-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, RpaQs88gBmAQqkgIlFDFi/Con+VoT8X9b0JN2dctQMCK3NO/uEhaq3j3OTClm0f4 0+1W85B1fAwlSIr4W2QLIA== 0001193125-07-077072.txt : 20070409 0001193125-07-077072.hdr.sgml : 20070409 20070409162353 ACCESSION NUMBER: 0001193125-07-077072 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20061231 FILED AS OF DATE: 20070409 DATE AS OF CHANGE: 20070409 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SENETEK PLC /ENG/ CENTRAL INDEX KEY: 0000789944 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 770039728 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-14691 FILM NUMBER: 07756564 BUSINESS ADDRESS: STREET 1: 23 PALACE STREET STREET 2: LONDON CITY: UNITED KINGDOM STATE: X0 ZIP: SW1E 5HW BUSINESS PHONE: 7072263900 MAIL ADDRESS: STREET 1: 620 AIRPARK RD STREET 2: LONDON SW1E 5HW CITY: NAPA STATE: CA ZIP: 94450 10-K 1 d10k.htm FORM 10-K Form 10-K
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 


FORM 10-K

(Mark One)

 

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

For The Fiscal Year Ended December 31, 2006.

OR

 

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

For the transition period from                      to                     .

Commission File No. 0-14691

 


SENETEK PLC

(Exact Name of registrant as specified in its Charter)

 

England   77-0039728
(State or other jurisdiction of
incorporation or organization)
  (I.R.S. Employer
Identification No.)
831 Latour Court, Napa, California, U.S.A.   94558
(Address of principal executive offices)   (Zip code)

Registrant’s telephone number, including area code: (707) 226-3900

 


Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

  

Name of each exchange on which registered

None    None

Securities registered pursuant to Section 12(g) of the Act:

AMERICAN DEPOSITARY SHARES

(each American Depositary share represents

1 Ordinary share, pound sterling 0.05 par value)

(Title of Class)

 


Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.  Yes  ¨  No  x

Indicate by check mark if the registrant not required to file reports pursuant to Section 13 or Section 15(d) of the Act.  Yes  ¨  No  x

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes  x  No  ¨

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of the registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K    x

Indicate by checkmark whether the registrant is a large accelerated filer, an accelerated filer or a non-accelerated filer. See definition “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one):

Large accelerated filer  ¨                                         Accelerated filer  ¨                                         Non-accelerated filer  x

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).  Yes  ¨  No  x

The aggregate market value of the registrant’s common stock held by non-affiliates of the registrant, computed by reference to the price at which the common stock was last sold, or the average bid and asked price of such common stock, as of June 30, 2006 was $15,106,292.

As of March 27, 2007, the Registrant had 60,960,624 ordinary shares outstanding, including 60,596,373 shares issued at March 27, 2007 represented by American Depositary shares.

 



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Table of Contents

INDEX

 

          Page
PART I   

Item 1.

  

Business

   1

Item 1A.

  

Risk Factors

   15

Item 1B.

  

Unresolved Staff Comments

   18

Item 2.

  

Properties

   18

Item 3.

  

Legal Proceedings

   19

Item 4.

  

Submission of Matters to a Vote of Security Holders

   19
PART II   

Item 5.

  

Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

   20

Item 6.

  

Selected Financial Data

   27

Item 7.

  

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

   28

Item 7A.

  

Quantitative and Qualitative Disclosures About Market Risk

   37

Item 8.

  

Financial Statements and Supplementary Data

   38

Item 9.

  

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

   38

Item 9A.

  

Controls and Procedures

   38

Item 9B.

  

Other Information

   38
PART III   

Item 10.

  

Directors and Executive Officers of the Registrant

   39

Item 11.

  

Executive Compensation

   41

Item 12.

  

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

   48

Item 13.

  

Certain Relationships and Related Transactions

   49

Item 14.

  

Principal Accountant Fees and Services

   49
PART IV   

Item 15.

  

Exhibits and Financial Statement Schedules

   51
  

Signatures and Power of Attorney

   60


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FORWARD-LOOKING STATEMENTS

This Annual Report on Form 10-K contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements herein which are not of historical fact may constitute such forward-looking statements. In particular, words such as “may”, “could”, “would”, “should”, “can”, “might”, “expect”, “estimate”, “project”, “anticipate” and the like identify the statement to which they refer as forward-looking. Forward-looking statements by their nature involve substantial uncertainty, and actual results may differ materially from those expressed in such statements. Important factors identified by the Company that it believes could result in such material differences are described in this Annual Report in the sections titled “Competition”, “Government Regulation” and “Intellectual Property” on pages 10 through 14 of this Annual Report, “Risk Factors”, on pages 15 through 18 of this Annual Report, and “Management’s Discussion and Analysis of Financial Condition and Results of Operations”, on pages 28 through 37. However, the Company can give no assurance that it has identified all of the important factors that may result in material differences between actual results and its forward-looking statements, and the Company assumes no obligation to correct or update any forward-looking statements which may prove to be inaccurate, whether as a result of new information, future events or otherwise, except as may be required in connection with future reports of the Company pursuant to the Securities Exchange Act of 1934, as amended.

PART I

ITEM 1—BUSINESS

Overview

Senetek PLC is a life sciences product development company with an extensive array of intellectual properties targeting the science of aging targeting skincare and dermatological therapeutics, erectile dysfunction, nutrition and cancer. The Company’s mission is to be a leader in the development and commercialization of life sciences technology.

Senetek PLC, together with its subsidiaries (the “Company” which may be referred to as “Senetek”), is a public limited company organized under the laws of England in 1983. Senetek has four wholly-owned subsidiaries, Senetek Drug Delivery Technologies Inc. (“SSDT”), Senetek Asia Limited (“HK”) and Senetek Denmark ApS, corporations formed by Senetek under the laws of Delaware, Hong Kong and Denmark, respectively, and Carmé Cosmeceutical Sciences Inc. (“CCSI”), a Delaware corporation.

You should read the “Risk Factors” section beginning on page 10 of this Annual Report which discusses certain risks that could affect the Company. For detailed financial information, please consult the Company’s financial statements included in this Annual Report.

The Company’s corporate website is located at www.senetekplc.com. Its Annual Reports on Form 10-K for the 2005 and 2004 fiscal years, in addition to its interim financial reports on Form 10-Q for fiscal 2006 and 2005, are available on its website, and SEC filings will similarly be available as soon as practicable after they are filed with the SEC. Its other SEC filings may be obtained from the Company in electronic or paper format free of charge by writing the Company at ir@senetek.net or at Investor Relations, 831 Latour Court, Napa, California, 94558.

Recent Developments

On March 16, 2007, the Company received $1,312,000 in settlement of claims against professional services providers arising over past performance related matters. $1,200,000 of this amount was paid in cash and the remainder represents a write-off of fees owed.

 

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The Company has recorded the settlement as income in the quarter ended March 31, 2007. In conjunction with the settlement, the Company recorded approximately $10,000 in related legal costs and expenses.

On March 30, 2007, Senetek PLC and Valeant Pharmaceuticals North America (“Valeant”) completed a License and Intellectual Property Acquisition Agreement (“License Acquisition Agreement”). Under the terms of the License Acquisition Agreement, the Company has granted Valeant a paid up license for Kinetin and Zeatin and assigned to Valeant future royalties from other Kinetin licensees, in return for a cash payment of $21 million, a waiver of $6 million in future marketing credits the Company otherwise would have owed to Valeant, and a right to share in future royalties due to Valeant from other Kinetin licensees through 2011.

This transaction was non-dilutive to the Company’s shareholders and provides it the working capital to rapidly accelerate development of its rich pipeline of proprietary compounds, to acquire products, and to achieve its corporate goal of commercializing one new compound each year. The Company’s focus will be direct participation in sales and marketing of new products employing its new compounds to achieve a greater economic benefit to us. The Company will also target the potentially lucrative prescription dermatological drug market for indications that are addressable by its products.

In connection with this transaction, the Company terminated its line of credit with Silicon Valley Bank and paid off the outstanding balance of $1,500,000.

The Company’s revenue from Kinetin and Zeatin in 2006 was $7,042,000, or 84% of its total revenue. Of this, $5,624,000, or 67% of total revenue, was from Valeant.

The Company expects its 2007 revenue and net income to increase significantly from 2006. The $21 million cash payment will be fully includable in 2007 revenues along with approximately $3,750,000 in previously deferred revenue. However the Company expects its revenues in 2008 and beyond to decrease significantly unless the Company is able to develop new sources of revenues to replace its royalties from Valeant.

Commercial Products

Skincare and Dermatological Therapeutics

Kinetin and Zeatin

The Company has developed and patented Kinetin (N6-furfuryladenine), a cytokinin (naturally occurring plant growth factor) which has been found to retard aging of plants. In research done on human skin fibroblasts, Kinetin delayed the signs of cell aging, multi-nucleation and loss of organizational structure, as well as other biochemical and morphologic changes associated with aging. Kinetin also has been shown to be a powerful antioxidant, acting as a free radical scavenger. In clinical studies at the University of California, Irvine, Kinetin showed excellent response rates in ameliorating the clinical signs of photo damaged skin, including the appearance of fine lines and wrinkles, reducing mottled hyperpigmentation and smoothing roughness, and in contrast to other anti-aging products such as retinoids and alpha-hydroxy acids, Kinetin did not produce any clinical signs or symptoms of skin irritation, did not result in skin sensitivity to the sun, and did not break down the skin’s natural barrier function causing moisture loss but in fact significantly reduced trans-epidermal moisture loss.

Zeatin is an analogue of Kinetin. In an in vitro study completed early in 2004 at the University of Aarhus, Denmark, evaluating the effects of two concentrations of Zeatin on cultured human skin fibroblasts over their approximately 300 day lifespan, uniformly positive results were obtained. These results were reported in Rejuvenation Research in December 2004. These results were confirmed and broadened in human clinical trials announced via press release by the Company in January 2005. These studies were conducted at the Department of Dermatology, University of California at Irvine and RCTS, Inc., an independent commercial laboratory in Irving, Texas.

 

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The Company has licensed Kinetin and Zeatin with a strategy to build a global distribution system across all channels of distribution with partners that have the capability to successfully market finished Kinetin and Zeatin based products. Licensees are:

Kinetin

 

Licensee/Trademark

 

Channel of Trade

 

Geography

  License Expiration

Valeant Pharmaceuticals International

Kinerase®

  All channels of trade subject to rights of licensees listed below   Exclusive Worldwide   2010

The Body Shop

Skin Releaf®

  Body Shop retail stores, kiosks, catalogs and websites  

Non-exclusive

North America

Europe

Asia

  2013
Osmotics Corporation   Prestige (department stores and perfumeries)  

Non-exclusive

Worldwide

  2020
Obagi Medical Products (OMP)   Certain drug stores and cosmetic stores  

Non-exclusive

Japan

  2020

Revlon Consumer Products Corporation

Almay® Kinetin

  Mass market  

Non-exclusive

Worldwide

  2011
Vivier Pharma Inc.   Dermatologists, pharmacies and other ethical (physician) markets  

Non-exclusive

United States and Canada

  2008
Panion & BF Biotech Inc.   Ethical, prestige, salon, spa (except Korea) and stores owned or controlled by Formosa Biomedical Technology  

Non-exclusive

Most Asian nations

  2011

Lavipharm S.A.

Castalia®

  Ethical and pharmacy  

Non-exclusive

Greece, Cyprus and certain near Asian and Latin American countries

  2011

Ferrosan A/S

Imedeen®

  Prestige, natural products, mass market and direct-to-consumer  

Non-exclusive

Worldwide

  2020
pH Advantage LLC   Prestige retail stores, salons, spas and direct-to-consumer   United States   2011

Zeatin

 

Licensee/Trademark

  

Channel of Trade

  

Geography

   License Expiration Date

Valeant Pharmaceuticals International

Kinerase®

   All channels of trade    Exclusive Worldwide    2010

 

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In 2003, the Company completed development of its own proprietary product line, Kinetin Plus Age Defiant®, consisting of eight products. A July 2005 amendment to the Valeant Pharmaceuticals International license required the Company to discontinue sales of this product line by January 15, 2006 and to dispose of its remaining inventory. All related inventory as of December 31, 2005 was sold (as required) by the January 15, 2006 date.

Pyratine-6 (PRK 124) and 4HBAP

Pyratine-6 and 4HBAP are two recently developed skincare compounds that have undergone successful clinical trials. They have shown significant results related to treatment for fine and course wrinkles, roughness and hyperpigmentation.

For both compounds, the Company may opt to enter marketing collaborations where it will potentially benefit from a higher percentage of revenues or to develop or co-develop its own distribution capability within certain channels which can be efficiently serviced without significant infrastructure.

Erectile Dysfunction

The Company developed and patented Invicorp®, an intracavernous injection therapy for the treatment of male erectile dysfunction (“ED”). Senetek’s patent covers several alternative combinations of active ingredients, though the formulation for which clinical trials were conducted and regulatory filings made is limited to one of these, a combination of vasoactive intestinal polypeptide (“VIP”), a 28-amino-acid peptide found naturally in the human male and female urogenital tracts and central and peripheral nervous systems, and phentalomine mesylate (“PMS”), which was found to enhance VIP’s ability to cause erection by binding to smooth-muscle receptors in the corpus cavernosum, inducing smooth-muscle relaxation and increased blood flow.

In June 2004, the Company entered into an exclusive license with Ardana Bioscience Ltd, a privately-held specialty pharmaceutical company dedicated to improving reproductive health, for Ardana to manufacture and market Invicorp® in the European Union and European Free Trade Area. Under the license agreement, Ardana assumed full financial responsibility for completing the European drug regulatory process for Invicorp® and seeking national marketing approvals throughout Europe. The license agreement provides for Senetek to receive royalties that potentially reach 12% based on Ardana’s and its sub-licensees’ net sales of Invicorp® plus milestone payments upon regulatory approvals in specified major markets and achievement of specified cumulative net sales in Europe. Under its agreement, Ardana has certain rights with respect to the manufacture and marketing of Invicorp® in other world markets.

Invicorp® was approved for marketing in Denmark in December 2006 under the European Mutual Recognition Procedure (“MRP”) and Ardana began commercial sales of Invicorp® in Denmark. Following Denmark’s approval of the MRP dossier for Invicorp® and release of translated copies to those Member States selected to receive it, such Member States will have a period in which they may review and comment upon the dossier, following which each State may grant or withhold marketing authorization or impose conditions or limitations upon such authorization.

In February 2006, the Company entered into an exclusive license with Plethora Solutions Holdings PLC, a London Stock Exchange-traded specialty pharmaceuticals company focused on the development and marketing of products for the diagnosis, treatment and management of urological disorders, to manufacture and market Invicorp® in North America. Under the terms of the license agreement, Plethora assumes full financial responsibility for the drug regulatory process for Invicorp® in North America and for establishing this important new therapy in the key North American market, and was granted certain rights with respect to the manufacture and marketing of Invicorp® in other world markets, subject to the prior rights of Ardana Bioscience Ltd. The license agreement provides for Senetek to participate in the success of Invicorp® through double digit royalties based on Plethora’s and its sub-licensees’ net sales of Invicorp® plus predetermined milestone payments upon achievement of regulatory approvals and cumulative net sales targets.

 

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Management believes that the commercial potential of products for the treatment of ED is significant, and that the Company’s license agreements with Ardana and Plethora, as they may be expanded or augmented, may generate significant income in the future as this drug gains marketing approvals. In a study released in 2002 by the pharmaceuticals market research firm of Decision Resources, Inc., it was estimated that in 2001 some 70 million men in the seven major pharmaceutical markets covered by the study (the United States, France, Germany, Italy, Spain, the United Kingdom and Japan) suffered from some degree of ED. The incidence of ED increases with age, and therefore is expected to grow as the median age of the world’s population increases. ED is also associated with a number of common conditions including arteriosclerosis, diabetes, hypertension and the use of such medications as beta blockers and tricyclic antidepressants. According to the 2002 Study, major-market sales of drugs and devices to treat ED totaled $1.3 billion in 2001 and are expected to grow at an annual rate of 10%, reaching $3.6 billion in 2011. Oral medications (principally Pfizer, Inc.’s sildenafil product Viagra®) represented in excess of 92% of total 2001 sales of ED products in the studied markets, but these oral therapies are ineffective, medically contraindicated or otherwise unsuitable for significant numbers of ED sufferers, who opt for “second line” injection therapies or penile implants, or who may forego therapy altogether. Specifically, the 2002 Study found that men whose ED is classified as moderate to severe (those most likely to seek treatment) show a markedly lower response rate to sildenafil and other oral therapies than do those with mild ED; that certain patient groups (including diabetics, who have a high incidence of ED) experience particularly low response rates to sildenafil; that sildenafil is contraindicated for patients who take any form of nitrates (a group that represents 5-10% of men with ED); and that men who take both sildenafil and drugs such as erythromycin or cholesterol-lowering agents, which are metabolized by the same isoenzymes as sildenafil, are at risk for developing higher than desirable serum levels of sildenafil. Clinical trials of Invicorp® suggest that it could become the preferred therapy for all of these patient types, as it has been found to have favorable side-effect and drug-interaction profiles, permitting it to be prescribed for men with the various contraindications referred to above, and has been shown to be highly safe and effective in patients of all etiologies, as well as patients who have failed previous therapy.

Diagnostic Monoclonal Antibodies

In 1995, the Company entered into a license agreement with the Research Foundation for Mental Hygiene (“RFMH”), an agency of the State of New York, under which the Company was granted exclusive rights to certain of RFMH’s cell lines capable of producing monoclonal antibodies for research on various diseases including Alzheimer’s Disease. The license was to expire 10 years from inception as to the cell lines originally covered and, as to cell lines subsequently added to the license, 10 years from their inclusion. Until mid 2000, the Company marketed these cell lines to major pharmaceutical companies, but in that year it decided to enter into an agreement for the remaining term of the RFMH license with Signet Laboratories, Inc. (“Signet”), a leading medical diagnostic and research company, under which Signet assumed the marketing of these monoclonal antibodies and development of new antibodies and assays based on the cell lines covered by the RFMH license, with Senetek to receive percentages of Signet’s net sales, subject to certain minimum royalty guarantees, and Senetek to remit a portion to RFMH in accordance with the terms of its license.

In May 2004, the Company entered into an interim extension of its agreement with RFMH and in April 2005, the Company entered into a further amendment of the agreement with RFMH under which the licenses on all existing cell lines and any new cell lines were extended through June 2011, subject to renewal, on substantially the same terms with a guaranty of royalty receipts to RFMH of $430,000 per year through the new term of the license. In connection therewith, the Company entered into a new agreement with Signet, effective as of April 1, 2005 for its continued manufacture, marketing and sale of all monoclonal antibodies produced from the cell lines licensed by RFMH on revised royalty terms but subject to a guaranty that the Company’s net revenue from such sales would not be significantly less than under the original agreement, for the term of the new agreement.

In May 2006, the Company agreed to assign the Signet agreement to Covance Antibody Services, Inc. (“Covance”) in conjunction with Covance’s acquisition of Signet.

 

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Under the Company’s agreement with Covance, the Company is entitled to receive from Covance 60% of the first $2,000,000 in annual net sales of licensed products and 35% thereafter in order for Covance to remain the exclusive distributor. Should Covance not attain their minimum sales goal of $1,880,000, it has the right to cure by making a payment to Senetek in the fourth quarter in the amount equal to 33% of the amount by which Covance’s net sales are less than $1,880,000. In any case, the Company is entitled to a minimum in total payments from Covance of $860,000 per year. Under the Company’s license agreement with RFMH, RFMH is entitled to receive from Senetek 27% of Covance’s net sales of licensed products, with a minimum annual total of $430,000.

Other Commercial Arrangements

Drug Delivery Technology

The Company developed and patented Reliaject®; a unique autoinjector system assembled using highly automated precision equipment, which employs an ultra-fine gauge needle preset to achieve the appropriate penetration before drug flow occurs, thereby reducing reliance upon the patient’s technique for accuracy and safe delivery. Some of the clinical trials and subsequent “named patient” supply of Invicorp® in England involved the use of the Reliaject® auto injector, and patient response was highly favorable. The Company’s license agreements with Ardana Bioscience and Plethora Solutions both provide that in connection with any license or sale of Reliaject® to a third party, the Company will require the licensee or purchaser to negotiate in good faith with Senetek’s Invicorp® licensees for a cost-plus manufacturing contract to produce Reliaject® pre-filled with Invicorp®, if requested by the licensees.

Reliaject® can be adapted for self-administration of a broad range of parenteral drugs, including epinephrine for emergency treatment of anaphylactic shock from food allergies or insect stings, atropine, a counter-measure for exposure to toxic chemical and biological agents, and injectable treatments for migraines and infertility. The Company has developed the parts required for the use of Reliaject® with epinephrine, the leading therapeutic agent for emergency treatment of acute anaphylactic shock.

In March 2006, the Company sold to Ranbaxy Pharmaceuticals Inc. all of its patents, trademarks and automated manufacturing equipment for the Reliaject® device. The Company received a down-payment of $500,000 and under the terms of the sale agreement, the Company is to receive additional milestone payments based on regulatory approvals and cumulative sales targets. In addition, the Company is to receive a specified percentage (similar to a set royalty) for a period of 15 years on Ranbaxy’s and its licensees’ quarterly net sales in North America of Reliaject® pre-filled with either epinephrine or six other scheduled parenteral drugs (including Invicorp®). Percentages will be negotiated on its net sales in any other markets for which it may be licensed and on its net sales in North America of Reliaject® pre-filled with non-scheduled parenteral drugs. Under the agreement, Ranbaxy is assuming all expenses of obtaining regulatory approvals and of marketing the product, and will be making significant infrastructure investments, including building out the required clean room suites at its New Brunswick, New Jersey facility to house the highly automated Reliaject® production line. Ranbaxy Pharmaceuticals is a wholly-owned subsidiary of Ranbaxy Laboratories Limited, the tenth largest generic pharmaceutical company in the world and a leader in development and marketing of new delivery methodologies for proven drugs.

As with Invicorp®, management believes that the Reliaject® device has significant commercial potential, and that the Company’s agreement with Ranbaxy Pharmaceuticals is well designed to permit the Company to participate in that success. Anaphylactic shock, most frequently due to allergic reactions to peanut-based food additives (which is the therapeutic indication for which change parts for the Reliaject® currently exist), is a growing health problem. This acute self-medication market is believed to be growing at over 25% annually as health and educational organizations build popular awareness of these risks. Epipen®, the leading autoinjector currently marketed for anaphylactic shock, accounts for sales of over $150 million a year in North America alone, and management believes that the greater ease of use and patient comfort associated with Reliaject® could provide Ranbaxy with significant competitive advantages over Epipen® for this market as well as in the military and homeland security sectors for administration of antidotes to chemical and biological agents.

 

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Product Pipeline

Historically, the Company’s strategy had been to leverage its available research and development resources by channeling its efforts through research agreements with third-party consultants, clinicians and research scientists having particular expertise in its areas of interest with a direct focus on getting its products into the market. The Company has increased its portfolio of active compounds for evaluation by entering into cooperative research agreements and collaborations with the Institute of Experimental Botany in Prague, Czech Republic, the Institute of Bioorganic Chemistry of the Polish Academy of Sciences in Poznan, Poland and PROTEOMAGE, the European Integrated Project on Healthy Aging, financed by the European Union.

Skincare and Dermatological Therapeutics

The Company is actively pursuing the identification, screening, testing, development and marketing of a wide variety of cytokinins and non-cytokinin naturally-occurring compounds. The table below presents the studies completed to date for compounds that are in its advanced-stage pipeline.

 

Compound

  

Cellular

Toxicity

   Cellular Biological
Activity
   Histological Findings
in Mice
  

Battery of

Safety Tests

for an IND

  

Anti-Aging

Clinical Trials

   Acne Rosacea
Clinical Trials

PRK124

   X    X    X    X    X    In Process

4HBAP

   X    X    X    X    X   

AK801

   X    X    X         

PA100

   X    X            

FC201

   X    X            

DH310

   X    X            

2AK

   X    X            

MTZ

   X    X            

MTK

   X    X            

The Company expects safety and clinical trials of AK801 to begin in the second quarter of 2007. The Company expects to advance at least two of the other compounds through safety and clinical testing in 2007.

Cancer Therapy

In November 2006, the Company acquired exclusive rights to anticancer technology for treatment of brain tumors using interference RNA. The rights were acquired from the Polish Academy of Sciences in exchange for royalty payments to be paid to the Institute upon commercialization. The treatment, developed by the Institute in cooperation with the Department of Neurosurgery and Neurotramatology, University of Medical Sciences in Poznan, uses RNA interference to inhibit the production of tenascin-C, whose expression has been suggested to correlate with the grade of malignancy of brain tumors. Recently, the technology has been applied to patients with glioblastoma multiforme, a severe form of brain tumor, with resounding success.

The Company’s commercial strategy with respect to this treatment is to partner with a pharmaceutical or RNA specialty company for development, testing and marketing.

Science Advisory Board and Scientific Collaboration

The Company’s Scientific Advisory Board is headed by Professor Brian Clark, Ph.D., Sc.D., the Company’s Chief Scientist. Professor Clark is the discoverer of Initiation Codon for Protein Synthesis, 1965/1966 and the First Crystallization of tRNA, 1968; Head of the European Chinese Biotechnology Transfer Task Force and Past President of the International Union of Biochemistry and Molecular Biology. Board members include:

 

   

Sir John Walker, Ph.D., F.R.S.

Nobel Prize in Chemistry, 1997; Expert in Nutrition & Aging

 

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Professor Anthony Linnane, A.M., Ph.D., D.Sc., F.A.A., F.R.S.

Executive Director, Centre for Molecular Biology and Medicine Melbourne, Australia; Fellow, Royal Society

 

   

Professor Claudio Francheschi, M.D.

Professor, University of Bologna and Scientific Director of the Italian National Research Center on Aging-Department of Gerontological Studies, Bologna, Italy

 

   

Dr. Gerald Weinstein, M.D., Clinical Investigator

University of California Department of Dermatology, Irvine (Emeritus); World Renowned Expert on Photo Damaged Skin and Psoriasis

Scientific Collaborators to the Company include:

 

   

Professor Miroslav Strnad

Director, Institute of Experimental Botany, Olomouc Czech Republic

 

   

Professor dr. hab. Jan Barciszewski

Institute of Bioorganic Chemistry, Polish Academy of Sciences, Poznan Poland

A key element of the Company’s strategic business plan is to add to its existing portfolio of cytokinins and other compounds that have strong anti-aging properties. This task is being undertaken under the direction of the Company’s Chief Scientist. The Company is leveraging its relationship network to enhance and add to its already rich portfolio of existing skincare and dermatological compounds.

The Company has entered into a cooperative research agreement with the Institute of Experimental Botany in Prague, Czech Republic. The principal fields of scientific work in the Institute consist of plant physiology, genetics and biotechnology. In genetic research, the Institute carries out work on induced mutagenesis and DNA repair, induction of genetic variability in tissue and cell cultures in vitro, and the molecular genetics of pollen. Its physiological focuses include adaptation and acclimation mechanisms of photosynthesis, hormonal and ecological control of plant growth and development, the mechanisms of action of growth regulators, physiology of plant viruses and plant pathophysiology. Senetek’s agreement with the Institute, as initially signed, provided for a “one off” relationship in which Senetek would have a specified period of access to the Institute’s then existing portfolio of compounds with the right to an exclusive license of any selected compounds in the fields of medical and cosmetic skin care, on pre-set terms. In October 2004, this agreement was expanded to provide Senetek with ongoing access to all of the Institute’s developing technology with dermatological potential with a right to an exclusive worldwide license of selected compounds for all fields of use, plus a right of first offer on any other technology for an exclusive worldwide license within the field of dermatological anti-aging applications. In December 2005, this agreement was further expanded, Senetek being granted the right to receive exclusive global licenses, for all applications, to any cytokinin developed, in-licensed or otherwise acquired by the Institute and the right to co-exploit with the Institute any cytokinins that Senetek does not elect to in-license. Under the agreement, Senetek paid $70,000 in 2006 and $20,000 in 2005 to support the Institute’s continued research on certain cytokinins and is committed to paying $170,000 in support of this and additional research into other classes of naturally-derived cytokinins. The parties also agreed to co-fund the prosecution of four new global patent applications. Senetek has evaluated and screened more than 18 new compounds sourced from the Institute.

In November 2006, the Company signed agreements with the Institute of Bioorganic Chemistry of the Polish Academy of Sciences in Poznan, Poland for the exclusive rights to three compounds for the treatment of skin aging, as well as technology used for the treatment of brain tumors using interference RNA. The collaboration with the Institute will provide Senetek three new compounds with differentiating benefits for treating skin aging and possibly other aging conditions through their use in licensed cosmeceutical, nutritional and prescription products. In addition, Senetek acquired the rights to technology developed by the Institute in cooperation with Department of Neurosurgery and Neurotraumatology, University of Medical Sciences in

 

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Poznan, Poland for the treatment of human brain tumors using RNA interference. Under the terms of the collaborative agreement, Senetek will have rights for all applications of the in-licensed technology in exchange for royalty payments to be paid to the Institute upon commercialization.

In February 2006, Senetek signed a cooperative research agreement with two noted researchers in Greece, Dr. Efstathios S. Gonos, Director of Research of the Department of Molecular and Cellular Ageing, Institute of Biological Research and Biotechnology, of the National Hellenic Research Foundation, and his colleague Dr. Ioanna Chinou, Associate Professor of the Division of Pharmacognosy-Chemistry of Natural Products, School of Pharmacy, of Athens University. Drs. Gonos and Chinou have been investigating certain plant extracts and their analogs in relation to their proteasome activation and damaged protein scavenging bioactivity. The agreement gives Senetek the exclusive right to prescreen all compounds within this category identified and developed by the researchers, with access to all of their related scientific data, and provides for Senetek to participate in funding the testing and development of those compounds it may select and in filing and prosecuting patents covering these and related inventions, with Senetek having the option to enter into exclusive global licenses for all applications of the covered compounds.

The Company operates a dedicated laboratory facility in leased space at the Science Park adjacent to the University of Aarhus, Denmark. Under the direction of Dr. Clark, the laboratory conducts compound screening, testing for cellular toxicity, testing for cellular biological activity and initial safety testing. The facility consists of two fully equipped laboratories and three administrative offices which house a full-time research biologist and a chemical technician.

As new active ingredients successfully pass biological activity testing and initial safety testing, Senetek collaborates with the Department of Dermatology of the University of California at Irvine for comprehensive consulting and pre-clinical and clinical testing services. The Department’s faculty has extensive experience in collaborating with the pharmaceutical and cosmetic industries in new product development and is internationally recognized for its contributions in both basic and clinical dermapharmacology. The initial clinical trials of Kinetin, applying the same protocols as the Department used for the FDA New Drug Application evaluations of Johnson & Johnson’s Renova®, were performed there under the direction of Dr. Gerald Weinstein, then Department Chairman, and, Dr. Jerry McCullough. Dr. McCullough, who succeeded Dr. Weinstein as Department Chairman and with whom the Company has a consulting agreement, remains closely involved in Senetek’s in vivo studies.

These relationships form the basis for a continuous, interactive flow of new product identification, evaluation and testing activity between Senetek’s dedicated laboratory in Aarhus, its research and development collaborations, and the University of California-Irvine and other clinical evaluators and testers the Company employs, as appropriate.

The Company’s research and development expenditures amounted to $1,313,000, $1,435,000 and $1,504,000 in 2006, 2005 and 2004, respectively. See Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations”. The Company expects research and development spending to increase as it accelerates development of its pipeline of proprietary technologies for skincare. Research and development expenditures associated with cancer therapy are expected to be minimal as the Company intends to partner with a pharmaceutical or an RNA specialty company to fund these costs. Research and development expense associated with Invicorp® are expected to be zero because the Company’s licensees, Ardana Bioscience and Plethora Solutions have assumed responsibility for further regulatory and market development work for these products. Covance Antibody Services Inc. bears responsibility for new product development for monoclonal antibodies.

 

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Marketing and Manufacturing

Marketing

Consistent with the Company’s strategy of building a high-margin revenue stream, all of its current Kinetin and Zeatin revenues has been derived from license agreements under which its licensees assume responsibility for marketing and maintaining required government approvals within their respective licensed territories. In the case of emerging skincare and dermatological therapeutic products, the Company may opt to enter marketing collaborations where it will potentially benefit from a higher percentage of revenues or to develop or co-develop its own distribution capability within certain channels which can be efficiently serviced without significant infrastructure. In the case of Invicorp® and Monoclonal Antibodies, the Company’s commercial partners have undertaken full responsibility for sales, distribution and marketing, as well as regulatory compliance. In the case of cancer therapy, the Company intends to partner with a pharmaceutical or an RNA specialty company to help fund these costs.

Manufacturing

Most of the Company’s existing licenses for core products in the Skincare Segment grant its licensees the right to manufacture as well as market licensed products. In the case of those licenses which grant only marketing rights or require the licensee to produce and package product from Senetek-supplied bulk, the Company contracts with third parties for the manufacture and/or filling and labeling of the skincare products covered by such licenses. While the Company relies on particular suppliers for the raw materials and componentry used in the manufacture of such products, should these suppliers become unavailable or unable to supply in required volumes, management believes that alternative sources of approvable supplies would be available.

With regard to the Company’s ED medication, Invicorp®, its license agreements with Ardana Bioscience and Plethora Solutions grant its licensees the exclusive right to manufacture the product. The active ingredients, VIP and PMS, are currently available from suppliers in quantities believed to be adequate for the licensees’ requirements following marketing approvals in their respective territories. These suppliers have developed synthetic production methods that are included in the product marketing application updates with regulatory authorities in Europe. Management believes that, should these suppliers become unavailable or unable to supply in required volumes, alternative sources of approvable supplies are available, although the licensees could experience regulatory delays associated with qualifying the new active ingredient manufacturers. Covance Antibody Services Inc. manufactures and sells the monoclonal antibodies produced from the cell lines licensed to us.

Competition

The bulk of the Company’s current revenues are derived from licenses to manufacture and/or market products containing its patented Kinetin and Zeatin active ingredients, with smaller amounts being derived from agreements for the manufacture and sale of monoclonal antibodies used in research and from “named patient” sales of Invicorp® in England. While the Company’s patents and patent licenses currently protect it from competition from sales of products within the specific scope of its patents and license rights, many companies are engaged in the development and marketing of products competitive with its patented and licensed products. Regarding the Company’s ED product, Invicorp®, assuming necessary marketing approvals are obtained, the Company or its commercial partners will compete directly with other companies having established ED injectable products in the marketplace, including Pfizer, Schwarz Pharma, and Vivus, which market Caverject®, Edex® and Muse®, respectively. However, although management believes Invicorp® offers advantages over these therapies including a favorable side effect profile, high level of efficacy in organic ED, natural erection and termination, and shorter time to onset. Pfizer, the manufacturer of the oral sildenafil product Viagra®, and two other recent market entrants, Eli Lilly’s Cialis® and Bayer/GlaxoSmithKline’s Levitra®, control the bulk of the ED therapy market, which currently represents in excess of 92% of the worldwide ED market. However, the

 

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Company considers Invicorp® to be complementary to, rather than competitive with, these oral therapies as it addresses the needs of patients for whom the oral therapies are contra-indicated, not effective or not well-tolerated. Reliaject®, the proprietary autoinjector technology recently sold to Ranbaxy in which the Company has retained continuing rights to participate in net sales and product milestones, assuming necessary marketing approvals are obtained, will allow Ranbaxy to compete directly with King Pharmaceuticals’ Epipen®, the leading autoinjector currently marketed for anaphylactic shock. But management believes that the greater ease of use and patient comfort associated with Reliaject® could provide Ranbaxy with significant competitive advantages over Epipen® for this market as well as in the military and homeland security sectors for administration of antidotes to chemical and biological agents. The monoclonal antibody market is diverse and fragmented throughout the world and the monoclonal antibodies sold by any one source, including Covance, represent a very small percentage of the total market.

The life science industry, including biopharmaceutical, pharmaceutical and cosmeceutical industries is highly competitive. The Company competes and will continue to compete with research and development programs at biotechnology, biopharmaceutical, pharmaceutical and cosmeceutical companies, as well as academic institutions, government agencies and public and private organizations throughout the world. Virtually all of its existing or potential competitors have substantially greater financial, technical and human resources than Senetek’s. The Company’s commercial competitors have the capability and resources to develop or acquire and market products that compete with its existing and planned products, and the timing of the market introduction of its own and its competitors’ products will be important competitive factors affecting its future results.

The Company cannot predict the extent to which any of the pharmaceutical products the Company currently out-licenses or has sold with ongoing payment rights, including will become commercially viable. Assuming that these products are approved for sale in a sufficient number of the countries in which approvals are sought, management believes that competition for Invicorp® will be based, among other things, on product efficacy, ease of administration, convenience, speed of onset and third party reimbursement, while competition for Reliaject® will be based, among other things, on price, entry into additional therapeutic categories and marketing acumen. The Company’s competitive position and ability to remain viable in the future also will depend upon its ability to contract for effective and productive research and attract and retain qualified personnel to develop and effectively exploit the results of such research. The Company expects competition to intensify in all fields in which the Company is involved.

Government Regulation

General

The research, pre-clinical development, clinical trials, manufacturing and marketing of the pharmaceutical products are subject to extensive regulation, including pre-marketing approval requirements, of the FDA and equivalent foreign regulatory agencies. Product development and approval within this regulatory framework take a number of years and involve the expenditure of substantial resources. Many products ultimately do not reach the market because of toxicity or lack of effectiveness as demonstrated by required testing. Furthermore, regulatory agencies may suspend clinical trials at any time if it is believed that the subjects participating in such trials are being exposed to unacceptable health risks. In addition, there can be no assurance that this regulatory framework will not change or that additional regulations will not arise at any stage during product development that may affect approval, delay an application, or require additional expenditures. Accordingly, the Company cannot assure that the regulatory requirements for the commercialization of Reliaject® and Invicorp® will be completed successfully within any specified time period, if at all, or that pre-marketing approvals will be granted.

The business comprising the Company’s skincare and dermatological therapeutic products does not currently include any prescription drugs and therefore is generally is not subject to pre-marketing approval. However various statutes and regulatory restrictions apply to this business in the United States and most other countries. For future compounds the Company will consider taking some through the drug approval process, either in addition to or instead of the cosmeceutical route.

 

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Product Approval-United States

In the United States, the Federal Food, Drug and Cosmetic Act and the Public Health Service Act govern the testing, manufacture, safety, efficacy, labeling, storage, record keeping, approval, advertising and promotion of the Company’s pharmaceuticals. The steps required before a pharmaceutical product may be marketed in the United States include:

 

   

Preclinical laboratory testing;

 

   

Submission to the FDA of an Investigational New Drug Application which must become effective before human clinical trials may commence;

 

   

Adequate and well-controlled human clinical trials to establish the safety and efficacy of the drug;

 

   

Submission of a New Drug Application to the FDA; and

 

   

FDA approval of the New Drug Application prior to any commercial sale or shipment of the drug.

Clinical trials of new pharmaceuticals in humans are designed to establish both the safety and the efficacy of the pharmaceutical in treating a particular disease or condition. These studies are usually conducted in three phases of testing. In Phase I, a small number of volunteers are given the new compound in order to identify toxicities and characterize the compound’s behavior in humans. In Phase II, small numbers of patients with the targeted disease are given the compound to test its efficacy in treating the targeted disease and to establish dose levels. Phase III studies are large-scale studies designed to confirm a compound’s efficacy for the targeted disease and identify toxicities that might not have been seen in smaller studies. Once adequate data have been obtained in clinical testing to demonstrate that the compound is both safe and effective for the intended use, all available data is submitted to the FDA as part of the New Drug Application.

Senetek’s Investigational New Drug application to the FDA for Invicorp® was withdrawn. Under the terms of its license agreement with Plethora Solutions, it has agreed to assume all regulatory responsibility and cost in North America, which will include meetings with the FDA to discuss reinstatement of the Investigational New Drug application and the clinical trials and other support that would be required for approval, while there can be no assurance that this effort ultimately will be successful. Plethora Solutions recently received FDA approval to commence Phase III studies of Invicorp®.

Current FDA regulations govern the manufacture, labeling, advertising and marketing of over-the-counter drug products covered by the Federal Food, Drug and Cosmetics Act, which are required to obtain pre-market approval if they do not fall within the parameters of FDA-issued “monographs”. These regulations cover sunscreen products, including certain products of the Company’s existing licensees. Currently, such regulations do not apply to non-drugs, though the FDA does regulate issues such as labeling and has the power to seize products found to be mislabeled or adulterated.

There can be no assurance that the Federal Food, Drug and Cosmetics Act or the regulations thereunder will not be changed so as to increase the pre-marketing approval and pharmacovigilence requirements for products subject to regulation as drugs or to subject non-drug products to increased regulation.

Product Approval—Other Countries

Marketing of pharmaceutical products in other countries requires regulatory approval from the notified bodies in each particular country. The current approval process varies from country to country, and the time to approval may vary from that required for FDA approval, although the review of clinical studies by regulatory agencies in foreign jurisdictions to establish the safety and efficacy of the product generally follows a similar process to that in the United States. Similarly, non-pharmaceutical products generally are not subject to pre-marketing approval requirements in foreign countries although they are regulated in a manner similar to the United States and, in the case of certain countries such as Japan, such products may require reformulation to remove ingredients, such as certain preservatives, not considered acceptable by the particular country.

 

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Invicorp® was approved for marketing in Denmark in December 2006 under the European Mutual Recognition Procedure (“MRP”). Following Denmark’s approval of the MRP dossier for Invicorp® and release of translated copies to those Member States selected to receive it, such Member States will have a period in which they may review and comment upon the dossier, following which each State may grant or withhold marketing authorization or impose conditions or limitations upon such authorization. No assurance can be given as to the number of Member States that will ultimately authorize marketing by Ardana following release of the MRP dossier.

Post-Approval

The marketing and manufacture of pharmaceutical products are subject to post-approval regulatory review, and later discovery of previously unknown problems with a product, manufacturer or facility may result in the regulatory agencies requiring further clinical research or imposing restrictions on the product or the manufacturer, including withdrawal of the product from the market. Additionally, any adverse reactions or events involving such products must be reported to these agencies. Previously unidentified adverse events or an increased frequency of adverse events occurring post-approval could result in labeling modifications, additional contraindications and other restrictions that could adversely affect future marketability. Ultimately, marketing approvals may be withdrawn if compliance with regulatory standards is not maintained or if a product is found to present an unacceptable risk. Any such restriction, suspension or revocation of regulatory approvals could have a material adverse effect on us.

Third-Party Reimbursement

Management believes that the availability of third-party reimbursement of all or a portion of the cost of Invicorp® and RNA interference cancer therapy may affect the overall marketability of the products.

In the United States, government-funded and private insurance programs reimburse or pay directly all or a portion of the cost of many medical treatments, prescription drugs and medical devices. The U.S. Health Care Financing Administration (“HCFA”) sets reimbursement policy for the Medicare program in the United States, and has established a national coverage policy for the diagnosis and treatment of ED in Medicare beneficiaries. Private insurance coverage for ED treatment, however, varies widely across the United States, and the introduction and popularity of Pfizer’s Viagra® resulted in some plans establishing broad coverage exclusions for ED treatment. It is not clear whether such plans would include injectable therapy for moderate to severe ED within the same exclusion as these oral therapies.

Outside of the United States, most third-party reimbursement programs are governmentally funded. In some countries, no reimbursement currently is made for ED therapy, while other countries limit the amount of reimbursement or limit reimbursement to ED treatment that is related to specific other medical conditions. In addition, in certain European countries, the sales price of a product must be approved. The pricing review period often begins after market approval is granted. Restrictions on the pricing of Invicorp® could adversely affect the profitability of the product.

Intellectual Property

The Company relies on a combination of patents, trade secrets, trademarks and confidentiality agreements to protect its business interests. It believes that patents are of material importance to the success of its business model and that trademarks are also of significance. The Company’s strategy is to consider new products and compounds only if they are patentable and to file patent applications to protect inventions and improvements considered important to the development of its business in the principal countries where protection from manufacture or marketing of infringing products is commercially warranted. As of December 31, 2006, the Company held 72 issued patents and 18 pending patent applications, comprised of patents covering certain

 

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combinations of active ingredients for the treatment of ED, granted in 19 countries and pending in 16 other countries, patents for the class of cytokinins including Kinetin and Zeatin for ameliorating the effects of aging on skin, granted in 36 countries and pending in two other countries, patents for such cytokinins for ameliorating the effects of hyperproliferative skin diseases, including psoriasis, granted in 16 countries and one United States patent assigned to the Company in 2003 for the use of a class of cytokinins (including Kinetin) in the treatment of inflammatory diseases.

It is noted, however, that patents, including those for pharmaceuticals and skincare ingredients, generally involve complex legal and factual issues. In the United States, for example, the first inventor to conceive and document a novel invention is generally entitled to patent it, even if another person who subsequently conceived the invention was the first person to file a patent application on it. This issue of priority of invention may be further complicated by the fact that patent applications in the United States are not published until 18 months after filing. Accordingly, a patent-holder may be subject to interference proceedings in the U.S. Patent and Trademark Office (“PTO”) long after the patent was issued based upon another party’s claim of earlier invention. Furthermore, as only novel and unobvious inventions are patentable, a patent-holder may be subject to proceedings in federal court attacking the validity of the patent based on alleged obviousness in view of the “prior art”, or on alleged improprieties in prosecuting the patent in the PTO. Issues of novelty and abuse of patent also may arise under the laws of most foreign countries in which the Company holds patents or has filed patent applications. The Company has successfully defended against claims of invalidity and unenforceability of its patents covering Kinetin and Zeatin. However, while it believes that its patents are valid and enforceable, there can be no assurance that if, in the future, it must enforce any one or more of its patents, or such patents are challenged by a third party, such patents ultimately would be upheld. Similarly, while management believes that the Company’s products do not infringe the valid claims of any third party’s patents, there can be no assurance that it would prevail if a third party sought to enforce its patent against the Company by a suit for an injunction or damages.

Interference and similar proceedings in the PTO or equivalent foreign patent offices, whether brought by the Company to protect its patents or brought by a third party challenging such patents, are time-consuming, disruptive of management time and attention and highly costly, and injunctive and other patent litigation in court is likely to be many times more time-consuming, disruptive and costly. Furthermore, in the United States (unlike many foreign countries) a party generally is not entitled to reimbursement of any portion of its legal fees and expenses even if it is wholly successful in its prosecution or defense, so that the Company could be exposed to costs which could have a material adverse effect on its business even if the Company were successful in enforcing its patents against an infringer or successful in defending against proceedings to invalidate its patents or proceedings alleging infringement by the Company of a third party’s patents. Additionally, if the Company were unsuccessful in proceedings challenging its patents, third parties licensed by the Company under those patents might seek to terminate such licenses and cease paying royalties. If the Company were unsuccessful in defending against a claim that it had infringed a third party’s patent, even unknowingly, the Company could be subject to a permanent injunction against engaging in the infringing business as well as an award of damages measured by the profits obtained from past infringement. Additionally, because of the Company’s relative lack of financial and management resources, it could be less able than its competitors to bear such risks.

Discontinued Operations

The Company previously developed or acquired a number of skincare products designed to meet specific niche segments of the market: Mill Creek, Sleepy Hollow Botanicals and Biotene H-24, sold in the health store channel, as well as Silver Fox, a product for gray hair (the “Mill Creek Line”), and Allercreme, a hypoallergenic range of skincare and cosmetic products for women with sensitive skin, developed in conjunction with dermatologists and sold in the mass market (the “Allercreme Line”). The Company determined that continued marketing of these lines was outside of its strategic direction due to their low margin potential and excessive costs of marketing.

 

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In 1999, the Company entered into a license agreement with United States International Trading Corporation (“USITC”) under which USITC purchased the Company’s inventories of finished goods and componentry for the Mill Creek Line and paid a licensing fee for the exclusive right to manufacture and market these products in exchange for royalties subject to specified annual minimums. Under the license agreement, USITC was granted an option to purchase the rights to the Mill Creek Line for $2.8 million. In September 2002, USITC exercised this option, and the Company conveyed to USITC the trademarks and all other rights to the Mill Creek Line for $2.7 million ($100,000 having been previously paid), of which $400,000 was paid in cash at closing, and the balance of $2.3 million was represented by a secured promissory note providing for twenty-three consecutive quarterly payments of $100,000 each beginning in September 2003 with interest at an annual rate of 10%. As of July 2004, however, only $188,000 had been paid by USITC, all of which was allocated to interest under the terms of the note, and the Company gave notice of default to USITC. On November 10, 2004, the Company and USITC entered into an agreement to restructure the note. Under the terms of the restructuring, Senetek received $240,000 for the period from August through November 2004, and in December 2004 received $1,120,000 together with a $400,000, two and one half year, secured amortizing note bearing interest at 8% per annum. Under the terms of the agreement, if USITC fails to pay any of the quarterly payments due under the new $400,000 note, all of its obligations under the original $2.3 million note, less amounts actually paid, will be reinstated and subject to acceleration for non-performance. To date, USITC is current in its payments under this note.

Employees

As of December 31, 2006, the Company had nine full-time employees, comprised of two employees at its research facility in Denmark, and seven employees at its Napa, California headquarters.

ITEM 1A— RISK FACTORS

As stated in the preamble to this Annual Report on Form 10-K, this document contains numerous forward-looking statements, which management believes to be a fair reflection of its risks and opportunities. However, such statements by their nature are future-related and involve substantial uncertainties. In addition to those factors referred to elsewhere in Part I of this Annual Report, particularly the Sections in Item 1 entitled “Competition”, “Government Regulation” and “Intellectual Property”, and in Part II of this Annual Report, particularly in Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations”, the Company has identified the following factors that may affect whether future events may differ materially from the expectations described in such forward-looking statements.

Limited Product Portfolio and Relatively Fixed Revenue Stream.    Substantially the Company’s entire current revenue base is derived from royalties earned on licensees’ sales of products containing active ingredients the use of which is licensed to them by the Company, which generally are paid quarterly and recognized in income when received. In addition, part of current revenues reflect license fees, which are amortized into income over the terms of the licenses, and payments received from Covance on sales of monoclonal antibodies produced from cell lines licensed to the Company from RFMH, net of the amounts remitted to RFMH under the terms of the Company’s license agreement with RFMH. If the Company’s patents were successfully challenged and its licensees sought to terminate their licenses, its revenue stream could be substantially curtailed, and if RFMH’s patents were successfully challenged or the State of New York ceased supporting the Foundation, the Company’s revenues from Covance would be reduced or eliminated. Additionally, the Company’s present licensee revenue stream is tied to its licensees’ sales of licensed product. Accordingly, it is limited to the growth in their sales of licensed products within their existing territories. Although the recent agreement with Valeant Pharmaceuticals, by which the Company monetized its Kinetin revenue stream, supplied significant working capital and insulated itself from future changes in licensed product sales, should it be faced with significant cash requirements in the future in excess of its internally generated funds, its capital resources might be inadequate to fund its capital needs. Although the Company is confident in its ability to develop new compounds for additional licensing and enter into commercial collaborations permitting the Company to directly participate in sales of some of the new

 

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products based on these compounds, the skincare business has become increasingly competitive. These increasingly difficult market conditions, coupled with the time required to develop new compounds, negotiate new licenses and other commercial agreements and achieve new product launches, make it difficult for the Company to significantly increase its revenue in a short time frame. Unless it can successfully develop and commercialize new products or acquire rights to commercially viable new products it will experience significant decreases in revenues because it has monetized its largest source on ongoing revenue (i.e., its contract with Valeant). In the immediate future, the Company anticipates that revenues will fall significantly beginning in the second quarter of 2007 because it does not have a new product ready for commercial sale at this time.

Reliance on Other Organizations for Research and Development and Regulatory Function.    The Company relies on a number of significant collaborative relationships for a large part of its new product research and development activities. These collaborations with external research laboratories and pharmaceuticals licensees pose a number of risks including its inability to control whether its counter-parties will devote adequate resources to their efforts or fully perform their contractual undertakings, failure of which could lead to delays in commercializing products, revenue curtailment and the expense and management distraction of dispute resolution.

Fluctuating Operating Results and American Depository Shares (“ADS”) Price.    The Company’s future operating revenues will largely depend upon its ability to develop and/or acquire new commercially viable products. Because its expenses are relatively fixed in the short-term, its earnings will decline if revenue declines in a given quarter. As noted above, after the payment of the Valeant contract in the first quarter of 2007, the Company is anticipating declines in quarterly revenue beginning in the second quarter of 2007. With the closing of the Valeant contract, in particular, the Company does not believe that period to period comparisons of its results of operations are a good indication of its future performance which will depend upon its development and/or acquisition of commercially viable new product. In future quarters, the Company’s operating results could be below the expectations of securities analysts or investors. In that case, its ADS price could fluctuate significantly or decline.

Acquisition-Related Risks.    One means by which Senetek might achieve more direct involvement in the sales of products based upon its proprietary active ingredients could be to complete an equity-based business acquisition. However, completion of any significant business acquisition by Senetek would involve substantial risks, including that the Company’s small management cadre would be diverted from the operating needs of Senetek’s business, that the professional fees of attorneys, accountants and other advisors incurred in executing such a transaction would divert needed financial resources from the Company’s business, that these expenses and the costs of integrating the two companies’ assets and operations could result in dilution of earnings, at least in the short term, and that management might be unable to successfully achieve the synergies from the combination of the two companies upon which forecasts of longer term incremental earnings were based.

There is also a risk, particularly for so long as the Company’s ADSs’ market price remains at historically depressed levels, that the Company could become the subject of an unsolicited acquisition by a third party, through a tender offer or other transaction that might not assure the Company’s ADS holders of fair value for their interests in the Company. The English Companies Act, under which Senetek is organized, does not permit adoption of so-called defensive provisions in the Company’s Articles of Association to make such a transaction more difficult or to force such an acquirer to negotiate terms with the Company’s Board of Directors on behalf of the Company’s shareholders.

Intellectual Property and Enforcement.    The Company’s success will depend in part on its ability to obtain and maintain meaningful patent protection for its technologies, both in the United States and in other countries. The Company relies on its issued patents and pending patent applications in the United States and in other countries to protect its intellectual property and its competitive position. The Company cannot assure that any of the currently pending or future patent applications will issue as patents, or that any patents issued to it will not be challenged, invalidated or held unenforceable. Further, the Company cannot assure that its intellectual property

 

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rights will be sufficiently broad to prevent third parties from producing competing products similar in design to its products. In addition to patent protection, the Company also relies on protection of trade secrets, know-how and confidential and proprietary information. The Company enters into confidentiality agreements with its employees, consultants and prospective commercial partners upon commencement of a relationship, but it cannot assure that these agreements will provide meaningful protection against the unauthorized use or disclosure of its trade secrets or other confidential information.

The Company’s commercial success also depends in part on avoiding the infringement of other parties’ patents or proprietary rights and the breach of any licenses pursuant to which it practices its technologies. Management believes that it does not infringe third parties’ patents or other rights but cannot assure that it will not be found in the future to infringe these or other proprietary rights of third parties, either with products it is currently developing or with new products that it may seek to develop in the future. If third parties assert infringement claims against the Company, it will be forced either to defend or enter into license arrangements with them. The expenses of such defense could divert funds from needed investment in its business, but it cannot assure that it could enter into licenses on commercially reasonable terms to avoid such expense. Further, an adverse determination in litigation or interference proceedings to which the Company may become a party could subject it to significant liabilities to third parties, could put its patents at risk of being invalidated or interpreted narrowly and could put its patent applications at risk of not issuing.

Regulation by Government Agencies.    The production and sale of pharmaceutical products is highly regulated. The ability of the Company’s Invicorp licensees and the purchaser of Reliaject to secure regulatory approvals for these products and to continue to satisfy regulatory requirements will determine the future success of its Pharmaceuticals Segment. These parties may not receive required regulatory approvals for licensed products or receive approvals in a timely manner. In particular, the United States Food and Drug Administration and comparable agencies in foreign countries, including the Medicines Agency of Denmark, which is Reference Member State for the European Union Mutual Recognition Procedure, and the Medicines and Healthcare Regulatory Agency in the United Kingdom, must approve human therapeutic and preventive products before they are marketed. This approval process can involve lengthy and detailed laboratory and clinical testing, sampling activities and other costly and time-consuming procedures. Delays in obtaining regulatory approvals could adversely affect the marketing of products and the Company’s ability to receive milestone payments and royalties. While management believes that its existing licensees and other commercial counter-parties have the competency and financial resources to successfully gain regulatory approvals and the required marketing authorizations, the Company can give no assurance of this or that it or its licensees or other commercial counter-parties will be able to obtain the necessary approvals for clinical testing or for the manufacturing and marketing of any new pharmaceutical products that it develops.

New Product Pipeline.    The Company has a pipeline of new products and new indications for existing products in development, but success in developing these products and entering into productive licensing arrangements for them is essential to the success of its business plan and cannot be assured. As a result of regulatory and competitive uncertainties and the unpredictability new product research and development, the Company cannot provide any assurance that it will be able to successfully develop and market new products.

Competitive Therapies.    There can be no assurance that new ED medications will not be developed to fulfill many if not all of ED patients’ needs that are currently unmet, or that the Company’s injection therapy will in fact gain acceptance. Oral medications currently represent approximately 92% of the worldwide market for ED treatment because of their ease of use and non-invasive path of administration. Pfizer’s Viagra, Eli Lilly’s Cialis and Bayer/GlaxoSmithKline’s Levitra represent virtually all of this oral medication market. While management believes that there will nevertheless be a market for the Company’s Invicorp ED injectable therapy because of its greater efficacy, favorable side-effect and contraindication profiles, and relatively aesthetic delivery systems, there can be no assurance of this. Similarly, while management believes that Reliaject is a superior disposable autoinjector to those currently marketed for emergency treatment of anaphylactic shock and that Reliaject would

 

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also be successful as a delivery device for Invicorp, there can be no assurance that King Pharmaceutical, which currently has the bulk of autoinjector sales, will not develop devices that will meet or exceed the capabilities of Reliaject or that Reliaject can successfully compete with devices currently on the market.

Research and Development.    The Company’s field is characterized by extensive research efforts. Its research could prove unproductive. Furthermore, other companies could engage in research or development which renders the Company’s programs non-competitive or obsolete. Other companies with which it competes generally have substantially greater financial resources to undertake additional and more effective research. In particular the Company faces intense competition for the discovery and development of ingredients to address signs of photoaging and other skincare conditions from large, global companies with far greater research, development and marketing resources than its own, and there can be no assurance that its existing products or new products developed for its Skincare Segment will maintain market acceptance in competition with existing and new offerings of its competitors.

Potential Product Liability.    During recent years, lawsuits resulting in very substantial liability have been filed against companies engaged in the sale of pharmaceutical and other medical-related products or devices, which have subsequently proved harmful to human health. Many of these cases have exposed companies to liability long after the products have been brought to market even though, at the time of their development, based on extensive research, there were no discernable risks of injury. Thus, notwithstanding United States Food and Drug Administration or other foreign governmental approval, if granted, and notwithstanding the indemnification provisions in the Company’s Invicorp licenses and Reliaject purchaser, there can be no assurance that the Company will not be subject to liability from the use of its products, or that its product liability coverage will be adequate to protect against future claims.

Management Infrastructure.    The Company currently employs nine people, has a very small management team and has no succession plan. Should it lose any management resources and be unable to attract high caliber replacements to continue implementing its business plan, it could be materially adversely affected. There can be no assurance that the Company will be able to staff its requirements in a manner adequate to support its planned future growth.

ITEM 1B—UNRESOLVED STAFF COMMENTS

Not applicable.

ITEM 2—PROPERTIES

For most of 2005, the Company leased approximately 31,000 square feet in Napa, California for its headquarters under a lease expiring in December 2007. The headquarters facility included approximately 10,000 square feet of manufacturing and research and development space, and 10,000 square feet of warehouse space and 11,000 square feet of administrative offices. The Company also leased 900 square feet of office space in St. Neots, United Kingdom, under a 5-year lease with a 3 month rolling break option. In October 2005, the Company vacated its St. Neots office and in November 2005 the Company entered into an agreement with the landlord of its Napa headquarters facility, terminating the lease in exchange for a settlement payment by the Company, and it vacated that office. The Company currently sub-leases a 3,000 square foot facility in Napa for its headquarters under a lease maturing in February 2008. During October 2003, the Company entered into a quarterly lease agreement at a business park adjacent to Aarhus University in Denmark for approximately 2,000 square feet. The facility is used for research and development and was renovated and equipped in 2004. The lease requires quarterly payment and can be cancelled by giving three months notice. Management believes that present facilities are adequate for is current needs.

 

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ITEM 3—LEGAL PROCEDINGS

On September 16, 2005, the Company filed suit in the Superior Court of California for the County of Los Angeles against Bachem, Inc., doing business as Bachem California, a subsidiary of Swiss pharmaceutical company Bachem Holding, AG. The suit alleged fraud and negligent misrepresentation by Bachem in connection with its production and sale to Senetek in 1997 of vasoactive intestinal polypeptide, an active ingredient in Senetek’s patented erectile dysfunction treatment, Invicorp, for a purchase price of $1,100,000. Bachem has answered the Complaint and denied the Company’s material allegations. In October 2006, the Company requested and received a dismissal of the California suit and filed a breach of contract suit against Bachem for the same matter in the United Kingdom. The parties are proceeding with pretrial discovery.

On March 16, 2007, the Company received $1,312,000 in settlement of claims against a professional services provider for past performance related matters. The Company has recorded the settlement as income in the quarter ended March 31, 2007. In conjunction with the settlement, the Company recorded approximately $10,000 in related legal costs and expenses.

ITEM 4—SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS

On December 12, 2006 Senetek PLC held a combined Annual General Meeting and Extraordinary General Meeting of Shareholders (the “Meeting”) pursuant to a Notice and Proxy Statement duly filed pursuant to Regulation 14A under the Securities Exchange Act of 1934.

The following persons, each of whom had been appointed a Director of the Company in May 2006, were elected Directors of the Company at the Meeting: Rodger Bogardus and Kerry Dukes. The following persons’ terms of office as Directors of the Company continued after the Meeting: Frank J. Massino and Anthony Williams.

The following is a brief description of each matter voted upon at the Meeting, including the votes cast for, against and withheld and the number of abstentions and broker non-votes as to each such matter:

 

Description of Matter

   Votes For    Votes Against    Votes Withheld    Non-Votes

Election of Rodger Bogardus

   57,628,501    2,892,463    92,809    346,851

Election of Kerry Dukes

   57,571,868    2,948,368    93,537    346,851

Adoption of Senetek Equity Plan

   51,556,312    9,013,633    43,828    346,851

Receipt of Annual Accounts for 2005 and Directors’ Report on those Accounts

   56,763,421    2,457,045    1,393,307    346,851

Appointment of Macias Gini & O’Connell LLP and BDO Stoy Hayward as the Company’s independent auditors for 2006

   58,169,711    2,279,791    164,271    346,851

 

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PART II

ITEM 5—MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

There is currently no established public trading market for the Company’s ordinary shares. Senetek ADSs, each representing one ordinary share and evidenced by one American Depositary Receipt (“ADR”) began trading on the over-the-counter market in the United States in November 1984 and were traded through The NASDAQ SmallCap Market from May 1986 through November 10, 2004. On November 10, 2004, the Company’s ADSs were delisted from the NASDAQ Stock Market and began trading on the electronic over-the-counter quotation system of the National Association of Securities Dealers (the “NASD”), the Over-the-Counter Bulletin Board (the “OTCBB”) under the symbol “SNTKY”. The OTCBB is a regulated quotation service for subscribing members of the NASD that displays the real-time quotes, last-sale prices and volume information in over-the-counter securities. The OTCBB market quotations reflect inter-dealer prices, without retail mark-up, mark-down or commission and may not represent actual transactions. The depository for these ADSs is The Bank of New York.

The following table sets out the range of high and low closing bid prices for the Company’s ADSs during each quarter of its two most recent fiscal years, as reported by the OTCBB, as reported to the NASD by the NASD’s member firms.

Fiscal Year Ended December 31, 2006

 

     HIGH    LOW

QUARTER ENDED:

     

March 31

   $ 0.32    $ 0.18

June 30

     0.34      0.23

September 30

     0.30      0.21

December 31

     0.26      0.19

Fiscal Year Ended December 31, 2005

 

     HIGH    LOW

QUARTER ENDED:

     

March 31

   $ 0.39    $ 0.23

June 30

     0.28      0.18

September 30

     0.36      0.19

December 31

     0.25      0.18

As of March 27, 2007 there were 60,960,624 ordinary shares outstanding and 208 holders of record of ADSs representing 60,596,373 American Depository shares. The trading prices of the Company’s ADSs on March 27, 2007, were a high of $0.24 and a low of $0.23.

 

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LOGO

Dividends.    Senetek has not paid, nor does it currently contemplate the payment of, any cash dividends on the ordinary shares. The decision whether to pay, and the amount of any dividends, will be based upon, among other things, the Company’s earnings, capital requirements, financial conditions and applicable law. Any dividend, either cash or stock, must be recommended by the Board of Directors and approved by the shareholders through the Board of Directors. The Board of Directors is, however, empowered to declare interim dividends. However, under the English Companies Act of 1985, a limited company may not declare or pay cash dividends while it has an accumulated deficit. The Company had an accumulated deficit of ($90,842,000) at December 31, 2006. Accordingly, the Board of Directors will not be in a position to consider the question of dividends until the accumulated deficit has been absorbed by profits or by the application against the deficit with the approval of shareholders and the United Kingdom Companies’ Court, which forms part of the Chancery Division of the High Court, of an equivalent figure forming part of the share premium on the Company’s balance sheet.

Taxation

The following discussion describes the material US Federal income tax and UK tax consequences of the purchase, ownership and disposition of the Company’s shares or ADSs (evidenced by ADRs) for beneficial owners:

 

   

who are residents of the United States for purposes of the current applicable United Kingdom/United States Income Tax Convention (either the “Income Tax Convention” or the “New Income Tax Convention”, as described below under “New Income Tax Convention”) and the United Kingdom/United States Estate and Gift Tax Convention (the “Estate and Gift Tax Convention” and, together with the Income Tax Convention, the “Conventions”);

 

   

whose ownership of the Company’s shares or ADSs is not, for the purposes of the Conventions, attributable to a permanent establishment in the United Kingdom;

 

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who otherwise qualify for the full benefits of the Conventions; and

 

   

who are US holders (as defined below).

The statements of US federal income tax and UK tax laws set out below:

 

   

are based on the laws in force and as interpreted by the relevant taxation authorities as at the date of this annual report;

 

   

are subject to any changes in US law or the laws of England and Wales, in the interpretation thereof by the relevant taxation authorities, or in the Conventions, occurring after such date; and

 

   

are based, in part, on representations of the depositary, and assume that each obligation in the Deposit Agreement and any related agreement will be performed in accordance with its terms.

No assurance can be given that taxing authorities or the courts will agree with this analysis.

This discussion does not address all aspects of US and UK taxation that may be relevant to you and is not intended to reflect the individual tax position of any beneficial owner, including tax considerations that arise from rules of general application to all taxpayers or to certain classes of investors or that are generally assumed to be known by investors. The portions of this summary relating to US Federal taxation are based upon the US Internal Revenue Code of 1986, as amended (the “Code”), its legislative history, existing and proposed US Treasury regulations promulgated thereunder, published rulings by the US Internal Revenue Service (“IRS”), and court decisions, all in effect as at the date hereof, all of which authorities are subject to change or differing interpretations, which changes or differing interpretations could apply retroactively. This summary is limited to investors who hold the Company’s shares or ADSs as capital assets within the meaning of Section 1221 of the Code, generally property held for investment, and this summary does not purport to deal with the US Federal or UK taxation consequences for investors in special tax situations, such as dealers in securities or currencies, persons whose functional currency is not the US Dollar, life insurance companies, tax exempt entities, financial institutions, traders in securities that elect to use a “mark-to-market” method of accounting for their securities holdings, regulated investment companies, persons holding the Company’s shares or ADSs as part of a hedging, integrated, conversion or constructive sale transaction or straddle or persons subject to the alternative minimum tax, who may be subject to special rules not discussed below. In particular, the following summary does not address the adverse tax treatment to you that would follow if you own, directly or by attribution, 10% or more of the Company’s outstanding voting share capital and the Company is classified as a “controlled foreign corporation” for US Federal tax purposes.

As used herein, the term “US holder” means a beneficial owner of the Company’s shares or ADSs who or which is:

 

   

a citizen or resident of the United States;

 

   

a corporation (or other entity that is treated as a corporation for US Federal income tax purposes) created or organized in or under the laws of the United States or any political subdivision thereof;

 

   

an estate, the income of which is subject to US Federal income taxation regardless of its source; or

 

   

a trust (1) that is subject to the supervision of a court within the United States and the control of one or more US holders as described in section 7701(a)(30) of the Code or (2) that has a valid election in effect under applicable US Treasury regulations to be treated as a US holder.

If a partnership (or an entity that is treated as a partnership for US Federal income tax purposes) holds the Company’s shares or ADSs, the tax treatment of a partner will generally depend upon the status of the partner and the activities of the partnership. If you are a partner of a partnership holding the Company’s shares or ADSs, you should consult your tax advisors.

 

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The summary does not include any description of the tax laws of any State or local government or of any jurisdictions other than the United States and the United Kingdom that may be applicable to the ownership of the Company’s shares or ADSs. You are urged to consult your own tax advisor regarding the US Federal, State, and local tax consequences to you of the ownership of the Company’s shares or ADSs, as well as the tax consequences to you in the United Kingdom and any other jurisdictions.

For the purposes of the Conventions and the Code, you will be treated as the owner of the Company’s shares represented by the ADSs evidenced by the ADRs.

New Income Tax Convention

The United States and the United Kingdom have concluded a new income tax convention (the “New Income Tax Convention”). The New Income Tax Convention has been ratified by the competent authorities in both countries. The New Income Tax Convention is effective:

 

   

in respect of US or UK withholding taxes, for amounts paid on or after May 1, 2003;

 

   

in the US, in respect of other taxes, for taxable periods beginning on or after January 1, 2004;

 

   

in the UK, for individuals from April 1, 2004; and

 

   

in the UK, for corporations from the first financial year beginning on or after April 1, 2004;

Except that a person entitled to the benefit of the existing Income Tax Convention may elect to remain subject to the terms of that convention and not the New Income Tax Convention for a further period of one year.

The New Income Tax Convention contains rules that modify the treatment under the Income Tax Convention of US holders who own shares or ADSs of a UK corporation in several aspects. Throughout the following discussions, the Company has included specific references to the new rules under the New Income Tax Convention as appropriate. You should consult your own tax advisors as to how the Income Tax Convention and New Income Tax Convention would affect you with respect to your ownership of the Company’s shares or ADSs (including the application of the anti-conduit rules contained in the New Income Tax Convention) and if and how you should elect to defer the application of the New Income Tax Convention.

Taxation of Capital Gains

United Kingdom

If you are not resident or ordinarily resident in the United Kingdom for UK tax purposes, you will not be liable for UK tax on capital gains realized or accrued on the sale or other disposition of shares or ADSs unless the shares or ADSs are held in connection with your trade or business (which for this purpose includes a profession or a vocation) carried on in the United Kingdom through a branch or agency and the shares or ADSs are or have been used, held or acquired for the purposes of such trade or business or such branch or agency.

A US holder who is an individual who has on or after March 17, 1998 ceased to be resident or ordinarily resident in the United Kingdom in the preceding five years and who disposes of shares or ADSs during that period may also be liable for UK tax on capital gains notwithstanding that the person may not be resident in the United Kingdom at the time of the disposal.

United States

Subject to the Passive Foreign Investment Company discussion below, gain or loss realized by you on the sale or other disposition of the shares or ADSs will be subject to US Federal income tax as capital gain or loss in an amount equal to the difference between your tax basis in the shares or ADSs and the amount realized on the

 

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disposition. The capital gain or loss will be long-term capital gain or loss if the US holder has held the shares or ADSs for more than one year at the time of the sale or exchange. A gain or loss realized by you generally will be treated as US source gain or loss for US foreign tax credit purposes.

Passive Foreign Investment Company Considerations

Generally, for US Federal income tax purposes, the Company will be a “passive foreign investment company”, or a “PFIC”, for any taxable year if either (1) 75% or more of its gross income is “passive” income or (2) 50% or more of the value of its assets, determined on the basis of a quarterly average, is attributable to assets that produce or are held for the production of passive income. Passive income generally includes dividends, interest, royalties and rents not arising from the active conduct of a trade or business, and gains from the sale of assets that produce such income. If the Company is a PFIC in any taxable year that you own its shares or ADSs, you may be subject to tax at the highest ordinary income rates applicable to you and pay interest on such tax based on your holding period in the shares of ADSs, on (1) a portion of any gain recognized on the sale of its shares or ADSs and (2) any “excess distribution” paid on its shares or ADSs (generally, a distribution in excess of 125% of the average annual distributions paid by the Company in the three preceding taxable years).

Based on the Company’s current activities and assets, it does not believe that it is a PFIC, and it does not expect to become a PFIC in the foreseeable future for US Federal income tax purposes. The Company’s belief that it is not a PFIC and its expectation that it will not become a PFIC in the future is based on its current and planned activities, and may change in the future. The determination of whether it is a PFIC is made annually. Accordingly, it may be possible that the Company will become a PFIC in the current or any future year due to changes in its asset or income composition.

UK Inheritance and Gift Tax

If you are an individual domiciled in the United States and are not a national of the United Kingdom for the purposes of the Estate and Gift Tax Convention, any share or ADS beneficially owned by you will not be subject to UK inheritance tax on your death or on a gift made by you during your lifetime, provided that any applicable US Federal gift or estate tax liability is paid, except where the share or ADS is part of the business property of your UK permanent establishment or pertains to your UK fixed base used for the performance of independent personal services. The Estate and Gift Tax Convention generally provides for tax paid in the United Kingdom to be credited against tax payable in the United States, based on priority rules set out in that Convention, in the exceptional case where a share or ADS is subject to both UK inheritance tax and US Federal gift or estate tax. Where the shares or ADSs have been placed in trust by a settlor who, at the time of the settlement, was a US holder, the shares or ADSs will generally not be subject to UK inheritance tax if the settlor, at the time of the settlement, was domiciled in the United States for the purposes of the Estate and Gift Tax Convention and was not a national of the United Kingdom.

US Gift and Estates Taxes

If you are an individual US holder, you will be subject to US gift and estate taxes with respect to the shares or ADSs in the same manner and to the same extent as with respect to other types of personal property.

UK Stamp Duty and Stamp Duty Reserve Tax

Subject to certain exemptions, stamp duty will be charged at the rate of 1.5% rounded up to the nearest £5, or there will be a charge to the stamp duty reserve tax at the rate of 1.5% on the amount or value of the consideration paid, or in some circumstances the issue price or open market value, on a transfer or issue of shares (1) to, or to a nominee for, a person whose business is or includes the provision of clearance services, or (2) to, or to a nominee for, a person whose business is or includes the issuing of depositary receipts. It is understood that the UK Inland Revenue Stamp Office considers the depositary to fall within one or the other of the above two

 

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categories. The stamp duty reserve tax on the deposit of ordinary shares with the depositary will be payable by the person depositing those shares. Where stamp duty reserve tax is charged on a transfer of shares and ad valorem stamp duty is chargeable on the instrument effecting the transfer, the amount of the stamp duty reserve tax charged is an amount equal to the excess, if any, of the stamp duty reserve tax charge due on the transfer after the deduction of the stamp duty paid.

You will not be entitled to a foreign tax credit with respect to any UK stamp duty or stamp duty reserve tax, but may be entitled to a deduction subject to applicable limitations under the Code. You are urged to consult your own tax advisors regarding the availability of a deduction under their particular circumstances.

Transfers of ADRs

No UK stamp duty will be payable on an instrument transferring an ADR or on a written agreement to transfer an ADR provided that the instrument of transfer or the agreement to transfer is executed and remains at all times outside the United Kingdom. Where these conditions are not met, the transfer of, or agreement to transfer an ADR could, depending on the circumstances, attract a charge to ad valorem stamp duty at the rate of 0.5% of the value of the consideration (rounded up to the nearest £5) plus interest and penalties if not stamped within 30 days of execution.

No stamp duty reserve tax will be payable in respect of an agreement to transfer an ADR, whether made in or outside the United Kingdom.

Where no sale is involved and no transfer of beneficial ownership has occurred, a transfer of shares by the depositary or its nominee to the holder of an ADR upon cancellation of the ADR is subject to UK stamp duty of £5 per instrument of transfer.

Issue and Transfer of Ordinary Shares in Registered Form

Except in relation to persons whose business is or includes the issue of depositary receipts of the provision of clearance services or their nominees, the allotment and issue of shares by the Company will not normally give rise to a charge to UK stamp duty or stamp duty reserve tax.

Transfers of shares, as opposed to ADSs, will attract ad valorem stamp duty normally at the rate of 0.5% of the value of the consideration (rounded up to the nearest £5). A charge to stamp duty reserve tax, normally at the rate of 0.5% of the consideration, arises, in the case of an unconditional agreement to transfer shares, on the date of the agreement, and in the case of a conditional agreement the date on which the agreement becomes unconditional. The stamp duty reserve tax is payable on the seventh day of the month following the month in which the charge arises. Where an instrument of transfer is executed and duly stamped before the expiry of a period of six years beginning with the date of that agreement, any stamp duty reserve tax that has not been paid ceases to be payable, and if any stamp duty reserve tax has been paid a claim may be made for its repayment.

Information Reporting and Backup Withholding

Payments that relate to the ordinary shares or ADSs that are made in the United States or by a US related financial intermediary will be subject to information reporting. Information reporting generally will require each paying agent making payments, which relate to a share or ADS, to provide the IRS with information, including the beneficial owner’s name, address, taxpayer identification number, and the aggregate amount of dividends paid to such beneficial owner during the calendar year. These reporting requirements, however, do not apply to all beneficial owners. Specifically, corporations, securities broker-dealers, other financial institutions, tax-exempt organizations, qualified pension and profit sharing trusts and individual retirement accounts are all exempt from reporting requirements.

 

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If you are a depositary participant or indirect participant holding shares or ADSs on behalf of a beneficial owner, or paying agent making payments for a share or ADS, you may be required to backup withhold, as a backup against the beneficial owner’s US Federal income tax liability, a portion of each payment of dividends on the Company’s shares or ADSs in the event that the beneficial owner of a share or ADS:

 

   

fails to establish its exemption from the information reporting requirements;

 

   

is subject to the reporting requirements described above and fails to supply its correct taxpayer identification number in the manner required by applicable law; or

 

   

under-reports its tax liability.

This backup withholding tax is not an additional tax and may be credited against US Federal income tax liability if the required information is furnished to the IRS.

Taxation of Dividends

The Company has not included a detailed discussion of the tax consequences to holders of ordinary shares or ADSs of the payment of dividends in light of the Company’s present inability to pay dividends. As noted above, pursuant to the English Companies Act of 1985 a company may not pay a dividend while it has an accumulated deficit. As of December 31, 2006, the Company’s accumulated deficit is approximately $91 million.

EQUITY COMPENSATION PLAN INFORMATION

(As at December 31, 2006)

 

Plan category

  

Number of

securities to be

issued upon

exercise of

outstanding

options, warrants
and rights

  

Weighted-average

exercise price of

outstanding

options, warrants

and rights

  

Number of

securities remaining

available for

future issuance

under equity

compensation plans

(excluding securities

reflected in
Column 1)

Equity compensation plans approved by security holders

   5,552,740    $ 0.71    2,568,750
                

 

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ITEM 6—SELECTED FINANCIAL DATA

The selected consolidated statements of operations data presented below for each of the years in the five-year period ended December 31, 2006 and the selected consolidated balance sheet data as of December 31, 2006 and 2005 have been derived from and should be read in conjunction with the Company’s audited consolidated financial statements included in Part IV of this Report on Form 10-K. The selected consolidated statements of operations data for the years ended December 31, 2003 and 2002 and the selected consolidated balance sheet data as of December 31, 2004, 2003 and 2002 have been derived from the audited consolidated financial statements contained in the Company’s annual reports to shareholders for those years.

 

     Year ended December 31
     2006    2005     2004     2003     2002
     ($ in thousands, except per share data)

CONSOLIDATED STATEMENTS OF OPERATIONS DATA:

           

Revenues

   $ 8,431    $ 5,871     $ 7,550     $ 8,226     $ 9,409
                                     

Income (loss) from continuing operations before discontinued operations

     1,660      (1,872 )     (862 )     (5,068 )     847

Discontinued operations

     223      133       1,428       74       694
                                     

Net income (loss)

     1,883      (1,739 )     566       (4,994 )     1,541
                                     

EARNINGS PER SHARE:

           

Basic and diluted income (loss) from continuing operations before discontinued operations

   $ 0.03    $ (0.03 )   $ (0.01 )   $ (0.09 )   $ 0.02

Discontinued operations

     —        —         0.02       —         0.01
                                     

Basic and diluted net income (loss) per ordinary share outstanding

   $ 0.03    $ (0.03 )   $ 0.01     $ (0.09 )   $ 0.03
                                     
     As of December 31
     2006    2005     2004     2003     2002
     ($ in thousands)

CONSOLIDATED BALANCE SHEET DATA:

           

Total Assets

   $ 6,915    $ 6,532     $ 8,443     $ 4,627     $ 10,114
                                     

Long Term Liabilities

     4,058      4,863       7,341       4,111       7,990
                                     

 

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ITEM 7—MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION

Company Overview

The Company is a life sciences product development company with an extensive array of intellectual properties covering in excess of 2,000 patented and patent applied for compounds and uses targeting the science of aging to include skincare and dermatological therapeutics, erectile dysfunction, nutrition and cancer.

The Company’s business is comprised of two segments, Skincare and Pharmaceutical.

The Skincare segment represents dermatological/skincare compounds principally addressing photoaging and other skincare needs that the Company licenses to pharmaceutical and cosmetic companies. The Company currently has a number of licensing agreements including significant licensing arrangements with Valeant Pharmaceutical and the Body Shop.

Skincare products include Kinetin (N6-furfuryladenine) which has been found to retard aging of plants and, in research done on human skin fibroblasts, has delayed the signs of cell aging, multi-nucleation and loss of organizational structure, and Zeatin, an analogue of Kinetin. The Company is also at varying stages in the process of evaluating, developing and marketing a number of other biologically active compounds to supplement its Skincare business.

The Pharmaceutical segment is comprised of:

 

 

 

Invicorp®, an intracavernous injection therapy for the treatment of ED licensed to Ardana Bioscience Ltd. and Plethora Solutions Holdings PLC who have assumed full financial and drug regulatory process responsibility. The Company’s license agreements provide that it participate in the success of Invicorp® through royalties and predetermined milestone payments.

 

   

Reliaject®; a unique autoinjector system assembled using highly automated precision equipment, which employs an ultra-fine gauge needle preset to achieve the appropriate penetration before drug flow, thereby reducing reliance upon the patient’s technique for accuracy and safe delivery. In March 2006, the Company sold to Ranbaxy Pharmaceuticals Inc. all of its patents, trademarks and automated manufacturing equipment for the Reliaject® device. The Company received a down-payment of $500,000 and under the terms of the sale agreement, the Company is to receive additional payments based on regulatory approvals and cumulative sales milestones. In addition, the Company is to receive a specified percentage (similar to a set royalty) for a period of 15 years on Ranbaxy’s and its licensees’ quarterly net sales in North America of Reliaject® pre-filled with epinephrine and other parenteral drugs. Percentages will be negotiated on its net sales in any other markets for which it may be licensed and on its net sales in North America of Reliaject® pre-filled with non-scheduled parenteral drugs. Under the agreement, Ranbaxy is assuming all expenses of obtaining regulatory approvals and of marketing the product.

 

   

Monoclonal antibodies used in Alzheimer’s and other disease research which the Company licenses from RFMH and sells to Covance Antibody Services Inc.

Consistent with the Company’s strategy of building a high-margin revenue stream, its 2006 Kinetin and Zeatin revenues are derived from license agreements under which its licensees assume responsibility for marketing and maintaining required government approvals within their respective licensed territories. On March 30, 2007, Senetek PLC and Valeant completed a License Acquisition Agreement. Under the terms of the License Acquisition Agreement, the Company has granted Valeant a paid up license for Kinetin and Zeatin and assigned to Valeant future royalties from other Kinetin licensees, in return for a cash payment of $21 million, a waiver of $6 million in future marketing credits the Company otherwise would have owed to Valeant, and a right to share in future royalties due to Valeant from other Kinetin licensees through 2011.

 

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In the case of emerging skincare and dermatological therapeutic products, the Company may opt to enter marketing collaborations where it will potentially benefit from a higher percentage of revenues or to develop or co-develop its own distribution capability within certain channels which can be efficiently serviced without significant infrastructure. In the case of Invicorp®, Reliaject® and monoclonal antibodies, the Company’s commercial partners have undertaken full responsibility for research, sales, distribution and marketing and, where applicable, regulatory compliance.

The Company conducts research and development of new skincare products at its dedicated laboratory facility in Aarhus, Denmark. In addition, it leverages its research and development staff and resources through research agreements with third-party consultants, clinicians and research scientists having particular expertise in its areas of interest.

The markets in which the Company competes are highly competitive. The Company continuously strives to make advances and compete based on forward-looking technology, superior performance and quality, and by identifying and developing products that will achieve competitive advantage.

Overview of Operating Results

 

     2006     2005     2004  
     ($ in thousands)  

Skincare Revenues

   $ 7,042     $ 4,764     $ 6,202  

Pharmaceutical Revenues

     1,389       1,107       1,348  
                        

Total Revenues

     8,431       5,871       7,550  
                        

Gross Profit

     7,423       4,995       6,494  

Operating Expenses

     (4,816 )     (6,056 )     (6,619 )
                        

Operating Income (Loss)

     2,607       (1,061 )     (125 )
                        

Net Income (Loss)

   $ 1,883     $ (1,739 )   $ 566  

The Company is focusing on revenue growth in its Skincare business. Its objective is to increase royalty, license and product revenues from its existing products and to develop new skincare products. The Company’s goal is to leverage the strength and expertise of its research and development staff and its third-party consultants, clinicians and contracted research scientists to meet market demand for advanced skincare products. The Company’s pharmaceutical products have been licensed to commercial partners who have undertaken full responsibility for sales, distribution and marketing and, where applicable, regulatory compliance.

During 2006 the Company made progress toward its revenue growth goals. The Company completed clinical testing and trial on one new biologically active compound, Pyratine-6, and it is currently in discussions with potential licensees. Clinical trials were also completed for another compound, 4HBAP. A number of other biologically active new compounds have advanced in clinical testing and trial.

For 2006, revenues from both Skincare and Pharmaceuticals increased compared to 2005 and 2004. Revenues for 2006 were $8,431,000 up 44% from 2005 and 12% from 2004. The increase is principally attributed to increased royalties from Valeant Pharmaceuticals International stemming from the July 2005 amendment to its Kinetin and Zeatin license agreement, and higher sales of monoclonal and polyclonal antibodies by the Company’s commercial partner. Additionally, deferred revenues decreased as past cash advances of royalties were amortized to income.

The gross profit rate for 2006 was 88% compared to 85% in 2005 and 86% in 2004. The increase was due to higher royalty based skincare sales in 2006 compared to prior years while the Company’s costs of good did not increase significantly due to its royalty business model.

 

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Beginning in the first quarter of 2006, the Company adopted Statement of Financial Accounting Standards 123(R), “Share Based Payment,” on a modified prospective basis. The Company incurred $171,000 of stock based compensation operating expense for 2006 as a result of the adoption. Stock compensation expense in future quarters could increase if new stock option grants are made to new and current employees and Directors.

2006 operating expenses decreased by 21% from 2005 and 27% from 2004 principally as a result of retrenchments made during 2005 (closure of the United Kingdom office, personnel reductions and the move of the corporate office to smaller facilities). The Company expects to increase investment in research and development of new skincare products and to market newly developed compounds. Its future operating expenses may rise due to this investment.

In March 2006, the Company retired its outstanding Senior Secured Notes along with related stock warrants and issued new warrants. The unamortized discount on the date of retirement, $927,000, was expensed in 2006 and that expense is reflected in Net Income.

In March 2006, the Company recognized a $250,000 gain on the sale of the Reliaject® assets to Ranbaxy Pharmaceutical which is included in Net Income for 2006.

Liquidity and Capital Resources

 

     2006     2005     2004  
     ($ in thousands)  

Cash, Cash Equivalents and Short-Term Investments

   $ 3,368     $ 3,187     $ 4,522  

Current Ratio

     1.41       1.00       2.55  

Increase (Decrease) in Cash, Cash Equivalents and Short-Term Investments

   $ 181     $ (1,335 )   $ 3,335  

Principal Payments on Debt

     (3,289 )     (30 )     (1,630 )

Borrowing on Bank Line of Credit

     1,500       —         —    

As of December 31, 2006, the Company’s principal sources of liquidity included cash and cash equivalents resulting from Company operations and available borrowings. Management believes its cash and cash equivalents and cash expected to be generated by its business activities will be sufficient to meet its working capital needs for at least the next twelve months. Should the Company be faced with currently unanticipated significant cash requirements in connection with gaining regulatory approvals of its products currently in development or in connection with protecting its patents or defending against patent infringement litigation, the Company’s present capital resources might be inadequate to fund its capital needs. Additionally, if the Company were to engage in a business combination transaction, its current cash position could be adversely impacted and its need for additional financing accelerated, although the impact of any such transaction cannot be evaluated at this time.

Net cash provided by continuing operating activities totaled $1,269,000 for 2006 compared to a net use of cash in operating activities of $(1,428,000) for 2005. The change is primarily attributed to the year-over-year increase in income from continuing operations offset by an increase in trade receivables commensurate with increased revenues.

Cash, cash equivalents and short-term investments increased to $3,368,000 at December 31, 2006 from $3,187,000 at December 31, 2005, principally reflecting net cash provided by continuing and discontinued operations of $1,290,000 in 2006, net cash proceeds of $500,000 from the sale of Reliaject® assets, and borrowings of $1,500,000, the maximum available, on the Company’s revolving line of credit with Silicon Valley Bank reduced by $3,289,000 paid to retire the Senior Secured Notes on March 31, 2006.

The financial statements set forth in Part IV of this Report have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) and are presented in U.S. dollars.

 

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Revenues

 

      Summary of Annual Revenue  
     2006   

% change in

2006

    2005   

% change in

2005

    2004   

% change in

2004

 
     ($ in thousands)  

Segment

  

Skincare

               

Royalties from Licensing

   $ 6,682    43.8 %   $ 4,648    (19.9 )%   $ 5,800    75.0 %

Product Sales

     360    210.3 %     116    (71.1 )%     402    (89.8 )%
                           

Total Skincare

     7,042    47.8 %     4,764    (23.2 )%     6,202    (14.7 )%
                           

Pharmaceutical

               

Royalties on Monoclonal Antibodies

     1,311    22.4 %     1,071    (18.7 )%     1,318    42.3 %

Sales of Polyclonal Antibodies

     65    —         —      —         —      —    

Sales of ED Product

     13    (63.9 )%     36    20.0 %     30    11.1 %
                           

Total Pharmaceutical

     1,389    25.5 %     1,107    (17.9 )%     1,348    41.4 %
                           

Total Revenue

   $ 8,431    43.6 %   $ 5,871    (22.2 )%   $ 7,550    (8.2 )%
                           

Substantially all of the Company’s revenue base in 2006, 2005 and 2004 was derived from license fees and royalties on its patented Kinetin and Zeatin skincare ingredients and remittances received from Covance Antibody Services Inc. on sales of monoclonal antibodies produced from cell lines licensed by the Company from RFMH. On March 30, 2007, Senetek completed a License Acquisition Agreement with Valeant. Under the terms of the License Acquisition Agreement, the Company has granted Valeant a paid up license for Kinetin and Zeatin and assigned to Valeant future royalties from other Kinetin licensees, in return for a cash payment of $21 million, a waiver of $6 million in future marketing credits the Company otherwise would have owed to Valeant, and a right to share in future royalties due to Valeant from other Kinetin licensees through 2011. Additionally, if RFMH’s patents were successfully challenged, the Company’s revenue from Covance’s sales would be substantially reduced or eliminated.

Skincare Segment

Skincare revenues increased $2,278,000, or 47.8%, for 2006 compared to 2005. A comparative increase in Valeant royalty revenues of $2,645,000 stemming from the July 2005 amendment to the license agreement was offset by a $407,000 decrease in royalty revenue from Revlon due to a scale back of a Revlon product line containing Kinetin. Other Kinetin licensees delivered generally comparable or slightly increased license revenues in 2006 compared with 2005 except for The Body Shop where royalties declined by $118,000 on reduced sales of Kinetin based products.

Skincare revenues decreased $1,438,000, or 23.2%, for 2005 compared to 2004. This decline resulted principally from the inclusion in 2004 results of non-recurring payments totaling $1,500,000 from OMP, Inc. in settlement of the Company’s lawsuit against OMP and non-recurring payment totaling $235,000 from Eagle-Picher Technologies in settlement of the Company’s lawsuit against it. Without these settlements, 2005 revenue would have slightly exceeded revenue in 2004. During 2005, Valeant royalty revenues increased by $912,000 reflecting the revised Valeant agreement entered into in May 2004. This increase was partially offset by declines of $502,000 in the Body Shop and $284,000 in Revlon royalties. Under the Company’s license agreement with The Body Shop, it receives royalties when The Body Shop purchases Kinetin products for its outlets. The Body Shop made additional purchases in 2004 in conjunction with planned international expansion, but its international outlets, many of which are franchisee operations, did not generate expected sales levels and accordingly the replenishment orders expected in 2005 did not materialize. Revlon royalties declined as they focused more on color cosmetics and less on skincare technology and as reductions in their skincare distribution generate product returns, which reduce royalty remittances.

 

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The Company expects its 2007 revenue and net income to increase significantly from 2006 as a result of the License Acquisition Agreement. The $21 million cash payment will be fully includable in 2007 revenues along with approximately $3,750,000 in previously deferred revenue. Future revenues will decline until replaced by revenue from other sources.

The Company is dependent upon successful development of new active ingredients for its future revenue growth.

Pharmaceuticals Segment

2006 Pharmaceutical revenues were $1,389,000, a 25.5% increase over 2005. Monoclonal antibody royalties increased $240,000 due to increased sales by Covance Antibody Services, Inc. (“Covance”). During 2006, the Company sold $65,000 of polyclonal antibodies supplied by RFMH to Covance.

The 18.7% decrease in royalties on pharmaceutical products for 2005 compared to 2004 was due to a $247,000 decrease in royalties on sales of monoclonal antibodies.

Revenues from sales of monoclonal and polyclonal antibodies are expected to fluctuate as the sales of these products follow patterns determined by project-driven research organizations. The Company’s agreement with Covance Antibody Services, Inc. guarantees them minimum payments for monoclonal antibodies of $860,000 in 2007 through 2010 and $442,000 in 2011.

Gross Profit

 

     Summary of Gross Profit  
     2006     % change
2006
    2005     % change
2005
    2004     % change
2004
 
     ($ in thousands)  

Segment

            

Skincare

   $ 6,720     49.3 %   $ 4,500     (23.2 )%   $ 5,861     (4.6 )%

Pharmaceutical

     703     42.0 %     495     (21.8 )%     633     (6.7 )%
                              

Total

   $ 7,423     48.6 %   $ 4,995     (23.1 )%   $ 6,494     (4.8 )%
                              

As a % of Skincare Revenue

     95.4 %       94.5 %       94.5 %  

As a % of Pharmaceutical Revenue

     50.6 %       44.7 %       47.0 %  

As a % of Total Revenue

     88.0 %       85.1 %       86.0 %  

Gross profit for 2006 increased from 2005 in total and as a percentage of revenue for both Skincare and Pharmaceuticals due to increased revenues and a larger component of high margin royalty income.

Gross profit for 2005 decreased from 2004 due to lower Skincare and Pharmaceutical sales. Pharmaceutical gross margin was lower in 2005 compared to 2004 because of 2005 costs associated with the amendment of the monoclonal antibody sales and marketing and royalty agreements.

Historical gross profit percent from Skincare revenues is high because it is primarily royalty based. To the extent this royalty model continues in the future, the Company expects comparable percentages. In the case of emerging skincare products, it may opt to develop or co-develop its own distribution capability within certain channels which can be efficiently serviced without significant infrastructure. In this case, the Company would expect its revenues and gross profit to be higher but its gross profit percentage to be lower.

Gross profit from monoclonal and polyclonal antibodies is expected to fluctuate as the sales of these products follow patterns determined by project-driven research organizations. The Company’s agreement with RFMH guarantees them minimum royalty payments for monoclonal antibodies of $430,000 in 2007 through 2010 and $221,000 in 2011.

 

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Research and Development

 

      Summary of Research and Development  
     2006    

% change in

2006

    2005     % change in
2005
    2004     % change in
2004
 
     ($ in thousands)  

Research and Development

   $ 1,313     (8.5 )%   $ 1,435     (4.6 )%   $ 1,504     (3.6 )%

As a % of Total Revenue

     15.6 %       24.4 %       19.9 %  

Research and development expense consists primarily of employee related expenses, contract costs of research agreements with third-party consultants, clinicians and research scientists and product testing.

Research and development expense decreased 8.5% in the 2006 compared to 2005. This comparative decrease was attributed to complete curtailment in 2005 of all research spending for Pharmaceuticals in conjunction with agreements with the Company’s commercial partners who have undertaken full responsibility for research on these products Comparative spending for skincare research and development increased by approximately 20% which is attributable to clinical test work on PRK 124 and 4HBAP.

Research and development spending in 2005 was slightly lower compared to 2004. Skincare research and development spending rose to approximately $1,100,000 in 2005 compared to approximately $700,000 in 2004 due to accelerated development costs for Zeatin and new skincare compound screening costs. Research spending for Pharmaceuticals dropped as a result of the curtailment discussed in the preceding paragraph.

The Company expects to continue to allocate substantial resources to Skincare product development as a percentage of revenue, and research and development expense may increase in the future.

Administration, Sales and Marketing

 

      Summary of Administration, Sales and Marketing  
     2006     % change
2006
    2005     % change
2005
    2004     % change
2004
 
     ($ in thousands)  

Administration, Sales and Marketing

   $ 3,503     (24.2 )%   $ 4,621     (9.7 )%   $ 5,115     (18.8 )%

As a % of Total Revenue

     41.5 %       78.7 %       67.7 %  

For the years ended December 31, 2006, 2005 and 2004, the following Administration, Sales and Marketing expenses were incurred:

 

      2006    2005    2004
     ($ in thousands)

Expense Category

  

Payroll, Benefits and Consulting

   $ 1,570    $ 1,654    $ 1,775

Legal and Other Professional Fees

     779      1,043      1,674

Rent and Office Expenses

     376      796      719

Insurance-Liability

     295      359      387

Travel and Related

     271      238      282

Advertising

     37      59      —  

Other

     175      472      278
                    

Total

   $ 3,503    $ 4,621    $ 5,115
                    

Administration, sales and marketing expenses have declined since 2004 due to retrenchments made during 2005 (closure of the United Kingdom office, personnel reductions and the move of the corporate office to smaller

 

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facilities). Higher legal expenses in 2004 included costs for actions against Kinetin patent infringers that did not occur to the same extent in 2005 and 2006. Comparative Legal and Other Professional Fees have continued to decrease as litigation and patent infringement have diminished

Other Income and Expense

The primary recurring components of other income and expense are interest income on cash, cash equivalents and marketable securities and interest expense on the Company’s borrowings.

In April 1999, the Company issued $7,389,000 in aggregate principal amount of secured promissory notes. In connection with the issuance of these promissory notes, the Company issued Series A, B and C warrants for an aggregate of 3 million ordinary shares at $1.20 per share, 3.3 million ordinary shares at $1.50 per share and 1.2 million ordinary shares at $2.00 per share. The Series A, B and C warrants originally expired 10 years from the date of issuance, or April 14, 2009. The estimated fair value of the warrants was recorded as notes payable discount and was amortized as additional interest expense over the terms of the promissory notes. On June 20, 2001, under an amendment to the Securities Purchase Agreement, the maturity of these notes was extended to April 2004. During 2003 and 2004, the Company further amended the promissory notes and Series A, B and C warrants resulting in an increase in the related discount of $1,447,000 and $367,000 respectively. On March 31, 2006, the Company paid the outstanding principal amount of the notes and accrued interest, with the result that the notes and outstanding Series A, B and D warrants were canceled. The Company recognized a loss of approximately $927,000, representing the unamortized discount on the notes, related to the extinguishment of the debt. The amortization of the discount on the notes, which is included in interest expense, amounted to $243,000 for 2006, $545,000 for 2005 and $515,000 for 2004.

On March 20, 2006, the Company sold to Ranbaxy Pharmaceuticals Inc. all of its patents, trademarks and automated manufacturing equipment for the Reliaject® device (the “Reliaject® assets”). The Company received a down-payment of $500,000 for the Reliaject® assets, which had a corresponding recorded value of $250,000. The $250,000 gain was recorded to other income.

Included in other income for 2004 is a $235,000 reflecting settlement of a lawsuit brought by the Company against Eagle-Picture Technologies Inc. related to its subsidiary ChemSyn Laboratories, and active ingredient manufacturer.

Discontinued Operations

On December 31, 2002, the Company closed a transaction in which USITC purchased its rights to the Mill Creek personal care line, the Silver Fox hair care line and other brands. On November 10, 2004, the Company and USITC entered into an agreement to restructure a note associated with the purchase. Under the terms of the restructuring, Senetek received $1,435,000 in cash and a $400,000, two and one half year, secured amortizing note bearing interest at 8% per annum. Under the terms of the agreement, if USITC fails to pay any of the quarterly payments due under the new $400,000 note, all of its obligations under the original $2.3 million note, less amounts actually paid, will be reinstated and subject to acceleration for non-performance. During 2004, $435,000 of the payments was classified as interest income and $1 million was classified as a Gain on Sale of Operation. 2004 net income included $1,435,000 of cash payments from USITC paid under the terms of this settlement and classified as income from discontinued operations. In 2006 and 2005, payments of $223,000 and $133,000, respectively, made by USITC on the $400,000 promissory note given as part of the settlement were recognized as income from discontinued operations.

Taxation

Refer to Income Taxes below and Note 12 to the Financial Statements for discussion of the Company’s significant deferred tax assets and liabilities and net operating loss carryforwards.

 

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Contractual Obligations

The Company has contractual obligations related to non-cancelable lease agreements totaling $56,000 in 2007 and $13,000 in 2008 and is committed to provide $170,000 in support to the Institute of Experimental Botany in Prague, Czech Republic for its continued research on certain cytokinins and other classes of naturally-derived cytokinins. Contractual obligations related to employment agreements are detailed in the “Compensation Discussion & Analysis” under Part III, Item 11 of this report on Form 10-K. The Company has a contractual obligation to RFMH for minimum payments of $430,000 per year through June 2011 which is fully offset by contractual minimum payments receivable from Covance of $860,000 per year.

Government Policy

It is the Company’s opinion that there are no aspects of government policy which, as far as can be foreseen, are likely to have a material effect on the conduct of its business, except as generally described in Part I, Item 1, of this Form 10-K under the heading “Government Regulation.”

Impact of Inflation

Management believes that inflation has not had any material effect on the results of the Company’s operations to date.

Critical Accounting Policies

A “critical accounting policy” is one which is both important to the portrayal of the Company’s financial condition and results of operations and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. The Company’s significant accounting policies are described in the Notes to the consolidated financial statements included in this Form 10-K. Management believes that the following accounting policies fit the definition of critical accounting policies. The critical accounting policies were discussed with the entire board of directors of the Company.

Revenue Recognition

Royalties from the Company’s skincare licensees are recognized based on estimates that approximate the point products have been sold by the licensees. The Company receives sales reports from the licensee and based upon this information, plus subsequent cash receipts, records royalty revenue. Royalty revenue is generally paid by the licensee within 30 days of quarter end. Estimates are adjusted to reflect actual results within one quarter of product sales by licensee. Historically, license revenue has not differed significantly from management’s estimates. Revenue from the sale of the Company’s skincare products and of Invicorp® is recognized at the time of shipment, which is when legal title and risk of loss is transferred to the Company’s customers, and is recorded at the net invoiced value of goods supplied to customers after deduction of sales and value added tax where applicable. Royalties received from the Company’s licensee on their sale of monoclonal antibodies are recognized based upon a percentage of actual sales pursuant to the contract terms. Upfront license fees received from the licensing of manufacturing and distribution rights for the Company’s skincare products are deferred and recognized as revenue is earned, which is generally on a straight-line basis over the life of the contract.

Impairment of Goodwill and Other Long-lived Assets

The Company assesses the impairment of goodwill annually and other long-lived assets such as property and equipment and other intangibles whenever events or changes in circumstances indicate that the carrying value may not recoverable. Factors it considers important which could trigger an impairment review include the following:

 

   

Significant underperformance relative to expected historical or projected future operating results;

 

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Significant changes in the manner of the Company’s use of the acquired assets or the strategy for its overall business;

 

   

Significant negative industry or economic trends.

When the Company determines that the carrying value of goodwill and other long-lived assets and property and equipment may not be recoverable based upon the existence of one or more of the above indicators of impairment, it measures any impairment based on a projected discounted cash flow method using a discount rate determined by its management to be commensurate with the risk inherent in its current business model.

The Company reviews the carrying value of its property and equipment and intangible assets for impairment in value whenever events or changes in circumstances indicate that the carrying amount of assets may not be recoverable. The determination of fair value is a critical and complex consideration when assessing impairment that involves significant assumptions and estimates. These assumptions and estimates are based on the Company’s best judgments.

On March 30, 2007, Senetek completed a License Acquisition Agreement with Valeant. Under the terms of the License Acquisition Agreement, the Company granted Valeant a paid up license for Kinetin and Zeatin and assigned to Valeant future royalties from other Kinetin licensees, in return for a cash payment of $21 million, a waiver of $6 million in future marketing credits the Company otherwise would have owed to Valeant, and a right to share in future royalties due to Valeant from other Kinetin licensees through 2011. As a result of this transaction, goodwill of $1,308,000 was determined to be impaired and concurrently written off in March 2007.

Income Taxes

As a result of the Company’s historical losses, it has significant deferred tax assets that could be utilized if it generates future taxable income and is otherwise required to pay income taxes. However, pursuant to the “change in ownership” provisions of the Tax Reform Act of 1986, utilization of its net operating loss (“NOL”) carryovers may be limited if a cumulative change of ownership of more than 50% occurs within any three-year period. The Company has not determined if such a change in ownership has occurred or the amount of the loss carryover limitation, if any. Management believes that the Company’s current business model will ultimately lead to sustained profitability and that the deferred tax asset will have value, but due to the Company’s lack of profitable historical operating history, potential limitations on usage of operating losses and general uncertainty, it provided for a 100% valuation allowance against its entire deferred tax asset. Should the Company’s operating results and analysis of “change in ownership” provisions indicate that its profitability is more likely than not to lead to the utilization of all or a portion of the deferred tax asset, it will reverse all or a portion of the Company’s valuation allowance. Subsequent changes to the estimated net realizable value of the deferred tax asset could cause its provision for income taxes to vary significantly from period to period, although its cash tax payments would remain unaffected until the benefit of the NOL is utilized, assuming that a “change in ownership” does not limit those losses.

While the Company has closed its UK office, it is continuing Named Patient Sales of Invicorp® in the UK and is actively engaged in promoting regulatory approval and commercialization of Invicorp® through its licensee in the UK, Ardana Bioscience Ltd, and believes that this continuation of trade preserves the Company’s NOLs. Management is budgeting for improved performance and future operating results which may generate future taxable income and it may reduce the valuation allowance when realization is deemed to be more likely than not. The United Kingdom tax-loss carryforwards are available indefinitely against profits from the same trade carried on in the United Kingdom, but could be limited if there was a greater than 50% change in ownership in any three-year period.

On January 1, 2006, the Company adopted SFAS 123(R), “Share-Based Payment”, which requires the measurement and recognition of compensation expense for all share-based payment awards made to the Company’s employees and directors, including employee stock options and employee stock purchases, based on estimated fair values.

 

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The Company adopted SFAS 123(R) using the modified prospective method, which requires the Company to record compensation expense for all awards granted after the date of adoption, and for the unvested portion of previously granted awards that remain outstanding at the date of adoption. Accordingly, prior period amounts presented herein have not been restated to reflect the adoption of SFAS 123(R). The fair value concepts were not changed significantly in SFAS 123(R); however, in adopting SFAS 123(R), companies must choose among alternative valuation models and amortization assumptions. After assessing alternative valuation models and amortization assumptions, the Company will continue using both the Black-Scholes option-pricing formula and straight-line amortization of compensation expense over the requisite service period of the grant. The Company will reconsider use of this model if additional information becomes available in the future that indicates another model would be more appropriate, or if grants issued in future periods have characteristics that cannot be reasonably estimated using this model. Under SFAS No. 123, “Accounting for Stock Based Compensation” (“SFAS 123”), the Company was not required to estimate forfeitures in the expense calculation for the stock compensation pro forma footnote disclosure; however, SFAS 123(R) requires an estimate of forfeitures and upon adoption the Company changed its methodology to include an estimate of forfeitures. The adoption of SFAS 123(R) had no effect on cash flows from operating activities.

Subsequent Events

On March 16, 2007, the Company received $1,312,000 in settlement of claims against professional services provider arising over past performance related matters. $1,200,000 of this amount was paid in cash and the remainder represents a write-off of fees owed. The Company has recorded the settlement as income in the quarter ended March 31, 2007. In conjunction with the settlement, the Company recorded $10,000 in related legal costs and expenses.

On March 30, 2007, Senetek completed a License Acquisition Agreement with Valeant. Under the terms of the License Acquisition Agreement, the Company has granted Valeant a paid up license for Kinetin and Zeatin and assigned to Valeant future royalties from other Kinetin licensees, in return for a cash payment of $21 million, a waiver of $6 million in future marketing credits the Company otherwise would have owed to Valeant, and a right to share in future royalties due to Valeant from other Kinetin licensees through 2011. In connection with this transaction, the Company terminated its line of credit with Silicon Valley Bank and paid off the outstanding balance of $1,500,000. The $21 million cash payment will be fully includable in 2007 revenues along with approximately $3,750,000 in previously deferred revenue related to the prior license agreement.

ITEM 7A—QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Interest Rate Risk

As of December 31, 2006, interest expense under the Company’s Revolving Credit Agreement is accrued at 1% above Silicon Valley Bank’s announced prime lending rate with a minimum of 8.25% per annum. A change of interest rate of +/-1% would impact interest expense by $15,000. Effective March 30, 2007, the Revolving Credit Agreement was terminated and all outstanding amounts were repaid.

Foreign Currency Exchange Rate Risk

The Company is at market risk of exchange rate variability between the pound sterling, Danish Kroner and U.S. dollar. However, it believes that fluctuations in interest rates and currency exchange rates in the near term would not materially affect its consolidated operating results, financial position or cash flows as it has limited risks related to currency exchange rate fluctuations because of the limited amount of transactions denominated in foreign currencies, and accordingly it does not hedge this risk.

Foreign Currencies

The Company has operations in Denmark and in the UK where it relies upon outsource providers. The functional currencies are the Danish Kroner and Pound Sterling respectively. The Company follows currency

 

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translation principles established by SFAS No. 52, “Foreign Currency Translation”. All assets and liabilities in the balance sheets of its foreign operations are translated at period-end exchange rates. All income and expenditure items in the profit and loss account of foreign operations are translated at average annual exchange rates. Translation gains and losses arising from the translation of the financial statements of the operations are not included in determining net income but are accumulated in a separate component of stockholders’ equity. Foreign currency transaction gains and losses are included in the determination of net income in the period in which they occur. The Company does not use any methods to hedge the effect of changes in the Danish Kroner or Pound sterling exchange rates.

ITEM 8—FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

See Item 15(a) (1) and 15(a) (2) of Part IV of this Report on Form 10-K.

ITEM 9—CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

On August 10, 2005, the Company’s Board of Directors accepted the resignation of BDO Seidman, LLP (“BDO”) as its independent accountants and approved the engagement of Macias Gini & O’Connell LLP (“MGO”) as its independent accountants for the fiscal year ended December 31, 2005. MGO were also engaged as the Company’s independent accountants for the year ended December 31, 2006.

BDO provided auditing services to the Company for the year ended December 31, 2004. During this time, which specifically includes the fiscal year ended December 31, 2004, and the subsequent interim period through August 10, 2005, there were no disagreements between BDO and the Company on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure, which disagreements, if not resolved to BDO’s satisfaction, would have caused them to make reference to the subject matter of the disagreement in connection with its reports. Furthermore, there were no reportable events described under Item 304(a) (1) (v) of Regulation S-K.

The audit report issued by BDO on the Company’s consolidated financial statements as of and for the year ended December 2004 did not contain an adverse opinion, or a disclaimer of opinion, nor was it qualified or modified as to uncertainty, audit scope or accounting principles.

During the year ended December 31, 2004 and through August 10, 2005, the Company did not consult with MGO regarding any of the matters or events set forth in Item 304(a)(2)(i) and (ii) of Regulation S-K.

ITEM 9A—CONTROLS AND PROCEDURES

The Company’s chief executive officer and its principal financial officer have evaluated the effectiveness of its “disclosure controls and procedures” (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of December 31, 2006. Based on that evaluation, its chief executive officer and its principal financial officer have concluded that its disclosure controls and procedures were effective to provide reasonable assurance that information that it is required to disclose in reports that the Company files with the SEC is recorded, processed, summarized and reported within the time periods specified by the Exchange Act rules.

It should be noted that any system of controls, however well designed and operated, can provide only reasonable assurance regarding management’s control objectives. In addition, the design of any control system is based in part upon certain assumptions about the likelihood of future events. Because of these and other inherent limitations of control systems, there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions, regardless of how remote.

During 2006, there were no changes to the Company’s internal controls over financial reporting which were identified in connection with the evaluation of its disclosure controls and procedures required by the Exchange Act rules and which have materially affected, or are reasonably likely to materially affect, its internal controls over financial reporting.

ITEM 9B—OTHER INFORMATION

None.

 

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PART III

ITEM 10—DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT

As of December 31, 2006 the Company had four Directors.

 

Name

  

Position with Company

  

Director

Since

   Age

Frank J. Massino

  

Chairman of the Board of Directors and Chief Executive Officer

   1998    58

Anthony Williams

  

Vice Chairman of the Board of Directors

   2003    61

Kerry Dukes

  

Director

   2006    44

Rodger Bogardus

  

Director

   2006    66

Mr. Massino became Chairman and Chief Executive Officer of Senetek PLC in November 1998. Prior to becoming Chairman and Chief Executive Officer of Senetek, Mr. Massino served as President of Carmé Cosmeceutical Sciences, Inc., a wholly-owned subsidiary of Senetek. Drawing on professional management experience at major corporations such as Glaxo, Ortho Pharmaceutical Corporation, Johnson & Johnson, Pfizer and IBM, Mr. Massino has reshaped the corporate structure of Senetek, defined its strategic direction and focused the Company soundly on its core competencies. During his career, Mr. Massino has successfully negotiated more than 50 licensing agreements with major pharmaceutical companies. For nine years he held executive management positions at Ortho Pharmaceutical, including Director of Business Development and New Products, and in 1982 was named “Division Manager of the Year.” While at Ortho, Mr. Massino was involved in the development of Renova, which in 1995, was also approved for anti-aging applications under the Renova trademark, and directed major product launches. As Product Director of Marketing and Division Sales Manager at Glaxo Inc., he repositioned a mature line of corticosteroids into a $60 million psoriasis business, successfully launched two new ethical pharmaceutical products and championed the internal development of two critically important product line extensions. Mr. Massino holds a degree in Finance and Chemistry from the University of Illinois and is a graduate of the Marketing Management Program of the Columbia Executive Program at Columbia University and the Management of Managers Program of the Graduate School of Business Administration at the University of Michigan. Mr. Massino is highly experienced in drug delivery technology and holds a patent on a drug delivery device. He is an active member of the Licensing Executives Society. Under the Company’s Articles of Association, as an Executive Director, Mr. Massino’s term as a director does not expire.

Mr. Williams was appointed a Director in February 2003 for a three-year term in accordance with the Company’s Articles of Association. Since September 2005 he has been a partner at Baker & McKenzie LLP, global law firm headquartered in Chicago, and for more than thirty years prior to that he was a Corporate Partner at Coudert Brothers LLP, a New York City-based international law firm where he also had served as Chairman of the Executive Committee of Coudert Brothers from 1993 to 2001 and as Administrative Partner, responsible for worldwide operations. He is a graduate of Harvard University and New York University School of Law. He has been admitted to the Bar at the United States Supreme Court, the State of New York and State of California. Mr. Williams sits on the board of the following companies and organizations: RAG American Coal Holdings, Inc., DBT America Inc., Trautman Wasserman & Company Inc., IE Holdings, Ltd., Brook Capital Corporation, Plymouth Holdings Limited, River Ventures, Inc., Fenn Wright & Manson and the German American Chamber of Commerce. Coudert Brothers LLP filed for bankruptcy protection in September 2006.

Mr. Dukes was appointed a Director in May 2006 and elected by the shareholders in December 2006. Mr. Dukes is Chief Executive Officer and co-founder of Ardour Capital Investments LLC, a registered investment banking and securities broker-dealer firm in New York City. Mr. Dukes has more than 20 years experience in the investment banking and securities businesses and has served on the Boards of Directors of

 

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public companies, including Commonwealth Associates Growth Fund and Food Integrated Resources. Prior to Ardour Capital Investments, Mr. Dukes served as Director, Senior Managing Partner and Head of Global Activities of BlueStone Capital Partners, a registered securities broker-dealer and investment bank from 1995 to 2001 and as Chief Operating Officer and Managing Director of Commonwealth Associates Growth Fund from 1988 to 1995. Mr. Dukes attended the State University of New York.

MrBogardus was appointed a Director in May 2006 and elected by the shareholders in December 2006. Mr. Bogardus is Chief Executive Officer and founder of Ingredia Resources LLC, Manahawkin, New Jersey, a privately held company that consults in designing, developing and marketing functional ingredients for use in topically applied personal care products. Prior thereto, Mr. Bogardus was Vice President and Category Head, Research and Development, of GlaxoSmithKline, a global healthcare company, with responsibility for denture care brands, from July 2001 to July 2002, and Senior Vice President, Research & Technology, of Block Drug Company, a global healthcare company, from January 1999 to June 2001, when Block Drug was acquired by GlaxoSmithKline. From 1992 through 1998 Mr. Bogardus was Senior Vice President, Global Research and Development Group, of Mary Kay, Inc., a direct selling cosmetics company; from 1986 through 1992 he was Director, European Technology Center, of Colgate-Palmolive Company, a global personal care products company; and prior thereto he held responsible product research and development positions with Richardson-Vicks, Inc., a subsidiary of Procter & Gamble Company, S.C. Johnson & Son, Inc. and The Gillette Company, all global personal care products companies. Mr. Bogardus holds a B.S. degree in Chemistry from Milliken University.

Executive Officers

Frank J. Massino, Chairman of the Board of Directors and Chief Executive Officer (see above).

William O’Kelly, age 52, has been Chief Financial Officer of the Company since April 2006 and Secretary of the Company since August 2006. From July 2005 until April 2006 Mr. O’Kelly was a financial consultant to Netopia, Inc, a manufacturer and distributor of broadband customer premises equipment, remote management software and broadband services. From July 2001 to July 2005 he was Chief Financial Officer and Secretary of Agentis Software, an application development software company which he co-founded; and from April 1998 to July 2001 he was Vice President-Finance and Treasurer of Informix Software, a database software company with revenues in excess of $1 billion. Prior to that he was Chief Financial Officer of Chemical Supplier Technology, an on-site manufacturer of high purity chemicals for silicon wafer and chip fabrication factories from February 1996 to April 1998 and Corporate Controller of Air Liquide America Corporation, an industrial gas manufacturing subsidiary with revenues in excess of $1 billion from August 1993 to February 1996. For 16 years prior to that he performed audit and tax services with the accounting firm of Ernst & Young. Mr. O’Kelly is a certified public accountant and holds a BS degree in Accounting from the University of Florida.

Independent Directors

The Board has determined that the following Directors of the Company (constituting a majority of all Directors) are “independent” within the meaning of the listing standards of the NASDAQ Stock Market: Mr. Bogardus, Mr. Dukes and Mr. Williams.

Financial Expert

The Board of Directors has determined that Mr. Dukes is an “audit committee financial expert” by reason, among other things, of his experience as chief executive officer of a registered securities investment banking and broker-dealer firm and as an investment banker involved in over 20 registered public offerings of securities. Mr. Dukes and Mr. Bogardus constitute the Audit Committee of the Board.

 

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Communication with Directors

Individuals may submit communications to the Board or to the non-management Director by sending the communications in writing to the attention of the Secretary of the Company at Senetek PLC, 831 Latour Court, Napa, CA 94558. All communications that relate to matters that are within the scope of responsibilities of the Board and the Committees will be forwarded to the appropriate Director.

Director Nomination Process

All four of the seats on the Nominating Committee are currently vacant and the functions of the Committee are performed by the full Board. The duties of the Nominating Committee consist, among other things, of identifying individuals qualified to become Board members, selecting, or recommending to the Board, the Director nominees for the next Annual General Meeting, selecting, or recommending to the Board, Director candidates to fill any vacancies on the Board, and receiving proposals for Director nominees from beneficial holders of the Company’s ordinary shares. A copy of the Nominating Committee’s charter is available on the Company’s website at www.senetekplc.com. The Nominating Committee makes an assessment of the suitability of candidates for election to the Board, taking into account business experience, independence, and character. The Board has not, thus far, considered it appropriate to adopt specific, minimum objective criteria for director nominees. There have been no material changes to the procedures by which security holders may recommend nominees to the Board since the distribution of the Company’s last proxy statement for its election of directors.

Section 16(a) Beneficial Ownership Reporting Compliance

Section 16(a) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), requires the Company’s directors and executive officers, and persons who own more than ten percent of a registered class of its equity securities, to file with the Commission and any exchange or other system on which such securities are traded or quoted, initial reports of ownership and reports of changes in ownership of common shares and other equity securities of the Corporation.

To its knowledge, based solely on a review of the copies of such reports furnished to the Company, it believes that all reporting obligations of its officers, directors and greater than 10% shareholders under Section 16(a) were satisfied during the year ended December 31, 2006.

Code of Ethics

The Company has adopted a code of ethics that applies to all of its employees, Directors and consultants, and includes additional provisions specifically applicable to its chief executive officer and senior financial officers. A copy of this code of ethics (which is entitled “Senetek PLC—Code of Business Conduct”) can be found on the Company’s website at senetekplc.com. In the event of any amendment to, or waiver from, the code of ethics, the Company will publicly disclose the amendment or waiver by posting the information on its website.

ITEM 11—EXECUTIVE COMPENSATION

Compensation Discussion and Analysis

The Company’s executive compensation program is designed to attract and retain highly qualified executive officers, align executive performance with its strategic and financial objectives and reward management for successful performance in achieving these objectives. Strategic objectives primarily relate to development and commercialization of new products. The principal financial objective is achievement of the financial plan. Four elements of compensation are employed to achieve these goals:

Base Salary

Base salary provides the executive with a reasonable and competitive cash compensation program designed to allow the executive to receive a remuneration that is consistent with similarly performing executives at similar

 

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enterprises. The Company uses the services of an independent compensation consultant, Financial Concepts, to determine the competitiveness of executive officer compensation. The Compensation Committee reviews base salaries annually and makes adjustments based on recommendations from the compensation consultant which the committee deems appropriate to maintain base compensation consistent with similarly performing executives at similar enterprises The Compensation Committee takes into account each executive’s responsibilities, experience and performance in considering changes to base salary. Generally, base salaries are targeted at the 50th percentile of executive base salaries for the appropriate market comparison group, as determined by Financial Concepts.

Benefits

The Company furnishes executive officers benefits intended to provide healthcare, retirement and other specified benefits common in the life science industry. Healthcare is provided through a group policy available to all employees. The Company maintains a 401(k) contributory retirement plan and match 100% of employee contributions up to 3% of cash compensation and 50% of employee contributions between 3% and 5% of cash compensation. The Company provides its Chairman and Chief Executive Officer with term life insurance with a death benefit of approximately three times base compensation payable to his designee and disability insurance with a monthly benefit of approximately 80% of base compensation.

Management believes the benefits the Company provides is competitive with life science industry standards.

Short Term Incentive

Short term incentive is an annual performance-based incentive that rewards achievement of annual strategic and financial objectives that are established by the Board of Directors. Payments are made in a combination of cash and restricted stock, generally 75% cash and 25% restricted stock.

Long Term Incentive

In addition to base salary, benefits and short term incentive compensation, the Company provides its executives with long term compensation. Long term incentive compensation is designed to reward achievement of strategic long term objectives related to commercialization of new product as established by the Board of Directors, to establish ownership in the Company and to retain talented executives. The Company awards its executives equity grants in the form of stock options. The Company typically makes awards annually, in June, based on each executive’s responsibility, experience, performance and ability to influence its long-term growth and profitability. Stock options, granted at an exercise price equal to the closing market price on the date of the grant and exercisable for seven years are designed to build long-term net worth for the executive tied directly to increasing shareholder value. Stock options vest over four years from the date of grant to provide a time based performance incentive or are based on achievement of predetermined performance objectives such as those associated with the June 6, 2006 stock option grants described below.

There are no security ownership requirements or guidelines, and no policies in place to address the economic risk of equity ownership.

The Company grants equity awards in accordance with the following plans:

Terms of Stock Equity Plans

In May 2006, the Company adopted the Senetek Equity Plan providing for issuance of non-qualified options and restricted stock to employees, non-employees and board members. Options are granted at the discretion of the Compensation Committee. The options will generally become exercisable over 48 months with expiration seven years from grant date. The Compensation Committee has the discretion to use a different vesting schedule.

 

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There are two other share option plans (Plan 1 and Plan 2) under which stock options to employees, non-executive Directors and consultants have been issued. Both share option plans expired in December 2005. Options issued under the two expired plans remain in place, subject to the original terms of each plan which were for options to generally become exercisable over 48 months with expiration seven years from grant date. The Compensation Committee of the Board of Directors had the discretion to use a different vesting schedule.

Material Terms of Grant Based Awards

On June 6, 2006, the Compensation Committee awarded 1,200,000 non-qualified options to Mr. Massino and 200,000 non-qualified options to Mr. O’Kelly. For Mr. Massino, the award was relatively large because it was the first since 2002 and also because 800,000 previously granted options expired in 2006. For Mr. O’Kelly, it was an initial employment award in line with past Company practices. The option grants have a term of seven years and were priced at the Company’s share market price at the close of business on the grant date. The option grants vest 25% with respect to calendar year 2006, 25% with respect to 2007, 25% with respect to 2008 and 25% with respect to 2009 if and only if one of the two conditions (“A” or “B”) described below are satisfied. If neither condition is satisfied with respect to the calendar year, the tranche applicable to that year plus any unvested cumulative tranches from prior years are carried forward to the following year and fully vested if one of the two conditions are met with respect to that year.

Condition A

At any time during the calendar year, the closing price of Senetek PLC American Depositary Shares for a consecutive 60 day period averages “X” or higher, as defined below (provided that options shall not vest within the first six months after grant).

Condition B

“Net Operating Income” for the calendar year is greater than or equal to “Y” as defined below. For purposes of this calculation, “Net Operating Income” is defined as Operating Income computed in accordance with U.S. Generally Accepted Accounting Principles plus all operating expenses associated with any program to migrate from a UK legal entity to a US legal entity and operating expenses associated with the evaluation or institution of a share buyback program. Such expenses include, but are not limited to, professional fees, travel and temporary help and specifically exclude imputed value of any CEO or CFO compensation expense except if that compensation expense is directly attributable to the subject programs.

 

Calendar Year

   Condition A: X equals    Condition B: Y equals

2006

   $ 0.50    $ 1,200,000

2007

   $ 0.70    $ 2,040,000

2008

   $ 0.98    $ 2,356,000

2009

   $ 1.37    $ 2,697,000

On December 18, 2006, the Compensation Committee awarded 300,000 non-qualified options to Mr. Massino. The options grant has a term of seven years and was priced at the Company’s share market price at the close of business on the grant date. The options grant vests ratably over 48 months from the grant date and are not subject to future performance conditions.

On December 18, 2006, the Compensation Committee awarded 156,250 restricted shares to Mr. Massino and 50,000 restricted shares to Mr. O’Kelly. 100% of the shares vest on the first anniversary of the grant date provided that the recipient has not terminated service via resignation or been terminated for cause. Vesting of the shares is not subject to any future performance conditions.

The Company does not plan to release material non public information for the purpose of affecting executive compensation and it does not plan or coordinate grants to existing or new executives around the release of material non public information.

 

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Executive Compensation Tables and Narrative Disclosure

Current Compensation

SUMMARY COMPENSATION TABLE

 

Name and Principal Position

   Year    Salary    Bonus    Stock
Awards(3)
   Option
Awards(3)
   All Other
Compensation(1)
   Total

Frank J. Massino

Chairman and Chief Executive Officer (PEO)

   2006    $ 340,000    $ 93,750    $ 3,604    $ 106,142    $ 42,577    $ 586,073

William F. O’Kelly (2)

Chief Financial Officer and Secretary (PFO)

   2006      142,500      25,000      1,157      16,144      9,152      193,953

(1) Detail of All Other Compensation

 

     401(k)
Employer
Match
   Life
Insurance
   Disability
Insurance
   Car
Allowance
   Total

Frank J. Massino

2006

   $ 4,000    $ 13,079    $ 13,498    $ 12,000    $ 42,577

William F. O’Kelly

2006

     4,652      —        —        4,500      9,152
(2) Mr. O’Kelly was appointed Chief Financial Officer and Secretary in April 2006.
(3) Stock and option compensation expense is computed in accordance with SFAS 123(R). See Note 10 of Notes to Consolidated Financial Statements for computation details.

GRANTS OF PLAN-BASED AWARDS

 

Name and Principal Position

   Grant Date    Number of Shares    Exercise
Price
   Grant
Date Fair
Value of
Stock and
Option
Awards
      Estimated
Future
Payouts
Under
Equity
Incentive
Plan
Awards
   All
Other
Stock
Awards
   All
Other
Option
Awards
     

Frank J. Massino

Chairman and Chief Executive Officer (PEO)

   June 6, 2006
December 18, 2006
December 18, 2006
   1,200,000
—  
—  
   —  
156,250
—  
   —  
—  
300,000
   $
$
$
0.26
0.20
0.20
   $
$
$
208,900
31,250
39,600

William F. O’Kelly

Chief Financial Officer and Secretary (PFO)

   June 6, 2006
December 18, 2006
   200,000
—  
   —  
50,000
   —  
—  
   $
$
0.26
0.20
   $
$
34,800
10,000

Effective January 1, 2006, Mr. Massino’s base salary was increased from $319,000 to $340,000. Effective January 1, 2007, Mr. Massino’s base salary was increased from $340,000 to $360,000. Effective January 1, 2007, Mr. O’Kelly’s base salary was increased from $190,000 to $215,000. The salary increases were in line with the recommendation from the independent compensation consultant.

The Compensation Committee awarded the base salary increases described in the preceding paragraph, the 2006 cash bonuses included in the “Summary Compensation Table” and the 2006 equity grants fully described in the preceding section entitled Material Terms of Grant Based Awards. The Compensation Committee engaged Mr. Jim Adams of Financial Concepts, an independent compensation consultant, to assist in the process. The

 

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consultant’s work included a benchmark of Senetek executive compensation against seven peer group public life science companies including IGI, Barrier Therapeutics, Photomedix, Antares Pharmaceutical, Bentley Pharmaceutical, Vivus and Palatin Technologies. Senetek’s 2006 Chief Executive Officer’s total compensation was 66% of the average of the peer group. Senetek’s 2006 Chief Financial Officer’s total compensation (annualized to allow for comparison) was 56% of the average of the peer group. The Compensation Committee concluded that 2006 total compensation for the Chief Executive Officer and the Chief Financial Officer was fair and adequate based on the consultant’s work.

Employment Agreements

The Company maintains employment agreements with key executives principally to define terms under which employment will cease and to provide explicit benefits if termination of employment occurs for certain reasons. These termination benefits are generally comparable to its benchmarked public companies and have been constructed to provide an orderly transition for the Company if a termination event were to occur.

Material Terms of Employment Agreements

The Company has an employment agreement dated November 1, 1998 with Mr. Massino, as amended effective June 30, 2000, October 31, 2002, January 1, 2003 and April 2006. The agreement and amendments provide for a perpetual three-year term and an annual salary of $340,000 per annum subject to discretionary increases by the Compensation Committee from time to time. Mr. Massino’s base salary was increased from $340,000 to $360,000 as of January 1, 2007. The contract also provides for an automobile allowance of $1,000 per month and reimbursement of related automobile operating expenses. Under the agreement, Mr. Massino is entitled to an annual bonus, to be determined by the Compensation Committee, and is eligible to participate in the Company’s management bonus plan, if any.

Under the terms of the employment agreement, in the event that Mr. Massino’s employment is terminated by the Company (other than for “permanent disability” or “cause”, as such terms are defined in the agreement) or by Mr. Massino for “good reason” (as defined in the agreement), Mr. Massino would become entitled to a lump sum payment equal to the product of multiplying his base salary (and a deemed bonus, if any, as determined in accordance with the agreement) by three (i.e., the number of years remaining under the “evergreen” provisions of his employment agreement). Further, in such circumstance, all unvested and/or unexercisable options held by Mr. Massino would become immediately vested and exercisable. The agreement also provides for payment upon consummation of certain changes of control (as defined below), provided that the Company would not be required, on a change of control, to pay Mr. Massino any amounts that would constitute an “excess parachute payment” under the Internal Revenue Code. For purposes of the employment agreement with Mr. Massino, a “change of control” would include, among other events set forth in that agreement, (i) a sale, lease or transfer of all or substantially all of its assets, (ii) the adoption by its shareholders of a plan relating to Senetek’s liquidation or dissolution, (iii) Senetek’s merger or consolidation, following which its shareholders immediately prior to such event hold less than 50% of the voting power of the surviving or resulting corporation, (iv) an acquisition by an individual or group of more than 50% of the Company’s voting securities, and (v) a change in the Board of Directors that results in less than a majority of the Board being comprised of directors that have served on the Board of Directors for at least 12 months or who were approved by a majority of the Board at the time of their election or appointment.

The Company has a payment agreement dated March 5, 2007 with Mr. O’Kelly that requires the Company to make certain severance payments to Mr. O’Kelly in the event his employment is terminated under certain circumstances. If: (A) following a Change of Control, the Company does not retain Mr. O’Kelly as Chief Financial Officer or he is not offered a position of Equivalent Authority by the Company or a Successor Enterprise or (B) Mr. O’Kelly does not continue his employment with the Company or a Successor Enterprise after a Relocation, then, in either such event, the Company will continue to pay him his base salary as at the date of the Change of Control or Relocation for a period of six months following his separation from the Company or the Successor Enterprise.

 

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The Compensation Committee believes the change in control provisions for the Chief Executive Officer and the Chief Financial Officer are appropriate because neither individual would likely be retained in the event of such a transaction and the provision of change in control benefits serves as an incentive in the best interest of shareholders if such a transaction is under consideration.

Current Equity Holdings and Realization on Equity Holdings

OUTSTANDING EQUITY AWARDS

 

    Option Awards   Stock Awards

Name and Principal Position

  Number of
Securities
Underlying
Unexercised
Options
Exercisable
  Number of
Securities
Underlying
Unexercised
Options
Unexercisable(1)
  Equity
Incentive Plan
Awards:
Number of
Securities
Underlying
Unexercised
Unearned
Options(2)
  Option
Exercise
Price
  Option
Expiration
Date
  Number of
Shares That
Have
Not Vested(3)
  December 31,
2006 Market
Value of
Shares
That Have
Not Vested

Frank J. Massino

  3,125   296,875   —     $ 0.20   12/17/13   156,250   $ 37,500

Chairman and Chief Executive Officer (PEO)

  300,000   —     900,000   $ 0.26   06/05/13   —       —  
  300,000   —     —     $ 0.55   12/16/09   —       —  
  600,000   —     —     $ 1.00   01/09/09   —       —  
  1,250,000   —     —     $ 1.41   11/13/07   —       —  

William F. O’Kelly

  50,000   —     150,000   $ 0.26   06/05/13   50,000   $ 12,000

Chief Financial Officer and Secretary (PFO)

             

(1) Vesting at 6,250 shares per month through December 17, 2010.
(2) Vesting in accordance with provisions described above in “Long-Term Incentive—Material Terms of Grant Based Awards”
(3) Vest on December 17, 2007

There were no options exercised or stock awards vested during 2006 for any named executives, therefore the “Option Exercises and Stock Vested” table has not been included.

Post Employment Compensation

Neither a “Pension Benefit Table” nor a “Non-Qualified Deferred Compensation Table” has been included as there were no applicable transactions in the reporting periods.

Potential Payments upon Termination or Change in Control

The Company currently has an employment agreement with Mr. Massino and a payment agreement with Mr. O’Kelly that include severance and change of control provisions. These provisions are fully described in the preceding section titled Material Terms of Employment Agreements. In the event Mr. Massino was to be terminated without cause or in the event of a change in control as described above, Mr. Massino would be entitled to a minimum lump sum payment of $340,000 (his current salary) plus a deemed bonus times three. In addition, all unvested stock options and restricted stock would immediately vest. In the event Mr. O’Kelly was to be terminated as a result of a change in control or relocation as described above, Mr. O’Kelly would be entitled to a lump sum payment of $107,500. No severance or change of control payments have been made or are currently due with respect to these agreements. There are no other employment agreements in place and no claims existed at December 31, 2006 with respect to employment agreements with past employees.

 

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The Company made severance payments to one former employee, Mr. Wade Nichols, its former Executive Vice President of Corporate Development and General Counsel, during the year ended December 31, 2005 in the amount of $108,250 representing post termination salary continuation for five months plus $7,000 in relocation expenses. In exchange for the above, all obligations under Mr. Nichols’ employment agreement were canceled and Mr. Nichols surrendered his claim for an option to purchase 150,000 shares. Mr. Nichols was also paid hourly based consulting fees of $104,000 and $32,000 in 2006 and 2005, respectively, for legal services.

Director Compensation Tables and Narrative Disclosure

DIRECTOR COMPENSATION TABLE

 

Name (1)

   Fees Earned or
Paid in Cash
   Option
Awards(2)
(3)
   Total

Anthony Williams

   $ 10,000    $ 16,144    $ 26,144

Kerry Dukes

   $ 6,400    $ 8,073    $ 14,473

Rodger Bogardus

   $ 6,400    $ 8,073    $ 14,473

(1) Mr. Massino is Chairman of the Board. His compensation is discussed elsewhere in the Compensation Discussion & Analysis. Mr. Williams was a Director for all of 2006. Mr. Dukes and Mr. Bogardus became Directors on May 11, 2006.
(2) Stock option compensation expense is computed in accordance with SFAS 123(R). See Note 10 of Notes to the Consolidated Financial Statements for computation details. Grant date fair value of option awards during 2006 were as follows: Mr. Williams, $34,800; Mr. Dukes, $17,400; Mr. Bogardus, $17,400.
(3) Mr. Williams holds an aggregate total of 450,000 stock options at December 31, 2006. Mr. Dukes and Mr. Bogardus each hold an aggregate total of 100,000 stock options at December 31, 2006.

Non-employee Directors receive a $2,500 quarterly cash stipend. New non-employee Directors historically have been granted an option to purchase up to 150,000 shares upon joining the Board. There is no established policy requiring such a grant. Subsequent equity grants in the form of stock options, restricted stock or a combination of stock options and restricted stock typically take place annually and are based on each Directors responsibility, experience, performance and ability to influence the Company’s long-term growth and profitability.

Compensation Committee

Compensation Committee Practices and Procedures

The Compensation Committee of the Board of Directors, comprised solely of independent Directors, has the responsibility and authority to establish the compensation program for the Company’s Executive Officers. The Compensation Committee is comprised of Mr. Kerry Dukes (Chairman) and Mr. Rodger Bogardus. The Compensation Committee has the responsibility and authority to establish the compensation program for the Company’s Executive Officers. To assist in performing its duties and to enhance its objectivity and independence, the committee obtains advice from an outside compensation consultant.

In addition, the committee may also request independent compensation survey data and proxy information from companies similar in nature and size for comparative purposes. The Company’s executives may advise the committee but play no role in compensation decisions. The committee reserves the right to also consider other unique factors in setting compensation levels and to adjust or recover for awards of payments if the Company adjusts or restates performance measures in a manner that would reduce the size of an award or payment.

 

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Compensation Committee Interlocks

No current or past member of the Compensation Committee at any time was a current or former officer or employee of Senetek or any of its subsidiaries. No executive officer of Senetek served as a director or member of the Compensation Committee of another entity, one of whose executive officers served as a Director or as a member of the Company’s Compensation Committee. Baker & McKenzie LLP, a law firm of which Mr. Williams, a former member of the Compensation Committee and a current Director, was a partner, performed legal services for Senetek during 2006 and received legal fees. See Item 13, “Certain Relationship and Related Transactions”.

COMPENSATION COMMITTEE REPORT

The Compensation Committee reviewed the preceding Compensation Discussion and Analysis and has discussed its contents with management.

Based on the review and discussions, the Compensation Committee has recommended to the Board of Directors that the Compensation Discussion and Analysis be included, where required, in reports to the Securities and Exchange Commission under the Securities Exchange Act of 1934.

 

Date: March 27, 2007
/s/    K. J. DUKES        
Kerry Dukes, Chairman, Compensation Committee
/s/    R. E. BOGARDUS        

Rodger Bogardus, Member, Compensation Committee

ITEM 12—SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

The following table sets forth certain information regarding the beneficial ownership of Senetek’s outstanding ordinary shares as of March 27, 2007 by (i) each of Senetek’s Directors who is also a stockholder; (ii) its Chief Executive Officer; (iii) its other executive officers currently in office; and (iv) all executive officers and Directors of Senetek as a group. There are no persons believed by Senetek to own beneficially more than 5% of the Company’s outstanding ordinary Shares. The holders listed below have sole voting power and investment power over the shares beneficially held by them. The address of each of its Directors and executive officers is that of Senetek.

 

Name of Beneficial Owner

   Number of
Shares
Beneficially
Owned(1)
    Percentage
of Class(1)
 

Frank J. Massino

   2,728,651 (2)   4.3 %

William F. O’Kelly

   65,000 (2)   *  

Anthony Williams

   551,182 (2)   *  

Kerry Dukes

   30,000 (2)   *  

Rodger Bogardus

   75,000 (2)   *  
            

All Directors and Executive Officers as a group

   3,449,833     5.4 %

* Less than one percent
(1)

For purposes of this table, a person or a group of persons is deemed to have “beneficial ownership” as of a given date of any shares which that person has the right to acquire within 60 days after that date. For

 

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purposes of computing the percentage of outstanding shares held by each person or group of persons named above on a given date, any shares which that person or persons has the right to acquire within 60 days after that date are deemed to be outstanding, but are not deemed to be outstanding for the purpose of computing the percentage ownership of any other person.

(2) Includes the following number of shares issuable upon exercise of options or warrants that currently are exercisable or will become exercisable within 60 days of March 2007: Mr. Massino: 2,453,000; Mr. O Kelly: 50,000; Mr. Williams 300,000; Mr. Dukes: 25,000; and Mr. Bogardus: 25,000

ITEM 13—CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS

Anthony Williams, a Director of the Company, has been a partner of the law firm of Baker & McKenzie LLP since September 2005 and prior to that was a partner of the law firm of Coudert Brothers LLP. Both law firms have rendered legal services to the Company. Legal fees paid to Baker & McKenzie LLP and Coudert Brothers LLP in 2006, 2005 and 2004 aggregated $232,000, $518,000 and $530,000, respectively.

The Company is required to pay the two discoverers of Kinetin an equal royalty based on the Company revenues from Kinetin. One of the discoverers of Kinetin, Dr. Brian Clark, is the Chief Scientist for the Company. Total royalty expense related to Kinetin sales for 2006, 2005 and 2004 were $158,000, $107,000 and $104,000, respectively, of which Dr. Clark received 50%. For his role as Chief Scientist, Dr. Clark is paid an annual consulting fee of $108,000.

ITEM 14—PRINCIPAL ACCOUNTANT FEES AND SERVICES

The Board of Directors appointed Macias Gini & O’Connell LLP (“Macias Gini”) as independent accountants to examine the Company’s consolidated financial statements for the year ended December 31, 2006 and to render other professional services as required and appointed BDO Stoy Hayward (“BDO Stoy”) as its independent accountants to examine the Company’s English accounts and reports.

Aggregate fees billed by the Company’s principal accountants, Macias Gini & O’Connell LLP for 2006 and 2005, for audit services related to the most recent two years, and for other professional services billed in the most recent two fiscal years, were as follows:

 

MACIAS GINI & O’CONNELL—Principal Accountants in the United States:

         

Type of Service

   2006    2005

Audit Fees (1)

   $ 149,000    $ 118,000

Other Audit-Related Fees (2)

     —        —  

Tax Fees (3)

     —        —  

All Other Fees (4)

     —        —  
             

Total

   $ 149,000    $ 118,000
             

(1) Audit Fees: This category consists of fees for professional services rendered by Macias Gini for audits of the Company’s annual financial statements, review of the financial statements included in its quarterly reports on Form 10-Q and services that are normally provided by the independent auditors in connection with statutory and regulatory filings or engagements for those fiscal years. This category also includes advice on audit and accounting matters that arose during, or as a result of, the audit or the review of interim financial statements and statutory audits required by non-U.S. jurisdictions.
(2) Other Audit-Related Fees: None
(3) Tax Fees: None
(4) All Other Fees: None

 

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Aggregate fees billed by the Company’s principal accountants in the United Kingdom, BDO Stoy for 2006 and 2005, for audit services related to the most recent two years, and for other professional services billed in the most recent two fiscal years, were as follows:

 

BDO STOY HAYWARD LLP—Principal Accountants in the United Kingdom:

         

Type of Service

   2006    2005

Audit Fees (1)

   $ 64,000    $ 85,000

Other Audit-Related Fees (2)

     —        —  

Tax Fees (3)

     35,000      32,000

All Other Fees (4)

     —        —  
             

Total

   $ 99,000    $ 117,000
             
(1) Audit Fees: This category consists of fees for professional services rendered by BDO Stoy for audits of the Company’s annual financial statements and services that are normally provided by the independent auditors in connection with statutory and regulatory filings or engagements for those fiscal years. This category also includes advice on audit and accounting matters that arose during, or as a result of, the audit and statutory audits required by United Kingdom jurisdictions.
(2) Other Audit-Related Fees: None
(3) Tax Fees: This category consists of fees for professional services rendered by BDO Stoy for United Kingdom tax compliance including tax return preparation, technical tax advice and tax planning.
(4) All Other Fees: None

The Audit Committee established a policy governing the Company’s use of the Company’s auditors for non-audit services. Under the policy, management may use non-audit services of the auditors that are permitted under SEC rules and regulations, provided that management obtains the Audit Committee’s approval before such services are rendered. In 2006, all fees identified above under the captions “Audit Fees”, “Other Audit-Related Fees”, “Tax Fees” and “All Other Fees” were approved by the Audit Committee or the full Board when the Board lacked sufficient non-management Directors to constitute an Audit Committee. The Audit Committee determined that the rendering of other professional services for audit related matters, tax compliance and tax advice was compatible with these firms maintaining their independence. In 2006, no hours were expended on the principal accountant’s engagement to audit the financial statements that were attributable to work performed by persons other than the principal accountant’s full-time, permanent employees.

 

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PART IV

ITEM 15—EXHIBITS and FINANCIAL STATEMENT SCHEDULES

(a)(1) The following consolidated financial statements are included in Item 8:

 

Report of Independent Registered Public Accounting Firms:

  

Macias Gini & O’Connell LLP

   61

BDO Seidman, LLP

   62

Consolidated Balance Sheets as of December 31, 2006 and 2005

   63

Consolidated Statements of Operations for the years ended December 31, 2006, 2005 and 2004

   64

Consolidated Statements of Stockholders’ Deficit and Comprehensive Income (Loss) for the years ended December 31, 2006, 2005 and 2004

   65

Consolidated Statements of Cash Flows for the years ended December 31, 2006, 2005 and 2004

   66

Notes to the Consolidated Financial Statements

   67

Schedule II—Valuation and Qualifying Accounts

   89

(a)(2) The following financial statement schedules are submitted herewith:

Schedule II is included in Item 8.

(a)(3) The following Exhibits are filed or incorporated by reference as part of this Report on Form 10-K:

 

    3.1  

  

Certificate of Incorporation of Senetek PLC.

  

Filed as an Exhibit with corresponding Exhibit Number to Registrant’s Registration Statement on Form F-1, Registration No. 33-3535, and incorporated herein by reference.

    3.2  

  

Memorandum and Articles of Association of Senetek PLC (defining the rights of security holders, subject to the provisions of the United Kingdom Companies Act 1985).

  

Filed as an Exhibit with corresponding Exhibit Number to Registrant’s Registration Statement on Form F-1, Registration No. 33-3535, and incorporated herein by reference.

  10.1  

  

Senetek No. 1 Share Option Scheme for Employees.

  

Filed as an Exhibit to Registrant’s Report on Form S-8 on October 8, 1993, Registration No. 33-70136, and incorporated herein by reference.

  10.2  

  

Asset Purchase Agreement dated as of July 31, 1995, between Carme International, Inc. a wholly owned subsidiary of Senetek PLC and Carme Inc.

  

Filed as an Exhibit on Form 8-K, dated October 10, 1995 (as amended), and incorporated herein by reference.

+10.3  

  

Senetek No. 2 Executive Share Option Scheme for Non-Executive Directors and Consultants.

  

Filed as an Exhibit to Registrant’s Registration Statement on Form S-8 on October 8, 1993, Registration No. 33-70136, and incorporated herein by reference.

  10.4  

  

Deposit Agreement dated October 3, 2005 between Senetek PLC and The Bank of New York, and incorporated herein by reference.

+10.14

  

Service Agreement dated December 30, 1998 between Senetek PLC and Mr. F. J. Massino.

  

Filed as an exhibit to Registrant’s Annual Report on Form 10-K for the year ended December 31, 1998 and incorporated herein by reference.

 

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10.16

  

Securities Purchase Agreement dated April 13, 1999 by and among Senetek PLC and certain other parties thereto.

  

Filed as an exhibit to Registrant’s Annual Report on Form 10-K for the year ended December 31, 1998 and incorporated herein by reference.

10.17

  

Securities Purchase Agreement (“Securities Purchase Agreement”) dated April 14, 1999 between Senetek PLC and the various purchasers designated in the agreement.

 

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 1999 and incorporated herein by reference.

10.18

  

Form of Senior Secured Note due April 14, 2002 issued by Senetek PLC pursuant to the Securities Purchase Agreement.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 1999 and incorporated herein by reference.

10.19

  

Form of Series A Warrant issued by Senetek pursuant to the Securities Purchase Agreement.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 1999 and incorporated herein by reference.

10.20

  

Form of Series B Warrant issued by Senetek pursuant to the Securities Purchase Agreement.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 1999 and incorporated herein by reference.

10.21

  

Form of Series C Warrant issued by Senetek pursuant to the Securities Purchase Agreement.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 1999 and incorporated herein by reference.

10.22

  

Registration Rights Agreement dated as of April 14, 1999 among Senetek PLC and the parties designated therein.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 1999 and incorporated herein by reference.

10.23

  

Security Agreement dated as of April 14, 1999 by and between Senetek PLC and the parties designated therein.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 1999 and incorporated herein by reference.

10.24

  

Pledge Agreement dated as of April 14, 1999 by and between Senetek PLC and the parties designated therein.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 1999 and incorporated herein by reference.

10.25

  

Pledge Agreement dated April 14, 1999 by and between Senetek Drug Delivery Technologies Inc. and the parties designated therein.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 1999 and incorporated herein by reference.

10.26

  

Guaranty dated as of April 14,1999 executed by Senetek Drug Delivery Technologies Inc. and Carme Cosmeceutical Sciences Inc.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 1999 and incorporated herein by reference.

10.27

  

Patent and Security Agreement dated as of April 14, 1999 between Senetek PLC and the parties designated therein.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 1999 and incorporated herein by reference.

 

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10.28

  

Fixed and Floating Security Document dated April 14, 1999 executed by Senetek PLC in favor of the Collateral Agent named therein.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 1999 and incorporated herein by reference.

10.30

  

Settlement Agreement dated April 13, 1999 among Senetek PLC and the parties named therein.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 1999 and incorporated herein by reference.

10.31

  

Form of Amended Series A Warrant issued by Senetek pursuant to the Securities Purchase Agreement.

  

Filed as an exhibit to Amendment No. 1 of Registrant’s Registration Statement on Form S-3, Registration No. 333-37782, filed on January 23, 2001 and incorporated herein by reference.

10.32

  

Form of Amended B Warrant issued by Senetek pursuant to the Securities Purchase Agreement.

  

Filed as an exhibit to Amendment No. 1 of Registrant’s Registration Statement on Form S-3, Registration No. 333-37782, filed on January 23, 2001 and incorporated herein by reference.

10.33

  

Form of Amended C Warrant issued by Senetek pursuant to the Securities Purchase Agreement.

  

Filed as an exhibit to Amendment No. 1 of Registrant’s Registration Statement on Form S-3, Registration No. 333-37782, filed on January 23, 2001 and incorporated herein by reference.

10.34

  

First Amendment to the Securities Purchase Agreement dated as of June 20, 2001 by and among Senetek PLC and the various purchasers designated in the agreement.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 2001 and incorporated herein by reference.

10.35

  

Form of Amended and Restated Senior Secured Note due April 14, 2004 issued by Senetek PLC pursuant to the First Amendment to the Securities Purchase Agreement.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 2001 and incorporated herein by reference.

10.36

  

Form of Amended and Restated Series A Warrant, issued by Senetek PLC pursuant to the First Amendment to the Securities Purchase Agreement.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 2001 and incorporated herein by reference.

10.37

  

Form of Amended and Restated Series B Warrant, issued by Senetek PLC pursuant to the First Amendment to the Securities Purchase Agreement.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 2001 and incorporated herein by reference.

10.38

  

Form of Amended and Restated Series C Warrant, issued by Senetek PLC pursuant to the First Amendment to the Securities Purchase Agreement.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 2001 and incorporated herein by reference.

 

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10.39

  

Amended and Restated Registration Rights Agreement dated as of June 20, 2001 among Senetek PLC and the parties designated therein.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 2001 and incorporated herein by reference.

10.40

  

First Amendment to the Security Agreement dated as of June 20, 2001 by and between Senetek PLC and the parties designated therein.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 2001 and incorporated herein by reference.

10.41

  

First Amendment to the Pledge Agreement dated as of June 20, 2001 by and between Senetek PLC and the parties designated therein.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 2001 and incorporated herein by reference.

10.42

  

First Amendment to the Pledge Agreement dated as of June 20, 2001 by and between Senetek Drug Delivery Technologies, Inc. and the parties designated therein.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the quarter ended June 30, 2001 and incorporated herein by reference.

10.43

  

First Amendment to the Guaranty dated as of June 20, 2001 executed by Senetek Drug Delivery Technologies, Inc. and Carme Cosmeceutical Sciences, Inc.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the Quarter ended June 30, 2001 and incorporated herein by reference.

10.44

  

First Amendment to the Patent and Trademark Security Agreement dated as of June 20, 2001 by and between Senetek PLC and the parties designated therein.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the Quarter ended June 30, 2001 and incorporated herein by reference.

10.45

  

Investment Advice Agreement dated as of June 20, 2001 by and between Senetek PLC and Scorpion Investments, Inc.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the Quarter ended June 30, 2001 and incorporated herein by reference.

10.46

  

Revolving Credit Agreement dated as of June 20, 2001 by and between Senetek PLC and Wallington Investments, Ltd.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the Quarter ended June 30, 2001 and incorporated herein by reference.

10.47

  

Form of Revolving Note, issued by Senetek PLC pursuant to the Revolving Credit.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the Quarter ended June 30, 2001 and incorporated herein by reference.

10.48

  

Distribution Agreement dated as of October 15, 1998, by and between Carme Cosmeceutical Sciences, Inc. and ICN Pharmaceuticals.

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the fiscal year ended December 31, 2001 and incorporated herein by reference.

10.49

  

License and Supply Agreement dated as of May 26, 2000 by and between Senetek PLC and Buth-Na-Bodhaige, Inc.

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the fiscal year ended December 31, 2001 and incorporated herein by reference.

 

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  10.50

  

License Agreement dated as of June 8, 2000 between Senetek PLC and Revlon Consumer Products Corporation.

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the fiscal year ended December 31, 2001 and incorporated herein by reference.

  10.51

  

Production and Marketing Agreement dated as of August 15, 2000 between Senetek PLC and Signet Laboratories, Inc.

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the fiscal year ended December 31, 2001 and incorporated herein by reference.

  10.52

  

Warrant to Purchase 1,000,000 Ordinary Shares of Senetek PLC issued June 8, 2000 to Revlon Consumer Products Corporation.

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the fiscal year ended December 31, 2001 and incorporated herein by reference.

  10.53

  

Amendment to Agreement dated as of November 30, 2000 by and between Senetek PLC and Buth-Na-Bodhaige.

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the Fiscal Year ended December 31, 2001 and incorporated herein by reference.

  10.54

  

First Amendment to License Agreement dated June 8, 2000 by and between Senetek PLC and Revlon Consumer Products Corporation.

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the Fiscal Year ended December 31, 2001 and incorporated herein by reference.

*10.55

  

Development and Distribution Agreement dated November 12, 2002 by and between Senetek PLC and Douglas Pharmaceuticals Limited.

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the Fiscal Year ended December 31, 2002 and incorporated herein by reference.

*10.56

  

License Agreement dated March 12, 2002 by and between Senetek PLC and Enprani Co., Ltd.

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the Fiscal Year ended December 31, 2002 and incorporated herein by reference.

*10.57

  

License and Supply Agreement dated November 12, 2002 by and between Senetek PLC and Shaklee Corporation.

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the Fiscal Year ended December 31, 2002 and incorporated herein by reference.

*10.58

  

License Agreement dated September 30, 2002 by and between Senetek and Vivier Pharma Inc.

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the Fiscal Year ended December 31, 2002 and incorporated herein by reference.

*10.59

  

License Agreement dated January 1, 2003 by and between Senetek PLC and Panion & BF Biotech, Inc.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended March 31, 2003 and incorporated herein by reference.

+10.60

  

Employment contract dated March 3, 2003 between the Company and Bradley D. Holsworth.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended March 31, 2003 and incorporated herein by reference.

 

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*10.61

  

License Agreement dated March 21, 2003 by and between Senetek PLC and Lavipharm S.A.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended March 31, 2003 and incorporated herein by reference.

+10.62

  

Employment contract dated April 1, 2003 between the Company and Wade Nichols.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended June 30, 2003 and incorporated herein by reference.

  10.63

  

Research Collaboration Agreement dated June 10, 2003 by and between Senetek PLC and Beiersdorf A.G.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended June 30, 2003 and incorporated herein by reference.

*10.64

  

Cooperative Research and Development Agreement dated June 11, 2003 by and between Senetek PLC and Institute of Experimental Botany, Academy of Sciences, Czech Republic.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended June 30, 2003 and incorporated herein by reference.

  10.65

  

Second Amendment to the Securities Purchase Agreement dated September 4, 2003 by and between Senetek PLC and various purchasers designated in the Agreement.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended September 30, 2003 and incorporated herein by reference.

  10.66

  

Amendment No. 1 to the Amended and Restated Registration Rights Agreement dated September 4, 2003.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended September 30, 2003 and incorporated herein by reference.

  10.67

  

Form of Second Amended and Restated Senior Secured Notes Due April 1, 2007 dated September 4, 2003.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended September 30, 2003 and incorporated herein by reference.

  10.68

  

Form of Series D Warrant issued by Senetek PLC pursuant to the Second Amendment to the Securities Purchase Agreement dated September 4, 2003.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended September 30, 2003 and incorporated herein by reference.

*10.69

  

License Agreement dated August 1, 2003 between ICN Pharmaceuticals, Inc. and Senetek PLC.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended September 30, 2003 and incorporated herein by reference.

*10.70

  

Amendment #1 dated December 1, 2003 to the license agreement dated August 1, 2003 between Valeant Pharmaceuticals (formerly ICN Pharmaceuticals) and Senetek PLC.

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the period ended December 31, 2003 and incorporated herein by reference.

  10.71

  

Amended License Agreement dated February 1, 2004 by and between Senetek PLC and Panion & BF Biotech, Inc.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended September 30, 2003 and incorporated herein by reference.

 

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  10.72  

  

Deferred Compensation Plan for Company Executives effective January 1, 2004.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended March 31, 2004 and incorporated herein by reference.

+10.73  

  

Deferred Compensation Plan for Directors effective January 1, 2004.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended March 31, 2004 and incorporated herein by reference.

*10.74  

  

Settlement agreement between OMP, Inc. and Senetek PLC dated March 26, 2004.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended March 31, 2004 and incorporated herein by reference.

+10.75  

  

Consulting Agreement with Stewart Slade May 1, 2004, and incorporated herein by reference.

  10.76  

  

Agreement with Valeant Pharmaceuticals International for Zeatin dated May 4, 2004.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended June 30, 2004 and incorporated herein by reference.

*10.77  

  

Amended License Agreement with Valeant Pharmaceuticals International for Kinetin dated May 4, 2004.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended June 30, 2004 and incorporated herein by reference.

  10.78  

  

Consulting Agreement with Andreas Tobler dated June 1, 2004.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended June 30, 2004 and incorporated herein by reference.

  10.79  

  

License Agreement with Ardana Bioscience Limited dated June 17, 2004.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended June 30, 2004 and incorporated herein by reference.

*10.80  

  

Amendment to the License Agreement with Research Foundation for Mental Hygiene, Inc dated May 10, 2004.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended June 30, 2004 and incorporated herein by reference.

  10.81  

  

Agreement with Tri-Artisan Partners LLC dated May 4, 2004.

  

Filed as an exhibit to Registrant’s Report on Form 10-Q for the period ended September 30, 2004 and incorporated herein by reference.

  10.82  

  

Third Amended and Restated Employment Agreement between Senetek PLC and Frank J. Massino dated as of January 1, 2003, and incorporated herein by reference.

  10.83  

  

Second Amendment to License Agreement between Senetek PLC and Revlon Consumer Products Corporation dated as of July 1, 2004, and incorporated herein by reference.

  10.84  

  

Settlement Agreement between Senetek PLC and Eagle-Picher dated September 28, 2004.

  

Filed as an exhibit to Registrant’s report on Form 10-K for the fiscal year-ended December 31, 2004 and incorporated herein by reference.

  10.85  

  

3rd Amendment to the Securities Purchase Agreement dated as of September 30, 2004 by and between the Company and the holders of the Company’s Senior Secured Notes, Series A Warrants and Series B Warrants.

  

Filed as an exhibit to Registrant’s Report on Form 8-K filed October 5, 2004 and incorporated herein by reference.

 

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*10.86  

  

Letter Agreement dated September 30, 2004 by and between the Company and the holders of the Company’s Series D Warrants.

  

Filed as an exhibit to Registrant’s Report on Form 8-K filed October 5, 2004 and incorporated herein by reference.

*10.87  

  

Amendment to License Agreement between Senetek PLC and Valeant Pharmaceuticals International dated as of October 31, 2004, and incorporated herein by reference.

  10.88  

  

Forbearance Agreement between U.S. International Trading Corporation and Senetek PLC dated November 8, 2004.

  

Filed as an exhibit to Registrant’s report on Form 10-K for the fiscal year-ended December 31, 2004 and incorporated herein by reference.

*10.89  

  

License Agreement between the Company and Ferrosan A/S dated December 8, 2004.

  

Filed as an exhibit to Registrant’s report on Form 10-K for the fiscal year-ended December 31, 2004 and incorporated herein by reference.

*10.90  

  

Amended and restated agreement between Senetek PLC and Signet Laboratories dated as of January 1, 2005, and incorporated herein by reference.

+10.91  

  

Severance agreement between the Company and Wade H. Nichols dated as of March 23, 2005, and incorporated herein by reference.

+10.92  

  

Consulting agreement between the Company and Wade H. Nichols dated as of April 1, 2005, and incorporated herein by reference.

*10.93  

  

License Agreement between Senetek and pH Advantage, LLC dated as of April 30, 2005, and incorporated herein by reference.

*10.94  

  

Amendment to License Agreement between Senetek PLC and Valeant Pharmaceuticals International dated as of July 15, 2005, and incorporated herein by reference.

*10.95  

  

License Agreement between Senetek PLC and Ofra Cosmetics dated as of September 15, 2005, and incorporated herein by reference.

  10.96  

  

Second Amendment to Agreement on Cooperative Research and Development between Senetek PLC and Institute of Experimental Botany dated as of November 10, 2005, and incorporated herein by reference.

*10.97  

  

License Agreement between Senetek PLC and Plethora Solutions Limited dated as of February 16, 2006, and incorporated herein by reference.

  10.98  

  

Agreement on Cooperative Research and Development between Senetek PLC, and Dr. Efstathios S. Gonos and Dr. Ioanna Chinou dated as of March 6, 2006, and incorporated herein by reference.

*10.99  

  

Asset Sale and Purchase Agreement between Senetek PLC and Ranbaxy Pharmaceuticals Inc. dated as of March 15, 2006, and incorporated herein by reference.

  10.100

  

Prepayment Agreement between Senetek PLC and the Holders of Senetek’s Senior Secured Notes and Warrants dated as of March 30, 2006, and incorporated herein by reference.

  10.101

  

Series E Warrant dated March 31, 2006 issued to Wallington Investment Holdings Ltd., and incorporated herein by reference.

  10.102

  

Series E Warrant dated March 31, 2006 issued to Alba Limited, and incorporated herein by reference.

  10.103

  

Resignation and Indemnity Consulting Agreement between Senetek PLC and Rani Aliahmad dated as of March 31, 2006, and incorporated herein by reference.

  10.104

  

Resignation and Indemnity Agreement Consulting Agreement between Senetek PLC and Michael Khoury dated as of March 31, 2006, and incorporated herein by reference.

 

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  10.105

  

Loan and Security Agreement between Senetek PLC and Silicon Valley Bank dated as of March 30, 2006, and incorporated herein by reference.

  10.106

  

Intellectual Property Security Agreement between Senetek PLC and Silicon Valley Bank dated as of March 30, 2006, and incorporated herein by reference.

  10.107

  

Securities Account Control Agreement between Senetek PLC, U.S. Bank, N.A., SVB Asset Management and Silicon Valley Bank dated as of March 30, 2006, and incorporated herein by reference.

  10.108

  

Amendment dated as of May 19, 2006 among Signet Laboratories, Inc., Senetek PLC, Research Foundation for Mental Hygiene and Covance Antibody Services, Inc.

  10.109

  

Contract for Personal Services between Senetek PLC and Brian Clark dated August 1, 2006.

*10.110

  

Agreement on Cooperative Research and Development dated October 17, 2006 between Senetek PLC and Institute of Bioorganic Chemistry, Polish Academy of Sciences—Phloretamide.

*10.111

  

Agreement on Cooperative Research and Development dated October 17, 2006 between Senetek PLC and Institute of Bioorganic Chemistry, Polish Academy of Sciences—Plant Nucleic Acids.

*10.112

  

Agreement on Cooperative Research and Development dated October 17, 2006 between Senetek PLC and Institute of Bioorganic Chemistry, Polish Academy of Sciences—Brain Tumor treatment with Interference RNA.

*10.113

  

Agreement on Cooperative Research and Development dated October 17, 2006 between Senetek PLC and Institute of Bioorganic Chemistry, Polish Academy of Sciences—Furfurylcytosine.

+10.114

  

Payments in the Event of Certain Changes Agreement between Senetek PLC and William F. O’Kelly dated March 5, 2007.

  10.115

  

License and Intellectual Property Acquisition Agreement dated March 30, 2007 between Senetek PLC and Valeant Pharmaceuticals North America.

  21       

  

Subsidiaries of Senetek PLC.

  

Filed as an exhibit to Registrant’s Report on Form 10-K for the Fiscal Year ended December 31, 2001 and incorporated herein by reference.

  23.1    

  

Consent of Independent Registered Public Accounting Firm, Macias Gini & O’Connell LLP.

  23.2    

  

Consent of Independent Registered Public Accounting Firm, BDO Seidman, LLP.

  24       

  

Power of Attorney Included on the signature page to this Annual Report on Form 10-K.

  31.1    

  

Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

  31.2    

  

Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

  32       

  

Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

* Confidential treatment has been requested as to certain portions of those exhibits.
+ Agreements related to Management Contracts or Compensation Plans.

 

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SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, in the city of Napa, State of California, on this April 9, 2007.

 

SENETEK PLC
By:   /s/    F. J. MASSINO        
  Frank J. Massino
 

Chairman of the Board and

Chief Executive Officer

POWER OF ATTORNEY TO SIGN AMENDMENTS

KNOW ALL MEN BY THESE PRESENTS, that each person whose signature appears below does hereby constitute and appoint Frank J. Massino and William F. O’Kelly, and each of them, with full power of substitution and full power to act without the other, his true and lawful attorney-in-fact and agent to act for him in his name, place and stead, in any and all capacities to sign any or all amendments to this Annual Report on Form 10-K, and to file the same, with all exhibits hereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to all intents and purposes, as they or he might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or any of them, may lawfully do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed by the following persons in the capacities and on the dates indicated.

 

Signature

  

Title

 

Date

/s/    F. J. MASSINO        

Frank J. Massino

  

Chairman of the Board and Chief Executive Officer (Principal Executive Officer)

  April 9, 2007

/s/    W. F. O’KELLY        

William F. O’Kelly

  

Chief Financial Officer (Chief Accounting Officer)

  April 9, 2007

/s/    A. WILLIAMS        

Anthony Williams

  

Vice Chairman of the Board, Director

  April 9, 2007

 

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To Board of Directors and

Stockholders of Senetek PLC

Napa, California

We have audited the accompanying consolidated balance sheets of Senetek PLC and its subsidiaries (the Company) as of December 31, 2006 and 2005 and the related consolidated statements of operations, stockholders’ deficit and comprehensive income (loss) and cash flows for each of the two years in the period ended December 31, 2006. We have also audited the accompanying financial statement schedule. These financial statements and the schedule are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements and schedule based on our audits.

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

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Senetek PLC and its subsidiaries at December 31, 2006 and 2005 and the results of their operations and their cash flows for each of the two years in the period ended December 31, 2006 in conformity with accounting principles generally accepted in the United States of America. Also, in our opinion, the related schedule presents fairly, in all material respects, the information set forth therein.

 

/s/    MACIAS GINI & O’CONNELL LLP        
Macias Gini & O’Connell LLP

Sacramento, California

April 9, 2007

 

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To Board of Directors and

Stockholders of Senetek PLC

Napa, California

We have audited the accompanying consolidated statements of operations, stockholders’ deficit and comprehensive income (loss) and cash flows of Senetek PLC and subsidiaries for the year ended December 31, 2004. We have also audited the schedule listed in the accompanying index for 2004. These financial statements and the schedule are the responsibility of Senetek PLC’s management. Our responsibility is to express an opinion on these consolidated financial statements and the schedule based on our audit.

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

In our opinion the consolidated financial statements referred to above present fairly, in all material respects, the results of operations and cash flows of Senetek PLC and subsidiaries for the year ended December 31, 2004 in conformity with accounting principles generally accepted in the United States of America.

Also, in our opinion, the schedule presents fairly, in all material respects, the information set forth therein for 2004.

 

/s/    BDO SEIDMAN, LLP        
BDO Seidman, LLP

San Francisco, California

March 7, 2005, except for Note 15D,

which is as of March 24, 2005

 

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SENETEK PLC

CONSOLIDATED BALANCE SHEETS

($ in thousands, except share and per share amounts)

 

     December 31  
     2006     2005  

ASSETS

    

Current Assets

    

Cash and Cash Equivalents

   $ 3,368     $ 1,553  

Short Term Investments (Note 6)

     —         1,634  

Trade Receivables (net of allowance for doubtful accounts of $150 in 2006 and $120 in 2005) (Note 13)

     1,831       1,207  

Non-trade Receivables (net of provision $0 in 2006 and 2005)

     18       22  

Inventory (net of provision of $0 in 2006 and $429 in 2005) (Note 4)

     32       109  

Prepaids and Deposits

     141       189  
                

Total Current Assets

     5,390       4,714  

Property and Equipment—net (Note 5)

     210       242  

Intangibles

     7       18  

Asset Held for Sale (Note 5)

     —         250  

Goodwill (Note 2g)

     1,308       1,308  
                

Total Assets

   $ 6,915     $ 6,532  
                

LIABILITIES AND STOCKHOLDERS’ DEFICIT

    

Current Liabilities

    

Accounts Payable (Note 16)

   $ 859     $ 466  

Accrued Liabilities (Note 7)

     672       1,255  

Deferred Revenue and License Fees (Note 2d)

     797       797  

Line of Credit—Current

     1,500       —    

Notes Payable—Current (net of discount of $1,103 in 2005) (Note 8)

     —         2,186  
                

Total Current Liabilities

     3,828       4,704  
                

Long Term Liabilities

    

Other Long Term Liabilities (Note 15)

     —         8  

Deferred License Fees (Note 2d)

     4,058       4,855  
                

Commitments, Contingencies and Subsequent Events (Notes 15 and 18)

     —         —    

Stockholders’ Deficit (Notes 9, 10 and 11)

    

Ordinary Shares (Note 15)

    

Authorized shares: $0.10 (5 pence) par value: 100,000,000; Issued and Outstanding shares 2006 and 2005: 60,960,624

     4,919       4,919  

Share Premium

     84,920       84,749  

Accumulated Deficit

     (90,842 )     (92,725 )

Accumulated Other Comprehensive Income—Currency Translation

     32       22  
                

Total Stockholders’ Deficit

     (971 )     (3,035 )
                

Total Liabilities and Stockholders’ Deficit

   $ 6,915     $ 6,532  
                

See accompanying notes to consolidated financial statements.

 

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SENETEK PLC

CONSOLIDATED STATEMENTS OF OPERATIONS

 

     Year Ended December 31  
     2006     2005     2004  
     ($ in thousands, except for per
share data)
 

Revenue (Note 3)

      

Royalties and Licensing Fees

   $ 7,993     $ 5,719     $ 7,118  

Product Sales

     438       152       432  
                        

Total Revenue

     8,431       5,871       7,550  
                        

Cost of Sales

      

Royalties & Licensing (Note 16)

     796       720       715  

Product Sales

     212       156       341  
                        

Total Cost of Sales

     1,008       876       1,056  
                        

Gross Profit

     7,423       4,995       6,494  
                        

Operating Expenses

      

Research and Development

     1,313       1,435       1,504  

Administration, Sales and Marketing (Note 16)

     3,503       4,621       5,115  
                        

Total Operating Expenses

     4,816       6,056       6,619  
                        

Operating Income (Loss)

     2,607       (1,061 )     (125 )

Interest Income

     108       94       35  

Interest Expense (including amortization of debt discount) (Note 8)

     (358 )     (825 )     (930 )

Write-off debt discount on retirement of Senior Secured Notes

     (927 )     —         —    

Other Income (Expense), net

     (2 )     4       171  

Gain on Sale of Assets

     251       —         —    
                        

Income (Loss) from Continuing Operations Before Income Taxes

     1,679       (1,788 )     (849 )

Provision for Income Taxes (Note 12)

     (19 )     (84 )     (13 )
                        

Income (Loss) from Continuing Operations

     1,660       (1,872 )     (862 )
                        

Discontinued Operations (Note 13)

      

Gain on Sale of Operations

     202       111       1,000  

Interest on Sale of Operations

     21       22       435  

Provision for Income Taxes (Note 13)

     —         —         (7 )
                        

Income from Discontinued Operations

     223       133       1,428  
                        

Net Income (Loss) attributable to Ordinary Stockholders

   $ 1,883     $ (1,739 )   $ 566  
                        

Per share basic amounts

      

Income (loss) from Continuing Operations

   $ 0.03     $ (0.03 )   $ (0.01 )

Income from Discontinued Operations

     0.00       0.00       0.02  
                        

Per share basic amounts

     0.03       (0.03 )     0.01  
                        

Per share diluted amounts

      

Income (loss) from Continuing Operations

   $ 0.03     $ (0.03 )   $ (0.01 )

Income from Discontinued Operations

     0.00       0.00       0.02  
                        

Per share diluted amounts

     0.03       (0.03 )     0.01  
                        

Weighted Average Basic Ordinary Shares Outstanding

     60,961       60,913       60,108  

Weighted Average Diluted Ordinary Shares Outstanding

     61,876       60,913       60,108  

See accompanying notes to consolidated financial statements.

Net income for 2006 included stock-based compensation expense of $171,000, in accordance with Statement of Financial Accounting Standards (“SFAS”) 123(R), “Share Based Payment.” There was no stock-based compensation expense under SFAS 123, “Accounting for Stock-Based Compensation,” in 2005 or 2004 because the Company did not adopt the recognition provisions of SFAS 123. Net loss including pro forma stock-based compensation expense as previously disclosed in the notes to the Consolidated Financial Statements in the Form 10-K was $(1,970,000) or $(0.03) per basic and diluted share for 2005. Net income including pro forma stock-based compensation expense as previously disclosed in the notes to the consolidated financial statements in the Form 10-K was $64,000 or $0.00 per basic and diluted share for 2004. See Note 2 to the Consolidated Financial Statements for additional information.

 

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SENETEK PLC

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT AND

COMPREHENSIVE INCOME (LOSS)

($ in thousands, except for share data)

 

    Shares   Amount   Share
Premium
  Accumulated
Deficit
    Accumulated
Other
Comprehensive
Income-
Currency
Translation
    Net
Stockholders’
Deficit
 

Balances January 1, 2004:

  59,052,153   $ 4,763   $ 83,806   $ (91,552 )   $ 54     $ (2,929 )

Stock based compensation expense related to employee and director stock options

  —       —       29     —         —         29  

Proceeds from warrant exercise

  1,609,545     129     499     —         —         628  

Fair value of warrant modification related to debt refinancing

  —       —       367     —         —         367  

Comprehensive income:

           

Net income attributable to ordinary stockholders

  —       —       —       566       —         566  

Translation reserve

  —       —       —       —         (22 )     (22 )
                             

Total comprehensive income (loss)

  —       —       —       566       (22 )     544  
                                       

Balances December 31, 2004

  60,661,698   $ 4,892   $ 84,701   $ (90,986 )   $ 32     $ (1,361 )
                                       

Stock based compensation expense related to employee and director stock options

  —       —       3     —         —         3  

Proceeds from stock issued in connection with deferred compensation plan

  298,926     27     45     —         —         72  

Comprehensive loss:

           

Net income attributable to ordinary stockholders

  —       —       —       (1,739 )     —         (1,739 )

Translation reserve

  —       —       —       —         (10 )     (10 )
                             

Total comprehensive loss

  —       —       —       (1,739 )     (10 )     (1,749 )
                                       

Balances December 31, 2005

  60,960,624   $ 4,919   $ 84,749   $ (92,725 )   $ 22     $ (3,035 )
                                       

Stock based compensation expense related to employee and director stock options

  —       —       171     —         —         171  

Comprehensive income:

           

Net income attributable to ordinary stockholders

  —       —       —       1,883       —         1,883  

Translation reserve

  —       —       —       —         10       10  
                             

Total comprehensive income

  —       —       —       1,883       10       1,893  
                                       

Balances December 31, 2006

  60,960,624   $ 4,919   $ 84,920   $ (90,842 )   $ 32     $ (971 )
                                       

See accompanying notes to consolidated financial statements.

 

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SENETEK PLC

CONSOLIDATED STATEMENTS OF CASH FLOWS

 

     Year Ended December 31  
     2006     2005     2004  
     ($ in thousands)  

CASH FLOWS FROM OPERATING ACTIVITIES:

      

Net income (loss)

   $ 1,883     $ (1,739 )   $ 566  

Gain from sale of discontinued operations

     (202 )     (111 )     (1,000 )

Income from discontinued operations

     (21 )     (22 )     (428 )
                        

Income (loss) from continuing operations

     1,660       (1,872 )     (862 )

Adjustments to reconcile net income (loss) to net cash provided (used) by operating activities:

      

Gain on sale of assets

     (251 )     —         —    

Depreciation and amortization, including $176, $545 and $515 related to debt discount in 2006, 2005, and 2004

     252       695       652  

Write off of debt discount on retirement of senior secured notes

     927       —         —    

Bad debt and inventory reserves

     (399 )     64       119  

Stock based compensation

     171       3       29  

Stock issued for deferred compensation

     —         72       —    

Write down on fixed asset disposals

     —         225       —    

Changes in assets and liabilities:

      

Trade receivables

     (654 )     (153 )     (469 )

Non-trade receivables

     4       99       (99 )

Inventory

     506       84       84  

Prepaids and deposits

     48       107       9  

Accounts payable and accrued liabilities

     (198 )     60       (314 )

Deferred revenue and license fees

     (797 )     (812 )     4,045  
                        

Net cash provided by (used in) continuing operations

     1,269       (1,428 )     3,194  

Net cash provided by discontinued operations

     21       22       428  
                        

Net cash provided by (used in) operating activities

     1,290       (1,406 )     3,622  
                        

CASH FLOWS FROM INVESTING ACTIVITIES:

      

Proceeds from sale of discontinued operations

     202       111       1,000  

Proceeds from maturities of short term investments

     1,634       —         —    

Proceeds from sale of assets held for sale

     500       —         —    

Purchase of property and equipment

     (32 )     —         (263 )

Purchase of short term investments

     —         (50 )     (1,584 )
                        

Net cash provided by (used in) investing activities

     2,304       61       (847 )
                        

CASH FLOWS FROM FINANCING ACTIVITIES:

      

Principal payment on debt

     —         (30 )     (1,630 )

Prepayment of senior secured notes

     (3,289 )     —         —    

Proceeds from bank line of credit

     1,500       —         —    

Exercise of warrants

     —         —         628  

Effects of exchange rate changes on cash

     10       (10 )     (22 )
                        

Net cash used in financing activities

     (1,779 )     (40 )     (1,024 )
                        

NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

     1,815       (1,385 )     1,751  

Cash and cash equivalents at the beginning of the year

     1,553       2,938       1,187  
                        

Cash and cash equivalents at the end of the year

   $ 3,368     $ 1,553     $ 2,938  
                        

Supplemental disclosures of cash flow information

      

Interest

   $ 358     $ 280     $ 415  

Income taxes

     —         84       20  

Non-cash financing transactions:

In September 2004, the Company modified the terms of 6.3 million warrants to the holders of notes payable in connection with the notes payable refinancing. The incremental value of the warrants of $367,000 is being treated as additional discount on the notes payable.

In March 2005, the Company issued 298,926 shares of common stock in settlement of approximately $72,000 of accrued liabilities associated with the termination of its Deferred Compensation Plans.

See accompanying notes to consolidated financial statements

 

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1. Business

Senetek PLC (“Senetek”) is a life sciences product development company with an extensive array of intellectual properties targeting the science of aging including skincare and dermatological therapeutics, erectile dysfunction, nutrition and cancer.

Senetek PLC is a public limited company organized under the laws of England and has four wholly-owned subsidiaries, Senetek Drug Delivery Technologies, Inc. (“SSDT”), Senetek Asia Limited (“HK”) and Senetek Denmark ApS, corporations formed by Senetek under the laws of Delaware, Hong Kong and Denmark, respectively, and Carme Cosmeceutical Sciences Inc. (“CCSI”), a Delaware corporation.

 

2. Principal Accounting Policies

(a) Basis of Consolidation

The consolidated financial statements incorporate the accounts of Senetek PLC and its wholly owned subsidiaries. All significant inter-company balances and transactions have been eliminated in consolidation. The accounts have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”).

(b) Use of Estimates

The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts in Senetek’s financial statements and notes thereto. On a regular basis, management evaluates these estimates and assumptions. Actual results may differ materially from these estimates.

Examples of significant estimates and assumptions made by management involve the establishment of provisions for bad debt, the determination of fair value of stock compensation awards, realizability of deferred tax assets, impairment of long lived assets, and goodwill valuation.

(c) Cash and Cash Equivalents

For the purposes of the statement of cash flows and balance sheet, the Company considers any highly liquid investments purchased with an original maturity of three months or less to be cash equivalents.

At times, cash balances may be in excess of FDIC insurance limits. The Company has not experienced any losses with respect to bank balances in excess of government provided insurance. At December 31, 2006, the Company held $3,164,000 in bank balances in excess of the insurance limits.

(d) Revenue, Deferred Revenues and Accounts Receivable

Revenue from the sale of skincare products, polyclonal antibodies and named patient product sales of Invicorp® is recognized at the time of shipment, which is when legal title and risk of loss is transferred to the Company’s customers, and is recorded at the net invoiced value of goods supplied to customers after deduction of sales and value added tax where applicable. Remittances received from the Company’s marketer, Covance Antibody Services, Inc. (“Covance”) on its sales of monoclonal antibodies are recognized based upon a percentage of actual Covance sales pursuant to the contract terms. Upfront license fees received from the licensing of manufacturing and distribution rights for the Company’s skincare products are deferred and recognized as revenue is earned, which is generally on a straight-line basis over the life of the contract. Royalties

 

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from the Company’s skincare licensees are recognized based on estimates that approximate the percentage due on products estimated to have been sold by the licensees. The Company receives sales reports from the licensee and based upon this information, plus subsequent cash receipts, records royalty revenue. Historically, license revenue has not differed significantly from management’s estimates. Estimates are adjusted to reflect actual results within one quarter of product shipment.

In May 2004, the Company entered into two agreements with Valeant. Under these agreements, Valeant was granted the right to enter into an exclusive world wide license for Zeatin (or another proprietary compound if clinical testing of Zeatin showed its commercialization was not feasible) on substantially the same commercial terms as the Company’s license with Valeant for its Kinetin products, and the license agreement for Valeant’s Kinetin products was amended to extend its term, expand its reach to additional channels of trade, and provide for a royalty reduction of $250,000 per quarter beginning in 2005 to support Valeant’s planned increases in promotional support for the brand as it exploits these additional markets and channels of trade. In conjunction with the agreement, the Company received $5 million and is amortizing this amount into income over an 8 year period at a quarterly rate of $156,250. As of December 31, 2006, $625,000 of this is included in short term deferred revenue and $3,125,000 in long term deferred revenue. The remaining current and long term portion of deferred revenue and license fees at December 31, 2006 relates to a prepaid license fee received from Revlon in fiscal year 2000 which is amortized at the rate of approximately $172,000 per year over the remaining life of the agreement. In July 2005, Valeant exercised its option to obtain an exclusive global license for Zeatin in all classes of trade, and its Kinetin license agreement was amended to grant such license for Zeatin. Valeant’s rights to Kinetin were similarly broadened, subject to terms of Senetek’s existing Kinetin licenses, which Senetek undertook not to expand or renew. In return, Senetek is contractually entitled to receive royalties on Valeant’s net sales of Zeatin products at the same rate as is applicable to net sales of Kinetin products and Valeant guarantees combined minimum royalties from sales of Zeatin and Kinetin products of $6 million in 2006, $7 million in 2007 and $8 million in each of 2008, 2009 and 2010, payable quarterly, subject to the above $250,000 quarterly credit.

On March 30, 2007, the Company completed a License Acquisition Agreement with Valeant. Under the terms of the License Acquisition Agreement, the Company has granted Valeant a paid up license for Kinetin and Zeatin and assigned to Valeant future royalties from other Kinetin licensees, in return for a cash payment of $21 million, a waiver of $6 million in future marketing credits the Company otherwise would have owed to Valeant, and a right to share in future royalties due to Valeant from other Kinetin licensees through 2011. The $21 million cash payment will be fully includable in 2007 revenue along with approximately $3,750,000 in previously deferred revenue related to the prior license agreement.

Accounts receivable are uncollateralized customer obligations typically due in 30 days under the terms of respective license agreements. The Company performs continuing credit evaluations of its customers’ financial condition. Senior management reviews accounts receivable on a monthly basis to determine if any receivables will potentially be uncollectible. The Company includes any accounts receivable balances that are determined to be uncollectible in its allowance for doubtful accounts. After all attempts to collect a receivable have failed, the receivable is written off against the allowance. Based on the information available to us, management believes the allowance for doubtful accounts as of December 31, 2006 is adequate.

(e) Inventories and Inventory Reserves

Inventories, consisting of raw materials, are stated at the lower of cost or market value. Cost is determined using the average costing method.

 

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Reserves for slow moving and obsolete inventories are developed based on historical experience, product demand and shelf life of a product. The Company continuously evaluates the adequacy of inventory reserves and makes adjustments to the reserves as required.

(f) Property and Equipment

Property and equipment are stated at cost less accumulated depreciation. Depreciation is calculated on a straight line basis using the following estimated useful lives:

 

   

Office Furniture, Fixtures and Equipment: 3 to 15 years

 

   

Laboratory equipment: 5 years

 

   

Leasehold improvements are amortized over the estimated useful lives of the assets or the related lease term, whichever is the shorter.

(g) Goodwill

Intangible assets consist of goodwill arising from business combinations. Prior to 2002, goodwill, representing the excess of the purchase price over the estimated fair value of the net assets of the acquired business (Carme), was amortized over the period of expected benefit of 15 years. However, effective January 1, 2002, the Company adopted Statement of Financial Accounting Standards (“SFAS”) No. 142, “Goodwill and Other Intangible Assets,” which requires that the Company cease amortization of all intangible assets having indefinite useful economic lives. Such assets including goodwill are not to be amortized until their lives are determined to be finite, however, a recognized intangible asset with an indefinite useful life should be tested for impairment annually or on an interim basis if events or circumstances indicate that the fair value of the asset has decreased below its carrying value. At December 31, 2006, the Company evaluated its goodwill and determined that fair value had not decreased below carrying value and no adjustment to impair goodwill was necessary in accordance with SFAS No. 142.

On March 30, 2007, Senetek completed a License Acquisition Agreement with Valeant. Under the terms of the License Acquisition Agreement, the Company granted Valeant a paid up license for Kinetin and Zeatin (acquired in conjunction with Carme acquisition) and assigned to Valeant future royalties from other Kinetin licensees, in return for a cash payment of $21 million, a waiver of $6 million in future marketing credits the Company otherwise would have owed to Valeant, and a right to share in future royalties due to Valeant from other Kinetin licensees through 2011. As a result of this transaction and the related significant reduction on future royalties from the Kinetin and Zeatin products, goodwill of $1,308,000 was determined to be impaired and concurrently written off in March 2007.

(h) Impairment of Long-Lived Assets

The Company reviews the carrying value of its property and equipment and intangible assets for impairment in value whenever events or changes in circumstances indicate that the carrying amount of assets may not be recoverable. See Note 5.

(i) Research and Development

Expenditures on research and development are expensed as incurred.

 

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(j) Foreign Exchange

All assets and liabilities in the balance sheets of foreign branches and subsidiaries whose functional currency is other than U.S. dollars are translated at period-end exchange rates. All income and expenditure items in the profit and loss account of foreign branches and subsidiaries whose functional currency is other than U.S. dollars are translated at average annual exchange rates. Translation gains and losses arising from the translation of the financial statements of foreign branches and subsidiaries whose functional currency is other than the U.S. dollar are not included in determining net income but are accumulated in a separate component of stockholders’ deficit. Foreign currency transaction gains and losses are included in the determination of net income (loss) in the period in which they occur. The functional currency of the Company’s United Kingdom and Denmark operations is the Pound Sterling and Danish Kroner.

(k) Calculation of the Number of Shares and Net Income (Loss) per Share

Earnings (loss) per share were computed under the provisions of SFAS No. 128, “Earnings per Share”. Basic earnings per share are computed using the weighted average number of ordinary shares outstanding during the period. Diluted earnings per share incorporate the incremental shares issuable upon the assumed exercise of dilutive stock options and warrants using the treasury stock method. The following is a reconciliation of the numerators and denominators of the basic and fully diluted earnings per share computation.

 

     December 31  
     2006    2005     2004  
     (in thousands)  

Numerator:

       

Income (loss) from continuing operations

   $ 1,660    $ (1,872 )   $ (862 )

Income from discontinued operations (Note 13)

     223      133       1,428  
                       

Net income (loss)

   $ 1,883    $ (1,739 )   $ 566  
                       

Denominator:

       

Basic weighted average ordinary shares outstanding

     60,961      60,913       60,108  

Stock options “in the money” calculated using treasury stock method

     915      —         —    
                       

Diluted weighted average ordinary shares outstanding

     61,876      60,913       60,108  
                       

Options and warrants to purchase stock and shares issuable upon the conversion of debt to stock, totaling 6,085,000, 18,984,001 and 20,316,001 were outstanding at December 31, 2006, 2005 and 2004 but were excluded from the calculation of diluted earnings per share as their effect would have been antidilutive.

(l) Financial Instruments

The carrying values of cash, receivables and current liabilities approximate their fair values due to the short-term nature of these items. The estimated fair values of the Company’s long term notes payable at December 31, 2006 and 2005 is approximately $0 and $2,700,000, respectively. The carrying values of these notes at December 31, 2006 and 2005 are $0 and $2,186,000. Fair value is the amount at which the instrument could be exchanged in a current transaction between willing parties, other than in a forced sale or liquidation.

(m) Income Taxes

The Company recognizes deferred tax liabilities and assets for the expected future tax consequences of events that have been included in the financial statements or tax returns. Accordingly, deferred tax liabilities and assets are determined based on the difference between the financial statement and tax bases of assets and liabilities using

 

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enacted rules in effect for the year in which differences are expected to reverse. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.

A valuation allowance is established to reduce the deferred tax assets when the Company determines it is more likely than not that the related tax benefits will not be realized. The Company periodically reviews the valuation of deferred tax assets in light of expected future operating results.

(n) Stock Compensation Expense

On January 1, 2006, the Company adopted SFAS 123(R), “Share Based Payment,” which requires the measurement and recognition of compensation expense for all share-based payment awards made to the Company’s employees and directors for employee stock options. Accordingly, stock based compensation cost is measured at grant date, based on the estimated fair value of the award, and is recognized as expense over the employee requisite service period. The Company’s stock compensation is accounted for as an expense and an addition to equity. The Company previously applied Accounting Principles Board Opinion No. 25, “Accounting for Stock Issued to Employees”, and related interpretations and provided the required pro forma disclosures of SFAS 123, “Accounting for Stock-Based Compensation”. See Note 10 for additional information.

(o) Advertising Expenses

The Company’s policy is to expense advertising costs as incurred. Advertising costs in 2006 and 2005 amounted to $36,000 and $56,000, respectively, and were incurred in connection with press releases, website support, and an email campaign. No advertising costs were incurred in 2004.

(p) Recent accounting pronouncements

In July 2006, the Financial Accounting Standards Board (“FASB”) issued FASB Interpretation No. 48 (“FIN 48”), Accounting for Uncertainty in Income Taxes-An Interpretation of FASB Statement No. 109to clarify the accounting for uncertainty in income taxes recognized in accordance with SFAS 109, Accounting for Income Taxes”. This interpretation prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of an uncertain tax position taken or expected to be taken in a tax return. FIN 48 is effective for annual financial statements covering the first fiscal year beginning after December 15, 2006. Management believes that adoption of FIN 48 will not have a material impact on the financial statements.

In September 2006, the SEC issued Staff Accounting Bulletin (“SAB”) No. 108, “Considering the Effects of Prior Year Misstatements When Quantifying Misstatements in Current Year Financial Statements,” to clarify how the effects of the carryover or reversal of prior year misstatements should be considered in quantifying a current year misstatement. The staff believes that registrants must quantify the impact of correcting all misstatements using two common approaches and would require adjustment when either approach results in quantifying a misstatement that is material, after considering all relevant quantitative and qualitative factors. SAB No. 108 is effective for annual financial statements covering the first fiscal year ending after November 15, 2006. Management believes that adoption of SAB No. 108 did not have a material impact on the financial statements.

In September 2006, the FASB issued SFAS No. 157, “Fair Value Measurements,” which is effective for fiscal years beginning after November 15, 2007, and interim periods within those fiscal years. The standard applies whenever other standards require (or permit) assets or liabilities to be measured at fair value. The standard does not expand the use of fair value in any new circumstances. SFAS No. 157 clarifies the definition of fair value, provides enhanced guidance for using fair value to measure assets and liabilities, and requires

 

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expanded disclosures about fair value measurements. The Company does not expect the adoption of SFAS No. 157 to have a material impact on its financial position, results of operations or cash flows.

In September 2006, the SEC issued new rule No. 33-8732A regarding Executive Compensation and Related Person Disclosure, adopting amendments to the disclosure requirements for executive and director compensation, related person transactions, director independence and other corporate governance matters and security ownership of officers and directors. Among other changes, the rule requires that disclosure under the amended items generally be provided in plain English. The rule is effective for Forms 8-K for triggering events that occur on or after November 7, 2006, and in Forms 10-K and in any proxy or information statements for fiscal years ending on or after December 15, 2006.

In February 2007, the FASB issued SFAS No. 159, “The Fair Value Option for Financial Assets and Financial Liabilities,” which is effective for fiscal years beginning after November 15, 2007. Early adoption is permitted in certain circumstances provided that the entity also elects to adopt the provisions of SFAS No. 157, “Fair Value Measurements.” SFAS No. 159 permits entities to choose to measure many financial instruments and certain other items at fair value. The objective is to improve financial reporting by providing entities with the opportunity to mitigate volatility in reported earnings caused by measuring related assets and liabilities differently without having to apply complex hedge accounting provisions. The Company is currently evaluating the impact on the financial statements of adopting SFAS No. 159.

(q) Shipping and handling costs

The Company records shipping and handling fees billed to customers as revenue included in product sales. Costs associated with shipping and handling activities are comprised of outbound freight and associated direct labor costs, and are recorded in cost of sales.

 

3. Concentration of Risk

The Company’s customers are located principally in the United States. Four customers in the skincare segment and one customer in the pharmaceutical segment accounted for approximately 67%, 1%, 7%, 3% and 16% of net revenues and 68%, 1%, 5%, 0% and 21% of receivables in 2006. The same customers were 51%, 2%, 12%, 11% and 18% of net revenue in 2005 and 27%, 21%, 16%, 12%, and 17% in 2004. There is a significant concentration of credit risk with respect to these customers.

 

4. Inventory

Inventory is valued at the lower of cost or market. Inventory at December 31, 2006 of $32,000 consists of raw materials. The December 31, 2005 inventory of $109,000 is comprised of $77,000 in raw materials and $32,000 in finished goods. The December 31, 2005 inventory is net of reserves of $62,000 for raw materials and $367,000 for finished goods. In conjunction with the sale of certain of its raw materials inventory and finished goods inventory in January 2006, the Company reversed its inventory reserves.

 

     December 31,
2006
   December 31,
2005
     ($ in thousands)

Finished goods

   $ —      $ 32

Raw materials

     32      77
             
   $ 32    $ 109
             

 

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5. Property and Equipment and Assets Held for Sale

Property and equipment and asset held for sale are summarized as follows:

 

     December 31,
2006
   December 31,
2005
     ($ in thousands)

Cost:

     

Office furniture and fixtures

   $ 333    $ 315

Plant and laboratory equipment

     377      346

Leasehold improvements

     93      99
             
     803      760
             

Accumulated depreciation:

     

Office Furniture and Fixtures

     280      255

Plant and Laboratory equipment

     278      248

Leasehold Improvements

     35      15
             
     593      518
             

Net Carrying Value

   $ 210    $ 242
             

Asset Held for Sale (1)

   $ —      $ 250
             

(1) On March 20, 2006, the Company sold to Ranbaxy Pharmaceuticals Inc, all of its patents, trademarks and automated manufacturing equipment for the Reliaject® device (the “Reliaject® assets”). The Company received a down-payment of $500,000 for the Reliaject® assets, which had a corresponding recorded value of $250,000. Under the terms of the sales agreement, the Company is to receive additional milestone payments based on regulatory approvals and cumulative sales targets. In addition, The Company is to receive a specified percentage (similar to a set royalty) for a period of 15 years on Ranbaxy’s and its licensees’ quarterly net sales in North America of Reliaject® pre-filled with epinephrine and other parenteral drugs (including Invicorp®). Percentages will be negotiated on its net sales in any other markets for which it may be licensed and on its net sales in North America of Reliaject® pre-filled with non-scheduled parenteral drugs. Under the agreement, Ranbaxy is assuming all expenses of obtaining regulatory approvals and of marketing the product.

 

6. Short-Term Investments:

Short-term investments represent certificates of deposit with various financial institutions totaling $1,634,000 at December 31, 2005. Each certificate of deposit has a principal balance of $99,000 and is outstanding for a period of approximately 95 to 180 days. At December 31, 2005, the Company classified all of its investments as available-for-sale. The fair market value approximates the cost and it is the intent of the Company to hold these investments until they mature.

 

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7. Accrued Liabilities

Accrued liabilities comprise the following:

 

     December 31,
2006
   December 31,
2005
     ($ in thousands)

Accrued Salaries and Benefits

   $ 211    $ 265

Legal and Professional Fees

     154      365

Audit and Accountancy Fees

     118      377

Other Liabilities and Accruals

     189      248
             
   $ 672    $ 1,255
             

 

8. Notes Payable

On March 30, 2006, the Company entered into an agreement for a revolving line of credit (the “Revolving Credit Agreement”) with Silicon Valley Bank providing for the Company to borrow from time to time up to the lesser of $1,500,000 or 80% of the succeeding four calendar quarters’ minimum guaranteed royalty payments due under the Company’s Kinetin and Zeatin license agreement with Valeant Pharmaceuticals International as amended July 2005. The Revolving Credit Agreement has a term of two years, and the Company granted the Bank a first position security interest on its patents covering certain cytokinins, including Kinetin and Zeatin, and the proceeds thereof, including the Company’s license agreements thereunder. Amounts outstanding under the Revolving Credit Agreement bear interest at the greater of 8.25% per annum or 1% above the Bank’s prime lending rate from time to time, and the Company is obligate to pay a fee equal to 3% of any unused portion of the amount available form time to time, and 3% of the maximum availability through the remaining portion of the two year term if the Bank terminates the Revolving Credit Agreement before its maturity for non-compliance by the Company with its terms. The Revolving Credit Agreement contains various affirmative and negative covenants, including maintenance of positive EBITDA (earnings before interest, taxes, depreciation and amortization) for each rolling three-month period during the term, limitations on indebtedness to, investment in or guarantees of third parties, conduct of the Company’s business only in the ordinary course, absence of material adverse changes in the Company’s financial results, condition or prospects, and absence of material transactions including mergers, consolidations, sales of material assets and changes of control, as defined. On March 30, 2007, the Company terminated its line of credit with Silicon Valley Bank and paid off the outstanding balance of $1,500,000 as a condition of the License Acquisition Agreement with Valeant. Refer to Note 18 to the Financial Statements for the discussion of the retirement of the line of credit.

On March 31, 2006, the Company entered into an agreement (the “Prepayment Agreement”) with the holders of its outstanding $3,289,000 principal amount of senior secured notes (the “Notes”) and its Series A, B, and D warrants exercisable for 3,000,000, 3,300,000 and 3,437,500 ordinary shares, respectively, at exercise prices of $1.00, $1.25 and $0.40, respectively, per share, issued pursuant to the Securities Purchase Agreement entered into in 1999 and amended in 2003 and 2004. The Prepayment Agreement provided that on the date of prepayment of the balance of the Notes (the “Note Closing Date”), all of the outstanding Series A, B, and D warrants would be cancelled, the Securities Purchase Agreement as amended would be terminated, and the Company would issue new Series E warrants to purchase a total of 3,000,000 ordinary shares on substantially the same terms as the Series D warrants, including its March 4, 2011, expiration date, but at an exercise price of $0.25 per share. The Prepayment Agreement permits the holders of the Series E warrants to register under the Securities Act of 1933 the ordinary shares purchasable thereunder on Form S-3 Registration Statements on up to two separate occasions and indemnifies the holders against delays in receipt of ADSs following proper tenders of ordinary shares, in each case on the same terms as applied to the Series D warrants. In addition, the Prepayment Agreement provided that on the Closing Date, the Note holders’ two designees as Directors of Senetek would resign.

 

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On March 31, 2006, the Company paid the outstanding principal amount of the Notes and accrued interest, with the result that the Notes and outstanding Series A, B, and D warrants were canceled, the Noteholders’ designees on the Company’s Board of Directors resigned, the Securities Purchase Agreement was terminated, and the Series E warrants were issued. The Company recognized a loss of approximately $927,000, representing the unamortized discount on the Notes, related to the extinguishment of the debt. The fair value of the Series E warrants was determined to be less than the fair value of the cancelled warrants; therefore the Company did not recognize any additional expense related to the issuance of warrants. In 2006, the Company paid $243,000 in interest related to the Notes.

 

9. Stock Option Plan

In December 1985, Senetek adopted a share option plan (the “No. 1 Plan”) for employees with shareholder approval. Under the No. 1 Plan, options to purchase ordinary shares are granted by the Board of Directors, subject to the exercise price of the option being not less than the market value of an ordinary share on the grant date. After the first twelve months following the date of the grant, options are exercisable at the rate of 25 percent, for each full year of employment. In the event the optionee’s employment is terminated, the option may not be exercised unless the Board of Directors so permits. The options expire seven years from the date of the grant. On May 16, 1997, shareholders approved the extension of the No. 1 Plan until December 1, 2005 and an increase in the number of shares available for grant to 6,000,000. The No. 1 Plan expired by its terms in December 2005.

The following table summarizes option transactions under the No. 1 Plan for the three years ended December 31, 2006:

 

     Shares
Available
For Grant
    Options
Outstanding
   

Weighted
Average
Exercise

price

Balance at January 1, 2004

   146,975     3,946,125     $ 1.39

Forfeited/Cancelled

   66,625     (66,625 )     1.22
              

Balance at December 31, 2004

   213,600     3,879,500       1.39

Forfeited/Cancelled

   355,000     (355,000 )     2.11

Cancelled due to Plan Termination

   (568,600 )   —         —  
              

Balance at December 31, 2005

   —       3,524,500       1.32

Forfeited/Cancelled

   —       (1,174,500 )     1.61
              

Balance at December 31, 2006

   —       2,350,000     $ 1.18
              

The following table summarizes information about the No. 1 Plan options outstanding at December 31, 2006.

 

Range of

Exercise Price

  

Number

Outstanding

  

Weighted

Average Remaining

Contractual Life

in years

   Weighted
Average
Exercise Price
  

Number

Exercisable

   Exercise Price of
Exercisable
Options

$0.41–$0.55

   320,500    3.02    $0.54    311,802    $0.54

$1.00–$1.41

   2,030,000    1.26    1.27    2,029,688    1.27
                  

$0.41–$1.41

   2,350,000    1.50    $1.18    2,341,490    $1.18
                  

 

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In May 1987, the Company adopted a share option plan (“the No. 2 Plan”) for Non-Executive Directors and Consultants with shareholder approval. Under the No. 2 Plan, options to purchase ordinary shares were granted by the Board of Directors, subject to the exercise price being not less than the market value of an ordinary share on the grant date. Options granted under this plan are exercisable in their entirety one year after the date of grant. In the event the optionee ceases to be a non-executive Director or consultant, the option may not be exercised unless the Board of Directors so permits. The options expire seven years from the date of grant. In 1997, shareholders approved an extension of the Plan until December 1, 2005 and an increase in the number of shares available for grant to 4,000,000. The No. 2 Plan expired by its terms in December 2005.

The following table summarizes option transactions under the No. 2 Plan for the three years ended December 31, 2006:

 

     Shares
Available
For Grant
    Options
Outstanding
    Weighted
Average
Exercise
price

Balance at January 1, 2004

   1,096,025     2,442,000     $ 1.21

Granted

   (150,000 )   150,000       0.69

Forfeited/Cancelled

   150,000     (150,000 )     1.15
              

Balance at December 31, 2004

   1,096,025     2,442,000       1.18

Forfeited/Cancelled

   917,000     (917,000 )     1.39

Cancelled due to Plan Termination

   (2,013,025 )   —         —  
              

Balance at December 31, 2005

   —       1,525,000       1.06

Forfeited/Cancelled

   —       (745,000 )     1.37
              

Balance at December 31, 2006

   —       780,000     $ 0.76
              

The following table summarizes information about the No. 2 Plan for non-executive Directors and consultants’ options outstanding at December 31, 2006.

 

Range of

Exercise Price

  

Number

Outstanding

  

Weighted

Average Remaining

Contractual Life

in years

   Weighted
Average
Exercise Price
  

Number

Exercisable

   Weighted
Average Exercise
Price of
Exercisable Options

$0.41–$0.69

   650,000    3.73    $ 0.56    650,000    $ 0.56

$1.41–$1.88

   130,000    1.54      1.77    130,000      1.77
                  

$  .41–$1.88

   780,000    3.36    $ 0.76    780,000    $ 0.76
                  

Not included in the above are options granted to non-executive Directors and consultants outside the No. 2 Plan under the general powers granted to the Directors for the allotment of equity securities, approved at the Annual General Meeting of the Company held on May 16, 1997. As of December 31, 2004 there were 60,000 options outstanding with an exercise price of $1.50. During 2005, these options were forfeited.

In May 2006, the Company adopted the Senetek Equity Plan providing for issuance of non-qualified options and restricted stock to employees, non-employees and board members. Options are granted at the discretion of the Compensation Committee of the Board of Directors. The options will generally become exercisable for 20% of the option shares one year from the date of grant and then ratably over the following 36 months. The Compensation Committee of the Board of Directors has the discretion to use a different vesting schedule. The Plan is subject to the approval of the Company’s stockholders within twelve months after the date of the Board’s

 

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initial adoption of the Plan. 1,900,000 stock options were granted on June 6, 2006 at a price of $0.26 per share, 25,000 stock options were granted on August 1, 2006 at a price of $0.24 per share and 300,000 stock options were granted on December 18, 2006 at a price of $0.20 per share. The grants were made at the closing stock price on the grant date. On December 18, 2006, 206,250 shares of restricted stock were granted under the Senetek Equity Plan.

The following table summarizes option and restricted stock transactions under the Senetek Equity Plan in 2006.

 

     Shares
Available
for Grant
    Options and
Restricted
Stock
Outstanding
   Weighted
Average
Exercise
Price

Balance at January 1, 2006

       

Adoption of Plan

   5,000,000       

Granted

   (2,431,250 )   2,431,250    $ 0.25
             

Balance at December 31, 2006

   2,568,750     2,431,250    $ 0.25
                 

The following table summarizes information about the Senetek Equity Plan options and restricted stock outstanding at December 31, 2006:

 

Range of

Exercise Price

  

Number

Outstanding

  

Weighted
Average Remaining

Contractual Life

in years

  

Weighted

Average

Exercise Price

  

Number

Exercisable

  

Weighted
Average Exercise
Price of

Exercisable Options

$0.20 – $0.26

   2,431,250    6.1    $ 0.25    483,750    $ 0.22

The intrinsic value of the Company’s outstanding vested stock options at December 31, 2006 and December 31, 2005 was $0 as the exercise prices of such options exceeded the market price of the Company’s stock.

 

10. Stock Compensation Expense

On January 1, 2006, the Company adopted SFAS 123(R), which requires the measurement and recognition of compensation expense for all share-based payment awards made to the Company’s employees and directors for employees’ stock options. Accordingly, stock-based compensation cost is measured at grant date, based on the estimated fair value of the award, and is recognized as expense over the employee requisite service period. The Company’s stock compensation is accounted for as an expense and an addition to equity. The Company previously applied Accounting Principals Board Opinion No. 25, “Accounting for Stock Issued to Employees”, and related interpretations and provided the required pro forma disclosures of SFAS 123, “Accounting for Stock-Based Compensation”.

Prior to the adoption of SFAS 123(R)

Prior to the adoption of SFAS 123(R), the Company provided the disclosures required under SFAS 123 as amended by SFAS148, “Accounting for Stock-Based Compensation—Transition and Disclosures.” No employee stock-based compensation was reflected in net loss for 2005, because all options granted under those plans had an exercise price equal to the market value of the underlying common stock on the date of the grant.

 

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Impact of adoption of SFAS 123(R)

The Company elected to adopt the modified prospective application method as provided by SFAS 123(R). Accordingly, during 2006, the Company recorded stock-based compensation cost totaling the amount that would have been recognized during the period(s) had the fair value method been applied since the effective date of SFAS 123. Previously reported amounts have not been restated. The fair value of option grants is estimated on the date of grant using a binomial option-pricing model.

Assumptions used to value the stock-based compensation balance were as follows:

 

Average

   2006     2005     2004  

Risk free interest rate

   5.0 %   4.5 %   4.0 %

Expected dividend yield

   0 %   0 %   0 %

Expected stock volatility

   80 %   81 %   83 %

Expected life of options

   7.0 years     7.0 years     7.0 years  

The following table summarized stock-based compensation expense related to employee stock options under SFAS 123(R) for 2006, which was allocated as follows (in thousands):

 

     2006

Administration, Sales and Marketing

   $ 164

Research and Development

     7
      

Stock-based compensation expense included in operating expenses and net income

   $ 171
      

The table below reflects basic and diluted net loss per share for 2006 compared with the pro forma information for the 2005 and 2004 (in thousands except per-share amounts):

 

     Year ended December 31  
     2006    2005     2004  

Reported net income (loss)

   $ 1,883    $ (1,739 )   $ 566  

Stock-based compensation expense related to employee stock options (1)

     —        (231 )     (502 )

Net income (loss), including the effect of stock-based compensation expense

     1,883      (1,970 )     64  

Basic and diluted earnings (loss) per share—as reported

     0.03      (0.03 )     0.01  

Basic and diluted earnings (loss) per share, including the effect of stock-based compensation

     0.03      (0.03 )     0.00  

(1) In 2006, stock compensation expense is already included in reported net income.

As of January 1, 2006, the Company had an unrecorded deferred stock-based compensation related to stock options, adjusted for estimated forfeitures, of $10,000.

On June 6, 2006, the Company granted 1,900,000 stock options with an estimated total grant-date fair value of $331,000. Of this amount, the Company estimated that the stock-based compensation for awards not expected to vest was $32,000.

On August 1, 2006, the Company granted 25,000 stock options with an estimated total grant-date fair value of $4,000. Of this amount, the Company estimated that the stock-based compensation for awards not expected to vest was $1,000.

 

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On December 18, 2006, the Company granted 300,000 stock options with an estimated total grant-date fair value of $40,000. The Company estimates that all awards will vest.

On December 18, 2006, the Company granted 206,250 shares of restricted stock with an estimated total grant-date fair value of $41,000. The Company estimates that all awards will vest.

During 2006, the Company recorded stock-based compensation related to stock options of $171,000.

As of December 31, 2006, the unrecorded deferred stock-based compensation balance related to stock options and restricted stock was $222,000 expected to be recognized over a weighted average period of 2.82 years.

 

11. Stockholders’ Equity

The following warrants were issued and amended in association with the new Securities Purchase Agreement and the Settlement Agreement, dated on April 14, 1999 and the retirement of Senior Secured notes in March 2006, and are outstanding at December 31, 2006:

 

Warrant Type

  

Warrants

Issued and

unexercised

  

Exercise

Price

  

Expiration

Date

Series E

   3,000,000    $ 0.25    March 2011

General

   100,000    $ 0.62    September 2009
          
   3,100,000      
          

The series E warrants were issued in association with the retirement of senior secured Notes in March 2006. The warrants referred to above entitled the holder to purchase ordinary shares convertible into American Depository Receipts of the Company at the purchase prices referred to above at any time commencing 90 days from the date of subscription and prior to the expiration date. The offer and sale of the warrants was made in compliance with and in reliance upon the provision of Regulation S under the United States Securities Act of 1933, as amended.

 

12. Taxation

Senetek is incorporated in England with two U.S. subsidiaries, a Danish subsidiary and one Hong Kong subsidiary. The Company is subject to United Kingdom corporation tax on a worldwide basis with relief for foreign taxes in cases where double taxation relief agreements have been established. The U.S. subsidiaries are subject to United States tax on a worldwide basis (including state taxes) with similar relief for foreign taxes.

 

     Year ended December 31  
     2006     2005     2004  
     ($ in thousands)  

Income (loss) from continuing and discontinued operations before income taxes included the following:

      

US Income (Loss)

   $ 2,631     $ (568 )   $ 1,526  

Foreign (Loss)

     (729 )     (1,087 )     (940 )
                        

Total

   $ 1,902     $ (1,655 )   $ 586  
                        

 

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Income tax expense is comprised of the following:

 

     December 31
     2006    2005    2004
     ($ in thousands)

Current federal taxes continuing operations

   $ 17    $ 69    $ 6

Current state taxes continuing operations

     2      15      7
                    

Total Tax Continuing Operations

   $ 19    $ 84    $ 13
                    

Current federal taxes – discontinued operations

   $ —      $ —      $ 7

Current state taxes – discontinued operations

     —        —        —  
                    

Total Tax Discontinued Operations

   $ —      $ —      $ 7
                    

Income tax expense (benefit) differed from the amounts computed by applying the US federal income tax rate of 34% to pretax income losses from continuing operations as a result of the following:

 

       2006     2005     2004  

Computed expected tax expense (benefit)

     34 %   (34 )%   (34 )%

State tax rate, net of federal benefit

     6     (6 )   (6 )

Permanent differences

     1     13     22  

Utilization of tax loss carryforward

     22     —       —    

Timing differences and losses for which no benefit has been recognized

     (78 )   32     20  

Credits and other

     16     —       —    
                    

Total tax expense-continuing operations

     1 %   5 %   2 %
                    

Deferred tax assets are comprised of the following:

 

     December 31  
     2006     2005  
     ($ in Thousands)  

Net operating loss carryforwards

   $ 27,101     $ 27,347  

Reserves and accruals

     1,742       3,112  

Stock-based compensation

     858       —    

Tax Credits

     206       206  

Other

     (122 )     736  
                

Gross Deferred Tax Asset

   $ 29,785     $ 31,401  

Valuation Allowance

     (29,785 )     (31,401 )
                

Net Deferred Tax Asset

   $ —       $ —    
                

Provisional tax losses available to the Company in the United Kingdom are estimated to be approximately $50,711,000 at the end of fiscal year 2006. The deferred tax asset value of these losses is approximately $15,974,000 but no benefit has been recognized in the financial statements, as the benefit is offset by an equal valuation allowance. As of December 31, 2006, management did not consider it more likely than not that it would generate taxable income to utilize such tax loss carryforwards. The United Kingdom tax-loss carryforwards are available indefinitely against profits from the same trade carried on in the United Kingdom. The United Kingdom tax loss carryforwards could be limited if there was a greater than 50% charge in ownership in any three year period.

 

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The federal provisional tax losses available in the U.S. are estimated to be approximately $31,941,000 at the end of fiscal year 2006. The deferred tax asset value of these losses is approximately $10,860,000 but no benefit has been recognized in the financial statements as the benefit is offset by an equal valuation allowance. As of December 31, 2006, management did not consider it more likely than not that it would generate taxable income to utilize such tax loss carryforwards. Federal net operating losses expire at varying dates from 2008 through 2026. California net operating losses are estimated to be approximately $4,575,000. The resulting deferred tax asset from California net operating losses is approximately $267,000. A 100% provision has also been established for this asset. California net operating losses expire at varying dates from 2010 through 2016. Available Federal and State operating losses could be limited if there was a greater than 50% change in ownership in any three year period. The net change in the total valuation allowance for the years ended December 31, 2006, 2005 and 2004 was a decrease of $1,616,000, and increases of $28,000 and $3,429,000, respectively.

On March 30, 2007, the Company completed a License Acquisition Agreement with Valeant. Under the terms of the License Acquisition Agreement, the Company has granted Valeant a paid up license for Kinetin and Zeatin and assigned to Valeant future royalties from other Kinetin licensees, in return for a cash payment of $21 million, a waiver of $6 million in future marketing credits the Company otherwise would have owed to Valeant, and a right to share in future royalties due to Valeant from other Kinetin licensees through 2011. The Company anticipates that its United Kingdom, U.S. Federal and California provisional taxes losses at December 31, 2006 will be available to offset portions of the taxable income associated with this transaction.

 

13. Discontinued Operations

On December 31, 2002, the Company closed a transaction in which USITC purchased Senetek’s rights to the Mill Creek personal care line, the Silver Fox hair care line and other brands acquired in the 1995 acquisition of Carmé Inc. (referred to hereafter as the intellectual property) for $500,000 cash including a 1999 deposit, and a promissory note of $2.3 million payable in 23 quarterly installments commencing September 30, 2003 towards the agreed-upon purchase price of $2.8 million.

Based on the prior history with the customer, the gain on the transaction was recognized when collection is probable, which was deemed to be when cash is received. Accordingly, the original balance of the unpaid promissory note of $2.3 million was netted with the deferred gain on the Company’s balance sheet. Gain on the transaction in excess of the initial receipts of $500,000 was deferred until collection is deemed to be probable. All gains arising from this transaction will be classified as a component of discontinued operations.

On November 10, 2004, the Company and USITC entered into an agreement to restructure the note. Under the terms of the restructuring, Senetek received $1,435,000 during 2004, together with a $400,000 two and one half year, secured amortizing note bearing interest at 8% per annum. Under the terms of the agreement, if USITC fails to pay any of the quarterly payments due under the new $400,000 note, all of its obligations under the original $2.3 million note, less amounts actually paid, will be reinstated and subject to acceleration for non-performance. In 2006, Senetek received $223,000 in payments comprised of $202,000 in principal and $21,000 in interest. In 2005, Senetek received $133,000 in payments comprised of $111,000 in principal and $22,000 in interest. In 2004, Senetek received $1,435,000 in payments comprised of $1,000,000 classified as a Gain on Sale of Operation and $435,000 classified as interest income. At December 31, 2006, USITC is current in their payments on the note.

 

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14. Segment Reporting

Senetek is a life science product development company engaged in developing and marketing proprietary products that fulfill important unmet consumer needs related to aging. Its business is comprised of two business segments: dermatological/skincare compounds principally addressing photoaging and other skincare needs (“Skincare”); and pharmaceuticals, currently principally those addressing sales of monoclonal antibodies, sexual dysfunction and drug delivery of liquid injectable products (automatic injectors) (“Pharmaceutical”). The Company’s organization is structured in a functional manner. Effective January 1, 2006, for purposes of making operating decisions and assessing financial performance, the Company’s Chief Operating Decision Maker reviews financial information presented on a consolidated basis accompanied by disaggregated information for revenues and cost of goods by operating segment. As a result, operating expenses are no longer segregated by segment for purposes of assessing financial performance.

Financial information regarding the operating segments was as follows:

 

     2006     2005     2004  
     Skincare     Pharma-
ceutical
    Total     Skincare     Pharma-
ceutical
    Total     Skincare     Pharma-
ceutical
    Total  

Revenues

   $ 7,042     $ 1,389     $ 8,431     $ 4,764     $ 1,107     $ 5,871     $ 6,202     $ 1,348     $ 7,550  

Cost of sales

     322       686       1,008       264       612       876       341       715       1,056  
                                                                        

Gross profit

   $ 6,720     $ 703     $ 7,423     $ 4,500     $ 495     $ 4,995     $ 5,861     $ 633     $ 6,494  
                                                                        

Gross profit percentage

     95 %     51 %     88 %     94 %     45 %     85 %     95 %     47 %     86 %

Unallocated operating expenses

         4,816           6,056           6,619  
                                    

Operating income (expense)

       $ 2,607         ($ 1,061 )         ($125 )
                                    

The Company’s customers are principally in the United States.

The Company has no material operating assets outside the United States. In March 2006, the Company sold assets with a recorded value of $250,000 that had been previously included in its disclosures of Pharmaceutical segment assets as of December 31, 2005 (see Note 5).

 

Geographic Areas

   2006    2005    2004
     ($ in thousands)

Net Revenues-Continuing Operations

        

United States

   $ 8,051    $ 4,831    $ 4,486

United Kingdom

     262      750      26

Japan

     58      97      1,605

Other foreign countries

     60      193      1,433
                    

Total Consolidated

   $ 8,431    $ 5,871    $ 7,550
                    

Long Lived Assets

        

United States

   $ 1,348    $ 1,631    $ 1,923

United Kingdom and Denmark

     177      187      270
                    

Total Long Lived Assets

   $ 1,525    $ 1,818    $ 2,193
                    

 

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The Company’s registered office is located in the United Kingdom. The majority of its employees are based in the United States from where it liaises with the U.S. investing public and from where the primary sales and development of skincare activities are directed.

 

15. Commitments and Contingencies

(a) Research

Under an agreement with the Institute of Experimental Botany, Senetek paid $70,000 in 2006 to support the Institute’s continued research on certain cytokinins and is committed to pay $90,000 in 2007 and $80,000 in 2008 in support of this and additional research into other classes of naturally-derived cytokinins.

In April 2005, the Company entered into an amendment of the agreement with RFMH, under which the licenses on all existing monoclonal antibody cell lines and any new cell lines were extended through June 2011 with a minimum guaranty of royalty receipts to RFMH of $430,000 per year through the new term of the license. In connection therewith, the Company entered into a new agreement with Signet Laboratories Inc., effective as of April 1, 2005 for its continued manufacture, marketing and sale of all monoclonal antibodies produced from the cell lines licensed by RFMH on revised royalty terms but subject to a guaranty that the Company’s net revenue from such sales would not be significantly less than under the original agreement, for the term of the new agreement.

In May 2006, the Company agreed to assign the Signet agreement to Covance Antibody Services, Inc. (“Covance”) in conjunction with Covance’s acquisition of Signet, on substantially the same terms, with a minimum guaranty of royalty receipts to Senetek of $860,000 per year through the term of the license.

(b) Commitments under Operating Leases

Minimum future lease payments and operating expense reimbursements under non-cancelable leases are as follows:

 

Years Ending December 31

   Future Minimum Payment
     ($ in thousands)

2007

   $ 56

2008

     13

2009

     5

2010

     5

2011

     1
      
   $ 80
      

Rent expense was approximately $196,000, $419,000, and 386,000 in 2006, 2005 and 2004 respectively.

(c) Litigation

On April 11, 2003, the Company filed lawsuit against OMP, Inc. (“OMP”) in the Los Angeles County Superior Court for common law misappropriation, breach of confidence, breach of contract, breach of implied covenant of good faith and fair dealing, intentional and negligent interference with prospective economic advantage, statutory and common law unfair competition, and unjust enrichment, and on October 28, 2003, OMP filed a lawsuit against Senetek in the United States District Court for the Northern District of California for

 

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violation of the Sherman Act and unfair competition as a result of Senetek’s alleged abuse of patents. In March 2004, the Company entered into a settlement agreement with OMP under which, in exchange for Senetek granting OMP the ongoing non-exclusive right to market and sell specified Obagi-K products containing Kinetin in Japan limited to its existing channel of trade, Senetek received an up front payment of $1.5 million in April 2004 and is to receive an additional $500,000 of quarterly royalty payments based on sales in Japan of skincare products containing Kinetin under the Obagi name. Through December 31, 2006, the Company had earned $259,000 of the total $500,000.

On June 2, 2003, the Company commenced a lawsuit in the High Court of Justice, Chancery Division, in London, England against Eagle-Picher Technologies, LLC and Eagle-Picher Industries Inc., both Ohio corporations (“Eagle-Pitcher”) alleging that the Defendants failed to perform under an April 1998 agreement pursuant to which they agreed to manufacture and supply phentalomine mesylate meeting required pharmacopoeial specifications for use as an active ingredient in the Company’s proprietary Invicorp® erectile dysfunction drug. In September 2004, the Company entered into a settlement agreement with Eagle-Pitcher under which in December 2004 the Company received a lump sum payment of $235,000 in release of all claims.

On September 16, 2005, the Company filed suit in the Superior Court of California for the County of Los Angeles against Bachem, Inc., doing business as Bachem California, a subsidiary of Swiss pharmaceutical company Bachem Holding, AG. The suit alleged fraud and negligent misrepresentation by Bachem in connection with its production and sale to Senetek in 1997 of vasoactive intestinal polypeptide, an active ingredient in Senetek’s patented erectile dysfunction treatment, Invicorp, for a purchase price of $1,100,000. Bachem has answered the Complaint and denied the Company’s material allegations. In October 2006, the Company requested and received a dismissal of the California suit and filed a breach of contract suit against Bachem for the same matter in the United Kingdom. The parties are proceeding with pretrial discovery.

(d) Employment Contracts and Deferred Compensation Plans

The Company has an employment agreement dated November 1, 1998, with Mr. Frank J. Massino, the Company’s Chairman and CEO, as amended effective June 30, 2000, October 31, 2002, January 1, 2003, and April 2006. The agreement and amendments, which were approved by the Compensation Committee of the Board of Directors, provide for a perpetual three-year term and an annual salary of $340,000 per annum. Mr. Massino’s base salary was increased to $360,000 effective January 1, 2007. The contract also provides for an automobile allowance of $1,000 per month and reimbursement of related automobile operating expenses. Under the agreement, Mr. Massino is entitled to an annual bonus, to be determined by the Compensation Committee, and is eligible to participate in the Company’s management bonus plan, if any. In the event that Mr. Massino’s employment is terminated by the Company (other than for “permanent disability” or “cause”, as such terms are defined in the agreement) or by Mr. Massino for “good reason” (as defined in the agreement), Mr. Massino would become entitled to a lump sum payment equal to the product of multiplying his base salary (and a deemed bonus, if any, as determined in accordance with the agreement) by three (i.e., the number of years remaining under the “evergreen” provisions of his employment agreement). Further, in such circumstance, all unvested and/or unexercisable options held by Mr. Massino would become immediately vested and exercisable. The agreement also provides for payment of three years’ worth of additional compensation upon consummation of certain changes of control (as defined in the agreement), provided that the Company would not be required, on a change of control, to pay Mr. Massino any amounts that would constitute an “excess parachute payment” under the Internal Revenue Code.

The Company has a payment agreement dated March 5, 2007 with Mr. William O’Kelly, the Company’s Chief Financial Officer that requires the Company to make certain severance payments to Mr. O’Kelly in the

 

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event his employment is terminated under certain circumstances. If: (A) following a Change of Control, the Company does not retain Mr. O’Kelly as Chief Financial Officer or he is not offered a position of Equivalent Authority by the Company or a Successor Enterprise or (B) Mr. O’Kelly does not continue his employment with the Company or a Successor Enterprise after a Relocation, then, in either such event, the Company will continue to pay his base salary as at the date of the Change of Control or Relocation for a period of six months following his separation from the Company or the Successor Enterprise.

In January 2004, the Company established Deferred Compensation Plans (the “Plans”) for the board of Directors and the executive officers of the Company. Under the terms of the Plans, the Director’s quarterly stipend and 10% of executive officers salary was to be paid in stock. The Plan’s were terminated effective December 31, 2004 and in March 2005 the Company issued 298,926 shares of stock due under the terms of the Plans.

(e) Indemnifications

Under its Articles of Association, the Company is required to indemnify its officers and Directors for all costs, losses and liabilities they may incur as a result of the officer or Director’s serving in such capacity subject to statutory restrictions. The term of the indemnification period is for the officer’s or Director’s lifetime.

The maximum potential amount of future payments the Company could be required to make under the indemnification provisions contained in its Articles of Association is unlimited except as provided by applicable law. However, the Company has a Director’s and Officer’s liability insurance policy that limits its exposure and enables it to recover all or a portion of any future amounts paid by the Company to indemnify a Director or officer. As a result of its insurance policy coverage, management believes the estimated fair value of these indemnification obligations is minimal and has no liabilities recorded for these agreements as of December 31, 2006.

The Company enters into indemnification provisions under its agreements with other companies in its ordinary course of business, typically with licensees, research institutes at which studies are conducted, landlords, investment bankers and financial advisers. Under these provisions the Company generally indemnifies and holds harmless the indemnified party for losses suffered or incurred by the indemnified party as a result of their performance of such agreements except in cases of their negligence or default. These indemnification provisions often include indemnifications relating to representations made by the Company, including those with regard to intellectual property rights. These indemnification provisions generally survive termination of the underlying agreement. In some cases, the Company has obtained insurance providing coverage for losses such as these, against which the Company has agreed to indemnify a third party. The maximum potential amount of future payments the Company could be required to make under these indemnification provisions generally is limited. The Company has not incurred material costs in connection with defending these indemnification agreements. As a result, management believes the estimated fair value of these obligations is minimal. Accordingly, the Company has no liabilities recorded for these agreements as of December 31, 2006.

(e) Settlement

During 2002, the Company negotiated a settlement with a group of Danish doctors related to their foregoing royalties against future Invicorp® sales. The Company will pay a total of $150,000 over a five year period, $7,500 quarterly through March 2007. The Company recorded the entire $150,000 as expense in 2002. As of December 31, 2006, $7,500 is unpaid.

 

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NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

 

16. Related Party Transactions

The Company is required to pay the two discoverers of Kinetin an equal royalty based on the Company revenues from Kinetin. One of the discoverers of Kinetin is Dr. Brian Clark; the Chief Scientist for the Company. Total royalty expense related to Kinetin Sales for 2006, 2005, and 2004 totaled $158,000, $107,000 and $104,000 respectively, of which Dr. Clark received 50%. As of December 31, 2006 and 2005, $158,000 and $107, 000 is included in accounts payable. For his role as Chief Scientist, Dr. Clark is paid an annual fee of $108,000.

Mr. Anthony Williams, a Director of the Company, has been a partner of the law firm of Baker & McKenzie LLP since September 2005 and prior to that was a partner of the law firm of Coudert Brother LLP. Both law firms have rendered legal services to the Company. 2006 legal fees paid to Baker & McKenzie LLP totaled $232,000. Legal fees paid to Baker & McKenzie LLP and Coudert Brothers LLP in 2005 aggregated $518,000. In 2004, the Company paid $530,000 for legal fees and expense reimbursement to Coudert Brothers LLP.

On June 1, 2004 the Company entered into (i) an agreement with Mr. Andreas Tobler, Chief Operating Officer, Managing Director of Europe, terminating his employment effective May 1, 2004 and providing for management to recommend to the Nominating Committee that Mr. Tobler be elected a Director at the 2004 Annual General Meeting, (ii) a consulting agreement with Mr. Tobler providing for his services in connection with the licensing or other disposition of certain businesses within the Company’s Pharmaceutical Segment and the development of the Company’s Skincare Segment from May 1, 2004 through November 1, 2005 for fees totaling $198,000, and (iii) a licensing agreement with Mr. Tobler providing for him to be paid an introductory fee based upon the Company’s revenues from certain new licensing transactions introduced by Mr. Tobler equal to 5% of the Company’s revenue in the first year of any such license, decreasing by 1% per year through the fifth year of revenues from any such license. During 2005 and 2004, Mr. Tobler earned $99,000 and $115,500, respectively, under the consulting agreement. No payments were made in 2006 and this agreement was terminated effective April 1, 2006.

On May 1, 2004, the Company entered into a consulting agreement with Stewart Slade, Senetek’s Company Secretary and formerly an officer, pursuant to which Mr. Slade agreed to perform services related to the handling, development, evaluation, testing and regulatory compliance of the Company’s proprietary drug Invicorp® and its proprietary automatic injection device Reliaject®, including the timely handling of all aspects of inquiries by the United Kingdom Medicines and Healthcare Regulatory Agency (“MHRA”) concerning the Company’s named patient supply program (“NPSP”) of Invicorp® 1 and 2, the sign-off of all shipments of Invicorp® 1 and 2 under the NPSP, and assisting with information requests made by MHRA and prospective licensees or purchasers of Invicorp® and/or Reliaject®. The agreement provided for consulting fees at the rate of UK £5,000 per calendar month, payable monthly arrears after invoicing by the consultant or, if the agreement continued beyond July 31, 2004, fees at the rate of UK £400 per day of Consulting Services provided. During 2005 and 2004, Mr. Slade earned $126,000 and $110,000 respectively, under the consulting agreement. No payments were made in 2006.

The Company had an employment agreement with Mr. Brad Holsworth, formerly Senetek’s Chief Financial Office, with an effective term commencing March 1, 2003 and ending April 30, 2005. The agreement provided for salary of $185,000 per annum and an automobile allowance of $500 per month. Under the agreement, Mr. Holsworth was eligible to participate in the Company’s management bonus plan and management was required to recommend that Mr. Holsworth be issued options to purchase 175,000 ordinary shares under the No. 1 Plan. Mr. Holsworth subsequently agreed to surrender his claim for an award of these options in exchange for the payment of one week’s salary. In the event that Mr. Holsworth’s employment was terminated by the Company (other than for legal disability or cause, as defined in the agreement) or by Mr. Holsworth in the event

 

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SENETEK PLC

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

 

of certain material breaches of the agreement by the Company, Mr. Holsworth would have become entitled to continued payment of his compensation, at the rate of compensation then in effect, for a period of 12 months following his termination.

The Company has an employment agreement with Mr. Wade Nichols, formerly Senetek’s Executive Vice President-Corporate Development and General Counsel, with an effective term commencing March 1, 2003 and ending February 28, 2005. The agreement provided for salary of $243,000 per annum and an automobile allowance of $600 per month. Under the agreement, Mr. Nichols was eligible to participate in the Company’s management bonus plan. On March 23, 2005, the Company and Mr. Nichols entered into an agreement pursuant to which his employment with the Company terminated effective as of March 31, 2005. This termination agreement provided, among other things, for continuation of Mr. Nichols’ salary (at its current rate) for a period of five months following this departure and for reimbursement of certain relocation costs in the amount of $7,000. In connection with entering into this termination agreement Mr. Nichols agreed to surrender his claim for an award of options on 150,000 shares that had been provided for in his employment agreement. Effective April 1, 2005, the Company entered into a consulting agreement with Mr. Nichols pursuant to which Mr. Nichols agreed to perform services within the areas of his expertise as former General Counsel and Head of Corporate Development of the Company, as and if requested by the Company, for a fee of $200 per hour for work performed locally or $1,000 per day for any work requiring long-distance travel. The agreement is terminable by either party on thirty days notice. During 2006 and 2005, Mr. Nichols earned $104,000 and $32,000, respectively, under the consulting agreement.

New non-management Directors historically were granted an option to purchase 150,000 ordinary shares upon joining the Board, although there is no established policy requiring such grants. No options were granted to Directors in or subsequent to 2005 related to their Board duties, and as described in Note 9, “Stock Option Plans” the stock option plan under which non-management Directors had historically been granted options expired by its terms in December 2005. Inasmuch as Mr. Aliahmad and Mr. Khoury, who became Directors in April 2005 had not been granted stock options at the commencement of their Board service, in connection with their resignations on the Closing Date of the Repayment Agreement described under Note 8, Notes Payable-Retirement of Senior Secured Notes and Outstanding Warrants”, the Company paid to each of them $20,000, approximately the Black Scholes value of three-year stock options to purchase 150,000 ordinary shares of the Company, and entered into agreements obligating the Company to indemnify them against any liabilities or costs of defense arising out of their Board of Directors service to the fullest extent permitted by law, as required by the Company’s Articles of Association.

 

17. Quarterly Information (unaudited)

 

     First
Quarter
    Second
Quarter
   Third
Quarter
   Fourth
Quarter
   2006

2006

             

Net Revenue

   $ 2,269     $ 2,005    $ 2,027    $ 2,130    $ 8,431

Gross Profit

     1,927       1,805      1,819      1,871      7,423

Operating income from continuing operations

     815       534      726      531      2,607

Income (Loss) from continuing operations

     (58 )     507      726      530      1,660

Income from discontinued operations

     45       44      45      45      223

Net Income (loss)

     (13 )     551      771      575      1,883

Basic and diluted income per share:

             

Continuing operations

   $ —       $ 0.01    $ 0.01    $ 0.01    $ 0.03

Discontinued operations

     —         —        —        —        —  
                                   

Net Income per share

   $ —       $ 0.01    $ 0.01    $ 0.01    $ 0.03
                                   

 

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SENETEK PLC

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

 

     First
Quarter
    Second
Quarter
    Third
Quarter
    Fourth
Quarter
    2005  

2005

          

Net Revenue

   $ 1,239     $ 1,477     $ 1,644     $ 1,511     $ 5,871  

Gross Profit

     1,047       1,296       1,332       1,320       4,995  

Operating income (loss) from continuing operations

     (456 )     84       (43 )     (646 )     (1,061 )

Loss from continuing operations

     (628 )     (132 )     (266 )     (846 )     (1,872 )

Income from discontinued operations

     44       44       —         45       133  

Net loss

     (584 )     (88 )     (266 )     (801 )     (1,739 )

Basic and diluted loss per share:

          

Continuing operations

   $ (0.01 )   $ —       $ (0.01 )   $ (0.01 )   $ (0.03 )

Discontinued operations

     —         —         —         —         —    
                                        

Net loss per share

   $ (0.01 )   $ —       $ (0.01 )   $ (0.01 )   $ (0.03 )
                                        

 

18. Subsequent Events

On March 16, 2007, the Company received $1,312,000 in settlement of claims against professional services provider arising over past performance related matters. $1,200,000 of this amount was paid in cash and the remainder represents a write-off of fees owed. The Company has recorded the settlement as income in the quarter ended March 31, 2007. In conjunction with the settlement, the Company recorded $10,000 in related legal costs and expenses.

On March 30, 2007, the Company completed a License Acquisition Agreement with Valeant. Under the terms of the License Acquisition Agreement, the Company has granted Valeant a paid up license for Kinetin and Zeatin and assigned to Valeant future royalties from other Kinetin licensees, in return for a cash payment of $21 million, a waiver of $6 million in future marketing credits the Company otherwise would have owed to Valeant, and a right to share in future royalties due to Valeant from other Kinetin licensees through 2011. As a result of this transaction, goodwill of $1,308,000 was determined to be impaired and concurrently written off in March 2007.

In connection with this transaction, the Company terminated its line of credit with Silicon Valley Bank and paid off the outstanding balance of $1,500,000.

The $21 million cash payment will be fully includable in 2007 revenues along with approximately $3,750,000 in previously deferred revenue related to the prior license agreement.

 

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Table of Contents

SCHEDULE II

SENETEK PLC

VALUATION AND QUALIFYING ACCOUNTS

 

     Balance,
Beginning of
Period
   Additions
Charges to Revenues
or Costs and
Expenses
   Deductions-
Write-offs
Charged to Reserve
    Balance,
End of Period

ALLOWANCES AGAINST TRADE AND NON-TRADE RECEIVABLE—

          

Year Ended December 31,

          

2006

   $ 120,000    $ 35,000    $ (5,000 )   $ 150,000

2005

     80,000      40,000      —         120,000

2004

     78,000      35,000      (33,000 )     80,000

ALLOWANCES AGAINST INVENTORIES—

          

Year Ended December 31,

          

2006

   $ 429,000    $ 3,000    $ (432,000 )   $ —  

2005

     404,000      108,000      (83,000 )     429,000

2004

     320,000      84,000      —         404,000

 

89

EX-10.108 2 dex10108.htm AMENDMENT DATED AS OF MAY 19, 2006 AMONG SIGNET LABORATORES, INC. Amendment dated as of May 19, 2006 among Signet Laboratores, Inc.

Exhibit 10.108

AMENDMENT

This Amendment (this “Amendment”), dated as of May 19, 2006 (the “Effective Date”), is entered into by and among, Signet Laboratories, Inc., a Delaware corporation (“Signet”), Senetek Plc, a United Kingdom company (“Senetek”), Research Foundation for Mental Hygiene, Inc. (“RFMH”) and Covance Antibody Services, Inc., a California corporation (“Covance”).

Senetek and RFMH are parties to an Agreement dated July 21, 1994, and subsequently amended (the “Basic Agreement”). Senetek and Signet are parties to an Agreement dated January 1, 2005, and subsequently amended (the “Secondary Agreement”) concerning the subject matter of the Basic Agreement. Signet and Covance are parties to an Asset Purchase Agreement dated April 10, 2006 (the “APA”) in which Covance has agreed to acquire substantially all of the assets of Signet and to assume certain liabilities of Signet related to the assets acquired, including Signet’s rights and obligations under the Secondary Agreement arising on and after the effective date of such assignment (the “Closing Date”).

In consideration of the mutual covenants and conditions set forth below, the adequacy of which is acknowledged, the parties agree as follows:

1. Senetek consents to the assignment of the Secondary Agreement as described above, waives any breach or default under the Secondary Agreement arising from or related to such assignment, and releases Signet from all liabilities and obligations under the Secondary Agreement occurring on or after the Closing Date. RFMH consents to the assignment of the Secondary Agreement as described above and waives any breach or default under the Basic Agreement arising from or related to such assignment. Covance agrees to pay, perform and discharge all liabilities and obligations of Signet under the Secondary Agreement arising on or after the Closing Date.

2. It shall be a condition of Senetek’s and RFMH’s consents to the assignment of the Secondary Agreement pursuant to paragraph 1 and their agreements therein that Covance shall be responsible only for liabilities and obligations under the Secondary Agreement arising on and after the Closing Date, that on the Closing Date Signet shall deposit with Silicon Valley Bank, as escrow agent (the “Escrow Agent”), by wire transfer, the sum of Fifty Thousand Dollars ($50,000.00) to be held by the Escrow Agent pursuant to the terms of the form of Escrow Agreement annexed hereto as Exhibit B as security for the prompt payment, performance and discharge by Signet of any and all liabilities and obligations of Signet under the Secondary Agreement arising prior to the Closing Date. Escrow shall be cleared within 30 days after the Closing Date.

3. RFMH and Senetek confirm that the definition of “Licensed Cell Lines” for purposes of the Basic Agreement, and Senetek and Signet confirm that the definition of “Cell Lines” for purposes of the Secondary Agreement, includes all cell lines set forth in Exhibit A, and that the expiry for all cell lines set forth in Exhibit A is July 1 0,2011.

4. RFMH agrees that in the event Senetek elects to terminate the Basic Agreement pursuant to Section 9.1 of the Basic Agreement, or RFMH elects to terminate the Basic

 

- 1 -


Agreement pursuant to (i) Sections 9.8 of the Basic Agreement or (ii) Section 9.2 of the Basic Agreement provided that Signet shall not have been primarily responsible for the breach giving rise to RFMH’s right of termination, (a) RFMH shall promptly notify Signet in writing, and (b) Signet may, in its sole discretion, agree to assume all rights and future obligations of Senetek pursuant to the Basic Agreement, as of the effective date of such termination, by notifying RFMH in writing within forty five (45) days of its receipt of such notice from RFMH, thereby establishing a direct contractual relationship between RFMH and Signet pursuant to the then existing terms and conditions of the RFMH Agreement. For clarity, Signet shall not be required to assume any liability or obligation of Senetek, including but not limited to the liabilities associated with the breach of agreement giving rise to RFMH’s option to terminate under Section 9.2, that arose prior to the time the direct contractual relationship between RFMH and Signet commenced. On and after the Closing Date, all references in this paragraph 4 and in paragraph 5 and 6 shall be deemed replaced with references to Covance.

5. Signet, Senetek and Covance further agree that the following sentence shall be added to section 3.5 of the Secondary Agreement:

“Where a Cell Line Product is not sold on independent arm’s length terms, but is used by Signet or an affiliate of Signet, Net Sales shall include the fair market value of such products. Fair market value shall be deemed to be the average selling price for such product during the prior calendar quarter.

6. Signet, Senetek, and Covance further agree that section 3.4 of the Secondary Agreement shall be replaced as follows:

“In the event that Signet’s aggregate Net Sales of Cell Line Products for any calendar year (“Yearly Net Sales”) are less than $1,880,000 (“Minimum Sales”), Signet shall remit to Senetek, together with the payment due for the fourth calendar quarter of such year, an amount equal to:

33% of the shortfall, if any, of Minimum Sales from Yearly Net Sales,

Aggregate payments to Senetek related to Net Sales for any calendar year, shall not be less than $860,000.

 

- 2 -


Signet, Senetek, RFMH and Covance have caused this Agreement to be executed, effective as of the Effective Date.

 

SIGNET LABORATORIES, INC.     SENETEK PLC
By   /s/ Ronald J. Casciato, Ph. D.     By   /s/ William O’Kelly
Name:   Ronald J. Casciato, Ph. D.     Name:   William O’Kelly
Title:   CEO     Title:   CFO
Date:   May 19, 2006     Date:   May 21, 2006

 

RESEARCH FOUNDATION FOR HYGIENE, INC.     COVANCE ANTIBODY SERVICES INC.
By   /s/ Robert E. Burke     By   /s/ Christian Fritze
Name:   Robert E. Burke     Name:   Christian Fritze
Title:   Managing Director     Title:   Asst. VP
Date:   May 30, 2006     Date:   June 2, 2006

 

- 3 -


EXHIBIT A

4G8 6ElO 3F4 lEll 2H4 4D6 4B12 7D9

4B4 5-25 3-39 l7C7 D8B7 4E2 D6ElO

E6D7 lOD12 5F3 4H6 5C7 6Dll

 

- 4 -

EX-10.109 3 dex10109.htm CONTRACT FOR PERSONAL SERVICES BETWEEN SENETEK PLC AND BRIAN CLARK Contract for Personal Services between Senetek PLC and Brian Clark

Exhibit 10.109

CONTRACT FOR PERSONAL SERVICES

 

Between     

Senetek PLC

831 Latour Court, Suite A

Napa, California 94558

(“Company”)

And     

Brian Clark

(“Chief Scientist”)

Scope

Effective August 1, 2006, Brian Clark is appointed Chief Scientist of Senetek PLC reporting to the Chairman and Chief Executive Officer of the Company.

Responsibility

The Chief Scientist will work under the direction of the Chairman and CEO of the Company. Such direction will be principally provided via a rolling three month schedule of activities and objectives, mutually agreed by the Chief Scientist and the Chairman and CEO on a monthly basis.

Required Time Commitment

Chief Scientist will commit 31 weeks per year to Senetek business and give Senetek business first order of priority with respect to other business activities in which he may be engaged.

Other Business Activities

Chief Scientist may be engaged in business activities other than Senetek but such business activities shall not be of a nature that is directly competitive with Senetek and will be subject to Senetek priority as discussed in the paragraph above.

Fee

$9,000 per month, payable on the 15th day of the month.

Location and Travel

Chief Scientist will be based in Aarhus, Denmark. Expenses for travel undertaken on Senetek business will be reimbursed provided it is agreed in advance with the Chairman and CEO.

Other Expenses and Support

Non-travel expenses undertaken for Senetek business will be reimbursed subject to advance approval by the Chairman and CEO or the CFO of Senetek PLC.


Contract for Personal Services

Page 2

Administrative support will be provided by Senetek PLC – Napa.

Term and Termination

This contact will remain in force until terminated by either party to the contract. Such termination is solely at the will of either party, subject to a three month notice period.

 

/s/ Senetek PLC   August 8, 2006
Senetek PLC   Date
/s/ Brian Clark   August 8, 2006
Brian Clark   Date
EX-10.110 4 dex10110.htm AGREEEMENT ON COOPERATIVE RESEARCH AND DEVELOPMENT - PHLORETAMIDE Agreeement on Cooperative Research and Development - Phloretamide

Exhibit 10.110

AGREEMENT ON COOPERATIVE RESEARCH AND DEVELOPMENT

between

Institute of Bioorganic Chemistry, Polish Academy of Sciences

(hereinafter referred to as “RESEARCHERS”)

and

Senetek PLC

831 Latour Court, Suite A

Napa, California 94558 USA

(hereinafter referred to as “SENETEK”)

WHEREAS the RESEARCHERS, are performing basic research on phloretamide (the “Compounds”) and are willing to provide to SENETEK samples of the Compounds and their analogs and related information developed by the RESEARCHERS, including any covered by patents and/or patent applications owned by the RESEARCHERS, for testing, possible further development by SENETEK, and ultimately possible licensing to and commercialization by SENETEK; and

WHEREAS SENETEK is a company developing pharmaceutical and cosmeceutical products and, in connection with such business, has made certain inventions regarding cytokinins and cytokinin analogs and methods of using them for various indications related to ameliorating signs of aging and anti-inflammatory indications which are covered by the SENETEK PATENTS, as hereinafter defined; and

WHEREAS SENETEK is interested in testing and evaluating, in cooperation with the RESEARCHERS, the Compounds, including the Compounds in combination with active ingredients covered by the SENETEK PATENTS, as hereinafter defined, developed by the RESEARCHERS and in obtaining licenses covering such of these compounds as it may select as hereinafter provided.

NOW THEREFORE in consideration of above-mentioned premises the parties agree as follows:

 

Phloretamide


ARTICLE 1 - DEFINITIONS

AFFILIATES as used herein shall mean any legal entity which, at the EFFECTIVE DATE or during the validity of this Agreement:

 

   

directly or indirectly controls SENETEK,

 

   

is under the same direct or indirect control as SENETEK, or

 

   

is directly controlled by SENETEK

A legal entity is considered controlling another:

 

   

when it directly or indirectly owns over 50% (fifty percent) of the capital of this legal entity or more than 50% (fifty percent) of the voting rights of its shareholders or associates; or

 

   

when it has the direct or indirect de facto, directly or indirectly, the power to decide within this legal entity how the affairs shall be conducted.

AGREEMENT as used herein shall mean this agreement and any and all f\nnexes, appendices and other addenda to it as it may be varied from time to time

COMPOUNDS as used herein means phloretamide and its analogs and derivatives, developed, in-licensed or otherwise acquired by the RESEARCHERS that may be used for any application. TESTING as used herein means any testing to determine the most suitable COMPOUNDS for patenting and further development.

RESEARCHERS as used herein means the the Institute of Bioorganic Chemistry, Polish Academy of Sciences

PARTY as used herein means any of the PARTIES to this AGREEMENT as the case may be, and all of them when used in plural.

NEW PATENT APPLICATIONS as used herein means patent applications of the RESEARCHERS to be prepared and filed in the name of the RESEARCHERS with technical and financial support of SENETEK, including those the subject of which is medical and cosmetic skincare applications of COMPOUNDS, and any and all patents issued thereon or having a priority date based thereon.

RESEARCHERS’ PATENTS as used herein means any currently owned patents and patent applications of RESEARCHERS covering COMPOUNDS, other than NEW PATENT APPLICATIONS.

SENETEK PATENTS as used herein means SENETEK’s issued patents (U.S. Patents 5,371,089, 5,602,139, 5,614,407,5,021,422, 5,164,394, and 5,151,425 and the corresponding international and foreign patents) related to the use of cytokinins for anti-inflammatory indications and for medical skin care applications and/or cosmetic skin care applications, and any patents hereafter issued which are entitled to the same priority date(s) as such issued patents.

 

Phloretamide

2


PRODUCT as used herein means any product which or the process of production of which falls within a VALID CLAIM of a patent licensed to SENETEK pursuant to this AGREEMENT.

SUB-LICENSEES as used herein mean any third parties who may obtain a license from SENETEK to develop and/or commercially exploit any COMPOUND covered by a patent licensed to SENETEK pursuant to this AGREEMENT.

FIRST COMMERCIAL SALE as used herein means the first commercial sale of a PRODUCT to a third party made by either SENETEK or its AFFILIATES or SUBLICENSEES.

NET SALES as used herein means the gross amount invoiced by SENETEK and its AFFILIATES to their customers or by SUB-LICENSEES and their AFFILIATES to their customers, including distributors and third parties, for sales of PRODUCTS, less any normal trade discounts and credit notes issued in respect of returned PRODUCTS, any purchase, sales, import, or value added taxes, and charges in respect to carriage. Should SENETEK or a SUB-LICENSEE sell PRODUCTS to an AFFILIATE (or vice-versa) which thereafter sell them to an unrelated third party, the sales between the AFFILIATE (or SENETEK or SUBLICENSEE) and the unrelated third party (and not the sales between SENETEK or SUBLICENSEE and its AFFILIATE) shall be considered NET SALES.

VALID CLAIM as used herein means any claim of an issued and unexpired patent or a claim of a pending patent application licensed to SENETEK pursuant to this AGREEMENT which has not been held un-patentable, invalid or unenforceable by a court or other government agency of competent jurisdiction and has not been admitted to be invalid or unenforceable through reissue, re-examination, disclaimer or otherwise; provided, however, that if the holding of such court or agency is later reversed by a court or agency with overriding authority, the claim shall be reinstated as a VALID CLAIM after the date of such reversal.

EFFECTIVE DATE as used herein shall mean the date of the last signature of this AGREEMENT by the PARTIES.

All plurals may be read in the singular and vice versa.

The headings are inserted for convenience only and shall be ignored in construing this AGREEMENT.

ARTICLE 2 - SCOPE OF THE AGREEMENT

 

2.1 Subject to the terms and conditions of this AGREEMENT, SENETEK shall from time to time, as provided in Article 3 below, obtain from the RESEARCHERS such of the COMPOUNDS as SENETEK may designate.

 

2.2 During the term of this AGREEMENT SENETEK will screen and conduct TESTING of these COMPOUNDS.

 

Phloretamide

3


2.3 If SENETEK finds one or more of the TESTED COMPOUNDS of interest and wishes to exploit it or them commercially, SENETEK and the RESEARCHERS will negotiate and sign license agreements, as defined in Article 3.5 hereof.

 

2.4 SENETEK will pay royalty related to the NET SALES of PRODUCTS to RESEARCHERS as set in the ANNEX 1—License Agreement Term Sheet, attached to this AGREEMENT.

ARTICLE 3 - DUTIES OF THE PARTIES

 

3.1 Promptly after the EFFECTIVE DATE, and thereafter at least once every calendar year, the RESEARCHERS shall provide SENETEK with a complete listing and description of all COMPOUNDS developed, in licensed or otherwise acquired by the RESEARCHERS, together with all chemical and biological information in their possession with respect to such COMPOUNDS and specifying those COMPOUNDS, if any, which are covered by RESEARCHERS’ PATENTS.

 

3.2 Not later than two (2) weeks after delivery of such information by the RESEARCHERS, SENETEK will select and advise the RESEARCHERS, in writing, of those COMPOUNDS on which it wishes to conduct TESTING at that time. Notwithstanding the foregoing, as regards COMPOUNDS which the RESEARCHERS’ listing under Article 3.1 specifies are covered by the RESEARCHERS’ PATENTS, if SENETEK does not give the RESEARCHERS written advice that it wishes to conduct TESTING of any such COMPOUND within four (4) months after it receives the listing provided for in Article 3.1, SENETEK shall be considered to have waived its rights to such COMPOUND for all purposes of this AGREEMENT and the RESEARCHERS shall be free to commercialize such COMPOUND themselves, or enter into an evaluation agreement or license or other agreement with respect thereto with any third party on such terms as they may determine in their sole discretion, subject, however, to SENETEK’s rights, if any, under the SENETEK PATENTS and provided, however, that before RESEARCHERS shall enter into an evaluation agreement or license or other agreement with any third party, RESEARCHERS shall give notice to SENETEK of the terms on which they propose to enter into such evaluation agreement or license or other agreement and SENETEK shall have thirty (30) days to enter into such agreement with the RESEARCHERS on the same terms, providing these terms are not worse for the RESEARCHERS than the terms in Annex 1- License Agreement Term Sheet, in which case the terms of Annex 1 will be used.

 

3.3 The RESEARCHERS shall within two (2) weeks of receipt of each advice of SENETEK specifying selected COMPOUNDS it then wishes to TEST, deliver the selected COMPOUNDS to SENETEK in a quantity of at least 100 mg each.

 

3.4 If practicable, not later than nine (9) months after each delivery by the RESEARCHERS of the listing of COMPOUNDS as provided in Article 3.1, SENETEK will provide the RESEARCHERS with a report of the results of the TESTING of the new COMPOUNDS set forth in such listing. SENETEK will also indicate those COMPOUNDS for which SENETEK wishes to be granted a license. SENETEK may, if it so chooses, deliver such reports and indicate COMPOUNDS it wishes to license on more than one occasion during such period. Such license shall be exclusive and worldwide, for all applications.

 

Phloretamide

4


3.5 Within three (3) months of SENETEK’s decision to license COMPOUNDS as provided in Article 3.4, the PARTIES will enter into a License Agreement with respect to such COMPOUNDS having principal terms as set forth in Annex 1- License Agreement Term. The final details of the License Agreement will be negotiated in good faith by the PARTIES hereto.

 

3.6 If SENETEK does not deliver one or more reports as provided in Article 3.4 or, having delivered such report or reports, decides not to execute a License Agreement negotiated by the PARTIES as provided in Article 3.5, as to any particular COMPOUND or COMPOUNDS covered by any NEW PATENT APPLICATION, then the PARTIES will agree how to commercialize such COMPOUNDS and how to share revenues from such commercialization. Any such agreement on particular COMPOUNDS will be recorded in writing, signed by all PARTIES, and will become an appendix to this AGREEMENT. In case of COMPOUNDS covered by RESEARCHERS’ PATENTS, RESEARCHERS shall be free to commercialize such COMPOUND or COMPOUNDS themselves or enter into an evaluation agreement or license or other agreement with respect thereto with any third party on such terms as they may determine in their sole discretion, subject, however, to SENETEK’s rights, if any, under the SENETEK PATENTS.

 

3.7 RESEARCHERS agree that they will not enter into any cooperative research and development agreement with any third party involving any chemical compounds other than COMPOUNDS for cosmeceutical or anti-aging dermatological uses without first offering to SENETEK the opportunity to enter into such cooperative research and development agreement instead of such third party on the same terms as those proposed by or to such third party. SENETEK will exercise its right of first refusal within 4 weeks of receiving the proposed cooperative research and development agreement.

 

3.8 RESEARCHERS represent and warrant to SENETEK that their entering into and performing this AGREEMENT will not violate any agreement or obligation of either of the RESEARCHERS with or to any third party or give rise to any claim by any third party. The RESEARCHERS shall deliver to SENETEK, together with the AGREEMENT signed on their behalf, letters signed by authorized representatives of Ministry of Science and Information (MNII) and any other legal entity with which any of RESEARCHERS are affiliated, waiving any claim against SENETEK related to the subject matter of this AGREEMENT.

ARTICLE 4 - ADDITIONAL CONSIDERATION; DEVELOPMENT OF SELECTED COMPOUNDS

In addition to the RESEARCHERS’ rights of patent ownership under Article 5, as additional consideration for the rights granted to SENETEK herein SENETEK agrees that if SENETEK advises the RESEARCHERS as provided in Article 3.2 that it wishes RESEARCHERS to conduct TESTING on any COMPOUND or COMPOUNDS, SENETEK will be obligated to payor reimburse the RESEARCHERS for the expenses of such TESTING and/or further evaluation, in vitro testing, and development of the selected COMPOUNDS (collectively with

 

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the TESTING, the ‘R&D”). Such payments to the RESEARCHERS shall be made by bank transfer monthly, as such expenses are incurred, to the account titled:

BANK NAME:.

ADDRESS:

BRANCH NO:

SWIFT NO:

ACCOUNT NO:

NAME OF ACCOUNT HOLDER:

IBAN:

If the PARTIES agree that any R&D can most efficiently and effectively be done by the RESEARCHERS or by a third party laboratory with which the RESEARCHERS have a relationship, such expenses shall be billed at the RESEARCHERS’ direct cost of conducting or contracting out such activities. If the PARTIES agree that any R&D can most efficiently and effectively be done by SENETEK’s dedicated laboratories or by a third party laboratory or academic institution with which SENETEK has a relationship, SENETEK shall pay for such activities and provide the RESEARCHERS with documentation of such payment.

It is agreed by the PARTIES that they shall consult in good faith regarding the nature, scope and costs of all R&D, the protocols therefor and the most efficient and effective sourcing thereof, provided that if agreement cannot be reached between the PARTIES within a reasonable time (having in mind the time limits set forth herein), SENETEK’s position shall prevail. SENETEK shall own all rights to any and all test reports and test results from R&D paid for or reimbursed by SENETEK as above provided, and the RESEARCHERS agree not to make any publication or other disclosure thereof without SENETEK’S prior written approval.

ARTICLE 5 - INTELLECTUAL PROPERTY AND EXPLOITATION OF THE RESULTS

 

5.1 INVENTIONS THAT MAY BE CREATED UNDER RESEARCH CO-OPERATION OF PARTIES

In the event and on each occasion that the TESTING of the COMPOUNDS reveals an effect of any of the COMPOUNDS that is not covered by the SENETEK PATENTS or the RESEARCHERS’ PATENTS and that merits patent protection, the following arrangement shall apply:

(a) the PARTIES shall collaborate in the preparation of documents required for the filing of a patent application on each such invention;

(b) all such patent applications shall be filed and owned by the RESEARCHERS, and SENETEK shall have the right to an exclusive licence for use world-wide, for all applications;

(c) each patent application shall include the names of those employees of the PARTIES (as co-inventors) that were responsible for the development of the invention;

(d) the PARTIES will agree on the filing of foreign patent protection;

(e) in case SENETEK executes its right to license a COMPOUND covered by a patent prepared under this Article 5.1, SENETEK will take over the cost of obtaining and maintaining the patent protection of the invention; provided that if such patent covers COMPOUNDS which SENETEK has elected not to license or claims fields of use for COMPOUNDS licensed to SENETEK that are beyond the fields of use SENETEK has

 

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elected to license, the PARTIES shall share such cost according to the commercial potential of SENETEK’S COMPOUND and/or field of use and such COMPOUND(S) and/or fields of use not licensed to SENETEK.

(f) the license fee paid by SENETEK for the grant to it of an exclusive license shall take into account the contribution made by SENETEK (both of cash and intellectual property) to the jointly developed invention;

(g) if the RESEARCHERS do not wish to file a patent application covering a jointly developed invention in a certain TERRITORY, SENETEK may file a patent application covering the jointly developed invention in such TERRITORY at its own cost in which case the patent protection obtained shall be owned one hundred percent (100%) by SENETEK.

 

5.2 All scientific data regarding patent applications will be written by the RESEARCHERS, in English, and will be presented to SENETEK for review and comments. Each patent application will be first filed in the country of origin as a provisional patent application, and within one year it will be filed as PCT in all other territories to be covered.

ARTICLE 6 - CONFIDENTIALITY

 

6.1 In consideration of the use of the COMPOUNDS by SENETEK and receipt by the RESEARCHERS of periodic reports on results of TESTING, and in consideration of joint research performed by PARTIES, each receiving PARTY agrees that during the term of this AGREEMENT, it will not, except to the extent authorized by disclosing PARTY in writing, use for any purpose other than those described herein, or publish, disclose or release to any third party, any information regarding the R&D or TESTING conducted on such COMPOUND, except as may be required in connection with the filing and prosecution of NEW PATENT APPLICATIONS. Each RESEARCHER, by signing this AGREEMENT, agrees to be bound by all of the terms of this Article 6 with the same effect as if such RESEARCHER were the RESEARCHERS.

 

6.2 The above restraints on use, release, and/or disclosure shall not apply to information or effects and applications of COMPOUNDS which:

 

   

at the time of delivery or disclosure are known to the receiving PARTY;

 

   

at the time of delivery or disclosure or subsequent thereto are generally available to the public through no fault of the receiving PARTY;

 

   

subsequent to the time of delivery or disclosure are independently developed by an employee or agent of the receiving PARTY who does so without reference to or knowledge of the disclosing PARTY’S information or the COMPOUNDS;

 

   

subsequent to the time of delivery or disclosure become or are made available to the receiving PARTY by a third party having the lawful right to do so; or

 

   

subsequent to the time of such delivery or disclosure become subject of another agreement between the PARTIES hereto which permits use, release and/or disclosure.

The PARTY seeking to assert any of the above exceptions shall have the burden of proof.

 

6.3 The PARTIES shall maintain the obligation of confidentiality for five years after the expiration of this AGREEMENT.

 

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ARTICLE 7 - FORCE MAJEURE

 

7.1 Neither PARTY shall be liable for failure in performance hereunder if occasioned by any cause beyond the control of the P ARTY, such as for example fire, flood, strikes, inevitable accidents, war, embargo, blockade, legal restrictions, governmental relations, etc.

 

7.2 The occurrence of the Force Majeure shall be notified to the other PARTY in writing within 10 working days and shall be verified by the respective chamber of commerce within further 10 working days at the latest. Each PARTY undertakes to do its utmost in order to re-establish conditions favorable for the performance of this AGREEMENT and shall inform the other PARTY about steps it has taken. The term of this AGREEMENT will be extended by the period the Force Majeure had lasted.

ARTICLE 8 - TERM OF THE AGREEMENT

 

8.1 This AGREEMENT shall be become effective on the EFFECTIVE DATE and shall continue and remain in effect according to its terms without limitation of time until the expiration of the last VALID CLAIM of any NEW PATENT APPLICATION, unless terminated in accordance with Article 8.2 or 8.3.

 

8.2 This AGREEMENT can be prematurely terminated by agreement of both PARTIES or may be prematurely terminated by a PARTY upon not less than six months’ prior written notice to the other PARTY.

 

8.3 A PARTY shall have the right to terminate this AGREEMENT forthwith at any time by notice in writing to the other PARTY if the other PARTY commits a material breach of any of the terms of this AGREEMENT and does not within 30 days of receipt of notice of the breach (if the same be capable of remedy) remedy such breach.

 

8.4 Termination of this AGREEMENT for any reason shall not bring to an end the confidentiality obligations of the PARTIES hereto; and/or the rights and obligations (if any) on each PARTY hereunder.

ARTICLE 9 - DISPUTES

 

9.1 In the event of any difference or dispute arising between the PARTIES hereto concerning the construction or performance of this AGREEMENT or its validity, the PARTIES shall first consult together in good faith and attempt to settle the matter amicably.

 

9.2 Any disputes relating to the interpretation, construction, performance or validity of this AGREEMENT which cannot be resolved under Article 10.1 above, shall be referred to a final decision of a panel of three (3) arbitrators (the “Panel”), appointed under and acting in accordance with the Rules of the Arbitration Court of the International Chamber of Commerce in Paris. The seat of the Arbitration Court shall be in Vienna.

 

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9.3 The PARTIES specifically agree that if they are unable in good faith to reach agreement as to any details of the license agreement or agreements referred to in Article 3.5, they shall submit such disagreement to the Panel and request that the Panel determine such disagreement in a manner consistent with ordinary course business practices as applied by reasonable business persons in the industry to which this AGREEMENT relates. Such determination by the Panel shall be treated as a decision of the Panel for all purposes of this Article 10.

 

9.4 Both PARTIES agree that the decision of the Panel shall be final and binding and that they shall undertake to abide by and execute the award rendered by the arbitrators without delay. The enforcement of such an award may be applied for at any court of competent jurisdiction.

 

9.5 The AGREEMENT as well as the mutual obligations arising under it shall be exclusively governed by the provisions of the substantive law of Austria.

ARTICLE 10 - GENERAL

 

10.1 This AGREEMENT constitutes the sole and entire understanding either oral or written on the subject matter of the AGREEMENT. No further agreement or understanding shall be binding upon either PARTY hereto unless in writing signed by both PARTIES. This AGREEMENT shall not be assignable by any of the PARTIES hereto, without prior written consent of the other PARTIES.

 

10.2 The payments properly due to the RESEARCHERS under the AGREEMENT shall in no event be refundable to SENETEK. In the event of termination or expiration of this AGREEMENT SENETEK will pay all and any sums due to RESEARCHERS up to the date of expiration or termination. In the event that SENETEK shall be required to pay a tax on any payment to the RESEARCHERS, it shall deduct the amount of said tax from the payment due to the RESEARCHERS and shall provide the RESEARCHERS with a copy of the Certificate of the tax having been paid pursuant to an Agreement on Avoidance of Double Taxation or for other reasons.

 

10.3 The time periods provided for herein during which a PARTY is permitted or required to take any action shall be tolled and extended for such period of time, if any, as the other PARTY is in breach of any term of this AGREEMENT.

 

10.4 SENETEK hereby confirms that it has the expertise necessary to make use of any licensed patents and to develop, make, have made, sell, use, and otherwise commercially exploit the PRODUCTS.

 

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IN WITNESS WHEREOF, the PARTIES hereto have caused this AGREEMENT to be executed by their duly authorized representatives in a manner legally binding upon them as of the EFFECTIVE DATE.

 

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ANNEX 1

LICENSE AGREEMENT TERM SHEET

 

Term of License:    The term of the Valid Claims of the licensed patent(s).
Licensed Territory:    World-wide.
Scope of License:    Exclusive, for all applications.
Consideration:    Royalty of XXX of Senetek’s or its Affiliates’ Net Sales of licensed Products other than products covered by SENETEK PATENTS, and XXX of Senetek’s or its Affiliates’ Net Sales of licensed Products covered by SENETEK PATENTS,
   Royalty of XXX of Senetek’s SUB-LICENSEES’ Net Sales of sub-licensed products other than products covered by SENETEK PATENTS, and XXX of Senetek’s SUBLICENSEES’ Net Sales of sub-licensed products covered by SENETEK PATENTS
Sub-licensing/ Assignment:    No limitation
Senetek Covenants:    Validity and enforceability of License Compliance with law in performing License
RESEARCHERS’ Covenants:    Validity and enforceability of License Maintenance and defense of licensed patents
Indemnification:    By Senetek for liability from any non-compliance with law in manufacture, marketing or sale of licensed products.
   By the RESEARCHERS for invalidity or unenforceability of licensed patents up to the value of payments received from SENETEK in preceding calendar year.
Termination:    By either Party for material breach by the other Party or insolvency or liquidation of the other Party.
Confidentiality:    Per basic AGREEMENT Agreed press release upon signing
Applicable Law:    Per basic AGREEMENT.
Other Terms:    See Annex 2

 

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ANNEX 2

COMMERCIAL TERMS GOVERNING LICENSE

1. SENETEK will inform RESEARCHERS in writing of the dates of each FIRST COMMERCIAL SALE, within 2 (two) months of occurrence of such FIRST COMMERCIAL SALE.

2. Where PRODUCT is sold in a currency other then US Dollars, the rate of exchange to be used for converting such currency into US Dollars shall be the exchange rate, as published in the Financial Times, at the end of the relevant accounting period.

3. The payments shall be made within 60 days of the end of calendar quarter, and shall be accompanied by a statement which shall show on a country by country basis for the previous quarter all monies due to the RESEARCHERS. Said sales report shall include the sales figures used to calculate the royalties due to the RESEARCHERS, as well as the quantities sold, the unit price of any quantity of the PRODUCTS both by SENETEK and its AFFILIATES or SUB-LICENSEES.

4. The royalty properly due to the RESEARCHERS shall in no event be refundable to SENETEK.

5. In the event that SENETEK shall be required to pay a tax on any payment to the RESEARCHERS, it shall deduct the amount of said tax from the payment due to the RESEARCHERS and shall provide the RESEARCHERS with a copy of the Certificate of the tax having been paid pursuant to an Agreement on Avoidance of Double Taxation or for other reasons.

6. SENETEK shall prepare accounts, which shall include all the elements necessary to precisely calculate the NET SALES and NET ROYALTY within the framework of the AGREEMENT. If necessary these accounts shall be made available once a year with 30 days notice to the RESEARCHERS or an accredited designee of the RESEARCHERS during the term of the AGREEMENT and for one year thereafter. These accounts shall be prepared annually within 90 (ninety) days of the closing date of December 31 of each year which represents the end of SENETEK’s fiscal year.

7. Any sums which remain unpaid within the periods set out hereunder shall be subject to interest of 3% (three percent) over above LIBOR as published in the Financial Times at the end of the relevant accounting period, without prejudice to the RESEARCHERS’ right to terminate the contract in accordance with Article 10 of the present AGREEMENT.

8. The RESEARCHERS shall have the right once a year with 30 days notice to audit or have audited the sales accounts kept by SENETEK. Should there be an audit, an expert accountant shall be appointed by mutual agreement of both PARTIES at the expense of the RESEARCHERS, except that if the amount of installments shown by such audit to be due to the RESEARCHERS exceed the amount actually paid by SENETEK by 5% (five percent), then such expenses shall be paid by SENETEK and any back payments shall be reimbursed with per the Agreement.

9. SENETEK agrees to make reasonable efforts to make, have made, sell and otherwise commercially exploit the PRODUCTS, using similar efforts devoted to products of similar nature and similar markets.

 

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10. SENETEK agrees to provide annual reports on the development and exploitation of the PRODUCTS.

11. SENETEK and its AFFILIATES agree not to use the names of the RESEARCHERS, any trademark, distinctive sign or adaptations thereof which belongs to the RESEARCHERS or the names of RESEARCHERS inventors or of any RESEARCHERS agent, on packaging, labeling, advertising or promotional materials for the PRODUCTS without receiving prior written approval from the RESEARCHERS and the natural person concerned, as the case may be.

12. PRODUCTS shall be commercialized by SENETEK, its AFFILIATES and its SUBLICENSEES under their own trademarks. The RESEARCHERS shall have no rights to such trademarks. All administrative authorizations obtained by SENETEK, its AFFILIATES or its LICENSEES for the purpose of manufacturing and/or commercializing the PRODUCTS shall be obtained for them. The RESEARCHERS shall claim no rights thereto.

13. SENETEK accepts the obligation to inform by writing the RESEARCHERS of all administrative marketing approvals that it obtains for the purpose of manufacturing and/or commercializing the PRODUCTS no later than 3 (three) months after obtaining such final authorizations.

 

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EX-10.111 5 dex10111.htm AGREEMENT ON COOPERATIVE RESEARCH AND DEVELOPMENT - PLANT NUCLEIC ACIDS Agreement on Cooperative Research and Development - Plant Nucleic Acids

Exhibit 10.111

AGREEMENT ON COOPERATIVE RESEARCH AND DEVELOPMENT

Institute of Bioorganic Chemistry, Polish Academy of Sciences

(hereinafter referred to as “RESEARCHERS”)

and

SenetekPLC

831 Latour Court, Suite A

Napa, California 94558 USA

(hereinafter referred to as “SENETEK”)

WHEREAS the RESEARCHERS are performing basic research on plant nucleic acids (the “Compounds”) and are willing to provide to SENETEK samples of the Compounds and their analogs and related information developed by the RESEARCHERS, including any covered by patents and/or patent applications owned by the RESEARCHERS, for testing, possible further development by SENETEK, and ultimately possible licensing to and commercialization by SENETEK; and

WHEREAS SENETEK is a company developing pharmaceutical and cosmeceutical products and, in connection with such business, has made certain inventions regarding cytokinins and cytokinin analogs and methods of using them for various indications related to ameliorating signs of aging and anti-inflammatory indications which are covered by the SENETEK PATENTS, as hereinafter defined; and

WHEREAS SENETEK is interested in testing and evaluating, in cooperation with the RESEARCHERS, the Compounds, including the Compounds in combination with active ingredients covered by the SENETEK PATENTS, as hereinafter defined, developed by the RESEARCHERS and in obtaining licenses covering such of these compounds as it may select as hereinafter provided.

NOW THEREFORE in consideration of above-mentioned premises the parties agree as follows:

 

Plant Nucleic Acids


ARTICLE 1 - DEFINITIONS

AFFILIATES as used herein shall mean any legal entity which, at the EFFECTIVE DATE or during the validity of this Agreement:

 

   

directly or indirectly controls SENETEK,

 

   

is under the same direct or indirect control as SENETEK, or

 

   

is directly controlled by SENETEK

A legal entity is considered controlling another:

 

   

when it directly or indirectly owns over 50% (fifty percent) of the capital of this legal entity or more than 50% (fifty percent) of the voting rights of its shareholders or associates; or

 

   

when it has the direct or indirect de facto, directly or indirectly, the power to decide within this legal entity how the affairs shall be conducted.

AGREEMENT as used herein shall mean this agreement and any and all Annexes, appendices and other addenda to it as it may be varied from time to time

COMPOUNDS as used herein means plant nucleic acids and their analogs and derivatives, developed, in-licensed or otherwise acquired by the RESEARCHERS that may be used for any application.

TESTING as used herein means any testing to determine the most suitable COMPOUNDS for patenting and further development.

RESEARCHERS as used herein means the Institute of Bioorganic Chemistry, Polish Academy of Sciences

PARTY as used herein means any of the PARTIES to this AGREEMENT as the case may be, and all of them when used in plural.

NEW PATENT APPLICATIONS as used herein means patent applications of the RESEARCHERS to be prepared and filed in the name of the RESEARCHERS with technical and financial support of SENETEK, including those the subject of which is medical and cosmetic skincare applications of COMPOUNDS, and any and all patents issued thereon or having a priority date based thereon.

RESEARCHERS’ PATENTS as used herein means any currently owned patents and patent applications of RESEARCHERS covering COMPOUNDS, other than NEW PATENT APPLICATIONS.

SENETEK PATENTS as used herein means SENETEK’s issued patents (U.S. Patents 5,371,089,5,602,139, 5,614,407, 5,021,422, 5,164,394, and 5,151,425 and the corresponding international and foreign patents) related to the use of cytokinins for anti-inflammatory indications and for medical skin care applications and/or cosmetic skin care applications, and any patents hereafter issued which are entitled to the same priority date(s) as such issued patents.

 

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PRODUCT as used herein means any product which or the process of production of which falls within a VALID CLAIM of a patent licensed to SENETEK pursuant to this AGREEMENT.

SUB-LICENSEES as used herein mean any third parties who may obtain a license from SENETEK to develop and/or commercially exploit any COMPOUND covered by a patent licensed to SENETEK pursuant to this AGREEMENT.

FIRST COMMERCIAL SALE as used herein means the first commercial sale of a PRODUCT to a third party made by either SENETEK or its AFFILIATES or SUBLICENSEES.

NET SALES as used herein means the gross amount invoiced by SENETEK and its AFFILIATES to their customers or by SUB-LICENSEES and their AFFILIATES to their customers, including distributors and third parties, for sales of PRODUCTS, less any normal trade discounts and credit notes issued in respect of returned PRODUCTS, any purchase, sales, import, or value added taxes, and charges in respect to carriage. Should SENETEK or a SUB-LICENSEE sell PRODUCTS to an AFFILIATE (or vice-versa) which thereafter sell them to an unrelated third party, the sales between the AFFILIATE (or SENETEK or SUBLICENSEE) and the unrelated third party (and not the sales between SENETEK or SUBLICENSEE and its AFFILIATE) shall be considered NET SALES.

VALID CLAIM as used herein means any claim of an issued and unexpired patent or a claim of a pending patent application licensed to SENETEK pursuant to this AGREEMENT which has not been held un-patentable, invalid or unenforceable by a court or other government agency of competent jurisdiction and has not been admitted to be invalid or unenforceable through reissue, re-examination, disclaimer or otherwise; provided, however, that if the holding of such court or agency is later reversed by a court or agency with overriding authority, the claim shall be reinstated as a VALID CLAIM after the date of such reversal.

EFFECTIVE DATE as used herein shall mean the date of the last signature of this AGREEMENT by the PARTIES.

All plurals may be read in the singular and vice versa.

The headings are inserted for convenience only and shall be ignored in construing this AGREEMENT.

ARTICLE 2 - SCOPE OF THE AGREEMENT

 

2.1 Subject to the terms and conditions of this AGREEMENT, SENETEK shall from time to time, as provided in Article 3 below, obtain from the RESEARCHERS such of the COMPOUNDS as SENETEK may designate.

 

2.2 During the term of this AGREEMENT SENETEK will screen and conduct TESTING of these COMPOUNDS..

 

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2.3 If SENETEK finds one or more of the TESTED COMPOUNDS of interest and wishes to exploit it or them commercially, SENETEK and the RESEARCHERS will negotiate and sign license agreements, as defined in Article 3.5 hereof.

 

2.4 SENETEK will pay royalty related to the NET SALES of PRODUCTS to RESEARCHERS as set in the ANNEX 1 - License Agreement Term Sheet, attached to this AGREEMENT.

ARTICLE 3 - DUTIES OF THE PARTIES

 

3.1 Promptly after the EFFECTIVE DATE, and thereafter at least once every calendar year, the RESEARCHERS shall provide SENETEK with a complete listing and description of all COMPOUNDS developed, in licensed or otherwise acquired by the RESEARCHERS, together with all chemical and biological information in their possession with respect to such COMPOUNDS and specifying those COMPOUNDS, if any, which are covered by RESEARCHERS’ PATENTS.

 

3.2 Not later than two (2) weeks after delivery of such information by the RESEARCHERS, SENETEK will select and advise the RESEARCHERS, in writing, of those COMPOUNDS on which it wishes to conduct TESTING at that time. Notwithstanding the foregoing, as regards COMPOUNDS which the RESEARCHERS’ listing under Article 3.1 specifies are covered by the RESEARCHERS’ PATENTS, if SENETEK does not give the RESEARCHERS written advice that it wishes to conduct TESTING of any such COMPOUND within four (4) months after it receives the listing provided for in Article 3.1, SENETEK shall be considered to have waived its rights to such COMPOUND for all purposes of this AGREEMENT and the RESEARCHERS shall be free to commercialize such COMPOUND themselves or enter into an evaluation agreement or license or other agreement with respect thereto with any third party on such terms as they may determine in their sole discretion, subject, however, to SENETEK’s rights, if any, under the SENETEK PATENTS and provided, however, that before RESEARCHERS shall enter into an evaluation agreement or license or other agreement with any third party, RESEARCHERS shall give notice to SENETEK of the terms on which they propose to enter into such evaluation agreement or license or other agreement and SENETEK shall have thirty (30) days to enter into such agreement with the RESEARCHERS on the same terms, providing these terms are not worse for the RESEARCHERS than the terms in Annex 1- License Agreement Term Sheet, in which case the terms of Annex 1 will be used.

 

3.3 The RESEARCHERS shall within two (2) weeks of receipt of each advice of SENETEK specifying selected COMPOUNDS it then wishes to TEST, deliver the selected COMPOUNDS to SENETEK in a quantity of at least 100 mg each.

 

3.4 If practicable, not later than nine (9) months after each delivery by the RESEARCHERS of the listing of COMPOUNDS as provided in Article 3.1, SENETEK will provide the RESEARCHERS with a report of the results of the TESTING of the new COMPOUNDS set forth in such listing. SENETEK will also indicate those COMPOUNDS for which SENETEK wishes to be granted a license. SENETEK may, if it so chooses, deliver such reports and indicate COMPOUNDS it wishes to license on more than one occasion during such period. Such license shall be exclusive and worldwide, for all applications.

 

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3.5 Within three (3) months of SENETEK’s decision to license COMPOUNDS as provided in Article 3.4, the PARTIES will enter into a License Agreement with respect to such COMPOUNDS having principal terms as set forth in Annex 1- License Agreement Term. The final details of the License Agreement will be negotiated in good faith by the PARTIES hereto.

 

3.6 If SENETEK does not deliver one or more reports as provided in Article 3.4 or, having delivered such report or reports, decides not to execute a License Agreement negotiated by the PARTIES as provided in Article 3.5, as to any particular COMPOUND or COMPOUNDS covered by any NEW PATENT APPLICATION, then the PARTIES will agree how to commercialize such COMPOUNDS and how to share revenues from such commercialization. Any such agreement on particular COMPOUNDS will be recorded in writing, signed by all PARTIES, and will become an appendix to this AGREEMENT. In case of COMPOUNDS covered by RESEARCHERS’ PATENTS, RESEARCHERS shall be free to commercialize such COMPOUND or COMPOUNDS themselves or enter into an evaluation agreement or license or other agreement with respect thereto with any third party on such terms as they may determine in their sole discretion, subject, however, to SENETEK’s rights, if any, under the SENETEK PATENTS.

 

3.7 RESEARCHERS agree that they will not enter into any cooperative research and development agreement with any third party involving any chemical compounds other than COMPOUNDS for cosmeceutical or anti-aging dermatological uses without first offering to SENETEK the opportunity to enter into such cooperative research and development agreement instead of such third party on the same terms as those proposed by or to such third party. SENETEK will exercise its right of first refusal within 4 weeks of receiving the proposed cooperative research and development agreement.

 

3.8 RESEARCHERS represent and warrant to SENETEK that their entering into and performing this AGREEMENT will not violate any agreement or obligation of either of the RESEARCHERS with or to any third party or give rise to any claim by any third party. The RESEARCHERS shall deliver to SENETEK, together with the AGREEMENT signed on their behalf, letters signed by authorized representatives of Ministry of Science and Information (MNII) and any other legal entity with which any of RESEARCHERS are affiliated, waiving any claim against SENETEK related to the subject matter of this AGREEMENT.

ARTICLE 4 - ADDITIONAL CONSIDERATION; DEVELOPMENT OF SELECTED COMPOUNDS

In addition to the RESEARCHERS’ rights of patent ownership under Article 5, as additional consideration for the rights granted to SENETEK herein SENETEK agrees that if SENETEK advises the RESEARCHERS as provided in Article 3.2 that it wishes RESEARCHERS to conduct TESTING on any COMPOUND or COMPOUNDS, SENETEK will be obligated to payor reimburse the RESEARCHERS for the expenses of such TESTING and/or further evaluation, in vitro testing, and development of the selected COMPOUNDS (collectively with

 

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5


the TESTING, the ‘R&D”). Such payments to the RESEARCHERS shall be made by bank transfer monthly, as such expenses are incurred, to the account titled:

BANK NAME:.

ADDRESS:

BRANCH NO:

SWIFT NO:

ACCOUNT NO:

NAME OF ACCOUNT HOLDER:

IBAN:

If the PARTIES agree that any R&D can most efficiently and effectively be done by the RESEARCHERS or by a third party laboratory with which the RESEARCHERS have a relationship, such expenses shall be billed at the RESEARCHERS’ direct cost of conducting or contracting out such activities. If the PARTIES agree that any R&D can most efficiently and effectively be done by SENETEK’s dedicated laboratories or by a third party laboratory or academic institution with which SENETEK has a relationship, SENETEK shall pay for such activities and provide the RESEARCHERS with documentation of such, payment.

It is agreed by the PARTIES that they shall consult in good faith regarding the nature, scope and costs of all R&D, the protocols therefore and the most efficient and effective sourcing thereof, provided that if agreement cannot be reached between the PARTIES within a reasonable time (having in mind the time limits set forth herein), SENETEK’s position shall prevail. SENETEK shall own all rights to any and all test reports and test results from R&D paid for or reimbursed by SENETEK as above provided, and the RESEARCHERS agree not to make any publication or other disclosure thereof without SENETEK’S prior written approval.

ARTICLE 5 - INTELLECTUAL PROPERTY AND EXPLOITATION OF THE RESULTS

 

5.1 INVENTIONS THAT MAY BE CREATED UNDER RESEARCH CO-OPERATION OF PARTIES

In the event and on each occasion that the TESTING of the COMPOUNDS reveals an effect of any of the COMPOUNDS that is not covered by the SENETEK PATENTS or the RESEARCHERS’ PATENTS and that merits patent protection, the following arrangement shall apply:

(a) the PARTIES shall collaborate in the preparation of documents required for the filing of a patent application on each such invention;

(b) all such patent applications shall be filed and owned by the RESEARCHERS, and SENETEK shall have the right to an exclusive license for use world-wide, for all applications;

(c) each patent application shall include the names of those employees of the PARTIES (as co-inventors) that were responsible for the development of the invention;

(d) the PARTIES will agree on the filing of foreign patent protection;

(e) in case SENETEK executes its right to license a COMPOUND covered by a patent prepared under this Article 5.1, SENETEK will take over the cost of obtaining and maintaining the patent protection of the invention; that if such patent covers COMPOUNDS which SENETEK has elected not to license or claims fields of use for

 

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COMPOUNDS licensed to SENETEK that are beyond the fields of use SENETEK has elected to license, the PARTIES shall share such cost according to the commercial potential of SENETEK’S COMPOUND and/or field of use and such COMPOUND(S) and/or fields of use not licensed to SENETEK.

(f) the license fee paid by SENETEK for the grant to it of an exclusive license shall take into account the contribution made by SENETEK (both of cash and intellectual property) to the jointly developed invention;

(g) if the RESEARCHERS do not wish to file a patent application covering a jointly developed invention in a certain TERRITORY, SENETEK may file a patent application covering the jointly developed invention in such TERRITORY at its own cost in which case the patent protection obtained shall be owned one hundred percent (100%) by SENETEK.

 

5.2 All scientific data regarding patent applications will be written by the RESEARCHERS, in English, and will be presented to SENETEK for review and comments. Each patent application will be first filed in the country of origin as a provisional patent application, and within one year it will be filed as PCT in all other territories to be covered.

ARTICLE 6 - CONFIDENTIALITY

 

6.1 In consideration of the use of the COMPOUNDS by SENETEK and receipt by the RESEARCHERS of periodic reports on results of TESTING, and in consideration of joint research performed by PARTIES, each receiving PARTY agrees that during the term of this AGREEMENT, it will not, except to the extent authorized by disclosing PARTY in writing, use for any purpose other than those described herein, or publish, disclose or release to any third party, any information regarding the R&D or TESTING conducted on such COMPOUND, except as may be required in connection with the filing and prosecution of NEW PATENT APPLICATIONS. Each RESEARCHER, by signing this AGREEMENT, agrees to be bound by all of the terms of this Article 6 with the same effect as if such RESEARCHER were the RESEARCHERS.

 

6.2 The above restraints on use, release, and/or disclosure shall not apply to information or effects and applications of COMPOUNDS which:

 

   

at the time of delivery or disclosure are known to the receiving PARTY;

 

   

at the time of delivery or disclosure or subsequent thereto are generally available to the public through no fault of the receiving PARTY;

 

   

subsequent to the time of delivery or disclosure are independently developed by an employee or agent of the receiving PARTY who does so without reference to or knowledge of the disclosing PARTY’S information or the COMPOUNDS;

 

   

subsequent to the time of delivery or disclosure become or are made available to the receiving PARTY by a third party having the lawful right to do so; or

 

   

subsequent to the time of such delivery or disclosure become subject of another agreement between the PARTIES hereto which permits use, release and/or disclosure.

The PARTY seeking to assert any of the above exceptions shall have the burden of proof.

 

6.3 The PARTIES shall maintain the obligation of confidentiality for five years after the expiration of this AGREEMENT.

 

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ARTICLE 7 - FORCE MAJEURE

 

7.1 Neither PARTY shall be liable for failure in performance hereunder if occasioned by any cause beyond the control of the PARTY, such as for example fire, flood, strikes, inevitable accidents, war, embargo, blockade, legal restrictions, governmental relations, etc.

 

7.2 The occurrence of the Force Majeure shall be notified to the other PARTY in writing within 10 working days and shall be verified by the respective chamber of commerce within further 10 working days at the latest. Each PARTY undertakes to do its utmost in order to re-establish conditions favorable for the performance of this AGREEMENT and shall inform the other PARTY about steps it has taken. The term of this AGREEMENT will be extended by the period the Force Majeure had lasted.

ARTICLE 8 - TERM OF THE AGREEMENT

 

8.1 This AGREEMENT shall be become effective on the EFFECTIVE DATE and shall continue and remain in effect according to its terms without limitation of time until the expiration of the last VALID CLAIM of any NEW PATENT APPLICATION, unless terminated in accordance with Article 8.2 or 8.3.

 

8.2 This AGREEMENT can be prematurely terminated by agreement of both PARTIES or may be prematurely terminated by a PARTY upon not less than six months’ prior written notice to the other PARTY.

 

8.3 A PARTY shall have the right to terminate this AGREEMENT forthwith at any time by notice in writing to the other PARTY if the other PARTY commits a material breach of any of the terms of this AGREEMENT and does not within 30 days of receipt of notice of the breach (if the same be capable of remedy) remedy such breach.

 

8.4 Termination of this AGREEMENT for any reason shall not bring to an end the confidentiality obligations of the PARTIES hereto; and/or the rights and obligations (if any) on each PARTY hereunder.

ARTICLE 9 - DISPUTES

 

9.1 In the event of any difference or dispute arising between the PARTIES hereto concerning the construction or performance of this AGREEMENT or its validity, the PARTIES shall first consult together in good faith and attempt to settle the matter amicably.

 

9.2 Any disputes relating to the interpretation, construction, performance or validity of this AGREEMENT which cannot be resolved under Article 10.1 above, shall be referred to a final decision of a panel of three (3) arbitrators (the “Panel”), appointed under and acting in accordance with the Rules of the Arbitration Court of the International Chamber of Commerce in Paris. The seat of the Arbitration Court shall be in Vienna.

 

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9.3 The PARTIES specifically agree that if they are unable in good faith to reach agreement as to any details of the license agreement or agreements referred to in Article 3.5, they shall submit such disagreement to the Panel and request that the Panel determine such disagreement in a manner consistent with ordinary course business practices as applied by reasonable business persons in the industry to which this AGREEMENT relates. Such determination by the Panel shall be treated as a decision of the Panel for all purposes of this Article 10.

 

9.4 Both PARTIES agree that the decision of the Panel shall be final and binding and that they shall undertake to abide by and execute the award rendered by the arbitrators without delay. The enforcement of such an award may be applied for at any court of competent jurisdiction.

 

9.5 The AGREEMENT as well as the mutual obligations arising under it shall be exclusively governed by the provisions of the substantive law of Austria.

ARTICLE 10 - GENERAL

 

10.1 This AGREEMENT constitutes the sole and entire understanding either oral or written on the subject matter of the AGREEMENT. No further agreement or understanding shall be binding upon either PARTY hereto unless in writing signed by both PARTIES. This AGREEMENT shall not be assignable by any of the PARTIES hereto, without prior written consent of the other PARTIES.

 

10.2 The payments properly due to the RESEARCHERS under the AGREEMENT shall in no event be refundable to SENETEK. In the event of termination or expiration of this AGREEMENT SENETEK will pay all and any sums due to RESEARCHERS up to the date of expiration or termination. In the event that SENETEK shall be required to pay a tax on any payment to the RESEARCHERS, it shall deduct the amount of said tax from the payment due to the RESEARCHERS and shall provide the RESEARCHERS with a copy of the Certificate of the tax having been paid pursuant to an Agreement on A voidance of Double Taxation or for other reasons.

 

10.3 The time periods provided for herein during which a PARTY is permitted or required to take any action shall be tolled and extended for such period of time, if any, as the other PARTY is in breach of any term of this AGREEMENT.

 

10.4 SENETEK hereby confirms that it has the expertise necessary to make use of any licensed patents and to develop, make, have made, sell, use, and otherwise commercially exploit the PRODUCTS.

 

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IN WITNESS WHEREOF, the PARTIES hereto have caused this AGREEMENT to be executed by their duly authorized representatives in a manner legally binding upon them as of the EFFECTIVE DATE.

 

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ANNEX 1

LICENSE AGREEMENT TERM SHEET

 

Term of License:    The term of the Valid Claims of the licensed patent(s).
Licensed Territory:    World-wide.
Scope of License:    Exclusive, for all applications.
Consideration:    Royalty of XXX of Senetek’s or its Affiliates’ Net Sales of licensed Products other than products covered by SENETEK PATENTS, and XXX of Senetek’s or its Affiliates’ Net Sales of licensed Products covered by SENETEK PATENTS,
   Royalty of XXX of Senetek’s SUB-LICENSEES’ Net Sales of sub-licensed products other than products covered by SENETEK PATENTS, and XXX of Senetek’s SUBLICENSEES’ Net Sales of sub-licensed products covered by SENETEK PATENTS
Sub-licensing/Assignment:    No limitation
Senetek Covenants:    Validity and enforceability of License Compliance with law in performing License
RESEARCHERS’ Covenants:    Validity and enforceability of License Maintenance and defense of licensed patents
Indemnification:    By Senetek for liability from any non-compliance with law in manufacture, marketing or sale of licensed products.
   By the’ RESEARCHERS for invalidity or unenforceability of licensed patents up to the value of payments received from SENETEK in preceding calendar year.
Termination:    By either Party for material breach by the other Party or insolvency or liquidation of the other Party.
Confidentiality:    Per basic AGREEMENT Agreed press release upon signing
Applicable Law:    Per basic AGREEMENT.
Other Terms:    See Annex 2

 

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ANNEX2

COMMERCIAL TERMS GOVERNING LICENSE

1. SENETEK will inform RESEARCHERS in writing of the dates of each FIRST COMMERCIAL SALE, within 2 (two) months of occurrence of such FIRST COMMERCIAL SALE.

2. Where PRODUCT is sold in a currency other then US Dollars, the rate of exchange to be used for converting such currency into US Dollars shall be the exchange rate, as published in the Financial Times, at the end of the relevant accounting period.

3. The payments shall be made within 60 days of the end of calendar quarter, and shall be accompanied by a statement which shall show on a country by country basis for the previous quarter all monies due to the RESEARCHERS. Said sales report shall include the sales figures used to calculate the royalties due to the RESEARCHERS, as well as the quantities sold, the unit price of any quantity of the PRODUCTS both by SENETEK and its AFFILIATES or SUB-LICENSEES.

4. The royalty properly due to the RESEARCHERS shall in no event be refundable to SENETEK.

5. In the event that SENETEK shall be required to pay a tax on any payment to the RESEARCHERS, it shall deduct the amount of said tax from the payment due to the RESEARCHERS and shall provide the RESEARCHERS with a copy of the Certificate of the tax having been paid pursuant to an Agreement on Avoidance of Double Taxation or for other reasons.

6. SENETEK shall prepare accounts, which shall include all the elements necessary to precisely calculate the NET SALES and NET ROYALTY within the framework of the AGREEMENT. If necessary these accounts shall be made available once a year with 30 days notice to the RESEARCHERS or an accredited designee of the RESEARCHERS during the term of the AGREEMENT and for one year thereafter. These accounts shall be prepared annually within 90 (ninety) days of the closing date of December 31 of each year which represents the end of SENETEK’s fiscal year.

7. Any sums which remain unpaid within the periods set out hereunder shall be subject to interest of 3% (three percent) over above LIBOR as published in the Financial Times at the end of the relevant accounting period, without prejudice to the RESEARCHERS’ right to terminate the contract in accordance with Article 10 of the present AGREEMENT.

8. The RESEARCHERS shall have the right once a year with 30 days notice to audit or have audited the sales accounts kept by SENETEK. Should there be an audit, an expert accountant shall be appointed by mutual agreement of both PARTIES at the expense of the RESEARCHERS, except that if the amount of installments shown by such audit to be due to the RESEARCHERS exceed the amount actually paid by SENETEK by 5% (five percent), then such expenses shall be paid by SENETEK and any back payments shall be reimbursed with per the Agreement.

9. SENETEK agrees to make reasonable efforts to make, have made, sell and otherwise commercially exploit the PRODUCTS, using similar efforts devoted to products of similar nature and similar markets.

 

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10. SENETEK agrees to provide annual reports on the development and exploitation of the PRODUCTS.

11. SENETEK and its AFFILIATES agree not to use the names of the RESEARCHERS, any trademark, distinctive sign or adaptations thereof which belongs to the RESEARCHERS or the names of RESEARCHERS inventors or of any RESEARCHERS agent, on packaging, labeling, advertising or promotional materials for the PRODUCTS without receiving prior written approval from the RESEARCHERS and the natural person concerned, as the case may be.

12. PRODUCTS shall be commercialized by SENETEK, its AFFILIATES and its SUBLICENSEES under their own trademarks. The RESEARCHERS shall have no rights to such trademarks. All administrative authorizations obtained by SENETEK, its AFFILIATES or its LICENSEES for the purpose of manufacturing and/or commercializing the PRODUCTS shall be obtained for them. The RESEARCHERS shall claim no rights thereto.

13. SENETEK accepts the obligation to inform by writing the RESEARCHERS of all administrative marketing approvals that it obtains for the purpose of manufacturing and/or commercializing the PRODUCTS no later than 3 (three) months after obtaining such final authorizations.

 

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EX-10.112 6 dex10112.htm AGREEMENT ON COOPERATIVE RESEARCH AND DEVELOPMENT - BRAIN TUMOR TREATMENT Agreement on Cooperative Research and Development - Brain Tumor Treatment

Exhibit 10.112

AGREEMENT ON COOPERATIVE RESEARCH AND DEVELOPMENT

between

Institute of Bioorganic Chemistry, Polish Academy of Sciences

(hereinafter referred to as “RESEARCHERS”)

and

Senetek PLC

831 Latour Court, Suite A

Napa, California 94558 USA

(hereinafter referred to as “SENETEK”)

WHEREAS the RESEARCHERS are performing basic research on brain tumor treatment with interference RNA (iRNA—intervention with RNAi) (the “Treatment”) and are willing to provide to SENETEK information developed by the RESEARCHERS, including any covered by patents and/or patent applications owned by the RESEARCHERS, for possible licensing to and commercialization by SENETEK.

NOW THEREFORE in consideration of above-mentioned premises the parties agree as follows:

 

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ARTICLE 1 - DEFINITIONS

AFFILIATES as used herein shall mean any legal entity which, at the EFFECTIVE DATE or during the validity of this Agreement:

 

   

directly or indirectly controls SENETEK,

 

   

is under the same direct or indirect control as SENETEK, or

 

   

is directly controlled by SENETEK

A legal entity is considered controlling another:

 

   

when it directly or indirectly owns over 50% (fifty percent) of the capital of this legal entity or more than 50% (fifty percent) of the voting rights of its shareholders or associates; or

 

   

when it has the direct or indirect de facto, directly or indirectly, the power to decide within this legal entity how the affairs shall be conducted.

AGREEMENT as used herein shall mean this agreement and any and all Annexes, appendices and other addenda to it as it may be varied from time to time

TREATMENT as used herein means brain tumor treatment with interference RNA (iRNA intervention with RNAi), developed, in-licensed or otherwise acquired by the RESEARCHERS.

RESEARCHERS as used herein means the aforementioned Institute of Bioorganic Chemistry, Polish Academy of Sciences

PARTY as used herein means any of the PARTIES to this AGREEMENT as the case may be, and all of them when used in plural.

NEW PATENT APPLICATIONS as used herein means patent applications of the RESEARCHERS to be prepared and filed in the name of the RESEARCHERS with technical and financial support of SENETEK, for any aspect of the TREATMENT, and any and all patents issued thereon or having a priority date based thereon.

RESEARCHERS’ PATENTS as used herein means any currently owned patents and patent applications of RESEARCHERS covering TREATMENT, other than NEW PATENT APPLICATIONS.

SUB LICENSEE as used herein means any third parties who may obtain a license from SENETEK to develop and/or commercially exploit the TREATMENT covered by a patent licensed to SENETEK pursuant to this AGREEMENT.

FIRST COMMERCIAL SALE as used herein means the first use of the TREATMENT by a third party under agreement with either SENETEK or its AFFILIATES or SUB LICENSEES.

 

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NET SALES as used herein means the gross amount invoiced by SENETEK and its AFFILIATES to their customers or by SUB-LICENSEES and their AFFILIATES to their customers, including distributors and third parties, for use of TREATMENT,

VALID CLAIM as used herein means any claim of an issued and unexpired patent or a claim of a pending patent application licensed to SENETEK pursuant to this AGREEMENT which has not been held un-patentable, invalid or unenforceable by a court or other government agency of competent jurisdiction and has not been admitted to be invalid or unenforceable through reissue, re-examination, disclaimer or otherwise; provided, however, that if the holding of such court or agency is later reversed by a court or agency with overriding authority, the claim shall be reinstated as a VALID CLAIM after the date of such reversal.

EFFECTIVE DATE as used herein shall mean the date of the last signature of this AGREEMENT by the PARTIES.

All plurals may be read in the singular and vice versa.

The headings are inserted for convenience only and shall be ignored in construing this AGREEMENT.

ARTICLE 2 - SCOPE OF THE AGREEMENT

 

2.1 Subject to the terms and conditions of this AGREEMENT, SENETEK shall develop the TREATMENT for commercialization.

 

2.2 SENETEK will pay royalty related to the NET SALES of TREATMENT to RESEARCHERS as set in the ANNEX I—License Agreement Term Sheet, attached to this AGREEMENT.

ARTICLE 3 - DUTIES OF THE PARTIES

 

3.1 RESEARCHERS agree that they will not enter into any cooperative research and development agreement with any third party involving any brain tumor treatment with interference RNA without first offering to SENETEK the opportunity to enter into such cooperative research and development agreement instead of such third party on the same terms as those proposed by or to such third party. SENETEK will exercise its right of first refusal within 4 weeks of receiving the proposed cooperative research and development agreement.

 

3.2 RESEARCHERS represent and warrant to SENETEK that their entering into and performing this AGREEMENT will not violate any agreement or obligation of any of the RESEARCHERS with or to any third party or give rise to any claim by any third party. The RESEARCHERS shall deliver to SENETEK, together with the AGREEMENT signed on their behalf, letters signed by authorized representatives of Ministry of Science and Information (MNII) and any other legal entity with which any of RESEARCHERS are affiliated, waiving any claim against SENETEK related to the subject matter of this AGREEMENT.

 

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ARTICLE 4 - INTELLECTUAL PROPERTY AND EXPLOITATION OF THE RESULTS

 

4.1 INVENTIONS THAT MAY BE CREATED UNDER RESEARCH CO-OPERATION OF PARTIES

In the event and on each occasion that development work on the TREATMENT reveals an effect of the TREATMENT that is not covered by RESEARCHERS’ PATENTS and that merits patent protection, the following arrangement shall apply:

(a) the PARTIES shall collaborate in the preparation of documents required for the filing of a patent application on each such invention;

(b) all such patent applications shall be filed and owned by the RESEARCHERS, and SENETEK shall have the right to an exclusive license for use world-wide, for all applications;

(c) each patent application shall include the names of those employees of the PARTIES (as co-inventors) that were responsible for the development of the invention;

(d) the PARTIES will agree on the filing of foreign patent protection;

(e) in case SENETEK executes its right to license a TREATMENT covered by a patent prepared under this Article 5.1, SENETEK will take over the cost of obtaining and maintaining the patent protection of the invention;

(f) the license fee paid by SENETEK for the grant to it of an exclusive license shall take into account the contribution made by SENETEK (both of cash and intellectual property) to the jointly developed invention;

(g) if the RESEARCHERS do not wish to file a patent application covering a jointly developed invention in a certain TERRITORY, SENETEK may file a patent application covering the jointly developed invention in such TERRITORY at its own cost in which case the patent protection obtained shall be owned one hundred percent (100%) by SENETEK.

 

4.2 All scientific data regarding patent applications will be written by the RESEARCHERS, in English, and will be presented to SENETEK for review and comments. Each patent application will be first filed in the country of origin as a provisional patent application, and within one year it will be filed as PCT in all other territories to be covered.

ARTICLE 5 - CONFIDENTIALITY

 

5.1 Each receiving PARTY agrees that during the term of this AGREEMENT, it will not, except to the extent authorized by disclosing PARTY in writing, use for any purpose other than those described herein, or publish, disclose or release to any third party, any information regarding the R&D or TESTING conducted on TREATMENT, except as may be required in connection with the filing and prosecution of NEW PATENT APPLICATIONS. Each RESEARCHER, by signing this AGREEMENT, agrees to be bound by all of the terms of this Article 6 with the same effect as if such RESEARCHER were the RESEARCHERS.

 

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5.2 The above restraints on use, release, and/or disclosure shall not apply to information or effects and applications of TREATMENT which:

 

   

at the time of delivery or disclosure are known to the receiving PARTY;

 

   

at the time of delivery or disclosure or subsequent thereto are generally available to the public through no fault of the receiving PARTY;

 

   

subsequent to the time of delivery or disclosure are independently developed by an employee or agent of the receiving PARTY who does so without reference to or knowledge of the disclosing PARTY’S information or the TREATMENT;

 

   

subsequent to the time of delivery or disclosure become or are made available to the receiving PARTY by a third party having the lawful right to do so; or

 

   

subsequent to the time of delivery become subject of another agreement between the PARTIES hereto which permits use, release and/or disclosure.

The PARTY seeking to assert any of the above exceptions shall have the burden of proof.

 

5.3 The PARTIES shall maintain the obligation of confidentiality for five years after the expiration of this AGREEMENT.

ARTICLE 6 - FORCE MAJEURE

 

6.1 Neither PARTY shall be liable for failure in performance hereunder if occasioned by any cause beyond the control of the PARTY, such as for example fire, flood, strikes, inevitable accidents, war, embargo, blockade, legal restrictions, governmental relations, etc.

 

6.2 The occurrence of the Force Majeure shall be notified to the other PARTY in writing within 10 working days and shall be verified by the respective chamber of commerce within further 10 working days at the latest. Each PARTY undertakes to do its utmost in order to re-establish conditions favorable for the performance of this AGREEMENT and shall inform the other PARTY about steps it has taken. The term of this AGREEMENT will be extended by the period the Force Majeure had lasted.

ARTICLE 7 - TERM OF THE AGREEMENT

 

7.1 This AGREEMENT shall be become effective on the EFFECTIVE DATE and shall continue and remain in effect according to its terms without limitation of time until the expiration of the last VALID CLAIM of any NEW PATENT APPLICATION, unless terminated in accordance with Article 7.2 or 7.3.

 

7.2 This AGREEMENT can be prematurely terminated by agreement of both PARTIES or may be prematurely terminated by a PARTY upon not less than six months’ prior written notice to the other PARTY.

 

7.3

A PARTY shall have the right to terminate this AGREEMENT forthwith at any time by notice in writing to the other PARTY if the other PARTY commits a material breach of

 

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any of the terms of this AGREEMENT and does not within 30 days of receipt of notice of the breach (if the same be capable of remedy) remedy such breach.

 

7.4 Termination of this AGREEMENT for any reason shall not bring to an end the confidentiality obligations of the PARTIES hereto; and/or the rights and obligations (if any) on each PARTY hereunder.

ARTICLE 8 - DISPUTES

 

8.1 In the event of any difference or dispute arising between the PARTIES hereto concerning the construction or performance of this AGREEMENT or its validity, the PARTIES shall first consult together in good faith and attempt to settle the matter amicably.

 

8.2 Any disputes relating to the interpretation, construction, performance or validity of this AGREEMENT which cannot be resolved under Article 10.1 above, shall be referred to a final decision of a panel of three (3) arbitrators (the “Panel”), appointed under and acting in accordance with the Rules of the Arbitration Court of the International Chamber of Commerce in Paris. The seat of the Arbitration Court shall be in Vienna.

 

8.3 The PARTIES specifically agree that if they are unable in good faith to reach agreement as to any details of the license agreement or agreements referred to in Article 3.5, they shall submit such disagreement to the Panel and request that the Panel determine such disagreement in a manner consistent with ordinary course business practices as applied by reasonable business persons in the industry to which this AGREEMENT relates. Such determination by the Panel shall be treated as a decision of the Panel for all purposes of this Article 10.

 

8.4 Both PARTIES agree that the decision of the Panel shall be final and binding and that they shall undertake to abide by and execute the award rendered by the arbitrators without delay. The enforcement of such an award may be applied for at any court of competent jurisdiction.

 

8.5 The AGREEMENT as well as the mutual obligations arising under it shall be exclusively governed by the provisions of the substantive law of Austria.

ARTICLE 9 - GENERAL

 

9.1 This AGREEMENT constitutes the sole and entire understanding either oral or written on the subject matter of the AGREEMENT. No further agreement or understanding shall be binding upon either PARTY hereto unless in writing signed by both PARTIES. This AGREEMENT shall not be assignable by any of the PARTIES hereto, without prior written consent of the other PARTY.

 

9.2

The payments properly due to the RESEARCHERS under the AGREEMENT shall in no event be refundable to SENETEK. In the event of termination or expiration of this AGREEMENT SENETEK will pay all and any sums due to RESEARCHERS up to the date of expiration or termination. In the event that SENETEK shall be required to pay a tax on any payment to the RESEARCHERS, it shall deduct the amount of said tax from

 

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the payment due to the RESEARCHERS and shall provide the RESEARCHERS with a copy of the Certificate of the tax having been paid pursuant to an Agreement on Avoidance of Double Taxation or for other reasons.

 

9.3 The time periods provided for herein during which a PARTY is permitted or required to take any action shall be tolled and extended for such period of time, if any, as the other PARTY is in breach of any term of this AGREEMENT.

 

9.4 SENETEK hereby confirms that it has the expertise necessary to make use of any licensed patents…

 

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IN WITNESS WHEREOF, the PARTIES hereto have caused this AGREEMENT to be executed by their duly authorized representatives in a manner legally binding upon them as of the EFFECTIVE DATE.

 

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ANNEX 1

LICENSE AGREEMENT TERM SHEET

 

Term of License:    The term of the Valid Claims of the licensed patent(s).
Licensed Territory:    World-wide.
Scope of License:    Exclusive, for all applications.
Consideration:    Royalty of XXX of Senetek’s or its Affiliates’ Net Sales of licensed TREATMENT
   Royalty of XXX of Senetek’s SUB-LICENSEES’ Net Sales of licensed TREATMENT
Sub-licensing/ Assignment:    No limitation
Senetek Covenants:    Validity and enforceability of License Compliance with law in performing License
RESEARCHERS’ Covenants:    Validity and enforceability of License Maintenance and defense of licensed patents
Indemnification:    By Senetek for liability from any non-compliance with law in manufacture, marketing or sale of licensed products.
   By the RESEARCHERS for invalidity or unenforceability of licensed patents up to the value of payments received from SENETEK in preceding calendar year.
Termination:    By either Party for material breach by the other Party or insolvency or liquidation of the other Party.
Confidentiality:    Per basic AGREEMENT Agreed press release upon signing
Applicable Law:    Per basic AGREEMENT.
Other Terms:    See Annex 2

 

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ANNEX2

COMMERCIAL TERMS GOVERNING LICENSE

1. SENETEK will inform RESEARCHERS in writing of the dates of each FIRST COMMERCIAL SALE, within 2 (two) months of occurrence of such FIRST COMMERCIAL SALE.

2. Where TREATMENT is sold in a currency other then US Dollars, the rate of exchange to be used for converting such currency into US Dollars shall be the exchange rate, as published in the Financial Times, at the end of the relevant accounting period.

3. The payments shall be made within 60 days of the end of calendar quarter, and shall be accompanied by a statement which shall show on a country by country basis for the previous quarter all monies due to the RESEARCHERS.

4. The royalty properly due to the RESEARCHERS shall in no event be refundable to SENETEK.

5. In the event that SENETEK shall be required to pay a tax on any payment to the RESEARCHERS, it shall deduct the amount of said tax from the payment due to the RESEARCHERS and shall provide the RESEARCHERS with a copy of the Certificate of the tax having been paid pursuant to an Agreement on Avoidance of Double Taxation or for other reasons.

6. SENETEK shall prepare accounts, which shall include all the elements necessary to precisely calculate the NET ROYALTY within the framework of the AGREEMENT. If necessary these accounts shall be made available once a year with 30 days notice to the RESEARCHERS or an accredited designee of the RESEARCHERS during the term of the AGREEMENT and for one year thereafter. These accounts shall be prepared annually within 90 (ninety) days of the closing date of December 31 of each year which represents the end of SENETEK’s fiscal year.

7. Any sums which remain unpaid within the periods set out hereunder shall be subject to interest of 3% (three percent) over above LIBOR as published in the Financial Times at the end of the relevant accounting period, without prejudice to the RESEARCHERS’ right to terminate the contract in accordance with Article 9 of the present AGREEMENT.

8. The RESEARCHERS shall have the right once a year with 30 days notice to audit or have audited the sales accounts kept by SENETEK. Should there be an audit, an expert accountant shall be appointed by mutual agreement of both PARTIES at the expense of the RESEARCHERS, except that if the amount of installments shown by such audit to be due to the RESEARCHERS exceed the amount actually paid by SENETEK by 5% (five percent), then such expenses shall be paid by SENETEK and any back payments shall be reimbursed with per the Agreement.

9. SENETEK agrees to make reasonable efforts to commercially exploit the TREATMENT, using similar efforts devoted to products of similar nature and similar markets.

10. SENETEK agrees to provide annual reports on the development and exploitation of the TREATMENT.

 

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11. SENETEK and its AFFILIATES agree not to use the names of the RESEARCHERS, any trademark, distinctive sign or adaptations thereof which belongs to the RESEARCHERS or the names of RESEARCHERS inventors or of any RESEARCHERS agent, on packaging, labeling, advertising or promotional materials for without receiving prior written approval from the RESEARCHERS and the natural person concerned, as the case may be.

12. TREATMENT shall be commercialized by SENETEK, its AFFILIATES and its SUBLICENSEES under their own trademarks. The RESEARCHERS shall have no rights to such trademarks. All administrative authorizations obtained by SENETEK, its AFFILIATES or its LICENSEES for the purpose of manufacturing and/or commercializing the TREATMENT shall be obtained for them. The RESEARCHERS shall claim no rights thereto.

13. SENETEK accepts the obligation to inform by writing the RESEARCHERS of all administrative marketing approvals that it obtains for the purpose of manufacturing and/or commercializing the PRODUCTS no later than 3 (three) months after obtaining such [mal authorizations.

 

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EX-10.113 7 dex10113.htm AGREEMENT ON COOPERATIVE RESEARCH AND DEVELOPMENT - FURFURYLCYTOSINE Agreement on Cooperative Research and Development - Furfurylcytosine

Exhibit 10.113

AGREEMENT ON COOPERATIVE RESEARCH AND DEVELOPMENT

Institute of Bioorganic Chemistry, Polish Academy of Sciences

(hereinafter referred to as “RESEARCHERS”)

and

Senetek PLC

831 Latour Court, Suite A

Napa, California 94558 USA

(hereinafter referred to as “SENETEK”)

WHEREAS the RESEARCHERS are performing basic research on Furfurylcytosine (the “Compounds”) and are willing to provide to SENETEK samples of the Compounds and their analogs and related information developed by the RESEARCHERS, including any covered by patents and/or patent applications owned by the RESEARCHERS, for testing, possible further development by SENETEK, and ultimately possible licensing to and commercialization by SENETEK; and

WHEREAS SENETEK is a company developing pharmaceutical and cosmeceutical products and, in connection with such business, has made certain inventions regarding cytokinins and cytokinin analogs and methods of using them for various indications related to ameliorating signs of aging and anti-inflammatory indications which are covered by the SENETEK PATENTS, as hereinafter defined; and

WHEREAS SENETEK is interested in testing and evaluating, in cooperation with the RESEARCHERS, the Compounds, including the Compounds in combination with active ingredients covered by the SENETEK PATENTS, as hereinafter defined, developed by the RESEARCHERS and in obtaining licenses covering such of these compounds as it may select as hereinafter provided.

NOW THEREFORE in consideration of above-mentioned premises the parties agree as follows:

 

Furfurylcytosine


ARTICLE 1 - DEFINITIONS

AFFILIATES as used herein shall mean any legal entity which, at the EFFECTIVE DATE or during the validity of this Agreement:

 

   

directly or indirectly controls SENETEK,

 

   

is under the same direct or indirect control as SENETEK, or

 

   

is directly controlled by SENETEK

A legal entity is considered controlling another:

 

   

when it directly or indirectly owns over 50% (fifty percent) of the capital of this legal entity or more than 50% (fifty percent) of the voting rights of its shareholders or associates; or

 

   

when it has the direct or indirect de facto, directly or indirectly, the power to decide within this legal entity how the affairs shall be conducted.

AGREEMENT as used herein shall mean this agreement and any and all Annexes, appendices and other addenda to it as it may be varied from time to time

COMPOUNDS as used herein means Furfurylcytosine and its analogs and derivatives, developed, in-licensed or otherwise acquired by the RESEARCHERS that may be used for any application.

TESTING as used herein means any testing to determine the most suitable COMPOUNDS for patenting and further development.

RESEARCHERS as used herein means the Institute of Bioorganic Chemistry, Polish Academy of Sciences.

PARTY as used herein means any of the PARTIES to this AGREEMENT as the case may be, and all of them when used in plural.

NEW PATENT APPLICATIONS as used herein means patent applications of the RESEARCHERS to be prepared and filed in the name of the RESEARCHERS with technical and financial support of SENETEK, including those the subject of which is medical and cosmetic skincare applications of COMPOUNDS, and any and all patents issued thereon or having a priority date based thereon.

RESEARCHERS’ PATENTS as used herein means any currently owned patents and patent applications of RESEARCHERS covering COMPOUNDS, other than NEW PATENT APPLICATIONS.

SENETEK PATENTS as used herein means SENETEK’s issued patents (U.S. Patents 5,371,089, 5,602,139, 5,614,407, 5,021,422, 5,164,394, and 5,151,425 and the corresponding international and foreign patents) related to the use of cytokinins for anti-inflammatory indications and for medical skin care applications and/or cosmetic skin care applications, and any patents hereafter issued which are entitled to the same priority date(s) as such issued patents.

 

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PRODUCT as used herein means any product which or the process of production of which falls within a VALID CLAIM of a patent licensed to SENETEK pursuant to this AGREEMENT.

SUB-LICENSEES as used herein mean any third parties who may obtain a license from SENETEK to develop and/or commercially exploit any COMPOUND covered by a patent licensed to SENETEK pursuant to this AGREEMENT.

FIRST COMMERCIAL SALE as used herein means the first commercial sale of a PRODUCT to a third party made by either SENETEK or its AFFILIATES or SUBLICENSEES.

NET SALES as used herein means the gross amount invoiced by SENETEK and its AFFILIATES to their customers or by SUB-LICENSEES and their AFFILIATES to their customers, including distributors and third parties, for sales of PRODUCTS, less any normal trade discounts and credit notes issued in respect of returned PRODUCTS, any purchase, sales, import, or value added taxes, and charges in respect to carriage. Should SENETEK or a SUB-LICENSEE sell PRODUCTS to an AFFILIATE (or vice-versa) which thereafter sell them to an unrelated third party, the sales between the AFFILIATE (or SENETEK or SUBLICENSEE) and the unrelated third party (and not the sales between SENETEK or SUBLICENSEE and its AFFILIATE) shall be considered NET SALES.

VALID CLAIM as used herein means any claim of an issued and unexpired patent or a claim of a pending patent application licensed to SENETEK pursuant to this AGREEMENT which has not been held un-patentable, invalid or unenforceable by a court or other government agency of competent jurisdiction and has not been admitted to be invalid or unenforceable through reissue, re-examination, disclaimer or otherwise; provided, however, that if the holding of such court or agency is later reversed by a court or agency with overriding authority, the claim shall be reinstated as a VALID CLAIM after the date of such reversal.

EFFECTIVE DATE as used herein shall mean the date of the last signature of this AGREEMENT by the PARTIES.

All plurals may be read in the singular and vice versa.

The headings are inserted for convenience only and shall be ignored in construing this AGREEMENT.

ARTICLE 2 - SCOPE OF THE AGREEMENT

 

2.1 Subject to the terms and conditions of this AGREEMENT, SENETEK shall from time to time, as provided in Article 3 below, obtain from the RESEARCHERS such of the COMPOUNDS as SENETEK may designate.

 

2.2 During the term of this AGREEMENT SENETEK will screen and conduct TESTING of these COMPOUNDS.

 

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2.3 If SENETEK finds one or more of the TESTED COMPOUNDS of interest and wishes to exploit it or them commercially, SENETEK and the RESEARCHERS will negotiate and sign license agreements, as defined in Article 3.5 hereof.

 

2.4 SENETEK will pay royalty related to the NET SALES of PRODUCTS to RESEARCHERS as set in the ANNEX 1-License Agreement Term Sheet, attached to this AGREEMENT.

ARTICLE 3 - DUTIES OF THE PARTIES

 

3.1 Promptly after the EFFECTIVE DATE, and thereafter at least once every calendar year, the RESEARCHERS shall provide SENETEK with a complete listing and description of all COMPOUNDS developed, in licensed or otherwise acquired by the RESEARCHERS, together with all chemical and biological information in their possession with respect to such COMPOUNDS and specifying those COMPOUNDS, if any, which are covered by RESEARCHERS’ PATENTS.

 

3.2 Not later than two (2) weeks after delivery of such information by the RESEARCHERS, SENETEK will select and advise the RESEARCHERS, in writing, of those COMPOUNDS on which it wishes to conduct TESTING at that time. Notwithstanding the foregoing, as regards COMPOUNDS which the RESEARCHERS’ listing under Article 3.1 specifies are covered by the RESEARCHERS’ PATENTS, if SENETEK does not give the RESEARCHERS written advice that it wishes to conduct TESTING of any such COMPOUND within four (4) months after it receives the listing provided for in Article 3.1, SENETEK shall be considered to have waived its rights to such COMPOUND for all purposes of this AGREEMENT and the RESEARCHERS shall be free to commercialize such COMPOUND themselves or enter into an evaluation agreement or license or other agreement with respect thereto with any third party on such terms as they may determine in their sole discretion, subject, however, to SENETEK’s rights, if any, under the SENETEK PATENTS and provided, however, that before RESEARCHERS shall enter into an evaluation agreement or license or other agreement with any third party, RESEARCHERS shall give notice to SENETEK of the terms on which they propose to enter into such evaluation agreement or license or other agreement and SENETEK shall have thirty (30) days to enter into such agreement with the RESEARCHERS on the same terms, providing these terms are not worse for the RESEARCHERS than the terms in Annex 1- License Agreement Term Sheet, in which case the terms of Annex 1 will be used.

The RESEARCHERS shall within two (2) weeks of receipt of each advice of

 

3.3 SENETEK specifying selected COMPOUNDS it then wishes to TEST, deliver the selected COMPOUNDS to SENETEK in a quantity of at least 100 mg each.

 

3.4 If practicable, not later than nine (9) months after each delivery by the RESEARCHERS of the listing of COMPOUNDS as provided in Article 3.1, SENETEK will provide the RESEARCHERS with a report of the results of the TESTING of the new COMPOUNDS set forth in such listing. SENETEK will also indicate those COMPOUNDS for which SENETEK wishes to be granted a license. SENETEK may, if it so chooses, deliver such reports and indicate COMPOUNDS it wishes to license on more than one occasion during such period. Such license shall be exclusive and worldwide, for all applications.

 

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3.5 Within three (3) months of SENETEK’s decision to license COMPOUNDS as provided in Article 3.4, the PARTIES will enter into a License Agreement with respect to such COMPOUNDS having principal terms as set forth in Annex 1- License Agreement Term. The final details of the License Agreement will be negotiated in good faith by the PARTIES hereto.

 

3.6 If SENETEK does not deliver one or more reports as provided in Article 3.4 or, having delivered such report or reports, decides not to execute a License Agreement negotiated by the PARTIES as provided in Article 3.5, as to any particular COMPOUND or COMPOUNDS covered by any NEW PATENT APPLICATION, then the PARTIES will agree how to commercialize such COMPOUNDS and how to share revenues from such commercialization. Any such agreement on particular COMPOUNDS will be recorded in writing, signed by all PARTIES, and will become an appendix to this AGREEMENT. In case of COMPOUNDS covered by RESEARCHERS’ PATENTS, RESEARCHERS shall be free to commercialize such COMPOUND or COMPOUNDS themselves or enter into an evaluation agreement or license or other agreement with respect thereto with any third party on such terms as they may determine in their sole discretion, subject, however, to SENETEK’s rights, if any, under the SENETEK PATENTS.

 

3.7 RESEARCHERS agree that they will not enter into any cooperative research and development agreement with any third party involving any chemical compounds other than COMPOUNDS for cosmeceutical or anti-aging dermatological uses without first offering to SENETEK the opportunity to enter into such cooperative research and development agreement instead of such third party on the same terms as those proposed by or to such third party. SENETEK will exercise its right of first refusal within 4 weeks of receiving the proposed cooperative research and development agreement.

 

3.8 RESEARCHERS represent and warrant to SENETEK that their entering into and performing this AGREEMENT will not violate any agreement or obligation of any of the RESEARCHERS with or to any third party or give rise to any claim by any third party. The RESEARCHERS shall deliver to SENETEK, together with the AGREEMENT signed on their behalf, letters signed by authorized representatives of Ministry of Science and Information (MNII) and any other legal entity with which any of RESEARCHERS are affiliated, waiving any claim against SENETEK related to the subject matter of this AGREEMENT.

ARTICLE 4 - ADDITIONAL CONSIDERATION; DEVELOPMENT OF SELECTED COMPOUNDS

In addition to the RESEARCHERS’ rights of patent ownership under Article 5, as additional consideration for the rights granted to SENETEK herein SENETEK agrees that if SENETEK advises the RESEARCHERS as provided in Article 3.2 that it wishes RESEARCHERS to conduct TESTING on any COMPOUND or COMPOUNDS, SENETEK will be obligated to payor reimburse the RESEARCHERS for the expenses of such TESTING and/or further evaluation, in vitro testing, and development of the selected COMPOUNDS (collectively with

 

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5


the TESTING, the ‘R&D”). Such payments to the RESEARCHERS shall be made by bank transfer monthly, as such expenses are incurred, to the account titled:

BANK NAME:.

ADDRESS:

BRANCH NO:

SWIFT NO:

ACCOUNT NO:

NAME OF ACCOUNT HOLDER:

IBAN:

If the PARTIES agree that any R&D can most efficiently and effectively be done by the RESEARCHERS or by a third party laboratory with which the RESEARCHERS have a relationship, such expenses shall be billed at the RESEARCHERS’ direct cost of conducting or contracting out such activities. If the PARTIES agree that any R&D can most efficiently and effectively be done by SENETEK’s dedicated laboratories or by a third party laboratory or academic institution with which SENETEK has a relationship, SENETEK shall pay for such activities and provide the RESEARCHERS with documentation of such payment.

It is agreed by the PARTIES that they shall consult in good faith regarding the nature, scope and costs of all R&D, the protocols therefore and the most efficient and effective sourcing thereof, provided that if agreement cannot be reached between the PARTIES within a reasonable time (having in mind the time limits set forth herein), SENETEK’s position shall prevail. SENETEK shall own all rights to any and all test reports and test results from R&D paid for or reimbursed by SENETEK as above provided, and the RESEARCHERS agree not to make any publication or other disclosure thereof without SENETEK’S prior written approval.

ARTICLE 5 - INTELLECTUAL PROPERTY AND EXPLOITATION OF THE RESULTS

 

5.1 INVENTIONS THAT MAY BE CREATED UNDER RESEARCH CO-OPERATION OF PARTIES

In the event and on each occasion that the TESTING of the COMPOUNDS reveals an effect of any of the COMPOUNDS that is not covered by the SENETEK PATENTS or the RESEARCHERS’ PATENTS and that merits patent protection, the following arrangement shall apply:

(a) the PARTIES shall collaborate in the preparation of documents required for the filing of a patent application on each such invention;

(b) all such patent applications shall be filed and owned by the RESEARCHERS, and SENETEK shall have the right to an exclusive license for use world-wide, for all applications;

(c) each patent application shall include the names of those employees of the PARTIES ( as co-inventors) that were responsible for the development of the invention;

(d) the PARTIES will agree on the filing of foreign patent protection;

(e) in case SENETEK executes its right to license a COMPOUND covered by a patent prepared under this Article 5.1, SENETEK will take over the cost of obtaining and maintaining the patent protection of the invention; provided that if such patent covers COMPOUNDS which SENETEK has elected not to license or claims fields of use for COMPOUNDS licensed to SENETEK that are beyond the fields of use SENETEK has

 

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6


elected to license, the PARTIES shall share such cost according to the commercial potential of SENETEK’S COMPOUND and/or field of use and such COMPOUND(S) and/or fields of use not licensed to SENETEK.

(f) the license fee paid by SENETEK for the grant to it of an exclusive license shall take into account the contribution made by SENETEK (both of cash and intellectual property) to the jointly developed invention;

(g) if the RESEARCHERS do not wish to file a patent application covering a jointly developed invention in a certain TERRITORY, SENETEK may file a patent application covering the jointly developed invention in such TERRITORY at its own cost in which case the patent protection obtained shall be owned one hundred percent (100%) by SENETEK.

 

5.2 All scientific data regarding patent applications will be written by the RESEARCHERS, in English, and will be presented to SENETEK for review and comments. Each patent application will be first filed in the country of origin as a provisional patent application, and within one year it will be filed as PCT in all other territories to be covered.

ARTICLE 6 - CONFIDENTIALITY

 

6.1 In consideration of the use of the COMPOUNDS by SENETEK and receipt by the RESEARCHERS of periodic reports on results of TESTING, and in consideration of joint research performed by PARTIES, each receiving PARTY agrees that during the term of this AGREEMENT, it will not, except to the extent authorized by disclosing PARTY in writing, use for any purpose other than those described herein, or publish, disclose or release to any third party, any information regarding the R&D or TESTING conducted on such COMPOUND, except as may be required in connection with the filing and prosecution of NEW PATENT APPLICATIONS. Each RESEARCHER, by signing this AGREEMENT, agrees to be bound by all of the terms of this Article 6 with the same effect as if such RESEARCHER were the RESEARCHERS.

 

6.2 The above restraints on use, release, and/or disclosure shall not apply to information or effects and applications of COMPOUNDS which:

 

   

at the time of delivery or disclosure are known to the receiving PARTY;

 

   

at the time of delivery or disclosure or subsequent thereto are generally available to the public through no fault of the receiving PARTY;

 

   

subsequent to the time of delivery or disclosure are independently developed by an employee or agent of the receiving PARTY who does so without reference to or knowledge of the disclosing PARTY’S information or the COMPOUNDS;

 

   

subsequent to the time of delivery or disclosure become or are made available to the receiving PARTY by a third party having the lawful right to do so; or

 

   

subsequent to the time of such delivery or disclosure become subject of another agreement between the PARTIES hereto which permits use, release and/or disclosure.

The PARTY seeking to assert any of the above exceptions shall have the burden of proof.

 

6.3 The PARTIES shall maintain the obligation of confidentiality for five years after the expiration of this AGREEMENT.

 

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ARTICLE 7 - FORCE MAJEURE

 

7.1 Neither PARTY shall be liable for failure in performance hereunder if occasioned by any cause beyond the control of the PARTY, such as for example fire, flood, strikes, inevitable accidents, war, embargo, blockade, legal restrictions, governmental relations, etc.

 

7.2 The occurrence of the Force Majeure shall be notified to the other PARTY in writing within 10 working days and shall be verified by the respective chamber of commerce within further 10 working days at the latest. Each P ARTY undertakes to do its utmost in order to re-establish conditions favorable for the performance of this AGREEMENT and shall inform the other PARTY about steps it has taken. The term of this AGREEMENT will be extended by the period the Force Majeure had lasted.

ARTICLE 8 - TERM OF THE AGREEMENT

 

8.1 This AGREEMENT shall be become effective on the EFFECTIVE DATE and shall continue and remain in effect according to its terms without limitation of time until the expiration of the last VALID CLAIM of any NEW PATENT APPLICATION, unless terminated in accordance with Article 8.2 or 8.3.

 

8.2 This AGREEMENT can be prematurely terminated by agreement of both PARTIES or may be prematurely terminated by a PARTY upon not less than six months’ prior written notice to the other PARTY.

 

8.3 A PARTY shall have the right to terminate this AGREEMENT forthwith at any time by notice in writing to the other PARTY if the other PARTY commits a material breach of any of the terms of this AGREEMENT and does not within 30 days of receipt of notice of the breach (if the same be capable of remedy) remedy such breach.

 

8.4 Termination of this AGREEMENT for any reason shall not bring to an end the confidentiality obligations of the PARTIES hereto; and/or the rights and obligations (if any) on each PARTY hereunder.

ARTICLE 9 - DISPUTES

 

9.1 In the event of any difference or dispute arising between the PARTIES hereto concerning the construction or performance of this AGREEMENT or its validity, the PARTIES shall first consult together in good faith and attempt to settle the matter amicably.

 

9.2 Any disputes relating to the interpretation, construction, performance or validity of this AGREEMENT which cannot be resolved under Article 10.1 above, shall be referred to a final decision of a panel of three (3) arbitrators (the “Panel”), appointed under and acting in accordance with the Rules of the Arbitration Court of the International Chamber of Commerce in Paris. The seat of the Arbitration Court shall be in Vienna.

 

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9.3 The PARTIES specifically agree that if they are unable in good faith to reach agreement as to any details of the license agreement or agreements referred to in Article 3.5, they shall submit such disagreement to the Panel and request that the Panel determine such disagreement in a manner consistent with ordinary course business practices as applied by reasonable business persons in the industry to which this AGREEMENT relates. Such determination by the Panel shall be treated as a decision of the Panel for all purposes of this Article 10.

 

9.4 Both PARTIES agree that the decision of the Panel shall be final and binding and that they shall undertake to abide by and execute the award rendered by the arbitrators without delay. The enforcement of such an award may be applied for at any court of competent jurisdiction.

 

9.5 The AGREEMENT as well as the mutual obligations arising under it shall be exclusively governed by the provisions of the substantive law of Austria.

ARTICLE 10- GENERAL

 

10.1 This AGREEMENT constitutes the sole and entire understanding either oral or written on the subject matter of the AGREEMENT. No further agreement or understanding shall be binding upon either PARTY hereto unless in writing signed by both PARTIES. This AGREEMENT shall not be assignable by any of the PARTIES hereto, without prior written consent of the other PARTIES.

 

10.2 The payments properly due to the RESEARCHERS under the AGREEMENT shall in no event be refundable to SENETEK. In the event of termination or expiration of this AGREEMENT SENETEK will pay all and any sums due to RESEARCHERS up to the date of expiration or termination. In the event that SENETEK shall be required to pay a tax on any payment to the RESEARCHERS, it shall deduct the amount of said tax from the payment due to the RESEARCHERS and shall provide the RESEARCHERS with a copy of the Certificate of the tax having been paid pursuant to an Agreement on Avoidance of Double Taxation or for other reasons.

 

10.3 The time periods provided for herein during which a PARTY is permitted or required to take any action shall be tolled and extended for such period of time, if any, as the other PARTY is in breach of any term of this AGREEMENT.

 

10.4 SENETEK hereby confirms that it has the expertise necessary to make use of any licensed patents and to develop, make, have made, sell, use, and otherwise commercially exploit the PRODUCTS.

 

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IN WITNESS WHEREOF, the PARTIES hereto have caused this AGREEMENT to be executed by their duly authorized representatives in a manner legally binding upon them as of the EFFECTIVE DATE.

 

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ANNEX 1

LICENSE AGREEMENT TERM SHEET

 

Term of License:    The term of the Valid Claims of the licensed patent(s).
Licensed Territory:    World-wide.
Scope of License:    Exclusive, for all applications.
Consideration:    Royalty of XXX of Senetek’s or its Affiliates’ Net Sales of licensed Products other than products covered by SENETEK PATENTS, and XXX of Senetek’s or its Affiliates’ Net Sales of licensed Products covered by SENETEK PATENTS,
   Royalty of XXX of Senetek’s SUB-LICENSEES’ Net Sales of sub-licensed products other than products covered by SENETEK PATENTS, and XXX of Senetek’s SUBLICENSEES’ Net Sales of sub-licensed products covered by SENETEK PATENTS
Sub-licensing! Assignment:    No limitation
Senetek Covenants:    Validity and enforceability of License Compliance with law in performing License
RESEARCHERS’ Covenants:    Validity and enforceability of License Maintenance and defense of licensed patents
Indemnification:    By Senetek for liability from any non-compliance with law in manufacture, marketing or sale of licensed products.
   By the RESEARCHERS for invalidity or unenforceability of licensed patents up to the value of payments received from SENETEK in preceding calendar year.
Termination:    By either Party for material breach by the other Party or insolvency or liquidation of the other Party.
Confidentiality:    Per basic AGREEMENT Agreed press release upon signing
Applicable Law:    Per basic AGREEMENT.
Other Terms:    See Annex 2

 

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ANNEX2

COMMERCIAL TERMS GOVERNING LICENSE

1. SENETEK will inform RESEARCHERS in writing of the dates of each FIRST COMMERCIAL SALE, within 2 (two) months of occurrence of such FIRST COMMERCIAL SALE.

2. Where PRODUCT is sold in a currency other then US Dollars, the rate of exchange to be used for converting such currency into US Dollars shall be the exchange rate, as published in the Financial Times, at the end of the relevant accounting period.

3. The payments shall be made within 60 days of the end of calendar quarter, and shall be accompanied by a statement which shall show on a country by country basis for the previous quarter all monies due to the RESEARCHERS. Said sales report shall include the sales figures used to calculate the royalties due to the RESEARCHERS, as well as the quantities sold, the unit price of any quantity of the PRODUCTS both by SENETEK and its AFFILIATES or SUB-LICENSEES.

4. The royalty properly due to the RESEARCHERS shall in no event be refundable to SENETEK.

5. In the event that SENETEK shall be required to pay a tax on any payment to the RESEARCHERS, it shall deduct the amount of said tax from the payment due to the RESEARCHERS and shall provide the RESEARCHERS with a copy of the Certificate of the tax having been paid pursuant to an Agreement on Avoidance of Double Taxation or for other reasons.

6. SENETEK shall prepare accounts, which shall include all the elements necessary to precisely calculate the NET SALES and NET ROYALTY within the framework of the AGREEMENT. If necessary these accounts shall be made available once a year with 30 days notice to the RESEARCHERS or an accredited designee of the RESEARCHERS during the term of the AGREEMENT and for one year thereafter. These accounts shall be prepared annually within 90 (ninety) days of the closing date of December 31 of each year which represents the end of SENETEK’s fiscal year.

7. Any sums which remain unpaid within the periods set out hereunder shall be subject to interest of 3% (three percent) over above LIBOR as published in the Financial Times at the end of the relevant accounting period, without prejudice to the RESEARCHERS’ right to terminate the contract in accordance with Article 10 of the present AGREEMENT.

8. The RESEARCHERS shall have the right once a year with 30 days notice to audit or have audited the sales accounts kept by SENETEK. Should there be an audit, an expert accountant shall be appointed by mutual agreement of both PARTIES at the expense of the RESEARCHERS, except that if the amount of installments shown by such audit to be due to the RESEARCHERS exceed the amount actually paid by SENETEK by 5% (five percent) then such expenses shall be paid by SENETEK and any back payments shall be reimburse with per the Agreement.

 

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9. SENETEK agrees to make reasonable efforts to make, have made, sell and otherwise commercially exploit the PRODUCTS, using similar efforts devoted to products of similar nature and similar markets.

10. SENETEK agrees to provide annual reports on the development and exploitation of the PRODUCTS.

11. SENETEK and its AFFILIATES agree not to use the names of the RESEARCHERS, any trademark, distinctive sign or adaptations thereof which belongs to the RESEARCHERS or the names of RESEARCHERS inventors or of any RESEARCHERS agent, on packaging, labeling, advertising or promotional materials for the PRODUCTS without receiving prior written approval from the RESEARCHERS and the natural person concerned, as the case may be.

12. PRODUCTS shall be commercialized by SENETEK, its AFFILIATES and its SUBLICENSEES under their own trademarks. The RESEARCHERS shall have no rights to such trademarks. All administrative authorizations obtained by SENETEK, its AFFILIATES or its LICENSEES for the purpose of manufacturing and/or commercializing the PRODUCTS shall be obtained for them. The RESEARCHERS shall claim no rights thereto.

13. SENETEK accepts the obligation to inform by writing the RESEARCHERS of all administrative marketing approvals that it obtains for the purpose of manufacturing and/or commercializing the PRODUCTS no later than 3 (three) months after obtaining such final authorizations.

 

Furfurylcytosine

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EX-10.114 8 dex10114.htm PAYMENTS IN THE EVENT OF CERTAIN CHANGES AGREEMENT, WILLIAM F. O'KELLY Payments in the Event of Certain Changes Agreement, William F. O'Kelly

Exhibit 10.114

March 5, 2007

Mr. William O’Kelly

2185 West Pueblo Avenue

Napa, CA 94558

Re: Payments in the Event of Certain Changes

Dear Bill:

In connection with your employment with Senetek Plc (the “Company”) the Board of Directors has agreed that you should have the benefit of certain protections in the event of certain changes of circumstance that are specifically described in this letter. Defined terms have the meaning ascribed to them in Section 4 of this letter agreement.

1. Change of Control:

Following a Change of Control, you shall be entitled to a Termination Payment if: (A) you are not retained as Chief Financial Officer of the Company and (B) you are not offered a position of Equivalent Authority by the Company or its Successor Enterprise and (C) if you have not been terminated following the Change of Control, you elect not to continue your employment (in any capacity) with Company or the Successor Enterprise within 30 days following the Change of Control.

2. Relocation of the Company:

You shall be entitled to a Termination Payment if you do not continue employment (in any capacity) with the Company or a Successor Enterprise following a Relocation. It is agreed and understood that if you continue your employment for any period following a Relocation, you shall not be entitled to a Termination Payment.

3. Single Payment:

For avoidance of doubt, it is understood and agreed that you would only be entitled to receive one single Termination Payment in any circumstance (i.e., even if both a Change of Control and a Relocation had occurred).


4. Defined terms:

As used in this letter, the terms listed below have the following meanings:

Change of Control means (a) the sale, lease or other transfer of all or substantially all of the assets of the Company to any person or group (as such term is used in Section 13(d)(3) of the Securities Exchange Act of 1934, as amended); (b) the adoption by the stockholders of the Company of a plan relating to the liquidation or dissolution of the Company; (c) the merger or consolidation of the Company with or into another entity or the merger of another entity into the Company or any subsidiary thereof with the effect that immediately after such transaction the stockholders of the Company immediately prior to such transaction (or their related parties) hold less than fifty percent (50%) of the total voting power of all securities generally entitled to vote in the election of directors, managers or trustees of the entity surviving such merger of consolidation; (d) the acquisition by any person or group of more than fifty percent (50%) of the voting power of all securities of the Company generally entitled to vote in the election of directors of the Company; or (e) that the majority of the Board is composed of members who (i) have served less than twelve months and (ii) were not nominated or appointed by a majority of the Board (or a duly constituted committee of the Board) in connection with their election or appointment. As used in this paragraph, the term “related parties” shall mean with respect to any person (x) the spouse and lineal ascendants and descendants of such person. and any sibling of any of such persons and (y) any trust, corporation, partnership or other entity, the beneficiaries, stockholders, partners, owners or persons beneficially holding an eighty percent (80%) or more controlling interest of which consist of persons referred to in (x) above.

Equivalent Authority means a position as Principal or Chief Financial Officer or Principal or Chief Accounting Officer or another position in finance or accounting that would require you to report directly to either (i) the Chief Executive Officer or (ii) the audit committee of the Board of Directors. It is further agreed that any position that you are offered with the Company or Successor Enterprise following a Change of Control for which the base salary (on an annual basis) is at least as great your base salary immediately prior to the Change of Control shall be deemed to be a position of Equivalent Authority for purposes of this letter.

Relocation means that the principal executive offices of the Company (or a Successor Enterprise) shall be located in anywhere outside of the geographic boundaries following counties, each of which is located in the State of California —[Lake, Napa Sonoma, Marin, Contra Costa, San Francisco, Alameda, Sacramento, San Mateo, Yolo]; provided, however, that a Relocation shall not have occurred if the Company or Successor Enterprise shall have: (i) provided you with office space within one of the foregoing counties or (ii) permission to continue your employment with the Company from a home office.

Successor Enterprise means any corporation, partnership, limited liability company or other business enterprise (i) into which the Company is merged or with which the Company is consolidated and (ii) any corporation, partnership, limited liability company or other business enterprise that acquires, purchases or otherwise succeeds to all or substantially all of the assets of the Company.

 

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Termination Payment means an amount equal to six months of your base salary as at the date of the Change of Control or Relocation. The Termination Payment shall be made in six equal monthly payments commencing with the month immediately following the month in which you first became entitled to a Termination Payment.

5. No Guarantee of Continued Employment; Terms and Conditions of [Employment Manual] Apply, Other Provisions:

This letter shall not be deemed to constitute any guarantee or promise of continued employment. The terms and conditions of your employment shall continue to be governed by the Company’s [Employment Manual], as the same may be amended, altered, changed or supplement from time to time hereafter, except that the provisions of this letter shall apply in the specific circumstances set forth herein, notwithstanding any different or other provisions in the Employment Manual that govern payments to employees upon a change of control or relocation of the Company. The rights and benefits set forth in this letter are personal to you and may not be assigned or transferred to any other party. The Company’s obligations under the terms of this letter shall be binding upon the Company’s successors and assigns, including any Successor Enterprise. This letter agreement supersedes and replaces any earlier agreement (oral or written) between you and the Company with respect to the subject matter hereof and may only be amended by a further written agreement between you and the Company (or its successors or assigns).

If you are in agreement with the terms of this letter agreement, please so acknowledge by executed a copy of this letter in the signature space provided below and by returning the executed copy to the undersigned.

 

Very truly yours,
/s/ Frank J. Massino

Frank J. Massino,

for and on behalf of Senetek Plc

 

Agreed and acknowledged:
/s/ William O’Kelly
William O’Kelly

 

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EX-10.115 9 dex10115.htm LICENSE AND INTELLECTUAL PROPERTY ACQUISITION AGREEMENT DATED MARCH 30, 2007 License and Intellectual Property Acquisition Agreement dated March 30, 2007

Exhibit 10.115

LICENSE AND INTELLECTUAL PROPERTY ACQUISITION AGREEMENT

This License and Intellectual Property Acquisition Agreement (as amended from time to time, this “Agreement”), dated this 30th day of March, 2007, but effective as of January 1, 2007 (the “Effective Date”), is made by and between Senetek PLC, an English corporation (“Senetek”) and Valeant Pharmaceuticals North America, a Delaware corporation (“Valeant”).

W I T N E S S E T H:

WHEREAS, Senetek has developed and holds certain patents and other intellectual property rights relating in and to the use of formulated products containing Kinetin and Zeatin;

WHEREAS, Valeant is a manufacturer and distributor of a broad range of pharmaceutical products worldwide;

WHEREAS, Senetek and Valeant Pharmaceuticals International (“VPI”), an Affiliate of Valeant, have previously entered into that certain License Agreement, dated August 1, 2003, as amended (the “Original License Agreement”);

WHEREAS, VPI has assigned all of its rights under the Original License Agreement to Valeant in accordance with Section 10.5 of the Original License Agreement;

WHEREAS, Valeant now desires to acquire from Senetek, and Senetek desires to transfer to Valeant, certain intellectual property rights relating to Kinetin and Zeatin; and

WHEREAS, Valeant and Senetek desire to terminate the Original License Agreement and enter into this Agreement with respect to such intellectual property;

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


ARTICLE 1

DEFINITIONS AND INTERPRETATION

Section 1.1 Definitions. When used in this Agreement, each of the following capitalized terms shall have the respective meanings set forth below:

(a) “Affiliate” means, with respect to a Person, any corporation, partnership, proprietorship or other legal entity directly or indirectly controlled by, controlling, or under common control with another legal entity; “control” meaning, for purposes hereof, the effective power to elect at least a majority of the Board or Directors or other management body of a legal entity or to effectively direct the management of a legal entity, by the ownership of voting securities, by contract, or otherwise.

(b) “Applicable Law” means all applicable provisions of all statutes, laws, rules, regulations, administrative codes, ordinances, decrees, orders, decisions, guidance documents, injunctions, awards, judgments, and permits and licenses of or from Government Entities relating to or governing the use or regulation of the subject item, including, where applicable, tax law.

(c) “Business Day” means a day which is not a Saturday, a Sunday, or a day upon which federally chartered banks in the United States are required to be closed.

(d) “Commercially Reasonable Efforts” means that commercially reasonable degree of effort, expertise, knowledge and resources which one skilled, able, familiar with and experienced in the matters set forth herein would utilize and otherwise apply with respect to fulfilling a like obligation subject to the then existing legal, contractual and other restrictions.

(e) “Confidential Information” means any and all non-public information of a Party or its Affiliates, whether or not related to the subject matter of this Agreement or any of the Existing License Agreements, which (i) is marked as confidential or with words of like effect, or (ii) is disclosed orally, but identified as confidential information by subsequent writing within five (5) days of such disclosure, or (iii) on its face is of such a nature that a reasonable business person would necessarily regard it as confidential, subject to Article 8. Confidential Information may include the non-public information of a Third Party that has disclosed such information to a Party or its Affiliates in the course of its business.

(f) “Effective Date” has the meaning set forth in the Preamble.

 

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(g) “Encumbrance” means claims, security interests, liens, pledges, charges, escrows, options, proxies, rights of first refusal, preemptive rights, mortgages, hypothecations, assessments, prior assignments, title retention agreements, conditional sales agreements, indentures, deeds of trust, leases, levies or security agreements of any kind whatsoever imposed upon the subject property or item.

(h) “Existing License Agreement” means any agreement, whether written or oral, between Senetek and any Third Party, or by which Senetek is bound, which exists as of the Effective Date and by which Senetek grants or purports to grant any rights in, to or under the Intellectual Property or any portion of the Intellectual Property, including but not limited to those agreements listed on Schedule 4.1(e).

(i) “Final Adjudication” means any decision by a Government Entity of competent jurisdiction if either (a) any and all appeals (including to other Government Entities of competent jurisdiction) in connection with the adjudication are exhausted or (b) the time for any such appeal shall have passed without such appeal having been perfected.

(j) “Government Entity” means any competent governmental agency, board, authority, commission, court or other governmental entity having lawful jurisdiction over the subject matter.

(k) “Intellectual Property” means the Patents, together with any copyrights and any other intellectual and industrial property rights of any sort throughout the world that Senetek owns or has rights to on the Effective Date, and that relate to the making, using, selling, offering to sell, importing or exporting of any products for human use containing any of the Licensed Compounds, but excluding the Know-How.

(l) “Intellectual Property and Know-How Records” means all documentation, including, without limitation, books of account, financial records and other books and records, maintained, owned or controlled by Senetek, whether in electronic or tangible form, relating to the Intellectual Property and Know-How.

(m) “Know-How” means all Trade Secrets and other information, data, documents, materials and knowledge, including Confidential Information, that Senetek owns or has rights to on the Effective Date, to the extent such is useful or necessary for the making, using, selling, offering to sell, importing or exporting of any products for human use containing any of the Licensed Compounds or any component thereof including, but not limited to, (i) information related to any pharmaceutical, chemical, biological and biochemical product covered under the

 

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Patents, (ii) technical and non-technical data, information relating to the results of tests, assays, methods and/or processes, (iii) drawings, plans, diagrams, specifications and/or other documents containing this information, and further means and includes any and all proprietary special knowledge, expertise, discoveries, formulations, processes and technical, regulatory or other information, and (iv) any of the foregoing as they may relate to the items or matters listed on Schedule 1.1(m).

(n) “Licensed Compounds” means Kinetin and Zeatin.

(o) “Party” or “Parties” means Senetek or Valeant, or Senetek and Valeant, whichever the context requires.

(p) “Patents” means those U.S. and foreign patents and patent applications listed on Schedule 4.1(g)(ii)(A), together with all patents and patent applications owned by and licensed by Senetek that claim priority to or common priority with, divisions, continuations, continuations-in-part, together with any substitutions, replacements, reissues, renewals, re-examinations, extensions or additions thereto, and all worldwide counterparts thereof.

(q) “Patent License Term” has the meaning set forth in Section 2.1.

(r) “Person” means any individual, corporation, limited liability company, partnership, association, trust, unincorporated organization, other legal entity or government or political subdivision thereof.

(s) “Regulatory Approvals” means, as related to the Intellectual Property and/or Senetek’s operation of the business related to the Licensed Compounds in the Territory, all material permits, licenses, certificates, approvals, product registrations, filings and authorizations issued by any Government Authority to Senetek or its representatives.

(t) “Territory” means all the countries and territories of the world.

(u) “Third Party” means any Person other than Senetek or Valeant or their Affiliates.

(v) “Trademarks” means all trademarks, service marks, certification marks, trade names, commercial names or collective marks, registered or at common law, names, symbols, or devices, or any combination thereof, adopted and used by Senetek to identify and distinguish its products, processes, services and/or other uses of the Licensed Compounds from those of any Third Party.

 

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(w) “Trade Secret” means information possessed by Senetek on the Effective Date, including any formula, pattern, compilation, program, device technique, or process that derives or could reasonably be expected to derive independent economic value, actual or potential, from not being generally known to and not being readily ascertainable by proper means by other persons who can obtain economic value from its disclosure or use.

(x) “Valid Claim” means any claim in an unexpired patent or patent application included within the Patents that has not been disclaimed or held invalid or enforceable by a Government Entity of competent jurisdiction in a Final Adjudication.

Section 1.2 Construction. Unless the context of this Agreement otherwise requires: (a) words of any gender include each other gender; (b) words using the singular or plural number also include the plural or singular number, respectively; (c) the terms “hereof,” “herein,” “hereby” and derivative or similar words refer to this entire Agreement; (d) the terms “Article,” “Section” “Schedule” or “Exhibit” refer to the specified Article, Section, Schedule or Exhibit of this Agreement; (e) the term “or” has, except where the context otherwise dictates, the inclusive meaning represented by the phrase, “and/or”; and (f) the term “including” or any variation thereof means “including without limitation” or any variation thereof and shall not be construed to limit any general statement which it follows to the specific or similar items or matters immediately following it, unless otherwise expressly stated.

ARTICLE 2

CONVEYANCE OF INTELLECTUAL PROPERTY RIGHTS AND KNOW-HOW

Section 2.1 Intellectual Property. Senetek hereby grants to Valeant an exclusive (even as to Senetek), assignable, fully paid up, non-royalty bearing license under the Intellectual Property, free and clear of any Encumbrances (except as provided in Section 2.3), with the right to grant sublicenses, to make, use, offer to sell, sell, import, and export any products for human use containing any of the Licensed Compounds throughout the world. The term of such license with respect to the Patents (the “Patent License Term”) shall run in each country having issued any of the Patents for the period beginning on the Effective Date and ending upon the expiration of all issued Patents issued by such country containing a Valid Claim. The term of such license with respect to the Intellectual Property, other than the Patents, shall be perpetual.

Section 2.2 Know-How. Senetek hereby sells, assigns, sets over, transfers, and conveys to Valeant an undivided XXXXXXX interest in all of Senetek’s right, title and interest in and to all of the Know-How, free and clear of any Encumbrances (except as provided in

 

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Section 2.3). Anything in this Agreement to the contrary notwithstanding, during the Patent License Term, Senetek shall not, without Valeant’s prior written consent, in any country having issued any of the Patents until the expiration of all Patents issued by such country containing a Valid Claim, (i) license or disclose the Know-How, or any interest therein, to a Third Party for the making, using, selling, offering to sell, importing or exporting of any products for human use containing any of the Licensed Compounds, or (ii) use the Know-How for the selling, offering to sell, importing or exporting of any products for human use containing any of the Licensed Compounds (it being understood that Senetek may use the Know-How for researching and developing such products or any other products).

Section 2.3 Limitations. The license in Section 2.1 and the conveyance in Section 2.2 are made subject to the terms and provisions of the Existing License Agreements, and Valeant’s rights to use the Know-How pursuant to Section 2.2 shall not include any Confidential Information obtained by Senetek from any licensee, the disclosure of which (i) would violate the terms and provisions of the Existing License Agreements or (ii) would violate applicable antitrust or trade regulation laws or applicable rules of any Government Entity.

Section 2.4 Right of First Offer Following Expiration of Patents. Effective upon the expiration of the first to expire of any or all Patents in any particular country and at all times thereafter, Valeant shall have the right of first offer to obtain the right to sell in such country any skin care product developed, being developed or otherwise acquired by Senetek or its Affiliates which is either (i) a systemic (oral or injectable) product containing as its primary active ingredient either Kinetin or Zeatin, or (ii) a topical product containing as an active ingredient either Kinetin or Zeatin (any such developed or acquired product or product in development being referred to in this Section 2.4 as a “product”) provided that such right of first offer shall not apply with regard to products that are both (a) protected through patents or other exclusivity as to, owned by, or vested in a Third Party, and (b) as to which Senetek or its Affiliates have not acquired on or prior to the Effective Date the right to grant marketing rights to others. At such time as Senetek determines, based on preliminary in vitro or other studies or other information (clinical or otherwise) (collectively, the “Data”), that such product exhibits action that may make it commercially marketable, Senetek shall give written notice thereof to Valeant, together with all Data in Senetek’s possession or control. Valeant shall have sixty (60) days from the date that it receives such notice to deliver an offer to Senetek setting forth in reasonable detail the principal commercial terms upon which Valeant would purchase, market and resell such product. If Senetek elects not to accept Valeant’s offer (or if no offer is made within such period), Senetek shall be free to (i) grant a license to sell such product in the relevant country to others on terms

 

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no better to such other party than those offered by Valeant (or, if Senetek has made a counter offer, on terms no better to such other party than those offered by Senetek to Valeant), (ii) exercise the right to sell such product itself, or (iii) any combination thereof, all in Senetek’s sole discretion; provided, however, that in connection with entering into a definitive agreement with such other party, Senetek shall provide to such other party preliminary Data no different than the preliminary Data provided to Valeant. If Senetek develops or acquires Data with respect to such product different than the Data made available to Valeant, Senetek shall give another written notice to Valeant, together with such different Data, and Valeant shall have sixty (60) days from the date that it receives such notice to deliver an offer to Senetek in accordance with the terms specified above regarding the first notice (it being the intention of the Parties that such procedure be repeated until such time as the studies developed by or for Senetek demonstrate “proof of concept” for such product).

ARTICLE 3

CONSIDERATION

Section 3.1 Closing Payments. Concurrently with the execution of this Agreement, Valeant will pay to Senetek, by wire transfer of immediately available funds to an account specified in writing by Senetek, a one-time payment of Twenty-One Million Dollars ($21,000,000) (the “Closing Payment”).

Section 3.2 Earn Out Payment. In addition, Senetek shall be entitled to earn, and if earned, Valeant shall pay Senetek, an earn out payment (the “Earn Out Payment”) as follows:

(a) Senetek shall be entitled to receive the Earn Out Payment, and Valeant shall be obligated to pay Senetek the Earn Out Payment, only if Valeant receives in excess of XXXXXXXXXX in Net Royalties during the Earn Out Period.

(b) If Valeant receives in excess of XXXXXXXXXX in Net Royalties during the Earn Out Period (the amount of any such excess Net Royalties being hereinafter referred to as the “Excess Royalties”), then Valeant shall pay Senetek as the Earn Out Payment:

(i) XXX of the first XXXXXXXXX of Excess Royalties received during the Earn Out Period; and

(ii) XXX of any additional Excess Royalties received during the Earn Out Period.

 

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(c) The Earn Out Payment, if any, shall be paid in one or more quarterly installments. The timing and amount of each such quarterly installment shall depend on when and in what amounts the Excess Royalties are received. Within thirty (30) days following the last day of any calendar quarter during the Earn Out Period within which any Excess Royalties are received, Valeant shall pay Senetek the accrued portion, if any, of the Earn Out Payment then due.

(d) Either Party may, upon written notice to the other Party, request an independent audit and determination of the Earn Out Payment calculation with respect to any completed calendar quarter during the Earn Out Period (each such calendar quarter being hereinafter referred to as an “Audited Quarter”); provided that the Party requesting the audit provide such written request to the other Party within 12 months following the last day of the Audited Quarter. In the event that an audit is requested in accordance herewith, the Parties shall select an independent public accounting firm (the “Auditor”) to perform the audit, and each Party shall cooperate fully in the audit and shall bear one-half of the Auditors fees and expenses. The Auditor’s determination of the Earn Out Payment for the Audited Quarter shall be final and binding on both Parties, and within 10 days following the Parties’ receipt of the Auditor’s determination, each Party agrees that it will make whatever payment to the other Party is required, if any, to cause the Earn Out Payment made with respect to the Audited Quarter, if any, to equal the Earn Out Payment for such Audited Quarter as determined by the Auditor.

(e) For purposes hereof, (i) the term “Earn Out Period” shall mean the five year period commencing on the Effective Date and ending on December 31, 2011, and (ii) the term “Net Royalties” shall mean the total royalties paid to Valeant under the Existing License Agreements with respect to the Earn Out Period (whether received directly from the licensees or from Senetek in accordance with this Agreement), less any credits or refunds required to be given or paid by Valeant with respect thereto.

Section 3.3 Royalty Credit. In addition to the foregoing, Valeant shall and hereby does waive the application of the Unused Prepaid Royalty Credit (as hereinafter defined) in accordance with Section 3.11 of the Original License Agreement, and forgives any refund thereof, and in lieu of such refund, the Parties hereby agree that the Unused Prepaid Royalty Credit shall be credited as (and accounted by both Parties as) an additional cash payment made by Valeant to Senetek hereunder. For purposes hereof, the “Unused Prepaid Royalty Credit” shall mean XXXXXXX, being that portion of the royalty credit due to Valeant pursuant to the Amendment to License Agreement, dated May 4, 2004, to the Original License Agreement as a prepayment of future royalties which has not, as of the Effective Date, been credited to VPI or

 

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Valeant under Section 3.11 of the Original License Agreement. Senetek shall not be entitled to receive any other royalties or payments hereunder.

ARTICLE 4

REPRESENTATIONS AND WARRANTIES

Section 4.1 Representations and Warranties of Senetek. Senetek hereby represents and warrants to Valeant, as of the Effective Date and as of the Execution Date, as follows:

(a) Organization and Authority. Senetek is a corporation duly organized, validly existing and in good standing under the laws of England. Senetek has full corporate power and authority to execute and deliver this Agreement and effect the transactions contemplated hereby and has duly authorized the execution, delivery and performance of this Agreement and the transactions or documents contemplated hereby by all necessary corporate action. Senetek has all corporate power and authority necessary to own its assets and carry on its business as it is now conducted. Senetek is duly licensed or qualified to do business and is in good standing in England and California and each other jurisdiction in which its operations or ownership of assets in connection with this Agreement requires such licensing or qualification. This Agreement is the valid and legally binding obligation of Senetek, enforceable against it in accordance with its terms, subject to applicable bankruptcy, moratorium, reorganization, insolvency and similar laws of general application relating to or affecting the rights and remedies of creditors generally and to general equitable principles (regardless of whether in equity or at law).

(b) Consents; No Violations. The execution, delivery and performance by Senetek of this Agreement and the consummation by Senetek of the transactions contemplated hereby will not require any notice to, filing with, or the consent, approval or authorization of, any Person or Government Authority. Neither the execution and delivery of this Agreement nor the consummation of the transactions contemplated hereby will (i) violate or result in a breach or result in the acceleration or termination of, or the creation in any Third Party of the right to accelerate, terminate, modify or cancel, any indenture, contract, lease, sublease, loan agreement, note or other obligation or liability to which Senetek is a party or by which it is bound or to which any of the Intellectual Property or Know-How is subject, (ii) conflict with, violate or result in a breach of any provision of the organizational documents of Senetek, or (iii) conflict with or violate any Applicable Law with respect to Senetek or the Intellectual Property or Know-How. Senetek is not a party to or bound by any agreement, written or oral, which encumbers, restricts or otherwise compromises Senetek’s ability to enforce the Existing License Agreements.

 

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(c) Compliance with Laws. Except as set forth on Schedule 4.1(c), with respect to the Intellectual Property, Senetek is in compliance with all Applicable Law.

(d) Litigation. There are no lawsuits, claims or any civil, administrative or criminal actions, suits, or proceedings or governmental investigations existing, pending, or to the knowledge of Senetek, threatened, with respect to the Intellectual Property, the Know-How or this Agreement or the transactions contemplated hereby. Senetek is not subject to any decree or order of any Government Authority that would impair or delay its ability to perform its obligations under this Agreement

(e) Existing License Agreements. Schedule 4.1(e)(i) sets forth a complete and correct list of all of the Existing License Agreements. Except as set forth on Schedule 4.1(e)(ii), such Existing License Agreements are the only agreements, written or oral, existing between Senetek and any Third Party or by which Senetek is bound which purport to grant any rights in, to or under the Intellectual Property, the Know-How or any portion thereof. Senetek has delivered to or made available to Valeant true and complete copies of all of the Existing License Agreements. All of the Existing License Agreements are, as to Senetek (and, as to the other parties thereto, are to Senetek’s best knowledge), legal, valid and binding agreements in full force and effect and enforceable in accordance with their terms. Senetek is not in breach or default, and no event has occurred that with notice or lapse of time would constitute a breach or default, by Senetek permitting termination, modification, or acceleration, under any Existing License Agreement. To Senetek’s knowledge, no other party to any Existing License Agreement is in breach or default under, or has repudiated any provision of, any Existing License Agreement.

(f) Payments Under Existing License Agreements. Schedule 4.1(f) sets forth, on a contract-by-contract basis, a complete and correct list of all of the royalty payments and other payments past due to Senetek from the licensees or from other Third Parties under the Existing License Agreements. To Senetek’s knowledge, as of the date of this Agreement, the licensees and other Third Parties under the Existing License Agreements are current as to all payments due to Senetek.

(g) Intellectual Property and Know-How.

(i) Except as set forth in Schedule 4.1(e)(ii), Senetek is the owner, licensee or sublicensee (as applicable), free and clear of any Encumbrance, of all right, title and interest in and to the Intellectual Property, and has the full and unrestricted right to license the Intellectual Property to Valeant on the terms of this Agreement.

 

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(ii) The following schedules set forth a true and complete list of the following:

(A) Schedule 4.1(g)(ii)(A) - The Patents, including (A) issued Patents and for each, its number, issue date, title, priority information and current legal status, for each jurisdiction in which such patent has been issued; (B) Patent applications (including provisional applications, divisional applications, continuation applications, continuation-in-part applications, re-examination applications and reissue applications) and for each, the application number, date of filing, title, priority information and current legal status for each jurisdiction in which such patent application is pending; (C) a summary description of all patents and patent applications (including provisional patent applications) related to the Intellectual Property that Senetek has abandoned; and (D) a summary description of all issued patents and patent applications (including provisional patent applications) related to the Intellectual Property that have been rejected by the patenting authority in any jurisdiction;

(B) Schedule 4.1(g)(ii)(B) - Trademarks, including, (A) if registered, the registration number thereof, and the class of goods or the description of goods or services covered thereby, the jurisdictions in which such Trademark is registered, the current legal status and the expiration date for each jurisdiction in which such Trademark has been registered; and (B) if unregistered, the application serial number thereof (if any), the date of filing (if any), the jurisdictions in which such application was filed or such trademark was used and the class of goods or the description of goods or services sought to be covered thereby or for which such trademark was used.

(iii) None of the Patents is involved in any litigation, reissue, interference, reexamination, or opposition, and to the knowledge of Senetek, there has been no threat or other indication that any such proceeding will hereafter be commenced. The Patents (excluding patent applications) are in good standing, without challenge of any kind known to Senetek, have not been adjudged invalid

 

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or unenforceable in whole or in part, and to Senetek’s best knowledge there is no valid basis for any adjudication of invalidity or unenforceability thereof.

(iv) None of the Trademarks or registrations or applications to use or register such items are involved in any cancellation, nullification, interference, conflict, concurrent use or opposition proceeding, and there has been no threat or other indication that any such proceeding will hereafter be commenced.

(v) No legal proceedings are pending, or to the knowledge of Senetek are threatened, against Senetek based upon, challenging or seeking to deny or restrict the use of any of the Intellectual Property or the Know-How.

(vi) All maintenance fees, annuity fees or renewal fee payments currently due for each jurisdiction in which each patent, patent application, trademark, trademark application, trade name, trade name registration, brand name, brand name registration, service mark, service mark registration, copyright, copyright application, domain name or domain name application included within the Intellectual Property has issued or is pending have been paid.

(vii) Except as described in Schedule 4.1(g)(vii), to Senetek’s knowledge, no Third Party is engaging in any activity that infringes or misappropriates the Intellectual Property or the Know-How.

(viii) Senetek has delivered or made available to Valeant true and complete copies of the issued Patents and all applications therefore included in the Intellectual Property and all applications and registrations for Trademarks.

(ix) Senetek has, with respect to the Intellectual Property and the Know-How, used Commercially Reasonable Efforts to maintain its Trade Secrets in confidence, including entering into licenses and contracts that generally require licensees, contractors and other third persons with access to such Trade Secrets to keep such Trade Secrets confidential.

(x) To Senetek’s knowledge, there has been no misappropriation of any Trade Secrets or other Confidential Information of Senetek with respect to the Intellectual Property and the Know-How.

 

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(xi) Senetek has secured valid written assignments from all current and former consultants and employees who contributed to the creation or development of the Intellectual Property of such Person’s ownership interest therein. To Senetek’s knowledge, none of the employees or consultants of Senetek is in violation thereof. All employees of, consultants to or vendors of Senetek with access to Confidential Information with respect to the Intellectual Property and the Know-How are parties to written agreements under which each such employee, consultant or vendor is obligated to maintain the confidentiality of such Confidential Information of Senetek. To Senetek’s knowledge, none of the employees, consultants or vendors of Senetek or any of its subsidiaries is in violation of such agreements.

(xii) The execution, delivery and performance of this Agreement, and the consummation of the transactions contemplated hereby, will not result in or give rise to any right of termination or other right to impair or limit, or otherwise result in a breach of, any of Senetek’s rights to own or retain a license to any of the Intellectual Property or the Know-How.

(h) Books and Records. All of the Intellectual Property and Know-How Records have been made available by Senetek to Valeant for examination, are complete and correct in all material respects, and have been maintained in accordance with sound business practices.

(i) Regulatory Compliance.

(i) Schedule 4.1(i) sets forth a complete and correct list of the Regulatory Approvals to which Senetek is a party or holds (as applicable), and which relate to the Intellectual Property or the operation of the business related to the Intellectual Property by Senetek. Senetek has provided to Valeant complete and correct copies of the Regulatory Approvals. The Regulatory Approvals are in full force and effect and have been duly and validly issued.

(ii) Senetek has all Regulatory Approvals necessary for or used to carry on the business related to the Intellectual Property as being conducted by Senetek as of the Effective Date and which are required by Applicable Law.

(iii) Except as set forth on Schedule 4.1(i), Senetek is in compliance with all of the Regulatory Approvals listed on Schedule 4.1(i), and Senetek has not received any notification, written or oral, from any Third Party with respect to

 

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any alleged or possible violations or improprieties with respect to any such Regulatory Approvals, and to Senetek’s knowledge, there are no facts or circumstances that would form a reasonable basis for any such violation or impropriety.

(j) Financial Statements. Senetek has previously provided to Valeant historical royalty revenue information with respect to the Existing License Agreements (the “Historical Financial Information”). Such Historical Financial Information is true and correct in all material respects, and has been prepared and presented on a consistent basis using recognized professional accounting standards.

(k) Disclosure. No representation or warranty or other statement made by Senetek in this Agreement contains any untrue statement of material fact or omits to state a material fact necessary to make any of them, in light of the circumstances in which they are made, not misleading. Except as set forth in Schedule 4.1(k), Senetek does not have any knowledge of any material fact that has specific application to Senetek or the Intellectual Property or Know-How that would reasonably be expected to have a material adverse effect on Senetek or the Intellectual Property or Know-How that has not been set forth in this Agreement or the schedules or exhibits hereto.

Section 4.2 Representations and Warranties of Valeant. Valeant hereby represents and warrants to Senetek, as of the Effective Date and as of the Execution Date, as follows:

(a) Organization and Authority of Valeant. Valeant is a corporation duly organized, validly existing and in good standing under its jurisdiction of formation. Valeant has full corporate power and corporate authority to execute and deliver this Agreement and effect the transactions contemplated hereby and thereby and has duly authorized the execution, delivery and performance of this Agreement the and transactions or documents contemplated hereby by all necessary corporate action. Valeant has all corporate power and corporate authority necessary to own its assets and carry on its business as currently conducted. This Agreement is the valid and legally binding obligation of Valeant, enforceable against it in accordance with its terms, subject to applicable bankruptcy, moratorium, reorganization, insolvency and similar laws of general application relating to or affecting the rights and remedies of creditors generally and to general equitable principles (regardless of whether in equity or at law).

(b) Organization and Authority of VPI. VPI is a corporation duly organized, validly existing and in good standing under its jurisdiction of formation. VPI has full corporate power

 

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and corporate authority to execute and deliver this Agreement and effect the transactions contemplated hereby and thereby and has duly authorized the execution, delivery and performance of this Agreement the and transactions or documents contemplated hereby by all necessary corporate action. VPI has all corporate power and corporate authority necessary to own its assets and carry on its business as currently conducted. This Agreement is the valid and legally binding obligation of VPI, enforceable against it in accordance with its terms, subject to applicable bankruptcy, moratorium, reorganization, insolvency and similar laws of general application relating to or affecting the rights and remedies of creditors generally and to general equitable principles (regardless of whether in equity or at law).

(c) Consents; No Violations of Valeant. Neither the execution, delivery or performance of this Agreement, nor compliance by Valeant with any of the provisions hereof, will (i) violate or conflict with any provision of the Certificate or Articles of Incorporation or Bylaws of Valeant, (ii) violate, conflict with, or result in a breach of any provision of, or constitute a default (or an event which, with notice or lapse of time or both, would constitute a default) under, or result in the creation of any Encumbrance upon any of Valeant’s assets under, any of the terms, conditions or provisions of any material contract, indebtedness, note, bond, indenture, security or pledge agreement, commitment, license, lease, franchise, permit, agreement, or other instrument or obligation to which Valeant is a party, or (iii) violate any statute, rule, regulation, ordinance, code, order, judgment, ruling, writ, injunction, decree or award applicable to Valeant, except, in the case of each of clauses (i), (ii) and (iii) above, for such violations, conflicts, breaches, defaults or creations of Encumbrances which, in the aggregate, would not have a material adverse affect on the business of Valeant taken as a whole or any adverse effect on its ability to fully perform this Agreement.

(d) Consents; No Violations of VPI. Neither the execution, delivery or performance of this Agreement, nor compliance by VPI with any of the provisions hereof, will (i) violate or conflict with any provision of the Certificate or Articles of Incorporation or Bylaws of VPI, (ii) violate, conflict with, or result in a breach of any provision of, or constitute a default (or an event which, with notice or lapse of time or both, would constitute a default) under, or result in the creation of any Encumbrance upon any of VPI assets under, any of the terms, conditions or provisions of any material contract, indebtedness, note, bond, indenture, security or pledge agreement, commitment, license, lease, franchise, permit, agreement, or other instrument or obligation to which VPI is a party, or (iii) violate any statute, rule, regulation, ordinance, code, order, judgment, ruling, writ, injunction, decree or award applicable to VPI, except, in the case of each of clauses (i), (ii) and (iii) above, for such violations, conflicts, breaches, defaults or

 

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creations of Encumbrances which, in the aggregate, would not have a material adverse affect on the business of VPI taken as a whole or any adverse effect on its ability to fully perform this Agreement.

(e) Litigation. There are no lawsuits, claims or any civil, administrative or criminal actions, suits, or proceedings or governmental investigations existing, pending, or to the knowledge of Valeant, threatened, with respect to this Agreement or the transactions contemplated hereby. Valeant is not subject to any decree or order of any Government Authority that would impair or delay its ability to perform its obligations under this Agreement.

Section 4.3 Survival of Representations and Warranties. The representations and warranties made in this Agreement shall survive the termination of this Agreement for the full period prescribed by the statute of limitations applicable to claims for the breach of such representation or warranty.

ARTICLE 5

ADDITIONAL COVENANTS

Section 5.1 Restrictions on Transfer of Patents. Senetek shall not assign, sell or, transfer the Patents or any rights therein to a non-Affiliate, except in accordance with Article 8 hereof. Any purported transfer of the Patents or any rights therein in violation of this Section 5.1 shall be void and without effect and shall not operate to transfer the Patents or any rights therein to the purported transferee.

Section 5.2 Provision of Information. Within ten (10) days following the date of this Agreement, Senetek will provide to Valeant or its designee, on a non-exclusive basis and subject to the limitations set forth in Section 2.3 of this Agreement, true and correct copies of all information in its possession or control, whether in tangible or electronic form, relating to the Intellectual Property and the Know-How, including but not limited to any clinical data, study reports, any information relating to manufacturing, any agreements in respect of the Intellectual Property and the Know-How, analytical results, analytical method validation reports, raw material and sourcing information, quality audit findings, stability reports, any other relevant technical information relating to the Intellectual Property and the Know-How, and any related correspondence and filings with any Government Entity (including notes or minutes of any meeting with any Government Entity).

Section 5.3 Lealand Clark Patent. Senetek is the exclusive assignee of United States Patent No. 5,151,425 (the “Lealand Clark Patent”). Until such time as Senetek’s rights to

 

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the Lealand Clark Patent expire, Senetek shall cooperate with Valeant, at Valeant’s request and expense, in any reasonable efforts to commercialize any products based on the Lealand Clark Patent or otherwise extend the term of Senetek’s exclusive assignment of the Lealand Clark Patent.

ARTICLE 6

RIGHTS AND OBLIGATIONS AS TO THE INTELLECTUAL PROPERTY

Section 6.1 Patent Maintenance. Senetek will be responsible, at its own expense, for preparing, filing, prosecuting and maintaining (collectively, “Maintaining” or “Maintenance”) the Patents. Valeant shall provide such assistance as Senetek reasonably requires in relation to the Maintenance of the Patents. Valeant will consult with Senetek as to the Maintenance of the Patents and will furnish to Senetek copies of all material documents relevant to any such Maintenance. Valeant will furnish such documents and consult with Senetek in sufficient time (at least thirty (30) days prior to any first deadline for taking any actions) before any action by Senetek is due. At Senetek’s expense and reasonable request, Valeant shall provide reasonable assistance in connection with the Maintenance of the Patents. If Senetek shall refuse or fail to take any action required under this Section 6.1, Valeant shall be entitled to take such action for the account, and in the name, of Senetek, any cost or expenses incurred by Valeant shall be subject to indemnification by Senetek pursuant to Section 9.1.

Section 6.2 Infringement.

(a) Each Party shall promptly give Notice to the other of any infringement, imitation or act by Third Parties inconsistent with the ownership of and rights to the Intellectual Property provided for in this Agreement or any act of unfair competition by Third Parties relating to any of the Intellectual Property (any of the foregoing shall be referred to as an “infringement”). If the infringement involves manufacture, use or sale by a Third Party which is within the scope of Valeant’s exclusive rights pursuant to Section 2.1 (hereinafter an “Exclusivity Infringement”), Valeant shall have the first right and obligation to proceed to restrain such infringement in its own name and/or in the name of any of its Affiliates, and if the infringement involves manufacture, use or sale by a Third Party which is outside the scope of Valeant’s exclusive rights pursuant to Section 2.1 (hereinafter an “Other Infringement”), Senetek shall have the first right and obligation to proceed to restrain such infringement in its own name and/or in the name of any of its Affiliates. The Party having the first right and obligation to proceed as above provided is hereinafter called the “Primary Party” and the other Party is hereinafter called the “Secondary Party”.

 

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(b) Promptly upon receiving knowledge or Notice of an infringement, the Primary Party shall promptly commence commercially reasonable action to restrain such infringement or otherwise enforce its rights, and the Secondary Party shall cooperate fully in such action, if so requested shall join as a party to any appropriate legal proceedings for such purpose, and shall have the right to participate in, but not control, any such proceedings through counsel of its choice and at its expense. If within thirty (30) days after the Primary Party becomes aware of such infringement it fails to commence commercially reasonable action as above described, the Secondary Party shall have the right to institute such action, in its own name or in the name of the Primary Party or any of their respective Affiliates, as appropriate, and the Primary Party shall cooperate fully in such action and shall have the right to participate in but not control such proceeding, through counsel of its choice and at its expense, all as above described.

(c) Any recovery by either Party as a result of any claim, demand, legal proceeding or other action contemplated by this Section 6.2 or any settlement thereof shall first be applied to reimburse each Party for the reasonable costs of the actions taken by such party pursuant to this Section 6.2 (or, if the recovery is less than the aggregate reasonable costs of the Parties, the same shall be distributed between the Parties in proportion to the reasonable costs borne by them).

(d) To the extent that the infringement involved only an Exclusivity Infringement, then (i) if Valeant undertook such proceeding within the time prescribed by clause (b) above, any recovery in excess of the reasonable costs reimbursable to the Parties as above provided shall be retained by Valeant or (ii) if Valeant failed to undertake such action and Senetek undertook the actions with respect thereto prescribed by clause (b) above, any recovery in excess of the reasonable costs reimbursable to the Parties as above provided shall be divided between the Parties ratably based on the relative loss suffered by the two Parties.

(e) To the extent that the infringement involved only an Other Infringement, then (i) if Senetek undertook such proceeding within the time prescribed by clause (b) above, any recovery in excess of the reasonable costs reimbursable to the Parties as above provided shall be retained by Senetek or (ii) if Senetek failed to undertake such action and Valeant undertook the actions with respect thereto prescribed by clause (b) above, any recovery in excess of the reasonable costs reimbursable to the Parties as above provided shall be divided between the Parties ratably based on the relative loss suffered by the two Parties.

(f) In the event the Parties agree that Valeant’s practicing the rights licensed to it by this Agreement in accordance with the terms hereof would infringe a Third Party patent, the Parties shall negotiate in good faith with respect to the reasonable royalty or other consideration

 

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that a Person in the exercise of Commercially Reasonable Efforts would pay for a non-exclusive license from such Third Party sufficient to permit Valeant to practice the rights licensed to it by this Agreement in accordance with the terms hereof. If the Parties are unable to reach agreement with respect thereto within thirty (30) days, the matter shall be referred to a panel of the World Intellectual Property Organization selected in accordance with the procedures of such organization, and such panel’s decision shall be final and binding on the parties. Once such amount has been agreed or determined by such panel, Valeant may, in its sole discretion, seek to obtain a license of the nature described above from the Third Party on such terms as it shall determine in its sole discretion. In the event Valeant obtains such a license, in addition to any other remedies which may be available to Valeant under this Agreement or otherwise, Senetek shall reimburse Valeant up to the amount of the royalty or other consideration agreed or determined by such panel, when and as Valeant is contractually obligated to pay royalty or other consideration to such Third Party, and any payments due from Valeant in connection with such license that are in excess of such amount shall be borne by Valeant.

Section 6.3 Valeant’s Compliance with Law. In performing this Agreement, Valeant shall comply in all material respects with all laws, regulations, ordinances, orders, decrees and other requirements applicable to the storage, shipment, marketing and sale of all products containing any Licensed Compounds or otherwise applicable to Valeant’s practice of the Intellectual Property licensed to it hereunder.

Section 6.4 Covenant Not to Challenge the Patents. In consideration of the benefits of this Agreement, during the Patent License Term, Valeant, for itself and its Affiliates, successors and permitted assigns and sub-licensees, covenants that it and they will not dispute the validity or enforceability of the Patents or any claim or other element thereof in any proceeding of any nature, will not assert, either affirmatively or defensively, in any proceeding of any nature, any matter inconsistent with said validity and enforceability, agrees and acknowledges that the foregoing shall act as a complete defense and bar to any proceeding of any nature challenging such validity and enforceability or any of them, and consents to the entry of temporary and permanent injunctions to bar any breach or threatened breach of any of the foregoing, without the filing on behalf of Senetek of any bond or other security.

 

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ARTICLE 7

RIGHTS AND OBLIGATIONS AS TO AND UNDER

THE EXISTING LICENSE AGREEMENTS

Section 7.1 Maintenance of Existing License Agreements. Subject to Section 7.3 below, Senetek covenants and agrees that it will continue to perform its obligations under, and enforce its rights under, the Existing License Agreements as in effect on the Effective Date. Senetek may not amend, modify, extend, renew or waive any provision of an Existing License Agreement without the prior written consent of Valeant, which consent may be withheld in Valeant’s sole discretion. In addition, Senetek shall not amend or modify any existing agreements, enter into, assume or otherwise permit itself to become bound by any agreements, or otherwise take any actions the effect of which shall be to encumber, restrict or otherwise compromise its ability to enforce the Existing License Agreements.

Section 7.2 Assignment of Future Payments Under Existing License Agreements. For and in consideration of the amounts payable to Senetek by Valeant hereunder, and subject to Section 7.3 below, Senetek shall and hereby does assign, set over, transfer and convey to Valeant all of Senetek’s right, title and interest in and to all royalty payments and other payments due to Senetek from the licensees under the Existing License Agreements arising from their performance of and compliance with the Existing License Agreements on and after the date of execution of this Agreement (collectively, the “Future Payments”). Senetek shall at all times use its Commercially Reasonable Efforts to collect the Future Payments, and shall remit the full amount of each Future Payment to Valeant, without offset, promptly following Senetek’s receipt thereof. Anything herein to the contrary notwithstanding, once received by Senetek, all Future Payments shall be the property of Valeant and shall be held in trust by Senetek for the benefit of Valeant until Senetek remits such amounts to Valeant.

Section 7.3 Future Assignment of Existing License Agreements. Following the Effective Date, Valeant may from time to time in its sole discretion request Senetek to assign to Valeant, at no additional cost to Valeant, all of Senetek’s rights under one or more of the Existing License Agreements. Upon receipt of such a request, Senetek shall use its Commercially Reasonable Efforts to effect the assignment, provided, however, that Senetek shall not be required to effect any such assignment if, based on a written opinion of counsel (in form and substance acceptable to Valeant), Senetek reasonably concludes that such assignment would violate applicable antitrust or trade regulation laws or rules or require the consent of any Government Entity. Any such assignment shall be effected using such form of assignment as Valeant shall reasonably request. The Parties acknowledge and agree that any such assignment

 

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shall require the prior written consent of the licensee under the Existing License Agreement, and Senetek shall not be obligated to compensate the licensee in exchange for the licensee’s consent. In the event that Senetek does assign an Existing License Agreement to Valeant as contemplated herein, as of the effective date of the assignment, Senetek shall be relieved of its obligations to (i) maintain the Existing License Agreement under Section 7.1 above, and (ii) collect the Future Payments pertaining to the Existing License Agreement under Section 7.2 above; provided, however, Senetek shall nonetheless continue to be obligated to promptly remit to Valeant any Future Payments that it does receive, if any, under the Existing License Agreement and shall still hold all such amounts in trust for the benefit of Valeant until such time as it remits such amounts to Valeant. In addition, in the event that Senetek does assign an Existing License Agreement to Valeant as contemplated herein, Valeant shall indemnify Senetek from any liability to the licensees under the Existing License Agreements arising after the effective date of such assignment (except to the extent that such liability resulted from a default by or other act of Senetek under the Existing License Agreement occurring prior to the effective date of the assignment).

Section 7.4 Royalty Payments and Set Offs.

(a) Pre-Execution Date. All royalty or other payments due from the licensees under the Existing License Agreements with respect to products manufactured or sales booked by the licensees before the date of execution of this Agreement or otherwise related to their performance under the Existing License Agreement prior to the date of execution of this Agreement , whether such royalty payments are paid to Senetek or to Valeant, and all infringement or other legal claims arising from wrongful acts committed by Third Parties prior to the date of execution of this Agreement related to the Existing License Agreements shall be the property of and belong to Senetek. In the event that any such royalty or other payments are made to Valeant, Valeant shall promptly remit the full amount of such royalty or other payments, without offset, to Senetek and shall be deemed to hold such royalty payments in trust for the benefit of Senetek until such time as Valeant remits the royalty or other payments to Senetek. Any refunds or credits (related to sales prior to the date of execution of this Agreement) due to the licensee or Third Party with respect to such royalty or other payments shall be the sole responsibility of Senetek.

(b) Post-Execution Date. All royalty or other payments made by the licensees under the Existing License Agreements with respect to sales booked by the licensees on or after the date of execution of this Agreement or otherwise related to their performance under the Existing License Agreement on or after the date of execution of this Agreement, whether such royalty

 

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payments are paid to Senetek or to Valeant, and all legal claims arising from wrongful acts committed by Third Parties on or after the date of execution of this Agreement related to the Existing License Agreements, shall be the property of and belong to Valeant. In the event that any such royalty payments are made to Senetek, Senetek shall promptly remit the full amount of such royalty payments, without offset, to Valeant and shall be deemed to hold such royalty payments in trust for the benefit of Valeant until such time as Senetek remits the royalty payments to Valeant. Any refunds or credits (related to sales after the date of execution of this Agreement) due to the licensee with respect to such royalty payments shall be the sole responsibility of Valeant.

Section 7.5 Expiration or Termination of Existing License Agreements. Upon the expiration or termination of an Existing License Agreement, all rights held by Senetek under the Existing License Agreement, including but not limited to any rights in and to any of the Intellectual Property held by the licensee under the Existing License Agreement, shall automatically and immediately (and without any additional action by Valeant or the payment by Valeant of any additional consideration) revert to Valeant and shall for all purposes thereafter be deemed to be included among the rights acquired or licensed by Valeant under this Agreement.

ARTICLE 8

RIGHT OF FIRST OFFER RE PATENTS

In the event that Senetek ever decides (either on its own initiative or in response to a bona fide Third Party offer) to sell the Patents or any rights therein to a non-Affiliate, Senetek shall immediately give written notice thereof to Valeant. Valeant shall then have sixty (60) days from the date that it receives such notice to deliver an offer to Senetek setting forth in reasonable detail the principal commercial terms upon which Valeant would purchase the Patents or such rights therein. If Senetek elects not to accept Valeant’s offer to purchase the Patents or such rights therein (or if no offer is made within such period), Senetek shall be free to sell the Patents or such rights therein to another Person on terms no better to such Person than those offered by Valeant (or, if Senetek has made a counter offer, on terms no better to such other Person than those offered by Senetek to Valeant).

ARTICLE 9

CONFIDENTIALITY

Section 9.1 Confidential Information. Subject to Section 9.2, each Party will maintain in confidence all Confidential Information disclosed by the other Party pursuant to this

 

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Agreement and will not use such Confidential Information for any purpose except as permitted by this Agreement. Neither Party will disclose such information and materials to anyone other than those of its sublicensees, Affiliates, potential sub-licensees, employees, consultants, agents or subcontractors as are necessary in connection with such Party’s performance of this Agreement and each Party agrees to use Commercially Reasonable Efforts to protect such Confidential Information but in no event less care than it uses to maintain the confidentiality of its own proprietary information.

Section 9.2 Disclosure. The obligation of confidentiality in this Agreement does not apply to the extent that:

(a) either Party or their Affiliates (as such, the “Recipient”) are required to disclose Confidential Information by order or regulation of a governmental agency or a court of competent jurisdiction, or under the securities laws of any jurisdiction or in connection with any filing of information with the U.S. Securities and Exchange Commission or any stock exchange upon which its securities are listed, except that the Recipient will not make any such disclosure (other than as required under the securities laws of any jurisdiction or in connection with any filing of information with the U.S. Securities and Exchange Commission or any stock exchange upon which its securities are listed) without first notifying the other Party and allowing such other Party a reasonable opportunity to seek injunctive relief from (or protective order with respect to) the obligation to make such disclosure;

(b) the Recipient can demonstrate that (i) the disclosed Confidential Information was at the time of such disclosure to the Recipient already in (or later enters) the public domain other than as a result of actions of the Recipient, Recipient’s Affiliates, employees, sublicensees, agents or subcontractors in violation of this Agreement; (ii) the disclosed Confidential Information was rightfully known by the Recipient or its Affiliates (as shown by its written records) prior to the date of disclosure to the Recipient in connection with the negotiation, execution or performance of this Agreement or independently generated by the Recipient or its Affiliates at any time; or (iii) the disclosed Confidential Information was received by the Recipient or its Affiliates on an unrestricted basis from a source unrelated to either Party to this Agreement and not under a duty of confidentiality to the other Party;

(c) with respect to a disclosure by Valeant, disclosure is made to a government regulatory agency as part of such agency’s product license approval process for a product;

 

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(d) the disclosure is of Know-How, and such disclosure is permitted under this Agreement; or

(e) disclosure is necessary to obtain or secure patent protection of any technology.

In addition to disclosures described above, each Party may disclose Confidential Information belonging to the other Party to the extent such disclosure is necessary in the following instances: (i) filing or prosecuting patent rights as permitted by this Agreement; (ii) regulatory filings for products such Party has a license or right to develop hereunder; and (iii) prosecuting or defending litigation as permitted by this Agreement.

Section 9.3 Announcements. Schedule 9.3(i) sets forth an agreed press release by Senetek to be issued promptly following the execution of this Agreement. Except for such release and except as may otherwise be required by law or the listing rules of any exchange on which either party’s securities may be listed or quoted, for which the releasing party shall provide prior notice to the other party and the opportunity to comment on any required disclosure, neither party will disclose the terms of this Agreement to any other Person; provided, however, that each party may make such disclosure of the terms of this Agreement to its employees and agents as is necessary to permit such party to perform its obligations under this Agreement; provided further that any such employee or agent agrees to maintain the confidentiality of this Agreement; and provided further that either party may make such disclosures of the terms of this Agreement as are necessary to enter into license and other agreements that do not conflict with the terms of this Agreement. Valeant acknowledges that this Agreement may be deemed to be a “material contract” as that term is defined by Item 601(b)(10) of Regulation S-K, and that Senetek may therefore be required to file such document as an exhibit to reports or registration statements filed under the United States Securities Act or Securities Exchange Act, provided that Senetek shall redact commercial terms and file for confidential treatment to the extent permitted by applicable rules of the United States Securities and Exchange Commission.

ARTICLE 10

INDEMNIFICATION

Section 10.1 Indemnification by Senetek. Senetek shall indemnify, defend and hold harmless Valeant and its Affiliates and their respective officers, directors, agents, and employees (collectively, the “Valeant Indemnitees”) from and against any and all losses, liabilities, claims, damages (including consequential damages), expenses (including costs of investigation and defense and reasonable attorneys’ fees and expenses) or diminution of value (collectively,

 

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Losses”) to the extent that such Valeant Losses are based on, result from or arise in connection with the breach of any representation or warranty made by Senetek in this Agreement or any failure of Senetek to duly perform or observe any provision, obligation, covenant or agreement to be performed or observed by Senetek pursuant to this Agreement; provided, however, that Senetek shall not be obligated to indemnify, defend or hold harmless any Valeant Indemnitee under this Section 9.1 for any Losses incurred by a Valeant Indemnitee to the extent such Losses arise out of or are attributable to: (a) any act or omission by a Valeant Indemnitee, which constitutes negligence, recklessness, gross negligence, or willful misconduct on the part of such Valeant Indemnitee, (b) the breach of any representation or warranty made by Valeant in this Agreement, or (c) any failure of Valeant to perform or observe any provision, obligation, covenant or agreement to be performed or observed by Valeant pursuant to this Agreement.

Section 10.2 Indemnification by Valeant. Valeant shall indemnify, defend and hold harmless Senetek and its Affiliates and their respective officers, directors, agents, and employees (collectively, the “Senetek Indemnitees”) from and against any and all Losses, to the extent that such Senetek Losses are based on, result from or arise in connection with the breach of any representation or warranty made by Valeant in this Agreement or any failure of Valeant to duly perform or observe any provision, obligation, covenant or agreement to be performed or observed by Valeant pursuant to this Agreement; provided, however, that Valeant shall not be obligated to indemnify, defend or hold harmless any Senetek Indemnitee under this Section 10.2 for any Losses incurred by a Senetek Indemnitee to the extent such Losses arise out of or are attributable to: (a) any act or omission by a Senetek Indemnitee, which constitutes negligence, recklessness, gross negligence, or willful misconduct on the part of such Senetek Indemnitee, (b) the breach of any representation or warranty made by Senetek in this Agreement, or (c) any failure of Senetek to perform or observe any provision, obligation, covenant or agreement to be performed or observed by Senetek pursuant to this Agreement.

Section 10.3 Procedure.

(a) In the event a Party’s right to indemnification hereunder arises out of or results from a Third Party claim (a “Third Party Claim”), each indemnified Party (an “Indemnified Party”) shall give Notice to the indemnifying Party (the “Indemnifying Party”) in writing (and in reasonable detail) of the Third Party Claim within ten (10) Business Days after receipt by such Indemnified Party of notice of the Third Party Claim, or otherwise becoming aware of the existence or threatened existence thereof. Failure to give such notice shall not constitute a defense, in whole or in part, to any claim by an Indemnified Party hereunder except to the extent the rights of the Indemnifying Party are materially prejudiced by such failure to give notice. The

 

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Indemnifying Party shall notify the Indemnified Party of its intentions as to defense of the Third Party Claim or potential Third Party Claim in writing within ten (10) Business Days after receipt of Notice of the Third Party Claim;

(b) With respect to any Third Party Claim, the Indemnifying Party shall assume exclusive control of the defense and settlement (including all decisions relating to litigation, defense and appeal) of any such Third Party Claim (so long as it has confirmed its indemnification obligation responsibility to such Indemnified Party under this Section 10.3 with respect to a given Third Party Claim); provided, however, that the Indemnifying Party may not settle such Third Party Claim in any manner that would require payment by the Indemnified Party, or would materially adversely affect the rights granted to the Indemnified Party hereunder, or would materially conflict with the terms of this Agreement, or adversely affect the Intellectual Property, without first obtaining the Indemnified Party’s prior written consent; and

(c) With respect to any Third Party Claim, the Indemnified Party shall reasonably cooperate with the Indemnifying Party in its defense of the Third Party Claim (including, without limitation, making documents and records available for review and copying and making persons within its control available for pertinent testimony in accordance with the confidentiality provisions of Article 8, and entering into appropriate joint counsel or other agreements to protect any attorney-client or attorney work product privileged material) at the Indemnifying Party’s expense. With respect to any Third Party Claim, if the Indemnifying Party assumes defense of the Third Party Claim, an Indemnified Party may participate in, but not control, the defense of such Third Party Claim using attorneys of its choice and at its sole cost and expense, with such cost and expense not being covered by the Indemnifying Party. With respect to any Third Party Claim, an Indemnifying Party shall have no obligation or liability under this Article 9 as to any Third Party Claim for which settlement or compromise of such Third Party Claim or an offer of settlement or compromise of such Third Party Claim is made by an Indemnified Party without the prior written consent of the Indemnifying Party, which consent shall not be unreasonably withheld. With respect to any Third Party Claim, if an Indemnifying Party notifies the Indemnified Party in writing that it will not defend the Indemnified Party against such a Third Party Claim asserted against the Indemnified Party, or if the Indemnifying Party assumes the defense of the Third Party Claim in accordance with this Section 9.3 yet fails to defend or take other reasonable, timely action, in response to such Third Party Claim asserted against the Indemnified Party, the Indemnified Party shall have the right to defend or take other reasonable action to defend its interests in such proceedings, and shall have the right to litigate, settle or otherwise dispose of any such Third Party Claim, without the consent of the Indemnifying Party, and all costs and expenses related thereto shall be indemnified by the Indemnifying Party pursuant to this Article 9

 

-26-


Section 10.4 Insurance. Each Party shall maintain at its expense commercial general liability insurance with an insurance company or companies rated at least Best AA in a principal amount of not less than Two Million Dollars (US$2,000,000) per occurrence and Five Million Dollars (US$5,000,000) in the annual aggregate. Within thirty (30) calendar days after the date of this Agreement, each Party shall furnish to the other a certificate evidencing such insurance. Either Party may elect to suspend its performance hereunder until the other Party’s insurance is in place and the certificate of coverage is provided, and may thereafter suspend its performance if it reasonably believes such insurance is not in place until the other Party provides reasonable assurance that such coverage is in place without any gap in coverage and will be maintained as required by this Agreement. The term of such insurance shall run for the period beginning on the Effective Date and ending upon the expiration of the last to expire of the Patents containing a Valid Claim.

ARTICLE 11

MISCELLANEOUS PROVISIONS

Section 11.1 Governing Law and Jurisdiction. This Agreement shall be governed by and interpreted in accordance with the laws of the State of California (regardless of that or any other jurisdiction’s choice of law principles). Each party irrevocably submits to the exclusive jurisdiction of the United States Federal District Court for the Southern District of California and the state courts of California sitting in Orange County, California for all purposes related to this Agreement.

Section 11.2 Bankruptcy. All rights and licenses granted under or pursuant to this Agreement by Senetek to Valeant are, and will otherwise be deemed to be, for purposes of Section 365(n) of the Title 11 of the United States Code (the “Bankruptcy Code”), licenses of rights to “intellectual property” as defined under Section 101(35A) of the Bankruptcy code. Valeant, as a Valeant of such rights under this Agreement, will retain and may fully exercise all of its rights and elections under the Bankruptcy Code.

Section 11.3 Modification. This Agreement may not be amended or modified except in a writing signed by a duly authorized officer of the party against whom enforcement of such amendment is sought.

 

-27-


Section 11.4 Waiver. The failure on the part of a Party to exercise or enforce any rights conferred upon it hereunder shall not be deemed to be a waiver of any such rights or operate to bar the exercise or enforcement thereof at any time or times thereafter. The observance of any term of this Agreement may be waived (either generally or in a particular instance and either retroactively or prospectively) by the Party entitled to enforce such term, but any such wavier shall be effective only if in writing signed by the non-waiver Party.

Section 11.5 Force Majeure. Neither Party shall lose any rights hereunder or be liable to the other Party for damages or losses on account of failure of performance by the defaulting Party if the failure is occasioned by government action, war, terrorism, fire, explosion, flood, strike, lockout, embargo, shortage of materials or utilities, vendor failure to supply, act of God, or any other cause beyond the control and without the fault or negligence of the defaulting Party, provided that the Party claiming force majeure has exerted all reasonable efforts to avoid or remedy such force majeure, provided, further, however, that in no event shall a Party be required to settle any labor dispute or disturbance. Such excuse shall continue as long as the condition preventing the performance continues. Upon cessation of such condition, the affected Party shall promptly resume performance hereunder. Each Party agrees to give the other Party prompt written notice of the occurrence of any such condition, the nature thereof, and the extent to which the affected Party will be unable to perform its obligations hereunder. Each Party further agrees to use all Commercially Reasonable Efforts to correct the condition as quickly as possible and to give the other Party prompt written notice when it is again fully able to perform its obligations.

Section 11.6 Severability. It is the intention of the Parties to comply with all applicable domestic or foreign laws in connection with the performance of its obligations hereunder. In the event that any provision of this Agreement, or any part hereof, is found invalid or unenforceable, the remainder of this Agreement will be binding on the Parties hereto, and will be construed as if the invalid or unenforceable provision or part thereof had been deleted, and the Agreement shall be deemed modified to the extent necessary to render the surviving provisions enforceable to the fullest extent permitted by law without impairing the Parties’ evident original intent.

Section 11.7 Headings. The headings in this Agreement are solely for convenience of reference and shall not be used for purposes of interpreting or construing the provisions hereof.

Section 11.8 Assignment. This Agreement may not be assigned or otherwise transferred by either Party without the prior written consent of the other Party, except that either Party may assign this Agreement to an Affiliate without the consent of the other Party. Any

 

-28-


purported assignment in contravention of this Section 11.8 shall be null and void and of no effect. No assignment by either Party shall release such Party from responsibility for the performance by such Party of any of its obligations hereunder.

Section 11.9 No Unsolicited Bids. Valeant, for itself and its Affiliates, successors and permitted assigns, irrevocably agrees that it and they will not, individually or as a member of any “group” (as such term is defined under the United States Securities Exchange Act) (i) purchase, own or acquire rights in securities of Senetek or American Depositary Shares representing, or options, warrants or other rights to purchase, securities of Senetek, representing in the aggregate five percent (5%) or more of the outstanding equity securities of Senetek, or (ii) make any public or confidential offer or proposal to Senetek or its management or Board of Directors or any member thereof with a view to entering into any acquisition of or combination involving Senetek or any of its material assets, or (iii) participate in any proxy contest or other process intended to cause the adoption of any shareholder resolution what has not been recommended for adoption by the Board of Directors of Senetek. This Section 10.9 will be suspended and be of no force or effect during the pendency of any action described in clauses (i), (ii) or (iii) above taken by any party other than Valeant or any Affiliate of Valeant or “group” of which Valeant or any Affiliate of Valeant is a member.

Section 11.10 Relationship of Parties. In making and performing this Agreement, the Parties are acting, and intend to be treated, as independent entities and nothing contained in this Agreement shall be construed or implied to create an agency, partnership, joint venture, or similar relationship between the Parties.

Section 11.11 No Third Party Beneficiaries. This Agreement does not confer any rights, remedies, agreements, undertakings, obligations or liabilities on any person other than Valeant and the successors-in-interest and permitted assigns of each Party.

 

-29-


Section 11.12 Notices. Unless otherwise provided herein, any notice required or permitted to be given hereunder (a “Notice”) shall be mailed by certified mail or generally recognized express courier service with signature required for delivery, postage prepaid, sent by facsimile transmission, or delivered by hand to the Party to whom such Notice is required or permitted to be given hereunder, at the following address for such Party:

 

Senetek:    Senetek PLC
   831 Latour Court
   Napa, CA 94558
   Fax: 707-226-3999
Valeant:    Valeant Pharmaceuticals International
   One Enterprise
   Aliso Viejo, California 92656
   Attn: General Counsel
   FAX: 949-461-6641

or at such other address or fax number as the Party may have designated by Notice hereunder. If mailed, any such Notice shall be deemed to have been given as of the date of receipt, as evidenced by the date appearing on the delivery notice. If delivered by hand, any such Notice shall be deemed to have been given when received by the party or agent of such party to whom such Notice is given, as evidenced by written and dated receipt of the receiving Party

Section 11.13 Entire Agreement. This Agreement together with its exhibits and schedules constitutes the entire agreement and understanding between the parties hereto with respect to the subject matter of this Agreement and shall supersede any prior agreements, negotiations, understandings, representations, statements and writings relating thereto.

Section 11.14 Termination of Original License Agreement. Upon the execution of this Agreement, the Original License Agreement and any and all side letters and understandings, oral or in writing, entered into between Senetek and VPI during the Term of the Original License Agreement, shall automatically be terminated, and thereafter the Parties shall have no further rights and obligations thereunder, except to the extent that such rights and obligations expressly survive the termination thereof under the terms of the Original License Agreement.

Section 11.15 Post-Termination Survival of Certain Terms and Provisions. Anything herein to the contrary notwithstanding, Articles VIII, IX, and X, and Sections 2.2 – 2.4, 6.3, 6.4, 7.3-7.5, 11.9, and 11.14-11.16 shall survive the termination or expiration of this Agreement indefinitely.

 

-30-


Section 11.16 Guaranty of Valeant’s Payment Obligations. In consideration for the rights granted to Valeant hereunder, and as a condition to Senetek’s entering into this Agreement, the Parties agree that VPI shall guaranty Valeant’s payment obligations hereunder, and by restrictively endorsing this Agreement in the space provided on the signature page below, VPI agrees that it shall guaranty Valeant’s payment obligations hereunder. Notwithstanding the foregoing, VPI shall have no obligation to Senetek hereunder, and Senetek shall not pursue any recovery against VPI pursuant to this Section 11.16, until Senetek shall have exercised its rights to seek indemnification from Valeant hereunder in accordance with Article 10 hereof.

[Remaining of page intentionally left blank]

 

-31-


IN WITNESS WHEREOF, the undersigned have executed and delivered this Agreement on the date first above written.

 

SENETEK PLC
By:   /s/ Frank Massino
Name:   Frank Massino
Title:   Chairman and CEO
VALEANT PHARMACEUTICALS NORTH AMERICA
By:   /s/ Timothy Tyson
Name:   Timothy Tyson
Title:   President and Chief Executive Officer

The undersigned is executing this Agreement solely for purposes of acknowledging its obligations under Section 11.16

 

VALEANT PHARMACEUTICAL INTERNATIONAL
By:   /s/ Timothy Tyson
Name:   Timothy Tyson
Title:   President and Chief Executive Officer

 

-32-


SCHEDULE 1.1(m)

KNOW-HOW

Skin Irritation on Lotion M 50 PPM by Gibraltar Laboratories

Skin Irritation on Lotion M 100 PPM by Gibraltar Laboratories

Skin Irritation on Lotion M 250 PPM by Gibraltar Laboratories

Skin Irritation on Lotion M 500 PPM by Gibraltar Laboratories

Skin Irritation on Lotion M 1000 PPM by Gibraltar Laboratories

Skin Irritation on Lotion V 100 PPM by Gibraltar Laboratories

Skin Irritation on Lotion V 1000 PPM by Gibraltar Laboratories

Ames Metabolic Activation Test to Assess the Potential Mutagenic Effect of SEN 001 by Huntington Life Sciences

An Assessment of the Mutagenic Potential of SEN 001 Using the Mouse Lymphoma in Locus Assay by Huntington Life Sciences

Acute Oral Toxicity of Mice of SEN 001 by Huntington Research Centre

Delayed Contact Hypersensitivity in the Guinea-Pig with SEN 001 by Huntington Research Centre

Factor X and Furfural Bacterial Mutation Assay by Huntington Life Sciences

Kinetin Mouse Micronucleus Test by Huntington Life Sciences


In Vitro Percutaneous Absorption of [14C]-Kinetin Lotion Versus Serum in Human Cadaver Skin by The University of California, Irvine

A Clinical Study of Topical Zeatin (0.10%, 0.025%) for Improving the Appearance of Photodamaged Skin by RCTS, Inc.

Human Repeated Insult Patch Test (HRIPT) by RCTS, Inc.

In Vitro Mammalian Chromosome Screening Assay in Human Peripheral Blood Lymphocytes by BioReliance

In Vitro Chromosome Aberration Screening Assay by BioReliance

Salmonella Plate Incorporation Mutagenicity Assay by BioReliance

Chorioallantoic Membrane Vascular Assay (CAMVA-14 Day) by MB Research

Evaluation of Cutaneous Effects of Topical Cytokinins in the Hairless Mouse Assay by The University of California, Irvine

Manufacturing Know-How and Technology Transfer

Zeatin Material Safety Data Sheet

Zeatin Production Process


SCHEDULE 4.1(b)

ENCUMBRANCES

1. Senetek is a party to a Loan and Security Agreement effective as of March 30, 2006 with Silicon Valley Bank pursuant to which certain Encumbrances exist affecting the Intellectual Property.


SCHEDULE 4.1(c)

COMPLIANCE WITH LAWS

None


SCHEDULE 4.1(e)(i)

EXISTING LICENSE AGREEMENTS

 

Licensee/Trademark

  

Channel of Trade

  

Geography

   License
Expiration

Valeant Pharmaceuticals International

Kinerase ®

   All channels of trade subject to rights of licensees listed below    Exclusive Worldwide    2010
The Body Shop    Body Shop retail stores, kiosks, catalogs and websites    Non-exclusive North America Europe Asia    2013
Osmotics Corporation    Prestige (department stores and perfumeries)    Non-exclusive Worldwide    2020
OMP, Inc.    Those mass market drug stores and cosmetics shops in which OMP sold Kinetin products on settlement date    Non-exclusive Japan    2020

Revlon Consumer Products Corporation

Almay ®

   Mass market    Non-exclusive Worldwide    2011
Med Beauty A-G    Estheticians and beauty salons    Exclusive – Switzerland Non-Exclusive - Germany and Russia    2005
Vivier Pharma Inc.    Dermatologists, pharmacies and other ethical (physician) markets    Non-exclusive United States and Canada    2008
Panion & BF Biotech Inc.    Ethical, prestige, salon, spa (except Korea) and stores owned or controlled by Formosa Biomedical Technology    Non-exclusive Most Asian nations    2011


Licensee/Trademark

  

Channel of Trade

  

Geography

   License
Expiration

Lavipharm S.A.

Castalia ®

   Ethical and pharmacy    Non-exclusive Greece, Cyprus and certain near Asian and Latin America countries    2011

Ferrosan A/S

Imedeen ®

   Prestige, natural products, mass market and direct-to-consumer    Non-exclusive Worldwide    2020
Dermaquest    Natural Products    Worldwide    None
ph Advantage LLC    Prestige retail stores, salons, spas and direct-to-consumer    United States    2011


SCHEDULE 4.1(e)(ii)

CERTAIN AGREEMENTS AFFECTING

THE INTELLECTUAL PROPERTY AND KNOW-HOW

1. Senetek is a party to an Agreement for the Funding of Research Grants and the Transfer of Exclusive Rights to Technology with Dr. Brian Clark dated as of February 1, 1987, as amended through March 15, 2007, pursuant to which Dr. Clark is entitled to a payment on the Effective Date.

2. Senetek is the beneficiary of an Assignment from Lealand L. Clark dated as of December 2, 2002 of U.S. Patent No. 5,151,425.

3. Senetek is a party to various agreements with the Regents of the University of California pursuant to which certain of the clinical trials and other investigations comprising Know-How were performed and which govern the use of certain of such Know-How and commercial references to the University.


SCHEDULE 4.1(f)

ROYALTY AND OTHER PAYMENTS

PAST DUE UNDER EXISTING LICENSE AGREEMENTS

None


SCHEDULE 4.1(g)(ii)(A)

DESCRIPTION OF PATENTS AND PATENT APPLICATIONS

 

FETF

File No.

   Country    Inventor   

Serial No

Filing Date

  

Publication No.

Publication Date

  

Patent No

Issue Date

  

Title

45619    Canada    Rattan    559,960
2/26/88
      1,339,503
10/21/97
   Method and Composition for Ameliorating the Adverse Effects of Aging
49097    U.S.    Boland, et al.    364,364
6/8/89
      5,021,422
6/4/91
   Method and Composition for Treating Hyperproliferative Skin Diseases
51196    U.S.    Bolund    679,732
4/3/91
      5,164,394
11/17/92
   Method and Composition For Treating Hyperproliferative Skin Diseases
51608    Argentina    Rattan    320120
7/11/91
      250273
1/28/97
   Method and Composition for Ameliorating the Adverse Effects of Aging
51608    Australia    Rattan    81884/91
5/16/91
      666836
7/9/96
   Method and Composition for Ameliorating the Adverse Effects of Aging
51608    Austria    Rattan    91912579.9
5/16/91
         Method and Composition for Ameliorating the Adverse Effects of Aging
51608    Belgium    Rattan    91912579.9
5/16/91
      0584068
10/6/99
   Method and Composition for Ameliorating the Adverse Effects of Aging
51608    Brazil    Rattan    PI 9107307
5/16/91
      PI 9107307
10/31/00
   Method and Composition for Ameliorating the Adverse Effects of Aging


FETF

File No.

   Country    Inventor   

Serial No

Filing Date

  

Publication No.

Publication Date

  

Patent No

Issue Date

  

Title

51608    Canada    Rattan    2,108,369
5/16/91
      2,108,369
1/28/03
   Method and Composition for Ameliorating the Adverse Effects of Aging
51608    China    Rattan    91104472.8
6/28/91
      ZL91104472
11/27/97
   Method and Composition for Ameliorating the Adverse Effects of Aging
51608    Denmark    Rattan    91912579.9
5/16/91
      0584068
10/6/99
   Method and Composition for Ameliorating the Adverse Effects of Aging
51608    Finland    Rattan    935039
5/16/91
      111219
6/30/03
   Method and Composition for Ameliorating the Adverse Effects of Aging
51608    France    Rattan    91912579.9
5/16/91
      0584068
10/6/99
   Method and Composition for Ameliorating the Adverse Effects of Aging
51608    Germany    Rattan    91912579.9
5/16/91
      0584068
10/6/99
   Method and Composition for Ameliorating the Adverse Effects of Aging
51608    Great
Britain
   Rattan    91912579.9
5/16/91
      0584068
10/6/99
   Method and Composition for Ameliorating the Adverse Effects of Aging
51608    Greece    Rattan    91912579.9
5/16/91
      0584068
10/6/99
   Method and Composition for Ameliorating the Adverse Effects of Aging
51608    Ireland    Rattan    1715/91
5/20/91
      82964
7/2/03
   Method and Composition for Ameliorating the Adverse Effects of Aging
51608    Israel    Rattan    1991/1715
5/25/91
      98204
2/12/95
   Method and Composition for Ameliorating the Adverse Effects of Aging
51608    Italy    Rattan    91912579.9
5/16/91
      0584068
10/6/99
   Method and Composition for Ameliorating the Adverse Effects of Aging
51608    Japan    Rattan    512066/91
5/16/91
      3103375
8/25/00
   Method and Composition for Ameliorating the Adverse Effects of Aging


FETF

File No.

   Country    Inventor   

Serial No

Filing Date

  

Publication No.

Publication Date

  

Patent No

Issue Date

  

Title

21608    Japan    Rattan    512066/91
5/16/91
      486600
10/24/03
   Method and Composition for Ameliorating the Adverse Effects of Aging
51608    Luxembourg    Rattan    91912579.9
5/16/91
      0584068
10/6/99
   Method and Composition for Ameliorating the Adverse Effects of Aging
51608    Malaysia    Rattan    PI9100865
5/22/91
      MY-120650-A
11/30/05
   Method and Composition for Ameliorating the Adverse Effects of Aging
51608    Mexico    Rattan    25,886
5/22/91
      178834
7/21/95
   Method and Composition for Ameliorating the Adverse Effects of Aging
51608    Netherlands    Rattan    91912579.9
5/16/91
      0584068
10/6/99
   Method and Composition for Ameliorating the Adverse Effects of Aging
51608    New Zealand    Rattan    238210
5/21/91
      238210
3/4/94
   Method and Composition for Ameliorating the Adverse Effects of Aging
1608    New Zealand    Rattan    247836
6/10/93
      247836
8/8/97
   Method and Composition for Ameliorating the Adverse Effects of Aging
51608    Norway    Rattan    934115
5/16/91
      304814
2/22/99
   Method and Composition for Ameliorating the Adverse Effects of Aging
51608    Philippines    Rattan    42893
8/8/91
         Method and Composition for Ameliorating the Adverse Effects of Aging
51608    Saudi Arabia    Rattan    91120262
12/10/91
         Method and Composition for Ameliorating the Adverse Effects of Aging
51608    Spain    Rattan    91912579.9
5/16/91
   2140392
3/1/00
   0584068
10/6/99
   Method and Composition for Ameliorating the Adverse Effects of Aging
51608    Sweden    Rattan    91912579.9
5/16/91
      0584068
10/6/99
   Method and Composition for Ameliorating the Adverse Effects of Aging


FETF

File No.

   Country    Inventor   

Serial No

Filing Date

  

Publication No.

Publication Date

  

Patent No

Issue Date

  

Title

51608    Switzerland    Rattan    91912579.9
5/16/91
      0584068
10/6/99
   Method and Composition for Ameliorating the Adverse Effects of Aging
51608    Taiwan    Rattan    80105893
7/29/91
      076376
5/23/96
   Method and Composition for Ameliorating the Adverse Effects of Aging
51608    Venezuela    Rattan    727
6/6/91
      53803
6/6/91
   Method and Composition for Ameliorating the Adverse Effects of Aging
51609    Austria    Bolund, et al.    91910063.6
5/16/91
      0584062
1/7/98
   Method and Composition for Hyperproliferative Skin Diseases
51609    Belgium    Bolund, et al.    91910063.6
5/16/91
      0584062
1/7/98
   Method and Composition for Hyperproliferative Skin Diseases
51609    Canada    Bolund, et al.    2,107,896
5/16/91
      2,107,896
7/30/02
   Method and Composition for Hyperproliferative Skin Diseases
51609    Demark    Bolund, et al.    91910063.6
5/16/91
      0584062
1/7/98
   Method and Composition for Hyperproliferative Skin Diseases
51609    France    Bolund, et al.    91910063.6
5/16/91
      0584062
1/7/98
   Method and Composition for Hyperproliferative Skin Diseases
51609    Germany    Bolund, et al.    91910063.6
5/16/91
      0584062
1/7/98
   Method and Composition for Hyperproliferative Skin Diseases
51609    Great
Britain
   Bolund, et al.    91910063.6
5/16/91
      0584062
1/7/98
   Method and Composition for Hyperproliferative Skin Diseases
51609    Greece    Bolund, et al.    91910063.6
5/16/91
      0584062
1/7/98
   Method and Composition for Hyperproliferative Skin Diseases


FETF

File No.

   Country    Inventor   

Serial No

Filing Date

  

Publication No.

Publication Date

  

Patent No

Issue Date

  

Title

51609    Italy    Bolund, et al.    91910063.6
5/16/91
      0584062
1/7/98
   Method and Composition for Hyperproliferative Skin Diseases
51609    Japan    Bolund, et al.    509454/91
5/16/91
      3103374
8/24/00
   Method and Composition for Hyperproliferative Skin Diseases
51609    Luxembourg    Bolund, et al.    91910063.6
5/16/91
      0584062
1/7/98
   Method and Composition for Hyperproliferative Skin Diseases
51609    Netherlands    Bolund, et al.    91910063.6
5/16/91
      0584062
1/7/98
   Method and Composition for Hyperproliferative Skin Diseases
51609    Sweden    Bolund, et al.    91910063.6
5/16/91
      0584062
1/7/98
   Method and Composition for Hyperproliferative Skin Diseases
51609    Switzerland    Bolund, et al.    91910063.6
5/16/91
      0584062
1/7/98
   Method and Composition for Hyperproliferative Skin Diseases
55710    U.S.    Rattan    206,041
3/4/94
      5,371,089
12/6/94
   Method and Composition for Ameliorating the Adverse Effects of Aging
56270    U.S.    Rattan    292,721
8/18/94
      5,602,139
2/11/97
   Method for Ameliorating the Adverse Effects of Aging
56539    U.S.    Rattan    314,361
9/28/94
      5,614,407
3/25/97
   Method for Ameliorating the Adverse Effects of Aging
87801    US    L. Clark    718,362
9/29/92
      5,151,425    Method and Composition for treating Inflammation and the Immunological Response Thereto


SCHEDULE (g)(ii)(B)

TRADEMARKS

None


SCHEDULE 4.1(g)(vii)

INFRINGEMENTS

Senetek from time to time has become aware of infringements of the Patents. In all such cases arising in the United States, Senetek has successfully taken action to terminate such infringements and Senetek is not aware of any such infringements as of the Effective Date. As respects infringements outside the United States, Senetek similarly has taken action to terminate infringements of which it has become aware and Senetek is not aware of any such infringements as of the Effective Date. However, as respects certain Asian markets, and most particularly Taiwan, Senetek has found that court proceedings are not effective in permanently restraining infringements because the infringing party resumes manufacturing or selling activities under a different name or using a different product formulation.


SCHEDULE 4.1(i)

REGULATORY APPROVALS

None


SCHEDULE 4.1(k)

CERTAIN RISK FACTORS

Reliance on Other Organizations for Research and Development and Regulatory Functions. We rely on a number of significant collaborative relationships for a large part of our new product research and development activities and all of our Pharmaceutical Segment regulatory activities. These collaborations with external research laboratories and pharmaceuticals licensees pose a number of risks including our inability to control whether our counter-parties will devote adequate resources to their efforts or fully perform their contractual undertakings, failure of which could lead to delays in commercializing products, revenue curtailment and the expense and management distraction of dispute resolution.

Acquisition-Related Risks. One means by which Senetek might achieve eligibility for initial listing on the Nasdaq Capital Market or the American Stock Exchange could be to complete an equity-based business acquisition. However, completion of any significant business acquisition by Senetek would involve substantial risks, including that the Company’s small management cadre would be diverted from the operating needs of Senetek’s business, that the professional fees of attorneys, accountants and other advisors incurred in executing such a transaction would divert needed financial resources from the Company’s business, that these expenses and the costs of integrating the two companies’ assets and operations could result in dilution of earnings, at least in the short term, and that management might be unable to successfully achieve the synergies from the combination of the two companies upon which forecasts of longer term incremental earnings were based. There is also a risk, particularly for so long as our ADSs’ market price remains at historically depressed levels, that the Company could become the subject of an unsolicited acquisition by a third party, through a tender offer or other transaction that might not assure the Company’s ADS holders of fair value of their interests in the Company. The English Companies Act, under which Senetek is organized, does not permit adoption of so-called defensive provisions in the Company’s Articles of Association to make such a transaction more difficult or to force such an acquirer to negotiate terms with the Company’s Board of Directors on behalf of the Company’s shareholders although the Company’s revolving credit agreement with Silicon Valley Bank would permit the lender to terminate the agreement and declare amounts outstanding to be due and payable in the event of a “change in control” as defined in the agreement. See Item 7, “Subsequent Events”.


New Product Pipeline. As a result of regulatory and competitive uncertainties, along with potentially limited funding sources, we cannot provide any assurance that we will be able to successfully develop and market new products. We have a pipeline of new products and new indications for existing products in development, but success in developing these products and entering into productive licensing arrangements for them is essential to the success of our business plan and cannot be assured.

Research and Development. Our field is characterized by extensive research efforts. Our research could prove unproductive. Furthermore, other companies could engage in research or development, which renders our programs non-competitive or obsolete. Other companies with which we compete generally have substantially greater financial resources to undertake additional and more effective research. In particular we face intense competition for the discovery and development of ingredients to address signs of photoaging and other skincare conditions from large, global companies with far greater research, development and marketing resources than ours, and there can be no assurance that our existing products or new products developed for our Skincare Segment will maintain market acceptance in competition with existing and new offerings of our competitors.

Management Infrastructure. We currently employ nine people, have a very small management team and have no succession plan. Should we lose any management resources and be unable to attract high caliber replacements to continue implementing our business plan, we could be materially adversely affected. There can be no assurance that we will be able to staff our requirements in a manner adequate to support our planned future growth.


SCHEDULE 9.3(i)

SENETEK PRESS RELEASE

For Senetek PLC

Investor Contacts:

KCSA Worldwide

Todd Fromer / Garth Russell

212-896-1215 / 212-896-1250

tfromer@kcsa.com / grussell@kcsa.com

Senetek PLC Grants Paid Up License to Valeant Pharmaceuticals

Senetek Receives $21 Million Cash Plus Share of Future Third Party Royalties

and Forgiveness of $6 Million in Credits

NAPA, Calif., March XX, 2007—Senetek PLC (OTCBB: SNTKY), a life sciences product development company targeting the science of aging, today announced the signing of a monetization agreement with Valeant Pharmaceuticals North America, the lead licensee of Senetek’s patented Kinetin anti-aging active ingredient and the exclusive licensee of Zeatin, a new Kinetin analog. Under the agreement, Senetek has granted Valeant a paid up license for Kinetin and Zeatin and has assigned to Valeant future royalties from other Kinetin licensees, in return for Senetek receiving a cash payment of $21 million, forgiveness of a $6 million prepaid royalty credit reimbursement obligation that Senetek otherwise would have owed to Valeant, and a right to share in future royalties due to Valeant from other Kinetin licensees through 2011.

Under an August 2005 agreement with Valeant, Senetek had granted Valeant a global exclusive license for Zeatin and had similarly broadening its license for Kinetin, subject to the terms of pre-existing Kinetin license agreements with third parties, and in return Valeant had agreed to minimum royalties of $27 million through 2010 net of prepaid royalties.

Frank J. Massino, Chairman and Chief Executive Officer of Senetek PLC, commented, “This transaction is non-dilutive to our shareholders and provides us the working capital to rapidly accelerate development of our rich pipeline of proprietary compounds, to acquire products, and to achieve our corporate goal of commercializing one new compound each year. Senetek’s new focus will place increased emphasis on direct marketing efforts of new products with our sights on achieving greater revenues and larger economic benefits. This new strategic direction will


also redirect our product development efforts to target unmet needs in the lucrative and growing prescription dermatological therapeutic market.”

About Senetek PLC

Senetek PLC (OTCBB: SNTKY) is a life sciences product development company with a portfolio of intellectual properties targeting the science of aging, including skincare and dermatological therapeutics, erectile dysfunction and nutrition. Kinetin, Senetek’s lead commercial product, is currently licensed and marketed by 14 pharmaceutical and cosmeceutical companies, and Senetek has entered into an exclusive global license with Valeant Pharmaceuticals for Senetek’s proprietary anti-aging skincare compound Zeatin. In addition, Senetek has entered into exclusive licenses for Europe and North America, respectively, for its patented combination drug treatment for erectile dysfunction, Invicorp®, has an exclusive manufacturing distributorship for its proprietary diagnostic monoclonal antibodies, and recently sold, with retained rights of profit participation, its patented drug delivery system, Reliaject®.

For more information, visit the company’s website at http://www.senetekplc.com/

This news release contains statements that may be considered ‘forward-looking statements’ within the meaning of the Private Securities Litigation Reform Act, including those that might imply commercial potential and successful evaluation and development of new compounds and success in forging direct distribution arrangements. Forward-looking statements by their nature involve substantial uncertainty, and actual results may differ materially from those that might be suggested by such statements. Important factors identified by the Company that it believes could result in such material differences are described in the Company’s Annual Report on Form 10-K/A for the year 2005. However, the Company necessarily can give no assurance that it has identified or will identify all of the factors that may result in any particular forward-looking statement materially differing from actual results, and the Company assumes no obligation to correct or update any forward-looking statements which may prove to be inaccurate, whether as a result of new information, future events or otherwise.

# # #

This document is available on the KCSA Worldwide Website at www.kcsa.com.

EX-23.1 10 dex231.htm CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCT. FIRM, MACIAS GINI & O'CONNELL LLP Consent of Independent Registered Public Acct. Firm, Macias Gini & O'Connell LLP

Exhibit 23.1

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

We hereby consent to the incorporation by reference in the Registration Statements on Forms S-3 (No. 333-83782, No. 333-37782 and No. 333-112352) of Senetek PLC and its subsidiaries of our report dated April 9, 2007, relating to the consolidated financial statements and financial statements schedule, which appears in this Form 10-K.

 

/s/    Macias Gini & O’Connell LLP

Sacramento, California

April 9, 2007

EX-23.2 11 dex232.htm CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM, BDO SEIDMAN, LLP Consent of Independent Registered Public Accounting Firm, BDO Seidman, LLP

Exhibit 23.2

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

We hereby consent to the incorporation by reference in the Registration Statements on Forms S-3 (No. 333-83782, No. 333-37782 and No. 333-112352) of Senetek PLC of our report dated March 7, 2005, except for Note 15d, which is as of March 24, 2005, relating to the consolidated financial statements and financial statements schedule, which appears in this Form 10-K.

/s/    BDO Seidman, LLP

San Francisco, California

April 9, 2007

EX-31.1 12 dex311.htm CERTIFICATION OF THE CHIEF EXECUTIVE OFFICER Certification of the Chief Executive Officer

Exhibit 31.1

Certification of Chief Executive Officer

Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, Frank J. Massino, certify that:

 

  1. I have reviewed this annual report on Form 10-K of Senetek PLC for the year ended December 31, 2006;

 

  2. Based on my knowledge, this annual report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this annual report;

 

  3. Based on my knowledge, the financial statements, and other financial information included in this annual report, fairly presents in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this annual report;

 

  4. The registrant’s other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15c and 15d-15e) for the registrant and we have:

 

  a. Designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this annual report is being prepared;

 

  b. Evaluated the effectiveness of the registrant’s disclosure controls and procedures as of a date within 90 days prior to the filing date of this annual report (the Evaluation Date); and

 

  c. Presented in this annual report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date:

 

  5. The registrant’s other certifying officers and I have disclosed, based on our most recent evaluation, to the registrant’s auditors and the audit committee of registrant’s board of Directors (or persons performing the equivalent function):

 

  a. All significant deficiencies in the design or operation of internal controls which could adversely affect the registrant’s ability to record, process, summarize and report financial data and have identified for the registrant’s auditors any material weaknesses in internal controls; and

 

  b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controls; and

 

  6. The registrant’s other certifying officers and I have indicated in this annual report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.

 

/s/    Frank J. Massino

Frank J. Massino

Chief Executive Officer

Date: April 9, 2007

EX-31.2 13 dex312.htm CERTIFICATION OF THE CHIEF FINANCIAL OFFICER Certification of the Chief Financial Officer

Exhibit 31.2

Certification of Chief Financial Officer

Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, William F. O’Kelly, certify that:

 

  1. I have reviewed this annual report on Form 10-K of Senetek PLC for the year ended December 31, 2006;

 

  2. Based on my knowledge, this annual report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this annual report;

 

  3. Based on my knowledge, the financial statements, and other financial information included in this annual report, fairly presents in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this annual report;

 

  4. The registrant’s other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15c and 15d-15e) for the registrant and we have:

 

  a. Designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this annual report is being prepared;

 

  b. Evaluated the effectiveness of the registrant’s disclosure controls and procedures as of a date within 90 days prior to the filing date of this annual report (the Evaluation Date); and

 

  c. Presented in this annual report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date:

 

  5. The registrant’s other certifying officers and I have disclosed, based on our most recent evaluation, to the registrant’s auditors and the audit committee of registrant’s board of Directors (or persons performing the equivalent function):

 

  a. All significant deficiencies in the design or operation of internal controls which could adversely affect the registrant’s ability to record, process, summarize and report financial data and have identified for the registrant’s auditors any material weaknesses in internal controls; and

 

  b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controls; and

 

  6. The registrant’s other certifying officers and I have indicated in this annual report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.

 

/s/    William F. O’Kelly

William F. O’Kelly

Chief Financial Officer

Date: April 9, 2007

EX-32 14 dex32.htm CERTIFICATION OF THE CHIEF EXECUTIVE OFFICER AND THE CHIEF FINANCIAL OFFICER Certification of the Chief Executive Officer and the Chief Financial Officer

Exhibit 32

CERTIFICATIONS OF CEO AND CFO PURSUANT TO 18 U.S.C. SECTION 1350

AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OZLEY ACT OF 2002

In connection with the Annual Report of Senetek PLC (the “Company”) on Form 10-K for the period ending December 31, 2006 as filed with the Securities and Exchange Commission (the “Report”), Frank J. Massino, as Chief Executive Officer of the Company, and William F. O’Kelly, Chief Financial Officer of the Company, each hereby certifies, pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of his knowledge:

 

  (1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

  (2) The information contained in the Report fairly represents, in all material respects, the financial condition and results of operations of the Company.

April 9, 2007

 

/s/    Frank J. Massino

Frank J. Massino

Chief Executive Officer

/s/    William F. O’Kelly

William F. O’Kelly

Chief Financial Officer

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-----END PRIVACY-ENHANCED MESSAGE-----