthquakes, or storms, labor disturbances, shortages of public utilities, common carriers, or raw materials, or any other cause, or causes of similar effects, except, however, any economic occurrence.  During any such case of Force Majeure, this Agreement shall not be terminated, but only suspended and the Party so affected shall continue to perform its obligations as soon as such case of Force Majeure is removed or alleviated.

 
24

 
LICENSE AGREEMENT

12.4         Severability .  If any one or more of the provisions contained in this Agreement is held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired thereby, unless the absence of the invalidated provision(s) adversely affects the substantive rights of the Parties.  The Parties shall in such an instance use their reasonable best efforts to replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, implement the purposes of this Agreement.
 
12.5         Amendment; Waiver .  This Agreement may not be modified, amended or rescinded, in whole or part, except by a written instrument signed by the Parties; provided that any unilateral undertaking or waiver made by one Party in favor of the other shall be enforceable if undertaken in a writing signed by the Party to be charged with the undertaking or waiver.  CANFITE hereby agrees to negotiate in good faith with EYEFITE to amend this Agreement to the extent necessary to reflect the initial public offering in the United States of shares of capital stock of EYEFITE or Parent of EYEFITE.  No delay or omission by either Party hereto in exercising any right or power occurring upon any noncompliance or default by the other Party with respect to any of the terms of this Agreement shall impair any such right or power or be construed to be a waiver thereof.  A waiver by either of the Parties of any of the covenants, conditions or agreements to be performed by the other shall not be construed to be a waiver of any succeeding breach thereof or of any other covenant, condition or agreement herein contained.
 
12.6         Notices .   Except as otherwise provided herein, all notices under this Agreement shall be sent by certified mail or by overnight courier service, postage prepaid, to the following addresses of the respective Parties:
 
 
If to EYEFITE, to:
Eye-Fite Ltd
 
c/o Kantor & Co.
 
12 Aba Hillel Street,
 
Ramat Gan, Israel
 
Attention:  Ronen Kantor, Adv.
 
Facsimile:  (972) 36133372
 
 
With a required copy to:
Kantor & Co.
 
12 Aba Hillel Street,
 
Ramat Gan, Israel
 
Attention: Ronen Kantor, Adv.
 
Facsimile: (972) 36133372

 
If to CANFITE, to:
CAN-FITE Biopharma Ltd.
 
 
10 Bareket Street,
 
 
Petach Tikva, Israel
 
Attention:  Prof. Pnina Fishman, CEO and Director
 
 
Facsimile:
 
 
With a required copy to:
Kantor & Co.
 
12 Aba Hillel Street,
 
Ramat Gan, Israel
 
Attention:  Ronen Kantor, Adv.
 
Facsimile:  (972) 36133372
 
 
25

 
LICENSE AGREEMENT
 
or to such address as each Party may hereafter designate by notice to the other Party.  A notice shall be deemed to have been given on the date it is received by all required recipients for the noticed Party.
 
12.7         Dispute Resolution .  Disputes arising under or in connection with this Agreement shall be resolved pursuant to this Section  12.7; provided, however, that in the event a dispute cannot be resolved without an adjudication of the rights or obligations of a Third Party (other than a CANFITE Indemnitee or EYEFITE Indemnitee identified in Sections  10.6(a) or 10.6(b), as applicable), the dispute procedures set forth in this Section  12.7 shall be inapplicable as to such dispute.
 
(a)             In the event of a dispute between the Parties, the Parties shall first attempt in good faith to resolve such dispute by negotiation and consultation between themselves.  In the event that such dispute is not resolved on an informal basis within forty-five (45) days, any Party may, by written notice to the other, have such dispute referred to each of the Parties’ respective CEOs or his or her designee (who shall be a senior executive), who shall attempt in good faith to resolve such dispute by negotiation and consultation for a thirty (30) day period following receipt of such written notice .
 
(b)             In the event the Parties’ CEOs (or designees) are not able to resolve such dispute, either Party may at any time after such 30-day period submit such dispute to be finally settled by arbitration administered   in accordance with the Commercial Arbitration Rules of the American Arbitration Association (“ AAA ”) in effect at the time of submission.  The arbitration shall be heard and determined by three (3) arbitrators.  EYEFITE and CANFITE shall each appoint one (1) arbitrator and the third arbitrator shall be selected by the two Party-appointed arbitrators, or, failing agreement within sixty (60) days following the date of receipt by the respondent of the claim,   by the AAA.  Such arbitration shall take place in New York, NY.  The arbitration award so given shall be a final and binding determination of the dispute, shall be fully enforceable in any court of competent jurisdiction, and shall not include any damages expressly prohibited by Section  10.4.
 
(c)             Costs of arbitration are to be divided by the Parties in the following manner: EYEFITE shall pay for the arbitrator it chooses, CANFITE shall pay for the arbitrator it chooses, and the costs of the third arbitrator shall be divided equally between the Parties.  Except in a proceeding to enforce the results of the arbitration or as otherwise required by law, neither Party nor any arbitrator may disclose the existence, content or results of any arbitration hereunder without the prior written consent of both Parties.
 
12.8         Applicable Law .  This Agreement shall be governed by and construed in accordance with the Laws of the State of Israel, without regard to any conflicts of law provisions.
 
12.9         Further Assurances .  Each Party agrees to do and perform all such further acts and things and shall execute and deliver such other agreements, certificates, instruments and documents necessary or that the other Party may deem advisable in order to carry out the intent and accomplish the purposes of this Agreement and to evidence, perfect or otherwise confirm its rights hereunder.
 
12.10       Relationship of the Parties .  Each Party is an independent contractor under this Agreement .  Nothing contained herein is intended or is to be construed so as to constitute CANFITE and EYEFITE as partners, agents or joint venturers.  Neither Party shall have any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any contract, agreement or undertaking with any Third Party.  There are no express or implied third party beneficiaries hereunder (except for EYEFITE Indemnitees other than EYEFITE and CANFITE Indemnitees other than CANFITE for purposes of Section  10.6) and PHS under Section 6 and Section 10.8(b).

 
26

 
LICENSE AGREEMENT

12.11       Entire Agreement .  This Agreement (along with the Exhibits), together with the PHS Agreement, contains the entire understanding of the Parties with respect to the subject matter hereof and supersedes and replaces any and all previous arrangements and understandings, including the Confidentiality Agreement, whether oral or written, between the Parties with respect to the subject matter hereof.
 
12.12       Headings .  The captions to the several Sections hereof are not a part of this Agreement , but are merely guides or labels to assist in locating and reading the several Sections hereof.
 
12.13       Waiver of Rule of Construction .  Each Party has had the opportunity to consult with counsel in connection with the review, drafting and negotiation of this Agreement.  Accordingly, the rule of construction that any ambiguity in this Agreement shall be construed against the drafting party shall not apply.
 
12.14       Interpretation .  Whenever any provision of this Agreement uses the term “including” (or “includes”), such term shall be deemed to mean “including without limitation” (or “ includes without limitations”).  “Herein,” “hereby,” “hereunder,” “hereof” and other equivalent words refer to this Agreement as an entirety and not solely to the particular portion of this Agreement in which any such word is used.  All definitions set forth herein shall be deemed applicable whether the words defined are used herein in the singular or the plural.  Unless otherwise provided, all references to Sections and Exhibits in this Agreement are to Sections and Exhibits of this Agreement.  References to any Sections include Sections and subsections that are part of the related Section ( e.g ., a section numbered “Section  2.1” would be part of “ Section 2”, and references to “Section  2.1” would also refer to material contained in the subsection described as “Section  2.1(a)”)
 
12.15       Counterparts; Facsimiles .  This Agreement may be executed in two or more counterparts , each of which shall be deemed an original and all of which together shall constitute one and the same instrument.  Facsimile execution and delivery of this Agreement by either Party shall constitute a legal, valid and binding execution and delivery of this Agreement by such Party.

 
27

 
LICENSE AGREEMENT

IN WITNESS WHEREOF, the Parties have caused this License Agreement to be executed by their respective duly authorized officers as of the Effective Date.
 
 
CANFITE BIOPHARMA LTD.
   
 
By:
/s/ Pnina Fishman
/s/ Motti Farbstein
   
(Signature)
 
       
 
Name:
Pnina Fishman
Motti Farbstein
       
 
Title:
CEO
COO
       
 
Date:
November 21, 2011
 
   
 
EYEFITE LTD.
   
 
By:
/s/Pnina Fishman
/s/Motti Farbstein
   
(Signature)
 
       
 
Name:
Pnina Fishman
Motti Farbstein
       
 
Title:
Director
Director
       
 
Date:
November 21, 2011
 

 
 

 
LICENSE AGREEMENT

EXHIBIT A - CANFITE PATENT RIGHTS
 
The CANFITE Patent Rights that are licensed to EYEFITE within the framework of this Agreement are summarized in a tabulated format below. Each Table lists all cases belonging to a single patent family (each patent family consisting of patent cases that descend from the same priority application(s)). Each table is headed by CANFITE's respective case number and internal title (which may corresponds to the formal title).
 
CF19
 
Method for treating Sjogren's Syndrome
 
Country
 
Application Serial
No. 
 
Filing Date
 
Status
Europe*
 
05762145.0
 
18-Jul-2005
 
Pending
Japan*
 
2007-523232
 
18-Jul-2005
 
Issued Patent, Serial No. 4642847
US 3
  
11/604,905
  
28-Nov-06
  
Issued Patent, Serial No. 7,825,102
* All cases are national phase applications of PCT application No. IL2005/00762, which claims priority from US provisional application No. 60/591,628 filed on July 28, 2004
 
CF27
 
Treatment of dry eye
 
Country
 
Application Serial
No. 
 
Filing Date
 
Status
US
 
12/774,927
 
11-May-10
 
Pending
Australia*
 
2006336834
 
1-Feb-06
 
Issued Patent, Serial No. 2006336834
Brazil*
 
PI 0621052-0
 
1-Feb-06
 
Pending
Canada*
 
2,622,975
 
1-Feb-06
 
Pending
China*
 
200680047569.7
 
1-Feb-06
 
Pending
Europe*
 
06701840.8
 
1-Feb-06
 
Pending
Israel*
 
191271
 
1-Feb-06
 
Pending
India*
 
1415/MUMP/2008
 
1-Feb-06
 
Pending
Japan*
 
2008-551950
 
1-Feb-06
 
Pending
Rep. of Korea*
 
10-2008-7020322
 
1-Feb-06
 
Pending
Mexico*
  
MX/a/2008/09506
  
1-Feb-06
  
Pending
* All cases are national phase applications of PCT application No. IL2006/000130, which claims priority from US provisional application No. 60/762,506 filed on January 27, 2006

 
 

 
LICENSE AGREEMENT
 
CF31
 
Process for producing CF101 (IB-MECA)
 
Country
 
Application Serial
No. 
 
Date
 
Status
US*
 
12/450,094
 
13-Mar-08
 
 Pending
China*
 
200880007952.9
 
13-Mar-08
 
Pending
India*
 
1734/MUMNP/2009
 
13-Mar-08
 
Pending
 Japan*
 
2009-553282
 
13-Mar-08
 
Pending
Europe*
 
08719985.7
 
13-Mar-08
 
Pending
Israel*
  
200711
  
13-Mar-08
  
Pending
* All cases are national phase applications of PCT application No. IL2008/000360, which claims priority from US provisional application No. 60/906,838 filed on March 14, 2007
 
CF42
 
Composition for reduction of Intraocular Pressure
 
Country
 
Application Serial
No. 
 
Date
 
Status
PCT*
 
PCT/IL2010/000393
 
16-May-10
 
Published as WO 2010/134067
National patent applications in the US, Europe, Japan, China and other regions based on the PCT application
  
N/A
  
Not yet filed
  
To be filed by 16-Nov-2011 as national/regional applications based on PCT/IL2010/000393
* Claiming priority from the Israeli patent application No. 198787, filed on May 17, 2009

 
 

 
LICENSE AGREEMENT
 
CF44
 
Method for the Treatment of Uveitis
 
Co-owned by CANFITE and PHS. Licensed is CANFITE's share.
 
Country
 
Application Serial
No. 
 
Date
 
Status
PCT*
  
PCT/IL2011/000193
  
20-Feb-11
  
Filed
* Claims priority from US provisional application No. 61/310,043, filed on March 3, 2010

 
 

 
LICENSE AGREEMENT

EXHIBIT B - DEVELOPMENT PLAN
 
EYEFITE's clinical development plan is directed to at least three ophthalmic indications of CF101:
 
 
1.
Dry Eye Syndrome (DES) - a Phase II clinical trial for CF101 in the treatment of DES was already completed.  The Phase II trial data demonstrated positive results in patients with moderate to severe DES and also served as the basis for an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for a Phase III trial in the same patient population.  The FDA approved the IND in September 2010 and Eye-Fite will conduct a Phase III clinical trial in patients with moderate to severe DES in the United States, Europe and Israel. This Phase III trial will start no later than the first anniversary from signing this Agreement.
 
Eye-Fite anticipates that at least one additional Phase III clinical trial will be needed, and anticipates that it will be initiated by the end of second quarter 2014.
 
 
2.
Glaucoma – although the Phase II DES trial was not designed to assess the effects of treatment on intraocular pressure (IOP), it was noted that the CF101-treated group showed a statistically significant decrease in IOP from baseline. This observation indicated that CF101 may also have potential as a treatment for Glaucoma and lead to the initiation of the current Phase II clinical trial examining the safety and efficacy of CF101 administered in subjects with elevated intraocular pressure. This study is currently conducted in Israel, and maybe be expanded to additional countries at a later stage.  Eye-Fite anticipates that the interim analysis data will be released no later the first quarter of 2013.
 
 
3.
Uveitis - pre-clinical pharmacology studies conducted in collaboration with a research group from the U.S. National Institute of Health demonstrated that CF101 is effective in suppressing ocular inflammation in experimental murine models of Uveitis. Eye-Fite will continue to carry out some further pharmacological studies followed by an initiation of a Phase II trial in Uveitis, that EYEFITE anticipates to initiate no later than the third quarter of 2012.
 
The Development Plan may be revised from time-to-time by EYEFITE, after obtaining the approval of CANFITE, which will not be unreasonably withheld .

 
 

 
LICENSE AGREEMENT

EXHIBIT C - PHS PATENTS
 
 
·
US patent No. 5,773,423
 
 
·
European patent No. EP0708781 and national patents based thereon

 
 

 
LICENSE AGREEMENT

EXHIBIT D - ITEMS TO BE DELIVERED
 
 
1.
CF101 CIB
 
2.
FDA IND documentation for Dry Eye Syndrome
 
3.
Phase 3 Dry Eye Syndrome Protocol
 
4.
Dry eye related manuscript “Treatment of Dry Eye Syndrome with Orally Administered CF101 - Data from a Phase 2 Clinical Trial”
 
5.
Phase 2 Glaucoma Protocol
 
6.
Uveitis related manuscript “ Inhibition of experimental auto-immune Uveitis by the A3 adenosine receptor agonist CF101”
 
7.
Uveitis Orphan Drug Application.

 
 

 
LICENSE AGREEMENT

Exhibit E – ROYALTY PAYMENT OPTIONS

The OTT License Number MUST appear on payments, reports and correspondence.
 
Automated Clearing House (ACH) for payments through U.S. banks only

The NIH encourages our licensees to submit electronic funds transfer payments through the Automated Clearing House (ACH).  Submit your ACH payment through the U.S. Treasury web site located at:   https://www.pay.gov.   Locate the "NIH Agency Form" through the Pay.gov "Agency List".

Electronic Funds Wire Transfers

The following account information is provided for wire payments.  In order to process payment via Electronic Funds Wire Transfer sender MUST supply the following information within the transmission:

Drawn on a U.S. bank account via FEDWIRE should be sent directly to the following account:

 
Beneficiary Account:
Federal Reserve Bank of New York or TREAS NYC
 
 
Bank:
Federal Reserve Bank of New York
 
 
ABA#
021030004
 
 
Account Number:
750800 31
 
 
Bank Address:
33 Liberty Street, New York, NY 10045
 
 
Payment Details:
License Number (L-249-2001)
 
 
Name of Licensee
 
Drawn on a foreign bank account should be sent directly to the following account.  Payment must be sent in U.S. Dollars (USD) using the following instructions:
 
 
Beneficiary Account:
Federal Reserve Bank of New York/ITS or FRBNY/ITS
 
 
Bank:
Citibank N.A. (New York)
 
 
SWIFT Code:
CITIUS33
 
 
Account Number:
36838868
 
 
Bank Address:
388 Greenwich Street, New York, NY 10013
 
 
Payment Details (Line 70):
NIH 75080031
 
 
License Number (L-249-2001)
 
 
Name of Licensee
 
 
Detail of Charges (line 71a):
Charge Our
 
 
 

 
LICENSE AGREEMENT
 
Checks
 
All checks should be made payable to “NIH Patent Licensing”
 
Checks drawn on a U.S. bank account and sent by US Postal Service should be sent directly to the following address:
 
National Institutes of Health (NIH)
P.O. Box 979071
St. Louis, MO 63197-9000
 
Checks drawn on a U.S. bank account and sent by overnight or courier should be sent to the following address:
 
US Bank
Government Lockbox SL-MO-C2GL
1005 Convention Plaza
St. Louis, MO 63101
Phone: 314-418-4087
 
Checks drawn on a foreign bank account should be sent directly to the following address:
 
National Institutes of Health (NIH)
Office of Technology Transfer
Royalties Administration Unit
6011 Executive Boulevard
Suite 325, MSC 7660
Rockville, Maryland 20852

 
 

 
Exhibit 10.3
SERVICES AGREEMENT

THIS SERVICES AGREEMENT (the “ Agreement ”) made as of this 21 day of November, 2011 (the “ Effective Date ”) by and between CAN-FITE BIOPHARMA LTD. , an Israeli-registered public company whose principal place of business is located at 10 Bareket Street, Petach Tikva, Israel ( “ CanFite ”), DENALI CONCRETE MANAGEMENT INC. , a Nevada-registered company, whose principal place of business is located at 123 West Nye Lane, Suite 129, Carson City, NV 89706 ( "Denali" ), USA and its wholly owned subsidiary, EYEFITE LTD. , an Israeli-registered private company whose principal place of business is located at 12 Abba Hillel Silver, Ramat Gan 52506 , Israel ( "EyeFite" ; Denali and EyeFite collectively, the “ Company ”)
 
WHEREAS
following Effective Date, the Company shall be engaged in the clinical development of the therapeutic drug CF101 (" CF101 ") for the field of ophthalmic diseases (the “ Activities ”); and
 
WHEREAS
the Company wishes to engage CanFite and CanFite wishes to be engaged by the Company, to provide services to the Company in connection with the Activities, as hereinafter set forth.
 
NOW THEREFORE , in consideration of the mutual undertakings and promises herein contained, the parties hereby agree as follows:
 
1.
THE ENGAGEMENT
 
1.1
Subject to the terms hereof, the Company hereby engages CanFite, and CanFite is hereby engaged by the Company as a service provider to the Company in connection with the Services (as hereinafter defined) to be provided by CanFite pursuant to this Agreement.

1.2
CanFite shall provide the Services under the direction of, subject to the approval of, and shall report to, the Company's President and CEO (the “CEO” ), or such person designated by the CEO or by the Company’s Board of Directors.
 
1.3
Without derogating from any other provision herein, CanFite acknowledges and agrees that during the term hereof the Company is free at all times to engage additional service providers, or to use its own employees, in addition to the Services to be provided by CanFite pursuant to this Agreement.
 
2.
REPRESENTATIONS BY CANFITE
 
 
CanFite hereby represents and warrants as follows:
 
2.1
There is no limitation and/or restriction in any agreement to which it is party, or by which it is bound, on its ability to enter into this Agreement and/or to enter into a business relationship with the Company in accordance with the provisions of this Agreement.
 
 
1

 
 
2.2
CanFite will exercise reasonable care and diligence to prevent, and will not take, any action which could result in a conflict with, or be prejudicial to, the interests of the Company.
 
2.3
In rendering the Services, CanFite will be deemed to be, and it expressly agrees and confirms that it is, an independent contractor, and neither this Agreement nor the performance of any of the terms hereof will be deemed to constitute or create any other relationship between CanFite and the Company.
 
2.4
CanFite shall not be considered an employee, agent or legal representative of the Company for any purpose whatsoever.
 
2.5
CanFite is not granted and it shall not exercise the right or authority to assume or create any obligation or responsibility on behalf of or in the name of the Company, including without limitation, contractual obligations and obligations based on warranties or guarantees.
 
2.6
For avoidance of doubt, it is herby clarified that the Company will be responsible for any payments (in the same service fee mechanism detailed in Schedule B) which are based on agreements that were already signed in regards to the services detailed in Schedule A of this Agreement.
 
3.
TERM AND TERMINATION
 
3.1
Subject to the provisions of Section 3.2 below, this Agreement shall take effect from the Effective Date and shall continue in full force and effect until terminated by either party as set forth below (the “Term ”) unless:
 
 
3.1.1
Following the first anniversary of this Agreement, either party shall have given not less than six (6) months’ prior written notice to the other terminating this Agreement; or
 
 
3.1.2
either party shall have given notice to the other terminating this Agreement in accordance with the provisions of Section 3.2 hereof.
 
3.2
Without prejudice to the provision of Section 3.1 above:
 
 
3.2.1
the Company shall have the right to terminate this Agreement for “cause”, at any time, by giving CanFite notice of termination for such cause, stating the reasons constituting the cause.  In such event, this Agreement shall be terminated as of the time of delivery of the said notice.  For purposes hereof “ cause ” shall mean (a) a breach of trust by CanFite, including for example, but not limited to, acts of theft or embezzlement; or (b) material breach by CanFite of this Agreement which shall not be remedied within fifteen (15) days after service of notice by the Company on CanFite specifying the breach and requiring remedy thereof, if possible; or (c) CanFite becoming bankrupt or insolvent or ceasing, or threatening to cease, to carry on business or being unable to pay its debts as they fall due, or a receiver or other encumbrance being appointed to the undertaking and assets or any material part thereof of CanFite..

 
2

 
 
 
3.2.2
CanFite shall have the right to terminate this Agreement for “cause”, at any time, by giving the Company notice of termination for such cause, stating specifically the reasons constituting the cause.  In such event, this Agreement shall be terminated as of the time of delivery of the said notice.  For the purposes hereof “ cause ” shall mean (a) a material breach by the Company of this Agreement or the License Agreement dated November 21, 2011, which breach shall not have been remedied within fifteen (15) days of service of a notice in writing by CanFite on the Company requiring remedy of such breach; or (b) the Company becoming bankrupt or insolvent or ceasing, or threatening to cease, to carry on business or being unable to pay its debts as they fall due, or a receiver or other encumbrance being appointed to the undertaking and assets or any material part thereof of the Company..
 
4.
EXTENT AND SCOPE OF SERVICES
 
During the Term, CanFite shall provide the Company with the Services as detailed in Schedule A attached hereto.
 
5.
COMPENSATION
 
5.1
In consideration of the fulfillment of CanFite's obligations hereunder, including the provision of the Services to the Company, the Company shall pay CanFite a fee (the “ Services Fee ”) as set forth in Schedule B attached hereto, upon the performance and in consideration for the Services listed in Schedule A attached hereto. Furthermore, the Company hereby grants to CanFite a royalty to be paid to CanFite from any and all proceeds (including, but not limited to, sales revenues, and up front, milestones and royalties payments from third parties) received by the Company (or any affiliate of the Company including its wholly owned subsidiary, Eye-Fite Ltd.) or any of its affiliates in relation to the Activities related to CF101, of 2.5% of any such proceeds (the " Additional Fees "). The terms of the Additional Fees are set out in Schedule B attached hereto.
 
5.2
CanFite shall deliver to the Company a monthly invoice for the Services Fee and the Company shall pay the amounts included in such monthly invoice within 30 days of receipt of such invoice.
 
 
3

 
 
6.
INTELLECTUAL PROPERTY RIGHTS

6.1
Inventorship of information, know-how, data, discoveries, developments, designs, inventions, methods, processes, techniques, materials, formulae, trade secrets, trademarks, copyrights, patents and patent applications and other proprietary information conceived and/or reduced to practice in connection with, or as a result of, CanFite's Activities hereunder (the “ Intellectual Property Rights ”) shall belong to CanFite (each a “ CanFite Invention ”). CanFite hereby grants to EyeFite a royalty-free, a field of use exclusive license to use and exploit CanFite Inventions for treatment of ophthalmic diseases by the use of CF101 as detailed in the License Agreement between CanFite and EyeFite which is annexed hereto as Annex A (the "License Agreement" ).

6.2
Nothing in this Section 6 shall apply to any designs, know-how, information and/or intellectual property rights owned by or in the possession of CanFite before the Effective Date, and CanFite is free to make any use whatsoever of such designs, know-how, information and/or intellectual property rights, subject, however, to the terms of the License Agreement.
 
7.
LIMITED WARRANTY AND RESTRICITONS OF CANFITE’S LIABILITY
 
7.1
Notwithstanding anything in this Agreement, CanFite does not exclude or restrict its liability (if any) in respect of any of the following:
 
 
 (a)        a deliberate neglect of CanFite in the provision of the Services with knowledge of such neglect.
 
 
 (b)
fraud;
 
 
(c)
the death of, or personal injury to, any person caused by negligence;
 
 
(d)
any liability which by statute it cannot exclude.
 
7.2
The monies payable under this Agreement have been agreed between CanFite and the Company on the basis of the provisions in this Agreement restricting the liability of CanFite to the Company.  The Company expressly agrees that these restrictions are reasonable because of (amongst other things) the level of the monies agreed and the likelihood that the damages which would otherwise be payable to the Company could be disproportionately greater than the value of the obligations of the Company under this Agreement.  The Company acknowledges that it could have required CanFite to accept increased liability under this Agreement in return for higher charges.  The Company shall arrange and take out its own insurance cover for any losses it could suffer or incur which are not recoverable under this Agreement.
 
7.3
The Company shall not issue legal proceedings against CanFite in respect of any cause of action arising under or out of this Agreement unless it does so within 6 months from when the Company ought reasonably to have been aware of the relevant facts giving rise to that cause of action.
 
 
4

 
 
7.4
CanFite will not be liable to the Company for any indirect, incidental or consequential or pure economic loss or damage (including any loss of business, revenue, profit, reputation or anticipated savings) caused directly or indirectly by any means whatsoever (including negligence or breach of statutory duty on the part of CanFite, its representatives, or any other of its agents and sub-contractors, or the employees of CanFite or its agents or subcontractors).
 
7.5
The aggregate liability of CanFite in respect of all claims by the Company in respect of each event (which term includes a series of connected events) and arising out of this Agreement or any breach of this Agreement for which CanFite is held liable, is limited to the higher of: the following:
 
 
(a)
The monies payable to CanFite by the Company under this Agreement during the first contract year; or
 
 
(b)
The monies payable to the Company by CanFite under this Agreement during the contract year during which the liability arises.

8.          INDEMNITY

To the extent permitted by law, each party (the “ Indemnifying Party ”) shall defend, Indemnify and hold harmless the other party (an “ Indemnified Party ”) and its officers, agents, servants and employees from any claim, demand, cause of action, damage, cost, expense, loss or liability, in law or in equity, of any nature (collectively the “ Liabilities ”) to which the Indemnified Party may become subject as a result of (i) the breach of any of the Indemnifying Party’s representations, warranties or obligations set forth herein, or (ii) arising out of the negligence or willful misconduct of the Indemnifying Party or its agents, contractors, officers or employees.
 
9.
MISCELLANEOUS

9.1
This Agreement shall be subject to the laws of the State of Israel.

9.2
This Agreement is the entire agreement between the parties with respect to the subject matter hereof, and supersedes all prior understandings, agreements and discussions between them, either written or oral, with respect to such subject matter.

9.3
No alteration of or modification to any of the provisions of this Agreement shall be valid unless made in writing and signed by both parties.

9.4
The failure of either Party hereto to enforce at any time or for any period any provision of this Agreement shall not be construed as a waiver of such right or provision, and such Party shall be entitled to enforce such right or provision at any time as it shall see fit.

 
5

 

9.5
Any notice required or permitted hereunder shall be given in writing and shall be deemed given if sent by facsimile transmission or registered airmail to the address of the Party. If sent by facsimile, it shall be deemed to have arrived twenty-four (24) hours after transmission, and if sent by registered airmail, it shall be deemed to have arrived ten (10) days after posting.

9.6
CanFite shall not assign this Agreement to any third party, in whole or in part, without the prior written consent of the Company which shall be at the Company’s sole discretion.

IN WITNESS WHEREOF, the parties have executed this Agreement

/s/ Pnina Fishman  / s/ Motti Farbstein
 
/s/Mathew G. Rule
CAN-FITE BIOPHARMA LTD.
 
DENALI CONCRETE MANAGEMENT INC.
Name: Pnina Fishman    Motti Farbstein   Name: Mathew G. Rule
Title:
CEO
COO
 
Title:
President
Date:
November 21, 2011
 
Date:
November 21, 2011

/s/Pnina Fishman
 
/s/Motti Farbstein
EYE-FITE LTD.
 
EYE-FITE LTD.
Name:
Pnina Fishman
 
Motti Farbstein
Title:
Director
 
Director
Date:
November 21, 2011
 
November 21, 2011
 
 
6

 

Schedule A

THE SERVICES
 
CanFite shall manage, for and on behalf of the Company, all activities relating to pre-clinical and clinical studies performed for the development of the ophthalmic indications of CF101, including pre-clinical studies, drug manufacturing and supply, QT study in human beings, payments to consultants such as Dr. Bill Kerns and Dr. Mike Silverman for their role involved in the on-going clinical trials and all activities need to be conducted in order to launch CF101 to the market for the ophthalmic indications.
 
CanFite and the Company may, from time to time, mutually agree in writing to add or amend the Services provided hereunder.

 
7

 

 
Schedule B

THE SERVICE FEE
 
The Service Fee shall consist of all reasonable expenses and costs incurred by CanFite in its provision of the Services hereunder plus 15% (to such amounts VAT, if applicable, will be added ) , and in relation to expenses and costs of intellectual property maintenance, CanFite shall "pass through" any such payments and expenses made to third parties and shall receive reimbursement for such costs and expenses from the Company.
 
Any and all taxes regarding the payments made to CanFite hereunder (Service Fee and the Royalty) shall be borne solely by CanFite. All payments due to be made by the Company under this Agreement shall be made free and clear of, and without deduction or withholding for, or on account of, any taxes, except to the extent Company is required by law to deduct or withhold any taxes on any amounts payable hereunder. In such an event, unless CanFite shall provide the Company with any exemption from tax deduction or withholding if and to the extent CanFite has one – the Company shall deduct such taxes as required by law, provided that such taxes are paid to the appropriate tax authorities.
 
ADDITIONAL FEES ON SUBLICENSE REVENUES
 
As additional consideration for the Activities hereunder, the Company agrees to pay to CanFite additional fees (“ Additional Fees ") equal to 2.5% of any revenues received by the Company (or any affiliate of the Company including its wholly owned subsidiary, Eyefite Ltd.) for rights to CF101 from third-party sublicensees (including up front payments, developmental or commercial milestones, royalties on net sales and any similar payments, but not including payments to support or reimburse the Company for research, development, manufacturing or commercial expenses or for equity.  Additional Fees shall be due and payable to CanFite within thirty (30) days of receipt by the Company.  No Additional Fees shall be owed to Can-Fite if the Company terminates the Services Agreement for cause pursuant to Section 3.2.1 prior to the date eighteen (18) months after the Effective Date (the “ Vesting Date ”).
 
Can-Fite will have the right, at any time after the Effective Date until the expiry of 5 years from the Effective Date, to receive in exchange for its rights to the Additional Fees, a warrant to purchase 2,160,102 shares of Common Stock of the Company (the “Shares”) at a price of $1.144 per share; provided, however, that, in the event that, within 12 months of the Effective Date, the Company or its affiliates complete any transaction that has an aggregate value of more than US$100 Million (inclusive of any amounts that are held in escrow, subject to earn-outs, development or commercial milestone or any other contingencies and aggregate potential royalty payments based on market projections), then Can-Fite shall have the right to purchase the Shares at par value; provided that, prior thereto, the Company has not terminated the Services Agreement for cause pursuant to Section 3.2.1. Additional terms and conditions of the Warrants shall include anti-dilution, cashless exercise and other customary terms and conditions which shall be set out in a mutually agreed upon Warrant Agreement attached hereto as Schedule C .
 
 
8

 
Exhibit 21.1

 
SUBSIDIARIES OF DENALI CONCRETE MANAGEMENT, INC.

The sole subsidiary of Denali Concrete Management, Inc. is Eyefite Ltd., an Israeli company, which is wholly owned by Denali.
 
 
 

 
Exhibit 99.1
 
EYE FITE LTD.

FINANCIAL STATEMENTS

AS of September 30, 2011

IN U.S. DOLLARS

INDEX

   
Page
     
     
Report of Independent Registered Public Accounting Firm
 
2
     
Balance Sheet
 
3
     
Statement of Operations
 
4
     
Statement of Changes in Stockholders' Deficiency
 
5
     
Statements of Cash Flows
 
6
     
Notes to Financial Statements
 
7 - 8

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

 
 

 

Kost Forer Gabbay & Kasierer
3 Aminadav St.
Tel-Aviv 67067, Israel
 
Tel:   972 (3)6232525
Fax: 972 (3)5622555
www.ey.com

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Shareholders and Board of Directors of

EYE FITE LTD.

We have audited the accompanying balance sheet of Eye Fite Ltd. (the "Company") as of September 30, 2011, and the related statement of operations, changes in shareholders' deficiency and cash flow for the period from June 27, 2011 (the inception date) to September 30, 2011. 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 audit.

We conducted our audit 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 misstatement. We were not engaged to perform an audit of the Company's internal control over financial reporting. Our audit 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 internal control over financial reporting. Accordingly we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. We believe that our audit provide a reasonable basis for our opinion.

In our opinion, the financial statements referred to above, present fairly, in all material respects, the financial position of the Company as of September 30, 2011, and the results of its operations and cash flows for the period from June 27, 2011 (the inception date) to September 30, 2011, in conformity with U.S. generally accepted accounting principles.

The accompanying financial statements have been prepared assuming that Company will continue as a going concern. As more fully described in Note 1c, the Company has not commenced its operations and has no capital resources. This condition raises substantial doubt about the Company's ability to continue as a going concern. The financial statements do not include any adjustments to reflect the possible future effects on the recoverability of liabilities that may result from the outcome of this uncertainty.

 
  /s/Kost Forer Gabbay & Kasierer
Tel-Aviv, Israel
KOST FORER GABBAY & KASIERER
November  21, 2011
     A Member of Ernst & Young Global

 
- 2 -

 

EYE FITE LTD.

BALANCE SHEET
U.S. dollars, except share and per share data

   
September 30,
2011
 
       
Total assets
  $ -  
         
LIABILITIES AND STOCKHOLDERS' DEFICIENCY
       
         
Accounts payable
  $ 883  
         
Total current liabilities
    883  
         
SHAREHOLDERS' DEFICIENCY:
       
Ordinary Shares of  NIS 0.01 par value - Authorized: 10,000,000  share at September 30, 2011; Issued and Outstanding: 1 share at  September 30, 2011
    - *)
Accumulated deficit
    (883 )
         
Total stockholders' deficiency
    (883 )
         
Total liabilities and stockholders' deficiency
  $ -  

*)
Represents an amount lower than $ 1.

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

 
- 3 -

 

EYE FITE LTD.

STATEMENT OF OPERATIONS
U.S. dollars

   
Period from
June 27, 2011
(inception date)
to 
September 30,
2011
 
       
Operating expenses:
     
General and administrative
  $ 883  
         
Total operating expenses
    883  
         
Net loss
  $ 883  

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

 
- 4 -

 

EYE FITE LTD.

STATEMENT OF CHANGES IN STOCKHOLDERS' DEFICIENCY
U.S. dollars, except share data

   
Ordinary shares
   
Accumulated
   
Total
stockholders'
 
   
Number
   
Amount
   
deficit
   
deficiency
 
                         
Balance as of June 27, 2011   (inception date)
    -     $ -     $ -     $ -  
Issuance of common stock
    1       - *)     -       - *)
Net loss
    -       -       (883 )     (883 )
                                 
Balance as of September 30, 2011
    1     $ - *)   $ (883 )   $ (883 )

*)
Represents an amount lower than $ 1.

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

 
- 5 -

 

EYE FITE LTD.

STATEMENT OF CASH FLOWS
U.S. dollars

   
Period from
June 27, 2011
(inception date)
to 
September 30,
2011
 
       
Cash flows from operating activities:
     
       
Net loss
  $ (883 )
         
Adjustments to reconcile net loss to net cash used in operating activities:
       
         
Increase  in accounts payable
    883  
         
Net cash from operating activities
    -  
         
Change  in cash and cash equivalents
    -  
         
Cash and cash equivalents at the beginning of the period
    -  
         
Cash and cash equivalents at the end of the period
  $ -  

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

 
- 6 -

 

EYE FITE LTD.

NOTES TO FINANCIAL STATEMENTS
U.S. dollars

NOTE 1:-
GENERAL

 
a.
Eye Fite Ltd. (or the "Company" or "Eye Fite"), was founded on June 27, 2011 in contemplation with the execution of the proposed transaction between Can Fite Biopharma Ltd. (the "Parent Company" or "Can Fite") a public company in Israel and Denali Concrete Management Inc. ("Denali") a public shell company in the US, as further detailed in Note 1.b. below. As of September 30, 2011, the Company has not commenced its operations. As further described below, a license will be granted to the Company upon consummation of the proposed transaction.

The Company was established in order to conduct research and development activities using an exclusive worldwide license for a therapeutic drug CF101 solely for the field of ophthalmic diseases after the consummation of the following transaction.

According to the proposed transaction, upon closing, Denali will acquire all the outstanding shares of the Company, in consideration for the grant by Denali to Can-Fite of shares (and warrants to purchase shares of Denali) of Denali representing approximately 87% of the fully diluted issued and outstanding share capital of Denali. Immediately prior and as a condition to the closing of the transaction, Denali will enter into subscription agreements with new investors pursuant to which Denali will receive additional funds in amount of $ 3,300,000 in consideration for issuing of 2,910,455 Ordinary shares of Denali at a price per share of $1.144. In addition, Denali will issue to Can Fite 2,097,626 Ordinary shares, at a price per share of $1.144, in exchange for Ordinary shares of Can Fite with market value equal to $ 2,400,000. Can-Fite will make additional equity investment in Denali in amount of $ 500,000 in consideration for issuing an aggregate of 437,005 Ordinary shares of Denali at a price per share of $1.144. Consequently, Can-Fite holdings of the outstanding share capital of Denali will be diluted. The Transaction will be accounted for as a reverse recapitalization wherein Denali will be treated as the acquirer.

In contemplation with the proposed transaction, for each two Ordinary shares purchased, the new investors will be granted by Denali a one warrant to acquire one Ordinary share of Denali. The exercise price of the warrants is $ 1.72 per Ordinary share. The warrants are exercisable for a period of five years. The warrant terms include a full-ratchet anti-dilution protective provisions for the benefit of the new investors in the (including Can-Fite) in the event that Denali enters into another financing during the 12 months following the closing of the Financing at a price which is lower than $1.144 per common stock of Denali.

In connection with consummation of the proposed transaction, Eye-Fite and Can-Fite will enter into a license agreement, pursuant to which Can-Fite will granted to Eye-Fite a sole and exclusive worldwide license for the use of CF101, solely in the field of ophthalmic diseases ("CF101"). Eye-Fite shall be obligated to make to PHS (NIH), which its patents are included in the license to Eye-Fite, for as long as the PHS Agreement is in effect, a nonrefundable minimum annual royalty fees and potential future royalties of 4.0% to 5.5% on net sales. In addition Eye-Fite will be obligated to certain milestone payments ranging from $ 25,000 to $ 500,000 upon the achievement of various development milestones for each indication.  Eye-Fite will also be required to make payments of 20% of sublicensing revenues, excluding royalties and net of the required milestone payments.

 
- 7 -

 

EYE FITE LTD.

NOTES TO FINANCIAL STATEMENTS
U.S. dollars

NOTE 1:-
GENERAL (Cont.)

Following the closing of the transaction, a service agreement will be signed between Can-Fite, Denali and the Company and according to this agreement, Can-Fite will manage the activities relating to pre-clinical and clinical studies performed for the development of the ophthalmic indications of CF101. As consideration for Can-Fite’s services pursuant to the Services Agreement, Eye-Fite shall pay to Can-Fite a service fee (consisting of all expenses and costs incurred by Can-Fite plus 15%) and a royalty payment equal to 2.5% of any and all proceeds received by Eye-Fite relating to the activities regarding the drug (the "Royalty"). Can-Fite will have the right, at any time until the expiry of 5 years from the closing of the transaction, to convert the Royalty into an additional 2,160,102 shares of common stock of the Company (subject to adjustment in certain circumstances).

 
b.
As described above, in contemplation with the proposed transaction Can-Fite will license to the Company certain assets that relate to the right to use and further develop the intellectual property and know-how of CF101 solely for the field of ophthalmic diseases. Prior to the consummation of the proposed transaction Can Fite incurred in its research and development activities of the above assets direct costs that amounted to approximately $ 250,000, $ 153,000 and $ 598,000 in the years ended December 31, 2009 and 2010 and the nine-month period ended September 30, 2011.

 
c.
Upon closing of the proposed transaction as described above the Company's plan is to devote substantially all of its efforts toward research and development activities. The Company has no capital resources to carry its research and development activities.

There are no assurances that the Company will be successful in obtaining an adequate level of financing needed for its long-term research and development activities.

These conditions raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying financial statements do not include any adjustments to reflect the possible future effects on recoverability of liabilities that may result from the outcome of this uncertainty.
 
NOTE 2:-
SIGNIFICANT ACCOUNTING POLICIES

The financial statements have been prepared in conformity with accounting principles generally accepted in the United States ("U.S. GAAP").

NOTE 3:-
SHAREHOLDERS EQUITY

The Ordinary share, at the inception date, was issued without consideration. The Ordinary shareholder is entitled to participate and vote in general meetings, the right to participate in the distribution of earnings and residual rights on dissolution.
 
- - - - - - - - - - - - - - - - - - -

 
- 8 -

 
Exhibit 99.2
Denali Concrete Management, Inc.
UNAUDITED PRO FORMA CONSOLIDATED BALANCE SHEET
September 30, 2011
 
   
Historical
                         
   
Denali Concrete
   
Historical
   
 
         
 
 
   
Management, Inc.
   
Eye Fite Ltd.
   
Pro forma
   
   
   
Pro forma
 
   
30-Sep-11
   
30-Sep-11
   
Adjustments
   
Note
   
Condolidated
 
Assets
                             
Current Assets
                             
Cash
  $     $ 0     $ 500,000     C     $  
                      2,987,919     E          
                      97,000     F          
                      (7,750 )   G          
                      (89,250 )   H       3,487,919  
                                       
License
                    1     A       1  
Investment - Can Fite
                  2,400,000     B       2,400,000  
Prepaid Assets
            0                      
Total current assets
                5,887,920             5,887,920  
                                       
Debt issuance costs
          -                      
Property and equioment, net
            0                      
Total assets
  $ -     $ -     $ 5,887,920           $ 5,887,920  
                                       
Liabilities and Shareholders’ Deficit
                                     
                                       
Current liabilities:
                                     
Accrued liabilities, related parties
  $ 31,256     $ -     $ (31,256 )   H     $  
Accounts payable and accrued expenses
    2,311       883       (2,311 )   H       883  
Notes payable, related parties
    56,465       0       (56,465 )   H        
                                       
Total current liabilities
    90,032       883       (90,032 )           883  
                                       
Shareholders’ deficit:
                                     
Preferred stock
                                 
Common stock
    11,370       - *                      
                      1     A          
                      2,098     B          
                      437     C          
                      (1 )   D          
                      36,000     D          
                      2,910     E          
                      1,920     F          
                      (7,750 )   G       46,985  
                                       
Additional paid-in capital
    127,535       (883 )                      
                      2,397,902     B          
                      308,208     B          
                      499,563     C          
                      46,322     C          
                      (35,999 )   D          
                      3,315,009     E          
                      308,508     E          
                      95,080     F          
                      42,400     J          
                      (228,937 )   I       6,874,708  
                                       
Money raising costs
                    (330,000 )   E       (330,000 )
                                       
Retained earnings
    (228,937 )     -                        
                      782     H          
                      228,937     I          
                      (705,438 )   B,C,E,J       (704,656 )
                                       
Total shareholders' deficit
    (90,032 )     (883 )     5,977,952             5,887,037  
                                       
Total liabilities and shareholders' deficit
  $ -     $ -     $ 5,887,920           $ 5,887,920  

See accompanying notes to financial statements
  
 
1

 
 
Denali Concrete Management Inc.
Pro Forma Consolidated Statement of Operations
For the Nine Months Ended September 30, 2011

   
Historical
                         
   
Denali Concrete
   
Historical
   
   
          
 
 
   
Management, Inc.
   
Eye Fite Ltd.
   
Pro forma
   
 
   
Pro forma
 
   
September 30, 2011
   
September 30, 2011
   
Adjustments
   
Note
   
Condolidated
 
                               
Revenues:
                             
Revenues
  $ -     $ -     $ -           $ -  
Cost of revenues
    -       -       -                
                                       
Gross profit
    -       -       -             -  
                                       
Operating costs and expenses:
                                     
Selling, general and administrative
    -       883                     883  
Warrant and option expenses
            -       308,208     B          
                      46,322     C          
                      308,508     E          
                      42,400     J       705,438  
                                       
Management and consulting fees, related parties
            -       -             -  
Legal and accounting
    25,977       -       -             25,977  
Other
    2,502       -       -             2,502  
                                       
Total operating costs and expenses
    28,479       883       705,438             734,800  
                                       
Operating loss
    (28,479 )     (883 )     (705,438 )           (734,800 )
                                       
Other income (expenses)
                                     
Interest expense, related parties
    (4,365 )     -       -             (4,365 )
Gain on retention of deposit
    50,000       -       -             50,000  
Gain on forgiveness of debt
            -       782             782  
Total other income (expenses)
    45,635       -       782             46,417  
                                       
Net income (loss)
  $ 17,156     $ (883 )   $ (704,656 )         $ (688,383 )
                                       
Basic and diluted net income (loss) per common share
    (0.01 )                           (0.01 )
                                       
Basic and diluted weighted average common shares outstanding
    47,795,516                             47,795,516  

See accompanying notes to fianncial statements
 
 
2

 
 
Notes to the Unaudited Pro Forma Condensed Consolidated Financial Statements

1.  Description of the Acquisition and Basis of Presentation

On June 5, 2011, the Company entered into an agreement (the “Agreement”) with Can-Fite Biopharma Ltd., an Israeli corporation (“Can-Fite”), whereby the parties agreed to consummate various transactions.  Under the Agreement, Can-Fite agreed to grant an exclusive license for the use of CF101 (Can-Fite’s therapeutic drug candidate) solely in the field of ophthalmic diseases to its wholly-owned subsidiary, Eyefite EyefiteLtd., a private company incorporated under the laws of the State of Israel (“Eyefite”), and the Company agreed to recapitalize its capital stock prior to the consummation of the transactions contemplated by the Agreement so that, upon the consummation of the various transactions, Can-Fite would transfer all of its interest in Eyefite to the Company in exchange for an approximately 90% equity interest in the Company, on a fully diluted basis, prior to the Financing (as defined below).  The Agreement expired on August 28, 2011, but the parties have continued to negotiate, and anticipate consummating, a proposed transaction under terms similar to those set forth in the Agreement.  In connection with the closing of the transactions contemplated by the Agreement, the Company expects to issue approximately 2,910,456 shares of its common stock to certain investors in a private placement in exchange for $3,317,919 in cash (less money raising costs), 2,907,626 million shares to Can-Fite in exchange for $2.4 million in ordinary shares of Can-Fite (as determined by reference to the previous trading day’s closing price for Can-Fite shares on the Tel Aviv Stock Exchange), and 437,005 shares to Can-Fite in exchange for $500,000 (together, the “Financing”). For each two (2) shares of Denali purchased in the Financing, each investor (including Can-Fite) will receive one (1) warrant valid for a period of 5 years from the closing of the Financing, to acquire one (1) share of Denali for an exercise price which is based on a $75 million valuation for Denali, provided that the capitalization of the Company is increased to 100,000,000 common shares.  Denali will further agree to full-ratchet anti-dilution protective provisions for the benefit of the investors in the Financing (including Can-Fite) in the event that Denali enters into another financing during the 12 months following the closing of the Financing at a price which is lower than the effective per share price of the Financing. In connection with the Financing Denali expects to pay commissions to third parties in the amount of approximately $330,000. The Company and Can-Fite further agreed to enter into a services agreement to set forth the terms by which Can-Fite will manage, as an independent contractor, all activities relating to pre-clinical and clinical studies performed for the development of the ophthalmic indications of CF101.  

On or about November 21, 2011, in accordance with the closing of the proposed transaction, the Company entered into a stock purchase agreement (the “Stock Purchase Agreement”) with Can-Fite, whereby Can-Fite will purchase 36,000,000 shares of common stock of the Company in exchange for surrendering to the Company all of the issued and outstanding common stock of Eyefite. As a result of the consummation of the actions contemplated by the Stock Purchase Agreement, Eyefite will become the Company’s wholly-owned subsidiary and Can-Fite will become the Company’s majority shareholder.

 
3

 
 
In connection with the consummation of the transactions contemplated by the Agreement and the Stock Purchase Agreement, there will be a change in a majority of the members of the Company’s Board of Directors other than at a meeting of shareholders.  The Company’s Articles of Incorporation and Bylaws provide that the Board of Directors has the authority to set the size of the Board so long as the number of directors is not reduced to less than one.  The Bylaws further provide that vacancies on the Board shall be filled by the remaining director.  Accordingly, immediately prior to the consummation of the transactions contemplated by the Agreement and the Stock Purchase Agreement, the Board of Directors of the Company will expand the size of the Board from one member to three members.  Mathew Rule, the current sole director of the Company, will resign as sole director of the Company immediately prior to the consummation of the transactions contemplated by the Agreement and the Stock Purchase Agreement and, prior to his resignation, he will approve the appointment of Pnina Fishman, Ilan Cohn and Guy Regev as new directors of the Company effective as of the date of his resignation.  Mathew Rule will also resign as our Chief Executive Officer and Chief Financial Officer and we will appoint Pnina Fishman as our Interim Chief Executive Officer and Itay Weinstein as our Interim Chief Financial Officer.    

 
The organizational history of Eyefite Ltd. is described in Eyefite’s audited financial statements as of September 30, 2011, which are included elsewhere in this Report on Form 8-K.

 
Basis of Presentation
 
Certain disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles in the United States have been condensed or omitted as permitted by SEC rules and regulations.
 
These pro forma unaudited condensed consolidated financial statements are not necessarily indicative of the results of operations that would have been achieved had the transaction actually taken place at the dates indicated and do not purport to be indicative of future position or operating results.
 
The unaudited pro forma condensed consolidated balance sheet was prepared combining the historical balance sheet of Eyefite Ltd. at September 30, 2011 and the historical balance sheet of Denali at September 30, 2011, as described above.  
 
The unaudited pro forma condensed consolidated statement of operations includes the historical operations of Eyefite for the period ended September 30, 2011 and the historical operations of Denali.

 
Effective November 21, 2011 Eyefite Ltd (“Eyefite”) acquired Denali Concrete Management, Inc. (“Denali” or “Company”), a Nevada corporation, whereby Denali was the legal acquirer and Eyefite the accounting acquirer.  Accordingly, the Company is presenting the historical financial information of Eyefite prior to September 30, 2011.

 
4

 
 
2.  Pro Forma Adjustments and Assumptions

The accompanying unaudited pro forma consolidated financial information gives effect to the Share Exchange as if it had occurred at an earlier date, and has been prepared for illustrative purposes only and is not necessarily indicative of the consolidated financial position or results of operations in future periods or the results that actually would have been realized had Eyefite and Denali been a combined company during the specified periods.  The unaudited pro forma consolidated balance sheet set forth below represents the combined financial position of Eyefite and Denali as of September 30, 2011, as if the reverse acquisition occurred on September 30, 2011.  The unaudited pro forma consolidated statement of operations for the nine months ended September 30, 2011 represents the combined results of operations of Eyefite and Denali, as if the reverse acquisition occurred on the first day of the period presented. Since Eyefite was formed in June 2011, there is not a Pro Forma Consolidated Statement of Operations for the year ended December 31, 2010.

The pro forma adjustments were based on the preliminary information available at the time of the preparation of the unaudited pro forma consolidated financial information. The unaudited pro forma consolidated financial information, including the notes thereto, are qualified in their entirety by reference to, and should be read in conjunction with, the historical consolidated financial statements incorporated included with this Form 8-K.

 
A.
Reflects the granting of the license to Eyefite Ltd. by Can-Fite in exchange for 1,000 shares of Eyefite Ltd.  These shares are exchanged with Can-Fite for 36,000,000 shares of Denali stock (see Note D).

 
B.
Reflects the issuance of 2,907,626 shares of Denali in exchange for $2.4 million of Can-Fite shares.  In addition, for every two (2) shares of Denali stock, a warrant is issued to purchase one (1) share of Denali stock at $1.72.  These warrants expire in 5 years.  A Black Scholes calculation yields an expense of $308,208.

 
C.
Reflects the purchase by Can-Fite of 437,005 shares of Denali stock for $500,000, a share price of just over $1.144 (stock recapitalization).  In addition, for every 2 Denali shares purchased, Can-Fite received one (1) warrant to purchase Denali stock at $1.72.  These warrants expire in 5 years.  A Black Scholes calculation yields an expense of $46,322.

 
D.
Reflects the issuance of 36,000,000 shares of Denali stock in exchange for 100% of the outstanding shares of Eyefite Ltd stock (“Stock Purchase Agreement”) (see Note A above).  The share value for the transaction was computed at par value for an effective value of the merger of $36,000.

 
E.
Reflects the issuance of 2,910,456 shares of Denali stock to 5 investors in a private placement at $1.144 per share, raising $2,987,919 after $330,000 in money raising costs were paid.  In addition, for every 2 shares of Denali stock issued, the investor received one (1) warrant to purchase an additional share of Denali stock at $1.72.  These warrants expire in 5 years.  A Black Scholes calculation yields expenses of $308,508.
 
 
5

 
 
 
F.
Reflects the sale of 1,920,000 shares of Denali stock to 5 investors for $97,000 in a private placement.  The proceeds from this transaction were earmarked to repurchase stock and retire Denali indebtedness at the close of the transaction.

 
G.
Reflects the repurchase of 7,750,000 Denali shares from the previous majority shareholder at par value for $7,750 with funds earmarked for stock repurchase (see F above).

 
H.
Reflects the retiring of outstanding debt from Denali including accrued liabilities, accounts payable and accrued expenses, and notes payable from the earmarked funds (see F above).

 
I.
Reflects the pro forma adjustments to record the elimination of Denali historical equity from the pro forma financial statements.

 
J.
Reflects the issuance of 340,000 options to purchase Denali stock at $1.144 per share.  These options vest immediately and expire 3 years from the date of issue.  A Black Scholes calculation yielded an expense of $58,820.

 
K.
We compute net income per share in accordance with FASB ASC 260, Earnings per Share. Under the provisions of FASB ASC 260, basic net income per share is computed by dividing net income attributable to common shareholders by the weighted average number of shares of common stock outstanding during the period. The 36,000,000 shares issued to the shareholder of Eyefite Ltd. as a result of the reverse merger together with the 2,097,626 shares issued in exchange for $2.4M of Can-Fite shares and the 437,005 shares issued to Can-Fite for $500,000, the 4,830,456shares issued to private investors and existing 3,620,430 outstanding shares of the company that remained outstanding after the repurchase of previous majority shareholder stock are assumed to have been outstanding since the beginning of the earliest period presented (January 1, 2011), resulting in 46,985,517 shares being outstanding for purposes of basic net income per share.

 
6