-----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, DD757zNOIZgy3mD5Dxzh+8eMbX2ohwh5BmU6QLfR+3Lx8iZ+VfccQdYuH9jQllO8 Kr2hqc/3qOjnM2Py8aL9bg== 0001193125-05-047981.txt : 20080717 0001193125-05-047981.hdr.sgml : 20060524 20050311164800 ACCESSION NUMBER: 0001193125-05-047981 CONFORMED SUBMISSION TYPE: SB-2/A PUBLIC DOCUMENT COUNT: 30 FILED AS OF DATE: 20050311 DATE AS OF CHANGE: 20050516 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ORION ACQUISITION CORP II CENTRAL INDEX KEY: 0001011835 STANDARD INDUSTRIAL CLASSIFICATION: BLANK CHECKS [6770] IRS NUMBER: 133863260 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: SB-2/A SEC ACT: 1933 Act SEC FILE NUMBER: 333-122431 FILM NUMBER: 05676045 BUSINESS ADDRESS: STREET 1: 501 SECOND STREET STREET 2: SUITE 211 CITY: SAN FRANCISCO STATE: CA ZIP: 94107 BUSINESS PHONE: 415-543-3470 MAIL ADDRESS: STREET 1: 501 SECOND STREET STREET 2: SUITE 211 CITY: SAN FRANCISCO STATE: CA ZIP: 94107 FORMER COMPANY: FORMER CONFORMED NAME: ORION ACQUISITION CORP II DATE OF NAME CHANGE: 19960408 SB-2/A 1 dsb2a.htm FORM SB-2 AMENDMENT NO. 1 Form SB-2 Amendment No. 1
Table of Contents

As filed with the Securities and Exchange Commission on March 11, 2005

Registration No. 333-122431


UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

AMENDMENT NO. 1

TO

FORM SB-2

REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933

 


 

Orion Acquisition Corp. II

(name of small business issuer in its charter)

Delaware   2834   13-3863260
(state of incorporation)  

(primary standard industrial

classification code number)

  (I.R.S. employer identification no.)

501 Second Street, Suite 211

San Francisco, California 94107

(415) 543-3470

(address of principal place of business or intended principal place of business)

C. Patrick Machado

Senior Vice President and Chief Financial Officer

Orion Acquisition Corp. II

501 Second Street, Suite 211

San Francisco, California 94107

(415) 543-3470

(name, address and telephone number of agent for service)

Copies to:

Michael W. Hall, Esq.

Bradley A. Bugdanowitz, Esq.

Latham & Watkins LLP

135 Commonwealth Drive

Menlo Park, California 94025

(650) 328-4600

 


 

Approximate date of proposed sale to the public:    As soon as practicable after the effective date of this registration statement.

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act of 1933, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering:  ¨

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act, other than securities offered only in connection with dividend or interest reinvestment plans, check the following box:  x

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering:  ¨

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering:  ¨

If delivery of the prospectus is expected to be made pursuant to Rule 434, check the following box:  ¨

 


 

THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(a) OF THE SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME EFFECTIVE ON SUCH DATE AS THE SECURITIES AND EXCHANGE COMMISSION ACTING PURSUANT TO SAID SECTION 8(a) MAY DETERMINE.

 



Table of Contents

Prospectus

 


 

ORION ACQUISITION CORP. II

 

Up to 16,056,115 Shares

Common Stock, par value $0.01 per share

 


 

This prospectus relates to the sale by selling stockholders of up to 15,830,615 shares of our common stock and the sale by us of up to 225,500 shares of our common stock issuable upon the exercise of outstanding warrants.

 

We will not receive any proceeds in this offering from the sale of the shares of common stock held by the selling stockholders. We may receive proceeds in this offering to the extent that holders of warrants elect to exercise such warrants and to pay cash in connection with such exercise for the shares of common stock issuable thereunder.

 

Pursuant to certain registration rights agreements entered into by and among us and certain selling stockholders, subject to certain exceptions, we have agreed to pay all expenses of the company and all reasonable expenses of the selling stockholders (excluding transfer taxes and underwriters’ discounts, commissions and the like of the selling stockholders), in each case incurred in connection with the registration of the shares of common stock covered by this prospectus.

 

Our common stock is quoted on the OTC Bulletin Board under the symbol “MTMR.” On January 25, 2005, the average of the high ask and low bid prices, respectively, of our common stock as reported on the OTC Bulletin Board was $3.25 per share.

 


 

Investing in our common stock involves a high degree of risk. Please carefully consider the “ Risk Factors” beginning on page 5 of this prospectus.

 


 

NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED OF THE SHARES OF COMMON STOCK OR PASSED ON THE ADEQUACY OR ACCURACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.

 


 

The date of this prospectus is                         , 2005


Table of Contents

TABLE OF CONTENTS

 

     Page

SUMMARY

   1

RISK FACTORS

   5

FORWARD-LOOKING STATEMENTS

   15

USE OF PROCEEDS

   16

DIVIDEND POLICY

   16

DETERMINATION OF OFFERING PRICE

   16

MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION

   17

BUSINESS

   19

MANAGEMENT

   34

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS

   36

DESCRIPTION OF TRANSACTIONS

   39

DESCRIPTION OF CAPITAL STOCK

   41

PRINCIPAL AND SELLING STOCKHOLDERS

   44

MARKET FOR COMMON STOCK AND RELATED MATTERS

   48

PLAN OF DISTRIBUTION

   49

LEGAL MATTERS

   51

EXPERTS

   51

WHERE YOU CAN FIND MORE INFORMATION

   51

PROVISION FOR INDEMNIFICATION

   52

EXPLANATORY NOTE

   54

CONSOLIDATED FINANCIAL STATEMENTS OF ORION ACQUISITION CORP. II

   F-1

Financial Statements Index

   F-1

Report of Singer Lewak Greenbaum & Goldstein LLP, Independent Registered Public Accounting Firm of Orion Acquisition Corp. II

   F-2

Consolidated Balance Sheet as of December 31, 2004

   F-3

Consolidated Statements of Operations for the year ended December 31, 2004, for the period from inception (September 4, 2003) to December 31, 2003, and for the period from inception (September 4, 2003) to December 31, 2004

   F-4

Consolidated Statements of Stockholders’ Equity for the period from inception (September 4, 2003) to December 31, 2004

   F-5

Consolidated Statements of Cash Flows for the year ended December 31, 2004, for the period from inception (September 4, 2003) to December 31, 2003, and for the period from inception (September 4, 2003) to December 31, 2004

   F-6

Notes to Consolidated Financial Statements

   F-7

 

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SUMMARY

 

The following summary provides an overview of certain information about our company and the offering and may not contain all the information that may be important to you. This summary is qualified in its entirety by and should be read together with the information contained in other parts of this prospectus. You should carefully read this entire prospectus before making a decision about whether to invest in our common stock.

 

The Company

 

We are a life sciences company based in San Francisco, California. Our business strategy is to identify and acquire development stage medical technologies, including both pharmaceuticals and medical devices, that have promising scientific, clinical and commercial prospects and strong intellectual property positions, and to develop those technologies through a largely outsourced model to achieve positive results in clinical studies or other such value-enhancing milestone events. If we successfully reach such milestone events, we will then consider selling or partnering a given program to a larger pharmaceutical or medical device company or, alternatively, to continue development ourselves to achieve the next milestone event. We believe that our competitive advantages are our ability to identify and acquire medical technologies with favorable risk/reward ratios, our focus on rapid development, and our use of largely outsourced development functions, which allows us to minimize infrastructure and fixed costs and maximize flexibility.

 

We have acquired and are currently developing two technologies, both of which are small molecule drugs targeted at Alzheimer’s disease. Our lead product candidate, Dimebon, is scheduled to enter a randomized, double-blind, placebo-controlled Phase II efficacy study in Alzheimer’s disease patients in Russia in the second or third quarter of 2005. Our second product candidate, NT0904, is in the preclinical research phase. We are also evaluating other medical technologies for potential acquisition, and will continue to do so. We will consider medical technologies based on their scientific, clinical and commercial potential, and intellectual property position, and will not limit ourselves to neurology or any other specific field of medicine.

 

The company is the product of the merger between Medivation, Inc. and Medivation Acquisition Corp., a wholly owned subsidiary of Orion Acquisition Corp. II, which was completed as part of the transactions, including the merger and the financing, on December 17, 2004. Prior to the merger, Orion Acquisition Corp. II had not engaged in any substantive commercial operations, and Medivation, Inc. was a privately held life sciences company. Neither Orion Acquisition Corp. II nor Medivation, Inc. has generated any revenues to date. Orion Acquisition Corp. II was incorporated in Delaware in October 1995 as a “blank check company”, as the term is defined in Rule 419 of Regulation C of the Securities Act of 1933, for the purpose of acquiring an operating business by purchase, merger, combination or otherwise. Medivation, Inc. was incorporated in Delaware in September 2003. From its inception in September 2003 to December 17, 2004, Medivation, Inc.’s activities consisted of identifying and acquiring the intellectual property covering our Dimebon and NT0904 product candidates, obtaining approval from the Russian Ministry of Health to conduct our planned Phase II study of Dimebon, arranging for the manufacture of Dimebon drug substance for use in that study, and obtaining financing for that study and our other business operations. During this period, Medivation, Inc. funded its operations through the sale of $1,850,000 in convertible bridge notes to two investors. See “Certain Relationships and Related Transactions—Transactions with Mr. Grano—Convertible Bridge Notes and Warrants” and “—Transactions with Dara BioSciences, Inc.”

 

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The Transactions

 

On December 17, 2004, Orion Acquisition Corp. II entered into an agreement and plan of merger by and among Orion Acquisition Corp. II, Medivation Acquisition Corp. and Medivation, Inc., providing for the merger of Medivation Acquisition Corp. with and into Medivation, Inc., and pursuant to which Medivation, Inc. became the surviving corporation and a wholly owned subsidiary of Orion Acquisition Corp. II. Pursuant to the merger agreement, each outstanding share of common stock of Medivation, Inc. was converted into 0.122935 shares of the Series B Preferred Stock of the company. In addition, in connection with the transactions, Orion Acquisition Corp. II entered into purchase agreements with respect to the private placement by Orion Acquisition Corp. II of an aggregate of 7,741,935 shares of common stock to certain accredited investors at a price of $1.55 per share.

 

At the next annual meeting of the holders of our common stock, we will propose for approval an amendment to our amended and restated certificate of incorporation to change the name of the company to “Medivation, Inc.”

 

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Summary Consolidated Financial Data

 

The summary consolidated financial data set forth below is a summary derived from our consolidated financial statements and notes thereto, and should be read in conjunction with our consolidated financial statements and notes thereto and the information contained under the caption “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in each case appearing elsewhere in this prospectus.

 

Statement of Operations Data

 

     Year ending
December 31, 2004


   

Inception
(September 4, 2003)

to December 31,
2003


   

Inception
(September 4, 2003)

to December 31,
2004


 

Total operating expenses:

   $ 2,784,851     $ 392,137     $ 3,176,988  

Total other expense:

     87,896       8,512       96,208  

Net loss:

   $ (2,874,147 )   $ (401,449 )   $ (3,275,595 )

 

Balance Sheet and Other Data

 

     As of
December 31, 2004


Cash and cash equivalents:

   $ 10,671,707

Total assets:

     11,116,543

Accounts payable:

     375,435

Total stockholders’ equity:

     10,090,273

 

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The Offering

 

Shares of common stock offered by the selling stockholders

15,830,615

 

Shares of common stock offered by us to holders of warrants upon exercise thereof

225,500

 

Shares of common stock to be outstanding after this offering

17,996,178*

 

Use of proceeds

We will not receive any proceeds in this offering from the sale of the shares of common stock held by the selling stockholders. We may receive proceeds in this offering to the extent that holders of warrants elect to exercise such warrants and to pay cash in connection with such exercise for the shares of common stock issuable thereunder. If applicable, we intend to use such proceeds for general corporate purposes, including working capital and other general and administrative expenses.

 

Risk factors

Investing in our common stock involves a high degree of risk. Please carefully consider the “Risk Factors” beginning on page 5 of this prospectus.

 

OTC Bulletin Board symbol

“MTMR.”

 

Estimated expenses to be paid by the company on behalf of the selling stockholders

$190,000


* The number of shares of common stock to be outstanding after this offering represents the sum of: (a) 9,581,141 shares of our common stock outstanding as of January 28, 2005; (b) 1,049,991 shares of our common stock issuable upon exercise of our warrants outstanding as of January 28, 2005; (c) 110,000 shares of our common stock issuable upon conversion of our Series A Preferred Stock outstanding as of January 28, 2005; (d) 6,638,490 shares of our common stock issuable upon conversion of our Series B Preferred Stock outstanding as of January 28, 2005; and (e) 616,556 shares of our common stock issuable upon exercise of our options outstanding as of January 28, 2005.

 

Corporate Information

 

We are headquartered at 501 Second Street, Suite 211, San Francisco, California 94107, and our phone number is (415) 543-3470. We are a Delaware corporation that was incorporated in October 1995.

 

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RISK FACTORS

 

You should carefully consider the following material risks in addition to the other information set forth in this prospectus before making an investment in our common stock. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently believe to be immaterial may also adversely affect our business.

 

Risks Related to our Business

 

We have incurred net losses since inception, and if we do not realize sufficient levels of revenue in the future, our business could be harmed.

 

We are a development stage company and have never recognized any revenue from the sale of products or any other source. We have not completed development of any of our product candidates, and do not expect that any of our present or future product candidates will be commercially available for a number of years, if at all. We have incurred losses since inception and expect to continue to incur substantial and increasing losses for the foreseeable future as we increase our spending to finance our Phase II clinical trial of Dimebon, the animal studies of Dimebon in the U.S. required to support an investigational new drug application to the U.S. Food and Drug Administration, our other research and development activities, and the costs associated with being a public company. Our operating losses have had, and will continue to have, an adverse impact on our working capital, total assets and stockholders’ equity. We do not know whether or when we will generate revenue or become profitable because of the significant uncertainties with respect to our ability to generate revenue from any of our current or future product candidates. If we do not realize sufficient revenue levels to achieve profitability, our business could be harmed and you may lose all or part of your investment.

 

Because we depend on financing from third parties for our operations, our business may fail if such financing becomes unavailable or is offered on commercially unreasonable terms.

 

To date, we have financed all of our operations through borrowings and the sale of our equity securities. We believe that our existing cash will be sufficient to fund our currently planned operations through completion of our Phase II clinical study of Dimebon in Alzheimer’s disease patients in Russia, which is scheduled for completion in June 2006. However, we will require significant additional capital to develop Dimebon beyond Phase II, should the Phase II results be positive, and to acquire and develop other product candidates.

 

Our future capital requirements will depend on many factors, including:

 

    the scope and results of our preclinical and clinical trials;

 

    whether we experience delays in our preclinical and clinical development programs, or slower than anticipated product development;

 

    whether we identify other product candidates that we wish to acquire, and the costs of acquiring and developing those product candidates;

 

    whether we are able to enter into collaborative partnerships with regard to any of our product development programs, and the terms of any such collaboration;

 

    the timing and requirements of, and the costs involved in, obtaining regulatory approvals for our product candidates from the FDA and comparable foreign regulatory agencies;

 

    as necessitated by our outsourced model, the availability of third parties to perform the key development tasks on our product candidates, including conducting preclinical and clinical studies and manufacturing the drugs or other product candidates to be tested in those studies, and the associated costs of those services;

 

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    the availability and cost of raw materials required to manufacture drugs and other product candidates for testing in our preclinical and clinical studies; and

 

    the costs involved in preparing, filing, prosecuting, maintaining, defending the validity of, and enforcing, patent claims and other patent-related costs, including litigation costs and the results of such litigation.

 

We may not be able to obtain additional financing when we need it on acceptable terms or at all. If we cannot raise funds on acceptable terms, we may not be able to develop or enhance our product candidates, take advantage of future opportunities or respond to competitive pressures or unanticipated requirements. For these reasons, any inability to raise additional capital when we require it would seriously harm our business.

 

Our business strategy depends on our ability to identify and acquire additional product candidates which we may never acquire or identify for reasons that may not be in our control, or are otherwise unforeseen or unforeseeable to us.

 

A key component of our business strategy is to diversify our product development risk by identifying, acquiring and developing additional development stage product candidates, whether drugs or medical devices. However, we may not be able to identify other promising technologies. In addition, the competition to acquire promising medical technologies is fierce, and many of our competitors are large, multinational pharmaceutical, biotechnology and medical device companies with considerably more financial, development and commercialization resources and experience than we have. Thus, even if we succeed in identifying promising technologies, we may not be able to acquire rights to them on acceptable terms or at all. If we are unable to identify and acquire new technologies, we will be unable to diversify our product risk. We believe that any such failure would have a significant negative impact on our prospects because the risk of failure of any particular development program in the pharmaceutical and medical device fields, including that of our Dimebon and NT0904 programs, is extremely high.

 

Our current ownership of patent rights to only two product candidates is insufficient to implement our business strategy successfully.

 

We presently own patent rights to only two product candidates: Dimebon (including certain related compounds) and the NT0904 family of compounds. The patent rights covering both of these product candidates are based on inventions made at the Institute of Physiologically Active Compounds in Russia. Our patent rights to Dimebon cover the use of that drug to treat neurodegenerative diseases, including Alzheimer’s disease, and for anti-depressant and anti-aging purposes, and our patent rights to the NT0904 family include those molecules and uses thereof. In order to implement our business strategy successfully, we will need to identify, evaluate and acquire other promising development stage medical technologies on acceptable terms.

 

Our reliance on third parties for the operation of our business may result in inefficient allocation of management resources, material delays and/or cost overruns in our development programs.

 

Our business model requires us to keep our employee count relatively low and rely largely on outside consultants to perform key product development tasks, such as conducting preclinical and clinical studies and manufacturing the product candidates to be tested in those studies. In order to execute this component of our strategy successfully, we will need to identify, engage and properly manage those activities of qualified external consultants. For example, we need to monitor the activities of our consultants closely to ensure that they are performing their tasks correctly, on time and on budget. Because all of our consultants work for other clients in addition to us, we also need to ensure that our consultants are appropriately prioritizing our projects. If we fail to manage our consultants well, we could incur material delays, cost overruns or both in our development programs, as well as other material disruptions to our business.

 

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Because we depend on our management to oversee the execution of development plans for our existing product candidates and to identify and acquire promising new product candidates, the loss of any of our managers would harm our business.

 

Our future success depends upon the continued services of our executive officers. We are particularly dependent on the continued services of Dr. Hung, our President and Chief Executive Officer and a member of our board of directors. Dr. Hung identified the Dimebon product candidate for acquisition, and has primary responsibility for identifying and evaluating other potential product candidates. We believe that Dr. Hung’s services in this capacity would be difficult to replace. None of our executive officers is bound by an employment agreement for any specific term, and they may terminate their employment at any time. In addition, we do not have “key person” life insurance policies covering any of our executive officers. The loss of the services of any of our executive officers could delay the development of our existing product candidates, and delay or preclude the identification and acquisition of new product candidates, either of which events could harm our business.

 

Risks Related to our Product Development Candidates

 

The application of Dimebon to treat Alzheimer’s disease is novel and in the early stages of development and, as a result, we may never market Dimebon to treat Alzheimer’s disease or any other condition.

 

Dimebon has never been approved in Russia or elsewhere for the treatment of Alzheimer’s disease, and the development of Dimebon for that indication is at an early stage. While we have received approval from the Russian Ministry of Health to proceed directly to a Phase II clinical study in that country, subject to ethics committee approval of any changes we may choose to make to our approved protocol, in the U.S. and Europe we will need to pursue a traditional drug development plan, beginning with animal studies. Dimebon will require significant additional development, preclinical studies and clinical trials, regulatory clearances and additional investment by us or our collaborators, if any, before applications for marketing approval can be submitted. We may not be able to complete these studies successfully or obtain approval to market Dimebon to treat Alzheimer’s disease or any other indication.

 

Most of the previously conducted Russian studies of Dimebon must be repeated pursuant to U.S. standards and the results of those new studies may demonstrate that Dimebon is not a safe or effective treatment for Alzheimer’s disease.

 

We have chosen to develop Dimebon as a potential treatment for Alzheimer’s disease based on the Russian studies submitted in support of Dimebon’s approval in Russia as an oral antihistamine in 1982, the later Russian studies of Dimebon in various animal models of Alzheimer’s disease described elsewhere in this prospectus under “Business—Our Dimebon Program—Preclinical Data” and the pilot 14-patient clinical study of Dimebon in Alzheimer’s disease patients described elsewhere in this prospectus under “Business—Our Dimebon Program—Clinical Data”. These studies were not performed in accordance with U.S. regulatory standards. For example, we lack sufficient documentation to establish that the Dimebon used in the Russian studies complies with the applicable manufacturing standards of the FDA. Furthermore, the Russian pilot clinical study used study endpoints different from those currently required by the FDA for approval of Alzheimer’s disease therapeutics. Thus, most of the previously conducted Russian studies will need to be repeated in order to meet FDA and European regulatory requirements to market in those jurisdictions. We do not know if any of the prior Russian results will be reproduced in the preclinical and clinical studies that we plan to perform to determine whether Dimebon is a safe and effective treatment for Alzheimer’s disease. Even if the prior results are reproduced, we do not know if the results of later stage clinical trials will be positive because product candidates in later stages of clinical trials often fail to show the desired safety and efficacy traits despite having progressed through preclinical or early-stage clinical testing. Finally, many of the animal and human studies required to prove that Dimebon is safe and effective by FDA standards have never been performed in Russia or elsewhere. Thus, we do not know if Dimebon will ever demonstrate the requisite safety or efficacy to obtain marketing approval in the U.S., Europe or any other country to treat Alzheimer’s disease or any other condition.

 

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Chronic use of Dimebon has never been tested in humans and may never be approved to treat Alzheimer’s disease as a result of unforeseen risks to humans.

 

The approved human use of Dimebon in Russia is as an oral antihistamine. Patients typically take oral antihistamines only for a short duration of time, generally 14 days or less. By contrast, the clinical trials required to obtain regulatory approval to sell Dimebon to treat Alzheimer’s disease will require patients to be treated with Dimebon for six months. If Dimebon were approved, use in actual Alzheimer’s disease patients could involve treatment with Dimebon for even longer periods of time. Dimebon has been tested in animals for periods of six months and longer, and found to be safe to the animals tested in those studies. To date the longest human exposure to Dimebon in a documented clinical study that we are aware of is two months. We do not know whether use of Dimebon for six months or longer will prove to be safe in humans. Safety issues may arise from such chronic exposure that did not arise from shorter-term use of the drug. Should such issues arise, they could delay or prevent our ability to obtain approval to sell Dimebon to treat Alzheimer’s disease, and give rise to potential product liability claims against us.

 

Conducting a clinical study in Russia involves risks not typically associated with U.S. studies which may result in unforeseen or unforeseeable delay and cost overruns in our Russian Phase II clinical study.

 

In order to generate data that will be suitable for submission to regulatory agencies in the U.S. and Western Europe, we plan to conduct our Russian Phase II clinical study in compliance with good clinical practices. We have not yet confirmed that the clinical sites we intend to use in this study are, or have the capacity to become, good clinical practices compliant. Ensuring good clinical practices compliance of Russian clinical sites will involve risks, including risks associated with language barriers and the fact that Russian clinical investigators in general have only limited experience in conducting clinical studies to rigorous Western standards. We intend to mitigate this risk by engaging expert consultants to confirm that all sites are good clinical practices compliant, or can become good clinical practices compliant, and to monitor and audit the ongoing performance of our study at those sites to ensure that good clinical practices and all other regulatory requirements are adhered to. Failure to attain and prove good clinical practices compliance would adversely impact the value of any data generated from our planned Russian study, including its submissibility to regulatory agencies in the U.S. and Western Europe and its value to potential acquirers/corporate partners. In addition, should we be unable to identify a sufficient number of Russian sites with the capability to perform our study in compliance with good clinical practices, or should it take more time or money than currently anticipated to perform any required site training activities or to accrue a sufficient number of patients into our study, our Phase II study in Russia could be delayed, run over budget, or both.

 

We have not received U.S. government approval to export, or Russian government approval to import, Dimebon from the U.S. to Russia for use in our planned Phase II study.

 

In order to maximize the persuasive value of the data generated in our proposed Russian Phase II study, we intend to use Dimebon tablets manufactured under current good manufacturing practices. Because there presently are no current good manufacturing practices compliant manufacturing facilities in Russia, we plan to import the Dimebon into Russia from the U.S. or other country where current good manufacturing practices manufacturing facilities exist. Under U.S. law, export of Dimebon tablets from the U.S. to Russia for use in a clinical study not being conducted under a U.S. investigational new drug application requires an export license and FDA approval, neither of which we have yet obtained. The FDA may deny or delay approval if it concludes that there are not enough existing data to support initiating the Russian study, despite any prior approval by Russian regulators. Under Russian law, an import license is also required to import U.S.-produced Dimebon tablets into Russia for clinical trial use, and we have not yet obtained that license. Should the FDA or the applicable Russian authorities deny or delay its approval, we would need to implement alternative strategies for exporting current good manufacturing practices Dimebon tablets to Russia, which could result in additional delays and costs, or use Russian produced Dimebon in our Phase II study. Because Russian produced Dimebon is not manufactured in accordance with current good manufacturing practices, if we are forced to use such material the results of our study would be less persuasive and may not be submissible to the FDA or other foreign regulatory agencies in support of an application to market Dimebon to treat Alzheimer’s disease.

 

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Our business strategy depends on our ability to conduct our clinical trials efficiently and successfully, and our failure to so conduct our clinical trials may result in the failure of our business.

 

The clinical trial process is expensive, uncertain and takes many years. Neither Dimebon nor any other product candidates of ours is currently approved for sale for the treatment of Alzheimer’s disease anywhere in the world, and Dimebon may never be approved for sale for, or become commercially viable as, a treatment for Alzheimer’s disease. If we are unable to complete clinical trials of any of our current or future product candidates, or if the results of these trials are not satisfactory, we may not be able to obtain marketing approval for any products or may obtain approval for indications that are not as broad as we wanted. If this occurs, our business will be materially harmed, our ability to generate revenue will be severely impaired and you may lose part or all of your investment.

 

Before obtaining regulatory approval for the sale of our product candidates, they must be subjected to extensive clinical trials to demonstrate their safety and efficacy for humans. The clinical trials of any product candidates that we develop for sale in the U.S. must comply with regulation by numerous federal, state and local government authorities in the U.S., principally the FDA, and by similar agencies in other countries. In the case of Dimebon and other potential drug product candidates, we will be required to obtain and maintain an effective investigational new drug application to conduct human clinical trials in the U.S. and must obtain and maintain regulatory approval before proceeding to successive phases of our clinical trials. Similar regulatory requirements apply to medical devices, and may become relevant to us should we acquire any medical device product candidates. Securing FDA approval requires the submission of extensive preclinical and clinical data and supporting information for each therapeutic indication to establish the product candidate’s safety and efficacy. Neither Dimebon nor any other product candidate of ours has begun preclinical or clinical trials in the U.S. It takes years to complete the testing of a new drug or medical device, and failure can occur at any stage of testing. For example, our testing may be delayed or halted due to any of the following:

 

    any preclinical test or clinical trial may fail to produce safety and efficacy results satisfactory to the FDA or foreign regulatory authorities;

 

    preclinical and clinical data can be interpreted in different ways, which could delay, limit or prevent regulatory approval;

 

    negative or inconclusive results from a preclinical test or clinical trial or adverse medical events during a clinical trial could cause a preclinical study or clinical trial to be repeated or a program to be terminated, even if other studies or trials relating to the program are successful;

 

    the FDA or foreign regulatory authorities can place a clinical hold on a trial if, among other reasons, it finds that patients enrolled in the trial are or would be exposed to an unreasonable and significant risk of illness or injury;

 

    the FDA might not approve the clinical processes or facilities that we utilize, or the processes or facilities of our collaborators, including without limitation the vendors who will be manufacturing drug substance and drug product for us;

 

    any regulatory approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the product not commercially viable; and

 

    we may encounter delays or rejections based on changes in FDA policies or the policies of foreign regulatory authorities during the period in which we develop a drug or the period required for review of any new drug application.

 

In addition, we may encounter delays or rejections based on our inability to enroll a sufficient number of patients to complete our clinical trials, including our planned Phase II clinical study of Dimebon in Alzheimer’s disease patients. Patient enrollment depends on many factors, including the size of the patient population, the nature of the trial protocol, the proximity of patients to clinical sites and the eligibility criteria for the study. Delays in planned patient enrollment may result in increased costs, program delays or both, which could have a harmful effect on our ability to develop Dimebon or any other product candidates.

 

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We may require financial, product development and clinical trial support from collaborative partners with whom we currently have not entered into any such partnerships and our failure to acquire any such support from collaborative partners may cause our business to fail.

 

Our business strategy entails developing medical product candidates to achieve value-enhancing milestone events, and then determining whether to partner the program or continue development internally until the next milestone event. Based on this strategy, we intend to explore a possible collaboration with a large pharmaceutical and biotechnology company to commercialize Dimebon at some point after completion of our randomized, double-blind, placebo-controlled Phase II study in Russia, should the results of that study warrant further development. We may also be required to enter into collaborative relationships to assist with the development process prior to commercialization and to complete clinical trials of other product candidates. We have not entered into any collaborations to date. It may be difficult for us to find third parties that are willing to enter into collaborations on acceptable economic terms or at all. If we are not able to enter into collaborative relationships for our Dimebon product candidate or any other product candidate, we would be required to undertake and fund further development, clinical trials, manufacturing and marketing activities solely at our own expense. If we are unable to finance those activities, we would have to substantially reduce our development efforts and our business and prospects would be materially and adversely harmed for that reason.

 

If we enter into collaborative relationships we will be dependent upon our partners, and we may be unable to prevent them from taking actions that may be harmful to our business or inconsistent with our business strategy.

 

Our business strategy may require us to secure collaborations with pharmaceutical, biotechnology or medical device companies covering later-stage clinical development and commercialization of Dimebon and any other product candidates. However, the agreements governing any collaboration are unlikely to provide us with control over the activities of our collaboration partner. For example, future collaboration partners, if any, are likely to have the right to terminate the collaboration at their option. Our partners may decide to terminate a drug development program under circumstances where we might have continued such a program. Any collaborator may be unwilling or unable to fulfill its obligations to us, including its development and commercialization responsibilities in respect of our product candidates. Our collaborators will have significant discretion in determining the efforts and level of resources that they dedicate to our collaborations. In addition, our collaborators may develop and commercialize, either alone or with others, products and services that are similar to or competitive with the products that are the subject of the collaboration with us.

 

Our success likely will depend on our collaborators’ abilities to establish the safety and efficacy of the drugs in later-stage Phase III clinical trials, obtain regulatory approvals from the FDA and other foreign regulatory agencies and commercialize products developed from our product candidates. In addition to testing and seeking regulatory approval, we likely will be dependent on our collaborators for the manufacture of clinical scale quantities of our product candidates and would be dependent on them in the future for commercial scale manufacture, distribution, sales, marketing and reimbursement. These third parties may not be successful in manufacturing our product candidates on a commercial scale or in commercializing them. If any future collaborator terminates its collaboration with us or fails to perform or satisfy its obligations to us, the development or commercialization of our product candidate would be delayed and our business and prospects would be materially and adversely affected for that reason.

 

We face intense competition in development and commercialization of Dimebon and any other future product candidates, which increases the possibility that our business may fail.

 

The drug and medical device development markets are intensely competitive in general, and the market for developing Alzheimer’s disease drugs is particularly competitive. There are four drugs currently marketed to treat Alzheimer’s disease, and these drugs all target at least one of the same mechanisms as does Dimebon. Companies marketing these FDA-approved Alzheimer’s disease therapeutics include some of the world’s largest and most experienced pharmaceutical companies, such as Pfizer Inc., Novartis AG and Johnson & Johnson.

 

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In addition to the four currently marketed Alzheimer’s disease therapeutics, dozens of additional small molecule and recombinant protein candidates targeting many disparate mechanisms believed to play a role in the pathogenesis of Alzheimer’s disease are currently in development. General classes of agents currently in development by other companies for the treatment of Alzheimer’s disease, arranged by purported mechanism of action, include the following:

 

    Neuroprotection strategies:

 

    Antioxidants

 

    Anti-inflammatories

 

    Hormonal agents

 

    Neurotrophic factors

 

    Anti-excitotoxicity agents

 

    AMPA receptor modulators

 

    Anti-apoptosis agents

 

    Amyloid protein ß lowering/disrupting strategies

 

    Neuroregenerative strategies

 

    Neural cell implants

 

    Downstream compensatory strategies

 

    Cholinesterase inhibitors

 

    Cholinergic agonists

 

    GABA antagonists

 

    Nutriceuticals

 

Most, if not all, of these competing drug development programs are being conducted by pharmaceutical and biotechnology companies with considerably greater financial resources, human resources and experience than ours.

 

If we are able to obtain regulatory approval to sell Dimebon or any other product to treat Alzheimer’s disease, we will face significant competition from the approved Alzheimer’s disease drugs, as well as from any of the drugs currently under development that may subsequently be approved. Bases on which we would have to compete successfully include efficacy, safety, price and cost-effectiveness. In addition, we would have to compete against these other drugs with several different categories of decision makers—including physicians, patients, government and private third-party payors, technology assessment groups and patient advocacy organizations. Even if one of our Alzheimer’s disease product candidates is approved, we cannot guarantee that we will be able to compete successfully on any of these bases. Any future product candidates that we may develop will face similar competitive pressures. If we cannot compete successfully on any of the bases described above, our business will not succeed.

 

If our product candidates are approved for sale our commercial success will depend on reimbursement from third-party payors, and failure to achieve coverage and acceptable reimbursement levels would harm our business.

 

Third-party payors, including public insurers such as Medicare and Medicaid, and private insurers, pay for a large share of health care products and services consumed in the U.S. In Europe, Canada and other major international markets, third-party payors also pay for a significant portion of health care products and services, and certain of those countries have nationalized health care systems in which the government pays for all such products and services. Even if approved by the FDA and other regulatory agencies, our products are unlikely to achieve commercial success unless they are covered widely by third-party payors and reimbursed at a rate which

 

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generates an acceptable commercial return for us and any collaborative partner. It is increasingly difficult to obtain coverage and acceptable reimbursement levels from third-party payors, and we may be unable to achieve these objectives. Achieving coverage and acceptable reimbursement levels typically involves negotiating with individual payors, and is a time-consuming and costly process. In addition, we would face competition in such negotiations from other approved drugs against which we compete, and the marketers of such other drugs are likely to be significantly larger than us and therefore enjoy significantly more negotiating leverage. Failure to achieve coverage and acceptable reimbursement levels could harm our business.

 

We may be subject to product liability or other litigation, which if successful could materially and adversely harm our business and financial condition as a result of the costs of liabilities that may be imposed thereby, result in an inefficient allocation of our critical resources and delay the implementation of our business strategy.

 

Our business exposes us to the risk of product liability claims that is inherent in the development of drugs and medical devices. If one of our product candidates harms people, or is alleged to, we may be subject to costly and damaging product liability claims brought against us by clinical trial participants, consumers, health care providers, pharmaceutical companies or others. We have product liability insurance covering our Russian Phase II clinical study of Dimebon, but do not have insurance for any of our other development activities. If we are unable to obtain insurance at an acceptable cost or otherwise protect against potential product liability claims, we may be exposed to significant litigation costs and liabilities, which may materially and adversely affect our business and financial position. If we are sued for injuries allegedly caused by any of our product candidates, our litigation costs and liability could exceed our total assets and our ability to pay. In addition, we may from time to time become involved in various lawsuits and legal proceedings which arise in the ordinary course of our business. Any litigation to which we are subject could require significant involvement of our senior management and may divert management’s attention from our business and operations. Litigation costs or an adverse result in any litigation that may arise from time to time may adversely impact our operating results or financial condition.

 

Risks Related to our Intellectual Property

 

We may be unable to adequately protect our proprietary technology which could adversely affect our ability to compete.

 

We rely on a combination of patent, trademark and trade secret laws and restrictions on disclosure to protect our intellectual property rights, both in the U.S. and abroad. As of January 28, 2005, we owned the rights to one issued patent in the U.S., Europe and Hong Kong, covering the use of Dimebon and certain related compounds to treat neurodegenerative diseases, including Alzheimer’s disease. A corresponding patent application is pending in Canada, and a continuation application is pending in the U.S. We also own two other pending patent applications, one claiming the use of Dimebon for anti-aging purposes and the other claiming the NT0904 family of compounds. We intend to prosecute both of these patent applications in the U.S., Europe and any other jurisdictions we deem appropriate. However, issued patents or pending patent applications might not adequately protect our intellectual property rights, that any future patent applications will be approved or that any issued patents will not be challenged by third parties. Other parties may independently develop similar or competing technology or design around any patents that may be issued to us. We also enter into confidentiality agreements with our employees, consultants and suppliers and control access to and distribution of our confidential information and intellectual property. We cannot be certain that the steps we have taken will prevent the misappropriation of our intellectual property, particularly in foreign countries where the laws may not protect our proprietary rights as fully as in the U.S.

 

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We could become subject to litigation regarding intellectual property rights, which could divert management attention, cause us to incur significant costs and prevent us from selling or using the challenged technology.

 

In recent years, there has been significant litigation in the U.S. and elsewhere involving pharmaceutical patents and other intellectual property rights. In particular, generic pharmaceutical manufacturers have been very aggressive in attacking the validity of patents held by proprietary pharmaceutical companies, especially if these patents are commercially significant. If Dimebon or any of our potential future product candidates succeeds, we may face challenges to our existing or future patents. For example, in the prosecution of our issued U.S. patent, the prior owners missed a filing deadline with the U.S. Patent & Trademark Office, which resulted in the patent application being deemed abandoned. The prior owners petitioned the PTO to revive the patent application alleging that missing the deadline was unintentional, and the PTO approved the petition and issued the patent. However, as with any other decision the PTO makes, this decision could be challenged in subsequent litigation in an attempt to invalidate the issued U.S. Dimebon patent and any other U.S. patent that may issue based on the same patent application.

 

In the future, we may be a party to litigation to protect our intellectual property or as a result of an alleged infringement of others’ intellectual property. These claims and any resulting lawsuit, if successful, could subject us to significant liability for damages and invalidation of our proprietary rights. These lawsuits, regardless of their success, would likely be time-consuming and expensive to litigate and resolve and would divert management time and attention. Any potential intellectual property litigation also could force us to do one or more of the following:

 

    discontinue our products that use the challenged intellectual property; or

 

    obtain from the owner of the infringed intellectual property right a license to sell or use the relevant technology, which license may not be available on reasonable terms, or at all.

 

If we are forced to take any of these actions, our business may be seriously harmed. Although we carry general liability insurance, our insurance does not cover potential claims of this type.

 

We may in the future initiate claims or litigation against third parties for infringement of our proprietary rights to protect these rights or to determine the scope and validity of our proprietary rights or the proprietary rights of competitors. These claims could result in costly litigation and the diversion of our technical and management personnel, and we may not prevail in making these claims.

 

We may need to obtain licenses of third-party technology that may not be available to us or are available only on commercially unreasonable terms, and which may cause us to operate our business in a more costly or otherwise adverse manner that was not anticipated.

 

From time to time we may be required to license technology from third parties to develop our existing and future product candidates. Third-party licenses may not be available to us on commercially reasonable terms, or at all. The inability to obtain any third-party license required to develop any of our product candidates could cause us to abandon any related development efforts, which could seriously harm our business and operations.

 

Risks Related to the Offering and the Common Stock

 

The number of shares of common stock eligible for sale could depress our stock price.

 

We are registering a total of 16,056,115 shares of our common stock pursuant to the registration statement of which this prospectus is a part. As of January 28, 2005, the shares covered by the registration statement will constitute approximately 89% of the fully-diluted shares of common stock of the company. In addition, as of January 28, 2005, a total of 6,638,490 shares of common stock, which are issuable upon conversion of the 331,925 shares of Series B Preferred Stock in the merger and which represent approximately 37% of the fully-diluted shares of common stock of the company, are subject to

 

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lock-up agreements restricting their sale until the earlier of (a) completion of the planned Phase II clinical study of Dimebon in Russia; and (b) December 17, 2006. At the discretion of the company’s board of directors, the persons subject to the lock-up agreements, including Dr. Hung, our President and Chief Executive Officer, and C. Patrick Machado, our Senior Vice President and Chief Financial Officer, may be permitted to sell their shares prior to the end of this period. The possible sale of a significant number of these shares may cause the market price of our common stock to decline.

 

Our common stock is not and may never qualify to be listed on a national securities exchange.

 

Our common stock is quoted on the OTC Bulletin Board under the symbol “MTMR.” In connection with the financing, we have agreed to use our best efforts to list our common stock on the Nasdaq SmallCap Market. However, we do not currently meet the listing requirements for the Nasdaq SmallCap Market or any national securities exchange, and we cannot guarantee that we will be able to do so in the future. As a result, we cannot predict the extent to which a trading market will develop or how liquid that market might become. If an active trading market does not develop, you may have difficulty selling the shares of common stock that you buy. If you purchase shares of our common stock, you may not be able to resell those shares at or above the prices offered by the selling stockholders.

 

We do not intend to pay dividends on our common stock.

 

We have not in the past paid, and do not expect for the foreseeable future to pay, dividends on our common stock. Instead, we anticipate that all of our earnings, if any, in the foreseeable future will be used for working capital and other general corporate purposes. Any future determination to pay dividends on our common stock will be at the discretion of our board of directors and will depend upon, among other factors, our results of operations, financial condition, capital requirements and contractual restrictions.

 

Our principal stockholders exert substantial influence over us and may exercise their control in a manner adverse to your interests.

 

Upon the completion of the offering, certain stockholders and their affiliates may continue to own a substantial amount of our outstanding common stock. These stockholders may have the power to direct our affairs and be able to determine the outcome of certain matters submitted to stockholders for approval. Because a limited number of persons control us, transactions could be difficult or impossible to complete without the support of those persons. Subject to applicable law, it is possible that these persons will exercise control over us in a manner adverse to your interests.

 

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FORWARD-LOOKING STATEMENTS

 

This prospectus includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements other than statements of historical facts contained in this prospectus, including statements regarding our future financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions described in “Risk Factors” and elsewhere in this prospectus. These risks are not exhaustive. Other sections of this prospectus include additional factors which could adversely impact our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those projected in the forward-looking statements.

 

 

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USE OF PROCEEDS

 

We will not receive any proceeds in this offering from the sale of the shares of common stock held by the selling stockholders. We may receive proceeds in this offering to the extent that holders of warrants elect to exercise such warrants and to pay cash in connection with such exercise for the shares of common stock issuable thereunder. If all such warrants are exercised for cash, the aggregate net proceeds to us from the sale of the shares of common stock issuable upon exercise of such warrants will be approximately $1,306,136. If applicable, we intend to use such proceeds for general corporate purposes, including working capital and other general and administrative expenses. We have not identified the amounts we plan to spend on each of these areas or the timing of expenditures. Pending specific application of the net proceeds, we plan to invest the net proceeds in short-term, investment grade, interest-bearing securities.

 

The principal purpose of the offering of the shares of common stock issuable upon the exercise of outstanding warrants is to enable us to issue such shares of common stock in compliance with applicable securities laws.

 

DIVIDEND POLICY

 

We have not in the past paid, and do not expect for the foreseeable future to pay, dividends on our common stock. Instead, we anticipate that all of our earnings, if any, in the foreseeable future will be used for working capital and other general corporate purposes. Any future determination to pay dividends on our common stock will be at the discretion of our board of directors and will depend upon, among other factors, our results of operations, financial condition, capital requirements and contractual restrictions.

 

DETERMINATION OF OFFERING PRICE

 

We have been informed by the selling stockholders that they may, from time to time, sell, transfer or otherwise dispose of any or all of their shares of common stock or interests in shares of common stock on any stock exchange, market or trading facility on which the shares are traded or in private transactions. These dispositions may be at fixed prices, at prevailing market prices at the time of sale, at prices related to the prevailing market price, at varying prices determined at the time of sale or at negotiated prices. No independent third party has been consulted concerning the offering price for the shares or the fairness of the offering price used for the shares.

 

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION

 

The following discussion should be read in conjunction with and is qualified in its entirety by reference to our consolidated financial statements included elsewhere in this prospectus. Except for the historical information contained herein, the discussions in this section contain forward-looking statements that involve risks and uncertainties. Actual results could differ materially from those discussed below. See “Risk Factors” and “Forward-Looking Statements” for a discussion of these risks and uncertainties.

 

Our corporate strategy is to identify and acquire development stage medical technologies, including both pharmaceuticals and medical devices, that have promising scientific, clinical and commercial prospects and strong intellectual property positions, and to develop those technologies through a largely outsourced model to achieve positive results in clinical studies or other such value-enhancing milestone events. If we successfully reach such milestone events, we will then consider selling or partnering a given program to a larger pharmaceutical or medical device company or, alternatively, to continue development ourselves to achieve the next milestone event. We have acquired and are currently developing two technologies, both of which are small molecule drugs targeted at Alzheimer’s disease. Our lead product candidate, Dimebon, is scheduled to enter a randomized, double-blind, placebo-controlled Phase II efficacy study in Alzheimer’s disease patients in Russia in the second or third quarter of 2005. Our second product candidate, NT0904, is in the preclinical research phase. We are also evaluating other medical technologies for potential acquisition, and will continue to do so.

 

From its inception in September 2003 to December 17, 2004, Medivation’s activities consisted of identifying and acquiring the intellectual property covering our Dimebon and NT0904 product candidates, obtaining approval from the Russian Ministry of Health to conduct our planned Phase II study of Dimebon, arranging for the manufacture of Dimebon drug substance for use in that study, and obtaining financing for that study and our other business operations. During this period, Medivation funded its operations through the sale of $1,850,000 in convertible bridge notes to two investors. See “Certain Relationships and Related Transactions— Transactions with Mr. Grano—Convertible Bridge Notes and Warrants” and “—Transactions with Dara BioSciences, Inc.”

 

On December 17, 2004, Medivation became a wholly owned subsidiary of the company pursuant to an agreement and plan of merger by and among Orion, Medivation Acquisition Corp. and Medivation. Pursuant to the merger agreement, each outstanding share of common stock of Medivation was converted into 0.122935 shares of the Series B Preferred Stock of the company. Following the merger, the business conducted by the company is the business conducted by Medivation before the merger. Also on December 17, 2004, immediately following completion of the merger, the company sold an aggregate of 7,741,935 shares of its common stock to accredited investors at a price of $1.55 per share. Of these shares, 6,903,399 were sold for cash and the remaining 838,536 were issued in exchange for cancellation of outstanding bridge notes of Medivation that we assumed in the merger. For a list of persons that have historically provided our significant funding, see “Certain Relationships and Related Transactions.”

 

The merger was accounted for as a reverse merger under generally accepted accounting principles. Therefore, in the consolidated financial statements included herein: (1) Orion’s historical accumulated deficit for periods prior to December 17, 2004, in the amount of $422,120, was eliminated against additional-paid-in-capital, (2) the previously issued shares of Series A Preferred Stock and common stock of Orion are presented as having been issued in the merger on December 17, 2004, and (3) the shares of Series B Preferred Stock of Orion issued to the former Medivation stockholders in the merger are presented as having been outstanding since the inception of Medivation on September 4, 2003.

 

The significant sources of funding for our operations since Medivation’s inception on September 4, 2003 have consisted of the sales of $1,850,000 in convertible bridge notes in 2003 and 2004. For a list of persons that have historically provided Medivation’s significant funding, see “Certain Relationships and Related Transactions.” We have not generated any revenue from operations to date, and do not expect to generate operating revenue for several years, if ever. As of December 31, 2004, we had cash and cash equivalents of $10,671,707, accounts payable and other current liabilities to be paid in cash of $379,421, and no long term debt. Based on our business

 

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plan, we believe that our cash and cash equivalents, net of liabilities, will be sufficient to fund our operations through the scheduled completion of our Phase II efficacy study of Dimebon in Alzheimer’s disease patients in June 2006. However, we caution you that this is a forward-looking statement and is subject to significant risk and uncertainty. See “Forward-Looking Statements.”

 

The process of seeking regulatory approval to sell our product candidates is lengthy and very expensive, and cannot be completed for any of our existing product candidates by June 2006. We will therefore need to raise additional financing, whether through sales of our equity securities, collaborations or otherwise, to continue with any further development activities beyond that time. In addition, should we identify one or more new product candidates that we wish to acquire, we may need to raise additional financing sooner than June 2006 to finance the acquisition and subsequent development of any such new product candidate(s). We also may need to raise additional financing before June 2006 should we experience unforeseen delays, cost overruns or both in the development of any of our existing product candidates. We cannot be sure that we will be able to raise additional financing when needed on acceptable terms or at all. If we fail to do so, you may lose some or all of your investment.

 

Our business plan for the next twelve months consists of clinical development of Dimebon in Russia, preclinical development of Dimebon in the U.S., preclinical research on NT0904 and/or related molecules, and the identification, evaluation and potential acquisition of one or more new development stage medical product candidate(s). Based on our business plan, we expect to achieve the following development milestones on our existing two product candidates by June 2006: (a) completion of our randomized, double-blind, placebo-controlled Phase II efficacy study of Dimebon in Alzheimer’s disease patients in Russia; (b) completion of the animal studies required to support an investigational new drug application to the FDA to commence Phase I clinical testing of Dimebon in the U.S.; and (c) completion of preclinical research required to reach a decision on whether to begin preclinical development of our NT0904 family of compounds. As of December 31, 2004, the remaining estimated costs to fund the above three activities were approximately $4,500,000, $1,500,000 and $500,000, respectively, all of which we presently have sufficient cash to fund. However, we caution you that these are forward-looking statements and are subject to significant risk and uncertainty. See “Forward-Looking Statements.”

 

We historically have conducted our business operations on a largely outsourced model, and expect to continue to do so. Thus, we do not expect to purchase or sell any plant or significant equipment, or to significantly increase our number of employees, for the foreseeable future.

 

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BUSINESS

 

The Company

 

We are a life sciences company based in San Francisco, California. Our business strategy is to identify and acquire development stage medical technologies, including both pharmaceuticals and medical devices, that have promising scientific, clinical and commercial prospects and strong intellectual property positions, and to develop those technologies through a largely outsourced model to achieve positive results in clinical studies or other such value-enhancing milestone events. If we successfully reach such milestone events, we will then consider selling or partnering a given program to a larger pharmaceutical or medical device company or, alternatively, to continue development ourselves to achieve the next milestone event. We believe that our competitive advantages are our ability to identify and acquire medical technologies with favorable risk/reward ratios, our focus on rapid development, and our use of largely outsourced development functions, which allows us to minimize infrastructure and fixed costs and maximize flexibility.

 

We have acquired and are currently developing two technologies, both of which are small molecule drugs targeted at Alzheimer’s disease. Our lead product candidate, Dimebon, is scheduled to enter a randomized, double-blind, placebo-controlled Phase II efficacy study in Alzheimer’s disease patients in Russia in the second or third quarter of 2005. Our second product candidate, NT0904, is in the preclinical research phase. We are also evaluating other medical technologies for potential acquisition, and will continue to do so. We will consider medical technologies based on their scientific, clinical and commercial potential, and intellectual property position, and will not limit ourselves to neurology or any other specific field of medicine.

 

The company is the product of the merger between Medivation and merger sub, a wholly owned subsidiary of Orion, which was completed as part of the transactions, including the merger and the financing, on December 17, 2004. Prior to the merger, Orion had not engaged in any substantive commercial operations, and Medivation was a privately held life sciences company. Neither Orion nor Medivation has generated any revenues to date. Orion was incorporated in Delaware in October 1995 for the purpose of acquiring an operating business by purchase, merger, combination or otherwise. Medivation was incorporated in Delaware in September 2003. From its inception in September 2003 to December 17, 2004, Medivation’s activities consisted of identifying and acquiring the intellectual property covering our Dimebon and NT0904 product candidates, obtaining approval from the Russian Ministry of Health to conduct our planned Phase II study of Dimebon, arranging for the manufacture of Dimebon drug substance for use in that study, and obtaining financing for that study and our other business operations. During this period, Medivation funded its operations through the sale of $1,850,000 in convertible bridge notes to two investors. See “Certain Relationships and Related Transactions—Transactions with Mr. Grano—Convertible Bridge Notes and Warrants” and “—Transactions with Dara BioSciences, Inc.”

 

Consistent with our strategy of outsourcing key development functions, as of January 28, 2005, we had only three employees, all of whom are full-time, and use consultants to provide the majority of our development activities.

 

The Transactions

 

On December 17, 2004, Orion entered into an agreement and plan of merger by and among Orion, merger sub and Medivation, providing for the merger of the merger sub with and into Medivation, and pursuant to which Medivation became the surviving corporation and a wholly owned subsidiary of Orion. Pursuant to the merger agreement, each outstanding share of common stock of Medivation was converted into 0.122935 shares of the Series B Preferred Stock of the company. In addition, in connection with the transactions, Orion entered into purchase agreements with respect to the private placement by Orion of an aggregate of 7,741,935 shares of common stock to certain accredited investors at a price of $1.55 per share. Of these shares, 6,903,399 were sold for cash and the remaining 838,536 were issued in exchange for cancellation of outstanding bridge notes of Medivation that we assumed in the merger.

 

At the next annual meeting of the holders of our common stock, we will propose for approval an amendment to our amended and restated certificate of incorporation to change the name of the company to “Medivation, Inc.”

 

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The Alzheimer’s Disease Opportunity

 

Alzheimer’s disease, the leading cause of dementia, is characterized by the progressive loss of memory, thinking (cognitive function) and the ability to perform the activities of daily living (global function). According to information available on the website of the Alzheimer’s Association (www.alz.org), Alzheimer’s disease currently affects approximately 4.5 million people in the U.S., including as many as 10% of people aged 65 and older and nearly 50% of those aged 85 and older. Due to the aging baby boomer population and the increased prevalence of Alzheimer’s disease in older populations, the Alzheimer’s Association has projected that Alzheimer’s disease cases in the U.S. will rise to as many as 16 million by 2050 unless a cure or prevention is found. According to a published article in Scientific American, worldwide cases of Alzheimer’s disease are expected to reach 22 million by 2025. According to information on the website of the American Health Assistance Foundation (www.ahaf.org), Alzheimer’s disease kills 100,000 people per year in the U.S. According to the Alzheimer’s Association, on average between three and 20 years pass between a patient’s initial diagnosis with Alzheimer’s disease and his or her death, with an average duration of eight years. The Alzheimer’s Association has estimated that total annual expenditures on Alzheimer’s disease in the U.S. exceed $100 billion annually, and that the average lifetime cost per Alzheimer’s disease patient is $170,000.

 

FDA-Approved Therapeutics and Purported Mechanisms of Action

 

The precise physical changes in the brain that produce Alzheimer’s disease are complex and not completely understood. However, the two best-validated drug targets for Alzheimer’s disease are cholinesterase and the N-methyl-D-aspartate receptor, or NMDA receptor. There are only four currently used drugs that the FDA has approved for the treatment of Alzheimer’s disease. Three of these drugs are believed to inhibit cholinesterase, and one is believed to inhibit the NMDA receptor. These four drugs and their respective marketers, FDA approval dates (as listed in the FDA’s on-line edition of its Orange Book) and purported mechanisms of action are set forth in the following table.

 

Drug


    

Marketed by


    

FDA Approval


    

Purported Mechanism


Aricept® (donepezil)

     Pfizer Inc./Eisai Co., Ltd.      November 25, 1996      Cholinesterase inhibition

Exelon® (rivastigmine)

     Novartis AG      April 21, 2000      Cholinesterase inhibition

Reminyl® (galantamine)

     Johnson & Johnson      February 28, 2001      Cholinesterase inhibition

Namenda® (memantine)

     Forest Laboratories, Inc.      October 16, 2003      NMDA receptor inhibition

 

Cholinesterase

 

Acetylcholine is a specialized brain chemical or neurotransmitter which is important for normal brain function. In Alzheimer’s disease, a loss of function in areas of the brain associated with memory, cognitive function and global function occurs. Levels of acetylcholine are lower than normal in the brains of patients with Alzheimer’s disease. The impairment of memory, cognitive function and global function seen in Alzheimer’s disease has been attributed, at least in part, to these lower levels of acetylcholine. Acetylcholine is normally degraded by an enzyme called cholinesterase. Inhibition of cholinesterase results in less degradation of acetylcholine and therefore an increase in acetylcholine levels. Aricept®, Exelon® and Reminyl®, which the FDA has approved for the treatment of mild-to-moderate Alzheimer’s disease, all are purported to work by inhibiting cholinesterase and thereby increasing brain levels of acetylcholine.

 

NMDA Receptor

 

Glutamate is one of the most important neurotransmitters in the human body, accounting for approximately 70% of all synapses (junctions between two cells) in the central nervous system. Glutamate as a neurotransmitter activates brain cells (neurons) by binding to a receptor on the neuron cell surface called the NMDA receptor. In normal brain function, binding of the NMDA receptor by glutamate initiates an influx of calcium into the neuron, which plays a role in normal brain function. One theory of the underlying physical changes (pathophysiology) that occur in the brains of Alzheimer’s disease patients, known as the “excitotoxicity” theory, holds that the

 

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NMDA receptor is excessively activated by glutamate. According to this theory, excessive activation of the NMDA receptor by glutamate in Alzheimer’s disease patients causes excessive quantities of calcium to enter neurons, which in turn kills or damages the neurons and causes some of the impaired brain functions seen in Alzheimer’s disease. The drug most recently approved by the FDA to treat Alzheimer’s disease, Namenda®, is purported to work by inhibiting the NMDA receptor.

 

Combination Therapy

 

Namenda combined with Aricept® is significantly more effective in treating the symptoms of Alzheimer’s disease than Aricept® alone. A study published in the Journal of the American Medical Association concluded that Namenda® combined with Aricept® is significantly more effective in treating the symptoms of Alzheimer’s disease than Aricept® alone. This study compared the use of a combination of Namenda®, an NMDA receptor inhibitor, and Aricept®, a cholinesterase inhibitor, to Aricept® alone in 404 patients with moderate-to-severe Alzheimer’s disease. After six months of dosing, patients who took the combination therapy (Namenda® plus Aricept®) had significantly better outcomes on measurements of cognition, activities of daily living, global outcome and behavior compared to patients who took Aricept® alone. This study was reported by its authors to be the first to show superiority of dual target inhibition (NMDA receptor and cholinesterase inhibition) over single target inhibition (cholinesterase inhibition only) in Alzheimer’s disease patients. This study suggests that combination therapy directed at both cholinesterase and the NMDA receptor eventually may become an important clinical approach to treating Alzheimer’s disease.

 

Market Size

 

Based on financial information publicly disclosed by the marketers of Alzheimer’s disease therapeutics, these drugs constitute more than a billion dollar market per year worldwide. Aricept®, the largest selling cholinesterase inhibitor, generated more than $1 billion in combined global sales for Pfizer Inc. and Eisai Co., Ltd. in 2002, while Exelon®, the second largest-selling cholinesterase inhibitor, generated $367 million in global sales for Novartis AG in 2003. While Forest Laboratories, Inc.’s NMDA receptor antagonist Namenda® was only approved in October 2003, by September 30, 2004, it already had achieved sales of $173 million in its first three quarters on the market.

 

The market performance of the existing Alzheimer’s disease therapeutics is particularly noteworthy given that their clinical performance to date has been modest. Specifically, none of the drugs approved by the FDA to treat Alzheimer’s disease has been proven to prevent or slow the underlying process of brain deterioration (neurodegeneration) in patients with Alzheimer’s disease. Rather, these drugs have been shown only to address the symptoms of Alzheimer’s disease—primarily loss of cognitive and global function. Furthermore, in the studies submitted in support of applications for FDA approval of these drugs, none of these drugs was shown to improve both cognitive and global function in the patients studied. Thus, we believe that there is room for improvement in this large and growing pharmaceutical market, and have chosen to invest in our Dimebon and NT0904 programs based in part on that belief. However, our ability to achieve this objective is subject to a high level of risk. See “Risk Factors—Risks Related to our Product Development Candidates.”

 

Our Dimebon Program

 

Background

 

Dimebon is a Russian drug which was approved in 1982 by the Russian Ministry of Health for use as an oral antihistamine. According to the manufacturer of Dimebon sold in Russia, more than 28 million doses of the drug have been manufactured for human use in Russia since Dimebon’s approval in 1982. Dimebon has been used in Russia for the treatment of allergic conditions such as allergic rhinitis and allergic dermatitis.

 

In the early 1990s, scientists at the Institute of Physiologically Active Compounds in Chernogolovka, Russia, a scientific institute of the Russian Academy of Sciences, began screening large libraries of chemical

 

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compounds for NMDA receptor inhibition, based on data that implicated dysfunctional NMDA receptor activation in Alzheimer’s disease. The Institute of Physiologically Active Compounds researchers identified a class of molecules, called gamma carbolines, which they believed to inhibit the NMDA receptor. Based on their further research, the Institute of Physiologically Active Compounds scientists concluded that Dimebon, a gamma carboline derivative, interacted with the NMDA receptor in a manner that rendered it a suitable candidate for further development work. The Institute of Physiologically Active Compounds researchers later performed experiments showing that Dimebon also appears to inhibit cholinesterase—a drug target which became validated in 1993 when the FDA approved the first purported cholinesterase inhibitor for the treatment of Alzheimer’s disease—and mitochondrial permeability transition pores—a drug target which, while not validated for the treatment of Alzheimer’s disease, has been linked to Alzheimer’s disease in the published literature.

 

Dimebon’s Purported Mechanisms of Action

 

Dimebon appears to inhibit both of the two FDA-validated drug targets for Alzheimer’s disease—the NMDA receptor and cholinesterase. Experiments performed at the Institute of Physiologically Active Compounds in Russia compared the ability of both Dimebon and Namenda® (the NMDA receptor inhibitor approved by the FDA in 2003 to treat moderate-to-severe Alzheimer’s disease) to inhibit the NMDA receptor. These experiments showed that both Dimebon and Namenda® appeared to inhibit the NMDA receptor, but with differing affinities depending on the type of neuron involved. The range of affinities of each drug for the NMDA receptors on various types of neurons overlapped in this experiment, although in the majority of neurons tested Namenda® appeared to inhibit the NMDA receptor with higher affinity than did Dimebon. Confirmatory experiments performed by a U.S. contract laboratory repeated the Russian findings that Dimebon appears to inhibit the NMDA receptor, although with a lower affinity than does Namenda®. Low affinity of a product candidate for its target is frequently considered to be an undesirable characteristic from a drug development standpoint. However, the optimal level of affinity with which a drug must bind the NMDA receptor, and the particular types of neurons in which such binding must occur, to safely and effectively treat Alzheimer’s disease is not known.

 

Experiments performed at the Institute of Physiologically Active Compounds in Russia, and confirmed in two U.S. contract laboratories, have demonstrated that Dimebon also inhibits both of the two primary forms of cholinesterase—acetylcholinesterase and butyrylcholinesterase. Each of the cholinesterase inhibitors approved by the FDA to treat Alzheimer’s disease also inhibits both the acetyl and the butyryl forms of cholinesterase. Based on published data regarding the affinities with which the three FDA approved cholinesterase inhibitors bind their targets, Dimebon appears to inhibit butyrylcholinesterase more strongly than do two of the three FDA-approved drugs, while all three of the FDA-approved drugs inhibit acetylcholinesterase more strongly than Dimebon appears to do. The optimal level of affinity with which a drug must bind cholinesterase—whether the acetyl form, the butyrl form, or both forms—to safely and effectively treat Alzheimer’s disease is not known.

 

Dimebon also may block mitochondrial permeability transition pores, a potential new drug target for the treatment of Alzheimer’s disease. Experiments conducted at the Institute of Physiologically Active Compounds in Russia have demonstrated that Dimebon inhibits the ability of substances to flow into and out of mitochondria (structures located within cells that are responsible for generating energy). In this experiment, the Institute of Physiologically Active Compounds scientists administered APß 25-35 to a preparation of mitochondria in a test tube. APß 25-35 is a fragment of the beta amyloid peptide, which is believed to play a leading role in the pathophysiology of Alzheimer’s disease, and is known to cause mitochondria to swell, presumably by increasing the permeability of the mitochondrial walls. Dimebon was then administered to the mitochondria that had been treated with APß 25-35, and found to reduce this mitochondrial swelling, presumably by reducing the mitochondrial wall permeability caused by the APß 25-35. The scientists who conducted these experiments believe that Dimebon achieves this effect by blocking a type of pore, called mitochondrial permeability transition pores, through which substances pass into and out of mitochondria.

 

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Blocking mitochondrial permeability transition pores is not a validated mechanism for treating Alzheimer’s disease. However, there is scientific basis to believe that this activity may be relevant in treating Alzheimer’s disease. One of the theories of the underlying pathophysiology of Alzheimer’s disease holds that the disease is caused in part by the death of neurons. Studies in the published literature have shown that opening mitochondrial pores can lead to neuron death by allowing excess calcium to flow between the cytoplasm (the area of the cell surrounding the mitochondria) and the mitochondria, and by allowing so-called “suicide factors” (substances which induce cells to kill themselves) to escape from the mitochondria into the cytoplasm. The Russian experiment described above suggests that Dimebon can reduce mitochondrial permeability induced by APß 25-35, whether by means of blocking mitochondrial permeability transition pores or through some other mechanism, which for the above reasons may protect neurons from dying.

 

Preclinical Data

 

Preclinical experiments performed at the Institute of Physiologically Active Compounds in Russia have shown Dimebon to improve learning and memory in two animal models of Alzheimer’s disease.

 

The Rat Active Avoidance Test. In the first model—called the rat active avoidance test—a rat is housed in a box with two chambers separated by a wall, each with a light overhead. The floor of the box is metallic and is engineered so that a few seconds after the overhead light in a chamber is turned on, an electrical shock is transmitted to the floor beneath the light. The rat quickly learns to move to the adjacent, non-electrically charged chamber as soon as the overhead light is turned on.

 

In this model, a condition of memory and cognition impairment was generated by injecting AF64A into the brains of rats. AF64A is a neurotoxin that, when injected into rat brains, appears to impair the rats’ cognition and memory. In this study, 75 rats were divided into four groups. The first group of animals was the control group, and received injections of saline only, while the second, third and fourth groups were injected with the neurotoxin. On the second day after these injections, and for each of the next ten days, the three neurotoxin-treated groups received, respectively, placebo, Dimebon and Tacrine (the first cholinesterase inhibitor approved by the FDA to treat Alzheimer’s disease, but no longer in use). After these treatments, the rats were trained to complete the active avoidance test, and then formal testing was begun. Trained animals were tested for the number of times they were able successfully to avoid electrical shock, as well as for time required to move to the non-electrically charged chamber of the box.

 

The performance level in the active avoidance test of rats that did not receive neurotoxin, measured by the number of times the rats successfully completed the test, was defined as 100. Based on that scale, the performance level of rats receiving the neurotoxin but neither Dimebon or Tacrine dropped to 65. By contrast, the performance of neurotoxin treated rats that also received Dimebon or Tacrine was 90, a result 38% better than that of the neurotoxin treated rats that received only placebo and almost as good as that of the control rats—which did not receive any neurotoxin. The relative benefits of Dimebon and Tacrine were even higher when the rats were evaluated on whether they could successfully complete the active avoidance test eight times consecutively. The performance level of the control animals on this test again was defined as 100, and dropped to 40 in the neurotoxin treated rats that were not given either Dimebon or Tacrine. For the neurotoxin treated rats that received Dimebon or Tacrine, the performance level in completing the active avoidance test eight times in a row was 90, a result 125% better than that of the neurotoxin treated rats that received only placebo and almost as good as that of the rats that did not receive any neurotoxin. Based on these two measurements of successful completion, Dimebon and Tacrine performed comparably in this experiment.

 

When measured based on time needed for the rats successfully to complete the active avoidance test, Dimebon and Tacrine again both performed better than placebo, but in this instance Dimebon also performed better than Tacrine. Specifically, the control rats required on average 4.8 seconds to complete the active avoidance test, while the animals receiving neurotoxin required more time—on average 5.5 seconds—to do so. By contrast, the Tacrine-treated rats completed the test in an average of four seconds, and the Dimebon-treated

 

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rat required only an average of three seconds to do so. It is noteworthy that, based on the time to completion measurement in this experiment, both the Dimebon and Tacrine-treated animals performed better than the animals that did not receive any neurotoxin.

 

The Morris Rat Water Maze Test. In this model, a rat swims in a five-foot diameter vat of water with a small submerged platform which the swimming rat cannot see. An overhead video camera tracks the rat’s swimming path, which is digitized, mapped and measured. The rat swims randomly in the vat of water with no place to rest until it finds the submerged platform. The rat is trained to find the platform and once it does and remembers the location of the platform, the route that the rat takes from its starting place to the platform becomes more direct and less random. Control rats eventually learn and remember the location of the platform and swim in a fairly direct route to the platform.

 

LOGO

 

In these experiments, rats received injections of the neurotoxin AF64A directly into their brains. One day after the neurotoxin was administered, rats were treated orally with placebo, Aricept®, Namenda® or Dimebon, respectively, for approximately three and one-half weeks. For approximately the first week and a half of treatment, the rats were trained to find the submerged platform. Training was then stopped, and assessments of memory (“retention”) were made at approximately 2 weeks (“retention 1”) and approximately 4 weeks (“retention 2”).

 

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The results of these experiments are depicted in the chart below. Neurotoxin-treated animals that were not also treated with any drug did not learn or remember the location of the platform and swam randomly. By contrast, neurotoxin-treated animals which were also treated with Aricept®, Namenda® or Dimebon all showed comparable improvement in their ability to learn and remember the platform’s location, as indicated by the more direct (less random) swimming pattern to the submerged platform. After drug treatment was discontinued at the end of approximately three and a half weeks, rats treated with Aricept® appeared to forget the location of the submerged platform, as evidenced by their swimming pattern becoming more random and less direct, while rats treated with Namenda® or Dimebon continued to remember the location. In this regard, Namenda® and Dimebon, which both appear to inhibit the NMDA receptor, appeared in these experiments to perform better than Aricept® in durability of response.

 

LOGO

Clinical Data

 

Dimebon appeared to improve some aspects of memory, cognitive and global function in a pilot open-label clinical study in 14 Alzheimer’s disease patients conducted at the Moscow Center for Gerontology in Russia. The patients were treated with oral Dimebon, three times daily for two months. Patients’ memory, cognitive and global function were assessed by two psychiatric scales, the Hasegawa Dementia Scale and a scale developed by one of the investigators in the study, called the Bukatina Scale. Baseline scores for individual patients were determined prior to drug treatment and then subsequent memory and functional assessments were performed by two psychiatrists on patients treated open-label with Dimebon. After two months of Dimebon treatment, treatment was stopped and patient psychiatric assessments for memory and cognitive function continued for an additional two months. Patients treated with Dimebon experienced an improvement in memory and cognition after two months of therapy, although the endpoints used in this study were not those currently required by the FDA for approval of Alzheimer’s disease therapeutics and the study was not placebo-controlled. Furthermore, after Dimebon was discontinued at week eight, a deterioration in cognitive function in the Alzheimer’s disease patients was observed. We used the results of this study, which were published in Annals of the New York Academy of Sciences, to help make our decision to acquire the Dimebon technology.

 

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Development Plan for our Dimebon Program

 

Our business strategy for our Dimebon program is to advance development as quickly and efficiently as possible to the most significant near term value-enhancing milestone event—the generation of Phase II efficacy data from a rigorously conducted clinical trial in Russia. We also intend simultaneously to pursue development of Dimebon in the U.S.

 

Development in Russia

 

We have received approval from the Russian Ministry of Health to conduct a Phase II efficacy study of Dimebon in Russia, subject to ethics committee approval of any amendments we may choose to make to our approved protocol for this study. This randomized, double-blind, placebo-controlled study will enroll up to 160 patients with mild-to-moderate Alzheimer’s disease at approximately ten to fifteen sites. We intend to perform this study in compliance with good clinical practices, using Dimebon produced under current good manufacturing practices. We expect the treatment period (six months) and study endpoints to reflect those used in pivotal registration studies for drugs previously approved by the FDA to treat Alzheimer’s disease, in order to maximize the persuasive value of the data generated. We have been advised by our regulatory consultants that this study, if conducted in compliance with good clinical practices using drug produced under current good manufacturing practices, will be submissible to regulatory agencies in the U.S. and Europe. We expect to begin this study in the second or third quarter of 2005 and to complete it by June 2006. However, we caution you that this is a forward-looking statement and subject to significant risk and uncertainty. See “Forward-Looking Statements.”

 

Development in the United States

 

Simultaneously with the Russian Phase II study, we intend to embark upon a traditional FDA registration pathway for Dimebon in the U.S. Because Dimebon has not previously been approved for use in the U.S., this pathway will entail generating data from animal testing required to support an investigational new drug application to the FDA, and obtaining FDA approval of the investigational new drug application, before we can begin human testing in the U.S.

 

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Potential Future Indications for Dimebon

 

Anti-Aging Indications

 

In an experiment performed at the Institute of Physiologically Active Compounds in Russia, Dimebon was shown to reduce certain aging-associated conditions, and to increase survival, in normally aging mice. In this study, 100 normally aging mice, which have a typical lifespan of approximately two years, were given either Dimebon (dissolved in their daily drinking water, 50 mice) or a placebo (drinking water control, 50 mice) for 13 months. At the end of the study, Dimebon was found to reduce several common signs of aging—cataracts (82% reduction), balding (42% reduction) and cachexia (age-associated weight loss). Most significantly, Dimebon was shown to prolong survival in this experiment. At the end of the study, 83% more mice were alive in the Dimebon group than in the control group. The survival data from this study are depicted in the chart below. The results of this study suggest that the prevention and/or treatment of cataracts, balding and cachexia may all be potential future indications for Dimebon. We own a pending patent application based on the results of this study. See “Business—Intellectual Property.”

 

LOGO

 

Prolonging Survival in Pets

 

We believe that the 83% survival advantage observed in the Institute of Physiologically Active Compounds mouse study is noteworthy. While developing a drug to prolong survival in humans would require extremely long and costly clinical studies, development of Dimebon as a treatment to prolong survival in pets would require significantly less time and cost and may represent a significant market opportunity for us. We intend to explore the feasibility of this potential opportunity, including by entering into exploratory discussions with potential collaborators in the pet food industry.

 

The NT0904 Program

 

We own a pending patent application covering a group of potential small molecule drugs in a class of compounds known as alkylisothioureas. Scientists at the Institute of Physiologically Active Compounds in Russia have performed laboratory and animal tests on various members of this compound family. The specific molecule that generated the most interesting results in those experiments is known as NT0904.

 

Experiments performed at the Institute of Physiologically Active Compounds in Russia have shown that NT0904 appears to inhibit the NMDA receptor with an affinity comparable to that of Namenda®, the NMDA

 

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receptor inhibitor approved by the FDA in October 2003 to treat moderate to severe Alzheimer’s disease. In addition, in these experiments NT0904 also appeared to enhance or potentiate the activity of a second drug target known as the AMPA receptor. Drugs that enhance the activity of the AMPA receptor are sometimes referred to in the published literature as “ampakines.” Reports in the published literature have hypothesized that ampakines may enhance memory in general, and in particular that they may help reduce the loss of memory experienced by Alzheimer’s disease patients.

 

Scientists at the Institute of Physiologically Active Compounds in Russia studied the effects of NT0904 in the Morris Rat Water Maze Test—the same animal model of Alzheimer’s disease in which they tested Dimebon as described above. In these experiments, rats were divided into five groups. Animals in group (a) were the controls, and did not receive either neurotoxin or any drug. Animals in group (b) received injections of the neurotoxin AF64A directly into their brains, but did not receive any drug. Animals in groups (c), (d) and (e) received both neurotoxin and a drug—with animals in group (c) receiving Aricept®, those in group (d) receiving Namenda® and those in group (e) receiving NT0904. The results of these experiments, depicted below, show that rats receiving Aricept®, Namenda® and NT0904 (groups (c), (d) and (e)) showed improvement in their ability to learn and remember the platform’s location, as indicated by the more direct (less random) swimming pattern to the submerged platform, as compared to neurotoxin-treated rats that did not receive any drug (group (b)).

 

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LOGO

 

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The AMPA receptor is not a validated target for memory enhancement, Alzheimer’s disease or any other condition. However, we believe that the laboratory and animal data summarized above are interesting, and we therefore intend to conduct further research on NT0904 to determine whether or not to begin preclinical development of that molecule to treat Alzheimer’s disease, to enhance memory or for some other neurological indication.

 

Intellectual Property

 

As of January 28, 2005, we owned issued patents in the U.S., Europe and Hong Kong covering the use of Dimebon and certain related compounds to treat neurodegenerative diseases, including Alzheimer’s disease. A corresponding patent application is pending in Canada, and a continuation application is pending in the U.S. We also own a pending patent application claiming the use of Dimebon for anti-aging purposes, and a pending patent application claiming NT0904 and related compounds and their use. We own all of this intellectual property and have full control over prosecution and enforcement against potential infringers. We intend to prosecute this intellectual property in the U.S., Europe and other jurisdictions that we deem appropriate.

 

Neurodegenerative Diseases

 

Medivation owns patent rights covering the use of Dimebon and related compounds to treat neurodegenerative diseases, including Alzheimer’s disease. These rights include one issued patent in each of the U.S., Europe and Hong Kong, and a pending patent application in each of the U.S. and Canada. The U.S. patent (U.S. 6,187,785) was issued on February 13, 2001, and the European patent (EP 0 876 818 B1) was issued on December 18, 2002. The U.S. and European patents expire in October 2016. However, if we succeed in receiving regulatory approval to sell Dimebon, then under current laws our patent protection for Dimebon for the first approved indication may be eligible for extension for up to five additional years. A continuation application is pending in the U.S. We purchased these patent rights from Selena Pharmaceuticals, Inc. on October 10, 2003.

 

Anti-Aging

 

Medivation owns a patent application claiming the use of Dimebon and certain related compounds as anti-aging agents. This patent application, which was filed in Russia in December 2003 and internationally under the Patent Cooperation Treaty in December 2004, is based on the results of the 13-month mouse study described elsewhere in this prospectus. If any patents issue on this application, they generally will have a term ending in December 2024. We purchased this patent application on March 21, 2004, from its inventors, both of whom are scientists at the Institute of Physiologically Active Compounds in Chernogolovka, Russia.

 

NT0904 Compounds

 

Medivation also owns a pending patent application claiming this class of small molecules and their uses to treat certain neurological diseases. This patent application was filed in Russia in December 2002 and internationally under the Patent Cooperation Treaty in December 2003. If any patents issue on this application, they generally will have a term ending in December 2023, subject to potential patent term extensions based on time required to obtain regulatory approval for products covered by the patent application. We purchased this patent application from the Institute of Physiologically Active Compounds on July 13, 2004.

 

Institute of Physiologically Active Compounds Partnership

 

On March 24, 2004, we entered into a preferred partnership letter agreement with the Institute of Physiologically Active Compounds. Under this agreement, Medivation has the right of first negotiation on any inventions made in the laboratory of Dr. Sergey Bachurin at the Institute of Physiologically Active Compounds within the fields of (a) Dimebon and certain related compounds; (b) diagnosis, treatment and prevention of diseases and disorders of the brain; and (c) anti-aging. Dr. Bachurin is an inventor on all of our existing patents

 

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and patent applications. In return, Medivation granted the Institute of Physiologically Active Compounds rights of first negotiation to perform any animal experiments required by Medivation for which the Institute of Physiologically Active Compounds has the capability to perform in a timely manner and in compliance with all applicable regulatory requirements. The term of this agreement ends on March 24, 2007. We purchased the anti-aging and NT0904 patent rights, described above, pursuant to the exercise of our rights of first negotiation under this agreement with the Institute of Physiologically Active Compounds.

 

Intellectual Property Protection

 

We require our employees and consultants to execute non-disclosure and proprietary rights agreements at the beginning of employment or consulting arrangements with us. These agreements acknowledge our exclusive ownership of all intellectual property, including, but not limited to patents, developed by the individual during the course of his or her work with us and require that all proprietary information disclosed to the individual remain confidential. We intend to enforce vigorously our intellectual property rights if infringement or misappropriation occurs.

 

Competition

 

The drug development market is intensely competitive in general, and the market for developing Alzheimer’s disease drugs is particularly competitive. There are four drugs currently marketed to treat Alzheimer’s disease, and these drugs all target at least one of the same mechanisms as does Dimebon. Companies marketing these FDA-approved Alzheimer’s disease therapeutics include some of the world’s largest and most experienced pharmaceutical companies, such as Pfizer Inc., Novartis AG and Johnson & Johnson.

 

In addition to the four currently marketed Alzheimer’s disease therapeutics, dozens of additional small molecule and recombinant protein candidates targeting many disparate mechanisms believed to play a role in the pathogenesis of Alzheimer’s disease are currently in development. General classes of agents currently in development by other companies for the treatment of Alzheimer’s disease, arranged by purported mechanism of action, include the following:

 

    Neuroprotection strategies

 

    Antioxidants

 

    Anti-inflammatories

 

    Hormonal agents

 

    Neurotrophic factors

 

    Anti-excitotoxicity agents

 

    AMPA receptor modulators

 

    Anti-apoptosis agents

 

    Amyloid protein ß lowering/disrupting strategies

 

    Neuroregenerative strategies

 

    Neural cell implants

 

    Downstream compensatory strategies

 

    Cholinesterase inhibitors

 

    Cholinergic agonists

 

    GABA antagonists

 

    Nutriceuticals

 

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Most, if not all, of these competing drug development programs are being conducted by pharmaceutical and biotechnology companies with considerably greater financial resources, human resources and experience than Medivation.

 

If we are able to obtain regulatory approval to sell Dimebon or any other product to treat Alzheimer’s disease, we will face significant competition from the approved Alzheimer’s disease drugs, as well as from any of the drugs currently under development that may subsequently be approved, as mentioned above. Bases on which we would have to compete successfully include efficacy, safety, price and cost-effectiveness. In addition, we would have to compete against these other drugs with several different categories of decision makers—including physicians, patients, government and private third-party payors, technology assessment groups and patient advocacy organizations. Even if one of our Alzheimer’s disease drug candidates is approved, we cannot guarantee that we will be able to compete successfully on any of these bases. See “Risk Factors—Risks Related to our Business.”

 

Manufacturing

 

We have entered into an agreement with Pisgah Labs, Inc., a U.S. contract laboratory, to manufacture bulk Dimebon drug substance for use in our preclinical and clinical studies. The laboratory has manufactured 16 kilograms of Dimebon drug substance, under current good manufacturing practices conditions. We expect this to be sufficient drug substance to supply all of our requirements for our upcoming Phase II efficacy study in Russia and for our investigational new drug-enabling preclinical studies in the U.S. We also have entered into an agreement with QS Pharma, LLC, a second U.S. contract laboratory, to manufacture finished Dimebon tablets, under current good manufacturing practices conditions, for use in our upcoming Phase II clinical study in Russia. Work on this project began in January 2005. We selected both contract laboratories under a competitive bidding process in which we received bids from multiple vendors. Work under both agreements is performed on a fixed-price basis. We believe that sufficient raw materials and manufacturing capacity exist to produce all of our requirements for Dimebon bulk substance and finished Dimebon tablets for the foreseeable future, in a timely and cost-effective manner.

 

Scientific and Clinical Advisory Board

 

We maintain a Scientific and Clinical Advisory Board comprised of scientists and physicians with experience relevant to our company and our product candidates. Members of the Scientific and Clinical Advisory Board have agreed to consult and advise us in their respective areas of expertise. We have placed special emphasis on identifying members of the Scientific and Clinical Advisory Board with expertise in the treatment of Alzheimer’s disease. As of January 28, 2005, the Scientific and Clinical Advisory Board consisted of the following members:

 

Paul Aisen, M.D. Dr. Aisen is a Professor of Neurology and Medicine, Vice Chair of the Department of Neurology and the Director of the Memory Disorders Program at Georgetown University School of Medicine. Dr. Aisen was one of the first Alzheimer’s disease clinical trialists in the U.S., and was an investigator in the pivotal FDA registration studies for Namenda®. Dr. Aisen also serves as the Associate Director of the Alzheimer’s Disease Comparative Study Group.

 

Sergey Bachurin, Ph.D., D.Sc., Prof. Dr. Bachurin is the lead inventor of our current technologies. Dr. Bachurin is the Vice Director of the Institute of Physiologically Active Compounds in Chernogolovka, Russia, and a member of the Russian Academy of Sciences. Dr. Bachurin has served as a visiting scholar at several U.S. academic research centers, including the University of California, San Francisco, Tufts University and St. Elizabeth’s Medical Center.

 

Rachelle Doody, M.D., Ph.D. Dr. Doody is the Effie Marie Cain Professor and Director of Alzheimer’s Disease Research at the Alzheimer’s Disease and Memory Disorder Center at Baylor College of Medicine.

 

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Dr. Doody participated in the development of CIBIC-plus, one of the primary cognitive assessment endpoints that the FDA has used for the currently approved Alzheimer’s drugs. Dr. Doody has worked on clinical studies for all of the FDA-approved cholinesterase drugs for Alzheimer’s disease.

 

Benjamin Lewin, Ph.D. Dr. Lewin is the founding editor of Cell, a leading international journal in the field of biology and, until 1999, also served as the Chief Executive Officer of the publisher of Cell, Cell Press. Dr. Lewin holds a M.Sc. from the University of London, and a M.A. and a Ph.D. from the University of Cambridge. Dr. Lewin also has authored multiple books and scientific publications in the field of genetics.

 

Roger Tung, Ph.D. Dr. Tung has had more than twenty years of experience in scientific and scientific management positions at the Squibb Institute for Medical Research, Merck Research Laboratories and Vertex Pharmaceuticals Incorporated, serving most recently as Vice President, Drug Discovery, of Vertex Pharmaceuticals Incorporated in San Diego from February 2002 until January 2005. Dr. Tung discovered both of the currently marketed products of Vertex Pharmaceuticals Incorporated, and is an inventor on 33 issued U.S. patents. Dr. Tung holds a Ph.D. in Pharmaceutical Chemistry from the University of Wisconsin – Madison.

 

Employees

 

Consistent with our strategy of outsourcing key development functions, as of January 31, 2005, we had three employees, all of whom are full-time. In addition to our employees, we hire consultants from time to time to provide the majority of our development functions.

 

Facilities

 

We currently lease approximately 3,000 square feet of office space in one building located at 501 Second Street, Suite 211, San Francisco, California 94107 for all of our operations. The telephone number at our office is (415) 543-3470. Our lease expires in October 2005. We believe that this facility is adequate for our business needs, both currently and for the foreseeable future.

 

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MANAGEMENT

 

The following table sets forth certain information as of January 28, 2005, with respect to:

 

    our Chief Executive Officer, or any person acting in a similar capacity, during the fiscal year ended December 31, 2004;

 

    our most highly compensated executive officer, other than the foregoing Chief Executive Officer, who served as an executive officer of the company as of December 31, 2004 (who we sometimes refer to in this prospectus, together with the foregoing chief executive officer as of December 31, 2004, as the “named executive officers”); and

 

    our directors during our fiscal year ended December 31, 2004.

 

Name


  Age

 

Title


David T. Hung, M.D.

  47   President, Chief Executive Officer, Director

C. Patrick Machado

  40   Senior Vice President, Chief Financial Officer

Christopher A. Marlett

  40   Director, Former Chief Executive Officer

Anthony DiGiandomenico

  38   Director

 

There are no family relationships between any of the persons named above. Our directors hold office until their successors are elected and qualified.

 

David T. Hung, M.D. Dr. Hung became our President and Chief Executive Officer, and a member of our board of directors, pursuant to the merger on December 17, 2004. Dr. Hung also has served as the President and Chief Executive Officer, and member of the board of directors, of our wholly owned subsidiary Medivation since its inception in September 2003. From 1998 until 2001, Dr. Hung was employed by ProDuct Health, Inc., a privately held medical device company, as Chief Scientific Officer (1998-1999) and as President and Chief Executive Officer (1999-2001). In 2001, ProDuct Health, Inc. was acquired by Cytyc Corporation. Dr. Hung served as a consultant to Cytyc Corporation from 2001 until 2002 to assist with transitional matters related to Cytyc Corporation’s acquisition of ProDuct Health, Inc. Dr. Hung received an M.D. from the University of California, San Francisco, School of Medicine, and an A.B. in Biology from Harvard College.

 

C. Patrick Machado. Mr. Machado became our Senior Vice President and Chief Financial Officer pursuant to the merger on December 17, 2004. Mr. Machado also has served as the Senior Vice President and Chief Financial Officer, and member of the board of directors, of our wholly owned subsidiary Medivation since its inception in September 2003. From 1998 until 2001, Mr. Machado was employed by ProDuct Health, Inc., a privately held medical device company, as Vice President, Chief Financial Officer and General Counsel (1998-2000) and as Senior Vice President and Chief Financial Officer (2000-2001). From 2001 until 2002, Mr. Machado served as a consultant to Cytyc Corporation to assist with transitional matters related to Cytyc Corporation’s acquisition of ProDuct Health, Inc. Mr. Machado received a J.D. from Harvard Law School and a B.A. and B.S. in German and Economics, respectively, from Santa Clara University.

 

Christopher A. Marlett. Mr. Marlett has served on our board of directors since 1999. Prior to the merger on December 17, 2004, Mr. Marlett also served as our President and Chief Executive Officer. Mr. Marlett is a co-founder of MDB Capital Group LLC, an investment banking firm formed in December 1996, and has served as a principal of MDB Capital Group LLC since that time. Mr. Marlett received a B.S. in Business Administration from the University of Southern California.

 

Anthony DiGiandomenico. Mr. DiGiandomenico has served on our board of directors since 1999. Prior to the merger on December 17, 2004, Mr. DiGiandomenico also served as our Chief Financial Officer. Mr. DiGiandomenico is a co-founder of MDB Capital Group LLC, and has served as a member of MDB Capital Group LLC since December 1996. Mr. DiGiandomenico received a B.S. in Finance from the University of Colorado, and an M.B.A. from the Haas School of Business at the University of California, Berkeley. Mr. DiGiandomenico serves as a director of Vitacube Systems Holdings, Inc.

 

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Summary Compensation Table

 

The following table sets forth certain summary compensation for the periods indicated with respect to:

 

    our named executive officers as of December 31, 2004; and

 

    our former Chief Executive Officer during a portion of our fiscal year ended December 31, 2004.

 

 

Name


 

Year


  Annual Compensation

  Long Term Compensation

      Awards

  Payouts

    Salary

  Bonus

  Other Annual
Compensation


  Restricted
Stock
Awards


  Securities
Underlying
Options


  LTIP
Payouts


  All Other
Payouts


David T. Hung, M.D.

President, Chief Executive Officer, Director

  2004
2003
2002
  248,625
  49,583
 

 

 

 

 

 

C. Patrick Machado

Senior Vice President,

Chief Financial Officer

  2004
2003
2002
  190,125
  37,917
 

 

 

 

 

 

Christopher A. Marlett††

Director

  2004
2003
2002
 

 

 

 

 

 

 


Data with respect to Messrs. Hung and Machado for the fiscal years ended December 31, 2003 and December 31, 2004 reflect payments to them by Medivation in their respective capacities as employees of Medivation through December 17, 2004, and payments to them in their respective capacities as employees of Orion thereafter . In addition, no data for the fiscal year ended December 31, 2002, has been presented with respect to Messrs. Hung and Machado as Medivation was incorporated in September 2003.
†† For the fiscal years ended December 31, 2002, and 2003, and until December 17, 2004, the company did not compensate its officers or directors. Mr. Marlett served as the Chief Executive Officer of the company until December 17, 2004.

 

Board of Directors

 

As of January 28, 2005, our board of directors consisted of three members, Dr. Hung, our President and Chief Executive Officer, and Messrs. Marlett and DiGiandomenico, our former President and Chief Executive Officer and former Chief Financial Officer, respectively. Messrs. Marlett and DiGiandomenico are principals of MDB Capital Group LLC.

 

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CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS

 

MDB Capital Group LLC Services

 

MDB Capital Group LLC served as a placement agent in the financing, which refers to the private placement by Orion of an aggregate of 7,741,935 shares of common stock on December 17, 2004, to certain accredited investors. As compensation for these services, MDB Capital Group LLC and certain of its affiliates received an aggregate of 572,878 shares of common stock and warrants to purchase an aggregate of 572,878 shares of common stock having an exercise price of $1.55 per share. The compensation of MDB Capital Group LLC was negotiated on an arm’s length basis between MDB Capital Group LLC and Medivation. Messrs. Marlett and DiGiandomenico, current members of our board of directors and who, prior to December 17, 2004, had served as our President and Chief Executive Officer and Chief Financial Officer, respectively, are principals of MDB Capital Group LLC. Messrs. Marlett and DiGiandomenico, as of January 28, 2005, each beneficially owned less than one percent of our outstanding common stock in their individual capacities. In addition, as of January 28, 2005, MDB Capital Group LLC beneficially owned approximately 4.9% of the fully-diluted common stock.

 

Registration Rights Agreements

 

In connection with the financing, Orion entered into registration rights agreements providing for the registration for resale of the shares sold pursuant to the financing, as well as certain other shares of common stock of Orion. The registration rights agreements require us to register for resale an aggregate of 14,327,607 shares of common stock. Pursuant to the registration rights agreements, we agreed to file a registration statement with respect to these shares no later than January 31, 2005, and to have such registration statement declared effective no later than March 31, 2005. If we fail to file, or to have declared effective, such registration statement by such respective deadlines, we agreed to pay certain liquidated amounts to the parties to such registration rights agreements who purchased shares in the financing.

 

The registrations rights agreements were entered into by and among Orion and the parties named in the table below:

 

David T. Hung, M.D.

C. Patrick Machado

Selena Pharmeceuticals, Inc.

Joseph F. Barletta

Steven R. Becker

John Braniff

Bushido Capital Master Fund, LP

Cimarron Overseas Equity Master Fund LP

R. L. Clarkson

Richard D. Clarkson

Richard L. Clarkson,
f/b/o Lucille S. Ball

Edgewater Ventures

Robert Charles Friese

Gamma Opportunity Capital Partners, LP

Joseph J. Grano, Jr.

Joel T. Leonard Trust,
dated October 25, 1994

Maurice Micek,
custodian for Andrew Micek UGMA NE

Maurice Micek,
custodian for Benjamin Micek UGMA NE

 

Edward Negley

Steven O’Kuhn

ProMed Offshore Fund II, Ltd.

ProMed Offshore Fund, Ltd.

ProMed Partners II, LP

ProMed Partners LP

Arthur Shartsis

Silicon Prairie Partners, LP

Special Situations Cayman Fund, L.P.

Special Situations Fund III, L.P.

Special Situations Private Equity Fund, L.P.

Jeff & Jean Stroud, JTWROS

James Patrick Tierney

Topix, Inc.

Trust Under Will of A. Wilfred May,
dated November 11, 1969

John A. Raiser Irrevocable Trust,
dated March 2, 1988

Shon Kwong & Laura Micek

Lewin Investments LLC

D. Clay & Elissa McCollor

MDB Capital Group LLC*

 

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Greg J. Micek,
guardian for Alexandria L. Micek

Greg J. Micek,
guardian for Gregory J. Micek, Jr.

John Micek,
custodian for Gabriel Micek UTMA CA

John Micek,
custodian for Jordan Micek UTMA CA

John Micek,
custodian for Peter Micek UTMA CA

John Micek III

Maurice Micek

 

TTC Private Equity Partners LLC

Cedric Vanzura

Walker Smith Capital (QP), LP

Walker Smith Capital, LP

Walker Smith International Fund, Ltd

Melvyn Weiss

WS Opportunity Fund (QP), LP

WS Opportunity Fund International Ltd.

WS Opportunity Fund, LP

Steven L. Zelinger

Dara BioSciences, Inc.

Anthony DiGiandomenico


* MDB Capital Group LLC was not a party to the voting agreements.

 

Voting Agreements

 

In connection with the transactions, each of the persons holding shares of common stock of Medivation immediately prior to the effective time of the merger and each person who purchased shares in the financing, entered into voting agreements which provide for the agreement by such persons to vote any shares of common stock or other voting securities of the company owned by such persons in favor of: (a) an amendment to the amended and restated certificate of incorporation of the company resulting in an increase in the number of shares of authorized common stock, from 10,000,000 shares of authorized common stock to at least 25,000,000 shares of authorized common stock; (b) the election to the board of directors of the company the following individuals: (i) Mr. Steve Gorlin; (ii) David T. Hung, M.D.; (iii) one nominee acting as the representative of the individuals who held shares of common stock of Medivation immediately prior to the effective time of the merger; and (iv) two nominees acting as representatives of MDB Capital Group LLC; and (c) a change of the name of the company. The voting agreements were entered into by and among Orion and the parties named in the table in this section “Certain Relationships and Related Transactions—Registration Rights Agreements” above. The individuals who are to be elected to our board of directors have not yet been nominated to serve. As of January 28, 2005, an aggregate of 14,380,425 shares, or approximately 79.9% of the fully-diluted shares, of common stock of the company were covered by such voting agreements.

 

Acquisition of Selena Pharmaceuticals, Inc. Patent Rights

 

On October 10, 2003, Medivation purchased from Selena Pharmaceuticals, Inc. certain patent rights, including issued patents in the U.S. and Europe, covering the use of Dimebon and related compounds to treat Alzheimer’s disease and other neurodegenerative diseases. The purchase price for such rights consisted of $25,000 in cash and 900,000 shares of common stock of Medivation, which were converted into 110,642 shares of our Series B Preferred Stock in connection with the merger. As of January 28, 2005, Selena Pharmaceuticals, Inc. beneficially owned approximately 12.3% of the fully-diluted common stock. The purchase agreement with respect to the acquisition of such rights, among other things, requires us to make certain milestone payments to the inventors of the patent rights upon the occurrence of stated events, and to pay the inventors royalties on the sale of products covered by such purchased rights.

 

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Transactions with Dr. Hung

 

On November 16, 2004, Dr. Hung, our current President and Chief Executive Officer and a member of our board of directors, entered into an agreement with Medivation pursuant to which Dr. Hung guaranteed, in an amount not to exceed $78,000, the performance of Medivation of its contractual obligation to pay certain professional fees incurred by Medivation in connection with the transactions. In return for such guarantee, Medivation issued warrants to Dr. Hung exercisable for shares of Medivation equity securities. In connection with the merger, the warrants exercisable for shares of Medivation equity securities issued to Dr. Hung in connection with such guarantee were assumed by us and converted into warrants exercisable for an aggregate of 10,065 shares of our common stock at an exercise price of $1.55 per share. As of January 28, 2005, Dr. Hung beneficially owned approximately 9.6% of the fully-diluted common stock.

 

Transactions with Mr. Grano

 

Convertible Bridge Notes and Warrants

 

On June 8, August 1, and September 1, 2004, Medivation issued and sold to Joseph J. Grano, Jr. convertible bridge notes of Medivation, together with warrants exercisable for equity securities of Medivation. The aggregate principal amount of all such convertible bridge notes was $600,000, and each accrued interest at the rate of 4.5% per annum. As of December 17, 2004, the aggregate principal balance, plus accrued interest, remaining outstanding on the convertible bridge notes was $610,775, and was assumed by the company and converted into shares of common stock of the company at a conversion price of $1.55 per share in the financing. In connection with the merger, the warrants exercisable for equity securities of Medivation, issued in connection with the convertible bridge notes, were also assumed by the company and converted into warrants exercisable for an aggregate of 77,419 shares of our common stock at an exercise price of $1.55 per share.

 

Consulting Agreement

 

In addition, pursuant to a Consulting Agreement between Medivation and Mr. Grano entered in July 2004, Medivation issued to Mr. Grano options to purchase shares of Medivation common stock in July and December 2004. In connection with the merger, these options were assumed by the company and converted into options to purchase shares of our common stock.

 

As of January 28, 2005, Mr. Grano beneficially owned an aggregate of 1,279,033 shares of our common stock, or approximately 4.1% of the fully-diluted common stock.

 

Transactions with Dara BioSciences, Inc.

 

On October 10, 2003, and April 1, 2004, Medivation issued to Dara BioSciences, Inc. convertible bridge notes of Medivation, together with warrants exercisable for equity securities of Medivation. The aggregate principal amount of all such convertible bridge notes was $1,250,000, and each accrued interest at the rate of 4.5% per annum. In connection with the financing, (a) an aggregate principal balance of $688,955 remaining outstanding on the convertible bridge notes was assumed by the company and converted into shares of common stock of the company at a conversion price of $1.55 per share; and (b) an aggregate principal balance of $622,720 in principal plus accrued interest remaining outstanding on the convertible bridge notes was repaid by us. In connection with the merger, the equity securities of Medivation issued in connection with the convertible bridge notes were also assumed by the company and converted into warrants exercisable for an aggregate of 161,290 shares of our common stock at an exercise price of $1.55 per share.

 

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DESCRIPTION OF TRANSACTIONS

 

The company is the product of the merger between Medivation and merger sub, a wholly owned subsidiary of Orion, which was completed as part of the transactions, including the merger and the financing. Prior to the merger, Orion had not engaged in any substantive commercial operations, and Medivation was a privately held life sciences company. Orion was incorporated in Delaware in October 1995 for the purpose of acquiring an operating business by purchase, merger, combination or otherwise. Medivation was incorporated in Delaware in September 2003. The following is a brief description of the merger and the financing, which we sometimes refer to collectively as “the transactions” in this prospectus.

 

Overview

 

On December 17, 2004, Orion entered into an agreement and plan of merger by and among Orion, merger sub and Medivation providing for the merger of merger sub with and into Medivation, and pursuant to which each outstanding share of common stock of Medivation was converted into 0.122935 shares of the Series B Preferred Stock of the company. In addition, in connection with the transactions, Orion entered into purchase agreements with respect to the private placement by Orion of an aggregate of 7,741,935 shares of common stock to certain accredited investors at a price of $1.55 per share.

 

Merger Agreement

 

Pursuant to the merger agreement, among other things, effective as of December 17, 2004, (a) David T. Hung, M.D. was elected to the board of directors of the company and was appointed as the President and Chief Executive Officer of the company; (b) C. Patrick Machado was appointed as the Senior Vice President and Chief Financial Officer of the company; (c) Christopher A. Marlett resigned from the positions of President and Chief Executive Officer of the company, and continues to serve on the board of directors of the company; and (d) Anthony DiGiandomenico resigned from the position of Chief Financial Officer of the company, and continues to serve on the board of directors of the company.

 

In addition, pursuant to the merger agreement, the company agreed that it shall prepare and file with the Commission as soon as practicable after December 17, 2004, a proxy statement with respect to an annual meeting of the holders of common stock for the purpose of obtaining the approval of the holders of the common stock of each of the following actions: (a) an amendment to the amended and restated certificate of incorporation of the company resulting in an increase in the number of shares of authorized common stock, from 10,000,000 shares of authorized common stock to at least 25,000,000 shares of authorized common stock; (b) the election to the board of directors of the company the following individuals: (i) Mr. Steve Gorlin; (ii) David T. Hung, M.D.; (iii) one (1) nominee acting as the representative of the individuals who held shares of common stock of Medivation immediately prior to the effective time of the merger; and (iv) two nominees acting as representatives of MDB Capital Group LLC; and (c) a change of the name of the company.

 

Series B Preferred Stock

 

On December 15, 2004, we amended and restated the certificate of designations, preferences, rights and limitations of the Series B Preferred Stock. The amendment to and restatement of the certificate of designations, among other things, (a) increased the number of shares of common stock that shall be issuable upon conversion of the shares of the Series B Preferred Stock from 10 shares of common stock for each share of Series B Preferred Stock to 20 shares of common stock for each share of Series B Preferred Stock; and (b) provided that, until all the shares of Series B Preferred Stock shall have been automatically converted into shares of common stock, (i) all actions submitted for approval by holders of shares of common stock shall in addition require the approval of the holders of a majority of the shares of Series B Preferred Stock (voting as a separate series); and (ii) all actions taken by the board of directors of the company shall require the approval of the director nominated by the holders of the shares of Series B Preferred Stock. Shares of the Series B Preferred Stock shall be automatically converted into shares of common stock upon receipt of stockholder approval to increase the authorized common stock to at least 25,000,000 shares.

 

Purchase Agreements

 

In connection with the financing, Orion entered into purchase agreements with respect to the private placement of an aggregate of 7,741,935 shares of common stock to certain accredited investors at a price of $1.55 per share.

 

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Registration Rights Agreements

 

In connection with the financing, Orion entered into registration rights agreements providing for the registration for resale of the shares sold pursuant to the financing, as well as certain other shares of common stock of Orion. The registration rights agreements require us to register for resale an aggregate of 14,327,607 shares of common stock. Pursuant to the registration rights agreements, we agreed to file a registration statement with respect to these shares no later than January 31, 2005, and to have such registration statement declared effective no later than March 31, 2005. If we fail to file, or to have declared effective, such registration statement by such respective deadlines, we agreed to pay certain liquidated amounts to the parties to such registration rights agreements who purchased shares in the financing.

 

Voting Agreements

 

In connection with the transactions, each of the persons holding shares of common stock of Medivation immediately prior to the effective time of the merger and each person who purchased shares in the financing, entered into voting agreements which provide for the agreement by such persons to vote any shares of common stock or other voting securities of the company owned by such persons in favor of: (a) an amendment to the amended and restated certificate of incorporation of the company resulting in an increase in the number of shares of authorized common stock, from 10,000,000 shares of authorized common stock to at least 25,000,000 shares of authorized common stock; (b) the election to the board of directors of the company the following individuals: (i) Mr. Steve Gorlin; (ii) David T. Hung, M.D.; (iii) one nominee acting as the representative of the individuals who held shares of common stock of Medivation immediately prior to the effective time of the merger; and (iv) two nominees acting as representatives of MDB Capital Group LLC; and (c) a change of the name of the company.

 

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DESCRIPTION OF CAPITAL STOCK

 

General Matters

 

Pursuant to our amended and restated certificate of incorporation, the total amount of our authorized capital stock is 11,000,000 shares, which consists of 10,000,000 shares of authorized common stock, par value $0.01 per share, and 1,000,000 shares of authorized preferred stock, par value $0.01 per share. With respect to the authorized preferred stock, 200 shares have been designated as Series A Preferred Stock and 450,000 shares have been designated as Series B Preferred Stock. As of January 28, 2005, we had outstanding 9,581,141 shares of common stock, and 110 shares and 331,925 shares of Series A Preferred Stock and Series B Preferred Stock, respectively.

 

According to the records of our transfer agent, American Stock Transfer & Trust Company, as of December 14, 2004, we had 15 holders of record of our common stock. As of January 28, 2005, we had one holder of record of our Series A Preferred Stock and four holders of record of our Series B Preferred Stock.

 

The following summary of our capital stock does not purport to be complete and is subject to and qualified in its entirety by, our amended and restated certificate of incorporation and our bylaws, each of which are included as exhibits to the registration statement of which this prospectus forms a part and by the provisions of applicable law.

 

Common Stock

 

The holders of shares of common stock are entitled to one vote for each share held of record on all matters submitted to a vote of the stockholders. All shares of our common stock are entitled to share equally in any dividends our board of directors may declare from legally available sources.

 

Our common stock is quoted on the OTC Bulletin Board under the symbol “MTMR”. The transfer agent and registrar for our common stock is American Stock Transfer & Trust Company.

 

Preferred Stock

 

The board of directors is authorized, subject to any limitations imposed by law, without stockholder approval, from time to time to issue up to a total of 1,000,000 shares of preferred stock, in one or more series, each series to have rights and preferences, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences, as the board of directors may determine.

 

As of January 28, 2005, the Series A Preferred Stock and the Series B Preferred Stock were the only series of preferred stock designated by the company.

 

Series A Preferred Stock

 

Holders of Series A Preferred Stock are not entitled to vote their shares with respect to the election of directors or any other matter submitted to the stockholders, unless required by law or upon conversion of their shares of Series A Preferred Stock into shares of common stock. Each share of Series A Preferred Stock is convertible into 1,000 shares of common stock at the holder’s election for a period of one year commencing on December 17, 2004. Each share of Series A Preferred Stock is redeemable at the option of the holder thereof at any time at a price per share equal to the price per share originally paid to the company for such share. Upon our liquidation, dissolution or winding up, the holders of Series A Preferred Stock are entitled to receive their initial purchase price per share of Series A Preferred Stock prior and in preference to any distribution to the holders of shares of common stock. The Series A Preferred Stock is not entitled to any preemptive rights.

 

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Series B Preferred Stock

 

In the event of any liquidation, dissolution or winding up of the company, either voluntary or involuntary, subject to the rights of other series of preferred stock that are in existence or may, from time to time, come into existence, the assets of the company available for distribution to stockholders shall be distributed among the holders of shares of the Series B Preferred Stock and among the holders of shares of common stock on the basis of each share of Series B Preferred Stock receiving an amount of cash or other distributable property that is the conversion rate (as defined below) times the amount payable or distributable for each share of common stock.

 

The Series B Preferred Stock does not have any redemption rights. The Series B Preferred Stock will not be entitled to dividends unless the company pays cash dividends or dividends in other property to holders of outstanding shares of common stock, in which event, each outstanding share of the Series B Preferred Stock will be entitled to receive dividends of cash or property equivalent to that paid in respect of one share of common stock times the conversion rate.

 

In the event that the company increases the number of shares of authorized common stock to be equal to or in excess of 25,000,000 shares of common stock, then upon the filing and acceptance of any change in the amended and restated certificate of incorporation reflecting the increase in capital, whether by amendment or restatement, all the outstanding shares of Series B Preferred Stock will immediately and automatically convert into shares of common stock without any notice required on the part of the company or the holder. In such event, holders of Series B Preferred Stock will be entitled to receive shares of common stock at the conversion rate of twenty shares of fully paid and non-assessable common stock for one share of Series B Preferred Stock.

 

The holders of record of shares of Series B Preferred Stock shall be entitled to vote together with the holders of the shares of common stock upon all matters submitted to such holders for a vote, the vote of each share of Series B Preferred Stock to be equal to the then conversion rate. So long as any shares of Series B Preferred Stock are outstanding, the holders of shares of Series B Preferred Stock voting as a separate class shall have the right to elect one member of the board of directors of the company, which director shall be subject to removal only upon the vote of the holders of a majority of the Series B Preferred Stock.

 

In addition, so long as any shares of Series B Preferred Stock are outstanding, the company shall not without first obtaining the approval (by vote or written consent, as provided by law) of the holders of at least sixty percent of the then outstanding shares of Series B Preferred Stock, voting as a separate class (a) create (by reclassification or otherwise) any new class or series of shares having rights, preferences or privileges equal or senior to the Series B Preferred Stock; (b) alter or change the rights, preferences or privileges of the Series B Preferred Stock; (c) amend the amended and restated certificate of incorporation in a manner that materially adversely affects the rights, preferences or privileges of the holders of the Series B Preferred Stock; (d) increase or decrease the authorized number of shares of Preferred Stock of the company; (e) liquidate or wind-up the company; (f) redeem, purchase or otherwise acquire (or pay into or set funds aside for a sinking fund for such purpose) any share or shares of preferred stock or common stock; or (g) take any other action which is required to be taken only with the consent or approval of the holders of the company’s capital stock, whether pursuant to the amended and restated certificate of incorporation or the provisions of the Delaware General Corporation Law. In addition, so long as any shares of Series B Preferred Stock are outstanding, the company shall not take any action which is required to be taken only with the consent or approval of a majority of the board of directors without the consent or approval of the director nominated by the holders of the shares of Series B Preferred Stock.

 

Registration Rights Agreements

 

In connection with the financing, Orion entered into registration rights agreements providing for the registration for resale of the shares sold pursuant to the financing, as well as certain other shares of common stock of Orion. The registration rights agreements require us to register for resale an aggregate of 14,327,607 shares of common stock. Pursuant to the registration rights agreements, we agreed to file a registration statement

 

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with respect to these shares no later than January 31, 2005, and to have such registration statement declared effective no later than March 31, 2005. If we fail to file, or to have declared effective, such registration statement by such respective deadlines, we agreed to pay certain liquidated amounts to the parties to such registration rights agreements who purchased shares in the financing.

 

Warrants

 

As of January 28, 2005, the aggregate number of shares of common stock issuable upon exercise of outstanding warrants was 1,049,991. If all outstanding warrants are exercised in connection with this offering for cash, the estimated net aggregate proceeds to us from the sale of the shares of common stock issuable upon exercise of such warrants will be approximately $1,306,136.

 

Prior to Transactions. As of December 16, 2004, the date immediately prior to effective date of the merger, Orion had outstanding Class B Warrants to purchase 225,500 shares of common stock. On the effective date of the merger, all outstanding Class B Warrants became exercisable during the period beginning on December 17, 2004, and ending on December 17, 2005 for an aggregate of 225,500 shares of common stock at an exercise price of $0.125 per share.

 

Subsequent to Transactions. Pursuant to the merger, previously issued Medivation warrants were assumed by us and became exercisable to purchase an aggregate of 251,613 shares of our common stock at an exercise price of $1.55 per share. In addition, as compensation for the services of MDB Capital Group LLC as placement agent in connection with the financing, MDB Capital Group LLC and certain affiliates received a warrant exercisable for an aggregate of 572,878 shares of common at an exercise price of $1.55 per share. The expiration dates of the warrants previously issued by Medivation and held by Dr. Hung and Mr. Machado are November 16, 2014. The expiration dates of the warrants previously issued by Medivation and held by Dara BioSciences, Inc. are October 10, 2013, and April 1, 2014. The expiration dates of the warrants previously issued by Medivation and held by Mr. Grano are each the earlier to occur of (a) a change of control of the company; and (b) the tenth anniversary of the issuance date of the applicable warrant, or June 8, 2014, September 1, 2014, and August 1, 2014, respectively. The expiration date of the warrant held by MDB Capital Group LLC is December 17, 2009.

 

Delaware General Corporation Law

 

Provisions of the Delaware General Corporation Law could discourage potential acquisition proposals and could delay, deter or prevent a change in control. The anti-takeover provisions of the Delaware General Corporation Law impose various impediments to the ability of a third party to acquire control of us, even if a change in control would be beneficial to our existing stockholders. In addition, Section 203 of the Delaware General Corporation Law, unless its application has been waived, provides certain default anti-takeover protections in connection with transactions between the company and an “interested stockholder” of the company. Although we have not waived application of Section 203 of the Delaware General Corporation Law, because our common stock is not listed on any national securities exchange or authorized for quotation on the NASDAQ Stock Market, we are not afforded the anti-takeover protections of Section 203 of the Delaware General Corporation Law. Additionally, provisions of our amended and restated certificate of incorporation and bylaws could deter, delay or prevent a third party from acquiring us, even if doing so would benefit our stockholders, including without limitation, the authority of the board of directors to issue, without stockholder approval, preferred stock with such terms as the board of directors may determine.

 

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PRINCIPAL AND SELLING STOCKHOLDERS

 

The following table sets forth certain information with respect to the beneficial ownership of our common stock as of March 1, 2005, for:

 

    each of our directors;

 

    each of our named executive officers;

 

    all of our directors and named executive officers as a group;

 

    each person who we know beneficially owns more than 5% of our common stock; and

 

    each selling stockholder.

 

Beneficial ownership data in the table below has been calculated based on Commission rules requiring that all equity securities exercisable for or convertible into shares of our common stock within 60 days of March 1, 2005, shall be deemed to be outstanding for the purpose of computing the percentage of ownership of any person holding such exercisable or convertible equity securities, but shall not be deemed to be outstanding for computing the percentage of ownership of any other person.

 

Except as indicated by footnote, and subject to applicable community property laws, each person identified in the table possesses sole voting and investment power with respect to all capital stock shown to be held by that person. The address of each named executive officer and director, unless indicated otherwise by footnote, is c/o Orion Acquisition Corp. II, 501 Second Street, Suite 211, San Francisco, California 94107.

 

     Shares Beneficially
Owned Prior to
Offering


    Offered

  

Shares Beneficially
Owned After

Offering


     Number

   Percent

       Number

   Percent

Named Executive Officers and Directors

                         

David T. Hung, M.D.(1)

   1,645,095    14.65 %   1,645,095    —      *

Christopher A. Marlett(2)

   1,173,652    11.83     637,470    536,180    5.30%

C. Patrick Machado(3)

   494,579    4.91     494,579    —      *

Anthony DiGiandomenico(4)

   118,773    1.24     37,748    81,025    *

All named executive officers and directors as a group (four persons)(1-4)

   3,432,099    32.63     2,814,894    617,205    6.14

5% Stockholders

                         

Dara BioSciences, Inc.(5)

   2,818,607    23.58     2,818,607    —      *

Selena Pharmaceuticals, Inc.(6)

   2,212,830    18.76     2,212,830    —      *

Special Situations Private Equity Fund, L.P.(7)

   1,290,322    13.47     1,290,322    —      *

Joseph J. Grano, Jr.(8)

   1,279,033    12.53     729,533    549,500    5.42

Special Situations Fund III, L.P.(9)

   967,742    10.10     967,742    —      *

MDB Capital Group LLC(10)

   903,470    9.17     633,290    270,180    2.82

TTC Private Equity Partners LLC(11)

   504,780    5.27     504,780    —      *

Other Selling Stockholders

                         

703149 Ontario Inc.(12)

   429,016    4.38     429,016    —      *

ProMed Partners L.P.†

   351,030    3.66     351,030    —      *

ProMed Offshore Fund II, Ltd.†

   345,850    3.61     345,850    —      *

Walker Smith International Fund, Ltd.

   333,484    3.48     333,484    —      *

Special Situations Cayman Fund, L.P.

   322,581    3.37     322,581    —      *

Walker Smith Capital (QP), L.P.

   257,420    2.69     257,420    —      *

 

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Table of Contents
     Shares Beneficially
Owned Prior to
Offering


   Offered

  

Shares
Beneficially
Owned After

Offering


     Number

   Percent

      Number

   Percent

Robert Charles Friese

   161,290    1.68    161,290    —      *

Cimarron Overseas Equity Master Fund L.P.

   129,032    1.35    129,032    —      *

Lewin Investments LLC

   129,032    1.35    129,032    —      *

Silicon Prairie Partners, L.P.

   129,032    1.35    129,032    —      *

Trust Under Will of A. Wilfred May,
dated November 11, 1969

   129,032    1.35    129,032    —      *

Melvyn Weiss

   96,774    1.01    96,774    —      *

SRB Greenway Capital (QP), L.P.

   86,700    *    86,700    —      *

The Hung Shaber Family 2004 Irrevocable Trust,
dated December 29, 2004
(13)

   86,060    *    86,060    —      *

ProMed Partners II L.P.†

   85,370    *    85,370    —      *

Bushido Capital Master Fund, L.P.

   80,645    *    80,645    —      *

Gamma Opportunity Capital Partners, L.P.

   80,645    *    80,645    —      *

Topix, Inc.†

   80,000    *    80,000    —      *

Arthur Shartsis

   65,000    *    65,000    —      *

Edgewater Ventures

   64,516    *    64,516    —      *

Edward Negley

   64,516    *    64,516    —      *

John Braniff†

   64,516    *    64,516    —      *

John Micek III

   64,516    *    64,516    —      *

ProMed Offshore Fund, Ltd.†

   56,460    *    56,460    —      *

Walker Smith Capital, L.P.

   54,258    *    54,258    —      *

Karen Simi(14)

   51,612    *    51,612    —      *

WS Opportunity Fund International Ltd.

   48,710    *    48,710    —      *

WS Opportunity Fund (QP), L.P.

   44,322    *    44,322    —      *

James Patrick Tierney

   40,000    *    40,000    —      *

WS Opportunity Fund, L.P.

   36,000    *    36,000    —      *

R. L. Clarkson

   35,000    *    35,000    —      *

Richard D. Clarkson

   35,000    *    35,000    —      *

Richard L. Clarkson, f/b/o Lucille S. Ball

   35,000    *    35,000    —      *

Clay D. McCollor and Elissa McCollor

   32,258    *    32,258    —      *

Joel T. Leonard Trust, dated October 25, 1994

   32,258    *    32,258    —      *

Joseph F. Barletta†

   32,258    *    32,258    —      *

Maurice Micek

   32,258    *    32,258    —      *

Shon Kwong and Laura Micek

   32,258    *    32,258    —      *

Steven O’Kuhn

   32,258    *    32,258    —      *

David O. Zenker, Jr.†

   29,052    *    29,052    —      *

Steven L. Zelinger

   16,200    *    16,200    —      *

John Micek, Custodian for Gabriel Micek

   16,129    *    16,129    —      *

John Micek, Custodian for Jordan Micek

   16,129    *    16,129    —      *

John Micek, Custodian for Peter Micek

   16,129    *    16,129    —      *

Maurice Micek, Custodian for Andrew Micek

   16,129    *    16,129    —      *

Maurice Micek, Custodian for Benjamin Micek

   16,129    *    16,129    —      *

Brock Capital Group LLC†

   15,846    *    15,846    —      *

Christopher MacIntyre(15)

   15,484    *    15,484    —      *

Cedric Vanzura

   15,000    *    15,000    —      *

Greg J. Micek, Guardian for Gregory J. Micek Jr.

   12,903    *    12,903    —      *

SRB Greenway Capital, L.P.

   10,074    *    10,074    —      *

Robert Guinta†

   7,923    *    7,923    —      *

 

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Table of Contents
     Shares
Beneficially
Owned Prior to
Offering


   Offered

  

Shares
Beneficially
Owned After

Offering


     Number

   Percent

      Number

   Percent

Greg J. Micek, Guardian for Alexandria L. Micek

   6,452    *    6,452    —      *

John A. Raiser Irrevocable Trust dated March 2, 1988

   6,452    *    6,452    —      *

Julie Dad(16)

   4,000    *    4,000    —      *

Jeff Stroud and Jean Stroud

   3,226    *    3,226    —      *

Kimberly Renner(17)

   2,684    *    2,684    —      *

* Represents beneficial ownership of less than 1%.
Selling stockholder is a registered broker-dealer or an affiliate thereof.
  (1) Consists of 10,065 shares of common stock issuable upon exercise of warrants exercisable within 60 days and 1,635,030 shares of common stock issuable upon conversion of shares of Series B Preferred Stock convertible within 60 days.
  (2) Consists of 258,090 shares of common stock and 12,090 shares of common stock issuable upon exercise of warrants exercisable within 60 days. Also includes shares held of record by MDB Capital Group LLC, of which Mr. Marlett is a principal and the principal equity holder. See Note 10, below. The address for Mr. Marlett is c/o MDB Capital Group LLC, 401 Wilshire Boulevard, Suite 1020, Santa Monica, California 90401.
  (3) Consists of 2,839 shares of common stock issuable upon exercise of warrants exercisable within 60 days and 491,740 shares of common stock issuable upon conversion of shares of Series B Preferred Stock convertible within 60 days.
  (4) Consists of 116,028 shares of common stock and 2,745 shares of common stock issuable upon exercise of warrants exercisable within 60 days. The address for Mr. DiGiandomenico is c/o MDB Capital Group LLC, 401 Wilshire Boulevard, Suite 1020, Santa Monica, California 90401.
  (5) Consists of 444,487 shares of common stock; 161,290 shares of common stock issuable upon exercise of warrants exercisable within 60 days; and 2,212,830 shares of common stock issuable upon conversion of shares of Series B Preferred Stock convertible within 60 days. Dara Biosciences, Inc. has sole voting and investment control over the shares. Steve Gorlin, Louis Herlands, Richard A. Franco and W. Hamilton Jordan are members of the board of directors of Dara Biosciences, Inc. The address for Dara BioSciences is 4505 Falls of Neuse Road, Suite 125, Raleigh, North Carolina 27609.
  (6) Consists of 2,212,830 shares of common stock issuable upon conversion of shares of Series B Preferred Stock convertible within 60 days. Selena Pharmaceuticals, Inc. has sole voting and investment control over the shares. Sergey Sablin, Elena Sablin, Michael Weiner and Eugene Somoza are members of the board of directors of Selena Pharmaceuticals, Inc. The address for Selena Pharmaceuticals is 167 Skyview Way, San Francisco, CA 94131.
  (7) MG Advisers, L.L.C. is the general partner of and investment adviser to the Special Situations Private Equity Fund, L.P. Austin W. Marxe and David M. Greenhouse are the principal owners of MG Advisers, L.L.C. and are principally responsible for the selection, acquisition and disposition of the portfolio securities by the investment adviser on behalf of its fund. The address for Special Situations Private Equity Fund, L.P. is 153 East 53rd Street, 51st Floor, New York, New York 10022.
  (8) Consists of 652,114 shares of common stock; and 77,419 shares of common stock issuable upon exercise of warrants exercisable within 60 days; and 549,500 shares of common stock issuable upon exercise of options exercisable within 60 days. Mr. Grano is a consultant to the Company. The address for Mr. Grano is c/o Centurion Holdings LLC, 375 Park Avenue, New York, NY 10152-0192.
  (9) MGP Advisors Limited is the general partner of Special Situations Fund III, L.P. AWM Investment Company, Inc. is the general partner of MGP Advisors Limited. Austin W. Marxe and David M. Greenhouse are the principal owners of MGP Advisors Limited and AWM Investment Company, Inc. The address for Special Situations Fund III, L.P. is 153 East 53rd Street, 51st Floor, New York, New York 10022.

 

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(10) Consists of 574,735 shares of common stock and 328,735 shares of common stock issuable upon exercise of warrants exercisable within 60 days. The address for MDB Capital Group LLC is 401 Wilshire Boulevard, Suite 1020, Santa Monica, California 90401.
(11) Tiedemann Trust Company is the managing member of TTC Private Equity Partners LLC. Michael Tiedemann, Senior Managing Director and Head of Investment Management for Tiedemann Trust Company, has voting and investment power over the shares. The address for TTC Private Equity Partners LLC is 1201 North Market Street, Suite 1406, Wilmington, Delaware 19801.
(12) Consists of 214,508 shares of common stock and 214,508 shares of common stock issuable upon exercise of warrants exercisable within 60 days.
(13) Consists of 86,060 shares of common stock issuable upon conversion of shares of Series B Preferred Stock convertible within 60 days.
(14) Consists of 25,806 shares of common stock and 25,806 shares of common stock issuable upon exercise of warrants exercisable within 60 days.
(15) Consists of 7,742 shares of common stock and 7,742 shares of common stock issuable upon exercise of warrants exercisable within 60 days.
(16) Consists of 2,000 shares of common stock and 2,000 shares of common stock issuable upon exercise of warrants exercisable within 60 days.
(17) Consists of 1,342 shares of common stock and 1,342 shares of common stock issuable upon exercise of warrants exercisable within 60 days.

 

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MARKET FOR COMMON STOCK AND RELATED MATTERS

 

Common Stock Prices

 

Our common stock is quoted on the OTC Bulletin Board under the symbol “MTMR.” The following table sets forth on a per share basis the high and low bid prices, respectively, of our common stock as reported on the OTC Bulletin Board for the periods indicated. The company is the product of the merger between Medivation and a wholly owned subsidiary of Orion, which was completed as part of the transactions, including the merger and the financing, on December 17, 2004. Prior to the merger, Orion had not engaged in any substantive commercial operations. Accordingly, prices in the table below for any period prior to the transactions do not reflect commercial operations of Medivation.

 

     High Bid

   Low Bid

Year ended December 31, 2003

             

First quarter

   $ 0.75    $ 0.45

Second quarter

   $ 0.85    $ 0.51

Third quarter

   $ 0.85    $ 0.81

Fourth quarter

   $ 1.01    $ 0.81

Year ended December 31, 2004

             

First quarter

   $ 1.70    $ 0.98

Second quarter

   $ 7.00    $ 1.70

Third quarter

   $ 3.40    $ 1.50

Fourth quarter

   $ 4.10    $ 0.55

Year ended December 31, 2005

             

First quarter (through January 25, 2005)

   $ 4.00    $ 2.50

 

On January 25, 2005, the average of the high ask and low bid prices, respectively, of our common stock as reported on the OTC Bulletin Board on January 25, 2005, was $3.25 per share. According to the records of our transfer agent, American Stock Transfer & Trust Company, as of March 8, 2005, we had 78 holders of record of common stock.

 

The source of the information provided in the table above is the OTC Bulletin Board®, Quarterly Trade and Quote Summary Report, and represents prices between dealers without adjustments for retail markups, markdowns or commissions, and may not represent actual transactions.

 

Equity Compensation Plans

 

The following table sets forth certain information concerning shares of our common stock issuable and available for issuance under our stockholder approved and non-stockholder approved equity compensation plans, in each case as of December 31, 2004. All such options were issued to consultants of Medivation under an equity compensation plan approved by the holders of common stock of Medivation prior to the merger and assumed in connection therewith.

 

    

Shares Issuable

upon Exercise
of Options


   Weighted Average
Exercise Price
of Options


   Shares Available
for Issuance
under Plan


Equity compensation plans approved by stockholders

   616,556    $ 0.85    489,859

Equity compensation plans not approved by stockholders

          
    
         

Total

   616,556    $    489,859
    
         

 

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Table of Contents

PLAN OF DISTRIBUTION

 

The selling stockholders, which as used herein includes donees, pledgees, transferees or other successors-in-interest selling shares of common stock or interests in shares of common stock received after the date of this prospectus from a selling stockholder as a gift, pledge, partnership distribution or other transfer, may, from time to time, sell, transfer or otherwise dispose of any or all of their shares of common stock or interests in shares of common stock on any stock exchange, market or trading facility on which the shares are traded or in private transactions. These dispositions may be at fixed prices, at prevailing market prices at the time of sale, at prices related to the prevailing market price, at varying prices determined at the time of sale, or at negotiated prices.

 

The selling stockholders may use any one or more of the following methods when disposing of shares or interests therein:

 

    ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;

 

    block trades in which the broker-dealer will attempt to sell the shares as agent, but may position and resell a portion of the block as principal to facilitate the transaction;

 

    purchases by a broker-dealer as principal and resale by the broker-dealer for its account;

 

    an exchange distribution in accordance with the rules of the applicable exchange;

 

    privately negotiated transactions;

 

    short sales effected after the date the registration statement of which this prospectus is a part is declared effective by the Commission;

 

    through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise;

 

    broker-dealers may agree with the selling stockholders to sell a specified number of such shares at a stipulated price per share;

 

    a combination of any such methods of sale; and

 

    any other method permitted pursuant to applicable law.

 

The selling stockholders may, from time to time, pledge or grant a security interest in some or all of the shares of common stock owned by them and, if they default in the performance of their secured obligations, the pledgees or secured parties may offer and sell the shares of common stock, from time to time, under this prospectus, or under an amendment to this prospectus under Rule 424(b)(3) or other applicable provision of the Securities Act amending the list of selling stockholders to include the pledgee, transferee or other successors in interest as selling stockholders under this prospectus. The selling stockholders also may transfer the shares of common stock in other circumstances, in which case the transferees, pledgees or other successors in interest will be the selling beneficial owners for purposes of this prospectus.

 

In connection with the sale of shares of our common stock or interests therein, the selling stockholders may enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales of shares of the common stock in the course of hedging the positions they assume. The selling stockholders may also sell shares of our common stock short and deliver these securities to close out their short positions, or loan or pledge the shares of common stock to broker-dealers that in turn may sell these securities. The selling stockholders may also enter into option or other transactions with broker-dealers or other financial institutions or the creation of one or more derivative securities which require the delivery to such broker-dealer or other financial institution of shares offered by this prospectus, which shares such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).

 

The aggregate proceeds to the selling stockholders from the sale of the shares of common stock offered by them will be the purchase price of the shares of common stock less discounts or commissions, if any. Each of the

 

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Table of Contents

selling stockholders reserves the right to accept and, together with their agents from time to time, to reject, in whole or in part, any proposed purchase of shares of common stock to be made directly or through agents. We will not receive any of the proceeds from this offering. Upon any exercise of the warrants by payment of cash, however, we will receive the exercise price of the warrants.

 

The selling stockholders also may resell all or a portion of the shares in open market transactions in reliance upon Rule 144 under the Securities Act, provided that they meet the criteria and conform to the requirements of that rule.

 

The selling stockholders and any underwriters, broker-dealers or agents that participate in the sale of the shares of common stock or interests therein may be “underwriters” within the meaning of Section 2(11) of the Securities Act. Any discounts, commissions, concessions or profit they earn on any resale of the shares may be underwriting discounts and commissions under the Securities Act. Selling stockholders who are “underwriters” within the meaning of Section 2(11) of the Securities Act will be subject to the prospectus delivery requirements of the Securities Act.

 

To the extent required, the shares of our common stock to be sold, the names of the selling stockholders, the respective purchase prices and public offering prices, the names of any agents, dealer or underwriter, any applicable commissions or discounts with respect to a particular offer will be set forth in an accompanying prospectus supplement or, if appropriate, a post-effective amendment to the registration statement that includes this prospectus.

 

In order to comply with the securities laws of some states, if applicable, the common stock may be sold in these jurisdictions only through registered or licensed brokers or dealers. In addition, in some states the common stock may not be sold unless it has been registered or qualified for sale or an exemption from registration or qualification requirements is available and is complied with.

 

We have advised the selling stockholders that the anti-manipulation rules of Regulation M under the Securities Exchange Act of 1934, as amended, may apply to sales of shares in the market and to the activities of the selling stockholders and their affiliates. In addition, we will make copies of this prospectus (as it may be supplemented or amended from time to time) available to the selling stockholders for the purpose of satisfying the prospectus delivery requirements of the Securities Act. The selling stockholders may indemnify any broker-dealer that participates in transactions involving the sale of the shares against certain liabilities, including liabilities arising under the Securities Act.

 

We have agreed to indemnify the selling stockholders against liabilities, including liabilities under the Securities Act and state securities laws, relating to the registration of the shares offered by this prospectus.

 

We have agreed with the selling stockholders to keep the registration statement of which this prospectus constitutes a part effective until the earlier of (a) such time as all of the shares covered by this prospectus have been disposed of pursuant to and in accordance with the registration statement; or (b) the date on which the shares may be sold pursuant to Rule 144(k) of the Securities Act.

 

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Table of Contents

LEGAL MATTERS

 

Latham & Watkins LLP, Menlo Park, California will opine as to the validity of the shares of common stock being offered by this prospectus.

 

EXPERTS

 

The consolidated financial statements as of and for the periods therein indicated included in the prospectus have been audited by Singer Lewak Greenbaum & Goldstein LLP, independent registered public accounting firm of Orion Acquisition Corp. II, to the extent and for the periods set forth in their report appearing in this prospectus, and are included in reliance upon such report given upon the authority of Singer Lewak Greenbaum & Goldstein LLP as experts in auditing and accounting.

 

WHERE YOU CAN FIND MORE INFORMATION

 

We have filed a registration statement on Form SB-2 with the Commission of which this prospectus is a part under the Securities Act with respect to the shares of common stock offered by this prospectus. This prospectus does not contain all of the information included in the registration statement, and statements contained in this prospectus concerning the provisions of any document are not necessarily complete. For further information about us and the shares of common stock covered by this prospectus, you should read the registration statement including its exhibits.

 

We file annual reports on Form 10-KSB, quarterly reports of Form 10-QSB, current reports on Form 8-K, proxy statements and other information with the Commission under the Exchange Act. You may read and copy this information at Commission’s Public Reference Room at 450 Fifth Street, N.W., Washington, D.C., 20549. Please call the Commission at (800) 732-0330 for further information on the operation of the Commission’s Public Reference Room. The Commission also maintains an Internet site that contains reports, proxy statements and other information about issuers, like us, who file electronically with the Commission. The address of the Commission’s web site is www.sec.gov.

 

We intend to furnish our holders of common stock with annual reports containing financial statements audited by an independent accounting firm and to make available quarterly reports containing unaudited financial information for the first three quarters of each year.

 

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Table of Contents

PROVISION FOR INDEMNIFICATION

 

Commission Position on Indemnification

 

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to our directors, officers and their respective controlling persons, or otherwise, we have been advised that in the opinion of the Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable.

 

Delaware General Corporation Law

 

Section 145 of the Delaware General Corporation Law provides that a corporation may indemnify directors and officers as well as other employees and individuals against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by such person in connection with any threatened, pending or completed actions, suits or proceedings in which such person is made a party by reason of such person being or having been a director, officer, employee or agent to the company. The Delaware General Corporation Law provides that Section 145 is not exclusive of other rights to which those seeking indemnification may be entitled under any bylaw, agreement, vote of stockholders or disinterested directors or otherwise.

 

Section 102(b)(7) of the Delaware General Corporation Law permits a corporation to provide in its certificate of incorporation that a director of the corporation shall not be personally liable to the corporation or its stockholders for monetary damages for breach of fiduciary duty as a director, except for liability for any breach of the director’s duty of loyalty to the corporation or its stockholders, for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law, for unlawful payments of dividends or unlawful stock repurchases, redemptions or other distributions or for any transaction from which the director derived an improper personal benefit.

 

Amended and Restated Certificate of Incorporation

 

Article Ninth of the amended and restated certificate of incorporation of the company provides that the personal liability of the directors of the company shall be eliminated to the fullest extent permitted by the provisions of Section 102(b)(7) of the Delaware General Corporation Law, as the same may be amended and supplemented.

 

Article Tenth of the amended and restated certificate of incorporation of the company provides that company shall, to the fullest extent permitted by the provisions of Section 145 of the Delaware General Corporation Law, as the same may be amended and supplemented, indemnify any and all persons whom it shall have power to indemnify under said section from and against any and all of the expenses, liabilities or other matters referred to in or covered by said section, and the indemnification provided for therein shall not be deemed exclusive of any other rights to which those indemnified may be entitled under any bylaw, agreement, vote of stockholders or disinterested directors or otherwise, both as to action in his official capacity and as to action in another capacity while holding such office, and shall continue as to a person who has ceased to be a director, officer, employee or agent and shall inure to the benefit of the heirs, executors and administrators of such a person.

 

Indemnification Agreements

 

We also enter into indemnification agreements with our directors and officers. The indemnification agreements provide indemnification to our directors and officers under certain circumstances for acts or omissions which may not be covered by directors’ and officers’ liability insurance.

 

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Table of Contents

Liability Insurance

 

We have also obtained directors’ and officers’ liability insurance, which insures against liabilities that our directors or officers may incur in such capacities.

 

Registration Rights Agreements

 

Section 6 of each of the registration rights agreements of the selling stockholders provides that we will indemnify and hold harmless each selling stockholder and its officers, directors, members, employees and agents, successors and assigns, and each other person, if any, who controls such selling stockholder within the meaning of the Securities Act, against any losses, claims, damages or liabilities, joint or several, to which they may become subject under the Securities Act or otherwise, insofar as such losses, claims, damages or liabilities (or actions in respect thereof) arise out of or are based upon (a) any untrue statement or alleged untrue statement of any material fact contained in the registration statement, preliminary prospectus or final prospectus contained therein, or any amendment or supplement thereof; (b) any blue sky application or other document executed by us specifically for that purpose or based upon written information furnished by us filed in any state or other jurisdiction in order to qualify any or all of the registrable securities under the securities laws thereof; (c) the omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading; (d) any violation by us or our agents of any rule or regulation promulgated under the Securities Act applicable to us or our agents and relating to action or inaction required of us in connection with such registration; or (e) any failure to register or qualify the securities covered by the registration statement included in any such registration in any state where we or our agents have affirmatively undertaken or agreed in writing that we will undertake such registration or qualification on behalf of any selling stockholder, and will reimburse such selling stockholder, and each such officer, director or member and each such controlling person for any legal or other expenses reasonably incurred by them in connection with investigating or defending any such loss, claim, damage, liability or action; provided, however, that we will not be liable in any such case if and to the extent that any such loss, claim, damage or liability arises out of or is based upon an untrue statement or alleged untrue statement or omission or alleged omission so made in conformity with information furnished by such selling stockholder or any such controlling person in writing specifically for use in such registration statement or prospectus.

 

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EXPLANATORY NOTE

 

As used in this prospectus:

 

    “Class B Warrants” refers to the Class B Warrants issued by Orion in its initial public offering in 1996;

 

    “the financing” refers to the private placement by Orion of an aggregate of 7,741,935 shares of common stock on December 17, 2004, to certain accredited investors;

 

    “Medivation” refers to Medivation, Inc. on or prior to December 17, 2004, the effective date of the merger;

 

    “the merger” refers to the merger effective on December 17, 2004, by and among Orion, merger sub and Medivation, pursuant to which Medivation became a wholly owned subsidiary of Orion;

 

    “merger sub” refers to the wholly owned subsidiary of Orion that was merged with and into Medivation in connection with the merger;

 

    “Orion” refers to Orion Acquisition Corp. II on or prior to December 17, 2004, the effective date of the merger;

 

    “preferred stock” refers to the Series A Preferred Stock and the Series B Preferred Stock, collectively, of the company;

 

    “the transactions” refers to the financing and the merger, collectively;

 

    “warrants” refers to the warrants of the company exercisable for shares of our common stock, including the Class B Warrants; and

 

    “We,” “our,” “us” and “the company” refer to Orion and Medivation, collectively, on a consolidated basis after giving effect to the transactions.

 


 

Unless otherwise noted in this prospectus, all information in this prospectus assumes:

 

    the sale by each selling stockholder of all shares of common stock covered by this prospectus;

 

    the conversion in full of outstanding shares of our Series A Preferred Stock into shares of common stock of the company, at the conversion rate of 1,000 shares of common stock for each share of our Series A Preferred Stock;

 

    the conversion in full of outstanding shares of our Series B Preferred Stock into shares of common stock of the company, at the conversion rate of 20 shares of common stock for each share of our Series B Preferred Stock;

 

    the exercise in full of outstanding options and warrants exercisable for shares of our common stock; and

 

    an aggregate of 17,996,178 shares of our common stock to be outstanding, which we sometimes refer to in this prospectus as the “fully-diluted” number of shares of common stock, and which represents the sum of the following:

 

    9,581,141 shares of our common stock outstanding as of January 28, 2005;

 

    1,049,991 shares of our common stock issuable upon exercise of our warrants outstanding as of January 28, 2005;

 

    110,000 shares of our common stock issuable upon conversion of our Series A Preferred Stock outstanding as of January 28, 2005;

 

    6,638,490 shares of common stock issuable upon conversion of our Series B Preferred Stock outstanding as of January 28, 2005; and

 

    616,556 shares of our common stock issuable upon exercise of our options outstanding as of January 28, 2005.

 

54


Table of Contents

FINANCIAL STATEMENTS

Financial Statements Index

 

     Page

Report of Singer Lewak Greenbaum & Goldstein LLP, Independent Registered Public Accounting Firm of Orion Acquisition Corp. II

   F-2

Consolidated Balance Sheet as of December 31, 2004

   F-3

Consolidated Statements of Operations for the year ended December 31, 2004, for the period from inception (September 4, 2003) to December 31, 2003, and for the period from inception (September 4, 2003) to December 31, 2004

   F-4

Consolidated Statements of Stockholders’ Equity for the period from inception (September 4, 2003) to December 31, 2004

   F-5

Consolidated Statements of Cash Flows for the year ended December 31, 2004, for the period from inception (September 4, 2003) to December 31, 2003, and for the period from inception (September 4, 2003) to December 31, 2004

   F-6

Notes to Consolidated Financial Statements

   F-7

 

F-1


Table of Contents

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

To the Board of Directors

Orion Acquisition Corp. II and subsidiary

San Francisco, California

 

We have audited the accompanying consolidated balance sheet of Orion Acquisition Corp. II and subsidiary as of December 31, 2004, and the related consolidated statements of operations, stockholders’ equity, and cash flows for the period from September 4, 2003 (inception) to December 31, 2003 and for the year ended December 31, 2004. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits.

 

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

 

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the consolidated financial position of Orion Acquisition Corp. II and subsidiary as of December 31, 2004, and the results of their operations and their cash flows for the period from September 4, 2003 (inception) to December 31, 2003 and for the year ended December 31, 2004 in conformity with accounting principles generally accepted in the United States of America.

 

SINGER LEWAK GREENBAUM & GOLDSTEIN LLP

 

Los Angeles, California

January 25, 2005

 

F-2


Table of Contents

ORION ACQUISITION CORP. II

(A DEVELOPMENT STAGE COMPANY)

 

CONSOLIDATED BALANCE SHEET

DECEMBER 31, 2004

 

ASSETS

        

Current assets

        

Cash and cash equivalents

   $ 10,671,707  

Prepaid expenses and other current assets

     300,208  
    


Total current assets

     10,971,915  

Intellectual property (net of amortization)

     144,628  
    


TOTAL ASSETS

   $ 11,116,543  
    


LIABILITIES AND STOCKHOLDERS’ EQUITY

        

Current liabilities

        

Warrant liability

   $ 633,149  

Accounts payable

     375,435  

Series A convertible redeemable preferred stock

     11,000  

Series B convertible preferred stock liability

     2,700  

Other current liabilities

     3,986  
    


Total current liabilities

     1,026,270  

COMMITMENTS AND CONTINGENCIES

        

Stockholders’ equity

        

Preferred stock, $0.01 par value per share
1,000,000 shares authorized

      

Common stock, $0.01 par value per share
10,000,000 shares authorized
9,581,141 shares issued and outstanding

     95,811  

Additional paid-in capital

     13,270,057  

Deficit accumulated during the development stage

     (3,275,595 )
    


Total stockholders’ equity

     10,090,273  
    


TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

   $ 11,116,543  
    


 

SEE ACCOMPANYING NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

F-3


Table of Contents

ORION ACQUISITION CORP. II

(A DEVELOPMENT STAGE COMPANY)

 

CONSOLIDATED STATEMENTS OF OPERATIONS

YEAR ENDED DECEMBER 31, 2004

INCEPTION (SEPTEMBER 4, 2003) TO DECEMBER 31, 2003

INCEPTION (SEPTEMBER 4, 2003) TO DECEMBER 31, 2004

 

    

Year Ended

December 31, 2004


   

Inception

(Sept. 4, 2003) to

December 31, 2003


   

Inception

(Sept. 4, 2003) to

December 31, 2004


 

Operating expenses:

                        

General and administrative:

                        

Consulting fees

     455,722       36,156       491,878  

Payroll expense

     303,122       75,438       378,560  

Other general and administrative

     303,173       63,221       366,394  

Research and development

     1,613,569       217,322       1,830,891  

Stock-based compensation

     109,265             109,265  
    


 


 


Total operating expenses

     2,784,851       392,137       3,176,988  
    


 


 


Loss from operations

     (2,784,851 )     (392,137 )     (3,176,988 )
    


 


 


Other expense:

                        

Interest expense (net)

     70,191       8,512       78,703  

Warrants issued to guarantors

     17,505             17,505  
    


 


 


Total other expense

     87,896       8,512       96,208  
    


 


 


Loss before provision for income taxes:

     (2,872,547 )     (400,649 )     (3,273,195 )
    


 


 


Provision for income taxes:

     1,600       800       2,400  
    


 


 


Net loss:

   $ (2,874,147 )   $ (401,449 )   $ (3,275,595 )
    


 


 


Basic and diluted loss per share:

   $ (0.41 )   $ (0.09 )   $ (0.51 )
    


 


 


Weighted average common shares outstanding assuming conversion of Series B convertible preferred stock:

     7,010,205       4,425,660       6,378,784  
    


 


 


 

 

SEE ACCOMPANYING NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

F-4


Table of Contents

ORION ACQUISITION CORP. II

(A DEVELOPMENT STAGE COMPANY)

 

CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY

INCEPTION (SEPTEMBER 4, 2003) TO DECEMBER 31, 2004

 

     COMMON STOCK

   ADDITIONAL
PAID-IN
CAPITAL


    ACCUMULATED
(DEFICIT)


   

TOTAL

STOCKHOLDERS'
EQUITY


 
     SHARES

   AMOUNT

      

Balances at inception (September 4, 2003)

      $    $     $     $  

Net loss

                         (401,449 )     (401,449 )
    
  

  


 


 


Balances as of December 31, 2003

                   (401,449 )     (401,449 )

Common stock issued for:

                                    

Cash in the Offering

   6,903,399      69,034      10,631,236               10,700,270  

Debt conversion in the Offering

   838,536      8,385      1,291,345               1,299,731  

Placement agent services to MDB Capital Group LLC

   572,878      5,729      882,232               887,961  

Placement agent services to Brock Capital Group LLC

   52,821      528      81,345               81,873  

Offering expenses

                 (1,602,981 )             (1,602,981 )

Warrants issued to guarantors

                 17,505               17,505  

Stock-based compensation expense

                 109,265               109,265  

Reverse merger transaction:

                                    

Elimination of retained earnings

                 (422,120 )             (422,120 )

Previously issued Orion stock

   1,213,507      12,135      2,282,231               2,294,366  

Net loss

                       (2,874,147 )     (2,874,147 )
    
  

  


 


 


Balances as of December 31, 2004

   9,581,141    $ 95,811    $ 13,270,057     $ (3,275,595 )   $ 10,090,273  
    
  

  


 


 


 

 

 

SEE ACCOMPANYING NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

 

F-5


Table of Contents

ORION ACQUISITION CORP. II

(A DEVELOPMENT STAGE COMPANY)

 

CONSOLIDATED STATEMENTS OF CASH FLOWS

YEAR ENDED DECEMBER 31, 2004

INCEPTION (SEPTEMBER 4, 2003) THROUGH DECEMBER 31, 2003

INCEPTION (SEPTEMBER 4, 2003) THROUGH DECEMBER 31, 2004

 

     Year ending
Dec. 31, 2004


    Inception
(Sep. 4, 2003) to
Dec. 31, 2003


    Inception
(Sep. 4, 2003) to
Dec. 31, 2004


 

Cash flows from operating activities:

                        

Net loss

   $ (2,874,147 )   $ (401,449 )   $ (3,275,595 )

Adjustments to reconcile net loss to net cash used by operating activities:

                        

Impairment of intellectual property

     75,000             75,000  

Depreciation and amortization

     5,940       332       6,272  

Stock-based compensation

     109,265             109,265  

Warrants issued to guarantors

     17,505             17,505  

Changes in operating assets and liabilities:

                        

Prepaid expenses and other current assets

     (292,498 )     (7,710 )     (300,208 )

Accounts payable

     351,655       23,780       375,435  

Other current liabilities

     (6,139 )     10,125       3,986  
    


 


 


Net cash provided by (used in) operating activities:

     (2,613,419 )     (374,922 )     (2,988,341 )
    


 


 


Cash flows from investing activities:

                        

Pre-Merger cash balances in Orion accounts

     1,928,839             1,928,839  

Purchase of intellectual property

     (200,000 )     (25,000 )     (225,000 )
    


 


 


Net cash provided by (used in) investing activities:

     1,728,839       (25,000 )     1,703,839  
    


 


 


Cash flows from financing activities:

                        

Proceeds from issuance of convertible notes

     850,000       1,000,000       1,850,000  

Repayment of unconverted portion of convertible notes

     (595,861 )           (595,861 )

Proceeds from sale of common stock in the Offering

     10,700,270             10,700,270  

Proceeds from sale of Series B preferred stock

           1,800       1,800  
    


 


 


Net cash provided by (used in) financing activities:

     10,954,409       1,001,800       11,956,209  
    


 


 


Net increase in cash

     10,069,829       601,878       10,671,707  

Cash at beginning of period

     601,878              
    


 


 


Cash at end of period

   $ 10,671,707     $ 601,878     $ 10,671,707  
    


 


 


Cash paid for interest

   $ 26,859     $     $ 26,859  

Supplemental schedule of non-cash investing and financing activities:

                        

Shares issued for conversion of debt (including accrued interest)

   $ 1,299,731     $     $ 1,299,731  

Shares issued to purchase intellectual property

           900       900  

Shares issued for placement agent services in the offering

     969,734             969,734  

Warrants issued for placement agent services in the offering

     633,149             633,149  
    


 


 


     $ 2,902,614     $ 900     $ 2,903,514  
    


 


 


 

SEE ACCOMPANYING NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

 

F-6


Table of Contents

ORION ACQUISITION CORP. II

(A DEVELOPMENT STAGE COMPANY)

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

December 31, 2004

 

1. DESCRIPTION OF BUSINESS

 

Orion Acquisition Corp. II (Orion or the Company), together with its wholly owned operating subsidiary Medivation, Inc. (Medivation), is a life sciences company based in San Francisco, California. The Company’s corporate strategy is to identify and acquire development stage medical technologies—including both pharmaceuticals and medical devices—that have promising scientific, clinical and commercial prospects and strong intellectual property positions, and to develop those technologies through a largely outsourced model to achieve valuation-enhancing milestone events. The Company currently has acquired and is developing two technologies, both of which are small molecule drugs targeted at Alzheimer’s disease. The Company’s lead drug candidate—Dimebon—is scheduled to enter a randomized, double-blind, placebo-controlled Phase II efficacy study in Alzheimer’s disease patients in Russia in the second or third quarter of 2005. The Company’s second drug candidate—NT0904—is in the preclinical research phase. The Company also is evaluating other medical technologies for potential acquisition.

 

2. THE MERGER

 

(a) Description of the Merger

 

On December 17, 2004, Medivation Acquisition Corp., a Delaware corporation and wholly owned subsidiary of the Company, merged with and into Medivation, Inc. (Medivation), a Delaware corporation, pursuant to an Agreement and Plan of Merger, dated as of December 17, 2004. Pursuant to the merger (the Merger), Medivation became a wholly owned subsidiary of the Company, the issued and outstanding shares of common stock of Medivation were converted into an aggregate of 331,925 shares of the Series B Preferred Stock of the Company, which is convertible into an aggregate of 6,638,490 shares of the Company’s Common Stock, and Orion’s pre-Merger cash balances of approximately $1,929,000 became available to fund the ongoing operations of the combined Company. After the Merger, but before giving effect to the Offering described in Note 6(a) below, the former Medivation stockholders owned approximately 81% of the Company’s issued and outstanding Common Stock, assuming conversion of all of the issued and outstanding Series B Preferred Stock and Series A Preferred Stock, and the exercise of all of the issued and outstanding Class B Warrants. Following the Merger, the business conducted by the Company is the business conducted by Medivation prior to the Merger.

 

As a result of the Merger, the 225,500 issued and outstanding Class B Warrants of the Company became exercisable to purchase an aggregate of 225,500 shares of the Company’s Common Stock at an exercise price of $0.125 per share. The Class B Warrants are exercisable until 5PM, New York City Time, on December 17, 2005.

 

(b) Accounting Treatment of the Merger; Financial Statement Presentation

 

The Merger was accounted for as a reverse merger under generally accepted accounting principles. Therefore: (1) the Company’s historical accumulated deficit for periods prior to December 17, 2004, in the amount of $422,120, was eliminated against additional-paid-in-capital, and (2) the consolidated financial statements present the previously issued shares of Series A Preferred Stock and Common Stock of Orion as having been issued pursuant to the Merger on December 17, 2004, and the shares of Series B Preferred Stock of the Company issued to the former Medivation stockholders in the Merger as having been outstanding since October 2003 (the month when Medivation first sold its equity securities). No goodwill or other intangible asset was recorded as a result of the Merger.

 

F-7


Table of Contents

ORION ACQUISITION CORP. II

(A DEVELOPMENT STAGE COMPANY)

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

December 31, 2004

 

(c) Summary Pro Forma Financial Information

 

The following tables set forth (1) the total operating expenses, other income (net of other expense) and net losses of Orion and Medivation for the year ended December 31, 2004, for the period from inception (September 4, 2003) to December 31, 2003 and for the period from inception (September 4, 2003) to December 31, 2004, (2) the consolidated pro-forma information for Orion and Medivation for the above periods assuming that the Merger was completed on September 4, 2003, and (3) the consolidated pro-forma information for the above periods as further adjusted to eliminate Orion’s legal expenses and interest income earned on loans made to Citadel, Inc. as part of the merger agreement between Orion and Citadel, Inc., which was signed on June 23, 2004 and terminated on September 15, 2004, but which would not have been entered into had the Merger been completed on September 4, 2003.

 

Year ended December 31, 2004

 

     Medivation

    Orion

    Pro-forma

    Adjustments

   

Pro-forma,

as-adjusted


 

Total operating expenses

   $ 2,876,298     $ 288,107     $ 3,164,405     $ (109,969 )   $ 3,054,436  

Other income (net of other expense)

     2,151       77,868       80,019       (71,609 )     8,410  

Net income (loss)

   $ (2,874,147 )   $ (210,239 )   $ (3,084,386 )   $ (38,360 )   $ (3,046,026 )

 

Inception (September 4, 2003) to December 31, 2003

 

     Medivation

    Orion

    Pro-forma

    Adjustments

  

Pro-forma,

as-adjusted


 

Total operating expenses

   $ 403,062     $ (28,892 )   $ 374,170        $ 374,170  

Other income (net of other expense)

     1,613       8,774       10,387          10,387  

Net income (loss)

   $ (401,449 )   $ 37,666     $ (363,783 )      $ (363,783 )

 

Inception (September 4, 2003) to December 31, 2004

 

     Medivation

    Orion

    Pro-forma

    Adjustments

   

Pro-forma,

as-adjusted


 

Total operating expenses

   $ 3,279,360     $ 259,215     $ 3,538,575     $ (109,969 )   $ 3,428,606  

Other income (net of other expense)

     3,765       86,642       90,406       (71,609 )     18,797  

Net income (loss)

   $ (3,275,595 )   $ (172,573 )   $ (3,448,169 )   $ (38,360 )   $ (3,409,809 )

 

3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

(a) Basis of Consolidation

 

The consolidated financial statements incorporate the accounts of Orion Acquisition Corp. II, an inactive parent company, and its wholly owned operating subsidiary, Medivation, Inc. All significant inter-company transactions have been eliminated in consolidation.

 

(b) Development Stage Company

 

For the period from inception (September 4, 2003) to date, the Company has been a development stage enterprise, and accordingly, the Company’s operations have been directed primarily toward developing its

 

F-8


Table of Contents

ORION ACQUISITION CORP. II

(A DEVELOPMENT STAGE COMPANY)

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

December 31, 2004

 

proprietary technologies. The Company has experienced net losses since its inception and as of December 31, 2004, had an accumulated deficit of $3,275,595. Such losses and accumulated deficit resulted from the Company’s absence of revenue and significant costs incurred in the development of the Company’s proprietary technologies. The Company expects to incur substantial losses as it continues its research and development activities, particularly the conduct of clinical trials.

 

(c) Estimates

 

The preparation of financial statements in conformity with generally accepted accounting principles requires that management make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Estimates and assumptions principally relate to services performed by third parties but not yet invoiced. Actual results could differ from those estimates.

 

(d) Cash Equivalents

 

The Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. At December 31, 2004, cash and cash equivalents included $10,671,707 in cash and money market securities. The Company deposits cash and cash equivalents with high credit quality financial institutions and is insured to the maximum limitations. The Company presently maintains checking and money market accounts at Bank of America, and a money market account at Wells Fargo Bank. Deposits in these accounts totaled $34,286, $1,791,300 and $448, respectively, as of December 31, 2004, and are insured by the Federal Deposit Insurance Corporation up to a maximum of $100,000. The Company also maintains brokerage accounts at Bank of America and Wells Fargo Bank, with balances of $8,000,000 and $845,673, respectively, as of December 31, 2004, all of which was held in money market funds as of that date. Deposits in these accounts are insured by the Securities Investor Protection Corporation up to a maximum of $500,000 (including cash claims limited to $100,000). In January 2005, the Company used $7,897,851 of the money market funds held it its Bank of America brokerage account to purchase U.S. government debt securities with maturities ranging from April 2005 to November 2005.

 

(e) Property and Equipment

 

Property and equipment purchases incurred to date have been minor and have thus been expensed through December 31, 2004. Property and equipment purchases are recorded at cost. Repairs and maintenance costs are expensed in the period incurred. Items of property and equipment with costs greater than $5,000 will be capitalized and depreciated or amortized on a straight-line basis over the estimated useful lives of the assets as follows:

 

Description


  

Estimated Useful Life


Office equipment; furniture and fixtures

   2-5 years

Leasehold improvements

   Lesser of estimated useful life or life of lease

 

(f) Intellectual Property

 

Intellectual property acquired from third parties is recorded at historical acquisition cost, and at December 31, 2004 consisted of issued patents and pending patent applications. Any milestone payments that become due to third parties from whom the Company has acquired patent rights will be added to intellectual

 

F-9


Table of Contents

ORION ACQUISITION CORP. II

(A DEVELOPMENT STAGE COMPANY)

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

December 31, 2004

 

property acquisition cost and capitalized. Intellectual property consisting of issued patents is amortized over the period beginning on the acquisition date and ending on the expiration date of the patent. Intellectual property consisting of patent applications is amortized over the period beginning on the acquisition date and ending on the expiration date of any patent that may issue on that application. Legal and other costs of prosecuting and maintaining patent rights are expensed as incurred.

 

(g) Income Taxes

 

The Company accounts for income taxes in accordance with SFAS No. 109, “Accounting for Income Taxes,” which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Under this method, deferred income taxes are recognized for the tax consequences in future years of differences between the tax bases of assets and liabilities and their financial reporting amounts at each year-end based on enacted tax laws and statutory tax rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established, when necessary, to reduce deferred tax assets to the amount expected to be realized. The provision for income taxes represents the tax payable for the period and the change during the period in deferred tax assets and liabilities.

 

(h) Research and Development

 

Research and development costs are charged to expense when incurred.

 

(i) Fair Value of Financial Instruments

 

The Company’s financial instruments include cash and cash equivalents and trade payables. At December 31, 2004 the fair values of cash and cash equivalents and trade payables approximated their financial statement carrying amounts.

 

(j) Stock Based Compensation

 

The Company accounts for its stock-based compensation arrangements for employees, contractors and directors using the intrinsic value method pursuant to Accounting Principles Board Opinion (APB) No. 25, “Accounting for Stock Issued to Employees,” as clarified by Financial Accounting Standards Board (FASB) Interpretation No. 44, “Accounting for Certain Transactions Involving Stock Compensation.” As such, compensation expense is recorded when, on the date of grant, the fair value of the underlying common stock exceeds the exercise price for stock options or the purchase price for issuances or sales of common stock. Statement of Financial Accounting Standard (SFAS) No. 123 “Accounting for Stock-Based Compensation,” established a fair value based method of accounting for stock-based compensation plans. The Company has adopted the disclosure only alternative under SFAS 123 which requires disclosure of the pro-forma effects of using the fair value method of accounting for stock-based compensation arrangements on earnings and earnings per share as if SFAS 123 had been adopted. The Company records compensation expense for the fair value of options granted to non-employees.

 

In December 2002, the FASB issued SFAS No. 148, “Accounting for Stock-based Compensation—Transition and Disclosure, an Amendment of FASB Statement No. 123.” SFAS No. 148 amends the disclosure requirements of SFAS No. 123 to require prominent disclosures in both annual and interim financial reports

 

F-10


Table of Contents

ORION ACQUISITION CORP. II

(A DEVELOPMENT STAGE COMPANY)

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

December 31, 2004

 

about the method of accounting for stock-based compensation and the effect of the method used on reported results. To date, the Company has not issued stock options to employees.

 

(k) Impairment or Disposal of Long-lived Assets

 

The Company evaluates its long-lived assets, primarily its intellectual property, for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets or intangibles may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. In the year ended December 31, 2004, the Company wrote off $75,000 of its historical patent acquisition costs to reflect management’s decision to stop work on a patent application that does not cover either of the Company’s Dimebon or NT0904 product candidates. Assets to be disposed of are reported at the lower of the carrying amount or fair value less cost to sell. The impairment amount is included in research and development expenses.

 

(l) Loss per Common Share

 

The Company calculates loss per share in accordance with SFAS No. 128, “Earnings per Share.” Basic loss per share is computed by dividing the loss available to common shareholders by the weighted-average number of common shares outstanding. Diluted loss per share is computed similar to basic loss per share except that the denominator is increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive.

 

The following potential common shares have been excluded from the computation of diluted net loss per share for the periods ended December 31, 2004 and 2003 because they are antidilutive:

 

Series B Preferred Stock

   6,638,490

Series A Preferred Stock

   110,000

Warrants

   1,049,991

Options

   616,556
    

TOTAL

   8,415,037
    

 

(m) Reclassifications

 

Certain prior year amounts have been reclassified in order to conform to current year presentation.

 

(n) Recently Issued Accounting Pronouncements

 

SFAS No. 151

 

In November 2004, the FASB issued SFAS No. 151, “Inventory Costs.” SFAS No. 151 amends the accounting for abnormal amounts of idle facility expense, freight, handling costs, and wasted material (spoilage) under the guidance in ARB No. 43, Chapter 4, “Inventory Pricing.” Paragraph 5 of ARB No. 43, Chapter 4, previously stated that “…under some circumstances, items such as idle facility expense, excessive spoilage, double freight, and rehandling costs may be so abnormal as to require treatment as current period charges….” This Statement requires that those items be recognized as current-period charges regardless of whether they meet

 

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ORION ACQUISITION CORP. II

(A DEVELOPMENT STAGE COMPANY)

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

December 31, 2004

 

the criterion of “so abnormal.” In addition, this Statement requires that allocation of fixed production overheads to the costs of conversion be based on the normal capacity of the production facilities. This statement is effective for inventory costs incurred during fiscal years beginning after June 15, 2005. Management does not expect adoption of SFAS No. 151 to have any impact on the Company’s financial statements.

 

SFAS No. 152

 

In December 2004, the FASB issued SFAS No. 152, “Accounting for Real Estate Time-Sharing Transactions.” The FASB issued this Statement as a result of the guidance provided in AICPA Statement of Position (SOP) 04-2, “Accounting for Real Estate Time-Sharing Transactions.” SOP 04-2 applies to all real estate time-sharing transactions. Among other items, the SOP provides guidance on the recording of credit losses and the treatment of selling costs, but does not change the revenue recognition guidance in SFAS No. 66, “Accounting for Sales of Real Estate,” for real estate time-sharing transactions. SFAS No. 152 amends Statement No. 66 to reference the guidance provided in SOP 04-2. SFAS No. 152 also amends SFAS No. 67, “Accounting for Costs and Initial Rental Operations of Real Estate Projects”, to state that SOP 04-2 provides the relevant guidance on accounting for incidental operations and costs related to the sale of real estate time-sharing transactions. SFAS No. 152 is effective for years beginning after June 15, 2005, with restatements of previously issued financial statements prohibited. This statement is not applicable to the Company.

 

SFAS No. 153

 

In December 2004, the FASB issued SFAS No. 153, “Exchanges of Nonmonetary Assets,” an amendment to Opinion No. 29, “Accounting for Nonmonetary Transactions.” Statement No. 153 eliminates certain differences in the guidance in Opinion No. 29 as compared to the guidance contained in standards issued by the International Accounting Standards Board. The amendment to Opinion No. 29 eliminates the fair value exception for nonmonetary exchanges of similar productive assets and replaces it with a general exception for exchanges of nonmonetary assets that do not have commercial substance. Such an exchange has commercial substance if the future cash flows of the entity are expected to change significantly as a result of the exchange. SFAS No. 153 is effective for nonmonetary asset exchanges occurring in periods beginning after June 15, 2005. Earlier application is permitted for nonmonetary asset exchanges occurring in periods beginning after December 16, 2004. Management does not expect adoption of SFAS No. 153 to have any impact on the Company’s financial statements.

 

SFAS No. 123(R)

 

In December 2004, the FASB issued SFAS No. 123(R), “Share-Based Payment.” SFAS 123(R) amends SFAS No. 123, “Accounting for Stock-Based Compensation,” and APB Opinion 25, “Accounting for Stock Issued to Employees.” SFAS No. 123(R) requires that the cost of share-based payment transactions (including those with employees and non-employees) be recognized in the financial statements. SFAS No. 123(R) applies to all share-based payment transactions in which an entity acquires goods or services by issuing (or offering to issue) its shares, share options, or other equity instruments (except for those held by an ESOP) or by incurring liabilities (1) in amounts based (even in part) on the price of the entity’s shares or other equity instruments, or (2) that require (or may require) settlement by the issuance of an entity’s shares or other equity instruments. This statement is effective (1) for public companies qualifying as SEC small business issuers, as of the first interim period or fiscal year beginning after December 15, 2005, or (2) for all other public companies, as of the first interim period or fiscal year beginning after June 15, 2005, or (3) for all nonpublic entities, as of the first fiscal

 

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ORION ACQUISITION CORP. II

(A DEVELOPMENT STAGE COMPANY)

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

December 31, 2004

 

year beginning after December 15, 2005. Management is currently assessing the effect of SFAS No. 123(R) on the Company’s financial statements.

 

4. INTELLECTUAL PROPERTY

 

At December 31, 2004, intellectual property consisted of three patent families—one covering the use of Dimebon and certain related compounds to treat neurodegenerative diseases, one covering the use of Dimebon and certain related compounds for anti-aging purposes, and one covering the NT0904 family of compounds and uses thereof. Cash purchases of patent rights totaled $200,000 in the year ended December 31, 2004 and $25,000 in the period from inception (September 4, 2003) to December 31, 2003. This intellectual property is being amortized over periods ranging from 156 months to 248 months. Amortization expense on the Company’s intellectual property was $5,940 in the year ended December 31, 2004, and $332 in the period from inception (September 4, 2003) to December 31, 2003. Total amortization expenses under the foregoing schedule in the years ended December 31, 2005 through December 31, 2009 for intellectual property costs capitalized on or before December 31, 2004 will be $8,274 per year.

 

5. CONVERTIBLE NOTES WITH WARRANTS

 

Between October 10, 2003 and September 1, 2004, Medivation issued convertible promissory notes, with associated warrant coverage, in a series of transactions with two investors. The notes bore interest at a rate of 4.5% per year, were convertible into the class of equity securities issued by Medivation at its next equity financing at the same price per share as paid by investors in that equity financing, and matured on October 10, 2004. The associated warrants were exercisable to purchase shares of the class of equity securities issued by Medivation in its next equity financing at the same price per share as paid by investors in that equity financing. Using the Black-Scholes option pricing model and the following assumptions as of the dates these warrants were issued—stock price of $0.0004; historical volatility of 90%; risk free rate of approximately 4.5%; dividend yield of 0%; and warrant life of 10 years—the warrants were assigned no value. Accordingly, 100% of the proceeds received by Medivation in these financing transactions were allocated to the convertible notes. The following table summarizes these convertible note transactions.

 

Date


   Principal
Balance of
Note


October 10, 2003

   $ 1,000,000

April 1, 2004

     250,000

June 8, 2004

     200,000

August 1, 2004

     200,000

September 1, 2004

     200,000

 

Principal and accrued interest on these convertible notes as of December 17, 2004 was $1,922,450. A total of $1,299,731 of this amount was converted in the Offering into 838,536 shares of Common Stock at a price of $1.55 per share, and the remaining $622,720 (consisting of $595,861 in principal plus $26,859 in accrued interest) was repaid from proceeds of the Offering. The outstanding balance on these convertible notes as of December 31, 2004 was $0. The associated warrants were assumed by the Company in the Merger and became exercisable to purchase an aggregate of 238,709 shares of the Company’s Common Stock at an exercise price of $1.55 per share. The warrants are fully vested and expire in 2013 and 2014.

 

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Table of Contents

ORION ACQUISITION CORP. II

(A DEVELOPMENT STAGE COMPANY)

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

December 31, 2004

 

6. STOCKHOLDER’S EQUITY

 

(a) Common Stock

 

On December 17, 2004, the Company issued 7,741,935 shares of its Common Stock in a private placement to accredited investors at a price of $1.55 per share (the Offering), 6,903,399 of which were sold for cash, generating $10,700,270 in gross proceeds. The remaining 838,536 shares were issued in exchange for cancellation of outstanding bridge notes of Medivation, in the aggregate amount of $1,299,731, which were assumed by the Company in the Merger (Note 5). The shares issued in the Offering were not subject to refund, redemption or rescission and, accordingly, were included as a component of stockholders’ equity, net of the applicable costs.

 

MDB Capital Group LLC (MDB) acted as placement agent with respect to certain investors in the Offering. As partial compensation for these services, the Company issued to MDB and certain of its affiliates an aggregate of 572,878 shares of Common Stock. The cost of these shares, in the amount of $887,961 based on the $1.55 purchase price of the shares in the Offering, was offset against additional paid-in-capital in the year ended December 31, 2004. MDB also received warrants as partial compensation for its placement agent services (Note 6(c)).

 

Brock Capital Group LLC (Brock) acted as placement agent with respect to certain investors in the Offering. As compensation for these services, the Company issued to Brock and certain of its affiliates an aggregate of 52,821 shares of Common Stock. The cost of these shares, in the amount of $81,873 based on the $1.55 purchase price of the shares in the Offering, was offset against additional paid-in-capital in the year ended December 31, 2004.

 

In connection with the Merger and the Offering, the Company, the former stockholders of Medivation, the investors in the Offering and MDB have entered into registration rights agreements, pursuant to which the Company has agreed to register with the Securities and Exchange Commission for re-offer and re-sale (a) the 6,638,490 shares of Common Stock issuable upon conversion of the Series B Preferred Stock received by the former stockholders of Medivation in the Merger, (b) the 7,741,935 shares of Common Stock sold in the Offering, and (c) the 572,878 shares of Common Stock issued to MDB, and the 572,878 shares of Common Stock issuable upon exercise of the warrant issued to MDB, for placement agent services rendered in connection with the Offering. The Company has agreed with investors in the Offering to file the registration statement no later than January 31, 2005, and to arrange to have the registration statement declared effective no later than March 31, 2005, and must pay the investors in the Offering an aggregate of $6,000 for each day that the Company misses either or both of these deadlines. The Company intends to include in the registration statement an additional 477,113 shares of its Common Stock underlying outstanding warrants, and the 52,821 shares of Common Stock issued to Brock Capital Group LLC as compensation for placement agent services in the Offering.

 

(b) Preferred Stock

 

The Company is authorized to issue 1,000,000 shares of preferred stock with such designations, voting, and other rights and preferences as may be determined from time to time by the Board of Directors.

 

Series A Convertible Redeemable Preferred Stock. The Company has outstanding 110 shares of Series A Convertible Redeemable Preferred Stock, which it issued for an aggregate purchase price of $11,000. The Series A Convertible Redeemable Preferred Stock is non-voting and does not bear dividends. Each share of Series A Convertible Redeemable Preferred Stock is convertible into 1,000 shares of the Company’s Common Stock at

 

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ORION ACQUISITION CORP. II

(A DEVELOPMENT STAGE COMPANY)

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

December 31, 2004

 

any time until December 17, 2005. The Series A Convertible Redeemable Preferred Stock is redeemable at any time, at the option of the holder(s) thereof, for a redemption price equal to its original purchase price. Because of this redemption feature, the Series A Convertible Redeemable Preferred Stock is reflected as a liability on the consolidated financial statements.

 

Series B Convertible Preferred Stock. Pursuant to the Merger, on December 17, 2004, the 2,700,000 issued and outstanding shares of Medivation Common Stock, $0.001 par value per share, were converted into an aggregate of 331,925 shares of Series B Convertible Preferred Stock of the Company. The shares of Medivation Common Stock were issued in private transactions in October 2003 for an aggregate price of $2,700. Payment for 1,800,000 of these shares was in cash, and payment for the remaining 900,000 shares was in intellectual property.

 

Each outstanding share of Series B Convertible Preferred Stock will convert automatically into 20 shares of Common Stock (subject to normal adjustments) at such time as the Company increases the number of authorized shares of Common Stock to be equal to or in excess of 25,000,000. The Series B Convertible Preferred Stock has no liquidation rights in preference to the Common Stock, no redemption rights, and no right to dividends, unless dividends are paid to holders of the Common Stock. Until the Series B Convertible Preferred Stock converts into Common Stock, (1) all matters submitted for a vote or consent of the stockholders of the Company will require approval of a majority of the outstanding shares of Series B Convertible Preferred Stock, voting separately as a series, and of a majority of the outstanding shares of Common Stock of the Company on an as-converted basis, (2) the holders of the Series B Convertible Preferred Stock have the right to nominate one member of the Company’s board of directors, and (3) all matters submitted for a vote or consent of the board of directors of the Company require the approval of Series B Board Representative.

 

Because the number of authorized shares of the Company’s common stock is not currently sufficient for the conversion of all of the shares Series B Convertible Preferred Stock, full conversion is contingent on the amendment of the Company’s certificate of incorporation to increase the number of authorized common shares. Pursuant to EITF 00-19, “Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock,” the fair value of the Series B Convertible Preferred Stock has been recorded as a current liability until the Company has sufficient authorized shares available to be delivered if the Series B Convertible Preferred Stock is converted to common stock.

 

(c) Warrants

 

On November 16, 2004, Medivation issued warrants to purchase its equity securities to two officers in return for their agreement to guarantee specified professional fees incurred by Medivation related to the Merger. These warrants were assumed by the Company in the Merger, and became exercisable to purchase an aggregate of 12,904 shares of the Company’s Common Stock at a price of $1.55 per share. The fair value of these warrants in the amount of $17,505 (based on the Black-Scholes option pricing model and the following assumptions: stock price of $1.55; historical volatility of 90%; risk free rate of approximately 4.5%; dividend yield of 0%; and warrant life of 10 years) was recorded as an expense in the statement of operations for the year ended December 31, 2004.

 

MDB Capital Group LLC (MDB) acted as placement agent with respect to certain investors in the Offering. As partial compensation for these services, the Company issued to MDB and certain of its affiliates warrants to purchase an aggregate of 572,878 shares of Common Stock at a price of $1.55 per share, exercisable for a period beginning on December 17, 2004 and ending five years thereafter. The fair value of these warrants is $633,149, based on the Black-Scholes option pricing model and the following assumptions: stock price of $1.55; historical

 

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ORION ACQUISITION CORP. II

(A DEVELOPMENT STAGE COMPANY)

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

December 31, 2004

 

volatility of 90%; risk free rate of approximately 4.5%; dividend yield of 0%; and warrant life of 5 years. Pursuant to Emerging Issues Task Force 00-19, “Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock,” the fair value of these warrants has been recorded as a current liability until the Company has sufficient authorized shares available to be delivered if the warrants were exercised. In addition, the Company is required to report the fluctuation to the fair value of the warrant liability in current operations. During the period from December 17, 2004 to December 31, 2004, the fair value of these warrants did not change.

 

(d) Equity Incentive Plan

 

Pursuant to the Merger, the Company assumed the Medivation Equity Incentive Plan (the Equity Incentive Plan), and reserved an aggregate of 1,106,415 shares of its Common Stock for issuance upon the exercise of awards granted under the Equity Incentive Plan.

 

The Equity Incentive Plan provides for the issuance of options and other equity-based awards, including restricted stock and stock appreciation rights. Options granted under the Equity Incentive Plan may be nonqualified or qualified incentive stock options under Section 422A of the Internal Revenue Code of 1986, as amended. The Equity Incentive Plan is administered by our board of directors, or a committee appointed by the Board, which determines recipients and types of options to be granted, including the vesting schedule, the number of shares subject to the options and the exercisability of the options. The term of the stock options granted under the Equity Incentive Plan may not exceed ten years. The exercise price for all options is determined by our board of directors, or by a committee appointed by the board, at the time of grant. The options may, but need not, contain provisions for early exercise and the right of first refusal. No incentive stock option may be granted to any person who, at the time of the grant, owns, or is deemed to own, stock constituting more than 10% of our total combined voting power, unless the option exercise price is at least 110% of the fair market value of the stock subject to the option on the date of grant, and the term of the option does not exceed five years from the date of grant.

 

Options granted under the Equity Incentive Plan vest at the rate specified in each optionee’s option agreement. Unless determined otherwise by the administrator of the Equity Incentive Plan, no stock option may be transferred by the optionee other than by will or the laws of descent or distribution and may be exercised during the lifetime of the optionee only by the optionee. An optionee whose relationship with us or any affiliate ceases for any reason, other than by death or permanent or total disability, may exercise options within the period of time as is specified in the optionee’s option agreement, which typically is at least thirty days. If no period of time is specified in the optionee’s option agreement, then the option is exercisable for a period of three months. When an optionee’s relationship with us or any affiliate ceases due to death or permanent or total disability, options may be exercised within the period of time as is specified in the optionee’s option agreement, which typically is at least six months. If no period of time is specified in the optionee’s option agreement, then the option is exercisable for a period of twelve months.

 

Upon our change in control, all outstanding options under the Equity Incentive Plan will be accelerated and become immediately exercisable. A change of control is defined in the Equity Incentive Plan to include, subject to certain exceptions (i) the acquisition, directly or indirectly, by any “person” or “group” (as defined in the Securities Exchange Act of 1934, as amended, and the rules thereunder) of “beneficial ownership” (as defined in the Securities Exchange Act of 1934, as amended, and the rules thereunder) of our voting securities that represent 50% or more of our combined outstanding voting power; (ii) during any period of two consecutive years, individuals who, at the beginning of such period, constitute our board of directors together with any new

 

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ORION ACQUISITION CORP. II

(A DEVELOPMENT STAGE COMPANY)

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

December 31, 2004

 

director(s), cease for any reason to constitute a majority thereof; (iii) the consummation, whether directly or indirectly and subject to certain exceptions, of (x) a merger, consolidation, reorganization, or business combination or (y) a sale or other disposition of all or substantially all of our assets or (z) our acquisition of assets or stock of another entity and (iv) our liquidation or dissolution. The Merger and the Offering did not constitute a change of control under the Equity Incentive Plan.

 

A summary of the status of the Equity Incentive Plan as of December 31, 2004 and the year then ended is presented below.

 

     2004

Fixed Options


   Shares

   Weighted-Average
Exercise Price


Outstanding at beginning of year

     0      —  

Granted

     616,556    $ 0.85

Exercised

     0      —  

Forfeited

     0      —  

Outstanding at year end

     616,556    $ 0.85

Weighted-average fair value of options granted during the year

   $ 1.43       

Weighted-average fair value of exercisable options

   $ 1.43       

 

The following table summarizes information about fixed stock options outstanding at December 31, 2004:

 

     Options Outstanding

   Options Exercisable

Exercise Prices


   Number
Outstanding at
12/31/04


   Weighted-Average
Remaining
Contractual Life


   Weighted-Average
Exercise Price


   Number
Exercisable at
12/31/04


   Weighted-Average
Exercise Price


$0.02

   280,717    9.5 years    $ 0.02    280,717    $ 0.02

$1.55

   335,839    10 years    $ 1.55    335,839    $ 1.55

 

All of the 616,556 options outstanding under the Equity Incentive Plan as of December 31, 2004 were issued by Medivation to its consultants. As of December 31, 2004, all 616,556 options were exercisable, but the shares of Common Stock issuable upon exercise of those options remained subject to repurchase at the option exercise price if the optionee’s term of service for Medivation ends. At December 31, 2004, 489,859 options were available for future grants under the Equity Incentive Plan.

 

For the year ended December 31, 2004, the Company recorded a stock-based compensation expense of $109,265 to reflect the appropriate portion of the total cost of the 616,556 options granted in 2004. All such options were granted to consultants as partial or total compensation for services to be provided under consulting agreements.

 

These options were assigned an aggregate value of $882,719 as of December 31, 2004 using the Black-Scholes option pricing model and the following assumptions: stock price of $1.55; historical volatility of 90%; risk free rate of approximately 4.5%; dividend yield of 0%; and option life of approximately 9.5 years. In accordance with Emerging Issues Task Force (EITF) Issue No. 96-18, “Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services,” and EITF Issue No. 00-18, “Accounting Recognition for Certain Transactions Involving Equity Instruments Granted to Other Than Employees,” the stock-based compensation expense recorded in the Company’s Statement of Operations for the year ended December 31, 2004, in the amount of $109,265, reflected the portion of the

 

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ORION ACQUISITION CORP. II

(A DEVELOPMENT STAGE COMPANY)

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

December 31, 2004

 

aggregate option value corresponding to the aggregate number of shares vested on the options through that date. As further portions of these options are earned in the future, the Company will recognize additional expense based on their then-current fair market value.

 

(e) Equity Transactions Related to the Reverse Merger

 

Because the Merger was accounted for as a reverse merger under generally accepted accounting principles, (1) the Company’s historical accumulated deficit for periods prior to December 17, 2004, in the amount of $422,120, was eliminated against additional-paid-in-capital, and (2) the consolidated financial statements present the previously issued shares of Series A Preferred Stock and Common Stock of Orion as having been issued pursuant to the Merger on December 17, 2004, and the shares of Series B Preferred Stock of the Company issued to the former Medivation stockholders in the Merger as having been outstanding since October 2003 (the month when Medivation first sold its equity securities).

 

7. COMMITMENTS AND CONTINGENCIES

 

The Company leases office facilities under a non-cancelable operating lease that expires in October 2005. Total rent expense under this operating lease for the year ended December 31, 2004 and for the period from inception (September 4, 2003) through December 31, 2003 was $62,517 and $10,420, respectively. Future lease obligations under this non-cancelable operating lease as of December 31, 2004 are $52,098.

 

The Company’s intellectual property at December 31, 2004 consisted of three patent families purchased by the Company from third parties (Note 4). The purchase agreements require the Company to make certain milestone payments upon the occurrence of stated events, and to pay royalties on the sale of any products covered by such purchased patent rights.

 

8. INCOME TAXES

 

The tax effects of temporary differences which give rise to the deferred tax provision at December 31, 2004 consisted of the following:

 

Deferred tax assets

        

Net operating loss carryforward

   $ 1,267,807  

Warrant based compensation

     54,308  

State tax-deferred

     (58,384 )

Less valuation allowance

     (1,263,731 )
    


Net deferred tax assets

   $  
    


 

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ORION ACQUISITION CORP. II

(A DEVELOPMENT STAGE COMPANY)

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

December 31, 2004

 

The following table presents the current and deferred income tax provision for (benefit from) federal and state income taxes for the year ended December 31, 2004 and for the period from inception (September 4, 2003) to December 31, 2003:

 

     Year ended
Dec. 31, 2004


   Inception
(Sept. 4, 2003) to
Dec. 31, 2003


Current

             

Federal

   $    $

State

     1,600      800
    

  

       1,600      800
    

  

Deferred

             

Federal

         

State

         
    

  

     $ 1,600    $ 800
    

  

 

The provision for income taxes differs from the amount that would result from applying the federal statutory rate for the year ended December 31, 2004 and for the period from inception (September 4, 2003) to December 31, 2003 as follows:

 

     Year ended
Dec. 31, 2004


    Inception
(Sept. 4, 2003) to
Dec. 31, 2003


 

Statutory regular federal income benefit rate

   (34.0 )%   (34.0 )%

State taxes

   (3.0 )%   (2.8 )%

Prior year adjustments

   (1.9 )%    

Change in valuation allowance

   38.8 %   36.9 %

Other

   0.1 %   (0.1 )%
    

 

Total

   0.0 %   0.0 %
    

 

 

The valuation allowance increased by $1,115,982 and $147,749 during the year ended December 31, 2004, and for the period from inception (September 4, 2003) to December 31, 2003, respectively. The deferred income tax benefit of the loss carryforward is the only significant deferred income tax asset or liability of the Company and has been offset by a valuation allowance since management does not believe the recoverability of this deferred tax asset during the next fiscal year is more likely than not. Accordingly, a deferred income tax benefit for the year ended December 31, 2004 has not been recognized in these financial statements.

 

As December 31, 2004, the Company had net operating loss carryforwards for federal and state income tax purposes of approximately $3,207,000 and $1,961,000, respectively. The net operating loss carryforwards begin expiring in 2022 and 2012, respectively.

 

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Table of Contents

ABOUT THIS PROSPECTUS

 

You should rely only on the information contained in this prospectus or to which we have referred you in this prospectus. We have not authorized anyone to provide you with information that is different. This prospectus may only be used where it is legal to sell the common stock covered by this prospectus. The information in this prospectus may only be accurate as of the date of this prospectus.

 


 

Medivation is a trademark in the U.S. This prospectus includes product names, trade names and trademarks of other companies. All other product names, trade names and trademarks appearing in this prospectus are the property of their respective holders. Aricept®, Exelon®, Reminyl® and Namenda® are registered trademarks of Pfizer Inc. and Eisai Co., Ltd., Novartis AG, Johnson & Johnson and Forest Laboratories, Inc., respectively; and, without limitation, any product name, trade name, or trademark in this prospectus followed immediately with the ® or  symbol is meant to indicate that the company has no product name, trade name, or trademark or other intellectual property rights with respect to such word.


Table of Contents

Prospectus

 

 


 

ORION ACQUISITION CORP. II

 

Up to 16,056,115 Shares

Common Stock, par value $0.01 per share

 


 

 

The date of this prospectus is                         , 2005


Table of Contents

PART II.

INFORMATION NOT REQUIRED IN PROSPECTUS

 

Item 24. Indemnification of Directors and Officers.

 

Delaware General Corporation Law

 

Section 145 of the Delaware General Corporation Law provides that a corporation may indemnify directors and officers as well as other employees and individuals against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by such person in connection with any threatened, pending or completed actions, suits or proceedings in which such person is made a party by reason of such person being or having been a director, officer, employee or agent to the company. The Delaware General Corporation Law provides that Section 145 is not exclusive of other rights to which those seeking indemnification may be entitled under any bylaw, agreement, vote of stockholders or disinterested directors or otherwise.

 

Section 102(b)(7) of the Delaware General Corporation Law permits a corporation to provide in its certificate of incorporation that a director of the corporation shall not be personally liable to the corporation or its stockholders for monetary damages for breach of fiduciary duty as a director, except for liability for any breach of the director’s duty of loyalty to the corporation or its stockholders, for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law, for unlawful payments of dividends or unlawful stock repurchases, redemptions or other distributions or for any transaction from which the director derived an improper personal benefit.

 

Amended and Restated Certificate of Incorporation

 

Article Ninth of the amended and restated certificate of incorporation of the company provides that the personal liability of the directors of the company shall be eliminated to the fullest extent permitted by the provisions of Section 102(b)(7) of the Delaware General Corporation Law, as the same may be amended and supplemented.

 

Article Tenth of the amended and restated certificate of incorporation of the company provides that the company shall, to the fullest extent permitted by the provisions of Section 145 of the Delaware General Corporation Law, as the same may be amended and supplemented, indemnify any and all persons whom it shall have power to indemnify under said section from and against any and all of the expenses, liabilities or other matters referred to in or covered by said section, and the indemnification provided for therein shall not be deemed exclusive of any other rights to which those indemnified may be entitled under any bylaw, agreement, vote of stockholders or disinterested directors or otherwise, both as to action in his official capacity and as to action in another capacity while holding such office, and shall continue as to a person who has ceased to be a director, officer, employee or agent and shall inure to the benefit of the heirs, executors and administrators of such a person.

 

Indemnification Agreements

 

We also enter into indemnification agreements with our directors and officers. The indemnification agreements provide indemnification to our directors and officers under certain circumstances for acts or omissions which may not be covered by directors’ and officers’ liability insurance.

 

Liability Insurance

 

We have also obtained directors’ and officers’ liability insurance, which insures against liabilities that our directors or officers may incur in such capacities.

 

II-1


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Registration Rights Agreements

 

Section 6 of each of the registration rights agreements of the selling stockholders provides that we will indemnify and hold harmless each selling stockholder and its officers, directors, members, employees and agents, successors and assigns, and each other person, if any, who controls such selling stockholder within the meaning of the Securities Act, against any losses, claims, damages or liabilities, joint or several, to which they may become subject under the Securities Act or otherwise, insofar as such losses, claims, damages or liabilities (or actions in respect thereof) arise out of or are based upon (a) any untrue statement or alleged untrue statement of any material fact contained in the registration statement, preliminary prospectus or final prospectus contained therein, or any amendment or supplement thereof; (b) any blue sky application or other document executed by us specifically for that purpose or based upon written information furnished by us filed in any state or other jurisdiction in order to qualify any or all of the registrable securities under the securities laws thereof; (c) the omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading; (d) any violation by us or our agents of any rule or regulation promulgated under the Securities Act applicable to us or our agents and relating to action or inaction required of us in connection with such registration; or (e) any failure to register or qualify the securities covered by the registration statement included in any such registration in any state where we or our agents have affirmatively undertaken or agreed in writing that we will undertake such registration or qualification on behalf of any selling stockholder, and will reimburse such selling stockholder, and each such officer, director or member and each such controlling person for any legal or other expenses reasonably incurred by them in connection with investigating or defending any such loss, claim, damage, liability or action; provided, however, that we will not be liable in any such case if and to the extent that any such loss, claim, damage or liability arises out of or is based upon an untrue statement or alleged untrue statement or omission or alleged omission so made in conformity with information furnished by such selling stockholder or any such controlling person in writing specifically for use in such registration statement or prospectus.

 

Item 25. Other Expenses of Issuance and Distribution.

 

The following table sets forth all expenses to be paid by us, other than underwriting discounts and commissions, in connection with this offering. Pursuant to registration rights agreements entered into by and among us and certain selling stockholders, subject to certain exceptions, we have agreed to pay all expenses of the company and all reasonable expenses of the selling stockholders (excluding transfer taxes and underwriters’ discounts, commissions and the like of the selling stockholders), in each case incurred in connection with the registration of the shares of common stock covered by the prospectus of which this registration statement forms a part. All amounts shown are estimates other than the registration fee.

 

     Amount to be Paid

SEC registration fee

     6,143

Printing and engraving

     50,000

Legal fees and expenses

     100,000

Accounting fees and expenses

     100,000

Blue sky fees and expenses (including legal fees)

     15,000

Transfer agent and registrar fees

     10,000

Miscellaneous

     8,857
    

Total

   $ 290,000
    

 

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Item 26. Recent Sales of Unregistered Securities.

 

Since February 1, 2002, we have issued the following unregistered securities.

 

Option Grants

 

On December 17, 2004, in connection with the merger, we issued options exercisable for 335,839 shares of common stock to a consultant under our 2004 Equity Incentive Plan at an exercise price of $1.55 per share. In addition, in connection with the merger, we assumed options exercisable for 280,717 shares of common stock at an exercise price of $0.02 per share. These transactions were effected in reliance on Section 4(2) of the Securities Act. Each of the recipients in these transactions is financially sophisticated and had access to adequate information concerning the company.

 

Warrants

 

On December 17, 2004, in connection with the financing, we issued warrants exercisable for 572,878 shares of common stock to MDB Capital Group LLC, an accredited investor, at an exercise price of $1.55 per share with respect to services provided to us in connection with the financing. In addition, in connection with the merger, we assumed warrants exercisable for 251,613 shares of common stock at an exercise price of $1.55 per share. These transactions were effected in reliance on Section 4(2) of the Securities Act. Each of these recipients is financially sophisticated and had access, either individually or through their representatives, to adequate information concerning the company.

 

Common Stock

 

On December 17, 2004, in connection with the financing, we issued 7,741,935 shares of our common stock to accredited investors at a purchase price of $1.55 for an aggregate consideration of $11,999,999.25, paid with a combination of cash and the cancellation of certain preexisting indebtedness of Medivation. This transaction was effected in reliance on Rule 506 of Regulation D under the Securities Act. Each of these recipients is financially sophisticated and had access, either individually or through their representatives, to adequate information concerning the company.

 

On December 17, 2004, in connection with the financing, we issued 625,699 shares of common stock to Brock Capital Group, LLC and MDB Capital Group, LLC, each of whom is an accredited investor with respect to services provided to us in connection with the financing. These transactions were effected in reliance on Section 4(2) of the Securities Act.

 

On August 5, 2004, in connection with the settlement of legal proceedings then pending against us, we issued 182,600 shares of common stock in exchange for the cancellation of 132,600 Class B Warrants. This transaction was effected in reliance on Section 3(a)(9) of the Securities Act. No consideration or other renumeration was given or paid, directly or indirectly, for the exchange.

 

Preferred Stock

 

On December 17, 2004, in connection with the merger, we issued 331,925 shares of Series B Preferred Stock to David T. Hung, M.D., C. Patrick Machado, Selena Pharmaceuticals, Inc. and Dara BioSciences, Inc., the four former stockholders of Medivation. These transactions were effected in reliance on Section 4(2) of the Securities Act. Each of these recipients is financially sophisticated and had access, either individually or through their representatives, to adequate information concerning the company.

 

Since February 1, 2002, Medivation, Inc. has issued the following unregistered securities.

 

Option Grants

 

Since Medivation’s inception in September 2003, Medivation has granted options to purchase 114,173 shares of its common stock to two of its consultants under its 2003 Equity Incentive Plan at exercise prices of $0.05 per share. These transactions were effected under Rule 701 of the Securities Act.

 

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Common Stock

 

On October 10, 2003 Medivation issued 900,000 shares of its common stock to Selena Pharmaceuticals, Inc., an accredited investor, in exchange for assignment of intellectual property rights. This transaction was effected in reliance on Rule 506 of Regulation D under the Securities Act.

 

On October 10, 2003 Medivation issued 900,000 shares of its common stock to Dara BioSciences, Inc. in exchange for $900 in cash. This transaction was effected in reliance on Rule Section 4(2) of the Securities Act.

 

On October 20, 2003, Medivation issued 700,000 shares and 200,000 shares of its common stock to David T. Hung, M.D. and C. Patrick Machado, each of whom are accredited investors, for $700 and $200 in cash, respectively. This transaction was effected in reliance on Rule Section 4(2) of the Securities Act.

 

Convertible Promissory Notes and Warrants

 

On October 10, 2003, Medivation issued a convertible promissory note having a principal amount of $1,000,000 and associated warrants to purchase capital stock of Medivation to Dara BioSciences, Inc., an accredited investor, in exchange for $1,000,000 in cash. This transaction was effected in reliance on Rule 506 of Regulation D under the Securities Act.

 

On April 1, 2004, Medivation issued a convertible promissory note having a principal amount of $250,000 and associated warrants to purchase capital stock of Medivation to Dara BioSciences, Inc., an accredited investor, in exchange for $250,000 in cash. This transaction was effected in reliance on Rule 506 of Regulation D under the Securities Act.

 

On June 8, 2004, Medivation issued a convertible promissory note having a principal amount of $200,000 and associated warrants to purchase capital stock of Medivation to Joseph Grano, an accredited investor, in exchange for $200,000 in cash. This transaction was effected in reliance on Rule 506 of Regulation D under the Securities Act.

 

On each of August 1, 2004 and September 1, 2004, Medivation issued a convertible promissory note having a principal amount of $200,000 and associated warrants to purchase capital stock of Medivation to Joseph Grano, an accredited investor, in exchange for an aggregate cash investment of $400,000 in cash. These transactions were effected in reliance on Rule Section 4(2) of the Securities Act.

 

On November 16, 2004, Medivation issued to each of David T. Hung and C. Patrick Machado, each of whom are accredited investors, warrants to purchase shares of its capital stock in exchange for the execution by them of guarantees of professional fees incurred by Medivation. These transactions were effected in reliance on Rule Section 4(2) of the Securities Act.

 

With respect to the transactions indicated above to have been effected in reliance on Section 4(2) of the Securities Act, recipients of securities in each such transaction represented their intentions to acquire the securities for investment only and not with a view to or for sale in connection with any distribution thereof and appropriate legends were affixed to the instruments representing such securities issued in such transactions. All recipients either received adequate information about Medivation or had adequate access, through their relationships with Medivation, to such information.

 

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Item 27. Exhibits.

 

Exhibit No.

 

Exhibit Description


  2.1   Agreement and Plan of Merger dated as of December 17, 2004, by and among the Orion Acquisition Corp. II, Medivation Acquisition Corp. and Medivation, Inc.(1)
  3.1(a)   Form of Certificate of Common Stock, par value $0.01 per share, of Orion Acquisition Corp. II (2)
  3.1(b)   Form of Certificate of Series B Convertible Preferred Stock, par value $0.01 per share, of Orion Acquisition Corp. II*
  3.1(c)   Amended and Restated Certificate of Incorporation of Orion Acquisition Corp. II (3)
  3.1(d)   Certificate of Amendment of Amended and Restated Certificate of Incorporation of Orion Acquisition Corp. II (4)
  3.1(e)   Form of Certificate of Designations of the Series B Convertible Preferred Stock of Orion Acquisition Corp. II (5)
  3.1(f)   Amended and Restated Certificate of Designations of the Series B Convertible Preferred Stock of Orion Acquisition Corp. II (6)
  3.2   Bylaws of Orion Acquisition Corp. II, together with all amendments and restatements thereto (7)
  4.1   Warrant Agency Agreement between American Stock Transfer & Company and Orion Acquisition Corp. II, dated April 1, 1996 (8)
  4.2   Form of Class B Unit Purchase Agreement of Orion Acquisition Corp. II (9)
  4.3   Form of Certificate of the Class B Warrants of Orion Acquisition Corp. II (10)
  5.1   Opinion of Latham & Watkins LLP
  9.1(a)   Voting Agreement by and between Orion Acquisition Corp. II and David T. Hung, M.D., dated as of December 17, 2004
  9.1(b)   Voting Agreement by and between Orion Acquisition Corp. II and C. Patrick Machado, dated as of December 17, 2004
  9.1(c)   Voting Agreement by and between Orion Acquisition Corp. II and Dara BioSciences, Inc., dated as of December 17, 2004
  9.1(d)   Voting Agreement by and between Orion Acquisition Corp. II and Selena Pharmaceuticals, Inc., dated as of December 17, 2004
  9.1(e)   Voting Agreement by and between Orion Acquisition Corp. II and the following investors: Joseph F. Barletta; Steven R. Becker; John Braniff; Bushido Capital Master Fund, LP; Cimarron Overseas Equity Master Fund LP; R. L. Clarkson; Richard D. Clarkson; Richard L. Clarkson, f/b/o Lucille S. Ball; Edgewater Ventures; Robert Charles Friese; Gamma Opportunity Capital Partners, LP; Joseph J. Grano, Jr.; Joel T. Leonard Trust, dated October 25, 1994; John A. Raiser Irrevocable Trust, dated March 2, 1998; Shon Kwong & Laura Micek; Lewin Investments LLC; D. Clay & Elissa McCollor; Greg J. Micek, guardian for Alexandria L. Micek; Greg J. Micek, guardian for Gregory J. Micek, Jr.; John Micek, custodian for Gabriel Micek UTMA CA; John Micek, custodian for Jordan Micek UTMA CA; John Micek, custodian for Peter Micek UTMA CA; John III Micek; Maurice Micek; Maurice Micek, custodian for Andrew Micek UGMA NE; Maurice Micek, custodian for Benjamin Micek UGMA NE; Edward Negley; Steven O’Kuhn; ProMed Offshore Fund II, Ltd.; ProMed Offshore Fund, Ltd.; ProMed Partners II, LP; ProMed Partners LP; Arthur Shartsis; Silicon Prairie Partners, LP; Special Situations Cayman Fund, L.P.; Special Situations Fund III, L.P.; Special Situations Private Equity Fund, L.P.; Jeff & Jean Stroud, JTWROS; James Patrick Tierney; Topix, Inc.; Trust Under Will of A. Wilfred May, datedNovember 11, 1969; TTC Private Equity Partners LLC; Cedric Vanzura; Walker Smith Capital (QP), LP; Walker Smith Capital, LP; Walker Smith International Fund, Ltd; Melvyn

 

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Exhibit No.

 

Exhibit Description


    Weiss; WS Opportunity Fund (QP), LP; WS Opportunity Fund International, Ltd.; WS Opportunity Fund, LP; Steven L. Zelinger; and Anthony DiGiandomenico, dated as of December 17, 2004.
10.1(a)   Lock-Up Agreement by and between Orion Acquisition Corp. II and David T. Hung, M.D., dated as of December 17, 2004
10.1(b)   Lock-Up Agreement by and between Orion Acquisition Corp. II and C. Patrick Machado, dated as of December 17, 2004
10.1(c)   Lock-Up Agreement by and between Orion Acquisition Corp. II and Dara BioSciences, Inc., dated as of December 17, 2004
10.1(d)   Lock-Up Agreement by and between Orion Acquisition Corp. II and Selena Pharmaceuticals, Inc., dated as of December 17, 2004
10.2(a)   Purchase Agreement by and among Orion Acquisition Corp. II and the following investors: Dara BioSciences, Inc.; Joseph F. Barletta; Steven R. Becker; John Braniff; Bushido Capital Master Fund, LP; Cimarron Overseas Equity Master Fund LP; R. L. Clarkson; Richard D. Clarkson; Richard L. Clarkson, f/b/o Lucille S. Ball; Edgewater Ventures; Robert Charles Friese; Gamma Opportunity Capital Partners, LP; Joseph J. Grano, Jr.; Joel T. Leonard Trust, dated October 25, 1994; John A. Raiser Irrevocable Trust, dated March 2, 1998; Shon Kwong & Laura Micek; Lewin Investments LLC; D. Clay & Elissa McCollor; Greg J. Micek, guardian for Alexandria L. Micek; Greg J. Micek, guardian for Gregory J. Micek, Jr.; John Micek, custodian for Gabriel Micek UTMA CA; John Micek, custodian for Jordan Micek UTMA CA; John Micek, custodian for Peter Micek UTMA CA; John III Micek; Maurice Micek; Maurice Micek, custodian for Andrew Micek UGMA NE; Maurice Micek, custodian for Benjamin Micek UGMA NE; Edward Negley; Steven O’Kuhn; ProMed Offshore Fund II, Ltd.; ProMed Offshore Fund, Ltd.; ProMed Partners II, LP; ProMed Partners LP; Arthur Shartsis; Silicon Prairie Partners, LP; Jeff & Jean Stroud, JTWROS; James Patrick Tierney; Topix, Inc.; Trust Under Will of A. Wilfred May, dated November 11, 1969; TTC Private Equity Partners LLC; Cedric Vanzura; Walker Smith Capital (QP), LP; Walker Smith Capital, LP; Walker Smith International Fund, Ltd; Melvyn Weiss; WS Opportunity Fund (QP), LP; WS Opportunity Fund International, Ltd.; WS Opportunity Fund, LP; Steven L. Zelinger; and Anthony DiGiandomenico, dated as of December 17, 2004.
10.2(b)   Purchase Agreement by and among Orion Acquisition Corp. II and Special Situations Fund III, L.P., Special Situations Cayman Fund, L.P. and Special Situations Private Equity Fund, L.P., dated as of December 17, 2004
10.3(a)   Registration Rights Agreement by and among Orion Acquisition Corp. II and Special Situations Fund III, L.P., Special Situations Cayman Fund, L.P. and Special Situations Private Equity Fund, L.P., dated as of December 17, 2004
10.3(b)   Registration Rights Agreement by and among Orion Acquisition Corp. II and the following investors: Joseph F. Barletta; Steven R. Becker; John Braniff; Bushido Capital Master Fund, LP; Cimarron Overseas Equity Master Fund LP; R. L. Clarkson; Richard D. Clarkson; Richard L. Clarkson, f/b/o Lucille S. Ball; Edgewater Ventures; Robert Charles Friese; Gamma Opportunity Capital Partners, LP; Joseph J. Grano, Jr.; Joel T. Leonard Trust, dated October 25, 1994; John A. Raiser Irrevocable Trust, dated March 2, 1998; Shon Kwong & Laura Micek; Lewin Investments LLC; D. Clay & Elissa McCollor; Greg J. Micek, guardian for Alexandria L. Micek; Greg J. Micek, guardian for Gregory J. Micek, Jr.; John Micek, custodian for Gabriel Micek UTMA CA; John Micek, custodian for Jordan Micek UTMA CA; John Micek, custodian for Peter Micek UTMA CA; John III Micek; Maurice Micek; Maurice Micek, custodian for Andrew Micek UGMA NE; Maurice Micek, custodian for Benjamin Micek UGMA NE; Edward Negley; Steven O’Kuhn; ProMed Offshore Fund II, Ltd.; ProMed Offshore Fund, Ltd.; ProMed Partners II, LP; ProMed Partners LP; Arthur Shartsis; Silicon Prairie Partners, LP; Jeff & Jean Stroud, JTWROS; James Patrick Tierney; Topix, Inc.; Trust Under Will of A. Wilfred May, dated November 11,

 

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Exhibit No.

 

Exhibit Description


    1969; TTC Private Equity Partners LLC; Cedric Vanzura; Walker Smith Capital (QP), LP; Walker Smith Capital, LP; Walker Smith International Fund, Ltd; Melvyn Weiss; WS Opportunity Fund (QP), LP; WS Opportunity Fund International, Ltd.; WS Opportunity Fund, LP; Steven L. Zelinger; and Anthony DiGiandomenico, dated as of December 17, 2004.
10.3(c)   Registration Rights Agreement by and among Orion Acquisition Corp. II and David T. Hung, M.D., C. Patrick Machado, Dara BioSciences, Inc., Selena Pharmaceuticals, Inc. and MDB Capital Group LLC, dated as of December 17, 2004
10.4(a)   Warrant to purchase Common Stock of Medivation, Inc. assumed by Orion Acquisition Corp. II issued to Dara BioSciences, Inc., dated as of April 1, 2004*
10.4(b)   Amendment Agreement by and between Orion Acquisition Corp. II and Dara BioSciences, Inc., dated as of December 17, 2004*
10.5(a)   Warrant to purchase Common Stock of Medivation, Inc. assumed by Orion Acquisition Corp. II issued to Joseph J. Grano, Jr., dated as of June 8, 2004*
10.5(b)   Warrant to purchase Common Stock of Medivation, Inc. assumed by Orion Acquisition Corp. II issued to Joseph J. Grano, Jr., dated as of August 1, 2004*
10.5(c)   Warrant to purchase Common Stock of Medivation, Inc. assumed by Orion Acquisition Corp. II issued to Joseph J. Grano, Jr., dated as of September 1, 2004*
10.5(d)   Amendment Agreement by and between Orion Acquisition Corp. II and Joseph J. Grano, Jr., dated as of December 17, 2004*
10.6   Warrant to purchase Common Stock of Medivation, Inc. assumed by Orion Acquisition Corp. II issued to David T. Hung, M.D., dated as of November 16, 2004*
10.7(a)   2004 Equity Incentive Plan of Medivation, Inc., assumed by Orion Acquisition Corp. II*
10.7(b)   Form of Stock Option Agreement of Medivation, Inc., assumed by Orion Acquisition Corp. II (11)
10.7(c)   Form of Stock Option Agreement of Medivation, Inc., assumed by Orion Acquisition Corp. II (12)
10.8   Preferred Partnership Letter Agreement between Medivation, Inc. and the Institute of Physiologically Active Compounds, dated as of March 24, 2004
10.9(a)   Agreement by and between Pisgah Labs, Inc. and Medivation, Inc., dated as of February 17, 2004
10.9(b)   Agreement by and between QS Pharma, LLC and Medivation, Inc., dated as of January 11, 2005
21.1   Subsidiaries of Orion Acquisition Corp. II*
23.1   Consent of Singer Lewak Greenbaum & Goldstein LLP, independent registered public accounting firm of Orion Acquisition Corp. II
23.2   Consent of Latham & Watkins LLP**
24.1   Power of Attorney (contained in this registration statement on Form SB-2)*

(1) Incorporated by reference to Exhibit 2.1 to Form 8-K of Orion Acquisition Corp. II, File No. 000-20837, dated December 20, 2004.
(2) Incorporated by reference to Exhibit 1.A. to Form 8-A of Orion Acquisition Corp. II, File No. 000-20837, dated June 10, 1996.
(3) Incorporated by reference to Exhibit 3.1 to Amendment No. 2 to Form SB-2 of Orion Acquisition Corp. II, File No. 333-03252, dated June 14, 1996.
(4) Incorporated by reference to Exhibit 3.2 to Form 10-KSB of Orion Acquisition Corp. II, File No. 000-20837, for the year ended December 31, 1999.

 

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(5) Incorporated by reference to Exhibit 2.2 to Form 8-K of Orion Acquisition Corp. II, File No. 000-20837, dated June 28, 2004.
(6) Incorporated by reference to Exhibit 5.1 to Form 8-K of Orion Acquisition Corp. II, File No. 000-20837, dated December 20, 2004.
(7) Incorporated by reference to Exhibit 3.2 to Form SB-2 of Orion Acquisition Corp. II, File No. 333-03252, dated April 5, 1996.
(8) Incorporated by reference to Exhibit 4.2 to Amendment No. 1 to Form SB-2 of Orion Acquisition Corp. II, File No. 333-03252, dated May 15, 1996.
(9) Incorporated by reference to Exhibit 4.5 to Amendment No. 1 to Form SB-2 of Orion Acquisition Corp. II, File No. 333-03252, dated May 15, 1996.
(10) Incorporated by reference to Exhibit 1.D. to Form 8-A of Orion Acquisition Corp. II, File No. 000-20837, dated June 10, 1996.
(11) Incorporated by reference to Exhibit 10.7(b) to Form 10-KSB of Orion Acquisition Corp. II, File No. 000-20837, dated February 11, 2005.
(12) Incorporated by reference to Exhibit 10.7(c) to Form 10-KSB of Orion Acquisition Corp. II, File No. 000-20837, dated February 11, 2005.
* Previously filed with, or as an exhibit to, this registration statement on Form SB-2, File No. 333-122431, dated January 31, 2005.
** Contained in exhibit 5.1 to this registration statement on Form SB-2.

 

Item 28. Undertakings.

 

The undersigned registrant hereby undertakes:

 

1. To file, during any period in which offers or sales of securities are being made, a post-effective amendment to this registration statement to (a) include any prospectus required by Section 10(a)(3) of the Securities Act; (b) reflect in the prospectus any facts or events which, individually or together, represent a fundamental change in the information in the registration statement; and, notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in the volume and price represent no more than a 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and (c) include any additional or changed material information on the plan of distribution.

 

2. For determining liability under the Securities Act, to treat each post-effective amendment as a new registration statement of the securities offered, and the offering of the securities at that time to be the initial bona fide offering.

 

3. To file a post-effective amendment to remove from registration any of the securities that remain unsold at the end of the offering.

 

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

 

In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

 

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SIGNATURES

 

In accordance with the requirements of the Securities Act, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements of filing on Form SB-2 and authorized this registration statement to be signed on its behalf by the undersigned in the City of San Francisco, State of California, on March 11, 2005.

 

ORION ACQUISITION CORP. II

By:

 

/s/     C. PATRICK MACHADO        


Name:   C. Patrick Machado
Title:   Senior Vice President and Chief Financial Officer

 

In accordance with the requirements of the Securities Act, this registration statement was signed by the following persons in the capacities and on the dates stated:

 

/s/    DAVID T. HUNG, M.D.*      


David T. Hung, M.D.

   President and Chief Executive Officer (Principal Executive Officer)   March 11, 2005

/s/    C. PATRICK MACHADO        


C. Patrick Machado

   Senior Vice President and Chief Financial Officer (Principal Accounting and Financial Officer)   March 11, 2005

/s/    CHRISTOPHER A. MARLETT*      


Christopher A. Marlett

  

Director

  March 11, 2005

/s/    ANTHONY DIGIANDOMENICO*      


Anthony DiGiandomenico

  

Director

  March 11, 2005

* Executed by attorney-in-fact

 

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EXHIBIT INDEX

 

Exhibit No.


   

Exhibit Description


  2.1     Agreement and Plan of Merger dated as of December 17, 2004, by and among the Orion Acquisition Corp. II, Medivation Acquisition Corp. and Medivation, Inc.(1)
  3.1(a)     Form of Certificate of Common Stock, par value $0.01 per share, of Orion Acquisition Corp. II (2)
  3.1(b)     Form of Certificate of Series B Convertible Preferred Stock, par value $0.01 per share, of Orion Acquisition Corp. II*
  3.1(c)     Amended and Restated Certificate of Incorporation of Orion Acquisition Corp. II (3)
  3.1(d)     Certificate of Amendment of Amended and Restated Certificate of Incorporation of Orion Acquisition Corp. II (4)
  3.1(e)     Form of Certificate of Designations of the Series B Convertible Preferred Stock of Orion Acquisition Corp. II (5)
  3.1(f)     Amended and Restated Certificate of Designations of the Series B Convertible Preferred Stock of Orion Acquisition Corp. II (6)
  3.2     Bylaws of Orion Acquisition Corp. II, together with all amendments and restatements thereto (7)
  4.1     Warrant Agency Agreement between American Stock Transfer & Company and Orion Acquisition Corp. II, dated April 1, 1996 (8)
  4.2     Form of Class B Unit Purchase Agreement of Orion Acquisition Corp. II (9)
  4.3     Form of Certificate of the Class B Warrants of Orion Acquisition Corp. II (10)
  5.1     Opinion of Latham & Watkins LLP
  9.1 (a)   Voting Agreement by and between Orion Acquisition Corp. II and David T. Hung, M.D., dated as of December 17, 2004
  9.1 (b)   Voting Agreement by and between Orion Acquisition Corp. II and C. Patrick Machado, dated as of December 17, 2004
  9.1 (c)   Voting Agreement by and between Orion Acquisition Corp. II and Dara BioSciences, Inc., dated as of December 17, 2004
  9.1 (d)   Voting Agreement by and between Orion Acquisition Corp. II and Selena Pharmaceuticals, Inc., dated as of December 17, 2004
  9.1 (e)   Voting Agreement by and between Orion Acquisition Corp. II and the following investors: Joseph F. Barletta; Steven R. Becker; John Braniff; Bushido Capital Master Fund, LP; Cimarron Overseas Equity Master Fund LP; R. L. Clarkson; Richard D. Clarkson; Richard L. Clarkson, f/b/o Lucille S. Ball; Edgewater Ventures; Robert Charles Friese; Gamma Opportunity Capital Partners, LP; Joseph J. Grano, Jr.; Joel T. Leonard Trust, dated October 25, 1994; John A. Raiser Irrevocable Trust, dated March 2, 1998; Shon Kwong & Laura Micek; Lewin Investments LLC; D. Clay & Elissa McCollor; Greg J. Micek, guardian for Alexandria L. Micek; Greg J. Micek, guardian for Gregory J. Micek, Jr.; John Micek, custodian for Gabriel Micek UTMA CA; John Micek, custodian for Jordan Micek UTMA CA; John Micek, custodian for Peter Micek UTMA CA; John III Micek; Maurice Micek; Maurice Micek, custodian for Andrew Micek UGMA NE; Maurice Micek, custodian for Benjamin Micek UGMA NE; Edward Negley; Steven O’Kuhn; ProMed Offshore Fund II, Ltd.; ProMed Offshore Fund, Ltd.; ProMed Partners II, LP; ProMed Partners LP; Arthur Shartsis; Silicon Prairie Partners, LP; Special Situations Cayman Fund, L.P.; Special Situations Fund III, L.P.; Special Situations Private Equity Fund, L.P.; Jeff & Jean Stroud, JTWROS; James Patrick Tierney; Topix, Inc.; Trust Under Will of A. Wilfred May, dated November 11, 1969; TTC Private Equity Partners LLC; Cedric Vanzura; Walker Smith Capital (QP), LP; Walker Smith Capital, LP; Walker Smith International Fund, Ltd; Melvyn Weiss; WS Opportunity Fund (QP), LP; WS Opportunity Fund International, Ltd.; WS Opportunity Fund, LP; Steven L. Zelinger; and Anthony DiGiandomenico, dated as of December 17, 2004.


Table of Contents

Exhibit No.


   

Exhibit Description


10.1 (a)   Lock-Up Agreement by and between Orion Acquisition Corp. II and David T. Hung, M.D., dated as of December 17, 2004
10.1 (b)   Lock-Up Agreement by and between Orion Acquisition Corp. II and C. Patrick Machado, dated as of December 17, 2004
10.1 (c)   Lock-Up Agreement by and between Orion Acquisition Corp. II and Dara BioSciences, Inc., dated as of December 17, 2004
10.1 (d)   Lock-Up Agreement by and between Orion Acquisition Corp. II and Selena Pharmaceuticals, Inc., dated as of December 17, 2004
10.2 (a)   Purchase Agreement by and among Orion Acquisition Corp. II and the following investors: Dara BioSciences, Inc.; Joseph F. Barletta; Steven R. Becker; John Braniff; Bushido Capital Master Fund, LP; Cimarron Overseas Equity Master Fund LP; R. L. Clarkson; Richard D. Clarkson; Richard L. Clarkson, f/b/o Lucille S. Ball; Edgewater Ventures; Robert Charles Friese; Gamma Opportunity Capital Partners, LP; Joseph J. Grano, Jr.; Joel T. Leonard Trust, dated October 25, 1994; John A. Raiser Irrevocable Trust, dated March 2, 1998; Shon Kwong & Laura Micek; Lewin Investments LLC; D. Clay & Elissa McCollor; Greg J. Micek, guardian for Alexandria L. Micek; Greg J. Micek, guardian for Gregory J. Micek, Jr.; John Micek, custodian for Gabriel Micek UTMA CA; John Micek, custodian for Jordan Micek UTMA CA; John Micek, custodian for Peter Micek UTMA CA; John III Micek; Maurice Micek; Maurice Micek, custodian for Andrew Micek UGMA NE; Maurice Micek, custodian for Benjamin Micek UGMA NE; Edward Negley; Steven O’Kuhn; ProMed Offshore Fund II, Ltd.; ProMed Offshore Fund, Ltd.; ProMed Partners II, LP; ProMed Partners LP; Arthur Shartsis; Silicon Prairie Partners, LP; Jeff & Jean Stroud, JTWROS; James Patrick Tierney; Topix, Inc.; Trust Under Will of A. Wilfred May, dated November 11, 1969; TTC Private Equity Partners LLC; Cedric Vanzura; Walker Smith Capital (QP), LP; Walker Smith Capital, LP; Walker Smith International Fund, Ltd; Melvyn Weiss; WS Opportunity Fund (QP), LP; WS Opportunity Fund International, Ltd.; WS Opportunity Fund, LP; Steven L. Zelinger; and Anthony DiGiandomenico, dated as of December 17, 2004.
10.2 (b)   Purchase Agreement by and among Orion Acquisition Corp. II and Special Situations Fund III, L.P., Special Situations Cayman Fund, L.P. and Special Situations Private Equity Fund, L.P., dated as of December 17, 2004
10.3 (a)   Registration Rights Agreement by and among Orion Acquisition Corp. II and Special Situations Fund III, L.P., Special Situations Cayman Fund, L.P. and Special Situations Private Equity Fund, L.P., dated as of December 17, 2004
10.3 (b)   Registration Rights Agreement by and among Orion Acquisition Corp. II and the following investors: Joseph F. Barletta; Steven R. Becker; John Braniff; Bushido Capital Master Fund, LP; Cimarron Overseas Equity Master Fund LP; R. L. Clarkson; Richard D. Clarkson; Richard L. Clarkson, f/b/o Lucille S. Ball; Edgewater Ventures; Robert Charles Friese; Gamma Opportunity Capital Partners, LP; Joseph J. Grano, Jr.; Joel T. Leonard Trust, dated October 25, 1994; John A. Raiser Irrevocable Trust, dated March 2, 1998; Shon Kwong & Laura Micek; Lewin Investments LLC; D. Clay & Elissa McCollor; Greg J. Micek, guardian for Alexandria L. Micek; Greg J. Micek, guardian for Gregory J. Micek, Jr.; John Micek, custodian for Gabriel Micek UTMA CA; John Micek, custodian for Jordan Micek UTMA CA; John Micek, custodian for Peter Micek UTMA CA; John III Micek; Maurice Micek; Maurice Micek, custodian for Andrew Micek UGMA NE; Maurice Micek, custodian for Benjamin Micek UGMA NE; Edward Negley; Steven O’Kuhn; ProMed Offshore Fund II, Ltd.; ProMed Offshore Fund, Ltd.; ProMed Partners II, LP; ProMed Partners LP; Arthur Shartsis; Silicon Prairie Partners, LP; Jeff & Jean Stroud, JTWROS; James Patrick Tierney; Topix, Inc.; Trust Under Will of A. Wilfred May, dated November 11, 1969; TTC Private Equity Partners LLC; Cedric Vanzura; Walker Smith Capital (QP), LP; Walker Smith Capital, LP; Walker Smith International Fund, Ltd; Melvyn Weiss; WS Opportunity Fund (QP), LP; WS Opportunity Fund International, Ltd.; WS Opportunity Fund, LP; Steven L. Zelinger; and Anthony DiGiandomenico, dated as of December 17, 2004.


Table of Contents

Exhibit No.


   

Exhibit Description


10.3 (c)   Registration Rights Agreement by and among Orion Acquisition Corp. II and David T. Hung, M.D., C. Patrick Machado, Dara BioSciences, Inc., Selena Pharmaceuticals, Inc. and MDB Capital Group LLC, dated as of December 17, 2004
10.4(a)     Warrant to purchase Common Stock of Medivation, Inc. assumed by Orion Acquisition Corp. II issued to Dara BioSciences, Inc., dated as of April 1, 2004*
10.4(b)     Amendment Agreement by and between Orion Acquisition Corp. II and Dara BioSciences, Inc., dated as of December 17, 2004*
10.5(a)     Warrant to purchase Common Stock of Medivation, Inc. assumed by Orion Acquisition Corp. II issued to Joseph J. Grano, Jr., dated as of June 8, 2004*
10.5(b)     Warrant to purchase Common Stock of Medivation, Inc. assumed by Orion Acquisition Corp. II issued to Joseph J. Grano, Jr., dated as of August 1, 2004*
10.5(c)     Warrant to purchase Common Stock of Medivation, Inc. assumed by Orion Acquisition Corp. II issued to Joseph J. Grano, Jr., dated as of September 1, 2004*
10.5(d)     Amendment Agreement by and between Orion Acquisition Corp. II and Joseph J. Grano, Jr., dated as of December 17, 2004*
10.6     Warrant to purchase Common Stock of Medivation, Inc. assumed by Orion Acquisition Corp. II issued to David T. Hung, M.D., dated as of November 16, 2004*
10.7(a)     2004 Equity Incentive Plan of Medivation, Inc., assumed by Orion Acquisition Corp. II*
10.7(b)     Form of Stock Option Agreement of Medivation, Inc., assumed by Orion Acquisition Corp. II (11)
10.7 (c)   Form of Stock Option Agreement of Medivation, Inc., assumed by Orion Acquisition Corp. II (12)
10.8     Preferred Partnership Letter Agreement between Medivation, Inc. and the Institute of Physiologically Active Compounds, dated as of March 24, 2004
10.9 (a)   Agreement by and between Pisgah Labs, Inc. and Medivation, Inc., dated as of February 17, 2004
10.9 (b)   Agreement by and between QS Pharma, LLC and Medivation, Inc., dated as of January 11, 2005
21.1     Subsidiaries of Orion Acquisition Corp. II*
23.1     Consent of Singer Lewak Greenbaum & Goldstein LLP, independent registered public accounting firm of Orion Acquisition Corp. II
23.2     Consent of Latham & Watkins LLP**
24.1     Power of Attorney (contained in this registration statement on Form SB-2)*

(1) Incorporated by reference to Exhibit 2.1 to Form 8-K of Orion Acquisition Corp. II, File No. 000-20837, dated December 20, 2004.
(2) Incorporated by reference to Exhibit 1.A. to Form 8-A of Orion Acquisition Corp. II, File No. 000-20837, dated June 10, 1996.
(3) Incorporated by reference to Exhibit 3.1 to Amendment No. 2 to Form SB-2 of Orion Acquisition Corp. II, File No. 333-03252, dated June 14, 1996.
(4) Incorporated by reference to Exhibit 3.2 to Form 10-KSB of Orion Acquisition Corp. II, File No. 000-20837, for the year ended December 31, 1999.
(5) Incorporated by reference to Exhibit 2.2 to Form 8-K of Orion Acquisition Corp. II, File No. 000-20837, dated June 28, 2004.
(6) Incorporated by reference to Exhibit 5.1 to Form 8-K of Orion Acquisition Corp. II, File No. 000-20837, dated December 20, 2004.
(7) Incorporated by reference to Exhibit 3.2 to Form SB-2 of Orion Acquisition Corp. II, File No. 333-03252, dated April 5, 1996.


Table of Contents
(8) Incorporated by reference to Exhibit 4.2 to Amendment No. 1 to Form SB-2 of Orion Acquisition Corp. II, File No. 333-03252, dated May 15, 1996.
(9) Incorporated by reference to Exhibit 4.5 to Amendment No. 1 to Form SB-2 of Orion Acquisition Corp. II, File No. 333-03252, dated May 15, 1996.
(10) Incorporated by reference to Exhibit 1.D. to Form 8-A of Orion Acquisition Corp. II, File No. 000-20837, dated June 10, 1996.
(11) Incorporated by reference to Exhibit 10.7(b) to Form 10-KSB of Orion Acquisition Corp. II, File No. 000-20837, dated February 11, 2005.
(12) Incorporated by reference to Exhibit 10.7(c) to Form 10-KSB of Orion Acquisition Corp. II, File No. 000-20837, dated February 11, 2005.
* Previously filed with, or as an exhibit to, this registration statement on Form SB-2, File No. 333-122431, dated January 31, 2005.
** Contained in exhibit 5.1 to this registration statement on Form SB-2.
EX-5.1 2 dex51.htm OPINION OF LATHAM & WATKINS LLP Opinion of Latham & Watkins LLP

Exhibit 5.1

 

[LETTERHEAD OF LATHAM & WATKINS LLP]

 

March 11, 2005

 

Orion Acquisition Corp. II

501 Second Street

San Francisco, California 94107

 

  Re: Registration Statement No. 333-122431; up to 16,056,045 shares of common stock, par value $0.01 per share

 

Ladies and Gentlemen:

 

We have acted as special counsel to Orion Acquisition Corp. II, a Delaware corporation (the “Company”), in connection with the Registration Statement on Form SB-2, filed under the Securities Act of 1933, as amended (the “Securities Act”), by the Company with the Securities and Exchange Commission (the “Commission”) on January 31, 2005 (File No. 333-122431), as amended (the “Registration Statement”), with respect to the registration of up to 16,056,045 shares of Common Stock, par value $0.01 per share (the “Shares”), of the Company (the “Common Stock”), up to 225,400 of which (the “Primary Shares”) are being offered by the Company and up to 15,830,645 of which (the “Secondary Shares”) are being offered by certain selling stockholders of the Company. This opinion letter is being furnished in accordance with the requirements of Item 601(b)(5) of Regulation S-B promulgated under the Securities Act, and no opinion is expressed herein as to any matter pertaining to the contents of the Registration Statement, other than as to the validity of the Shares.

 

In our capacity as your special counsel in connection with such registration, we are familiar with the proceedings taken and proposed to be taken by the Company in connection with the authorization, issuance and sale of the Shares, and for the purposes of this opinion, we have assumed such proceedings will be timely completed in the manner presently proposed. In addition, we have made such legal and factual examinations and inquiries, including an examination of originals or copies certified or otherwise identified to our satisfaction of such documents, corporate records and instruments, as we have deemed necessary or appropriate for purposes of this opinion. As to facts material to the opinions, statements and assumptions expressed herein, we have, with your consent, relied upon oral or written statements and representations of officers and other representatives of the Company and others. We have not independently verified such factual matters.

 

We are opining herein as to the Shares only under the General Corporation Law of the State of Delaware, and we express no opinion with respect to the applicability thereto, or the effect thereon, of the laws of any other jurisdiction or, in the case of the State of Delaware, any other laws.

 

Subject to the foregoing it is our opinion that, as of the date hereof:

 

1. The Primary Shares have been duly authorized by all necessary corporate action of the Company and, upon delivery and payment therefor in the manner contemplated by the Registration Statement, will be validly issued, fully-paid and non-assessable.

 

2. The Secondary Shares issuable upon conversion of the Company’s Series B Convertible Preferred Stock (the “Series B Preferred Stock”), upon approval by the holders of the Company’s capital stock and filing with the Delaware Secretary of State of an amendment to the Company’s Certificate of

 


Orion Acquisition Corp. II

March 11, 2005

Page 2

 

Incorporation authorizing sufficient Common Stock for conversion thereof, will be duly authorized by all necessary corporate action of the Company, and when and if issued upon conversion of the Series B Preferred Stock, will be validly issued, fully paid and nonassessable.

 

3. The Secondary Shares issuable upon exercise of the Company’s outstanding warrants to purchase Common Stock (the “Warrants”) have been duly authorized by all necessary corporate action of the Company, and when and if issued upon exercise of the Warrants and upon payment therefore in the manner contemplated by the Warrants, will be validly issued, fully paid and nonassessable.

 

4. The Secondary Shares outstanding on the date hereof have been duly authorized by all necessary corporate action of the Company, and are validly issued, fully paid and nonassessable.

 

This opinion letter is for your benefit in connection with the Registration Statement and may be relied upon by you and by persons entitled to rely upon it pursuant to the applicable provisions of federal securities laws. We consent to your filing this opinion as an exhibit to the Registration Statement, and to the reference to our firm in the Prospectus contained in the Registration Statement under the heading “Legal Matters.” In giving such consent, we do not thereby admit that we are in the category of persons whose consent is required under Section 7 of the Securities Act or the rules and regulations of the Commission thereunder.

 

Very truly yours,

 

/s/ Latham & Watkins LLP

 

EX-9.1(A) 3 dex91a.htm VOTING AGMT BY AND BETWEEN ORION ACQUISITION CORP. II AND DAVID T. HUNG Voting Agmt by and between Orion Acquisition Corp. II and David T. Hung

EXHIBIT 9.1 (a)

 

VOTING AGREEMENT

 

This Voting Agreement (the “Agreement”) is made effective as of December 17, 2004, by and among Orion Acquisition Corp. II, a Delaware corporation (the “Company”) and David T. Hung (“Dr. Hung”).

 

RECITALS

 

WHEREAS, pursuant to a Merger Agreement (the “Merger Agreement”), by and among the Company, Medivation Acquisition Corp., a Delaware corporation and wholly-owned subsidiary of the Company (“Newco”), and Medivation, Inc., a Delaware corporation (“Medivation”), Newco has been merged with and into Medivation (the “Merger”), with Medivation as the surviving corporation and a wholly-owned subsidiary of the Company;

 

WHEREAS, Dr. Hung and the other former stockholders of Medivation will receive in the Merger, in exchange for the issued and outstanding shares of Medivation common stock owned by them, shares of the Series B Preferred Stock of the Company;

 

WHEREAS, pursuant to a stock purchase agreement, dated of even date herewith (collectively, the “Stock Purchase Agreement”), by and between the Company and the Investors listed therein (collectively, the “Investors”) the Company has agreed to issue and sell to the Investors, and the Investors have agreed to purchase from the Company, up to a maximum of 7,800,000 shares of the Company’s Common Stock at a purchase price of $1.55 per share;

 

WHEREAS, it is a condition to the obligations of the Company and Medivation under the Merger Agreement, and it is also a condition to the obligations of the Company and the Investors under the Stock Purchase Agreement, that Dr. Hung agree to vote the shares of Company stock owned by each of them in the manner set forth in this Agreement; and

 

WHEREAS, the parties desire to enter into this Agreement and to provide that in exercising any voting rights related to the subject matter of this Agreement, the shares of the Company’s voting stock held by Dr. Hung shall be voted as provided in this Agreement.

 

AGREEMENT

 

NOW THEREFORE, in consideration of the mutual covenants and agreements set forth herein and for other good and valuable consideration the receipt and adequacy of which is hereby acknowledged, the parties hereto, intending to be legally bound, hereby agree as follows:

 

ARTICLE 1

 

General; Definitions

 

1.1 Certain Definitions. As used in this Agreement, the following terms shall have the following respective meanings:


(a) “Common Stock” shall mean the Company’s common stock, $0.01 par value per share, having the rights, preferences and privileges as set forth in the Company’s certificate of incorporation and bylaws, as amended and in effect on the date thereof.

 

(b) “Series B Preferred Stock” shall mean the Company’s Series B Preferred Stock, $0.01 par value per share, having the rights, preferences and privileges as set forth in the Company’s certificate of incorporation and bylaws, as amended and in effect on the date thereof.

 

(c) “Shares” shall mean, collectively, the shares of Common Stock sold to the Investors pursuant to the Stock Purchase Agreement.

 

ARTICLE 2

 

Agreement to Vote

 

2.1 Agreement to Vote. During the term of this Agreement, Dr. Hung hereby agrees and covenants to vote or cause to be voted all of his Shares then owned by him, or over which he has voting power at any regular or special meeting of stockholders, or, in lieu of any such meeting, to give his written consent in any action by written consent of the stockholders, in favor of each of the following items:

 

(a) The amendment of the Certificate of Incorporation of the Company to:

 

(i) increase the authorized shares of Common Stock of the Company to 50,000,000 shares; and

 

(ii) change the name of the Company to a name specified by the Board of Directors of the Company, which name shall include the word “Medivation”; and

 

(iii) make any other change that the Company’s Board of Directors has determined to be necessary or advisable in order to obtain listing of the Company’s Common Stock on the Nasdaq SmallCap Market.

 

(b) The election to the Company’s Board of Directors of the following five (5) individuals:

 

  (i) Steve Gorlin;

 

  (ii) David T. Hung, M.D.;

 

  (iii) One (1) nominee of the former stockholders of Medivation; and

 

  (iv) Two (2) nominees of MDB Capital Group LLC.

 

(c) In the event that any of the persons nominated pursuant to Section 2.1(b) is unable or unwilling to serve as a director, the election of such successor nominee as is designated by the parties entitled to designate such nominee pursuant to Section 2.1(b).

 

-2-


2.2 Further Assurances. Dr. Hung shall take such action as may be reasonably necessary to perform its obligations hereunder.

 

ARTICLE 3

 

Miscellaneous

 

3.1 Termination. This Agreement shall remain in effect until the conclusion of any stockholders meeting, and any adjournment thereof, duly called and held to consider and vote on the matters set forth in Section 2.1 hereof (the “Required Approvals”) (or the conclusion of any solicitation of consents to such matters in lieu of a stockholders meeting). From and after such date, this Agreement shall terminate automatically and without further action by any of the parties.

 

3.2 Prompt Action. The Company agrees to take all actions necessary to obtain the Required Approvals as promptly as is practicable following the closing of the transactions contemplated by the Merger Agreement and the Stock Purchase Agreement, including without limitation, filing an appropriate proxy statement with the Securities and Exchange Commission.

 

3.3 Successors; Legending of Shares. The terms of this Agreement shall be binding upon and inure to the benefit of the heirs, personal representatives, successors and assigns of the parties hereto and each transferee or assignee of the Shares subject to this Agreement shall continue to be subject to the terms hereof. During the term of this Agreement, each certificate representing the Shares subject to this Agreement shall be endorsed by the Company with a legend reading substantially as follows:

 

“THE SECURITIES REPRESENTED BY THIS CERTIFICATE ARE SUBJECT TO A VOTING AGREEMENT, A COPY OF WHICH MAY BE OBTAINED AT NO COST BY WRITTEN REQUEST MADE BY THE HOLDER OF RECORD OF THIS CERTIFICATE TO THE SECRETARY OF THE COMPANY.”

 

Within three (3) business days following termination of this Agreement, the Company shall provide to Dr. Hung new certificates from which the above legend has been removed.

 

3.4 Governing Law. This Voting Agreement shall be governed in all respects by the laws of the State of New York without regard to choice of laws or conflict of laws provisions thereof.

 

3.5 Specific Performance. In the event of a breach by any party of its obligation to vote or act as provided in this Agreement, any aggrieved party shall be entitled to a decree of specific performance. The aggrieved party shall not be denied specific performance by a court on the ground that a remedy at law is adequate or on other grounds relating to the jurisdiction of a court of equity.

 

-3-


3.6 Successors and Assigns. This Agreement and all rights, duties and obligations hereunder shall inure to the benefit of, and be binding upon, the successors, assigns, heirs, executors and administrators of the parties.

 

3.7 Entire Agreement; Amendment. This Agreement and any term hereof may be amended, waived, discharged or terminated (either generally or in a particular instance and either retroactively or prospectively) only by a written instrument signed by the Company and Dr. Hung; provided, however, that no amendment hereto shall affect the obligation of Dr. Hung to vote in favor of the Required Approvals. Any amendment or waiver of this Agreement so effected shall be binding upon each of the parties to this Agreement. This Agreement constitutes the full and entire understanding and agreement between the parties with regard to the subject matter hereof. Any prior agreements, understandings or representations with respect to the subject matter hereof, are superseded by this Agreement and shall have no further force or effect.

 

3.8 Notice. All notices and other communications required or permitted hereunder shall be in writing and shall be sent by first-class United States mail or delivered in person or sent via next day Federal Express delivery or any other nationally-recognized overnight delivery service or by facsimile (with confirmation of receipt), addressed:

 

(a) if to Dr. Hung, at such address as set forth in the Stock Purchase Agreement, or at such other address as Dr. Hung shall have furnished to the Company in writing;

 

(b) if to any other holder of any securities subject to this Agreement, at such address as such holder shall have furnished to the Company in writing, or, until any such holder so furnishes an address to the Company, then to and at the address of the last holder of such securities who has so furnished an address to the Company; or

 

(c) if to the Company, at the address set forth below the signature of the Company’s duly authorized representative.

 

Notice shall be deemed to be received for purposes of this Agreement (i) when delivered, if delivered in person, (ii) one (1) business day after having been deposited for delivery, if delivered by next day Federal Express delivery or any other nationally-recognized overnight delivery service, (iii) three (3) days after having been deposited in the United States mails with first class postage prepaid and addressed to the recipient and (iv) when sent, if delivered by facsimile (with confirmation of receipt).

 

3.9 Delays or Omissions. No delay or omission to exercise any right, power or remedy accruing to any party upon any breach or default under this Agreement shall impair any such right, power or remedy of such party, nor shall it be construed to be a waiver of any such breach or default or an acquiescence therein, or of or in any similar breach or default thereafter occurring; nor shall any waiver of any single breach or default be deemed a waiver of any other breach or default theretofore or thereafter occurring. Any waiver, permit, consent or approval of any kind or character of any breach or default under this Agreement, or any waiver on the part of any party of any provisions or conditions of this Agreement, must be made in writing and shall be effective only to the extent specifically set forth in such writing. All remedies, either under this Agreement or by law or otherwise afforded to any holder, shall be cumulative and not alternative.

 

-4-


3.10 Severability. Whenever possible, each provision of this Agreement shall be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Agreement shall be held to be prohibited by or invalid under applicable law, such provision shall be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of such provision or the remaining provisions of this Agreement.

 

3.11 Counterparts. This Agreement may be executed in any number of counterparts and by facsimile, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

 

[Remainder of this Page Intentionally Left Blank]

 

-5-


IN WITNESS WHEREOF, the undersigned have executed this Voting Agreement as of the date first set forth above.

 

COMPANY:       ORION ACQUISITION CORP. II
501 Second Street, Suite 211        
San Francisco, CA 94107        
Fax: (415) 543-3113   By:   /s/ C. Patrick Machado
        Name: C. Patrick Machado
        Title: Senior Vice President and Chief Financial Officer
DAVID T. HUNG, MD:        
501 Second Street, Suite 211        
San Francisco, CA 94107        
Fax: (415) 543-3113   By:   /s/ David T. Hung, M.D.
        Signature
EX-9.1(B) 4 dex91b.htm VOTING AGMT BY AND BETWEEN ORION ACQUISITION CORP. II AND C. PATRICK MACHADO Voting Agmt by and between Orion Acquisition Corp. II and C. Patrick Machado

EXHIBIT 9.1 (b)

 

VOTING AGREEMENT

 

This Voting Agreement (the “Agreement”) is made effective as of December 17, 2004, by and among Orion Acquisition Corp. II, a Delaware corporation (the “Company”) and C. Patrick Machado (“Mr. Machado”).

 

RECITALS

 

WHEREAS, pursuant to a Merger Agreement (the “Merger Agreement”), by and among the Company, Medivation Acquisition Corp., a Delaware corporation and wholly-owned subsidiary of the Company (“Newco”), and Medivation, Inc., a Delaware corporation (“Medivation”), Newco has been merged with and into Medivation (the “Merger”), with Medivation as the surviving corporation and a wholly-owned subsidiary of the Company;

 

WHEREAS, Mr. Machado and the other former stockholders of Medivation will receive in the Merger, in exchange for the issued and outstanding shares of Medivation common stock owned by them, shares of the Series B Preferred Stock of the Company;

 

WHEREAS, pursuant to a stock purchase agreement, dated of even date herewith (collectively, the “Stock Purchase Agreement”), by and between the Company and the Investors listed therein (collectively, the “Investors”) the Company has agreed to issue and sell to the Investors, and the Investors have agreed to purchase from the Company, up to a maximum of 7,800,000 shares of the Company’s Common Stock at a purchase price of $1.55 per share;

 

WHEREAS, it is a condition to the obligations of the Company and Medivation under the Merger Agreement, and it is also a condition to the obligations of the Company and the Investors under the Stock Purchase Agreement, that Mr. Machado agree to vote the shares of Company stock owned by each of them in the manner set forth in this Agreement; and

 

WHEREAS, the parties desire to enter into this Agreement and to provide that in exercising any voting rights related to the subject matter of this Agreement, the shares of the Company’s voting stock held by Mr. Machado shall be voted as provided in this Agreement.

 

AGREEMENT

 

NOW THEREFORE, in consideration of the mutual covenants and agreements set forth herein and for other good and valuable consideration the receipt and adequacy of which is hereby acknowledged, the parties hereto, intending to be legally bound, hereby agree as follows:

 

ARTICLE 1

 

General; Definitions

 

1.1 Certain Definitions. As used in this Agreement, the following terms shall have the following respective meanings:


        (a) “Common Stock” shall mean the Company’s common stock, $0.01 par value per share, having the rights, preferences and privileges as set forth in the Company’s certificate of incorporation and bylaws, as amended and in effect on the date thereof.

 

        (b) “Series B Preferred Stock” shall mean the Company’s Series B Preferred Stock, $0.01 par value per share, having the rights, preferences and privileges as set forth in the Company’s certificate of incorporation and bylaws, as amended and in effect on the date thereof.

 

        (b) “Shares” shall mean, collectively, the shares of Common Stock sold to the Investors pursuant to the Stock Purchase Agreement.

 

ARTICLE 2

 

Agreement to Vote

 

2.1 Agreement to Vote. During the term of this Agreement, Mr. Machado hereby agrees and covenants to vote or cause to be voted all of his Shares then owned by him, or over which he has voting power at any regular or special meeting of stockholders, or, in lieu of any such meeting, to give his written consent in any action by written consent of the stockholders, in favor of each of the following items:

 

        (a) The amendment of the Certificate of Incorporation of the Company to:

 

                (i) increase the authorized shares of Common Stock of the Company to 50,000,000 shares; and

 

                (ii) change the name of the Company to a name specified by the Board of Directors of the Company, which name shall include the word “Medivation” ;and

 

                (iii) make any other change that the Company’s Board of Directors has determined to be necessary or advisable in order to obtain listing of the Company’s Common Stock on the Nasdaq SmallCap Market.

 

        (b) The election to the Company’s Board of Directors of the following five (5) individuals:

 

                (i) Steve Gorlin;

 

                (ii) David T. Hung, M.D.;

 

                (iii) One (1) nominee of the former stockholders of Medivation; and

 

                (iv) Two (2) nominees of MDB Capital Group LLC.

 

        (c) In the event that any of the persons nominated pursuant to Section 2.1(b) is unable or unwilling to serve as a director, the election of such successor nominee as is designated by the parties entitled to designate such nominee pursuant to Section 2.1(b).

 

-2-


2.2 Further Assurances. Mr. Machado shall take such action as may be reasonably necessary to perform its obligations hereunder.

 

ARTICLE 3

 

Miscellaneous

 

3.1 Termination. This Agreement shall remain in effect until the conclusion of any stockholders meeting, and any adjournment thereof, duly called and held to consider and vote on the matters set forth in Section 2.1 hereof (the “Required Approvals”) (or the conclusion of any solicitation of consents to such matters in lieu of a stockholders meeting). From and after such date, this Agreement shall terminate automatically and without further action by any of the parties.

 

3.2 Prompt Action. The Company agrees to take all actions necessary to obtain the Required Approvals as promptly as is practicable following the closing of the transactions contemplated by the Merger Agreement and the Stock Purchase Agreement, including without limitation, filing an appropriate proxy statement with the Securities and Exchange Commission.

 

3.3 Successors; Legending of Shares. The terms of this Agreement shall be binding upon and inure to the benefit of the heirs, personal representatives, successors and assigns of the parties hereto and each transferee or assignee of the Shares subject to this Agreement shall continue to be subject to the terms hereof. During the term of this Agreement, each certificate representing the Shares subject to this Agreement shall be endorsed by the Company with a legend reading substantially as follows:

 

“THE SECURITIES REPRESENTED BY THIS CERTIFICATE ARE SUBJECT TO A VOTING AGREEMENT, A COPY OF WHICH MAY BE OBTAINED AT NO COST BY WRITTEN REQUEST MADE BY THE HOLDER OF RECORD OF THIS CERTIFICATE TO THE SECRETARY OF THE COMPANY.”

 

Within three (3) business days following termination of this Agreement, the Company shall provide to Mr. Machado new certificates from which the above legend has been removed.

 

3.4 Governing Law. This Voting Agreement shall be governed in all respects by the laws of the State of New York without regard to choice of laws or conflict of laws provisions thereof.

 

3.5 Specific Performance. In the event of a breach by any party of its obligation to vote or act as provided in this Agreement, any aggrieved party shall be entitled to a decree of specific performance. The aggrieved party shall not be denied specific performance by a court on the ground that a remedy at law is adequate or on other grounds relating to the jurisdiction of a court of equity.

 

-3-


3.6 Successors and Assigns. This Agreement and all rights, duties and obligations hereunder shall inure to the benefit of, and be binding upon, the successors, assigns, heirs, executors and administrators of the parties.

 

3.7 Entire Agreement; Amendment. This Agreement and any term hereof may be amended, waived, discharged or terminated (either generally or in a particular instance and either retroactively or prospectively) only by a written instrument signed by the Company and Mr. Machado; provided, however, that no amendment hereto shall affect the obligation of Mr. Machado to vote in favor of the Required Approvals. Any amendment or waiver of this Agreement so effected shall be binding upon each of the parties to this Agreement. This Agreement constitutes the full and entire understanding and agreement between the parties with regard to the subject matter hereof. Any prior agreements, understandings or representations with respect to the subject matter hereof, are superseded by this Agreement and shall have no further force or effect.

 

3.8 Notice. All notices and other communications required or permitted hereunder shall be in writing and shall be sent by first-class United States mail or delivered in person or sent via next day Federal Express delivery or any other nationally-recognized overnight delivery service or by facsimile (with confirmation of receipt), addressed:

 

        (a) if to Mr. Machado, at such address as set forth in the Stock Purchase Agreement, or at such other address as Mr. Machado shall have furnished to the Company in writing;

 

        (b) if to any other holder of any securities subject to this Agreement, at such address as such holder shall have furnished to the Company in writing, or, until any such holder so furnishes an address to the Company, then to and at the address of the last holder of such securities who has so furnished an address to the Company; or

 

        (c) if to the Company, at the address set forth below the signature of the Company’s duly authorized representative.

 

Notice shall be deemed to be received for purposes of this Agreement (i) when delivered, if delivered in person, (ii) one (1) business day after having been deposited for delivery, if delivered by next day Federal Express delivery or any other nationally-recognized overnight delivery service, (iii) three (3) days after having been deposited in the United States mails with first class postage prepaid and addressed to the recipient and (iv) when sent, if delivered by facsimile (with confirmation of receipt).

 

3.9 Delays or Omissions. No delay or omission to exercise any right, power or remedy accruing to any party upon any breach or default under this Agreement shall impair any such right, power or remedy of such party, nor shall it be construed to be a waiver of any such breach or default or an acquiescence therein, or of or in any similar breach or default thereafter occurring; nor shall any waiver of any single breach or default be deemed a waiver of any other breach or default theretofore or thereafter occurring. Any waiver, permit, consent or approval of any kind or character of any breach or default under this Agreement, or any waiver on the part of any party of any provisions or conditions of this Agreement, must be made in writing and shall be effective only to the extent specifically set forth in such writing. All remedies, either under this Agreement or by law or otherwise afforded to any holder, shall be cumulative and not alternative.

 

-4-


3.10 Severability. Whenever possible, each provision of this Agreement shall be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Agreement shall be held to be prohibited by or invalid under applicable law, such provision shall be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of such provision or the remaining provisions of this Agreement.

 

3.11 Counterparts. This Agreement may be executed in any number of counterparts and by facsimile, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

 

[Remainder of this Page Intentionally Left Blank]

 

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IN WITNESS WHEREOF, the undersigned have executed this Voting Agreement as of the date first set forth above.

 

COMPANY:   ORION ACQUISITION CORP. II

501 Second Street, Suite 211

       

San Francisco, CA 94107

       

Fax: (415) 543-3113

  By:  

/s/ David T. Hung, M.D.


       

Name: David T. Hung, M.D.

       

Title: President and Chief Executive Officer

C. PATRICK MACHADO:        

501 Second Street, Suite 211

       

San Francisco, CA 94107

       

Fax: (415) 543-3113

  By:  

/s/ C. Patrick Machado


       

Signature

EX-9.1(C) 5 dex91c.htm VOTING AGMT BY AND BETWEEN ORION ACQUISITION CORP. II AND DARA BIOSCIENCES, INC. Voting Agmt by and between Orion Acquisition Corp. II and Dara BioSciences, Inc.

EXHIBIT 9.1 (c)

 

VOTING AGREEMENT

 

This Voting Agreement (the “Agreement”) is made effective as of December 17, 2004, by and among Orion Acquisition Corp. II, a Delaware corporation (the “Company”) and Dara BioSciences, Inc., a Delaware corporation (“Dara”).

 

RECITALS

 

WHEREAS, pursuant to a Merger Agreement (the “Merger Agreement”), by and among the Company, Medivation Acquisition Corp., a Delaware corporation and wholly-owned subsidiary of the Company (“Newco”), and Medivation, Inc., a Delaware corporation (“Medivation”), Newco has been merged with and into Medivation (the “Merger”), with Medivation as the surviving corporation and a wholly-owned subsidiary of the Company;

 

WHEREAS, Dara and the other former stockholders of Medivation will receive in the Merger, in exchange for the issued and outstanding shares of Medivation common stock owned by them, shares of the Series B Preferred Stock of the Company;

 

WHEREAS, pursuant to a stock purchase agreement, dated of even date herewith (collectively, the “Stock Purchase Agreement”), by and between the Company and the Investors listed therein (collectively, the “Investors”) the Company has agreed to issue and sell to the Investors, and the Investors have agreed to purchase from the Company, up to a maximum of 7,800,000 shares of the Company’s Common Stock at a purchase price of $1.55 per share;

 

WHEREAS, it is a condition to the obligations of the Company and Medivation under the Merger Agreement, and it is also a condition to the obligations of the Company and the Investors under the Stock Purchase Agreement, that Dara agree to vote the shares of Company stock owned by each of them in the manner set forth in this Agreement; and

 

WHEREAS, the parties desire to enter into this Agreement and to provide that in exercising any voting rights related to the subject matter of this Agreement, the shares of the Company’s voting stock held by Dara shall be voted as provided in this Agreement.

 

AGREEMENT

 

NOW THEREFORE, in consideration of the mutual covenants and agreements set forth herein and for other good and valuable consideration the receipt and adequacy of which is hereby acknowledged, the parties hereto, intending to be legally bound, hereby agree as follows:

 

ARTICLE 1

 

General; Definitions

 

1.1 Certain Definitions. As used in this Agreement, the following terms shall have the following respective meanings:


        (a) “Common Stock” shall mean the Company’s common stock, $0.01 par value per share, having the rights, preferences and privileges as set forth in the Company’s certificate of incorporation and bylaws, as amended and in effect on the date thereof.

 

        (b) “Series B Preferred Stock” shall mean the Company’s Series B Preferred Stock, $0.01 par value per share, having the rights, preferences and privileges as set forth in the Company’s certificate of incorporation and bylaws, as amended and in effect on the date thereof.

 

        (b) “Shares” shall mean, collectively, the shares of Common Stock sold to the Investors pursuant to the Stock Purchase Agreement.

 

ARTICLE 2

 

Agreement to Vote

 

2.1 Agreement to Vote. During the term of this Agreement, Dara hereby agrees and covenants to vote or cause to be voted all of his Shares then owned by it, or over which it has voting power at any regular or special meeting of stockholders, or, in lieu of any such meeting, to give his written consent in any action by written consent of the stockholders, in favor of each of the following items:

 

        (a) The amendment of the Certificate of Incorporation of the Company to:

 

                (i) increase the authorized shares of Common Stock of the Company to 50,000,000 shares; and

 

                (ii) change the name of the Company to a name specified by the Board of Directors of the Company, which name shall include the word “Medivation” and

 

                (iii) make any other change that the Company’s Board of Directors has determined to be necessary or advisable in order to obtain listing of the Company’s Common Stock on the Nasdaq SmallCap Market.

 

        (b) The election to the Company’s Board of Directors of the following five (5) individuals:

 

                (i) Steve Gorlin;

 

                (ii) David T. Hung, M.D.;

 

                (iii) One (1) nominee of the former stockholders of Medivation; and

 

                (iv) Two (2) nominees of MDB Capital Group LLC.

 

        (c) In the event that any of the persons nominated pursuant to Section 2.1(b) is unable or unwilling to serve as a director, the election of such successor nominee as is designated by the parties entitled to designate such nominee pursuant to Section 2.1(b).

 

-2-


2.2 Further Assurances. Dara shall take such action as may be reasonably necessary to perform its obligations hereunder.

 

ARTICLE 3

 

Miscellaneous

 

3.1 Termination. This Agreement shall remain in effect until the conclusion of any stockholders meeting, and any adjournment thereof, duly called and held to consider and vote on the matters set forth in Section 2.1 hereof (the “Required Approvals”) (or the conclusion of any solicitation of consents to such matters in lieu of a stockholders meeting). From and after such date, this Agreement shall terminate automatically and without further action by any of the parties.

 

3.2 Prompt Action. The Company agrees to take all actions necessary to obtain the Required Approvals as promptly as is practicable following the closing of the transactions contemplated by the Merger Agreement and the Stock Purchase Agreement, including without limitation, filing an appropriate proxy statement with the Securities and Exchange Commission.

 

3.3 Successors; Legending of Shares. The terms of this Agreement shall be binding upon and inure to the benefit of the heirs, personal representatives, successors and assigns of the parties hereto and each transferee or assignee of the Shares subject to this Agreement shall continue to be subject to the terms hereof. During the term of this Agreement, each certificate representing the Shares subject to this Agreement shall be endorsed by the Company with a legend reading substantially as follows:

 

“THE SECURITIES REPRESENTED BY THIS CERTIFICATE ARE SUBJECT TO A VOTING AGREEMENT, A COPY OF WHICH MAY BE OBTAINED AT NO COST BY WRITTEN REQUEST MADE BY THE HOLDER OF RECORD OF THIS CERTIFICATE TO THE SECRETARY OF THE COMPANY.”

 

Within three (3) business days following termination of this Agreement, the Company shall provide to Dara new certificates from which the above legend has been removed.

 

3.4 Governing Law. This Voting Agreement shall be governed in all respects by the laws of the State of New York without regard to choice of laws or conflict of laws provisions thereof.

 

3.5 Specific Performance. In the event of a breach by any party of its obligation to vote or act as provided in this Agreement, any aggrieved party shall be entitled to a decree of specific performance. The aggrieved party shall not be denied specific performance by a court on the ground that a remedy at law is adequate or on other grounds relating to the jurisdiction of a court of equity.

 

-3-


3.6 Successors and Assigns. This Agreement and all rights, duties and obligations hereunder shall inure to the benefit of, and be binding upon, the successors, assigns, heirs, executors and administrators of the parties.

 

3.7 Entire Agreement; Amendment. This Agreement and any term hereof may be amended, waived, discharged or terminated (either generally or in a particular instance and either retroactively or prospectively) only by a written instrument signed by the Company and Dara; provided, however, that no amendment hereto shall affect the obligation of Dara to vote in favor of the Required Approvals. Any amendment or waiver of this Agreement so effected shall be binding upon each of the parties to this Agreement. This Agreement constitutes the full and entire understanding and agreement between the parties with regard to the subject matter hereof. Any prior agreements, understandings or representations with respect to the subject matter hereof, are superseded by this Agreement and shall have no further force or effect.

 

3.8 Notice. All notices and other communications required or permitted hereunder shall be in writing and shall be sent by first-class United States mail or delivered in person or sent via next day Federal Express delivery or any other nationally-recognized overnight delivery service or by facsimile (with confirmation of receipt), addressed:

 

        (a) if to Dara, at such address as set forth in the Stock Purchase Agreement, or at such other address as Dara shall have furnished to the Company in writing;

 

        (b) if to any other holder of any securities subject to this Agreement, at such address as such holder shall have furnished to the Company in writing, or, until any such holder so furnishes an address to the Company, then to and at the address of the last holder of such securities who has so furnished an address to the Company; or

 

        (c) if to the Company, at the address set forth below the signature of the Company’s duly authorized representative.

 

Notice shall be deemed to be received for purposes of this Agreement (i) when delivered, if delivered in person, (ii) one (1) business day after having been deposited for delivery, if delivered by next day Federal Express delivery or any other nationally-recognized overnight delivery service, (iii) three (3) days after having been deposited in the United States mails with first class postage prepaid and addressed to the recipient and (iv) when sent, if delivered by facsimile (with confirmation of receipt).

 

3.9 Delays or Omissions. No delay or omission to exercise any right, power or remedy accruing to any party upon any breach or default under this Agreement shall impair any such right, power or remedy of such party, nor shall it be construed to be a waiver of any such breach or default or an acquiescence therein, or of or in any similar breach or default thereafter occurring; nor shall any waiver of any single breach or default be deemed a waiver of any other breach or default theretofore or thereafter occurring. Any waiver, permit, consent or approval of any kind or character of any breach or default under this Agreement, or any waiver on the part of any party of any provisions or conditions of this Agreement, must be made in writing and shall be effective only to the extent specifically set forth in such writing. All remedies, either under this Agreement or by law or otherwise afforded to any holder, shall be cumulative and not alternative.

 

-4-


3.10 Severability. Whenever possible, each provision of this Agreement shall be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Agreement shall be held to be prohibited by or invalid under applicable law, such provision shall be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of such provision or the remaining provisions of this Agreement.

 

3.11 Counterparts. This Agreement may be executed in any number of counterparts and by facsimile, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

 

[Remainder of this Page Intentionally Left Blank]

 

-5-


IN WITNESS WHEREOF, the undersigned have executed this Voting Agreement as of the date first set forth above.

 

COMPANY:   

ORION ACQUISITION CORP. II

501 Second Street, Suite 211

        

San Francisco, CA 94107

        

Fax: (415) 543-3113

   By:  

/s/ David T. Hung, M.D.


        

Name: David T. Hung, M.D.

        

Title: President and Chief Executive Officer

DARA:   

DARA BIOSCIENCES, INC.

1234 Airport Rd., Suite 109

        

Destin, FL 32541

        

Fax: (850)650-1010

   By:  

/s/ John C. Thomas


        

Name: John C. Thomas

        

Title: Chief Financial Officer

EX-9.1(D) 6 dex91d.htm VOTING AGMT BY AND BETWEEN ORION ACQUISITION CORP. II AND SELENA PHARMACEUTICALS Voting Agmt by and between Orion Acquisition Corp. II and Selena Pharmaceuticals

EXHIBIT 9.1(d)

 

VOTING AGREEMENT

 

This Voting Agreement (the “Agreement”) is made effective as of December 17, 2004, by and among Orion Acquisition Corp. II, a Delaware corporation (the “Company”) and Selena Pharmaceuticals, Inc., a California corporation (“Selena”).

 

RECITALS

 

WHEREAS, pursuant to a Merger Agreement (the “Merger Agreement”), by and among the Company, Medivation Acquisition Corp., a Delaware corporation and wholly-owned subsidiary of the Company (“Newco”), and Medivation, Inc., a Delaware corporation (“Medivation”), Newco has been merged with and into Medivation (the “Merger”), with Medivation as the surviving corporation and a wholly-owned subsidiary of the Company;

 

WHEREAS, Selena and the other former stockholders of Medivation will receive in the Merger, in exchange for the issued and outstanding shares of Medivation common stock owned by them, shares of the Series B Preferred Stock of the Company;

 

WHEREAS, pursuant to a stock purchase agreement, dated of even date herewith (collectively, the “Stock Purchase Agreement”), by and between the Company and the Investors listed therein (collectively, the “Investors”) the Company has agreed to issue and sell to the Investors, and the Investors have agreed to purchase from the Company, up to a maximum of 7,800,000 shares of the Company’s Common Stock at a purchase price of $1.55 per share;

 

WHEREAS, it is a condition to the obligations of the Company and Medivation under the Merger Agreement, and it is also a condition to the obligations of the Company and the Investors under the Stock Purchase Agreement, that Selena agree to vote the shares of Company stock owned by each of them in the manner set forth in this Agreement; and

 

WHEREAS, the parties desire to enter into this Agreement and to provide that in exercising any voting rights related to the subject matter of this Agreement, the shares of the Company’s voting stock held by Selena shall be voted as provided in this Agreement.

 

AGREEMENT

 

NOW THEREFORE, in consideration of the mutual covenants and agreements set forth herein and for other good and valuable consideration the receipt and adequacy of which is hereby acknowledged, the parties hereto, intending to be legally bound, hereby agree as follows:

 

ARTICLE 1

 

General; Definitions

 

1.1 Certain Definitions. As used in this Agreement, the following terms shall have the following respective meanings:

 

(a) “Common Stock” shall mean the Company’s common stock, $0.01 par value per share, having the rights, preferences and privileges as set forth in the Company’s certificate of incorporation and bylaws, as amended and in effect on the date thereof.


(b) “Series B Preferred Stock” shall mean the Company’s Series B Preferred Stock, $0.01 par value per share, having the rights, preferences and privileges as set forth in the Company’s certificate of incorporation and bylaws, as amended and in effect on the date thereof.

 

(b) “Shares” shall mean, collectively, the shares of Common Stock sold to the Investors pursuant to the Stock Purchase Agreement.

 

ARTICLE 2

 

Agreement to Vote

 

2.1 Agreement to Vote. During the term of this Agreement, Selena hereby agrees and covenants to vote or cause to be voted all of his Shares then owned by it, or over which it has voting power at any regular or special meeting of stockholders, or, in lieu of any such meeting, to give his written consent in any action by written consent of the stockholders, in favor of each of the following items:

 

(a) The amendment of the Certificate of Incorporation of the Company to:

 

(i) increase the authorized shares of Common Stock of the Company to 50,000,000 shares; and

 

(ii) change the name of the Company to a name specified by the Board of Directors of the Company, which name shall include the word “Medivation” and

 

(iii) make any other change that the Company’s Board of Directors has determined to be necessary or advisable in order to obtain listing of the Company’s Common Stock on the Nasdaq SmallCap Market.

 

(b) The election to the Company’s Board of Directors of the following five (5) individuals:

 

(i) Steve Gorlin;

 

(ii) David T. Hung, M.D.;

 

(iii) One (1) nominee of the former stockholders of Medivation; and

 

(iv) Two (2) nominees of MDB Capital Group LLC.

 

(c) In the event that any of the persons nominated pursuant to Section 2.1(b) is unable or unwilling to serve as a director, the election of such successor nominee as is designated by the parties entitled to designate such nominee pursuant to Section 2.1(b).

 

-2-


2.2 Further Assurances. Selena shall take such action as may be reasonably necessary to perform its obligations hereunder.

 

ARTICLE 3

 

Miscellaneous

 

3.1 Termination. This Agreement shall remain in effect until the conclusion of any stockholders meeting, and any adjournment thereof, duly called and held to consider and vote on the matters set forth in Section 2.1 hereof (the “Required Approvals”) (or the conclusion of any solicitation of consents to such matters in lieu of a stockholders meeting). From and after such date, this Agreement shall terminate automatically and without further action by any of the parties.

 

3.2 Prompt Action. The Company agrees to take all actions necessary to obtain the Required Approvals as promptly as is practicable following the closing of the transactions contemplated by the Merger Agreement and the Stock Purchase Agreement, including without limitation, filing an appropriate proxy statement with the Securities and Exchange Commission.

 

3.3 Successors; Legending of Shares. The terms of this Agreement shall be binding upon and inure to the benefit of the heirs, personal representatives, successors and assigns of the parties hereto and each transferee or assignee of the Shares subject to this Agreement shall continue to be subject to the terms hereof. During the term of this Agreement, each certificate representing the Shares subject to this Agreement shall be endorsed by the Company with a legend reading substantially as follows:

 

“THE SECURITIES REPRESENTED BY THIS CERTIFICATE ARE SUBJECT TO A VOTING AGREEMENT, A COPY OF WHICH MAY BE OBTAINED AT NO COST BY WRITTEN REQUEST MADE BY THE HOLDER OF RECORD OF THIS CERTIFICATE TO THE SECRETARY OF THE COMPANY.”

 

Within three (3) business days following termination of this Agreement, the Company shall provide to Selena new certificates from which the above legend has been removed.

 

3.4 Governing Law. This Voting Agreement shall be governed in all respects by the laws of the State of New York without regard to choice of laws or conflict of laws provisions thereof.

 

3.5 Specific Performance. In the event of a breach by any party of its obligation to vote or act as provided in this Agreement, any aggrieved party shall be entitled to a decree of specific performance. The aggrieved party shall not be denied specific performance by a court on the ground that a remedy at law is adequate or on other grounds relating to the jurisdiction of a court of equity.

 

-3-


3.6 Successors and Assigns. This Agreement and all rights, duties and obligations hereunder shall inure to the benefit of, and be binding upon, the successors, assigns, heirs, executors and administrators of the parties.

 

3.7 Entire Agreement; Amendment. This Agreement and any term hereof may be amended, waived, discharged or terminated (either generally or in a particular instance and either retroactively or prospectively) only by a written instrument signed by the Company and Selena; provided, however, that no amendment hereto shall affect the obligation of Selena to vote in favor of the Required Approvals. Any amendment or waiver of this Agreement so effected shall be binding upon each of the parties to this Agreement. This Agreement constitutes the full and entire understanding and agreement between the parties with regard to the subject matter hereof. Any prior agreements, understandings or representations with respect to the subject matter hereof, are superseded by this Agreement and shall have no further force or effect.

 

3.8 Notice. All notices and other communications required or permitted hereunder shall be in writing and shall be sent by first-class United States mail or delivered in person or sent via next day Federal Express delivery or any other nationally-recognized overnight delivery service or by facsimile (with confirmation of receipt), addressed:

 

(a) if to Selena, at such address as set forth in the Stock Purchase Agreement, or at such other address as Selena shall have furnished to the Company in writing;

 

(b) if to any other holder of any securities subject to this Agreement, at such address as such holder shall have furnished to the Company in writing, or, until any such holder so furnishes an address to the Company, then to and at the address of the last holder of such securities who has so furnished an address to the Company; or

 

(c) if to the Company, at the address set forth below the signature of the Company’s duly authorized representative.

 

Notice shall be deemed to be received for purposes of this Agreement (i) when delivered, if delivered in person, (ii) one (1) business day after having been deposited for delivery, if delivered by next day Federal Express delivery or any other nationally-recognized overnight delivery service, (iii) three (3) days after having been deposited in the United States mails with first class postage prepaid and addressed to the recipient and (iv) when sent, if delivered by facsimile (with confirmation of receipt).

 

3.9 Delays or Omissions. No delay or omission to exercise any right, power or remedy accruing to any party upon any breach or default under this Agreement shall impair any such right, power or remedy of such party, nor shall it be construed to be a waiver of any such breach or default or an acquiescence therein, or of or in any similar breach or default thereafter occurring; nor shall any waiver of any single breach or default be deemed a waiver of any other breach or default theretofore or thereafter occurring. Any waiver, permit, consent or approval of any kind or character of any breach or default under this Agreement, or any waiver on the part of any party of any provisions or conditions of this Agreement, must be made in writing and shall be effective only to the extent specifically set forth in such writing. All remedies, either under this Agreement or by law or otherwise afforded to any holder, shall be cumulative and not alternative.

 

-4-


3.10 Severability. Whenever possible, each provision of this Agreement shall be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Agreement shall be held to be prohibited by or invalid under applicable law, such provision shall be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of such provision or the remaining provisions of this Agreement.

 

3.11 Counterparts. This Agreement may be executed in any number of counterparts and by facsimile, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

 

[Remainder of this Page Intentionally Left Blank]

 

-5-


IN WITNESS WHEREOF, the undersigned have executed this Voting Agreement as of the date first set forth above.

 

COMPANY:    ORION ACQUISITION CORP. II
501 Second Street, Suite 211          
San Francisco, CA 94107          
Fax: (415) 543-3113    By:   

/s/ David T. Hung, M.D.


     Name:    David T. Hung, M.D.
     Title:    President and Chief Executive Officer
SELENA:    SELENA PHARMACEUTICALS, INC.
167 Skyview Way          
San Francisco, CA 94131          
Fax: (415) 826-0247    By:   

/s/ Sergey O. Sablin


     Name:    Sergey O. Sablin
     Title:    President
EX-9.1(E) 7 dex91e.htm VOTING AGMT BY AND BETWEEN ORION ACQUISITION CORP. II AND INVESTORS Voting Agmt by and between Orion Acquisition Corp. II and investors

EXHIBIT 9.1(e)

 

VOTING AGREEMENT

 

This Voting Agreement (the “Agreement”) is made effective as of December 17, 2004, by and among Orion Acquisition Corp. II, a Delaware corporation (the “Company”) and the investors in the Company whose names are set forth on the signature pages to this Agreement (each an “Investor” and collectively, the “Investors”).

 

RECITALS

 

WHEREAS, pursuant to a Merger Agreement, dated as of December 17, 2004 (the “Merger Agreement”), by and between the Company, Medivation Acquisition Corp., a Delaware corporation and wholly-owned subsidiary of the Company (“Newco”), and Medivation, Inc., a Delaware corporation (“Medivation”), Newco has been merged with and into Medivation (the “Merger”), with Medivation as the surviving corporation and a wholly-owned subsidiary of the Company;

 

WHEREAS, pursuant to a stock purchase agreement, dated as of December 17, 2004 (the “Stock Purchase Agreement”), by and between the Company and the Investors, the Company has agreed to issue and sell to the Investors, and the Investors have agreed to purchase from the Company, up to a maximum of 2,580,645 shares of the Company’s Common Stock at a purchase price of $1.55 per share;

 

WHEREAS, pursuant to additional stock purchase agreements, each dated as of December 17, 2004, by and between the Company and the investors listed therein (collectively, the “Additional Investors”), the Company has agreed to issue and sell to the Additional Investors, and the Additional Investors have agreed to purchase from the Company, up to a maximum of 5,219,355 additional shares of the Company’s Common Stock at a purchase price of $1.55 per share;

 

WHEREAS, the Stock Purchase Agreement provides that the Company and the Additional Investors execute voting agreements which provide for substantially similar voting obligations as those provided for herein;

 

WHEREAS, it is a condition to the obligations of the Company and Medivation under the Merger Agreement, and it is also a condition to the obligations of the Company and the Investors under the Stock Purchase Agreement, that each Investor agree to vote the shares of Company stock owned by each of them in the manner set forth in this Agreement; and

 

WHEREAS, the parties desire to enter into this Agreement and to provide that in exercising any voting rights related to the subject matter of this Agreement, the shares of the Company’s voting stock held by them shall be voted as provided in this Agreement.

 

AGREEMENT

 

NOW THEREFORE, in consideration of the mutual covenants and agreements set forth herein and for other good and valuable consideration the receipt and adequacy of which is hereby acknowledged, the parties hereto, intending to be legally bound, hereby agree as follows:


ARTICLE 1

 

General; Definitions

 

1.1 Certain Definitions. As used in this Agreement, the following terms shall have the following respective meanings:

 

(a) “Common Stock” shall mean the Company’s common stock, $0.01 par value per share, having the rights, preferences and privileges as set forth in the Company’s certificate of incorporation and bylaws, as amended and in effect on the date thereof.

 

(b) “Preferred Stock” shall mean the Series B Preferred Stock, $0.01 par value per share, of the Company.

 

(c) “Shares” shall mean, collectively, the shares of Common Stock sold to the Investors pursuant to the Stock Purchase Agreement.

 

ARTICLE 2

 

Agreement to Vote

 

2.1 Agreement to Vote. During the term of this Agreement, each Investor hereby agrees and covenants, severally and not jointly, to vote or cause to be voted all of his, her or its Shares then owned by him, her or it or over which he, she or it has voting power at any regular or special meeting of stockholders, or, in lieu of any such meeting, to give his, her or its written consent in any action by written consent of the stockholders, in favor of each of the following items:

 

(a) The amendment of the Certificate of Incorporation of the Company to:

 

(i) increase the authorized shares of Common Stock of the Company to 50,000,000 shares;

 

(ii) change the name of the Company to a name specified by the Board of Directors of the Company, which name shall include the word “Medivation”; and

 

(iii) make any other change that the Company’s Board of Directors has determined to be necessary or advisable in order to obtain listing of the Company’s Common Stock on the Nasdaq SmallCap Market.

 

(b) The election to the Company’s Board of Directors of the following five (5) individuals:

 

(i) Steve Gorlin;

 

(ii) David T. Hung, M.D.;

 

(iii) One (1) nominee of the former stockholders of Medivation; and

 

(iv) Two (2) nominees of MDB Capital Group LLC.


(c) In the event that any of the persons nominated pursuant to Section 2.1(b) is unable or unwilling to serve as a director, the election of such successor nominee as is designated by the parties entitled to designate such nominee pursuant to Section 2.1(b).

 

2.2 Further Assurances. Each Investor shall take such action as may be reasonably necessary to perform its obligations hereunder.

 

ARTICLE 3

 

Miscellaneous

 

3.1 Termination. This Agreement shall remain in effect until the conclusion of any stockholders meeting, and any adjournment thereof, duly called and held to consider and vote on the matters set forth in Section 2.1 hereof (the “Required Approvals”) (or the conclusion of any solicitation of consents to such matters in lieu of a stockholders meeting). From and after such date, this Agreement shall terminate automatically and without further action by any of the parties.

 

3.2 Prompt Action. The Company agrees to take all actions necessary to obtain the Required Approvals as promptly as is practicable following the closing of the transactions contemplated by the Merger Agreement and the Stock Purchase Agreement, including without limitation, filing an appropriate proxy statement with the Securities and Exchange Commission.

 

3.3 Successors; Legending of Shares. The terms of this Agreement shall be binding upon and inure to the benefit of the heirs, personal representatives, successors and assigns of the parties hereto and each transferee or assignee of the Shares subject to this Agreement shall continue to be subject to the terms hereof. During the term of this Agreement, each certificate representing the Shares subject to this Agreement shall be endorsed by the Company with a legend reading substantially as follows:

 

“THE SECURITIES REPRESENTED BY THIS CERTIFICATE ARE SUBJECT TO A VOTING AGREEMENT, A COPY OF WHICH MAY BE OBTAINED AT NO COST BY WRITTEN REQUEST MADE BY THE HOLDER OF RECORD OF THIS CERTIFICATE TO THE SECRETARY OF THE COMPANY.”

 

Within three (3) business days following termination of this Agreement, the Company shall provide to each Investor new certificates from which the above legend has been removed.

 

3.4 Governing Law. This Voting Agreement shall be governed in all respects by the laws of the State of New York without regard to choice of laws or conflict of laws provisions thereof.

 

3.5 Specific Performance. In the event of a breach by any party of its obligation to vote or act as provided in this Agreement, any aggrieved party shall be entitled to a decree of


specific performance. The aggrieved party shall not be denied specific performance by a court on the ground that a remedy at law is adequate or on other grounds relating to the jurisdiction of a court of equity.

 

3.6 Successors and Assigns. This Agreement and all rights, duties and obligations hereunder shall inure to the benefit of, and be binding upon, the successors, assigns, heirs, executors and administrators of the parties.

 

3.7 Entire Agreement; Amendment. This Agreement and any term hereof may be amended, waived, discharged or terminated (either generally or in a particular instance and either retroactively or prospectively) only by a written instrument signed by the Company and the Investors; provided, however, that no amendment hereto shall affect the obligation of the Investors to vote in favor of the Required Approvals. Any amendment or waiver of this Agreement so effected shall be binding upon each of the parties to this Agreement. This Agreement constitutes the full and entire understanding and agreement between the parties with regard to the subject matter hereof. Any prior agreements, understandings or representations with respect to the subject matter hereof, are superseded by this Agreement and shall have no further force or effect.

 

3.8 Notice. All notices and other communications required or permitted hereunder shall be in writing and shall be sent by first-class United States mail or delivered in person or sent via next day Federal Express delivery or any other nationally-recognized overnight delivery service or by facsimile (with confirmation of receipt), addressed:

 

(a) if to an Investor, at such address as set forth in the Stock Purchase Agreement, or at such other address as the Investor shall have furnished to the Company in writing;

 

(b) if to any other holder of any securities subject to this Agreement, at such address as such holder shall have furnished to the Company in writing, or, until any such holder so furnishes an address to the Company, then to and at the address of the last holder of such securities who has so furnished an address to the Company; or

 

(c) if to the Company, at the address set forth below the signature of the Company’s duly authorized representative.

 

Notice shall be deemed to be received for purposes of this Agreement (i) when delivered, if delivered in person, (ii) one (1) business day after having been deposited for delivery, if delivered by next day Federal Express delivery or any other nationally-recognized overnight delivery service, (iii) three (3) days after having been deposited in the United States mails with first class postage prepaid and addressed to the recipient and (iv) when sent, if delivered by facsimile (with confirmation of receipt).

 

3.9 Delays or Omissions. No delay or omission to exercise any right, power or remedy accruing to any party upon any breach or default under this Agreement shall impair any such right, power or remedy of such party, nor shall it be construed to be a waiver of any such breach or default or an acquiescence therein, or of or in any similar breach or default thereafter occurring; nor shall any waiver of any single breach or default be deemed a waiver of any other


breach or default theretofore or thereafter occurring. Any waiver, permit, consent or approval of any kind or character of any breach or default under this Agreement, or any waiver on the part of any party of any provisions or conditions of this Agreement, must be made in writing and shall be effective only to the extent specifically set forth in such writing. All remedies, either under this Agreement or by law or otherwise afforded to any holder, shall be cumulative and not alternative.

 

3.10 Severability. Whenever possible, each provision of this Agreement shall be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Agreement shall be held to be prohibited by or invalid under applicable law, such provision shall be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of such provision or the remaining provisions of this Agreement.

 

3.11 Counterparts. This Agreement may be executed in any number of counterparts and by facsimile, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

 

[Remainder of this Page Intentionally Left Blank]


IN WITNESS WHEREOF, the undersigned have executed this Voting Agreement as of the date first set forth above.

 

COMPANY:    ORION ACQUISITION CORP. II
501 Second Street, Suite 211          
San Francisco, CA 94107          
Fax: (415) 543-3113    By:   

/s/ David T. Hung, M.D.


     Name:    David T. Hung, M.D.
     Title:    President and Chief Executive Officer
INVESTORS:          
     By:   

/s/ Investors


     Name:     
     Title:     
EX-10.1(A) 8 dex101a.htm LOCK-UP AGMT BY AND BETWEEN ORION ACQUISITION CORP. II AND DAVID T. HUNG Lock-Up Agmt by and between Orion Acquisition Corp. II and David T. Hung

EXHIBIT 10.1(a)

 

LOCK-UP AGREEMENT

 

December 17, 2004

 

Orion Acquisition Corp. II

401 Wilshire Boulevard – Suite 1020

Santa Monica, California 90401

 

Ladies and Gentlemen:

 

In connection with a private offering of stock by Orion Acquisition Corp. II, (“Corporation”) and the merger (“Merger”) between a subsidiary of the Corporation and Medivation, Inc., a Delaware corporation (“Medivation”), (i) to induce the Corporation to sell such stock to “accredited” or otherwise sophisticated investors (“Investors”), (ii) to induce the Investors to purchase stock of the Corporation, and (iii) to induce the Corporation to consummate the Merger, the undersigned, agrees to neither directly nor indirectly:

 

  (1) sell or offer or contract to sell or offer, grant any option or warrant for the sale of, assign, transfer, pledge, hypothecate, or otherwise encumber or dispose of ( all being referred to as a “Transfer”) any legal or beneficial interest in any Restricted Shares. “Restricted Shares” shall mean (a) the shares of the Series B Preferred Stock, $.01 par value, of the Corporation to be received by the undersigned in the Merger in exchange for the issued and outstanding shares of Medivation Common Stock, $.001 par value, held by the undersigned immediately prior to consummation of the Merger (the “Restricted Series B Shares”), (b) the shares of the Common Stock, $.01 per share, of the Corporation issuable upon conversion of the Restricted Series B Shares (the “Restricted Common Shares”), and (c) any other securities of the Corporation that may become issuable with respect to any of the Restricted Series B Shares and/or the Restricted Common Shares, by way of stock split, stock dividend or otherwise; or

 

  (2) enter into any swap or any other agreement or any transaction that transfers, in whole or in part, directly or indirectly, the economic consequence of ownership of any of the Restricted Shares, whether such swap transaction is to be settled by delivery of any Restricted Shares or other securities of any person, in cash or otherwise,

 

for the period commencing the date of the consummation of the Merger and ending on the later of (i) first anniversary of the consummation of the Merger, or (ii) the closing of the database for the Corporation’s (including though its subsidiary) planned Phase II randomized, double-blinded, placebo controlled study of Dimebon in Alzheimer’s disease patients in Russia, which is expected to occur in the first half of 2006, but, notwithstanding the foregoing time periods, the lock-up period will not exceed two years after the consummation of the Merger.

 

Notwithstanding the foregoing limitations, this lock-up agreement will not prevent any Transfer of any or all of the Restricted Shares, [i] either during the undersigned’s lifetime or on the undersigned’s death, by gift, will or intestate succession, to the undersigned’s “family member” or to trusts, family limited partnerships and similar entities for the benefit of the undersigned or the undersigned’s “family members”; or if the undersigned is an entity, to the stockholders, members or other owners of such entity, provided, however, that in each and any such event it shall be a condition to the Transfer that the transferee execute an agreement stating that the transferee is receiving and holding the Restricted Shares subject to the provision of this lock-up agreement, and other than to return the Restricted Shares to the former ownership, there shall be no further Transfer of the Restricted Shares except in accordance with this lock-up agreement, or [ii] upon the approval by unanimous written consent of the then board of directors of the Corporation. For purposes of this sub-paragraph, “family member” shall mean spouse, lineal descendants, stepchildren, father, mother, brother or sister of the transferor or of the transferor’s spouse.


The undersigned has submitted or in the future will submit any certificates representing the Restricted Shares to the Corporation so that it may apply the appropriate legend thereto to reflect the existence and general terms of this lock-up agreement.

 

This lock-up agreement will be legally binding on the undersigned and on the undersigned’s heirs, successors, executors, administrators, conservators and permitted assigns, executed as an instrument governed by the laws of the State of California.

 

Very truly yours,

 

 
    /s/ David T. Hung, M.D.
    David T. Hung, M.D.
    President and Chief Executive Officer
    86,055
    Number of Series B Restricted Shares

 

2

EX-10.1(B) 9 dex101b.htm LOCK-UP AGMT BY AND BETWEEN ORION ACQUISITION CORP. II AND C. PATRICK MACHADO Lock-Up Agmt by and between Orion Acquisition Corp. II and C. Patrick Machado

Exhibit 10.1(b)

 

LOCK-UP AGREEMENT

 

December 17, 2004

 

Orion Acquisition Corp. II

401 Wilshire Boulevard – Suite 1020

Santa Monica, California 90401

 

Ladies and Gentlemen:

 

In connection with a private offering of stock by Orion Acquisition Corp. II, ("Corporation") and the merger (“Merger”) between a subsidiary of the Corporation and Medivation, Inc., a Delaware corporation (“Medivation”), (i) to induce the Corporation to sell such stock to “accredited” or otherwise sophisticated investors (“Investors”), (ii) to induce the Investors to purchase stock of the Corporation, and (iii) to induce the Corporation to consummate the Merger, the undersigned, agrees to neither directly nor indirectly:

 

  (1) sell or offer or contract to sell or offer, grant any option or warrant for the sale of, assign, transfer, pledge, hypothecate, or otherwise encumber or dispose of ( all being referred to as a “Transfer”) any legal or beneficial interest in any Restricted Shares. “Restricted Shares” shall mean (a) the shares of the Series B Preferred Stock, $.01 par value, of the Corporation to be received by the undersigned in the Merger in exchange for the issued and outstanding shares of Medivation Common Stock, $.001 par value, held by the undersigned immediately prior to consummation of the Merger (the “Restricted Series B Shares”), (b) the shares of the Common Stock, $.01 per share, of the Corporation issuable upon conversion of the Restricted Series B Shares (the “Restricted Common Shares”), and (c) any other securities of the Corporation that may become issuable with respect to any of the Restricted Series B Shares and/or the Restricted Common Shares, by way of stock split, stock dividend or otherwise; or

 

  (2) enter into any swap or any other agreement or any transaction that transfers, in whole or in part, directly or indirectly, the economic consequence of ownership of any of the Restricted Shares, whether such swap transaction is to be settled by delivery of any Restricted Shares or other securities of any person, in cash or otherwise,

 

for the period commencing the date of the consummation of the Merger and ending on the later of (i) first anniversary of the consummation of the Merger, or (ii) the closing of the database for the Corporation’s (including though its subsidiary) planned Phase II randomized, double-blinded, placebo controlled study of Dimebon in Alzheimer’s disease patients in Russia, which is expected to occur in the first half of 2006, but, notwithstanding the foregoing time periods, the lock-up period will not exceed two years after the consummation of the Merger.

 

Notwithstanding the foregoing limitations, this lock-up agreement will not prevent any Transfer of any or all of the Restricted Shares, [i] either during the undersigned’s lifetime or on the undersigned’s death, by gift, will or intestate succession, to the undersigned’s “family member” or to trusts, family limited partnerships and similar entities for the benefit of the undersigned or the undersigned’s “family members”; or if the undersigned is an entity, to the stockholders, members or other owners of such entity, provided, however, that in each and any such event it shall be a condition to the Transfer that the transferee execute an agreement stating that the transferee is receiving and holding the Restricted Shares subject to the provision of this lock-up agreement, and other than to return the Restricted Shares to the former ownership, there shall be no further Transfer of the Restricted Shares except in accordance with this lock-up agreement, or [ii] upon the approval by unanimous written consent of the then board of directors of the Corporation. For purposes of this sub-paragraph, “family member” shall mean spouse, lineal descendants, stepchildren, father, mother, brother or sister of the transferor or of the transferor’s spouse.

 

The undersigned has submitted or in the future will submit any certificates representing the Restricted Shares to the Corporation so that it may apply the appropriate legend thereto to reflect the existence and general terms of this lock-up agreement.


This lock-up agreement will be legally binding on the undersigned and on the undersigned’s heirs, successors, executors, administrators, conservators and permitted assigns, executed as an instrument governed by the laws of the State of California.

 

Very truly yours,

 
    /s/ C. Patrick Machado
    C. Patrick Machado
    Sr. Vice President and Chief Financial Officer
    24,587
    Number of Series B Restricted Shares

 

2

EX-10.1(C) 10 dex101c.htm LOCK-UP AGMT BY AND BETWEEN ORION ACQUISITION CORP. II AND DARA BIOSCIENCES, INC Lock-Up Agmt by and between Orion Acquisition Corp. II and Dara BioSciences, Inc

EXHIBIT 10.1(c)

 

LOCK-UP AGREEMENT

 

December 17, 2004

 

Orion Acquisition Corp. II

401 Wilshire Boulevard – Suite 1020

Santa Monica, California 90401

 

Ladies and Gentlemen:

 

In connection with a private offering of stock by Orion Acquisition Corp. II, (“Corporation”) and the merger (“Merger”) between a subsidiary of the Corporation and Medivation, Inc., a Delaware corporation (“Medivation”), (i) to induce the Corporation to sell such stock to “accredited” or otherwise sophisticated investors (“Investors”), (ii) to induce the Investors to purchase stock of the Corporation, and (iii) to induce the Corporation to consummate the Merger, the undersigned, agrees to neither directly nor indirectly:

 

  (1) sell or offer or contract to sell or offer, grant any option or warrant for the sale of, assign, transfer, pledge, hypothecate, or otherwise encumber or dispose of ( all being referred to as a “Transfer”) any legal or beneficial interest in any Restricted Shares. “Restricted Shares” shall mean (a) the shares of the Series B Preferred Stock, $.01 par value, of the Corporation to be received by the undersigned in the Merger in exchange for the issued and outstanding shares of Medivation Common Stock, $.001 par value, held by the undersigned immediately prior to consummation of the Merger (the “Restricted Series B Shares”), (b) the shares of the Common Stock, $.01 per share, of the Corporation issuable upon conversion of the Restricted Series B Shares (the “Restricted Common Shares”), and (c) any other securities of the Corporation that may become issuable with respect to any of the Restricted Series B Shares and/or the Restricted Common Shares, by way of stock split, stock dividend or otherwise; or

 

  (2) enter into any swap or any other agreement or any transaction that transfers, in whole or in part, directly or indirectly, the economic consequence of ownership of any of the Restricted Shares, whether such swap transaction is to be settled by delivery of any Restricted Shares or other securities of any person, in cash or otherwise,

 

for the period commencing the date of the consummation of the Merger and ending on the later of (i) first anniversary of the consummation of the Merger, or (ii) the closing of the database for the Corporation’s (including though its subsidiary) planned Phase II randomized, double-blinded, placebo controlled study of Dimebon in Alzheimer’s disease patients in Russia, which is expected to occur in the first half of 2006, but, notwithstanding the foregoing time periods, the lock-up period will not exceed two years after the consummation of the Merger.

 

Notwithstanding the foregoing limitations, this lock-up agreement will not prevent any Transfer of any or all of the Restricted Shares, [i] either during the undersigned’s lifetime or on the undersigned’s death, by gift, will or intestate succession, to the undersigned’s “family member” or to trusts, family limited partnerships and similar entities for the benefit of the undersigned or the undersigned’s “family members”; or if the undersigned is an entity, to the stockholders, members or other owners of such entity, provided, however, that in each and any such event it shall be a condition to the Transfer that the transferee execute an agreement stating that the transferee is receiving and holding the Restricted Shares subject to the provision of this lock-up agreement, and other than to return the Restricted Shares to the former ownership, there shall be no further Transfer of the Restricted Shares except in accordance with this lock-up agreement, or [ii] upon the approval by unanimous written consent of the then board of directors of the Corporation. For purposes of this sub-paragraph, “family member” shall mean spouse, lineal descendants, stepchildren, father, mother, brother or sister of the transferor or of the transferor’s spouse.


The undersigned has submitted or in the future will submit any certificates representing the Restricted Shares to the Corporation so that it may apply the appropriate legend thereto to reflect the existence and general terms of this lock-up agreement.

 

This lock-up agreement will be legally binding on the undersigned and on the undersigned’s heirs, successors, executors, administrators, conservators and permitted assigns, executed as an instrument governed by the laws of the State of California.

 

Very truly yours,

 

 
    /s/ John C. Thomas
    John C. Thomas
    Chief Financial Officer of Dara BioSciences, Inc.
    110,642
    Number of Series B Restricted Shares

 

2

EX-10.1(D) 11 dex101d.htm LOCK-UP AGMT BY AND BETWEEN ORION ACQUISITION CORP. II AND SELENA PHARM Lock-Up Agmt by and between Orion Acquisition Corp. II and Selena Pharm

Exhibit 10.1(d)

 

LOCK-UP AGREEMENT

 

December 17, 2004

 

Orion Acquisition Corp. II

401 Wilshire Boulevard – Suite 1020

Santa Monica, California 90401

 

Ladies and Gentlemen:

 

In connection with a private offering of stock by Orion Acquisition Corp. II, (“Corporation”) and the merger (“Merger”) between a subsidiary of the Corporation and Medivation, Inc., a Delaware corporation (“Medivation”), (i) to induce the Corporation to sell such stock to “accredited” or otherwise sophisticated investors (“Investors”), (ii) to induce the Investors to purchase stock of the Corporation, and (iii) to induce the Corporation to consummate the Merger, the undersigned, agrees to neither directly nor indirectly:

 

  (1) sell or offer or contract to sell or offer, grant any option or warrant for the sale of, assign, transfer, pledge, hypothecate, or otherwise encumber or dispose of ( all being referred to as a “Transfer”) any legal or beneficial interest in any Restricted Shares. “Restricted Shares” shall mean (a) the shares of the Series B Preferred Stock, $.01 par value, of the Corporation to be received by the undersigned in the Merger in exchange for the issued and outstanding shares of Medivation Common Stock, $.001 par value, held by the undersigned immediately prior to consummation of the Merger (the “Restricted Series B Shares”), (b) the shares of the Common Stock, $.01 per share, of the Corporation issuable upon conversion of the Restricted Series B Shares (the “Restricted Common Shares”), and (c) any other securities of the Corporation that may become issuable with respect to any of the Restricted Series B Shares and/or the Restricted Common Shares, by way of stock split, stock dividend or otherwise; or
  (2) enter into any swap or any other agreement or any transaction that transfers, in whole or in part, directly or indirectly, the economic consequence of ownership of any of the Restricted Shares, whether such swap transaction is to be settled by delivery of any Restricted Shares or other securities of any person, in cash or otherwise,

 

for the period commencing the date of the consummation of the Merger and ending on the later of (i) first anniversary of the consummation of the Merger, or (ii) the closing of the database for the Corporation’s (including though its subsidiary) planned Phase II randomized, double-blinded, placebo controlled study of Dimebon in Alzheimer’s disease patients in Russia, which is expected to occur in the first half of 2006, but, notwithstanding the foregoing time periods, the lock-up period will not exceed two years after the consummation of the Merger.

 

Notwithstanding the foregoing limitations, this lock-up agreement will not prevent any Transfer of any or all of the Restricted Shares, [i] either during the undersigned’s lifetime or on the undersigned’s death, by gift, will or intestate succession, to the undersigned’s “family member” or to trusts, family limited partnerships and similar entities for the benefit of the undersigned or the undersigned’s “family members”; or if the undersigned is an entity, to the stockholders, members or other owners of such entity, provided, however, that in each and any such event it shall be a condition to the Transfer that the transferee execute an agreement stating that the transferee is receiving and holding the Restricted Shares subject to the provision of this lock-up agreement, and other than to return the Restricted Shares to the former ownership, there shall be no further Transfer of the Restricted Shares except in accordance with this lock-up agreement, or [ii] upon the approval by unanimous written consent of the then board of directors of the Corporation. For purposes of this sub-paragraph, “family member” shall mean spouse, lineal descendants, stepchildren, father, mother, brother or sister of the transferor or of the transferor’s spouse.

 

The undersigned has submitted or in the future will submit any certificates representing the Restricted Shares to the Corporation so that it may apply the appropriate legend thereto to reflect the existence and general terms of this lock-up agreement.


This lock-up agreement will be legally binding on the undersigned and on the undersigned’s heirs, successors, executors, administrators, conservators and permitted assigns, executed as an instrument governed by the laws of the State of California.

 

Very truly yours,

 

 
    /s/ Sergey O. Sablin
    Sergey O. Sablin
    President of Selena Pharmaceuticals, Inc.
    110,642
    Number of Series B Restricted Shares

 

2

EX-10.2(A) 12 dex102a.htm PURCHASE AGREEMENT BY AND AMONG ORION ACQUISITION CORP. II AND INVESTORS Purchase Agreement by and among Orion Acquisition Corp. II and investors

EXHIBIT 10.2(a)

 

PURCHASE AGREEMENT

 

THIS PURCHASE AGREEMENT (“Agreement”) is made as of the 17th day of December, 2004 by and among Orion Acquisition Corp. II, a Delaware corporation (the “Company”), and the Investors set forth on the signature pages affixed hereto (each an “Investor” and collectively the “Investors”).

 

Recitals

 

A. The Company has entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Medivation Acquisition Corp., a Delaware corporation (“Merger Sub”), and Medivation, Inc., a Delaware corporation (“Medivation”), pursuant to which, among other things, Merger Sub will merge with and into Medivation with Medivation as the surviving entity thereof (the “Merger”); and

 

B. The Company and the Investors are executing and delivering this Agreement in reliance upon the exemption from securities registration afforded by the provisions of Regulation D (“Regulation D”), as promulgated by the U.S. Securities and Exchange Commission (the “SEC”) under the Securities Act of 1933, as amended; and

 

C. The Investors wish to purchase from the Company, and the Company wishes to sell and issue to the Investors, upon the terms and conditions stated in this Agreement, shares of the Company’s Common Stock, par value $0.01 per share (together with any securities into which such shares may be reclassified the “Common Stock”), at purchase price of $1.55 per share;

 

D. Contemporaneous with the sale of the Common Stock, the parties hereto will execute and deliver a Registration Rights Agreement, in the form attached hereto as Exhibit A (the “Registration Rights Agreement”), pursuant to which the Company will agree to provide certain registration rights under the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder, and applicable state securities laws, and a Voting Agreement, in the form attached hereto as Exhibit B (the “Voting Agreement”), pursuant to which the Investors will agree to vote their Shares as specified therein.

 

In consideration of the mutual promises made herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:

 

1. Definitions. In addition to those terms defined above and elsewhere in this Agreement, for the purposes of this Agreement, the following terms shall have the meanings set forth below:

 

Affiliate” means, with respect to any Person, any other Person which directly or indirectly through one or more intermediaries Controls, is controlled by, or is under common control with, such Person.


Business Day” means a day, other than a Saturday or Sunday, on which banks in New York City are open for the general transaction of business.

 

Common Stock Equivalents” means any securities of the Company or the Subsidiaries which would entitle the holder thereof to acquire at any time Common Stock, including without limitation, any debt, preferred stock, rights, options, warrants or other instrument that is at any time convertible into or exchangeable for, or otherwise entitles the holder thereof to receive, Common Stock.

 

Company’s Knowledge” means the actual knowledge of the executive officers (as defined in Rule 405 under the 1933 Act) of the Company, after due inquiry.

 

Confidential Information” means trade secrets, confidential information and know-how (including but not limited to ideas, formulae, compositions, processes, procedures and techniques, research and development information, computer program code, performance specifications, support documentation, drawings, specifications, designs, business and marketing plans, and customer and supplier lists and related information).

 

Control” (including the terms “controlling”, “controlled by” or “under common control with”) means the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a Person, whether through the ownership of voting securities, by contract or otherwise.

 

Effective Date” means the date on which the initial Registration Statement (as defined in the Registration Rights Agreement) is declared effective by the SEC.

 

Effectiveness Deadline” means the date on which the initial Registration Statement (as so defined) is required to be declared effective by the SEC under the terms of the Registration Rights Agreement.

 

Intellectual Property” means all of the following: (i) patents, patent applications, patent disclosures and inventions (whether or not patentable and whether or not reduced to practice); (ii) trademarks, service marks, trade dress, trade names, corporate names, logos, slogans and Internet domain names, together with all goodwill associated with each of the foregoing; (iii) copyrights and copyrightable works; (iv) registrations, applications and renewals for any of the foregoing; and (v) proprietary computer software (including but not limited to data, data bases and documentation).

 

Material Adverse Effect” means a material adverse effect on (i) the assets, liabilities, results of operations, condition (financial or otherwise), business, or prospects of the Company and its Subsidiaries taken as a whole, or (ii) the ability of the Company to perform its obligations under the Transaction Documents.

 

Nasdaq” means The Nasdaq Stock Market, Inc.

 

-2-


Person” means an individual, corporation, partnership, limited liability company, trust, business trust, association, joint stock company, joint venture, sole proprietorship, unincorporated organization, governmental authority or any other form of entity not specifically listed herein.

 

Private Placement Memorandum” means the Company’s Private Placement Memorandum, dated November 30, 2004, and any amendments or supplements thereto provided to the Investors prior to the date hereof.

 

Purchase Price” means the product obtained by multiplying $1.55 by the number of Shares to be purchased pursuant to this Agreement.

 

SEC Filings” has the meaning set forth in Section 4.6.

 

Registration Statement” has the meaning set forth in the Registration Rights Agreement.

 

Shares” means the shares of Common Stock being purchased by the Investors hereunder.

 

Subsidiary” of any Person means another Person, an amount of the voting securities, other voting ownership or voting partnership interests of which is sufficient to elect at least a majority of its Board of Directors or other governing body (or, if there are no such voting interests, 50% or more of the equity interests of which) is owned directly or indirectly by such first Person. Without limiting the generality of the foregoing, Medivation shall be considered a Subsidiary of the Company from and after the effective date of the Merger.

 

Transaction Documents” means this Agreement, the Registration Rights Agreement, the Voting Agreement and the Merger Agreement.

 

1933 Act” means the Securities Act of 1933, as amended, or any successor statute, and the rules and regulations promulgated thereunder.

 

1934 Act” means the Securities Exchange Act of 1934, as amended, or any successor statute, and the rules and regulations promulgated thereunder.

 

2. Purchase and Sale of the Shares. Subject to the terms and conditions of this Agreement, on the Closing Date, each of the Investors shall severally, and not jointly, purchase, and the Company shall sell and issue to the Investors, the Shares in the respective amounts set forth opposite the Investors’ names on the signature pages attached hereto in exchange for the Purchase Price as specified in Section 3 below.

 

3. Closing. Promptly following the Closing (defined below), the Company shall deliver to each Investor, at the address set forth on the signature page hereof, a certificate or certificates, registered in such name or names as the Investors may designate, representing the Shares in exchange for payment therefor by a wire transfer in same day funds to be sent to the

 

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account of the Company as instructed in writing by the Company or released from escrow, as applicable, in an amount representing such Investor’s pro rata portion of the Purchase Price as set forth on the signature pages to this Agreement (the “Closing”). The Closing of the purchase and sale of the Shares shall take place at the offices of Latham & Watkins LLP, 505 Montgomery Street, Suite 1900, San Francisco, California 94111, or at such other location and on such other date as the Company and the Investors shall mutually agree.

 

4. Representations and Warranties of the Company. The Company hereby represents and warrants to the Investors that, except as set forth in the schedules delivered herewith (collectively, the “Disclosure Schedules”):

 

4. 1 Organization, Good Standing and Qualification. Each of the Company and its Subsidiaries is a corporation duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation and has all requisite corporate power and authority to carry on its business as now conducted and to own its properties. Each of the Company and its Subsidiaries is duly qualified to do business as a foreign corporation and is in good standing in each jurisdiction in which the conduct of its business or its ownership or leasing of property makes such qualification or leasing necessary unless the failure to so qualify has not and could not reasonably be expected to have a Material Adverse Effect. The Company’s only Subsidiary is Medivation, and Medivation has no Subsidiaries.

 

4.2 Authorization. The Company has full power and authority and has taken all requisite action on the part of the Company, its officers, directors and stockholders necessary for (i) the authorization, execution and delivery of the Transaction Documents, (ii) authorization of the performance of all obligations of the Company hereunder or thereunder, and (iii) the authorization, issuance (or reservation for issuance) and delivery of the Shares. The Transaction Documents constitute the legal, valid and binding obligations of the Company, enforceable against the Company in accordance with their terms, subject to bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium and similar laws of general applicability, relating to or affecting creditors’ rights generally.

 

4.3 Capitalization. Schedule 4.3 sets forth (a) the authorized capital stock of the Company on the date hereof; (b) the number of shares of capital stock issued and outstanding; (c) the number of shares of capital stock issuable pursuant to the Company’s stock plans (including, after giving effect to the Merger); (d) the number of shares of capital stock issuable pursuant to the Merger and (e) the number of shares of capital stock issuable and reserved for issuance pursuant to securities (other than the Shares) exercisable for, or convertible into or exchangeable for any shares of capital stock of the Company. All of the issued and outstanding shares of the Company’s capital stock have been duly authorized and validly issued and are fully paid, nonassessable and free of pre-emptive rights and were issued in full compliance with applicable state and federal securities law and any rights of third parties. Except as described on Schedule 4.3, all of the issued and outstanding shares of capital stock of each Subsidiary have been duly authorized and validly issued and are fully paid, nonassessable and free of pre-emptive rights, were issued in full compliance with applicable state and federal securities law and any rights of third parties and are owned by the Company, beneficially and of record, subject to no lien, encumbrance or other adverse claim. Except as described on Schedule 4.3,

 

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no Person is entitled to pre-emptive or similar statutory or contractual rights with respect to any securities of the Company. Except as described on Schedule 4.3, there are no outstanding warrants, options, convertible securities or other rights, agreements or arrangements of any character under which the Company or any of its Subsidiaries is or may be obligated to issue any equity securities of any kind and except as contemplated by this Agreement, neither the Company nor any of its Subsidiaries is currently in negotiations for the issuance of any equity securities of any kind. Except as described on Schedule 4.3 and except for the Registration Rights Agreement and the Voting Agreement (including similar voting agreements to be entered into in connection with the Other Agreements), there are no voting agreements, buy-sell agreements, option or right of first purchase agreements or other agreements of any kind among the Company and any of the securityholders of the Company relating to the securities of the Company held by them. Except as described on Schedule 4.3 and except as provided in the Registration Rights Agreement, no Person has the right to require the Company to register any securities of the Company under the 1933 Act, whether on a demand basis or in connection with the registration of securities of the Company for its own account or for the account of any other Person.

 

Except as described on Schedule 4.3 or as disclosed in the Private Placement Memorandum, the issuance and sale of the Shares hereunder will not obligate the Company to issue shares of Common Stock or other securities to any other Person (other than the Investors) and will not result in the adjustment of the exercise, conversion, exchange or reset price of any outstanding security.

 

Except as described on Schedule 4.3, the Company does not have outstanding stockholder purchase rights or “poison pill” or any similar arrangement in effect giving any Person the right to purchase any equity interest in the Company upon the occurrence of certain events.

 

4.4 Valid Issuance. The Shares have been duly and validly authorized and, when issued and paid for pursuant to this Agreement, will be validly issued, fully paid and nonassessable, and shall be free and clear of all encumbrances and restrictions (other than those created by the Investors), except for restrictions on transfer set forth in the Transaction Documents or imposed by applicable securities laws.

 

4.5 Consents. The execution, delivery and performance by the Company of the Transaction Documents and the offer, issuance and sale of the Shares require no consent of, action by or in respect of, or filing with, any Person, governmental body, agency, or official other than filings that have been made pursuant to applicable state securities laws and post-sale filings pursuant to applicable state and federal securities laws which the Company undertakes to file within the applicable time periods. Subject to the accuracy of the representations and warranties of each Investor set forth in Section 5 hereof, the Company has taken all action necessary to exempt (i) the issuance and sale of the Shares and (ii) the other transactions contemplated by the Transaction Documents from the provisions of any shareholder rights plan or other “poison pill” arrangement, any anti-takeover, business combination or control share law or statute binding on the Company or to which the Company or any of its assets and properties may be subject and any provision of the Company’s Certificate of Incorporation or By-laws that

 

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is or could reasonably be expected to become applicable to the Investors as a result of the transactions contemplated hereby, including without limitation, the issuance of the Shares and the ownership, disposition or voting of the Shares by the Investors or the exercise of any right granted to the Investors pursuant to this Agreement or the other Transaction Documents.

 

4.6 Delivery of SEC Filings; Business. The Company has made available to the Investors through the EDGAR system, true and complete copies of the Company’s most recent Annual Report on Form 10-KSB for the fiscal year ended December 31, 2003 (the “10-KSB”), and all other reports filed by the Company pursuant to the 1934 Act since the filing of the 10-KSB and prior to the date hereof (collectively, the “SEC Filings”). The SEC Filings are the only filings required of the Company pursuant to the 1934 Act for such period. Except as described in the Private Placement Memorandum, the Company and its Subsidiaries are engaged in all material respects only in the business described in the SEC Filings and the SEC Filings contain a complete and accurate description in all material respects of the business of the Company and its Subsidiaries, taken as a whole.

 

4.7 Use of Proceeds. The net proceeds of the sale of the Shares hereunder shall be used by the Company as described in the Private Placement Memorandum.

 

4.8 No Material Adverse Change. Since December 31, 2003, except as identified and described in the SEC Filings or the Private Placement Memorandum or as described on Schedule 4.8, there has not been:

 

(i) any change in the consolidated assets, liabilities, financial condition or operating results of the Company from that reflected in the financial statements included in the Company’s Quarterly Report on Form 10-QSB for the quarter ended September 30, 2004, except for changes in the ordinary course of business which have not and could not reasonably be expected to have a Material Adverse Effect, individually or in the aggregate;

 

(ii) any declaration or payment of any dividend, or any authorization or payment of any distribution, on any of the capital stock of the Company, or any redemption or repurchase of any securities of the Company;

 

(iii) any material damage, destruction or loss, whether or not covered by insurance to any assets or properties of the Company or its Subsidiaries;

 

(iv) any waiver, not in the ordinary course of business, by the Company or any Subsidiary of a material right or of a material debt owed to it;

 

(v) any satisfaction or discharge of any lien, claim or encumbrance or payment of any obligation by the Company or a Subsidiary, except in the ordinary course of business and which is not material to the assets, properties, financial condition, operating results or business of the Company and its Subsidiaries taken as a whole (as such business is presently conducted and as it is proposed to be conducted);

 

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(vi) any change or amendment to the Company’s Certificate of Incorporation or by-laws, or material change to any material contract or arrangement by which the Company or any Subsidiary is bound or to which any of their respective assets or properties is subject;

 

(vii) any material labor difficulties or labor union organizing activities with respect to employees of the Company or any Subsidiary;

 

(viii) any material transaction entered into by the Company or a Subsidiary other than in the ordinary course of business;

 

(ix) the loss of the services of any key employee, or material change in the composition or duties of the senior management of the Company or any Subsidiary;

 

(x) the loss or threatened loss of any customer which has had or could reasonably be expected to have a Material Adverse Effect; or

 

(xi) any other event or condition of any character that has had or could reasonably be expected to have a Material Adverse Effect.

 

4.9 SEC Filings.

 

(a) At the time of filing thereof, the SEC Filings complied as to form in all material respects with the requirements of the 1934 Act and did not contain any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements made therein, in the light of the circumstances under which they were made, not misleading.

 

(b) Each registration statement and any amendment thereto filed by the Company since January 1, 2001 pursuant to the 1933 Act and the rules and regulations thereunder, as of the date such statement or amendment became effective, complied as to form in all material respects with the 1933 Act and did not contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary in order to make the statements made therein not misleading; and each prospectus filed pursuant to Rule 424(b) under the 1933 Act, as of its issue date and as of the closing of any sale of securities pursuant thereto did not contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary in order to make the statements made therein, in the light of the circumstances under which they were made, not misleading.

 

4.10 No Conflict, Breach, Violation or Default. The execution, delivery and performance of the Transaction Documents by the Company, the consummation of the Merger and the issuance and sale of the Shares will not conflict with or result in a breach or violation of any of the terms and provisions of, or constitute a default under (i) the Company’s Certificate of Incorporation or the Company’s Bylaws, both as in effect on the date hereof (true and complete copies of which have been made available to the Investors through the EDGAR system), or (ii)(a) any statute, rule, regulation or order of any governmental agency or body or any court,

 

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domestic or foreign, having jurisdiction over the Company, any Subsidiary or any of their respective assets or properties, or (b) any agreement or instrument to which the Company or any Subsidiary is a party or by which the Company or a Subsidiary is bound or to which any of their respective assets or properties is subject.

 

4.11 Tax Matters. The Company and each Subsidiary has timely prepared and filed all tax returns required to have been filed by the Company or such Subsidiary with all appropriate governmental agencies and timely paid all taxes shown thereon or otherwise owed by it. The charges, accruals and reserves on the books of the Company in respect of taxes for all fiscal periods are adequate in all material respects, and there are no material unpaid assessments against the Company or any Subsidiary nor, to the Company’s Knowledge, any basis for the assessment of any additional taxes, penalties or interest for any fiscal period or audits by any federal, state or local taxing authority except for any assessment which is not material to the Company and its Subsidiaries, taken as a whole. All taxes and other assessments and levies that the Company or any Subsidiary is required to withhold or to collect for payment have been duly withheld and collected and paid to the proper governmental entity or third party when due. There are no tax liens or claims pending or, to the Company’s Knowledge, threatened against the Company or any Subsidiary or any of their respective assets or property. Except as described on Schedule 4.11, there are no outstanding tax sharing agreements or other such arrangements between the Company and any Subsidiary or other corporation or entity.

 

4.12 Title to Properties. Except as disclosed in the SEC Filings, the Company and each Subsidiary has good and marketable title to all real properties and all other properties and assets owned by it, in each case free from liens, encumbrances and defects that would materially affect the value thereof or materially interfere with the use made or currently planned to be made thereof by them; and except as disclosed in the SEC Filings, the Company and each Subsidiary holds any leased real or personal property under valid and enforceable leases with no exceptions that would materially interfere with the use made or currently planned to be made thereof by them.

 

4.13 Certificates, Authorities and Permits. The Company and each Subsidiary possess adequate certificates, authorities or permits issued by appropriate governmental agencies or bodies necessary to conduct the business now operated by it, and neither the Company nor any Subsidiary has received any notice of proceedings relating to the revocation or modification of any such certificate, authority or permit that, if determined adversely to the Company or such Subsidiary, could reasonably be expected to have a Material Adverse Effect, individually or in the aggregate.

 

4.14 No Labor Disputes. No material labor dispute with the employees of the Company or any Subsidiary exists or, to the Company’s Knowledge, is imminent.

 

4.15 Intellectual Property.

 

(a) All Intellectual Property of the Company and its Subsidiaries is currently in compliance with all legal requirements (including timely filings, proofs and payments of fees) and is valid and enforceable. No Intellectual Property of the Company or its

 

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Subsidiaries which is necessary for the conduct of Company’s and each of its Subsidiaries’ respective businesses as currently conducted or as currently proposed to be conducted has been or is now involved in any cancellation, dispute or litigation, and, to the Company’s Knowledge, no such action is threatened. No patent of the Company or its Subsidiaries has been or is now involved in any interference, reissue, re-examination or opposition proceeding.

 

(b) All of the licenses and sublicenses and consent, royalty or other agreements concerning Intellectual Property which are necessary for the conduct of the Company’s and each of its Subsidiaries’ respective businesses as currently conducted or as currently proposed to be conducted to which the Company or any Subsidiary is a party or by which any of their assets are bound (other than generally commercially available, non-custom, off-the-shelf software application programs having a retail acquisition price of less than $10,000 per license) (collectively, “License Agreements”) are valid and binding obligations of the Company or its Subsidiaries that are parties thereto and, to the Company’s Knowledge, the other parties thereto, enforceable in accordance with their terms, except to the extent that enforcement thereof may be limited by bankruptcy, insolvency, reorganization, moratorium, fraudulent conveyance or other similar laws affecting the enforcement of creditors’ rights generally, and there exists no event or condition which will result in a material violation or breach of or constitute (with or without due notice or lapse of time or both) a default by the Company or any of its Subsidiaries under any such License Agreement.

 

(c) The Company and its Subsidiaries own or have the valid right to use all of the Intellectual Property that is necessary for the conduct of the Company’s and each of its Subsidiaries’ respective businesses as currently conducted or as currently proposed to be conducted and for the ownership, maintenance and operation of the Company’s and its Subsidiaries’ properties and assets, free and clear of all liens, encumbrances, adverse claims or obligations to license all such owned Intellectual Property and Confidential Information, other than licenses entered into in the ordinary course of the Company’s and its Subsidiaries’ businesses. The Company and its Subsidiaries have a valid and enforceable right to use all third party Intellectual Property and Confidential Information used or held for use in the respective businesses of the Company and its Subsidiaries.

 

(d) To the Company’s Knowledge, the conduct of the Company’s and its Subsidiaries’ businesses as currently conducted does not infringe or otherwise impair or conflict with (collectively, “Infringe”) any Intellectual Property rights of any third party or any confidentiality obligation owed to a third party, and, to the Company’s Knowledge, the Intellectual Property and Confidential Information of the Company and its Subsidiaries which are necessary for the conduct of Company’s and each of its Subsidiaries’ respective businesses as currently conducted or as currently proposed to be conducted are not being Infringed by any third party. There is no litigation or order pending or outstanding or, to the Company’s Knowledge, threatened or imminent, that seeks to limit or challenge or that concerns the ownership, use, validity or enforceability of any Intellectual Property or Confidential Information of the Company and its Subsidiaries and the Company’s and its Subsidiaries’ use of any Intellectual Property or Confidential Information owned by a third party, and, to the Company’s Knowledge, there is no valid basis for the same.

 

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(e) The consummation of the transactions contemplated hereby and by the other Transaction Documents will not result in the alteration, loss, impairment of or restriction on the Company’s or any of its Subsidiaries’ ownership or right to use any of the Intellectual Property or Confidential Information which is necessary for the conduct of Company’s and each of its Subsidiaries’ respective businesses as currently conducted or as currently proposed to be conducted.

 

(f) The Company and its Subsidiaries have taken reasonable steps to protect the Company’s and its Subsidiaries’ rights in their Intellectual Property and Confidential Information. Each employee, consultant and contractor who has had access to Confidential Information which is necessary for the conduct of Company’s and each of its Subsidiaries’ respective businesses as currently conducted or as currently proposed to be conducted has executed an agreement to maintain the confidentiality of such Confidential Information and has executed appropriate agreements that are substantially consistent with the Company’s standard forms thereof. Except under confidentiality obligations, there has been no material disclosure of any of the Company’s or its Subsidiaries’ Confidential Information to any third party.

 

4.16 Environmental Matters. Neither the Company nor any Subsidiary is in violation of any statute, rule, regulation, decision or order of any governmental agency or body or any court, domestic or foreign, relating to the use, disposal or release of hazardous or toxic substances or relating to the protection or restoration of the environment or human exposure to hazardous or toxic substances (collectively, “Environmental Laws”), owns or operates any real property contaminated with any substance that is subject to any Environmental Laws, is liable for any off-site disposal or contamination pursuant to any Environmental Laws, and is subject to any claim relating to any Environmental Laws, which violation, contamination, liability or claim has had or could reasonably be expected to have a Material Adverse Effect, individually or in the aggregate; and there is no pending or, to the Company’s Knowledge, threatened investigation that might lead to such a claim.

 

4.17 Litigation. Except as described on Schedule 4.17, there are no pending actions, suits or proceedings against or affecting the Company, its Subsidiaries or any of its or their properties; and to the Company’s Knowledge, no such actions, suits or proceedings are threatened or contemplated.

 

4.18 Financial Statements; Earnings Forecast. (a) The financial statements included in each SEC Filing present fairly, in all material respects, the consolidated financial position of the Company as of the dates shown and its consolidated results of operations and cash flows for the periods shown, and such financial statements have been prepared in conformity with United States generally accepted accounting principles applied on a consistent basis (“GAAP”) (except as may be disclosed therein or in the notes thereto, and, in the case of quarterly financial statements, as permitted by Form 10-Q under the 1934 Act). Except as set forth in the financial statements of the Company included in the SEC Filings filed prior to the date hereof and in the financial statements included in the Private Placement Memorandum, or as described on Schedule 4.18, neither the Company nor any of its Subsidiaries has incurred any liabilities, contingent or otherwise, except those incurred in the ordinary course of business, consistent (as to amount and nature) with past practices since the date of such financial statements, none of which, individually or in the aggregate, have had or could reasonably be expected to have a Material Adverse Effect.

 

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(b) The financial projections contained in the Private Placement Memorandum are reasonable in light of the historical operations and results of the Company and Medivation, were made by management of Medivation prior to the Merger in good faith based on factual assumptions believed to be true, represent management’s good faith best estimate of the future operating performance of the Company and its Subsidiaries after giving effect to the Merger and were prepared on an accounting basis consistent with the financial statements of Medivation included in the Private Placement Memorandum.

 

4.19 Insurance Coverage. The Company and each Subsidiary maintains in full force and effect insurance coverage that is customary for comparably situated companies for the business being conducted and properties owned or leased by the Company and each Subsidiary, and the Company reasonably believes such insurance coverage to be adequate against all liabilities, claims and risks against which it is customary for comparably situated companies to insure.

 

4.20 Brokers and Finders. No Person will have, as a result of the transactions contemplated by the Transaction Documents, any valid right, interest or claim against or upon the Company, any Subsidiary, Medivation or an Investor for any commission, fee or other compensation pursuant to any agreement, arrangement or understanding entered into by or on behalf of the Company, other than as described in the Private Placement Memorandum or on Schedule 4.20.

 

4.21 No Directed Selling Efforts or General Solicitation. Neither the Company nor any Person acting on its behalf has conducted any general solicitation or general advertising (as those terms are used in Regulation D) in connection with the offer or sale of any of the Securities.

 

4.22 No Integrated Offering. Neither the Company nor any of its Affiliates, nor any Person acting on its or their behalf has, directly or indirectly, made any offers or sales of any Company security or solicited any offers to buy any security, under circumstances that would adversely affect reliance by the Company on Section 4(2) for the exemption from registration for the transactions contemplated hereby or would require registration of the Securities under the 1933 Act.

 

4.23 Private Placement. The offer and sale of the Securities to the Investors as contemplated hereby is exempt from the registration requirements of the 1933 Act.

 

4.24 Questionable Payments. Neither the Company nor any of its Subsidiaries nor, to the Company’s Knowledge, any of their respective current or former stockholders, directors, officers, employees, agents or other Persons acting on behalf of the Company or any Subsidiary, has on behalf of the Company or any Subsidiary or in connection with their respective businesses: (a) used any corporate funds for unlawful contributions, gifts, entertainment or other unlawful expenses relating to political activity; (b) made any direct or

 

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indirect unlawful payments to any governmental officials or employees from corporate funds; (c) established or maintained any unlawful or unrecorded fund of corporate monies or other assets; (d) made any false or fictitious entries on the books and records of the Company or any Subsidiary; or (e) made any unlawful bribe, rebate, payoff, influence payment, kickback or other unlawful payment of any nature.

 

4.25 Transactions with Affiliates. Except as disclosed in the SEC Filings or in the Private Placement Memorandum, or as disclosed on Schedule 4.25, none of the officers or directors of the Company and, to the Company’s Knowledge, none of the employees of the Company is presently a party to any transaction with the Company or any Subsidiary (other than as holders of stock options and/or warrants, and for services as employees, officers and directors), including any contract, agreement or other arrangement providing for the furnishing of services to or by, providing for rental of real or personal property to or from, or otherwise requiring payments to or from any officer, director or such employee or, to the Company’s Knowledge, any entity in which any officer, director, or any such employee has a substantial interest or is an officer, director, trustee or partner.

 

4.26 Internal Controls. The Company is in material compliance with the provisions of the Sarbanes-Oxley Act of 2002 currently applicable to the Company. The Company and the Subsidiaries maintain a system of internal accounting controls sufficient to provide reasonable assurance that (i) transactions are executed in accordance with management’s general or specific authorizations, (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with generally accepted accounting principles and to maintain asset accountability, (iii) access to assets is permitted only in accordance with management’s general or specific authorization, and (iv) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences. The Company has established disclosure controls and procedures (as defined in 1934 Act Rules 13a-14 and 15d-14) for the Company and designed such disclosure controls and procedures to ensure that material information relating to the Company, including the Subsidiaries, is made known to the certifying officers by others within those entities, particularly during the period in which the Company’s most recently filed period report under the 1934 Act, as the case may be, is being prepared. The Company’s certifying officers have evaluated the effectiveness of the Company’s controls and procedures as of the end of the period covered by the most recently filed periodic report under the 1934 Act (such date, the “Evaluation Date”). The Company presented in its most recently filed periodic report under the 1934 Act the conclusions of the certifying officers about the effectiveness of the disclosure controls and procedures based on their evaluations as of the Evaluation Date. Since the Evaluation Date, there have been no significant changes in the Company’s internal controls (as such term is defined in Item 307(b) of Regulation S-K) or, to the Company’s Knowledge, in other factors that could significantly affect the Company’s internal controls. The Company maintains and will continue to maintain a standard system of accounting established and administered in accordance with GAAP and the applicable requirements of the 1934 Act.

 

4.27 Disclosures. Except as described in Schedule 4.27, neither the Company nor any Person acting on its behalf has provided the Investors or their agents or counsel with any information that constitutes or might constitute material, non-public information. The Private

 

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Placement Memorandum and the other written materials delivered to the Investors in connection with the transactions contemplated by the Transaction Documents do not contain any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements contained therein, in light of the circumstances under which they were made, not misleading.

 

4.28 Merger Agreement. A true and complete copy of the Merger Agreement, together with all exhibits and schedules thereto, has been provided to the Investors. The Merger Agreement has been duly authorized, executed and delivered by each of the parties thereto and constitutes the legal, valid and binding obligation of each of the parties thereto, enforceable against each of them in accordance with their terms, subject to bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium and similar laws of general applicability, relating to or affecting creditors’ rights generally. The representations and warranties made in the Merger Agreement by each of the parties thereto are true and correct and will be true and correct at all times prior to and on the date of the Closing (the “Closing Date”), except to the extent any such representation or warranty expressly speaks as of an earlier date, in which case such representation or warranty shall be true and correct as of such earlier date. Each of the parties to the Merger Agreement has performed or will perform prior to the Closing Date all obligations and conditions required to be performed or observed by it pursuant to the Merger Agreement on or prior to the Closing Date. The description of the Merger Agreement contained in the Private Placement Memorandum is true and complete in all material respects.

 

5. Representations and Warranties of the Investors. Each of the Investors hereby severally, and not jointly, represents and warrants to the Company that:

 

5.1 Organization and Existence. Such Investor is a validly existing corporation, limited partnership or limited liability company and has all requisite corporate, partnership or limited liability company power and authority to invest in the Shares pursuant to this Agreement.

 

5.2 Authorization. The execution, delivery and performance by such Investor of the Transaction Documents to which such Investor is a party have been duly authorized and will each constitute the valid and legally binding obligation of such Investor, enforceable against such Investor in accordance with their respective terms, subject to bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium and similar laws of general applicability, relating to or affecting creditors’ rights generally.

 

5.3 Purchase Entirely for Own Account. The Shares to be received by such Investor hereunder will be acquired for such Investor’s own account, not as nominee or agent, and not with a view to the resale or distribution of any part thereof in violation of the 1933 Act, and such Investor has no present intention of selling, granting any participation in, or otherwise distributing the same in violation of the 1933 Act without prejudice, however, to such Investor’s right at all times to sell or otherwise dispose of all or any part of such Shares in compliance with applicable federal and state securities laws. Nothing contained herein shall be deemed a representation or warranty by such Investor to hold the Shares for any period of time. Such Investor is not a broker-dealer registered with the SEC under the 1934 Act or an entity engaged in a business that would require it to be so registered.

 

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5.4 Investment Experience. Such Investor acknowledges that it can bear the economic risk and complete loss of its investment in the Shares and has such knowledge and experience in financial or business matters that it is capable of evaluating the merits and risks of the investment contemplated hereby.

 

5.5 Disclosure of Information. Such Investor has had an opportunity to receive all information related to the Company requested by it and to ask questions of and receive answers from the Company regarding the Company, its business and the terms and conditions of the offering of the Shares. Such Investor acknowledges receipt of copies of the SEC Filings and the Private Placement Memorandum. Neither such inquiries nor any other due diligence investigation conducted by such Investor shall modify, amend or affect such Investor’s right to rely on the Company’s representations and warranties contained in this Agreement.

 

5.6 Restricted Securities. Such Investor understands that the Shares are characterized as “restricted securities” under the U.S. federal securities laws inasmuch as they are being acquired from the Company in a transaction not involving a public offering and that under such laws and applicable regulations such securities may be resold without registration under the 1933 Act only in certain limited circumstances.

 

5.7 Legends. It is understood that, except as provided below, certificates evidencing the Shares may bear the following or any similar legend:

 

(a) “The securities represented hereby may not be transferred unless (i) such securities have been registered for sale pursuant to the Securities Act of 1933, as amended, (ii) such securities may be sold pursuant to Rule 144(k), or (iii) the Company has received an opinion of counsel reasonably satisfactory to it that such transfer may lawfully be made without registration under the Securities Act of 1933 or qualification under applicable state securities laws.”

 

(b) If required by the authorities of any state in connection with the issuance of sale of the Shares, the legend required by such state authority.

 

(c) “The securities represented hereby are subject to a voting agreement, a copy of which may be obtained from the Company.”

 

5.8 Accredited Investor. Such Investor is an accredited investor as defined in Rule 501(a) of Regulation D, as amended, under the 1933 Act.

 

5.9 No General Solicitation. Such Investor did not learn of the investment in the Shares as a result of any public advertising or general solicitation.

 

5.10 Brokers and Finders. No Person will have, as a result of the transactions contemplated by the Transaction Documents, any valid right, interest or claim against or upon

 

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the Company, any Subsidiary or an Investor for any commission, fee or other compensation pursuant to any agreement, arrangement or understanding entered into by or on behalf of such Investor.

 

5.11 Prohibited Transactions. During the last thirty (30) days prior to the date hereof, neither such Investor nor any Affiliate of such Investor which (x) had knowledge of the transactions contemplated hereby, (y) has or shares discretion relating to such Investor’s investments or trading or information concerning such Investor’s investments, including in respect of the Shares, or (z) is subject to such Investor’s review or input concerning such Affiliate’s investments or trading (collectively, “Trading Affiliates”) has, directly or indirectly, effected or agreed to effect any short sale, whether or not against the box, established any “put equivalent position” (as defined in Rule 16a-1(h) under the 1934 Act) with respect to the Common Stock, granted any other right (including, without limitation, any put or call option) with respect to the Common Stock or with respect to any security that includes, relates to or derived any significant part of its value from the Common Stock or otherwise sought to hedge its position in the Shares (each, a “Prohibited Transaction”). Prior to the earliest to occur of (i) the termination of this Agreement, (ii) the Effective Date or (iii) the Effectiveness Deadline, such Investor shall not, and shall cause its Trading Affiliates not to, engage, directly or indirectly, in a Prohibited Transaction. Such Investor acknowledges that the representations, warranties and covenants contained in this Section 5.11 are being made for the benefit of the Investors as well as the Company and that each of the other Investors shall have an independent right to assert any claims against such Investor arising out of any breach or violation of the provisions of this Section 5.11.

 

6. Conditions to Closing.

 

6.1 Conditions to the Investors’ Obligations. The obligation of each Investor to purchase the Shares at the Closing is subject to the fulfillment to such Investor’s satisfaction, on or prior to the Closing Date, of the following conditions, any of which may be waived by such Investor (as to itself only):

 

(a) The representations and warranties made by the Company in Section 4 hereof qualified as to materiality shall be true and correct at all times prior to and on the Closing Date, except to the extent any such representation or warranty expressly speaks as of an earlier date, in which case such representation or warranty shall be true and correct as of such earlier date, and, the representations and warranties made by the Company in Section 4 hereof not qualified as to materiality shall be true and correct in all material respects at all times prior to and on the Closing Date, except to the extent any such representation or warranty expressly speaks as of an earlier date, in which case such representation or warranty shall be true and correct in all material respects as of such earlier date. The Company shall have performed in all material respects all obligations and conditions herein required to be performed or observed by it on or prior to the Closing Date.

 

(b) The Company shall have obtained any and all consents, permits, approvals, registrations and waivers necessary or appropriate for consummation of the purchase and sale of the Securities and the consummation of the other transactions contemplated by the Transaction Documents, all of which shall be in full force and effect.

 

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(c) The Company shall have executed and delivered the Registration Rights Agreement.

 

(d) The Company shall have entered into one or more lock-up agreements in the form of Exhibit 6.14 to the Merger Agreement with the Persons listed in Schedule 6.14 to the Merger Agreement.

 

(e) The Company shall have effected the exchange of the Bridge Notes (as such term is defined in the Private Placement Memorandum) for not more than an aggregate of 1,070,000 shares of Common Stock on the terms described in the Private Placement Memorandum.

 

(f) The Merger shall have become effective and the other transactions to be consummated under the Merger Agreement on or prior to the closing date specified in the Merger Agreement shall have been consummated in compliance with the terms of the Merger Agreement.

 

(g) The Company shall have entered into one or more subscription agreements with one or more accredited investors reasonably satisfactory to the Investors that contain terms no more favorable to the subscriber than the terms of this Agreement (the “Other Agreements”) and one or more voting agreements in the form attached hereto as Exhibit B with such other investors.

 

(h) The Company shall have received gross proceeds from the sale of the Shares as contemplated hereby and under the Other Agreements of at least Eight Million Three Hundred Forty Two Thousand Dollars ($8,342,000).

 

(i) No judgment, writ, order, injunction, award or decree of or by any court, or judge, justice or magistrate, including any bankruptcy court or judge, or any order of or by any governmental authority, shall have been issued, and no action or proceeding shall have been instituted by any governmental authority, enjoining or preventing the consummation of the transactions contemplated hereby or in the other Transaction Documents.

 

(j) The Company shall have delivered a Certificate, executed on behalf of the Company by its Chief Executive Officer or its Chief Financial Officer, dated as of the Closing Date, certifying to the fulfillment of the conditions specified in subsections (a), (b), (d), (e), (f), (g), (h), (i) and (m) of this Section 6.1.

 

(k) The Company shall have delivered a Certificate, executed on behalf of the Company by its Secretary, dated as of the Closing Date, certifying the resolutions adopted by the Board of Directors of the Company approving the transactions contemplated by this Agreement and the other Transaction Documents and the issuance of the Shares, certifying the current versions of the Certificate of Incorporation and Bylaws of the Company and certifying as to the signatures and authority of persons signing the Transaction Documents and related documents on behalf of the Company.

 

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(l) The Investors shall have received an opinion from Graubard Miller LLP, the Company’s counsel, dated as of the Closing Date, in form and substance reasonably acceptable to the Investors and addressing such legal matters as the Investors may reasonably request.

 

(m) No stop order or suspension of trading shall have been imposed by Nasdaq, the SEC or any other governmental or regulatory body with respect to public trading in the Common Stock.

 

6.2 Conditions to Obligations of the Company. The Company’s obligation to sell and issue the Shares at the Closing is subject to the fulfillment to the satisfaction of the Company on or prior to the Closing Date of the following conditions, any of which may be waived by the Company:

 

(a) The representations and warranties made by the Investors in Section 5 hereof, other than the representations and warranties contained in Sections 5.3, 5.4, 5.5, 5.6, 5.7, 5.8 and 5.9 (the “Investment Representations”), shall be true and correct in all material respects when made, and shall be true and correct in all material respects on the Closing Date with the same force and effect as if they had been made on and as of said date. The Investment Representations shall be true and correct in all respects when made, and shall be true and correct in all respects on the Closing Date with the same force and effect as if they had been made on and as of said date. The Investors shall have performed in all material respects all obligations and conditions herein required to be performed or observed by them on or prior to the Closing Date.

 

(b) The Investors shall have executed and delivered the Registration Rights Agreement.

 

(c) The Investors shall have delivered the Purchase Price to the Company.

 

(d) The Investors shall have executed and delivered one or more Voting Agreements.

 

(e) The Merger shall have become effective.

 

6.3 Termination of Obligations to Effect Closing; Effects.

 

(a) The obligations of the Company, on the one hand, and the Investors, on the other hand, to effect the Closing shall terminate as follows:

 

(i) Upon the mutual written consent of the Company and the Investors;

 

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(ii) By the Company if any of the conditions set forth in Section 6.2 shall have become incapable of fulfillment, and shall not have been waived by the Company;

 

(iii) By an Investor (with respect to itself only) if any of the conditions set forth in Section 6.1 shall have become incapable of fulfillment, and shall not have been waived by the Investor; or

 

(iv) By either the Company or any Investor (with respect to itself only) if the Closing has not occurred on or prior to the earliest to occur of (i) the effective date of the Merger, (ii) the termination of the Merger Agreement or (iii) December 31, 2004;

 

provided, however, that, except in the case of clause (i) above, the party seeking to terminate its obligation to effect the Closing shall not then be in breach of any of its representations, warranties, covenants or agreements contained in this Agreement or the other Transaction Documents if such breach has resulted in the circumstances giving rise to such party’s seeking to terminate its obligation to effect the Closing.

 

(b) In the event of termination by the Company or any Investor of its obligations to effect the Closing pursuant to this Section 6.3, written notice thereof shall forthwith be given to the other Investors and the other Investors shall have the right to terminate their obligations to effect the Closing upon written notice to the Company and the other Investors. Nothing in this Section 6.3 shall be deemed to release any party from any liability for any breach by such party of the terms and provisions of this Agreement or the other Transaction Documents or to impair the right of any party to compel specific performance by any other party of its obligations under this Agreement or the other Transaction Documents.

 

7. Covenants and Agreements of the Company.

 

7.1 Reports. The Company will furnish to such Investors and/or their assignees such information relating to the Company and its Subsidiaries as from time to time may reasonably be requested by such Investors and/or their assignees; provided, however, that the Company shall not disclose material nonpublic information to the Investors, or to advisors to or representatives of the Investors, unless prior to disclosure of such information the Company identifies such information as being material nonpublic information and provides the Investors, such advisors and representatives with the opportunity to accept or refuse to accept such material nonpublic information for review and any Investor wishing to obtain such information enters into an appropriate confidentiality agreement with the Company with respect thereto.

 

7.2 No Conflicting Agreements. The Company will not take any action, enter into any agreement or make any commitment that would conflict or interfere in any material respect with the Company’s obligations to the Investors under the Transaction Documents.

 

7.3 Insurance. The Company shall not materially reduce the insurance coverages described in Section 4.19.

 

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7.4 Compliance with Laws. The Company will comply in all material respects with all applicable laws, rules, regulations, orders and decrees of all governmental authorities.

 

7.5 Listing of Underlying Shares and Related Matters. Promptly following the date hereof, the Company shall use its best efforts to cause the outstanding shares of Common Stock (including the Shares) to be listed on the Nasdaq SmallCap Market. Further, if the Company applies to have its Common Stock or other securities traded on any other principal stock exchange or market, it shall include in such application the Shares and will take such other action as is necessary to cause such Common Stock to be so listed. The Company will use its best efforts to continue the listing and trading of its Common Stock on the Nasdaq SmallCap Market and, in accordance, therewith, will use its best efforts to comply in all respects with the Company’s reporting, filing and other obligations under the bylaws or rules of such market or exchange, as applicable.

 

7.6 Termination of Covenants. The provisions of Sections 7.1 through 7.4 shall terminate and be of no further force and effect on the date on which the Company’s obligations under the Registration Rights Agreement to register or maintain the effectiveness of any registration covering the Registrable Securities (as such term is defined in the Registration Rights Agreement) shall terminate.

 

7.7 Removal of Legends. Upon the earlier of (i) registration for resale pursuant to the Registration Rights Agreement and receipt by the Company of an executed certificate of subsequent sale in substantially the form attached hereto as Exhibit D (a “Certificate of Subsequent Sale”) or (ii) Rule 144(k) becoming available the Company shall, upon an Investor’s written request, promptly cause certificates evidencing the Investor’s Shares to be replaced with certificates which do not bear such restrictive legends. From and after the effectiveness of the Registration Statement, the Company shall provide the transfer agent for the Shares with irrevocable written instructions, in form and substance reasonably satisfactory to the Investors, to register the transfer of any Shares upon receipt of the certificate or certificates representing such Shares along with a Certificate of Subsequent Sale relating to such Shares. When the Company is required to cause unlegended certificates to replace previously issued legended certificates, if unlegended certificates are not delivered to an Investor at its address as set forth on the signature pages of this Agreement (as may be updated from time to time by such investor in compliance with Section 9.4 of this Agreement) within three (3) Business Days (five (5) Business Days for any Investor which is not a U.S. Person) of submission by that Investor of legended certificate(s) to the Company’s transfer agent, with a copy to the Company, together with a Certificate of Subsequent Sale or, in the event of a sale under Rule 144(k), a representation letter in customary form, the Company shall be liable to the Investor for liquidated damages in an amount equal to 1.5% of the aggregate purchase price of the Securities evidenced by such certificate(s) for each thirty (30) day period (or portion thereof) beyond such three (3) Business Day that the unlegended certificates have not been so delivered.

 

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8. Survival and Indemnification.

 

8.1 Survival. The representations, warranties, covenants and agreements contained in this Agreement shall survive for a period of eighteen months following the Closing of the transactions contemplated by this Agreement.

 

8.2 Indemnification. The Company agrees to indemnify and hold harmless each Investor and its Affiliates and their respective directors, officers, employees and agents from and against any and all losses, claims, damages, liabilities and expenses (including without limitation reasonable attorney fees and disbursements and other expenses incurred in connection with investigating, preparing or defending any action, claim or proceeding, pending or threatened and the costs of enforcement thereof) (collectively, “Losses”) to which such Person may become subject as a result of any breach of representation, warranty, covenant or agreement made by or to be performed on the part of the Company under the Transaction Documents, and will reimburse any such Person for all such amounts as they are incurred by such Person.

 

8.3 Conduct of Indemnification Proceedings. Promptly after receipt by any Person (the Indemnified Person”) of notice of any demand, claim or circumstances which would or might give rise to a claim or the commencement of any action, proceeding or investigation in respect of which indemnity may be sought pursuant to Section 8.2, such Indemnified Person shall promptly notify the Company in writing and the Company shall assume the defense thereof, including the employment of counsel reasonably satisfactory to such Indemnified Person, and shall assume the payment of all fees and expenses; provided, however, that the failure of any Indemnified Person so to notify the Company shall not relieve the Company of its obligations hereunder except to the extent that the Company is materially prejudiced by such failure to notify. In any such proceeding, any Indemnified Person shall have the right to retain its own counsel, but the fees and expenses of such counsel shall be at the expense of such Indemnified Person unless: (i) the Company and the Indemnified Person shall have mutually agreed to the retention of such counsel; or (ii) in the reasonable judgment of counsel to such Indemnified Person representation of both parties by the same counsel would be inappropriate due to actual or potential differing interests between them. The Company shall not be liable for any settlement of any proceeding effected without its written consent, which consent shall not be unreasonably withheld, but if settled with such consent, or if there be a final judgment for the plaintiff, the Company shall indemnify and hold harmless such Indemnified Person from and against any loss or liability (to the extent stated above) by reason of such settlement or judgment. Without the prior written consent of the Indemnified Person, which consent shall not be unreasonably withheld, the Company shall not effect any settlement of any pending or threatened proceeding in respect of which any Indemnified Person is or could have been a party and indemnity could have been sought hereunder by such Indemnified Party, unless such settlement includes an unconditional release of such Indemnified Person from all liability arising out of such proceeding.

 

9. Miscellaneous.

 

9.1 Successors and Assigns. This Agreement may not be assigned by a party hereto without the prior written consent of the Company or the Investors, as applicable, provided, however, that an Investor may assign its rights and delegate its duties hereunder in whole or in part to an Affiliate or to a third party acquiring some or all of its Securities in a

 

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private transaction without the prior written consent of the Company or the other Investors, after notice duly given by such Investor to the Company and the other Investors, provided, that no such assignment or obligation shall affect the obligations of such Investor hereunder. The provisions of this Agreement shall inure to the benefit of and be binding upon the respective permitted successors and assigns of the parties. Nothing in this Agreement, express or implied, is intended to confer upon any party other than the parties hereto or their respective successors and assigns any rights, remedies, obligations, or liabilities under or by reason of this Agreement, except as expressly provided in this Agreement.

 

9.2 Counterparts; Faxes. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. This Agreement may also be executed via facsimile, which shall be deemed an original.

 

9.3 Titles and Subtitles. The titles and subtitles used in this Agreement are used for convenience only and are not to be considered in construing or interpreting this Agreement.

 

9.4 Notices. Unless otherwise provided, any notice required or permitted under this Agreement shall be given in writing and shall be deemed effectively given as hereinafter described (i) if given by personal delivery, then such notice shall be deemed given upon such delivery, (ii) if given by telex or telecopier, then such notice shall be deemed given upon receipt of confirmation of complete transmittal, (iii) if given by mail, then such notice shall be deemed given upon the earlier of (A) receipt of such notice by the recipient or (B) three days after such notice is deposited in first class mail, postage prepaid, and (iv) if given by an internationally recognized overnight air courier, then such notice shall be deemed given one business day after delivery to such carrier. All notices shall be addressed to the party to be notified at the address as follows, or at such other address as such party may designate by ten days’ advance written notice to the other party:

 

If to the Company:

 

Orion Acquisition Corp. II

501 Second Street, Suite 211

San Francisco, CA 94107

Attention: Chief Financial Officer

Fax: (415) 543-3113

 

With a copies to:

 

MDB Capital Group LLC

401 Wilshire Boulevard, Suite 1020

Santa Monica, CA 90401

Attention: Mr. Christopher Marlett

Fax: (310) 526-5020

 

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And to:

 

Latham & Watkins LLP

135 Commonwealth Drive

Menlo Park, CA 94025

Attention: Michael W. Hall, Esq.

Fax: (650) 463-2600

 

Graubard Miller

600 Third Avenue

New York, NY 10016

Attention: Andrew Hudders, Esq.

Fax: (212) 818-8881

 

If to the Investors:

 

to the addresses set forth on the signature pages hereto.

 

9.5 Expenses. The parties hereto shall pay their own costs and expenses in connection herewith. In the event that legal proceedings are commenced by any party to this Agreement against another party to this Agreement in connection with this Agreement or the other Transaction Documents, the party or parties which do not prevail in such proceedings shall severally, but not jointly, pay their pro rata share of the reasonable attorneys’ fees and other reasonable out-of-pocket costs and expenses incurred by the prevailing party in such proceedings.

 

9.6 Amendments and Waivers. Any term of this Agreement may be amended and the observance of any term of this Agreement may be waived (either generally or in a particular instance and either retroactively or prospectively), only with the written consent of the Company and the Investors. Any amendment or waiver effected in accordance with this paragraph shall be binding upon each holder of any Securities purchased under this Agreement at the time outstanding, each future holder of all such Securities, and the Company.

 

9.7 Publicity. Except as set forth below, no public release or announcement concerning the transactions contemplated hereby shall be issued by the Company or the Investors without the prior consent of the Company (in the case of a release or announcement by the Investors) or the Investors (in the case of a release or announcement by the Company) (which consents shall not be unreasonably withheld), except as such release or announcement may be required by law or the applicable rules or regulations of any securities exchange or securities market, in which case the Company or the Investors, as the case may be, shall allow the Investors or the Company, as applicable, to the extent reasonably practicable in the circumstances, reasonable time to comment on such release or announcement in advance of such issuance. By 8:30 a.m. (New York City time) on the trading day immediately following the Closing Date, the Company shall issue a press release disclosing the consummation of the transactions contemplated by this Agreement. No later than the third trading day following the Closing Date, the Company will file a Current Report on Form 8-K attaching the press release described in the

 

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foregoing sentence as well as copies of the Transaction Documents. No later than the date on which the Company files the Registration Statement, the Company shall publicly disclose any material nonpublic information referenced in Schedule 4.27. In addition, the Company will make such other filings and notices in the manner and time required by the SEC. Notwithstanding the foregoing, the Company shall not publicly disclose the name of any Investor, or include the name of any Investor in any filing with the SEC (other than the Registration Statement and any exhibits to filings made in respect of this transaction in accordance with periodic filing requirements under the 1934 Act) or any regulatory agency, without the prior written consent of such Investor, except to the extent such disclosure is required by law or trading market regulations, in which case the Company shall provide the Investors with prior notice of such disclosure.

 

9.8 Severability. Any provision of this Agreement that is prohibited or unenforceable in any jurisdiction shall, as to such jurisdiction, be ineffective to the extent of such prohibition or unenforceability without invalidating the remaining provisions hereof but shall be interpreted as if it were written so as to be enforceable to the maximum extent permitted by applicable law, and any such prohibition or unenforceability in any jurisdiction shall not invalidate or render unenforceable such provision in any other jurisdiction. To the extent permitted by applicable law, the parties hereby waive any provision of law which renders any provision hereof prohibited or unenforceable in any respect.

 

9.9 Entire Agreement. This Agreement, including the Exhibits and the Disclosure Schedules, and the other Transaction Documents constitute the entire agreement among the parties hereof with respect to the subject matter hereof and thereof and supersede all prior agreements and understandings, both oral and written, between the parties with respect to the subject matter hereof and thereof.

 

9.10 Further Assurances. The parties shall execute and deliver all such further instruments and documents and take all such other actions as may reasonably be required to carry out the transactions contemplated hereby and to evidence the fulfillment of the agreements herein contained.

 

9.11 Governing Law; Consent to Jurisdiction; Waiver of Jury Trial. This Agreement shall be governed by, and construed in accordance with, the internal laws of the State of New York without regard to the choice of law principles thereof. Each of the parties hereto irrevocably submits to the exclusive jurisdiction of the courts of the State of New York located in New York County and the United States District Court for the Southern District of New York for the purpose of any suit, action, proceeding or judgment relating to or arising out of this Agreement and the transactions contemplated hereby. Service of process in connection with any such suit, action or proceeding may be served on each party hereto anywhere in the world by the same methods as are specified for the giving of notices under this Agreement. Each of the parties hereto irrevocably consents to the jurisdiction of any such court in any such suit, action or proceeding and to the laying of venue in such court. Each party hereto irrevocably waives any objection to the laying of venue of any such suit, action or proceeding brought in such courts and irrevocably waives any claim that any such suit, action or proceeding brought in any such court has been brought in an inconvenient forum. EACH OF THE PARTIES HERETO WAIVES

 

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ANY RIGHT TO REQUEST A TRIAL BY JURY IN ANY LITIGATION WITH RESPECT TO THIS AGREEMENT AND REPRESENTS THAT COUNSEL HAS BEEN CONSULTED SPECIFICALLY AS TO THIS WAIVER.

 

9.12 Independent Nature of Investors’ Obligations and Rights. The obligations of each Investor under any Transaction Document are several and not joint with the obligations of any other Investor, and no Investor shall be responsible in any way for the performance of the obligations of any other Investor under any Transaction Document. The decision of each Investor to purchase Securities pursuant to the Transaction Documents has been made by such Investor independently of any other Investor. Nothing contained herein or in any Transaction Document, and no action taken by any Investor pursuant thereto, shall be deemed to constitute the Investors as a partnership, an association, a joint venture or any other kind of entity, or create a presumption that the Investors are in any way acting in concert or as a group with respect to such obligations or the transactions contemplated by the Transaction Documents. Each Investor acknowledges that no other Investor has acted as agent for such Investor in connection with making its investment hereunder and that no Investor will be acting as agent of such Investor in connection with monitoring its investment in the Securities or enforcing its rights under the Transaction Documents. Each Investor shall be entitled to independently protect and enforce its rights, including, without limitation, the rights arising out of this Agreement or out of the other Transaction Documents, and it shall not be necessary for any other Investor to be joined as an additional party in any proceeding for such purpose. The Company acknowledges that each of the Investors has been provided with the same Transaction Documents for the purpose of closing a transaction with multiple Investors and not because it was required or requested to do so by any Investor.

 

[signature page follows]

 

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IN WITNESS WHEREOF, the parties have executed this Agreement or caused their duly authorized officers to execute this Agreement as of the date first above written.

 

The Company:    ORION ACQUISITION CORP. II
     By:  

/s/ David T. Hung, M.D.


     Name:   David T. Hung, M.D.
     Title:   President and Chief Executive Officer

 

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The Investors:    By:  

/s/ Investors


         Signature
     Name:  

 


         Print Name
     Title:  

 


         If Investor is an Entity, Print Title
     For:  

 


         If Investor is an Entity, Print Name of Entity
Aggregate Purchase Price: $         
Number of Shares:         
Address for Notice:   

 


    

 


    

 


 

-26-


EXHIBIT D

 

PURCHASER’S CERTIFICATE OF SUBSEQUENT SALE

 

Attention:    Orion Acquisition Corp. II
     Chief Financial Officer

 

The undersigned, [an officer of, or other person duly authorized by]

                                                                                                                                                                                                 [fill in official name of individual or institution] hereby certifies that he/she [said institution] is the Purchaser of the shares evidenced by the attached certificate, and as such, sold such shares on                                      in accordance with [date] Registration Statement number                                                       [fill in the number of or otherwise identify Registration Statement] and the requirement of delivering a current prospectus by the Company has been complied with in connection with such sale.

 

Print or Type:          
    

Name of Purchaser
(Individual or Institution):

  

 


    

Name of Individual
Representing
Purchaser (if an Institution):

  

 


    

Title of Individual
Representing
Purchaser (if an Institution):

  

 


Signature by:          
    

Individual Purchaser
or Individual representing Purchaser:

  

 


 

-27-

EX-10.2(B) 13 dex102b.htm PURCHASE AGMT BY AND AMONG ORION ACQUISITION CORP. II AND SPECIAL SITUATIONS Purchase Agmt by and among Orion Acquisition Corp. II and Special Situations

EXHIBIT 10.2(b)

 

PURCHASE AGREEMENT

 

THIS PURCHASE AGREEMENT (“Agreement”) is made as of the 17th day of December, 2004 by and among Orion Acquisition Corp. II, a Delaware corporation (the “Company”), and the Investors set forth on the signature pages affixed hereto (each an “Investor” and collectively the “Investors”).

 

Recitals

 

A. The Company has entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Medivation Acquisition Corp., a Delaware corporation (“Merger Sub”), and Medivation, Inc., a Delaware corporation (“Medivation”), pursuant to which, among other things, Merger Sub will merge with and into Medivation with Medivation as the surviving entity thereof (the “Merger”); and

 

B. The Company and the Investors are executing and delivering this Agreement in reliance upon the exemption from securities registration afforded by the provisions of Regulation D (“Regulation D”), as promulgated by the U.S. Securities and Exchange Commission (the “SEC”) under the Securities Act of 1933, as amended; and

 

C. The Investors wish to purchase from the Company, and the Company wishes to sell and issue to the Investors, upon the terms and conditions stated in this Agreement, an aggregate of up to 2,580,645 shares of the Company’s Common Stock, par value $0.01 per share (together with any securities into which such shares may be reclassified the “Common Stock”), at purchase price of $1.55 per share; and

 

D. Contemporaneous with the sale of the Common Stock, the parties hereto will execute and deliver a Registration Rights Agreement, in the form attached hereto as Exhibit A (the “Registration Rights Agreement”), pursuant to which the Company will agree to provide certain registration rights under the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder, and applicable state securities laws, and a Voting Agreement, in the form attached hereto as Exhibit B (the “Voting Agreement”), pursuant to which the Investors will agree to vote their Shares as specified therein.

 

In consideration of the mutual promises made herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:

 

1. Definitions. In addition to those terms defined above and elsewhere in this Agreement, for the purposes of this Agreement, the following terms shall have the meanings set forth below:

 

Affiliate” means, with respect to any Person, any other Person which directly or indirectly through one or more intermediaries Controls, is controlled by, or is under common control with, such Person.


Business Day” means a day, other than a Saturday or Sunday, on which banks in New York City are open for the general transaction of business.

 

Common Stock Equivalents” means any securities of the Company or the Subsidiaries which would entitle the holder thereof to acquire at any time Common Stock, including without limitation, any debt, preferred stock, rights, options, warrants or other instrument that is at any time convertible into or exchangeable for, or otherwise entitles the holder thereof to receive, Common Stock.

 

Company’s Knowledge” means the actual knowledge of the executive officers (as defined in Rule 405 under the 1933 Act) of the Company, after due inquiry.

 

Confidential Information” means trade secrets, confidential information and know-how (including but not limited to ideas, formulae, compositions, processes, procedures and techniques, research and development information, computer program code, performance specifications, support documentation, drawings, specifications, designs, business and marketing plans, and customer and supplier lists and related information).

 

Control” (including the terms “controlling”, “controlled by” or “under common control with”) means the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a Person, whether through the ownership of voting securities, by contract or otherwise.

 

Effective Date” means the date on which the initial Registration Statement (as defined in the Registration Rights Agreement) is declared effective by the SEC.

 

Effectiveness Deadline” means the date on which the initial Registration Statement (as so defined) is required to be declared effective by the SEC under the terms of the Registration Rights Agreement.

 

Intellectual Property” means all of the following: (i) patents, patent applications, patent disclosures and inventions (whether or not patentable and whether or not reduced to practice); (ii) trademarks, service marks, trade dress, trade names, corporate names, logos, slogans and Internet domain names, together with all goodwill associated with each of the foregoing; (iii) copyrights and copyrightable works; (iv) registrations, applications and renewals for any of the foregoing; and (v) proprietary computer software (including but not limited to data, data bases and documentation).

 

Material Adverse Effect” means a material adverse effect on (i) the assets, liabilities, results of operations, condition (financial or otherwise), business, or prospects of the Company and its Subsidiaries taken as a whole, or (ii) the ability of the Company to perform its obligations under the Transaction Documents.

 

-2-


Nasdaq” means The Nasdaq Stock Market, Inc.

 

Person” means an individual, corporation, partnership, limited liability company, trust, business trust, association, joint stock company, joint venture, sole proprietorship, unincorporated organization, governmental authority or any other form of entity not specifically listed herein.

 

Private Placement Memorandum” means the Company’s Private Placement Memorandum, dated November     , 2004, and any amendments or supplements thereto provided to the Investors prior to the date hereof.

 

Purchase Price” means up to Four Million Dollars ($4,000,000).

 

SEC Filings” has the meaning set forth in Section 4.6.

 

Registration Statement” has the meaning set forth in the Registration Rights Agreement.

 

Shares” means the shares of Common Stock being purchased by the Investors hereunder.

 

Subsidiary” of any Person means another Person, an amount of the voting securities, other voting ownership or voting partnership interests of which is sufficient to elect at least a majority of its Board of Directors or other governing body (or, if there are no such voting interests, 50% or more of the equity interests of which) is owned directly or indirectly by such first Person. Without limiting the generality of the foregoing, Medivation shall be considered a Subsidiary of the Company from and after the effective date of the Merger.

 

Transaction Documents” means this Agreement, the Registration Rights Agreement, the Voting Agreement and the Merger Agreement.

 

1933 Act” means the Securities Act of 1933, as amended, or any successor statute, and the rules and regulations promulgated thereunder.

 

1934 Act” means the Securities Exchange Act of 1934, as amended, or any successor statute, and the rules and regulations promulgated thereunder.

 

2. Purchase and Sale of the Shares. Subject to the terms and conditions of this Agreement, on the Closing Date, each of the Investors shall severally, and not jointly, purchase, and the Company shall sell and issue to the Investors, the Shares in the respective amounts set forth opposite the Investors’ names on the signature pages attached hereto in exchange for the Purchase Price as specified in Section 3 below.

 

3. Closing. Upon confirmation that the other conditions to closing specified herein have been satisfied or duly waived by the Investors, the Company shall deliver to Lowenstein

 

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Sandler PC, in trust, a certificate or certificates, registered in such name or names as the Investors may designate, representing the Shares, with instructions that such certificates are to be held for release to the Investors only upon payment in full of the Purchase Price to the Company by all the Investors. Upon such receipt by Lowenstein Sandler PC of the certificates, each Investor shall promptly, but no more than one Business Day thereafter, cause a wire transfer in same day funds to be sent to the account of the Company as instructed in writing by the Company, in an amount representing such Investor’s pro rata portion of the Purchase Price as set forth on the signature pages to this Agreement. On the date (the “Closing Date”) the Company receives the Purchase Price, the certificates evidencing the Shares shall be released to the Investors (the “Closing”). The Closing of the purchase and sale of the Shares shall take place at the offices of Lowenstein Sandler PC, 1251 Avenue of the Americas, 18th Floor, New York, New York 10020, or at such other location and on such other date as the Company and the Investors shall mutually agree.

 

4. Representations and Warranties of the Company. The Company hereby represents and warrants to the Investors that, except as set forth in the schedules delivered herewith (collectively, the “Disclosure Schedules”):

 

4. 1 Organization, Good Standing and Qualification. Each of the Company and its Subsidiaries is a corporation duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation and has all requisite corporate power and authority to carry on its business as now conducted and to own its properties. Each of the Company and its Subsidiaries is duly qualified to do business as a foreign corporation and is in good standing in each jurisdiction in which the conduct of its business or its ownership or leasing of property makes such qualification or leasing necessary unless the failure to so qualify has not and could not reasonably be expected to have a Material Adverse Effect. The Company’s only Subsidiary is Medivation, and Medivation has no Subsidiaries.

 

4.2 Authorization. The Company has full power and authority and has taken all requisite action on the part of the Company, its officers, directors and stockholders necessary for (i) the authorization, execution and delivery of the Transaction Documents, (ii) authorization of the performance of all obligations of the Company hereunder or thereunder, and (iii) the authorization, issuance (or reservation for issuance) and delivery of the Shares. The Transaction Documents constitute the legal, valid and binding obligations of the Company, enforceable against the Company in accordance with their terms, subject to bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium and similar laws of general applicability, relating to or affecting creditors’ rights generally.

 

4.3 Capitalization. Schedule 4.3 sets forth (a) the authorized capital stock of the Company on the date hereof; (b) the number of shares of capital stock issued and outstanding; (c) the number of shares of capital stock issuable pursuant to the Company’s stock plans (including, after giving effect to the Merger); (d) the number of shares of capital stock issuable pursuant to the Merger and (e) the number of shares of capital stock issuable and reserved for issuance pursuant to securities (other than the Shares) exercisable for, or convertible into or exchangeable for any shares of capital stock of the Company. All of the issued and outstanding shares of the Company’s capital stock have been duly authorized and validly issued

 

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and are fully paid, nonassessable and free of pre-emptive rights and were issued in full compliance with applicable state and federal securities law and any rights of third parties. Except as described on Schedule 4.3, all of the issued and outstanding shares of capital stock of each Subsidiary have been duly authorized and validly issued and are fully paid, nonassessable and free of pre-emptive rights, were issued in full compliance with applicable state and federal securities law and any rights of third parties and are owned by the Company, beneficially and of record, subject to no lien, encumbrance or other adverse claim. Except as described on Schedule 4.3, no Person is entitled to pre-emptive or similar statutory or contractual rights with respect to any securities of the Company. Except as described on Schedule 4.3, there are no outstanding warrants, options, convertible securities or other rights, agreements or arrangements of any character under which the Company or any of its Subsidiaries is or may be obligated to issue any equity securities of any kind and except as contemplated by this Agreement, neither the Company nor any of its Subsidiaries is currently in negotiations for the issuance of any equity securities of any kind. Except as described on Schedule 4.3 and except for the Registration Rights Agreement and the Voting Agreement (including similar voting agreements to be entered into in connection with the Other Agreements), there are no voting agreements, buy-sell agreements, option or right of first purchase agreements or other agreements of any kind among the Company and any of the securityholders of the Company relating to the securities of the Company held by them. Except as described on Schedule 4.3 and except as provided in the Registration Rights Agreement, no Person has the right to require the Company to register any securities of the Company under the 1933 Act, whether on a demand basis or in connection with the registration of securities of the Company for its own account or for the account of any other Person.

 

Except as described on Schedule 4.3 or as disclosed in the Private Placement Memorandum, the issuance and sale of the Shares hereunder will not obligate the Company to issue shares of Common Stock or other securities to any other Person (other than the Investors) and will not result in the adjustment of the exercise, conversion, exchange or reset price of any outstanding security.

 

Except as described on Schedule 4.3, the Company does not have outstanding stockholder purchase rights or “poison pill” or any similar arrangement in effect giving any Person the right to purchase any equity interest in the Company upon the occurrence of certain events.

 

4.4 Valid Issuance. The Shares have been duly and validly authorized and, when issued and paid for pursuant to this Agreement, will be validly issued, fully paid and nonassessable, and shall be free and clear of all encumbrances and restrictions (other than those created by the Investors), except for restrictions on transfer set forth in the Transaction Documents or imposed by applicable securities laws.

 

4.5 Consents. The execution, delivery and performance by the Company of the Transaction Documents and the offer, issuance and sale of the Shares require no consent of, action by or in respect of, or filing with, any Person, governmental body, agency, or official other than filings that have been made pursuant to applicable state securities laws and post-sale filings pursuant to applicable state and federal securities laws which the Company undertakes to

 

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file within the applicable time periods. Subject to the accuracy of the representations and warranties of each Investor set forth in Section 5 hereof, the Company has taken all action necessary to exempt (i) the issuance and sale of the Shares and (ii) the other transactions contemplated by the Transaction Documents from the provisions of any shareholder rights plan or other “poison pill” arrangement, any anti-takeover, business combination or control share law or statute binding on the Company or to which the Company or any of its assets and properties may be subject and any provision of the Company’s Certificate of Incorporation or By-laws that is or could reasonably be expected to become applicable to the Investors as a result of the transactions contemplated hereby, including without limitation, the issuance of the Shares and the ownership, disposition or voting of the Shares by the Investors or the exercise of any right granted to the Investors pursuant to this Agreement or the other Transaction Documents.

 

4.6 Delivery of SEC Filings; Business. The Company has made available to the Investors through the EDGAR system, true and complete copies of the Company’s most recent Annual Report on Form 10-KSB for the fiscal year ended December 31, 2003 (the “10-KSB”), and all other reports filed by the Company pursuant to the 1934 Act since the filing of the 10-KSB and prior to the date hereof (collectively, the “SEC Filings”). The SEC Filings are the only filings required of the Company pursuant to the 1934 Act for such period. Except as described in the Private Placement Memorandum, the Company and its Subsidiaries are engaged in all material respects only in the business described in the SEC Filings and the SEC Filings contain a complete and accurate description in all material respects of the business of the Company and its Subsidiaries, taken as a whole.

 

4.7 Use of Proceeds. The net proceeds of the sale of the Shares hereunder shall be used by the Company as described in the Private Placement Memorandum.

 

4.8 No Material Adverse Change. Since December 31, 2003, except as identified and described in the SEC Filings or the Private Placement Memorandum or as described on Schedule 4.8, there has not been:

 

(i) any change in the consolidated assets, liabilities, financial condition or operating results of the Company from that reflected in the financial statements included in the Company’s Quarterly Report on Form 10-QSB for the quarter ended September 30, 2004, except for changes in the ordinary course of business which have not and could not reasonably be expected to have a Material Adverse Effect, individually or in the aggregate;

 

(ii) any declaration or payment of any dividend, or any authorization or payment of any distribution, on any of the capital stock of the Company, or any redemption or repurchase of any securities of the Company;

 

(iii) any material damage, destruction or loss, whether or not covered by insurance to any assets or properties of the Company or its Subsidiaries;

 

(iv) any waiver, not in the ordinary course of business, by the Company or any Subsidiary of a material right or of a material debt owed to it;

 

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(v) any satisfaction or discharge of any lien, claim or encumbrance or payment of any obligation by the Company or a Subsidiary, except in the ordinary course of business and which is not material to the assets, properties, financial condition, operating results or business of the Company and its Subsidiaries taken as a whole (as such business is presently conducted and as it is proposed to be conducted);

 

(vi) any change or amendment to the Company’s Certificate of Incorporation or by-laws, or material change to any material contract or arrangement by which the Company or any Subsidiary is bound or to which any of their respective assets or properties is subject;

 

(vii) any material labor difficulties or labor union organizing activities with respect to employees of the Company or any Subsidiary;

 

(viii) any material transaction entered into by the Company or a Subsidiary other than in the ordinary course of business;

 

(ix) the loss of the services of any key employee, or material change in the composition or duties of the senior management of the Company or any Subsidiary;

 

(x) the loss or threatened loss of any customer which has had or could reasonably be expected to have a Material Adverse Effect; or

 

(xi) any other event or condition of any character that has had or could reasonably be expected to have a Material Adverse Effect.

 

4.9 SEC Filings.

 

(a) At the time of filing thereof, the SEC Filings complied as to form in all material respects with the requirements of the 1934 Act and did not contain any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements made therein, in the light of the circumstances under which they were made, not misleading.

 

(b) Each registration statement and any amendment thereto filed by the Company since January 1, 2001 pursuant to the 1933 Act and the rules and regulations thereunder, as of the date such statement or amendment became effective, complied as to form in all material respects with the 1933 Act and did not contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary in order to make the statements made therein not misleading; and each prospectus filed pursuant to Rule 424(b) under the 1933 Act, as of its issue date and as of the closing of any sale of securities pursuant thereto did not contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary in order to make the statements made therein, in the light of the circumstances under which they were made, not misleading.

 

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4.10 No Conflict, Breach, Violation or Default. The execution, delivery and performance of the Transaction Documents by the Company, the consummation of the Merger and the issuance and sale of the Shares will not conflict with or result in a breach or violation of any of the terms and provisions of, or constitute a default under (i) the Company’s Certificate of Incorporation or the Company’s Bylaws, both as in effect on the date hereof (true and complete copies of which have been made available to the Investors through the EDGAR system), or (ii)(a) any statute, rule, regulation or order of any governmental agency or body or any court, domestic or foreign, having jurisdiction over the Company, any Subsidiary or any of their respective assets or properties, or (b) any agreement or instrument to which the Company or any Subsidiary is a party or by which the Company or a Subsidiary is bound or to which any of their respective assets or properties is subject.

 

4.11 Tax Matters. The Company and each Subsidiary has timely prepared and filed all tax returns required to have been filed by the Company or such Subsidiary with all appropriate governmental agencies and timely paid all taxes shown thereon or otherwise owed by it. The charges, accruals and reserves on the books of the Company in respect of taxes for all fiscal periods are adequate in all material respects, and there are no material unpaid assessments against the Company or any Subsidiary nor, to the Company’s Knowledge, any basis for the assessment of any additional taxes, penalties or interest for any fiscal period or audits by any federal, state or local taxing authority except for any assessment which is not material to the Company and its Subsidiaries, taken as a whole. All taxes and other assessments and levies that the Company or any Subsidiary is required to withhold or to collect for payment have been duly withheld and collected and paid to the proper governmental entity or third party when due. There are no tax liens or claims pending or, to the Company’s Knowledge, threatened against the Company or any Subsidiary or any of their respective assets or property. Except as described on Schedule 4.11, there are no outstanding tax sharing agreements or other such arrangements between the Company and any Subsidiary or other corporation or entity.

 

4.12 Title to Properties. Except as disclosed in the SEC Filings, the Company and each Subsidiary has good and marketable title to all real properties and all other properties and assets owned by it, in each case free from liens, encumbrances and defects that would materially affect the value thereof or materially interfere with the use made or currently planned to be made thereof by them; and except as disclosed in the SEC Filings, the Company and each Subsidiary holds any leased real or personal property under valid and enforceable leases with no exceptions that would materially interfere with the use made or currently planned to be made thereof by them.

 

4.13 Certificates, Authorities and Permits. The Company and each Subsidiary possess adequate certificates, authorities or permits issued by appropriate governmental agencies or bodies necessary to conduct the business now operated by it, and neither the Company nor any Subsidiary has received any notice of proceedings relating to the revocation or modification of any such certificate, authority or permit that, if determined adversely to the Company or such Subsidiary, could reasonably be expected to have a Material Adverse Effect, individually or in the aggregate.

 

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4.14 No Labor Disputes. No material labor dispute with the employees of the Company or any Subsidiary exists or, to the Company’s Knowledge, is imminent.

 

4.15 Intellectual Property.

 

(a) All Intellectual Property of the Company and its Subsidiaries is currently in compliance with all legal requirements (including timely filings, proofs and payments of fees) and is valid and enforceable. No Intellectual Property of the Company or its Subsidiaries which is necessary for the conduct of Company’s and each of its Subsidiaries’ respective businesses as currently conducted or as currently proposed to be conducted has been or is now involved in any cancellation, dispute or litigation, and, to the Company’s Knowledge, no such action is threatened. No patent of the Company or its Subsidiaries has been or is now involved in any interference, reissue, re-examination or opposition proceeding.

 

(b) All of the licenses and sublicenses and consent, royalty or other agreements concerning Intellectual Property which are necessary for the conduct of the Company’s and each of its Subsidiaries’ respective businesses as currently conducted or as currently proposed to be conducted to which the Company or any Subsidiary is a party or by which any of their assets are bound (other than generally commercially available, non-custom, off-the-shelf software application programs having a retail acquisition price of less than $10,000 per license) (collectively, “License Agreements”) are valid and binding obligations of the Company or its Subsidiaries that are parties thereto and, to the Company’s Knowledge, the other parties thereto, enforceable in accordance with their terms, except to the extent that enforcement thereof may be limited by bankruptcy, insolvency, reorganization, moratorium, fraudulent conveyance or other similar laws affecting the enforcement of creditors’ rights generally, and there exists no event or condition which will result in a material violation or breach of or constitute (with or without due notice or lapse of time or both) a default by the Company or any of its Subsidiaries under any such License Agreement.

 

(c) The Company and its Subsidiaries own or have the valid right to use all of the Intellectual Property that is necessary for the conduct of the Company’s and each of its Subsidiaries’ respective businesses as currently conducted or as currently proposed to be conducted and for the ownership, maintenance and operation of the Company’s and its Subsidiaries’ properties and assets, free and clear of all liens, encumbrances, adverse claims or obligations to license all such owned Intellectual Property and Confidential Information, other than licenses entered into in the ordinary course of the Company’s and its Subsidiaries’ businesses. The Company and its Subsidiaries have a valid and enforceable right to use all third party Intellectual Property and Confidential Information used or held for use in the respective businesses of the Company and its Subsidiaries.

 

(d) To the Company’s Knowledge, the conduct of the Company’s and its Subsidiaries’ businesses as currently conducted does not infringe or otherwise impair or conflict with (collectively, “Infringe”) any Intellectual Property rights of any third party or any confidentiality obligation owed to a third party, and, to the Company’s Knowledge, the Intellectual Property and Confidential Information of the Company and its Subsidiaries which are necessary for the conduct of Company’s and each of its Subsidiaries’ respective businesses as

 

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currently conducted or as currently proposed to be conducted are not being Infringed by any third party. There is no litigation or order pending or outstanding or, to the Company’s Knowledge, threatened or imminent, that seeks to limit or challenge or that concerns the ownership, use, validity or enforceability of any Intellectual Property or Confidential Information of the Company and its Subsidiaries and the Company’s and its Subsidiaries’ use of any Intellectual Property or Confidential Information owned by a third party, and, to the Company’s Knowledge, there is no valid basis for the same.

 

(e) The consummation of the transactions contemplated hereby and by the other Transaction Documents will not result in the alteration, loss, impairment of or restriction on the Company’s or any of its Subsidiaries’ ownership or right to use any of the Intellectual Property or Confidential Information which is necessary for the conduct of Company’s and each of its Subsidiaries’ respective businesses as currently conducted or as currently proposed to be conducted.

 

(f) The Company and its Subsidiaries have taken reasonable steps to protect the Company’s and its Subsidiaries’ rights in their Intellectual Property and Confidential Information. Each employee, consultant and contractor who has had access to Confidential Information which is necessary for the conduct of Company’s and each of its Subsidiaries’ respective businesses as currently conducted or as currently proposed to be conducted has executed an agreement to maintain the confidentiality of such Confidential Information and has executed appropriate agreements that are substantially consistent with the Company’s standard forms thereof. Except under confidentiality obligations, there has been no material disclosure of any of the Company’s or its Subsidiaries’ Confidential Information to any third party.

 

4.16 Environmental Matters. Neither the Company nor any Subsidiary is in violation of any statute, rule, regulation, decision or order of any governmental agency or body or any court, domestic or foreign, relating to the use, disposal or release of hazardous or toxic substances or relating to the protection or restoration of the environment or human exposure to hazardous or toxic substances (collectively, “Environmental Laws”), owns or operates any real property contaminated with any substance that is subject to any Environmental Laws, is liable for any off-site disposal or contamination pursuant to any Environmental Laws, and is subject to any claim relating to any Environmental Laws, which violation, contamination, liability or claim has had or could reasonably be expected to have a Material Adverse Effect, individually or in the aggregate; and there is no pending or, to the Company’s Knowledge, threatened investigation that might lead to such a claim.

 

4.17 Litigation. Except as described on Schedule 4.17, there are no pending actions, suits or proceedings against or affecting the Company, its Subsidiaries or any of its or their properties; and to the Company’s Knowledge, no such actions, suits or proceedings are threatened or contemplated.

 

4.18 Financial Statements; Earnings Forecast. (a) The financial statements included in each SEC Filing present fairly, in all material respects, the consolidated financial position of the Company as of the dates shown and its consolidated results of operations and cash flows for the periods shown, and such financial statements have been prepared in conformity

 

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with United States generally accepted accounting principles applied on a consistent basis (“GAAP”) (except as may be disclosed therein or in the notes thereto, and, in the case of quarterly financial statements, as permitted by Form 10-Q under the 1934 Act). Except as set forth in the financial statements of the Company included in the SEC Filings filed prior to the date hereof and in the financial statements included in the Private Placement Memorandum, or as described on Schedule 4.18, neither the Company nor any of its Subsidiaries has incurred any liabilities, contingent or otherwise, except those incurred in the ordinary course of business, consistent (as to amount and nature) with past practices since the date of such financial statements, none of which, individually or in the aggregate, have had or could reasonably be expected to have a Material Adverse Effect.

 

(b) The financial projections contained in the Private Placement Memorandum are reasonable in light of the historical operations and results of the Company and Medivation, were made by management of Medivation prior to the Merger in good faith based on factual assumptions believed to be true, represent management’s good faith best estimate of the future operating performance of the Company and its Subsidiaries after giving effect to the Merger and were prepared on an accounting basis consistent with the financial statements of Medivation included in the Private Placement Memorandum.

 

4.19 Insurance Coverage. The Company and each Subsidiary maintains in full force and effect insurance coverage that is customary for comparably situated companies for the business being conducted and properties owned or leased by the Company and each Subsidiary, and the Company reasonably believes such insurance coverage to be adequate against all liabilities, claims and risks against which it is customary for comparably situated companies to insure.

 

4.20 Brokers and Finders. No Person will have, as a result of the transactions contemplated by the Transaction Documents, any valid right, interest or claim against or upon the Company, any Subsidiary, Medivation or an Investor for any commission, fee or other compensation pursuant to any agreement, arrangement or understanding entered into by or on behalf of the Company, other than as described in the Private Placement Memorandum or on Schedule 4.20.

 

4.21 No Directed Selling Efforts or General Solicitation. Neither the Company nor any Person acting on its behalf has conducted any general solicitation or general advertising (as those terms are used in Regulation D) in connection with the offer or sale of any of the Securities.

 

4.22 No Integrated Offering. Neither the Company nor any of its Affiliates, nor any Person acting on its or their behalf has, directly or indirectly, made any offers or sales of any Company security or solicited any offers to buy any security, under circumstances that would adversely affect reliance by the Company on Section 4(2) for the exemption from registration for the transactions contemplated hereby or would require registration of the Securities under the 1933 Act.

 

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4.23 Private Placement. The offer and sale of the Securities to the Investors as contemplated hereby is exempt from the registration requirements of the 1933 Act.

 

4.24 Questionable Payments. Neither the Company nor any of its Subsidiaries nor, to the Company’s Knowledge, any of their respective current or former stockholders, directors, officers, employees, agents or other Persons acting on behalf of the Company or any Subsidiary, has on behalf of the Company or any Subsidiary or in connection with their respective businesses: (a) used any corporate funds for unlawful contributions, gifts, entertainment or other unlawful expenses relating to political activity; (b) made any direct or indirect unlawful payments to any governmental officials or employees from corporate funds; (c) established or maintained any unlawful or unrecorded fund of corporate monies or other assets; (d) made any false or fictitious entries on the books and records of the Company or any Subsidiary; or (e) made any unlawful bribe, rebate, payoff, influence payment, kickback or other unlawful payment of any nature.

 

4.25 Transactions with Affiliates. Except as disclosed in the SEC Filings or in the Private Placement Memorandum, or as disclosed on Schedule 4.25, none of the officers or directors of the Company and, to the Company’s Knowledge, none of the employees of the Company is presently a party to any transaction with the Company or any Subsidiary (other than as holders of stock options and/or warrants, and for services as employees, officers and directors), including any contract, agreement or other arrangement providing for the furnishing of services to or by, providing for rental of real or personal property to or from, or otherwise requiring payments to or from any officer, director or such employee or, to the Company’s Knowledge, any entity in which any officer, director, or any such employee has a substantial interest or is an officer, director, trustee or partner.

 

4.26 Internal Controls. The Company is in material compliance with the provisions of the Sarbanes-Oxley Act of 2002 currently applicable to the Company. The Company and the Subsidiaries maintain a system of internal accounting controls sufficient to provide reasonable assurance that (i) transactions are executed in accordance with management’s general or specific authorizations, (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with generally accepted accounting principles and to maintain asset accountability, (iii) access to assets is permitted only in accordance with management’s general or specific authorization, and (iv) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences. The Company has established disclosure controls and procedures (as defined in 1934 Act Rules 13a-14 and 15d-14) for the Company and designed such disclosure controls and procedures to ensure that material information relating to the Company, including the Subsidiaries, is made known to the certifying officers by others within those entities, particularly during the period in which the Company’s most recently filed period report under the 1934 Act, as the case may be, is being prepared. The Company’s certifying officers have evaluated the effectiveness of the Company’s controls and procedures as of the end of the period covered by the most recently filed periodic report under the 1934 Act (such date, the “Evaluation Date”). The Company presented in its most recently filed periodic report under the 1934 Act the conclusions of the certifying officers about the effectiveness of the disclosure controls and procedures based on their evaluations as of the Evaluation Date. Since the Evaluation Date,

 

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there have been no significant changes in the Company’s internal controls (as such term is defined in Item 307(b) of Regulation S-K) or, to the Company’s Knowledge, in other factors that could significantly affect the Company’s internal controls. The Company maintains and will continue to maintain a standard system of accounting established and administered in accordance with GAAP and the applicable requirements of the 1934 Act.

 

4.27 Disclosures. Except as described in Schedule 4.27, neither the Company nor any Person acting on its behalf has provided the Investors or their agents or counsel with any information that constitutes or might constitute material, non-public information. The Private Placement Memorandum and the other written materials delivered to the Investors in connection with the transactions contemplated by the Transaction Documents do not contain any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements contained therein, in light of the circumstances under which they were made, not misleading.

 

4.28 Merger Agreement. A true and complete copy of the Merger Agreement, together with all exhibits and schedules thereto, has been provided to the Investors. The Merger Agreement has been duly authorized, executed and delivered by each of the parties thereto and constitutes the legal, valid and binding obligation of each of the parties thereto, enforceable against each of them in accordance with their terms, subject to bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium and similar laws of general applicability, relating to or affecting creditors’ rights generally. The representations and warranties made in the Merger Agreement by each of the parties thereto are true and correct and will be true and correct at all times prior to and on the Closing Date, except to the extent any such representation or warranty expressly speaks as of an earlier date, in which case such representation or warranty shall be true and correct as of such earlier date. Each of the parties to the Merger Agreement has performed or will perform prior to the Closing Date all obligations and conditions required to be performed or observed by it pursuant to the Merger Agreement on or prior to the Closing Date. The description of the Merger Agreement contained in the Private Placement Memorandum is true and complete in all material respects.

 

5. Representations and Warranties of the Investors. Each of the Investors hereby severally, and not jointly, represents and warrants to the Company that:

 

5.1 Organization and Existence. Such Investor is a validly existing corporation, limited partnership or limited liability company and has all requisite corporate, partnership or limited liability company power and authority to invest in the Shares pursuant to this Agreement.

 

5.2 Authorization. The execution, delivery and performance by such Investor of the Transaction Documents to which such Investor is a party have been duly authorized and will each constitute the valid and legally binding obligation of such Investor, enforceable against such Investor in accordance with their respective terms, subject to bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium and similar laws of general applicability, relating to or affecting creditors’ rights generally.

 

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5.3 Purchase Entirely for Own Account. The Shares to be received by such Investor hereunder will be acquired for such Investor’s own account, not as nominee or agent, and not with a view to the resale or distribution of any part thereof in violation of the 1933 Act, and such Investor has no present intention of selling, granting any participation in, or otherwise distributing the same in violation of the 1933 Act without prejudice, however, to such Investor’s right at all times to sell or otherwise dispose of all or any part of such Shares in compliance with applicable federal and state securities laws. Nothing contained herein shall be deemed a representation or warranty by such Investor to hold the Shares for any period of time. Such Investor is not a broker-dealer registered with the SEC under the 1934 Act or an entity engaged in a business that would require it to be so registered.

 

5.4 Investment Experience. Such Investor acknowledges that it can bear the economic risk and complete loss of its investment in the Shares and has such knowledge and experience in financial or business matters that it is capable of evaluating the merits and risks of the investment contemplated hereby.

 

5.5 Disclosure of Information. Such Investor has had an opportunity to receive all information related to the Company requested by it and to ask questions of and receive answers from the Company regarding the Company, its business and the terms and conditions of the offering of the Shares. Such Investor acknowledges receipt of copies of the SEC Filings and the Private Placement Memorandum. Neither such inquiries nor any other due diligence investigation conducted by such Investor shall modify, amend or affect such Investor’s right to rely on the Company’s representations and warranties contained in this Agreement.

 

5.6 Restricted Securities. Such Investor understands that the Shares are characterized as “restricted securities” under the U.S. federal securities laws inasmuch as they are being acquired from the Company in a transaction not involving a public offering and that under such laws and applicable regulations such securities may be resold without registration under the 1933 Act only in certain limited circumstances.

 

5.7 Legends. It is understood that, except as provided below, certificates evidencing the Shares may bear the following or any similar legend:

 

(a) “The securities represented hereby may not be transferred unless (i) such securities have been registered for sale pursuant to the Securities Act of 1933, as amended, (ii) such securities may be sold pursuant to Rule 144(k), or (iii) the Company has received an opinion of counsel reasonably satisfactory to it that such transfer may lawfully be made without registration under the Securities Act of 1933 or qualification under applicable state securities laws.”

 

(b) If required by the authorities of any state in connection with the issuance of sale of the Shares, the legend required by such state authority.

 

(c) “The securities represented hereby are subject to a voting agreement, a copy of which may be obtained from the Company.”

 

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5.8 Accredited Investor. Such Investor is an accredited investor as defined in Rule 501(a) of Regulation D, as amended, under the 1933 Act.

 

5.9 No General Solicitation. Such Investor did not learn of the investment in the Shares as a result of any public advertising or general solicitation.

 

5.10 Brokers and Finders. No Person will have, as a result of the transactions contemplated by the Transaction Documents, any valid right, interest or claim against or upon the Company, any Subsidiary or an Investor for any commission, fee or other compensation pursuant to any agreement, arrangement or understanding entered into by or on behalf of such Investor.

 

5.11 Prohibited Transactions. During the last thirty (30) days prior to the date hereof, neither such Investor nor any Affiliate of such Investor which (x) had knowledge of the transactions contemplated hereby, (y) has or shares discretion relating to such Investor’s investments or trading or information concerning such Investor’s investments, including in respect of the Shares, or (z) is subject to such Investor’s review or input concerning such Affiliate’s investments or trading (collectively, “Trading Affiliates”) has, directly or indirectly, effected or agreed to effect any short sale, whether or not against the box, established any “put equivalent position” (as defined in Rule 16a-1(h) under the 1934 Act) with respect to the Common Stock, granted any other right (including, without limitation, any put or call option) with respect to the Common Stock or with respect to any security that includes, relates to or derived any significant part of its value from the Common Stock or otherwise sought to hedge its position in the Shares (each, a “Prohibited Transaction”). Prior to the earliest to occur of (i) the termination of this Agreement, (ii) the Effective Date or (iii) the Effectiveness Deadline, such Investor shall not, and shall cause its Trading Affiliates not to, engage, directly or indirectly, in a Prohibited Transaction. Such Investor acknowledges that the representations, warranties and covenants contained in this Section 5.11 are being made for the benefit of the Investors as well as the Company and that each of the other Investors shall have an independent right to assert any claims against such Investor arising out of any breach or violation of the provisions of this Section 5.11.

 

6. Conditions to Closing.

 

6.1 Conditions to the Investors’ Obligations. The obligation of each Investor to purchase the Shares at the Closing is subject to the fulfillment to such Investor’s satisfaction, on or prior to the Closing Date, of the following conditions, any of which may be waived by such Investor (as to itself only):

 

(a) The representations and warranties made by the Company in Section 4 hereof qualified as to materiality shall be true and correct at all times prior to and on the Closing Date, except to the extent any such representation or warranty expressly speaks as of an earlier date, in which case such representation or warranty shall be true and correct as of such earlier date, and, the representations and warranties made by the Company in Section 4 hereof not qualified as to materiality shall be true and correct in all material respects at all times prior to and on the Closing Date, except to the extent any such representation or warranty expressly

 

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speaks as of an earlier date, in which case such representation or warranty shall be true and correct in all material respects as of such earlier date. The Company shall have performed in all material respects all obligations and conditions herein required to be performed or observed by it on or prior to the Closing Date.

 

(b) The Company shall have obtained any and all consents, permits, approvals, registrations and waivers necessary or appropriate for consummation of the purchase and sale of the Securities and the consummation of the other transactions contemplated by the Transaction Documents, all of which shall be in full force and effect.

 

(c) The Company shall have executed and delivered the Registration Rights Agreement.

 

(d) The Company shall have entered into one or more lock-up agreements in the form of Exhibit      to the Merger Agreement with the Persons listed in Schedule      to the Merger Agreement.

 

(e) The Company shall have effected the exchange of the Bridge Notes (as such term is defined in the Private Placement Memorandum) for not more than an aggregate of 1,070,000 shares of Common Stock on the terms described in the Private Placement Memorandum.

 

(f) The Merger shall have become effective and the other transactions to be consummated under the Merger Agreement on or prior to the closing date specified in the Merger Agreement shall have been consummated in compliance with the terms of the Merger Agreement.

 

(g) The Company shall have entered into one or more subscription agreements with one or more accredited investors reasonably satisfactory to the Investors that contain terms no more favorable to the subscriber than the terms of this Agreement (the “Other Agreements”) and one or more voting agreements in the form attached hereto as Exhibit B with such other investors.

 

(h) The Company shall have received gross proceeds from the sale of the Shares as contemplated hereby and under the Other Agreements of at least Ten Million Three Hundred Forty Two Hundred Thousand Dollars ($10,342,000).

 

(i) No judgment, writ, order, injunction, award or decree of or by any court, or judge, justice or magistrate, including any bankruptcy court or judge, or any order of or by any governmental authority, shall have been issued, and no action or proceeding shall have been instituted by any governmental authority, enjoining or preventing the consummation of the transactions contemplated hereby or in the other Transaction Documents.

 

(j) The Company shall have delivered a Certificate, executed on behalf of the Company by its Chief Executive Officer or its Chief Financial Officer, dated as of the Closing Date, certifying to the fulfillment of the conditions specified in subsections (a), (b), (d), (e), (f), (g), (h), (i) and (m) of this Section 6.1.

 

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(k) The Company shall have delivered a Certificate, executed on behalf of the Company by its Secretary, dated as of the Closing Date, certifying the resolutions adopted by the Board of Directors of the Company approving the transactions contemplated by this Agreement and the other Transaction Documents and the issuance of the Shares, certifying the current versions of the Certificate of Incorporation and Bylaws of the Company and certifying as to the signatures and authority of persons signing the Transaction Documents and related documents on behalf of the Company.

 

(l) The Investors shall have received an opinion from Graubard Miller LLP, the Company’s counsel, dated as of the Closing Date, in form and substance reasonably acceptable to the Investors and addressing such legal matters as the Investors may reasonably request.

 

(m) No stop order or suspension of trading shall have been imposed by Nasdaq, the SEC or any other governmental or regulatory body with respect to public trading in the Common Stock.

 

6.2 Conditions to Obligations of the Company. The Company’s obligation to sell and issue the Shares at the Closing is subject to the fulfillment to the satisfaction of the Company on or prior to the Closing Date of the following conditions, any of which may be waived by the Company:

 

(a) The representations and warranties made by the Investors in Section 5 hereof, other than the representations and warranties contained in Sections 5.3, 5.4, 5.5, 5.6, 5.7, 5.8 and 5.9 (the “Investment Representations”), shall be true and correct in all material respects when made, and shall be true and correct in all material respects on the Closing Date with the same force and effect as if they had been made on and as of said date. The Investment Representations shall be true and correct in all respects when made, and shall be true and correct in all respects on the Closing Date with the same force and effect as if they had been made on and as of said date. The Investors shall have performed in all material respects all obligations and conditions herein required to be performed or observed by them on or prior to the Closing Date.

 

(b) The Investors shall have executed and delivered the Registration Rights Agreement.

 

(c) The Investors shall have delivered the Purchase Price to the Company.

 

(d) The Investors shall have executed and delivered one or more Voting Agreements.

 

(e) The Merger shall have become effective.

 

-17-


6.3 Termination of Obligations to Effect Closing; Effects.

 

(a) The obligations of the Company, on the one hand, and the Investors, on the other hand, to effect the Closing shall terminate as follows:

 

(i) Upon the mutual written consent of the Company and the Investors;

 

(ii) By the Company if any of the conditions set forth in Section 6.2 shall have become incapable of fulfillment, and shall not have been waived by the Company;

 

(iii) By an Investor (with respect to itself only) if any of the conditions set forth in Section 6.1 shall have become incapable of fulfillment, and shall not have been waived by the Investor; or

 

(iv) By either the Company or any Investor (with respect to itself only) if the Closing has not occurred on or prior to the earliest to occur of (i) the effective date of the Merger, (ii) the termination of the Merger Agreement or (iii) December 31, 2004;

 

provided, however, that, except in the case of clause (i) above, the party seeking to terminate its obligation to effect the Closing shall not then be in breach of any of its representations, warranties, covenants or agreements contained in this Agreement or the other Transaction Documents if such breach has resulted in the circumstances giving rise to such party’s seeking to terminate its obligation to effect the Closing.

 

(b) In the event of termination by the Company or any Investor of its obligations to effect the Closing pursuant to this Section 6.3, written notice thereof shall forthwith be given to the other Investors and the other Investors shall have the right to terminate their obligations to effect the Closing upon written notice to the Company and the other Investors. Nothing in this Section 6.3 shall be deemed to release any party from any liability for any breach by such party of the terms and provisions of this Agreement or the other Transaction Documents or to impair the right of any party to compel specific performance by any other party of its obligations under this Agreement or the other Transaction Documents.

 

7. Covenants and Agreements of the Company.

 

7.1 Reports. The Company will furnish to such Investors and/or their assignees such information relating to the Company and its Subsidiaries as from time to time may reasonably be requested by such Investors and/or their assignees; provided, however, that the Company shall not disclose material nonpublic information to the Investors, or to advisors to or representatives of the Investors, unless prior to disclosure of such information the Company identifies such information as being material nonpublic information and provides the Investors, such advisors and representatives with the opportunity to accept or refuse to accept such material nonpublic information for review and any Investor wishing to obtain such information enters into an appropriate confidentiality agreement with the Company with respect thereto.

 

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7.2 No Conflicting Agreements. The Company will not take any action, enter into any agreement or make any commitment that would conflict or interfere in any material respect with the Company’s obligations to the Investors under the Transaction Documents.

 

7.3 Insurance. The Company shall not materially reduce the insurance coverages described in Section 4.19.

 

7.4 Compliance with Laws. The Company will comply in all material respects with all applicable laws, rules, regulations, orders and decrees of all governmental authorities.

 

7.5 Listing of Underlying Shares and Related Matters. Promptly following the date hereof, the Company shall use its best efforts to cause the outstanding shares of Common Stock (including the Shares) to be listed on the Nasdaq SmallCap Market. Further, if the Company applies to have its Common Stock or other securities traded on any other principal stock exchange or market, it shall include in such application the Shares and will take such other action as is necessary to cause such Common Stock to be so listed. The Company will use its best efforts to continue the listing and trading of its Common Stock on the Nasdaq SmallCap Market and, in accordance, therewith, will use its best efforts to comply in all respects with the Company’s reporting, filing and other obligations under the bylaws or rules of such market or exchange, as applicable.

 

7.6 Termination of Covenants. The provisions of Sections 7.1 through 7.4 shall terminate and be of no further force and effect on the date on which the Company’s obligations under the Registration Rights Agreement to register or maintain the effectiveness of any registration covering the Registrable Securities (as such term is defined in the Registration Rights Agreement) shall terminate.

 

7.7 Removal of Legends. Upon the earlier of (i) registration for resale pursuant to the Registration Rights Agreement and receipt by the Company of an executed certificate of subsequent sale in substantially the form attached hereto as Exhibit D (a “Certificate of Subsequent Sale”) or (ii) Rule 144(k) becoming available the Company shall, upon an Investor’s written request, promptly cause certificates evidencing the Investor’s Shares to be replaced with certificates which do not bear such restrictive legends. From and after the effectiveness of the Registration Statement, the Company shall provide the transfer agent for the Shares with irrevocable written instructions, in form and substance reasonably satisfactory to the Investors, to register the transfer of any Shares upon receipt of the certificate or certificates representing such Shares along with a Certificate of Subsequent Sale relating to such Shares. When the Company is required to cause unlegended certificates to replace previously issued legended certificates, if unlegended certificates are not delivered to an Investor at its address as set forth on the signature pages of this Agreement (as may be updated from time to time by such investor in compliance with Section 9.4 of this Agreement) within three (3) Business Days (five (5) Business Days for any Investor which is not a U.S. Person) of submission by that Investor of

 

-19-


legended certificate(s) to the Company’s transfer agent together with a Certificate of Subsequent Sale (a copy of which will be provided to the Company) or, in the event of a sale under Rule 144(k), a representation letter in customary form, the Company shall be liable to the Investor for liquidated damages in an amount equal to 1.5% of the aggregate purchase price of the Securities evidenced by such certificate(s) for each thirty (30) day period (or portion thereof) beyond such three (3) Business Day that the unlegended certificates have not been so delivered.

 

8. Survival and Indemnification.

 

8.1 Survival. The representations, warranties, covenants and agreements contained in this Agreement shall survive for a period of eighteen months following the Closing of the transactions contemplated by this Agreement.

 

8.2 Indemnification. The Company agrees to indemnify and hold harmless each Investor and its Affiliates and their respective directors, officers, employees and agents from and against any and all losses, claims, damages, liabilities and expenses (including without limitation reasonable attorney fees and disbursements and other expenses incurred in connection with investigating, preparing or defending any action, claim or proceeding, pending or threatened and the costs of enforcement thereof) (collectively, “Losses”) to which such Person may become subject as a result of any breach of representation, warranty, covenant or agreement made by or to be performed on the part of the Company under the Transaction Documents, and will reimburse any such Person for all such amounts as they are incurred by such Person.

 

8.3 Conduct of Indemnification Proceedings. Promptly after receipt by any Person (the Indemnified Person”) of notice of any demand, claim or circumstances which would or might give rise to a claim or the commencement of any action, proceeding or investigation in respect of which indemnity may be sought pursuant to Section 8.2, such Indemnified Person shall promptly notify the Company in writing and the Company shall assume the defense thereof, including the employment of counsel reasonably satisfactory to such Indemnified Person, and shall assume the payment of all fees and expenses; provided, however, that the failure of any Indemnified Person so to notify the Company shall not relieve the Company of its obligations hereunder except to the extent that the Company is materially prejudiced by such failure to notify. In any such proceeding, any Indemnified Person shall have the right to retain its own counsel, but the fees and expenses of such counsel shall be at the expense of such Indemnified Person unless: (i) the Company and the Indemnified Person shall have mutually agreed to the retention of such counsel; or (ii) in the reasonable judgment of counsel to such Indemnified Person representation of both parties by the same counsel would be inappropriate due to actual or potential differing interests between them. The Company shall not be liable for any settlement of any proceeding effected without its written consent, which consent shall not be unreasonably withheld, but if settled with such consent, or if there be a final judgment for the plaintiff, the Company shall indemnify and hold harmless such Indemnified Person from and against any loss or liability (to the extent stated above) by reason of such settlement or judgment. Without the prior written consent of the Indemnified Person, which consent shall not be unreasonably withheld, the Company shall not effect any settlement of any pending or threatened proceeding in respect of which any Indemnified Person is or could have been a party and indemnity could have been sought hereunder by such Indemnified Party, unless such settlement includes an unconditional release of such Indemnified Person from all liability arising out of such proceeding.

 

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9. Miscellaneous.

 

9.1 Successors and Assigns. This Agreement may not be assigned by a party hereto without the prior written consent of the Company or the Investors, as applicable, provided, however, that an Investor may assign its rights and delegate its duties hereunder in whole or in part to an Affiliate or to a third party acquiring some or all of its Securities in a private transaction without the prior written consent of the Company or the other Investors, after notice duly given by such Investor to the Company and the other Investors, provided, that no such assignment or obligation shall affect the obligations of such Investor hereunder. The provisions of this Agreement shall inure to the benefit of and be binding upon the respective permitted successors and assigns of the parties. Nothing in this Agreement, express or implied, is intended to confer upon any party other than the parties hereto or their respective successors and assigns any rights, remedies, obligations, or liabilities under or by reason of this Agreement, except as expressly provided in this Agreement.

 

9.2 Counterparts; Faxes. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. This Agreement may also be executed via facsimile, which shall be deemed an original.

 

9.3 Titles and Subtitles. The titles and subtitles used in this Agreement are used for convenience only and are not to be considered in construing or interpreting this Agreement.

 

9.4 Notices. Unless otherwise provided, any notice required or permitted under this Agreement shall be given in writing and shall be deemed effectively given as hereinafter described (i) if given by personal delivery, then such notice shall be deemed given upon such delivery, (ii) if given by telex or telecopier, then such notice shall be deemed given upon receipt of confirmation of complete transmittal, (iii) if given by mail, then such notice shall be deemed given upon the earlier of (A) receipt of such notice by the recipient or (B) three days after such notice is deposited in first class mail, postage prepaid, and (iv) if given by an internationally recognized overnight air courier, then such notice shall be deemed given one business day after delivery to such carrier. All notices shall be addressed to the party to be notified at the address as follows, or at such other address as such party may designate by ten days’ advance written notice to the other party:

 

If to the Company:

 

Orion Acquisition Corp. II

501 Second Street, Suite 211

San Francisco, CA 94107

Attention: Chief Financial Officer

Fax: (415) 543-3113

 

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        With a copies to:

 

MDB Capital Group LLC

401 Wilshire Boulevard, Suite 1020

Santa Monica, CA 90401

Attention: Mr. Christopher Marlett

Fax: (310) 526-5020

 

        And to:

 

Latham & Watkins, LLP

505 Montgomery Street, Suite 1900

San Francisco, CA 94111

Attention: Brad Budganowitz, Esq.

Fax: (415) 395-8095

 

Graubard Miller

600 Third Avenue

New York, NY 10016

Attention: Andrew Hudders, Esq.

Fax: (212) 818-8881

 

        If to the Investors:

 

to the addresses set forth on the signature pages hereto.

 

9.5 Expenses. The parties hereto shall pay their own costs and expenses in connection herewith, except that the Company shall pay the reasonable fees and expenses of Lowenstein Sandler PC, not to exceed $35,000. Such expenses shall be paid not later than the Closing. The Company shall reimburse the Investors upon demand for all reasonable out-of-pocket expenses incurred by the Investors, including without limitation reimbursement of attorneys’ fees and disbursements, in connection with any amendment, modification or waiver of this Agreement or the other Transaction Documents, but excluding any such amendment, modification or waiver that is requested by one or more of the Investors. In the event that legal proceedings are commenced by any party to this Agreement against another party to this Agreement in connection with this Agreement or the other Transaction Documents, the party or parties which do not prevail in such proceedings shall severally, but not jointly, pay their pro rata share of the reasonable attorneys’ fees and other reasonable out-of-pocket costs and expenses incurred by the prevailing party in such proceedings.

 

9.6 Amendments and Waivers. Any term of this Agreement may be amended and the observance of any term of this Agreement may be waived (either generally or in a particular instance and either retroactively or prospectively), only with the written consent of the Company and the Investors. Any amendment or waiver effected in accordance with this paragraph shall be binding upon each holder of any Securities purchased under this Agreement at the time outstanding, each future holder of all such Securities, and the Company.

 

-22-


9.7 Publicity. Except as set forth below, no public release or announcement concerning the transactions contemplated hereby shall be issued by the Company or the Investors without the prior consent of the Company (in the case of a release or announcement by the Investors) or the Investors (in the case of a release or announcement by the Company) (which consents shall not be unreasonably withheld), except as such release or announcement may be required by law or the applicable rules or regulations of any securities exchange or securities market, in which case the Company or the Investors, as the case may be, shall allow the Investors or the Company, as applicable, to the extent reasonably practicable in the circumstances, reasonable time to comment on such release or announcement in advance of such issuance. By 8:30 a.m. (New York City time) on the trading day immediately following the Closing Date, the Company shall issue a press release disclosing the consummation of the transactions contemplated by this Agreement. No later than the third trading day following the Closing Date, the Company will file a Current Report on Form 8-K attaching the press release described in the foregoing sentence as well as copies of the Transaction Documents. No later than the date on which the Company files the Registration Statement, the Company shall publicly disclose any material nonpublic information referenced in Schedule 4.27. In addition, the Company will make such other filings and notices in the manner and time required by the SEC. Notwithstanding the foregoing, the Company shall not publicly disclose the name of any Investor, or include the name of any Investor in any filing with the SEC (other than the Registration Statement and any exhibits to filings made in respect of this transaction in accordance with periodic filing requirements under the 1934 Act) or any regulatory agency, without the prior written consent of such Investor, except to the extent such disclosure is required by law or trading market regulations, in which case the Company shall provide the Investors with prior notice of such disclosure.

 

9.8 Severability. Any provision of this Agreement that is prohibited or unenforceable in any jurisdiction shall, as to such jurisdiction, be ineffective to the extent of such prohibition or unenforceability without invalidating the remaining provisions hereof but shall be interpreted as if it were written so as to be enforceable to the maximum extent permitted by applicable law, and any such prohibition or unenforceability in any jurisdiction shall not invalidate or render unenforceable such provision in any other jurisdiction. To the extent permitted by applicable law, the parties hereby waive any provision of law which renders any provision hereof prohibited or unenforceable in any respect.

 

9.9 Entire Agreement. This Agreement, including the Exhibits and the Disclosure Schedules, and the other Transaction Documents constitute the entire agreement among the parties hereof with respect to the subject matter hereof and thereof and supersede all prior agreements and understandings, both oral and written, between the parties with respect to the subject matter hereof and thereof.

 

9.10 Further Assurances. The parties shall execute and deliver all such further instruments and documents and take all such other actions as may reasonably be required to carry out the transactions contemplated hereby and to evidence the fulfillment of the agreements herein contained.

 

-23-


9.11 Governing Law; Consent to Jurisdiction; Waiver of Jury Trial. This Agreement shall be governed by, and construed in accordance with, the internal laws of the State of New York without regard to the choice of law principles thereof. Each of the parties hereto irrevocably submits to the exclusive jurisdiction of the courts of the State of New York located in New York County and the United States District Court for the Southern District of New York for the purpose of any suit, action, proceeding or judgment relating to or arising out of this Agreement and the transactions contemplated hereby. Service of process in connection with any such suit, action or proceeding may be served on each party hereto anywhere in the world by the same methods as are specified for the giving of notices under this Agreement. Each of the parties hereto irrevocably consents to the jurisdiction of any such court in any such suit, action or proceeding and to the laying of venue in such court. Each party hereto irrevocably waives any objection to the laying of venue of any such suit, action or proceeding brought in such courts and irrevocably waives any claim that any such suit, action or proceeding brought in any such court has been brought in an inconvenient forum. EACH OF THE PARTIES HERETO WAIVES ANY RIGHT TO REQUEST A TRIAL BY JURY IN ANY LITIGATION WITH RESPECT TO THIS AGREEMENT AND REPRESENTS THAT COUNSEL HAS BEEN CONSULTED SPECIFICALLY AS TO THIS WAIVER.

 

9.12 Independent Nature of Investors’ Obligations and Rights. The obligations of each Investor under any Transaction Document are several and not joint with the obligations of any other Investor, and no Investor shall be responsible in any way for the performance of the obligations of any other Investor under any Transaction Document. The decision of each Investor to purchase Securities pursuant to the Transaction Documents has been made by such Investor independently of any other Investor. Nothing contained herein or in any Transaction Document, and no action taken by any Investor pursuant thereto, shall be deemed to constitute the Investors as a partnership, an association, a joint venture or any other kind of entity, or create a presumption that the Investors are in any way acting in concert or as a group with respect to such obligations or the transactions contemplated by the Transaction Documents. Each Investor acknowledges that no other Investor has acted as agent for such Investor in connection with making its investment hereunder and that no Investor will be acting as agent of such Investor in connection with monitoring its investment in the Securities or enforcing its rights under the Transaction Documents. Each Investor shall be entitled to independently protect and enforce its rights, including, without limitation, the rights arising out of this Agreement or out of the other Transaction Documents, and it shall not be necessary for any other Investor to be joined as an additional party in any proceeding for such purpose. The Company acknowledges that each of the Investors has been provided with the same Transaction Documents for the purpose of closing a transaction with multiple Investors and not because it was required or requested to do so by any Investor.

 

[signature page follows]

 

-24-


IN WITNESS WHEREOF, the parties have executed this Agreement or caused their duly authorized officers to execute this Agreement as of the date first above written.

 

The Company:    ORION ACQUISITION CORP. II
     By:  

/s/ David T. Hung, M.D.


     Name:   David T. Hung, M.D.
     Title:   President and Chief Executive Officer

 

-25-


The Investors:    SPECIAL SITUATIONS FUND III, L.P.
     By:  

/s/ Austin W. Marxe


     Name:   Austin W. Marxe
     Title:   General Partner

 

Aggregate Purchase Price: $ 1,500,000

Number of Shares: 967,742

 

Address for Notice:     
     153 E. 53rd Street
     55th Floor
     New York, NY 10022
     with a copy to:
     Lowenstein Sandler PC
     65 Livingston Avenue
     Roseland, NJ 07068
     Attn: John D. Hogoboom, Esq.
     Telephone: 973.597.2500
     Facsimile: 973.597.2400

 

    

SPECIAL SITUATIONS CAYMAN FUND III, L.P.

     By:  

/s/ Austin W. Marxe


     Name:   Austin W. Marxe
     Title:   General Partner

 

Aggregate Purchase Price: $ 500,000

Number of Shares: 322,581

 

Address for Notice:     
     153 E. 53rd Street
     55th Floor
     New York, NY 10022

 

-26-


     with a copy to:
     Lowenstein Sandler PC
     65 Livingston Avenue
     Roseland, NJ 07068
     Attn: John D. Hogoboom, Esq.
     Telephone: 973.597.2500
     Facsimile: 973.597.2400

 

     SPECIAL SITUATIONS PRIVATE EQUITY FUND, L.P.
     By:  

/s/ Austin W. Marxe


     Name:   Austin W. Marxe
     Title:   General Partner

 

Aggregate Purchase Price: $ 2,000,000

Number of Shares: 1,290,323

 

Address for Notice:     
     153 E. 53rd Street
     55th Floor
     New York, NY 10022
     with a copy to:
     Lowenstein Sandler PC
     65 Livingston Avenue
     Roseland, NJ 07068
     Attn: John D. Hogoboom, Esq.
     Telephone: 973.597.2500
     Facsimile: 973.597.2400

 

-27-

EX-10.3(A) 14 dex103a.htm REGISTRATION RIGHTS AGMT BY AND AMONG ORION ACQUISITION CORP. II Registration Rights Agmt by and among Orion Acquisition Corp. II

EXHIBIT 10.3(a)

 

REGISTRATION RIGHTS AGREEMENT

 

This Registration Rights Agreement (the “Agreement”) is made and entered into as of this 17th day of December, 2004 by and among Orion Acquisition Corp. II, a Delaware corporation (the “Company”), and the “Investors” named in that certain Purchase Agreement by and among the Company and the Investors (the “Purchase Agreement”).

 

The parties hereby agree as follows:

 

1. Certain Definitions.

 

As used in this Agreement, the following terms shall have the following meanings:

 

Affiliate” means, with respect to any person, any other person which directly or indirectly controls, is controlled by, or is under common control with, such person.

 

Business Day” means a day, other than a Saturday or Sunday, on which banks in New York City are open for the general transaction of business.

 

Common Stock” shall mean the Company’s common stock, par value $0.01 per share, and any securities into which such shares may hereinafter be reclassified.

 

Investors” shall mean the Investors identified in the Purchase Agreement and any Affiliate or permitted transferee of any Investor who is a subsequent holder of any Registrable Securities.

 

Prospectus” shall mean the prospectus included in any Registration Statement, as amended or supplemented by any prospectus supplement, with respect to the terms of the offering of any portion of the Registrable Securities covered by such Registration Statement and by all other amendments and supplements to the prospectus, including post-effective amendments and all material incorporated by reference in such prospectus.

 

Register,” “registered” and “registration” refer to a registration made by preparing and filing a Registration Statement or similar document in compliance with the 1933 Act (as defined below), and the declaration or ordering of effectiveness of such Registration Statement or document.

 

Registrable Securities” shall mean the Shares and any other securities issued or issuable with respect to or in exchange for Registrable Securities; provided, that, a security shall cease to be a Registrable Security upon (A) sale pursuant to a Registration Statement or Rule 144 under the 1933 Act, or (B) such security becoming eligible for sale by the Investors pursuant to Rule 144(k).

 

Registration Statement” shall mean any registration statement of the Company filed under the 1933 Act that covers the resale of any of the Registrable Securities pursuant to the provisions of this Agreement, amendments and supplements to such Registration Statement, including post-effective amendments, all exhibits and all material incorporated by reference in such Registration Statement.

 

Required Investors” means the Investors holding a majority of the Registrable Securities.


SEC” means the U.S. Securities and Exchange Commission.

 

Shares” means the shares of Common Stock issued pursuant to the Purchase Agreement.

 

1933 Act” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.

 

1934 Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.

 

2. Registration.

 

(a) Registration Statements.

 

(i) Promptly following the closing of the purchase and sale of the securities contemplated by the Purchase Agreement (the “Closing Date”) but no later than forty-five (45) days after the Closing Date (the “Filing Deadline”), the Company shall prepare and file with the SEC one Registration Statement on Form SB-2 (or, if Form SB-2 is not then available to the Company, on such form of registration statement as is then available to effect a registration for resale of the Registrable Securities, subject to the Required Investors’ consent), covering the resale of the Registrable Securities. Such Registration Statement shall include the plan of distribution attached hereto as Exhibit A. Such Registration Statement also shall cover, to the extent allowable under the 1933 Act and the rules promulgated thereunder (including Rule 416), such indeterminate number of additional shares of Common Stock resulting from stock splits, stock dividends or similar transactions with respect to the Registrable Securities. The Company shall use its reasonable best efforts to obtain from each person who now has piggyback registration rights a waiver of those rights with respect to the Registration Statement. The Registration Statement (and each amendment or supplement thereto, and each request for acceleration of effectiveness thereof) shall be provided in accordance with Section 3(c) to the Investors and their counsel prior to its filing or other submission. If a Registration Statement covering the Registrable Securities is not filed with the SEC on or prior to the Filing Deadline, the Company will make pro rata payments to each Investor, as liquidated damages and not as a penalty, in an amount equal to 1.5% of the aggregate amount invested by such Investor for each 30-day period or pro rata for any portion thereof following the date by which such Registration Statement should have been filed for which no Registration Statement is filed with respect to the Registrable Securities. Such payments shall constitute the Investors’ sole monetary remedy for such events but shall not limit the Investors’ right to seek specific performance of the provisions hereof. Such payments shall be made to each Investor in cash.

 

(ii) Promptly following the date (the “Qualification Date”) upon which the Company becomes eligible to use a registration statement on Form S-3 to register the Registrable Securities or Additional Shares, as applicable, for resale, but in no event more than ten (10) Business Days after the Qualification Date (the “Qualification Deadline”), the Company shall file a registration statement on Form S-3 covering the Registrable Securities (or a post-effective amendment on Form S-3 to the registration statement on Form SB-2) (a “Shelf Registration Statement”) and shall use commercially reasonable efforts to cause such Shelf Registration Statement to be declared effective as promptly as practicable thereafter. If a Shelf Registration Statement covering the Registrable Securities is not filed with the SEC on or prior to the Qualification Deadline, the Company will make pro rata payments to each Investor, so

 

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long as all of the Investors’ Shares have not been sold pursuant to a Registration Statement prior to such date, as liquidated damages and not as a penalty, in an amount equal to 1.5% of the aggregate amount invested by such Investor for each 30-day period or pro rata for any portion thereof following the date by which such Shelf Registration Statement should have been filed for which no such Shelf Registration Statement is filed with respect to the Registrable Securities. Such payments shall constitute the Investors’ sole monetary remedy for such events but shall not limit the Investors’ right to seek specific performance of the provisions hereof. Such payments shall be made to each Investor in cash. In the event that all of the Investors’ Shares have been sold pursuant to a Registration Statement, the liquidated damages provision in this Section 2(a)(ii) shall be of no further force or effect; provided, however, that no such sale shall affect the right of the Investors to receive liquidated damages accruing prior to such sale.

 

(b) Expenses. The Company will pay all expenses associated with each registration, including filing and printing fees, the Company’s counsel and accounting fees and expenses, costs associated with clearing the Registrable Securities for sale under applicable state securities laws, listing fees, fees and expenses of one counsel to the Investors not to exceed an aggregate of $35,000 and the Investors’ reasonable expenses in connection with the registration, but excluding stock transfer taxes, discounts, commissions, fees of underwriters, selling brokers, dealer managers or similar securities industry professionals with respect to the Registrable Securities being sold.

 

(c) Effectiveness.

 

(i) The Company shall use commercially reasonable efforts to have the Registration Statement declared effective as soon as practicable. The Company shall notify the Investors by facsimile or e-mail as promptly as practicable, and in any event, within twenty-four (24) hours, after any Registration Statement is declared effective and shall promptly (but in any event within two Business Days of such effective date) provide the Investors with copies of any related Prospectus to be used in connection with the sale or other disposition of the securities covered thereby. If (A)(x) a Registration Statement covering the Registrable Securities is not declared effective by the SEC prior to the earlier of (1) 105 days after the Closing Date or (2) March 31, 2005 or (y) a Shelf Registration Statement is not declared effective by the SEC within 90 days after the Qualification Deadline or (B) after a Registration Statement has been declared effective by the SEC, sales cannot be made pursuant to such Registration Statement for a period in excess of the Allowed Delay (as defined below), then the Company will make pro rata payments to each Investor, so long as all of the Investors’ Shares have not been sold pursuant to a Registration Statement prior to such date, as liquidated damages and not as a penalty, in an amount equal to 1.5% of the aggregate amount invested by such Investor for each 30-day period or pro rata for any portion thereof following the date by which such Registration Statement should have been effective (the “Blackout Period”). Such payments shall constitute the Investors’ sole monetary remedy for such events but shall not limit the Investors’ right to seek specific performance of the provisions hereof. The amounts payable as liquidated damages pursuant to this paragraph shall be paid monthly within three (3) Business Days of the last day of each month following the commencement of the Blackout Period until the termination of the Blackout Period. Such payments shall be made to each Investor in cash. In the event that all of the Investors’ Shares have been sold pursuant to a Registration Statement, the liquidated damages provision in this Section 2(c) shall be of no further force or effect; provided, however, that no such sale shall affect the right of the Investors to receive liquidated damages accruing prior to such sale.

 

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(ii) In the event (A) of any request by the SEC or any other federal or state governmental authority during the period of effectiveness of the Registration Statement for amendments or supplements to a Registration Statement or related Prospectus or for additional information; (B) of the issuance by the SEC or any other federal or state governmental authority of any stop order suspending the effectiveness of a Registration Statement or the initiation of any proceedings for that purpose; (C) of the receipt by the Company of any notification with respect to the suspension of the qualification or exemption from qualification of any of the Shares for sale in any jurisdiction or the initiation or threatening of any proceeding for such purpose; or (D) of any event or circumstance which necessitates the making of any changes in the Registration Statement or Prospectus, or any document incorporated therein by reference, so that, in the case of the Registration Statement, it will not contain any untrue statement of a material fact or any omission to state a material fact required to be stated therein or necessary to make the statements therein not misleading, and that in the case of the Prospectus, it will not contain any untrue statement of a material fact or any omission to state a material fact required to be stated therein or necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading; then for not more than twenty (20) consecutive days or for a total of not more than forty-five (45) days in any twelve (12) month period, the Company may delay the disclosure of material non-public information concerning the Company, by suspending the use of any Prospectus included in any registration contemplated by this Section containing such information, the disclosure of which at the time is not, in the good faith opinion of the Company, in the best interests of the Company (an “Allowed Delay”); provided, that the Company shall promptly (a) notify the Investors in writing of the existence of (but in no event, without the prior written consent of an Investor, shall the Company disclose to such Investor any of the facts or circumstances regarding) any material non-public information giving rise to an Allowed Delay, (b) advise the Investors in writing to cease all sales under the Registration Statement until the end of the Allowed Delay and (c) use commercially reasonable efforts to terminate an Allowed Delay as promptly as practicable.

 

3. Company Obligations. The Company will use commercially reasonable efforts to effect the registration of the Registrable Securities in accordance with the terms hereof, and pursuant thereto the Company will, as expeditiously as possible:

 

(a) use commercially reasonable efforts to cause such Registration Statement to become effective and to remain continuously effective for a period that will terminate upon the earlier of (i) the date on which all Registrable Securities covered by such Registration Statement as amended from time to time, have been sold, and (ii) the date on which all Registrable Securities covered by such Registration Statement may be sold pursuant to Rule 144(k) (the “Effectiveness Period”) and advise the Investors in writing when the Effectiveness Period has expired;

 

(b) prepare and file with the SEC such amendments and post-effective amendments to the Registration Statement and the Prospectus as may be necessary to keep the Registration Statement effective for the period specified in Section 3(a) and to comply with the provisions of the 1933 Act and the 1934 Act with respect to the distribution of all of the Registrable Securities covered thereby;

 

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(c) provide copies to and permit counsel designated by the Investors to review each Registration Statement and all amendments and supplements thereto no fewer than three (3) Business Days prior to their filing with the SEC and not file any document to which such counsel reasonably objects provide, that such objection is based on counsel’s belief that the Registration Statement or such amendment or supplement contains a material misstatement or omission;

 

(d) furnish to the Investors and their legal counsel (i) promptly after the same is prepared and publicly distributed, filed with the SEC, or received by the Company (but not later than two (2) Business Days after the filing date, receipt date or sending date, as the case may be) one (1) copy of any Registration Statement and any amendment thereto, each preliminary prospectus and Prospectus and each amendment or supplement thereto, and each letter written by or on behalf of the Company to the SEC or the staff of the SEC, and each item of correspondence from the SEC or the staff of the SEC, in each case relating to such Registration Statement (other than any portion of any thereof which contains information for which the Company has sought confidential treatment), and (ii) such number of copies of a Prospectus, including a preliminary prospectus, and all amendments and supplements thereto and such other documents as each Investor may reasonably request in order to facilitate the disposition of the Registrable Securities owned by such Investor that are covered by the related Registration Statement;

 

(e) use commercially reasonable efforts to (i) prevent the issuance of any stop order or other suspension of effectiveness and, (ii) if such order is issued, obtain the withdrawal of any such order at the earliest possible moment;

 

(f) prior to any public offering of Registrable Securities, use commercially reasonable efforts to register or qualify or cooperate with the Investors and their counsel in connection with the registration or qualification of such Registrable Securities for offer and sale under the securities or blue sky laws of California, Connecticut, Massachusetts, New Jersey, New York, Pennsylvania and Texas and do any and all other commercially reasonable acts or things necessary or advisable to enable the distribution in such jurisdictions of the Registrable Securities covered by the Registration Statement; provided, however, that the Company shall not be required in connection therewith or as a condition thereto to (i) qualify to do business in any jurisdiction where it would not otherwise be required to qualify but for this Section 3(f), (ii) subject itself to general taxation in any jurisdiction where it would not otherwise be so subject but for this Section 3(f), or (iii) file a general consent to service of process in any such jurisdiction;

 

(g) use commercially reasonable efforts to cause all Registrable Securities covered by a Registration Statement to be listed on each securities exchange, interdealer quotation system or other market on which similar securities issued by the Company are then listed;

 

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(h) immediately notify the Investors, at any time when a Prospectus relating to Registrable Securities is required to be delivered under the 1933 Act, upon discovery that, or upon the happening of any event as a result of which, the Prospectus included in a Registration Statement, as then in effect, includes an untrue statement of a material fact or omits to state any material fact required to be stated therein or necessary to make the statements therein not misleading in light of the circumstances then existing, and at the request of any such holder, promptly prepare and furnish to such holder a reasonable number of copies of a supplement to or an amendment of such Prospectus as may be necessary so that, as thereafter delivered to the purchasers of such Registrable Securities, such Prospectus shall not include an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading in light of the circumstances then existing; and

 

(i) otherwise use commercially reasonable efforts to comply with all applicable rules and regulations of the SEC under the 1933 Act and the 1934 Act, take such other actions as may be reasonably necessary to facilitate the registration of the Registrable Securities hereunder; and make available to its security holders, as soon as reasonably practicable, but not later than the Availability Date (as defined below), an earnings statement covering a period of at least twelve (12) months, beginning after the effective date of each Registration Statement, which earnings statement shall satisfy the provisions of Section 11(a) of the 1933 Act, including Rule 158 promulgated thereunder (for the purpose of this subsection 3(i), “Availability Date” means the 45th day following the end of the fourth fiscal quarter that includes the effective date of such Registration Statement, except that, if such fourth fiscal quarter is the last quarter of the Company’s fiscal year, “Availability Date” means the 90th day after the end of such fourth fiscal quarter).

 

(j) With a view to making available to the Investors the benefits of Rule 144 (or its successor rule) and any other rule or regulation of the SEC that may at any time permit the Investors to sell shares of Common Stock to the public without registration, the Company covenants and agrees to: (i) make and keep public information available, as those terms are understood and defined in Rule 144, until the earlier of (A) six months after such date as all of the Registrable Securities may be resold pursuant to Rule 144(k) or any other rule of similar effect or (B) such date as all of the Registrable Securities shall have been resold; (ii) file with the SEC in a timely manner all reports and other documents required of the Company under the 1934 Act; and (iii) furnish to each Investor upon request, as long as such Investor owns any Registrable Securities, (A) a written statement by the Company that it has complied with the reporting requirements of the 1934 Act, (B) a copy of the Company’s most recent Annual Report on Form 10-KSB or Quarterly Report on Form 10-QSB and (C) such other information as may be reasonably requested in order to avail such Investor of any rule or regulation of the SEC that permits the selling of any such Registrable Securities without registration.

 

4. Due Diligence Review; Information. The Company shall make available, during normal business hours, for inspection and review by the Investors, advisors to and representatives of the Investors (who may or may not be affiliated with the Investors and who are reasonably acceptable to the Company), all financial and other records, all SEC Filings (as defined in the Purchase Agreement) and other filings with the SEC, and all other corporate documents and properties of the Company as may be reasonably necessary for the purpose of such review, and cause the Company’s officers and directors, within a reasonable time period, to

 

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supply all such information reasonably requested by the Investors or any such representative, advisor or underwriter in connection with such Registration Statement (including, without limitation, in response to all questions and other inquiries reasonably made or submitted by any of them), prior to and from time to time after the filing and effectiveness of the Registration Statement for the sole purpose of enabling the Investors and such representatives, advisors and underwriters and their respective accountants and attorneys to conduct initial and ongoing due diligence with respect to the Company and the accuracy of such Registration Statement.

 

The Company shall not disclose material nonpublic information to the Investors, or to advisors to or representatives of the Investors, unless prior to disclosure of such information the Company identifies such information as being material nonpublic information and provides the Investors, such advisors and representatives with the opportunity to accept or refuse to accept such material nonpublic information for review.

 

The right of any Investor to obtain information from the Company pursuant to this Section 4 shall be expressly conditioned upon such Investor entering into an appropriate confidentiality agreement with the Company with respect thereto.

 

5. Obligations of the Investors.

 

(a) Each Investor shall furnish in writing to the Company such information regarding itself, the Registrable Securities held by it and the intended method of disposition of the Registrable Securities held by it, as shall be reasonably required to effect the registration of such Registrable Securities and shall execute such documents in connection with such registration as the Company may reasonably request. At least five (5) Business Days prior to the first anticipated filing date of any Registration Statement, the Company shall notify each Investor of the information the Company requires from such Investor if such Investor elects to have any of the Registrable Securities included in the Registration Statement. An Investor shall provide such information to the Company at least two (2) Business Days prior to the first anticipated filing date of such Registration Statement if such Investor elects to have any of the Registrable Securities included in the Registration Statement.

 

(b) Each Investor, by its acceptance of the Registrable Securities agrees to cooperate with the Company as reasonably requested by the Company in connection with the preparation and filing of a Registration Statement hereunder, unless such Investor has notified the Company in writing of its election to exclude all of its Registrable Securities from such Registration Statement.

 

(c) Each Investor agrees that, upon receipt of any notice from the Company of either (i) the commencement of an Allowed Delay pursuant to Section 2(c)(ii) or (ii) the happening of an event pursuant to Section 3(h) hereof, such Investor will immediately discontinue disposition of Registrable Securities pursuant to the Registration Statement covering such Registrable Securities, until the Investor’s receipt of the copies of the supplemented or amended prospectus filed with the SEC and until any related post-effective amendment is declared effective and, if so directed by the Company, the Investor shall deliver to the Company (at the expense of the Company) or destroy (and deliver to the Company a certificate of destruction) all copies in the Investor’s possession of the Prospectus covering the Registrable Securities current at the time of receipt of such notice.

 

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6. Indemnification.

 

(a) Indemnification by the Company. The Company will indemnify and hold harmless each Investor and its officers, directors, members, employees and agents, successors and assigns, and each other person, if any, who controls such Investor within the meaning of the 1933 Act, against any losses, claims, damages or liabilities, joint or several, to which they may become subject under the 1933 Act or otherwise, insofar as such losses, claims, damages or liabilities (or actions in respect thereof) arise out of or are based upon: (i) any untrue statement or alleged untrue statement of any material fact contained in any Registration Statement, any preliminary prospectus or final prospectus contained therein, or any amendment or supplement thereof; (ii) any blue sky application or other document executed by the Company specifically for that purpose or based upon written information furnished by the Company filed in any state or other jurisdiction in order to qualify any or all of the Registrable Securities under the securities laws thereof (any such application, document or information herein called a Blue Sky Application); (iii) the omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading; (iv) any violation by the Company or its agents of any rule or regulation promulgated under the 1933 Act applicable to the Company or its agents and relating to action or inaction required of the Company in connection with such registration; or (v) any failure to register or qualify the Registrable Securities included in any such Registration in any state where the Company or its agents has affirmatively undertaken or agreed in writing that the Company will undertake such registration or qualification on an Investor’s behalf and will reimburse such Investor, and each such officer, director or member and each such controlling person for any legal or other expenses reasonably incurred by them in connection with investigating or defending any such loss, claim, damage, liability or action; provided, however, that the Company will not be liable in any such case if and to the extent that any such loss, claim, damage or liability arises out of or is based upon an untrue statement or alleged untrue statement or omission or alleged omission so made in conformity with information furnished by such Investor or any such controlling person in writing specifically for use in such Registration Statement or Prospectus. It is agreed that the indemnity agreement contained in this Section 6(a) shall not apply to amounts paid in settlement of any such losses, claim, damage, liability or action if such settlement is effected without the consent of the Company (which consent shall not be unreasonably withheld or delayed).

 

(b) Indemnification by the Investors. Each Investor agrees, severally but not jointly, to indemnify and hold harmless, to the fullest extent permitted by law, the Company, its directors, officers, employees, stockholders and each person who controls the Company (within the meaning of the 1933 Act) against any losses, claims, damages, liabilities and expense (including reasonable attorney fees) resulting from any untrue statement of a material fact or any omission of a material fact required to be stated in the Registration Statement or Prospectus or preliminary prospectus or amendment or supplement thereto or necessary to make the statements therein not misleading, to the extent, but only to the extent that such untrue statement or omission is contained in any information furnished in writing by such Investor to the Company specifically for inclusion in such Registration Statement or Prospectus or amendment or supplement thereto. In no event shall the liability of an Investor be greater in amount than the dollar amount of the proceeds (net of all expense paid by such Investor in connection with any claim relating to this Section 6 and the amount of any damages such Investor has otherwise been required to pay by reason of such untrue statement or omission)

 

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received by such Investor upon the sale of the Registrable Securities included in the Registration Statement giving rise to such indemnification obligation. It is agreed that the indemnity agreement contained in this Section 6(b) shall not apply to amounts paid in settlement of any such losses, claim, damage, liability or action if such settlement is effected without the consent of the affected Investor(s) (which consent shall not be unreasonably withheld or delayed).

 

(c) Conduct of Indemnification Proceedings. Any person entitled to indemnification hereunder shall (i) give prompt notice to the indemnifying party of any claim with respect to which it seeks indemnification and (ii) permit such indemnifying party to assume the defense of such claim with counsel reasonably satisfactory to the indemnified party; provided that any person entitled to indemnification hereunder shall have the right to employ separate counsel and to participate in the defense of such claim, but the fees and expenses of such counsel shall be at the expense of such person unless (a) the indemnifying party has agreed to pay such fees or expenses, or (b) the indemnifying party shall have failed to assume the defense of such claim and employ counsel reasonably satisfactory to such person or (c) in the reasonable judgment of any such person, based upon written advice of its counsel, a conflict of interest exists between such person and the indemnifying party with respect to such claims (in which case, if the person notifies the indemnifying party in writing that such person elects to employ separate counsel at the expense of the indemnifying party, the indemnifying party shall not have the right to assume the defense of such claim on behalf of such person); and provided, further, that the failure of any indemnified party to give notice as provided herein shall not relieve the indemnifying party of its obligations hereunder, except to the extent that such failure to give notice shall materially adversely affect the indemnifying party in the defense of any such claim or litigation. It is understood that the indemnifying party shall not, in connection with any proceeding in the same jurisdiction, be liable for fees or expenses of more than one separate firm of attorneys at any time for all such indemnified parties. No indemnifying party will, except with the consent of the indemnified party, consent to entry of any judgment or enter into any settlement that does not include as an unconditional term thereof the giving by the claimant or plaintiff to such indemnified party of a release from all liability in respect of such claim or litigation.

 

(d) Contribution. If for any reason the indemnification provided for in the preceding paragraphs (a) and (b) is unavailable to an indemnified party or insufficient to hold it harmless, other than as expressly specified therein, then the indemnifying party shall contribute to the amount paid or payable by the indemnified party as a result of such loss, claim, damage or liability in such proportion as is appropriate to reflect the relative fault of the indemnified party and the indemnifying party, as well as any other relevant equitable considerations. No person guilty of fraudulent misrepresentation within the meaning of Section 11(f) of the 1933 Act shall be entitled to contribution from any person not guilty of such fraudulent misrepresentation. In no event shall the contribution obligation of a holder of Registrable Securities be greater in amount than the dollar amount of the proceeds (net of all expenses paid by such holder in connection with any claim relating to this Section 6 and the amount of any damages such holder has otherwise been required to pay by reason of such untrue or alleged untrue statement or omission or alleged omission) received by it upon the sale of the Registrable Securities giving rise to such contribution obligation.

 

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7. Miscellaneous.

 

(a) Amendments and Waivers. This Agreement may be amended only by a writing signed by the Company and the Required Investors. The Company may take any action herein prohibited, or omit to perform any act herein required to be performed by it, only if the Company shall have obtained the written consent to such amendment, action or omission to act, of the Required Investors.

 

(b) Notices. All notices and other communications provided for or permitted hereunder shall be made as set forth in Section 9.4 of the Purchase Agreement.

 

(c) Assignments and Transfers by Investors. The provisions of this Agreement shall be binding upon and inure to the benefit of the Investors and their respective successors and assigns. An Investor may transfer or assign, in whole or from time to time in part, to one or more persons its rights hereunder in connection with the transfer of Registrable Securities by such Investor to such person, provided that such Investor complies with all laws applicable thereto and provides written notice of assignment to the Company promptly after such assignment is effected.

 

(d) Assignments and Transfers by the Company. This Agreement may not be assigned by the Company (whether by operation of law or otherwise) without the prior written consent of the Required Investors, provided, however, that the Company may assign its rights and delegate its duties hereunder to any surviving or successor corporation in connection with a merger or consolidation of the Company with another corporation, or a sale, transfer or other disposition of all or substantially all of the Company’s assets to another corporation, without the prior written consent of the Required Investors, after notice duly given by the Company to each Investor.

 

(e) Benefits of the Agreement. The terms and conditions of this Agreement shall inure to the benefit of and be binding upon the respective permitted successors and assigns of the parties. Nothing in this Agreement, express or implied, is intended to confer upon any party other than the parties hereto or their respective successors and assigns any rights, remedies, obligations, or liabilities under or by reason of this Agreement, except as expressly provided in this Agreement.

 

(f) Counterparts; Faxes. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. This Agreement may also be executed via facsimile, which shall be deemed an original.

 

(g) Titles and Subtitles. The titles and subtitles used in this Agreement are used for convenience only and are not to be considered in construing or interpreting this Agreement.

 

(h) Severability. Any provision of this Agreement that is prohibited or unenforceable in any jurisdiction shall, as to such jurisdiction, be ineffective to the extent of such prohibition or unenforceability without invalidating the remaining provisions hereof but shall be interpreted as if it were written so as to be enforceable to the maximum extent permitted

 

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by applicable law, and any such prohibition or unenforceability in any jurisdiction shall not invalidate or render unenforceable such provision in any other jurisdiction. To the extent permitted by applicable law, the parties hereby waive any provision of law which renders any provisions hereof prohibited or unenforceable in any respect.

 

(i) Further Assurances. The parties shall execute and deliver all such further instruments and documents and take all such other actions as may reasonably be required to carry out the transactions contemplated hereby and to evidence the fulfillment of the agreements herein contained.

 

(j) Entire Agreement. This Agreement is intended by the parties as a final expression of their agreement and intended to be a complete and exclusive statement of the agreement and understanding of the parties hereto in respect of the subject matter contained herein. This Agreement supersedes all prior agreements and understandings between the parties with respect to such subject matter.

 

(k) Governing Law; Consent to Jurisdiction; Waiver of Jury Trial. This Agreement shall be governed by, and construed in accordance with, the internal laws of the State of New York without regard to the choice of law principles thereof. Each of the parties hereto irrevocably submits to the exclusive jurisdiction of the courts of the State of New York located in New York County and the United States District Court for the Southern District of New York for the purpose of any suit, action, proceeding or judgment relating to or arising out of this Agreement and the transactions contemplated hereby. Service of process in connection with any such suit, action or proceeding may be served on each party hereto anywhere in the world by the same methods as are specified for the giving of notices under this Agreement. Each of the parties hereto irrevocably consents to the jurisdiction of any such court in any such suit, action or proceeding and to the laying of venue in such court. Each party hereto irrevocably waives any objection to the laying of venue of any such suit, action or proceeding brought in such courts and irrevocably waives any claim that any such suit, action or proceeding brought in any such court has been brought in an inconvenient forum. EACH OF THE PARTIES HERETO WAIVES ANY RIGHT TO REQUEST A TRIAL BY JURY IN ANY LITIGATION WITH RESPECT TO THIS AGREEMENT AND REPRESENTS THAT COUNSEL HAS BEEN CONSULTED SPECIFICALLY AS TO THIS WAIVER.

 

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IN WITNESS WHEREOF, the parties have executed this Agreement or caused their duly authorized officers to execute this Agreement as of the date first above written.

 

The Company:    ORION ACQUISITION CORP. II
     By:  

/s/ David T. Hung, M.D.


     Name:   David T. Hung, M.D.
     Title:   President and Chief Executive Officer

 

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The Investors:    SPECIAL SITUATIONS FUND III, L.P.
     By:  

/s/ Austin W. Marxe


     Name:   Austin W. Marxe
     Title:   General Partner
     SPECIAL SITUATIONS CAYMAN FUND, L.P.
     By:  

/s/ Austin W. Marxe


     Name:   Austin W. Marxe
     Title:   General Partner
     SPECIAL SITUATIONS PRIVATE EQUITY FUND, L.P.
     By:  

/s/ Austin W. Marxe


     Name:   Austin W. Marxe
     Title:   General Partner

 

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Exhibit A

 

Plan of Distribution

 

The selling stockholders, which as used herein includes donees, pledgees, transferees or other successors-in-interest selling shares of common stock or interests in shares of common stock received after the date of this prospectus from a selling stockholder as a gift, pledge, partnership distribution or other transfer, may, from time to time, sell, transfer or otherwise dispose of any or all of their shares of common stock or interests in shares of common stock on any stock exchange, market or trading facility on which the shares are traded or in private transactions. These dispositions may be at fixed prices, at prevailing market prices at the time of sale, at prices related to the prevailing market price, at varying prices determined at the time of sale, or at negotiated prices.

 

The selling stockholders may use any one or more of the following methods when disposing of shares or interests therein:

 

    ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;

 

    block trades in which the broker-dealer will attempt to sell the shares as agent, but may position and resell a portion of the block as principal to facilitate the transaction;

 

    purchases by a broker-dealer as principal and resale by the broker-dealer for its account;

 

    an exchange distribution in accordance with the rules of the applicable exchange;

 

    privately negotiated transactions;

 

    short sales effected after the date the registration statement of which this Prospectus is a part is declared effective by the SEC;

 

    through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise;

 

    broker-dealers may agree with the selling stockholders to sell a specified number of such shares at a stipulated price per share;

 

    a combination of any such methods of sale; and

 

    any other method permitted pursuant to applicable law.

 

The selling stockholders may, from time to time, pledge or grant a security interest in some or all of the shares of common stock owned by them and, if they default in the performance of their secured obligations, the pledgees or secured parties may offer and sell the shares of common stock, from time to time, under this prospectus, or under an amendment to this

 

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prospectus under Rule 424(b)(3) or other applicable provision of the Securities Act amending the list of selling stockholders to include the pledgee, transferee or other successors in interest as selling stockholders under this prospectus. The selling stockholders also may transfer the shares of common stock in other circumstances, in which case the transferees, pledgees or other successors in interest will be the selling beneficial owners for purposes of this prospectus.

 

In connection with the sale of our common stock or interests therein, the selling stockholders may enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales of the common stock in the course of hedging the positions they assume. The selling stockholders may also sell shares of our common stock short and deliver these securities to close out their short positions, or loan or pledge the common stock to broker-dealers that in turn may sell these securities. The selling stockholders may also enter into option or other transactions with broker-dealers or other financial institutions or the creation of one or more derivative securities which require the delivery to such broker-dealer or other financial institution of shares offered by this prospectus, which shares such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).

 

The aggregate proceeds to the selling stockholders from the sale of the common stock offered by them will be the purchase price of the common stock less discounts or commissions, if any. Each of the selling stockholders reserves the right to accept and, together with their agents from time to time, to reject, in whole or in part, any proposed purchase of common stock to be made directly or through agents. We will not receive any of the proceeds from this offering. Upon any exercise of the warrants by payment of cash, however, we will receive the exercise price of the warrants.

 

The selling stockholders also may resell all or a portion of the shares in open market transactions in reliance upon Rule 144 under the Securities Act of 1933, provided that they meet the criteria and conform to the requirements of that rule.

 

The selling stockholders and any underwriters, broker-dealers or agents that participate in the sale of the common stock or interests therein may be “underwriters” within the meaning of Section 2(11) of the Securities Act. Any discounts, commissions, concessions or profit they earn on any resale of the shares may be underwriting discounts and commissions under the Securities Act. Selling stockholders who are “underwriters” within the meaning of Section 2(11) of the Securities Act will be subject to the prospectus delivery requirements of the Securities Act.

 

To the extent required, the shares of our common stock to be sold, the names of the selling stockholders, the respective purchase prices and public offering prices, the names of any agents, dealer or underwriter, any applicable commissions or discounts with respect to a particular offer will be set forth in an accompanying prospectus supplement or, if appropriate, a post-effective amendment to the registration statement that includes this prospectus.

 

In order to comply with the securities laws of some states, if applicable, the common stock may be sold in these jurisdictions only through registered or licensed brokers or dealers. In addition, in some states the common stock may not be sold unless it has been registered or qualified for sale or an exemption from registration or qualification requirements is available and is complied with.

 

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We have advised the selling stockholders that the anti-manipulation rules of Regulation M under the Exchange Act may apply to sales of shares in the market and to the activities of the selling stockholders and their affiliates. In addition, we will make copies of this prospectus (as it may be supplemented or amended from time to time) available to the selling stockholders for the purpose of satisfying the prospectus delivery requirements of the Securities Act. The selling stockholders may indemnify any broker-dealer that participates in transactions involving the sale of the shares against certain liabilities, including liabilities arising under the Securities Act.

 

We have agreed to indemnify the selling stockholders against liabilities, including liabilities under the Securities Act and state securities laws, relating to the registration of the shares offered by this prospectus.

 

We have agreed with the selling stockholders to keep the registration statement of which this prospectus constitutes a part effective until the earlier of (1) such time as all of the shares covered by this prospectus have been disposed of pursuant to and in accordance with the registration statement or (2) the date on which the shares may be sold pursuant to Rule 144(k) of the Securities Act.

 

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EX-10.3(B) 15 dex103b.htm REGISTRATION RIGHTS AGMT BY AND AMONG ORION ACQUISITION CORP. II AND INVESTORS Registration Rights Agmt by and among Orion Acquisition Corp. II and investors

EXHIBIT 10.3(b)

 

REGISTRATION RIGHTS AGREEMENT

 

This Registration Rights Agreement (the “Agreement”) is made and entered into as of this 17th day of December, 2004 by and among Orion Acquisition Corp. II, a Delaware corporation (the “Company”), and the “Investors” listed in that certain Purchase Agreement by and among the Company and the Investors (the “Purchase Agreement”).

 

The parties hereby agree as follows:

 

1. Certain Definitions.

 

As used in this Agreement, the following terms shall have the following meanings:

 

Affiliate” means, with respect to any person, any other person which directly or indirectly controls, is controlled by, or is under common control with, such person.

 

Business Day” means a day, other than a Saturday or Sunday, on which banks in New York City are open for the general transaction of business.

 

Common Stock” shall mean the Company’s common stock, par value $0.01 per share, and any securities into which such shares may hereinafter be reclassified.

 

Investors” shall mean the Investors identified in the Purchase Agreement and any Affiliate or permitted transferee of any Investor who is a subsequent holder of any Registrable Securities.

 

Prospectus” shall mean the prospectus included in any Registration Statement, as amended or supplemented by any prospectus supplement, with respect to the terms of the offering of any portion of the Registrable Securities covered by such Registration Statement and by all other amendments and supplements to the prospectus, including post-effective amendments and all material incorporated by reference in such prospectus.

 

Register,” “registered” and “registration” refer to a registration made by preparing and filing a Registration Statement or similar document in compliance with the 1933 Act (as defined below), and the declaration or ordering of effectiveness of such Registration Statement or document.

 

Registrable Securities” shall mean the Shares and any other securities issued or issuable with respect to or in exchange for Registrable Securities; provided, that, a security shall cease to be a Registrable Security upon (A) sale pursuant to a Registration Statement or Rule 144 under the 1933 Act, or (B) such security becoming eligible for sale by the Investors pursuant to Rule 144(k).

 

Registration Statement” shall mean any registration statement of the Company filed under the 1933 Act that covers the resale of any of the Registrable Securities pursuant to the provisions of this Agreement, amendments and supplements to such Registration Statement, including post-effective amendments, all exhibits and all material incorporated by reference in such Registration Statement.

 

Required Investors” means the Investors holding a majority of the Registrable Securities.


SEC” means the U.S. Securities and Exchange Commission.

 

Shares” means the shares of Common Stock issued pursuant to the Purchase Agreement.

 

1933 Act” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.

 

1934 Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.

 

2. Registration.

 

(a) Registration Statements.

 

(i) Promptly following the closing of the purchase and sale of the securities contemplated by the Purchase Agreement (the “Closing Date”) but no later than forty-five (45) days after the Closing Date (the “Filing Deadline”), the Company shall prepare and file with the SEC one Registration Statement on Form SB-2 (or, if Form SB-2 is not then available to the Company, on such form of registration statement as is then available to effect a registration for resale of the Registrable Securities, subject to the Required Investors’ consent), covering the resale of the Registrable Securities. Such Registration Statement shall include the plan of distribution attached hereto as Exhibit A. Such Registration Statement also shall cover, to the extent allowable under the 1933 Act and the rules promulgated thereunder (including Rule 416), such indeterminate number of additional shares of Common Stock resulting from stock splits, stock dividends or similar transactions with respect to the Registrable Securities. The Company shall use its reasonable best efforts to obtain from each person who now has piggyback registration rights a waiver of those rights with respect to the Registration Statement. The Registration Statement (and each amendment or supplement thereto, and each request for acceleration of effectiveness thereof) shall be provided in accordance with Section 3(c) to the Investors and their counsel prior to its filing or other submission. If a Registration Statement covering the Registrable Securities is not filed with the SEC on or prior to the Filing Deadline, the Company will make pro rata payments to each Investor, as liquidated damages and not as a penalty, in an amount equal to 1.5% of the aggregate amount invested by such Investor for each 30-day period or pro rata for any portion thereof following the date by which such Registration Statement should have been filed for which no Registration Statement is filed with respect to the Registrable Securities. Such payments shall constitute the Investors’ sole monetary remedy for such events but shall not limit the Investors’ right to seek specific performance of the provisions hereof. Such payments shall be made to each Investor in cash.

 

(ii) Promptly following the date (the “Qualification Date”) upon which the Company becomes eligible to use a registration statement on Form S-3 to register the Registrable Securities or Additional Shares, as applicable, for resale, but in no event more than ten (10) Business Days after the Qualification Date (the “Qualification Deadline”), the Company shall file a registration statement on Form S-3 covering the Registrable Securities (or a post-effective amendment on Form S-3 to the registration statement on Form SB-2) (a “Shelf Registration Statement”) and shall use commercially reasonable efforts to cause such Shelf Registration Statement to be declared effective as promptly as practicable thereafter. If a Shelf Registration Statement covering the Registrable Securities is not filed with the SEC on or prior to the Qualification Deadline, the Company will make pro rata payments to each Investor, so

 

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long as such Investors’ Shares have not been sold pursuant to a Registration Statement prior to such date, as liquidated damages and not as a penalty, in an amount equal to 1.5% of the aggregate amount invested by such Investor for each 30-day period or pro rata for any portion thereof following the date by which such Shelf Registration Statement should have been filed for which no such Shelf Registration Statement is filed with respect to the Registrable Securities. Such payments shall constitute the Investors’ sole monetary remedy for such events but shall not limit the Investors’ right to seek specific performance of the provisions hereof. Such payments shall be made to each Investor in cash. In the event that all of any particular Investor’s Shares have been sold pursuant to a Registration Statement, the liquidated damages provision in this Section 2(a)(ii) shall be of no further force or effect with respect to such Investor; provided, however, that no such sale shall affect the right of the Investors to receive liquidated damages accruing prior to such sale.

 

(b) Expenses. The Company will pay all expenses associated with each registration, including filing and printing fees, the Company’s counsel and accounting fees and expenses, costs associated with clearing the Registrable Securities for sale under applicable state securities laws, listing fees, fees and expenses of one counsel to the Investors not to exceed an aggregate of $35,000 and the Investors’ reasonable expenses in connection with the registration, but excluding stock transfer taxes, discounts, commissions, fees of underwriters, selling brokers, dealer managers or similar securities industry professionals with respect to the Registrable Securities being sold.

 

(c) Effectiveness.

 

(i) The Company shall use commercially reasonable efforts to have the Registration Statement declared effective as soon as practicable. The Company shall notify the Investors by facsimile or e-mail as promptly as practicable, and in any event, within twenty-four (24) hours, after any Registration Statement is declared effective and shall promptly (but in any event within two Business Days of such effective date) provide the Investors with copies of any related Prospectus to be used in connection with the sale or other disposition of the securities covered thereby. If (A)(x) a Registration Statement covering the Registrable Securities is not declared effective by the SEC prior to the earlier of (1) 105 days after the Closing Date or (2) March 31, 2005 or (y) a Shelf Registration Statement is not declared effective by the SEC within 90 days after the Qualification Deadline or (B) after a Registration Statement has been declared effective by the SEC, sales cannot be made pursuant to such Registration Statement for a period in excess of the Allowed Delay (as defined below), then the Company will make pro rata payments to each Investor, so long as all of such Investor’s Shares have not been sold pursuant to a Registration Statement prior to such date, as liquidated damages and not as a penalty, in an amount equal to 1.5% of the aggregate amount invested by such Investor for each 30-day period or pro rata for any portion thereof following the date by which such Registration Statement should have been effective (the “Blackout Period”). Such payments shall constitute the Investors’ sole monetary remedy for such events but shall not limit the Investors’ right to seek specific performance of the provisions hereof. The amounts payable as liquidated damages pursuant to this paragraph shall be paid monthly within three (3) Business Days of the last day of each month following the commencement of the Blackout Period until the termination of the Blackout Period. Such payments shall be made to each Investor in cash. In the event that all of any particular Investor’s Shares have been sold pursuant to a Registration Statement, the

 

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liquidated damages provision in this Section 2(c) shall be of no further force or effect with respect to such Investor; provided, however, that no such sale shall affect the right of the Investors to receive liquidated damages accruing prior to such sale.

 

(ii) In the event (A) of any request by the SEC or any other federal or state governmental authority during the period of effectiveness of the Registration Statement for amendments or supplements to a Registration Statement or related Prospectus or for additional information; (B) of the issuance by the SEC or any other federal or state governmental authority of any stop order suspending the effectiveness of a Registration Statement or the initiation of any proceedings for that purpose; (C) of the receipt by the Company of any notification with respect to the suspension of the qualification or exemption from qualification of any of the Shares for sale in any jurisdiction or the initiation or threatening of any proceeding for such purpose; or (D) of any event or circumstance which necessitates the making of any changes in the Registration Statement or Prospectus, or any document incorporated therein by reference, so that, in the case of the Registration Statement, it will not contain any untrue statement of a material fact or any omission to state a material fact required to be stated therein or necessary to make the statements therein not misleading, and that in the case of the Prospectus, it will not contain any untrue statement of a material fact or any omission to state a material fact required to be stated therein or necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading; then for not more than twenty (20) consecutive days or for a total of not more than forty-five (45) days in any twelve (12) month period, the Company may delay the disclosure of material non-public information concerning the Company, by suspending the use of any Prospectus included in any registration contemplated by this Section containing such information, the disclosure of which at the time is not, in the good faith opinion of the Company, in the best interests of the Company (an “Allowed Delay”); provided, that the Company shall promptly (a) notify the Investors in writing of the existence of (but in no event, without the prior written consent of an Investor, shall the Company disclose to such Investor any of the facts or circumstances regarding) any material non-public information giving rise to an Allowed Delay, (b) advise the Investors in writing to cease all sales under the Registration Statement until the end of the Allowed Delay and (c) use commercially reasonable efforts to terminate an Allowed Delay as promptly as practicable.

 

3. Company Obligations. The Company will use commercially reasonable efforts to effect the registration of the Registrable Securities in accordance with the terms hereof, and pursuant thereto the Company will, as expeditiously as possible:

 

(a) use commercially reasonable efforts to cause such Registration Statement to become effective and to remain continuously effective for a period that will terminate upon the earlier of (i) the date on which all Registrable Securities covered by such Registration Statement as amended from time to time, have been sold, and (ii) the date on which all Registrable Securities covered by such Registration Statement may be sold pursuant to Rule 144(k) (the “Effectiveness Period”) and advise the Investors in writing when the Effectiveness Period has expired;

 

(b) prepare and file with the SEC such amendments and post-effective amendments to the Registration Statement and the Prospectus as may be necessary to keep the Registration Statement effective for the period specified in Section 3(a) and to comply with the provisions of the 1933 Act and the 1934 Act with respect to the distribution of all of the Registrable Securities covered thereby;

 

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(c) provide copies to and permit counsel designated by the Investors to review each Registration Statement and all amendments and supplements thereto no fewer than three (3) Business Days prior to their filing with the SEC and not file any document to which such counsel reasonably objects provide, that such objection is based on counsel’s belief that the Registration Statement or such amendment or supplement contains a material misstatement or omission;

 

(d) furnish to the Investors and their legal counsel (i) promptly after the same is prepared and publicly distributed, filed with the SEC, or received by the Company (but not later than two (2) Business Days after the filing date, receipt date or sending date, as the case may be) one (1) copy of any Registration Statement and any amendment thereto, each preliminary prospectus and Prospectus and each amendment or supplement thereto, and each letter written by or on behalf of the Company to the SEC or the staff of the SEC, and each item of correspondence from the SEC or the staff of the SEC, in each case relating to such Registration Statement (other than any portion of any thereof which contains information for which the Company has sought confidential treatment), and (ii) such number of copies of a Prospectus, including a preliminary prospectus, and all amendments and supplements thereto and such other documents as each Investor may reasonably request in order to facilitate the disposition of the Registrable Securities owned by such Investor that are covered by the related Registration Statement;

 

(e) use commercially reasonable efforts to (i) prevent the issuance of any stop order or other suspension of effectiveness and, (ii) if such order is issued, obtain the withdrawal of any such order at the earliest possible moment;

 

(f) prior to any public offering of Registrable Securities, use commercially reasonable efforts to register or qualify or cooperate with the Investors and their counsel in connection with the registration or qualification of such Registrable Securities for offer and sale under the securities or blue sky laws of California, Connecticut, Massachusetts, New Jersey, New York, Pennsylvania and Texas and do any and all other commercially reasonable acts or things necessary or advisable to enable the distribution in such jurisdictions of the Registrable Securities covered by the Registration Statement; provided, however, that the Company shall not be required in connection therewith or as a condition thereto to (i) qualify to do business in any jurisdiction where it would not otherwise be required to qualify but for this Section 3(f), (ii) subject itself to general taxation in any jurisdiction where it would not otherwise be so subject but for this Section 3(f), or (iii) file a general consent to service of process in any such jurisdiction;

 

(g) use commercially reasonable efforts to cause all Registrable Securities covered by a Registration Statement to be listed on each securities exchange, interdealer quotation system or other market on which similar securities issued by the Company are then listed;

 

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(h) immediately notify the Investors, at any time when a Prospectus relating to Registrable Securities is required to be delivered under the 1933 Act, upon discovery that, or upon the happening of any event as a result of which, the Prospectus included in a Registration Statement, as then in effect, includes an untrue statement of a material fact or omits to state any material fact required to be stated therein or necessary to make the statements therein not misleading in light of the circumstances then existing, and at the request of any such holder, promptly prepare and furnish to such holder a reasonable number of copies of a supplement to or an amendment of such Prospectus as may be necessary so that, as thereafter delivered to the purchasers of such Registrable Securities, such Prospectus shall not include an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading in light of the circumstances then existing; and

 

(i) otherwise use commercially reasonable efforts to comply with all applicable rules and regulations of the SEC under the 1933 Act and the 1934 Act, take such other actions as may be reasonably necessary to facilitate the registration of the Registrable Securities hereunder; and make available to its security holders, as soon as reasonably practicable, but not later than the Availability Date (as defined below), an earnings statement covering a period of at least twelve (12) months, beginning after the effective date of each Registration Statement, which earnings statement shall satisfy the provisions of Section 11(a) of the 1933 Act, including Rule 158 promulgated thereunder (for the purpose of this subsection 3(i), “Availability Date” means the 45th day following the end of the fourth fiscal quarter that includes the effective date of such Registration Statement, except that, if such fourth fiscal quarter is the last quarter of the Company’s fiscal year, “Availability Date” means the 90th day after the end of such fourth fiscal quarter).

 

(j) With a view to making available to the Investors the benefits of Rule 144 (or its successor rule) and any other rule or regulation of the SEC that may at any time permit the Investors to sell shares of Common Stock to the public without registration, the Company covenants and agrees to: (i) make and keep public information available, as those terms are understood and defined in Rule 144, until the earlier of (A) six months after such date as all of the Registrable Securities may be resold pursuant to Rule 144(k) or any other rule of similar effect or (B) such date as all of the Registrable Securities shall have been resold; (ii) file with the SEC in a timely manner all reports and other documents required of the Company under the 1934 Act; and (iii) furnish to each Investor upon request, as long as such Investor owns any Registrable Securities, (A) a written statement by the Company that it has complied with the reporting requirements of the 1934 Act, (B) a copy of the Company’s most recent Annual Report on Form 10-KSB or Quarterly Report on Form 10-QSB and (C) such other information as may be reasonably requested in order to avail such Investor of any rule or regulation of the SEC that permits the selling of any such Registrable Securities without registration.

 

4. Due Diligence Review; Information. The Company shall make available, during normal business hours, for inspection and review by the Investors, advisors to and representatives of the Investors (who may or may not be affiliated with the Investors and who are reasonably acceptable to the Company), all financial and other records, all SEC Filings (as defined in the Purchase Agreement) and other filings with the SEC, and all other corporate documents and properties of the Company as may be reasonably necessary for the purpose of such review, and cause the Company’s officers and directors, within a reasonable time period, to

 

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supply all such information reasonably requested by the Investors or any such representative, advisor or underwriter in connection with such Registration Statement (including, without limitation, in response to all questions and other inquiries reasonably made or submitted by any of them), prior to and from time to time after the filing and effectiveness of the Registration Statement for the sole purpose of enabling the Investors and such representatives, advisors and underwriters and their respective accountants and attorneys to conduct initial and ongoing due diligence with respect to the Company and the accuracy of such Registration Statement.

 

The Company shall not disclose material nonpublic information to the Investors, or to advisors to or representatives of the Investors, unless prior to disclosure of such information the Company identifies such information as being material nonpublic information and provides the Investors, such advisors and representatives with the opportunity to accept or refuse to accept such material nonpublic information for review.

 

The right of any Investor to obtain information from the Company pursuant to this Section 4 shall be expressly conditioned upon such Investor entering into an appropriate confidentiality agreement with the Company with respect thereto.

 

5. Obligations of the Investors.

 

(a) Each Investor shall furnish in writing to the Company such information regarding itself, the Registrable Securities held by it and the intended method of disposition of the Registrable Securities held by it, as shall be reasonably required to effect the registration of such Registrable Securities and shall execute such documents in connection with such registration as the Company may reasonably request. At least five (5) Business Days prior to the first anticipated filing date of any Registration Statement, the Company shall notify each Investor of the information the Company requires from such Investor if such Investor elects to have any of the Registrable Securities included in the Registration Statement. An Investor shall provide such information to the Company at least two (2) Business Days prior to the first anticipated filing date of such Registration Statement if such Investor elects to have any of the Registrable Securities included in the Registration Statement.

 

(b) Each Investor, by its acceptance of the Registrable Securities agrees to cooperate with the Company as reasonably requested by the Company in connection with the preparation and filing of a Registration Statement hereunder, unless such Investor has notified the Company in writing of its election to exclude all of its Registrable Securities from such Registration Statement.

 

(c) Each Investor agrees that, upon receipt of any notice from the Company of either (i) the commencement of an Allowed Delay pursuant to Section 2(c)(ii) or (ii) the happening of an event pursuant to Section 3(h) hereof, such Investor will immediately discontinue disposition of Registrable Securities pursuant to the Registration Statement covering such Registrable Securities, until the Investor’s receipt of the copies of the supplemented or amended prospectus filed with the SEC and until any related post-effective amendment is declared effective and, if so directed by the Company, the Investor shall deliver to the Company (at the expense of the Company) or destroy (and deliver to the Company a certificate of destruction) all copies in the Investor’s possession of the Prospectus covering the Registrable Securities current at the time of receipt of such notice.

 

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6. Indemnification.

 

(a) Indemnification by the Company. The Company will indemnify and hold harmless each Investor and its officers, directors, members, employees and agents, successors and assigns, and each other person, if any, who controls such Investor within the meaning of the 1933 Act, against any losses, claims, damages or liabilities, joint or several, to which they may become subject under the 1933 Act or otherwise, insofar as such losses, claims, damages or liabilities (or actions in respect thereof) arise out of or are based upon: (i) any untrue statement or alleged untrue statement of any material fact contained in any Registration Statement, any preliminary prospectus or final prospectus contained therein, or any amendment or supplement thereof; (ii) any blue sky application or other document executed by the Company specifically for that purpose or based upon written information furnished by the Company filed in any state or other jurisdiction in order to qualify any or all of the Registrable Securities under the securities laws thereof (any such application, document or information herein called a Blue Sky Application); (iii) the omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading; (iv) any violation by the Company or its agents of any rule or regulation promulgated under the 1933 Act applicable to the Company or its agents and relating to action or inaction required of the Company in connection with such registration; or (v) any failure to register or qualify the Registrable Securities included in any such Registration in any state where the Company or its agents has affirmatively undertaken or agreed in writing that the Company will undertake such registration or qualification on an Investor’s behalf and will reimburse such Investor, and each such officer, director or member and each such controlling person for any legal or other expenses reasonably incurred by them in connection with investigating or defending any such loss, claim, damage, liability or action; provided, however, that the Company will not be liable in any such case if and to the extent that any such loss, claim, damage or liability arises out of or is based upon an untrue statement or alleged untrue statement or omission or alleged omission so made in conformity with information furnished by such Investor or any such controlling person in writing specifically for use in such Registration Statement or Prospectus. It is agreed that the indemnity agreement contained in this Section 6(a) shall not apply to amounts paid in settlement of any such losses, claim, damage, liability or action if such settlement is effected without the consent of the Company (which consent shall not be unreasonably withheld or delayed).

 

(b) Indemnification by the Investors. Each Investor agrees, severally but not jointly, to indemnify and hold harmless, to the fullest extent permitted by law, the Company, its directors, officers, employees, stockholders and each person who controls the Company (within the meaning of the 1933 Act) against any losses, claims, damages, liabilities and expense (including reasonable attorney fees) resulting from any untrue statement of a material fact or any omission of a material fact required to be stated in the Registration Statement or Prospectus or preliminary prospectus or amendment or supplement thereto or necessary to make the statements therein not misleading, to the extent, but only to the extent that such untrue statement or omission is contained in any information furnished in writing by such Investor to the Company specifically for inclusion in such Registration Statement or Prospectus or amendment or supplement thereto. In no event shall the liability of an Investor be greater in amount than the dollar amount of the proceeds (net of all expense paid by such Investor in connection with any claim relating to this Section 6 and the amount of any damages such Investor has otherwise been required to pay by reason of such untrue statement or omission)

 

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received by such Investor upon the sale of the Registrable Securities included in the Registration Statement giving rise to such indemnification obligation. It is agreed that the indemnity agreement contained in this Section 6(b) shall not apply to amounts paid in settlement of any such losses, claim, damage, liability or action if such settlement is effected without the consent of the affected Investor(s) (which consent shall not be unreasonably withheld or delayed).

 

(c) Conduct of Indemnification Proceedings. Any person entitled to indemnification hereunder shall (i) give prompt notice to the indemnifying party of any claim with respect to which it seeks indemnification and (ii) permit such indemnifying party to assume the defense of such claim with counsel reasonably satisfactory to the indemnified party; provided that any person entitled to indemnification hereunder shall have the right to employ separate counsel and to participate in the defense of such claim, but the fees and expenses of such counsel shall be at the expense of such person unless (a) the indemnifying party has agreed to pay such fees or expenses, or (b) the indemnifying party shall have failed to assume the defense of such claim and employ counsel reasonably satisfactory to such person or (c) in the reasonable judgment of any such person, based upon written advice of its counsel, a conflict of interest exists between such person and the indemnifying party with respect to such claims (in which case, if the person notifies the indemnifying party in writing that such person elects to employ separate counsel at the expense of the indemnifying party, the indemnifying party shall not have the right to assume the defense of such claim on behalf of such person); and provided, further, that the failure of any indemnified party to give notice as provided herein shall not relieve the indemnifying party of its obligations hereunder, except to the extent that such failure to give notice shall materially adversely affect the indemnifying party in the defense of any such claim or litigation. It is understood that the indemnifying party shall not, in connection with any proceeding in the same jurisdiction, be liable for fees or expenses of more than one separate firm of attorneys at any time for all such indemnified parties. No indemnifying party will, except with the consent of the indemnified party, consent to entry of any judgment or enter into any settlement that does not include as an unconditional term thereof the giving by the claimant or plaintiff to such indemnified party of a release from all liability in respect of such claim or litigation.

 

(d) Contribution. If for any reason the indemnification provided for in the preceding paragraphs (a) and (b) is unavailable to an indemnified party or insufficient to hold it harmless, other than as expressly specified therein, then the indemnifying party shall contribute to the amount paid or payable by the indemnified party as a result of such loss, claim, damage or liability in such proportion as is appropriate to reflect the relative fault of the indemnified party and the indemnifying party, as well as any other relevant equitable considerations. No person guilty of fraudulent misrepresentation within the meaning of Section 11(f) of the 1933 Act shall be entitled to contribution from any person not guilty of such fraudulent misrepresentation. In no event shall the contribution obligation of a holder of Registrable Securities be greater in amount than the dollar amount of the proceeds (net of all expenses paid by such holder in connection with any claim relating to this Section 6 and the amount of any damages such holder has otherwise been required to pay by reason of such untrue or alleged untrue statement or omission or alleged omission) received by it upon the sale of the Registrable Securities giving rise to such contribution obligation.

 

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7. Miscellaneous.

 

(a) Amendments and Waivers. This Agreement may be amended only by a writing signed by the Company and the Required Investors. The Company may take any action herein prohibited, or omit to perform any act herein required to be performed by it, only if the Company shall have obtained the written consent to such amendment, action or omission to act, of the Required Investors.

 

(b) Notices. All notices and other communications provided for or permitted hereunder shall be made as set forth in Section 9.4 of the Purchase Agreement.

 

(c) Assignments and Transfers by Investors. The provisions of this Agreement shall be binding upon and inure to the benefit of the Investors and their respective successors and assigns. An Investor may transfer or assign, in whole or from time to time in part, to one or more persons its rights hereunder in connection with the transfer of Registrable Securities by such Investor to such person, provided that such Investor complies with all laws applicable thereto and provides written notice of assignment to the Company promptly after such assignment is effected.

 

(d) Assignments and Transfers by the Company. This Agreement may not be assigned by the Company (whether by operation of law or otherwise) without the prior written consent of the Required Investors, provided, however, that the Company may assign its rights and delegate its duties hereunder to any surviving or successor corporation in connection with a merger or consolidation of the Company with another corporation, or a sale, transfer or other disposition of all or substantially all of the Company’s assets to another corporation, without the prior written consent of the Required Investors, after notice duly given by the Company to each Investor.

 

(e) Benefits of the Agreement. The terms and conditions of this Agreement shall inure to the benefit of and be binding upon the respective permitted successors and assigns of the parties. Nothing in this Agreement, express or implied, is intended to confer upon any party other than the parties hereto or their respective successors and assigns any rights, remedies, obligations, or liabilities under or by reason of this Agreement, except as expressly provided in this Agreement.

 

(f) Counterparts; Faxes. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. This Agreement may also be executed via facsimile, which shall be deemed an original.

 

(g) Titles and Subtitles. The titles and subtitles used in this Agreement are used for convenience only and are not to be considered in construing or interpreting this Agreement.

 

(h) Severability. Any provision of this Agreement that is prohibited or unenforceable in any jurisdiction shall, as to such jurisdiction, be ineffective to the extent of such prohibition or unenforceability without invalidating the remaining provisions hereof but shall be interpreted as if it were written so as to be enforceable to the maximum extent permitted

 

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by applicable law, and any such prohibition or unenforceability in any jurisdiction shall not invalidate or render unenforceable such provision in any other jurisdiction. To the extent permitted by applicable law, the parties hereby waive any provision of law which renders any provisions hereof prohibited or unenforceable in any respect.

 

(i) Further Assurances. The parties shall execute and deliver all such further instruments and documents and take all such other actions as may reasonably be required to carry out the transactions contemplated hereby and to evidence the fulfillment of the agreements herein contained.

 

(j) Entire Agreement. This Agreement is intended by the parties as a final expression of their agreement and intended to be a complete and exclusive statement of the agreement and understanding of the parties hereto in respect of the subject matter contained herein. This Agreement supersedes all prior agreements and understandings between the parties with respect to such subject matter.

 

(k) Governing Law; Consent to Jurisdiction; Waiver of Jury Trial. This Agreement shall be governed by, and construed in accordance with, the internal laws of the State of New York without regard to the choice of law principles thereof. Each of the parties hereto irrevocably submits to the exclusive jurisdiction of the courts of the State of New York located in New York County and the United States District Court for the Southern District of New York for the purpose of any suit, action, proceeding or judgment relating to or arising out of this Agreement and the transactions contemplated hereby. Service of process in connection with any such suit, action or proceeding may be served on each party hereto anywhere in the world by the same methods as are specified for the giving of notices under this Agreement. Each of the parties hereto irrevocably consents to the jurisdiction of any such court in any such suit, action or proceeding and to the laying of venue in such court. Each party hereto irrevocably waives any objection to the laying of venue of any such suit, action or proceeding brought in such courts and irrevocably waives any claim that any such suit, action or proceeding brought in any such court has been brought in an inconvenient forum. EACH OF THE PARTIES HERETO WAIVES ANY RIGHT TO REQUEST A TRIAL BY JURY IN ANY LITIGATION WITH RESPECT TO THIS AGREEMENT AND REPRESENTS THAT COUNSEL HAS BEEN CONSULTED SPECIFICALLY AS TO THIS WAIVER.

 

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IN WITNESS WHEREOF, the parties have executed this Agreement or caused their duly authorized officers to execute this Agreement as of the date first above written.

 

The Company:         ORION ACQUISITION CORP. II
          By:  

/s/ David T. Hung, M.D.


          Name:   David T. Hung, M.D.
          Title:   President and Chief Executive Officer

 

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The Investors:         By:  

/s/ Investors


              Signature
          Name:  

 


              Print Name
          Title:  

 


              If Investor is an Entity, Print Title
          For:  

 


              If Investor is an Entity, Print Name of Entity

 

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Exhibit A

 

Plan of Distribution

 

The selling stockholders, which as used herein includes donees, pledgees, transferees or other successors-in-interest selling shares of common stock or interests in shares of common stock received after the date of this prospectus from a selling stockholder as a gift, pledge, partnership distribution or other transfer, may, from time to time, sell, transfer or otherwise dispose of any or all of their shares of common stock or interests in shares of common stock on any stock exchange, market or trading facility on which the shares are traded or in private transactions. These dispositions may be at fixed prices, at prevailing market prices at the time of sale, at prices related to the prevailing market price, at varying prices determined at the time of sale, or at negotiated prices.

 

The selling stockholders may use any one or more of the following methods when disposing of shares or interests therein:

 

    ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;

 

    block trades in which the broker-dealer will attempt to sell the shares as agent, but may position and resell a portion of the block as principal to facilitate the transaction;

 

    purchases by a broker-dealer as principal and resale by the broker-dealer for its account;

 

    an exchange distribution in accordance with the rules of the applicable exchange;

 

    privately negotiated transactions;

 

    short sales effected after the date the registration statement of which this Prospectus is a part is declared effective by the SEC;

 

    through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise;

 

    broker-dealers may agree with the selling stockholders to sell a specified number of such shares at a stipulated price per share;

 

    a combination of any such methods of sale; and

 

    any other method permitted pursuant to applicable law.

 

The selling stockholders may, from time to time, pledge or grant a security interest in some or all of the shares of common stock owned by them and, if they default in the performance of their secured obligations, the pledgees or secured parties may offer and sell the shares of common stock, from time to time, under this prospectus, or under an amendment to this


prospectus under Rule 424(b)(3) or other applicable provision of the Securities Act amending the list of selling stockholders to include the pledgee, transferee or other successors in interest as selling stockholders under this prospectus. The selling stockholders also may transfer the shares of common stock in other circumstances, in which case the transferees, pledgees or other successors in interest will be the selling beneficial owners for purposes of this prospectus.

 

In connection with the sale of our common stock or interests therein, the selling stockholders may enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales of the common stock in the course of hedging the positions they assume. The selling stockholders may also sell shares of our common stock short and deliver these securities to close out their short positions, or loan or pledge the common stock to broker-dealers that in turn may sell these securities. The selling stockholders may also enter into option or other transactions with broker-dealers or other financial institutions or the creation of one or more derivative securities which require the delivery to such broker-dealer or other financial institution of shares offered by this prospectus, which shares such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).

 

The aggregate proceeds to the selling stockholders from the sale of the common stock offered by them will be the purchase price of the common stock less discounts or commissions, if any. Each of the selling stockholders reserves the right to accept and, together with their agents from time to time, to reject, in whole or in part, any proposed purchase of common stock to be made directly or through agents. We will not receive any of the proceeds from this offering. Upon any exercise of the warrants by payment of cash, however, we will receive the exercise price of the warrants.

 

The selling stockholders also may resell all or a portion of the shares in open market transactions in reliance upon Rule 144 under the Securities Act of 1933, provided that they meet the criteria and conform to the requirements of that rule.

 

The selling stockholders and any underwriters, broker-dealers or agents that participate in the sale of the common stock or interests therein may be “underwriters” within the meaning of Section 2(11) of the Securities Act. Any discounts, commissions, concessions or profit they earn on any resale of the shares may be underwriting discounts and commissions under the Securities Act. Selling stockholders who are “underwriters” within the meaning of Section 2(11) of the Securities Act will be subject to the prospectus delivery requirements of the Securities Act.

 

To the extent required, the shares of our common stock to be sold, the names of the selling stockholders, the respective purchase prices and public offering prices, the names of any agents, dealer or underwriter, any applicable commissions or discounts with respect to a particular offer will be set forth in an accompanying prospectus supplement or, if appropriate, a post-effective amendment to the registration statement that includes this prospectus.

 

In order to comply with the securities laws of some states, if applicable, the common stock may be sold in these jurisdictions only through registered or licensed brokers or dealers. In addition, in some states the common stock may not be sold unless it has been registered or qualified for sale or an exemption from registration or qualification requirements is available and is complied with.

 

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We have advised the selling stockholders that the anti-manipulation rules of Regulation M under the Exchange Act may apply to sales of shares in the market and to the activities of the selling stockholders and their affiliates. In addition, we will make copies of this prospectus (as it may be supplemented or amended from time to time) available to the selling stockholders for the purpose of satisfying the prospectus delivery requirements of the Securities Act. The selling stockholders may indemnify any broker-dealer that participates in transactions involving the sale of the shares against certain liabilities, including liabilities arising under the Securities Act.

 

We have agreed to indemnify the selling stockholders against liabilities, including liabilities under the Securities Act and state securities laws, relating to the registration of the shares offered by this prospectus.

 

We have agreed with the selling stockholders to keep the registration statement of which this prospectus constitutes a part effective until the earlier of (1) such time as all of the shares covered by this prospectus have been disposed of pursuant to and in accordance with the registration statement or (2) the date on which the shares may be sold pursuant to Rule 144(k) of the Securities Act.

 

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EX-10.3(C) 16 dex103c.htm REG. RIGHTS AGMT BY AND AMONG ORION ACQUISITION CORP. II AND DAVID T. HUNG Reg. Rights Agmt by and among Orion Acquisition Corp. II and David T. Hung

EXHIBIT 10.3(c)

 

REGISTRATION RIGHTS AGREEMENT

 

This Registration Rights Agreement (the “Agreement”) is made and entered into as of this 17th day of December, 2004 by and among Orion Acquisition Corp. II, a Delaware corporation (the “Company”), on the one hand, and David T. Hung, M.D., C. Patrick Machado, Dara Biosciences, Inc. and Selena Pharmaceuticals, Inc. (collectively the “Medivation Stockholders”) and MDB Capital Group LLC, a California limited liability company (the “MDB Holders”, and together with the Medivation Stockholders, the “Holders”) on the other hand.

 

The parties hereby agree as follows:

 

1. Certain Definitions.

 

As used in this Agreement, the following terms shall have the following meanings:

 

Affiliate” means, with respect to any person, any other person which directly or indirectly controls, is controlled by, or is under common control with, such person.

 

Business Day” means a day, other than a Saturday or Sunday, on which banks in New York City are open for the general transaction of business.

 

Common Stock” shall mean the Company’s common stock, par value $0.01 per share, and any securities into which such shares may hereinafter be reclassified.

 

Holder Registrable Securities” shall mean the MDB Registrable Securities and the Medivation Registrable Securities.

 

Holder Shares” shall mean the MDB Shares and the Medivation Shares.

 

Investor Registrable Securities” shall mean the Investor Shares and any other securities issued or issuable with respect to or in exchange for Investor Shares; provided, that, a security shall cease to be an Investor Registrable Security upon (A) sale pursuant to a Registration Statement or Rule 144 under the 1933 Act, or (B) such security becoming eligible for sale by the Investors pursuant to Rule 144(k).

 

Investor Registration Rights Agreement” means the registration rights agreement, dated on or about the date hereof, between the Company and the Investors.

 

Investor Shares” means the shares of Common Stock issued pursuant to the Purchase Agreement.

 

Investors” shall mean the Investors identified in the Purchase Agreement and any Affiliate or permitted transferee of any Investor who is a subsequent holder of any Registrable Securities.

 

MDB Registrable Securities” shall mean the MDB Shares and any other securities issued or issuable with respect to or in exchange for MDB Registrable Shares; provided, that, a security shall cease to be a MDB Registrable Security upon (A) sale pursuant to a Registration Statement or Rule 144 under the 1933 Act, or (B) such security becoming eligible for sale by the MDB Holders pursuant to Rule 144(k).

 

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MDB Shares” shall mean the shares of Common Stock issued to the MDB Holders, and the shares of Common Stock issuable upon the exercise of the Warrant dated December 16, 2004, issued by the Company to the MDB Holders, in each case in connection with the Merger and the Purchase Agreement.

 

Medivation Registrable Securities” shall mean the Medivation Shares and any other securities issued or issuable with respect to or in exchange for Medivation Registrable Shares; provided, that, a security shall cease to be a Medivation Registrable Security upon (A) sale pursuant to a Registration Statement or Rule 144 under the 1933 Act, or (B) such security becoming eligible for sale by the applicable Medivation Stockholder pursuant to Rule 144(k).

 

Medivation Shares” means the shares of Common Stock issuable upon conversion of the shares of Series B Preferred Stock issued to the Medivation Stockholders and the shares of Common Stock issuable upon the exercise of the Warrants dated December 16, 2004, issued by the Company to certain Medivation Stockholders, in each case in connection with the Merger.

 

Merger” shall mean the merger of Medivation Acquisition Corp., a Delaware corporation and wholly-owned subsidiary of the Company, with and into Medivation, Inc., a Delaware corporation.

 

Prospectus” shall mean the prospectus included in any Registration Statement, as amended or supplemented by any prospectus supplement, with respect to the terms of the offering of any portion of the Registrable Securities covered by such Registration Statement and by all other amendments and supplements to the prospectus, including post-effective amendments and all material incorporated by reference in such prospectus.

 

Purchase Agreement” means, collectively, those certain stock purchase agreements by and between the Company and the Investors.

 

Register,” “registered” and “registration” refer to a registration made by preparing and filing a Registration Statement or similar document in compliance with the 1933 Act (as defined below), and the declaration or ordering of effectiveness of such Registration Statement or document.

 

Registrable Securities” shall mean the Holder Registrable Securities and the Investor Registrable Securities, collectively.

 

Registration Statement” shall mean any registration statement of the Company filed under the 1933 Act that covers the resale of any of the Holder Registrable Securities pursuant to the provisions of this Agreement, amendments and supplements to such Registration Statement, including post-effective amendments, all exhibits and all material incorporated by reference in such Registration Statement.

 

Required Investors” means the Investors holding a majority of the Investor Registrable Securities.

 

Required Medivation Stockholders” means Medivation Stockholders holding a majority of the Medivation Registrable Securities.

 

SEC” means the U.S. Securities and Exchange Commission.

 

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Series B Preferred Stock” shall mean the Company’s Series B preferred stock, par value $0.01 per share, and any securities into which such shares may hereinafter be reclassified.

 

Shares” means the Holder Shares and the Investor Shares, collectively.

 

1933 Act” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.

 

1934 Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.

 

2. Registration.

 

(a) Registration Statements. The Company agrees to include the Holder Registrable Securities in any Registration Statement filed by the Company pursuant to the Investor Registration Rights Agreement.

 

(b) Expenses. The Company will pay all expenses associated with each registration, including filing and printing fees, the Company’s counsel and accounting fees and expenses, costs associated with clearing the Holder Registrable Securities for sale under applicable state securities laws, and listing fees, but the Company will not be responsible for paying any stock transfer taxes, discounts, commissions, fees and expenses of counsel to the Holders, fees of underwriters, selling brokers, dealer managers or similar securities industry professionals with respect to the Holder Registrable Securities being sold.

 

(c) Effectiveness.

 

(i) The Company shall use commercially reasonable efforts to have the Registration Statement declared effective as soon as practicable. The Company shall notify the Holders by facsimile or e-mail as promptly as practicable, and in any event, within twenty-four (24) hours, after any Registration Statement is declared effective and shall promptly (but in any event within two Business Days of such effective date) provide the Holders with copies of any related Prospectus to be used in connection with the sale or other disposition of the securities covered thereby.

 

(ii) In the event (A) of any request by the SEC or any other federal or state governmental authority during the period of effectiveness of the Registration Statement for amendments or supplements to a Registration Statement or related Prospectus or for additional information; (B) of the issuance by the SEC or any other federal or state governmental authority of any stop order suspending the effectiveness of a Registration Statement or the initiation of any proceedings for that purpose; (C) of the receipt by the Company of any notification with respect to the suspension of the qualification or exemption from qualification of any of the Shares for sale in any jurisdiction or the initiation or threatening of any proceeding for such purpose; or (D) of any event or circumstance which necessitates the making of any changes in the Registration Statement or Prospectus, or any document incorporated therein by reference, so that, in the case of the Registration Statement, it will not contain any untrue statement of a material fact or any

 

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omission to state a material fact required to be stated therein or necessary to make the statements therein not misleading, and that in the case of the Prospectus, it will not contain any untrue statement of a material fact or any omission to state a material fact required to be stated therein or necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading; then the Company may delay the disclosure of material non-public information concerning the Company, by suspending the use of any Prospectus included in any registration contemplated by this Section containing such information, the disclosure of which at the time is not, in the good faith opinion of the Company, in the best interests of the Company (an “Allowed Delay”); provided, that the Company shall promptly (a) notify the Holders in writing of the existence of (but in no event, without the prior written consent of a Holder, shall the Company disclose to such Holder any of the facts or circumstances regarding) any material non-public information giving rise to an Allowed Delay, (b) advise the Holders in writing to cease all sales under the Registration Statement until the end of the Allowed Delay and (c) use commercially reasonable efforts to terminate an Allowed Delay as promptly as practicable.

 

3. Company Obligations. The Company will use commercially reasonable efforts to effect the registration of the Holder Registrable Securities in accordance with the terms hereof, and pursuant thereto the Company will, as expeditiously as possible:

 

(a) use commercially reasonable efforts to cause such Registration Statement to become effective and to remain continuously effective for a period that will terminate upon the earlier of (i) the date on which all Holder Registrable Securities covered by such Registration Statement as amended from time to time, have been sold, and (ii) the date on which all Holder Registrable Securities covered by such Registration Statement may be sold pursuant to Rule 144(k) (the “Effectiveness Period”) and advise the Holders in writing when the Effectiveness Period has expired;

 

(b) prepare and file with the SEC such amendments and post-effective amendments to the Registration Statement and the Prospectus as may be necessary to keep the Registration Statement effective for the period specified in Section 3(a) and to comply with the provisions of the 1933 Act and the 1934 Act with respect to the distribution of all of the Registrable Securities covered thereby;

 

(c) furnish to the Holders (i) promptly after the same is prepared and publicly distributed, filed with the SEC, or received by the Company one (1) copy of any Registration Statement and any amendment thereto, each preliminary prospectus and Prospectus and each amendment or supplement thereto (other than any portion of any thereof which contains information for which the Company has sought confidential treatment), and (ii) such number of copies of a Prospectus, including a preliminary prospectus, and all amendments and supplements thereto and such other documents as each Holder may reasonably request in order to facilitate the disposition of the Holder Registrable Securities owned by such Holder that are covered by the related Registration Statement;

 

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(d) use commercially reasonable efforts to (i) prevent the issuance of any stop order or other suspension of effectiveness and, (ii) if such order is issued, obtain the withdrawal of any such order at the earliest possible moment;

 

(e) prior to any public offering of Holder Registrable Securities, use commercially reasonable efforts to register or qualify or cooperate with the Holders and their counsel in connection with the registration or qualification of such Holder Registrable Securities for offer and sale under the securities or blue sky laws of California, Connecticut, Massachusetts, New Jersey, New York, Pennsylvania and Texas and do any and all other commercially reasonable acts or things necessary or advisable to enable the distribution in such jurisdictions of the Holder Registrable Securities covered by the Registration Statement; provided, however, that the Company shall not be required in connection therewith or as a condition thereto to (i) qualify to do business in any jurisdiction where it would not otherwise be required to qualify but for this Section 3(e), (ii) subject itself to general taxation in any jurisdiction where it would not otherwise be so subject but for this Section 3(e), or (iii) file a general consent to service of process in any such jurisdiction;

 

(f) use commercially reasonable efforts to cause all Holder Registrable Securities covered by a Registration Statement to be listed on each securities exchange, interdealer quotation system or other market on which similar securities issued by the Company are then listed;

 

(g) immediately notify the Holders, at any time when a Prospectus relating to Holder Registrable Securities is required to be delivered under the 1933 Act, upon discovery that, or upon the happening of any event as a result of which, the Prospectus included in a Registration Statement, as then in effect, includes an untrue statement of a material fact or omits to state any material fact required to be stated therein or necessary to make the statements therein not misleading in light of the circumstances then existing, and at the request of any such holder, promptly prepare and furnish to such holder a reasonable number of copies of a supplement to or an amendment of such Prospectus as may be necessary so that, as thereafter delivered to the purchasers of such Holder Registrable Securities, such Prospectus shall not include an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading in light of the circumstances then existing; and

 

(h) otherwise use commercially reasonable efforts to comply with all applicable rules and regulations of the SEC under the 1933 Act and the 1934 Act, take such other actions as may be reasonably necessary to facilitate the registration of the Holder Registrable Securities hereunder; and make available to its security holders, as soon as reasonably practicable, but not later than the Availability Date (as defined below), an earnings statement covering a period of at least twelve (12) months, beginning after the effective date of each Registration Statement, which earnings statement shall satisfy the provisions of Section 11(a) of the 1933 Act, including Rule 158 promulgated thereunder (for the purpose of this subsection 3(i), “Availability Date” means the 45th day following the end of the fourth fiscal quarter that includes the effective date of such Registration Statement, except that, if such fourth fiscal quarter is the last quarter of the Company’s fiscal year, “Availability Date” means the 90th day after the end of such fourth fiscal quarter).

 

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(i) With a view to making available to the Holders the benefits of Rule 144 (or its successor rule) and any other rule or regulation of the SEC that may at any time permit the Investors to sell shares of Common Stock to the public without registration, the Company covenants and agrees to: (i) make and keep public information available, as those terms are understood and defined in Rule 144, until the earlier of (A) six months after such date as all of the Holder Registrable Securities may be resold pursuant to Rule 144(k) or any other rule of similar effect or (B) such date as all of the Holder Registrable Securities shall have been resold; (ii) file with the SEC in a timely manner all reports and other documents required of the Company under the 1934 Act; and (iii) furnish to each Investor upon request, as long as such Investor owns any Holder Registrable Securities, (A) a written statement by the Company that it has complied with the reporting requirements of the 1934 Act, (B) a copy of the Company’s most recent Annual Report on Form 10-KSB or Quarterly Report on Form 10-QSB and (C) such other information as may be reasonably requested in order to avail such Holder of any rule or regulation of the SEC that permits the selling of any such Holder Registrable Securities without registration.

 

4. Due Diligence Review; Information. The Company shall make available, during normal business hours, for inspection and review by the Holders, advisors to and representatives of the Holders (who may or may not be affiliated with the Holders and who are reasonably acceptable to the Company), all financial and other records, all SEC Filings (as defined in the Purchase Agreement) and other filings with the SEC, and all other corporate documents and properties of the Company as may be reasonably necessary for the purpose of such review, and cause the Company’s officers and directors, within a reasonable time period, to supply all such information reasonably requested by the Holders or any such representative, advisor or underwriter in connection with such Registration Statement (including, without limitation, in response to all questions and other inquiries reasonably made or submitted by any of them), prior to and from time to time after the filing and effectiveness of the Registration Statement for the sole purpose of enabling the Holders and such representatives, advisors and underwriters and their respective accountants and attorneys to conduct initial and ongoing due diligence with respect to the Company and the accuracy of such Registration Statement.

 

The right of any Holder to obtain information from the Company pursuant to this Section 4 shall be expressly conditioned upon such Holder entering into an appropriate confidentiality agreement with the Company with respect thereto.

 

5. Obligations of the Holders.

 

(a) Each Holder shall furnish in writing to the Company such information regarding itself, the Holder Registrable Securities held by it, and the intended method of disposition of the Holder Registrable Securities as shall be reasonably required to effect the registration of such Registrable Securities and shall execute such documents in connection with such registration as the Company may reasonably request. At least five (5)

 

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Business Days prior to the first anticipated filing date of any Registration Statement, the Company shall notify each Holder of the information the Company requires from such Holder if such Holder elects to have any of its Holder Registrable Securities included in the Registration Statement. A Holder shall provide such information to the Company at least two (2) Business Days prior to the first anticipated filing date of such Registration Statement if such Holder elects to have any of its Holder Registrable Securities included in the Registration Statement.

 

(b) Each Holder, by its acceptance of the Holder Registrable Securities agrees to cooperate with the Company as reasonably requested by the Company in connection with the preparation and filing of a Registration Statement hereunder, unless such Holder has notified the Company in writing of its election to exclude all of its Holder Registrable Securities from such Registration Statement.

 

(c) Each Holder agrees that, upon receipt of any notice from the Company of either (i) the commencement of an Allowed Delay pursuant to Section 2(c)(ii) or (ii) the happening of an event pursuant to Section 3(g) hereof, such Holder will immediately discontinue disposition of Holder Registrable Securities pursuant to the Registration Statement covering such Holder Registrable Securities until the Holder’s receipt of the copies of the supplemented or amended prospectus filed with the SEC and until any related post-effective amendment is declared effective and, if so directed by the Company, the Holder shall deliver to the Company (at the expense of the Company) or destroy (and deliver to the Company a certificate of destruction) all copies in the Holder’s possession of the Prospectus covering the Holder Registrable Securities current at the time of receipt of such notice.

 

6. Indemnification.

 

(a) Indemnification by the Company. The Company will indemnify and hold harmless each Holder and its officers, directors, members, employees and agents, successors and assigns, and each other person, if any, who controls such Holder within the meaning of the 1933 Act, against any losses, claims, damages or liabilities, joint or several, to which they may become subject under the 1933 Act or otherwise, insofar as such losses, claims, damages or liabilities (or actions in respect thereof) arise out of or are based upon: (i) any untrue statement or alleged untrue statement of any material fact contained in any Registration Statement, any preliminary prospectus or final prospectus contained therein, or any amendment or supplement thereof; (ii) any blue sky application or other document executed by the Company specifically for that purpose or based upon written information furnished by the Company filed in any state or other jurisdiction in order to qualify any or all of the Holder Registrable Securities under the securities laws thereof (any such application, document or information herein called a “Blue Sky Application”); (iii) the omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading; (iv) any violation by the Company or its agents of any rule or regulation promulgated under the 1933 Act applicable to the Company or its agents and relating to action or inaction required of the Company in connection with such registration; or (v) any failure to register or qualify the Holder Registrable Securities included in any such Registration in any state where the Company or its agents has affirmatively undertaken or agreed in writing that the Company will undertake such

 

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registration or qualification on a Holder’s behalf and will reimburse such Holder, and each such officer, director or member and each such controlling person for any legal or other expenses reasonably incurred by them in connection with investigating or defending any such loss, claim, damage, liability or action; provided, however, that the Company will not be liable in any such case if and to the extent that any such loss, claim, damage or liability arises out of or is based upon an untrue statement or alleged untrue statement or omission or alleged omission so made in conformity with information furnished by such Holder or any such controlling person in writing specifically for use in such Registration Statement or Prospectus. It is agreed that the indemnity agreement contained in this Section 6(a) shall not apply to amounts paid in settlement of any such losses, claim, damage, liability or action if such settlement is effected without the consent of the Company (which consent shall not be unreasonably withheld or delayed).

 

(b) Indemnification by the Holders. Each Holder agrees, severally but not jointly, to indemnify and hold harmless, to the fullest extent permitted by law, the Company, its directors, officers, employees, stockholders and each person who controls the Company (within the meaning of the 1933 Act) against any losses, claims, damages, liabilities and expense (including reasonable attorney fees) resulting from any untrue statement of a material fact or any omission of a material fact required to be stated in the Registration Statement or Prospectus or preliminary prospectus or amendment or supplement thereto or necessary to make the statements therein not misleading, to the extent, but only to the extent that such untrue statement or omission is contained in any information furnished in writing by such Holder to the Company specifically for inclusion in such Registration Statement or Prospectus or amendment or supplement thereto. In no event shall the liability of a Holder be greater in amount than the dollar amount of the proceeds (net of all expense paid by such Holder in connection with any claim relating to this Section 6 and the amount of any damages such Holder has otherwise been required to pay by reason of such untrue statement or omission) received by such Holder upon the sale of the Holder Registrable Securities included in the Registration Statement giving rise to such indemnification obligation. It is agreed that the indemnity agreement contained in this Section 6(b) shall not apply to amounts paid in settlement of any such losses, claim, damage, liability or action if such settlement is effected without the consent of the affected Holder(s) (which consent shall not be unreasonably withheld or delayed).

 

(c) Conduct of Indemnification Proceedings. Any person entitled to indemnification hereunder shall (i) give prompt notice to the indemnifying party of any claim with respect to which it seeks indemnification and (ii) permit such indemnifying party to assume the defense of such claim with counsel reasonably satisfactory to the indemnified party; provided that any person entitled to indemnification hereunder shall have the right to employ separate counsel and to participate in the defense of such claim, but the fees and expenses of such counsel shall be at the expense of such person unless (a) the indemnifying party has agreed to pay such fees or expenses, or (b) the indemnifying party shall have failed to assume the defense of such claim and employ counsel reasonably satisfactory to such person or (c) in the reasonable judgment of any such person, based upon written advice of its counsel, a conflict of interest exists between such person and the indemnifying party with respect to such claims (in which case, if the person notifies the indemnifying party in writing that such person elects to employ separate counsel at the expense of the indemnifying party, the indemnifying party shall

 

-8-


not have the right to assume the defense of such claim on behalf of such person); and provided, further, that the failure of any indemnified party to give notice as provided herein shall not relieve the indemnifying party of its obligations hereunder, except to the extent that such failure to give notice shall materially adversely affect the indemnifying party in the defense of any such claim or litigation. It is understood that the indemnifying party shall not, in connection with any proceeding in the same jurisdiction, be liable for fees or expenses of more than one separate firm of attorneys at any time for all such indemnified parties. No indemnifying party will, except with the consent of the indemnified party, consent to entry of any judgment or enter into any settlement that does not include as an unconditional term thereof the giving by the claimant or plaintiff to such indemnified party of a release from all liability in respect of such claim or litigation.

 

(d) Contribution. If for any reason the indemnification provided for in the preceding paragraphs (a) and (b) is unavailable to an indemnified party or insufficient to hold it harmless, other than as expressly specified therein, then the indemnifying party shall contribute to the amount paid or payable by the indemnified party as a result of such loss, claim, damage or liability in such proportion as is appropriate to reflect the relative fault of the indemnified party and the indemnifying party, as well as any other relevant equitable considerations. No person guilty of fraudulent misrepresentation within the meaning of Section 11(f) of the 1933 Act shall be entitled to contribution from any person not guilty of such fraudulent misrepresentation. In no event shall the contribution obligation of a holder of Registrable Securities be greater in amount than the dollar amount of the proceeds (net of all expenses paid by such holder in connection with any claim relating to this Section 6 and the amount of any damages such holder has otherwise been required to pay by reason of such untrue or alleged untrue statement or omission or alleged omission) received by it upon the sale of the Registrable Securities giving rise to such contribution obligation.

 

7. Miscellaneous.

 

(a) Amendments and Waivers. This Agreement may be amended only by a writing signed by the Company and the Required Medivation Stockholders. The Company may take any action herein prohibited, or omit to perform any act herein required to be performed by it, only if the Company shall have obtained the written consent to such amendment, action or omission to act, of the Required Medivation Stockholders.

 

(b) Notices. All notices and other communications required or permitted hereunder shall be in writing and shall be sent by first-class United States mail or delivered in person or sent via next day Federal Express delivery or any other nationally-recognized overnight delivery service or by facsimile (with confirmation of receipt), addressed to the respective party at the address set forth opposite its signature on this Agreement.

 

(c) Assignments and Transfers by Holders. The provisions of this Agreement shall be binding upon and inure to the benefit of the Holders and their respective successors and assigns. A Holder may transfer or assign, in whole or from time to time in part, to one or more persons its rights hereunder in connection with the transfer of Holder Registrable

 

-9-


Securities by such Holder to such person, provided that such Holder complies with all laws applicable thereto and provides written notice of assignment to the Company promptly after such assignment is effected.

 

(d) Assignments and Transfers by the Company. This Agreement may not be assigned by the Company (whether by operation of law or otherwise) without the prior written consent of the Required Medivation Stockholders, provided, however, that the Company may assign its rights and delegate its duties hereunder to any surviving or successor corporation in connection with a merger or consolidation of the Company with another corporation, or a sale, transfer or other disposition of all or substantially all of the Company’s assets to another corporation, without the prior written consent of the Required Medivation Stockholders, after notice duly given by the Company to each Holder.

 

(e) Benefits of the Agreement. The terms and conditions of this Agreement shall inure to the benefit of and be binding upon the respective permitted successors and assigns of the parties. Nothing in this Agreement, express or implied, is intended to confer upon any party other than the parties hereto or their respective successors and assigns any rights, remedies, obligations, or liabilities under or by reason of this Agreement, except as expressly provided in this Agreement.

 

(f) Counterparts; Faxes. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. This Agreement may also be executed via facsimile, which shall be deemed an original.

 

(g) Titles and Subtitles. The titles and subtitles used in this Agreement are used for convenience only and are not to be considered in construing or interpreting this Agreement.

 

(h) Severability. Any provision of this Agreement that is prohibited or unenforceable in any jurisdiction shall, as to such jurisdiction, be ineffective to the extent of such prohibition or unenforceability without invalidating the remaining provisions hereof but shall be interpreted as if it were written so as to be enforceable to the maximum extent permitted by applicable law, and any such prohibition or unenforceability in any jurisdiction shall not invalidate or render unenforceable such provision in any other jurisdiction. To the extent permitted by applicable law, the parties hereby waive any provision of law which renders any provisions hereof prohibited or unenforceable in any respect.

 

(i) Further Assurances. The parties shall execute and deliver all such further instruments and documents and take all such other actions as may reasonably be required to carry out the transactions contemplated hereby and to evidence the fulfillment of the agreements herein contained.

 

(j) Entire Agreement. This Agreement is intended by the parties as a final expression of their agreement and intended to be a complete and exclusive statement of the

 

-10-


agreement and understanding of the parties hereto in respect of the subject matter contained herein. This Agreement supersedes all prior agreements and understandings between the parties with respect to such subject matter.

 

(k) Governing Law; Consent to Jurisdiction; Waiver of Jury Trial. This Agreement shall be governed by, and construed in accordance with, the internal laws of the State of California without regard to the choice of law principles thereof. Each of the parties hereto irrevocably submits to the exclusive jurisdiction of the courts of the State of California located in The City and County of San Francisco and the United States District Court for the Northern District of California for the purpose of any suit, action, proceeding or judgment relating to or arising out of this Agreement and the transactions contemplated hereby. Service of process in connection with any such suit, action or proceeding may be served on each party hereto anywhere in the world by the same methods as are specified for the giving of notices under this Agreement. Each of the parties hereto irrevocably consents to the jurisdiction of any such court in any such suit, action or proceeding and to the laying of venue in such court. Each party hereto irrevocably waives any objection to the laying of venue of any such suit, action or proceeding brought in such courts and irrevocably waives any claim that any such suit, action or proceeding brought in any such court has been brought in an inconvenient forum. EACH OF THE PARTIES HERETO WAIVES ANY RIGHT TO REQUEST A TRIAL BY JURY IN ANY LITIGATION WITH RESPECT TO THIS AGREEMENT AND REPRESENTS THAT COUNSEL HAS BEEN CONSULTED SPECIFICALLY AS TO THIS WAIVER.

 

(l) Lock-Up Agreements. Each Medivation Stockholder expressly acknowledges that it has signed a lock-up agreement, of even date herewith (the “Lock-Up Agreements”), providing for certain restrictions on its ability to transfer its Medivation Registrable Securities. Each Medivation Stockholder expressly acknowledges and agrees that its rights to sell or dispose of all or any portion of, or any interest in, its Medivation Registrable Securities are subject to the overriding restrictions set forth in the Lock-Up Agreements.

 

IN WITNESS WHEREOF, the parties have executed this Agreement or caused their duly authorized officers to execute this Agreement as of the date first above written.

 

The Company:  

ORION ACQUISITION CORP. II

501 Second Street, Suite 211         
San Francisco, CA 94107         
    By:   

/s/ David T. Hung, M.D.


    Name:    David T. Hung, M.D.
    Title:    President and Chief Executive Officer

 

 

-11-


The Medivation Stockholders:
David T. Hung, M.D.
By:  

/s/ David T. Hung, M.D.


C. Patrick Machado
By:  

/s/ C. Patrick Machado


Dara Biosciences, Inc.
By:  

/s/ John C. Thomas


Name:   John C. Thomas
Title:   Chief Financial Officer and Secretary
Selena Pharmaceuticals, Inc.
By:  

/s/ Sergey O. Sablin


Name:   Sergey O. Sablin
Title:   President and Chief Executive Officer
The MDB Holders:
MDB Capital Group LLC.
By:  

/s/ Christopher A. Marlett


Name:  

Christopher A. Marlett

Title:  

Managing Principal

 

-12-

EX-10.8 17 dex108.htm PREFERRED PARTNERSHIP LETTER AGREEMENT Preferred Partnership Letter Agreement

EXHIBIT 10.8

 

March 24, 2004

 

Sergey O. Bachurin, D.Sc.

Vice Director

Institute of Physiologically Active Compounds

Russian Academy of Sciences

142432, Chernogolovka, Moscow Region

IPAC RAS, Russia

 

Dear Sergey,

 

On behalf of my colleagues and myself, I am delighted to write to confirm the revised terms of the preferred partnership relationship that we have agreed to establish between the Institute of Physiologically Active Compounds (the “Institute”) and Medivation, Inc. (“Medivation”). The terms set forth in this letter will replace in their entirety the terms set forth in the preferred partnership letter that we entered into shortly after our visit to Moscow last November.

 

Pursuant to this relationship, Medivation agrees to give the Institute the first opportunity to perform any nonclinical experiments involving dimebon that the Institute has the capability of performing in a timely manner and in compliance with all applicable regulatory requirements.

 

In return, the Institute agrees to give Medivation the first opportunity to license or acquire exclusive, worldwide intellectual property rights in any inventions made in your laboratory (“Inventions”) within the following fields (collectively, the “Medivation Field”): (a) dimebon, dimebon-analogs, and/or uses of any of the foregoing; (b) treatment, prevention and/or diagnosis of diseases or disorders of the brain; and (c) anti-aging. The Institute has not granted, and during the term of our preferred partnership will not grant, to any other party rights to any Inventions within the Medivation Field that are senior to the rights granted to Medivation, or that would in any manner impair the ability of the Institute to perform its obligations hereunder. The Institute will notify Medivation promptly and in writing of each Invention within the Medivation Field that is made during the term of our preferred partnership and, if Medivation elects to pursue licensing negotiations, it must notify the Institute of that decision within thirty (30) days after receiving the written notice from the Institute. If Medivation elects to pursue licensing negotiations, the Institute will negotiate with Medivation exclusively and in good faith for a period of at least ninety (90) days. If, following the end of the ninety (90) day negotiation period the parties have not reached a mutually satisfactory agreement, or if Medivation does not elect to pursue licensing negotiations within thirty (30) days after receipt of the Institute’s written notice, then the Institute shall be free to exploit the applicable technology in any manner it chooses, whether alone and/or with third parties of its choice, without any further obligation to Medivation with respect to such technology.

 

The specific terms of all transactions contemplated in this letter will be subject to the mutual agreement of both the Institute and Medivation. This would include, without limitation, all financial terms, timelines, milestones and deliverables for any nonclinical experiments and licensing transactions. Neither the Institute nor Medivation will have any obligation to enter into any such transactions unless the terms are acceptable to it in its sole discretion.

 

The preferred partnership relationship between the Institute and Medivation will begin on the date noted at the top of this letter, and will remain in effect for an initial term of three (3) years thereafter. Following the expiration of the initial term, both the Institute and Medivation will have the right to terminate this relationship, for any reason in their sole discretion, by delivering written notice of termination to the other party. Any such termination will take effect thirty (30) days after delivery of that notice.

 

Sergey, I hope that this letter correctly reflects your understanding of the terms of our preferred

 

1


partnership. If it does, please execute the letter on behalf of the Institute and return it to me by fax at (415) 543-3113.

 

We all look forward to a long and mutually rewarding relationship with you and the Institute.

 

With best personal regards,

 

C. Patrick Machado

Senior VP & CFO

Medivation, Inc.

 

 

APPROVED AND AGREED TO:

 

INSTITUTE    MEDIVATION

Signature:

   /s/    Signature: /s/

Name:

        Name:

Title:

        Title:

Address:

   142432, Chernogolovka    501 Second Street, Suite 211
     Moscow Region    San Francisco, CA 94107
     IPAC RAS, Russia     

Phone:

        (415) 543-3470

Fax:

        (415) 543-3113

 

2

EX-10.9(A) 18 dex109a.htm AGREEMENT BY AND BETWEEN PISGAH LABS, INC. AND MEDIVATION, INC. Agreement by and between Pisgah Labs, Inc. and Medivation, Inc.

Exhibit 10.9(a)

 

February 17, 2004

 

Mr. Patrick Machado

Medivation, Inc.

501 Second Street

Suite 211

San Francisco, CA 94107

 

Tel: 415-543-3470, x201

Fax: 415-543-3113

 

Re: GLP and cGMP Preparation of Dimebon, API

 

Dear Pat:

 

Based on correspondences from Dr. Berlin (Hoyle Consulting) pertaining to the synthesis of Dimebon, API, and the subsequent telephone conversations that you and I have had on the subject, I am writing to confirm the mutual agreement of Pisgah Labs and Medivation, Inc. for the manufacture of an estimated eight kilos of non-GMP dimebon API, and one kilo of GMP dimebon API. This Agreement also covers certain additional work, including development of HPLC assay and impurities test procedures, that are optional at Medivation’s discretion.

 

The synthesis documentation that Medivation has previously provided to Pisgah Labs is very helpful and there does not appear to be any unusual or atypical processing steps. I recognize certain precautions will have to be maintained to prevent the undesired polymerization of the vinylpyridine during its purification and for its subsequent reaction with the carboline.

 

The project will consist of three phases. Phase 1 will involve synthesis of one kilo of non-GMP material, with a target delivery date of April 29, 2004. Phase 2 will involve synthesis of an estimated seven kilos of non-GMP material, with a target delivery date of September 1, 2004, it being understood that the actual quantity of material required in Phase 2 will not be known definitively until after the pre-IND meeting is held with FDA. Phase 3 will involve synthesis of one kilo of cGMP material, with a target delivery date of December 1, 2004.

 

Page 1 of 8


Phase 1 will begin upon execution of this Agreement. Phase 2 and Phase 3 will begin on the dates on which Medivation authorizes Pisgah Labs in writing to begin those phases.

 

The specification and stability protocols for the material to be delivered are attached as Attachment 1) and incorporated into this Agreement.

 

Pisgah Labs will start the project immediately with delivery of the materials in accordance with the target delivery dates specified above. It is recognized that “time is of the essence” and pending raw material lead times or unforeseen circumstances, Pisgah Labs will make reasonable commercial efforts to meet the desired project delivery dates. Pisgah Labs will confirm the synthetic process on a convenient scale while identifying process monitoring methodologies. With the final product, Pisgah Labs will, at the discretion of Medivation, either a) identify an acceptable HPLC assay and impurities methodology or b) transfer such assay and methodologies developed elsewhere and provided by Medivation.

 

Attached as Attachment 2) is a top-level spreadsheet for initiating and executing the project. The amounts quoted include the costs of obtaining all starting materials required to produce dimebon according to the synthesis used for commercial manufacture in the Russian market, which has been provided previously. It is understood that the charges set forth on Attachment 2) are Pisgah Labs’ good faith estimates based on its current understanding of the relevant facts. Should changes in those facts occur which would impact the estimated charges (e.g., change in the synthesis used for dimebon API, change in quantity of API required, etc.), the parties will discuss those changes and agree in good faith to reasonable revisions to the charges, it being understood that no increases in charge levels shall become binding until approved in writing by Medivation.

 

Attachment 2) also sets forth the prices for various additional items of work that Pisgah Labs will perform if requested to do so by Medivation, in Medivation’s discretion. Such additional work includes validation of HPLC assay and impurities methods, development of a stability indicating HPLC assay and execution of a stability testing protocol.

 

Payment terms for work covered by this Agreement will be as set forth in Attachment 2).

 

Any additional work required by Medivation, including the synthesis / purification / characterization of a reference standard and the potential synthesis of related foreign substances needed to validate the method, are not included in the estimated charges and, if requested by Medivation, will be charged separately.

 

If this letter correctly reflects the agreement between Pisgah Labs and Medivation, Inc. regarding the manufacture of dimebon API, please countersign this Agreement and return it to me. Upon your signature, this Agreement will be binding on both Pisgah Labs and Medivation. This Agreement will also include the terms and conditions listed in Attachment 3), which are incorporated herein.

 

Page 2 of 8


I look forward to working with you on this interesting project.

 

Sincerely,

 

PISGAH LABS, INC.

 

By:

 

Cliff R. King, Ph.D.

Its:

 

Vice President

 

APPROVED AND AGREED TO:

 

MEDIVATION, INC.

 

By:

 

C. Patrick Machado

Its:

 

Senior VP & Chief Financial Officer

 

Attachments

 

1) Specification and stability protocols

2) Charges

3) Terms and Conditions

 

Page 3 of 8


Attachment 1)

 

Specification and Stability Protocols

 

The following specification and stability protocols apply to the GMP dimebon di-hydrochloride API to be manufactured under this Agreement. Non-GMP batches may be release and stability tested to alternate protocols. The parties expect that the specification will evolve prior to IND filing, especially with respect to the related substances.

 

Table 1: Specification for Dimebon di-Hydrochloride

 

Test


 

Method


 

Acceptance Criteria


Appearance

  Visual   White to off-white powder

Identification

  USP<197R> (IR)   Sample spectrum comparable to reference spectrum

Identification (Chloride)

  USP<191>   Conforms to USP

Assay

  HPLC   97.0 to 103.0% (anhydrous)

Related Substances

    Single Largest

    Total

  HPLC  

NMT 0.2%

NMT 2.5%

Residual Solvents

    $$List Each

  GC   ICH Values

Moisture

 

USP<921>

(Karl Fisher)

  NMT 2.5%

Residue on Ignition

  USP<281>   NMT 0.02%

Heavy Metals

  USP<231>   NMT 0.002%

 

During the course of development it may also be necessary to evaluate particle size distribution, microbial quality, and crystalline form, as well. However, such tests can be performed under a process development protocol.

 

Table 2: Stability Protocol for GMP Dimebon di-Hydrochloride

 

Test


    

1


     3

     6

     9

     12

     18

     24

Appearance

     x, xx      x, xx      x, xx      x      x      x      x

Assay

     x, xx      x, xx      x, xx      x      x      x      x

Related Substances

     x, xx      x, xx      x, xx      x      x      x      x

Water

     x, xx      x, xx      x, xx      x      x      x      x

x = 25 ± 2°C/60 ± 5%RH; xx = 40 ± 2°C/75 ± 5% RH

 

Page 4 of 8


Attachment 2)

 

Charges

 

No.


  

Project Phase


  

Description


   Cost

  

Due


1

   Initiation: Phase 1    Secure raw materials, document raw material specifications; set-up analytical methods, begin process chemistry development    $ 100,000    50% w/in 10 days of signing this Agreement; 50% 30 days later

2

   Development    Confirm syntheses for API and final intermediates; Unexpected events charged at a Full Time Equivalent basis (FTE) of $18,000 / month + other pre-approved expenses    $ 32,000    50% w/in 10 days of signing this Agreement; 50% 30 days later

3

  

Non-GMP Batch:

Phase 1

   Establish synthetic, isolation and purification parameters consistent with meeting the API specifications    $ 22,000    W/in 10 days after delivery of first 1kg of non-GMP material

4

   Initiation: Phase 2    Secure raw materials    $ 37,500    W/in 10 days after initiation of Phase 2

5

  

Non-GMP Batch:

Phase 2

   Establish synthetic, isolation and purification parameters consistent with meeting the API specifications    $ 60,500    W/in 10 days after delivery of 7kg of non-GMP material

6

   cGMP Batch (<1kg)    Prepare approx. 1 kg API according to a batch sheet and perform the in-process and release tests.    $ 51,700    W/in 10 days after delivery of 1kg of cGMP material

7

   HPLC Assay and Impurities    Optional: Develop an assay and impurities method (not validated)    $ 10,700    Net 30 days invoice

8

   HPLC Assay (Stability Indicating)    Optional; develop stability indicating assay; perform stress tests on API and demonstrate no degradants interfere with the main peak.    $ 13,200    Net 30 days invoice

9

   HPLC Methods Validation    Optional; validate HPLC assay; reference standard and related foreign substances syntheses excluded.    $ 16,000    Net 30 days invoice

10

   Cross-over Cleaning Verification    For cGMP batch, document and demonstrate cleaning verification by appropriate analytical methodology    $ 4,500    Net 30 days invoice

 

Page 5 of 8


Attachment 3)

 

Terms and Conditions

 

1. Significant changes, unexpected expenses, or costs incurred associated with unexpected development, scale-up or validation activities will be assessed to Medivation, Inc. Medivation, Inc. will be advised, in advance, of charges outside this range and Medivation, Inc. may direct Pisgah Labs as to how to proceed.

 

2. The project consists of multiple phases as described in the Agreement and in Attachment 2).

 

3. Accordingly, Medivation, Inc. will pay Pisgah Labs in advance for initiating the project in accordance with Attachment 2), lines 1 and 2 (the “Advanced Payment”).

 

4. The Advanced Payment is non-refundable and represents Medivation, Inc.’s and Pisgah Labs’ commitment to resources in the time period requested.

 

5. Pisgah Labs will make reasonable commercial efforts to meet schedules and performance metrics notwithstanding schedule delays resulting from generally accepted force majeur cause(s) or delays.

 

6. Pisgah Labs understands that projects of this nature require flexibility and will negotiate in good faith additional payments for unexpected project events or changes in the work described.

 

7. EXCEPT AS PROVIDED IN ITEM 11 BELOW, PISGAH LABS HEREBY DISCLAIMS, AND PISGAH LABS HEREBY WAIVES, ALL EXPRESS WARRANTIES, AND ALL IMPLIED WARRANTIES, INCLUDING BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND/OR USE (INCLUDING MEDIVATION, INC.’S AND MEDIVATION, INC.’S CLIENTS’ REQUIREMENTS).

 

8. This Agreement may be terminated by Medivation upon thirty (30) days notice. In the unlikely event of termination, all further work on the project will stop and the parties will cooperate in good faith on a reasonable wind-down plan that will minimize project wind-down costs. It is understood that the Advance Payment shall be non-refundable notwithstanding any termination of this Agreement.

 

9. Pisgah Labs acknowledges and agrees that all technology related to Medivation’s dimebon dihydrochloride project, in general, and more specifically, to the manufacture, testing and/or use of dimebon dihydrochloride is the sole and exclusive property of Medivation, and further agrees that Pisgah Labs will fully cooperate with Medivation in the preparation, execution and submission of any and all documents reasonably required by Medivation to commercially exploit the value of the technology including, but not limited to, the assignment of all patent rights to Medivation.

 

Page 6 of 8


10. So long as Pisgah Labs continues to perform in compliance with this agreement and all other agreements that may subsequently be entered into between the parties: (a) Medivation agrees that it will not take all or any portion of the work set forth in Attachment 2) away from Pisgah Labs and give such work to a third party (it being understood that this provision does not apply to the work labeled ‘optional” in Attachment 2), and (b) Medivation also agrees that, should it require any further supplies of dimebon API beyond those set forth in Attachment 2), whether non-GMP or GMP, it will give Pisgah Labs the opportunity to bid on such work and will consider any such bid from Pisgah Labs in good faith, provided that the agreement clause (b) will terminate automatically upon the closing of a merger or acquisition of Medivation, or upon the closing of any transaction in which Medivation licenses or otherwise transfers the dimebon project to a third party.

 

11. Pisgah Labs acknowledges that the dimebon API produced by it will be used in animal and human testing that will be submitted to FDA, the EMEA and potentially other regulatory agencies in support of applications to sell dimebon to treat Alzheimer’s disease and potential other future indications. Accordingly, Pisgah Labs represents and warrants that all work hereunder shall be performed in compliance with all applicable laws, rules and regulations, including without limitation FDA current good manufacturing practices, in the case of the GMP material, and good laboratory practices, in the case of the non-GMP material. Pisgah Labs will furnish all certificates and other documentation required to confirm such compliance.

 

12. This Agreement represents the entire understanding of the parties, and supersedes any prior agreements or understandings between them, whether written or oral. This Agreement may be amended only in a written document signed by both parties. This Agreement will be interpreted pursuant to the laws of the State of Delaware, without regard to its conflict of law principles.

 

Page 7 of 8


CONTRACT ADDENDUM A

 

Replacement of Attachment 2

 

Effective March 18, 2004, this Contract Addendum A supercedes “Attachment 2” of the original contract dated February 17, 2004 between Medivation, Inc. and Pisgah Labs, Inc. Reference is made to another document, “Pisgah Labs; Dimebon Project Report; March 12, 2004” that delineates the motivation for this Contract Addendum. Project milestones require that Phase 2 of the project be re-defined.

 

The original contract language is: “Phase 2 will involve synthesis of an estimated seven kilos of non-GMP material with a target delivery date of September 1, 2004, it being understood that the actual quantity of material required in Phase 2 will not be known definitively until after the pre-IND meeting is held with FDA”.

 

Phase 2 shall now be defined as: “Phase 2 will involve synthesis of five kilograms of GMP Dimebon Dihydrochloride appropriate for clinical trials with a target delivery date of July 30, 2004”. As a consequence of this change to the Phase 2 definition, Phase 3 is eliminated from the original contract.

 

Except where timing inconsistencies or other activities are directly in conflict with the intentions described in the cited Project Report and / or contained within this Addendum, all other aspects of the original contract remain intact.

 

[intentionally left blank]

 

Page 1 of 3


Replacement Attachment 2)

 

Charges

 

No.


  

Project Phase


  

Description


  

Estimated

Cost


  

Due


1

   Initiation: Phase 1    Secure raw materials, document raw material specifications; set-up analytical methods, begin process chemistry development    $ 100,000    50% w/in 10 days of signing this Agreement; 50% 30 days later

2

   Development    Confirm syntheses for API and final intermediates; Unexpected events charged at a Full Time Equivalent basis (FTE) of $18,000 / month + other pre-approved expenses    $ 32,000    50% w/in 10 days of signing this Agreement; 50% 30 days later

3

  

Non-GMP Batch:

Phase 1

   Establish synthetic, isolation and purification parameters consistent with meeting the API specifications    $ 22,000    W/in 10 days after delivery of first 1kg of non-GMP material

4

   Initiation: Phase 2    Secure raw materials    $ 27,500    W/in 10 days after initiation of Phase 2

5

   Non-GMP Batch    Optional: Establish synthetic, isolation and purification parameters consistent with meeting the API specifications    $ 60,500    W/in 10 days after delivery of 7kg of non-GMP material

6

  

cGMP Preparation of gamma-carboline derivative

(< 24.6kg)

   Prepare the carboline in fixed equipment; 25kg tolyhydrazine min. order qty.; convert all to carboline. 200/300gal equipment; cross-over cleaning; establish in-house approval testing specs and methods    $ 39,203    Net 30 days upon batch completion

7

   Carboline Cross-over Cleaning    Conduct recovery studies; identify analytical method; establish cleaning procedure + batch sheet    $ 12,200    100% in 10 days

 

Page 2 of 3


8

   API
standard;

Purify and
Characterize
  Purify and characterize an analytical standard using Russian API. Assemble documentation package containing structure confirmation information and conformance to proposed release specifications.    $ 11,825    Net 30 days invoice

9

   API Particle
Size /
Milling
Experiment
  Determine particle size / distribution of Russian material; mill if necessary and re-measure; cross-over cleaning; perform recovery studies and establish appropriate analytical methodology    $ 16,800    Net 30 days invoice

10

   Cross-over
Cleaning
Verification
  If item 9 above is NOT executed, the cross-over cleaning component must still be performed for the GMP batch    $ 4,500    Net 30 days invoice

11

   HPLC
Assay and
Impurities
  Optional: Develop an assay and impurities method (not validated)    $ 10,700    Net 30 days invoice

12

   HPLC
Assay
(Stability
Indicating)
  Optional; develop stability indicating assay; perform stress tests on API and demonstrate no degradants interfere with the main peak.    $ 13,200    Net 30 days invoice

13

   5kg API for
Clinical
Trials
  Prepare 5kg GMP Dimebon Dihydrochloride; excludes MVP cost    $ 48,400    Net 30 days upon batch completion

14

   HPLC
Methods
Validation
 

Optional; validate HPLC assay; reference standard and related foreign substances syntheses excluded.

Note: Medivation may incur some cost for executing a method transfer validation protocol (from SRTL to Pisgah Labs) depending upon difficulty

   $ 16,000    Net 30 days invoice

 

CONTRACT ADDENDUM A IS APPROVED AND AGREED TO:

 

MEDIVATION, INC.   PISGAH LABS, INC

By:

   C. Patrick Machado   Cliff R. King

Its:

   Senior VP and Chief Financial Officer   Vice President

 

Page 3 of 3

EX-10.9(B) 19 dex109b.htm AGREEMENT BY AND BETWEEN QS PHARMA, LLC AND MEDIVATION, INC. Agreement by and between QS Pharma, LLC and Medivation, Inc.

EXHIBIT 10.9(b)

QSPharma

Quality with Speed®

Proposal 05-1575

11 January 2005

 

Pharmaceutical Development Agreement for Medivation

Dimebon Pharmaceutical Development

 

Project Scope

 

To verify and/or modify and qualify analytical methods for active pharmaceutical ingredient (API) and drug product, develop a 10 mg immediate release tablet that matches the current Russian tablet in dose, weight and size (Product), manufacture clinical trial material (CTM) of Product and matching Placebo, and conduct stability testing on CTM for Medivation Inc. (Client).

 

QS Pharma shall perform:

 

Analytical method transfer, development and/or qualification for API, Product & Placebo

Formulation development and feasibility batch manufacture of Product

CTM Product and Placebo manufacture and packaging

Stability testing of Product and CTM Product and Placebo

 

Analytical methods will be transferred and/or modified to support the CTM manufacture. Client will provide QS Pharma with the API, the identification (ID) test method for the API, and the current HPLC analytical methods for the API.

 

The key assumptions are summarized below:

    The CTM is intended only for use in Russia.
    Manufacture 120,000 tablets of Product and 100,000 tablets of Placebo.
    The tablet strength is 10 mg and the tablets must approximate the existing in total weight, shape and size.
    The bulk density of the dry blend will determine the number of batches required to meet the delivery. The theoretical bulk density projects one batch.
    The formulation has been made as a paste granulation to date.
    Qualified analytical methods for API ID, assay and impurity analysis will be provided by Client.
    GMP API is available immediately.
    CTM will be available for shipment within 14 weeks of contract execution and receipt at QS Pharma of the deposit, MSDS for each the API, the API and the API reference standard provided the CTM Product batch is made at risk with no stability data from the formulation development batch available prior to CTM manufacture. The addition of requiring stability data from the formulation development batch available prior to CTM manufacture will cause a commensurate + one week increase in the time required. For example, the addition of one month data prior to CTM manufacture will require a 19.3 week timeline.

 

Confidential

Page 1 of 9


QSPharma

Quality with Speed®

Proposal 05-1575

11 January 2005

 

1.0 Project Summary

 

Activity


        Fee (USD)

2.0 Health & Safety Evaluation

        1,000

3.0 Analytical Method Development

         

3.1 API

        1,000

3.2 Excipients per USP & Packaging Components

        16,000

3.3 Cleaning Verification

        12,000

3.4 Product

        28,000
         
     Sub-Total:    57,000
         

4.0 Formulation Development

         

4.1 Formulation Development & Feasibility Batch Manufacture

        50,000

4.2 Analytical Support (in-process & time zero, 1, 2 and 3 month stability testing)

        28,000

Project Support

        0
         
     Sub-Total:    78,000
         

5.0 CTM

         

5.1 Manufacture Product (120,000 tablets)

        30,000

5.2 Manufacture Placebo (100,000 tablets)

        25,000

5.3 Package Product & Placebo

        15,000

5.4 Storage and Material Management ($400/month)

        4,800

5.5 Label Packaged Product & Placebo

        35,000

5.6 Analytical Support for Manufacturing CTM Product and Placebo (release & 24 month stability testing)

        61,000

Project Support

        0
         
     Sub-Total:    170,800
         
     Total:    306,800
         
     Deposit:    100,000
         
     Balance:    206,800
         

 

2.0 Health and Safety Evaluation

 

Prior to the commencement of activities, a thorough review by QS Pharma of the Environmental Health and Safety (EHS) requirements for the API shall be completed. Client will provide the most current MSDS. Client will keep QS Pharma updated on all EHS, preclinical and clinical safety findings. The following quotation assumes that the EHS review will determine that API can be safely handled and manufactured at the QS Pharma facility. A summary report of this evaluation will be provided to the Client.

 

Confidential

Page 2 of 9


QSPharma

Quality with Speed®

Proposal 05-1575

11 January 2005

 

3.0 Analytical Methods

 

QS Pharma will perform the required method verification and qualification for the API and Product. The method verification and qualification will enable the ID testing of the API and the manufacture (cleaning verification), release and stability testing of Product. Client will provide the current API analytical methods.

 

3.1 API

 

API analytical methods will be utilized for ID testing. The test method required for the API ID testing will be provided by the Client. The ID test will be IR or UV spectra and will be conducted on receipt and compared to a Client-provided reference spectra. QS Pharma will author a specification for the ID of the API.

 

3.2 Excipients & Packaging Components

 

All excipients and packaging components will be selected based on the composition and packaging configuration of the Product. The required excipient and packaging component release testing will be decided based on Client input to meet cGMP reuquirements. The price estimate covers USP testing on three excipients (starch, lactose and magnesium stearate) and appropriate testing of the packaging components.

 

3.3 Cleaning Verification

 

Product manufacture requires the development of a cleaning verification for the API. The method is required since all development and CTM manufacture will be done in equipment with contact surfaces not dedicated solely to Product.

 

3.4 Product

 

Product analytical methods will be developed from API methods provided by Client for release and stability testing. The analytical methods include visual appearance/color, identification, assay, related substances, content uniformity, dissolution, moisture by halogen moisture analyzer balance and friability. The test methods for evaluation of the Product on release include visual appearance/color, identification, assay, related substances, content uniformity, dissolution, moisture by halogen moisture analyzer balance and friability. The test methods for evaluation of the Product at the stability time points shall include visual appearance/color, assay, related substances, dissolution, moisture by halogen moisture analyzer balance and friability.

 

4.0 Formulation Development

 

4.1 QS Pharma will utilize the current 10 mg tablet formulation composition to make a high shear wet granulation tablet that plans to utilize pregelatinized starch, lactose, magnesium stearate with fluid bed drying. The intent is to move from the paste granulation tablet formulation to a tablet formulation that employs current technology and is manufacturable. The process train is planned to include screens, a blender, high

 

Confidential

Page 3 of 9


QSPharma

Quality with Speed®

Proposal 05-1575

11 January 2005

 

shear granulator, fluid bed dryer and a tablet press. The ultimate scale will dictate the specific processing equipment. The characterization will include a feasibility batch that approximates the CTM batch size. Prior to the commencement of manufacturing, development batch records that specify the manufacturing procedures and acceptance criteria will be prepared by QS Pharma. These batches will be packaged in bulk with a sufficient quantity packaged into HDPE bottles for stability.

 

4.2 The initial and stability test methods are provided in 3.4. A single time zero analysis will cover all storage conditions. The stability protocol is proposed to include 25ñC/60% RH at 1, 2 and 3 months and 40ñC/75% RH at 1, 2 and 3 months.

 

5.0 CTM

 

QS Pharma will manufacture sufficient batches to meet Client requirements. The batches will be manufactured based on the process and composition identified in 4.0. The bulk density of the powder blend will determine the number of batches required to meet the delivery. All CTM batches will be manufactured under cGMP. Prior to the commencement of manufacturing, batch records that specify the manufacturing procedures and acceptance criteria will be prepared by QS Pharma, then supplied for prospective review and approval by Client.

 

5.1 The Product total batch size is 120,000 tablets (~6 kg of blend and 1.2 kg of API). The quantity specified is intended to cover processing losses and additional tablets for in-process, release testing, stability testing and retention.

 

5.2 The Placebo total batch size is 100,000 tablets (~5 kg of blend). The quantity specified is intended to cover processing losses and additional tablets for in-process, release testing, stability testing and retention.

 

5.3 The Product and Placebo batches will be packaged in the Client-specified 90 tablet count in HDPE bottles. Additional tablets will be packaged for release testing, stability testing and retention.

 

5.4 The CTM storage and material management shall include inventory management, controlled temperature storage at ambient temperature and humidity, domestic and international shipping preparation, overnight and same-day shipping preparation, shipment tracking, receipt confirmation and detailed monthly inventory, receiving and shipping report. The monthly charges are for the remainder of the two packaged batches that is not required for clinical provision at this time and the retention samples of the CTM.

 

5.5 QS Pharma will label and package the labeled bottles into kits as required by Client study design. The labeling, kit packaging and shipping will require the following activities – batch record generation, 100% label review of Client-provided released labels, labeling Placebo bottles, labeling Product bottles, labeling the box kits, insertion

 

Confidential

Page 4 of 9


QSPharma

Quality with Speed®

Proposal 05-1575

11 January 2005

 

of the Placebo bottles into the appropriate kit boxes, insertion of the Product bottles into the appropriate kit boxes, insertion of the kit boxes into the shipper boxes, labeling the shipper boxes and shipment of the shipper boxes. QA review will also occur prior to, during and after the process.

 

5.6 The CTM Product release and stability test methods are provided in 3.4. The release testing will cover the time zero analysis for all stability storage conditions. The stability protocols are proposed to include 25°C/60% RH at 1, 3, 6, 9, 12, 18 and 24 or Last Patient Out (LPO) months and 40°C/75% RH at 1, 3 and 6 months.

 

5.6 The CTM Placebo release test methods are assay (absence of active), appearance/color and friability. The release testing will cover the time zero analysis for all stability storage conditions. The stability test methods are assay (absence of active) for time zero only, appearance/color and friability. The protocol is proposed to include 25ñC/60% RH at 3, 6, 12 and 24 or LPO months.

 

6.0 Project Management

 

QS Pharma will provide project management support to monitor the progress of the project against established timelines. QS Pharma will update the Client with any changes that impact the predefined project timelines. QS Pharma shall be an extension of the Client Project Team and act as the Client Pharmaceutical Subteam. QS Pharma shall be available at Client’s request to participate in Client project team meetings and reviews.

 

7.0 Assumptions, Terms and Conditions

 

7.1. Development Activities. QS Pharma shall undertake and perform the work described in this Proposal (the “Development Activities”) which when accepted by Client shall become a contract binding on QS Pharma and Client (the “Contract”). No changes, deletions or additions to the Development Activities will be considered valid without mutual written agreement between Client and QS Pharma. Should unforeseen events occur requiring additional development efforts by QS Pharma beyond the Development Activities set forth in this Proposal, Client will be notified in advance of costs associated therewith.

 

7.2. Supply of Products. (a) Client shall supply QS Pharma with sufficient bulk quantities of the active ingredients for QS Pharma use in conducting the Development Activities under this Proposal. Such ingredients shall be supplied by Client at its expense.

 

(b) All other project specific items required to be purchased by QS Pharma and shall be billed back to Client at QS Pharma direct cost plus an additional 10% as a handling charge.

 

Confidential

Page 5 of 9


QSPharma

Quality with Speed®

Proposal 05-1575

11 January 2005

 

7.3. Payment for Service. (a) Client shall pay QS Pharma for the services to be provided during the term of this Proposal in such amounts and in such manner as set forth in this Proposal. All amounts quoted are in US$ funds and are valid for sixty (60) days from the date of this Proposal. All amounts quoted are subject to review by QS Pharma of all product specifications, development reports and Environmental, Health and Safety assessment. One review with changes is included in the fee for final reports. Any additional changes shall be invoiced separately at the then prevailing hourly rates.

 

(b) Project specific items, which include but are not limited to special equipment, tablet tooling, change parts, specialty coating runs, excipients, excipient testing, packaging components, laboratory columns and reagents, waste disposal, etc., obtained by QS Pharma from third party suppliers as well as services to be provided by any third party suppliers shall be billed back to Client upon QS Pharma receipt of invoice from any supplier of QS Pharma.

 

(c) Each QS Pharma invoice shall be due and payable within thirty (30) days of the date of such invoice. A late fee of 1.5% per month (18% annum) will be calculated on a daily basis and charged on all past due payments.

 

7.4. Payment Schedule. (a) Prior to the commencement of any Development Activities by QS Pharma pursuant to this Proposal, QS Pharma shall have received from Client a deposit in the amount set out in the Project Summary representing an initial payment for the services to be rendered by QS Pharma. This deposit amount will be held by QS Pharma as a deposit until the Development Activities, as modified from time to time, are fully completed or until this Contract expires or is terminated for whatever reason. The deposit amount shall be credited towards the final invoice for the Project.

 

(b) The balance of the payment shall be invoiced at the conclusion of each activity line item (2.0, 3.1, 3.2, 3.3, 3.4, 4.1, 5.1, 5.2, 5.3, and 5.5) and the provision of the applicable report or batch record, the balance due (~67.4% of the fee for the activity) will be billed. After the completion of each time point in line items 4.2, 5.4 and 5.6 and the provision of the applicable report, QS Pharma shall bill Client for the pro-rated balance due for that line item. The pro-rated balance due is ammortorized over the duration of the stability study or material management. The balance payment amounts shall be credited towards the final invoice for the Project. The billing shall occur on a monthly cycle with all items completed during the preceding month being billed.

 

7.5. Term and Termination. This Contract will take effect on the date of execution and shall continue until completion by QS Pharma of the Development Activities. Either party may terminate this Contract if the other party is in material breach of any provisions thereof and the breaching party fails to remedy any such breach within thirty (30) days of the notice of such breach by the non-breaching party.

 

Confidential

Page 6 of 9


QSPharma

Quality with Speed®

Proposal 05-1575

11 January 2005

 

Additionally, Client shall have the right to terminate this Contract immediately for any business reason. In either such case Client shall pay to (QS Pharma): (i) any fees and expenses due to QS Pharma for the services rendered up to the date of termination; (ii) all actual costs incurred by QS Pharma to complete activities associated with the termination and close of the Project; and (iii) any additional costs incurred by QS Pharma in connection with the Project that are required to fulfill applicable regulatory and contractual requirements.

 

7.6. Confidential Information. All proprietary and confidential information of either party disclosed or otherwise made known to the other party as a result of the Development Activities performed under this Contract shall be considered confidential property of the disclosing party (the “Confidential Information”). The Confidential Information shall be used by the receiving party, its employees and external advisors only for the purpose of performing the receiving party’s obligations hereunder. For purposes of this paragraph, Confidential Information shall not be deemed to include any information that is (i) known to the receiving party at the time of the disclosure, as evidenced by its written records prior to disclosure by the disclosing party; (ii) is or becomes available publicly other than as a result of a breach of this Contract by the receiving party, (iii) obtained from a third party lawfully in possession such information and under no obligation to maintain such information confidential.

 

Each party agrees that it will not reveal, publish or otherwise disclose the Confidential Information of the other party to any third party without prior written consent of the disclosing party. However, disclosure of Confidential Information may be made if required by law or by any regulatory or governmental authority to which the receiving party or any of its respective affiliates may be subject, in each case, on prior written notice to the disclosing party, so that the disclosing party may determine whether to seek a protective order or other appropriate remedy. This obligation of confidentiality and nondisclosure shall remain in effect for a period of ten (10) years after the effective date of termination of this Contract.

 

7.7. Inventions, Etc. All data and information generated or derived by QS Pharma as the results of Development Activities performed by QS Pharma under this Contract shall be and remain the exclusive property of Client. Any inventions that may evolve from the data and information described above or as the result of Development Activities performed by QS Pharma under this Contract shall belong to Client. Notwithstanding the foregoing, Client acknowledges that QS Pharma possesses certain inventions, processes, know-how, trade secrets, other intellectual properties and other assets, including but not limited to, analytical methods, computer technical expertise and software which have been independently developed by QS Pharma (collectively “QS Pharma Property”). Client and QS Pharma agree that any QS Pharma Property or improvement thereto which are used, improved, modified or developed by QS Pharma under or during the term of this Contract, is the product of QS Pharma technical expertise possessed and developed by QS Pharma prior to or during performance of this Contract and are the sole and exclusive property of QS Pharma.

 

Confidential

Page 7 of 9


QSPharma

Quality with Speed®

Proposal 05-1575

11 January 2005

 

7.8. Errors and Omissions. In the event of a material error by QS Pharma in the performance of the Development Activities, Client shall have the option to request QS Pharma to (1) repeat the service at QS Pharma own costs provided that Client provides the active ingredient, or (2) reimburse Client for the price for that particular service, excluding the cost of the active ingredient. In any event, QS Pharma shall not reimburse the amount of the active ingredient.

 

7.9. Indemnification. Client shall defend, indemnify and hold harmless QS Pharma and its affiliates and its and their respective directors, officers, employees and agents from and against any and all claims, damages, liabilities and expenses (including, without limitation, reasonable attorneys’ fees and expenses) (collectively, “Losses”) relating to or arising from or in connection with this Contract except to the extent such Losses are determined to have resulted from negligence or willful misconduct of QS Pharma. QS Pharma shall defend, indemnify and hold harmless Client and its affiliates and their respective directors, officers, employees and agents from and against any and all Losses relating to or arising from or in connection with this Contract, but only to the extent such Losses are determined to have resulted from negligence or willful misconduct of QS Pharma.

 

7.10. Indemnification Procedures. In the event that either party seeks indemnification, it shall inform the other party of the claim as soon as reasonably practicable after it receives notice thereof, shall permit the other party, at that party’s cost, to assume direction and control of the defense of the claim, and shall cooperate as reasonably requested (at the expense of the other party), in defense of the claim. Neither party shall settle or otherwise compromise any claim or suit in any manner that adversely affects that other party hereunder or imposes obligations on the other party in addition to those set forth in this Contract, without prior written consent of the other party, for which consent shall not be unreasonably withheld or delayed.

 

7.11. Miscellaneous. This Contract contains the entire understanding of the parties with respect to the subject matter herein and supersedes all previous agreements (oral and written), negotiations and discussions. The parties may modify or amend the provisions hereof only by an instrument in writing duly executed by both of the parties. Neither this Contract, nor any of either party’s rights hereunder, may be assigned or otherwise transferred by either party without the prior written consent of the other party. This Contract shall be interpreted and enforced under the laws of Delaware without regard to the conflict of laws provisions thereof. The obligation of the parties contained in Sections 7.6, 7.7, 7.8, 7.9 and 7.10 shall survive the expiration or earlier termination of this Contract.

 

Confidential

Page 8 of 9


QSPharma

Quality with Speed®

Proposal 05-1575

11 January 2005

 

QS Pharma and Client have executed this Contract in duplicate by the duly authorized officers of each party.

 

Client       QS Pharma
By:  

/s/

      By:  

/s/

Name:           Name:    
Title:           Title:    
Date:           Date:    

 

Confidential

Page 9 of 9

EX-23.1 20 dex231.htm CONSENT OF SINGER LEWAK GREENBAUM & GOLDSTEIN LLP Consent of Singer Lewak Greenbaum & Goldstein LLP

Exhibit 23.1

 

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

We consent to the use in this Amendment No. 1 to the Registration Statement of Orion Acquisition Corp. II on Form SB-2 of our report, dated January 25, 2005, appearing in the Prospectus, which is part of this Registration Statement.

 

We also consent to the reference to our Firm under the caption “Experts” in such Prospectus.

 

SINGER LEWAK GREENBAUM & GOLDSTEIN LLP

 

Los Angeles, California

March 10, 2005

 

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M$/!]%9[NO*Y3!4GR'[_ZK^-77S4./&2B_P!)G;LF0&W(LY51SQTF*P='3XFI MFJZMG*I'%:-9'9%/NO=%6P/\UGKKOWP.UMTT=>V#ZTJL9 MC^BNI,]MS:V=^1M754':529.MJOFFDE-1BXT@=C[KW0`1_S M]/BS2[`W7OO,=1?(W$1;%3:(W3MJJVWL7(;NQ]3O>+M_(;=HH\=AM^U]+E*R MKP/44EX-B[4[TRWQ^R%''MNI["I]P8BOBW=A*G(U%174]/0T&`B>LJ M9HM#1CW7NCJ=M?-;9W4?Q_ZL^1U=L3>FZME=JY[IS$4..VOD>O'R.U<=W16X MV@PN[-V;@RV^<;UW1[1V_49>F7)9*#-ST4:RJ\4LL;*Q]U[I`]9?S&>N^RNR M\1U;#UOV)MS.[EW-\K\!M:KR[;2JL9G*3XA5^Q\9O[.1RX?C?YR?77R(INKI>L/CEWKF:GM#X_[S^1\-)+DN MF<<-I[&VYG^R]K;])OC3W-41;7Z`^)G?N1VY#N/JQMR2XOY?9JBQVQ-LPNN\ M#M:ERFW\96BOR51692FI/&IB@:60/X_=>ZMHZ8[OV1WMM?";OV.<])A=Q[&Z MX[&P]3F-L9W`15.U^U=I4F]=IO#4Y:C@HLAD!A*Q#70TLLQH)R(IM$GI]^Z] MT,7OW7NO>_=>Z][]U[KWOW7NN+&P)^MN2/J2/S8?D^_=>Z)%\LOF8?BUE=DX MYNJ\CV(-];!^0>[,2N(WCM_`9AMP]&=:GLNBV90[=S4?\4W!/OV@IYZ2*JQZ MU#8ZHC5I8)(VU+[KW0K?$SY`T/RH^.O5W?U!A*7;,?8V&R%?5;:I,MELXFV\ MMA\_E]M9S;TV5SFT]C92LKL'F<+/2U1EQ5&%J8G5`Z!9']U[HQ/OW7NO>_=> MZ][]U[KWOW7NO>_=>Z][]U[KWOW7NO>_=>Z][]U[KWOW7NO>_=>Z][]U[KWO MW7NO>_=>Z][]U[KWOW7NO>_=>Z][]U[KWOW7NO>_=>Z][]U[KWOW7NO>_=>Z M][]U[KWOW7NO>_=>Z][]U[KWOW7NO>_=>Z][]U[KWOW7NO>_=>Z][]U[KWOW M7NO>_=>Z][]U[KWOW7NO>_=>Z][]U[KWOW7NO>_=>Z][]U[KWOW7NO>_=>Z] M[]U[KWOW7NO>_=>Z_]+=O^0`^/?VW5?^S!MMD4I[HV1_HH.Z!6&$=V?;9_\` MN.<5]G:/^-?9?Q'P_&<'0LA^0'\3%67WX2=8CLG_0AM,T1Z+3=QZ^_T%?WB[%/7RC^Z1'2R[>&?_O,,!Y`U1_P+ M^R.BY]^Z]T$':X_DI?Z:]Q?Z5G^,_P#IQ';^UAOW[U,A_>(]O?WBWY_=I^QQ MB'$`J!G5SVL9D_P_2S?J7^3*V4V`)).B8ZK_0_C3L1O'NIL+_ M`*&AMX'`+8M_=P;>;"A1B_O09?.T'V9%4(#[]U[H0?C9_P`-8_Z7NM/]ET;K M<=YGJZF/6?A3L'_2&.F_X=O?^$"G_OK(S^[FOP:;Y'3J^T]>KW[KW12-I#^2G_>39W]T'^%W]Y?\`9ANR MO[G_`&,>T?OO]F"%)CO](WV_E>PKFI/L?)YKXO1]G]M8_;D^Z]U#ZT'\D>_6 M?^B]_A8:H[6[@_T7C`1[5&9&VAN>C/;_`/!OW#F?,V>TB7R$U8C\AI?\G\P] M^Z]T+60'\J7_`$7;P&2?XG?Z(AU/V/\`WU-6FSSLP]/CY"Y\=E?Q?4RXP[5; MY-_Q'[FP51NOR>/_`"BP]^Z]T+_9R?`\=$=/'NB;XY-\;CD.KO\`0<.R8]DC MJ1:YJ3'GIX;%&XB-O&2/'BF&+,#:2A6P^EO=>Z`W="_RE1GL!_?23XE/NK_3 MQV&NUCFX]J+N/_9AA/MW_2N^W_NG.3_ORU0<7_'OMO5;P_<@"U_=>ZS=/C^4 M6<]TC_H3;X4CO_@SXWRC)_8?L?:^> MUD\_OW7NHV]!_*"^QW!_?U_A(<,.C.D3NG^/1]:#"-\=_P"+XG_9?!FON96Q M@ZR_BYH/[J^7_(Q*(C2$BP]^Z]T?#KT=+#=&\?\`1H>O'W;_``3KO^^QV:,$ MN5&W?X%7_P"BS^-_P?\`@FO]G[+5]O\`M6`]U[H6/?NO=>]^Z]U[ MW[KW7O?NO=>]^Z]T7ON!/B\=P;//?#!#8 MC;8%.G\).T_[L`;=_@9IK?;_`&0$&BVCCW[KW2U]^Z]U[W[KW7O?NO=>]^Z] MU[W[KW7O?NO=>]^Z]U[W[KW7O?NO=>]^Z]U[W[KW7O?NO=>]^Z]U[W[KW7O? MNO=>]^Z]U[W[KW7O?NO=>]^Z]U[W[KW7O?NO=>]^Z]U[W[KW7O?NO=>]^Z]U M[W[KW7O?NO=>]^Z]U[W[KW7O?NO=>]^Z]U[W[KW7O?NO=>]^Z]U[W[KW7O?N MO=>]^Z]U[W[KW7O?NO=>]^Z]U[W[KW7O?NO=>]^Z]U[W[KW7O?NO=>]^Z]U[ &W[KW7__9 ` end CORRESP 31 filename31.htm SEC LETTER

 

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Washington, D.C.

March 11, 2005

        

 

VIA EDGAR TRANSMISSION AND COURIER

 

Mr. John Reynolds

Assistant Director

Office of Emerging Growth Companies

Securities and Exchange Commission

Division of Corporation Finance

450 Fifth Street, N.W.

Washington, D.C. 20549

Mail Stop: 0511

 

  Re: Registration Statement on Form SB-2 filed January 31, 2005

(Registration No. 333-122431) of Orion Acquisition Corp. II

 

Dear Mr. Reynolds:

 

On behalf of Orion Acquisition Corp. II, a Delaware corporation (the “Registrant”), we hereby set forth the following information in response to the comments contained in the letter dated February 25, 2005 from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”). The comments are repeated below and are followed by a summary of the responsive actions taken. Amendment No. 1 (“Amendment No. 1”) to the Registrant’s Registration Statement on Form SB-2, filed with the Commission on January 31, 2005 (Registration No. 333-122431) (the “Registration Statement”), reflects the Registrant’s responses to the Staff’s comments.

 

In addition to the supplemental and other information provided to the Staff pursuant to this letter, the Registrant has enclosed herewith as a courtesy to the Staff four (4) paper hard copies of Amendment No. 1 to the Registration Statement, as filed with the Commission on March 11, 2005 (Registration No. 333-122431)(the “Amendment No. 1”), each of which has been marked to reflect the cumulative revisions made by the Registrant to the Registration Statement.

 

* * *


Securities and Exchange Commission

March 11, 2005

Page 2

 

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General

 

1. We note that the registration statement covers the resale of substantially all of the Orion Acquisition Corp. II’s outstanding securities, i.e., 16,056,115 shares of 18,006,141 shares that will be outstanding after the offering. Your offering, therefore, appears to be an “at the market” primary offering of equity securities by or on behalf of the registrant under Rule 415(a)(4) of Regulation C. Because you do not qualify to conduct a primary offering “at the market,” please revise the terms of your offering to provide that all offers and sales will be made at a disclosed fixed price for the duration of the offering, resales will be made on a prompt and continuous basis, and the selling shareholders will be identified as underwriters. Revise your disclosure throughout the prospectus accordingly.

 

We respectfully submit that the offering is not an “at the market” primary offering within the meaning of Staff guidance under Rule 415(a)(4) of Regulation C or otherwise. In “at the market offerings,” the investor which frequently enters into such arrangements typically agrees to purchase securities based on a formula, such as VWAP, is able to and does resell such securities immediately and there are put and call provisions.

 

Rather than constituting an at the market equity offering, the transactions consisted of a merger in which the Registrant acquired a privately held life sciences company and a private placement in which the Registrant raised $12 million in which the investors were at risk from the date of the investment on December 17, 2004. In the merger, securities of Medivation were converted into securities of the Registrant. The roughly $1,900,000 on the balance sheet of the Registrant at the time of the completion of the merger was insufficient to fund the operations of the combined entity through the achievement of the its next operating milestones. To address this, immediately following the merger the Registrant completed a private placement of $12 million of its common stock at a fixed price of $1.55 per share. The securities acquired in both the merger and the private placement were acquired irrevocably at closing on December 17, 2004 and at a fixed price. All of the holders of those securities have been subject to market risk since December 17, 2004. Registration rights agreements executed in connection with the private placement provided for the resale registration statement to be filed approximately six weeks following the completion of the transaction, to be declared effective more than three months after the closing. In these transactions there was only market risk for the securityholders, which is markedly different from the risk of an underwriter in an indirect primary offering. There was no formula, no average trading price, no VWAP, and no ability to resell the securities immediately which is typical in “at the market” equity offerings.

 

We believe that the shares registered for resale under the registration statement are appropriately characterized as secondary sales under Rule 415(a)(1)(i).

 

Specifically, the registration statement relates to three categories of securities:

 

    8,940,512 shares of common stock registered for resale issued in connection with the December 17, 2004 private placement;

 

    6,890,103 shares of common stock registered for resale issued in connection with the merger between the Registrant and Medivation, Inc. which closed on December 17, 2004; and

 

    225,500 shares of common stock issuable upon exercise of the Registrant’s outstanding Class B warrants.

 

In addition to the structural differences between an at the market equity offering and these transactions, Item D.29 of the Staff’s Manual of Publicly Available Telephone Interpretations recognizes that in determining whether an offering styled a secondary one is really on behalf of the issuer, consideration should be given to “how long the selling stockholders have held the shares, the circumstances under which they received them, their relationship to the issuer, the amount of shares involved, whether the sellers are in the business of underwriting securities and finally, whether under all the circumstances it appears that the


Securities and Exchange Commission

March 11, 2005

Page 3

 

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seller is acting as a conduit for the issuer.” We respectfully submit that these factors further to each of the categories of securities demonstrate that the selling stockholders are not and were not acting as underwriters, and that the issuer is not undertaking an “at market” primary offering.

 

1. Shares Issued in Connection with the Private Placement.

 

How long the selling shareholders have held the shares. All of the securities purchased in the private placement were purchased for cash or cancellation of indebtedness on December 17, 2004. Once the securities were issued, the investors had no mechanism to redeem, put, or otherwise require the Registrant to repurchase the securities. The investors’ decision to purchase the shares was irrevocable. There were only contractual registration rights.

 

Circumstances under which selling shareholders received the shares. Of the 8,940,512 shares registered in connection with the private placement, 6,903,399 shares or 77% were purchased by investors for cash at a fixed price of $1.55 per share, 838,536 shares or 9% were purchased by investors in exchange for cancellation of indebtedness, also at a fixed price of $1.55 per share, 625,699 shares or 7% were issued as consideration for services previously rendered to either Medivation or the Registrant to two placement agents, and warrants to purchase 572,878 shares or 6% were issued as consideration for services previously rendered to one placement agent, again as consideration for placement agent services. Each investor represented to the Registrant that it was acquiring the securities for its own account, not as nominee or agent, and not with a view to resale or distribution. A tabular representation of these securities is as follows:

 

Type of Consideration


   Shares

   Warrants

   Total

Cash

   6,903,399    —      6,903,399

Cancellation of Debt

   838,536    —      838,536

Services Previously Rendered

   625,699    572,878    1,198,577

Total

   8,367,634    572,878    8,940,512

 

Interpretation 3S.(b) in the March 1999 supplement to the Manual of Publicly Available Telephone Interpretations states that the Staff will not object if a company registers the resale of securities purchased in a Section 4(2)-exempt sale “if the investor is at market risk at the time of filing of the resale registration statement.” In contrast to many PIPE transactions in which the filing or effectiveness of the registration statement is a condition to the investors’ obligation to close the transaction, pursuant to the terms of registration rights agreements executed in connection with the private placement the registration statement was filed on January 31, 2005, more than one month following the closing of the private placement. Since the closing of the private placement, the price of the Registrant’s common stock has fluctuated from a high of $4.25 per share to a low of $1.75 per share. Investors have been at market risk throughout this period. Therefore, the registration for resale qualifies as a secondary offering rather than an indirect primary offering.


Securities and Exchange Commission

March 11, 2005

Page 4

 

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The relationship of the selling shareholders to the issuer. With three exceptions, none of the 51 investors in the private placement had any prior relationship to the Registrant or to Medivation, Inc. The table below sets for the name of each purchaser of shares the private placement, the number of shares purchased and whether there was any prior relationship between the investor and either Medivation or the Registrant. Each investor in the private placement is an “accredited investor” as that term is defined in Rule 501 of Regulation D under the Securities Act, and represented to the Registrant in writing as such; as to the financial sophistication of such investor and that such investor is acquiring the shares for its own account and not with a view to resale.

 

Securityholder


  

Shares

Received


  

Type of

Consideration


  

Prior

Relationship

with

Registrant


  

Prior

Relationship

with

Medivation


Special Situations Private Equity Fund, L.P.

   1,290,322    Cash    No    No

Special Situations Fund III, L.P.

   967,742    Cash    No    No

Joseph J. Grano, Jr.

   652,144    Cash; Debt Cancellation    No    Yes

TTC Private Equity Partners LLC

   504,780    Cash    No    No

Dara BioSciences, Inc.

   444,487    Debt Cancellation    No    Yes

ProMed Partners L.P.

   351,030    Cash    No    No

ProMed Offshore Fund II, Ltd.

   345,850    Cash    No    No

Walker Smith International Fund, Ltd.

   333,484    Cash    No    No

Special Situations Cayman Fund, L.P.

   322,581    Cash    No    No

Walker Smith Capital (QP), L.P.

   257,420    Cash    No    No

Robert Charles Friese

   161,290    Cash    No    No

Cimarron Overseas Equity Master Fund L.P.

   129,032    Cash    No    No

Lewin Investments LLC

   129,032    Cash    No    No

Silicon Prairie Partners, L.P.

   129,032    Cash    No    No

Trust Under Will of A. Wilfred May

   129,032    Cash    No    No

Steven Becker

   96,774    Cash    No    No

Melvyn Weiss

   96,774    Cash    No    No

ProMed Partners II L.P.

   85,370    Cash    No    No

Bushido Capital Master Fund, L.P.

   80,645    Cash    No    No

Gamma Opportunity Capital Partners, L.P.

   80,645    Cash    No    No

Topix, Inc.

   80,000    Cash    Yes    No

Arthur Shartsis

   65,000    Cash    No    No

Edgewater Ventures

   64,516    Cash    No    No

Edward Negley

   64,516    Cash    No    No

John Braniff

   64,516    Cash    No    No

John Micek III

   64,516    Cash    No    No

ProMed Offshore Fund, Ltd.

   56,460    Cash    No    No

Walker Smith Capital, L.P.

   54,258    Cash    No    No

WS Opportunity Fund Intl. Ltd.

   48,710    Cash    No    No

WS Opportunity Fund (QP), L.P.

   44,322    Cash    No    No

James Patrick Tierney

   40,000    Cash    No    No

WS Opportunity Fund, L.P.

   36,000    Cash    No    No

R. L. Clarkson

   35,000    Cash    No    No

Richard D. Clarkson

   35,000    Cash    No    No

Richard L. Clarkson, f/b/o Lucille S. Ball

   35,000    Cash    No    No

Anthony DiGiandomenico

   32,258    Cash    Yes    No

Clay D. McCollor and Elissa McCollor

   32,258    Cash    No    No

Joel T. Leonard Trust dated October 25, 1994

   32,258    Cash    No    No

Joseph F. Barletta

   32,258    Cash    No    No

Maurice Micek

   32,258    Cash    No    No

Shon Kwong and Laura Micek

   32,258    Cash    No    No

Steven O’Kuhn

   32,258    Cash    No    No

Steven L. Zelinger

   16,200    Cash    No    No

John Micek, Custodian for Gabriel Micek

   16,129    Cash    No    No

John Micek, Custodian for Jordan Micek

   16,129    Cash    No    No

John Micek, Custodian for Peter Micek

   16,129    Cash    No    No


Securities and Exchange Commission

March 11, 2005

Page 5

 

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Securityholder


  

Shares

Received


  

Type of

Consideration


  

Prior

Relationship

with

Registrant


  

Prior

Relationship

with

Medivation


Maurice Micek, Custodian for Andrew Micek

   16,129    Cash    No    No

Maurice Micek, Custodian for Benjamin Micek

   16,129    Cash    No    No

Cedric Vanzura

   15,000    Cash    No    No

Greg J. Micek, Guardian for Gregory J. Micek Jr.

   12,903    Cash    No    No

Greg J. Micek, Guardian for Alexandria L. Micek

   6,452    Cash    No    No

John A. Raiser Irrevocable Trust dated March 2, 1988

   6,452    Cash    No    No

Jeff Stroud and Jean Stroud

   3,226    Cash    No    No

 

The only investors in the private placement who had any prior relationship at all with the Registrant are Anthony DiGiandomenico and Topix, Inc. Mr. DiGiandomenico was the former Chief Financial Officer of the Registrant and is a member of the board of directors of the Registrant and a principal at MDB Capital Group LLC, which served as a placement agent in the private placement and which, prior to the private placement and Medivation, Inc. merger, was a principal stockholder of the Registrant. The principal stockholder of Topix, Inc. is Gregory Bailey, who is a principal of MDB Capital Group.

 

The only investors who had any prior relationship with Medivation are Dara BioSciences, Inc. and Joseph J. Grano, Jr. Dara Biosciences was an investor in and a stockholder of Medivation, Inc, but had no prior relationship with the Registrant. Dara Biosciences’ private placement shares were purchased in exchange for cancellation of indebtedness previously owed to it by Medivation, Inc. Mr. Grano was a consultant to and investor in Medivation, and also had no prior relationship to the Registrant. A portion of the shares issued to Mr. Grano in the private placement were purchased in exchange for cancellation of indebtedness previously owed to him by Medivation, Inc.

 

All of these investors purchased shares in the private placement on the same terms and subject to the same conditions as the other investors, who had no prior relationship with the Registrant.

 

In addition to the information set forth above, we note that while Brock Capital Group LLC did not invest in the private placement, it received 52,821 shares as consideration for services previously rendered as placement agent, which shares are included in the registration statement. Other than its role as placement agent in the private placement, Brock Capital Group had no prior relationship with the Registrant or with Medivation. We note further that MDB Capital Group also received 572,878 shares and warrants to purchase 572,878 shares at an exercise price of $1.55 per share, in each case as consideration for services previously rendered to the Registrant as placement agent. MDB Capital Group’s prior relationship with the Registrant is described above. These shares and the shares issuable upon exercise of the warrants are registered for resale under the registration statement.

 

The amount of shares involved. The amount of securities covered by the registration statement related to the private placement is 8,940,512 shares of 17,996,178 shares outstanding on a fully diluted basis, or approximately 50% of the Registrant’s capitalization. While this is a substantial portion of the Registrant’s capital stock, as the Staff indicated in Comment 7 of its February 25, 2005 letter to the Registrant, prior to the


Securities and Exchange Commission

March 11, 2005

Page 6

 

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merger with Medivation, Inc. and the private placement, the Registrant was a “blank check company” as that term is defined in Rule 419 of Regulation C. The valuation of the Registrant in the private placement was based on the combined valuation of the issuer, a “blank check” with no operations, and Medivation, Inc., a life sciences company with no historical revenues. The relatively low valuation of the Registrant combined with the need to raise additional capital in the private placement resulted in the issuance of a substantial number of shares of common stock, but did not change the character of the private placement, nor did it impact the status of the investors in the private placement as investors purchasing the securities for their own accounts and not with a view for resale or distribution.

 

Whether the sellers are in the business of underwriting securities. None of the selling stockholders who purchased shares in the private placement is currently in the business of underwriting securities. Each of MDB Capital Group LLC and Brock Capital Group LLC are registered broker-dealers, however, neither MDB nor Brock purchased shares in the private placement. We are informed by MDB Capital Group that they have not participated as an underwriter in an offering for more than five years, and by Brock Capital Group that they have never participated as an underwriter. Moreover, all of the securities registered for resale by MDB and Brock were received as consideration for their services as placement agents in the private placement. This is in contrast to the role of underwriters in an “at the market” primary offering, in which underwriters purchase securities from the issuer for immediate resale.

 

Whether under all the circumstances it appears that the seller is acting as a conduit for the issuer. The December 17, 2004 private placement negotiated at arm’s length terms with investors. 50 of the 54 investors in the private placement had no prior relationship with either the Registrant or Medivation. The resale registration statement was filed more than one month following the date of the investors’ irrevocable investment decision to purchase the shares from the Registrant at a fixed price, and all of the investors have been and continue to be at market risk. The selling stockholders are not participating in an “at the market offering” because the private placement was not structured as an “at the market offering”, in which broker-dealers typically agree to purchase securities based on a formula and are able to resell such securities immediately.

 

2. Shares Issued in Connection with the Medivation Merger. On December 17, 2004, the Registrant completed a merger transaction in which its wholly owned subsidiary was merged with and into Medivation, Inc., a privately held life sciences company. As more fully described in the registration statement, the following securities were both issued in connection with the merger, and are covered by the registration statement. Each share of Series B Preferred Stock is convertible into twenty shares of common stock.


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Selling Stockholder


   Series B
Preferred Stock


   Warrants to purchase
common stock


Dara Biosciences, Inc.

   110,642    161,290

Selena Pharmaceuticals, Inc.

   110,642   

David T. Hung, M.D.

   86,055    10,065

C. Patrick Machado

   24,587    2,839

Joseph J. Grano, Jr.

        77,419

 

How long the selling shareholders have held the shares. All of the securities issued in connection with the merger were issued by the Registrant upon conversion of securities of Medivation on December 17, 2004. All of the shares of Medivation common stock were issued on October 10, 2003 and October 20, 2003. Warrants to purchase shares of Medivation capital stock, converted into warrants to purchase the Registrant’s common stock pursuant to the merger, were issued to the following selling stockholders on the following dates: Dara Biosciences on October 10, 2003 and April 1, 2004, Joseph J. Grano Jr. on June 8, 2004, August 1, 2004 and September 1, 2004, and David T. Hung, M.D. and C. Patrick Machado on November 16, 2004.

 

Circumstances under which selling shareholders received the shares. All of the shares of Medivation common stock outstanding prior to the merger were issued in connection with Medivation’s formation in October of 2003 and, with one exception, in exchange for cash. Selena Pharmaceuticals purchased 900,000 shares of Medivation common stock on October 10, 2003 in exchange for contribution of intellectual property. Also in October, 2003, Dara Biosciences, David T. Hung, M.D. and C. Patrick Machado purchased 900,000 shares, 700,000 shares and 200,000 shares of Medivation founders’ common stock, respectively, for cash.

 

In addition, Medivation issued warrants to purchase shares of its capital stock in connection with a series of convertible promissory note financing transactions with warrant coverage to Mr. Grano and to Dara Biosciences. Mr. Grano loaned $600,000 to Medivation in three equal tranches of $200,000 in exchange for convertible promissory notes and warrants. Dara Biosciences loaned Medivation $1,250,000, also in exchange for convertible promissory notes and warrants. At the time of these transactions, Medivation had not commenced merger or PIPE discussions with the Registrant. Rather, these transactions were structured as customary silicon valley convertible note financings, in which the investors invested cash in a development stage company with the liquidation preference of debt and the opportunity of converting that debt into equity of a promising young company, and the issuer was able to raise financing without suffering the dilution associated with an equity financing at an early stage with an associated low valuation. At the time of these investments there was no contemplation of an immediate resale of securities; the issuer was a private company contemplating private venture financing, in contrast to an “at the market” offering in which investors would have an opportunity to resell their securities into the public market with little or no market risk.

 

Finally, Medivation issued to Dr. Hung and Mr. Machado warrants to purchase shares of its capital stock in November, 2004 as consideration for their execution of guarantees of the obligations of Medivation for professional services, should Medivation


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be unable to honor those obligations. Each of these warrants was assumed by the Registrant in the merger.

 

The relationship of the selling shareholders to the issuer. Prior to the merger, none of the holders of any type of equity security of Medivation had any affiliation whatsoever with the issuer. This distinguishes the merger transaction from an “at the market” primary offering in which underwriters contract with an issuer for purchase and immediate resale of the securities. The following summarizes relationships between individuals and entities which invested in Medivation and Medivation, at the time of those investments. Dr. Hung and Mr. Machado were Chief Executive Officer and Chief Financial Officer, respectively, and members of the board of directors of Medivation. Dr. Hung was also member of the board of directors of Dara Biosciences. Sergey Sablin, Ph.D., scientific director of Medivation, is a stockholder of Selena Pharmaceuticals. Joseph Grano, Jr. was a consultant to Medivation at the time of his investments.

 

The amount of shares involved. The amount of securities covered by the registration statement related to the merger, assuming conversion of all shares of the Registrant’s Series B Preferred Stock into common stock, is 6,890,103 shares of 17,996,141 shares outstanding on a fully diluted basis, or approximately 38% of the Registrant’s capitalization. While this is a substantial portion of the Registrant’s capital stock, as the Staff indicated in Comment 7 of its February 25, 2005 letter to the Registrant, prior to the merger with Medivation, Inc. and the private placement, the Registrant was a “blank check company” as that term is defined in Rule 419 of Regulation C. As a result, the relative valuations of the Registrant and Medivation in the merger reflected the fact that that while neither Medivation nor the Registrant had any historical revenues, Medivation owned certain intellectual property rights. The relatively low valuation of the Registrant in the merger resulted in the issuance of a substantial number of shares of capital stock, but did not change the character of the transaction or the status of the selling stockholders.

 

Whether the sellers are in the business of underwriting securities. None of the selling stockholders who received equity securities of the Registrant in connection with the merger is in the business of underwriting securities.

 

Whether under all the circumstances it appears that the seller is acting as a conduit for the issuer. The Medivation merger and subsequent registration for resale of the securities issued in the merger is structured as a customary acquisition of a private company by a public company coupled with a resale registration. The former securityholders of Medivation, having no prior affiliation with the issuer, formed their investment decisions in Medivation prior to the commencement of any business combination discussions with the Registrant. As a condition to the merger, holders of 100% of the common stock of Medivation, Dara Biosciences, Selena Pharmaceuticals, Dr. Hung and Mr. Machado, were each required to, and did, execute “lock-up” agreements by which they agreed to sell or otherwise dispose of their shares of the Registrant’s common stock until the later of one year following the closing of the merger or the achievement of a particular operating milestone in the Registrant’s Dimebon clinical trials. Together these facts demonstrate that the selling stockholders named in the registration statement are not acting as conduits for the issuer.


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3. Shares Issuable upon Exercise of Currently Outstanding Warrants. The Registrant has currently outstanding 225,500 Class B Warrants, each exercisable for one share of the Registrant’s common stock at an exercise price of $0.125 per share. The Class B Warrants were initially issued in 1995 pursuant to a registration statement on Form SB-2, Registration Number 333-3255. Item A.9 and A.55 of the Staff’s Manual of Publicly Available Telephone Interpretations provide that when the issuance of warrants or convertible securities are registered under the Act, the issuance of shares underlying those warrants must also be registered, and moreover that the Staff will not object if the issuer does not keep the prospectus up to date while those warrants are out of the money. By the terms of the Class B Warrants, the completion of the Medivation merger caused the warrants to become exercisable and as a result were “in the money.” As a result the Registrant seeks to register the issuance of the shares of common stock underlying the warrants pursuant to Section 5 of the Act as primary sales under Rule 415(a)(1)(iii).

 

Registration of the shares of common stock underlying the Class B Warrants is otherwise unrelated to the private placement and the merger. The decision to include the shares issuable upon exercise of the Class B Warrants was made to ease the administrative burden and additional cost of filing multiple registration statements. This transaction is therefore severable from the registration of the securities issued in connection with the private placement and the merger.


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2. With respect to the shares of common stock offered by the company to the holders of outstanding common stock purchase warrants, advise us supplementally about the disclosure appearing on page 15 that states, “the principal purpose of the offering of the shares of common stock issuable upon the exercise of outstanding warrants is to enable us to issue such shares of common stock in compliance with applicable securities laws.” Clarify what you mean by “applicable securities laws.” We remind you that it is the position of the staff that the securities underlying securities that were sold privately must also be sold privately pursuant to the same exemption from registration. They are part of the same transaction. Only the resales of the underlying securities may be registered by this registration statement and the exercise or conversion transaction between the Selling Shareholders and the Company remains private, subject to the limitations of available exemptions. Please advise us supplementally whether you have identified, as selling shareholders, the individuals who currently hold the outstanding common stock purchase warrants.

 

The Registrant has currently outstanding 225,500 Class B Warrants, each exercisable for one share of the Registrant’s common stock at an exercise price of $0.125 per share. The Class B Warrants were initially issued in 1995 pursuant to a registration statement on Form SB-2, Registration Number 333-3255. Item A.9 and A.55 of the Staff’s Manual of Publicly Available Telephone Interpretations provide that when the issuance of warrants or convertible securities are registered under the Act, the issuance of shares underlying those warrants must also be registered, and moreover that the Staff will not object if the issuer does not keep the prospectus up to date while those warrants are out of the money. By the terms of the Class B Warrants, the completion of the Medivation merger caused the warrants to become exercisable, and therefore “in the money.” As a result the Registrant seeks to register the issuance of the shares of common stock underlying the warrants pursuant to Section 5 of the Act.

 

We acknowledge the Staff’s comment that securities underlying securities that were sold privately must also be sold privately. With respect to the shares underlying warrants that were sold privately, we have revised the registration statement to reflect the registration for resale of the securities underlying privately sold warrants. We direct the Staff’s attention to the following selling stockholders identified in the selling stockholder table, each of whom holds warrants that were sold privately: David T. Hung, M.D., C. Patrick Machado, Dara Biosciences, Inc., Joseph J. Grano, Jr. and MDB Capital Group LLC. In addition, following receipt by MDB Capital Group LLC of warrants issued to it as consideration for its services in connection with the private placement, MDB Capital Group assigned a portion of its warrant to the following individuals, each of whom is consequently listed as a selling stockholder of shares issuable upon exercise thereof: Anthony DiGiandomenico, Christopher Marlett, 703149 Ontario Inc., Karen Simi, Christopher MacIntyre, Julie Dad and Kimberly Renner.


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3. If Medivation hosts an internet website, please disclose its internet address.

 

The Registrant confirms that it does not host an internet website.

 

4. The information under “About this Prospectus” and “Explanatory Note” should be placed in the inside back cover page of the prospectus, or elsewhere other than between the cover page and the summary. The summary should immediately follow the prospectus cover or the table of contents.

 

The Registration Statement has been revised to provide that the information under “About this Prospectus” and “Explanatory Note” has been placed in the inside back cover page and on page 54, respectively, of the prospectus; as a result, the Summary of such prospectus immediately follows the table of contents in Amendment No. 1.

 

Summary

 

5. Please explain “value-enhancing milestone events”.

 

The Registrant has revised the referenced disclosure on pages 1, 17 and 19 in response to the Staff’s comment.

 

6. State the full corporate names of Medivation and merger sub.

 

The Registrant has revised the referenced disclosure in response to the Staff’s comment to state the full corporate names of Medivation, Inc. and Medivation Acquisition Corp.

 

7. State that prior to the merger, Orion was a “blank check” as the term is defined in Rule 405 of Regulation C of the Securities Act.

 

The Registrant has revised the referenced disclosure in response to the Staff’s comment to state that prior to the merger, Orion was a “blank check company” as the term is defined in Rule 419 of Regulation C of the Securities Act.

 

8. As the registrant’s predecessor, the full background and development of the business of Medivation is required to be discussed— as a summary hereunder and fully in the Business section. Indicate that Medivation has had no revenues to date.

 

The Registrant has revised the referenced disclosure on pages 1, 17 and 19 in response to the Staff’s comment.

 

9. The estimated expenses of the offering to be paid by the company on behalf of the selling shareholders should be indicated.

 

The Registrant has revised the referenced disclosure on page 4 in response to the Staff’s comment.


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Risk Factors

 

10. In the introductory paragraph, clarify that you disclose all “material” risks here.

 

The Registrant has revised the referenced disclosure on page 5 in response to the Staff’s comment.

 

11. Revise your risk factor subheadings to ensure that your subheadings clearly reflect the material risk disclosed in the narrative. For example, the subheading for the third risk factor merely reads “We may be unable to identify and acquire additional product candidates.” Similarly, the subheading for the fourth risk factor reads “We currently own patent rights to only two products.” Please revise your subheadings, as appropriate, so that they adequately describe the specific risk or consequence that results or may result from the stated fact. To assist you in this regard, we refer you to “A Plain English Handbook — How to Create Clear SEC Disclosure Documents,” issued by the Office of Investor Education and Assistance, which is available on our website at www.sec.gov, and the updated version of Staff Legal Bulletin No. 7, dated June 7, 1999.

 

The Registrant has revised the referenced disclosure in response to the Staff’s comment.

 

12. To the extent possible, avoid the generic conclusion you make in some of your risk factors that the risk discussed would have a material adverse or negative affect on your business, results of operations or financial condition. Instead, replace this language with specific disclosure of how your business, results of operations or financial condition would be affected.

 

The Registrant has revised the referenced disclosure on pages 5, 6 and 10 in response to the Staff’s comment.

 

13. The first, second and fourth risk factors on page 11 appear duplicative. Please combine them.

 

The Registrant has revised the first and second risk factors previously on page 11 to combine them in response to the Staff’s comment. With respect to the fourth risk factor previously on page 11, the Registrant does not believe that risk factor to be duplicative with the first and second risk factors because it addresses the specific risks to the Registrant associated with litigation involving pharmaceutical patents of proprietary pharmaceutical companies. Because Dimebon is currently the Registrant’s lead product candidate, the success of the Registrant may depend on the Registrant’s pharmaceutical patent and other intellectual proprietary rights associated with Dimebon. Intellectual property litigation affecting one of the Registrant’s product candidates presents risks specifically applicable to the dependence of the Registrant on associated intellectual property rights, the occurrence of which may result in adverse consequences to the Registrant that are distinct from other types of litigation to which the Registrant may become subject.

 

In addition, because such risks relate exclusively to those associated with intellectual property rights, the Registrant believes any combination of such risks with the risk factors in the first and second paragraphs previously on page 11 would be inconsistent with the risk factor subheading. That is, risks specific to intellectual proprietary rights are more optimally located, and this is


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more effective, when located under the risk factor subheading titled “Risks Related to Intellectual Property”; to combine such risks, including the fourth risk factor on page 11, with any other risk factor subset would attenuate the effectiveness of such risk and disturb the internal organization given to this section.

 

14. The second risk factor on page 13 is common to every small business, to most other businesses and to the stock market in general most of the time. It should be deleted.

 

The Registrant has deleted the referenced disclosure on page 13 in response to the Staff’s comment.

 

Forward-Looking Statements

 

15. Please remove the tem “will” from the list of forward-looking statements.

 

The Registrant has revised the referenced disclosure on page 15 to delete the word “will” in response to the Staff’s comment.

 

Management’s Discussion and Analysis

 

16. Please expand Management’s Discussion and Analysis to discuss the reverse merger with Medivation and the common stock offering on December 17, 2004, and the related effects on the financial statements.

 

The Registrant has revised the referenced disclosure on page 17 in response to the Staff’s comment.

 

17. Please disclose the estimated costs associated with each milestone referenced in the fifth paragraph and disclose whether you currently have the cash required to Fund each the activities associated with each milestone.

 

The Registrant has revised the referenced disclosure on page 18 in response to the Staff’s comment.

 

18. For each significant source of funding, please name each source, disclose the principal terms of each source and file the agreement as an exhibit to the registration statement if not filed presently.

 

The Registrant has revised the referenced disclosure on page 17 and has filed each agreement as an exhibit to the Registration Statement in response to the Staff’s comment.

 

19. We do not see the sale of “debt securities” any place in the past financings of this company or the predecessor. Please clarify.

 

The Registrant has revised the referenced disclosure on page 17 in response to the Staff’s comment to include references to the sales by Medivation, Inc. of convertible promissory notes.


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20. The December 2004 private placement of 7,741,935 common shares should be fully discussed.

 

The Registrant has revised the referenced disclosure on page 17 in response to the Staff’s comment.

 

Business

 

21. Please specifically disclose the factual basis for and the context of all your beliefs, understandings, estimates, and opinions. This particularly pertains to your disclosure of all projections, statistics and assertions. Unless you can substantiate, on a reasonable basis, all of the projections, statistics and assertions that you cite, please remove them. To the extent you rely on industry analyses, please disclose whether the source is publicly available. If the source is not available for no or nominal charge, then the company must adopt the information as the company’s own or provide a consent for its use. Also, supplementally provide the staff with copies of all sources utilized for your disclosure of statistics. Some examples include the following. This is not an exhaustive list.

 

  a. all disclosure referencing studies or reports in the “published literature;”

 

  b. the disclosure in the two paragraphs of “The Alzheimer’s Disease Opportunity” subsection citing information from the Alzheimer’ s Association and Scientific American;

 

  c. the disclosure in the second sentence of the first paragraph of the “FDA- Approved Therapeutics and Purported Mechanisms of Action” subsection;

 

  d. the disclosure in the “Combination Therapy” section citing information from the Journal of the American Medical Association;

 

  e. much of the disclosure contained in the first paragraph of the “Market Size” subsection;

 

  f. the information in the “Preclinical Data” subsection discussing the results of preclinical experiments performed at the Institute of Physiologically Active Compounds;

 

  g. the information in the “Anti-Aging Indications” subsection discussing the results of the experiment performed at the Institute of Physiologically Active Compounds;

 

  h. the information discussing the results of the experiments using N10904;

 

The Registrant has revised the referenced disclosure on page 20 in response to the Staff’s comment. As a result of such additional disclosure, the Registrant believes that the factual basis for and context of all beliefs, understandings, estimates and opinions included in the Registration Statement have been disclosed and are currently reflected in Amendment No. 1. In


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addition, the Registrant hereby supplementally provides copies of all sources utilized for disclosure of statistics in the Registration Statement and Amendment No. 1, together with a copy of the Business section annotated, marked and numbered to reflect each statistic contained therein, and the source materials supplementally provided to the Staff are each numbered to correspond to the numbering on the annotated copy of the Business section.

 

22. Disclose whether the results of pilot open-label clinical study performed at the Moscow Center for Gerontology are published results. Also, further describe how the company intends to utilize the results of the clinical study.

 

The Registrant has revised the referenced disclosure on page 25 in response to the Staff’s comment.

 

23. Please file the preferred partnership letter agreement with the Institute of Physiologically Active Compounds as a material exhibit.

 

The Registrant has filed the referenced agreement as Exhibit 10.8 to the Registration Statement in response to the Staff’s comment.

 

Manufacturing

 

24. We note that you have entered two agreements with U.S. contract laboratories to manufacture bulk Dimebon drug substance and finished Dimebon tablets. Please disclose the material terms, financial and otherwise, of these agreements and file the agreements as material exhibits. Also, name the manufacturers pursuant to Item 101(b)(5).

 

The Registrant has revised the referenced disclosure on page 32, and has filed the referenced agreements as Exhibits 10.9(a) and 10.9(b) to the Registration Statement in response to the Staff’s comment.

 

Management

 

25. Please disclose Mr. DiGiandomenico’s affiliation with Vitacube Systems Holdings, Inc.

 

The Registrant has revised the referenced disclosure on page 34 in response to the Staff’s comment.

 

26. Indicate the nature of the business of ProDuct Health, Inc. in the information for C. Patrick Machado.

 

The Registrant has revised the referenced disclosure on page 34 in response to the Staff’s comment.

 

27. The alignment of the salary information in the summary compensation table should be corrected.

 

The Registrant has revised the referenced disclosure on page 35 in response to the Staff’s comment.


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28. The second footnote to the table states that the company did not compensate officer and directors during 2002, 2003 or 2004. Please reconcile with the tabular information.

 

The Registrant has revised the referenced disclosure on page 35 in response to the Staff’s comment.

 

Certain Relationships and Related Transactions

 

29. Define “the financing”.

 

In response to such comment of the Staff, the Registrant supplementally advises the Staff that “the financing” is currently defined on page 54 of the Registration Statement as follows “…[a]s used in this prospectus…’the financing’ refers to the private placement by Orion of an aggregate of 7,741,935 shares of common stock on December 17, 2004, to certain accredited investors.” In addition, on page 36 of the Registration Statement under the caption “Description of Transactions”, the term “the financing” is further defined with the following disclosure: “[i]n connection with the financing, Orion entered into purchase agreements with respect to the private placement of an aggregate of 7,741,935 shares of common stock to certain accredited investors at a price of $1.55 per share.” In addition, the Registrant has revised the referenced disclosure on page 36 in response to the Staff’s comment.

 

30. We do not understand the information for Brock Capital Group. The value of the services performed is not stated, the dates of the services are not stated and the relationship between Brock and the registrant at the time of the services is not stated.

 

Brock Capital Group LLC served as placement agent for Medivation, Inc. with respect to certain investors that participated in the December 17, 2004 private placement, which is also referred to in the Registration Statement as the “financing.” Brock Capital Group LLC received an aggregate of 52,821 shares of Common Stock of the Registrant as compensation for the services it provided through the completion of the financing as placement agent for Medivation, Inc., valued at the purchase price for shares of Common Stock in the financing at $1.55 per share, for an aggregate of $81,872.55. Upon further review of the relationship between Brock and the Registrant at the time of the services, the Registrant does not believe disclosure of this relationship is required under Item 404 of Regulation S-B and has deleted the referenced disclosure.

 

31. The parties to the registration rights agreements and the voting agreements should be named.

 

The Registrant has revised the referenced disclosure on pages 36 and 37 in response to the Staff’s comment.


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Voting Agreements

 

32. We note reference to the voting agreements as they pertain to the election to the board of directors of Messrs. Gorlin and Hung, one nominee acting as the representative of the individuals who held shares of common stock of Medivation immediately prior to the effective time of the merger, and two nominees acting as representatives of MDB Capital Group. Disclose whether these individuals have been so nominated and provide required disclosure pursuant to Item 401 of Regulation S-B.

 

The Registrant supplementally advises the Staff, the referenced disclosure been revised to reflect that, none of the above-referenced individuals has yet been nominated for election at the 2005 Annual Meeting to serve on the Board of Directors of the Registrant. The Registrant expects that prior to the filing of the Registrant’s proxy statement with respect to the Registrant’s 2004 Annual Meeting of Stockholders, currently anticipated to be held on April 15, 2005, the Registrant will nominate such nominees for election at the meeting to serve on the Registrant’s Board of Directors. The Registrant notes that in connection with the merger Dr. Hung was appointed to the Board of Directors.

 

33. Clarify the percentage of shares involved in the voting agreement(s).

 

The Registrant has revised the referenced disclosure on page 37 in response to the Staff’s comment.

 

Principal and Selling Stockholders

 

34. Please disclose if any of the selling shareholders are broker-dealers or affiliates of broker-dealers.

 

The Registrant has revised the referenced disclosure on pages 44 through 46 in response to the Staff’s comment.

 

35. For all 5% stockholders listed that are not natural persons, please identify the natural persons with voting or investment control.

 

The Registrant has revised the referenced disclosure on pages 46 and 47 in response to the Staff’s comment.

 

36. Clearly indicate the percentage of outstanding shares covered by the voting agreements.

 

The Registrant has revised the referenced disclosure on page 37 in response to the Staff’s comment.

 

37. Addresses for non-employee 5% record holders should be indicated.

 

The Registrant has revised the referenced disclosure on pages 46 and 47 in response to the Staff’s comment.


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38. Revise your principal /selling stockholder table so that all information provided via footnote corresponds to information presented in the table. For example, there are 17 footnotes yet the table only lists 15 footnotes.

 

The Registrant has revised the referenced disclosure on pages 44 through 47 in response to the Staff’s comment.

 

39. Revise your principal/selling stockholder table to remove all references to 5% stockholders and/or selling shareholders as “Affiliates of” For example, we refer you to references to “Affiliates of Marxe, Austin and Greenhouse, David,” “Affiliates of ProMed Partners,” “Affiliates of Walker Smith Capital,” and “Affiliates of Bailey, Gregory.” Please clearly identify the record holder in your tabular presentation and provide footnote treatment for any information relating to the existence of an “affiliate” relationship, i.e., the beneficial owner of the shares is required to be disclosed.

 

The Registrant has revised the referenced disclosure on pages 44 through 46 in response to the Staff’s comment.

 

Market for Common Stock and Related Matters

 

40. Please correct the obvious error in the number of common stock record holders.

 

The Registrant supplementally advises the Staff that based on records previously provided to the Registrant and prepared by American Stock Transfer & Trust Company, the Registrant’s registrar and transfer agent, which report is attached hereto as Exhibit A, as of December 14, 2004, there were an aggregate of 15 holders of record of the Registrant’s common stock, of which 1,075,347 shares were held of record in the name of Cede & Co.

 

In addition, the Registrant has revised the referenced disclosure on page 48 to disclose 78 record holders of the Registrant’s common stock as of March 8, 2005.

 

Plan of Distribution

 

41. The “pledgees, donees, transferees and or other successors-in-interest mentioned in the first paragraph must be identified in accordance with the disclosure requirements of Item 507 of Regulation S-B in the prospectus, or by amendment to the prospectus, prior to any sales by such persons.

 

The Registrant acknowledges the Staff’s comment.

 

Statements of Operations

 

42. Please explain to us supplementally why the calculation of weighted average common shares outstanding assumes the conversion of the Series B convertible preferred stock. Since conversion is contingent upon the approval of an increase in authorized common shares, it does not appear appropriate to assume conversion. Revise the financial statements accordingly, and revise Note 3(l) to explain the presentation of loss per share, and the effect of the recapitalization on the calculation.


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We have assumed conversion of the outstanding Series B convertible preferred stock in our weighted average shares outstanding calculations based on our understanding of the rules governing the accounting for reverse mergers under generally accepted accounting principles, and our desire to be able to present per share information in our financial statements. Specifically, we believe that GAAP reverse merger accounting requires us to present financial statements based on the contra-factual assumptions that (a) the Orion securities acquired by the former Medivation stockholders in the December 17, 2004 reverse merger (namely, the Series B convertible preferred stock in question) were outstanding since the inception of Medivation on September 4, 2003, and (b) the Orion securities that were issued and outstanding prior to December 17, 2004 were not issued and outstanding until that date. Based on this presentation, if we had not considered the common stock underlying the Series B preferred stock to be outstanding, the consequence would be that the combined company would have had no issued and outstanding shares of stock for any period prior to December 17, 2004. We believe that presenting financial statements showing no outstanding stock until December 17, 2004 would be confusing to investors, in large part because it would make it impossible to calculate per share loss for periods prior to that date.

 

43. Disclose the nature and amount of the major components of general and administrative expenses in a note or state them separately on the statement of operations for the periods presented.

 

The Registrant has revised the referenced disclosure on page F-4 in response to the Staff’s comment.

 

Statements of Cash Flows

 

44. On the statement of cash flows, please separately disclose cash paid for interest in connection with the convertible notes.

 

The Registrant has revised the referenced disclosure on page F-6 in response to the Staff’s comment.

 

Note 6- Stockholder’s Equity

 

45. Please review paragraphs 48 and 362 of SFAS 123, Accounting for Stock-Based Compensation, and revise the company’s stock plan footnote disclosures to comply with the requirements therein.

 

The Registrant has revised the referenced disclosure in Note 6(d) in response to the Staff’s comment.

 

General Comments

 

46. Provide a current consent in any amendment and ensure that the financial statements are updated as required by Item 310(g) of Regulation S-B.

 

The Registrant has included a current consent with Amendment No. 1.


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Part II — Information Not Required in Prospectus

 

Recent Sales of Unregistered Securities

 

47. For each sale of unregistered securities, please disclose the facts relied upon to make the exemption(s) from registration available. In the case of sales relying on the exemption contained in section 4(2), please address, among the other requirements of 4(2), the financial sophistication of the purchasers. Also, please disclose the basis for reliance upon the exemption contained in section 3(a)(9). See Item 701(d) of Regulation S-B.

 

The Registrant has revised the referenced disclosure on page II-3 in response to the Staff’s comment.

 

The Registrant supplementally advises the Staff of the following information concerning the sales of unregistered securities of both the Registrant and Medivation disclosed in the registration statement.

 

Sales of securities by Medivation in October 2003 constituted the initial formation and capitalization of Medivation. Sales of Medivation common stock to Dara BioSciences, Selena Pharmaceuticals, David Hung, M.D. and C. Patrick Machado were founders’ common stock at a price per share of $0.001 paid in cash, with the exception of Selena Pharmaceuticals, which contributed intellectual property rights.

 

The following is a list of all former holders of Medivation securities who were issued securities of Medivation and, in turn, received securities of the Registrant in connection with the merger, and information concerning their financial sophistication and access to information concerning Medivation and the Registrant:

 

David T. Hung, M.D.

C. Patrick Machado

Selena Pharmaceuticals, Inc.

Dara BioSciences, Inc.

Joseph Grano, Jr.

Dirk Thye, M.D.


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David Hung, M.D. was the President, Chief Executive Officer and member of the board of directors of Medivation, Inc. and is the Registrant’s President and Chief Executive Officer. Dr. Hung is an accredited investor and a financially sophisticated investor by virtue of his professional experience and investing activities. He is the former President, Chief Executive Officer and member of the board of directors of ProDuct Health, Inc., which was acquired by Cytyc Corporation.

 

C. Patrick Machado was the Senior Vice President, Chief Financial Officer and member of the board of directors of Medivation, Inc. and is the Registrant’s Senior Vice President and Chief Financial Officer. Mr. Machado is a accredited investor and a financially sophisticated investor by virtue of his professional experience. He is the former Chief Financial Officer, Senior Vice President and General Counsel of ProDuct Health, Inc., which was acquired by Cytyc Corporation. Mr. Machado received a J.D. from Harvard Law School.

 

Selena Pharmaceuticals, Inc. is a privately held life sciences company which contributed core technology associated with one of the Registrant’s product candidates in exchange for founder’s stock in connection with Medivation’s formation. Sergey Sablin is the principal stockholder of Selena Pharmaceuticals and is our Scientific Director and was particularly well situated to evaluate the investment in Medivation based on his relationship with Medivation and Selena Pharmaceuticals’ prior ownership of core intellectual property rights associated with one of Medivation’s product candidates.

 

Dara BioSciences, Inc. is a privately held life sciences company and an accredited investor and financially sophisticated investor by virtue of its experience in capital formation and venture capital financing transactions. Dara BioSciences has completed its own venture capital financing transactions of the type in which it participated in connection with Medivation’s formation and capital raising.

 

Joseph Grano, Jr. is an accredited investor and financially sophisticated by virtue of his professional experience. Mr. Grano was Chairman of UBS Financial Services Inc., (formerly UBS PaineWebber) from 2001 through 2004. Mr. Grano is also the Chairman of the Homeland Security Advisory Council under the U. S. Department of the Homeland Security.

 

Dirk Thye, M.D. is an accredited investor and a financially sophisticated investor by virtue of his professional experience. Dr. Thye is the former Senior Vice President of Clinical Development and a founder of Peninsula Pharmaceuticals, Inc. Dr. Thye was a consultant to Medivation and is a consultant to the Registrant.


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48. The required information during the past three years for Medivation, the predecessor, should be included.

 

The Registrant has revised the referenced disclosure on page II-3 in response to the Staff’s comment.

 

49. Name the “accredited investors” in the December 2004 financing.

 

The Registrant has revised the referenced disclosure on page II-3 in response to the Staff’s comment.

 

Exhibits

 

50. We note the legality opinion remains to be filed. Please file with your next amendment.

 

The Registrant has included the opinion of the Latham & Watkins LLP as Exhibit 5.1 to the Registration Statement.

 

51. Executed individual agreements for exhibits 9.1 through 10.3(c) should be filed. A Form is not sufficient.

 

The Registrant has filed individual agreements for Exhibits 9.1 through 10.3(c) to the Registration Statement as Exhibits 9.1(a) through 10.3(c) to the Registration Statement in response to the Staff’s comment.

 

Thank you for your prompt review of the Registrant’s filing. Please address any additional comments to the undersigned via facsimile at (415) 395-8095. If you have any questions regarding the foregoing, please do not hesitate to contact me at (415) 395-8284, or Michael W. Hall at (650) 463-2655.


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Very truly yours,

/s/    BRADLEY A. BUGDANOWITZ


Bradley A. Bugdanowitz

of LATHAM & WATKINS LLP

 

cc: Distribution List


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EXHIBIT A

 

LOGO


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