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): December 28, 2012


CACTUS VENTURES, INC.

(Exact name of registrant as specified in its charter)


Nevada

  

000-52446

  

000-52446

(State or other jurisdiction of

  

(Commission File Number)

  

(IRS Employer Identification No.)

incorporation)

  

  

  

  


501 Fifth Avenue, 3rd Floor

New York, NY

  

10017

(Address of principal executive offices)

  

(Zip Code)


Registrant’s telephone number, including area code: (212) 300-2131


123 W. Nye Lane, Suite 129 Carson City, NV  89706

(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 ( see General Instruction A.2. below):


        .

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))

 

 







CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS


This Current Report on Form 8-K (this “Report”) contains forward-looking statements. The forward-looking statements are contained principally in the sections entitled “Description of Business,” “Risk Factors,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “anticipates,” “believes,” “seeks,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “would” and similar expressions intended to identify forward-looking statements. Forward-looking statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. These risks and uncertainties include, but are not limited to, the factors described in the section captioned “Risk Factors” below. Given these uncertainties, you should not place undue reliance on these forward-looking statements.  Such statements may include, but are not limited to, information related to: anticipated operating results; relationships with our merchants and subscribers; consumer demand; financial resources and condition; changes in revenues; changes in profitability; changes in accounting treatment; cost of sales; selling, general and administrative expenses; interest expense; the ability to produce the liquidity or enter into agreements to acquire the capital necessary to continue our operations and take advantage of opportunities; legal proceedings and claims.


Also, forward-looking statements represent our estimates and assumptions only as of the date of this Report. You should read this Report and the documents that we reference and file or furnish as exhibits to this Report completely and with the understanding that our actual future results may be materially different from what we expect. Except as required by law, we assume no obligation to update any forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in any forward-looking statements, even if new information becomes available in the future.


USE OF CERTAIN DEFINED TERMS


Except as otherwise indicated by the context, references in this report to “we,” “us,” “our,” “our Company,” or “the Company” are to the combined business of Cactus Ventures, Inc. and its consolidated subsidiaries.


In addition, unless the context otherwise requires and for the purposes of this Report only:


  

Closing Date means December 28, 2012;

  

Exchange Act refers to the Securities Exchange Act of 1934, as amended;

  

Actinium or API refers to Actinium Pharmaceuticals, Inc., a Delaware corporation;

  

Cactus or CTVN refers to Cactus Ventures, Inc., a Nevada corporation;

  

SEC or refers to the Securities and Exchange Commission;

  

Securities Act refers to the Securities Act of 1933, as amended and;

 







INTRODUCTION


On December 28, 2012, Cactus entered into a transaction (the Share Exchange ), pursuant to which Cactus acquired 21% of the issued and outstanding equity securities of Actinium, in exchange for the issuance of 4,309,015 shares of common stock, par value $0.01 per share, of Cactus (the “Common Stock”), which were issued to the shareholders of Actinium.  As a result of the Share Exchange, the former shareholders of Actinium became the controlling shareholders of Cactus.  In connection with the Share Exchange, Diane S. Button, the former sole director and officer of Cactus submitted a resignation letter resigning from these positions, effective upon the closing of the Share Exchange, and the directors of Actinium were appointed to the Board of Directors of Cactus, and the officers of Actinium were appointed as the officers of Cactus. The Company intends to continue to exchange its shares of common stock for shares of Actinium held by the remaining Actinium shareholders.


The Share Exchange was accounted for as a reverse takeover/recapitalization effected by a share exchange, wherein Actinium is considered the acquirer for accounting and financial reporting purposes.  For more information about the acquisition of Actinium, see “Item 1.01—Share Exchange” and “Item 2.01—Description of Business—Our Corporate History and Background” of this Report.


As a result of the Share Exchange, Cactus is now a holding company operating through Actinium, a clinical-stage biopharmaceutical company developing certain cancer treatments.


To the extent that we are deemed to be a shell company, and in accordance with the requirements of Item 2.01(a)(f) of Form 8-K, this Report sets forth information that would be required if the Cactus was required to file a general form for registration of securities on Form 10 under the Exchange Act with respect to the Common Stock (which is the only class of Cactus’s securities subject to the reporting requirements of Section 13 or Section 15(d) of the Exchange Act upon consummation of the Share Exchange).


This Current Report contains summaries of the material terms of various agreements executed in connection with the transactions described herein. The summaries of these agreements are subject to, and are qualified in their entirety by, reference to these agreements, all of which are incorporated herein by reference.


This Current Report is being filed in connection with a series of transactions consummated by the Company and certain related events and actions taken by the Company.


This Current Report responds to 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 4.01

Changes in Registrant’s Certifying Accountant

 

Item 5.01

Changes in Control of Registrant


Item 5.02

Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers; Compensatory Arrangements of Certain Officers


Item 5.05

Amendments to the Registrant’s Code of Ethics, Waiver of the Code of Ethics

 

Item 5.06

Change in Shell Company Status


Item 9.01

Financial Statements and Exhibits








TABLE OF CONTENTS

 

ITEM

DESCRIPTION

PAGE

1.01

Entry into a Material Definitive Agreement

5

 

Acquisition of Actinium and Related Transactions

5

2.01

Completion of Acquisition or Disposition of Assets

6

 

Form 10 Disclosure

6

 

Description of Business

6

 

Risk Factors

16

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

31

 

Description of Property

39

 

Security Ownership of Certain Beneficial Owners and Management

39

 

Directors and Executive Officers

41

 

Executive Compensation

47

 

Certain Relationships and Related Transactions, and Director Independence

47

 

Legal Proceedings

49

 

Market Price And Dividends on our Common Equity and Related Stockholder Matters

49

 

Recent Sales of Unregistered Securities

50

 

Description of Securities

50

 

Indemnification of Directors and Officers

54

 

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

55

Item 3.02

Unregistered Sales of Equity Securities

55

Item 4.01

Changes in Registrant’s Certifying Accountant

55

Item 5.01

Changes in Control of Registrant

57

Item 5.02

Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers; Compensatory Arrangements of Certain Officers

57

Item 5.05

Amendments to the Registrant’s Code of Ethics, Waiver of the Code of Ethics

57

Item 5.06

Change in Shell Company Status

57

Item 9.01

Financial Statements and Exhibits

58

 

Signatures

60

 

Audited Consolidated Financial Statements for the years ended December 31, 2011 and 2010 for Actinium Pharmaceuticals, Inc.

Ex 99.1

 

Unaudited Interim Consolidated Financial Statements for the periods ended September 30, 2012 and 2011 for Actinium Pharmaceuticals, Inc.

Ex 99.2

 

Unaudited Pro Forma Combined Financial Information of Cactus Ventures, Inc. and Actinium Pharmaceuticals, Inc.

Ex 99.3









Item 1.01

Entry into a Material Definitive Agreement.


ACQUISITION OF ACTINIUM AND RELATED TRANSACTIONS


Acquisition of Actinium


On the Closing Date, Cactus entered into a Share Exchange Agreement (the “Exchange Agreement”) with (i) Actinium and (ii) the former shareholders of Actinium (the “Actinium Shareholders”) pursuant to which we acquired 12,939,986 shares of capital stock of Actinium from the Actinium Shareholders in exchange for the issuance of 4,309,015shares of Common Stock to the Actinium Shareholders (the “Share Exchange”). As part of the Share Exchange, Actinium paid $250,000 to the shareholders of Cactus before the consummation of the Share Exchange. As a result of the Share Exchange, the Actinium Shareholders, became the principal shareholders of Cactus.

 

The foregoing description of the Exchange Agreement is qualified in its entirety by reference to the provisions of the Exchange Agreement filed as Exhibit   2.1 to this Report, which is incorporated by reference herein.


The Offering


On October 1, 2012, prior to the closing of the Share Exchange Agreement, Actinium commenced an offering (the “Offering”) of units (the “Units”) each Unit consisting of an aggregate of (i) 181,818 shares of common stock of Actinium (the “Actinium Stock”); (ii) an “A” warrant to purchase 181,818 shares of Actinium Stock, exercisable at a price of $0.55 per share for a period of one hundred and twenty (120) days from the date of the final closing of the Offering (the “A Warrant”); and (iii) a “B” warrant to purchase 90,909 shares of Actinium Stock, exercisable at a price of $0.825 per share for a period of five (5) years from the date of the final closing (the “B Warrant”) (collectively, with the A Warrant, the “Investor Warrants”).  The Units were offered to Accredited Investors (as such term is defined in Rule 501 under the Securities Act) for $100,000 each.  Laidlaw & Company (UK) Ltd. was engaged by Actinium as its exclusive agent (the “Placement Agent”) to assist in placing the Units.  The minimum offering amount is $5,000,000 (the “Minimum Offering Amount”) and the maximum offering amount is $15,000,000 (the “Maximum Offering Amount”).  Actinium also granted the Placement Agent an option (the “Greenshoe Option”) to increase the Offering through the sale, in whole or in part, of an amount of Units equal to $5,000,000.


On December 19, 2012 and in contemplation of the closing of the Share Exchange, Actinium closed on the Minimum Offering Amount selling an aggregate of 9,366,273 Units (prior to the Share Exchange) to investors (the “Investors”), pursuant to subscription agreement (the “Subscription Agreements”) and Unit Purchase Agreements (the “Unit Purchase Agreements”) for gross proceeds in the amount of $5,151,450, and net proceeds in the amount of $4,469,776 after legal and other fees and expenses remitted to the Placement Agent.  Post the closing of the Share Exchange, the Offering will continue on the same terms on a pro-forma basis with the common shares offered at $1.65 per share, the 120 day warrants exercise price at $1.65 per share and the 5 year warrants exercise price at $2.48 per share.


Registration Rights


In connection with the Offering, Actinium entered into a 2012 investor rights agreement (the “Investor Rights Agreement”) with each of the Investors, under which it would be required, within 45 days after the final closing of the Offering (the “Filing Deadline”), to file a registration statement (the “Registration Statement”) registering for resale (i) all Common Stock issued to the Investors pursuant to the Share Exchange Agreement, in exchange for the Actinium Stock issued as part of the Units, and (ii) all shares of Common Stock issuable upon exercise of the warrants issued pursuant to the Share Exchange Agreement in exchange for the Investor Warrants (collectively, the “Registrable Shares”). The holders of any Registrable Shares removed from the Registration Statement as a result of a Rule 415 or other comment from the SEC shall have “piggyback” registration rights for such Registrable Shares with respect to any registration statement filed by Cactus following the effectiveness of the Registration Statement which would permit the inclusion of such Registrable Shares. Actinium has agreed to use its reasonable best efforts to have the Registration Statement declared effective within 30 days of being notified by the SEC that the Registration Statement will not be reviewed by the SEC (and in such case of no SEC review, not later than 60 days after the Filing Deadline) or within 180 days after the Filing Deadline in the event the SEC provides comments to the Registration Statement (the “Effectiveness Deadline”).   In addition, certain other holders of the Company’s common stock have demand registration rights at any time after the earlier of (i) October 2014, or (ii) three (3) months after API’s common stock becomes publicly traded.







Lock-Up Agreement


On the Closing Date and in connection with the Offering, we entered into lock-up agreements (collectively, the “Lock-Up Agreements”) with each of the officers, and directors, as well as the Placement Agent and any other controlling persons, under which they agreed to not sell or otherwise transfer any securities of Actinium or Cactus owned by them until the date that is the earlier of (i) twelve (12) months from the Closing Date; or (ii) six (6) months following the effective date of the Registration Statement. As of the date of this filing we have no signed a lock-up agreement with MSKCC, a 5% or more in care of Actinium’s issued and outstanding Common Stock. The Company expects MSKCC to sign a lock-up agreement, which will be filed by amendment to this Form 8-K.


In addition, on the Closing Date and in connection with the Share Exchange, we also entered into a lock-up agreement with our former principal shareholder, Diane Button, under which she agreed to not sell or otherwise transfer any securities of Cactus owned by her until the date that is the earlier of (i) the final closing of the Offering, or (ii) February 28, 2013.


The foregoing description of the Subscription Agreements, Unit Purchase Agreement, A Warrant, B Warrant, Investor Rights Agreement, and Lock-Up Agreements are qualified in its entirety by reference to the provisions of the Forms of Subscription Agreement, Unit Purchase Agreement, A Warrant, B Warrant, Investor Rights Agreement and Lock-Up Agreement filed as Exhibits 10.6, 10.7, 4.1, 4.2, 10.20 and 4.3, respectively, to this Report, which are incorporated by reference herein.


Item 2.01

Completion of Acquisition or Disposition of Assets.


The disclosure in Item 1.01 of this Report regarding the Share Exchange is incorporated herein by reference in its entirety.


FORM 10 DISCLOSURE


As disclosed elsewhere in this Report, we acquired Actinium on the Closing Date pursuant to the Share Exchange, which was accounted for as a recapitalization effected by a share exchange.  Item 2.01(f) of Form 8-K provides that if the Company was a shell company, other than a business combination related shell company (as those terms are defined in Rule 12b-2 under the Exchange Act) immediately before the Share Exchange, then the Company must disclose the information that would be required if the Company were filing a general form for registration of securities on Form 10 under the Exchange Act reflecting all classes of the Company’s securities subject to the reporting requirements of Section 13 of the Exchange Act upon consummation of the Share Exchange.


To the extent that the Company might have been considered to be a shell company immediately before the Share Exchange, we are providing below the information that we would be required to disclose on Form 10 under the Exchange Act if we were to file such form.  Please note that the information provided below relates to the combined Company after the acquisition of Actinium, except that information relating to periods prior to the date of the Share Exchange relate only to Actinium unless otherwise specifically indicated.


DESCRIPTION OF BUSINESS


Business Overview


We are a biopharmaceutical company focused on the $50 billion market for cancer drugs. Our most advanced products are Actimab -A, an antibody-drug construct containing actinium 225 (Ac-225), currently in human clinical trials for acute myeloid leukemia (AML) and Iomab -B, an antibody-drug construct containing iodine 131 (I-131), used in myeloconditioning for hematopoietic stem cells transplantation (HSCT) in various indications. API is currently designing a trial which the Company intends to submit for registration approval in HSCT in the settings of refractory and relapsed acute myeloid leukemia in older patients. The Company is developing its cancer drugs using its expertise in radioimmunotherapy. In addition, the Ac-225 based drugs development relies on the patented Alpha Particle Immunotherapy Technology (APIT) platform technology co-developed with Memorial Sloan- Kettering Cancer Center, and a related institution. The APIT technology couples monoclonal antibodies (mAb) with extremely potent but comparatively safe alpha particle emitting radioactive isotopes, in particular actinium 225 and bismuth 213. The final drug construct is designed to specifically target and kill cancer cells while minimizing side effects. The Company intends to develop a number of products for different types of cancer and derive revenue from partnering relationships with large pharmaceutical companies and/or direct sales of its products in specialty markets in the U.S.


Our Corporate History and Background


We were formed as a Nevada corporation on October 6, 1997, originally under the name Zurich U.S.A., Inc. On July 10, 2006, we changed our name to Cactus Ventures, Inc. and began pursuing our business of marketing sunglasses. The Company encountered numerous problems with various vendors and ceased its operations. The Company shifted its efforts to seeking a business combination opportunity with a business entity, and negotiated a merger of a target company into the Company.  Upon ceasing its operations, the Company was considered a “blank check” company as such term is defined under the Securities Act.







Upon completing the Share Exchange, the Company ceased being considered a “blank check” company and is now a clinical-stage biopharmaceutical company developing certain cancer treatments.


Acquisition of Actinium


On the Closing Date, Actinium completed a Share Exchange with Cactus, whereby Cactus acquired 21% of the issued and outstanding capital stock of Actinium from the Actinium Shareholders in exchange for the issuance of 4,309,015 shares of Common Stock to the Actinium Shareholders (the “Share Exchange”). Cactus has a class of securities registered under the Exchange Act of 1934 but its Common Stock is not registered under the Securities Act of 1933.  As part of the Share Exchange, Actinium paid $250,000 to the shareholders of Cactus before the consummation of the Share Exchange. As a result of the Share Exchange, Actinium became the wholly owned subsidiary of Cactus and the Actinium Shareholders became the principal shareholders of Cactus.


The Share Exchange was treated as a recapitalization effected through a share exchange, with Actinium as the accounting acquirer and the Cactus the accounting acquiree.  Unless the context suggests otherwise, when we refer in this Report to business and financial information for periods prior to the consummation of the Share Exchange, we are referring to the business and financial information of Actinium.


Effective following the expiration of the ten day period following the mailing of the information statement required by Rule 14f-1 under the Exchange Act, Diane S. Button has resigned from her position as member of the Board of Directors of the Company.   Effective upon the closing of the Share Exchange, Diane S. Button resigned as an officer of the Company.  Also effective upon the closing of the Share Exchange, Jack V. Talley was appointed to our Board of Directors.  Effective as of the expiration of the ten day period following the mailing of the information statement required by Rule 14f-1 under the Exchange Act Dr. Rosemary Mazanet, David Nicholson, Sandesh Seth and Sergio Traversa were appointed to our Board of Directors.  In addition, our Board of Directors appointed Jack V. Talley to serve as our President and Chief Executive Officer, Dragan Cicic to serve as our Chief Operating Officer and Chief Medical Officer, and Enza Guagenti to serve as our Chief Financial Officer, effective immediately upon the closing of the Share Exchange.

 

As a result of the Share Exchange, Actinium became a subsidiary of Cactus and Cactus assumed the business and operations of Actinium.  Cactus plans to change its name to more accurately reflect its new business operations.  As Cactus is a “reporting company” under the Exchange Act of 1934, and it is required to file periodic filings with the SEC, which include Actinium’s quarterly and annual financial statements.


Corporate History of Actinium


Actinium was incorporated in 2000 in the state of Delaware. Until the Share Exchange, Actinium was a clinical-stage, privately held biopharmaceutical company with:


·

Two clinical-stage products, Iomab.-B and Actimab.-A, in development for blood borne cancers;

·

Preclinical data in additional cancer indications;

·

A proprietary technology platform for novel radioimmunotherapy cancer treatments; and

·

A proprietary process for manufacturing of the alpha particle emitting radioactive isotope actinium 225 (Ac-225).


Iomab.-B has completed Phase I and Phase II trials as a preparatory regimen in conjunction with fludarabine and reduced intensity radiation conditioning in patients who are otherwise ineligible for hematopoietic stem cell transplantation (HSCT) and the Company expects it to enter a regulatory approval trial in 2013, subject to input from the FDA concerning the design and conduct of a pivotal trial. Actimab.-A is currently in a Phase I/II trial in newly diagnosed elderly acute myeloid leukemia (AML). In addition, using its patented Alpha Particle Immunotherapy Technology (APIT) platform and via its collaboration with the Memorial Sloan Kettering Cancer Center (MSKCC), the Company has preclinical data on potential drug candidates in several other cancer indications and expects to further develop these into clinical stage drug candidates.


The Actinium has one wholly owned subsidiary, MedActinium, Inc., a Delaware corporation, which is party to certain isotope related licenses and contracts on which the Company relies.







Upon Actinium’s formation in 2000, it acquired Pharmactinium, Inc. and MedActinium, Inc., and through Pharmactinium, Inc. acquired certain rights to the APIT platform. Core technology patents were in-licensed from N.V. Organon which also provided seed funding. Pharmactinium, Inc. was party to a research and development agreement with MSKCC beginning in 1996. In 2002, this agreement and relationship was significantly expanded to the current relationship with API and now includes research and development, preclinical development, clinical trials and commercial technology licenses. In 2007, Pharmactinium, Inc. was merged with and into the Company. In 2007, the Company also acquired its sister company, Actinium Pharmaceuticals, Limited (Bermuda) (the “Bermuda Company”), by a merger of the Bermuda Company into API and thereby also acquired certain patent licenses relating to APIT previously licensed by the Bermuda Company to API.


In 2000, API also began what has become a long term relationship with General Atlantic Investments Limited (GAIL), an entity which has provided most of the Company’s investment capital since 2000. In 2009, the parent of GAIL contributed and transferred its ownership of GAIL (now renamed Actinium Holdings, Limited), whose only asset at that time was the shares of API, to an indirect subsidiary of Memorial Sloan Kettering Cancer Center. In January 2012, the Company closed on $7,844,268 in gross funding through the sale of Series E Preferred Stock and a Senior Convertible Note financing. Our executive office is located at 501 Fifth Avenue, 3rd Floor, New York, NY 10017 and our telephone number is (212) 300-2131. Our website address is http://www.actiniumpharmaceuticals.com. Except as set forth below, the information on our website is not part of the Form 10 information for Actinium.


Summary of Scientific and Business Achievements:


The Company’s scientific and business achievements to date include:


·

In-licensing a Phase II clinical stage monoclonal antibody, BC8, with safety and efficacy data in more than 250 patients in need of Hematotoietic (HSCT, currently in 7 active Phase I and Phase II clinical trials;

·

Commencing a Company sponsored multi-center Phase I/II clinical trial for Actimab-A in elderly Acute Myeloid Leukemia;

·

Developing and organizing manufacturing of Actinium’s lead drug candidate which was accepted by the FDA for multi-center human use;

·

Supporting three physician sponsored clinical trials, including a Phase I and a Phase I/II trial with the alpha emitting radioactive isotope bismuth 213 (Bi-213) based AML drug and a Phase I clinical trial with the alpha emitting radioactive isotope actinium 225 (Ac-225) based AML drug;

·

In-licensing the AML targeting monoclonal antibody known as HuM195 or Lintuzumab;

·

Establishing clinical and preclinical development relationships with world-class institutions such as MSKCC, Fred Hutchinson Cancer Research Center (FHCRC) and University of Texas MD Anderson Cancer Center (the MD Anderson Cancer Center relationship includes clinical trail only), as well as leading clinical experts in the fields of AML and HSCT;

·

Securing rights to an intellectual property estate that covers key aspects of the Company’s proprietary technology platform;

·

Supporting a number of pipeline projects, including preclinical experiments in metastatic prostate cancer, metastatic colon cancer, antiangiogenesis and breast cancer models;

·

Maintaining contractual relationship with Oak Ridge National Laboratory (ORNL) of the Department of Energy (DOE) which gives API access to most of the current world supply of Ac-225; and

·

Successfully developing commercial production methods for actinium 225.


Business Strategy


API intends to potentially develop its most advanced clinical stage drug candidates through approval in the case of Iomab -B and up to and including a Phase II proof of concept human clinical trial (a trial designed to provide data on the drug s efficacy) in the case of Actimab -A. If these efforts are successful, API may elect to commercialize Iomab -B on its own or with a partner in the U.S. and/or outside of the U.S. to out-license the rights to develop and commercialize the product to a strategic partner. In the case of Actimab -A, API will most likely seek to enter into strategic partnerships whereby the strategic partner(s) co-fund(s) further human clinical trials of the drug that are needed to obtain regulatory approvals for commercial sale within and outside of the U.S. In parallel, the Company intends to identify and begin initial human trials with additional actinium-225 drug candidates in other cancer indications. API intends to retain marketing rights for its products in the U.S. whenever possible and outlicense marketing rights to its partners for the rest of the world.








Market Opportunity


API is competing in the marketplace for cancer treatments estimated at over $54 billion in 2011 sales per IMS Health and projected to exceed $76 billion per year by 2015, according to the Global Academy for Medical Education. While surgery, radiation and chemotherapy remain staple treatments for cancer, their use is limited by the fact that they often cause substantial damage to normal cells. On the other hand, targeted therapies exert most or all of their effect directly on cancer cells, but often lack sufficient killing power to eradicate all cancer cells with just the antibody. A new approach for treating cancer is to combine the precision of antibody-based targeting agents with the killing power of radiation or chemotherapy by attaching powerful killing agents to precise molecular carriers called monoclonal antibodies (mAb). API uses monoclonal antibodies labeled with radioisotopes to deliver potent doses of radiation directly to cancer cells while sparing healthy tissues. The radioisotopes we use are the alpha emitter Ac-225 and the beta emitter I-131. I-131 is among the best known and well characterized radioisotopes. It is used very successfully in treatment of papillary and follicular thyroid cancer as well as other thyroid conditions. It is also attached to a monoclonal antibody in treatment of Non-Hodgkin’s Lymphoma (NHL). It is also used experimentally with different carriers in other cancers. Ac-225 has many unique properties and the Company is a leader in developing this alpha emitter for clinical applications using its proprietary APIT technology.


API s most advanced products are Actimab -A, Ac-225 labeled mAb for treatment of newly diagnosed AML, a cancer of the blood, in patients ineligible for currently approved therapies, and Iomab -B, I-131 labeled mAb for preparation of relapsed and refractory AML patients for hematopoietic stem cell transplantation (HSCT). Iomab -B offers the only potentially curative treatment for these patients most of whom do not survive beyond a year after being diagnosed with this condition. Iomab -B has also demonstrated efficacy in HSCT preparation for other blood cancer indications, including Myelodysplastic Syndrome (MDS), acute lymphoblastic leukemia (ALL), Hodgkin s Lymphoma, and Non-Hodgkin s Lymphoma (NHL). These are all follow-on indications for which Iomab -B can be developed and it is the Companies intention to explore these opportunities. In 2013, the Company intends to begin preclinical development of the mAb used in Iomab -B by replacing I-131 with Ac-225. Such a follow-on product could have several advantages as a second generation product, including ease of transportation, minimal safety requirements for the centers using it, doses lower by orders of magnitude and significantly lower costs of manufacturing.


There are currently no approved treatments for either Actimab -A or Iomab -B targeted patients.


Other potential product opportunities in which a significant amount of preclinical work is being undertaken include metastatic colorectal cancer, metastatic prostate cancer and antiangiogenesis which reduces the blood supply to solid tumors.


The Company believes that its biggest market opportunity lies in the applicability of the Company’s APIT platform technology to a wide variety of cancers. A broad range of solid and blood borne cancers can be potentially targeted by monoclonal (mAbs) to enable treatment with its APIT technology. The APIT technology could potentially be applied to mAbs that are already FDA approved to create more efficacious and/or safer drugs (“biobetters”).


Clinical Trials


API has completed a Phase I and Phase I/II physician trial in AML at MSKCC using Bismab®-A, API s first generation AML drug that consists of bismuth-213 attached to the antibody Lintuzumab . The Phase II arm of the Bismab®-A drug study has shown signs of the drug s efficacy and safety, including reduction in peripheral blast counts and complete responses in some patients. Bi-213 is a daughter, i.e., product of the degradation of Ac-225, with cancer cell killing properties similar to Ac-225 but is less potent.


API has commenced its first company sponsored Phase I/II multi-center trial with fractionated (two) doses of Actimab -A, Actinium s lead product for treatment of elderly AML that consists of an AML specific monoclonal antibody (HuM195, also known as Lintuzumab ) and the actinium 225 radioactive isotope attached to it. The Company intends to conduct these trials at world-class cancer institutions such as MSKCC, Johns Hopkins Medicine, University of Pennsylvania Health System, Fred Hutchinson Cancer Center and MD Anderson Cancer Center MSKCC.


The Company also continues to sponsor a Phase I AML trial at MSKCC with a single-dose administration of Actimab -A. Initial data shows elimination of leukemia cells from blood in 67% of all evaluable patients who received a full dose and in 83% of those treated at dose levels above 0.5 microcuries (uCi/kg), and eradication of leukemia cells in both blood and bone marrow in 20% of all evaluable patients and 25% of those treated at dose levels above 0.5 uCi/kg. Dose levels in that trial have been reduced as we continue our work on establishing maximum tolerated dose.


This Phase I trial builds on the experience with Company’s first generation drug Bismab®-A that contains the same antibody used in Actimab -A but labeled with bismuth 213, a less potent alpha emitting daughter of actinium 225 used in Actimab -A. Bismab®-A trials and the Phase I Actimab -A trial were focused on relapsed, refractory and other difficult to treat acute myeloid leukemia patients. The new multicenter Phase I/II trial is focused on newly diagnosed AML patients who have historically had better outcomes. In addition, the new trial includes low doses of chemotherapy with the goal of further improving patient outcomes.







Operations


The Company’s current operations are primarily focused on furthering the development of its lead clinical drug candidates Actimab -A and Iomab -B. In the case of Actimab -A, key ongoing activities include progressing a multi-center Phase I/II trial, support for an ongoing Phase I clinical trial at Memorial Sloan Kettering Cancer Center in New York, managing isotope and other materials supply chain, and managing the manufacturing of the finished drug candidate product. API has secured access to much of the currently available world reserves of Ac-225 and Bi-213 through a renewable contractual arrangement with the U.S. Department of Energy (DOE). The Company projects that these quantities are sufficient to support early stages of commercialization of alpha isotopes based products. API has also developed its own proprietary process for industrial scale Ac-225 production in a cyclotron in quantities adequate to support full product commercialization.


Operations related to Iomab -B include planning for a registration trial which will include development of commercial scale manufacturing to be suitable for an approval trial and preparation of appropriate regulatory submissions.


Intellectual Property Portfolio


API’s technology and products are protected by an extensive intellectual property estate in excess of 60 patents and patent applications, both in the U.S. and other countries. The cornerstones of the portfolio are patents and patent applications covering use of Ac-225 and Bi-213 for medical purposes and production of the Ac-225 isotope. Additional patents and applications relate to the API’s proprietary manufacturing and treatment processes. Additionally, the Company believes that several of its programs are likely eligible for “Orphan Drug Protection” including its products intended for AML as well as bone marrow transplants. Orphan Drug Protection in the United States refers to the protection provided by the 1983 Orphan Drug Act which provides seven years of market exclusivity to drugs developed to address diseases that affect fewer than 200,000 patients in the United States.  Similar protection exists in Europe and provides for ten years of marketing exclusivity.


Key Strengths


API believes that the key elements for its market success include:


·

Clinical results to date imply lower development risk for its lead drug candidates: API’s lead drug candidates have been tested in over 300 patients and demonstrated favorable safety and efficacy profiles. Iomab -B has been administered to more than 250 patients in a number of Phase I and Phase II trials and has shown a clear survival benefit in the indication for which it is being developed.  Bismab®-A and Actimab -A, drugs based on the APIT platform have so far been tested in over 60 patients in 3 clinical trials. In each trial they exhibited few side effects and have shown indications of efficacy. The current proof-of-concept Actimab -A Phase I/II clinical trial is directed at a patient population that is generally easier to treat (newly diagnosed vs. relapsed/refractory in previous trials), and employs a more potent treatment regimen (low dose chemotherapy plus two doses of ActimabTM-A plus low dose chemotherapy vs. a single dose of ActimabTM-A in the physician sponsored trial).


·

Additional product opportunities from the APIT platform: API’s Alpha Particle Immunotherapy technology has the potential for broad applicability for the treatment of many cancer types, which allows the Company to add new product candidates to its pipeline based on well-defined patent protected methods. The next product from the platform is expected to be a second generation BC8 product linked to Ac-225, Actimab -B which could potentially significantly expand the market that is targeted by Iomab -B.


·

Collaboration with Memorial Sloan-Kettering Cancer Center (MSKCC): API s collaboration with MSKCC includes licensing, research and clinical trial arrangements involving MSKCC labs and clinicians and financial support with respect to certain pre-2012 R&D-related expenses.


·

Scientific backing of leading experts: API’s clinical advisory board and collaborators include some of the best recognized clinicians and scientists working at some of the highest regarded medical institutions in the U.S. and the world, including MSKCC, Johns Hopkins University, University of Pennsylvania, Fred Hutchinson Cancer Center and MD Anderson Cancer Center. This is expected to be beneficial to API both in clinical development and market acceptance assuming its drug candidates are approved.


·

Isotope supply secured for clinical trials: API has a contractual relationship with ORNL (Oak Ridge National Laboratory of the Department of Energy (DOE)) that provides the Company access to the largest known supply reserves of actinium 225. Iodine 131 is readily available from a number of qualified pharmaceutical supply vendors.







·

Proprietary alpha emitting isotope manufacturing fully developed: API has developed its own proprietary technology for commercial scale manufacturing of actinium 225. This is expected to ensure commercial supply of Ac-225 for Actimab -A, Actimab -B and other actinium-linked products should they be approved.


·

cGMP Actimab -A manufacturing developed: API has developed at a contractor s site full cGMP (current good manufacturing practices) manufacturing  processes for its drug candidate Actimab -A.


·

Substantial IP portfolio: API has an intellectual property portfolio in excess of 60 patents and patent applications, both in the U.S. and other countries, which cover clinical applications of the APIT technology and methods of manufacturing actinium 225 thus giving API control over both the applications of its technology and a supply chain of its key ingredients, actinium 225 and bismuth 213 alpha emitting isotopes.


Competition Overview


To API’s knowledge, there are no other commercial entities that have significant programs in place for developing Ac-225- or Bi-213-based drugs. In the wider field of medical oncology, the Company faces competition from: developers of other alpha emitter based drug candidates, other radioimmunotherapy based technologies, technologies for labeling antibodies with toxic drugs (antibody-drug conjugates), and for each disease indication from all drugs available and/or in development.


For Actinium’s lead indication, acute myeloid leukemia, there are a number of companies developing drugs for AML induction in the elderly. These drugs are most often small molecules. Until recently, our leukemia targeting monoclonal antibody HuM195 was under development as a native i.e. unconjugated mAb by Seattle Genetics, Inc., but its development has been discontinued due to lack of efficacy of the native mAb in that company’s pivotal trial in AML. To API’s knowledge, there are no clinical trials that have shown significant efficacy in this indication.


In the field of hematopoietic stem cell transplantation, pharmaceuticals currently used for bone marrow ablation/conditioning are generic drugs and to API’s knowledge there are no significant industry efforts to enter this area, especially not in older patients.


Government Regulation


Governmental authorities in the United States and other countries extensively regulate, among other things, the research, development, testing, manufacture, labeling, promotion, advertising, distribution and marketing of radioimmunotherapy pharmaceutical products such as those being developed by API. In the United States, the U.S. Food and Drug Administration (FDA) regulates such products under the Federal Food, Drug and Cosmetic Act (FDCA) and implements regulations. Failure to comply with applicable FDA requirements, both before and after approval, may subject us to administrative and judicial sanctions, such as a delay in approving or refusal by the FDA to approve pending applications, warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions and/or criminal prosecution.


U.S. Food and Drug Administration Regulation


Our research, development and clinical programs, as well as our manufacturing and marketing operations, are subject to extensive regulation in the United States and other countries. Most notably, all of our products sold in the United States are subject to the FDA as implemented and enforced by the FDA. Certain of our product candidates in the United States require FDA pre-marketing approval of a Biologics License Application (BLA) pursuant to 21 C.F.R. § 314. Foreign countries may require similar or more onerous approvals to manufacture or market these products.


Failure by us or by our suppliers to comply with applicable regulatory requirements can result in enforcement action by the FDA, the Nuclear Regulatory Commission or other regulatory authorities, which may result in sanctions, including but not limited to, untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties; customer notifications or repair, replacement, refunds, recall, detention or seizure of our products; operating restrictions or partial suspension or total shutdown of production; refusing or delaying our requests for BLA premarket approval of new products or modified products; withdrawing BLA approvals that have already been granted; and refusal to grant export.


Employees


As of December 28, 2012, we have 4 full-time employees and 1 part-time employee. None of these employees are covered by a collective bargaining agreement, and we believe our relationship with our employees is good. We also engage consultants on an as-needed basis to supplement existing staff.







Available Information


We are subject to the reporting requirements of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).  Reports filed with the SEC pursuant to the Exchange Act, including annual and quarterly reports, and other reports we file, can be inspected and copied at the public reference facilities maintained by the SEC at 100 F Street, N.E., Washington, D.C. 20549. Investors may obtain information on the operation of the public reference room by calling the SEC at 1-800-SEC-0330. Investors can request copies of these documents upon payment of a duplicating fee by writing to the SEC. The reports we file with the SEC are also available on the SEC’s website (http://www.sec.gov).


RISK FACTORS


  An investment in our common stock involves a high degree of risk. You should carefully consider the risks described below, together with all of the other information included in this Report, before making an investment decision. If any of the following risks actually occurs, our business, financial condition or results of operations could suffer. In that case, the trading price of our shares of common stock could decline and you may lose all or part of your investment. See “Cautionary Note Regarding Forward Looking Statements” above for a discussion of forward-looking statements and the significance of such statements in the context of this Report.


Risks Related to Our Business


We have generated no revenue from commercial sales to date and our future profitability is uncertain.


We have a limited operating history and our business is subject to all of the risks inherent in the establishment of a new business enterprise. Our likelihood of success must be considered in light of the problems, expenses, difficulties, complications and delays frequently encountered in connection with this development and expansion. Since we began our business, we have focused on research, development and clinical trials of product candidates, and have incurred losses since inception. As of September 30, 2012, we had a deficit accumulated during development stage of approximately $52.8 million. If we continue to incur operating losses and fail to become a profitable company, we may be unable to continue our operations. We expect to continue to operate at a net loss for at least the next several years as we continue our research and development efforts, continue to conduct clinical trials and develop manufacturing, sales, marketing and distribution capabilities. There can be no assurance that the products under development by us will be approved for sale in the U.S. or elsewhere. Furthermore, there can be no assurance that if such products are approved they will be successfully commercialized, and the extent of our future losses and the timing of our profitability are highly uncertain.


If we fail to obtain the capital necessary to fund our operations, we will be unable to continue or complete our product development and you will likely lose your entire investment.


We do not currently have sufficient capital for the development and commercialization of our lead product and we will need to continue to seek capital from time to time to continue development of our lead drug candidates and to acquire and develop other product candidates. Our first product is not expected to be commercialized until at least 2016 and we do not expect that the partnering revenues it will generate will be sufficient to fund our ongoing operations. We believe that we may need to raise substantial additional capital to fund our continuing operations and the development and commercialization of our product candidates in or before the last quarter of 2013.


Our business or operations may change in a manner that would consume available funds more rapidly than anticipated and substantial additional funding may be required to maintain operations, fund expansion, develop new or enhanced products, acquire complementary products, business or technologies or otherwise respond to competitive pressures and opportunities, such as a change in the regulatory environment or a change in preferred cancer treatment modalities. However, we may not be able to secure funding when we need it or on favorable terms. API’s Amended and Restated Certificate of Incorporation requires us to obtain the consent of our stockholders who hold a majority of our issued shares of stock and also the consent of a majority in interest of our Series E Preferred shareholders, prior to issuing any new shares of stock in consideration for new capital and also requires us, until one year after expiration of all lock-up agreements entered into in connection with the Share Exchange, to obtain the consent of the Placement Agent in order to increase or decrease the number of directors of the Company. In addition, API’s Amended and Restated Stockholders Agreement provides certain of our stockholders with preemptive rights, which obligate us to offer them the right to purchase an amount of any stock issuances in proportion to the shares already owned by such stockholders. We may not be able to raise sufficient funds to commercialize our products if our stockholders do not consent to our future proposed capital raising activities.







If we cannot raise adequate funds to satisfy our capital requirements, we will have to delay, scale-back or eliminate our research and development activities, clinical studies or future operations.  We may also be required to obtain funds through arrangements with collaborators, which arrangements may require us to relinquish rights to certain technologies or products that we otherwise would not consider relinquishing, including rights to future product candidates or certain major geographic markets.  We may further have to license our technology to others.  This could result in sharing revenues which we might otherwise have retained for ourselves.  Any of these actions may harm our business, financial condition and results of operations.  


The amount of capital we may need depends on many factors, including the progress, timing and scope of our product development programs; the progress, timing and scope of our preclinical studies and clinical trials; the time and cost necessary to obtain regulatory approvals; the time and cost necessary to further develop manufacturing processes and arrange for contract manufacturing; our ability to enter into and maintain collaborative, licensing and other commercial relationships; and our partners’ commitment of time and resources to the development and commercialization of our products.  


We have limited access to the capital markets and even if we can raise additional funding, we may be required to do so on terms that are dilutive to you.


We have limited access to the capital markets to raise capital.  The capital markets have been unpredictable in the recent past for radio-immunotherapy and other oncology companies and unprofitable companies such as ours.  In addition, it is generally difficult for development stage companies to raise capital under current market conditions.  The amount of capital that a company such as ours is able to raise often depends on variables that are beyond our control.  As a result, we may not be able to secure financing on terms attractive to us, or at all.  If we are able to consummate a financing arrangement, the amount raised may not be sufficient to meet our future needs.  If adequate funds are not available on acceptable terms, or at all, our business, including our technology licenses, results of operations, financial condition and our continued viability will be materially adversely affected.  


If we fail to obtain or maintain necessary U.S. Food and Drug Administration clearances for our radio-immunotherapy products, or if such clearances are delayed, we will be unable to commercially distribute and market our products.


Our products are subject to rigorous regulation by the FDA and numerous other federal, state and foreign governmental authorities.  The process of seeking regulatory clearance or approval to market a radio-immunotherapy product is expensive and time-consuming and, notwithstanding the effort and expense incurred, clearance or approval is never guaranteed.  If we are not successful in obtaining timely clearance or approval of API products from the FDA, we may never be able to generate significant revenue and may be forced to cease operations.  In particular, the FDA permits commercial distribution of a new radio-immunotherapy product only after the product has received approval of a Biologics License Application (“ BLA ”) filed with the U.S. Food and Drug Administration pursuant to 21 C.F.R. § 314, seeking permission to market the product in interstate commerce in the United States.  The BLA process is costly, lengthy and uncertain.  Any BLA application filed by the Company will have to be supported by extensive data, including, but not limited to, technical, preclinical, clinical trial, manufacturing and labeling data, to demonstrate to the FDA’s satisfaction the safety and efficacy of the product for its intended use.  


Obtaining clearances or approvals from the FDA and from the regulatory agencies in other countries could result in unexpected and significant costs for us and consume management’s time and other resources.  The FDA and other agencies could ask us to supplement our submissions, collect non-clinical data, conduct additional clinical trials or engage in other time-consuming actions, or it could simply deny our applications.  In addition, even if we obtain a BLA approval or pre-market approvals in other countries, the approval could be revoked or other restrictions imposed if post-market data demonstrates safety issues or lack of effectiveness.  We cannot predict with certainty how, or when, the FDA will act.  If we are unable to obtain the necessary regulatory approvals, our financial condition and cash flow may be materially adversely affected, and our ability to grow domestically and internationally may be limited.  Additionally, even if cleared or approved, the Company’s products may not be approved for the specific indications that are most necessary or desirable for successful commercialization or profitability.  








Our radio-immunotherapy product candidates are in the early stages of development; and we have not demonstrated that any of our products actually cure cancer.


Only two product candidates of the Company are currently in clinical development by the Company.  There is an ongoing Phase I AML trial at MSKCC under physician IND with a single dose of Actimab -A.  The Company has also commenced a Phase I/II multi-center AML trial with fractionated doses of Actimab -A.  Additionally, there are a number of physician IND trials that have been conducted or are currently ongoing at FHCRC with single doses of Iomab -A.  Neither API nor any relevant collaborative partner(s) has yet undertaken any clinical assessment or investigation of API radio-immunotherapy product candidates for other indications, including colon cancer or prostate cancer.  Significant further investment may be required to acquire antibody rights and to undertake necessary research and continued development.  Further laboratory and specific clinical testing will be required prior to regulatory approval of any product candidates.  Adverse or inconclusive results from pre-clinical testing or clinical trials of product candidates may substantially delay, or halt entirely, any further development of one or more of our products.  The projected timetables for continued development of the technologies and related product candidates by us may otherwise be subject to delay or suspension.


Modifications to our product candidates may require new BLA approvals.  


Once a particular API product candidate receives FDA approval or clearance, expanded uses or uses in new indications of our products may require additional human clinical trials and new regulatory approvals or clearances, including additional IND and BLA submissions and premarket approvals before we can begin clinical development, and/or prior to marketing and sales.  If the FDA requires new clearances or approvals for a particular use or indication, we may be required to conduct additional clinical studies, which would require additional expenditures and harm our operating results.  If the products are already being used for these new indications, we may also be subject to significant enforcement actions.  


Conducting clinical trials and obtaining clearances and approvals can be a time-consuming process, and delays in obtaining required future clearances or approvals could adversely affect our ability to introduce new or enhanced products in a timely manner, which in turn would harm our future growth.  


There is no guarantee that the FDA will grant BLA approval of our future product candidates and failure to obtain necessary clearances or approvals for our future product candidates would adversely affect our ability to grow our business.  


We have recently commenced a multi-center Phase I/II clinical trial for our lead drug candidate, Actimab -A, in AML and in the future expect to submit a BLA to the FDA for approval of this product.  This drug candidate is also the subject of an ongoing human safety trial being conducted under a physician IND at Memorial Sloan Kettering Cancer Center in New York City.  We are in the early stages of evaluating other drug candidates consisting of conjugates of Ac-225 with human or humanized antibodies for pre-clinical and clinical development in other types of cancer and the Company has recently acquired rights to Iomab , a Phase II clinical stage monoclonal antibody with safety and efficacy data in more than 250 patients in need of HSCT.  Product candidates utilizing this antibody would also require FDA approval of a BLA.  The FDA may not approve or clear these products for the indications that are necessary or desirable for successful commercialization.  Indeed, the FDA may refuse our requests for BLA market approval of new products, new intended uses or indications to existing or future product candidates.  Failure to receive approval for our new products would have an adverse effect on our ability to expand our business.  


Clinical trials necessary to support BLA approval of our future product candidates will be time consuming and expensive.  Delays or failures in our clinical trials will prevent us from commercializing our product candidates and will adversely affect our business, operating results and prospects and could cause us to cease operations.


Initiating and completing clinical trials necessary to support BLA approval of Actimab -A and other product candidates, will be time-consuming and expensive and the outcome uncertain.  Moreover, the results of early clinical trials are not necessarily predictive of future results, and any product candidate we advance into clinical trials may not have favorable results in later clinical trials.  We have worked with the FDA to develop a clinical trial designed to support initial safety and efficacy of Actimab -A and on October 6, 2008, and January 5, 2009, we submitted IND amendments to the FDA for the conduct of a multi-center Phase I/II clinical trial for treatment of AML.  The trial is now underway with the purpose of examining the use of Actimab-A in AML patients who are not eligible for approved forms of treatment with curative intent.  The trial is not designed to support final BLA approval of the product candidate and one or more additional trials will have to be conducted in the future before we file a BLA.  In addition, there can be no assurance that the data generated during the trial will meet our chosen safety and effectiveness endpoints or otherwise produce results that will eventually support the filing or approval of a BLA.  







Conducting successful clinical studies may require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit.  


Patient enrollment in clinical trials and completion of patient participation and follow-up depends on many factors, including the size of the patient population; the nature of the trial protocol; the attractiveness of, or the discomforts and risks associated with, the treatments received by enrolled subjects; the availability of appropriate clinical trial investigators; support staff; and proximity of patients to clinical sites and ability to comply with the eligibility and exclusion criteria for participation in the clinical trial and patient compliance.  For example, patients may be discouraged from enrolling in our clinical trials if the trial protocol requires them to undergo extensive post-treatment procedures or follow-up to assess the safety and effectiveness of our product candidates or if they determine that the treatments received under the trial protocols are not attractive or involve unacceptable risks or discomforts.  Patients may also not participate in our clinical trials if they choose to participate in contemporaneous clinical trials of competitive product candidates.  In addition, patients participating in refractory AML clinical trials are seriously and often terminally ill and therefore may not complete the clinical trial due to reasons including comorbid conditions or occurrence of adverse medical events related or unrelated to the investigational products, or death.  


Development of sufficient and appropriate clinical protocols to demonstrate safety and efficacy are required and we may not adequately develop such protocols to support clearance and approval.  


The FDA may require us to submit data on a greater number of patients than we originally anticipated and/or for a longer follow-up period or change the data collection requirements or data analysis applicable to our clinical trials.  They may also require additional data on certain categories of patients, should it emerge during the conduct of our clinical trials that certain categories of patients are likely to be affected in different and/or additional manner than most of the patients.  In addition to FDA requirements, our clinical trial requires the approval of the institutional review board, or IRB, at each site selected for participation in our current Actimab -A clinical trial.  We have submitted our clinical trial to the IRBs at participating sites for approval and we have thus far obtained approval from two IRBs, and are engaged in discussions with investigators at other sites to in order to complete the approval process with their respective hospital centers.  The Company’s clinical trial protocols have not been rejected by any IRB.  


Additional delays to the completion of clinical studies may result from modifications being made to the protocol during the clinical trial, if such modifications are warranted and/or required by the occurrences in the given trial .


Each such modification has to be submitted to the FDA.  This could result in the delay or halt of a clinical trial while the modification is evaluated.  In addition, depending on the quantity and nature of the changes made, FDA could take the position that some or all of the data generated by the clinical trial is not usable because the same protocol was not used throughout the trial.  This might require the enrollment of additional subjects, which could result in the extension of the clinical trial and the FDA delaying clearance or approval of a product candidate.  


There can be no assurance that the data generated using modified protocols will be acceptable to FDA.


There can be no assurance that the data generated using modified protocols will be acceptable to FDA or that if future modifications during the trial are necessary, that any such modifications will be acceptable to FDA.  If the FDA believes that its prior approval is required for a particular modification, it can delay or halt a clinical trial while it evaluates additional information regarding the change.  


Serious injury or death resulting from a failure of one of our drug candidates during current or future clinical trials could also result in the FDA delaying our clinical trials or denying or delaying clearance or approval of a product.


The ongoing Phase I clinical trial for Actimab -A conducted at MSKCC was designed to establish the maximum tolerated dose of the product.  As the Company expected, patients receiving highest dose of the drug administered in the trial so far had prolonged bone marrow suppression which could lead to fatal infections and other severe consequences.  Consequently, the dose levels of our drug in that trial were reduced as we continue our work on establishing maximum tolerated dose.  


Even though an adverse event may not be the result of the failure of our drug candidate, FDA or an IRB could delay or halt a clinical trial for an indefinite period of time while an adverse event is reviewed, and likely would do so in the event of multiple such events.  








Any delay or termination of our current or future clinical trials as a result of the risks summarized above, including delays in obtaining or maintaining required approvals from IRBs, delays in patient enrollment, the failure of patients to continue to participate in a clinical trial, and delays or termination of clinical trials as a result of protocol modifications or adverse events during the trials, may cause an increase in costs and delays in the filing of any submissions with the FDA, delay the approval and commercialization of our product candidates or result in the failure of the clinical trial, which could adversely affect our business, operating results and prospects.  Lengthy delays in the completion of our Actimab -A clinical trials would adversely affect our business and prospects and could cause us to cease operations.  


If the third parties on which we rely to conduct our clinical trials and to assist us with pre-clinical development do not perform as contractually required or expected, we may not be able to obtain regulatory approval for or commercialize our product candidates.  


We do not have the ability to independently conduct our pre-clinical and clinical trials for our product candidates and we must rely on third parties, such as contract research organizations, medical institutions, clinical investigators and contract laboratories to conduct such trials.  If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, if these third parties need to be replaced, or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our pre-clinical development activities or clinical trials may be extended, delayed, suspended or terminated, and we may not be able to obtain regulatory approval for, or successfully commercialize, our product candidates on a timely basis, if at all, and our business, operating results and prospects may be adversely affected.  Furthermore, our third-party clinical trial investigators may be delayed in conducting our clinical trials for reasons outside of their control.  


The future results of our current or future clinical trials may not support our product candidate claims or may result in the discovery of unexpected adverse side effects.


Even if our clinical trials are completed as planned, we cannot be certain that their results will support our product candidate claims or that the FDA or foreign authorities will agree with our conclusions regarding them.  Success in pre-clinical studies and early clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that the later trials will replicate the results of prior trials and pre-clinical studies.  The clinical trial process may fail to demonstrate that our product candidates are safe and effective for the proposed indicated uses.  If FDA concludes that the clinical trials for Actimab -A, or any other product candidate for which we might seek clearance, have failed to demonstrate safety and effectiveness, we would not receive FDA clearance to market that product candidate in the United States for the indications sought.  In addition, such an outcome could cause us to abandon the product candidate and might delay development of others.  Any delay or termination of our clinical trials will delay the filing of any submissions with the FDA and, ultimately, our ability to commercialize our product candidates and generate revenues.  It is also possible that patients enrolled in clinical trials will experience adverse side effects that are not currently part of a product candidate’s profile.  In addition, our clinical trials for Actimab -A involve a relatively small patient population.  Because of the small sample size, their results may not be indicative of future results.


Actimab -A and future product candidates may never achieve market acceptance.


Actimab -A and future product candidates that we may develop may never gain market acceptance among physicians, patients and the medical community.  The degree of market acceptance of any of product will depend on a number of factors, including the actual and perceived effectiveness and reliability of the product; the results of any long term clinical trials relating to use of the product; the availability, relative cost and perceived advantages and disadvantages of alternative technologies; the degree to which treatments using the product are approved for reimbursement by public and private insurers; the strength of our marketing and distribution infrastructure; and the level of education and awareness among physicians and hospitals concerning the product.


Failure of Actimab -A or any of our other product candidates to significantly penetrate current or new markets would negatively impact our business, financial condition and results of operations.








To be commercially successful, physicians must be persuaded that using our product candidates for treatment of AML and other cancers are effective alternatives to existing therapies and treatments.


We believe that oncologists and other physicians will not widely adopt a product candidate unless they determine, based on experience, clinical data, and published peer-reviewed journal articles, that the use of that product candidate provides an effective alternative to other means of treating specific cancers.  Patient studies or clinical experience may indicate that treatment with our product candidates does not provide patients with sufficient benefits in extension of life or quality of life.  We believe that recommendations and support for the use of each product candidate from influential physicians will be essential for widespread market acceptance.  Our product candidates are still in the development stage and it is premature to attempt to gain support from physicians at this time.  We can provide no assurance that such support will ever be obtained.  If our product candidates do not receive such support from these physicians and from long-term data, physicians may not use or continue to use, and hospitals may not purchase or continue to purchase, them.  


Even if our product candidates are approved by regulatory authorities, if we or our suppliers fail to comply with ongoing FDA regulation or if we experience unanticipated problems with our products, these products could be subject to restrictions or withdrawal from the market.  


Any product candidate for which we obtain FDA clearance or approval, and the manufacturing processes, reporting requirements, post-approval clinical data and promotional activities for such product candidate, will be subject to continued regulatory review, oversight and periodic inspections by the FDA.  In particular, we and our suppliers are required to comply with FDA’s Quality System Regulations, or QSR, and International Standards Organization, or ISO, regulations for the manufacture of products and other regulations which cover the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, storage and shipping of any product candidate for which we obtain clearance or approval.  Additionally, because our product candidates include radio-active isotopes, they will be subject to additional regulation and oversight from the United States Nuclear Regulatory Commission (NRC) and similar bodies in other jurisdictions.  Regulatory bodies, such as the FDA, enforce these regulations through periodic inspections.  The failure by us or one of our suppliers to comply with applicable statutes and regulations administered by the FDA and other regulatory bodies, or the failure to timely and adequately respond to any adverse inspectional observations or safety issues, could result in, among other things, enforcement actions by the FDA and/or other regulatory bodies.  


If any of these actions were to occur, it would harm our reputation and cause our future product sales and profitability to suffer and may prevent us from generating revenue.  Furthermore, our key component suppliers may not currently be or may not continue to be in compliance with all applicable regulatory requirements which could result in our failure to produce our product candidates on a timely basis and in the required quantities, if at all.  


Even if regulatory clearance or approval of a product candidate is granted, such clearance or approval may be subject to limitations on the intended uses for which a product may be marketed and reduce the potential to successfully commercialize that product and generate revenue from that product.  If the FDA determines that the product promotional materials, labeling, training or other marketing or educational activities constitute promotion of an unapproved use, it could request that we or our commercialization partners cease or modify our training or promotional materials or subject us to regulatory enforcement actions.  It is also possible that other federal, state or foreign enforcement authorities might take action if they consider such training or other promotional materials to constitute promotion of an unapproved use, which could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement.  


In addition, we may be required to conduct costly post-market testing and surveillance to monitor the safety or effectiveness of our products, and we must comply with adverse event and phamacovigilence reporting requirements, including the reporting of adverse events which occur in connection with, and whether or not directly related to, our products.  Later discovery of previously unknown problems with our products, including unanticipated adverse events or adverse events of unanticipated severity or frequency, manufacturing problems, or failure to comply with regulatory requirements, may result in changes to labeling, restrictions on such products or manufacturing processes, withdrawal of the products from the market, voluntary or mandatory recalls, a requirement to recall, replace or refund the cost of any product we manufacture or distribute, fines, suspension of regulatory approvals, product seizures, injunctions or the imposition of civil or criminal penalties which would adversely affect our business, operating results and prospects.








Our revenue stream will depend upon third party reimbursement.


The commercial success of our product candidates in both domestic and international markets will be substantially dependent on whether third-party coverage and reimbursement is available for patients that use our products.  However, the availability of insurance coverage and reimbursement for newly approved cancer therapies is uncertain, and therefore, third-party coverage may be particularly difficult to obtain even if our products are approved by the FDA as safe and efficacious.  Patients using existing approved therapies are generally reimbursed all or part of the product cost by Medicare or other third-party payors. Medicare, Medicaid, health maintenance organizations and other third-party payors are increasingly attempting to contain healthcare costs by limiting both coverage and the level of reimbursement of new drugs, and, as a result, they may not cover or provide adequate payment for these products.  Submission of applications for reimbursement approval generally does not occur prior to the filing of an NDA for that product and may not be granted until many months after NDA approval.  In order to obtain reimbursement arrangements for these products, we or our commercialization partners may have to agree to a net sales price lower than the net sales price we might charge in other sales channels.  The continuing efforts of government and third-party payors to contain or reduce the costs of healthcare may limit our revenue.  Initial dependence on the commercial success of our products may make our revenues particularly susceptible to any cost containment or reduction efforts.


We are dependent on third parties for manufacturing and marketing of our proposed proprietary products.  If we are not able to secure favorable arrangements with such third parties, our business and financial condition would be harmed.  


We will not manufacture any of our proposed proprietary products for commercial sale nor do we have the resources necessary to do so.  In addition, we currently do not have the capability to market drug products ourselves.  We intend to contract with specialized manufacturing companies to manufacture our proposed proprietary products and partner with larger pharmaceutical companies for their commercialization.  In connection with our efforts to commercialize our proposed proprietary products, we will seek to secure favorable arrangements with third parties to distribute, promote, market and sell them.  If we are not able to secure favorable commercial terms or arrangements with third parties for distribution, marketing, promotion and sales of our proposed proprietary products, we may have to retain promotional and marketing rights and seek to develop the commercial resources necessary to promote or co-promote or co-market certain or all of our proprietary product candidates to the appropriate channels of distribution in order to reach the specific medical market that we are targeting.  We may not be able to enter into any partnering arrangements on this or any other basis.  If we are not able to secure favorable partnering arrangements, or are unable to develop the appropriate resources necessary for the commercialization of our proposed proprietary products, our business and financial condition could be harmed.  In addition, we will have to hire additional employees or consultants, since our current employees have limited experience in these areas.  Sufficient employees with relevant skills may not be available to us.  Any increase in the number of our employees would increase our expense level, and could have an adverse effect on our financial position.  


In addition, we, or our potential commercial partners, may not successfully introduce our proposed proprietary products or they may not achieve acceptance by patients, health care providers and insurance companies.  Further, it is possible that we may not be able to secure arrangements to manufacture, market, distribute, promote and sell our proposed proprietary products at favorable commercial terms that would permit us to make a profit.  To the extent that corporate partners conduct clinical trials, we may not be able to control the design and conduct of these clinical trials.  


We may have conflicts with our partners that could delay or prevent the development or commercialization of our product candidates.  


We may have conflicts with our partners, such as conflicts concerning the interpretation of preclinical or clinical data, the achievement of milestones, the interpretation of contractual obligations, payments for services, development obligations or the ownership of intellectual property developed during our collaboration.  If any conflicts arise with any of our partners, such partner may act in a manner that is adverse to our best interests.  Any such disagreement could result in one or more of the following, each of which could delay or prevent the development or commercialization of our product candidates, and in turn prevent us from generating revenues: unwillingness on the part of a partner to pay us milestone payments or royalties we believe are due under a collaboration; uncertainty regarding ownership of intellectual property rights arising from our collaborative activities, which could prevent us from entering into additional collaborations; unwillingness by the partner to cooperate in the development or manufacture of the product, including providing us with product data or materials; unwillingness on the part of a partner to keep us informed regarding the progress of its development and commercialization activities or to permit public disclosure of the results of those activities; initiating litigation or alternative dispute resolution options by either party to resolve the dispute; or attempts by either party to terminate the agreement.  


Upon commercialization of our product candidates, we may be dependent on third parties to market, distribute and sell them.







Our ability to receive revenues may be dependent upon the sales and marketing efforts of any future co-marketing partners and third-party distributors.  At this time, we have not entered into an agreement with any commercialization partner and only plan to do so after the successful completion of Phase II clinical trials and prior to commercialization.  If we fail to reach an agreement with any commercialization partner, or if upon reaching such an agreement that partner fails to sell a large volume of our products, it may have a negative impact on our business, financial condition and results of operations.  


Our product candidates will face significant competition in the markets for them, and if they are unable to compete successfully, our business will suffer.


Our product candidates face, and will continue to face, intense competition from large pharmaceutical companies, as well as academic and research institutions.  We compete in an industry that is characterized by (i) rapid technological change, (ii) evolving industry standards, (iii) emerging competition and (iv) new product introductions.  Our competitors have existing products and technologies that will compete with our product candidates and technologies and may develop and commercialize additional products and technologies that will compete with our product candidates and technologies.  Because several competing companies and institutions have greater financial resources than us, they may be able to (i) provide broader services and product lines, (ii) make greater investments in research and development, or R&D, and (iii) carry on broader R&D initiatives.  Our competitors also have greater development capabilities than we do and have substantially greater experience in undertaking preclinical and clinical testing of product candidates, obtaining regulatory approvals, and manufacturing and marketing pharmaceutical products.  They also have greater name recognition and better access to customers than us.  Our chief competitors include companies such as Bayer Schering Pharma AG, GlaxoSmithKline Plc, Spectrum Pharmaceuticals, Inc. and Algeta ASA.


Adverse events involving our products may lead the FDA to delay or deny clearance for our product candidates or result in product recalls that could harm our reputation, business and financial results.  


Once a product candidate receives FDA clearance or approval, the agency has the authority to require the recall of commercialized products in the event of adverse side effects, material deficiencies or defects in design or manufacture.  The authority to require a recall must be based on an FDA finding that there is a reasonable probability that the device would cause serious injury or death.  Manufacturers may, under their own initiative, recall a product if any material deficiency in a product is found.  A government-mandated or voluntary recall by us or one of our distributors could occur as a result of adverse side effects, impurities or other product contamination, manufacturing errors, design or labeling defects or other deficiencies and issues.  Recalls of any of our products would divert managerial and financial resources and have an adverse effect on our financial condition and results of operations.  The FDA requires that certain classifications of recalls be reported to FDA within 10 working days after the recall is initiated.  Companies are required to maintain certain records of recalls, even if they are not reportable to the FDA.  We may initiate voluntary recalls involving our products in the future that we determine do not require notification of the FDA.  If the FDA disagrees with our determinations, they could require us to report those actions as recalls.  A future recall announcement could harm our reputation with customers and negatively affect our sales.  In addition, the FDA could take enforcement action for failing to report the recalls when they were conducted.


Our business depends upon securing and protecting critical intellectual property.


Our commercial success will depend in part on our obtaining and maintaining patent, trade secret, copyright and trademark protection of our technologies in the United States and other jurisdictions, as well as successfully enforcing this intellectual property and defending this intellectual property against third-party challenges.  We will only be able to protect our technologies from unauthorized use by third parties to the extent that valid and enforceable intellectual property protection, such as patents or trade secrets law, cover them.  In particular, we place considerable emphasis on obtaining patent and trade secret protection for significant new technologies, products and processes.  Furthermore, the degree of future protection of our proprietary rights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep our competitive advantage.  Moreover, the degree of future protection of our proprietary rights is uncertain for product candidates that are currently in the early stages of development because we cannot predict which of these product candidates will ultimately reach the commercial market or whether the commercial versions of these product candidates will incorporate proprietary technologies.








Our patent position is highly uncertain and involves complex legal and factual questions.


Accordingly, we cannot predict the breadth of claims that may be allowed or enforced under our patents or in third-party patents.  For example, we or our licensors might not have been the first to make the inventions covered by each of our pending patent applications and issued patents; we or our licensors might not have been the first to file patent applications for these inventions; others may independently develop similar or alternative technologies or duplicate any of our technologies; it is possible that none of our pending patent applications or the pending patent applications of our licensors will result in issued patents; our issued patents and issued patents of our licensors may not provide a basis for commercially viable technologies, or may not provide us with any competitive advantages, or may be challenged and invalidated by third parties; and, we may not develop additional proprietary technologies that are patentable.


As a result, our owned and licensed patents may not be valid and we may not be able to obtain and enforce patents and to maintain trade secret protection for the full commercial extent of our technology.  The extent to which we are unable to do so could materially harm our business.  


We or our licensors have applied for and will continue to apply for patents for certain products.  Such applications may not result in the issuance of any patents, and any patents now held or that may be issued may not provide us with adequate protection from competition.  Furthermore, it is possible that patents issued or licensed to us may be challenged successfully.  In that event, if we have a preferred competitive position because of such patents, such preferred position would be lost.  If we are unable to secure or to continue to maintain a preferred position, we could become subject to competition from the sale of generic products.  Failure to receive, inability to protect, or expiration of our patents for medical use, manufacture, conjugation and labeling of Ac-225, the antibodies that we license from third parties, or subsequent related filings, would adversely affect our business and operations.  


Patents issued or licensed to us may be infringed by the products or processes of others.  The cost of enforcing our patent rights against infringers, if such enforcement is required, could be significant, and the Company does not currently have the financial resources to fund such litigation.  Further, such litigation can go on for years and the time demands could interfere with our normal operations.  There has been substantial litigation and other proceedings regarding patent and other intellectual property rights in the pharmaceutical industry.  We may become a party to patent litigation and other proceedings.  The cost to us of any patent litigation, even if resolved in our favor, could be substantial.  Some of our competitors may be able to sustain the costs of such litigation more effectively than we can because of their substantially greater financial resources.  Litigation may also absorb significant management time.


Unpatented trade secrets, improvements, confidential know-how and continuing technological innovation are important to our scientific and commercial success.  Although we attempt to and will continue to attempt to protect our proprietary information through reliance on trade secret laws and the use of confidentiality agreements with our partners, collaborators, employees and consultants and other appropriate means, these measures may not effectively prevent disclosure of our proprietary information, and, in any event, others may develop independently, or obtain access to, the same or similar information.


Certain of our patent rights are licensed to us by third parties.  If we fail to comply with the terms of these license agreements, our rights to those patents may be terminated, and we will be unable to conduct our business.  


If we are found to be infringing on patents or trade secrets owned by others, we may be forced to cease or alter our product development efforts, obtain a license to continue the development or sale of our products, and/or pay damages.


Our manufacturing processes and potential products may violate proprietary rights of patents that have been or may be granted to competitors, universities or others, or the trade secrets of those persons and entities.  As the pharmaceutical industry expands and more patents are issued, the risk increases that our processes and potential products may give rise to claims that they infringe the patents or trade secrets of others.  These other persons could bring legal actions against us claiming damages and seeking to enjoin clinical testing, manufacturing and marketing of the affected product or process.  If any of these actions are successful, in addition to any potential liability for damages, we could be required to obtain a license in order to continue to conduct clinical tests, manufacture or market the affected product or use the affected process.  Required licenses may not be available on acceptable terms, if at all, and the results of litigation are uncertain.  If we become involved in litigation or other proceedings, it could consume a substantial portion of our financial resources and the efforts of our personnel.








Our ability to protect and enforce our patents does not guaranty that we will secure the right to commercialize our patents.


A patent is a limited monopoly right conferred upon an inventor, and his successors in title, in return for the making and disclosing of a new and non-obvious invention.  This monopoly is of limited duration but, while in force, allows the patent holder to prevent others from making and/or using its invention.  While a patent gives the holder this right to exclude others, it is not a license to commercialize the invention where other permissions may be required for commercialization to occur.  For example, a drug cannot be marketed without the appropriate authorization from the FDA, regardless of the existence of a patent covering the product.  Further, the invention, even if patented itself, cannot be commercialized if it infringes the valid patent rights of another party.


We rely on confidentiality agreements to protect our trade secrets.  If these agreements are breached by our employees or other parties, our trade secrets may become known to our competitors.


We rely on trade secrets that we seek to protect through confidentiality agreements with our employees and other parties.  If these agreements are breached, our competitors may obtain and use our trade secrets to gain a competitive advantage over us.  We may not have any remedies against our competitors and any remedies that may be available to us may not be adequate to protect our business or compensate us for the damaging disclosure.  In addition, we may have to expend resources to protect our interests from possible infringement by others.


The issued patents, which are licensed by API for the HuM-195 antibody, our acute myeloid leukemia targeting antibody, will begin to expire before we have commercialized Actimab -A.


The humanized antibody which we use in the conjugated Actimab -A product candidate is covered by the claims of issued patents that we license from Facet Biotech Corporation, a wholly-owned subsidiary of Abbott Laboratories ( Facet ).  Some of those patents will begin to expire in 2013.  After these patents expire, others may be eventually able to use an antibody with the same sequence in alpha particle drug products based on alpha particle emitters other than actinium 225 and bismuth 213.  Any process that would enable such a competition as described above is likely to require several years of development before achieving our product candidate’s current status and may be subject to significant regulatory hurdles, but is nevertheless a possibility that can affect the Company’s business in the future.


Additionally, because we expect that certain of these patents will expire prior to commercialization of Actimab -A, API expects that in order to attract a commercialization partner for that product candidate, it will may need to reach an agreement with Facet to reduce the milestone payments and royalties currently required to be paid under our license agreement for HuM-195.  There can be no assurance that the parties will be able to agree on an amendment to the terms of the license.  Failure to reach such an agreement could materially adversely affect API s ability to find a commercialization partner for Actimab -A which may materially harm our business.


The BC8 antibody utilized in Iomab -B is not patent protected.


The antibody we use in the conjugated Iomab product candidate is not covered by the claims of any issued or pending patents.  Accordingly, others may be eventually able to use an antibody with the same sequence in alpha particle drug products based on alpha particle emitters.  Any process that would enable such a competition as described above is likely to require several years of development before achieving our product candidate’s current status and may be subject to significant regulatory hurdles, but is nevertheless a possibility that could negatively impact the Company’s business in the future.








We may be unable to obtain a sufficient supply of Ac-225 medical grade isotope in order to continue clinical trials and to allow for the manufacture of commercial quantities of Actimab-A


There are limited quantities of Ac-225 available today.  The existing supplier of Ac-225 to the Company is Oak Ridge National Laboratory (ORNL).  It manufactures Ac-225 by eluting it from its supply of Thorium-229.  Although this has proven to be a very reliable source of production for a number of years, it is limited by the quantity of Thorium-229 at ORNL.  We believe that the current approximate maximum of Ac-225 production from this source is sufficient for approximately 1,000 - 2,000 patient treatments per year.  Since our needs are significantly below that amount at this time, and will continue to be below that for as long as we do not have a commercial product with a potential of selling more than 2,000 patient doses per year, we believe that this supply will be sufficient for completion of clinical trials and early commercialization.  To secure supplies beyond this amount, the Company has developed what it believes to be a scalable cost-effective process for manufacturing Ac-225 in a cyclotron at an estimated cost in excess of $5 million.  This work has been conducted at Technical University Munich (TUM) in Germany.  API is now in possession of detailed descriptions of all the developed manufacturing procedures and has rights to all relevant patent applications and other intellectual property.  However, we do not currently have access to a commercial cyclotron capable of producing medical grade Ac-225.  Although beam time on such cyclotrons is commercially available, the Company does not currently have a relationship with any entity that owns or controls a suitable cyclotron.  It has identified possible sources and estimates that it could secure the necessary beam time when needed at a cost of approximately $2 million per year.  The Company’s contract for supply of this isotope from ORNL extends through the end of 2012, is renewable for future years, and has already been renewed for several consecutive years.  However, there can be no assurance that ORNL will decide to renew the contract or that the U.S.  Department of Energy will not change its policies that allow for the sale of isotope to API.  Failure to acquire sufficient quantities of medical grade Ac-225 would make it impossible to effectively complete clinical trials and to commercialize Actimab -A and would materially harm our business.


We may undertake international operations, which will subject us to risks inherent with operations outside of the United States.


Although we do not have any foreign operations at this time, we intend to seek market clearances in foreign markets that we believe will generate significant opportunities.  However, even with the cooperating of a commercialization partner, conducting drug development in foreign countries involves inherent risks, including, but not limited to difficulties in staffing, funding and managing foreign operations; unexpected changes in regulatory requirements; export restrictions; tariffs and other trade barriers; difficulties in protecting, acquiring, enforcing and litigating intellectual property rights; fluctuations in currency exchange rates; and potentially adverse tax consequences.


If we were to experience any of the difficulties listed above, or any other difficulties, any international development activities and our overall financial condition may suffer and cause us to reduce or discontinue our international development and registration efforts.


We may not be successful in hiring and retaining key employees.


Our future operations and successes depend in large part upon the continued service of key members of our senior management team whom we are highly dependent upon to manage our business, in particular Mr. Jack V. Talley, our President and Chief Executive Officer and Dr. Dragan Cicic, our Chief Operating Officer and Chief Medical Officer.  If any member of our current senior management terminates his or her employment with us, such a departure may have a material adverse effect on our business.  


Our future success also depends on our ability to identify, attract, hire or engage, retain and motivate other well-qualified managerial, technical, clinical and regulatory personnel.  There can be no assurance that such professionals will be available in the market, or that we will be able to retain existing professionals or meet or continue to meet their compensation requirements.  Furthermore, the cost base in relation to such compensation, which may include equity compensation, may increase significantly, which could have a material adverse effect on us.  Failure to establish and maintain an effective management team and work force could adversely affect our ability to operate, grow and manage our business.


Managing our growth as we expand operations may strain our resources.


We expect to need to grow rapidly in order to support additional, larger, and potentially international, pivotal clinical trials of our drug candidates, which will place a significant strain on our financial, managerial and operational resources.  In order to achieve and manage growth effectively, we must continue to improve and expand our operational and financial management capabilities.  Moreover, we will need to increase staffing and to train, motivate and manage our employees.  All of these activities will increase our expenses and may require us to raise additional capital sooner than expected.  Failure to manage growth effectively could materially harm our business, financial condition or results of operations.







We may expand our business through the acquisition of rights to new product candidates that could disrupt our business, harm our financial condition and may also dilute current stockholders’ ownership interests in our company.


Our business strategy includes expanding our products and capabilities, and we may seek acquisitions of drug candidates, antibodies or technologies to do so.  Acquisitions involve numerous risks, including substantial cash expenditures; potentially dilutive issuance of equity securities; incurrence of debt and contingent liabilities, some of which may be difficult or impossible to identify at the time of acquisition; difficulties in assimilating acquired technologies or the operations of the acquired companies; diverting our management’s attention away from other business concerns; risks of entering markets in which we have limited or no direct experience; and the potential loss of our key employees or key employees of the acquired companies.


We can make no assurances that any acquisition will result in short-term or long-term benefits to us.  We may incorrectly judge the value or worth of an acquired product, company or business.  In addition, our future success would depend in part on our ability to manage the rapid growth associated with some of these acquisitions.  We cannot assure that we will be able to make the combination of our business with that of acquired products, businesses or companies work or be successful.  Furthermore, the development or expansion of our business or any acquired products, business or companies may require a substantial capital investment by us.  We may not have these necessary funds or they might not be available to us on acceptable terms or at all.  We may also seek to raise funds by selling shares of our preferred or common stock, which could dilute each current stockholder’s ownership interest in the Company.


Risks Related to Ownership of Our Common Stock


Shares of our capital stock are not registered under the Securities Act of 1933 and there is a lack of liquidity for our securities.


Though our Common Stock is listed on the OTC Bulletin Board (the “OTCBB”), there is little to no market for our Common Stock. Investors may have to bear the economic risk of an investment in the Company for an indefinite period of time.  At this time, the offer and sale of our securities will not be registered under the Securities Act or any state securities laws.  Each purchaser of Common Stock will be required to represent that it is purchasing such stock for its own account for investment purposes and not with a view to resale or distribution.  No transfer of Common Stock issued may be made unless such transfer is registered under the Securities Act and applicable state securities laws, or an exemption therefrom is available, which will be noted on a restrictive legend placed on each Common Stock certificate.  In connection with any such transfer, we may require the transferor to provide us with an opinion of legal counsel stating that the transfer complies with such securities laws and to pay any costs we incur in connection with such transfer and our review thereof as a precondition to the effectiveness of the transfer.  There is no public trading market for the shares of Common Stock issued or issuable upon the exercise of the Warrants and such trading market may never exist.


Resale of our securities is subject to significant restrictions.


Any of our securities that are sold are under exemptions from registration under applicable federal and state securities laws, as none of our securities have not been registered under the Securities Act or any state securities laws.  Until our securities have been registered, they may not be transferred or resold except in a transaction exempt from or not subject to the registration requirements of the Securities Act and applicable state securities laws.  The SEC has broad discretion to determine whether any registration statement will be declared effective and may delay or deny the effectiveness of any registration statement filed by us for a variety of reasons.  In the event that the effectiveness of any registration statement relating to resales of the shares of our securities is delayed or denied, or the registration statement, once effective, becomes unavailable for use by selling security holders, the transferability of the shares of Common Stock may be restricted and the value of such securities could be materially adversely affected.


If our ability to register our shares is limited, the ability of holders of our shares to sell them may be subject to substantial restrictions, and you may be required to hold such securities for a period of time prior to sale, in which case you could suffer a substantial loss on such shares.


If our ability to register the resale of shares of our Common Stock is limited, you may not be able to exercise all or some of your Warrants for shares of our Common Stock that are registered for resale.  There will be substantial restrictions on your ability to transfer any shares which are not registered for resale, and you may be required to hold the shares you receive upon exercise of your Warrants for some period of time after exercise.  During such time, the market price of our Common Stock may fluctuate and you could suffer a substantial or total loss with respect to such shares.







Because we became public by means of a “reverse merger,” we may not be able to attract the attention of major brokerage firms.


Additional risks may exist since we will become public through a “reverse merger.” Securities analysts of major brokerage firms may not provide coverage of us since there is little incentive to brokerage firms to recommend the purchase of our common stock. We cannot assure you that brokerage firms will want to conduct any secondary offerings on behalf of our company in the future. On December 19, 2012 and in contemplation of the closing of the Share Exchange, Actinium closed on the Minimum Offering Amount selling an aggregate of 9,366,273Units to Investors, pursuant to Subscription Agreements and Unit Purchase Agreements for gross proceeds in the amount of $5,151,450, and net proceeds in the amount of $4,469,776 after legal and other fees and expenses remitted to the Placement Agent.  Post the closing of the Share Exchange, the Offering will continue on the same terms on a pro-forma basis with the common shares offered at $1.65 per share, the 120 day warrants exercise price at $1.65 per share and the 5 year warrants exercise price at $2.48 per share.


The sale of securities by us in any equity or debt financing could result in dilution to our existing stockholders and have a material adverse effect on our earnings.


Any sale of common stock by us in a future private placement offering could result in dilution to the existing stockholders as a direct result of our issuance of additional shares of our capital stock.  In addition, our business strategy may include expansion through internal growth, by acquiring subscribers email lists, or by establishing strategic relationships with targeted customers and vendor.  In order to do so, or to finance the cost of our other activities, we may issue additional equity securities that could dilute our stockholders’ stock ownership.  We may also assume additional debt and incur impairment losses related to goodwill and other tangible assets if we acquire another company and this could negatively impact our earnings and results of operations.


Future sales of our common stock in the public market could lower the price of our common stock and impair our ability to raise funds in future securities offerings.


Future sales of a substantial number of shares of our common stock in the public market, or the perception that such sales may occur, could adversely affect the then prevailing market price of our common stock and could make it more difficult for us to raise funds in the future through a public offering of our securities.


Our Common Stock is quoted on the OTCBB which may have an unfavorable impact on our stock price and liquidity.


Our common stock is quoted on the OTCBB, which is a significantly more limited trading market than the New York Stock Exchange or The NASDAQ Stock Market.  The quotation of the Company’s shares on the OTCBB may result in a less liquid market available for existing and potential stockholders to trade shares of our common stock, could depress the trading price of our common stock and could have a long-term adverse impact on our ability to raise capital in the future.


There is limited liquidity on the OTCBB which may result in stock price volatility and inaccurate quote information.


When fewer shares of a security are being traded on the OTCBB, volatility of prices may increase and price movement may outpace the ability to deliver accurate quote information.  Due to lower trading volumes in shares of our common stock, there may be a lower likelihood of one’s orders for shares of our common stock being executed, and current prices may differ significantly from the price one was quoted at the time of one’s order entry.


Our common stock is extremely thinly traded, so you may be unable to sell at or near asking prices or at all if you need to sell your shares to raise money or otherwise desire to liquidate your shares.


Currently, the Company’s common stock is quoted in the OTCBB and future trading volume may be limited by the fact that many major institutional investment funds, including mutual funds, as well as individual investors follow a policy of not investing in OTCBB stocks and certain major brokerage firms restrict their brokers from recommending OTCBB stocks because they are considered speculative, volatile and thinly traded.  The OTCBB market is an inter-dealer market much less regulated than the major exchanges and our common stock is subject to abuses, volatility and shorting.  Thus, there is currently no broadly followed and established trading market for the Company’s common stock.  An established trading market may never develop or be maintained. Active trading markets generally result in lower price volatility and more efficient execution of buy and sell orders. Absence of an active trading market reduces the liquidity of the shares traded there.








The trading volume of our common stock has been and may continue to be extremely limited and sporadic.  As a result of such trading activity, the quoted price for the Company’s common stock on the OTCBB may not necessarily be a reliable indicator of its fair market value.  Further, if we cease to be quoted, holders would find it more difficult to dispose of our common stock or to obtain accurate quotations as to the market value of the Company’s common stock and as a result, the market value of our common stock likely would decline.


Our Common Stock is subject to price volatility unrelated to our operations.


After the closing of the Share Exchange we expect the market price of our Common Stock to fluctuate substantially due to a variety of factors, including market perception of our ability to achieve our planned growth, quarterly operating results of other companies in the same industry, trading volume in our common stock, changes in general conditions in the economy and the financial markets or other developments affecting the Company’s competitors or the Company itself. In addition, the OTCBB is subject to extreme price and volume fluctuations in general.  This volatility has had a significant effect on the market price of securities issued by many companies for reasons unrelated to their operating performance and could have the same effect on our common stock.


We are subject to penny stock regulations and restrictions and you may have difficulty selling shares of our common stock.


We are subject to the provisions of Section 15(g) and Rule 15g-9 of the Exchange Act, commonly referred to as the “penny stock rule.”  Section 15(g) sets forth certain requirements for transactions in penny stock, and Rule 15g-9(d) incorporates the definition of “penny stock” that is found in Rule 3a51-1 of the Exchange Act.  The SEC generally defines a penny stock to be any equity security that has a market price less than $5.00 per share, subject to certain exceptions. We will be subject to the SEC’s penny stock rules.


Since our Common Stock is deemed to be penny stock, trading in the shares of our common stock is subject to additional sales practice requirements on broker-dealers who sell penny stock to persons other than established customers and accredited investors.  “Accredited investors” are persons with assets in excess of $1,000,000 (excluding the value of such person’s primary residence) or annual income exceeding $200,000 or $300,000 together with their spouse. For transactions covered by these rules, broker-dealers must make a special suitability determination for the purchase of such security and must have the purchaser’s written consent to the transaction prior to the purchase. Additionally, for any transaction involving a penny stock, unless exempt the rules require the delivery, prior to the first transaction of a risk disclosure document, prepared by the SEC, relating to the penny stock market.  A broker-dealer also must disclose the commissions payable to both the broker-dealer and the registered representative and current quotations for the securities.  Finally, monthly statements must be sent disclosing recent price information for the penny stocks held in an account and information to the limited market in penny stocks. Consequently, these rules may restrict the ability of broker-dealer to trade and/or maintain a market in our common stock and may affect the ability of the Company’s stockholders to sell their shares of common stock.

 

There can be no assurance that our shares of common stock will qualify for exemption from the Penny Stock Rule. In any event, even if our common stock was exempt from the Penny Stock Rule, we would remain subject to Section 15(b)(6) of the Exchange Act, which gives the SEC the authority to restrict any person from participating in a distribution of penny stock if the SEC finds that such a restriction would be in the public interest.


Because we do not intend to pay dividends, stockholders will benefit from an investment in our Common Stock only if it appreciates in value.  


We have never declared or paid any cash dividends on our Preferred Stock or Common Stock.  For the foreseeable future, it is expected that earnings, if any, generated from our operations will be used to finance the growth of our business, and that no dividends will be paid to holders of the Company’s Preferred Stock or Common Stock.  As a result, the success of an investment in our Preferred Stock or Common Stock will depend upon any future appreciation in its value.  There is no guarantee that our Preferred Stock or Common Stock will appreciate in value.


Certain provisions of our Articles of Incorporation and Bylaws and Nevada law make it more difficult for a third party to acquire us and make a takeover more difficult to complete, even if such a transaction were in the stockholders’ interest.


Our Articles of Incorporation and Bylaws and certain provisions of Nevada State law could have the effect of making it more difficult or more expensive for a third party to acquire, or from discouraging a third party from attempting to acquire, control of the Company, even when these attempts may be in the best interests of our stockholders.  For example, Nevada law provides that approval of a majority of the stockholders is required to remove a director, which may make it more difficult for a third party to gain control of the Company.  This concentration of ownership limits the power to exercise control by the minority shareholders. 








Compliance with the reporting requirements of federal securities laws can be expensive.


When we become a public reporting company in the United States, we will be subject to the information and reporting requirements of the Exchange Act and other federal securities laws, and the compliance obligations of the Sarbanes-Oxley Act. The costs of preparing and filing annual and quarterly reports and other information with the SEC and furnishing audited reports to stockholders are substantial. In addition, we will incur substantial expenses in connection with the preparation of registration statements and related documents with respect to the registration of resale of the Common Stock.


Applicable regulatory requirements, including those contained in and issued under the Sarbanes-Oxley Act, may make it difficult for us to retain or attract qualified officers and directors, which could adversely affect the management of its business and its ability to obtain or retain listing of our Common Stock.


We may be unable to attract and retain those qualified officers, directors and members of board committees required to provide for effective management because of the rules and regulations that govern publicly held companies, including, but not limited to, certifications required by principal executive officers. The enactment of the Sarbanes-Oxley Act has resulted in the issuance of a series of related rules and regulations and the strengthening of existing rules and regulations by the SEC, as well as the adoption of new and more stringent rules by the stock exchanges. The perceived increased personal risk associated with these changes may deter qualified individuals from accepting roles as directors and executive officers.


Further, some of these changes heighten the requirements for board or committee membership, particularly with respect to an individual’s independence from the corporation and level of experience in finance and accounting matters. We may have difficulty attracting and retaining directors with the requisite qualifications. If we are unable to attract and retain qualified officers and directors, the management of our business and our ability to obtain or retain listing of our shares of Common Stock on any stock exchange (assuming we elect to seek and are successful in obtaining such listing) could be adversely affected.


If we fail to maintain an effective system of internal controls, we may not be able to accurately report our financial results or detect fraud.  Investors could lose confidence in our financial reporting and this may decrease the trading price of our Common Stock.


We must maintain effective internal controls to provide reliable financial reports and detect fraud. We have been assessing our internal controls to identify areas that need improvement. Failure to maintain an effective system of internal controls could harm our operating results and cause investors to lose confidence in our reported financial information. Any such loss of confidence would have a negative effect on the trading price of our Common Stock.


The price of our Common Stock may become volatile, which could lead to losses by investors and costly securities litigation.


The trading price of our Common Stock may be highly volatile and could fluctuate in response to factors such as:


·

actual or anticipated variations in our operating results;

·

announcements of developments by us or our competitors;

·

the timing of IND and/or NDA approval, the completion and/or results of our clinical trials;

·

regulatory actions regarding our products;

·

announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments;

·

adoption of new accounting standards affecting the our industry;

·

additions or departures of key personnel;

·

introduction of new products by us or our competitors;

·

sales of the our Common Stock or other securities in the open market; and

·

other events or factors, many of which are beyond our control.


The stock market is subject to significant price and volume fluctuations. In the past, following periods of volatility in the market price of a company’s securities, securities class action litigation has often been initiated against such a company. Litigation initiated against us, whether or not successful, could result in substantial costs and diversion of our management’s attention and Company resources, which could harm our business and financial condition.








MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

AND RESULTS OF OPERATIONS


The information and financial data discussed below is derived from the audited consolidated financial statements of Actinium for its fiscal years ended December 31, 2011 and 2010, and the unaudited consolidated financial statements of Actinium for its nine month periods ended September 30, 2012 and 2011.  The consolidated financial statements of Actinium were prepared and presented in accordance with generally accepted accounting principles in the United States. The information and financial data discussed below is only a summary and should be read in conjunction with the historical financial statements and related notes of Actinium contained elsewhere in this Report. The financial statements contained elsewhere in this Report fully represent Actinium’s financial condition and operations; however, they are not indicative of the Company’s future performance.  See “Cautionary Note Regarding Forward Looking Statements” above for a discussion of forward-looking statements and the significance of such statements in the context of this Report.


This discussion contains forward-looking statements reflecting our current expectations that involve risks and uncertainties.  Actual results may differ materially from those discussed in these forward-looking statements due to a number of factors, including those set forth in the section entitled “ Risk Factors ” and elsewhere herein.


Overview


We develop drugs for treatment of cancer with intent to cure or significantly improve survival of the affected patients.  As of now none of our drugs have been approved for sale in the United States or elsewhere.  We have no commercial operations in sales or marketing of our products.  All our product candidates are under development.  In order to market and sell our products we must conduct clinical trials on patients and obtain regulatory approvals from appropriate regulatory agencies like the Food and Drug Administration (FDA) in the United States and similar agencies elsewhere in the world.


Our products under development are monoclonal antibodies labeled with radioisotopes.  We have one program with an antibody labeled with a beta emitter and several programs based on a proprietary patent protected platform technology called alpha particle immunotherapy or APIT.  Our APIT technology is based on attaching actinium 225 (Ac-225) or bismuth 213 (Bi-213) alpha emitting radioisotopes to monoclonal antibodies. Alpha emitting radioisotopes are unstable chemical elements that decay by releasing alpha particles.  Alpha particles can kill any cell in whose immediate proximity they are released.  Monoclonal antibodies are genetically engineered proteins that target specifically certain cells, and can target cancer cells.  It is crucial for the success of our drug candidates to contain monoclonal antibodies that can successfully seek cancer cells and can kill them with the attached isotope while not harming nearby normal cells.  We do not have technology and operational capabilities to develop and manufacture such monoclonal antibodies and we therefore rely on collaboration with third parties to gain access to such monoclonal antibodies.  We have secured rights to two monoclonal antibodies, HuM195 (Lintuzumab), in 2003 through a collaborative licensing agreement with Abbott Laboratories and BC8 in 2012 with the Fred Hutchinson Cancer Research Center.  We expect to negotiate collaborative agreements with other potential partners that would provide us with access to additional monoclonal antibodies.  Establishing and maintaining such collaborative agreements is a key to our success as a company.


Under our own sponsorship as well as activity at FHCRC, we have four product candidates in active clinical trials: Actimab -A (HuM195-Ac-225), Iomab -B (BC8-I-131), BC8-Y-90 and BC8-SA.  At this time, the Company is actively pursuing development of Actimab -A and Iomab -B while BC8-Y-90 and BC8-SA are in physician sponsored clinical phase I trials at the Fred Hutchinson Cancer Research Center.


Actimab -A is a combination of the monoclonal antibody we have in-licensed, Lintuzumab (HuM195), and the alpha emitting isotope actinium 225.  Actimab -A has shown promising results throughout preclinical development and an ongoing clinical trial started in 2006 in treating acute myeloid leukemia (AML) in the elderly. We have expanded the number of patients and number of clinical centers by commencing a new AML clinical trial which we have launched in 2012. This trial targets newly diagnosed AML patients over the age of 60.  In order to conduct the trial we are engaged in funding, monitoring and quality assurance and control of the Lintuzumab antibody; procurement of actinium 225 isotope; funding, monitoring and quality assurance and control of the drug candidate Actimab -A manufacturing and organizing and monitoring clinical trials.  We estimate that the direct costs to completion of both parts of the ongoing Phase I/II trial will be approximately US $7 million.







Iomab -B is a combination of the in-licensed monoclonal antibody BC8 and the beta emitting radioisotope iodine 131.  This construct has been extensively tested in Phase I and Phase II clinical trials in approximately 250 patients with different blood cancer indications who were in need of a hematopoietic stem cell transplantation (HSCT).  Iomab -B is used to condition the bone marrow of these patients by destroying blood cancer cells in their bone marrow and elsewhere thus allowing for a subsequent transplant containing healthy donor bone marrow stem cells.  We have decided to develop this drug candidate by initially focusing on the patients over 50 with active acute myeloid leukemia in relapse and/or refractory to existing treatments.  Our intention is to request the FDA in 2013 to allow us to enter into a pivotal trial with Iomab -B.  We estimate the direct costs of such a trial to completion anticipated in 2015 will be approximately US $15-20 million.


We have primarily management position employees and consultants who direct, organize and monitor the activities described above through contractors.  Much of the in vivo laboratory and clinical work contracted for by the Company has been conducted at Memorial Sloan-Kettering Cancer Center in New York. The Company has also made clinical trial arrangements with other well known cancer centers.


Our Actimab -A drug candidate and its components are contract manufactured and maintained under our supervision by specialized contract manufacturers and suppliers in the U.S., including IsoTex Diagnostics, Oak Ridge National Laboratory, Pacific GMP, Fischer Bioservices, BioReliance and others.


The Company was established in 1993 in the Netherlands under the name of “Alphamedical Holding B.V.” and the Company was subsequently re-incorporated in Delaware in September 2000 as “Actinium Pharmaceuticals, Inc.”.


We are a development stage company and have never generated revenue. Currently we do not have a stable recurring source of revenues sufficient to cover our operating costs.  As of December 31, 2011, we had an accumulated deficit of $47.4 million. We incurred net losses of $3.4 million, $0.5 million, $3.4 million, $5.6 million and $5.6 million in the years ending December 31, 2011, 2010, 2009, 2008 and 2007, respectively.


Opportunities, Challenges and Risks


The market for drugs for cancer treatment is a large market in need of novel products, in which successful products can command multibillion dollars in annual sales.  A number of large pharmaceutical and biotechnology company regularly acquire products in development, with preference given to products in Phase II or later clinical trials. These deals are typically structured to include an upfront payment that ranges from several million dollars to tens of million dollars or more and additional milestone payments tied to regulatory submissions and approvals and sales milestones.  Our goal is to develop our product candidates through Phase II clinical trials and enter into partnership agreements with one or more large pharmaceutical and/or biotechnology companies. 


We believe our future success will be heavily dependent upon our ability to successfully conduct clinical trials and preclinical development of our drug candidates.  This will in turn depend on our ability to continue our collaboration with Memorial Sloan-Kettering Cancer Center and our Clinical Advisory Board members plan to continue and expand other research and clinical trial collaborations. In addition, we will have to maintain sufficient supply of actinium 225 and successfully maintain and if and when needed replenish or obtain our reserves of monoclonal antibodies.  We will have to maintain and improve manufacturing procedures we have developed for production of our drug candidates from the components that include the iodine 131 and actinium 225 isotopes, monoclonal antibodies and other materials.  It is possible that despite our best efforts our clinical trials results may not meet regulatory requirements for approval.  If our efforts are successful, we will be able to partner our development stage products on commercially favorable terms only if they enjoy appropriate patent coverage and/or considerable know-how and other protection that ensures market exclusivity.  For that reason we intend to continue our efforts to maintain existing and generate new intellectual property.  Intellectual property is a key factor in the success of our business as well as market exclusivity.


To achieve the goals discussed above we intend to continue to invest in research and development at high and constantly increasing rates thus incurring further losses until one or more of our products are sufficiently developed to partner them to large pharmaceutical and biotechnology companies. 







Results of Operations


Nine Months Ended September 30, 2012 Compared to Nine Months Ended September 30, 2011


The following table sets forth, for the periods indicated, data derived from our statements of operations:


 

 

For the Nine Months Ended

 

 

 

 

September 30,

 

 

 

 

2012

 

2011

 

Change

 

 

 

 

 

 

 

Revenues

$

-

$

-

$

-

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

    Research and development, net

 

2,723,459

 

231,640

 

2,491,819

    General and administrative

 

1,520,221

 

376,748

 

1,143,473

    Depreciation and amortization

 

429

 

477

 

(48)

    Total operating expenses

 

4,244,109

 

608,865

 

3,635,244

 

 

 

 

 

 

 

Loss from operations

 

(4,244,109)

 

(608,865)

 

(3,635,244)

 

 

 

 

 

 

 

Other (income) expense:

 

 

 

 

 

 

    Interest expense

 

952,241

 

-

 

952,241

    Change in fair value of derivative liabilities

 

287,604

 

-

 

287,604

    Total other (income) expense

 

1,239,845

 

-

 

1,239,845

 

 

 

 

 

 

 

Net loss

$

(5,483,954)

$

(608,865)

$

(4,875,089)

 

 

 

 

 

 

 


Revenues


We recorded no commercial revenues for the nine months ended September 30, 2012 and 2011.


Research and Development Expense


Research and development expenses increased by to $2,491,819 to $2,723,459 for the nine months ended September 30, 2012 compared to $231,640 for the nine months ended September 30, 2011. The increase is attributable to the costs incurred on initiation of the multi-center clinical trial for Actimab -A.  The Company also made its first milestone payment of $750,000 to Abbott Biotherapeutics Corp. upon reaching the milestone.  The increase also reflected in an agreement the Company made with MSKCC as of April 2010, in which MSKCC agreed to pay or reimburse the Company for certain costs and expenses related to the Company’s drug development and clinical study program.  This agreement expired on October 5, 2011. No reimbursement was due for the nine months ended September 30, 2012 and $966,341 was due with respect to the nine months ended September 30, 2011.


General and Administrative Expenses


Overall, total general and administrative expenses increased by $1,143,473 to $1,520,221 for the nine months ended September 30, 2012 compared to $376,748 for the nine months ended September 30, 2011. The increase was largely attributable to increases in professional fees and the stock-based compensation incurred by the Company as discussed below.


In connection with the offering of the Series E Preferred Stock, in January 2012, we issued warrants to purchase 400,013 shares (pre-Actinium Share exchange) of common stock to the transaction manager for consulting services related to assisting the Company in preparing to become a publicly traded company.   The fair value of $144,501, or $0.36 per share, was a noncash charge to general and administrative expenses for the nine months ended September 30, 2012.







In February 2012, the Company granted options to purchase 2,125,000 shares of common stock to its employees and consultants with a fair value of $531,913.  In July 2012, the Company granted options to purchase 90,000 shares of common stock to its consultants with a fair value of $23,700.  In August 2012, the Company granted options to purchase 2,875,000 shares of common stock to its employees and consultants with a fair value of $724,784.  For the nine months ended September 30, 2012, the Company recorded amortization of stock-based compensation of $312,500 as a noncash charge to general and administrative expenses.


The increase can also be attributed to additional professional fees of $555,782 related to the year-end audit, the quarterly review, legal fees, and management fees associated with the Company going public.  In addition to the professional fees incurred, we increased our personnel.  As such, payroll-related expenses for the nine months ended September 30, 2012 increased compared to the same period in 2011.


Interest Expense


Interest expense increased by $952,241 for the nine months ended September 30, 2012 compared to the nine months ended September 30, 2011. The increase in interest expense is directly attributable to interest accrued on the convertible debt, amortization of the convertible debt discount and deferred financing costs related to the convertible debt.


Net Loss


Net loss increased by $4,875,089 to $5,483,954 for the nine months ended September 30, 2012 compared $608,865 for to the nine months ended September 30, 2011. The increase was primarily due to additional costs incurred by the Company in research and development expenses, noncash stock-based compensation costs and professional fees as discussed above.


Year Ended December 31, 2011 Compared to Year Ended December 31, 2010


The following table sets forth, for the periods indicated, data derived from our statements of operations:


 

 

For the Years Ended

 

 

 

 

December 31,

 

 

 

 

2011

 

2010

 

Change

 

 

 

 

 

 

 

Revenues

$

-

$

-

$

-

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

    Research and development, net

 

323,788

 

93,117

 

230,671

    General and administrative

 

2,959,246

 

561,970

 

2,397,276

    Depreciation and amortization

 

633

 

72,101

 

(71,468)

    Total operating expenses

 

3,283,667

 

727,188

 

2,556,479

 

 

 

 

 

 

 

Loss from operations

 

(3,283,667)

 

(727,188)

 

(2,556,479)

 

 

 

 

 

 

 

Other (income) expense:

 

 

 

 

 

 

    Interest expense

 

175,094

 

78

 

175,016

    Gain on extinguishment of liabilities

 

-

 

(260,000)

 

260,000

    Change in fair value of derivative liabilities

 

(13,966)

 

-

 

(13,966)

    Total other (income) expense

 

161,128

 

(259,922)

 

421,050

 

 

 

 

 

 

 

Net loss

$

(3,444,795)

$

(467,266)

$

(2,977,529)

 

 

 

 

 

 

 


Revenues


We recorded no commercial revenues for the years ended December 31, 2011 and 2010.








Research and Development Expense


Research and development expenses increased by $230,671 to $323,788 for the year ended December 31, 2011 compared to $93,117 for the year ended December 31, 2010.  The increase is directly attributable to the initiation of the multi-center trial for Actimab -A.


General and Administrative Expenses


Overall, general and administrative expenses increased by $2,397,276 to $2,959,246 for the year ended December 31, 2011 compared to $561,970 for the year ended December 31, 2010. The increase was largely attributable to increases in professional fees and the stock-based compensation incurred by the Company as discussed below.


In connection with the offering of the Series E Preferred Stock, we issued warrants to purchase 930,272 shares (pre-Actinium share exchange) of common stock to the transaction manager for consulting services related to preparing the Company to become a publically traded company.  The fair value of $2,153,442, was a noncash charge to general and administrative expenses for the year ended December 31, 2011.


The increase can also be attributed to additional professional fees of $121,774 related to the management fees incurred associated with the Company going public.


Interest Expense


Interest expense was $175,094 for the year ended December 31, 2011 compared to $78 for the same period of 2010, an increase of $175,016.  The increase in interest expense is directly attributable to interest accrued on the convertible debt, amortization of the convertible debt discount and deferred financing costs related to the convertible debt.


Net Loss


Net loss increased by $2,977,529 to $3,444,795 for the year ended December 31, 2011 compared to $467,266 for the year ended December 31, 2010.  The increase was primarily due to additional costs incurred by the Company in research and development expenses, noncash stock-based compensation costs and professional fees as discussed above.


Liquidity and Capital Resources


We have financed our operations primarily through sales of the Company’s Common Stock and Preferred Stock and the issuance of Convertible Promissory Notes.


We did not have any cash or cash equivalents held in financial institutions located outside of the United States as of September 30, 2012 and December 31, 2011. We do not anticipate this practice will change in the future.


The following tables sets forth selected cash flow information for the periods indicated:


 

 

For the Nine Months Ended

 

 

September 30,

 

 

2012

 

2011

 

 

 

 

 

Cash provided by (used in) operating activities

$

(3,795,480)

$

31,215

Cash provided by (used in) investing activities

 

(1,812)

 

-

Cash provided by (used in) financing activities

 

660,163

 

-

 

 

 

 

 

Net increase (decrease) in cash

$

(3,137,129)

$

31,215

 

 

 

 

 








 

 

For the Years Ended

 

 

December 31,

 

 

2011

 

2010

 

 

 

 

 

Cash provided by (used in) operating activities

$

(517,592)

$

(609,740)

Cash provided by (used in) investing activities

 

-

 

-

Cash provided by (used in) financing activities

 

6,025,255

 

-

 

 

 

 

 

Net increase (decrease) in cash

$

5,507,663

$

(609,740)

 

 

 

 

 


Nine Months Ended September 30, 2012 Compared to Nine Months Ended September 30, 2011


Cash and cash equivalents as of September 30, 2012 were $2,566,669.


Net cash used in operating activities was $3,795,480 for the nine months ended September 30, 2012 compared to $31,215 provided by operations for the same period in 2011. Cash used in operations increased due to the increase in spending related to preparations and eventual launch and conduct of a multicenter trial and an increase in spending related to professional fees combined with an increase in payroll-related expenses.  Cash provided by operating activities for the nine months ended September 30, 2011 came from the R&D reimbursements received by the Company under the agreement with MSKCC.


Net cash provided by financing activities was $660,163 for the nine months ended September 30, 2012 compared to $0 for the same period in 2011. In January 2012, we sold 2,909,187 shares of Series E Preferred Stock at $0.26 per share. We raised funds through sale of the Company’s preferred stock to finance the expansion of our research and development efforts.


Year Ended December 31, 2011 Compared to Year Ended December 31, 2010


Cash and cash equivalents as of December 31, 2011 were $5,703,798 compared to $196,135 as of December 31, 2010. The increase in cash was mainly due to proceeds from sale of Series E Preferred Stock, net of offering costs and 8% Senior Subordinated Unsecured Convertible Promissory Notes.


Net cash used in operating activities was $517,592 for the year ended December 31, 2011 compared to $609,740 for the year ended December 31, 2010.  Cash used in the operation activities is primarily the result of the costs the Company incurred on research and development activities, net of reimbursements received from MSKCC.


Net cash provided by financing activities was $6,025,255 for the year ended December 31, 2011 compared to $0 for the year ended December 31, 2010. In 2011, we sold 23,697,119 shares of Series E Preferred Stock at $0.26 per share and raised $750,000 through a private offering of 8% Senior Subordinated Unsecured Convertible Promissory Notes.  We raised funds through sale of the Company’s preferred stock and the convertible notes in order to finance the expansion of our research and development activities and the costs associated the preparation for becoming a publicly traded company.


We have experienced cumulative losses of approximately $52,672,612 from inception (September 13, 2000) through September 30, 2012, and have a stockholders' deficit of $3,820,812. In addition, the Company has not completed its efforts to establish a stable recurring source of revenues sufficient to cover its operating costs for the next twelve months. These factors raise substantial doubt regarding the Company’s ability to continue as a going concern.


Recent Debt and Equity Offerings


During 2011, the Company raised $6,184,967 through an offering of 23,697,119 shares (pre-Actinium share exchange) of the 2011 Series E preferred shares and 5,924,285 warrants (pre-Actinium share exchange).  A net amount of $5,379,367 was received by the Company in 2011. Pursuant to the agreement, the Company paid Laidlaw & Company (UK) Ltd. (“Laidlaw & Co.”), the placement agent, total cash fees of $742,196, which consisted of placement agent commission of $618,497 and expense reimbursement of $123,699. In addition, the Company paid Laidlaw & Co.’s outside counsel, McCormick & O’Brien PLLC, $60,904 for its services as the placement agent’s legal counsel and Signature Bank $2,500 for the bank escrow fee.








On December 27, 2011, the Company completed a private offering of 8% Senior Subordinated Unsecured Convertible Promissory Notes (“Convertible Notes”) in the amount of $900,000 and received net proceeds of $750,000.  The convertible notes were issued at 83.33% of the principal amount resulting in an original issue discount of $150,000.The Convertible Notes mature one year from the date of issuance. Interest accrues at the rate of 8% per year on the outstanding principal amount, accrued semi-annually and to be paid at maturity.


In January 2012, the Company raised $759,300 through its final offering of the 2011 Series E preferred shares.  A net amount of $660,163 was received by the Company.   Pursuant to the agreement, the Company paid Laidlaw & Company (UK) Ltd. (“Laidlaw & Co.”), the placement agent, total cash fees of $99,137, which consisted of placement agent commission of $91,116 and expense reimbursement of $8,021.


Actinium intends to increase funds available to continue our research and development efforts, which include material supply, manufacturing, clinical development and pre-clinical trials and working capital.  In 2013, we expect cash needs of up to $20,000,000 to finance research and development, which include material supply, manufacturing, clinical trials and pre-clinical trials and to cover our ongoing working capital needs.  If all of the securities offered hereunder are sold, we believe that the net proceeds from this offering will provide us with the capital needed for these plans.


In the event we do not meet our cash needs of $20,000,000, it may be necessary for us to delay the timing of various product development efforts and focus on our ongoing clinical trial with Actimab -A.


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 is material to investors.


Seasonality


We do not have a seasonal business cycle. Our revenues and operating results are generally derived evenly throughout the calendar year.


Critical Accounting Policies


Our financial statements have been prepared in accordance with accounting principles generally accepted in the United States. To prepare these financial statements, we must make estimates and assumptions that affect the reported amounts of assets and liabilities. These estimates also affect our expenses. Judgments must also be made about the disclosure of contingent liabilities. Actual results could be significantly different from these estimates. We believe that the following discussion addresses the accounting policies that are necessary to understand and evaluate our reported financial results.


Derivatives


All derivatives are recorded at fair value and recorded on the balance sheet. Fair values for securities traded in the open market and derivatives are based on quoted market prices. Where market prices are not readily available, fair values are determined using market based pricing models incorporating readily observable market data and requiring judgment and estimates.








Fair Value of Financial Instruments


Fair value is defined as the price that would be received to sell an asset, or paid to transfer a liability, in an orderly transaction between market participants. A fair value hierarchy has been established for valuation inputs that gives the highest priority to quoted prices in active markets for identical assets or liabilities and the lowest priority to unobservable inputs. The fair value hierarchy is as follows:


Level 1 Inputs – Unadjusted quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date.


Level 2 Inputs – Inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. These might include quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (such as interest rates, volatilities, prepayment speeds, credit risks, etc.) or inputs that are derived principally from or corroborated by market data by correlation or other means.


Level 3 Inputs – Unobservable inputs for determining the fair values of assets or liabilities that reflect an entity's own assumptions about the assumptions that market participants would use in pricing the assets or liabilities.


Income Taxes


The Company uses the asset and liability method in accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and income tax carrying amounts of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company reviews deferred tax assets for a valuation allowance based upon whether it is more likely than not that the deferred tax asset will be fully realized. A valuation allowance, if necessary, is provided against deferred tax assets, based upon management’s assessment as to their realization.


Grant Proceeds


The Company received a grant on qualified therapeutic discovery project from the U.S Internal Revenue Service pursuant to the Protection and Affordable Care Credit.  The grant was recorded by the Company as a reduction of R&D costs.


Research and Development Costs


Research and development costs are expensed as incurred.


Share-Based Payments


The Company estimates the fair value of each stock option award at the grant date by using the Black-Scholes option pricing model and common shares based on the last common stock valuation done by third party valuation expert of the Company’s common stock on the date of the share grant. The fair value determined represents the cost for the award and is recognized over the vesting period during which an employee is required to provide service in exchange for the award. As share-based compensation expense is recognized based on awards ultimately expected to vest, the Company reduces the expense for estimated forfeitures based on historical forfeiture rates. Previously recognized compensation costs may be adjusted to reflect the actual forfeiture rate for the entire award at the end of the vesting period. Excess tax benefits, if any, are recognized as an addition to paid-in capital.


Recent Accounting Pronouncements


In May 2011, the Financial Accounting Standards Board (the “FASB”) provided amendments to achieve common fair value measurement and disclosure requirements in U.S. GAAP and IFRS. The amendments provide clarification and/or additional requirements relating to the following: (a) application of the highest and best use and valuation premise concepts, (b) measurement of the fair value of instruments classified in an entity’s shareholders’ equity, (c) measurement of the fair value of financial instruments that are managed within a portfolio, (d) application of premiums and discounts in a fair value measurement, and (e) disclosures about fair value measurements. These amendments will be effective prospectively for interim and annual periods beginning after December 15, 2011. The Company does not expect the adoption of the amendments to have a material impact on its financial position, results of operations or cash flows.






In September 2011, the FASB provided amendments requiring an entity to present the total of comprehensive income, the components of net income, and the components of other comprehensive income either in a singular continuous statement of comprehensive income or in two separate but continuous statements, eliminating the option to present the components of other comprehensive income as part of the statement of changes in stockholders’ equity.  Additionally, the amendments require an entity to present reclassification adjustments on the face of the financial statements from other comprehensive income to net income.  These amendments will be effective retrospectively for fiscal years, and interim periods within those years, beginning after December 15, 2011.  The Company does not expect the adoption of the amendments to have a material impact on its financial position, results of operations, or cash flows, but will require the Company to present the statements of comprehensive income separately from its statements of equity, as these are currently presented on a combined basis.


In December 2011, the FASB issued amended guidance to ASC 210, “ Balance Sheet ”, with respect to disclosure of offsetting assets and liabilities as part of the effort to establish common requirements in accordance with U.S. GAAP and IFRS. This amended guidance requires the disclosure of both gross information and net information about both financial statements and derivative instruments eligible for offset in the Company’s balance sheet and instruments and transactions subject to an agreement similar to a master netting arrangements. This guidance is effective for periods beginning on or after January 1, 2012, with respective disclosures required retrospectively for all comparative periods presented. The adoption of this guidance effective January 1, 2012 is not expected to have a material effect on the Company’s financial statements.


There were various accounting standards and interpretations issued during 2012 and 2011, none of which are expected to have a material impact on the Company’s financial position, operations or cash flows.


DESCRIPTION OF PROPERTY


The Company does not own any property. The Company has a short-term lease of its office space at 501 Fifth Avenue, 3rd Floor, New York, NY 10017 through January 31, 2013. Thereafter, it becomes a month to month agreement. The Company pays $4,376 monthly.


SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT


The following table shows the beneficial ownership of our Common Stock as of December 28, 2012 held by (i) each person known to us to be the beneficial owner of more than five percent (5%) of our Common and Preferred Stock; (ii) each director; (iii) each executive officer; and (iv) all directors and executive officers as a group.


Beneficial ownership is determined in accordance with the rules of the SEC, and generally includes voting power and/or investment power with respect to the securities held.  Shares of Common Stock subject to options and warrants currently exercisable or which may become exercisable within 60 days of December 28, 2012, are deemed outstanding and beneficially owned by the person holding such options or warrants for purposes of computing the number of shares and percentage beneficially owned by such person, but are not deemed outstanding for purposes of computing the percentage beneficially owned by any other person.  Except as indicated in the footnotes to this table, the persons or entities named have sole voting and investment power with respect to all shares of our Common Stock shown as beneficially owned by them.


The percentages below are based on fully diluted shares of our Common Stock equivalents, assuming a 100% share exchange by Actinium shareholders, as of December 28, 2012.  Unless otherwise indicated, the principal address of each of the persons below is c/o Actinium Pharmaceuticals, Inc., 501 Fifth Avenue, New York, NY 10017.


Executive Officers

and Directors

Number of Shares of Common

Stock and Preferred Stock

Beneficially Owned

Percentage of

Ownership(a)

Jack V. Talley

           0(1)

0.0%

Dragan Cicic, MD

163,037(2)

0.8%

Enza Guagenti

    2,248(3)

0.0%

Rosemary Mazanet

  48,285(4)

0.2%

David Nicholson

    3,996(5)

0.0%

Sandesh Seth

164,365(6)

0.8%

Sergio Traversa

           0(7)

0.0%

 

 

 

All Directors and Officers as a Group (7 persons)

381,931

1.8%

All other 5% holders

Actinium Holdings, Ltd. (8)


c/o Michael B. Sheffery

767 Third Avenue

30 th Floor

New York, NY 10017

5,697,504

21.4%







(a)

Based on 21,262,367 shares of Common Stock outstanding as of December 20, 2012.


(1) Options granted to purchase an aggregate of 699,300 shares of Common Stock of the Company at an exercise price of $0.784 per share. All shares are subject to vesting. No shares of Common Stock have vested as of December 20, 2012.


(2) Options granted to purchase an aggregate of 414,785 shares of Common Stock of the Company at an exercise price of $0.784 per share and options to purchase an aggregate of 99,900 shares of Common Stock of the Company at an exercise price of $1.50 per share. All shares are subject to vesting. 163,037 shares of Common Stock have vested as of December 20, 2012.


(3) Options granted to purchase an aggregate of 33,300 shares of Common Stock of the Company at an exercise price of $0.784 per share. All shares are subject to vesting. 2,248 shares of Common Stock have vested as of December 20, 2012.


(4) Options granted to purchase an aggregate of 83,250 shares of Common Stock of the Company at an exercise price of $0.784 per share and options to purchase an aggregate of 49,950 shares of Common Stock of the Company at an exercise price of $1.50 per share. All shares are subject to vesting. 48,285 shares of Common Stock have vested as of December 20, 2012.


(5) Options to purchase an aggregate of 49,950 shares of Common Stock of the Company at an exercise price of $0.784 per share and options to purchase an aggregate of 49,950 shares of Common Stock of the Company at an exercise price of $1.50 per share.  All shares are subject to vesting. 3,996 shares of Common Stock have vested as of December 20, 2012.


(6) Warrants to purchase an aggregate of 64,747 shares of Common Stock of the Company at an exercise price of $0.784 per share, exercisable on a cashless basis and warrants to purchase an aggregate of 99,618 of Common Stock of the Company at an exercise price of $0.784 per share, exercisable on a cashless basis issued to Amrosan, LLC, a partnership in which the majority member interest is owned by the family of Mr. Seth.  Excludes warrants to purchase an aggregate of 373,442 shares of Common Stock of the Company at par value per share, exercisable on a cashless basis issued to Amrosan, LLC as the warrants are not exercisable upon less than 90 days notice.  The holder may waive the 90 day exercise notice requirement by giving 65 days prior notice of such waiver.  The shares available by exercise of this Warrant are also restricted and may not be sold or otherwise transferred until the earlier of twelve months from the closing date of the going public transaction; or for six months after the planned Registration Statement is declared effective. Excludes 351,035 warrants issued to Carnegie Hill Asset Partners and irrevocable trust linked to Mr. Seth’s family whose terms are the same as those issued to Amrosan, LLC. Also excludes warrants held by the Placement Agent or its affiliates in connection with the Offering, the Bridge Notes Financing, the Series E financing and by designees of Jamess Capital Group, LLC in connection with the going public transaction. Also excludes options to purchase an aggregate of 49,950 shares of Common Stock of the Company at an exercise price of $1.50 per share. All shares are subject to vesting. No shares of Common Stock have vested as of December 20, 2012.  


(7) Options to purchase an aggregate of 49,950 shares of Common Stock of the Company at an exercise price of $1.50 per share.  No shares of Common Stock have vested as of December 20, 2012.


(8) Mr. Sheffery, a partner of Orbimed Advisors LLC, is the President and director of Actinium Holdings Ltd. (AHL).  AHL is wholly-owned by AHLB Holdings, LLC (AHLB), which is, in turn, wholly-owned by MSKCC.  Accordingly, such parties may be deemed to share beneficial ownership of the Common Stock of the Company held by AHL. Investment power with respect to the shares of the Company held by AHL is limited pursuant to a letter agreement, dated December 31, 2012, between MSKCC and Laidlaw.  The letter agreement provides that the shares of Common Stock held by AHL may not be transferred, subject to exceptions for certain related-party transfers, transfers to trusts and other private transfers, until, in general, the earlier of (i) twelve (12) months from the Closing Date; or (ii) six (6) months following the effective date of the Registration Statement.   AHL has certain registration rights with respect to its shares; however, such rights are, in certain respects subordinate to those of investors in certain recent private placements.


DIRECTORS AND EXECUTIVE OFFICERS


Effective following the expiration of the ten day period following the mailing of the information statement required by Rule 14f-1 under the Exchange Act Diane S. Button has resigned from her position as member of the Board of Directors of the Company.   Effective upon the closing of the Share Exchange, Diane S. Button resigned as an officer of the Company.  Also effective upon the closing of the Share Exchange, Jack V. Talley was appointed to our Board of Directors.  Effective as of the expiration of the ten day period following the mailing of the information statement required by Rule 14f-1 under the Exchange Act Dr. Rosemary Mazanet, David Nicholson, Sandesh Seth and Sergio Traversa were appointed to our Board of Directors.  In addition, our Board of Directors appointed Jack V. Talley to serve as our President and Chief Executive Officer, Dragan Cicic to serve as our Chief Operating Officer and Chief Medical Officer, and Enza Guagenti to serve as our Chief Financial Officer, effective immediately upon the closing of the Share Exchange.







The following sets forth information about our directors and executive officers as of the closing of the Share Exchange and following the expiration of the ten day period following the mailing of the information statement required by Rule 14f-1 under the Exchange Act:


Name

  

Age

  

Position

Jack V. Talley

  

56

  

Chief Executive Officer, President, and Director

Dragan Cicic, MD

  

49

  

Chief Operating Officer and Chief Medical Officer

Enza Guagenti, CPA

  

50

  

Chief Financial Officer

Rosemary Mazanet, MD, PhD

 

57

 

Director

David Nicholson, PhD

  

58

  

Director

Sandesh Seth, MS, MBA

  

48

  

Director

Sergio Traversa, MBA

  

52

  

Director


Jack V. Talley, Chief Executive Officer, President and Director


Jack V. Talley is the CEO, President and a Director of Actinium Pharmaceuticals, Inc. (API). Mr. Talley recently joined API from the position of President, Chief Executive Officer and a Director at EpiCept Corporation. Mr. Talley has more than 30 years of experience in the pharmaceutical industry. Prior to EpiCept, Mr. Talley was the Chief Executive Officer of Consensus Pharmaceuticals, Inc., a biotechnology drug discovery start-up company that developed a proprietary peptide-based combinatorial library screening process. Prior to joining Consensus, Mr. Talley led Penwest Ltd.’s efforts in its spin-off of its subsidiary Penwest Pharmaceuticals Co. in 1998 and served as President and Chief Operating Officer of Penwest Pharmaceuticals. Mr. Talley started his career at Sterling Drug Inc., where he was responsible for all U.S. marketing activities for prescription drugs, helped launch various new pharmaceutical products and participated in the 1988 acquisition of Sterling Drug by Eastman Kodak Co. Mr. Talley received his B.S. in Chemistry from the University of Connecticut and completed coursework towards an M.B.A. in Marketing from New York University, Graduate School of Business.


Dragan Cicic, MD, MBA, Chief Operating Officer and Chief Medical Officer


Dragan Cicic is the COO and CMO of Actinium Pharmaceuticals, Inc. (API). He joined the company in 2005 and previously held the position of the CEO and prior to that of the Medical Director at API. Dr. Cicic joined API from the position of Project Director of QED Technologies Inc., a life sciences strategic consulting and transactional group focused on emerging biotech, pharmaceuticals and medical devices companies. Dr. Cicic prepared business and strategic plans on behalf of those clients and assisted them in raising funding. He also represented corporate and private investors in identifying acquisition and/or investment targets and negotiating, structuring and consummating deals. Prior to joining QED Technologies, Dr. Cicic was an investment banker with SG Cowen Securities.


Dr. Cicic graduated as a Medical Doctor from the School of Medicine at The Belgrade University, and received his MBA from Wharton School at The University of Pennsylvania. He was also a Nieman Fellow at Harvard University.


Enza Guagenti, CPA, Chief Financial Officer


Enza Guagenti, CPA, is the CFO of Actinium Pharmaceuticals, Inc. (API). Ms. Guagenti has over 25 years of experience in health care management and accounting. Prior to becoming the CFO, Ms. Guagenti worked for API as the corporate accounting consultant for eight years. Ms. Guagenti held a senior management level position as Administrator for of an out-patient medical facility that services approximately 8,000 patients per year. She was responsible for all aspects of operations, which included financial oversight and reporting and maintaining regulatory compliance as mandated by CMS, NJDHSS and The Joint Commission. Ms. Guagenti implemented a financial reporting structure, financial and clinical benchmarks and processes that enhanced operations, controlled costs and improved patient care. Prior experience also includes serving as corporate controller for one of the largest infertility practices in NJ. As corporate controller, she was responsible for reporting on and consolidating four profit centers.


Ms. Guagenti served as President of the NJ Association of Ambulatory Surgery Center from 2003-2008. She has served on the Legal & Regulatory Committee of Governor Corzine’s Commission on Rationing of Healthcare Resources, 2008, and has served on various committees at the NJDHSS.


Ms. Guagenti received her Bachelor of Science in Accounting from Bloomfield College and graduated Magna Cum Laude. She is a Certified Public Accountant licensed in the state of NJ.







Rosemary Mazanet MD, PhD, Director


Rosemary Mazanet is a Director of the Company and a life sciences investment professional and executive with management and drug development experience. She is a Co-Founder and CSO of Apelles Investment Management, LLC, a public and private equity investment firm, focused on healthcare and the CEO of Diabetes America, Inc., the premier network of diabetes care and management centers. Prior to that, Dr. Mazanet was a General Partner, Director of Research and CSO of Oracle Partners, LP, a $1 Billion healthcare hedge fund. Dr. Mazanet has also been the CEO of several life sciences companies, including Breakthrough Therapeutics LLC and Access Pharmaceuticals (OTC: ACCP). She started her career in business as a Sr. Director of Clinical Research with Amgen, Inc.


In addition, Dr. Mazanet is a trustee of the University of Pennsylvania School of Medicine/Hospital and a director with and Cellumen, Inc. She trained in internal medicine at the Brigham and Women’s Hospital and in oncology at the Dana Farber Cancer Institute, both part of the Harvard Medical system, where she was a staff physician prior to joining Amgen. Dr. Mazanet holds a B.A. in Biology from the University of Virginia and an M.D. and a Ph.D. from the University of Pennsylvania.


C. David Nicholson, BS, PhD, Director


C. David Nicholson is a Director of the Company and joined the Executive Committee of Bayer CropScience on March 5, 2012 as Head of Research & Development responsible for the integration of the company’s R&D activities into one global organization. Dr. Nicholson graduated in pharmacology, earning his B.Sc. from the University of Manchester (1975) and his Ph.D. from the University of Wales (1980). Between 1978 and 1988, Dr. Nicholson worked in the pharmaceutical industry for the British company Beecham-Wülfing in Gronau, Germany. The main emphasis of his activities as group leader in a multidisciplinary project group was the development of cardiovascular drugs.


From 1988-2007, Dr, Nicholson held various positions of increasing seniority in the UK, the Netherlands and the USA with Organon a Business Unit of Akzo Nobel. Ultimately he became Executive Vice President, Research & Development, and member of the Organon Executive Management Committee. He implemented change programs, leading to maximizing effectiveness in research & development, ensuring customer focus and the establishment of a competitive pipeline of innovative drugs. In 2007, Dr. Nicholson transferred to Schering-Plough, Kenilworth, New Jersey, USA, as Senior Vice President, responsible for Global Project Management and Drug Safety. From 2009 to December 2011, he was Vice President Licensing and Knowledge Management at Merck in Rahway, New Jersey, USA, reporting to the President of Merck R&D. As an integration team member, David Nicholson played a role in the strategic mergers of Organon BioSciences, the human and animal health business of Dutch chemical giant Akzo-Nobel, and Schering-Plough in 2007 as well as of Schering-Plough and Merck in 2009. C. David Nicholson is presently on the Board of multiple biotechnology companies, including Actinium Pharmaceuticals, Inc.


Sandesh Seth, MS, MBA, Director


Mr. Sandesh Seth is a Director of the Company and the Head of Healthcare Investment Banking at Laidlaw & Company (UK) Ltd. Mr. Seth has over 20 years of experience which includes investment banking at Cowen & Co., equity research at Bear Stearns and Commonwealth Associates and in the pharmaceutical industry at Pfizer, Warner-Lambert, and SmithKline Beecham in strategic planning, business development and R&D project management respectively. Mr. Seth’s financial services experience includes 75+ completed transactions in which $5 billion+ in capital was raised. Transactions included venture investments, private placements, IPOs, FOs, PIPEs, Convertible and High-Yield Debt. Mr. Seth was also involved with various strategic initiatives such as mergers and acquisitions, leveraged and management buy-outs, and licensing and joint ventures, including the $100 billion merger of Pfizer and Warner-Lambert and the $20 billion merger of Pharmacia & Upjohn with Monsanto. Mr. Seth has an MBA in Finance from New York University; an M.S. in the Pharmaceutical Sciences from the University of Oklahoma Health Center and a B.Sc. in Chemistry from Bombay University. He has published several scientific articles and was awarded the University Regents Award for Research Excellence at the University of Oklahoma. Mr. Seth was designated as Regulatory Affairs Certified (R.A.C.) by the Regulatory Affairs Professionals Society which signifies proficiency with U.S. FDA regulations. He also holds the following Securities Industry Licenses: Series 7, 79 and 63.








Sergio Traversa, PharmD, MBA, Director


Mr. Traversa is a Director of the Company and the Chief Executive Officer of Relmada Therapeutics Inc. Previously, he was the co-founder and CEO of Medeor Inc. a spinoff pharmaceutical company from Cornell University. Dr. Traversa has over 25 years of experience in the healthcare sector in the United States and Europe, ranging from management positions in the pharmaceutical industry to investing and strategic advisory roles. He has held financial analyst, portfolio management and strategic advisory positions at large U.S. investment firms specializing in healthcare, including Mehta and Isaly and Mehta partners, ING Barings, Merlin BioMed and Rx Capital. Dr. Traversa was a founding partner of Ardana Capital, a pharmaceutical and biotechnology investment advisory firm. In Europe, he held the position of Area Manager for Southern Europe (Italy, Spain, Greece and Portugal) of Therakos Inc., a cancer and immunology division of Johnson & Johnson. Prior to Therakos, Dr. Traversa was at Eli Lilly, where he served as Marketing Manager of the Hospital Business Unit. He was also a member of the CNS team at Eli Lilly, where he participated in the launch of Prozac and the early development of Zyprexa and Cymbalta. Dr. Traversa started his career as a sales representative at Farmitalia Carlo Erba, the largest pharmaceutical company in Italy later sold to Pharmacia and now part of Pfizer. Dr. Traversa holds a Laurea degree in Pharmacy from the University of Turin (Italy) and an MBA in Finance and International Business from the New York University Leonard Stern School of Business.


Corporate Governance


The business and affairs of the Company are managed under the direction of the Board of Directors (the “Board”), which following the expiration of the ten day period following the mailing of the information statement required by Rule 14f-1 under the Exchange Act, will be comprised of Jack V. Talley, Rosemary Mazanet, MD, PhD, David Nicholson, PhD, Sandesh Seth, MS, MBA, and Sergio Traversa, MBA.


Term of Office


Directors are appointed for a one-year term to hold office until the next annual general meeting of stockholders or until removed from office in accordance with our bylaws. Our officers are appointed by our Board and hold office until removed by our Board.


All officers and directors listed above will remain in office until the next annual meeting of our stockholders, and until their successors have been duly elected and qualified. Our bylaws provide that officers are appointed annually by our Board and each executive officer serves at the discretion of our Board.


Director Independence


We use the definition of “independence” of The NASDAQ Stock Market to make this determination.  NASDAQ Listing Rule 5605(a)(2) provides that an “independent director” is a person other than an officer or employee of the company or any other individual having a relationship which, in the opinion of the Company’s Board, would interfere with the exercise of independent judgment in carrying out the responsibilities of a director.  The NASDAQ listing rules provide that a director cannot be considered independent if:


the director is, or at any time during the past three years was, an employee of the company;

the director or a family member of the director accepted any compensation from the company in excess of $120,000 during any period of 12 consecutive months within the three years preceding the independence determination (subject to certain exclusions, including, among other things, compensation for board or board committee service);

a family member of the director is, or at any time during the past three years was, an executive officer of the company;

the director or a family member of the director is a partner in, controlling stockholder of, or an executive officer of an entity to which the company made, or from which the company received, payments in the current or any of the past three fiscal years that exceed 5% of the recipient s consolidated gross revenue for that year or $200,000, whichever is greater (subject to certain exclusions);

the director or a family member of the director is employed as an executive officer of an entity where, at any time during the past three years, any of the executive officers of the company served on the compensation committee of such other entity; or

the director or a family member of the director is a current partner of the company’s outside auditor, or at any time during the past three years was a partner or employee of the company’s outside auditor, and who worked on the company’s audit.








Our Common Stock is not currently quoted or listed on any national exchange or interdealer quotation system with a requirement that a majority of our board of directors be independent and, therefore, the Company is not subject to any director independence requirements. Under the following three NASDAQ director independence rules a director is not considered independent: (a) NASDAQ Rule 5605(a)(2)(A), a director is not considered to be independent if he or she also is an executive officer or employee of the corporation, (b) NASDAQ Rule 5605(a)(2)(B), a director is not consider independent if he or she accepted any compensation from the company in excess of $120,000 during any period of twelve consecutive months within the three years preceding the determination of independence, and (c) NASDAQ Rule 5605(a)(2)(D), a director is not considered to be independent if he or she is a partner in, or a controlling shareholder or an executive officer of, any organization to which the company made, or from which the company received, payments for property or services in the current or any of the past three fiscal years that exceed 5% of the recipient's consolidated gross revenues for that year, or $200,000. Under such definitions, David Nicholson and Sergio Traversa are the only independent directors.


Committees of the Board of Directors

 

On December __, 2012, our board of directors formed three standing committees: audit, compensation, and corporate governance and nominating. Actions taken by our committees are reported to the full board. Each of our committees has a charter and each charter is posted on our website.

 

Audit Committee

Compensation of Committee

David Nicholson*

David Nicholson*

Sergio Traversa

Dr. Rosemary Mazanet

Dr. Rosemary Mazanet

 Sandesh Seth

* Indicates committee chair


Audit Co mmittee

 

Our audit committee, which currently consists of three directors, provides assistance to our board in fulfilling its legal and fiduciary obligations with respect to matters involving the accounting, financial reporting, internal control and compliance functions of the company. Our audit committee employs an independent registered public accounting firm to audit the financial statements of the company and perform other assigned duties. Further, our audit committee provides general oversight with respect to the accounting principles employed in financial reporting and the adequacy of our internal controls. In discharging its responsibilities, our audit committee may rely on the reports, findings and representations of the company’s auditors, legal counsel, and responsible officers. Our board has determined that all members of the audit committee are financially literate within the meaning of SEC rules and under the current listing standards of the Nasdaq Capital Market. Our board has also determined that Mr. Nicholson qualifies as an “audit committee financial expert.”

 

Compensation Committee

 

Our compensation committee, which currently consists of three directors, establishes executive compensation policies consistent with the company’s objectives and stockholder interests. Our compensation committee also reviews the performance of our executive officers and establishes, adjusts and awards compensation, including incentive-based compensation, as more fully discussed below. In addition, our compensation committee generally is responsible for:

 

  

establishing and periodically reviewing our compensation philosophy and the adequacy of compensation plans and programs for our directors, executive officers and other employees;


  

overseeing our compensation plans, including the establishment of performance goals under the company s incentive compensation arrangements and the review of performance against those goals in determining incentive award payouts;


  

overseeing our executive employment contracts, special retirement benefits, severance, change in control arrangements and/or similar plans;


  

acting as administrator of any company stock option plans; and


  

overseeing the outside consultant, if any, engaged by the compensation committee.








Our compensation committee periodically reviews the compensation paid to our non-employee directors and the principles upon which their compensation is determined. The compensation committee also periodically reports to the board on how our non-employee director compensation practices compare with those of other similarly situated public corporations and, if the compensation committee deems it appropriate, recommends changes to our director compensation practices to our board for approval.

 

Outside consulting firms retained by our compensation committee and management also will, if requested, provide assistance to the compensation committee in making its compensation-related decisions.


Family Relationships


There are no family relationships among any of our officers or directors.


Involvement in Certain Legal Proceedings


To our knowledge, none of our current directors or executive officers has, during the past ten years:


  

been convicted in a criminal proceeding or been subject to a pending criminal proceeding (excluding traffic violations and other minor offenses);

  

had any bankruptcy petition filed by or against the business or property of the person, or of any partnership, corporation or business association of which he was a general partner or executive officer, either at the time of the bankruptcy filing or within two years prior to that time;

  

been subject to any order, judgment, or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction or federal or state authority, permanently or temporarily enjoining, barring, suspending or otherwise limiting, his involvement in any type of business, securities, futures, commodities, investment, banking, savings and loan, or insurance activities, or to be associated with persons engaged in any such activity;

  

been found by a court of competent jurisdiction in a civil action or by the SEC or the Commodity Futures Trading Commission to have violated a federal or state securities or commodities law, and the judgment has not been reversed, suspended, or vacated;

  

been the subject of, or a party to, any federal or state judicial or administrative order, judgment, decree, or finding, not subsequently reversed, suspended or vacated (not including any settlement of a civil proceeding among private litigants), relating to an alleged violation of any federal or state securities or commodities law or regulation, any law or regulation respecting financial institutions or insurance companies including, but not limited to, a temporary or permanent injunction, order of disgorgement or restitution, civil money penalty or temporary or permanent cease-and-desist order, or removal or prohibition order, or any law or regulation prohibiting mail or wire fraud or fraud in connection with any business entity; or

  

been the subject of, or a party to, any sanction or order, not subsequently reversed, suspended or vacated, of any self-regulatory organization (as defined in Section 3(a)(26) of the Exchange Act), any registered entity (as defined in Section 1(a)(29) of the Commodity Exchange Act), or any equivalent exchange, association, entity or organization that has disciplinary authority over its members or persons associated with a member.


Except as set forth in our discussion below in “Certain Relationships and Related Transactions,” none of our directors or executive officers has been involved in any transactions with us or any of our directors, executive officers, affiliates or associates which are required to be disclosed pursuant to the rules and regulations of the SEC.


Code of Ethics


The Company has adopted a code of ethics, a copy of which is attached hereto at Exhibit 14.1.








EXECUTIVE COMPENSATION


The following table provides information regarding the compensation earned during the fiscal years ended December 31, 2011 and December 31, 2010 and expected to be earned for the fiscal year ended December 31, 2012 by our Chief Executive Officer and the two next most highly compensated executive officers.


Name/Position

Year

Salary

Bonus

Option

Awards

Other Compensation

Total

Jack Talley, CEO

2012

2011

2010

$250,000

        0.00

        0.00

$0.00

0.00

0.00

$58,412

        0.00

        0.00

$0.00

0.00

0.00

$308,412

        0.00

        0.00

Dragan Cicic, COO

2012

2011

2010

$190,658

  190,658

  190,658

$   0.00

 50,000

     0.00

$58,426

    9,717

    9,717

$0.00

0.00

0.00

$249,084

  250,375

  200,375

Enza Guagenti, CFO

2012

2011

2010

$90,000

        0.00

        0.00

$0.00

0.00

0.00

$3,394

        0.00

        0.00

$0.00

0.00

0.00

$  93,394

        0.00

        0.00


Under the terms of Dr. Cicic’s employment contract and the agreed upon written terms of employment for Mr. Talley and Ms Guagenti, these employees are entitled to receive severance of twelve months, twelve months and three months base salary, respectively, upon termination by the Company without cause, or upon resignation within thirty days after a change in job responsibilities and a reduction in base salary.


Director Compensation


Historical non-management Directors of the Company do not receive any cash compensation. Commencing October 1, 2012, non-management Directors of the Company will receive a quarterly cash retainer of $7,500 per calendar quarter for their service on the Board of Directors. They also receive reimbursement for out-of-pocket expenses and certain directors have received stock option grants for shares of Company Common Stock as described in the beneficial ownership table in the section titled “SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT.”


Outstanding Equity Awards at Fiscal Year-End Table


At December 31, 2011, Cactus had no outstanding equity awards.


CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS,

AND DIRECTOR INDEPENDENCE


Related Party Transactions


On January 18, 2001, API entered in a Clinical Trial Agreement with Memorial Sloan-Kettering Cancer Center (MSKCC) and Sloan-Kettering Institute of Cancer Research (“SKI”), an [affiliate] of MSKCC.  Through an indirect subsidiary, MSKCC is a principal stockholder of the Company.  The agreement provided for the conduct by SKI/MSKCC of Phase I/II clinical trials of the use of 213Bi-Hu195and cytarabine for the treatment of acute myeloid leukemia and for API’s partial sponsorship of the study in exchange for access to data resulting from the study.  API was obligated to pay SKI (a) $10,000 for each completed case report on a completed subject, and (b) $2,500 for each case report on an incomplete subject. The trial enrolled 31 patients, was completed in 2007 and all the money due to Memorial Sloan-Kettering Cancer Center (MSKCC) and Sloan-Kettering Institute of Cancer Research (“SKI”) were paid in full.


On February 11, 2002, API entered in a License, Development and Commercialization Agreement with SKI.  The agreement was amended in August 2006.  Pursuant to the agreement, API licenses certain intellectual property from SKI, including critical patents with respect to API’s core technology, and also supports ongoing research and clinical development of API related drug candidates.  Certain amounts due under this agreement were deferred and then forgiven under the forbearance-related arrangements described below.  On June 19, 2011, API nonetheless agreed to pay SKI (a) $50,000 in 2011, (b) $200,000 in 2012 and (c) $250,000 in 2013 under this agreement, in respect of the $50,000 annual patent maintenance fees and research payments. January 1, 2011, API has paid $50,000 for 2011 and $50,000 for 2012 under this Agreement and as of December 21, 2012, and additional $15, 000 was due from API under this agreement consisting of $50,000 in respect of the 2012 patent maintenance fee, $50,000 of patent expenses $100,000 research and development support.







On February 25, 2006, API entered in a Clinical Trial Agreement with Memorial Sloan-Kettering Cancer Center (MSKCC) and Sloan-Kettering Institute of Cancer Research (“SKI”), a party related to MSKCC.  Through an indirect subsidiary, MSKCC is a principal stockholder of the Company.  The agreement provides for the conduct by SKI/MSKCC of a Phase I clinical trials of the use of Actinium 225-HuM195 for the treatment of advanced myeloid malignancy and for API’s partial sponsorship of the study in exchange for access to data resulting from the study.  API is obligated to pay SKI (a) $10,000 for each completed case report on a completed subject, and (b) $2,500 for each case report on an incomplete subject. As of December 21, 2012, 18 subjects had been enrolled in this study, and partners intend to attempt to enroll and additional 3 subjects. The maximum compensation for which API is responsible for and the agreement is $328,000. Since the inception of the trial in 2006, API has paid $180,000 and since January 1, 2011, API has paid $70,000 under the agreement as of December 31, 2012 no money’s were do under this agreement.


In April 2010, SKI agreed, on behalf of itself and its related or affiliated entities, including MSKCC, to forbear from collecting or otherwise enforcing API’s then outstanding obligations to those entities and similar obligations arising during a defined forbearance period.  The initial outstanding obligations consisted of approximately $260,000 due under API’s license and clinical trials agreements with those entities. In June 2011, SKI agreed to forgive all current and future obligations subject to the forbearance in order to facilitate API’s financing efforts.  The forbearance period terminated on October 30, 2011, when the Company satisfied a financing condition to the termination of the forbearance period by raising in excess of $3,000.000 in new equity financing.  


In April, 2011, SKI agreed to lend API $215,100 in order to fund current operating expenses and addition essential expenditures due over the ensuing six-month period.  As of October 30, 2012, API had repaid $171,000 of such loans; the balance is due in January 2013.  The largest aggregate amount of these loans outstanding at any time was $215,100.


MSKCC agreed, subject to certain conditions, to utilize donated funds for certain clinical and preclinical programs and activities related to Actinium’s drug development and clinical study programs, including the payment of certain costs and expenses that would otherwise have been borne by Actinium. The following is a summary of activities related to the MSKCC arrangements at December 31, 2011 and 2010:


 

 

 

 

 

2011

 

 

2010

 

 

 

 

 

 

 

 

 

Qualified R&D costs incurred by API

 

$

655,786

 

$

528,319

Cash received from MSKCC

 

 

966,341

 

 

248,418


As of December 31, 2011 and 2010, the Company had reimbursement receivables for costs incurred of $237,834 and $279,401 from MSKCC, respectively.  These amounts have since been paid.


In October 2011, AHL agreed, in connection with API’s concurrent private offering, to waive its rights to anti-dilution adjustments in respect of its outstanding preferred stock and its preemptive rights to purchase the Series E Preferred Stock.  AHL also agreed to the restructuring of its registration rights in favor of the private placement purchasers and to the amendment of the stockholders agreement of API to permit, among other transactions, the share exchange and to reduce its board representation from two directors to one director.  API agreed (i) not to reduce the indemnification, advancement of expenses and similar rights of present and former directors and officers of API, (ii) until April 30, 2016 to maintain directors’ and officers’ liability insurance at least in the same manner and to the same extent as then in effect, and (iii) following any merger, asset transfer and certain other transactions to provide for the parity of such directors and officers in respect of indemnification, advancement of expenses and d&o insurance with such rights applicable to the non-continuing directors following such transactions.


On March 27, 2012, Actinium entered into an additional clinical trial agreement with Memorial Sloan-Kettering Cancer Center with respect to.  Actinium will pay $31,185 for each patient that has completed the clinical trial.  Upon execution of the agreement, Actinium is required to pay a start-up fee of $79,623, which was paid on July 10, 2012.


On December 31, 2012, AHL entered into a lock-up letter agreement with Laidlaw providing that the shares of Common Stock of the Company held by AHL may not be transferred , subject to exceptions for certain related-party transfers, transfers to trusts and other private transfers, until , in general, the earlier of (i) twelve (12) months from the Closing Date; or (ii) six (6) months following the effective date of the Registration Statement.   AHL has certain registration rights with respect to its shares; however, such rights are, in certain respects, subordinate to those of investors in certain recent private placements.


On January 1, 2012, API entered into a Consulting Services Agreement with Dr. Rosemary Mazanet, a director of Cactus.  Pursuant to the agreement, Dr. Mazanet is to provide, among other things, consulting services in the areas of implementation of the Actimab trial including all aspects of study initiation until first patient in at each clinical site.  Dr. Mazanet receives compensation of $100,000 per year and may receive additional compensation in the form of options at determined by the board of API.  Since January 1, 2011, Dr. Mazanet has received options to purchase 225,000 shares of common stock of API.







Jack Talley, Chief Executive Officer of Cactus, has an agreement pursuant to which he will maintain a 3% equity ownership on a fully diluted basis in Cactus up to the final closing of the Offering.  The maximum offering amount with greenshoe option of the Offering is $20,000,000. As of December 28, 2012, a total $5,151,450 has been raised in the Offering.


On August 7, 2012, API entered into an engagement agreement with the Placement Agent, which is affiliated with Mr. Seth, a director of Cactus Ventures, Inc. by virtue of the acquisition transaction of Actinium Pharmaceuticals, Inc.  Mr. Seth is Head of Healthcare Investment Banking for the Placement Agent.   Pursuant to the agreement, the Placement Agent was engaged as the exclusive agent for the Offering of the Units by API.  None of Cactus’ current officers or directors had a prior relationship or affiliation with Cactus prior to the closing of the Share Exchange.  In consideration for its services, the Placement Agent will receive (a) a cash fee equal to 10% of the gross proceeds raised in the Offering, (b) a non-accountable expense reimbursement equal to 2% of the gross proceeds raised in the Offering, and (c) reimbursement of $100,000 for legal expenses incurred by the Placement Agent.  The Placement Agent or its designees have also received warrants to purchase shares of API’s Common Stock in an amount equal to 10% of the shares of Common Stock issued as part of the Units sold in the Offering and the shares of Common Stock issuable upon exercise of the B Warrants included in such Units.  The Placement Agent will also receive the same fee and expense schedule for any cash exercise of Warrants within 6 months of the final closing of the Offering and a 5% solicitation fee for any Warrants exercised as a result of being called for redemption by the Company.  Upon the final closing of the Offering of the Units the Placement Agent has been engaged by API to provide certain financial advisory services to API for a period of at least 6 months for a monthly fee of $25,000.  The agreement also provides that (i) if API consummates any merger, acquisition, business combination or other transaction (other than the Share Exchange) with any party introduced to it by the Placement Agent, the Placement Agent would receive a fee equal to 10% of the aggregate consideration in such transactions, and (ii) if, within a period of 12 months after termination of the advisory services described above, API requires a financing or similar advisory transaction the Placement Agent will have the right to act as API’s financial advisor and investment banker in such financing or transaction pursuant to a set fee schedule set forth in the August 7, 2012 engagement agreement.  For a period ending one year after the expiration of all lock-up agreements entered into in connection with the Share Exchange, any change in the size of the API board of directors must be approved by the Placement Agent.  The Placement Agent also was engaged by API as placement agent for its Series E Preferred and notes financing in 2011 and, as a part of the fee for that engagement, designees of the Placement Agent also hold warrants to purchase 1,245,226 shares of API’s Common Stock.


On May 9, 2011, API entered into a transaction management agreement with Jamess Capital Group, LLC. (formerly known as Amerasia Capital Group, LLC), a consulting firm affiliated with Mr. Sandesh Seth, a director of the Cactus by virtue of his position as a director of Actinium Pharmaceuticals.  Mr. Seth is a Managing Partner of the consulting firm some of whose member interests are held by entities owned by officers and employees of the Placement Agent.  None of Cactus’ current officers or directors had a prior relationship or affiliation with Cactus prior to the closing of the Share Exchange.  Pursuant to the agreement, the management firm was engaged to provide consulting services to API related to the consummation of a going public transaction for API.  The management firm received a monthly fee of $12,500 which is terminable by API three months after the effective date of the going public transaction and designees of Jamess, including entities affiliated with Mr. Seth, were issued warrants to purchase common stock equal to 10% of the fully-diluted capital stock of API as of the effective date of the going public transaction. The fully diluted shares for this calculation included all issued and outstanding shares as well as those reserved under the Employee Stock Option Plan.  Jamess Capital Group does not retain beneficial ownership of the warrants as they were issued to designess of the members in amounts which do not qualify either Jamess or the warrant holders for inclusion in the beneficial ownership table.  The warrants contain a provision wherein the holder may waive the 90 day exercise notice requirement by giving 65 days prior notice of such waiver.  The shares available by exercise of this Warrant are also restricted and may not be sold or otherwise transfered until the earlier of twelve months from the closing date of the Pubco Transaction; or for six months after the planned Registration Statement is declared effective. The consulting firm is also eligible to be reimbursed upon the submission of proper documentation for ordinary and necessary out-of-pocket expenses not to exceed $5,000 per month.  


In 2010, API entered into an agreement with Guagenti & Associates LLC (“G&A”).  G&A is affiliated with Enza Guagenti, the Chief Financial Officer of Cactus.  Pursuant to the agreement, API leases storage space in Newark, NJ from G&A.  The rent is $300 per month.  Since January 1, 2011, API has paid $3,600 pursuant to this agreement.


Non-Competition Agreements


Our executive officers have signed non-competition agreements, which provide that all inventions become the immediate property of API and require invention assignments. The agreements provide that the executive officers will hold proprietary information in the strictest confidence and not use the confidential information for any purpose not expressly authorized by us.







LEGAL PROCEEDINGS


From time to time, we may become involved in various lawsuits and legal proceedings, which arise in the ordinary course of business. Litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm business. We are currently not aware of any such legal proceedings or claims that will have, individually or in the aggregate, a material adverse effect on our business, financial condition or operating results.


MARKET PRICE AND DIVIDENDS ON OUR COMMON EQUITY

AND RELATED STOCKHOLDER MATTERS


Market Information


Our common stock is listed on OTCBB, under the symbol “CTVN”.  However, there is no active market for our Common Stock and trading has been extremely limited.  The last quoted price for our Common Stock was $0.10 for a trade on June 1, 2012, as reported on www.otcbb.com.  However, as there is currently little to no market for our Common Stock, we believe that this last reported price does not accurately reflect the value of the Common Stock or the Company, and it may not be possible to sell Common Stock at this price.


Holders


As of the Closing Date and after giving effect to the Share Exchange, 4,709,015 shares of Common Stock were issued and outstanding, which were held by 118 holders of record.  There are no shares of Preferred Stock outstanding.


Of the 4,709,015 shares of Common Stock issued and outstanding, 4,309,015 of such shares are restricted shares under the Securities Act.  None of these restricted shares are eligible for resale absent registration or an exemption from registration under the Securities Act.  As of the date hereof, the exemption from registration provided by Rule 144 under the Securities Act is not available for these shares pursuant to Rule 144(i).








Registration Rights


The Subscribers are entitled to certain registration rights, including piggy-back registration rights, with respect to the shares of Common Stock purchased in the Offering.


Dividends


We have never declared or paid a cash dividend. Any future decisions regarding dividends will be made by our Board of Directors. We currently intend to retain and use any future earnings for the development and expansion of our business and do not anticipate paying any cash dividends in the foreseeable future. Our Board of Directors has complete discretion on whether to pay dividends. Even if our Board of Directors decides to pay dividends, the form, frequency and amount will depend upon our future operations and earnings, capital requirements and surplus, general financial condition, contractual restrictions and other factors that the Board of Directors may deem relevant.


Penny Stock


Our Common Stock is subject to provisions of Section 15(g) and Rule 15g-9 of the Exchange Act, commonly referred to as the “penny stock rule.” Section 15(g) sets forth certain requirements for transactions in penny stock, and Rule 15g-9(d) incorporates the definition of “penny stock” that is found in Rule 3a51-1 of the Exchange Act. The SEC generally defines a penny stock to be any equity security that has a market price less than $5.00 per share, subject to certain exceptions. The Company is subject to the SEC’s penny stock rules.


Since the Common Stock will be deemed to be penny stock, trading in the shares of our common stock is subject to additional sales practice requirements on broker-dealers who sell penny stock to persons other than established customers and accredited investors. “Accredited investors” are persons with assets in excess of $1,000,000 or annual income exceeding $200,000 or $300,000 together with their spouse. For transactions covered by these rules, broker-dealers must make a special suitability determination for the purchase of such security and must have the purchaser’s written consent to the transaction prior to the purchase. Additionally, for any transaction involving a penny stock, unless exempt the rules require the delivery, prior to the first transaction of a risk disclosure document, prepared by the SEC, relating to the penny stock market. A broker-dealer also must disclose the commissions payable to both the broker-dealer and the registered representative and current quotations for the securities. Finally, monthly statements must be sent disclosing recent price information for the penny stocks held in an account and information to the limited market in penny stocks. Consequently, these rules may restrict the ability of broker-dealer to trade and/or maintain a market in our common stock and may affect the ability of the Company’s stockholders to sell their shares of common stock.


Securities Authorized for Issuance under Equity Compensation Plans


We do not have in effect any compensation plans under which our equity securities are authorized for issuance.  The Company intends to adopt an equity compensation plan in which its directors, officers, employees and consultants shall be eligible to participate.  However, no formal steps have been taken as of the date of this Report to adopt such a plan.


RECENT SALES OF UNREGISTERED SECURITIES


Reference is made to the disclosure set forth under Item 3.02 of this Report, which disclosure is incorporated by reference into this section.


DESCRIPTION OF SECURITIES


Introduction


In the discussion that follows, we have summarized selected provisions of our articles of incorporation, bylaws and Nevada law relating to our capital stock. This summary is not complete. This discussion is subject to the relevant provisions of Nevada law and is qualified in its entirety by reference to our articles of incorporation and our bylaws. You should read the provisions of our certificate of incorporation and our bylaws as currently in effect for provisions that may be important to you.


Authorized Capital Stock


The total authorized shares of capital stock of the Company currently consists of 100,000,000 shares of common stock, par value $0.01 per share, and 10,000,000 shares of preferred stock, par value $0.01 per share.  







Common Stock


Holders of our common stock are entitled to receive notice of and to attend all meetings of our stockholders, and to one vote for each share on all matters submitted to a stockholder vote.  Holders of common stock do not have cumulative voting rights.  Therefore, holders of a majority of the shares of common stock voting for the election of directors can elect all of the directors.  Holders of our common stock representing a majority of the voting power of our capital stock issued, outstanding and entitled to vote, represented in person or by proxy, are necessary to constitute a quorum at any meeting of our stockholders.  A vote by the holders of a majority of our outstanding shares is required to effectuate certain fundamental corporate changes such as liquidation, merger or an amendment to our articles of incorporation.


In the event of liquidation, dissolution or winding up, each outstanding share entitles its holder to participate pro rata in all assets that remain after payment of liabilities and after providing for each class of stock, if any, having preference over the common stock.  Holders of our common stock have no pre-emptive rights, no conversion rights and there are no redemption provisions applicable to our common stock.


As of December 28, 2012, 4,709,015 shares of common stock are held by 118 stockholders.


Dividends


Holders of common stock are entitled to share in all dividends that the board of directors, in its discretion, declares from legally available funds.  We have not paid any cash dividends on our Common Stock and do not plan to pay any such dividends in the foreseeable future. We currently intend to use all available funds to develop our business. We can give no assurances that we will ever have excess funds available to pay dividends.


Preferred Stock


We are authorized to issue up to 10,000,000 shares of preferred stock, par value $0.01 per share, in one or more series as may be determined by our Board of Directors, who may establish, from time to time, the number of shares to be included in each series, may fix the designation, powers, preferences and rights of the shares of each such series and any qualifications, limitations or restrictions thereof. Any preferred stock so issued by the Board may rank senior to the common stock with respect to the payment of dividends or amounts upon liquidation, dissolution or winding up of us, or both. Moreover, while providing desirable flexibility in connection with possible acquisitions and other corporate purposes, under certain circumstances, the issuance of preferred stock or the existence of the unissued preferred stock might tend to discourage or render more difficult a merger or other change of control. We currently do not have any preferred stock outstanding.


Anti-takeover Effects of Our Articles of Incorporation and By-laws


Our Articles of Incorporation and Bylaws contain certain provisions that may have anti-takeover effects, making it more difficult for or preventing a third party from acquiring control of our Company or changing our Board of Directors and management. According to our Bylaws and Articles of Incorporation, neither the holders of our common stock nor the holders of our preferred stock have cumulative voting rights in the election of our directors. The combination of the present ownership by a few stockholders of a significant portion of our issued and outstanding common stock and lack of cumulative voting makes it more difficult for other stockholders to replace our Board of Directors or for a third party to obtain control of our Company by replacing our Board of Directors.


Anti-takeover Effects of Nevada Law


Business Combinations


The “business combination” provisions of Sections 78.411 to 78.444, inclusive, of the Nevada Revised Statutes, or NRS, generally prohibit a Nevada corporation with at least 200 stockholders of record, a “resident domestic corporation,” from engaging in various “combination” transactions with any “interested stockholder” unless certain conditions are met or the corporation has elected in its articles of incorporation to not be subject to these provisions.







A “combination” is generally defined to include (a) a merger or consolidation of the resident domestic corporation or any subsidiary of the resident domestic corporation with the interested stockholder or affiliate or associate of the interested stockholder; (b) any sale, lease, exchange, mortgage, pledge, transfer, or other disposition, in one transaction or a series of transactions, by the resident domestic corporation or any subsidiary of the resident domestic corporation to or with the interested stockholder or affiliate or associate of the interested stockholder having: (i) an aggregate market value equal to 5% or more of the aggregate market value of the assets of the resident domestic corporation, (ii) an aggregate market value equal to 5% or more of the aggregate market value of all outstanding shares of the resident domestic corporation, or (iii) 10% or more of the earning power or net income of the resident domestic corporation; (c) the issuance or transfer in one transaction or series of transactions of shares of the resident domestic corporation or any subsidiary of the resident domestic corporation having an aggregate market value equal to 5% or more of the resident domestic corporation to the interested stockholder or affiliate or associate of the interested stockholder; and (d) certain other transactions with an interested stockholder or affiliate or associate of the interested stockholder.


An “interested stockholder” is generally defined as a person who, together with affiliates and associates, owns (or within three years, did own) 10% or more of a corporation’s voting stock. An “affiliate” of the interested stockholder is any person that directly or indirectly through one or more intermediaries is controlled by or is under common control with the interested stockholder. An “associate” of an interested stockholder is any (a) corporation or organization of which the interested stockholder is an officer or partner or is directly or indirectly the beneficial owner of 10% or more of any class of voting shares of such corporation or organization; (b) trust or other estate in which the interested stockholder has a substantial beneficial interest or as to which the interested stockholder serves as trustee or in a similar fiduciary capacity; or (c) relative or spouse of the interested stockholder, or any relative of the spouse of the interested stockholder, who has the same home as the interested stockholder.


If applicable, the prohibition is for a period of two years after the date of the transaction in which the person became an interested stockholder, unless such transaction is approved by the board of directors prior to the date the interested stockholder obtained such status; or the combination is approved by the board of directors and thereafter is approved at a meeting of the stockholders by the affirmative vote of stockholders representing at least 60% of the outstanding voting power held by disinterested stockholders; and extends beyond the expiration of the two-year period, unless (a) the combination was approved by the board of directors prior to the person becoming an interested stockholder; (b) the transaction by which the person first became an interested stockholder was approved by the board of directors before the person became an interested stockholder; (c) the transaction is approved by the affirmative vote of a majority of the voting power held by disinterested stockholders at a meeting called for that purpose no earlier than two years after the date the person first became an interested stockholder; or (d) if the consideration to be paid to all stockholders other than the interested stockholder is, generally, at least equal to the highest of: (i) the highest price per share paid by the interested stockholder within the three years immediately preceding the date of the announcement of the combination or in the transaction in which it became an interested stockholder, whichever is higher, plus compounded interest and less dividends paid, (ii) the market value per share of common shares on the date of announcement of the combination and the date the interested stockholder acquired the shares, whichever is higher, plus compounded interest and less dividends paid, or (iii) for holders of preferred stock, the highest liquidation value of the preferred stock, plus accrued dividends, if not included in the liquidation value. With respect to (i) and (ii) above, the interest is compounded at the rate for one-year United States Treasury obligations from time to time in effect.


Applicability of the Nevada business combination law would discourage parties interested in taking control of our company if they cannot obtain the approval of our board of directors. These provisions could prohibit or delay a merger or other takeover or change in control attempt and, accordingly, may discourage attempts to acquire our company even though such a transaction may offer our stockholders the opportunity to sell their stock at a price above the prevailing market price. The Company has elected to not be governed by the Nevada business combination provisions.


Control Share Acquisitions


The “control share” provisions of Sections 78.378 to 78.3793, inclusive, of the NRS, apply to “issuing corporations,” which are Nevada corporations with at least 200 stockholders of record, including at least 100 stockholders of record who are Nevada residents, and which conduct business directly or indirectly in Nevada, unless the corporation has elected to not be subject to these provisions.


The control share statute prohibits an acquirer of shares of an issuing corporation, under certain circumstances, from voting its shares of a corporation’s stock after crossing certain ownership threshold percentages, unless the acquirer obtains approval of the target corporation’s disinterested stockholders. The statute specifies three thresholds: (a) one-fifth or more but less than one-third, (b) one-third but less than a majority, and (c) a majority or more, of the outstanding voting power. Generally, once a person acquires shares in excess of any of the thresholds, those shares and any additional shares acquired within 90 days thereof become “control shares” and such control shares are deprived of the right to vote until disinterested stockholders restore the right. These provisions also provide that if control shares are accorded full voting rights and the acquiring person has acquired a majority or more of all voting power, all other stockholders who do not vote in favor of authorizing voting rights to the control shares are entitled to demand payment for the fair value of their shares in accordance with statutory procedures established for dissenters’ rights.







A corporation may elect to not be governed by, or “opt out” of, the control share provisions by making an election in its articles of incorporation or bylaws, provided that the opt-out election must be in place on the 10th day following the date an acquiring person has acquired a controlling interest, that is, crossing any of the three thresholds described above. We have opted out of the control share statutes, and, provided the “opt out” election remains in place, we will not be subject to the control share statutes.


The effect of the Nevada control share statute is that the acquiring person, and those acting in association with the acquiring person, will obtain only such voting rights in the control shares as are conferred by a resolution of the stockholders at an annual or special meeting. The Nevada control share law, if applicable, could have the effect of discouraging takeovers of our company.


INDEMNIFICATION OF DIRECTORS AND OFFICERS


We are a Nevada corporation and generally governed by the Nevada Private Corporations Code, Title 78 of the Nevada Revised Statutes, or NRS.


Section 78.138 of the NRS provides that, unless the corporation’s Articles of Incorporation provide otherwise, a director or officer will not be individually liable unless it is proven that (i) the director’s or officer’s acts or omissions constituted a breach of his or her fiduciary duties, and (ii) such breach involved intentional misconduct, fraud, or a knowing violation of the law. Our Articles of Incorporation provide that no director or officer shall be personally liable to the corporation or any of its stockholders for damages for any breach of fiduciary duty as a director or officer except for liability of a director or officer for (i) acts or omissions involving intentional misconduct, fraud, or a knowing violation of law or (ii) payment of dividends in violation of Section 78-300 of the NRS.


Section 78.7502 of the NRS permits a company to indemnify its directors and officers against expenses, judgments, fines, and amounts paid in settlement actually and reasonably incurred in connection with a threatened, pending, or completed action, suit, or proceeding, if the officer or director (i) is not liable pursuant to NRS 78.138, or (ii) acted in good faith and in a manner the officer or director reasonably believed to be in or not opposed to the best interests of the corporation and, if a criminal action or proceeding, had no reasonable cause to believe the conduct of the officer or director was unlawful. Section 78.7502 of the NRS also precludes indemnification by the corporation if the officer or director has been adjudged by a court of competent jurisdiction, after exhaustion of all appeals, to be liable to the corporation or for amounts paid in settlement to the corporation, unless and only to the extent that the court determines that in view of all the circumstances, the person is fairly and reasonably entitled to indemnity for such expenses and requires a corporation to indemnify its officers and directors if they have been successful on the merits or otherwise in defense of any claim, issue, or matter resulting from their service as a director or officer.


Section 78.751 of the NRS permits a Nevada company to indemnify its officers and directors against expenses incurred by them in defending a civil or criminal action, suit, or proceeding as they are incurred and in advance of final disposition thereof, upon determination by the stockholders, the disinterested board members, or by independent legal counsel. Section 78.751 of NRS requires a corporation to advance expenses as incurred upon receipt of an undertaking by or on behalf of the officer or director to repay the amount if it is ultimately determined by a court of competent jurisdiction that such officer or director is not entitled to be indemnified by the company if so provided in the corporations articles of incorporation, bylaws, or other agreement. Section 78.751 of the NRS further permits the company to grant its directors and officers additional rights of indemnification under its articles of incorporation, bylaws, or other agreement.


Section 78.752 of the NRS provides that a Nevada company may purchase and maintain insurance or make other financial arrangements on behalf of any person who is or was a director, officer, employee, or agent of the company, or is or was serving at the request of the company as a director, officer, employee, or agent of another company, partnership, joint venture, trust, or other enterprise, for any liability asserted against him and liability and expenses incurred by him in his capacity as a director, officer, employee, or agent, or arising out of his status as such, whether or not the company has the authority to indemnify him against such liability and expenses.


The Bylaws implement the indemnification and insurance provisions permitted by Chapter 78 of the NRS by providing that the Company:


·

shall, to the maximum extent and in the manner specified in the [NRS], indemnify each of its directors and officers against expenses, judgments, fines, settlements, and other amounts actually and reasonably incurred in connection with any proceeding arising by reason of the fact that any such person is or was a director or officer of the Corporation. The Corporation shall have the power to advance expenses incurred in defending any proceeding prior to the disposition of the proceeding upon receipt of an undertaking by or on behalf of the director or officer to repay that amount if it shall be determined ultimately that the person is not entitled to indemnification.







At the present time, there is no pending litigation or proceeding involving a director, officer, employee, or other agent of ours in which indemnification would be required or permitted. We are not aware of any threatened litigation or proceeding that may result in a claim for such indemnification.


CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS

ON ACCOUNTING AND FINANCIAL DISCLOSURE


None


Item 3.02

Unregistered Sales of Equity Securities.


The information contained in Item 1.01 above is incorporated herein by reference in response to this Item 3.02.


The shares of common stock issued to the former shareholders of Actinium in connection with the Share Exchange were offered and sold in a private transaction in reliance upon exemptions from registration pursuant to Section 4(2) of the Securities Act and Regulation S promulgated under the Securities Act. Our reliance on Section 4(2) of the Securities Act was based upon the following factors: (a) the issuance of the securities was an isolated private transaction by us which did not involve a public offering; (b) there were only a limited number of offerees; (c) there were no subsequent or contemporaneous public offerings of the securities by us; (d) the securities were not broken down into smaller denominations; and (e) the negotiations for the sale of the stock took place directly between the offerees and us. Our reliance on Regulation S was based on that such shareholders were not a “U.S. person” as that term is defined in Rule 902(k) of Regulation S under the Act, and that such shareholders were acquiring our common stock, for investment purposes for their own respective accounts and not as nominees or agents, and not with a view to the resale or distribution thereof, and that the shareholders understood that the shares of our common stock may not be sold or otherwise disposed of without registration under the Securities Act or an applicable exemption therefrom.


The securities were offered and sold in reliance upon exemptions from registration pursuant to Section 4(2) of the Securities Act and Rule 506 of Regulation D (“Regulation D”) promulgated under the Securities Act.  The Company made this determination based on the representations of the investors which included, in pertinent part, that each such investor was an “accredited investor” within the meaning of Rule 501 of Regulation D and upon such further representations from each investor that (i) such investor is acquiring the securities for its own account for investment and not for the account of any other person and not with a view to or for distribution, assignment or resale in connection with any distribution within the meaning of the Securities Act, (ii) such investor agrees not to sell or otherwise transfer the purchased securities or shares underlying such securities unless they are registered under the Securities Act and any applicable state securities laws, or an exemption or exemptions from such registration are available, (iii) such investor has knowledge and experience in financial and business matters such that such investor is capable of evaluating the merits and risks of an investment in us, (iv) such investor  had access to all of the Company’s documents, records, and books pertaining to the investment and was provided the opportunity to ask questions and receive answers regarding the terms and conditions of the Offering and to obtain any additional information which the Company possessed or was able to acquire without unreasonable effort and expense, and (v) such investor has no need for the liquidity in its investment in us and could afford the complete loss of such investment. In addition, there was no general solicitation or advertising for securities issued in reliance upon Regulation D.


Item 4.01.

Changes in Registrant’s Certifying Accountant.


(a)

Dismissal of Independent Accountant Previously Engaged as Principal Accountant.


On December 28, 2012, the Company dismissed R.R. Hawkins & Associates International, a PC (“Hawkins”), as the independent registered public accounting firm of the Company.  The dismissal was approved by the Board of Directors.


The reports of Hawkins on the financial statements of the Company for the fiscal years ended December 31, 2011 and 2010, did not contain any adverse opinion or a disclaimer of opinion, and were not qualified or modified as to uncertainty, audit scope or accounting principles except an explanatory paragraph as to an uncertainty with respect to the Company’s ability to continue as a going concern.


During the fiscal years ended December 31, 2011 and 2010, and through the date of this report, there were no (1) disagreements with Hawkins on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure, which disagreements if not resolved to the satisfaction of Hawkins, would have caused them to make reference thereto in their reports on the financial statements for such years; or (2) “reportable events” as defined in Item 304(a)(1)(v) of Regulation S-K.


The Company has requested that Hawkins furnish it with a letter addressed to the SEC stating whether or not it agrees with the above statements and, if not, stating the respects in which it does not agree. A copy of such letter, dated December 28, 2012, indicating that it is in agreement with such disclosures is filed as Exhibit 16.1 to this Form 8-K.







(b)

Engagement of New Independent Accountant as Principal Accountant.


On December 28, 2012, the Board of Directors approved the appointment of GBH CPAs, PC (“GBH”) as the independent registered public accounting firm of the Company.


During the Company’s two most recent fiscal years and the subsequent interim periods preceding GBH’s engagement, neither the Company nor anyone on behalf of the Company consulted with GBH regarding the application of accounting principles to any specific completed or contemplated transaction, or the type of audit opinion that might be rendered on the Company’s financial statements, and GBH did not provide any written or oral advice that was an important factor considered by the Company in reaching a decision as to any accounting, auditing or financial reporting issue or any matter that was the subject of a “disagreement” or a “reportable event,” as such terms are defined in Item 304(a)(1) of Regulation S-K.


Item 5.01

Changes in Control of Registrant.


Reference is made to the disclosure set forth under Item 2.01 of this report, which disclosure is incorporated herein by reference.


Prior to the Share Exchange, Diane S. Button, the former sole officer and director of Cactus, owned 10,000,000 shares of Common Stock, comprising approximately 89.65%, of the issued and outstanding shares, and Bruce Holden owned 926,600, comprising approximately 8.3% of the issued and outstanding shares.


Item 5.02

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


On the Closing Date, Diane S. Button submitted a resignation letter to Cactus resigning from her position as the sole director and officer, effective upon the closing of the Share Exchange. The resignation of Ms. Button was not in connection with any known disagreement with us on any matter.


On the Closing Date, Jack V. Talley, Rosemary Mazanet, MD, PhD, David Nicholson, PhD, Sandesh Seth, MS, MBA, and Sergio Traversa, MBA were appointed by our Board of Directors to fill the vacancies created by the resignation of Ms. Button, effective upon the closing of the Share Exchange.


In addition, on the Closing Date, the Board of Directors appointed Jack V. Talley as the President and Chief Executive Officer, Dragan Cicic, MD as the Chief Operating Officer and Chief Medical Officer, and Enza Guagenti, CPA as the Chief Financial Officer, effective upon the closing of the Share Exchange.


For certain biographical and other information regarding the new directors and officers of the Company, see the disclosure under “Item 2.01—Directors and Executive Officers” of this Report, which disclosure is incorporated herein by reference.


Item 5.05         Amendments to the Registrant’s Code of Ethics, Waiver of the Code of Ethics.


On December 28, 2012, the Cactus Board of Directors adopted a Code of Ethics that applies to its executive officers and directors.


The foregoing description of the Code of Ethics is qualified in its entirety by reference to the provisions of the Code of Ethics filed as Exhibit 14.1 to this Report, which is incorporated by reference herein.


Item 5.06

Change in Shell Company Status.


To the extent that we might have been deemed to be a shell company prior to the closing of the Share Exchange, reference is made to the disclosure set forth under Items 2.01 and 5.01 of this Report, which disclosure is incorporated herein by reference.








Item 9.01

Financial Statements and Exhibits.


(a)

Financial Statements of Business Acquired.


In accordance with Item 9.01(a), the Audited Consolidated Financial Statements for the years ended December 31, 2011 and 2010, and the Unaudited Interim Consolidated Financial Statements for the periods ended September 30, 2012 and 2011 for Actinium are included with this Current Report as exhibit 99.1 and 99.2.


(b)

Pro Forma Financial Information.


In accordance with Item 9.01(b), unaudited pro forma combined financial information of Cactus are included with this Current Report as exhibit 99.3.

 

(c)

Shell Company Transactions.


Reference is made to Items 9.01(a) and 9.01(b) and the exhibits referred to therein which are incorporated herein by reference.


(d)

Exhibits.


Certain of the agreements filed as exhibits to this Report contain representations and warranties by the parties to the agreements that have been made solely for the benefit of the parties to the agreement. These representations and warranties:


  

may have been qualified by disclosures that were made to the other parties in connection with the negotiation of the agreements, which disclosures are not necessarily reflected in the agreements;

  

may apply standards of materiality that differ from those of a reasonable investor; and

  

were made only as of specified dates contained in the agreements and are subject to subsequent developments and changed circumstances.


Accordingly, these representations and warranties may not describe the actual state of affairs as of the date that these representations and warranties were made or at any other time. Investors should not rely on them as statements of fact.








Exhibit

Number

  

Description

2.1

  

  

Share Exchange Agreement, dated December 28, 2012, by and among Cactus Ventures, Inc., Actinium Pharmaceuticals, Inc., Diane S. Button, and the shareholders of Actinium Pharmaceuticals, Inc.

3.1

  

  

Articles of Incorporation of Cactus Ventures, Inc.(incorporated by reference to Exhibit 3.01 of the Company’s Registration Statement on Form 10-SB filed with the SEC on February 5, 2007).

3.2

 

 

Amendment No. 1 to the Articles of Incorporation of Cactus Ventures, Inc. (incorporated by reference to Exhibit 3.02 of the Company’s Registration Statement on Form 10-SB filed with the SEC on February 5, 2007).

3.3

 

 

Amendment No. 2 to the Articles of Incorporation of Cactus Ventures, Inc. (incorporated by reference to Exhibit 3.03 of the Company’s Registration Statement on Form 10-SB filed with the SEC on February 5, 2007).

3.4

 

 

Amendment No. 3 to the Articles of Incorporation of Cactus Ventures, Inc. (incorporated by reference to Exhibit 3.04 of the Company’s Registration Statement on Form 10-SB filed with the SEC on February 5, 2007).

3.5

 

 

Fifth Restated  Certificate of Incorporation of Actinium Pharmaceuticals, Inc.

3.6

 

 

Bylaws of Cactus Ventures, Inc. (incorporated by reference to Exhibit 3.05 of the Company’s Registration Statement on Form 10-SB filed with the SEC on February 5, 2007).

3.7

 

 

Bylaws of Actinium Pharmaceuticals, Inc.

4.1

 

 

Form of A Warrant, dated December 19, 2012.

4.2

 

 

Form of B Warrant, dated December 19, 2012.

4.3

 

 

Form of Lock Up Agreement, dated December ____, 2012.

10.1

  

  

Registration Rights Agreement, by and among Actinium Pharmaceuticals, Inc., General Atlantic Investments Limited, and Certain Stockholders, dated June 30, 2000.

10.2

  

  

Amendment No. 1 to June 30, 2000 Registration Rights Agreement, dated September 29, 2011.*

10.3

  

  

First Amended and Restated Stockholders Agreement, by and among Actinium Pharmaceuticals, Inc., Actinium Holdings Limited, N.V. Organon, and the Stockholders Listed Therein, dated October 5, 2011.*

10.4

  

  

Second Amended and Restated Investor Rights Agreement, by and among Actinium Pharmaceuticals, Inc., Actinium Holdings Limited, and the Investors Listed Therein, dated October 5, 2011.*

10.5

 

 

 Placement Agent Engagement Agreement, by and between Laidlaw & Company (UK) Ltd. and Actinium Pharmaceuticals, Inc., dated August 7, 2012.*

10.6

  

  

Form of Subscription Agreement, dated December 19, 2012.

10.7

 

 

Form of Unit Purchase Agreement, dated December 19, 2012.

10.8

 

 

Employment Agreement, dated January 2, 2006,  between Actinium Pharmaceuticals, Inc. and Dragan Cicic*

10.9

 

 

License, Development and Commercialization Agreement between Sloan-Kettering Institute of Cancer Research, and Actinium Pharmaceuticals, Inc., dated February 11, 2002; as amended by the First Amendment dated August 7, 2006*

10.10

 

 

Phase I/II Study on the safety and efficiency of 225ACAc-HuM195 in patients with advanced Myeloid malignancies with Millennix Oncology, Averion Project, dated December 6, 2006.*

10.11

 

 

Product Development and Patent License Agreement, dated February 27, 2003, by and between Abbott Biotherapeutics and Actinium Pharmaceuticals, Inc.*

10.12

 

 

Clinical Trial Agreement, dated July 19, 2012, by and between Fred Hutchinson Cancer Center and Actinium Pharmaceuticals, Inc.*

10.13

 

 

Employment Letter between Jack V. Talley and Actinium Pharmaceuticals, Inc., effective August 15, 2012.*

10.14

 

 

Employment Letter between Enza Guagenti and Actinium Pharmaceuticals, Inc., effective August 15, 2012.*

10.15

 

 

Clinical Trial Agreement, dated January 18, 2001, between Actinium Pharmaceuticals, Inc. and Memorial Sloan Kettering Cancer Center for the purpose of conducting a clinical trial entitled “Phase I/II trial of 213Bi-M195 and cytarabine for Acute Myeloid Leukemia.”*

10.16

 

 

Clinical Trial Agreement with The Trustees of the University of Pennsylvania, dated November 8, 2012.*

10.17

 

 

Clinical Trial Agreement, dated March 27, 2012, with Memorial Sloan Kettering Cancer Center.*

10.18

 

 

Clinical Trial Agreement, dated September 22, 2012, with Johns Hopkins University, dated September 24, 2012.*

10.19

 

 

License Agreement, dated June 14, 2012, for BC8 antibody with Fred Hutchinson Cancer Research Center.*

10.20

 

 

2012 Unit Investor Rights Agreement, dated December 19, 2012, by and among Actinium Pharmaceuticals, Inc., the persons identified on Exhibit A attached thereto hereto, and the Placement Agent (defined below).*

10.21

 

 

Project Agreement, dated September 30, 2011, between Actinium Pharmaceuticals, Inc. and Aptiv Solutions, Inc.*

10.22

 

 

Proposal, dated March 30, 2007, with IsoTherapeutics Group, LLC.*

10.23

 

 

Clinical Trial Agreement with The University of Texas M.D. Anderson Cancer, dated March 1, 2012.*

10.24

 

 

Amendment No. 1 to Research Agreement, dated November 7, 2012, between Actinium Pharmaceuticals, Inc. and The University of Texas M.D. Anderson Cancer.*

14.1

 

  

Code of Ethics.

16.1

 

 

Letter from R.R. Hawkins & Associates International, a PC.

99.1

 

 

Audited Consolidated Financial Statements for the years ended December 31, 2011 and 2010 for Actinium.

99.2

 

 

Unaudited Interim Consolidated Financial Statements for the periods ended September 30, 2012 and 2011 for Actinium

99.3

 

 

Unaudited pro forma combined financial information of Cactus Ventures, Inc. and Actinium Pharmaceuticals, Inc.


* To be filed by amendment due to size limitations.







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.



Dated: December 31, 2012

CACTUS VENTURES, INC.

  

  

  

  

By:

/s/ Jack V. Talley

Name:  Jack V. Talley

Title:  President and Chief Executive Officer







Exhibit 2.1







SHARE EXCHANGE AGREEMENT


BY AND AMONG


CACTUS VENTURES, INC.

AND

DIANE S. BUTTON

AND

ACTINIUM PHARMECEUTICALS, INC.

AND

THE SHAREHOLDERS OF ACTINIUM PHARMECEUTICALS, INC.


Dated as of: December 28, 2012










TABLE OF CONTENTS

ARTICLE I DEFINITIONS 1

Section 1.1

Definitions

1

ARTICLE II SHARE EXCHANGE; CLOSING 4

Section 2.1

Share Exchange.  In accordance with the Shareholder Approval, the Acquiree Shareholders have agreed to transfer to the Acquiror 100% of the Acquiree Shares.  At the Closing (as defined below), Acquiree will use its best efforts to cause the Acquiree Shareholders to sell, transfer, convey, assign and deliver shares of Acquiree Common Stock (the “ Acquiree Shares ”), representing at least 20% (the “ Minimum Exchange ”) of the issued and outstanding shares of Acquiree Common Stock as of December 28, 2012, to the Acquiror, and in consideration therefor the Acquiror shall issue a total of 4,309,015 fully paid and nonassessable share of Acquiror Common Stock (the “ Acquiror Shares ”) to the Acquiree Shareholders, as set forth beside the name of each such Acquiree Shareholder on Schedule I hereto (the “ Share Exchange ”). At the Closing each Acquiree Shareholder shall receive 0.333 shares (the “ Exchange Ratio ”) of Acquiror Common Stock for each Acquiree Share exchanged. At the Closing all of the Acquiree Shareholders’ options and warrants to purchase Acquiree Common Stock will be exchanged at the Exchange Ratio for new options or warrants, as applicable, to purchase Acquiror Common Stock, as set forth on Schedule II.  4

Section 2.4

Closing Deliveries by Acquiror and Acquiror Principal Shareholder

4

Section 2.5

Closing Deliveries by Acquiree and Acquiree Shareholders

4

Section 2.6

Section 368 Reorganization

4

ARTICLE III REPRESENTATIONS OF ACQUIREE SHAREHOLDERS 5

Section 3.1

Authority

5

Section 3.2

Binding Obligations

5

Section 3.3

No Conflicts

5

Section 3.4

Ownership of Shares

5

Section 3.5

Certain Proceedings

5

Section 3.6

No Brokers or Finders

5

Section 3.7

Investment Representations

6

Section 3.8

Stock Legends

7

Section 3.9

Disclosure

8

ARTICLE IV REPRESENTATIONS AND WARRANTIES OF THE ACQUIREE 8

Section 4.1

Organization and Qualification

8

Section 4.2

Authority

8

Section 4.3

Binding Obligations

9

Section 4.4

No Conflicts

9

Section 4.5

Subsidiaries

9

Section 4.6

Organizational Documents

9

Section 4.7

Capitalization

9

Section 4.8

No Brokers or Finders

10

Section 4.9

Disclosure

10

ARTICLE V REPRESENTATIONS AND WARRANTIES OF THE ACQUIROR AND  THE ACQUIROR PRINCIPAL SHAREHOLDER 10

Section 5.1

Organization and Qualification

10

Section 5.2

Authority

10

Section 5.3

Binding Obligations

11

Section 5.4

No Conflicts

11

Section 5.5

Subsidiaries

11

Section 5.6

Organizational Documents

11

Section 5.7

Capitalization

11

Section 5.8

Compliance with Laws

12

Section 5.9

Certain Proceedings

12

Section 5.10

No Brokers or Finders

12

Section 5.11

Contracts

13

Section 5.12

Tax Matters

13

Section 5.13

Labor Matters

13

Section 5.14

Employee Benefits

14

Section 5.15

Title to Assets

14

Section 5.16

Intellectual Property

14

Section 5.17

Environmental Laws

14

Section 5.18

SEC Reports

14

Section 5.19

Internal Accounting Controls

15

Section 5.20

Listing and Maintenance Requirements

15








Section 5.21

Application of Takeover Protections

15

Section 5.22

Transactions With Affiliates and Employees

15

Section 5.23

Liabilities

15

Section 5.24

Bank Accounts and Safe Deposit Boxes

15

Section 5.25

Investment Company

15

Section 5.26

Bank Holding Company Act

15

Section 5.27

Public Utility Holding Act

16

Section 5.28

Federal Power Act

16

Section 5.29

Money Laundering Laws

16

Section 5.30

Foreign Corrupt Practices

16

Section 5.31

DTC Eligibility

16

Section 5.32

Absence of Certain Changes or Events

16

Section 5.33

Disclosure

16

Section 5.34

Undisclosed Events

16

Section 5.35

Non-Public Information

16

ARTICLE VI CONDUCT PRIOR TO CLOSING 17

Section 6.1

Conduct of Business

17

Section 6.2

Restrictions on Conduct of Business

17

ARTICLE VII ADDITIONAL AGREEMENTS 18

Section 7.1

Access to Information

18

Section 7.2

Legal Requirements

18

Section 7.3

Notification of Certain Matters

18

Section 7.4

Acquisition Proposals

19

ARTICLE VIII POST CLOSING COVENANTS 19

Section 8.1

General

19

Section 8.2

Litigation Support

19

Section 8.3

Assistance with Post-Closing SEC Reports and Inquiries

19

Section 8.4

Public Announcements

19

ARTICLE IX TAX MATTERS 19

Section 9.1

Tax Periods Ending on or before the Closing Date

19

Section 9.2

Tax Periods Beginning Before and Ending After the Closing

20

Section 9.3

Indemnification

20

Section 9.4

Tax Sharing Agreements

20

Section 9.5

Certain Taxes

20

ARTICLE X CONDITIONS TO CLOSING 20

Section 10.1

Conditions to Obligation of the Parties Generally

20

Section 10.2

Conditions to Obligation of the Acquiree Parties

21

Section 10.3

Conditions to Obligation of the Acquiror Parties

22

ARTICLE XI TERMINATION 23

Section 11.1

Grounds for Termination

23

Section 11.2

Procedure and Effect of Termination

24

Section 11.3

Effect of Termination

24

ARTICLE XII SURVIVAL; INDEMNIFICATION 24

Section 12.1

Survival

24

Section 12.2

Indemnification by the Acquiror Principal Shareholder

24

Section 12.3

Matters Involving Third Parties

24

Section 12.4

Exclusive Remedy

25

ARTICLE XIII MISCELLANEOUS PROVISIONS 25

Section 13.1

Expenses

25

Section 13.2

Confidentiality

25

Section 13.3

Notices

26

Section 13.4

Further Assurances

27

Section 13.5

Waiver

27

Section 13.6

Entire Agreement and Modification

27

Section 13.7

Assignments, Successors, and No Third-Party Rights

27

Section 13.8

Severability

27

Section 13.9

Section Headings

27

Section 13.10

Construction

27



ii





Section 13.11

Counterparts

27

Section 13.12

Specific Performance

28

Section 13.13

Governing Law; Submission to Jurisdiction

28

Section 13.14

Waiver of Jury Trial

28




iii





SHARE EXCHANGE AGREEMENT


This SHARE EXCHANGE AGREEMENT (“ Agreement ”), dated as of December 28, 2012, is made by and among CACTUS VENTURES, INC., a corporation organized under the laws of Nevada (the “ Acquiror ”), DIANE S. BUTTON (the “ Acquiror Principal Shareholder ”), ACTINIUM PHARMECEUTICALS, INC., a corporation organized under the laws of Delaware (the “ Acquiree ”), and each of the Persons listed on Schedule I hereto who are shareholders of the Acquiree (collectively, the “ Acquiree Shareholders ,” and individually an “ Acquiree Shareholder ”).  Each of the Acquiror, Acquiror Principal Shareholder, Bruce Holden, Acquiree and Acquiree Shareholders are referred to herein individually as a “ Party ” and collectively as the “ Parties .”


RECITALS:

WHEREAS, Acquiree agreed to pay $250,000 to Acquiror in consideration of Acquiror causing shares of Acquiror Common Stock (as defined below) to be cancelled and all outstanding liabilities of Acquiror to be paid;


WHEREAS, on September 5, 2012, the Acquiree Shareholders approved the entering into a reverse merger transaction, which will result in the Acquiree becoming a subsidiary of a public company whose securities are traded on a public exchange or quotation service in the U.S (the “ Shareholder Approval ”);


WHEREAS, in accordance with the Shareholder Approval the Acquiree Shareholders have agreed to transfer to the Acquiror 100% of the Acquiree Shares (as defined below); and the Acquiror has agreed to acquire from the Acquiree Shareholders 100% of the Acquiree Shares (as defined below); and on the Closing Date (as defined below) Acquiree will use its best efforts to cause the Acquiree Shareholders to transfer at least 20% of the Acquiree Shares (as defined below), which Acquiree Shares constitute at least 20% of the outstanding shares of Acquiree Common Stock (as defined below), in exchange for the Acquiror Shares (as defined below), which Acquiror Shares shall constitute approximately 99% (after 100% exchange) of the issued and outstanding shares of Acquiror Common Stock (as defined below) immediately after the closing of the transactions contemplated herein, in each case, on the terms and conditions as set forth herein;


NOW, THEREFORE, in consideration of the foregoing premises, and the covenants, representations and warranties set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged and accepted, the Parties, intending to be legally bound, hereby agree as follows:


ARTICLE I
DEFINITIONS


Section 1.1

Definitions

.  For all purposes of and under this Agreement, the following terms shall have the following respective meanings:


Accredited Investor ” has the meaning set forth in Rule 501 under the Securities Act.


Acquiree ” has the meaning set forth in the preamble.


Acquiree Common Stock ” means the common stock, $0.01 par value per share, of the Acquiree.


Acquiree Indemnified Parties ” means the Acquiree and the Acquiree Shareholders and their respective Affiliates and the officers, directors and representatives of such Persons; provided that (i) the Acquiror shall be a member of the Acquiree Indemnified Parties after the Closing and (ii) none of the Acquiror Principal Shareholder nor the Acquiror Principal Shareholder’ Affiliates shall be members of the Acquiree Indemnified Parties at any time.


Acquiree Offering ” means the offer and sale by the Acquiree of a minimum of $5,000,000 of units (the “Units”), each Unit consisting of an aggregate of (i) 181,818 shares of Acquiree common stock; (ii) an “A” warrant to purchase 181,818 shares of Acquiree common stock, exercisable at a price of $0.55 per share for a period of one hundred and twenty (120) days from the date of the final closing of the offering; and (iii) a “B” warrant to purchase 90,909 shares of Acquiree common stock, exercisable at a price of $0.825 per share for a period of five (5) years from the date of the final closing.  


Acquiree Organizational Documents ” has the meaning set forth in Section 4.6 .









Acquiree Shareholder ” and “ Acquiree Shareholders ” have the respective meanings set forth in the preamble.


Acquiree Shares ” has the meaning set forth in Section 2.1 .


Acquiror ” has the meaning set forth in the recitals.


Acquiror Common Stock ” means the common stock, par value $0.01 per share, of the Acquiror.


Acquiror Disclosure Schedule ” has the meaning set forth in Article V .


Acquiror Most Recent Fiscal Year End ” means December 31, 2011.


Acquiror Principal Shareholder ” has the meaning set forth in the preamble.


Acquiror Shares ” has the meaning set forth in Section 2.1 .


 “ Acquisition Transaction ” means any transaction or series of transactions involving: (a) any merger, consolidation, share exchange, business combination, issuance of securities, acquisition of securities, tender offer, exchange offer or other similar transaction; or (b) any sale (other than sales of inventory in the Ordinary Course of Business), lease (other than in the Ordinary Course of Business), exchange, transfer (other than sales of inventory in the Ordinary Course of Business), license (other than nonexclusive licenses in the Ordinary Course of Business), acquisition or disposition of assets.


Action ” means any action, suit, inquiry, notice of violation, proceeding (including any partial proceeding such as a deposition) or investigation pending or threatened before or by any court, arbitrator, governmental or administrative agency, regulatory authority (federal, state, county, local or foreign), stock market, stock exchange or trading facility.


Affiliate ” has the meaning set forth in Rule 12b-2 of the regulations promulgated under the Exchange Act.


Agreement ” has the meaning set forth in the preamble.


BHCA ” has the meaning set forth in Section 5.26 .


Business Day ” shall mean any day other than a Saturday, Sunday or a day on which commercial banks in New York, New York are required or authorized to be closed.


Closing ” has the meaning set forth in Section 2.2 .


Closing Date ” has the meaning set forth in Section 2.2 .


Code ” means the Internal Revenue Code of 1986, as amended.


Competing Transaction Proposal ” means any inquiry, proposal, indication of interest or offer from any Third Party contemplating or otherwise relating to any Acquisition Transaction directly or indirectly involving the Acquiror, its business or any assets of the Acquiror (including, without limitation, any Acquisition Transaction involving Acquiror Principal Shareholder that would include the Acquiror, its business or any assets of the Acquiror).


Contract ” means any written or oral contract, lease, license, indenture, note, bond, agreement, arrangement, understanding, permit, concession, franchise or other instrument.


Damages ” has the meaning set forth in Section 12.2 .


DTC ” has the meaning set forth in Section 5.31 .


Environmental Laws ” has the meaning set forth in Section 5.17 .


ERISA ” means the Employee Retirement Income Security Act of 1974, as amended.



2






Exchange Act ” means the Securities Exchange Act of 1934, as amended, or any similar federal statute, and the rules and regulations of the SEC thereunder, all as the same will then be in effect.


FAST ” has the meaning set forth in Section 5.31 .


Federal Reserve ” has the meaning set forth in Section 5.26 .


GAAP ” means, with respect to any Person, generally accepted accounting principles in the U.S. applied on a consistent basis with such Person’s past practices.


Governmental Authority ” means any domestic or foreign, federal or national, state or provincial, municipal or local government, governmental authority, regulatory or administrative agency, governmental commission, department, board, bureau, agency or instrumentality, political subdivision, commission, court, tribunal, official, arbitrator or arbitral body.


Hazardous Materials ” has the meaning set forth in Section 5.17 .


Indebtedness ” means without duplication, (a) all indebtedness or other obligation of the Person for borrowed money, whether current, short-term, or long-term, secured or unsecured, (b) all indebtedness of the Person for the deferred purchase price for purchases of property outside the Ordinary Course of Business, (c) all lease obligations of the Person under leases which are capital leases in accordance with GAAP, (d) any off-balance sheet financing of the Person including synthetic leases and project financing, (e) any payment obligations of the Person in respect of banker’s acceptances or letters of credit (other than stand-by letters of credit in support of ordinary course trade payables), (f) any liability of the Person with respect to interest rate swaps, collars, caps and similar hedging obligations, (g) any liability of the Person under deferred compensation plans, phantom stock plans, severance or bonus plans, or similar arrangements made payable as a result of the transactions contemplated herein, (h) any indebtedness referred to in clauses (a) through (g) above of any other Person which is either guaranteed by, or secured by a security interest upon any property owned by, the Person and (i) accrued and unpaid interest of, and prepayment premiums, penalties or similar contractual charges arising as result of the discharge at the Closing of, any such foregoing obligation.


Indemnified Party ” has the meaning set forth in Section 12.3(a) .


Indemnifying Party ” has the meaning set forth in Section 12.3(a) .


Intellectual Property ” means all industrial and intellectual property, including, without limitation, all U.S. and non-U.S. patents, patent applications, patent rights, trademarks, trademark applications, common law trademarks, Internet domain names, trade names, service marks, service mark applications, common law service marks, and the goodwill associated therewith, copyrights, in both published and unpublished works, whether registered or unregistered, copyright applications, franchises, licenses, know-how, trade secrets, technical data, designs, customer lists, confidential and proprietary information, processes and formulae, all computer software programs or applications, layouts, inventions, development tools and all documentation and media constituting, describing or relating to the above, including manuals, memoranda, and records, whether such intellectual property has been created, applied for or obtained anywhere throughout the world.


Knowledge ” shall mean, except as otherwise explicitly provided herein, actual knowledge after reasonable investigation.  The Acquiror shall be deemed to have “Knowledge” of a matter if any of its officers, directors, stockholders, or employees has Knowledge of such matter.  Phrases such as “to the Knowledge of the Acquiror” or the “Acquiror’s Knowledge” shall be construed accordingly.


Laws ” means, with respect to any Person, any U.S. or non-U.S., federal, national, state, provincial, local, municipal, international, multinational or other Law (including common law), constitution, statute, code, ordinance, rule, regulation or treaty applicable to such Person.


Liability ” means any liability (whether known or unknown, whether asserted or unasserted, whether absolute or contingent, whether accrued or unaccrued, whether liquidated or unliquidated, and whether due or to become due), including any liability for Taxes.



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License ” means any security clearance, permit, license, variance, franchise, Order, approval, consent, certificate, registration or other authorization of any Governmental Authority or regulatory body, and other similar rights.


Lien ” means any mortgage, pledge, security interest, encumbrance, lien or charge of any kind, including, without limitation, any conditional sale or other title retention agreement, any lease in the nature thereof and the filing of or agreement to give any financing statement under the Uniform Commercial Code of any jurisdiction and including any lien or charge arising by Law.


Material Adverse Effect ” means, with respect to any Person, a material adverse effect on the business, financial condition, operations, results of operations, assets, customer, supplier or employee relations or future prospects of such Person.


Money Laundering Laws ” has the meaning set forth in Section 5.29 .


Order ” means any order, judgment, ruling, injunction, assessment, award, decree or writ of any Governmental Authority or regulatory body.


Ordinary Course of Business ” means the ordinary course of business consistent with past custom and practice (including with respect to quantity and frequency).


Party ” and “ Parties ” have the respective meanings set forth in the preamble.


Person ” means all natural persons, corporations, business trusts, associations, companies, partnerships, limited liability companies, joint ventures and other entities, governments, agencies and political subdivisions.


Post-Closing Period ” has the meaning set forth in Section 9.2 .


Pre-Closing Period ” has the meaning set forth in Section 9.2 .


Principal Market ” means the OTC Bulletin Board.


Registration Statements ” has the meaning set forth in Section 5.18(b) .


Regulation S ” means Regulation S under the Securities Act, as the same may be amended from time to time, or any similar rule or regulation hereafter adopted by the Commission.


SEC ” means the U.S. Securities and Exchange Commission, or any successor agency thereto.


SEC Reports ” has the meaning set forth in Section 5.18(a) .


Securities Act ” means the Securities Act of 1933, as amended, or any similar federal statute, and the rules and regulations of the Commission thereunder, all as the same will be in effect at the time.


Share Exchange ” has the meaning set forth in Section 2.1 .


Tax Return ” means all returns, declarations, reports, estimates, statements, forms and other documents filed with or supplied to or required to be provided to a Governmental Authority with respect to Taxes, including any schedule or attachment thereto and any amendment thereof.


Tax ” or “ Taxes ” means all taxes, assessments, duties, levies or other charge imposed by any Governmental Authority of any kind whatsoever together with any interest, penalties, fines or additions thereto and any liability for payment of taxes whether as a result of (i) being a member of an affiliated, consolidated, combined, unitary or similar group for any period, (ii) any tax sharing, tax indemnity or tax allocation agreement or any other express or implied agreement to indemnify any Person, (iii) being liable for another Person’s taxes as a transferee or successor otherwise for any period, or (iv) operation of Law.


Termination Date ” means January 31, 2012.


Third Party ” has the meaning set forth in Section 7.4(a) .



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Third Party Claim ” has the meaning set forth in Section 12.3(a) .


Transaction Documents ” means, collectively, this Agreement and all agreements, certificates, instruments and other documents to be executed and delivered in connection with the transactions contemplated by this Agreement.


Treasury Regulations ” means the income tax regulations, including temporary regulations, promulgated under the Code, as such regulations may be amended from time to time (including corresponding provisions of succeeding regulations).


U.S. ” means the United States of America.


U.S. Person ” has the meaning set forth in Regulation S under the Securities Act.


ARTICLE II
SHARE EXCHANGE; CLOSING


Section 2.1

Share Exchange .  In accordance with the Shareholder Approval, the Acquiree Shareholders have agreed to transfer to the Acquiror 100% of the Acquiree Shares.  At the Closing (as defined below), Acquiree will use its best efforts to cause the Acquiree Shareholders to sell, transfer, convey, assign and deliver shares of Acquiree Common Stock (the “ Acquiree Shares ”), representing at least 20% (the “ Minimum Exchange ”) of the issued and outstanding shares of Acquiree Common Stock as of December 28, 2012, to the Acquiror, and in consideration therefor the Acquiror shall issue a total of 4,309,015 fully paid and nonassessable share of Acquiror Common Stock (the “ Acquiror Shares ”) to the Acquiree Shareholders, as set forth beside the name of each such Acquiree Shareholder on Schedule I hereto (the “ Share Exchange ”). At the Closing each Acquiree Shareholder shall receive 0.333 shares (the “ Exchange Ratio ”) of Acquiror Common Stock for each Acquiree Share exchanged. At the Closing all of the Acquiree Shareholders’ options and warrants to purchase Acquiree Common Stock will be exchanged at the Exchange Ratio for new options or warrants, as applicable, to purchase Acquiror Common Stock, as set forth on Schedule II.


On or before the fourth (4th) business day after the date of this Agreement, the Acquiror shall file (i) a Current Report on Form 8-K describing all the material terms of the transactions contemplated by this Agreement and (ii) a Schedule 14f-1 Information Statement in the form required by the Exchange Act and attaching all the material transaction documents (including, without limitation, this Agreement.


Section 2.2

Closing .  Upon the terms and subject to the conditions of this Agreement, the transactions contemplated by this Agreement shall take place at a closing (the “ Closing ”) to be held at the offices of Anslow & Jaclin LLP located at 195 Route 9 South, Manalapan, NJ 07726, at a time and date to be specified by the Parties, which shall be no later than second (2nd) Business Day following the satisfaction or, if permitted pursuant hereto, waiver of the conditions set forth in Article IX , or at such other location, date and time as Acquiree and Acquiror Principal Shareholder shall mutually agree.  The date and time of the Closing is referred to herein as the “ Closing Date .”


Section 2.4

Closing Deliveries by Acquiror and Acquiror Principal Shareholder


At the Closing: (a) the Acquiror shall deliver, or cause to be delivered, a certificate evidencing the number of Acquiror Shares, set forth beside each Acquiree Shareholder’s name on Schedule I hereto; and (b) the Acquiror and the Acquiror Principal Shareholder, as applicable, shall deliver, or cause to be delivered, to the Acquiree and the Acquiree Shareholders, as applicable, the various documents required to be delivered as a condition to the Closing pursuant to Section 10.2 hereof.


Section 2.5

Closing Deliveries by Acquiree and Acquiree Shareholders


At the Closing: (a) Acquiree shall deliver $250,000 to Acquiror, (b) each Acquiree Shareholder shall deliver, or cause to be delivered, certificate(s) representing such Acquiree Shareholder’s Acquiree Shares, accompanied by an executed instrument of transfer for transfer by such Acquiree Shareholder of such Acquiree Shareholder’s Acquiree Shares to the Acquiror; and (C) the Acquiree and the Acquiree Shareholders, as applicable, shall deliver, or cause to be delivered, to the Acquiror and the Acquiror Principal Shareholder, as applicable, the various documents required to be delivered as a condition to the Closing pursuant to Section 10.3 hereof.



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Section 2.6

Section 368 Reorganization


For U.S. federal income Tax purposes, the Share Exchange is intended to constitute a “reorganization” within the meaning of Section 368(a)(1)(B) of the Code.  The Parties hereby adopt this Agreement as a “plan of reorganization” within the meaning of Sections 1.368-2(g) and 1.368-3(a) of the Treasury Regulations.  Notwithstanding the foregoing or anything else to the contrary contained in this Agreement, the Parties acknowledge and agree that no Party is making any representation or warranty as to the qualification of the Share Exchange as a reorganization under Section 368 of the Code or as to the effect, if any, that any transaction consummated prior to or after the Closing Date has or may have on any such reorganization status.  The Parties acknowledge and agree that each (i) has had the opportunity to obtain independent legal and tax advice with respect to the transaction contemplated by this Agreement, and (ii) is responsible for paying its own Taxes, including without limitation, any adverse Tax consequences that may result if the transaction contemplated by this Agreement is not determined to qualify as a reorganization under Section 368 of the Code.


ARTICLE III
REPRESENTATIONS OF ACQUIREE SHAREHOLDERS


The Acquiree Shareholders severally, and not jointly, hereby represent and warrant to the Acquiror that the statements contained in this Article III are correct and complete as of the date of this Agreement and will be correct and complete as of the Closing Date (as though made then and as thought the Closing Date were substituted for the date of this Agreement throughout this Article III ) (except where another date or period of time is specifically stated herein for a representation or warranty).


Section 3.1

Authority


Such Acquiree Shareholder has all requisite authority and power to enter into and deliver this Agreement and any of the other Transaction Documents to which such Acquiree Shareholder is a party, and any other certificate, agreement, document or instrument to be executed and delivered by such Acquiree Shareholder in connection with the transactions contemplated hereby and thereby and to perform its obligations hereunder and thereunder and to consummate the transactions contemplated hereby and thereby.  This Agreement has been, and each of the Transaction Documents to which such Acquiree Shareholder is a party will be, duly and validly authorized and approved, executed and delivered by such Acquiree Shareholder.


Section 3.2

Binding Obligations


Assuming this Agreement and the Transaction Documents have been duly and validly authorized, executed and delivered by the parties hereto and thereto other than such Acquiree Shareholder, this Agreement and each of the Transaction Documents to which such Acquiree Shareholder is a party are duly authorized, executed and delivered by such Acquiree Shareholder, and constitutes the legal, valid and binding obligations of such Acquiree Shareholder, enforceable against such Acquiree Shareholder in accordance with their respective terms, except as such enforcement is limited by general equitable principles, or by bankruptcy, insolvency and other similar Laws affecting the enforcement of creditors rights generally.


Section 3.3

No Conflicts


Neither the execution or delivery by such Acquiree Shareholder of this Agreement or any Transaction Document to which such Acquiree Shareholder is a party, nor the consummation or performance by such Acquiree Shareholder of the transactions contemplated hereby or thereby will, directly or indirectly, (a) contravene, conflict with, or result in a violation of any provision of the organizational documents of such Acquiree Shareholder (if such Acquiree Shareholder is not a natural Person); (b) contravene, conflict with, constitute a default (or an event or condition which, with notice or lapse of time or both, would constitute a default) under, or result in the termination or acceleration of, any agreement or instrument to which such Acquiree Shareholder is a party or by which the properties or assets of such Acquiree Shareholder are bound; or (c) contravene, conflict with, result in any breach of, or constitute a default (or an event that with notice or lapse of time or both would become a default) under, impair the rights of such Acquiree Shareholder under, or alter the obligations of any Person under, or create in any Person the right to terminate, amend, accelerate or cancel, or require any notice, report or other filing (whether with a Governmental Authority or any other Person) pursuant to, or result in the creation of a Lien on any of the assets or properties of the Acquiror under, any note, bond, mortgage, indenture, Contract, License, permit, franchise or other instrument or obligation to which such Acquiree Shareholder is a party or any of such Acquiree Shareholder’s assets and properties are bound or affected, except, in the case of clauses (b) or (c) for any such contraventions, conflicts, violations, or other occurrences as would not have a Material Adverse Effect on such Acquiree Shareholder.



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Section 3.4

Ownership of Shares


Such Acquiree Shareholder owns, of record and beneficially, and has good, valid and indefeasible title to and the right to transfer to the Acquiror pursuant to this Agreement, such Acquiree Shareholder’s Acquiree Shares free and clear of any and all Liens.  there are no options, rights, voting trusts, stockholder agreements or any other Contracts or understandings to which such Acquiree Shareholder is a party or by which such Acquiree Shareholder or such Acquiree Shareholder’s Acquiree Shares are bound with respect to the issuance, sale, transfer, voting or registration of such Acquiree Shareholder’s Acquiree Shares.  At the Closing Date, the Acquiror will acquire good, valid and marketable title to such Acquiree Shareholder’s Acquiree Shares free and clear of any and all Liens.


Section 3.5

Certain Proceedings


There is no Action pending against, or to the Knowledge of such Acquiree Shareholder, threatened against or affecting, such Acquiree Shareholder by any Governmental Authority or other Person with respect to such Acquiree Shareholder that challenges, or may have the effect of preventing, delaying, making illegal, or otherwise interfering with, any of the transactions contemplated by this Agreement.


Section 3.6

No Brokers or Finders


No Person has, or as a result of the transactions contemplated herein will have, any right or valid claim against such Acquiree Shareholder for any commission, fee or other compensation as a finder or broker, or in any similar capacity, based upon arrangements made by or on behalf of such Acquiree Shareholder and such Acquiree Shareholder will indemnify and hold the Acquiror and the Acquiror Principal Shareholder harmless against any liability or expense arising out of, or in connection with, any such claim.


Section 3.7

Investment Representations


Each Acquiree Shareholder severally, and not jointly, hereby represents and warrants, solely with respect to itself and not any other Acquiree Shareholder, to the Acquiror as follows:


(a)

Purchase Entirely for Own Account .  Such Acquiree Shareholder is acquiring such Acquiree Shareholder’s portion of the Acquiror Shares proposed to be acquired hereunder for investment for its own account and not with a view to the resale or distribution of any part thereof, and such Acquiror Shareholder has no present intention of selling or otherwise distributing such Acquiror Shares, except in compliance with applicable securities Laws.


(b)

Restricted Securities .  Such Acquiree Shareholder understands that the Acquiror Shares are characterized as “restricted securities” under the Securities Act inasmuch as this Agreement contemplates that, if acquired by the Shareholder pursuant hereto, the Acquiror Shares would be acquired in a transaction not involving a public offering.  The issuance of the Acquiror Shares hereunder is being effected in reliance upon an exemption from registration afforded under Section 4(2) of the Securities Act.  Such Acquiree Shareholder further acknowledges that if the Acquiror Shares are issued to such Acquiree Shareholder in accordance with the provisions of this Agreement, such Acquiror Shares may not be resold without registration under the Securities Act or the existence of an exemption therefrom.  Such Acquiree Shareholder represents that he is familiar with Rule 144 promulgated under the Securities Act, as presently in effect, and understands the resale limitations imposed thereby and by the Securities Act


(c)

Acknowledgment of Non-Registration .  Such Acquiree Shareholder understands and agrees that the Acquiror Shares to be issued pursuant to this Agreement have not been registered under the Securities Act or the securities Laws of any state of the U.S.



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(d)

Status .  By its execution of this Agreement, each Acquiree Shareholder represents and warrants to the Acquiror as indicated on its signature page to this Agreement, either that: (i) such Acquiree Shareholder is an Accredited Investor; or (ii) such Acquiree Shareholder is not a U.S. Person.  Each Acquiree Shareholder understands that the Acquiror Shares are being offered and sold to such Acquiree Shareholder in reliance upon the truth and accuracy of the representations, warranties, agreements, acknowledgments and understandings of such Acquiree Shareholder set forth in this Agreement, in order that the Acquiror may determine the applicability and availability of the exemptions from registration of the Acquiror Shares on which the Acquiror is relying.


(e)

Additional Representations and Warranties .  Such Acquiree Shareholder, severally and not jointly, further represents and warrants to the Acquiror as follows: (i) such Person qualifies as an Accredited Investor; (ii) such Person consents to the placement of a legend on any certificate or other document evidencing the Acquiror Shares substantially in the form set forth in Section 3.8(a) ; (iii) such Person has sufficient knowledge and experience in finance, securities, investments and other business matters to be able to protect such Person’s or entity’s interests in connection with the transactions contemplated by this Agreement; (iv) such Person has consulted, to the extent that it has deemed necessary, with its tax, legal, accounting and financial advisors concerning its investment in the Acquiror Shares and can afford to bear such risks for an indefinite period of time, including, without limitation, the risk of losing its entire investment in the Acquiror Shares; (v) such Person has had access to the SEC Reports; (vi) such Person has been furnished during the course of the transactions contemplated by this Agreement with all other public information regarding the Acquiror that such Person has requested and all such public information is sufficient for such Person to evaluate the risks of investing in the Acquiror Shares; (vii) such Person has been afforded the opportunity to ask questions of and receive answers concerning the Acquiror and the terms and conditions of the issuance of the Acquiror Shares; (viii) such Person is not relying on any representations and warranties concerning the Acquiror made by the Acquiror or any officer, employee or agent of the Acquiror, other than those contained in this Agreement or the SEC Reports; (ix) such Person will not sell or otherwise transfer the Acquiror Shares, unless either (A) the transfer of such securities is registered under the Securities Act or (B) an exemption from registration of such securities is available; (x) such Person understands and acknowledges that the Acquiror is under no obligation to register the Acquiror Shares for sale under the Securities Act; (xi) such Person represents that the address furnished in Schedule I is the principal residence if he is an individual or its principal business address if it is a corporation or other entity; (xii) such Person understands and acknowledges that the Acquiror Shares have not been recommended by any federal or state securities commission or regulatory authority, that the foregoing authorities have not confirmed the accuracy or determined the adequacy of any information concerning the Acquiror that has been supplied to such Person and that any representation to the contrary is a criminal offense; and (xiii) such Person acknowledges that the representations, warranties and agreements made by such Person herein shall survive the execution and delivery of this Agreement and the purchase of the Acquiror Shares.


(f)

Additional Representations and Warranties of Non-U.S. Persons .  Each Acquiree Shareholder that is not a U.S. Person, severally and not jointly, further represents and warrants to the Acquiror as follows: (i) at the time of (A) the offer by the Acquiror and (B) the acceptance of the offer by such Person, of the Acquiror Shares, such Person was outside the U.S; (ii) no offer to acquire the Acquiror Shares or otherwise to participate in the transactions contemplated by this Agreement was made to such Person or its representatives inside the U.S.; (iii) such Person is not purchasing the Acquiror Shares for the account or benefit of any U.S. Person, or with a view towards distribution to any U.S. Person, in violation of the registration requirements of the Securities Act; (iv) such Person will make all subsequent offers and sales of the Acquiror Shares either (A) outside of the U.S. in compliance with Regulation S; (B) pursuant to a registration under the Securities Act; or (C) pursuant to an available exemption from registration under the Securities Act; (v) such Person is acquiring the Acquiror Shares for such Person’s own account, for investment and not for distribution or resale to others; (vi) such Person has no present plan or intention to sell the Acquiror Shares in the U.S. or to a U.S. Person at any predetermined time, has made no predetermined arrangements to sell the Acquiror Shares and is not acting as an underwriter or dealer with respect to such securities or otherwise participating in the distribution of such securities; (vii) neither such Person, its Affiliates nor any Person acting on behalf of such Person, has entered into, has the intention of entering into, or will enter into any put option, short position or other similar instrument or position in the U.S. with respect to the Acquiror Shares at any time after the Closing Date through the one year anniversary of the Closing Date except in compliance with the Securities Act; (viii) such Person consents to the placement of a legend on any certificate or other document evidencing the Acquiror Shares substantially in the form set forth in   Section 3.8(b) and (ix) such Person is not acquiring the Acquiror Shares in a transaction (or an element of a series of transactions) that is part of any plan or scheme to evade the registration provisions of the Securities Act.



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(g)

Opinion .  Such Acquiree Shareholder will not transfer any or all of such Acquiree Shareholder’s Acquiror Shares pursuant to Regulation S or absent an effective registration statement under the Securities Act and applicable state securities law covering the disposition of such Acquiree Shareholder’s Acquiror Shares, without first providing the Acquiror with an opinion of counsel (which counsel and opinion are reasonably satisfactory to the Acquiror) to the effect that such transfer will be made in compliance with Regulation S or will be exempt from the registration and the prospectus delivery requirements of the Securities Act and the registration or qualification requirements of any applicable U.S. state securities laws


(h)

Consent .  Such Acquiree Shareholder understands and acknowledges that the Acquiror may refuse to transfer the Acquiror Shares, unless such Acquiree Shareholder complies with Section 3.7 and any other restrictions on transferability set forth herein.  Such Acquiree Shareholder consents to the Acquiror making a notation on its records or giving instructions to any transfer agent of the Acquiror’s Common Stock in order to implement the restrictions on transfer of the Acquiror Shares


Section 3.8

Stock Legends


Such Acquiree Shareholder hereby agrees with the Acquiror as follows:


(a)

The certificates evidencing the Acquiror Shares issued to those Acquiree Shareholders who are Accredited Investors, and each certificate issued in transfer thereof, will bear the following or similar legend:


THE SECURITIES REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR ANY STATE SECURITIES LAWS AND NEITHER SUCH SECURITIES NOR ANY INTEREST THEREIN MAY BE OFFERED, SOLD, PLEDGED, ASSIGNED OR OTHERWISE TRANSFERRED EXCEPT (1) PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT AND APPLICABLE STATE SECURITIES LAWS OR (2) PURSUANT TO AN AVAILABLE EXEMPTION FROM THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND APPLICABLE STATE SECURITIES LAWS, IN WHICH CASE THE HOLDER MUST, PRIOR TO SUCH TRANSFER, FURNISH TO THE COMPANY AN OPINION OF COUNSEL, WHICH COUNSEL AND OPINION ARE REASONABLY SATISFACTORY TO THE COMPANY, THAT SUCH SECURITIES MAY BE OFFERED, SOLD, PLEDGED, ASSIGNED OR OTHERWISE TRANSFERRED IN THE MANNER CONTEMPLATED PURSUANT TO AN AVAILABLE EXEMPTION FROM THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND APPLICABLE STATE SECURITIES LAWS.




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(b)

The certificates evidencing the Acquiror Shares issued to those Acquiree Shareholders who are not U.S. Persons, and each certificate issued in transfer thereof, will bear the following legend:


THE SECURITIES REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR ANY STATE SECURITIES LAWS AND NEITHER SUCH SECURITIES NOR ANY INTEREST THEREIN MAY BE OFFERED, SOLD, PLEDGED, ASSIGNED OR OTHERWISE TRANSFERRED EXCEPT (1) IN ACCORDANCE WITH THE PROVISIONS OF REGULATION S PROMULGATED UNDER THE SECURITIES ACT, AND BASED ON AN OPINION OF COUNSEL, WHICH COUNSEL AND OPINION ARE REASONABLY SATISFACTORY TO THE COMPANY, THAT THE PROVISIONS OF REGULATION S HAVE BEEN SATISFIED, (2) PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT AND APPLICABLE STATE SECURITIES LAWS OR (3) PURSUANT TO AN AVAILABLE EXEMPTION FROM THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND APPLICABLE STATE SECURITIES LAWS, IN WHICH CASE THE HOLDER MUST, PRIOR TO SUCH TRANSFER, FURNISH TO THE COMPANY AN OPINION OF COUNSEL, WHICH COUNSEL AND OPINION ARE REASONABLY SATISFACTORY TO THE COMPANY, THAT SUCH SECURITIES MAY BE OFFERED, SOLD, PLEDGED, ASSIGNED OR OTHERWISE TRANSFERRED IN THE MANNER CONTEMPLATED PURSUANT TO AN AVAILABLE EXEMPTION FROM THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND APPLICABLE STATE SECURITIES LAWS.  HEDGING TRANSACTIONS INVOLVING THE SECURITIES REPRESENTED BY THIS CERTIFICATE MAY NOT BE CONDUCTED UNLESS IN COMPLIANCE WITH THE SECURITIES ACT.


(c)

Other Legends .  The certificates representing such Acquiror Shares, and each certificate issued in transfer thereof, will also bear any other legend required under any applicable Law, including, without limitation, any state corporate and state securities law, or Contract.


Section 3.9

Disclosure


No representation or warranty of such Acquiree Shareholder contained in this Agreement or any other Transaction Document and no statement or disclosure made by or on behalf of such Acquiree Shareholder to the Acquiror or the Acquiror Principal Shareholder pursuant to this Agreement or any other agreement contemplated herein contains an untrue statement of a material fact or omits to state a material fact necessary to make the statements contained herein or therein not misleading.


ARTICLE IV
REPRESENTATIONS AND WARRANTIES OF THE ACQUIREE


The Acquiree hereby represents and warrants to the Acquiror that the statements contained in this Article IV are correct and complete as of the date of this Agreement and will be correct and complete as of the Closing Date (as though made then and as thought the Closing Date were substituted for the date of this Agreement throughout this Article IV ) (except where another date or period of time is specifically stated herein for a representation or warranty).


Section 4.1

Organization and Qualification


The Acquiree is a corporation duly organized, validly existing and in good standing under the Laws of the jurisdiction of its incorporation or organization, has all requisite corporate authority and power, Licenses, authorizations, consents and approvals to carry on its business as presently conducted and to own, hold and operate its properties and assets as now owned, held and operated by it, and is duly qualified to do business and in good standing in each jurisdiction in which the failure to be so qualified would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect on the Acquiree.



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Section 4.2

Authority


The Acquiree has all requisite authority and power (corporate and other), Licenses, authorizations, consents and approvals to enter into and deliver this Agreement and any of the other Transaction Documents to which the Acquiree is a party and any other certificate, agreement, document or instrument to be executed and delivered by the Acquiree in connection with the transactions contemplated hereby and thereby and to perform its obligations hereunder and thereunder and to consummate the transactions contemplated hereby and thereby.  The execution and delivery of this Agreement and the other Transaction Documents by the Acquiree and the performance by the Acquiree of its obligations hereunder and thereunder and the consummation by the Acquiree of the transactions contemplated hereby and thereby have been duly authorized by all necessary action on the part of the Acquiree.  The Acquiree does not need to give any notice to, make any filing with, or obtain any authorization, consent or approval of any Person or Governmental Authority in order for the Parties to execute, deliver or perform this Agreement or the transactions contemplated hereby.  This Agreement has been, and each of the Transaction Documents to which the Acquiree is a party will be, duly and validly authorized and approved, executed and delivered by the Acquiree.


Section 4.3

Binding Obligations


Assuming this Agreement and the Transaction Documents have been duly and validly authorized, executed and delivered by the parties hereto and thereto other than the Acquiree, this Agreement and each of the Transaction Documents to which the Acquiree is a party are duly authorized, executed and delivered by the Acquiree and constitutes the legal, valid and binding obligations of the Acquiree enforceable against the Acquiree in accordance with their respective terms, except as such enforcement is limited by general equitable principles, or by bankruptcy, insolvency and other similar Laws affecting the enforcement of creditors rights generally.


Section 4.4

No Conflicts


Neither the execution nor the delivery by the Acquiree of this Agreement or any Transaction Document to which the Acquiree is a party, nor the consummation or performance by the Acquiree of the transactions contemplated hereby or thereby will, directly or indirectly, (a) contravene, conflict with, or result in a violation of any provision of the Acquiree Organizational Documents, (b) contravene, conflict with or result in a violation of any Law, Order, charge or other restriction or decree applicable to the Acquiree, or by which the Acquiree or any of its respective assets and properties are bound or affected, (c) contravene, conflict with, result in any breach of, or constitute a default (or an event that with notice or lapse of time or both would become a default) under, impair the rights of the Acquiree under, or alter the obligations of any Person under, or create in any Person the right to terminate, amend, accelerate or cancel, or require any notice, report or other filing (whether with a Governmental Authority or any other Person) pursuant to, or result in the creation of a Lien on any of the assets or properties of the Acquiree under, any note, bond, mortgage, indenture, Contract, License, permit, franchise or other instrument or obligation to which the Acquiree is a party or by which the Acquiree or any of its respective assets and properties are bound or affected; or (d) contravene, conflict with, or result in a violation of, the terms or requirements of, or give any Governmental Authority the right to revoke, withdraw, suspend, cancel, terminate or modify, any licenses, permits, authorizations, approvals, franchises or other rights held by the Acquiree or that otherwise relate to the business of, or any of the properties or assets owned or used by, the Acquiree, except, in the case of clauses (b), (c), or (d), for any such contraventions, conflicts, violations, or other occurrences as would not have a Material Adverse Effect on the Acquiree.


Section 4.5

Subsidiaries


The Acquiree does not own, directly or indirectly, any equity or other ownership interest in any corporation, partnership, joint venture or other entity or enterprise.  There are no Contracts or other obligations (contingent or otherwise) of the Acquiror to retire, repurchase, redeem or otherwise acquire any outstanding shares of capital stock of, or other ownership interests in, any other Person or to provide funds to or make any investment (in the form of a loan, capital contribution or otherwise) in any other Person.


Section 4.6

Organizational Documents


The Acquiree has delivered or made available to the Acquiror a true and correct copy of the Articles of Incorporation and Bylaws of the Acquiree and any other organizational documents of the Acquiree, each as amended, and each such instrument is in full force and effect (the “ Acquiree Organizational Documents ”).  The Acquiree is not in violation of any of the provisions of the Acquiree Organizational Documents.




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Section 4.7

Capitalization


(a)

The total authorized shares of capital stock of Acquiree currently consists of (1) 283,463,176 shares of Common Stock, par value $0.01 per share, and (2) 41,536,824 shares of preferred stock, par value $0.01 per share, 1,000,000 of which are designated Series A Preferred Stock, 4,711,247 of which are designated Series B Preferred Stock, 800,000 of which are designated Series C-1 Preferred Stock, 666,667 of which are designated as Series C-2 Preferred Stock, 502,604 of which are designated Series C-3 Preferred Stock, 4,250,000 of which are designated as Series C-4 Preferred Stock, 3,000,000 of which are designated as Series D Preferred Stock, and 26,606,306 of which are designated as Series E Preferred Stock. At the close of business on December __, 2012, 2,407,545 shares of our Common Stock were issued and outstanding, all authorized shares of Series A, B, C-1, C-2, C-3, C-4 and D Preferred Shares were issued and outstanding and 26,606,306 shares of our Series E Preferred Stock were issued and outstanding. We are authorized under our 2003 Stock Option Plan to issue options to purchase up to 10,283,480 shares of our Common Stock. As of December __, 2012, Acquiree had stock options outstanding to purchase 5,947,400 shares of Common Stock. Except as set forth above, no shares of capital stock or other voting securities of the Acquiree were issued, reserved for issuance or outstanding.  All outstanding shares of the capital stock of the Acquiree are, and all such shares that may be issued prior to the Closing Date will be when issued, duly authorized, validly issued, fully paid and nonassessable and not subject to or issued in violation of any purchase option, call option, right of first refusal, preemptive right, subscription right or any similar right under any provision of the Laws of the jurisdiction of the Acquiree’s formation, the Acquiree Organizational Documents or any Contract to which the Acquiree is a party or otherwise bound.  There are not any bonds, debentures, notes or other Indebtedness of the Acquiree having the right to vote (or convertible into, or exchangeable for, securities having the right to vote) on any matters on which holders of Acquiree Common Stock may vote.  Except pursuant provided otherwise, there are no options, warrants, rights, convertible or exchangeable securities, “phantom” stock rights, stock appreciation rights, stock-based performance units, commitments, Contracts, arrangements or undertakings of any kind to which the Acquiree is a party or by which it is bound (x) obligating the Acquiree to issue, deliver or sell, or cause to be issued, delivered or sold, additional shares of capital stock or other equity interests in, or any security convertible or exercisable for or exchangeable into any capital stock of or other equity interest in, the Acquiree, (y) obligating the Acquiree to issue, grant, extend or enter into any such option, warrant, call, right, security, commitment, Contract, arrangement or undertaking or (z) that give any Person the right to receive any economic benefit or right similar to or derived from the economic benefits and rights occurring to holders of the capital stock of the Acquiree.  There are no outstanding Contracts or obligations of the Acquiree to repurchase, redeem or otherwise acquire any shares of capital stock of the Acquiree.  There are no registration rights, proxies, voting trust agreements or other agreements or understandings with respect to any class or series of any capital stock or other security of the Acquiree.


Section 4.8

No Brokers or Finders


No Person has, or as a result of the transactions contemplated herein will have, any right or valid claim against the Acquiree for any commission, fee or other compensation as a finder or broker, or in any similar capacity, based upon arrangements made by or on behalf of the Acquiree, and the Acquiree will indemnify and hold the Acquiror and the Acquiror Principal Shareholder and harmless against any liability or expense arising out of, or in connection with, any such claim.


Section 4.9

Disclosure


No representation or warranty of the Acquiree contained in this Agreement and no statement or disclosure made by or on behalf of the Acquiree to the Acquiror or the Acquiror Principal Shareholder pursuant to this Agreement or any other agreement contemplated herein contains an untrue statement of a material fact or omits to state a material fact necessary to make the statements contained herein or therein not misleading.




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ARTICLE V
REPRESENTATIONS AND WARRANTIES OF THE ACQUIROR AND

ARTICLE VITHE ACQUIROR PRINCIPAL SHAREHOLDER


The Acquiror and the Acquiror Principal Shareholder, jointly and severally, hereby represent and warrant to the Acquiree and each of the Acquiree Shareholders, subject to the exceptions and qualifications specifically set forth or disclosed in writing in the disclosure schedule delivered by the Acquiror Principal Shareholder to the Acquiree and the Acquiree Shareholders simultaneously herewith (the “ Acquiror Disclosure Schedule ”), that the statements contained in this Article V are correct and complete as of the date of this Agreement and will be correct and complete as of the Closing Date (as though made then and as thought the Closing Date were substituted for the date of this Agreement throughout this Article V ) (except where another date or period of time is specifically stated herein for a representation or warranty).  The Acquiror Disclosure Schedule shall be arranged according to the numbered and lettered paragraphs of this Article V and any disclosure in the Acquiror Disclosure Schedule shall qualify the corresponding paragraph in this Article V .  The Acquiree, the Acquiree Shareholders and, after the Closing, the Acquiror, shall be entitled to rely on the representations and warranties set forth in this Article V regardless of any investigation or review conducted by the Acquiree or the Acquiree Shareholders prior to the Closing.


Section 6.1

Organization and Qualification


The Acquiror is a corporation duly organized, validly existing and in good standing under the Laws of the jurisdiction of its incorporation or organization, has all requisite corporate authority and power, Licenses, authorizations, consents and approvals to carry on its business as presently conducted and to own, hold and operate its properties and assets as now owned, held and operated by it, and is duly qualified to do business and in good standing in each jurisdiction in which the failure to be so qualified would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect on the Acquiror.


Section 6.2

Authority


The Acquiror and the Acquiror Principal Shareholder have all requisite authority and power, Licenses, authorizations, consents and approvals to enter into and deliver this Agreement and any of the other Transaction Documents to which the Acquiror, the Acquiror Principal Shareholder or any of them is a party and any other certificate, agreement, document or instrument to be executed and delivered by the Acquiror, the Acquiror Principal Shareholder or any of them in connection with the transactions contemplated hereby and thereby and to perform their respective obligations hereunder and thereunder and to consummate the transactions contemplated hereby and thereby.  The execution and delivery of this Agreement and the other Transaction Documents by the Acquiror and the Acquiror Principal Shareholder and the performance by the Acquiror and the Acquiror Principal Shareholder of their respective obligations hereunder and thereunder and the consummation by the Acquiror and the Acquiror Principal Shareholder of the transactions contemplated hereby and thereby have been duly authorized by all necessary action on the part of the Acquiror and the Acquiror Principal Shareholder.  Neither the Acquiror nor the Acquiror Principal Shareholder needs to give any notice to, make any filing with, or obtain any authorization, consent or approval of any Person or Governmental Authority in order for the Parties to execute, deliver or perform this Agreement or the transactions contemplated hereby.  This Agreement has been, and each of the Transaction Documents to which the Acquiror, the Acquiror Principal Shareholder or any of them, as applicable, are a party will be, duly and validly authorized and approved, executed and delivered by the Acquiror and the Acquiror Principal Shareholder.


Section 6.3

Binding Obligations


Assuming this Agreement and the Transaction Documents have been duly and validly authorized, executed and delivered by the parties hereto and thereto other than the Acquiror and the Acquiror Principal Shareholder, this Agreement and each of the Transaction Documents to which the Acquiror, the Acquiror Principal Shareholder or any of them, as applicable, are a party are duly authorized, executed and delivered by the Acquiror and such Acquiror Principal Shareholder, as applicable, and constitutes the legal, valid and binding obligations of the Acquiror and such Acquiror Principal Shareholder, as applicable, enforceable against the Acquiror and such Acquiror Principal Shareholder, as applicable, in accordance with their respective terms, except as such enforcement is limited by general equitable principles, or by bankruptcy, insolvency and other similar Laws affecting the enforcement of creditors rights generally.




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Section 6.4

No Conflicts


Neither the execution nor the delivery by the Acquiror or the Acquiror Principal Shareholder of this Agreement or any Transaction Document to which the Acquiror, the Acquiror Principal Shareholder or any of them is a party, nor the consummation or performance by the Acquiror and the Acquiror Principal Shareholder of the transactions contemplated hereby or thereby will, directly or indirectly, (a) contravene, conflict with, or result in a violation of any provision of the Acquiror Organizational Documents, (b) contravene, conflict with or result in a violation of any Law, Order, charge or other restriction or decree of any Governmental Authority or any rule or regulation of the Principal Market applicable to the Acquiror or the Acquiror Principal Shareholder, or by which the Acquiror or the Acquiror Principal Shareholder or any of their respective assets and properties are bound or affected, (c) contravene, conflict with, result in any breach of, or constitute a default (or an event that with notice or lapse of time or both would become a default) under, impair the rights of the Acquiror under, or alter the obligations of any Person under, or create in any Person the right to terminate, amend, accelerate or cancel, or require any notice, report or other filing (whether with a Governmental Authority or any other Person) pursuant to, or result in the creation of a Lien on any of the assets or properties of the Acquiror under, any note, bond, mortgage, indenture, Contract, License, permit, franchise or other instrument or obligation to which the Acquiror or the Acquiror Principal Shareholder is a party or by which the Acquiror or the Acquiror Principal Shareholder or any of their respective assets and properties are bound or affected; or (d) contravene, conflict with, or result in a violation of, the terms or requirements of, or give any Governmental Authority the right to revoke, withdraw, suspend, cancel, terminate or modify, any Licenses, permits, authorizations, approvals, franchises or other rights held by the Acquiror or that otherwise relate to the business of, or any of the properties or assets owned or used by, the Acquiror, except, in the case of clauses (b), (c), or (d), for any such contraventions, conflicts, violations, or other occurrences as would not have a Material Adverse Effect on the Acquiror.


Section 6.5

Subsidiaries


The Acquiror does not own, directly or indirectly, any equity or other ownership interest in any corporation, partnership, joint venture or other entity or enterprise.  There are no Contracts or other obligations (contingent or otherwise) of the Acquiror to retire, repurchase, redeem or otherwise acquire any outstanding shares of capital stock of, or other ownership interests in, any other Person or to provide funds to or make any investment (in the form of a loan, capital contribution or otherwise) in any other Person.


Section 6.6

Organizational Documents


The Acquiror has delivered or made available to Acquiree a true and correct copy of the Certificate of Incorporation and Bylaws of the Acquiror and any other organizational documents of the Acquiror, each as amended, and each such instrument is in full force and effect (the “ Acquiror Organizational Documents ”).  The Acquiror is not in violation of any of the provisions of its Acquiror Organizational Documents.  The minute books (containing the records or meetings of the stockholders, the board of directors and any committees of the board of directors), the stock certificate books, and the stock record books of the Acquiror, each as provided or made available to the Acquiree, are correct and complete.




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Section 6.7

Capitalization


(a)

The authorized capital stock of the Acquiror consists of (i) 100,000,000 shares of Acquiror Common Stock of which (A) 11,155,008 shares of Acquiror Common Stock are issued and outstanding; and (ii) 100,000,000 shares of preferred stock, $0.01 par value per share, of which no shares of preferred stock are outstanding.  No shares of Acquiror Common Stock or any other class of preferred stock of the Acquiror are held by the Acquiror in its treasury.  Except as set forth above, no shares of capital stock or other voting securities of the Acquiror were issued, reserved for issuance or outstanding.  All outstanding shares of the capital stock of the Acquiror are, and all such shares that may be issued prior to the Closing Date will be when issued, duly authorized, validly issued, fully paid and nonassessable and not subject to or issued in violation of any purchase option, call option, right of first refusal, preemptive right, subscription right or any similar right under any provision of the Laws of the jurisidication of the Acquiror’s organization, the Acquiror Organizational Documents or any Contract to which the Acquiror is a party or otherwise bound.  There are not any bonds, debentures, notes or other Indebtedness of the Acquiror having the right to vote (or convertible into, or exchangeable for, securities having the right to vote) on any matters on which holders of Acquiror Common Stock may vote.  There are no options, warrants, rights, convertible or exchangeable securities, “phantom” stock rights, stock appreciation rights, stock-based performance units, commitments, Contracts, arrangements or undertakings of any kind to which the Acquiror is a party or by which it is bound (x) obligating the Acquiror to issue, deliver or sell, or cause to be issued, delivered or sold, additional shares of capital stock or other equity interests in, or any security convertible or exercisable for or exchangeable into any capital stock of or other equity interest in, the Acquiror, (y) obligating the Acquiror to issue, grant, extend or enter into any such option, warrant, call, right, security, commitment, Contract, arrangement or undertaking or (z) that give any Person the right to receive any economic benefit or right similar to or derived from the economic benefits and rights occurring to holders of the capital stock of the Acquiror.  Except as contemplated by the Spin Out, there are no outstanding Contracts or obligations of the Acquiror to repurchase, redeem or otherwise acquire any shares of capital stock of the Acquiror.  There are no registration rights, proxies, voting trust agreements or other agreements or understandings with respect to any class or series of any capital stock or other security of the Acquiror.  The stockholder list provided to the Acquiree and the Acquiree Shareholders is a current stockholder list generated by its stock transfer agent, and such list accurately reflects all of the issued and outstanding shares of the Acquiror Common Stock.


(b)

The issuance of the Acquiror Shares to the Acquiree Shareholders has been duly authorized and, upon delivery to the Acquiree Shareholders of certificates therefor, respectively, in accordance with the terms of this Agreement, the Acquiror Shares, will have been validly issued and fully paid, and will be nonassessable, have the rights, preferences and privileges specified, will be free of preemptive rights and will be free and clear of all Liens and restrictions, other than Liens created by the Acquiree Shareholders, and restrictions on transfer imposed by this Agreement and the Securities Act.


Section 6.8

Compliance with Laws


The business and operations of the Acquiror have been and are being conducted in accordance with all applicable Laws and Orders.  The Acquiror is not in conflict with, or in default or violation of and, to the Knowledge of the Acquiror or the Acquiror Principal Shareholder, is not under investigation with respect to and has not been threatened to be charged with or given notice of any violation of or default under, any (i) Law, rule, regulation, judgment or Order, or (ii) note, bond, mortgage, indenture, Contract, License, permit, franchise or other instrument or obligation to which the Acquiror or the Acquiror Principal Shareholder is a party or by which the Acquiro or the Acquiror Principal Shareholder or any of their respective assets and properties are bound or affected.  There is no agreement, judgment or Order binding upon the Acquiror or the Acquiror Principal Shareholder which has, or could reasonably be expected to have, the effect of prohibiting or materially impairing any business practice of the Acquiror or the conduct of business by the Acquiror as currently conducted.  The Acquiror has filed all forms, reports and documents required to be filed with any Governmental Authority and the Acquiror has made available such forms, reports and documents to Acquiree and the Acquiree Shareholders.  As of their respective dates, such forms, reports and documents complied in all material respects with the applicable requirements pertaining thereto and none of such forms, reports and documents 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 the light of the circumstances under which they were made, not misleading.




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Section 6.9

Certain Proceedings


There is no Action pending against, or to the Knowledge of the Acquiror or the Acquiror Principal Shareholder, threatened against or affecting, the Acquiror or the Acquiror Principal Shareholder by any Governmental Authority or other Person with respect to the Acquiror or their respective businesses or that challenges, or may have the effect of preventing, delaying, making illegal, or otherwise interfering with, any of the transactions contemplated by this Agreement.  The Acquiror is not in violation of and, to the Knowledge of Acquiror or the Acquiror Principal Shareholder, is not under investigation with respect to and has not been threatened to be charged with or given notice of any violation of, any applicable Law, rule, regulation, judgment or Order.  Neither the Acquiror, nor any director or officer (in his or her capacity as such) of the Acquiror, is or has been the subject of any Action involving a claim or violation of or liability under federal or state securities laws or a claim of breach of fiduciary duty.


Section 6.10

No Brokers or Finders


No Person has, or as a result of the transactions contemplated herein will have, any right or valid claim against the Acquiror or the Acquiror Principal Shareholder for any commission, fee or other compensation as a finder or broker, or in any similar capacity, based upon arrangements made by or on behalf of the Acquiror or the Acquiror Principal Shareholder, and the Acquiror Principal Shareholder will indemnify and hold the Acquiror, the Acquiree and the Acquiree Shareholders and harmless against any liability or expense arising out of, or in connection with, any such claim.


Section 6.11

Contracts

Except as disclosed in the SEC Reports, there are no Contracts that are material to the business, properties, assets, condition (financial or otherwise), results of operations or prospects of the Acquiror.  The Acquiror is not in violation of or in default under (nor does there exist any condition which upon the passage of time or the giving of notice would cause such a violation of or default under) any Contract to which it is a party or to which it or any of its properties or assets is subject, except for violations or defaults that would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect of the Acquiror.


Section 6.12

Tax Matters

.

(a)

Tax Returns .  The Acquiror has filed all Tax Returns required to be filed (if any) by or on behalf of the Acquiror and has paid all Taxes of the Acquiror required to have been paid (whether or not reflected on any Tax Return).  No Governmental Authority in any jurisdiction has made a claim, assertion or threat to the Acquiror that the Acquiror is or may be subject to taxation by such jurisdiction; there are no Liens with respect to Taxes on the Acquiror’s property or assets; and there are no Tax rulings, requests for rulings, or closing agreements relating to the Acquiror for any period (or portion of a period) that would affect any period after the date hereof.


(b)

No Adjustments, Changes .  Neither the Acquiror nor any other Person on behalf of the Acquiror (a) has executed or entered into a closing agreement pursuant to Section 7121 of the Code or any predecessor provision thereof or any similar provision of state, local or foreign law; or (b) has agreed to or is required to make any adjustments pursuant to Section 481(a) of the Code or any similar provision of state, local or foreign law.


(c)

No Disputes .  There is no pending audit, examination, investigation, dispute, proceeding or claim with respect to any Taxes of the Acquiror, nor is any such claim or dispute pending or contemplated.  The Acquiror has delivered to the Acquiree true, correct and complete copies of all Tax Returns and examination reports and statements of deficiencies assessed or asserted against or agreed to by the Acquiror, if any, since its inception and any and all correspondence with respect to the foregoing.


(d)

Not a U.S. Real Property Holding Corporation .  The Acquiror is not and has not been a U.S. real property holding corporation within the meaning of Section 897(c)(2) of the Code at any time during the applicable period specified in Section 897(c)(1)(A)(ii) of the Code.



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(e)

No Tax Allocation, Sharing .  The Acquiror is not and has not been a party to any Tax allocation or sharing agreement.


(f)

No Other Arrangements .  The Acquiror is not a party to any Contract or arrangement for services that would result, individually or in the aggregate, in the payment of any amount that would not be deductible by reason of Section 162(m), 280G or 404 of the Code.  The Acquiror is not a “consenting corporation” within the meaning of Section 341(f) of the Code.  The Acquiror does not have any “tax-exempt bond financed property” or “tax-exempt use property” within the meaning of Section 168(g) or (h), respectively of the Code.  The Acquiror does not have any outstanding closing agreement, ruling request, request for consent to change a method of accounting, subpoena or request for information to or from a Governmental Authority in connection with any Tax matter.  During the last two years, has not engaged in any exchange with a related party (within the meaning of Section 1031(f) of the Code) under which gain realized was not recognized by reason of Section 1031 of the Code.  The Acquiror is not a party to any reportable transaction within the meaning of Treasury Regulation Section 1.6011-4.


Section 6.13

Labor Matters


(a)

There are no collective bargaining or other labor union agreements to which the Acquiror is a party or by which it is bound.  No material labor dispute exists or, to the Knowledge of the Acquiror, is imminent with respect to any of the employees of the Acquiror.


(b)

Except as set forth in Section 5.13 of the Acquiror Disclosure Schedule, the Acquiror does not have any any employees, independent contractors or other Persons providing services to them.  The Acquiror is in full compliance with all Laws regarding employment, wages, hours, benefits, equal opportunity, collective bargaining, the payment of Social Security and other taxes, and occupational safety and health.  The Acquiror is not liable for the payment of any compensation, damages, taxes, fines, penalties or other amounts, however designated, for failure to comply with any of the foregoing Laws.


(c)

No director, officer or employee of the Acquiror is a party to, or is otherwise bound by, any Contract (including any confidentiality, non-competition or proprietary rights agreement) with any other Person that in any way adversely affects or will materially affect (a) the performance of his or her duties as a director, officer or employee of the Acquiror or (b) the ability of the Acquiror to conduct its business.  Each employee of the Acquiror is employed on an at-will basis and the Acquiror does not have any Contract with any of its employees which would interfere with its ability to discharge its employees.


Section 6.14

Employee Benefits

.

(a)

The Acquiror has not, or ever has, maintained or contributed to any bonus, pension, profit sharing, deferred compensation, incentive compensation, stock ownership, stock purchase, stock option, phantom stock, retirement, vacation, severance, disability, death benefit, hospitalization, medical or other plan, arrangement or understanding (whether or not legally binding) providing benefits to any current or former employee, officer or director of the Acquiror.  There are not any employment, consulting, indemnification, severance or termination agreements or arrangements between the Acquiror and any current or former employee, officer or director of the Acquiror, nor does the Acquiror have any general severance plan or policy.


(b)

The Acquiror has not, or ever has, maintained or contributed to any “employee pension benefit plans” (as defined in Section 3(2) of ERISA), “employee welfare benefit plans” (as defined in Section 3(1) of ERISA) or any other benefit plan for the benefit of any current or former employees, consultants, officers or directors of the Acquiror.



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(c)

Neither the consummation of the transactions contemplated hereby alone, nor in combination with another event, with respect to each director, officer, employee and consultant of the Acquiror, will result in (a) any payment (including, without limitation, severance, unemployment compensation or bonus payments) becoming due from the Acquiror, (b) any increase in the amount of compensation or benefits payable to any such individual or (c) any acceleration of the vesting or timing of payment of compensation payable to any such individual.  No arrangement or other Contract of the Acquiror provides benefits or payments contingent upon, triggered by, or increased as a result of a change in the ownership or effective control of the Acquiror.


Section 6.15

Title to Assets


The Acquiror does not own any real property.  The Acquiror has sufficient title to, or valid leasehold interests in, all of its properties and assets used in the conduct of its businesses.  All such assets and properties, other than assets and properties in which the Acquiror has leasehold interests, are free and clear of all Liens, except for Liens that, in the aggregate, do not and will not materially interfere with the ability of the Acquiror to conduct business as currently conducted.


Section 6.16

Intellectual Property


The Acquiror does not own, use or license any Intellectual Property in its business as presently conducted.


Section 6.17

Environmental Laws


The Acquiror (a) is in compliance with all Environmental Laws (as defined below), (b) has received all Licenses or other approvals required of them under applicable Environmental Laws to conduct their respective businesses and (c) is in compliance with all terms and conditions of any such License or approval where, in each of the foregoing clauses (a), (b) and (c), the failure to so comply could be reasonably expected to have, individually or in the aggregate, a Material Adverse Effect on the Acquiror.  The term “ Environmental Laws ” means all federal, state, local or foreign laws relating to pollution or protection of human health or the environment (including, without limitation, ambient air, surface water, groundwater, land surface or subsurface strata), including, without limitation, laws relating to emissions, discharges, releases or threatened releases of chemicals, pollutants, contaminants, or toxic or hazardous substances or wastes (collectively, “ Hazardous Materials ”) into the environment, or otherwise relating to the manufacture, processing, distribution, use, treatment, storage, disposal, transport or handling of Hazardous Materials, as well as all authorizations, codes, decrees, demands or demand letters, injunctions, judgments, Licenses, notices or notice letters, Orders, permits, plans or regulations issued, entered, promulgated or approved thereunder.


Section 6.18

SEC Reports

.

(a)

The Acquiror has filed all reports, schedules, forms, statements and other documents required to be filed by it with the SEC since February 5, 2007, pursuant to the Exchange Act (the “ SEC Reports ”).



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(b)

As of their respective dates, the SEC Reports and any registration statements filed by the Acquiror under the Securities Act (the “ Registration Statements ”) complied in all material respects with the requirements of the Exchange Act and the Securities Act, as applicable, and the rules and regulations of the SEC promulgated thereunder, and none of the SEC Reports or Registration Statements, when filed, contained any untrue statement of a material fact or omitted 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.  All material Contracts to which the Acquiror is a party or to which the property or assets of the Acquiror are subject have been filed as exhibits to the SEC Reports and the Registration Statements as and to the extent required under the Exchange Act and the Securities Act, as applicable.  The financial statements of the Acquiror included in the SEC Reports and the Registration Statements comply in all respects with applicable accounting requirements and the rules and regulations of the SEC with respect thereto as in effect at the time of filing, were prepared in accordance with GAAP applied on a consistent basis during the periods involved (except as may be indicated in the notes thereto, or, in the case of unaudited statements as permitted by Form 10-Q), and fairly present in all material respects (subject in the case of unaudited statements, to normal, recurring audit adjustments) the financial position of the Acquiror as at the dates thereof and the results of its operations and cash flows for the periods then ended.  The Acquiror was originally organized and operated  as a bona fide operating business without any pre-existing plan or strategy that the Acquiror would serve primarily as a merger or acquisition candidate for an unidentified company or companies. On February 5, 2007 the Acquiror filed a Form 10 indicating its shell status.  The disclosure set forth in the SEC Reports and Registration Statements regarding the Acquiror’s business is current and complete and accurately reflects operations of the Acquiror as it exists as of the date hereof.


Section 6.19

Internal Accounting Controls


The Acquiror maintains a system of internal accounting controls sufficient to provide reasonable assurance that (a) transactions are executed in accordance with management’s general or specific authorizations, (b) transactions are recorded as necessary to permit preparation of financial statements in conformity with generally accepted accounting principles and to maintain asset accountability, (c) access to assets is permitted only in accordance with management’s general or specific authorization, and (d) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences.  The Acquiror has established disclosure controls and procedures for the Acquiror and designed such disclosure controls and procedures to ensure that material information relating to the Acquiror is made known to the officers by others within the Acquiror.  The Acquiror’s officers have evaluated the effectiveness of the Acquiror’s controls and procedures.  Since the Acquiror Most Recent Fiscal Year End, there have been no significant changes in the Acquiror’s internal controls or, to the Knowledge of the Acquiror or the Acquiror Principal Shareholder, in other factors that could significantly affect the Acquiror’s internal controls.


Section 6.20

Listing and Maintenance Requirements


The Acquiror is, and has no reason to believe that it will not in the foreseeable future continue to be, in compliance with the listing and maintenance requirements for continued listing or quotation of the Acquiror Common Stock on the trading market on which the Acquiror Common Stock is currently listed or quoted.  The issuance and sale of the Acquiror Shares under this Agreement does not contravene the rules and regulations of the trading market on which the Acquiror Common Stock is currently listed or quoted, and no approval of the stockholders of the Acquiror is required for the Acquiror to issue and deliver to the Acquiree Shareholders the Acquiror Shares contemplated by this Agreement.


Section 6.21

Application of Takeover Protections


The Acquiror has taken all necessary action, if any, in order to render inapplicable any control share acquisition, business combination, poison pill (including any distribution under a rights agreement) or other similar anti-takeover provision under the Acquiror Organizational Documents or the Laws of its state of incorporation that is or could become applicable to the transactions contemplated hereby.




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Section 6.22

Transactions With Affiliates and Employees


Except as disclosed in the SEC Reports, no officer, director, employee or stockholder of the Acquiror or any Affiliate of any such Person, has or has had, either directly or indirectly, an interest in any transaction with the Acquiror (other than for services as employees, officers and directors), including any Contract or other arrangement providing for the furnishing of services to or by, providing for rental of real or personal property to or from, or otherwise requiring payments to or from any such Person or, to the Knowledge of the Acquiror or the Acquiror Principal Shareholder, any entity in which any such Person has an interest or is an officer, director, trustee or partner.


Section 6.23

Liabilities


Except as set forth on Section 5.23 of the Acquiror Disclosure Schedule, the Acquiror does not have any Liability (and there is no Action pending, or to the Knowledge of the Acquiror or the Acquiror Principal Shareholder, threatened against the Acquiror that would reasonably be expected to give rise to any Liability).  The Acquiror is not a guarantor nor is either otherwise liable for any Liability or obligation (including Indebtedness) of any other Person.  There are no financial or contractual obligations of the Acquiror (including any obligations to issue capital stock or other securities) executory after the Closing Date.  All Liabilities of the Acquiror shall have been paid off at or prior to the Closing and shall in no event remain Liabilities of the Acquiror, the Acquiree or the Acquiree Shareholders following the Closing.


Section 6.24

Bank Accounts and Safe Deposit Boxes


The Acquiror does not have any bank or other deposit or financial account, nor does the Acquiror have any lock boxes or safety deposit boxes.


Section 6.25

Investment Company


The Acquiror is, nor is it an affiliate of, and immediately following the Closing will not have become, an “investment company” within the meaning of the Investment Company Act of 1940, as amended.


Section 6.26

Bank Holding Company Act


The Acquiror is not subject to the Bank Holding Company Act of 1956, as amended (the “ BHCA ”) and to regulation by the Board of Governors of the Federal Reserve System (the “ Federal Reserve ”).  Neither the Acquiror nor any of its Affiliates owns or controls, directly or indirectly, five percent (5%) or more of the outstanding shares of any class of voting securities or twenty-five percent (25%) or more of the total equity of a bank or any equity that is subject to the BHCA and to regulation by the Federal Reserve.  Neither the Acquiror nor any of its Affiliates exercises a controlling influence over the management or policies of a bank or any entity that is subject to the BHCA and to regulation by the Federal Reserve.


Section 6.27

Public Utility Holding Act


The Acquiror is not a “holding company,” or an “affiliate” of a “holding company,” as such terms are defined in the Public Utility Holding Act of 2005.


Section 6.28

Federal Power Act


The Acquiror is not subject to regulation as a “public utility” under the Federal Power Act, as amended.


Section 6.29

Money Laundering Laws


The operations of the Acquiror are and have been conducted at all times in compliance with applicable financial recordkeeping and reporting requirements of the Currency and Foreign Transactions Reporting Act of 1970, as amended, the money laundering statutes of all U.S. and non-U.S. jurisdictions, the rules and regulations thereunder and any related or similar rules, regulations or guidelines, issued, administered or enforced by any Governmental Authority (collectively, the “ Money Laundering Laws ”) and no Proceeding involving the Acquiror with respect to the Money Laundering Laws is pending or, to the knowledge of the Acquiror, threatened.



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Section 6.30

Foreign Corrupt Practices


The Acquiror nor, to the Knowledge of the Acquiror or the Acquiror Principal Shareholder, any director, officer, agent, employee or other Person acting on behalf of the Acquiror has not, in the course of its actions for, or on behalf of, the Acquiror (a) used any corporate funds for any unlawful contribution, gift, entertainment or other unlawful expenses relating to political activity; (b) made any direct or indirect unlawful payment to any foreign or domestic government official or employee from corporate funds; (c) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, as amended; or (d) made any unlawful bribe, rebate, payoff, influence payment, kickback or other unlawful payment to any foreign or domestic government official or employee.


Section 6.31

DTC Eligibility


The Acquiror Common Stock is eligible for clearance and settlement through The Depository Trust Company (“ DTC ”).    There is no DTC “chill” or equivalent on the Acquiror Common Stock.  The name, address, telephone number, fax number, contact person and email address of the Acquiror’s transfer agent is set forth in Section 5.31 of the Acquiror Disclosure Schedule.


Section 6.32

Absence of Certain Changes or Events


Except as set forth in the SEC Reports, from the Acquiror Most Recent Fiscal Year End (a) the Acquiror have conducted its business only in Ordinary Course of Business; (b) there has not been any change in the assets, Liabilities, financial condition or operating results of the Acquiror, except changes in the Ordinary Course of Business that have not caused, in the aggregate, a Material Adverse Effect on the Acquiror; and (iii) the Acquiror has not completed or undertaken any of the actions set forth in Section 6.2 .  The Acquiror has not taken any steps to seek protection pursuant to any Law or statute relating to bankruptcy, insolvency, reorganization, receivership, liquidation or winding up, nor does the Acquiror have any Knowledge or reason to believe that any of their respective creditors intend to initiate involuntary bankruptcy proceedings or any actual knowledge of any fact which would reasonably lead a creditor to do so.


Section 6.33

Disclosure


All documents and other papers delivered or made available by or on behalf of the Acquiror, or the Acquiror Principal Shareholder in connection with this Agreement are true, complete, correct and authentic in all material respects.  No representation or warranty of the Acquiror or the Acquiror Principal Shareholder contained in this Agreement and no statement or disclosure made by or on behalf of the Acquiror, or the Acquiror Principal Shareholder to the Acquiree or any Acquiree Shareholder pursuant to this Agreement or any other agreement contemplated herein contains an untrue statement of a material fact or omits to state a material fact necessary to make the statements contained herein or therein not misleading.


Section 6.34

Undisclosed Events


No event, Liability, development or circumstance has occurred or exists, or is contemplated to occur with respect to the Acquiror or its businesses, properties, prospects, operations or financial condition, that would be required to be disclosed by the Acquiror under applicable securities laws on a registration statement on Form S-1 filed with the SEC relating to an issuance and sale by the Acquiror of its common stock and which has not been publicly announced or will not be publicly announced in a current report on Form 8-K filed by the Acquiror filed within four (4) Business Days after the Closing.


Section 6.35

Non-Public Information


Neither the Acquiror nor any Person acting on its behalf has provided the Acquiree or Acquiree Shareholders or their respective agents or counsel with any information that the Acquiror or the believes constitutes material, non-public information except insofar as the existence and terms of the proposed transactions hereunder may constitute such information and except for information that will be disclosed by the Acquiror in a current report on Form 8-K filed by the Acquiror within four (4) Business Days after the Closing.




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ARTICLE VII
CONDUCT PRIOR TO CLOSING


Section 7.1

Conduct of Business


At all times during the period commencing with the execution and delivery of this Agreement and continuing until the earlier of the termination of this Agreement pursuant to the terms hereof or the Closing, the Acquiror Principal Shareholder shall, and shall cause the Acquiror to, (a) carry on its business diligently and in the usual, regular and Ordinary Course of Business, in substantially the same manner as heretofore conducted and in compliance with all applicable Laws, (b) pay or perform its material obligations when due, (c) use its commercially reasonable efforts, consistent with past practices and policies, to preserve intact its present business organization, keep available the services of its present officers and employees and preserve its relationships with customers, suppliers, distributors, licensors, licensees and others with which it has business dealings, and (d) keep its business and properties substantially intact, including its present operations, physical facilities and working conditions.  In furtherance of the foregoing and subject to applicable Law, the Acquiror shall confer with Acquiree, as promptly as practicable, prior to taking any material actions or making any material management decisions with respect to the conduct of the business of the Acquiror.


Section 7.2

Restrictions on Conduct of Business


Without limiting the generality of the terms of Section 6.1 hereof, except (i) as required by the terms hereof, or (ii) to the extent that Acquiree shall otherwise consent in writing, at all times during the period commencing with the execution and delivery of this Agreement and continuing until the earlier of the termination of this Agreement pursuant to the terms hereof or the Closing, neither the Acquiror, nor the Acquiror Principal Shareholder shall do any of the following, or permit the Acquiror to do any of the following:


(a)

except as required by applicable Law, waive any stock repurchase rights, accelerate, amend or change the period of exercisability of options or restricted stock, or reprice options granted under any employee, consultant or director stock plans or authorize cash payments in exchange for any options granted under any of such plans;


(b)

enter into any partnership arrangements, joint development agreements or strategic alliances, other than in the Ordinary Course of Business;


(c)

(i) increase the compensation or fringe benefits of, or pay any bonuses or special awards to, any present or former director, officer, stockholder or employee of the Acquiror (except for increases in salary or wages in the Ordinary Course of Business) or increase any fees to any independent contractors, (ii) grant any severance or termination pay to any present or former director, officer or employee of the Acquiror, (iii) enter into, amend or terminate any employment Contract, independent contractor agreement or collective bargaining agreement, written or oral, or (iv) establish, adopt, enter into, amend or terminate any bonus, profit sharing, incentive, severance, or other plan, agreement, program, policy, trust, fund or other arrangement that would be an employee benefit plan if it were in existence as of the date of this Agreement, except as required by applicable Law;


(d)

issue, deliver, sell, authorize, pledge or otherwise encumber, or propose any of the foregoing with respect to, any shares of capital stock or any securities convertible into, or exercisable or exchangeable for, shares of capital stock of the Acquiror, or subscriptions, rights, warrants or options to acquire any shares of capital stock or any securities convertible into, or exercisable or exchangeable for, shares of capital stock of the Acquiror, or enter into other Contracts or commitments of any character obligating it to issue any such shares of capital stock of the Acquiror, or securities convertible into, or exercisable or exchangeable for, shares of capital stock of the Acquiror;


(e)

cause, permit or propose any amendments to any Acquiror Organizational Documents;



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(f)

acquire or agree to acquire by merging or consolidating with, or by purchasing any equity interest in or a portion of the assets of, or by any other manner, any business or any corporation, limited liability company, general or limited partnership, joint venture, association, business trust or other business enterprise or entity, or otherwise acquire or agree to acquire any assets other than in the Ordinary Course of Business;


(g)

adopt a plan of merger, complete or partial liquidation, dissolution, consolidation, restructuring, recapitalization or other reorganization;


(h)

except as required by applicable Law, adopt or amend any employee benefit plan or employee stock purchase or employee stock option plan, or enter into any employment Contract or collective bargaining agreement (other than offer letters and letter agreements entered into in the Ordinary Course of Business with employees who are terminable “at will”), pay any special bonus or special remuneration to any director or employee other than in the Ordinary Course of Business, or increase the salaries or wage rates or fringe benefits (including rights to severance or indemnification) of its officers;


(i)

except in the Ordinary Course of Business, modify, amend or terminate any Contract to which the Acquiror is a party, or waive, delay the exercise of, release or assign any rights or claims thereunder;


(j)

sell, lease, license, mortgage or otherwise encumber or subject to any Lien or otherwise dispose of any of its properties or assets, except in the Ordinary Course of Business;


(k)

 (i) incur any Indebtedness or guarantee any such Indebtedness of another Person, issue or sell any debt securities or warrants or other rights to acquire any debt securities of the Acquiror, guarantee any debt securities of another Person, enter into any “keep well” or other agreement to maintain any financial statement condition of another Person or enter into any arrangement having the economic effect of any of the foregoing, except for endorsements and guarantees for collection, short-term borrowings and lease obligations, in each case incurred in the Ordinary Course of Business, or (ii) make any loans, advances or capital contributions to, or investment in, any other Person, other than to the Acquiror;


(l)

pay, discharge or satisfy any claims (including claims of stockholders), Liabilities or obligations (absolute, accrued, asserted or unasserted, contingent or otherwise), except for the payment, discharge or satisfaction of liabilities or obligations in the Ordinary Course of Business or in accordance with their terms as in effect on the date hereof, or waive, release, grant, or transfer any rights of material value or modify or change in any material respect any existing License, Contract or other document, other than in the Ordinary Course of Business;


(m)

change any financial reporting or accounting principle, methods or practices used by it unless otherwise required by applicable Law or GAAP;


(n)

settle or compromise any litigation (whether or not commenced prior to the date of this Agreement);


(o)

(i) declare, set aside or pay any dividends on, or make any other distributions in respect of, any of its capital stock, (ii) split, combine or reclassify any of its capital stock or issue or authorize the issuance of any other securities in respect of, in lieu of or in substitution for shares of its capital stock, or (iii) redeem or otherwise acquire any shares of capital stock of the Acquiror or any other securities thereof or any rights, warrants or options to acquire any such shares or other securities;



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(p)

enter into any transaction with any of its directors, officers, stockholders, or other Affiliates;


(q)

make any capital expenditure in excess of $50,000;


(r)

(i) grant any license or sublicense of any rights under or with respect to any Intellectual Property; (ii) dispose of or let lapse and Intellectual Property, or any application for the foregoing, or any license, permit or authorization to use any Intellectual Property or (iii) amend, terminate any other Contract, license or permit to which the Acquiror is a party;


(s)

make, or permit to be made, without the prior written consent of Acquiree any material Tax election which would affect the Acquiror; or


(t)

commit to or otherwise to take any of the actions described in this Section 6.2 .


ARTICLE VIII
ADDITIONAL AGREEMENTS


Section 8.1

Access to Information


The Acquiror shall afford Acquiree its accountants, counsel and other representatives (including the Acquiree Shareholders), reasonable access, during normal business hours, to the properties, books, records and personnel of the Acquiror at any time prior to the Closing in order to enable Acquiree obtain all information concerning the business, assets and properties, results of operations and personnel of the Acquiror as Acquiree may reasonably request.  No information obtained in the foregoing investigation by Acquiree pursuant to this Section 7.1 shall affect or be deemed to modify any representation or warranty contained herein or the conditions to the obligations of the Acquiror or the Acquiror Principal Shareholder to consummate the transactions contemplated hereby.


Section 8.2

Legal Requirements


The Parties shall take all reasonable actions necessary or desirable to comply promptly with all legal requirements which may be imposed on them with respect to the consummation of the transactions contemplated by this Agreement (including, without limitation, furnishing all information required in connection with approvals of or filings with any Governmental Authority, and prompt resolution of any litigation prompted hereby), and shall promptly cooperate with, and furnish information to, the other Parties to the extent necessary in connection with any such requirements imposed upon any of them in connection with the consummation of the transactions contemplated by this Agreement.


Section 8.3

Notification of Certain Matters


Acquiree shall give prompt notice to the Acquiror Principal Shareholder, and the Acquiror Principal Shareholder shall give prompt notice to the Acquiree, of the occurrence, or failure to occur, of any event, which occurrence or failure to occur would be reasonably likely to cause (i) any representation or warranty contained in this Agreement to be untrue or inaccurate at the Closing, such that the conditions set forth in Article X hereof, as the case may be, would not be satisfied or fulfilled as a result thereof, or (ii) any material failure of any Acquiree, Acquiree Shareholder, the Acquiror or the Acquiror Principal Shareholder, as the case may be, or of any officer, director, employee or agent thereof, to comply with or satisfy any covenant, condition or agreement to be complied with or satisfied by it under this Agreement.  Notwithstanding the foregoing, the delivery of any notice pursuant to this Section 7.3 shall not limit or otherwise affect the rights and remedies available hereunder to the Party receiving such notice.




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Section 8.4

Acquisition Proposals


(a)

From the date of this Agreement until the Closing Date or, if earlier, the termination of this Agreement, neither the Acquiror nor the Acquiror Principal Shareholder will, and neither the Acquiror nor the Acquiror Principal Shareholder will authorize or permit the any representative of the Acquiror or the Acquiror Principal Shareholder to, directly or indirectly: (i) solicit, initiate, knowingly encourage, induce or facilitate the making, submission or announcement of any Competing Transaction Proposal from any Person (other than Acquiree or the Acquiree Shareholders, a “ Third Party ”) or take any action that could reasonably be expected to lead to a Competing Transaction Proposal, (ii) furnish any information regarding the Acquiror to any Third Party in connection with or in response to a Competing Transaction Proposal or an inquiry or indication of interest, (iii) engage in or continue any discussions or negotiations with any Third Party with respect to any Competing Transaction Proposal, (iv) approve, endorse or recommend any Competing Transaction Proposal or (v) enter into any letter of intent or similar document or any Contract contemplating or otherwise relating to any Competing Transaction Proposal.


(b)

Concurrently with the execution of this Agreement, Acquiror and the Acquiror Principal Shareholder shall immediately cease and cause to be terminated any existing discussions with any Person that relate to any Competing Transaction Proposal;


ARTICLE IX
POST CLOSING COVENANTS


Section 9.1

General


In case at any time after the Closing any further action is necessary to carry out the purposes of this Agreement, each of the Parties will take such further action (including the execution and delivery of such further instruments and documents) as any other Party reasonably may request.


Section 9.2

Litigation Support


In the event and for so long as any Party actively is contesting or defending against any action, suit, proceeding, hearing, investigation, charge, complaint, claim, or demand in connection with (i) any transaction contemplated under this Agreement or (ii) any fact, situation, circumstance, status, condition, activity, practice, plan, occurrence, event, incident, action, failure to act, or transaction that existed on or prior to the Closing Date involving the Acquiror, each of the other Parties will cooperate with such Party and such Party’s counsel in the contest or defense, make available any personnel under their control, and provide such testimony and access to their books and records as shall be reasonably necessary in connection with the contest or defense, all at the sole cost and expense of the contesting or defending Party.


Section 9.3

Assistance with Post-Closing SEC Reports and Inquiries


After the Closing Date, the Acquiror Principal Shareholder shall use its reasonable best efforts to provide such information available to them, including information, filings, reports, financial statements or other circumstances of the Acquiror occurring, reported or filed prior to the Closing, as may be necessary or required for the preparation of the post-Closing Date reports that the Acquiror is required to file with the SEC, or filings required to address and resolve matters as may relate to the period prior to the Closing and any SEC comments relating thereto or any SEC inquiry thereof.




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Section 9.4

Public Announcements


The Acquiror shall promptly, but no later than four (4) business days following the effective date of this Agreement, issue a press release disclosing the transactions contemplated hereby.  The Acquiror shall also file with the SEC a Form 8-K describing the material terms of the transactions contemplated hereby as soon as practicable following the Closing Date but in no event more than four (4) business days following the Closing Date.  Prior to the Closing Date, the Parties shall consult with each other in issuing the Form 8-K, the press release and any other press releases or otherwise making public statements or filings and other communications with the SEC or any regulatory agency or stock market or trading facility with respect to the transactions contemplated hereby and no Party shall issue any such press release or otherwise make any such public statement, filings or other communications without the prior written consent of the other Parties, which consent shall not be unreasonably withheld or delayed, except that no prior consent shall be required if such disclosure is required by Law, in which case the disclosing Party shall provide the other Parties with prior notice of no less than three (3) calendar days, of such public statement, filing or other communication and shall incorporate into such public statement, filing or other communication the reasonable comments of the other Parties.

ARTICLE X
TAX MATTERS

Section 10.1

Tax Periods Ending on or before the Closing Date

.  The Acquiror Principal Shareholder, at its expense, shall prepare or cause to be prepared in a manner consistent with prior practice and in accordance with applicable Law and file or cause to be filed all Tax Returns for the Acquiror for all periods ending on or prior to the Closing Date which are filed after the Closing Date.  The Acquiror Principal Shareholder shall permit the Acquiree to review and comment on each such Tax Return described in the preceding sentence at least twenty (20) Business Days prior to the date such Tax Returns are required to be filed and the Acquiror Principal Shareholder shall take into account in a reasonable manner any changes to such Tax Returns as are reasonably requested by the Acquiree.  The Acquiror Principal Shareholder shall be liable for and timely pay any Taxes of the Acquiror with respect to such periods.  Acquiree agrees to cause the Acquiror to execute the Tax Returns and any necessary documents relating to the filing of Tax Returns for which Acquiror Principal Shareholder is responsible for preparing, which are filed after the Closing Date except to the extent that the Acquiree may be subject to any liability or penalty as a result of the execution of such Tax Returns or documents.

Section 10.2

Tax Periods Beginning Before and Ending After the Closing

.  For any tax period of the Acquiror which includes the Closing Date but that does not end on the Closing Date, the Acquiree shall timely prepare and file, at the Acquiree’s expense, all Tax Returns for all such periods and shall pay the Taxes due with respect to such Tax Returns.  The Acquiree shall permit the Acquiror Principal Shareholder to review and comment on each such Tax Return described in the preceding sentence at least twenty (20) Business Days prior to the date such Tax Return is to be filed, and the Acquiree shall take into account in a reasonable manner any changes to such Tax Returns as are reasonably requested by the Acquiror Principal Shareholder.  The Acquiror Principal Shareholder shall promptly pay to the Acquiree the excess of (1) the Taxes that are apportioned to the Acquiror Principal Shareholder under the terms of this Section 9.2 , over (2) the amount of such Taxes that would have appeared on any such Tax Return that have been paid by the Acquiror or the Acquiror Principal Shareholder on or prior to the Closing Date.  For purposes of Section 9.2 , Acquiror Principal Shareholder shall be apportioned liability for Taxes for the period deemed to end at the close of business on the Closing Date (the “ Pre-Closing Period ”) and Acquiree shall be apportioned liability for Taxes for the period deemed to begin immediately after the Pre-Closing Period (the “ Post-Closing Period ”) to the greatest extent possible on the basis of the “closing of the books” method of apportionment; provided, however, in the case of Taxes (such as real estate taxes) not susceptible to such apportionment, such Tax liability shall be apportioned on the basis of the number of days elapsed in the Pre-Closing Period and Post-Closing Period.

Section 10.3

Indemnification

.  The Acquiror Principal Shareholder shall be responsible for, and indemnify, defend and hold the Acquiror from and against, any and all Taxes imposed on or with respect to the Acquiror, the Acquiror’s assets, operations or activities for all periods (or portions thereof) ending on or prior to the Closing Date.  The Acquiror shall be responsible for, and shall indemnify, defend and hold the Acquiror Principal Shareholder harmless from and against, any and all Taxes imposed on the Acquiror for all periods (or portions thereof) beginning after the Closing Date.  Whenever in accordance with this Article IX , the Acquiror shall be required to pay Taxes related to periods (or portions thereof) ending on or prior to the Closing Date or the Acquiror Principal Shareholder shall be required to pay taxes related to periods (or portions thereof) beginning after the Closing Date, such payments shall be made on the later of fifteen (15) days after requested or fifteen (15) days before the requesting Party is required to pay or cause to be paid the related Tax liability.  The obligations of the Parties set forth in this Section 9.3 shall be unconditional and absolute and shall remain in effect until the expiration of the applicable Tax statute of limitations.

Section 10.4

Tax Sharing Agreements

.  All tax sharing agreements or similar agreements with respect to or involving the Acquiror shall be terminated as of the open of business on the Closing Date and, after the Closing Date, the Acquiror shall not be bound thereby or have any Liability thereunder.  The Acquiror Principal Shareholder and the Acquiror shall take all actions necessary to terminate such agreements at such time.

Section 10.5

Certain Taxes



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.  All transfer, documentary, sales, use, stamp, registration and other such Taxes and fees (including any penalties and interest) incurred in connection with this Agreement, shall be paid by the Acquiror Principal Shareholder when due, and the Acquiror Principal Shareholder will, at their expense, file all necessary Tax Returns and other documentation with respect to all such transfer, documentary, sales, use, stamp, registration and other Taxes and fees, and, if required by applicable Law, the Acquiree will, and will cause its Affiliates to, join in the execution of any such Tax Returns and other documentation.

ARTICLE XI
CONDITIONS TO CLOSING

Section 11.1

Conditions to Obligation of the Parties Generally

.  The Parties shall not be obligated to consummate the transactions to be performed by each of them in connection with the Closing if, on the Closing Date, (i) any Action shall be pending or threatened before any Governmental Authority wherein an Order or charge would (A) prevent consummation of any of the transactions contemplated by this Agreement or (B) cause any of the transactions contemplated by this Agreement to be rescinded following consummation, (ii) any Law or Order which would have any of the foregoing effects shall have been enacted or promulgated by any Governmental Authority; or (iii) the Acquiree shall not have received an audit report with respect to its two most recently completed fiscal years from an independent accounting firm that is registered with the Public Company Accounting Oversight Board.

Section 11.2

Conditions to Obligation of the Acquiree Parties

.  The obligations of the Acquiree and the Acquiree Shareholders to enter into and perform their respective obligations under this Agreement are subject, at the option of the Acquiree and the Acquiree Shareholders, to the fulfillment on or prior to the Closing Date of the following conditions, any one or more of which may be waived by the Acquiree and the Acquiree Shareholders in writing:

(a)

The representations and warranties of the Acquiror and the Acquiror Principal Shareholder set forth in this Agreement shall be true and correct in all material respects as of the Closing Date (except to the extent such representations and warranties are specifically made as of a particular date, in which case such representations and warranties shall be true and correct as of such date);

(b)

The Acquiror and the Acquiror Principal Shareholder shall have performed and complied with all of their covenants hereunder in all material respects through the Closing, except to the extent that such covenants are qualified by terms such as “material” and “Material Adverse Effect,” in which case the Acquiror Principal Shareholder and the Acquiror shall have performed and complied with all of such covenants in all respects through the Closing;

(c)

No action, suit, or proceeding shall be pending or, to the Knowledge of the Acquiror, threatened before any Governmental Authority wherein an Order or charge would (A) affect adversely the right of the Acquiree Shareholders to own the Acquiror Shares or to control the Acquiror, or (B) affect adversely the right of the Acquiror to own its assets or to operate its business (and no such Order or charge shall be in effect), nor shall any Law or Order which would have any of the foregoing effects have been enacted or promulgated by any Governmental Authority;

(d)

No event, change or development shall exist or shall have occurred since the Acquiror Most Recent Fiscal Year End that has had or is reasonably likely to have a Material Adverse Effect on the Acquiror;

(e)

All consents, waivers, approvals, authorizations or Orders required to be obtained, and all filings required to be made, by the Acquiror for the authorization, execution and delivery of this Agreement and the consummation by it of the transactions contemplated by this Agreement, shall have been obtained and made by the Acquiror and Acquiror shall have delivered proof of same to the Acquiree and Acquiree Shareholders;

(f)

Acquiror shall have filed all reports and other documents required to be filed by it under the U.S. federal securities laws through the Closing Date;

(g)

Acquiror 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;

(h)

Trading in the Acquiror Common Stock shall not have been suspended by the SEC or any trading market (except for any suspensions of trading of not more than one trading day solely to permit dissemination of material information regarding the Acquiror) at any time since the date of execution of this Agreement, and the Acquiror Common Stock shall have been at all times since such date listed for trading on a trading market;

(i)

Acquiror shall have maintained the eligibility of the Acquiror Common Stock for clearance and settlement through DTC and no reason shall exist as to why such eligibility shall not continue immediately following the Closing;

(j)

There shall not be any outstanding obligation or Liability (whether accrued, absolute, contingent, liquidated or otherwise, whether due or to become due) of the Acquiror, whether or not known to the Acquiror, as of the Closing;

(k)

Acquiror shall have delivered to the Acquiree and Acquiree Shareholders a certificate, dated the Closing Date, executed by an officer of the Acquiror, certifying the satisfaction of the conditions specified in Sections 10.2(a) through 10.2(l) , inclusive, relating to the Acquiror;

(l)

The Acquiror Principal Shareholder shall have delivered to the Acquiree and Acquiree Shareholders a certificate, dated the Closing Date, executed by such Acquiror Principal Shareholder, certifying the satisfaction of the conditions specified in Section 10.2(a) and Section 10.2(b) , inclusive, relating to such Acquiror Principal Shareholder;

(m)

Acquiror shall have delivered to the Acquiree and the Acquiree Shareholders a certified copy of the Certificate of Incorporation of the Acquiror as certified by the Secretary of State (or comparable office) of the Acquiror’s jurisdiction of formation within five (5) days of the Closing Date;



27





(n)

Acquiror shall have delivered to the Acquiree and the Acquiree  Shareholders (i) a certificate evidencing the formation and good standing of the Acquiror in its jurisdiction of formation issued by the Secretary of State (or comparable office) of such jurisdiction of formation as of a date within five (5) days of the Closing Date; and (ii) a certificate evidencing the Acquiror’s qualification as a foreign corporation and good standing issued by the Secretary of State (or comparable office) of each jurisdiction in which the Acquiror conducts business and is required to so qualify, as of a date within five (5) days of the Closing Date;

(o)

Acquiror shall have delivered to the Acquiree and the Acquiree Shareholders a certificate duly executed by the Secretary of the Acquiror and dated as of the Closing Date, as to (i) the resolutions as adopted by the Acquiror’s board of directors, in a form reasonably acceptable to the Acquiree, approving this Agreement and the Transaction Documents to which it is a party and the transactions contemplated hereby and thereby; (ii) the Acquiror Organizational Documents, each as in effect at the Closing; and (iv) the incumbency of each authorized officer of the Acquiror signing this Agreement and any other agreement or instrument contemplated hereby to which the Acquiror is a party;

(p)

Acquiror shall have delivered to the Acquiree and the Acquiree Shareholders a statement from the Acquiror’s transfer agent regarding the number of issued and outstanding shares of Acquiror Common Stock immediately before the Closing;

(q)

Acquiror shall have delivered to the Acquiree and the Acquiree Shareholders such pay-off letters and releases relating to Liabilities of the Acquiror as the Acquiree shall request;

(r)

Acquiror shall have delivered to the Acquiree and the Acquiree Shareholders duly executed letters of resignation from all of the directors and officers of the Acquiror, effective as of the Closing;

(s)

Acquiror shall have delivered to the Acquiree and the Acquiree Shareholders resolutions of the Acquiror’s board of directors (i) appointing Jack V. Talley to serve as President and Chief Executive Officer; (ii) appointing Dragan Cicic to serve as Chief Operating Officer and Chief Medical officer; (iii) appointing Enza Guagenti to serve as Chief Financial Officer; and (iv) nominating Jack V. Talley as a member of the Acquiror’s board of directors, effective as of the Closing.   Dr. Rosemary Mazanet, David Nicholson, Sandesh Seth and Sergio Traversa will  also serve as members of the Acquiror’s board of directors, effective as of ten days after the filing of the Schedule 14f-1 Information Statement;

(t)

Execution of the Shareholder Release by and among Acquiror and Acquiror’s shareholders that have loaned money to Acquiror;

(u)

All of the conditions to the closing of the Acquiree Offering, other than the condition that the Closing hereunder shall have occurred, shall have been satisfied or waived;

(v)

Acquiree and the Acquiree Shareholders shall have completed their legal, accounting and business due diligence of the Acquiror and the results thereof shall be satisfactory to the Acquiree and the Acquiree Shareholders in their sole and absolute discretion; and

(w)

All actions to be taken by the Acquiror and the Acquiror Principal Shareholder in connection with consummation of the transactions contemplated hereby and all certificates, opinions, instruments, and other documents required to effect the transactions contemplated hereby shall be reasonably satisfactory in form and substance to the Acquiree and the Acquiree Shareholders.

Section 11.3

Conditions to Obligation of the Acquiror Parties

.  The obligations of the Acquiror and the Acquiror Principal Shareholder to enter into and perform their respective obligations under this Agreement are subject, at the option of the Acquiror and the Acquiror Principal Shareholder, to the fulfillment on or prior to the Closing Date of the following conditions, any one or more of which may be waived by the Acquiror and the Acquiror Principal Shareholder in writing:

(a)

The representations and warranties of the Acquiree and the Acquire Shareholders set forth in this Agreement shall be true and correct in all material respects as of the Closing Date (except to the extent such representations and warranties are specifically made as of a particular date, in which case such representations and warranties shall be true and correct as of such date);

(b)

The Acquiree and the Acquire Shareholders shall have performed and complied with all of their covenants hereunder in all material respects through the Closing, except to the extent that such covenants are qualified by terms such as “material” and “Material Adverse Effect,” in which case the Acquiree and the Acquire Shareholders shall have performed and complied with all of such covenants in all respects through the Closing;

(c)

All consents, waivers, approvals, authorizations or Orders required to be obtained, and all filings required to be made, by the Acquiror for the authorization, execution and delivery of this Agreement and the consummation by it of the transactions contemplated by this Agreement, shall have been obtained and made by the Acquiree and Acquiree shall have delivered proof of same to the Acquiror and Acquiror Principal Shareholder;

(d)

Acquiree shall have delivered to the Acquiror and Acquiror Principal Shareholder a certificate, dated the Closing Date, executed by an officer of the Acquiree, certifying the satisfaction of the conditions specified in Sections 10.3(a) through 10.3(c) , inclusive, relating to the Acquiree;

(e)

Acquiree shall have delivered to the Acquiror and the Acquiror Principal Shareholder a certificate duly executed by the Secretary of the Acquiror and dated as of the Closing Date, as to (i) the resolutions as adopted by the Acquiror’s board of directors, in a form reasonably acceptable to the Acquiree, approving this Agreement and the Transaction Documents to which it is a party and the transactions contemplated hereby and thereby; (ii) the Acquiree Organizational Documents, each as in effect at the



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Closing; and (iii) the incumbency of each authorized officer of the Acquiree signing this Agreement and any other agreement or instrument contemplated hereby to which the Acquiree is a party;

(f)

Acquiror and the Acquiror Principal Shareholder shall have completed their legal, accounting and business due diligence of the Acquiree and the results thereof shall be satisfactory to the Acquiror and the Acquiror Principal Shareholder in their sole and absolute discretion; and

(g)

All actions to be taken by the Acquiree and the Acquiree Shareholders in connection with consummation of the transactions contemplated hereby and all payments, certificates, opinions, instruments, and other documents required to effect the transactions contemplated hereby shall be reasonably satisfactory in form and substance to the Acquiror and the Acquiror Principal Shareholder.

ARTICLE XII
TERMINATION

Section 12.1

Grounds for Termination

.  Anything herein or elsewhere to the contrary notwithstanding, this Agreement may be terminated and the transactions contemplated hereby may be abandoned at any time prior to the Closing Date:

(a)

by the mutual written agreement of the Parties;

(b)

by Acquiree and the Acquiree Shareholders (by written notice of termination from Acquiree and the Acquiree Shareholders to the Acquiror and the Acquiror Principal Shareholder, in which reference is made to this subsection) if the Closing has not occurred on or prior to the Termination Date, unless the failure of the Closing to have occurred is attributable to a failure on the part of Acquiree or the Acquiree Shareholders to perform any material obligation to be performed by Acquiree or the Acquiree Shareholders pursuant to this Agreement at or prior to the Closing;

(c)

by the Acquiror (by written notice of termination from the Acquiror to the Acquiree and the Acquiree Shareholders, in which reference is made to this subsection) if the Closing has not occurred on or prior to the Termination Date, unless the failure of the Closing to have occurred is attributable to a failure on the part of the Acquiror Principal Shareholder to perform any material obligation required to be performed by any such Acquiror Principal Shareholder pursuant to this Agreement at or prior to the Closing;

(d)

by the Acquiror or the Acquiree (by written notice of termination from such Party to the other Parties) if a Governmental Authority of competent jurisdiction shall have issued a final non-appealable Order, or shall have taken any other action having the effect of, permanently restraining, enjoining or otherwise prohibiting the consummation of the transactions contemplated hereby; provided, however, that the right to terminate this Agreement under this Section 11.3(d) shall not be available to a Party if such Order was primarily due to the failure of such Party to perform any of its obligations under this Agreement;

(e)

by the Acquiror, Acquiree or the Acquiree Shareholders (by written notice of termination from such Party to the other Parties) if any event shall occur after the date hereof that shall have made it impossible to satisfy a condition precedent to the terminating Party’s obligations to perform its obligations hereunder, unless the occurrence of such event shall be due to the failure of the terminating Party to perform or comply with any of the agreements, covenants or conditions hereof to be performed or complied with by such Party at or prior to the Closing;

(f)

by Acquiree or the Acquiree Shareholders (by written notice of termination from Acquiree to the Acquiror Principal Shareholder, in which reference is made to this subsection) if, since the date of this Agreement, there shall have occurred any Material Adverse Effect on the Acquiror, or there shall have occurred any event or circumstance that, in combination with any other events or circumstances, could reasonably be expected to have, a Material Adverse Effect with respect to the Acquiror;

(g)

by the Acquiree (by written notice of termination from the Acquiree to the  Acquiror and the Acquiror Principal Shareholder, in which reference is made to the specific provision(s) of this subsection giving rise to the right of termination) if (i) any of Acquiror’s or the Acquiror Shareholder’s representations and warranties shall have been inaccurate as of the date of this Agreement or as of a date subsequent to the date of this Agreement (as if made on such subsequent date), such that the condition set forth in Section 10.3(a) would not be satisfied and such inaccuracy has not been cured by Acquiror or the Acquiror Principal Shareholder within five (5) Business Days after its receipt of written notice thereof and remains uncured at the time notice of termination is given, (ii) any of the Acquiror’s or Acquiror Principal Shareholder’s covenants contained in this Agreement shall have been breached, such that the condition set forth in Section 10.3(b) would not be satisfied, or (iii) any Action shall be initiated, threatened or pending which could reasonably be expected to materially and adversely affect the Acquiror or Acquiree (including, without limitation, any such Action relating to any alleged violation of, or non-compliance with, any applicable Law or any allegation of fraud or intentional misrepresentation); or

(h)

by the Acquiror and the Acquiror Principal Shareholder (by written notice of termination from the Acquiror to the  Acquiree and the Acquiree Shareholders, in which reference is made to the specific provision(s) of this subsection giving rise to the right of termination) if (i) any of Acquiree’s or the Acquiree Shareholder’s representations and warranties shall have been inaccurate as of the date of this Agreement or as of a date subsequent to the date of this Agreement (as if made on such subsequent date), such that the condition set forth in Section 10.2(a) would not be satisfied and such inaccuracy has not been cured by Acquiree or the Acquiree Shareholders within five (5) Business Days after its receipt of written notice thereof and remains uncured at the time notice of termination is given, or (ii) any of the Acquiree’s or Acquiree Shareholder’s covenants contained in this Agreement shall have been breached, such that the condition set forth in Section 10.2(b) would not be satisfied.

Section 12.2

Procedure and Effect of Termination



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.  In the event of the termination of this Agreement by the Acquiror Principal Shareholder or Acquiree pursuant to Section 11.1 hereof, written notice thereof shall forthwith be given to the other Party.  If this Agreement is terminated as provided herein (a) each Party will redeliver all documents, work papers and other material of any other Party relating to the transactions contemplated hereby, whether so obtained before or after the execution hereof, to the Party furnishing the same; provided, that each Party may retain one copy of all such documents for archival purposes in the custody of its outside counsel and (b) all filings, applications and other submission made by any Party to any Person, including any Governmental Authority, in connection with the transactions contemplated hereby shall, to the extent practicable, be withdrawn by such Party from such Person.

Section 12.3

Effect of Termination

.  If this Agreement is terminated pursuant to Section 10.1 hereof, this Agreement shall become void and of no further force and effect, except for the provisions of (i) Article XII , (iii) Sections 3.6 , 4.8 and 5.10 hereof relating to brokers’ fees or commissions, (iv) Section 11.2 and this Section 11.3 .

ARTICLE XIII
SURVIVAL; INDEMNIFICATION

Section 13.1

Survival

.  All representations, warranties, covenants, and obligations in this Agreement shall survive the Closing.  The right to indemnification, payment of damages or other remedy based on such representations, warranties, covenants, and obligations will not be affected by any investigation conducted with respect to, or any knowledge acquired (or capable of being acquired) at any time, whether before or after the execution and delivery of this Agreement, with respect to the accuracy or inaccuracy of or compliance with, any such representation, warranty, covenant, or obligation.  The waiver of any condition based on the accuracy of any representation or warranty, or on the performance of or compliance with any covenant or obligation, will not affect the right to indemnification, payment of damages, or other remedy based on such representations, warranties, covenants, and obligations.

Section 13.2

Indemnification by the Acquiror Principal Shareholder

.  From and after the execution of this Agreement, the Acquiror Principal Shareholder shall indemnify and hold harmless the Acquiree Indemnified Parties, from and against any all costs or expenses (including attorneys’ fees), judgments, fines, losses, claims, damages, liabilities and amounts paid in settlement (collectively, “ Damages ”) arising, directly or indirectly, from or in connection with: (a) any breach (or alleged breach) of any representation or warranty made by the Acquiror Principal Shareholder or the Acquiror in this Agreement or any Transaction Document or in any certificate delivered by the Acquiror Principal Shareholder or the Acquiror pursuant to this Agreement; or (b) any breach (or alleged breach) by the Acquiror Principal Shareholder or the Acquiror of any covenant or obligation of the Acquiror Principal Shareholder or the Acquiror in this Agreement or any Transaction Document required to be performed by the Acquiror Principal Shareholder or the Acquiror on or prior to the Closing Date or by the Acquiror Principal Shareholder after the Closing Date.

Section 13.3

Matters Involving Third Parties

.

(a)

If any third party shall notify any Acquiree Indemnified Parties (the “ Indemnified Party ”) with respect to any matter (a “ Third Party Claim ”) which may give rise to a claim for indemnification against the Acquiror Principal Shareholder (the “ Indemnifying Party ”) under this Article XII , then the Indemnified Party shall promptly notify each Indemnifying Party thereof in writing; provided, however, that no delay on the part of the Indemnified Party in notifying any Indemnifying Party shall relieve the Indemnifying Party from any obligation hereunder unless (and then solely to the extent) the Indemnifying Party is thereby prejudiced.

(b)

Any Indemnifying Party will have the right to defend the Indemnified Party against the Third Party Claim with counsel of its choice reasonably satisfactory to the Indemnified Party so long as (A) the Indemnifying Party notifies the Indemnified Party in writing within fifteen (15) days after the Indemnified Party has given notice of the Third Party Claim that the Indemnifying Party will indemnify the Indemnified Party from and against the entirety of any Damages the Indemnified Party may suffer resulting from, arising out of, relating to, in the nature of, or caused by the Third Party Claim, (B) the Indemnifying Party provides the Indemnified Party with evidence acceptable to the Indemnified Party that the Indemnifying Party will have the financial resources to defend against the Third Party Claim and fulfill its indemnification obligations hereunder, (C) the Third Party Claim involves only money damages and does not seek an injunction or other equitable relief, (D) settlement of, or an adverse judgment with respect to, the Third Party Claim is not, in the good faith judgment of the Indemnified Party, likely to establish a precedential custom or practice adverse to the continuing business interests of the Indemnified Party, and (E) the Indemnifying Party conducts the defense of the Third Party Claim actively and diligently.

(c)

So long as the Indemnifying Party is conducting the defense of the Third Party Claim in accordance with Section 12.3(b) above, (A) the Indemnified Party may retain separate co-counsel at its sole cost and expense and participate in the defense of the Third Party Claim, (B) the Indemnified Party will not consent to the entry of any judgment or enter into any settlement with respect to the Third Party Claim without the prior written consent of the Indemnifying Party (not to be withheld unreasonably), and (C) the Indemnifying Party will not consent to the entry of any judgment or enter into any settlement with respect to the Third Party Claim without the prior written consent of the Indemnified Party (not to be withheld unreasonably).

(d)

In the event any condition in Section 12.3(b) above is or becomes unsatisfied, however, (A) the Indemnified Party may defend against, and consent to the entry of any judgment or enter into any settlement with respect to, the Third Party Claim in any manner it reasonably may deem appropriate (and the Indemnified Party need not consult with, or obtain any consent from, any Indemnifying Party in connection therewith), (B) the Indemnifying Parties will reimburse the Indemnified Party



30





promptly and periodically for the costs of defending against the Third Party Claim (including reasonable attorneys’ fees and expenses), and (C) the Indemnifying Parties will remain responsible for any Damages the Indemnified Party may suffer resulting from, arising out of, relating to, in the nature of, or caused by the Third Party Claim to the fullest extent provided in this Article XI .

Section 13.4

Exclusive Remedy

.  The Parties acknowledge and agree that the indemnification provisions in this Article XII and in Article IX hereof shall be the exclusive remedies of the Parties with respect to the transactions contemplated by this Agreement, other than for fraud and willful misconduct.  Each Acquiror Principal Shareholder hereby agrees that such Acquiror Principal Shareholder will not make any claim for indemnification against the Acquiror by reason of the fact that such Acquiror Principal Shareholder was a director, officer, employee, or agent of the Acquiror or was serving at the request of the Acquiror as a partner, trustee, director, officer, employee, or agent of another entity (whether such claim is for judgments, damages, penalties, fines, costs, amounts paid in settlement, losses, expenses, or otherwise and whether such claim is pursuant to any statute, charter document, bylaw, agreement, or otherwise) with respect to any action, suit, proceeding, complaint, claim, or demand brought by the Acquiree against the Acquiror Principal Shareholder (whether such action, suit, proceeding, complaint, claim, or demand is pursuant to this Agreement, applicable Law, or otherwise).

ARTICLE XIV
MISCELLANEOUS PROVISIONS

Section 14.1

Expenses

.  Except as otherwise expressly provided in this Agreement, each Party will bear its respective expenses incurred in connection with the preparation, execution, and performance of this Agreement and the transactions contemplated by this Agreement, including all fees and expenses of agents, representatives, counsel, and accountants.  In the event of termination of this Agreement, the obligation of each Party to pay its own expenses will be subject to any rights of such Party arising from a breach of this Agreement by another Party.

Section 14.2

Confidentiality

.

(a)

The Parties will maintain in confidence, and will cause their respective directors, officers, employees, agents, and advisors to maintain in confidence, any written, oral, or other information obtained in confidence from another Person in connection with this Agreement or the transactions contemplated by this Agreement, unless (a) such information is already known to such Party or to others not bound by a duty of confidentiality or such information becomes publicly available through no fault of such Party, (b) the use of such information is necessary or appropriate in making any required filing with the SEC, or obtaining any consent or approval required for the consummation of the transactions contemplated by this Agreement, or (c) the furnishing or use of such information is required by or necessary or appropriate in connection with legal proceedings.

(b)

In the event that any Party is required to disclose any information of another Person pursuant to clause (b) or (c) of Section 13.2(a) above, the Party requested or required to make the disclosure (the “disclosing party”) shall provide the Person that provided such information (the “providing party”) with prompt notice of any such requirement so that the providing party may seek a protective Order or other appropriate remedy and/or waive compliance with the provisions of this Section 13.2 .  If, in the absence of a protective Order or other remedy or the receipt of a waiver by the providing party, the disclosing party is nonetheless, in the opinion of counsel, legally compelled to disclose the information of the providing party, the disclosing party may, without liability hereunder, disclose only that portion of the providing party’s information which such counsel advises is legally required to be disclosed, provided that the disclosing party exercises its reasonable efforts to preserve the confidentiality of the providing party’s information, including, without limitation, by cooperating with the providing party to obtain an appropriate protective Order or other relief assurance that confidential treatment will be accorded the providing party’s information.

(c)

If the transactions contemplated by this Agreement are not consummated, each Party will return or destroy all of such written information each party has regarding the other Parties.

Section 14.3

Notices

.  All notices, demands, consents, requests, instructions and other communications to be given or delivered or permitted under or by reason of the provisions of this Agreement or in connection with the transactions contemplated hereby shall be in writing and shall be deemed to be delivered and received by the intended recipient as follows: (i) if personally delivered, on the Business Day of such delivery (as evidenced by the receipt of the personal delivery service), (ii) if mailed certified or registered mail return receipt requested, two (2) Business Days after being mailed, (iii) if delivered by overnight courier (with all charges having been prepaid), on the Business Day of such delivery (as evidenced by the receipt of the overnight courier service of recognized standing), or (iv) if delivered by facsimile transmission or other electronic means, including email, on the Business Day of such delivery if sent by 6:00 p.m. in the time zone of the recipient, or if sent after that time, on the next succeeding Business Day.  If any notice, demand, consent, request, instruction or other communication cannot be delivered because of a changed address of which no notice was given (in accordance with this Section 13.4 ), or the refusal to accept same, the notice, demand, consent, request, instruction or other communication shall be deemed received on the second business day the notice is sent (as evidenced by a sworn affidavit of the sender).  All such notices, demands, consents, requests, instructions and other communications will be sent to the following addresses or facsimile numbers as applicable:



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If to Acquiror or the Acquiror Principal Shareholder, to:

 

Cactus Ventures, Inc.

123 W. Nye Lane, Suite 129

Carson City,  NV 89706

Attention: [____________]

Telephone No.: (831) 770-0217

Facsimile No.:

 

 

 

With copies to:

 

Cletha Walstrand
Attorney at Law

1322 Pachua

Ivins, UT 84378

Telephone No.: (435) 688-7317

Facsimile No.: (435) 688-7318

 

 

 

If to the Acquiree, to:

 

Actinium Pharmaceuticals, Inc.
501 Fifth Avenue, 3 rd Floor

New York, NY 10017

Attention: Jack Talley

Telephone No.: 212) 300-2131

Facsimile No.: 9800) 559-6927

 

 

 

With copies to:

 

Anslow & Jaclin, LLP
195 Route 9 South, Second Floor

Manalapan, New Jersey 07726

Attention: Richard I. Anslow, Esq.

Telephone No.: 732-409-1212

Facsimile No.: 732-577-1188

 

 

 

If to the Acquiree Shareholders, to:

 

The applicable address set forth on Schedule I hereto.


or such other addresses as shall be furnished in writing by any Party in the manner for giving notices hereunder.

Section 14.4

Further Assurances

.  The Parties agree (a) to furnish upon request to each other such further information, (b) to execute and deliver to each other such other documents, and (c) to do such other acts and things, all as the other Parties may reasonably request for the purpose of carrying out the intent of this Agreement and the documents referred to in this Agreement.

Section 14.5

Waiver

.  The rights and remedies of the Parties are cumulative and not alternative.  Neither the failure nor any delay by any Party in exercising any right, power, or privilege under this Agreement or the documents referred to in this Agreement will operate as a waiver of such right, power, or privilege, and no single or partial exercise of any such right, power, or privilege will preclude any other or further exercise of such right, power, or privilege or the exercise of any other right, power, or privilege.  To the maximum extent permitted by applicable Law, (a) no claim or right arising out of this Agreement or the documents referred to in this Agreement can be discharged by one Party, in whole or in part, by a waiver or renunciation of the claim or right unless in writing signed by the other Parties; (b) no waiver that may be given by a Party will be applicable except in the specific instance for which it is given; and (c) no notice to or demand on one Party will be deemed to be a waiver of any obligation of such Party or of the right of the Party giving such notice or demand to take further action without notice or demand as provided in this Agreement or the documents referred to in this Agreement.

Section 14.6

Entire Agreement and Modification

.  This Agreement supersedes all prior agreements between the Parties with respect to its subject matter and constitutes (along with the documents referred to in this Agreement) a complete and exclusive statement of the terms of the agreement between the Parties with respect to its subject matter.  This Agreement may not be amended except by a written agreement executed by the Party against whom the enforcement of such amendment is sought.

Section 14.7

Assignments, Successors, and No Third-Party Rights

.  No Party may assign any of its rights under this Agreement without the prior consent of the other Parties.  Subject to the preceding sentence, this Agreement will apply to, be binding in all respects upon, and inure to the benefit of and be enforceable by the respective successors and permitted assigns of the Parties.  Except as set forth in Article XII hereof, nothing expressed or referred to in this Agreement will be construed to give any Person other than the Parties any legal or equitable right, remedy, or claim under or with respect to this Agreement or any provision of this Agreement.

Section 14.8

Severability



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.  If any provision of this Agreement is held invalid or unenforceable by any court of competent jurisdiction, the other provisions of this Agreement will remain in full force and effect.  Any provision of this Agreement held invalid or unenforceable only in part or degree will remain in full force and effect to the extent not held invalid or unenforceable.

Section 14.9

Section Headings

.  The headings of Articles and Sections in this Agreement are provided for convenience only and will not affect its construction or interpretation.  All references to “Article” or “Articles” or “Section” or “Sections” refer to the corresponding Article or Articles or Section or Sections of this Agreement, unless the context indicates otherwise.

Section 14.10

Construction

.  The Parties have participated jointly in the negotiation and drafting of this Agreement.  In the event an ambiguity or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the Parties and no presumption or burden of proof shall arise favoring or disfavoring any Party by virtue of the authorship of any of the provisions of this Agreement.  Any reference to any federal, state, local, or foreign statute or Law shall be deemed also to refer to all rules and regulations promulgated thereunder, unless the context requires otherwise.  Unless otherwise expressly provided, the word “including” shall mean including without limitation.  The Parties intend that each representation, warranty, and covenant contained herein shall have independent significance.  If any Party has breached any representation, warranty, or covenant contained herein in any respect, the fact that there exists another representation, warranty, or covenant relating to the same subject matter (regardless of the relative levels of specificity) which the Party has not breached shall not detract from or mitigate the fact that the Party is in breach of such representation, warranty, or covenant.  All words used in this Agreement will be construed to be of such gender or number as the circumstances require.

Section 14.11

Counterparts

.  This Agreement may be executed in one or more counterparts, each of which will be deemed to be an original copy of this Agreement and all of which, when taken together, will be deemed to constitute one and the same agreement.  In the event that any signature is delivered by facsimile transmission or by e-mail delivery of a “.pdf” format data file, such signature shall create a valid and binding obligation of the Party executing (or on whose behalf such signature is executed) with the same force and effect as if such facsimile or “.pdf” signature page were an original thereof.

Section 14.12

Specific Performance

.  Each of the Parties acknowledges and agrees that the other Parties would be damaged irreparably in the event any of the provisions of this Agreement are not performed in accordance with their specific terms or otherwise are breached.  Accordingly, each of the Parties agrees that the other Parties shall be entitled to an injunction or injunctions to prevent breaches of the provisions of this Agreement and to enforce specifically this Agreement and the terms and provisions hereof in any action instituted in any court of the U.S. or any state thereof having jurisdiction over the Parties and the matter (subject to the provisions set forth in Section 13.13 below), in addition to any other remedy to which they may be entitled, at Law or in equity.

Section 14.13

Governing Law; Submission to Jurisdiction

.  This Agreement shall be governed by and construed in accordance with the Laws of the State of New York without regard to conflicts of Laws principles.  Each of the Parties submits to the jurisdiction of any state or federal court sitting in the State of New York, in any action or proceeding arising out of or relating to this Agreement and agrees that all claims in respect of the action or proceeding may be heard and determined in any such court.  Each of the Parties waives any defense of inconvenient forum to the maintenance of any action or proceeding so brought and waives any bond, surety, or other security that might be required of any other Party with respect thereto.  Any Party may make service on any other Party by sending or delivering a copy of the process to the Party to be served at the address and in the manner provided for the giving of notices in Section 13.3 above.  Nothing in this Section 13.13 , however, shall affect the right of any Party to serve legal process in any other manner permitted by Law or at equity.  Each Party agrees that a final judgment in any action or proceeding so brought shall be conclusive and may be enforced by suit on the judgment or in any other manner provided by Law or at equity.

Section 14.14

Waiver of Jury Trial

.  EACH OF THE PARTIES HEREBY IRREVOCABLY WANES ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING ARISING OUT OF OR RELATED TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY.


[Signatures follow on next page]




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IN WITNESS WHEREOF, the undersigned have caused this Agreement to be executed as of the date first above written.

ACQUIROR:

 

CACTUS VENTURES, INC.


By:

/s/ Diane Button

Name:

Diane S. Button

Title:

Chief Executive Officer and Chief Financial Officer

 

 

ACQUIROR PRINCIPAL SHAREHOLDER:



/s/ Diane Button

DIANE S. BUTTON






[Signatures continue on next page]



[Signature Page to Share Exchange Agreement]





IN WITNESS WHEREOF, the undersigned have caused this Agreement to be executed as of the date first above written.

ACQUIREE:

 

ACTINIUM PHARMACEUTICALS. INC.


By:

/S/ Jack Talley

Name:

Jack V. Talley

Title:

President




[Signature Page to Share Exchange Agreement]





IN WITNESS WHEREOF, the undersigned have caused this Agreement to be executed as of the date first above written.

ACQUIREE SHAREHOLDERS:

 

IF AN INDIVIDUAL:




_______________________________

Name:






IF AN ENTITY:


NAME OF ENTITY:

[

]



By:

__________________________

Name:

Title:












[Signature Page to Share Exchange Agreement]





SCHEDULE I

Acquiree Shareholder

 

Total

Acquiree Shares

Held Prior to

the Closing

 

Acquiror

Common Shares

to be Issued at

the Closing

 





 

 

 

 

 





 

 

 

 

 

Total

 

 

 

 

 











SCHEDULE II

Acquiree Shareholder

 

Total

Acquiree Options and Warrants Held Prior to

the Closing

 

Acquiror

Options and Warrants

to be Issued at

the Closing

 





 

 

 

 

 





 

 

 

 

 

Total

 

 

 

 

 








Exhibit 3.5

[F8K122112_EX3Z5001.JPG]




[F8K122112_EX3Z5002.JPG]




[F8K122112_EX3Z5003.JPG]




[F8K122112_EX3Z5004.JPG]




[F8K122112_EX3Z5005.JPG]




[F8K122112_EX3Z5006.JPG]




[F8K122112_EX3Z5007.JPG]




[F8K122112_EX3Z5008.JPG]




[F8K122112_EX3Z5009.JPG]




[F8K122112_EX3Z5010.JPG]




[F8K122112_EX3Z5011.JPG]




[F8K122112_EX3Z5012.JPG]




[F8K122112_EX3Z5013.JPG]




[F8K122112_EX3Z5014.JPG]




[F8K122112_EX3Z5015.JPG]




[F8K122112_EX3Z5016.JPG]




[F8K122112_EX3Z5017.JPG]




[F8K122112_EX3Z5018.JPG]




[F8K122112_EX3Z5019.JPG]




[F8K122112_EX3Z5020.JPG]




[F8K122112_EX3Z5021.JPG]




[F8K122112_EX3Z5022.JPG]




[F8K122112_EX3Z5023.JPG]




[F8K122112_EX3Z5024.JPG]




[F8K122112_EX3Z5025.JPG]




[F8K122112_EX3Z5026.JPG]




[F8K122112_EX3Z5027.JPG]




[F8K122112_EX3Z5028.JPG]




[F8K122112_EX3Z5029.JPG]




[F8K122112_EX3Z5030.JPG]




[F8K122112_EX3Z5031.JPG]




[F8K122112_EX3Z5032.JPG]




[F8K122112_EX3Z5033.JPG]




[F8K122112_EX3Z5034.JPG]



Exhibit 3.7

[F8K122112_EX3Z7001.JPG]




[F8K122112_EX3Z7002.JPG]




[F8K122112_EX3Z7003.JPG]




[F8K122112_EX3Z7004.JPG]




[F8K122112_EX3Z7005.JPG]




[F8K122112_EX3Z7006.JPG]




[F8K122112_EX3Z7007.JPG]




[F8K122112_EX3Z7008.JPG]




[F8K122112_EX3Z7009.JPG]




[F8K122112_EX3Z7010.JPG]




[F8K122112_EX3Z7011.JPG]




[F8K122112_EX3Z7012.JPG]




[F8K122112_EX3Z7013.JPG]




[F8K122112_EX3Z7014.JPG]




[F8K122112_EX3Z7015.JPG]




[F8K122112_EX3Z7016.JPG]




Exhibit 4.1

[F8K122112_EX4Z1001.JPG]




[F8K122112_EX4Z1002.JPG]




[F8K122112_EX4Z1003.JPG]




[F8K122112_EX4Z1004.JPG]




[F8K122112_EX4Z1005.JPG]




[F8K122112_EX4Z1006.JPG]




[F8K122112_EX4Z1007.JPG]




[F8K122112_EX4Z1008.JPG]




[F8K122112_EX4Z1009.JPG]




[F8K122112_EX4Z1010.JPG]




[F8K122112_EX4Z1011.JPG]




[F8K122112_EX4Z1012.JPG]




[F8K122112_EX4Z1013.JPG]




[F8K122112_EX4Z1014.JPG]




[F8K122112_EX4Z1015.JPG]




[F8K122112_EX4Z1016.JPG]



Exhibit 4.2

[F8K122112_EX4Z2001.JPG]




[F8K122112_EX4Z2002.JPG]




[F8K122112_EX4Z2003.JPG]




[F8K122112_EX4Z2004.JPG]




[F8K122112_EX4Z2005.JPG]




[F8K122112_EX4Z2006.JPG]




[F8K122112_EX4Z2007.JPG]




[F8K122112_EX4Z2008.JPG]




[F8K122112_EX4Z2009.JPG]




[F8K122112_EX4Z2010.JPG]




[F8K122112_EX4Z2011.JPG]




[F8K122112_EX4Z2012.JPG]




[F8K122112_EX4Z2013.JPG]




[F8K122112_EX4Z2014.JPG]




[F8K122112_EX4Z2015.JPG]




[F8K122112_EX4Z2016.JPG]




[F8K122112_EX4Z2017.JPG]




[F8K122112_EX4Z2018.JPG]



Exhibit 4.3


LOCK-UP LETTER AGREEMENT



Laidlaw & Company (UK) Ltd.

90 Park Avenue – 31 st Floor

New York, NY 10016


The investors set forth on the signature

pages of the Unit Purchase Agreement,

by and among Actinium Pharmaceuticals, Inc.

and each of the purchasers identified on Exhibit A

attached thereto


Dear Sirs:


The undersigned understands that Actinium Pharmaceuticals, Inc. (“API”) intends to enter into a Unit Purchase Agreement, by and among API and each of the purchasers identified on Exhibit A attached thereto (the “Agreement”) pursuant to which API intends to issue in units of API’s securities (the “Units”), with each Unit having a purchase price of $100,000 and consisting of one hundred eighty-one thousand eight hundred eighteen (181,818) shares of common stock of API (“API Common Stock”) and two Investor Warrants as follows: (i) an "A" Warrant to purchase one hundred eighty-one thousand eight hundred eighteen (181,818) shares of API Common Stock, exercisable at a price of $0.55 per share for a period of one hundred and twenty (120) days from the date of the final closing of the offering, and (ii) a "B" Warrant to purchase ninety thousand nine hundred nine (90,909) shares of API Common Stock, exercisable at a price of $0.825 per share for a period of five (5) years from the date of the final closing.


The undersigned also understands that API intends to enter into a Share Exchange Agreement with Cactus Ventures, Inc., a Nevada corporation (“Cactus”), pursuant to which Cactus will acquire 100% of the issued and outstanding equity securities of API, in exchange for the issuance of shares of common stock, par value $0.01 per share, of Cactus (the “ Cactus Common Stock”), which are to be issued to the shareholders of API, constituting approximately 99% of the issued and outstanding Cactus Common Stock after such issuance (the “Share Exchange”).  As a result of the Share Exchange, API will become the wholly owned subsidiary of Cactus and the former shareholders of API will became the controlling shareholders of Cactus.


In consideration of the execution of the Agreement by the purchasers and consummation of the Share Exchange, and for other good and valuable consideration, the undersigned hereby irrevocably agrees that the undersigned will not, directly or indirectly, that following the consummation of the Share exchange, sell or otherwise transfer any shares of Cactus Common Stock or other securities of Cactus owned by such person until (i) the date that is the earlier of twelve (12) months from the closing date of the Share Exchange; or (ii) six (6) months following the effective date of the Registration Statement.


In furtherance of the foregoing, Cactus and its transfer agent are hereby authorized to decline to make any transfer of securities if such transfer would constitute a violation or breach of this Lock-Up Letter Agreement.


It is understood that, if API notifies the undersigned that it does not intend to proceed with the Share Exchange or if the Agreement (other than the provisions thereof which survive termination) shall terminate or be terminated prior to the closing of the Share Exchange, then the undersigned will be released from the undersigned’s obligations under this Lock-Up Letter Agreement.





Laidlaw & Company

Page 2





The undersigned understands that API and the investors will proceed with the Agreement and Share Exchange in reliance on this Lock-Up Letter Agreement.


The undersigned hereby represents and warrants that the undersigned has full power and authority to enter into this Lock-Up Letter Agreement and that, upon request, the undersigned will execute any additional documents necessary in connection with the enforcement hereof.  Any obligations of the undersigned shall be binding upon the heirs, personal representatives, successors and assigns of the undersigned.


Very truly yours,



By:_________________________________

Name:

Title:



Dated:__________________________





-2-


Exhibit 10.1

[F8K122112_EX10Z1001.JPG]




[F8K122112_EX10Z1002.JPG]




[F8K122112_EX10Z1003.JPG]




[F8K122112_EX10Z1004.JPG]




[F8K122112_EX10Z1005.JPG]




[F8K122112_EX10Z1006.JPG]




[F8K122112_EX10Z1007.JPG]




[F8K122112_EX10Z1008.JPG]




[F8K122112_EX10Z1009.JPG]




[F8K122112_EX10Z1010.JPG]




[F8K122112_EX10Z1011.JPG]




[F8K122112_EX10Z1012.JPG]




[F8K122112_EX10Z1013.JPG]




[F8K122112_EX10Z1014.JPG]




[F8K122112_EX10Z1015.JPG]




[F8K122112_EX10Z1016.JPG]




[F8K122112_EX10Z1017.JPG]




[F8K122112_EX10Z1018.JPG]




[F8K122112_EX10Z1019.JPG]




[F8K122112_EX10Z1020.JPG]




[F8K122112_EX10Z1021.JPG]




[F8K122112_EX10Z1022.JPG]




[F8K122112_EX10Z1023.JPG]




[F8K122112_EX10Z1024.JPG]




[F8K122112_EX10Z1025.JPG]




[F8K122112_EX10Z1026.JPG]




[F8K122112_EX10Z1027.JPG]




[F8K122112_EX10Z1028.JPG]




[F8K122112_EX10Z1029.JPG]




[F8K122112_EX10Z1030.JPG]




[F8K122112_EX10Z1031.JPG]




[F8K122112_EX10Z1032.JPG]




[F8K122112_EX10Z1033.JPG]




[F8K122112_EX10Z1034.JPG]




[F8K122112_EX10Z1035.JPG]




[F8K122112_EX10Z1036.JPG]




[F8K122112_EX10Z1037.JPG]




[F8K122112_EX10Z1038.JPG]




[F8K122112_EX10Z1039.JPG]




[F8K122112_EX10Z1040.JPG]



Exhibit 10.6

[F8K122112_EX10Z6001.JPG]




[F8K122112_EX10Z6002.JPG]




[F8K122112_EX10Z6003.JPG]




[F8K122112_EX10Z6004.JPG]




[F8K122112_EX10Z6005.JPG]




[F8K122112_EX10Z6006.JPG]




[F8K122112_EX10Z6007.JPG]




[F8K122112_EX10Z6008.JPG]




[F8K122112_EX10Z6009.JPG]




[F8K122112_EX10Z6010.JPG]





[F8K122112_EX10Z6011.JPG]




[F8K122112_EX10Z6012.JPG]




[F8K122112_EX10Z6013.JPG]




[F8K122112_EX10Z6014.JPG]




[F8K122112_EX10Z6015.JPG]




[F8K122112_EX10Z6016.JPG]




[F8K122112_EX10Z6017.JPG]




[F8K122112_EX10Z6018.JPG]




[F8K122112_EX10Z6019.JPG]



Exhibit 10.7







UNIT PURCHASE AGREEMENT




BY AND AMONG




ACTINIUM PHARMACEUTICALS, INC.


AND


THE PURCHASERS PARTY HERETO
















October __, 2012





SCHEDULES AND EXHIBITS

TO

UNIT PURCHASE AGREEMENT


Schedule 3.1

Foreign Jurisdictions

Schedule 3.2

Subsidiaries; Joint Ventures, Partnerships

Schedule 3.3.3

Encumbered Shares

Schedule 3.3.4

Outstanding Options, Warrants and Stockholder Rights; Proxies; Stock Option Plans

Schedule 3.5

Financial Statements

Schedule 3.6

Absence of Liabilities

Schedule 3.7.1

Material Contracts

Schedule 3.7.4

Required Consents

Schedule 3.7.6

Acquisition Transactions

Schedule 3.9

Absence of Changes

Schedule 3.10

Title to Properties and Assets; Liens

Schedule 3.11.1

Owned Intellectual Property and Licensed Intellectual Property

Schedule 3.11.3

Outstanding Options or Rights to Acquire Intellectual Property

Schedule 3.11.4

Alleged Violations of Intellectual Property Rights

Schedule 3.11.10

Infringement of Intellectual Property Rights

Schedule 3.12

Compliance

Schedule 3.13

Litigation

Schedule 3.14

Tax Returns and Payments

Schedule 3.15.1

Employees

Schedule 3.15.2

Employee Claims

Schedule 3.16.1

Employee Benefit Plans

Schedule 3.16.2

Compliance with ERISA and the Code

Schedule 3.18

Leased Real Property

Schedule 3.19.1

Material Collaborators

Schedule 3.19.2

Material Suppliers

Schedule 3.21.2

Clinical Studies, Tests and Trials

Schedule 3.21.3

FDA, Government and Other Regulatory Correspondence

Schedule 3.21.10

FDA, Government and Other Regulatory Action Notice

Schedule 3.26

Insurance


Exhibit A

Schedule of Purchasers

Exhibit B-1

Form of A Warrant

Exhibit B-2

Form of B Warrant

Exhibit C

Form of Fifth Amended and Restated Certificate of Incorporation

Exhibit D

Funding Instructions

Exhibit E-1

Pre-Initial Closing Capitalization of the Company

Exhibit E-2

Post-Initial Closing Capitalization of the Company

Exhibit F

Form of Legal Opinion

Exhibit G

Form of Indemnification Agreement

Exhibit H

Form of 2012 Unit Investor Rights Agreement

Exhibit I

Form of First Amended and Restated Stockholders Agreement







ACTINIUM PHARMACEUTICALS, INC.

UNIT PURCHASE AGREEMENT


THIS UNIT PURCHASE AGREEMENT (the “ Agreement ”) is entered into on October __, 2012 by and among Actinium Pharmaceuticals, Inc., a Delaware corporation (the “ Company ”) and the purchasers identified on Exhibit A on the date hereof (which purchasers are hereinafter collectively referred to as the “ Purchasers ” and each individually as, a “ Purchaser ”).


BACKGROUND


A.

Unless otherwise defined in this Agreement, capitalized terms used in this Agreement shall have the respective meanings ascribed to such terms in Section 9.


B.

The Company has authorized a total of 325,000,000 shares, consisting of: (1) 283,463,176 shares of Common Stock, $0.01 par value per share (the “ Common Stock ”),  and (2) 41,536,824 shares of Preferred Stock, $0.01 par value per share of which (a) 1,000,000 shares are designated as Series A Convertible Participating Preferred Stock (the “ Series A Preferred Stock ”), (b) 4,711,247 shares are designated as Series B Preferred Stock (the “ Series B Preferred Stock ”), (c) 800,000 shares are designated as Series C-1 Preferred Stock (the “ Series C-1 Preferred Stock ”), (d) 666,667 shares are designated as Series C-2 Preferred Stock (the “ Series C-2 Preferred Stock ”), (e) 502,604 shares are designated as Series C-3 Preferred Stock (the “ Series C-3 Preferred Stock ”), (f) 4,250,000 shares are designated as Series C-4 Preferred Stock (the “ Series C-4 Preferred Stock ”, and collectively with the Series C-1 Preferred Stock, Series C-2 Preferred Stock and Series C-3 Preferred Stock, the “ Series C Preferred Stock ”), (g) 3,000,000 shares (the “ Series D Shares ”) are designated as Series D Preferred Stock (the “ Series D Preferred Stock ”); and, 26,606,306 shares (the “ Series E Shares ”) are designated as Series E Preferred Stock (the “ Series E Preferred Stock ”).


D.

Each Purchaser desires to purchase units (“ Units ”) of securities of the Company on the terms and conditions set forth herein.


E.

The Company desires to issue and sell the Units to each Purchaser in one or more closings (each a “ Closing ” and collectively the “ Closings ”) as set forth herein.


NOW, THEREFORE, in consideration of the representations, warranties, covenants and agreements herein contained and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties, intending to be legally bound, hereby agree as follows:


1.

AGREEMENT TO SELL AND PURCHASE.


1.1

Authorization of Shares and Warrants .   The board of directors of the Company has authorized (i) the sale of up to 200 Units, with each Unit consisting of 181,818 shares of Common Stock and warrants (the “ Warrants ”) consisting of (a) an A Warrant to purchase 181,818 shares of Common Stock at an exercise price of $0.55 per share for a period of 120 days following the Final Closing, and (y) a B Warrant to purchase 90,909 shares of Common Stock at an exercise price of $0.825 per share for a period of 5 years following the Final Closing, (ii) the issuance of up to 36,363,600 shares of Common Stock included as part of the authorized Units hereunder, (ii) the issuance of Warrants for the purchase of up to 54,545,400 shares of Common Stock, and (ii) the reservation of 54,545,400 shares of the Common Stock to be issued upon exercise of the Warrants (the “ Warrant Shares ”).  The Company Preferred Stock and Common Stock have the rights, preferences, privileges and restrictions set forth in the Fifth Amended and Restated Certificate of Incorporation of the Company in the form attached hereto as Exhibit C (the “ Certificate ”).


1.2

Initial Sale and Purchase of Units .  Subject to the terms and conditions hereof, and in reliance upon the representations, warranties and covenants contained herein, at the Initial Closing, the Company shall issue and sell to each Purchaser, and each Purchaser shall purchase from the Company, the number of Units set forth opposite such Purchaser’s name on Exhibit A under the “Initial Units”  column, at a purchase price of $100,000 per Unit (subject to appropriate and proportionate adjustment for stock dividends payable in shares of, stock splits and other subdivisions and combinations of, and recapitalizations and like occurrences with respect to, the Common Stock, the “ Per Unit Purchase Price ”).  The minimum purchase price by each Purchaser is one Unit, unless the Company and the Placement Agent agree, in their mutual discretion, to allow a Purchaser to purchase a partial Unit.  


1.3

Subsequent Sales and Purchases of Common Stock .   Subject to the terms and conditions hereof, and in reliance upon the representations, warranties and covenants contained herein, at each subsequent Closing, the Company shall issue and sell to each Purchaser who is identified as a “Subsequent Closing Purchaser” on Exhibit A (each, a “ Subsequent Closing Purchaser ”), and each Subsequent Closing Purchaser shall purchase from the Company, the number Units set forth opposite such Purchaser’s name on Exhibit A at the Per Unit Purchase Price.





1.4

Issuance of Warrants .  The Warrants shall be in form and substance substantially the same as the form of A Warrant in Exhibit B-1 and the form of B Warrant in Exhibit B-2 .   


2.

CLOSINGS, DELIVERY AND PAYMENT.


2.1

Initial Closing .  Subject to the conditions set forth in Section 5, the initial closing of the sale and purchase of the Units (the “ Initial Closing ”), shall take place electronically on such date and at such time as is agreed between the Company and the Placement Agent, in no event later than November 30, 2012, which date may be extended by the Company and the Placement Agent in their mutual discretion, to a date no later than January 31, 2013 (the “ Initial Closing Date ”).  The Units sold at the Initial Closing are sometimes referred to herein as “ Initial Units .”


2.2

Subsequent Closings .  Subject to the conditions set forth in Section 5, each Subsequent Closing shall take place electronically on such date, up to and including January 31, 2013, as the Company and the Placement Agent may designate (each a “ Subsequent Closing Date ”), except that if the Company has sold at least 150 Units on or before January 31, 2013, the Placement Agent may elect to place up to an additional 50 Units for sale in accordance with this Agreement until no later than February 28, 2013.  Subject to the foregoing, at Subsequent Closings, the Company may sell in the aggregate up to the authorized number of Units less the number of Units sold in all prior Closings up to a maximum of 200 Units.  The Units sold at the Subsequent Closings are sometimes referred to herein as “ Subsequent Units .


2.3

Delivery; Payment .  At each Closing, subject to the terms and conditions hereof, the Company will deliver to the Purchasers certificates representing the number of shares of Common Stock and corresponding Warrants to be purchased at such Closing by the Purchasers or the Subsequent Closing Purchasers, as the case may be, against payment of the full amount of the Purchase Price therefor in cash by wire transfer of immediately available funds in accordance with instructions attached hereto as Exhibit D , or as the Company shall otherwise direct.  Unless otherwise requested by any Purchaser, each Purchaser will receive at such Closing, one (1) certificate registered in its name representing the shares of Common Stock included in the Units purchased by such Purchaser and one (1) A Warrant and one (1) B Warrant for each Unit purchased by such Purchaser or Subsequent Closing Purchaser, as the case may be, at such Closing.  The Company and the Placement Agent, in their mutual discretion, may allow a Purchaser to purchase a partial Unit, in which case the Purchaser shall receive a certificate representing the appropriate number of shares of Common Stock included in such partial Unit and a partial A Warrant and partial B Warrant for the appropriate number of corresponding Warrant Shares.


3.

REPRESENTATIONS AND WARRANTIES OF THE COMPANY.


The Company represents and warrants to each of the Purchasers that the statements made in this Section 3, except as qualified in the disclosure schedules referenced herein and attached hereto (the “ Schedules ”), are true and correct on the date hereof and shall be true and correct as of the Subsequent Closing, except as qualified by any updated Schedules delivered at the Subsequent Closing in accordance with Section 5.1.1 hereof, all of which qualifications in the Schedules attached hereto and updated Schedules delivered at the Subsequent Closing shall be deemed to be representations and warranties as if made hereunder.  The Schedules shall be arranged to correspond to the numbered paragraphs contained in this Section 3, and the disclosure in any paragraph of the Schedules shall qualify other subsections in Section 3 only to the extent that it is readily apparent from a reading of the disclosure that such disclosure is applicable to such other subsections.  For purposes of this Section 3, “knowledge” shall mean the personal knowledge of any of the Company’s officers or directors or what they would have known upon having made reasonable inquiry.  


3.1

Organization, Good Standing and Qualification .  The Company is a corporation duly incorporated, validly existing and in good standing under the corporate and general laws of the State of Delaware.  Each of the other Actinium Entities is a corporation duly incorporated, validly existing and in good standing under the laws of its jurisdiction of incorporation.  Each Actinium Entity has all requisite corporate power and authority to own and operate its properties and assets.  The Company has all requisite corporate power and authority to execute and deliver this Agreement and the other Transaction Documents to which it is a party, and to issue and sell the Units, and to carry out the provisions of this Agreement, the other Transaction Documents and the Certificate and to carry on its business as currently conducted and as currently proposed to be conducted.  Each Actinium Entity is duly qualified, is authorized to do business and is in good standing as a foreign corporation in each jurisdiction listed on Schedule 3.1 , each of which jurisdictions are the only jurisdictions in which the nature of such Actinium Entity’s activities and properties (both owned and leased) makes such qualification necessary except where failure to be so qualified has not had, or could not reasonably be expected to have, a Material Adverse Effect.


3.2

Subsidiaries .   Schedule 3.2 contains a true and complete list of each of the Company’s Subsidiaries and their respective jurisdictions of organization.  Except as set forth on Schedule 3.2 , no Actinium Entity owns or controls any ownership interest or profits interest in any other corporation, limited liability company, limited partnership or other entity.  The Company owns and controls as to all matters 100% of the outstanding ownership and profits interests in each Subsidiary listed on Schedule 3.2 . Except as set forth on Schedule 3.2 , no Actinium Entity is a participant in any joint venture, partnership or similar arrangement.    





3.3

Capitalization Matters .  


3.3.1.

Immediately prior to the Initial Closing, the total authorized capital stock of the Company, consists of: (a) 283,463,176  shares of Common Stock, of which 2,407,805 shares are issued and outstanding; and (b) 41,536,824  shares of Preferred Stock, of which (i) 1,000,000 shares are designated as Series A Preferred Stock, all of which are issued and outstanding, (ii) 4,711,247 shares are designated as Series B Preferred Stock, all of which are issued and outstanding, (iii) 800,000 shares are designated as Series C-1 Preferred Stock, all of which are issued and outstanding, (iv) 666,667 shares are designated as Series C-2 Preferred Stock, all of which are issued and outstanding, (v) 502,604 shares are designated as Series C-3 Preferred Stock, all of which are issued and outstanding, (vi) 4,250,000 shares are designated as Series C-4 Preferred Stock, all of which are issued and outstanding, (vii) 3,000,000 shares are designated as Series D Preferred Stock, all of which  shares are issued and outstanding, and (viii) 26,606,306  shares of Series E Preferred Stock, all of which are issued and outstanding.


3.3.2.

Immediately prior to the Initial Closing, all issued and outstanding shares of the Company’s Common Stock, Series A Preferred Stock, Series B Preferred Stock, Series C-1 Preferred Stock, Series C-2 Preferred Stock, Series C-3 Preferred Stock, Series C-4 Preferred Stock, Series D Preferred Stock, and Series E Preferred Stock  (a) have been duly authorized and validly issued to the persons listed on Exhibit E-1 hereto in the amounts set forth thereon, (b) are fully paid and nonassessable, and (c) were issued in compliance with all applicable state and federal laws concerning the issuance of securities.


3.3.3.

Upon consummation of the purchase and sale of the Units contemplated by this Agreement, (a) all issued and outstanding shares of the Company’s Common Stock will be: (i) duly authorized, validly issued, fully paid and nonassessable, (ii) issued in compliance with all applicable state and federal laws concerning the issuance of securities, and (iii) except as set forth on Schedule 3.3.3 , free of any Encumbrances; provided, however , that the Company’s Units and the Warrant Shares may be subject to restrictions on transfer under state and/or federal securities laws; and (b) the Warrant Shares have been duly and validly authorized and reserved for issuance, and upon issuance in accordance with the Certificate will be fully paid and nonassessable.  The rights, preferences, privileges and restrictions of the Company’s Preferred Stock and Common Stock are as stated in the Certificate.


3.3.4.

Except as set forth on Schedule 3.3.4 , there are no outstanding options, warrants, rights (including conversion or preemptive rights and rights of first refusal), or other agreements of any kind for the purchase or acquisition from any Actinium Entity of any of such Actinium Entity’s securities.  Except as set forth on Schedule 3.3.4 , there are no proxies, stockholder agreements, or any other agreements between any Actinium Entity and any securityholder of such Actinium Entity or, to the knowledge of the Company, among any securityholders of any Actinium Entity, including agreements relating to the voting, transfer, redemption or repurchase of any securities of such Actinium Entity.  Except for the Company’s 2003 Stock Option Plan and the Company’s 2012 Stock Option Plan, which are attached to Schedule 3.3.4 , there are no stock option plans, stock purchase plans, equity incentive plans, stock appreciation rights, phantom stock or similar plans or rights applicable to any Actinium Entity.  The total outstanding capital stock of the Company on a fully-diluted basis immediately following the Initial Closing is as set forth on Exhibit E-2 .


3.4

Authorization; Binding Obligations .  All actions by or on behalf of the Company necessary for the authorization of this Agreement and the other Transaction Documents, the performance of all obligations of the Company hereunder and thereunder at each Closing and the authorization, sale, issuance and delivery of the Units pursuant hereto have been taken.  This Agreement (assuming due execution and delivery by the Purchasers) and the other Transaction Documents (assuming due execution and delivery by all other parties thereto), when executed and delivered, will be valid and binding obligations of the Company and enforceable against it in each case in accordance with its respective terms, except (a) as limited by applicable bankruptcy, insolvency, reorganization, moratorium or other laws of general application affecting enforcement of creditors’ rights, (b) general principles of equity that restrict the availability of equitable remedies, and (c) to the extent that the enforceability of the indemnification provisions of Section 7 may be limited by applicable law.  The sale of the Units and the subsequent exercise of the Warrants for Warrant Shares are not subject to any preemptive rights, rights of first refusal or other similar rights that have not expired or been waived or exercised as of each Closing. The execution, delivery and performance of, and the consummation of the transactions contemplated by, this Agreement and the other Transaction Documents, including without limitation the sale, issuance and delivery of the Units, have not resulted and will not result in (x) any violation of, or default under, or conflict with, or constitute, with or without the passage of time or the giving of notice or both, any violation of, or default under, or give rise to any right of termination, cancellation or acceleration under (i) any term or provision of (A) the Organizational Documents of any Actinium Entity, (B) any Contract, agreement, instrument, arrangement or understanding of any Actinium Entity, or (C) any Order to which any Actinium Entity is a party or by which any of them or any of their respective properties or assets are bound or (ii) any Requirement of Law applicable to any Actinium Entity or any of their respective properties or assets or (y) the creation of any Encumbrance upon any of the properties or assets of any Actinium Entity.





3.5

Financial Statements .  The Company has delivered to the Purchasers (a) the consolidated audited financial statements (balance sheet, statement of operations, statement of stockholders’ equity, and statement of cash flows) of the Actinium Entities as at December 31, 2010 and December 31, 2011 and (b) the consolidated unaudited financial statements (balance sheet, statement of operations, and statement of cash flows) of the Actinium Entities  for the six months ended June 30, 2012  (the “ Statement Date ”), copies of which are attached hereto as part of Schedule 3.5 (collectively, the “ Financial Statements ”).  The Financial Statements, together with the notes thereto, have been prepared in accordance with generally accepted accounting principles applied on a consistent basis throughout the periods indicated, and present fairly in all material respects the consolidated financial condition and position of the Actinium Entities as of the date of such Financial Statements and the results of operations and changes in stockholders’ equity and cash flows for the periods covered thereby, subject in the case of unaudited financial statements to normal year-end adjustments, which adjustments will not be materially adverse to the Actinium Entities, and an absence of notes.  


3.6

Absence of Liabilities .  No Actinium Entity has any Liabilities that are not reflected or disclosed in the balance sheet for the six month period ended on the Statement Date or set forth on Schedule 3.6 attached hereto, other than trade payables and accrued payroll incurred in the ordinary course of business consistent with past practice after such date and other liabilities incurred in the ordinary course of business consistent with past practice after such date that, individually or in the aggregate, has not had, or could not reasonably be expected to have, a material adverse effect on any of the business, properties, assets, financial condition, results of operations, prospects or Liabilities of the Actinium Entities, taken as a whole (a “ Material Adverse Effect ”).  No Actinium Entity is a guarantor or indemnitor of any Liability of any other Person.  Except for operating leases for personal or real property entered into in the ordinary course of business which do not require payments of more than $50,000 in the aggregate during any fiscal year, no Actinium Entity has issued any instruments, entered into any agreements, commitments or arrangements or incurred any obligations that would have, or would reasonably be expected to have, the effect of providing any Actinium Entity with “off balance sheet” financing.


3.7

Agreements; Action .


3.7.1.

Disclosure .   Schedule 3.7.1 sets forth a complete and accurate list of all the following Contracts to which any Actinium Entity or any of their respective properties or assets are a party or otherwise bound (each a “ Material Contract ”):


(a)

Contracts not made in the ordinary course of business;

(b)

each Contract pursuant to which (x) any Actinium Entity is granted rights to, or ownership in, any Intellectual Property by any other Person (excluding “shrink wrap” licenses for generally available, commercial, off-the-shelf Software that has not been modified), (y) any Actinium Entity purchases radioactive isotopes, components, raw materials, equipment, instruments, and other supplies and machinery that are material to the Actinium Entities’ businesses, or supplies any other Person with any radioactive isotopes, components, raw materials, equipment, instruments, and other supplies and machinery, or (z) any Actinium Entity grants another person rights to, or ownership in, any Intellectual Property;

(c)

Contracts relating to any feasibility, preclinical, clinical or other study, test or trial conducted by or on behalf of, or sponsored by, any Actinium Entity or in which any Actinium Entity or any of its drug compounds or pharmaceutical products  (collectively, the “ Products ”) is participating;

(d)

Contracts relating to the manufacture or production of any of the Products;

(e)

Contracts among one or more stockholders of any Actinium Entity which by their respective terms require performance after the date hereof;

(f)

Contracts or commitments involving future expenditures, actual or potential, in excess of $50,000 after the date hereof;

(g)

Contracts or commitments for the performance of services for any Actinium Entity by a third party which has a term of one (1) year or more;

(h)

Contracts or commitments to perform services which obligates any Actinium Entity to perform services which has a term of one (1) year or more;

(i)

Contracts or commitments relating to commission arrangements with any other Person;

(j)

Contracts (A) to employ, engage or terminate officers or other personnel and other Contracts with present or former officers, directors and other personnel of any Actinium Entity which by their respective terms require performance after the date hereof, or (B) that will result in the payment by any Actinium Entity of, or the creation of any Liability on the part of any Actinium Entity to pay, any severance, termination, “golden parachute,” or other similar payments to any present or former officers, directors or other personnel following termination of employment or engagement or otherwise;

(k)

indemnification agreements, except for the Indemnification Agreements;

(l)

any lease under which any Actinium Entity is either lessor or lessee of personal property requiring annual lease payments (including rent and any other charges) in excess of $50,000, and any lease under which any Actinium Entity is either lessor or lessee of any real property, including any Real Property Lease;





(m)

promissory notes, loans, agreements, indentures, evidences of indebtedness, letters of credit, guarantees, or other instruments relating to an obligation to pay money, whether any Actinium Entity shall be the borrower, lender or guarantor thereunder (excluding credit provided by any Actinium Entity in the ordinary course of business to purchasers of its products or services and obligations to pay vendors in the ordinary course of business and consistent with past practice);

(n)

Contracts containing covenants limiting the freedom of any Actinium Entity to engage in any activity anywhere in the world;

(o)

Contracts between any Actinium Entity and any United States federal, state or local government or any foreign government, or any Governmental or Regulatory Authority, or any agency or department thereof, or with any educational institution or part thereof;

(p)

any Contract or commitment for any charitable or political contribution by any Actinium Entity;

(q)

any power of attorney granted by any Actinium Entity in favor of any Person;

(r)

Contracts pertaining to any joint ventures, partnerships or similar arrangements;

(s)

any Contract or other arrangement with an Affiliate; and

(t)

any Contract not otherwise required to be listed pursuant to Subsections (a) – (s) above and with respect to which the consequences of a default, non-renewal or termination could reasonably be expected to have a Material Adverse Effect in the absence of a replacement Contract or arrangement therefor.


3.7.2.

The Company has provided or made available true and complete copies of all of the Material Contracts to the Purchasers.  Each of the Material Contracts is (a) in full force and effect, (b) a valid and binding obligation of, and is enforceable in accordance with its terms against the applicable Actinium Entity that is party thereto and, to the knowledge of the Company, each of the other parties thereto, except as such enforceability may be limited by bankruptcy, insolvency, moratorium or other law affecting the enforcement of creditors’ rights generally or by general equitable principles, (c) except for those Material Contracts disclosed pursuant to Section 3.7.1(a) and identified as such, was made in the ordinary course of business, and (d) contains no provision or covenant prohibiting or limiting the ability of any Actinium Entity to operate its business in the manner in which it is currently operated.


3.7.3.

To the best of the Company’s knowledge, each Actinium Entity has in all material respects performed the obligations required to be performed by it to date under each Material Contract to which it is a party and is not in default or breach thereof, and no event or condition has occurred, whether with or without the passage of time or the giving of notice, or both, that would constitute such a breach or default.  No Actinium Entity or any other party to any Material Contract has provided any notice to the other party or to any Actinium Entity, as applicable, of its intent to terminate, withdraw its participation in, or not renew any such Material Contract.  No Actinium Entity has, and to the knowledge of the Company, no other party to any Material Contract has, threatened to terminate, withdraw from participation in, or not renew any such Material Contract.  To the knowledge of the Company, no other party to any Material Contract is in breach or default under any provision thereof, and no event or condition has occurred, whether with or without the passage of time or the giving of notice, or both, that would constitute such a breach or default.


3.7.4.

Except as set forth on Schedule 3.7.4 , no Consent of any party to any Material Contract is required in connection with the transactions contemplated by this Agreement and the other Transaction Documents.


3.7.5.

The execution, delivery and performance of this Agreement and the other Transaction Documents do not and will not   (a) result in or give to any Person any right of termination, non-renewal, cancellation, withdrawal, acceleration or modification in or with respect to any Material Contract, (b) result in or give to any Person any additional rights or entitlement to increased, additional, accelerated or guaranteed payments under any such Material Contract or (c) result in the creation or imposition of any Liability or any Encumbrances upon the Actinium Intellectual Property or any Actinium Entity‘s assets under the terms of any such Material Contract.


3.7.6.

Except as set forth on Schedule 3.7.6 , no Actinium Entity or any representative thereof has engaged in the past twelve (12) months in any discussions regarding, and is not a party to or otherwise bound by any Contract in respect of, (a) any purchase, lease, license or other acquisition of any other Person, whether by equity purchase, merger, consolidation, reorganization or otherwise, or all or substantially all of the assets of any other Person, or the entering into by any Actinium Entity of any share exchange with any other Person, (b) Acquisition Transaction (as such term is defined in the Certificate) with respect to any of the Actinium Entities, or (c) Liquidation (as such term is defined in the Certificate) with respect to any of the Actinium Entities.


3.8

Intentionally omitted.     





3.9

Changes .  Except as set forth on Schedule 3.9 , since the Statement Date, there has not been:


3.9.1.

any effect, event, condition or circumstance (including, without limitation, the initiation of any litigation or other legal, regulatory or investigative proceeding) against the Company that individually or in the aggregate, with or without the passage of time, the giving of notice, or both, has had or could reasonably be expected to have a Material Adverse Effect;


3.9.2.

any resignation or termination of any director, officer, employee or consultant of any Actinium Entity, and no Actinium Entity has received notification of any impending resignation from any such Person;


3.9.3.

any material change in the contingent obligations of any Actinium Entity by way of guaranty, endorsement, indemnity, warranty or otherwise;


3.9.4.

any material damage, destruction or loss adversely affecting the assets, properties, business, financial condition or prospects of any Actinium Entity, whether or not covered by insurance;


3.9.5.

any waiver by any Actinium Entity of a valuable right or of any debt;


3.9.6.

any change in any compensation arrangement or agreement with any employee, consultant, officer, director or stockholder of any Actinium Entity that would increase the cost of any such agreement or arrangement to any Actinium Entity by more than $10,000 in each instance;


3.9.7.

any labor organization activity of the employees of any Actinium Entity;


3.9.8.

any declaration or payment of any dividend or other distribution of the assets of any Actinium Entity;


3.9.9.

any change in the accounting methods or practices followed by any Actinium Entity;


3.9.10.

any development, event, change, condition or circumstance that constitutes, whether with or without the passage of time or the giving of notice or both, a default under any Actinium Entity’s outstanding debt obligations; or


3.9.11.

any Contract or commitment made by any Actinium Entity to do any of the foregoing.


3.10

Title to Properties and Assets; Liens, etc .  Except as set forth on Schedule 3.10 , each Actinium Entity has good and marketable title to the properties and assets it owns, and each Actinium Entity has a valid license in all properties and assets licensed by it, including the properties and assets reflected as owned in the most recent balance sheet included in the Financial Statements, and has a valid leasehold interest in its leasehold estates, in each case subject to no Encumbrance, other than those resulting from Taxes which have not yet become delinquent or those of the lessors of leased property or assets.  All facilities, machinery, equipment, fixtures, vehicles and other properties owned, leased or used by each of the Actinium Entities are in good operating condition and repair, ordinary wear and tear excepted and are fit and usable for the purposes for which they are being used.  Each Actinium Entity is in compliance with all terms of each lease to which it is a party or is otherwise bound.  


3.11

Intellectual Property .  


3.11.1.

All registrations and applications for registration of all Owned Intellectual Property and all Licensed Intellectual Property (collectively, the “ Actinium Intellectual Property ”) and applications in process for the Owned Intellectual Property and the Licensed Intellectual Property are identified, by Actinium Entity, on Schedule 3.11.1 , identifying with respect to each such item of Actinium Intellectual Property, (a) the owner(s) thereof, (b) the jurisdiction(s) of registration, (c) the applicable registration or serial number, if any, (d) the date of expiration, if any, and (e) in the case of Licensed Intellectual Property, whether the applicable Actinium Entity’s rights with respect thereto are exclusive.  Except as set forth on Schedule 3.11.1 and identified as such, no Actinium Entity has licensed any Intellectual Property to or from any Person.  All of the registrations and applications for registration of the Actinium Intellectual Property are valid, subsisting and in full force and effect, and all actions and payments necessary for the maintenance and continuation of such Actinium Intellectual Property have been taken or paid on a timely basis.  Each Actinium Entity owns or possesses sufficient legal rights to use all of the Actinium Intellectual Property and the exclusive right to use all Owned Intellectual Property and all Licensed Intellectual Property which is identified in Schedule 3.11.1 as being exclusively licensed to any Actinium Entity.





3.11.2.

To the knowledge of the Company, the business as currently conducted and as proposed to be conducted by the Actinium Entities has not and will not constitute any infringement of the Intellectual Property rights of any other Person.  To the knowledge of the Company, the development of Product candidates and the use, manufacture or sale of the Actinium Entities’ Products based on the Actinium Intellectual Property does not, and will not, infringe the Intellectual Property rights of any third Person.  To the knowledge of the Company, no employee or agents of the Actinium Entities has misappropriated the Intellectual Property rights of any Person.


3.11.3.

Except as set forth on Schedule 3.11.3 , there are no outstanding options or other rights to acquire any Actinium Intellectual Property.  To the knowledge of the Company, each licensor of the Licensed Intellectual Property is the sole and exclusive owner of such Licensed Intellectual Property and has the sole and exclusive right and authority to grant licenses to such Licensed Intellectual Property.


3.11.4.

Except as set forth on Schedule 3.11.4 , no Actinium Entity has received any communications alleging or suggesting that it has violated or, by conducting its business as currently conducted or proposed to be conducted, would infringe or misappropriate any of the Intellectual Property rights of any other Person.


3.11.5.

It is not necessary to the business of any Actinium Entity, as currently conducted or as proposed to be conducted, to utilize any inventions, trade secrets or proprietary information of any of its employees, agents, developers, consultants or contractors made prior to their employment by or service to such Actinium Entity, except for inventions, trade secrets or proprietary information that have been assigned or licensed to any Actinium Entity.


3.11.6.

Since the date of the Company’s incorporation, there has not been any sale, assignment or transfer of any Actinium Intellectual Property or other intangible assets of any Actinium Entity.


3.11.7.

No Actinium Intellectual Property is subject to any interference, reissue, reexamination, opposition or cancellation proceeding or any other Legal Proceeding or subject to or otherwise bound by any outstanding Order or Contract (other than in the case of any Licensed Intellectual Property, the Contract pursuant to which the Company licenses the rights to such Licensed Intellectual Property) that restricts in any manner the use, transfer or licensing thereof by any Actinium Entity or may affect the validity, use or enforceability of such Actinium Intellectual Property.  No Actinium Entity has any knowledge of any fact or circumstance that would render any portion of the Actinium Intellectual Property invalid or unenforceable.  


3.11.8.

Each current and former officer, employee, agent, developer, consultant and contractor who (a) has had or has access to any Actinium Intellectual Property has executed a confidentiality and nondisclosure agreement that protects the confidentiality of the trade secrets of the Actinium Intellectual Property; and (b) contributed to or participated in the creation and/or development of the Actinium Intellectual Property either: (i) is a party to a “work made for hire” agreement under which one or more Actinium Entities is deemed to be the original owner/author of all right, title and interest in the Intellectual Property created or developed by such Person; or (ii) has executed an assignment or an agreement to assign in favor of one or more Actinium Entities of all such Person’s right, title and interest in the Intellectual Property.


3.11.9.

The execution and delivery of this Agreement and the other Transaction Documents and consummation of the transactions contemplated hereby and thereby will not result in the breach of, or create on behalf of any third party the right to terminate or modify, any license, sublicense, agreement or permission: (a) relating to or affecting any Actinium Intellectual Property; or (b) pursuant to which any Actinium Entity is granted a license or otherwise authorized to use any third party Intellectual Property.


3.11.10.

Except as set forth on Schedule 3.11.10 , to the knowledge of the Company, no Person is infringing, violating, misappropriating or making unauthorized use of any of the Actinium Intellectual Property.   The Actinium Entities have enforced and taken such commercially reasonable steps as are necessary to protect and preserve all rights in the Actinium Intellectual Property against the infringement, violation, misappropriation and unauthorized use thereof by any Person.  Each Actinium Entity has the right to: (a) bring actions for past, present and future infringement, dilution, misappropriation or unauthorized use of any Actinium Intellectual Property owned or licensed by such Actinium Entity, injury to goodwill associated with the use of any such Actinium Intellectual Property, unfair competition or trade practices violations of and other violation of such Actinium Intellectual Property; and (b) with respect to the Actinium Intellectual Property owned exclusively by any one or more Actinium Entities, receive all proceeds from the foregoing set forth in subsection (a) hereof, including, without limitation, licenses, royalties income, payments, claims, damages and proceeds of suit.





3.12

Compliance with Other Instruments .  Except as set forth on Schedule 3.12 , no Actinium Entity is in violation or default of any term of the Certificate, its Organizational Documents or its Bylaws, respectively (in each case, as amended to date), or of any provision of any Contract to which it is party or by which it is bound or of any Order applicable to any Actinium Entity, except for violations or defaults of any Contract (other than any Material Contract), which individually or in the aggregate has not had, or would not reasonably be expected to have, a Material Adverse Effect.  


3.13

Litigation .  Except as set forth on Schedule 3.13 , there is no Legal Proceeding pending or, to the knowledge of the Company, threatened against any Actinium Entity or any investigation of an Actinium Entity, nor is the Company aware of any fact that would make any of the foregoing reasonably likely to arise.  No Actinium Entity is a party or subject to the provisions of any Order.  Except as set forth on Schedule 3.13 , there is no Legal Proceeding by any Actinium Entity currently pending or that any Actinium Entity intends to initiate.


3.14

Tax Returns and Payments .  


3.14.1.

Except as set forth on Schedule 3.14 , each Actinium Entity has timely filed all Tax Returns required to be filed by it, and each Actinium Entity has timely paid all Taxes owed (whether or not shown on any Tax Return).  All such Tax Returns were complete and correct, and such Tax Returns correctly reflected the facts regarding the income, business, assets, operations, activities, status and other matters of such Actinium Entity and any other information required to be shown thereon.  Each Actinium Entity has withheld and paid all Taxes required to have been withheld and paid in connection with amounts paid or owing to any Employee, creditor, independent contractor, shareholder, member or other third party.  Each Actinium Entity has established adequate reserves for all Taxes accrued but not yet payable.  No Actinium Entity has been audited by nor have issues been raised or adjustments made or proposed by any tax authority in connection with any such Taxes or Tax Returns.  No deficiency assessment with respect to or proposed adjustment of any Actinium Entity’s Taxes is pending or, to the knowledge of the Company, threatened.  There is no tax lien (other than for current Taxes not yet due and payable), imposed by any taxing authority, outstanding against the assets, properties or the business of any Actinium Entity.  


3.14.2.

No Actinium Entity has agreed to make any adjustment under Section 481(a) of the Internal Revenue Code of 1986, as amended (the “ Code ”) (or any corresponding provision of state, local or foreign tax law) by reason of a change in accounting method or otherwise, and no Actinium Entity will be required to make any such adjustment as a result of the transactions contemplated by this Agreement.  No Actinium Entity has been or is a party to any tax sharing or similar agreement.  No Actinium Entity is or has ever been, a party to any joint venture, partnership, limited liability company, or other arrangement or Contract which could be treated as a partnership for federal income tax purposes.  No Actinium Entity is or has ever been, a “United States real property holding corporation” as that term is defined in Section 897 of the Code.


3.15

Employees .  


3.15.1.

All of the employees of each Actinium Entity (the “ Employees ”) are identified, by Actinium Entity, on Schedule 3.15.1 .  Except as set forth on Schedule 3.15.1 , (a) no Actinium Entity has, or has ever had any, collective bargaining agreements with any of its employees; (b) there is no labor union organizing activity pending or, to the knowledge of the Company, threatened with respect to any Actinium Entity; (c) no Employee has or is subject to any agreement or Contract to which any Actinium Entity is a party (including, without limitation, licenses, covenants or commitments of any nature) regarding his or her employment or engagement; (d) to the best of the Company’s knowledge, no Employee is subject to Order, that would interfere with his or her duties to the Actinium Entities or that would conflict with the Actinium Entities’ businesses as currently conducted and as proposed to be conducted; (e) no Employee is in violation of any term of any employment contract, proprietary information agreement or any other agreement relating to the right of any such Person to be employed by, or to contract with, any Actinium Entity; (f) to the best of the Company’s knowledge, the continued employment by any Actinium Entity of its present Employees, and the performance of their respective duties to such Actinium Entity, will not result in any violation of any term of any employment contract, proprietary information agreement or any other agreement relating to the right of any such individual to be employed by, or to contract with, such Actinium Entity, and no Actinium Entity has received any written notice alleging that such violation has occurred; (g) no Employee or consultant has been granted the right to continued employment by or service to any Actinium Entity or to any compensation following termination of employment with or service to such Actinium Entity; and (h) no Actinium Entity has any present intention to terminate the employment or engagement or service of any officer or any significant Employee or consultant.


3.15.2.

Except as set forth on Schedule 3.15.2 , there are no outstanding or, to the knowledge of the Company, threatened claims against any Actinium Entity or any Affiliate (whether under federal or state law, under any employment agreement, or otherwise) asserted by any present or former Employee or consultant of an Actinium Entity.  No Actinium Entity is in violation of any law or Requirement of Law concerning immigration or the employment of persons other than U.S. citizens.





3.16

Pension and Other Employee Benefit Plans .


3.16.1.

There are set forth or identified in Schedule 3.16.1 all of the plans, funds, policies, programs and arrangements sponsored or maintained by any Actinium Entity on behalf of any Employee or former employee of any Actinium Entity (or any dependent or beneficiary of any such Employee or former employee) with respect to (a) deferred compensation or retirement benefits; (b) severance or separation from service benefits (other than those required by law); (c) incentive, performance, stock, share appreciation or bonus awards; (d) health care benefits; (e) disability income or wage continuation benefits; (f) supplemental unemployment benefits; (g) life insurance, death or survivor’s benefits; (h) accrued sick pay or vacation pay; or (i) any other material benefit offered under any arrangement constituting an “employee benefit plan” within the meaning of Section 3(3) of the Employee Retirement Income Security Act of 1974, as amended (“ ERISA ”) and not excepted by Section 4 of ERISA (the foregoing being collectively called “ Employee Benefit Plans ”).   Schedule 3.16.1 sets forth all such Employee Benefit Plans subject to the provisions of Section 412 of the Code as well as any “multi-employer plans” within the meaning of Section 3(37) of ERISA or Section 4001(a)(3) of ERISA.  Except as set forth on Schedule 3.16.1 , the transactions contemplated by this Agreement will not result in any payment or series of payments by the Purchasers or any Actinium Entity of an “excess parachute payment” within the meaning of Section 280G of the Code or any other severance, bonus or other payment on account of such transactions.  Except as set forth on Schedule 3.16.1 , none of the Employee Benefit Plans is under investigation or audit by either the United States Department of Labor, the Internal Revenue Service or any other Governmental or Regulatory Authority.  


3.16.2.

Except as set forth on Schedule 3.16.2 , (a) each Actinium Entity has complied with its obligations under all applicable Requirements of Law including, without limitation, of ERISA and the Code with respect to such Employee Benefit Plans and all other arrangements that provide compensation or benefits to any Employee and the terms thereof, whether or not such person is directly employed by any Actinium Entity and (b) there are no pending or, to the knowledge of the Company, threatened actions or claims for benefits by any Employee, other than routine claims for benefits in the ordinary course of business.  No Employee Benefit Plan provides any benefits to any former employees.


3.16.3.

All Employee Benefit Plans that are intended to meet the requirements of Section 401(a) of the Code have been determined by the Internal Revenue Service to meet such requirements and have at all times operated in compliance with such requirements.  


3.16.4.

All employment Taxes, premiums for employee benefits provided through insurance, contributions to Employee Benefit Plans, and all other compensation and benefits to which Employees are entitled, have been timely paid or provided as applicable, and there is no liability for any such payments, contributions or premiums.


3.17

Registration Rights .  Except as required pursuant to the Investor Rights Agreement, no Actinium Entity is under any obligation, or has granted any rights that have not been terminated, to register any of such Actinium Entity’s currently outstanding securities or any of its securities that may hereafter be issued.


3.18

Real Property .  No Actinium Entity has any interest in any real estate, except that the Actinium Entities lease the properties described on Schedule 3.18 (the “ Leased Real Property ”).  The Leased Real Property is adequate for the operations of each of the Actinium Entities’ businesses as currently conducted and as contemplated to be conducted.  True and complete copies of the lease agreements (the “ Real Property Leases ”) pertaining to the Leased Real Property have been delivered to the Purchasers.  Except as set forth in Schedule 3.18 , each Actinium Entity has paid all amounts due from it, and is not in default under any of the Real Property Leases and there exists no condition or event, which, with the passage of time, giving of notice or both, would reasonably be expected to give rise to a default under or breach of the Real Property Leases.


3.19

Relationships with Collaborators and Suppliers .


3.19.1.

Collaborators .  Set forth on Schedule 3.19.1 is a list, by Actinium Entity, of the material collaborators, research partners and other material service providers of the Actinium Entities.  For the purposes of this Section “material collaborators” means scientific research collaborators who work with any Actinium Entity and whose work is expected to impact the development of the Actinium Intellectual Property and/or the Products, and includes, without limitation, any Person to whom any Actinium Entity has licensed any of the Actinium Intellectual Property (collectively, the “ Collaborators ”).  To the best of the Company’s knowledge, the Actinium Entities maintain good working relationships with all of the Collaborators.  The Company has delivered or made available to the Purchasers a list of each Actinium Entity’s Contracts with the Collaborators as set forth on Schedule 3.19.1 .  Except as set forth on Schedule 3.19.1 , none of such Collaborators has terminated or indicated an intention or plan or, to the knowledge of the Company, threatened to terminate its Contract with the applicable Actinium Entity, or to materially reduce the purchases of products or services from such Actinium Entity historically made by such Collaborator.





3.19.2.

Suppliers .  Set forth on Schedule 3.19.2 is a list of the material suppliers of the Actinium Entities.  For the purposes of this Section, “material suppliers” means suppliers who provide an essential and material element necessary for the research and development of the Actinium Intellectual Property or required for the Products (collectively, the “ Suppliers ”).  Except as set forth on Schedule 3.19.2 , none of such Suppliers has terminated or indicated an intention or plan or, to the knowledge of the Company, threatened to terminate its Contract with any Actinium Entity, or to materially reduce the supply of products or services to any Actinium Entity historically provided by such Supplier.


3.20

Budget .  The Company’s budget most recently delivered by the Company to the Purchasers (the “Budget ”) was prepared in good faith by the Company, and, based on the Company's experience and the assumptions used in preparing such Budget, constitutes a reasonable estimate of the costs and expenses expected to be incurred by the Actinium Entities during the time period covered thereby.  Nothing has come to the attention of the Actinium Entities’ management that would cause such estimated expenses to no longer be reasonable estimates.  The assumptions used in the preparation of such estimated expenses were fair and reasonable when made and continue to be fair and reasonable as of the date hereof.  


3.21

Permits; Regulatory .  


3.21.1.

No Regulatory Approval or Consent of, or any designation, declaration or filing with, any Governmental or Regulatory Authority or any other Person is required in connection with the valid execution, delivery and performance of this Agreement and the other Transaction Documents (including, without limitation, the issuance of the Units), except such Regulatory Approvals, Consents, designations, declarations or filings that have been duly and validly obtained or filed, or with respect to any filings that must be made after the Initial Closing or the Subsequent Closing as will be filed in a timely manner.  Each Actinium Entity has all franchises, Permits, licenses and any similar authority necessary for the conduct of its business as now being conducted, including, without limitation, the Food and Drug Administration (“ FDA ”) of the U.S. Department of Health and Human Services.


3.21.2.

Schedule 3.21.2 lists each feasibility, preclinical, clinical and other study, test and trial being conducted by or on behalf of or sponsored by any Actinium Entity or in which any Actinium Entity or any of its Products is participating.  The feasibility, preclinical, clinical and other studies, tests and trials conducted by or on behalf of or sponsored by any Actinium Entity or in which any Actinium Entity or any of the Actinium Entities’ Products have participated were and, if still pending, are being conducted in accordance with standard medical and scientific research procedures, the protocols established and approved therefor and all applicable Requirements of Law. The Company has no knowledge of any other studies or tests the results of which are inconsistent with or otherwise call into question the results of the above referenced studies and tests.


3.21.3.

Except as set forth on Schedule 3.21.3 , no Actinium Entity and, to the knowledge of the Company, no other Person has received any notice or other correspondence or communication from the FDA or any other Governmental or Regulatory Authority or other Person requiring the termination, suspension or modification of any of the above referenced feasibility, preclinical or clinical studies, tests or trials or alleging a violation of any applicable Requirements of Law in connection therewith, or any Products.


3.21.4.

The Actinium Entities have filed or caused to be filed and, to the knowledge of the Company, each other Person which has conducted or is conducting any feasibility, preclinical, clinical or other study, test or trial for or on behalf of the any Actinium Entity or any such study, test or trial that is being sponsored by any Actinium Entity has filed all required notices and other reports, including adverse experience reports.


3.21.5.

The Actinium Entities, or their designated agents (for and on behalf of the Actinium Entities), own or have the exclusive right to use all material regulatory documents.  For the purposes of this Section, “material regulatory documents” means all study, test and trial data and information and all correspondence and reports made to Governmental or Regulatory Authorities relating to or in connection with the Products or any feasibility, preclinical, clinical or other study, test or trial with respect thereto, which data, information, correspondence and reports are necessary or required to obtain approval from such Governmental or Regulatory Authority to conduct any feasibility, preclinical, clinical or other study, test or trial with respect to, or to manufacture, market or sell, any of the Products.


3.21.6.

No Actinium Entity or, to the knowledge of the Company, any other Person has received any notice or other correspondence or communication that any Governmental or Regulatory Authority (including, without limitation, the FDA) has commenced or, to the knowledge of the Company, threatened to initiate any action to withdraw or to hinder approval for a Product or to limit the ability of any Actinium Entity or any other Person to manufacture (or to have manufactured for it by a third party) any Product or to request the recall of any Product, or commenced or threatened to initiate any action to enjoin production of such Product at any facility.






3.21.7.

To the best of the Company’s knowledge, all manufacturing and production operations conducted by the Actinium Entities (or by third parties on behalf of the Actinium Entities including, without limitation, any manufacturing or production being done by any third party in connection with any feasibility, preclinical, clinical or other study, test or trial for or on behalf of any Actinium Entity or any such study, test or trial that is being sponsored by any Actinium Entity or in which any Actinium Entity or any of the Actinium Entities’ Products is participating), if any, relating to the manufacture or production of the Products are being conducted in compliance with all applicable Requirements of Law including to the extent mandated by relevant regulatory agencies, without limitation, current Good Manufacturing Practices or similar foreign requirements.


3.21.8.

No Actinium Entity or, to the knowledge of the Company, any other Person has received (a) any reports of inspection observations, (b) any establishment inspection reports or (c) any warning letters or any other documents from the FDA or any other Governmental or Regulatory Authority relating to the Products and/or arising out of the conduct of any Actinium Entity or any Person which has conducted or is conducting any feasibility, preclinical, clinical or other study, test or trial for or on behalf of any Actinium Entity or any such study, test or trial that is being sponsored by any Actinium Entity or in which any Actinium Entity’s Products is participating that assert a material violation or material non-compliance with any applicable Requirements of Law (including, without limitation, those of the FDA).


3.21.9.

In addition:


(a)

no Actinium Entity has made, or to the knowledge of the Company, any other Person that manufactures, tests or distributes any Product has made, with respect to any Product, an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental or Regulatory Authority or failed to disclose a material fact required to be disclosed to the FDA or any other Governmental or Regulatory Authority;

(b)

to the knowledge of the Company, no officer, employee or agent of any Actinium Entity has made and, no officer, employee or agent of any other Person that manufactures, tests or distributes any Product has made, with respect to any Product, an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental or Regulatory Authority or failed to disclose a material fact required to be disclosed to the FDA or any other Governmental or Regulatory Authority;

(c)

no Actinium Entity has been convicted of any crime;

(d)

to the knowledge of the Company, no officer, employee or agent of any Actinium Entity has been convicted of any felony;

(e)

no Actinium Entity or, to the knowledge of the Company, any other Person that manufactures, tests or distributes any Product has engaged in any conduct for which debarment is mandated by 21 U.S.C. §335a(a) or any similar Requirement of Law or authorized by 21 U.S.C. §335a(b) or any similar Requirement of Law;

(f)

to the knowledge of the Company, no officer, employee or agent of any Actinium Entity, and no officer, employee or agent of any other Person that manufactures, tests or distributes any Product has engaged in any conduct for which debarment is mandated by 21 U.S.C. §335a(a) or any similar Requirement of Law or authorized by 21 U.S.C. §335a(b) or any similar Requirement of Law; and

(g)

where and when applicable, each Actinium Entity and, to the knowledge of the Company, any other Persons that manufacture, test or distribute any Product are and have been in substantial compliance with the Medicare Anti-kickback Statute, 42 U.S.C. §1320a-7b(b) and implementing regulations codified at 42 C.F.R. §1001 and with all similar Requirements of Law.


3.21.10.

Except as set forth on Schedule 3.21.10 , no Actinium Entity or, to the knowledge of the Company, any other Person that manufactures, tests or distributes any Product, received any notice, correspondence or any other communication that the FDA or any other Governmental or Regulatory Authority has commenced, or threatened to initiate, any action to place a clinical hold on a clinical investigation of any Product, withdraw its approval that clinical investigations of any Product proceed or request the recall of any Product, or commenced, or overtly threatened to initiate, any adverse regulatory action against any Actinium Entity, the Person who manufactures, test or distributes the Product, or any of their respective agents, licensees or contract research organizations.





3.22

Environmental and Safety Laws .  No Actinium Entity has caused or allowed, or contracted with any party for, the generation, use, transportation, treatment, storage or disposal of any Hazardous Substances in connection with the operation of its business or otherwise, except in compliance with all applicable Environmental Laws.  To the best of the Company’s knowledge, each Actinium Entity and the operation of its business are in compliance with all applicable Environmental Laws.  To the best of the company’s knowledge, all of the Leased Real Property and all other real property which any one or more Actinium Entities occupy (the “ Premises ”) is in compliance with all applicable Environmental Laws and Orders or directives of any Governmental or Regulatory Authority having jurisdiction under such Environmental Laws, including, without limitation, any Environmental Laws or Orders or directives with respect to any cleanup or remediation of any release or threat of release of Hazardous Substances.  Each Actinium Entity and the operation of its business is and has been in compliance with all applicable Environmental Laws.  To the knowledge of the Company, there have occurred no and there are no events, conditions, circumstances, activities, practices, incidents, or actions that may give rise to any common law or statutory liability, or otherwise form the basis of any Legal Proceeding, any Order, any remedial or responsive action, or any investigation or study involving or relating to any Actinium Entity, based upon or related to the manufacture, processing, distribution, use, treatment, storage, disposal, transport or handling, or the emission, discharge, release or threatened release into the environment, of any pollutants, contaminants, chemicals, or industrial, toxic or Hazardous Substance.  To the knowledge of the Company, (a) there is no asbestos contained in or forming a part of any building, structure or improvement comprising a part of any of the Leased Real Property, (b) there are no polychlorinated byphenyls (PCBs) present, in use or stored on any of the Leased Real Property, and (c) no radon gas or the presence of radioactive decay products of radon are present on, or underground at any of the Leased Real Property at levels beyond the minimum safe levels for such gas or products prescribed by applicable Environmental Laws.  Each Actinium Entity has obtained and is maintaining in full force and effect all necessary Permits, licenses and approvals required by all Environmental Laws applicable to the Premises and the business operations conducted thereon, and is in compliance with all such Permits, licenses and approvals.  No Actinium Entity has caused or allowed a release, or a threat of release, of any Hazardous Substance onto, at or near the Premises, and, to the knowledge of the Company, neither the Premises nor any property at or near the Premises has ever been subject to a release, or a threat of release, of any Hazardous Substance.  


3.23

Offering Valid .  Assuming the accuracy of the representations and warranties of the Purchasers contained in the subscription agreements entered into by each Purchaser in connection with this Agreement, the offer, sale and issuance of the Common Stock and the Warrants will be exempt from the registration requirements of the Securities Act of 1933, as amended (the “ Securities Act ”), and will be exempt from registration and qualification) under applicable state securities laws.


3.24

Full Disclosure .  All information furnished, to be furnished or caused to be furnished to the Purchasers with respect to any Actinium Entity, any of the Actinium Entities’ businesses, assets, properties, financial position and performance and Liabilities applicable for the purposes of or in connection with this Agreement or any of the other Transaction Documents or any of the transactions contemplated hereby or thereby is or, if furnished after the date of this Agreement and before the applicable Closing Date, shall be true and complete in all material respects and, does not, and if furnished after the date of this Agreement and before such applicable Closing Date, shall not, contain any untrue statement of material fact or fail to state any material fact necessary to make such statement not misleading.


3.25

Minute Books .  A copy of the minute books of the Company was made available to the Purchasers for inspection, which contains minutes of all meetings of directors and stockholders and all actions by written consent without a meeting by the directors and stockholders since January 1, 2002, and accurately reflect all actions taken by the directors (and any committee of the directors) and stockholders with respect to all transactions referred to in such minutes.  


3.26

Insurance .   Schedule 3.26 sets forth, by Actinium Entity, a list of all policies or binders of fire, casualty, liability, product liability, worker’s compensation, vehicular or other insurance held by the Actinium Entities concerning its assets and/or its businesses (specifying for each such insurance policy the insurer, the policy number or covering note number with respect to binders, and each pending claim thereunder of more than $5,000).  Such policies and binders are valid and in full force and effect.  No Actinium Entity is in default with respect to any provision contained in any such policy or binder or has failed to give any notice or present any claim of which it has notice under any such policy or binder in a timely fashion.  No Actinium Entity has received or given a notice of cancellation or non-renewal with respect to any such policy or binder.  None of the applications for such policies or binders contain any material inaccuracy, and all premiums for such policies and binders have been paid when due.  No Actinium Entity has knowledge of any state of facts or the occurrence of any event that could reasonably be expected to form the basis for any claim against it not fully covered by the policies referred to on Schedule 3.26 .  No Actinium Entity has received written notice from any of their respective insurance carriers that any insurance premiums will be materially increased after the applicable Closing Date or that any insurance coverage listed on Schedule 3.26 will not be available after such Closing Date on substantially the same terms as now in effect.  


3.27

Investment Company Act .  No Actinium Entity is an “investment company”, or a company “controlled” by an “investment company”, within the meaning of the Investment Company Act of 1940, as amended.





3.28

Foreign Payments; Undisclosed Contract Terms .


3.28.1.

To the knowledge of the Company, no Actinium Entity has made any offer, payment, promise to pay or authorization for the payment of money or an offer, gift, promise to give, or authorization for the giving of anything of value to any Person in violation of the Foreign Corrupt Practices Act of 1977, as amended and the rules and regulations promulgated thereunder.


3.28.2.

To the knowledge of the Company, there are no understandings, arrangements, agreements, provisions, conditions or terms relating to, and there have been no payments made to any Person in connection with any agreement, Contract, commitment, lease or other contractual undertaking of any Actinium Entity which are not expressly set forth in such contractual undertaking.


3.29

No Broker .  Other than commissions (including fees, expenses and warrants) payable to the Placement Agent, no Actinium Entity has employed any broker or finder, or incurred any liability for any brokerage or finders fees in connection with the sale of the Units, or the Common Stock and Warrants underlying the Units pursuant to this Agreement or the other Transaction Documents.


3.30

Compliance with Laws .  No Actinium Entity is in violation of, or in default under, any Requirement of Law applicable to such Actinium Entity, or any Order issued or pending against such Actinium Entity or by which such Actinium Entity or any of such Actinium Entities’ properties are bound, except for such violations or defaults that have not had, and could not reasonably be expected to have, a Material Adverse Effect.  


4.

REPRESENTATIONS AND WARRANTIES OF THE PURCHASERS.


Each of the Purchasers hereby severally, and not jointly, represents and warrants to the Company that each such Purchaser’s representations in the subscription agreement entered into in connection with this Agreement are true and correct as of the Closing.


5.

CONDITIONS TO THE CLOSING.


5.1

Conditions to Purchasers’ Obligations at the Closings .  The obligations of the Purchasers to consummate the transactions contemplated herein to be consummated at the Initial Closing and of the Subsequent Closing, as the case may be, are subject to the satisfaction, on or prior to the date of such Closing, of the conditions set forth below and applicable thereto, which satisfaction shall be determined, or may be waived in writing, by the Purchasers or Subsequent Closing Purchasers, as the case may be, who are entitled to purchase at least a majority of the Common Stock to be purchased at such Closing:


5.1.1.

Representations and Warranties; Performance of Obligations .  Each of the representations and warranties of the Company contained herein shall be true and correct on and as of the Initial Closing Date.  As of the Initial Closing, the Company shall have performed and complied with the covenants and provisions of this Agreement required to be performed or complied with by it at or prior to the Initial Closing Date.  As to the Subsequent Closings, each of the representations and warranties of the Company contained herein shall be true and correct on and as of the Subsequent Closing Date, as qualified by any updated set of Schedules delivered at least five (5) days in advance of the Subsequent Closing to the Subsequent Closing Purchasers participating in the Subsequent Closing.  As to the Subsequent Closings, the Company shall have performed and complied with the covenants and provisions of this Agreement and the other Transaction Documents required to be performed or complied with by it at or prior to the Subsequent Closing Date.  At each Closing, the Purchasers participating in such Closing shall have received certificates of the Company dated as of the date of such Closing, signed by the president or chief executive officer of the Company, certifying as to the fulfillment of the conditions set forth in this Section 5.1 and the truth and accuracy of the representations and warranties of the Company contained herein (as qualified by the most recently delivered Schedules) as of the Initial Closing Date and, as to each Subsequent Closing, the Subsequent Closing Date.


5.1.2.

Issuance in Compliance with Laws .  The sale and issuance of the Units shall be legally permitted by all laws and regulations to which any of the Purchasers and the Company are subject.


5.1.3.

Filings, Consents, Permits, and Waivers .  The Company and the Purchasers shall have made all filings and obtained any and all Consents, Permits, waivers and Regulatory Approvals necessary for consummation of the transactions contemplated by the Agreement and the other Transaction Documents, except for such filings as are not due to be made until after the applicable Closing.





5.1.4.

Reservation of Warrant Shares .  The Warrant Shares shall have been duly authorized and reserved for issuance by the Board of Directors.


5.1.5.

2012 Unit Investor Rights Agreement .  Concurrently with the issuance of the Units occurring at the Initial Closing, the 2012 Unit Investor Rights Agreement, substantially in the form attached hereto as Exhibit H (the “ Investor Rights Agreement ”), shall have been executed and delivered by the Company and each Purchaser.


5.1.6.

First Amended and Restated Stockholders Agreement .  Concurrently with the issuance of Common Stock and Warrants occurring at the Initial Closing and any Subsequent Closings, the First Amended and Restated Stockholders Agreement, substantially in the form attached hereto as Exhibit I (the “ Amended and Restated Stockholders Agreement ”), shall have been executed and delivered by each Purchaser.


5.1.7.

Lock-Up Agreements .  The officers and directors of the Company, and each stockholder of the Company owning 5% or more (giving effect to the conversion or exercise of all convertible securities held by each such stockholder) of the issued and outstanding Common Stock as of the date of such Closing (but not including any Purchaser of Units), and any other controlling persons, and the Placement Agent, shall have executed a form of lock-up agreement reasonably satisfactory to the Placement Agent and the Company whereby each such person agrees that following the consummation of the Pubco Transaction (as defined in the Certificate) each such person shall not sell or otherwise transfer any shares of Pubco (as defined in the Investor Rights Agreement) owned by such person until (i) the date that is the earlier of twelve (12) months from the closing date of the Pubco Transaction; or (ii) six (6) months following the effective date of the Registration Statement (as defined in the Investor Rights Agreement).


5.1.8.

Legal Opinion .  At each Closing, the Placement Agent and the Purchasers or the Subsequent Closing Purchasers, as the case may be, shall have received a legal opinion addressed to each of them, dated as of such Closing Date, substantially in the form attached hereto as Exhibit F from Goodsill Anderson Quinn Stifel LLP.


5.1.9.

Non-Competition Agreements .  All officers, employees and consultants of the Company shall have entered into non-competition and assignment of proprietary information and inventions agreements in form reasonably satisfactory to Purchasers.


5.1.10.

Proceedings and Documents .  All corporate and other proceedings in connection with the transactions contemplated at the Closings and all documents and instruments incident to such transactions shall be reasonably satisfactory in substance and form to the Purchasers or the Subsequent Closing Purchasers, as the case may be, and their counsel, and the Purchasers or the Subsequent Closing Purchasers, as the case may be, and their counsel shall have received all such counterpart originals or certified or other copies of such documents as they may reasonably request.


5.1.11.

Proceedings and Litigation .  No action, suit or proceeding shall have been commenced by any Person against any party hereto seeking to restrain or delay the purchase and sale of the Units or the other transactions contemplated by this Agreement or any of the other Transaction Documents.


5.1.12.

Filing of Certificate .  As of the Initial Closing Date, the Certificate shall have been filed with the Secretary of State of the State of Delaware.


5.1.13.

No Material Adverse Effect .  As to the Subsequent Closing, since the Initial Closing Date, there shall not have occurred any effect, event, condition or circumstance (including, without limitation, the initiation of any litigation or other legal, regulatory or investigative proceeding) that individually or in the aggregate, with or without the passage of time, the giving of notice, or both, that has had, or could reasonably be expected to have, a Material Adverse Effect or which could adversely affect the Company’s ability to perform its respective obligations under this Agreement or any of the other Transaction Documents.


5.1.14.

Updated Disclosures .  As to the Subsequent Closing, the Company must have delivered to the Purchasers an updated set of Schedules in accordance with Section 5.1.1 and such updated Schedules do not reveal any information or the occurrence, since the Initial Closing Date, of any effect, event, condition or circumstance, which individually, or in the aggregate, has had or could reasonably be expected to have, a Material Adverse Effect and do not include any state of facts that occur as a result of the breach by the Company of any of its obligations under this Agreement or any of the other Transaction Documents.





5.1.15.

Payment of Purchase Price .  As to the Initial Closing, each Purchaser shall have delivered to the Company the total purchase price to be paid for such Purchaser’s Initial Units, in the amount set forth opposite such Purchaser’s name on Exhibit A , which shall be no less than $5,000,000 in aggregate gross proceeds.  As to each Subsequent Closing, each Subsequent Closing Purchaser shall have delivered to the Company the total purchase price to be paid for such Subsequent Closing Purchaser’s Subsequent Units.


5.1.16.

Delivery of Documents at the Initial Closing .  The Company shall have executed and delivered the following documents, on or prior to the Initial Closing Date:


(a)

Certificates .  Certificates representing the Common Stock to be purchased and sold on the Initial Closing Date;

(b)

Warrants:  Executed Warrants, in substantially the form of Exhibits B-1 and B-2 , for the Warrants to be issued on the Initial Closing Date;  

(c)

Legal Opinion .  The legal opinion required by Section 5.1.8 hereof;

(d)

Secretary’s Certificate .  A certificate of the Secretary of the Company (i) attaching and certifying as to the Certificate, (ii) attaching and certifying as to the Bylaws of the Company in effect at the Initial Closing, (iii) attaching and certifying as to copies of resolutions by the Board of Directors of the Company authorizing and approving this Agreement and the other Transaction Documents and the transactions contemplated hereby and thereby including without limitation, the issuance and delivery of the Units and copies of minutes of the Company’s 2012 Annual Stockholders Meeting authorizing and approving the transactions contemplated by this Agreement (collectively, the “ Minutes ”); and (iv) certifying as to the incumbency of the officers of the Company executing this Agreement and the other Transaction Documents; and

(e)

Indemnification Agreements .  Indemnification Agreements with each of the directors of the Company as of the Initial Closing substantially in the form attached hereto as Exhibit G .


5.1.17.

Delivery of Documents at the Subsequent Closing .  At the Subsequent Closing, the Company shall deliver, or shall cause to be delivered to the Subsequent Closing Purchasers the following documents, to be held in escrow pending the completion of the Subsequent Closing:


(a)

Certificates .  Certificates representing the Common Stock to be purchased and sold on the Subsequent Closing Date bearing the legends required to be placed on such certificates pursuant to the Transaction Documents;

(b)

Warrants:  Executed Warrants, in substantially the form of Exhibits B-1 and B-2 , for the Warrants to be issued on the Subsequent Closing Date;  

(c)

Compliance Certificate .  The certificate required by Section 5.1.16 hereof certifying that all representations and warranties made by the Company as of the Subsequent Closing Date are true, complete and correct as of the Subsequent Closing Date, as qualified by the updated Schedules delivered pursuant to Section 5.1.1 and that all covenants in this Agreement and the other Transaction Documents required to be performed by the Company prior to the Subsequent Closing Date have been so performed; and

(d)

Legal Opinion .  The legal opinion required by Section 5.1.7 hereof; and

(e)

Indemnification Agreements .  Indemnification Agreements, if any, for any newly-appointed directors of the Company since the Initial Closing substantially in the form attached hereto as Exhibit G .

(f)

Secretary’s Certificate .  A Certificate of the Secretary of the Company (i) certifying that the resolutions by the Board of Directors of the Company authorizing and approving this Agreement and the other Transaction Documents delivered at the Initial Closing have not been modified in any way or rescinded and are otherwise in effect as of the Subsequent Closing, (ii) certifying as to the incumbency of the officers of the Company executing any documents contemplated by this Agreement to be executed and delivered by the Company at the Subsequent Closing, and (iii) attaching and certifying as to (x) the Certificate as in effect at the Subsequent Closing, and (y) the Bylaws of the Company in effect at the Subsequent Closing.


5.2

Conditions to Obligations of the Company at the Closings .  The obligation of the Company to consummate the transactions contemplated herein to be consummated at the Initial Closing or the Subsequent Closing, as the case may be, is subject to the satisfaction, on or prior to the date of such Closing of the conditions set forth below and applicable thereto, any of which may be waived in writing by the Company:






5.2.1.

Representations and Warranties; Performance of Obligations .  Each of the representations and warranties of the Purchasers contained herein shall be true and correct on and as of the Initial Closing Date.  As of the Initial Closing Date, the Purchasers shall have performed and complied with the covenants and provisions of this Agreement required to be performed or complied with by them at or prior to the Initial Closing Date.  As to the Subsequent Closing, each of the representations and warranties of the Purchaser(s) contained herein shall be true and correct on and as of the Subsequent Closing Date.  As to the Subsequent Closing, the Subsequent Closing Purchaser(s) shall have performed and complied with the covenants and provisions of this Agreement required to be performed and complied with by them at or prior to the Subsequent Closing Date.


5.2.2.

Proceedings and Litigation .  No action, suit or proceeding shall have been commenced by any Governmental Authority against any party hereto seeking to restrain or delay the purchase and sale of the Common Stock or the other transactions contemplated by this Agreement.


5.2.3.

Qualifications .  All Permits, if any, that are required in connection with the lawful issuance and sale of the Units pursuant to this Agreement shall be obtained and effective as of the Initial Closing or Subsequent Closing, as applicable.


6.

COVENANTS OF THE PARTIES.


6.1

Filing of Certificate; Compliance .  Prior to the Initial Closing, the Company shall file the Certificate with the Secretary of State of the State of Delaware, in accordance with Delaware law.  The Company shall at all times from and after the Initial Closing Date, fully perform and observe all terms, conditions, provisions, and covenants required to be performed and observed by the Company pursuant to the Certificate.  


6.2

Commercially Reasonable Efforts .  Upon the terms and subject to the conditions set forth in this Agreement, the parties to this Agreement shall use their respective good faith commercially reasonable efforts to take, or cause to be taken, without any party being obligated to incur any material internal costs or make any payment or payments to any third party or parties which, individually or in the aggregate, are material and are not otherwise legally required to be made, all actions, and to do or cause to be done, and to assist and cooperate with the other parties in doing, all things necessary, proper or advisable for such party to consummate and make effective, in the most expeditious manner practicable, each Closing and the other transactions contemplated hereunder.


6.3

Post-Closing Filings .  In connection with each Closing, the Company and the Purchasers, if applicable, agree to file all required forms or filings under applicable securities laws.


7.

INDEMNIFICATION AND EXPENSES.


7.1

The Company Indemnification .  The Company shall indemnify and hold harmless each Purchaser and any of such Purchaser’s Affiliates and any Person which controls, is controlled by, or under common control with (within the meaning of the Securities Act) such Purchaser or any such Affiliate, and each of their respective directors and officers, and the successors and assigns and executors and estates of any of the foregoing (each, an “ Indemnified Party ”, and collectively, the “ Indemnified Parties ”) from and against all Indemnified Losses imposed upon, incurred by, or asserted against any of the Indemnified Parties resulting from, relating to or arising out of:


7.1.1.

any representation or warranty made in this Agreement or any of the other Transaction Documents or in any certificate or other instrument delivered by or on behalf of the Company not being true and correct in any material respect when made;


7.1.2.

any breach or non-fulfillment of any covenant or agreement to be performed by the Company under this Agreement or the other Transaction Documents;


7.1.3.

any third party action or claim against any Indemnified Party arising out of any misrepresentation or breach described in Section 7.1.1 or Section 7.1.2; or






7.1.4.

any third party action or claim relating in any way to the Indemnified Party’s status as a security holder of the Company, as a Person which controls, is controlled by or under common control with (within the meaning of the Securities Act) any such Indemnified Party or as a director or officer of any of the foregoing (including, without limitation, any and all Indemnifiable Losses arising under the Securities Act, the Securities Exchange Act of 1934, as amended, or similar securities law, or any other Requirements of Law or otherwise, which relate directly or indirectly to the registration, purchase, sale or ownership of any securities of the Company or to any fiduciary obligation owed with respect thereto), including, without limitation, in connection with any action or claim relating to any action taken or omitted to be taken or alleged to have been taken or omitted to have been taken by such Indemnified Party as a security holder; provided that the Company shall not be obligated to indemnify or hold harmless any Indemnified Party under this Section 7.1.4 against any Indemnified Losses resulting from or arising out of any such action or claim if it has been adjudicated by a final and non-appealable determination of a court or other trier of fact of competent jurisdiction that such Indemnified Losses were the result of (a) a breach of such Indemnified Party’s fiduciary duty, (b) any action or omission made by the Indemnified Party in bad faith, (c) such Indemnified Party’s willful misconduct, or (d) any criminal action on the part of such Indemnified Party.


7.2   Attorneys’ Fees and Expenses .  If any action at law or in equity (including arbitration) is necessary to enforce or interpret the terms of this Agreement, the Investor Rights Agreement (Exhibit H), the First Amended and Restated Stockholders Agreement (Exhibit I) or the Fifth Amended and Restated Certificate of Incorporation (Exhibit C), the prevailing party shall be entitled to reasonable attorneys’ fees, costs and necessary disbursements in addition to any other relief to which such party may be entitled as determined by such court, equity or arbitration proceeding.


8.

MISCELLANEOUS.


8.1

Governing Law; Submission to Jurisdiction; Waiver of Trial by Jury .  This Agreement shall be governed in all respects by the laws of the State of New York without regard to the conflict of laws principles of the State of New York or any other jurisdiction.  No suit, action or proceeding with respect to this Agreement or any of the Transaction Documents may be brought in any court or before any similar authority other than in a court of competent jurisdiction in the State of New York and the parties hereby submit to the exclusive jurisdiction of such courts for the purpose of such suit, proceeding or judgment.  Each of the parties hereto hereby irrevocably waives any right which it may have had to bring such an action in any other court, domestic or foreign, or before any similar domestic or foreign authority and agrees not to claim or plead the same.  Each of the parties hereto hereby irrevocably and unconditionally waives trial by jury in any legal action or proceeding in relation to this Agreement or any of the Transaction Documents and for any counterclaim therein.


8.2

Survival of Representations and Warranties .  The representations and warranties made by the Company and the Purchasers herein at each Closing shall survive such Closing for a period of twelve (12) months.  All statements contained in any certificate or other instrument delivered by or on behalf of any party to this Agreement, pursuant to or in connection with the transactions contemplated by this Agreement or any of the other Transaction Documents shall be deemed to be representations and warranties made by such party as of the date of such certificate or other instrument.


8.3

Successors and Assigns .  The provisions of this Agreement shall be binding upon and inure to the benefit of the parties hereto and their respective successors and assigns; provided that no party may assign, delegate or otherwise transfer any of its rights or obligations under this Agreement without the consent of each other party.  Notwithstanding the foregoing (a) any Purchaser may assign or transfer, in whole or, from time to time, in part, the right to purchase all or any portion of the Units to one or more of its Affiliates (subject to Affiliate qualification as an Accredited Investor) (b) subject to the terms and conditions of the Stockholders Agreement, from and after the Initial Closing Date, any Purchaser or other holder of Common Stock may assign, pledge or otherwise transfer, in whole or from time to time in part, its rights hereunder to any Person who acquires any interest in any Common Stock and (c) any Purchaser may assign or transfer any of its rights or obligations under this Agreement, in whole or from time to time in part, to the Company or any other Purchaser or any Affiliate of any other Purchaser.  As a condition of any transfer pursuant to this Section 8.3, the transferee must agree in writing for the benefit of all parties to this Agreement (which writing shall be in form and substance reasonably acceptable to all parties to this Agreement) to be bound by the terms and conditions of this Agreement and all other Transaction Documents with respect to any Common Stock being transferred hereunder.


8.4

Entire Agreement .  This Agreement, the Exhibits and Schedules hereto, the other Transaction Documents and each of the Exhibits delivered pursuant thereto constitute the full and entire understanding and agreement between the parties hereto with regard to the subject matter hereof and thereof and no party hereto shall be liable or bound to any other party hereto in any manner by any representations, warranties, covenants and agreements except as specifically set forth herein and therein.


8.5

Severability .  If any provision of the Agreement is held to be invalid, illegal or unenforceable, the validity, legality and enforceability of the remaining provisions of this Agreement shall not in any way be affected or impaired thereby.





8.6

Amendment and Waiver .  Any provision of this Agreement may be amended or waived if, but only if, such amendment or waiver is in writing and is signed by the Company and the Purchasers (and, to the extent of any assignment under Section 8.3 hereof, their respective permitted assigns and any permitted assigns thereof) holding a majority of the voting power of the then outstanding Common Stock and Warrant Shares purchased under this Agreement held by such holders, with each outstanding share of Common Stock having one vote and each outstanding Warrant Share having one vote.


8.7

Delays or Omissions .  No delay or omission to exercise any right, power or remedy accruing to any party, upon any breach, default or noncompliance by another party under this Agreement, the other Transaction Documents or the Certificate, shall impair any such right, power or remedy, nor shall it be construed to be a waiver of any such breach, default or noncompliance, or any acquiescence therein, or of or in any similar breach, default or noncompliance thereafter occurring.  Any waiver or approval of any kind or character on any Purchaser’s part of any breach, default or noncompliance under this Agreement, the other Transaction Documents or under the Certificate or any waiver on such party’s part of any provisions or conditions of the Agreement, the other Transaction Documents, or the Certificate must be in writing and shall be effective only to the extent specifically set forth in such writing.  All remedies, either under this Agreement, the other Transaction Documents, the Certificate, or otherwise afforded to any party, shall be cumulative and not alternative.


8.8

Notices .  All notices, requests, demands and other communications given or made in accordance with the provisions of this Agreement shall be addressed (i) if to a Purchaser, at such Purchaser’s address, fax number or email address, as furnished to the Company on the signature page below or as otherwise furnished to the Company by the Purchaser in writing, or (ii) if to the Company, to the attention of the President at such address, fax number or email address furnished to the Purchasers on the signature page below or as otherwise furnished by the Company in writing, and shall be made or sent by a personal delivery or overnight courier, by registered, certified or first class mail, postage prepaid, or by facsimile or electronic mail with confirmation of receipt, and shall be deemed to be given on the date of delivery when made by personal delivery or overnight courier, 48 hours after being deposited in the U.S. mail, or upon confirmation of receipt when sent by facsimile or electronic mail.  Any party may, by written notice to the other, alter its address, number or respondent, and such notice shall be considered to have been given three (3) days after the overnight delivery, airmailing, faxing or sending via e-mail thereof.


8.9

Expenses .  The Company shall pay all costs and expenses that it incurs with respect to the preparation, negotiation, execution, delivery and performance of this Agreement, including, without limitation, any costs and expenses of its counsel.  The Company shall pay the reasonable fees and expenses of independent counsel for the Placement Agent with respect to the negotiation and execution of this Agreement and the other Transaction Documents.  


8.10

Titles and Subtitles .  The titles of the sections and subsections of the Agreement are for convenience of reference only and are not to be considered in construing this Agreement.


8.11

Counterparts; Execution by Facsimile Signature .  This Agreement may be executed in any number of counterparts (including execution by facsimile), each of which shall be an original, but all of which together shall constitute one instrument.  This Agreement may be executed by facsimile signature(s) which shall be binding on the party delivering same, to be followed by delivery of originally executed signature pages.


8.12

Acknowledgment .  Any investigation or other examination that may have been made at any time by or on behalf of a party to whom representations and warranties are made in this Agreement or in any other Transaction Documents shall not limit, diminish, supersede, act as a waiver of, or in any other way affect the representations, warranties and indemnities contained in this Agreement and the other Transaction Documents, and the respective parties may rely on the representations, warranties and indemnities made to them in this Agreement and the other Transaction Documents irrespective of and notwithstanding any information obtained by them in the course of any investigation, examination or otherwise, whether before or after any Closing.


8.13

Publicity .  Except as otherwise required by law or applicable stock exchange rules, no announcement or other disclosure, public or otherwise, concerning the transactions contemplated by this Agreement shall be made, either directly or indirectly, by any party hereto which mentions another party (or parties) hereto without the prior written consent of such other party (or parties), which consent shall not be unreasonably withheld, delayed or conditioned.


8.14

No Third Party Beneficiaries .  Nothing in this Agreement, express or implied, is intended to confer on any person other than the parties hereto or their respective successors and assigns any rights, remedies, obligations or Liabilities under or by reason of this Agreement.


8.15

Pronouns .  All pronouns contained herein, and any variations thereof, shall be deemed to refer to the masculine, feminine or neutral, singular or plural, as to the identity of the parties hereto may require.





9.

DEFINITIONS.


As used in this Agreement, the following terms shall have the meanings herein specified:


9.1

Actinium Entities ” shall mean the Company and its direct and indirect Subsidiaries, collectively.


9.2

Actinium Entity ” shall mean any Person which comprises part of the Actinium Entities.


9.3

Actinium Intellectual Property ” shall have the meaning set forth in Section 3.11.1.


9.4

Affiliate ” shall mean, with respect to any Person specified: (i) any Person that directly or indirectly through one or more intermediaries controls, is controlled by or under common control with the Person specified; (ii) any director, officer, or Subsidiary of the Person specified; and (iii) the spouse, parents, children, siblings, mothers-in-law, fathers-in law, sons-in-law, daughters-in-law, brothers-in-law, and sisters-in-law of the Person specified, whether arising by blood, marriage or adoption, and any Person who resides in the specified Person’s home.  For purposes of this definition and without limitation to the previous sentence, (x) “control” (including, with correlative meanings, the terms “controlled by” and “under common control with”) of a Person means the power, direct or indirect, to direct or cause the direction of management and policies of such Person, whether through ownership of voting securities, by contract or otherwise, and (y) any Person beneficially owning, directly or indirectly, more than ten percent (10%) or more of any class of voting securities or similar interests of another Person shall be deemed to be an Affiliate of that Person.


9.5

Agreement ” shall have the meaning set forth in the preamble to this Agreement.


9.6

Budget ” shall have the meaning set forth in Section 3.20.


9.7

Certificate ” shall have the meaning set forth in Section 1.1.


9.8

Closing ” shall mean the Initial Closing or the Subsequent Closing, as applicable.


9.9

Code ” shall have the meaning set forth in Section 3.14.2.


9.10

Collaborators ” shall have the meaning set forth in Section 3.19.1.


9.11

Closing Date ” shall mean the Initial Closing Date or the Subsequent Closing Date, as applicable.


9.12

Common Stock ” shall have the meaning set forth in the Background section of this Agreement.


9.13

Company ” shall have the meaning set forth in the preamble to this Agreement.


9.14

Company Preferred Stock ” shall mean the Series A Preferred Stock, the Series B Preferred Stock, the Series C Preferred Stock, the Series D Preferred Stock and the Series E Preferred Stock, collectively.


9.15

Consents ” shall mean any consents, waivers, approvals, authorizations, or certifications from any Person or under any Contract, Organizational Document or Requirement of Law, as applicable.


9.16

Contracts ” shall mean any indentures, indebtedness, contracts, leases, agreements, instruments, licenses, undertakings and other commitments, whether written or oral.


9.17

Warrant Shares ” shall have the meaning set forth in Section 1.1.


9.18

Copyrights ” shall mean all copyrights, copyrightable works, mask works and databases, including, without limitation, any computer software (object code and source code), Internet web-sites and the content thereof, and any other works of authorship, whether statutory or common law, registered or unregistered, and registrations for and pending applications to register the same including all reissues, extensions and renewals thereto, and all moral rights thereto under the laws of any jurisdiction.


9.19

Employees ” shall have the meaning set forth in 3.15.1 .


9.20

Employee Benefit Plans ” shall have the meaning set forth in Section 3.16.1.





9.21

Encumbrances ” shall mean any security interests, liens, encumbrances, pledges, mortgages, conditional or installment sales Contracts, title retention Contracts, transferability restrictions and other claims or burdens of any nature whatsoever.


9.22

Environmental Laws ” shall mean any Federal, state or local law or ordinance or Requirement of Law or regulation pertaining to the protection of human health or the environment, including, without limitation, the Comprehensive Environmental Response, Compensation and Liability Act, 42 U.S.C. Sections 9601, et seq., the Emergency Planning and Community Right-to-Know Act, 42 U.S.C. Sections 11001, et seq., and the Resource Conservation and Recovery Act, 42 U.S.C. Sections 6901, et seq.  


9.23

ERISA ” shall have the meaning set forth in Section 3.16.1.


9.24

FDA ” shall have the meaning set forth in Section 3.21.1.


9.25

Final Closing ” shall mean the last Closing under this Agreement.


9.26

Financial Statements ” shall have the meaning set forth in Section 3.5.


9.27

Governmental or Regulatory Authority ” shall mean any court, tribunal, arbitrator, authority, agency, commission, official or other instrumentality of the government of the United States or of any foreign country, any state or any political subdivision of any such government (whether state, provincial, county, city, municipal or otherwise).  


9.28

Hazardous Substances ” shall mean oil and petroleum products, asbestos, polychlorinated biphenyls, urea formaldehyde and any other materials classified as hazardous or toxic under any Environmental Laws.


9.29

 “ Indemnification Agreements ” means the Indemnification Agreements with directors of the Company in the form attached hereto as Exhibit G .


9.30

Indemnified Losses ” shall mean all losses, Liabilities, obligations, claims, demands, damages, penalties, settlements, causes of action, costs and expenses arising out of any third party claim or action against an Indemnified Party, including, without limitation, the actual costs paid in connection with an Indemnified Party’s investigation and evaluation of any claim or right asserted against such Indemnified Party and all reasonable attorneys’, experts’ and accountants’ fees, expenses and disbursements and court costs including, without limitation, those incurred in connection with the Indemnified Party’s enforcement of the indemnification provisions of Section 7 of this Agreement.


9.31

Indemnified Party ” shall have the meaning set forth in Section 7.1.


9.32

 “ Initial Closing ” shall have the meaning set forth in Section 2.1.


9.33

Initial Closing Date ” shall have the meaning set forth in Section 2.1.


9.34

Initial Units ” shall have the meaning set forth in Section 2.1.


9.35

Intellectual Property ” shall mean all Copyrights, Patents, Trademarks, technology, trade secrets, know-how, inventions, methods, techniques and other intellectual property.


9.36

"Investor Rights Agreement ” shall have the meaning set forth in Section 5.1.5.


9.37

Leased Real Property ” shall have the meaning set forth in Section 3.18.


9.38

Legal Proceeding ” shall mean any action, suit, arbitration, claim or investigation by or before any Governmental or Regulatory Authority, any arbitration or alternative dispute resolution panel, or any other legal, administrative or other proceeding.


9.39

Liabilities ” shall mean all obligations and liabilities including, without limitation, direct or indirect indebtedness, guaranties, endorsements, claims, losses, damages, deficiencies, costs, expenses, or responsibilities, in any of the foregoing cases, whether fixed or unfixed, known or unknown, asserted or unasserted, choate or inchoate, liquidated or unliquidated, or secured or unsecured.






9.40

Licensed Intellectual Property ” shall mean all Copyrights, Patents, Trademarks, technology rights and licenses, trade secrets, know-how, inventions, methods, techniques and other intellectual property any one or more Actinium Entities have or has the right to use in connection with its business or their respective businesses, as applicable, pursuant to license, sublicense, agreement or permission.


9.41

Material Adverse Effect ” shall have the meaning set forth in Section 3.6.


9.42

Material Contract ” shall have the meaning set forth in Section 3.7.1.


9.43

Order ” shall mean any judgment, order, writ, decree, stipulation, injunction or other determination whatsoever of any Governmental or Regulatory Authority, arbitrator or any other Person whose finding, ruling or holding is legally binding or is enforceable as a matter of right (in any case, whether preliminary or final and whether voluntarily imposed or consented to).  


9.44

Organizational Documents ” shall mean, with respect to any Person, such Person’s articles or certificate of incorporation, by-laws or other governing or constitutive documents, if any.


9.45

Organon ” shall mean N.V. Organon, a Netherlands corporation.


9.46

Owned Intellectual Property ” shall mean all Copyrights, Patents, Trademarks, technology, trade secrets, know-how, inventions, methods, techniques and other intellectual property owned by the Company or any of its Subsidiaries.


9.47

Patents ” shall mean patents and patent applications (including, without limitation, provisional applications, utility applications and design applications), including, without limitation, reissues, patents of addition, continuations, continuations-in-part, substitutions, additions, divisionals, renewals, registrations, confirmations, re-examinations, certificates of inventorship, extensions and the like, any foreign or international equivalent of any of the foregoing, and any domestic or foreign patents or patent applications claiming priority to any of the above.


9.48

Permits ” shall mean all licenses, permits, certificates of authority, authorizations, approvals, registrations, franchises, rights, Orders, qualifications and similar rights or approvals granted or issued by any Governmental or Regulatory Authority relating to the Business.  


9.49

Per Unit Purchase Price ” shall have the meaning set forth in Section 1.2.