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As filed with the Securities and Exchange Commission on September 22, 2006
Registration No. 333-133273
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
AMENDMENT
NO. 1
TO
FORM
S-3
REGISTRATION STATEMENT
Under
The Securities Act of 1933
ORTHOLOGIC CORP.
(Exact name of registrant as specified in its charter)
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DELAWARE
(State or other jurisdiction of incorporation or organization)
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86-0585310
(I.R.S. Employer Identification No.) |
1275 West Washington Street
Tempe, Arizona 85281
(602) 286-5520
(Address, including zip code, and telephone number,
including area code, of registrants principal executive offices)
John M. Holliman, III, Executive Chairman
and principal executive officer
OrthoLogic Corp.
1275 West Washington Street
Tempe, Arizona 85281
(602) 286-5520
(Name, address, including zip code, and telephone number,
including area code, of agent for service)
Copy to:
Steven P. Emerick, Esq.
Quarles & Brady Streich Lang, LLP
One Renaissance Square, Two North Central Avenue
Phoenix, Arizona 85004
(602) 230-5517
Approximate date of commencement of proposed sale to the public: From time to time after
the effective date of this registration statement.
If the only securities being registered on this Form are being offered pursuant to dividend or
interest reinvestment plans, please check the following box. o
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 of 1933, other than securities
offered only in connection with dividend or interest reinvestment
plans, check the following box.
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If this Form is filed to register additional securities for an offering pursuant to Rule
462(b) under the Securities Act, please check the following box and list the Securities Act
registration statement number of the earlier effective registration statement for the same
offering. o
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. o
If this Form is a registration statement pursuant to General Instruction I.D. or a
post-effective amendment thereto that shall become effective upon filing with the Commission
pursuant to Rule 462(e) under the Securities Act, check the following box. o
If this Form is a post-effective amendment to a registration statement filed pursuant to
General Instruction I.D. filed to register additional securities or additional classes of
securities pursuant to Rule 413(b) under the Securities Act, check the following box. o
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, as amended, or until the registration
statement shall become effective on such date as the Commission, acting pursuant to said Section
8(a), may determine.
The information in this prospectus is not complete and may be changed. We may not sell these
securities until the registration statement filed with the Securities and Exchange Commission is
effective. This prospectus is not an offer to sell these securities and we are not soliciting an
offer to buy these securities in any state where the offer, solicitation or sale is not permitted.
PROSPECTUS
SUBJECT TO COMPLETION, DATED SEPTEMBER 22, 2006
ORTHOLOGIC CORP.
1,666,660 SHARES OF COMMON STOCK
This prospectus relates to the sale of up to an aggregate of 1,666,660 shares of our common
stock by PharmaBio Development Inc. (d/b/a NovaQuest) (NovaQuest). Such shares consist of
1,262,531 shares of common stock and 404,129 shares of common stock underlying warrants. NovaQuest
is sometimes referred to in this prospectus as the selling security holder. The prices at which
NovaQuest may sell the shares will be determined by the prevailing market price for the shares or
in negotiated transactions. We will not receive any of the proceeds from the resale by the selling
security holder of any of the securities covered by this prospectus, however, we have received $3.5
million from the sale of shares under a Common Stock and Warrant Purchase Agreement we have entered
into with NovaQuest. We will also receive the exercise price of the warrants described in this
prospectus (to the extent that the selling security holder does not utilize the cashless exercise
feature, if provided).
Our common stock is listed on The NASDAQ Global Market, under the symbol OLGC. Our
preferred stock is not listed or quoted on any exchange. On September 19, 2006, the closing price
of our common stock on The NASDAQ Global Market was $1.36 per share.
You should carefully consider the risk factors described under the heading Risk Factors and
Forward-Looking Statements in this prospectus, in addition to any risk factors which may be
included in any supplement, or which are incorporated by reference into this prospectus.
Investing in our securities involves a high degree of risk. Before buying any of our common
stock, you should carefully read the discussion of material risks of investing in our securities
under the heading Risk Factors and Forward-Looking Statements beginning on page 6 in this
prospectus.
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or passed upon the accuracy or adequacy of the
disclosures in this prospectus. Any representation to the contrary is a criminal offense.
The date of this prospectus is ___, 2006.
TABLE OF CONTENTS
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ABOUT THIS PROSPECTUS
You should rely only on the information contained or incorporated by reference in this
prospectus. We have not, and the selling security holder has not, authorized anyone to provide you
with different information. No one is making offers to sell or seeking offers to buy these
securities in any jurisdiction where the offer or sale is not permitted. You should assume that
the information contained in this prospectus is accurate as of the date on the front of this
prospectus only and that any information we have incorporated by reference is accurate as of the
date of the document incorporated by reference only, regardless of the time of delivery of this
prospectus or any sale of our common stock. Our business, financial condition, results of
operations and prospects may have changed since that date.
The information in this prospectus may not contain all of the information that may be
important to you. You should read the entire prospectus as well as the documents incorporated by
reference into this prospectus before making an investment decision. To obtain additional
information that may be important to you, you should also read the exhibits to the registration
statement of which this prospectus is a part and the additional information described below under
the heading Where You Can Find More Information.
When used in this prospectus, the terms OrthoLogic, we, our, us and the Company
refer to OrthoLogic Corp.
The address and telephone number of our principal executive offices are 1275 West Washington
Street, Tempe, Arizona 85281; telephone (602) 286-5520.
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PROSPECTUS SUMMARY
This summary highlights selected information from this prospectus and does not contain all of
the information that you need to consider in making your investment decision. You should carefully
read the entire prospectus, including the risks of investing discussed under Risk Factors and
Forward-Looking Statements beginning on page 6, the information incorporated by reference,
including our financial statements, and the exhibits to the registration statement of which this
prospectus is a part.
Our Company
OrthoLogic is a biotechnology company focused on the development and commercialization of the
novel synthetic peptide Chrysalin® (TP508) in two lead indications, both of which represent areas
of significant unmet medical need fracture repair and diabetic foot ulcer healing. Chrysalin, or
TP508, is a 23-amino acid synthetic peptide representing a receptor-binding domain of the human
thrombin molecule, a naturally occurring agent responsible for blood clotting and initiating the
natural healing cascade of cellular events responsible for tissue repair both soft tissue and
bone.
Recent Events
On August 29, 2006, OrthoLogic Corp. reported the results of preliminary interim analysis of
data from its Phase 2b dose-ranging clinical trial of the novel synthetic peptide
Chrysalin® (TP508) in unstable, displaced distal radius (wrist) fractures and
termination of the Phase 2b study. In the dataset of 240 subjects as a group that were evaluable in
the Phase 2b interim analysis, treatment with Chrysalin did not demonstrate benefit compared to
placebo in the primary efficacy endpoint of time to removal of immobilization. Individual findings
of efficacy in secondary endpoints, including radiographic healing, were not seen in this interim
analysis. Further, no dose response relationship was observed. The trial met the pre-specified
safety endpoint by demonstrating no significant difference in the incidence of adverse events
between the Chrysalin and placebo groups.
On April 5, 2006, James M. Pusey, MD resigned as our President and Chief Executive Officer and
as a Class I director of the company. John M. Holliman, III, a director of OrthoLogic since
September 1987 and Chairman of the Board of Directors since August 1997, assumed the title of
Executive Chairman on that date. In that position, Mr. Holliman serves as our principal executive
officer and leads our business and corporate strategic activities. Randolph C. Steer, MD, Ph.D.
was named our President on April 5, 2006, and is responsible for directing our strategy and
operations in all clinical development and regulatory areas.
On March 15, 2006, we reported results of our Phase 3 fracture repair human clinical trial.
For the primary endpoint, immobilization removal, no statistically significant difference between
placebo and a single injection of Chrysalin were achieved. Consistent with the Phase 1/2 human
clinical trial results, a statistically significant difference for a secondary endpoint,
radiographic evidence of radial cortical bridging, was achieved. However, no statistically
significant difference was noted in the studys other secondary endpoints. On March 15, 2006, we
temporarily halted our Phase 2b fracture repair dosing clinical trial to perform an interim
analysis of the data of the subjects enrolled to that date.
On February 23, 2006, we entered into an agreement to purchase certain assets and assume
certain liabilities of AzERx, Inc., in exchange for $390,000 in cash and 1,355,000 shares of our
common stock. The transaction closed on February 27, 2006. Under the terms of the agreement, we
acquired an exclusive license for the core intellectual property relating to AzERxs lead compound,
AZX100, a 24-amino acid peptide. AZX100 is currently being investigated for several applications,
including the treatment of vasospasm associated with subarachnoid hemorrhage, prevention of keloid
scarring, and treatment of asthma. We will continue to develop the new class of compounds in the
field of smooth muscle relaxation called Intracellular Actin Relaxing Molecules, or ICARMs, based
on the AZX100 technology.
We continue to explore other biopharmaceutical compounds that can complement our research
activity internally and broaden our potential pipeline for successful products.
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The Offering
On February 27, 2006 (the Closing Date), we closed the initial transactions relating to our
Common Stock and Warrant Purchase Agreement (the Purchase Agreement) dated February 24, 2006 with
PharmaBio Development Inc. (d/b/a NovaQuest) (NovaQuest), which provides for the purchase of
shares of our common stock in three tranches together with the issuance of accompanying warrants to
purchase shares of our common stock (the Initial Class A Warrant, the June Class A Warrant, and
the September Class A Warrant). We are also parties to an Amended and Restated Class B Warrant
Agreement (the Class B Warrant), an Amended and Restated Class C Warrant Agreement (the Class C
Warrant) and an Amended and Restated Class D Warrant Agreement (the Class D Warrant) with
NovaQuest to purchase in the aggregate up to 240,000 shares of our common stock at $1.91 a share
(the Class B Warrant, Class C Warrant and Class D Warrant are collectively referred to in this
prospectus as the Milestone Warrants). On July 3, 2006 we closed the second tranche and we have
elected not to complete the third proposed tranche, including the issuance of the September Class A
Warrant.
All of the shares being offered pursuant to this prospectus are being sold by the selling
security holder. See Selling Security Holder later in this prospectus.
We are obligated to file a registration statement to cover resale of the shares issued on the
Closing Date, the additional shares we elected to issue on July 3, 2006 pursuant to the Purchase
Agreement, as well as the shares to be issued upon exercise of the Initial Class A Warrant, the
June Class A Warrant and the Milestone Warrants (collectively referred to in this prospectus as
the Warrants).
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Issuer |
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OrthoLogic Corp. |
Common stock offered in this prospectus
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1,262,531 shares as of September 22, 2006 |
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Common stock underlying warrants offered in this
prospectus: |
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Shares underlying Initial Class A Warrant
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The Initial Class A Warrant, dated
February 24, 2006, is fully vested and
entitles the selling security holder to
purchase 46,706 shares of our common
stock at $6.39 per share. |
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Shares underlying June Class A Warrant
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The Additional Class A Warrant, dated
June 30, 2006, is fully vested and
entitles the selling security holder to
purchase 117,423 shares of our common
stock at $1.91 per share. |
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Shares underlying Class B Warrant
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The Amended and Restated Class B
Warrant, dated February 24, 2006, and
amended and restated as of June 30,
2006, entitles the selling security
holder to purchase up to 80,000 shares
of our common stock at $1.91 per share.
The Class B Warrant will vest based on
the achievement of a milestone
identified in the Class B Warrant. |
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Shares underlying Class C Warrant
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The Amended and Restated Class C
Warrant, dated February 24, 2006, and
amended and restated as of June 30,
2006, entitles the selling security
holder to purchase up to 80,000 shares
of our common stock at $1.91 per share.
The Class C Warrant will vest based on
the achievement of a milestone
identified in the Class C Warrant. |
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Shares underlying Class D Warrant
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The Amended and Restated Class D
Warrant, dated February 24, 2006, and
amended and restated as of June 30,
2006, entitles the selling security
holder to purchase up to 80,000 shares
of our common stock at $1.91 per share.
The Class D Warrant will vest based on
the achievement of a milestone
identified in the Class D Warrant. |
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Use of proceeds
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We will not receive any of the proceeds
from the resale by |
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Issuer |
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OrthoLogic Corp. |
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the selling security
holder of any of the securities covered
by this prospectus, however, we have
received $3.5 million from the initial
sale of shares under the Purchase
Agreement. We will also receive the
exercise price of the warrants described
in this prospectus (to the extent that
the selling security holder does not
utilize the cashless exercise feature,
if provided). We intend to use the net
proceeds we received from the sale of
securities to the selling security
holder for general corporate purposes,
including capital expenditures, working
capital needs, current and future
clinical trials of our drug candidates,
as well as other research and drug
development activities. |
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The NASDAQ Global Market symbol
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Our common stock is listed on The NASDAQ
Global Market under the symbol OLGC.
The Warrants are not, and will not be,
listed on any exchange or quoted on any
market. |
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Risk Factors
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You should carefully consider the
information under Risk Factors and
Forward-Looking Statements included in
this prospectus beginning on page 6 so
that you understand the risks associated
with an investment in our securities. |
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Registration Rights
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We agreed to file a registration
statement with respect to the shares of
common stock issuable upon exercise of
the Warrants, as well as other
securities issued to NovaQuest as
described in this prospectus. Subject
to certain suspension periods, we are
obligated to use our best efforts to
have the registration statement covering
these securities declared effective as
promptly as practicable following the
filing of the registration statement,
and to keep it effective until the
earlier of: (i) the sale under the
registration statement of all of the
shares of common stock covered by the
applicable registration rights
agreement; and (ii) such date as all
remaining unsold shares of common stock
covered by the applicable registration
rights agreement can be sold by the
selling security holder without
restriction pursuant to the requirements
of Rule 144 promulgated under the
Securities Act. |
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Following the effective date of the
registration statement, in certain
circumstances, we may suspend the
selling security holders use of the
registration statement to resell its
securities for up to 60 days (which need
not be consecutive) in any twelve month
period. See Description of Warrants
Registration Rights. |
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RISK FACTORS AND FORWARD-LOOKING STATEMENTS
Risks Related to Our Business
We are a biopharmaceutical company with no revenue generating operations and high investment costs.
We expect to incur losses for a number of years as we expand our research and development
projects. There is no assurance that our current level of funds will be sufficient to support all
research expenses to achieve commercialization of any of our product candidates. On November 26,
2003, we sold all of our revenue generating operations. We are now focused on developing and
testing the product candidates in our Chrysalin Product Platform and have allocated most of our
resources to bringing these product candidates to the market. However, on February 27, 2006 we
acquired the rights to AZX100, and we also intend to continue preclinical activities on AZX100 in
2006. We may invest in other peptide or small molecule-based therapeutics in the future, but there
can be no assurance that opportunities of this nature will occur at acceptable terms, conditions or
timing. We currently have no pharmaceutical products being sold or ready for sale and do not
expect to be able to introduce any pharmaceutical products for at least several years. As a result
of our significant research and development, clinical development, regulatory compliance and
general and administrative expenses and the lack of any products to generate revenue, we expect to
incur losses for at least the next several years and expect that our losses will increase as we
expand our research and development activities and incur significant expenses for clinical trials.
Our cash reserves, including the cash received from the sale of our bone growth stimulation device
business in November 2003, are the primary source of our working capital. There can be no
assurance that our cash resources will be sufficient to cover our future operating requirements, or
should there be a need, other sources of cash will be available, or if available, at acceptable
terms.
We do not expect to receive any revenue from product sales until we receive regulatory
approval and begin commercialization of our product candidates. We cannot predict when that will
occur or if it will occur.
We caution that our future cash expenditure levels are difficult to forecast because the
forecast is based on assumptions about the number of research projects we pursue, the pace at which
we pursue them, the quality of the data collected and the requests of the FDA to expand, narrow or
conduct additional clinical trials and analyze data. Changes in any of these assumptions can change
significantly our estimated cash expenditure levels.
Our product candidates are in various stages of development and may not be successfully developed
or commercialized.
If we fail to commercialize our product candidates, we will not be able to generate revenue.
We currently do not sell any products. Our product candidates are at the following stages of
development:
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Acceleration of Fracture Repair
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Phase 3 / Phase 2b human clinical trials |
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Diabetic Foot Ulcer Healing
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Phase 1/2 human clinical trials |
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Spine Fusion
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Phase 1/2 human clinical trials |
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Cartilage Defect Repair
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Late stage pre-clinical trials |
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Tendon Repair
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Early stage pre-clinical trials |
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Cardiovascular Repair
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Pre-clinical trials |
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Dental Bone Repair
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Pre-clinical trials |
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AZX100
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Pre-clinical testing |
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We are subject to the risk that: |
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the FDA finds some or all of our product candidates ineffective or unsafe; |
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we do not receive necessary regulatory approvals; |
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we are unable to get some or all of our product candidates to market in a timely manner; |
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we are not able to produce our product candidates in commercial quantities at reasonable costs; |
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our products undergo post-market evaluations resulting in marketing restrictions or
withdrawal of our products; or |
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the patients, insurance and/or physician community does not accept our products. |
In addition, our product development programs may be curtailed, redirected or eliminated at
any time for many reasons, including:
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adverse or ambiguous results; |
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undesirable side effects which delay or extend the trials; |
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inability to locate, recruit, qualify and retain a sufficient number of patients for our trials; |
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regulatory delays or other regulatory actions; |
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difficulties in obtaining sufficient quantities of the particular product candidate
or any other components needed for our pre-clinical testing or clinical trials; |
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change in the focus of our development efforts; and |
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re-evaluation of our clinical development strategy. |
We cannot predict whether we will successfully develop and commercialize any of our product
candidates. If we fail to do so, we will not be able to generate revenue.
Certain results from our Phase III and Phase 2b clinical trials showed that the differences in the
primary endpoint analyses between our lead compound, Chrysalin, and the placebo were not
statistically significant and this could result in a substantial delay in our ability to generate
revenue.
On March 15, 2006, we reported results of our Phase 3 fracture repair human clinical trial.
For the primary endpoint, immobilization removal, no statistically significant difference between
placebo and a single injection of Chrysalin were achieved. Consistent with the Phase 1/2 human
clinical trial results, a statistically significant difference for a secondary endpoint,
radiographic evidence of radial cortical bridging, was achieved. However, no statistically
significant difference was noted in the studys other secondary endpoints. These results may make
it more difficult to achieve regulatory approval of Chrysalin. On March 15, 2006, we temporarily
halted our Phase 2b fracture repair dosing clinical trial to perform an interim analysis of the
data of the subjects enrolled to that date.
On August 29, 2006, we reported the results of preliminary interim analysis of data from our
Phase 2b dose-ranging clinical trial of the novel synthetic peptide Chrysalin® (TP508)
in unstable, displaced distal radius (wrist) fractures and termination of the Phase 2b study. In
the dataset of 240 subjects as a group that were evaluable in the Phase 2b interim analysis,
treatment with Chrysalin did not demonstrate benefit compared to placebo in the primary efficacy
endpoint of time to removal of immobilization. Individual findings of efficacy in secondary
endpoints, including radiographic healing, were not seen in this interim analysis. Further, no
dose response relationship was observed. The trial met the pre-specified safety endpoint by
demonstrating no significant difference in the incidence of adverse events between the Chrysalin
and placebo groups.
The results of our late stage clinical trials may be insufficient to obtain FDA approval, which
could result in a substantial delay in our ability to generate revenue.
Positive results from pre-clinical studies and early clinical trials do not ensure positive
results in more advanced clinical trials. If we are unable to demonstrate that a product candidate
will be safe and effective in advanced clinical trials involving larger numbers of patients, we
will be unable to submit the NDA necessary to receive approval from the FDA to commercialize that
product.
On March 15, 2006, as discussed in the risk factor above, we reported results of our Phase 3
fracture repair human clinical trial. For the primary endpoint, immobilization removal, no
statistically significant difference between placebo and a single injection of Chrysalin were
achieved. Consistent with the Phase 1/2 human clinical trial results, a statistically significant
difference for a secondary endpoint, radiographic evidence of radial cortical bridging, was
achieved. However, no statistically significant difference was noted in the studys other
secondary endpoints. These results may make it more difficult to achieve regulatory approval of
Chrysalin. On March 15, 2006, we temporarily halted our Phase 2b fracture repair dosing clinical
trial to perform an interim analysis of the data of the subjects enrolled to that date.
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On August 29, 2006, as discussed in the risk factors above, we reported the results of
preliminary interim analysis of data from our Phase 2b dose-ranging clinical trial of the novel
synthetic peptide Chrysalin® (TP508) in unstable, displaced distal radius (wrist)
fractures and termination of the Phase 2b study. In the dataset of 240 subjects as a group that
were evaluable in the Phase 2b interim analysis, treatment with Chrysalin did not demonstrate
benefit compared to placebo in the primary efficacy endpoint of time to removal of immobilization.
Individual findings of efficacy in secondary endpoints, including radiographic healing, were not
seen in this interim analysis. Further, no dose response relationship was observed. The trial met
the pre-specified safety endpoint by demonstrating no significant difference in the incidence of
adverse events between the Chrysalin and placebo groups.
We will have to determine whether to redesign our Chrysalin fracture repair product candidate
and our protocols and continue with additional testing, or cease activities in this area.
Redesigning the product candidate or clinical protocols may not be economically practicable or
scientifically possible. A substantial delay in obtaining FDA approval or termination of the
Chrysalin fracture repair product candidate could result in a delay in our ability to generate
revenue and could have a material adverse effect on our business going forward.
The majority of our product candidates are all based on the same chemical peptide, Chrysalin. If
one of our Chrysalin product candidates reveals safety or fundamental inefficacy issues in clinical
trials, it could impact the development path for all our other current Chrysalin product
candidates.
The development of each of our product candidates in the Chrysalin Product Platform is based
on our knowledge and understanding of how the human thrombin molecule contributes to the repair of
soft tissue and bone. While there are important differences in each of the product candidates in
terms of their purpose (fracture repair, diabetic foot ulcer, etc.), each product candidate is
focused on accelerating the repair of soft tissue and bone and is based on the ability of Chrysalin
to mimic specific attributes of the human thrombin molecule to stimulate the bodys natural healing
processes.
Since we are developing the product candidates in the Chrysalin Product Platform in parallel,
we expect to learn from the results of each trial and apply some of our findings to the development
of the other product candidates in the platform. The fact that the results from the Phase 3 and
Phase 2b fracture repair human clinical trials showed no statistical significance between Chrysalin
and the placebo for the primary endpoint in the study will likely impact the development path or
future development of the other product candidates in the platform. In addition, if we find that
one of our biopharmaceutical product candidates is unsafe in the future, it could impact the
development of our other product candidates in clinical trials.
Patients may discontinue their participation in our clinical studies, which may negatively impact
the results of these studies and extend the timeline for completion of our development programs.
As with all clinical trials, we are subject to the risk that patients enrolled in our clinical
studies may discontinue their participation at any time during the study as a result of a number of
factors, including, withdrawing their consent or experiencing adverse clinical events, which may or
may not be judged related to our product candidates under evaluation. We are subject to the risk
that if a large number of patients in any one of our studies discontinue their participation in the
study, the results from that study may not be positive or may not support an NDA for regulatory
approval of our product candidates.
In addition, the time required to complete clinical trials is dependent upon, among other
factors, the rate of patient enrollment. Patient enrollment is a function of many factors,
including:
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the size of the patient population; |
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the nature of the clinical protocol requirements; |
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the diversion of patients to other trials or marketed therapies; |
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our ability to recruit and manage clinical centers and associated trials; |
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the proximity of patients to clinical sites; and |
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the patient eligibility criteria for the study. |
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Even if we obtain marketing approval, our products will be subject to ongoing regulatory oversight,
which may affect our ability to successfully commercialize any products we may develop.
Even if we receive regulatory approval of a product candidate, the approval may be subject to
limitations on the indicated uses for which the product is marketed or require costly
post-marketing follow-up studies. After we obtain marketing approval for any product, the
manufacturer and the manufacturing facilities for that product will be subject to continual review
and periodic inspections by the FDA and other regulatory agencies. The subsequent discovery of
previously unknown problems with the product, or with the manufacturer or facility, may result in
restrictions on the product or manufacturer, including withdrawal of the product from the market.
If we fail to comply with applicable regulatory requirements, we may be subject to fines,
suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating
restrictions and criminal prosecution.
If we cannot protect the Chrysalin patents, the AZX100 license and patents, or our intellectual
property generally, our ability to develop and commercialize our products will be severely limited.
Our success will depend in part on our ability to maintain and enforce patent protection for
Chrysalin and AZX100 and each product resulting from Chrysalin or AZX100. Without patent
protection, other companies could offer substantially identical products for sale without incurring
the sizable discovery, development and licensing costs that we have incurred. Our ability to
recover these expenditures and realize profits upon the sale of products would then be diminished.
Chrysalin and AZX100 are patented and there have been no successful challenges to the patents.
However, if there were to be a challenge to these patents or any of the patents for product
candidates, a court may determine that the patents are invalid or unenforceable. Even if the
validity or enforceability of a patent is upheld by a court, a court may not prevent alleged
infringement on the grounds that such activity is not covered by the patent claims. Any
litigation, whether to enforce our rights to use our or our licensors patents or to defend against
allegations that we infringe third party rights, will be costly, time consuming, and may distract
management from other important tasks.
As is commonplace in the biotechnology and pharmaceutical industry, we employ individuals who
were previously employed at other biotechnology or pharmaceutical companies, including our
competitors or potential competitors. To the extent our employees are involved in research areas
which are similar to those areas in which they were involved at their former employers, we may be
subject to claims that such employees and/or we have inadvertently or otherwise used or disclosed
the alleged trade secrets or other proprietary information of the former employers. Litigation may
be necessary to defend against such claims, which could result in substantial costs and be a
distraction to management and which may have a material adverse effect on us, even if we are
successful in defending such claims.
We also rely in our business on trade secrets, know-how and other proprietary information. We
seek to protect this information, in part, through the use of confidentiality agreements with
employees, consultants, advisors and others. Nonetheless, we cannot assure that those agreements
will provide adequate protection for our trade secrets, know-how or other proprietary information
and prevent their unauthorized use or disclosure. The risk that other parties may breach
confidentiality agreements or that our trade secrets become known or independently discovered by
competitors, could adversely affect us by enabling our competitors, who may have greater experience
and financial resources, to copy or use our trade secrets and other proprietary information in the
advancement of their products, methods or technologies.
Our success also depends on our ability to operate and commercialize products without infringing on
the patents or proprietary rights of others.
Third parties may claim that we or our licensors or suppliers are infringing their patents or
are misappropriating their proprietary information. In the event of a successful claim against us
or our licensors or suppliers for infringement of the patents or proprietary rights of others, we
may be required to, among other things:
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stop using our technologies; |
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stop certain research and development efforts; |
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develop non-infringing products or methods; and |
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obtain one or more licenses from third parties. |
A license required under any such patents or proprietary rights may not be available to us, or
may not be available on acceptable terms. If we or our licensors or suppliers are sued for
infringement, we could encounter substantial delays in, or be prohibited from, developing,
manufacturing and commercializing our product candidates.
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Some of our product candidates are in early stages of development and may never be commercialized.
Research, development and pre-clinical testing are long, expensive and uncertain processes.
Other than indications for fracture repair and diabetic ulcer healing, none of our other Chrysalin
or AZX100 product candidates has reached clinical trial testing. Our development of Chrysalin for
the repair of cartilage defects, tendons and cardiovascular repair is currently in pre-clinical
testing or the research stage and AZX100 is currently in the pre-clinical testing stage. Our
future success depends, in part, on our ability to complete pre-clinical development of these and
other product candidates and advance them to the clinical trials.
If we are unsuccessful in advancing our early stage product candidates into clinical testing
for any reason, our business prospects will be harmed.
Acquisition of New Class of Molecules, ICARMs
On February 23, 2006, we entered into an agreement to purchase certain assets and assume
certain liabilities of AzERx, Inc. for $390,000 in cash and the issuance of 1,355,000 shares of our
common stock, with a market value of $7.7 million determined by the closing share price on the date
the agreement was entered into. The transaction was completed (closed) on February 27, 2006. Under
the terms of the transaction, OrthoLogic acquired an exclusive license for the core intellectual
property relating to AZX100, and will continue to develop the new class of compounds in the field
of smooth muscle relaxation called Intracellular Actin Relaxing Molecules, or ICARMs, based on the
unique technology developed by AzERx. The acquisition provides us with a new technology platform
that diversifies the portfolio, and may provide more than one potential product. AzERxs lead
compound is AZX100, a 24-amino acid peptide. AZX100 is currently being investigated for medically
important and commercially significant applications such as the treatment of vasospasm associated
with subarachnoid hemorrhage, prevention of keloid scarring, and the treatment of asthma.
Preclinical and human in vitro studies have shown that this novel compound has the ability to relax
smooth muscle in multiple tissue types. While we performed a reasonable level of due diligence on
AZX100 and the rights acquired, there can be no assurances that we will recover the costs of our
investment from the future development of AZX100 or that commercially significant applications will
be developed.
The loss of our key management and scientific personnel may hinder our ability to execute our
business plan.
As a small company our success depends on the continuing contributions of our management team
and scientific personnel, and maintaining relationships with the network of medical and academic
centers in the United States that conduct our clinical trials. The resignation or retirement of
members of senior management or scientific personnel could materially adversely affect our business
prospects.
Reliance on Outside Suppliers and Consultants
We rely on outside suppliers and consultants for the manufacture of Chrysalin and AZX100 and
technical assistance in our research and development efforts. The inability of our suppliers to
meet our production quality requirements in a timely manner, or the lack of availability of
experienced consultants to assist in our research and development efforts, could have a material
effect on our ability to perform research or clinical trials.
We face an inherent risk of liability in the event that the use or misuse of our products results
in personal injury or death.
The use of our product candidates in clinical trials, and the sale of any approved products,
may expose us to product liability claims, which could result in financial losses. Our clinical
liability insurance coverage may not be sufficient to cover claims that may be made against us. In
addition, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient
amounts or scope to protect us against losses. Any claims against us, regardless of their merit,
could severely harm our financial condition, strain our management and other resources and
adversely impact or eliminate the prospects for commercialization of the product which is the
subject of any such claim.
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Risks of our Industry
We are in a highly regulated field with high investment costs and high risks.
Our Chrysalin Product Platform is currently in the human testing phase for three potential
products and earlier pre-clinical testing phases for two other potential products. AZX100 is
currently in pre-clinical testing. The FDA and comparable agencies in many foreign countries impose
substantial limitations on the introduction of new pharmaceuticals through costly and
time-consuming laboratory and clinical testing and other procedures. The process of obtaining FDA
and other required regulatory approvals is lengthy, expensive and uncertain. Chrysalin and AZX100
are new drugs and subject to the most stringent level of FDA review.
Even after we have invested substantial funds in the development of our Chrysalin products
and AZX100 and even if the results of our current clinical trials are favorable, there can be no
guarantee that the FDA will grant approval of Chrysalin and/or AZX100 for the indicated uses or
that it will do so in a timely manner.
If we successfully bring one or more products to market, there is no assurance that we will be
able to successfully manufacture or market the products or that potential customers will buy them
if, for example, a competitive product has greater efficacy or is deemed more cost effective. In
addition, the market in which we will sell any such products is dominated by a number of large
corporations that have vastly greater resources than we have, which may impact our ability to
successfully market our products or maintain any technological advantage we might develop. We also
would be subject to changes in regulations governing the manufacture and marketing of our products,
which could increase our costs, reduce any competitive advantage we may have and/or adversely
affect our marketing effectiveness.
The pharmaceutical industry is subject to stringent regulation, and failure to obtain regulatory
approval will prevent commercialization of our products.
Our research, development, pre-clinical and clinical trial activities and the manufacture and
marketing of any products that we may successfully develop are subject to an extensive regulatory
approval process by the FDA and other regulatory agencies in the United States and abroad. The
process of obtaining required regulatory approvals for drugs is lengthy, expensive and uncertain,
and any such regulatory approvals may entail limitations on the indicated usage of a drug, which
may reduce the drugs market potential.
In order to obtain FDA approval to commercialize any product candidate, an NDA must be
submitted to the FDA demonstrating, among other things, that the product candidate is safe and
effective for use in humans for each target indication. Our regulatory submissions may be delayed,
or we may cancel plans to make submissions for product candidates for a number of reasons,
including:
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negative or ambiguous pre-clinical or clinical trial results; |
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changes in regulations or the adoption of new regulations; |
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unexpected technological developments; and |
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developments by our competitors that are more effective than our product candidates. |
Consequently, we cannot assure that we will make our submissions to the FDA in the timeframe
that we have planned, or at all, or that our submissions will be approved by the FDA. Even if
regulatory clearance is obtained, post-market evaluation of our products, if required, could result
in restrictions on a products marketing or withdrawal of a product from the market as well as
possible civil and criminal sanctions.
Clinical trials are subject to oversight by institutional review boards and the FDA to ensure
compliance with the FDAs good clinical practice regulations, as well as other requirements for
good clinical practices. We depend, in part, on third-party laboratories and medical institutions
to conduct pre-clinical studies and clinical trials for our products and other third-party
organizations, usually universities, to perform data collection and analysis, all of which must
maintain both good laboratory and good clinical practices. If any such standards are not complied
with in our clinical trials, the FDA may suspend or terminate such trial, which would severely
delay our development and possibly end the development of a product candidate.
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We also currently and in the future will depend upon third party manufacturers of our
products, which are and will be required to comply with the applicable FDA Good Manufacturing
Practice regulations. We cannot be certain that our present or future manufacturers and suppliers
will comply with these regulations. The failure to comply with these regulations may result in
restrictions in the sale of, or withdrawal of the products from the market. Compliance by third
parties with these standards and practices are outside of our direct control.
In addition, we are subject to regulation under state and federal laws, including requirements
regarding occupational safety, laboratory practices, environmental protection and hazardous
substance control, and may be subject to other local, state, federal and foreign regulation. We
cannot predict the impact of such regulations on us, although they could impose significant
restrictions on our business and require us to incur additional expenses to comply.
If our competitors develop and market products that are more effective than ours, or obtain
marketing approval before we do, our commercial opportunities will be reduced or eliminated.
Competition in the pharmaceutical and biotechnology industries is intense and is expected to
increase. Several biotechnology and pharmaceutical companies, as well as academic laboratories,
universities and other research institutions, are involved in research and/or product development
for various treatments for or involving fracture repair and diabetic ulcer healing or smooth muscle
relaxation. Many of our competitors have significantly greater research and development
capabilities, experience in obtaining regulatory approvals and manufacturing, marketing, financial
and managerial resources than we have.
Our competitors may succeed in developing products that are more effective than the ones we
have under development or that render our proposed products or technologies noncompetitive or
obsolete. In addition, certain of such competitors may achieve product commercialization before we
do. If any of our competitors develops a product that is more effective than one we are developing
or plan to develop, or is able to obtain FDA approval for commercialization before we do, we may
not be able to achieve significant market acceptance for certain products of ours, which would have
a material adverse effect on our business.
For a summary of the competitive conditions relating to indications in which we are
considering for our AZX100 and ICARMs research and development activities, see the section in this
prospectus titled The Company AZX100 ICARMs Competition and the reports we file with the
Securities and Exchange Commission and incorporate by reference into the registration statement of
which this prospectus is a part. For a summary of the competitive conditions relating to
Chrysalin-based indications, please see our Annual Report on Form 10-K for the fiscal year ending
December 31, 2005, and other reports we file with the Securities and Exchange Commission and
incorporate by reference into the registration statement of which this prospectus is a part.
Our product candidates may not gain market acceptance among physicians, patients and the medical
community, including insurance companies and other third party payors. If our product candidates
fail to achieve market acceptance, our ability to generate revenue will be limited.
Even if we obtain regulatory approval for our products, market acceptance will depend on our
ability to demonstrate to physicians and patients the benefits of our products in terms of safety,
efficacy, and convenience, ease of administration and cost effectiveness. In addition, we believe
market acceptance depends on the effectiveness of our marketing strategy, the pricing of our
products and the reimbursement policies of government and third-party payors. Physicians may not
prescribe our products, and patients may determine, for any reason, that our product is not useful
to them. Insurance companies and other third party payors may determine not to reimburse for the
cost of the therapy. If any of our product candidates fails to achieve market acceptance, our
ability to generate revenue will be limited.
Healthcare reform and restrictions on reimbursements may limit our financial returns.
Our ability to successfully commercialize our products may depend in part on the extent to
which government health administration authorities, private health insurers and other third party
payors will reimburse consumers for the cost of these products. Third party payors are
increasingly challenging both the need for, and the price of, novel therapeutic drugs and
uncertainty exists as to the reimbursement status of newly approved
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therapeutics. Adequate third party reimbursement may not be available for our drug products
to enable us to maintain price levels sufficient to realize an appropriate return on our
investments in research and product development, which could restrict our ability to commercialize
a particular drug candidate.
Risks Related to Our Common Stock and the Warrants
Our stock price is volatile and fluctuates due to a variety of factors.
Our stock price has varied significantly in the past (from a high of $8.96 to a low of $1.25
from January 1, 2004 to August 30, 2006) and may vary in the future due to a number of factors,
including:
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announcement of the results of, or delays in, preclinical and clinical studies; |
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fluctuations in our operating results; |
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developments in litigation to which we or a competitor is subject; |
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announcements and timing of potential acquisitions, divestitures, capital raising
activities and conversions of preferred stock; |
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announcements of technological innovations or new products by us or our competitors; |
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FDA and other regulatory actions; |
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developments with respect to our or our competitors patents or proprietary rights; |
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public concern as to the safety of products developed by us or others; and |
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changes in stock market analyst recommendations regarding us, other drug development
companies or the pharmaceutical industry generally. |
In addition, the stock market has from time to time experienced significant price and volume
fluctuations that are unrelated to the operating performance of particular companies. These broad
market fluctuations may adversely affect the market price of our stock.
Additional authorized shares of our common stock available for issuance may have dilutive and other
material effects on our stockholders.
We are authorized to issue 100,000,000 shares of common stock. As of September 15, 2006,
there were 41,564,291 shares of common stock issued and outstanding. However, the total number of
shares of our common stock issued and outstanding does not include shares reserved in anticipation
of the exercise of options, warrants or additional investment rights. As of September 15, 2006 we
had stock options outstanding to purchase approximately 3,584,719 shares of our common stock, the
exercise price of which range between $1.70 per share to $8.00 per share, warrants outstanding to
purchase 46,706 shares of our common stock with an exercise price of $6.39, warrants outstanding to
purchase 357,423 shares of our common stock with an exercise price of $1.91 and we have reserved
shares of our common stock for issuance in connection with the potential exercise thereof.
Additionally, at our Annual Stockholder Meeting on May 12, 2006, our stockholders approved the
OrthoLogic 2005 Equity Incentive Plan, which provides an additional 2,000,000 shares of our common
stock for incentive awards. To the extent such options are exercised or additional stock is
issued, the holders of our common stock will experience further dilution. In addition, in the
event that any future financing or consideration for a future acquisition should be in the form of,
be convertible into or exchangeable for, equity securities, investors will experience additional
dilution.
Certain provisions of our amended and restated certificate of incorporation and bylaws will make it
difficult for stockholders to change the composition of our board of directors and may discourage
takeover attempts that some of our stockholders may consider beneficial.
Certain provisions of our amended and restated certificate of incorporation and bylaws may
have the effect of delaying or preventing changes in control if our board of directors determines
that such changes in control are not in the best interests of OrthoLogic Corp. and our
stockholders. These provisions include, among other things, the following:
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a classified board of directors with three-year staggered terms; |
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advance notice procedures for stockholder proposals to be considered at stockholders meetings; |
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the ability of our board of directors to fill vacancies on the board; |
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a prohibition against stockholders taking action by written consent; and |
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super majority voting requirements for the stockholders to modify or amend our bylaws
and specified provisions of our amended and restated certificate of incorporation. |
These provisions are not intended to prevent a takeover, but are intended to protect and
maximize the value of our stockholders interests. While these provisions have the effect of
encouraging persons seeking to acquire control of our company to negotiate with our board of
directors, they could enable our board of directors to prevent a transaction that some, or a
majority, of our stockholders might believe to be in their best interests and, in that case, may
prevent or discourage attempts to remove and replace incumbent directors. In addition, we are
subject to the provisions of Section 203 of the Delaware General Corporation Law, which prohibits
business combinations with interested stockholders. Interested stockholders do not include
stockholders whose acquisition of our securities is pre-approved by our board of directors under
Section 203.
We may issue additional shares of preferred stock that have greater rights than our common stock
and also have dilutive and anti-takeover effects.
We are permitted by our amended and restated certificate of incorporation to issue up to
2,000,000 shares of preferred stock. We can issue shares of our preferred stock in one or more
series and can set the terms of the preferred stock without seeking any further approval from our
common stockholders or other security holders. Any preferred stock that we issue may rank ahead of
our common stock in terms of dividend priority or liquidation rights and may have greater voting
rights than our common stock.
In connection with the Rights Agreement dated as of March 4, 1997 between us and the Bank of
New York, as amended (the Rights Agreement), our board approved the designation of 500,000 shares
of Series A Preferred Stock. The Rights Agreement and the exercise of rights to purchase Series A
Preferred Stock pursuant to the terms thereof may delay, defer or prevent a change in control
because the terms of any issued Series A Preferred Stock would potentially prohibit our
consummation of certain extraordinary corporate transactions without the approval of the Board. In
addition to the anti-takeover effects of the rights granted under the Rights Agreement, the
issuance of preferred stock, generally, could have a dilutive effect on our stockholders.
We have not previously paid dividends on our common stock and we do not anticipate doing so in the
foreseeable future.
We have not in the past paid any dividends on our common stock and do not anticipate that we
will pay any dividends on our common stock in the foreseeable future. Any future decision to pay a
dividend on our common stock and the amount of any dividend paid, if permitted, will be made at the
discretion of our board of directors.
If we do not maintain an effective registration statement or comply with applicable state
securities laws, the Warrant holders may not be able to exercise the Warrants.
For the holders of the Warrants to be able to exercise their Warrants, the shares of our
common stock to be issued upon exercise of those Warrants must be covered by an effective and
current registration statement and qualify or be exempt under the securities laws of the state or
other jurisdiction in which the Warrant holders live. We can give no assurance that we will be
able to continue to maintain a current registration statement relating to the shares of our common
stock underlying the Warrants or that an exemption from registration or qualification will be
available throughout their term. This may have an adverse effect on the ability of the Warrant
holders to exercise the Warrants.
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While the Warrants are outstanding, it may be more difficult to raise additional equity capital.
While the Warrants are outstanding, we may find it more difficult to raise additional equity
capital.
Future sales or the potential for sale of a substantial number of shares of our common stock could
cause the trading price of our common stock to decline and could impair our ability to raise
capital through subsequent equity offerings.
Sales of a substantial number of shares of our common stock in the public markets, or the
perception that these sales may occur, could cause the market price of our stock to decline and
could materially impair our ability to raise capital through the sale of additional equity
securities. This prospectus covers the resale of shares that previously were restricted, as well
as shares underlying warrants issued to the selling security holder. As a result, the number of
our securities eligible to be sold in the market will increase upon the effectiveness of this
registration statement. If the selling security holder sells a significant amount of this common
stock, or if there is a perception that such sales will be effected, the prices of those securities
could drop.
Exercise of the Warrants will dilute the ownership interests of existing stockholders.
The exercise of the Warrants will dilute the ownership interests of existing stockholders and
any sales in the public market of the common stock issuable upon such exercise could adversely
affect prevailing market prices of our common stock. In addition, the existence of the Warrants
may encourage short selling by market participants because exercise of the Warrants could depress
the price of our common stock.
You should consider the United States federal income tax consequences of owning the Warrants and
our common stock.
You are urged to consult your tax advisors with respect to the United States federal income
tax consequences resulting from an exercise of the Warrants, as well as the possibility of taxable
income resulting from certain changes to the terms of the Warrants.
We caution that the foregoing list of important factors is not exclusive and may not be up to
date. Developments in any of these areas could cause our results to differ materially from results
that have been or may be projected by us.
Forward-Looking Statements
All statements other than statements of historical facts included or incorporated by reference
into this prospectus, including statements regarding our future financial position, business
strategy, budgets, projected costs, and plans and objectives for future operations are
forward-looking statements within the meaning of the Private Securities Litigation Reform Act of
1995. These statements are subject to risks and uncertainties that could cause actual results to
differ materially from those anticipated as of the date of this prospectus. Forward-looking
statements generally can be identified by the use of forward-looking words such as may, could,
expect, intend, plan, seek, anticipate, believe, estimate, predict, potential,
continue, or the negative of these terms or other comparable terminology. You should not place
undue reliance on forward-looking statements since they involve known and unknown risks,
uncertainties and other factors which are, in some cases, beyond our control and which could
materially affect actual results, levels of activity, performance or achievements. Some of the
factors that could cause such a variance may be disclosed in a Risk Factors section elsewhere in
this prospectus and documents incorporated by reference into this prospectus, and include the
following:
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unfavorable results of our product candidate development efforts; |
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unfavorable results of our pre-clinical or clinical testing; |
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delays in obtaining, or failure to obtain FDA approvals; |
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increased regulation by the FDA and other agencies; |
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the introduction of competitive products; |
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impairment of license, patent or other proprietary rights; |
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failure to achieve market acceptance of our products; |
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the impact of present and future collaborative agreements; and |
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failure to successfully implement our drug development strategy. |
We urge you to consider these factors and to review carefully the description of risks in this
section titled Risk Factors and Forward-Looking Statements for a more complete discussion of the
risks of an investment in our securities. The forward-looking statements included in this
prospectus or incorporated by reference into this prospectus are made only as of the date of this
prospectus or the date of the incorporated document, and we undertake no obligation to publicly
update these statements to reflect subsequent events or circumstances.
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THE COMPANY
Overview of the Business
CHRYSALIN®
OrthoLogic is a biotechnology company focused on the development and commercialization of the
novel synthetic peptide Chrysalin® (TP508) in two lead indications, both of which represent areas
of significant unmet medical need fracture repair and diabetic foot ulcer healing. Chrysalin, or
TP508, is a 23-amino acid synthetic peptide representing a receptor-binding domain of the human
thrombin molecule, a naturally occurring agent responsible for blood clotting and initiating the
natural healing cascade of cellular events responsible for tissue repair both soft tissue and
bone.
On March 15, 2006, we reported results of our Phase 3 fracture repair human clinical trial.
For the primary endpoint, immobilization removal, no statistically significant difference between
placebo and a single injection of Chrysalin were achieved. Consistent with the Phase 1/2 human
clinical trial results, a statistically significant difference for a secondary endpoint,
radiographic evidence of radial cortical bridging, was achieved. However, no statistically
significant difference was noted in the studys other secondary endpoints. On March 15, 2006, we
temporarily halted our Phase 2b fracture repair dosing clinical trial to perform an interim
analysis of the data of the subjects enrolled to that date.
On August 29, 2006, we reported the results of preliminary interim analysis of data from our
Phase 2b dose-ranging clinical trial of the novel synthetic peptide Chrysalin® (TP508)
in unstable, displaced distal radius (wrist) fractures and termination of the Phase 2b study. In
the dataset of 240 subjects as a group that were evaluable in the Phase 2b interim analysis,
treatment with Chrysalin did not demonstrate benefit compared to placebo in the primary efficacy
endpoint of time to removal of immobilization. Individual findings of efficacy in secondary
endpoints, including radiographic healing, were not seen in this interim analysis. Further, no
dose response relationship was observed. The trial met the pre-specified safety endpoint by
demonstrating no significant difference in the incidence of adverse events between the Chrysalin
and placebo groups.
AZX100 ICARMs
On February 23, 2006 we entered into an agreement to purchase certain assets and assume
certain liabilities of AzERx, Inc. The transaction was completed (closed) on February 27, 2006.
Under the terms of the transaction, OrthoLogic acquired an exclusive license for the core
intellectual property relating to AZX100, and will continue to develop the new class of compounds
in the field of smooth muscle relaxation called Intracellular Actin Relaxing Molecules, or ICARMs,
based on the unique technology developed by AzERx. The acquisition provides us with a new
technology platform that diversifies the portfolio, and may provide more than one potential
product. AzERxs lead compound is AZX100, a 24-amino acid peptide. AZX100 is currently being
investigated for medically important and commercially significant applications such as the
treatment of vasospasm associated with subarachnoid hemorrhage (SAH), prevention of keloid
scarring, and the treatment of asthma. Preclinical and human in vitro studies have shown that this
novel compound has the ability to relax smooth muscle in multiple tissue types. We will continue
pre-clinical activities on AZX100 in 2006.
We continue to evaluate other biopharmaceutical compounds that can complement our research
activity internally and broaden our potential pipeline for successful products.
Additional Information about OrthoLogic
OrthoLogic Corp. was incorporated as a Delaware corporation in July 1987 as IatroMed, Inc. We
changed our name to OrthoLogic Corp. in July 1991. Our executive offices are located at 1275 West
Washington Street, Tempe, Arizona 85281, and our telephone number is
(602) 286-5520.
Our website address is www.orthologic.com. Our annual reports on Form 10-K, quarterly reports
on Form 10-Q and current reports on
Form 8-K, as well as any amendments to those reports, are
available free of charge
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through our website as soon as reasonably practical after we file or furnish them to the U.S.
Securities and Exchange Commission. Once at our website, go to the Investors section to locate
these filings.
In March 2004, we adopted a code of conduct that applies to all of our employees and has
particular sections that apply only to our principal executive officer and senior financial
officers. We posted the text of our code of conduct on our website in the Investors section of
our website under Code of Conduct. In addition, we will promptly disclose on our website (1) the
nature of any amendment to our code of conduct that applies to our principal executive officer and
senior financial officers, and (2) the nature of any waiver, including an implicit waiver, from a
provision of our code of ethics that is granted to one of these specified officers, the name of
such officer who is granted the waiver and the date of the waiver.
Chrysalin Product Platform
Chrysalin, or TP508, is a 23-amino acid synthetic peptide representing a receptor-binding
domain of the human thrombin molecule, a naturally occurring molecule in the body responsible for
both blood clotting and initiating many of the cellular events responsible for tissue repair.
Chrysalin mimics specific attributes of the thrombin molecule, stimulating the bodys natural
healing processes. Drugs based on the Chrysalin peptide can be used to mimic part of the thrombin
response without stimulating the events associated with blood clotting and therefore has the
potential to accelerate the natural cascade of healing events. The Chrysalin molecule serves as
the basis for a group of potential therapeutic products we refer to collectively as the Chrysalin
Product Platform. We have initiated or are conducting clinical trials for three potential
Chrysalin products: one trial for acceleration of fracture repair, a second trial for diabetic foot
ulcer, and a third pilot study for spine fusion. We have conducted pre-clinical testing for
cartilage defect repair, cardiovascular repair, dental bone repair, and tendon repair. As of
December 31, 2005 we have focused our efforts on the development and commercialization of fracture
repair and diabetic foot ulcer healing indications.
The development of each of our potential product candidates in the Chrysalin Product Platform
is based on our collective knowledge and understanding of how the human thrombin molecule
contributes to the repair of soft tissue and bone. While there are important differences in each
of the product candidates in terms of purpose (fracture repair, diabetic foot ulcer healing, etc.)
each product candidate is focused on accelerating and enhancing tissue repair and is based on the
ability of Chrysalin to mimic specific attributes of the human thrombin molecule to stimulate the
bodys natural healing process.
We are developing the Chrysalin-based product candidates in parallel. We expect to learn from
the results of each trial and apply the findings to the development of the other product
candidates. We believe there are distinct research activities within the product candidates whose
outcomes and results will apply across the product platform in terms of safety and efficacy. All
of our potential products in research and development are subject to extensive regulation by the
U.S. Food and Drug Administration, whose approval we must obtain before we can bring our products
to the market.
Acceleration of Fracture Repair
Every broken bone is called a fracture and approximately 30 million fractures are treated
every year throughout the developed world, as reported by medical reimbursement records in
countries with national healthcare systems. The treatment of a fracture depends on the severity of
the break. Simple fractures often heal themselves, with more complex closed fractures potentially
amenable to treatment by manipulation (also called reduction) without requiring surgery.
Fractures that break the skin (or open fractures) or where the fragments cannot be lined up
correctly usually require surgery. Sometimes plates, screws or pins are used for mechanical
stabilization, occasionally with the use of bone grafts, all of which are invasive, expensive and
time consuming procedures.
Chrysalin is a substance that, when injected through the skin into the fracture site at the
time of fracture reduction, was shown in a preliminary clinical trial to accelerate the healing of
the fracture. Chrysalin does this by mimicking certain stimulatory aspects of the thrombin
molecule. Fractures that heal faster lead to earlier return of function for the patient and
potentially improved clinical outcomes.
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In pre-clinical animal studies, a single injection of Chrysalin into the fracture gap
accelerated fracture healing by up to 50% as measured by mechanical testing. In late 1999, we
initiated a combined Phase 1/2 human clinical trial to evaluate the safety of Chrysalin and its
effect on the rate of healing in adult subjects with unstable distal radius fractures (fractures
around and in the wrist joint). We presented the results of this Phase 1/2 human clinical trial
for fracture repair at the 57th Annual Meeting of the American Society for Surgery of the Hand in
October 2002. The data from x-ray evaluations revealed that a single injection of Chrysalin into
the fracture gap resulted in a trend toward accelerated fracture healing compared with the saline
placebo control. There were no reportable adverse events attributable to Chrysalin in the study.
We completed patient enrollment in our pivotal Phase 3 human clinical trial evaluating the
efficacy of Chrysalin in patients with unstable and/or displaced distal radius (wrist) fractures in
May 2005. We enrolled a total of 503 study patients in 27 health centers throughout the United
States. The primary efficacy endpoint in the trial is to measure how quickly wrist fractures in
patients injected with Chrysalin heal, as measured by the removal of immobilization. Accelerated
removal of immobilization allows patients to initiate hand therapy and regain full function of
their wrists and hands sooner. The clinical trials secondary efficacy endpoints include
radiographic analysis of healing, as well as clinical, functional, and patient outcome parameters.
On March 15, 2006, we reported results of our Phase 3 fracture repair human clinical trial. For
the primary endpoint, immobilization removal, no statistically significant difference between
placebo and a single injection of Chrysalin were achieved. Consistent with the Phase 1/2 human
clinical trial results, a statistically significant difference for a secondary endpoint,
radiographic evidence of radial cortical bridging, were achieved. However, no statistically
significant difference was noted in the studys other secondary endpoints. To date, there have
been no adverse events related to Chrysalin reported in this Phase 3 trial.
At that time, we were also conducting a Phase 2b human clinical trial to establish the lower
dose range of Chrysalin versus a placebo control, as well as to provide information to support our
potential future fracture repair new drug application (NDA). Our enrollment goal was 500
patients in approximately 60 sites. On March 15, 2006, we temporarily halted our Phase 2b fracture
repair dosing clinical trial to perform an interim analysis of the data of the subjects enrolled to
that date.
On August 29, 2006, we reported the results of preliminary interim analysis of data from our
Phase 2b dose-ranging clinical trial of the novel synthetic peptide Chrysalin® (TP508)
in unstable, displaced distal radius (wrist) fractures and termination of the Phase 2b study. In
the dataset of 240 subjects as a group that were evaluable in the Phase 2b interim analysis,
treatment with Chrysalin did not demonstrate benefit compared to placebo in the primary efficacy
endpoint of time to removal of immobilization. Individual findings of efficacy in secondary
endpoints, including radiographic healing, were not seen in this interim analysis. Further, no
dose response relationship was observed. The trial met the pre-specified safety endpoint by
demonstrating no significant difference in the incidence of adverse events between the Chrysalin
and placebo groups.
We currently plan to approach the FDA and European regulatory authorities as to the acceptance
of a primary endpoint focused on radiographic healing. Our future fracture repair activity will be
determined by the results of these efforts.
Dermal Wound Healing
Our dermal wound healing studies are focused on healing diabetic foot ulcers, a common problem
for diabetic patients. Diabetic patients suffer from open wound foot ulcers because diabetes
related nerve damage causes the patient to lose sensation. Patients thus may not notice an injury
to the foot and neglect the injury. This fact and the diminished blood flow to extremities caused
by diabetes cause a diabetic patients wounds to heal more slowly or not at all.
Current standard treatment for diabetic foot ulcer wounds focuses on sanitation of the wound
and non-use of the foot (off loading) to allow for the bodys natural healing processes to occur.
These treatments require high patient compliance and effectively heal only approximately 33% of
these ulcers. Wounds that do not respond to treatment can sometimes result in amputation of the
affected limb.
20
We believe topical treatment of the wound with Chrysalin will promote new tissue growth
necessary for healing of a diabetic foot ulcer. CBI conducted a multicenter Phase 1/2 double blind
human trial with 60 patients, the results of which were presented at the Wound Healing Society in
May of 2002. We found no drug related adverse events or patient sensitivity to Chrysalin in the
trial and complete wound closure occurred in 70% of Chrysalin-treated ulcers relative to 33% in
placebo controls, a statistically significant difference. Our pre-clinical studies and the initial
Phase 1/2 human clinical trial evaluated Chrysalin in a saline formulation.
Spine Fusion
Spine fusion surgery is most commonly performed to treat degenerative disk disease, spinal
instability and other disorders of the spine that are believed to be the cause of back and neck
pain. The surgery involves the fusing of one or more vertebrae of the spine by placement of bone
graft material around the targeted area of the spine during surgery. The body then heals the
grafts over several months, which fuses the vertebrae together with newly formed bone so there is
no longer movement between the vertebrae.
The bone used for the graft in this procedure is taken from another bone in the patient,
usually from the iliac crest (hip bone) and is called autograft bone. In some procedures the
patients and physicians elect to use allograft bone which is bone processed from cadavers.
Autograft bone is currently the primary type of bone graft used in spinal fusion surgery and is
considered the gold standard. Allograft bone is often used but has not been an effective
stand-alone substitute for autograft bone because it has no bioactive component to stimulate bone
growth. The benefit of using allograft bone is it does not require a separate surgical procedure
from the same patient to harvest the bone for the graft.
Our potential solution to this problem is to combine Chrysalin, either in saline or in a
sustained release formulation, with commercially available allograft bone for use in spinal fusion
surgery as an alternative to autograft. A completed pre-clinical study, which was presented at the
North American Spine Society meeting in October 2004 in Chicago, showed that Chrysalin, in several
different formulations combined with allograft bone, caused varying degrees of bone formation in
spinal fusion models.
In addition, we completed enrollment in a small pilot Phase 1/2 human clinical trial
evaluating Chrysalin for spine fusion in the spring of 2004. This pilot study included
approximately 50 patients and no adverse events related to Chrysalin have been reported in this
study.
Cartilage Defect Repair
Cartilage tissue is the smooth, slippery cushion that exists where two bones meet to make a
joint. Because damaged cartilage generally does not heal but slowly breaks down over time, the
result can lead to a complete wearing away of the cartilage, leading to osteoarthritis.
The primary purpose of exploring Chrysalins potential role in cartilage defect repair is to
develop a technique to restore, rather than entirely replace, the original cartilage damaged due to
acute traumatic events. These techniques, if successful, may also provide a novel approach for
partial resurfacing of damaged joint (or articular) cartilage due to osteoarthritis. Our
potential solution to cartilage defects is to deliver Chrysalin within a sustained-release matrix
to the damaged cartilage.
We have completed several pre-clinical studies evaluating Chrysalin in sustained release
formulations for cartilage defect repair. The results to date have been presented at two major
international conferences on cartilage repair.
Cardiovascular Repair
Coronary artery disease is the narrowing of the arteries that carry blood through the heart
and is a leading cause of mortality in the United States and other parts of the western world. The
narrowing is usually caused by fatty deposits inside the artery walls that restrict the passage of
blood carrying oxygen to the heart muscle. This oxygen insufficiency is the primary cause of chest
pain (commonly referred to as angina) and, if left untreated, can lead to heart failure and,
ultimately, death. The most common treatments for the disease are a regimen of
21
pharmaceuticals that reduce the patients cholesterol (slowing the buildup of deposits along artery
walls) and surgical procedures to increase the blood flow through the arteries. Up to 15% of
patients, however, either cannot undergo the treatments or do not achieve sufficient blood flow
after the treatment.
A potentially new treatment for coronary artery disease is therapeutic angiogenesis, the
growing of new blood vessels to deliver blood to the diseased heart. In pre-clinical animal
studies conducted, Chrysalin injections into the damaged heart appear to trigger a complex sequence
of events that culminates in the bodys growth of new blood vessels, enhancing blood delivery to
the heart muscle.
Dental Bone Repair
Weve focused on the use of Chrysalin in two dental bone repair situations: dental implants
and maxillo-facial reconstruction. For some patients who need dental implants to replace missing
teeth, the patients bones in the jaw are not strong enough to hold the implanted teeth or
supporting structure. The standard treatment in these cases is to insert bone graft material into
or above the jaw bones and wait for the body to naturally grow bone around the graft material.
This process can take a year or longer, during which a patient must use a temporary external plate
with the temporary teeth. In a 2004 pre-clinical study done by CBI in conjunction with Louisiana
State University, the incorporation of Chrysalin together with a commercially available bone graft
material into the space above the rabbit jaw bones resulted in a significant increase in new bone
formation. This could translate in a shorter wait for patients to complete their dental implant
surgery.
Tendon Repair
Tendons are the soft tissue that connects muscles to bone. Tendons are crucial to the
biomechanical functions of the body. Injuries to tendons are very common, and typically these
injuries are treated either conservatively with rehabilitation techniques or with surgical
techniques. These injuries are often slow to heal or do not heal completely. We have conducted
preliminary research focused on whether Chrysalin accelerates tendon tissue repair which may result
in better restoration of function.
We are focusing our efforts on the fracture repair and diabetic foot ulcer healing product
candidates. The results of our efforts in these two product candidates will determine when and
what future actions are taken on the other product candidates described above.
AZX100 ICARMs
AZX100, a 24 amino acid peptide, is one of a new class of compounds in the field of smooth
muscle relaxation called Intracellular Actin Relaxing Molecules, or ICARMs.
AZX100 relaxes smooth muscle, which modulates the function of blood vessels, sphincters, the
gastrointestinal tract, the genitourinary tract, and the airways. Sustained abnormal contraction
of any of these muscles is called spasm. Any disorders known to be associated with excessive
constriction or inadequate dilation of smooth muscle represent potential applications for AZX100,
including:
|
|
|
Subarachnoid hemorrhage (SAH) induced spasm of the intracranial blood vessels |
|
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|
Spasm of vein grafts after harvest |
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|
Spasm of the portal vein (PHT) |
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Spasm of airway smooth muscle (asthma) |
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|
Spasm of lung vessels, which causes pulmonary (lung) hypertension |
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Male and female sexual dysfunction |
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Toxemia of pregnancy (pre-eclampsia/eclampsia) |
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|
Pre-term labor |
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Reynauds disease or phenomenon |
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|
Achalasia (spasm of the lower esophageal sphincter) |
|
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Non-occlusive mesenteric ischemia |
|
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|
Hemolytic-uremia |
22
|
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|
Prinzmetals angina (a form of coronary spasm that causes angina), and |
|
|
|
|
Anal fissure. |
AZX100 may also reverse the fibrotic phenotype of fibroblasts and smooth muscle cells in a
mechanism similar to that which causes vasorelaxation. Through phenotypic modulation of
fibroblasts and smooth muscle cells, AZX100 may inhibit the scarring that results from wound
healing and disease states in the dermis, blood vessels, lungs, liver and other organs.
We are currently evaluating AZX100 for applications such as the treatment of vasospasm
associated with subarachnoid hemorrhage, prevention of keloid scarring, and the treatment of
asthma. Preclinical and human in vitro studies have shown that this novel compound has the ability
to relax smooth muscle in multiple tissue types. We plan to continue pre-clinical activities in
support of AZX100 in 2006.
Competition
The following provides a summary of the competitive conditions relating to indications for
which we are considering for our AZX100 and ICARMs research and development activities. For a
summary of the competitive conditions relating to Chrysalin-based indications, please see our
Annual Report on Form 10-K for the fiscal year ended December 31, 2005, and other reports we file
with the Securities and Exchange Commission and incorporate by reference into the registration
statement of which this prospectus is a part.
Subarachnoid Hemorrhage (SAH)
Approved
The only current pharmacological treatment for SAH is the calcium channel antagonist Nimotop
(nimodipine). Although Nimotop significantly improves the outcome of surviving patients through a
neuroprotective effect, it has not been shown to alter the incidence or magnitude of vasospasm or
to decrease mortality. Nimotop carries in the label a black box warning regarding i.v. or other
parenteral administration.
In Development
The other potential competing products currently under development for SAH are endothelin
antagonists (endothelin has been implicated in SAH-induced vasospasm). Elevated plasma levels of
endothelin-1 (ET-1) have been shown to occur in patients with SAH-induced vasospasm, although the
timing of endothelin elevation has varied from as early as three days after SAH to 8 14 days
after SAH. Such differences indicate endothelin may not induce vasospasm, but rather may play a
role in vasospasm progression. Conflicting results have also been reported regarding the
cerebrospinal fluid levels of ET-1. Taken together, these studies indicate that endothelin may
contribute to SAH-induced vasospasm. Thus, clinical trials have been conducted for Acetelions
endothelial antagonists, clazosentan (specific ETA receptor antagonist) and bosentan
(Tracleer®, dual ETA and ETB receptor antagonist). Although bosentan appears
effective for pulmonary arterial hypertension, the trial for SAH was discontinued because of a lack
of efficacy.
Roche is developing a follow-up compound from bosentan, Ro 61-1790, to improve water
solubility and ETA potency and has demonstrated in vivo efficacy with a canine double
hemorrhage model. In the double hemorrhage model two blood clots must be placed to cause
vasospasm. While vasospasm can be demonstrated angiographically, it does not typically result in
cerebral infarction. Thus, Ro 61-1790 must be tested in humans to determine whether its
improvements will increase efficacy.
The primary disadvantage of endothelin antagonists is that they act on a single
vasoconstrictor, although additional mediators have been implicated in SAH. Therefore, targeting
downstream vasorelaxing pathways with administration of AZX100 may be more effective. In addition,
the ET receptor is internalized once it interacts with the ET peptide. Thus, this drug may only be
effective as a prevention measure, not treatment.
In addition, the recombinant haemostatic agent NovoSeven (activated factor VIIa) is currently
registered for treatment of bleeding of hemophelia patients, but has also been shown to be
effective against the intracerebral
23
hemorrhage (ICH) in phase 2b clinical trials. NovoSeven accelerates the coagulation process at the
site of ICH limiting hematoma.
Keloid Scarring
Approved
There is no approved pharmacologic treatment for scarless healing. In the setting of keloid
formation, the scars are often excised and treated with steroids with variable results.
In Development
The potential competing products are recombinant transforming growth ß-3 (TGF- ß-3) and
antiTGF- ß-1. Renovo is conducting phase 3 clinical trials in Europe on recombinant TGF- ß-3
(Justiva). While preliminary efficacy has been shown in healing in healthy individuals, like other
therapeutics, TGF- ß-3 addresses only part of the pathway that end in phosphorylation of our target
molecule and results in scar inhibition. The potential of the AZX100 to completely inhibit the
entire scarring pathways suggests that AZX100 may be more effective than TGF- ß-3 at scarless
healing, Renovo has also begun clinical trials on antiTGF- ß-1, which like TGF- ß-3 also blocks
part of the signaling cascade resulting in scar formation. AZX100 may be more effective than
antiTGF- ß-1 through more complete inhibition of the scarring cascade.
While many other companies are investigating therapeutics for wound healing, these
therapeutics will be synergistic with and not competitive with AZX100 as they are targeting more
rapid healing and not scar inhibition.
Asthma
Asthma ranks as the third highest reason for preventable hospitalizations in the U.S. with
470,000 hospitalizations and more than 5,000 deaths each year (American Academy of Allergy Asthma
and Immunology Report). Acute asthma accounts for an estimated two-million emergency department
visits annually. There are many competitors with asthma products approved or in development.
AZX100 has been shown to relax airway smooth muscle and may be developed for the treatment of
asthmatic attacks. Specific markets include severe acute asthma and asthma that is refractory to
current therapies. Severe asthma has been defined as asthma that is refractory to current
therapeutic approaches in clinical use (anti-inflammatory agents and bronchodilators). The current
approach is to use ß-adrenergic agonists, which activate the cAMP/PKA pathway. AZX100 is a mimetic
of the molecule downstream of this pathway and hence may be more sensitive and specific for the
treatment of severe asthma. In addition, patients with severe asthma present to the emergency room
for treatment, hence efficacy can be closely monitored and outcomes will be apparent in a short
time frame after treatment. Recent data has demonstrated that one out of every six asthmatics has
a mutation in the ß-adrenergic receptor. These patients do not respond to ß-adrenergic agonists
and in fact do worse when treated with ß-adrenergic agonists. This patient population would be
potentially treated with the AZX100 compound in that it acts downstream of the receptors.
For more information about the status of our drug development efforts, see Chrysalin Product
Platform above and review our Annual Report on Form 10-K for the fiscal year ended December 31,
2005, and other reports we file with the Securities and Exchange Commission and incorporate by
reference into the registration statement of which this prospectus is a part. Chrysalin, ICARMs
and OrthoLogic are registered United States domestic trademarks of OrthoLogic Corp.
MATERIAL CHANGES
On August 29, 2006, we reported the results of preliminary interim analysis of data from our
Phase 2b dose-ranging clinical trial of the novel synthetic peptide Chrysalin® (TP508)
in unstable, displaced distal radius (wrist) fractures and termination of the Phase 2b study. In
the dataset of 240 subjects as a group that were evaluable in the Phase 2b interim analysis,
treatment with Chrysalin did not demonstrate benefit compared to placebo in the primary efficacy
endpoint of time to removal of immobilization. Individual findings of efficacy in secondary
endpoints, including radiographic healing, were not seen in this interim analysis. Further, no
dose response
24
relationship was observed. The trial met the pre-specified safety endpoint by demonstrating no
significant difference in the incidence of adverse events between the Chrysalin and placebo groups.
On April 5, 2006, James M. Pusey, MD resigned as our President and Chief Executive Officer and
as a Class I director of the company. John M. Holliman, III, a director of OrthoLogic since
September 1987 and Chairman of the Board of Directors since August 1997, assumed the title of
Executive Chairman on that date. In that position, Mr. Holliman serves as our principal executive
officer and leads our business and corporate strategic activities. Randolph C. Steer, MD, Ph.D.
was named our President on April 5, 2006, and is responsible for directing our strategy and
operations in all clinical development and regulatory areas.
On March 15, 2006, we reported results of our Phase 3 fracture repair human clinical trial.
For the primary endpoint, immobilization removal, no statistically significant difference between
placebo and a single injection of Chrysalin were achieved. Consistent with the Phase 1/2 human
clinical trial results, a statistically significant difference for a secondary endpoint,
radiographic evidence of radial cortical bridging, was achieved. However, no statistically
significant difference was noted in the studys other secondary endpoints. On March 15, 2006, we
temporarily halted our Phase 2b fracture repair dosing clinical trial to perform an interim
analysis of the data of the 273 patients enrolled to that date.
On February 23, 2006, we entered into an agreement to purchase certain assets and assume
certain liabilities of AzERx, Inc. The transaction closed on February 27, 2006. Under the terms
of the agreement, we acquired an exclusive license for the core intellectual property relating to
AzERxs lead compound, AZX100, a 24-amino acid peptide. AZX100 is currently being investigated for
several applications, including the treatment of vasospasm associated with subarachnoid hemorrhage,
prevention of keloid scarring, and treatment of asthma. We will continue to develop the new class
of compounds in the field of smooth muscle relaxation called Intracellular Actin Relaxing
Molecules, or ICARMs, based on the AZX100 technology.
THE NOVAQUEST TRANSACTION
On February 27, 2006 (the Closing Date), we closed the initial transactions relating to our
Common Stock and Warrant Purchase Agreement (the Purchase Agreement) dated February 24, 2006 with
PharmaBio Development Inc. (d/b/a NovaQuest) (NovaQuest), an affiliate of Quintiles Transnational
Corp. and Quintiles, Inc., which provides for the purchase of shares of our common stock in three
tranches. On the Closing Date, NovaQuest purchased 359,279 shares of our common stock for a
purchase price of $2,000,000 based on the average closing stock price for the 15 trading days prior
to that date. In addition, we also entered into a Class A Warrant Agreement with NovaQuest on the
same date, whereby we issued NovaQuest a fully vested warrant to purchase 46,706 shares of our
common stock at $6.39 a share (the Initial Class A Warrant). On July 3, 2006, NovaQuest purchased
903,252 shares of our common stock for a purchase price of $1,500,000 based on the average closing
stock price for the 15 trading days prior to that date. In addition, we also entered into a Class
A Warrant Agreement with NovaQuest on the same date, whereby we issued NovaQuest a fully vested
warrant to purchase 117,423 shares of our common stock at $1.91 a share (the Additional Class A
Warrant). We are also parties to an Amended and Restated Class B Warrant Agreement (the Class B
Warrant), an Amended and Restated Class C Warrant Agreement (the Class C Warrant) and an Amended
and Restated Class D Warrant Agreement (the Class D Warrant) with NovaQuest to purchase in the
aggregate up to 240,000 shares of our common stock at $1.91 a share (the Class B Warrant, Class C
Warrant and Class D Warrant are collectively referred to in this prospectus as the Milestone
Warrants). The Milestone Warrants, all dated as of February 24, 2006, and amended and restated as
of June 30, 2006, will be exercisable for a ten-year period from February 24, 2006, and will vest
based on the achievement of certain milestones. As provided for in the Purchase Agreement, we have
elected not to offer for sale to NovaQuest the additional shares contemplated in the Purchase
Agreement with respect to the third tranche.
In connection with our entry into the Purchase Agreement, we also entered into a Master
Services Agreement with Quintiles, Inc. (Quintiles) whereby Quintiles will become our exclusive
clinical research organization service provider for our Chrysalin Product Platform and will provide
certain other technical assistance.
25
As consideration for entry into the Master Services Agreement, we have granted Quintiles the
right of first negotiation to promote Chrysalin if it is approved by the U.S. Food and Drug
Administration.
We are obligated to file a registration statement to cover the shares issued on the Closing
Date, the additional shares issued as of July 3, 2006, as well as the shares to be issued upon
exercise of the Initial Class A Warrant, the Additional Class A Warrant and the Milestone Warrants
(collectively referred to in this prospectus as the Warrants).
USE OF PROCEEDS
This prospectus relates to the sale of shares of our common stock that may be offered and sold
from time to time by NovaQuest, the selling security holder. We will not receive any of the
proceeds from the resale by the selling security holder of any of the securities covered by this
prospectus, however, we have received $3.5 million from the sale of shares under a Common Stock and
Warrant Purchase Agreement we have entered into with NovaQuest. We will also receive the exercise
price of the warrants described in this prospectus (to the extent that the selling security holder
does not utilize the cashless exercise feature, if provided). All of the proceeds from the resale
of the securities will go to the selling security holder who offers and sells its securities.
We intend to use the net proceeds we receive for general corporate purposes, including capital
expenditures, working capital needs, current and future clinical trials of our drug candidates, as
well as other research and drug development activities. We have not specifically identified the
precise amounts we will spend on each of these areas or the timing of these expenditures. The
amounts actually expended for each purpose may vary significantly depending upon numerous factors,
including progress with clinical trials for our drug candidates, the establishment of new
collaborative relationships with other companies, the availability of other financing, and other
factors.
26
SELLING SECURITY HOLDER
The following table provides certain information as of the date hereof regarding the
beneficial ownership of our common stock by the selling security holder prior to and after the
issuance of our common stock to the selling security holder pursuant to the Purchase Agreement.
Beneficial ownership is determined under the rules of the Securities and Exchange Commission and
generally includes voting or investment power with respect to securities.
Our registration of shares does not necessarily mean that the selling security holder will
sell all or any of these securities. We have assumed for purposes of the table below that the
selling security holder will sell all of the shares offered for sale. The selling security holder
may have sold, transferred or otherwise disposed of all or a portion of its shares, or acquired
additional shares, since the date on which it provided information regarding its securities.
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Shares of |
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|
|
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Common Stock |
|
|
Shares of |
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|
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|
|
Beneficially |
Selling Security |
|
Common Stock Beneficially |
|
Shares to be Sold |
|
Owned Upon |
Holder (1) |
|
Owned Before Offering |
|
in |
|
Completion of |
|
|
(2)(3) |
|
the Offering (2)(4) |
|
the Offering |
|
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Number |
|
% |
PharmaBio
Development Inc.
(d/b/a NovaQuest) |
|
|
1,426,660 |
|
|
|
1,666,660 |
|
|
|
0 |
|
|
|
4.01 |
(5)(6) |
|
|
|
(1) |
|
Neither NovaQuest nor any of its affiliates has held a position or office, or had any other
material relationship (other than for previous purchases under the Purchase Agreement), with
us. |
|
(2) |
|
Our registration of these securities does not necessarily mean that the selling security
holder will sell any or all of the securities. |
|
(3) |
|
Includes shares underlying the Initial Class A Warrant, the Additional Class A Warrant and
the shares of common stock issued to the selling security holder on February 27, 2006 and July
3, 2006 pursuant to the Purchase Agreement, but does not include the shares of common stock
issuable upon exercise of the Milestone Warrants, as the milestones contained in those
warrants are subject to a confidential treatment request with the SEC and, as of the date of
this prospectus, none of those milestones has been achieved. We are also assuming, for
purposes of the beneficial ownership determination, that none of the milestones in the
Milestone Warrants will be achieved within 60 days from the date of this selling security
holder table. |
|
(4) |
|
The figure in this column assumes that the selling security holder will fully exercise the
Initial Class A Warrant, the Additional Class A Warrant, and all of the Milestone Warrants.
The remaining balance includes the shares of common stock issued to the selling security
holder on February 27, 2006 (359,279 shares), and July 3, 2006 (903,252 shares). |
|
(5) |
|
Applicable percentage of ownership is based on 41,564,291 shares of common stock outstanding
as of September 15, 2006. |
|
(6) |
|
Percentage calculation assumes that all of the shares are sold by the selling security
holder. |
27
PLAN OF DISTRIBUTION
We will not receive any of the proceeds from the resale by the selling security holder of any
of the securities covered by this prospectus, however, we have received $3.5 million from the sale
of shares under a Common Stock and Warrant Purchase Agreement we have entered into with NovaQuest.
We will also receive the exercise price of the warrants described in this prospectus (to the extent
that the selling security holder does not utilize the cashless exercise feature, if provided). The
aggregate proceeds to the selling security holder from the sale of our common stock will be the
purchase price of the common stock less any discounts and commissions. The selling security holder
reserves the right to accept and, together with its agents, to reject, any proposed purchase of
common stock to be made directly or through agents. This prospectus covers the resale of shares of
our common stock by NovaQuest, the selling security holder. As used in this prospectus, to the
extent applicable, selling security holder includes holders of shares of our common stock
received from the selling security holder after the date of this prospectus and who received such
shares by gift or by other transfer by the selling security holder to an immediate family member of
such stockholder, by will or through operation of the laws of descent and distribution, and their
respective administrators, guardians, receivers, executors or other persons acting in a similar
capacity.
The common stock may be sold from time to time to purchasers:
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|
directly by the selling security holder and its successors, which includes its
transferees, pledgees or donees or their successors; or |
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through underwriters, broker-dealers or agents who may receive compensation in the
form of discounts, concessions or commissions from the selling security holder or the
purchasers of the common stock. These discounts, concessions or commissions may be in
excess of those customary in the types of transactions involved. |
The selling security holder and any underwriters, broker-dealers or agents who participate in the
distribution of the common stock may be deemed to be underwriters within the meaning of the
Securities Act of 1933, as amended (the Securities Act). As a result, any profits on the sale of
the common stock by the selling security holder and any discounts, commissions or concessions
received by any such broker-dealers or agents may be deemed to be underwriting discounts, and
underwriters within the meaning of the Securities Act will be subject to prospectus delivery
requirements of the Securities Act. If the selling security holder is deemed to be an underwriter,
it may be subject to certain statutory liabilities, including, without limitation, liabilities
under Sections 11, 12 and 17 of the Securities Act and Rule 10b-5 under the Securities Exchange Act
of 1934, as amended. If the common stock is sold through underwriters, broker-dealers or agents,
the selling security holder will be responsible for underwriting discounts or commissions or
agents commissions.
Neither we nor the selling security holder can presently estimate the amount of compensation
that any agent will receive. We know of no existing arrangements between the selling security
holder, any other stockholder, broker, dealer, underwriter, or agent relating to the sale or
distribution of the shares offered by this prospectus. At the time a particular offer of shares is
made, a prospectus supplement, if required, will be distributed that will set forth the names of
any agents, underwriters, or dealers and any compensation from the selling security holder, and any
other required information.
The common stock may be sold in one or more transactions at:
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fixed prices; |
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prevailing market prices at the time of sale; |
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prices related to such prevailing market prices; |
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varying prices determined at the time of sale; or |
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negotiated prices. |
These sales may be effected in transactions:
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on any national securities exchange or quotation service on which the common stock
may be listed or quoted at the time of the sale; |
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in the over-the-counter market; |
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otherwise than on such exchanges or services or in the over-the-counter market; |
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through the writing and exercise of options, whether such options are listed on an
options exchange or otherwise; or |
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through the settlement of short sales. |
These transactions may include block transactions or crosses. Crosses are transactions in
which the same broker acts as an agent on both sides of the trade.
In connection with the sales of the common stock or otherwise, the selling security holder may
enter into hedging transactions with broker-dealers or other financial institutions. These
broker-dealers or other financial institutions may in turn engage in short sales of the common
stock in the course of hedging their positions. The selling security holder may also sell the
common stock short and deliver common stock to close out short positions, or loan or pledge common
stock to broker-dealers that in turn may sell the common stock.
Broker-dealers engaged by the selling security holder may arrange for other brokers-dealers to
participate in sales. Broker-dealers may receive commissions or discounts from the selling
security holder (or, if any broker-dealer acts as agent for the purchaser of shares, from the
purchaser) in amounts to be negotiated. The selling security holder does not expect these
commissions and discounts to exceed what is customary in the types of transactions involved.
The selling security holder may from time to time pledge or grant a security interest in some
or all of the shares of common stock owned by it and, if it defaults in the performance of its
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 security
holders to include the pledgee, transferee or other successors in interest as selling security
holders under this prospectus.
We cannot be certain that the selling security holder will sell any or all of the common stock
pursuant to this prospectus. Further, we cannot assure you that the selling security holder will
not transfer, devise or gift the common stock by other means not described in this prospectus,
including sales under Rule 144 of the Securities Act. The common stock may be sold in some states
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 is available and complied with.
The selling security holder and any other person participating in the sale of the common stock will
be subject to the Securities Exchange Act of 1934, as amended (the Exchange Act). The Exchange
Act rules include, without limitation, Regulation M, which may limit the timing of purchases and
sales of any of the common stock by the selling security holder and any other such persons. In
addition, Regulation M may restrict the ability of any person engaged in the distribution of the
common stock and the ability of any person or entity to engage in market-making activities with
respect to the common stock. All of the foregoing may affect the marketability of the shares
offered by the selling security holder in this Prospectus.
We have agreed to pay substantially all expenses incidental to the registration, offering and
sale of the common stock to the public, other than commissions, fees and discounts of underwriters,
brokers, dealers and agents. We have also agreed to indemnify NovaQuest and related persons
against specified liabilities, including liabilities under the Securities Act.
Insofar as indemnification for liabilities arising under the Securities Act may be permitted
to our directors, officers, and controlling persons, we have been informed that in the opinion of
the Securities and Exchange Commission, this indemnification is against public policy as expressed
in the Securities Act and is, therefore, unenforceable.
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DESCRIPTION OF WARRANTS
On February 27, 2006 (the Closing Date), we closed the initial transactions relating to our
Common Stock and Warrant Purchase Agreement (the Purchase Agreement) dated February 24, 2006 with
PharmaBio Development Inc. (d/b/a NovaQuest) (NovaQuest), an affiliate of Quintiles Transnational
Corp. and Quintiles, Inc. On the Closing Date, NovaQuest purchased 359,279 shares of our common
stock for a purchase price of $2,000,000 based on the average closing stock price for the 15
trading days prior to that date. In addition, we also entered into a Class A Warrant Agreement
with NovaQuest dated as of the Closing Date, whereby we issued NovaQuest a fully vested warrant to
purchase 46,706 shares of our common stock at $6.39 a share (the Initial Class A Warrant). On
July 3, 2006, NovaQuest purchased 903,252 shares of our common stock for a purchase price of
$1,500,000 based on the average closing stock price for the 15 trading days prior to that date. In
addition, we also entered into a Class A Warrant Agreement with NovaQuest on the same date, whereby
we issued NovaQuest a fully vested warrant to purchase 117,423 shares of our common stock at $1.91
a share (the Additional Class A Warrant). We are also parties to an Amended and Restated Class B
Warrant Agreement, an Amended and Restated Class C Warrant Agreement and an Amended and Restated
Class D Warrant Agreement with NovaQuest to purchase in the aggregate up to 240,000 shares of our
common stock at $1.91 a share (the Milestone Warrants). The Milestone Warrants, all dated as of
February 24, 2006, and amended and restated as of June 30, 2006, will be exercisable for a ten-year
period from February 24, 2006, and will vest based on the achievement of certain milestones. The
Initial Class A Warrant, the Additional Class A Warrant and the Milestone Warrants will each be
referred to in this prospectus as a Warrant, and collectively, as the Warrants.
The following summary description of the Warrants sets forth some general terms and provisions
of the Warrants, but the summary does not purport to be complete and is qualified in all respects
by reference to the actual text of the Warrants, copies of which have been filed as exhibits to the
registration statement, of which this prospectus is a part. In the event of any conflict between
this description and the text of the warrants, the text of the Warrants shall govern. We urge you
to read the text of the Warrants because the Warrants, and not this description, define your rights
as a holder of the Warrants.
Exercise Period
The Initial Class A Warrant is exercisable at any time on or prior to 5:00 pm Eastern Time on
February 24, 2016. The Additional Class A Warrant, is exercisable at any time on or prior to 5:00
pm Eastern Time on June 30, 2016. The Milestone Warrants are exercisable, subject to a vesting
schedule based on the achievement of certain milestones, at any time on or prior to 5:00 pm Eastern
Time on February 24, 2016. The milestones set forth in the Milestone Warrants are subject to a
confidential treatment request with the Securities and Exchange Commission. The Milestone Warrants
will also fully vest upon the occurrence of certain change of control transactions.
Exercise Price and Other Terms
Each Warrant will entitle its holder to purchase the shares of common stock specified on the
face of the Warrant, subject to adjustment in accordance with the anti-dilution and other
adjustment provisions described below. The exercise price for the Initial Class A Warrant is $6.39
per share.The exercise price for the Additional Class A Warrant and each of the Milestone Warrants
is $1.91 per share. The holder of each Warrant will be able to exercise each Warrant, in whole
or part, by delivering to us the applicable warrant agreement, the exercise form properly completed
and executed and payment of the aggregate exercise price for the number of shares of common stock
as to which the Warrant is being exercised. The exercise price will be payable at the option of
each Warrant holder:
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by certified check, official bank check or wire transfer of immediately available
funds, payable to the order of OrthoLogic Corp.; or |
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with respect to the Milestone Warrants only, by cashless exercise, pursuant to which
the Milestone Warrant holder will receive the number of shares of common stock as is
equal to the product of (1) the number of shares of common stock being exercised under
the warrant multiplied by (2) a fraction, the numerator of which is the fair market
value per share of common stock at such time minus the exercise |
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price per share of common stock at such time, and the denominator of which is the fair
market value per share of common stock at such time. For purposes of the cashless
exercise feature in the Milestone Warrants, the fair market value of one share of our
common stock shall mean the closing price reported on the NASDAQ Global Market or the
principal exchange on which our common stock is listed, or the average of the closing
bid and asked prices of our common stock quoted in the over-the-counter market,
whichever is applicable, in each such case averaged over a period of fifteen (15)
consecutive trading days immediately preceding the date that the exercise form is
delivered to us. If our common stock is not traded on such market or exchange, or
over-the-counter, the fair market value of our common stock will be the price per share
which we could obtain from a willing buyer for shares sold by us from authorized but
unissued shares, as agreed upon by us and the selling security holder in good faith or,
absent such agreement, as shall be determined by arbitration instituted by either party
under the rules of the American Arbitration Association.
Each Warrant may be exercised in whole or in part at the applicable exercise price until its
applicable expiration date, as described above. No fractional shares of our common stock will be
issued upon the exercise of the Warrants. We will pay a cash adjustment instead of fractional
shares equal to the excess of the fair market value of such fractional share (determined in such
reasonable manner as may be prescribed by our Board of Directors in its discretion) over the
proportional part of the per share purchase price represented by such fractional share.
Upon exercise of each Warrant, we will deliver a stock certificate representing the number of
shares that were exercised under the Warrant, such certificate to be issued and delivered promptly
after the Warrant is exercised. If the Warrant is not fully exercised, we will execute a new
warrant exercisable for the remaining shares and deliver the new warrant at the same time as the
stock certificate for the exercised shares.
Adjustments
The exercise price of each Warrant and the number of shares of common stock purchasable upon
the exercise of each Warrant may, with certain exceptions, be subject to adjustment in certain
situations. We will compute such adjustment and provide the respective Warrant holder with a
certificate setting forth the adjustment and the facts on which it is based. The situations
requiring adjustment are as follows:
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Upon a (1) reorganization, consolidation or merger with or into another corporation
(other than a merger or share exchange in which we are the surviving corporation and
the common stock is not exchanged for or converted to securities, property or assets by
virtue of such transaction) or (2) sale, lease, license or other transfer of all or
substantially all of our property or assets, an adjustment will be made to enable the
Warrant holder to receive, in lieu of the shares of common stock that might otherwise
have been purchased upon exercise of the Warrant, the kind and number of shares and/or
other securities and/or property and assets and/or cash receivable in such event that
the holder would otherwise have been entitled to receive had the holder exercised the
Warrant immediately prior to such reorganization, consolidation, merger, lease, sale,
license or other transfer. |
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Upon a reclassification or otherwise that changes any of the securities as to which
purchase rights under a Warrant exist into the same or a different number of securities
of any other class or classes, an adjustment will be made to enable the Warrant holder
to receive, in lieu of the shares of common stock that might otherwise have been
purchased upon exercise of the Warrant, the kind and number of shares and/or other
securities in such event that the holder would otherwise have been entitled to receive
had the holder exercised the Warrant immediately prior to such reclassification or
other change or immediately prior to the record date with respect thereto, together
with an appropriate adjustment to the exercise price of the Warrant. |
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Upon a split, subdivision or combination of the securities as to which purchase
rights under a Warrant exist into a different number of securities of the same class,
an adjustment to the exercise price of the Warrant will be made to enable the Warrant
holder to receive the same proportion of shares that the holder would otherwise have
been entitled to receive had the holder exercised the Warrant immediately prior to such
split, subdivision or combination. |
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Warrant Holder Not A Stockholder
The Warrants do not entitle the holders to any voting or other rights as are accorded to our
stockholders nor are the holders subject to any liability for the exercise price or as a
stockholder whether asserted by us or our creditors.
Registration Rights
We agreed to file a registration statement with respect to the shares of common stock issuable
upon exercise of the Warrants, as well as other securities issued or to be issued from time to time
to NovaQuest. The following summary of the registration rights provided in such registration
rights agreement, as amended, a copy of which has been filed as an exhibit to the registration
statement of which this prospectus is a part, is not complete. Unless otherwise indicated, the
provisions set forth below summarize the provisions contained in the registration rights agreement,
as amended. This summary is not complete and you should refer to the registration rights
agreement, as amended, for a full description of the registration rights that apply to the Warrants
and the underlying shares of common stock. This summary is qualified in its entirety by the
registration rights agreement, as amended. In the event of any conflict between this description
and the registration rights agreement, the terms of the registration rights agreement, as amended,
will govern.
The holders of the Warrants and the common stock issuable upon exercise of the Warrants are
entitled to the benefits of a registration rights agreement. This prospectus is part of a
registration statement that we filed to meet our obligations to, among other things, register for
resale shares of common stock issuable upon exercise of the Warrants by the selling security
holder.
We will use our best efforts to have this registration statement declared effective as
promptly as practicable following the filing thereof, and to keep it effective until the earlier
of:
(1) the sale under the registration statement of all of the shares of common stock covered by
the registration rights agreement, as amended; and
(2) such date as all remaining unsold shares of common stock covered by the registration
rights agreement, as amended, can be sold by the selling security holder without restriction
pursuant to the requirements of Rule 144 promulgated under the Securities Act of 1933, as amended.
We will be permitted to suspend the use of this prospectus for a period not to exceed 60 days
(whether or not consecutive) during any twelve month period if our management determines in its
good faith judgment that our obligation to ensure that the registration statement and prospectus
are current and complete would require us to take actions that might reasonably be expected to have
a materially adverse effect on us and our stockholders, or upon our determination of the existence
of any fact or the happening of any event that makes any statement of a material fact made in the
registration statement, the prospectus, any amendment or supplement thereto, or any document
incorporated by reference therein untrue in any material respect, or that requires the making of
any additions to or changes in the registration statement or the prospectus, in order to make the
statements therein not misleading in any material respect. A holder of registrable securities that
sells registrable securities pursuant to the registration statement generally will be required to
provide information about itself and the specifics of the sale, be named as a selling security
holder in the related prospectus, deliver a prospectus to purchasers, be subject to relevant civil
liability provisions under the Securities Act in connection with such sales and be bound by the
provisions of the registration rights agreements which are applicable to such holder.
We will give notice of the effectiveness of the registration statement to all holders who have
provided us with a selling security holder notice and questionnaire. Each holder must complete the
notice and questionnaire in order to be named as a selling security holder in the prospectus and
prior to any intended distribution of registrable securities pursuant to the registration
statement.
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We will pay all registration expenses of the registration to be incurred by us in connection
with the selling security holders exercise of its registration rights under the registration
rights agreement, as amended.
DESCRIPTION OF CAPITAL STOCK
Our restated certificate of incorporation provides that we have the authority to issue 100
million shares of $0.0005 par value common stock and 2 million shares of $0.0005 par value
preferred stock.
The following is a summary of the material provisions of our common stock and preferred stock.
This summary does not purport to be exhaustive and is qualified in its entirety by reference to
applicable Delaware law and our restated certificate of incorporation and bylaws.
Common Stock
The holders of common stock are entitled to one vote per share on all matters to be voted upon
by the stockholders. Stockholders are not entitled to cumulate their votes for the election of
directors. Subject to preferences that may be applicable to any outstanding shares of preferred
stock, the holders of common stock are entitled to receive ratably such dividends, if any, as may
be declared from time to time by the board of directors out of funds legally available for that
purpose. In the event of our liquidation, dissolution or winding up, the holders of common stock
are entitled to share ratably in all assets remaining after payment of liabilities, subject to
prior distribution rights of preferred stock, if any, then outstanding. The common stock has no
preemptive or conversion rights or other subscription rights. There are no redemption or sinking
fund provisions applicable to the common stock. All outstanding shares of common stock are fully
paid and nonassessable, and the shares of common stock to be issued upon completion of this
offering will be fully paid and nonassessable.
The transfer agent for our common stock is Bank of New York.
Preferred Stock
Under our restated certificate of incorporation, our board of directors has the authority,
without further action by our stockholders, to issue up to 2 million shares of preferred stock in
one or more series and to fix the variations in the powers, preferences, rights, qualifications,
limitations or restrictions of the preferred stock, including dividend rights, conversion rights,
voting rights, terms of redemption and liquidation preferences, any or all of which may be greater
than the rights of our common stock. Our board of directors, without stockholder approval, can
issue preferred stock with voting, conversion or other rights that could adversely affect the
voting power and other rights of the holders of our common stock. As a result, preferred stock
could be issued quickly with terms that will delay or prevent a change of control or make removal
of management more difficult. In addition, the issuance of preferred stock may have the effect of
decreasing the market price of our common stock and may adversely affect the voting and other
rights of our common stock. At present, there are no shares of preferred stock outstanding and we
have no current plans to issue any shares of preferred stock.
Preferred Stock Purchase Rights
We have entered into a Rights Agreement, dated as of March 4, 1997, as amended, with Bank of
New York, pursuant to which each outstanding share of our common stock has attached one preferred
stock purchase right. Each share of our common stock subsequently issued prior to the expiration
of the Rights Agreement will likewise have attached one right. Under specified circumstances
involving a merger, an acquisition of 15% or more of our outstanding common stock, a tender offer
or exchange offer resulting in ownership of 20% or more of our common stock by an acquiring person
or a sale of 50% or more of our assets or earning power, the rights will entitle the holder thereof
to purchase 1/100 of a share of our Series A preferred stock for a purchase price of $25.00
(subject to adjustment), and to receive, upon exercise, common shares having a value equal to two
times the exercise price of the right. In this prospectus, unless the context requires otherwise,
all references to our common stock include the accompanying rights.
Currently, the rights are not exercisable and trade with our common stock.
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Delaware Law
We are subject to the provisions of Section 203 of the Delaware General Corporation Law. In
general, this statute prohibits a publicly held Delaware corporation from engaging in a business
combination with an interested stockholder for a period of three years after the date that the
person became an interested stockholder unless (with certain exceptions) the business combination
or the transaction in which the person became an interested stockholder is approved in a prescribed
manner. Generally, a business combination includes a merger, asset or stock sale, or other
transaction resulting in a financial benefit to the stockholder. Generally, an interested
stockholder is a person who, together with affiliates and associates, owns (or within three years
prior, did own) 15% or more of the corporations voting stock.
Certain Anti-Takeover Provisions
Stockholders rights and related matters are governed by Delaware corporate law, our restated
certificate of incorporation (the Restated Certificate) and our bylaws. Certain provisions of
the Restated Certificate and bylaws which are summarized below may discourage or have the effect of
delaying or deferring potential changes in control of OrthoLogic Corp. Our board of directors
believes that these provisions are in the best interests of stockholders because they will
encourage a potential acquirer to negotiate with the board of directors, which will be able to
consider the interests of all stockholders in a change-in-control situation. However, the
cumulative effect of these terms may be to make it more difficult to acquire and exercise control
of OrthoLogic Corp. and to make changes in our management.
The Restated Certificate provides for the approval of the holders of two-thirds of our
outstanding voting stock for a merger or a consolidation with, or a sale by us of all or
substantially all of our assets to, any person, firm or corporation, or any group thereof, which
owns, directly or indirectly, 5% or more of any class of our voting securities (an Interested
Person). In addition, two-thirds approval is required with respect to other transactions
involving any such Interested Person, including among other things, purchase by us or any of our
subsidiaries of all or substantially all of the assets or stock of an Interested Person and any
other transaction with an Interested Person which requires stockholder approval under Delaware law.
The two-thirds voting requirement is not applicable to any transaction approved by our board of
directors if a majority of the members of the board of directors voting to approve such transaction
were elected prior to the date on which the other party became an Interested Person or certain
other conditions are met (the Continuing Directors).
The Restated Certificate provides that each director will serve for a three-year term and that
approximately one-third of the directors are to be elected annually. Candidates for directors
shall be nominated only by the board of directors or by a stockholder who gives us written notice
no later than 20 days before the annual meeting or, in the case of a special meeting, the close of
business on the 15th day following the date on which notice of such special meeting is
first given to the stockholders. We may have three to nine directors as determined from time to
time by our Board, which currently consists of six members. Between stockholder meetings, our
Board may appoint new directors to fill vacancies or newly created directorships. The Restated
Certificate does not provide for cumulative voting at stockholder meetings for the election of
directors. Stockholders controlling at least 50% of the outstanding common stock can elect the
entire board of directors, while stockholders controlling 49% of the outstanding common stock may
not be able to elect any directors. A director may be removed from office only for cause and only
by the affirmative vote of a majority of the combined voting power of the then outstanding shares
of capital stock entitled to vote generally in the election of directors.
The Restated Certificate further provides that stockholder action must be taken at a meeting
of stockholders and may not be effected by any consent in writing. Special meetings of
stockholders may be called only by the President, a majority of the board of directors or the
holders of at least 35% of the outstanding shares of capital stock entitled to vote.
The Restated Certificate provides further that the foregoing provisions of the Restated
Certificate and bylaws may be amended or repealed only with the affirmative vote of at least
two-thirds of the shares entitled to vote, unless the amendment is recommended for stockholder
approval by a majority of the Continuing Directors. These provisions exceed the usual majority
vote requirement of Delaware law and are intended to prevent the holders of less than two-thirds of
the voting power from circumventing the foregoing terms by amending the
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Restated Certificate or bylaws. These provisions, however, enable the holders of more than
one-third of the voting power to prevent amendments to the foregoing anti-takeover provisions of
the Restated Certificate or bylaws even if they were favored by the holders of a majority of the
voting power.
The effect of such provisions of our Restated Certificate and bylaws may be to make more
difficult the accomplishment of a merger or other takeover or change in control of OrthoLogic Corp.
To the extent that these provisions have this effect, removal of our incumbent board of directors
and management may be rendered more difficult. Furthermore, these provisions may make it more
difficult for stockholders to participate in a tender or exchange offer for common stock and in so
doing may diminish the market value of the common stock.
Limitations on Personal Liability of Directors
Delaware law authorizes a Delaware corporation to eliminate or limit the personal liability of
a director to the corporation and its stockholders for monetary damages for breach of certain
fiduciary duties as a director. We believe that such a provision is beneficial in attracting and
retaining qualified directors, and accordingly the Restated Certificate includes a provision
eliminating liability for monetary damages for any breach of fiduciary duty as a director, except:
(1) for any breach of the duty of loyalty to OrthoLogic Corp. or our stockholders; (2) for acts or
omissions not in good faith or which involve intentional misconduct or a knowing violation of law;
(3) for any transaction from which the director derived an improper personal benefit; or (4) for
unlawful payments of dividends or unlawful stock repurchases or redemptions as provided in Section
174 of the Delaware General Corporation Law. Thus, pursuant to Delaware law, our directors are not
insulated from liability for breach of their duty of loyalty (requiring that, in making a business
decision, directors act in good faith and in the honest belief that the action was taken in the
best interest of the corporation). The foregoing provisions of the Restated Certificate may reduce
the likelihood of derivative litigation against directors and may discourage or deter stockholders
or management from bringing a lawsuit against directors for breaches of the fiduciary duties, even
though an action, if successful, might otherwise have benefited us and our stockholders. Further,
we have entered into indemnity agreements with all of our directors and officers for the
indemnification of and advancing of expenses to such persons to the fullest extent permitted by
law. We have also obtained insurance for the benefit of our officers and directors insuring such
persons against certain liabilities, including liabilities under the securities laws.
LEGAL MATTERS
The validity of the securities to be sold pursuant to this prospectus is being passed upon for
us by our counsel, Quarles & Brady Streich Lang LLP, Phoenix, Arizona.
EXPERTS
The financial statements, the related financial statement schedule, and managements report on
the effectiveness of internal control over financial reporting incorporated in this prospectus by
reference from Orthologic Corp.s Annual Report on Form 10-K for the year ended December 31, 2005
have been audited by Deloitte & Touche LLP, an independent registered public accounting firm, as
stated in their reports (which reports (1) express an unqualified opinion on the financial
statements and financial statement schedule and include an explanatory paragraph referring to the
fact that OrthoLogic Corp. is in the development stage at December 31, 2005, (2) express an
unqualified opinion on managements assessment regarding the effectiveness of internal control over
financial reporting, and (3) express an unqualified opinion on the effectiveness of internal
control over financial reporting), which are incorporated herein by reference, and have been so
incorporated in reliance upon the reports of such firm given upon their authority as experts in
accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
REGISTRATION STATEMENT AND OTHER GOVERNMENT FILINGS
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Securities and Exchange Commission
We have filed with the Securities and Exchange Commission (the SEC) a registration statement
on Form S-3 under the Securities Act with respect to our common stock offered in this prospectus.
This prospectus does not contain all of the information set forth in the registration statement and
the exhibits and schedules to the registration statement. For further information with respect to
us and our common stock, we refer you to the registration statement and its exhibits and schedules.
Statements contained in this prospectus as to the contents of any contract or other document are
not necessarily complete and, in each instance, reference is made to the copy of that contract or
document filed as an exhibit to the registration statement, each of these statements being
qualified in all respects by that reference.
We are subject to the information reporting requirements of the Securities Exchange Act of
1934, as amended. As such, we file annual, quarterly and special reports, proxy statements and
other documents with the SEC. These reports, proxy statements and other documents, as well as the
registration statement of which this prospectus is a part and the exhibits to such registration
statement, may be inspected and copied at the public reference facilities maintained by the SEC at
its Public Reference Room at 100 F Street, N.E., Room 1580, Washington, D.C. 20549. You may also
obtain copies of such material by mail from the public reference facilities of the SECs
Washington, D.C. offices, at prescribed rates. Please call the SEC at 1-800-SEC-0330 for further
information on its public reference facilities. The SEC also maintains a website that contains
reports, proxy and information statements and other information regarding registrants, including
us, that file electronically with the SEC at the address http://www.sec.gov. The registration
statement of which this prospectus is a part, including all exhibits and amendments to such
registration statement, is available on that website.
Nasdaq
Our common stock is listed on The NASDAQ Global Market. Material filed by us can also be
inspected and copied at the offices of the National Association of Securities Dealers, Inc. at 1735
K Street, N.W., Washington, D.C. 20006.
OrthoLogic Corp.
Most of our SEC filings also are available at our website at http://www.orthologic.com.
Information contained on our website is not part of this prospectus. We will provide you without
charge, upon your oral or written request, with a copy of any or all reports, proxy statements and
other documents we file with the SEC, as well as any or all of the documents incorporated by
reference in this prospectus or the registration statement of which it is a part (other than
exhibits to such documents unless such exhibits are specifically incorporated by reference into
such documents). Requests for such copies should be directed to:
OrthoLogic Corp.
Attention: Corporate Secretary
1275 West Washington Street
Tempe, Arizona 85281
Telephone number: (602) 286-5520
INFORMATION INCORPORATED BY REFERENCE
The SEC allows us to incorporate by reference in this prospectus certain information we file
with the SEC, which means that:
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incorporated documents are considered a part of this prospectus; |
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we can disclose important information to you by referring you to those documents; and |
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certain information that we file after the date of this prospectus with the SEC will
automatically update and supersede information contained in this prospectus and the
registration statement. |
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We incorporate by reference into this prospectus the following documents, and filings we make
after the initial filing of the registration statement but before it becomes effective, and any
future filings we make with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Securities
Exchange Act of 1934 after the date of this prospectus (other than current reports or portions
thereof furnished under Item 2.02 or Item 7.01 of Form 8-K) until we sell all of the securities
that we have registered under the registration statement of which this is a part:
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Our Annual Report on Form 10-K, as amended, for the year ended December 31, 2005; |
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Our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2006 and June 30, 2006; |
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Our Current Reports on Form 8-K filed with the SEC on January 19, 2006, February 16,
2006, March 1, 2006, March 3, 2006, March 7, 2006, March 15, 2006, April 11, 2006, May
18, 2006, June 20, 2006, July 6, 2006 and August 30, 2006; |
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The description of our common stock contained in our Registration Statement on Form
8-A dated January 28, 1993, and any further amendment or report updating that
description; and |
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The description of our Series A preferred stock purchase rights contained in our
Registration Statement on Form 8-A filed with the SEC on March 6, 1997, as amended as
described in Forms 8-K filed with the SEC on August 24, 1999 and October 20, 2003, and
any further amendment or report updating that description. |
37
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution.
The estimated expenses in connection with the issuance and distribution of the securities
covered by this registration statement, all of which will be paid by the registrant, are as
follows:
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SEC registration fee (actual) |
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$ |
708.91 |
(1) |
Printing and engraving expenses |
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$ |
1,000 |
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Legal fees and expenses |
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$ |
25,000 |
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Accounting fees and expenses |
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$ |
30,000 |
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Miscellaneous |
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$ |
1,000 |
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Total |
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$ |
57,708.91 |
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(1) |
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The filing fee of $708.91 has been previously paid. |
Item 15. Indemnification of Directors and Officers.
Section 145 of the General Corporation Law of the State of Delaware, or DGCL, empowers a
Delaware corporation to indemnify any person who was or is a party, or is threatened to be made a
party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal,
administrative or investigative (other than an action by or in the right of such corporation) by
reason of the fact that such person is or was an officer or director of such corporation, or is or
was serving at the request of such corporation as a director, officer, employee or agent of another
corporation, partnership, joint venture, trust or other enterprise. The indemnity may include
expenses (including attorneys fees), judgments, fines and amounts paid in settlement actually and
reasonably incurred by such person in connection with such action, suit or proceeding, provided
that such person acted in good faith and in a manner he reasonably believed to be in or not opposed
to the best interests of the corporation, and, with respect to any criminal action or proceeding,
had no reasonable cause to believe such persons conduct was unlawful.
A Delaware corporation may indemnify past or present officers and directors of such
corporation or of another corporation or other enterprise at the former corporations request, in
an action by or in the right of the corporation to procure a judgment in its favor under the same
conditions, except that no indemnification is permitted without judicial approval if the officer or
director is adjudged to be liable to the corporation. Where an officer or director is successful
on the merits or otherwise in defense of any action referred to above, or in defense of any claim,
issue or matter therein, the corporation must indemnify such person against the expenses (including
attorneys fees) which such person actually and reasonably incurred in connection therewith.
Section 145 further provides that any indemnification shall be made by the corporation only as
authorized in each specific case upon a determination that indemnification of such person is proper
because he has met the applicable standard of conduct (i) by the stockholders, (ii) by a majority
vote of the directors who are not parties to such action, suit or proceeding, even though less than
a quorum, (iii) by a committee of such directors designated by majority vote of such directors,
even though less than a quorum, or (iv) by independent legal counsel in a written opinion, if there
are no such disinterested directors, or if such disinterested directors so direct. Section 145
further provides that indemnification pursuant to its provisions is not exclusive of other rights
of indemnification to which a person may be entitled under any bylaw, agreement, vote of
stockholders or disinterested directors or otherwise.
We have directors and officers insurance which provides for indemnification of our officers
and directors and certain other persons against liabilities and expenses incurred by any of them in
certain stated proceedings and
II-1
under certain stated conditions. We have also entered into separate indemnification agreements
with each of our directors and certain officers that may require us, among other things, to
indemnify such directors and officers against certain liabilities that may arise by reason of their
status or service as directors or officers to the maximum extent permitted under Delaware law.
Our restated certificate of incorporation provides that indemnification shall be available to
the fullest extent permitted by the DGCL for all current or former directors or officers.
Reference is made to Item 17 for OrthoLogics undertakings with respect to indemnification for
liabilities arising under the Securities Act.
Item 16. Exhibits.
See the Exhibit Index following the Signatures page in this registration statement, which
Exhibit Index is incorporated herein by reference.
Item 17. Undertakings.
(a) The undersigned registrant hereby undertakes:
(1) to file, during any period in which offers or sales are being made, a post-effective
amendment to this registration statement: (i) to include any prospectus required by Section
10(a)(3) of the Securities Act; (ii) to reflect in the prospectus any facts or events arising after
the effective date of the registration statement (or the most recent post-effective amendment
thereof) which, individually or in the aggregate, represent a fundamental change in the information
set forth in the registration statement. 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 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 (iii) to include any material information with
respect to the plan of distribution not previously disclosed in the registration statement or any
material change to such information in the registration statement;
provided, however, that clauses (a)(1)(i), (a)(1)(ii) and (a)(1)(iii) above do not apply if the
registration statement is on Form S-3 and the information required to be included in a
post-effective amendment by those clauses is contained in reports filed with or furnished to the
Commission by the registrant pursuant to Section 13 or Section 15(d) of the Securities Exchange Act
of 1934 that are incorporated by reference in the registration statement, or is contained in a form
of prospectus filed pursuant to Rule 424(b) that is part of the registration statement;
(2) that, for the purpose of determining any liability under the Securities Act of 1933, each
such post-effective amendment shall be deemed to be a new registration statement relating to the
securities offered therein, and the offering of such securities at that time shall be deemed to be
the initial bona fide offering thereof;
(3) to remove from registration by means of a post-effective amendment any of the securities
being registered which remain unsold at the termination of the offering;
(4) that, for the purpose of determining liability under the Securities Act of 1933 to any
purchaser:
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(i) |
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each prospectus filed by the registrant
pursuant to Rule 424(b)(3) shall be deemed to be part of the
registration statement as of the date the filed prospectus was deemed
part of and included in the registration statement; and |
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(ii) |
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each prospectus required to be filed pursuant
to Rule 424(b)(2), (b)(5) or (b)(7) as part of a registration statement
in reliance on Rule 430B relating to an offering made pursuant to Rule
415(a)(1)(i), (vii) or (x) for the purpose of providing the information
required by Section 10(a) of the Securities Act of |
II-2
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1933 shall be deemed to be part of and included in the registration
statement as of the earlier of the date such form of prospectus is
first used after effectiveness or the date of the first contract of
sale of securities in the offering described in the prospectus. As
provided in Rule 430B, for liability purposes of the issuer and any
person that is at that date an underwriter, such date shall be deemed
to be a new effective date of the registration statement relating to
the securities in the registration statement to which the prospectus
relates, and the offering of such securities at that time shall be
deemed to be the initial bona fide offering thereof. Provided,
however, that no statement made in a registration statement or
prospectus that is part of the registration statement or made in a
document incorporated or deemed incorporated by reference into the
registration statement or prospectus that is part of the registration
statement will, as to a purchaser with a time of contract of sale
prior to such effective date, supersede or modify any statement that
was made in the registration statement or prospectus that was part of
the registration statement or made in any such document immediately
prior to such effective date; and |
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(iii) |
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each prospectus filed pursuant to Rule 424(b)
as part of a registration statement relating to an offering, other than
registration statements relying on Rule 430B or other than prospectuses
filed in reliance on Rule 430A, shall be deemed to be part of and
included in the registration statement as of the date it is first used
after effectiveness. Provided, however, that no statement made in a
registration statement or prospectus that is part of the registration
statement or made in a document incorporated or deemed incorporated by
reference into the registration statement or prospectus that is part of
the registration statement will, as to a purchaser with a time of
contract of sale prior to such first use, supersede or modify any
statement that was made in the registration statement or prospectus
that was part of the registration statement or made in any such
document immediately prior to such date of first use; |
(5) that, for the purpose of determining liability of the registrant under the Securities Act
of 1933 to any purchaser in the initial distribution of the securities, the undersigned registrant
undertakes that in a primary offering of securities of the undersigned registrant pursuant to this
registration statement, regardless of the underwriting method used to sell the securities to the
purchaser, if the securities are offered or sold to such purchaser by means of any of the following
communications, the undersigned registrant will be a seller to the purchaser and will be considered
to offer or sell such securities to such purchaser:
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(i) |
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Any preliminary prospectus or prospectus of the
undersigned registrant relating to the offering required to be filed
pursuant to Rule 424; |
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(ii) |
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Any free writing prospectus relating to the
offering prepared by or on behalf of the undersigned registrant or used
or referred to by the undersigned registrant; |
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(iii) |
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The portion of any other free writing
prospectus relating to the offering containing material information
about the undersigned registrant or its securities provided by or on
behalf of an undersigned registrant; and |
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(iv) |
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Any other communication that is an offer in the
offering made by the undersigned registrant to the purchaser. |
(b) The undersigned registrant hereby undertakes that, for purposes of determining any
liability under the Securities Act of 1933, each filing of the registrants annual report pursuant
to Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934 that is incorporated by
reference in this registration statement shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of such securities at that time shall
be deemed to be the initial bona fide offering thereof.
II-3
(c) Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be
permitted to directors, officers and controlling persons of the registrant pursuant to the
provisions described under Item 15 above, or otherwise, the registrant has been advised that in the
opinion of the Securities and Exchange Commission such indemnification is against public policy as
expressed in the 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 Act and will be governed by the final adjudication of such issue.
II-4
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the registrant certifies that it
has reasonable grounds to believe that it meets all of the requirements for filing on Form S-3 and
has duly caused this registration statement to be signed on its behalf by the undersigned,
thereunto duly authorized, in the City of Tempe, State of Arizona, on September 22, 2006.
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ORTHOLOGIC CORP.
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By: |
/s/ John M. Holliman, III
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John M. Holliman, III |
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Executive Chairman |
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POWER OF ATTORNEY
Pursuant to the requirements of the Securities Act of 1933, as amended, this registration
statement has been signed by the following persons in the capacities and on the date indicated.*
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Signature |
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Title |
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/s/ John M. Holliman, III
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Executive Chairman (Principal Executive Officer), |
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Chairman of the Board and Director |
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/s/ Les M. Taeger
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Senior Vice President and Chief Financial Officer |
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(Principal Financial and Accounting Officer) |
**
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Augustus A. White III, MD, Ph.D.
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Director |
**
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Frederic J. Feldman, Ph.D.
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Director |
**
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Michael D. Casey
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Director |
**
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William M. Wardell, MD, Ph.D.
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Director |
**
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Elwood D. Howse, Jr.
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Director |
* Each of the above signatures is affixed as of September 22, 2006.
** By: /s/ John M. Holliman, III
John M. Holliman, III, attorney in fact
S-1
ORTHOLOGIC CORP.
(the Company)
EXHIBIT INDEX
TO
FORM S-3 REGISTRATION STATEMENT
The following exhibits are filed with or incorporated by reference in this registration
statement:
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Incorporated Herein |
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Filed |
Exhibit |
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Description |
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By Reference To |
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Herewith |
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4.1
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Rights Agreement dated as of
March 4, 1997, between the
Company and Bank of New York,
and Exhibits A, B and C thereto
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Exhibit 4.1 to the Companys Registration
Statement on Form 8-A filed with the SEC on
March 6, 1997 |
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4.2
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First Amendatory Agreement to
March 4, 1997 Rights Agreement
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Exhibit 10.1 to the Companys Current Report
on Form 8-K filed with the SEC on August 24,
1999 |
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4.3
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Amendment No. 2 to March 4,
1997 Rights Agreement
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Exhibit 4.1 to the Companys Current Report
on Form 8-K filed with the SEC on October
20, 2003 |
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4.4
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Class A Warrant Agreement dated
February 24, 2006, between
OrthoLogic Corp. and PharmaBio
Development Inc. (d/b/a
NovaQuest)
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Exhibit 4.1 to the Companys Current Report
on Form 8-K, filed with the SEC on March 3,
2006 (the March 3rd 8-K) |
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4.5
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Amended and Restated Class B
Warrant Agreement dated
February 24, 2006, and amended
and restated as of June 30,
2006, between OrthoLogic Corp.
and PharmaBio Development Inc.
(d/b/a NovaQuest) (asterisks
located within exhibit denote
information that has been
deleted pursuant to a request
for confidential treatment
filed with the Securities and
Exchange Commission)
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X |
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4.6
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Amended and Restated Class C
Warrant Agreement dated
February 24, 2006, and amended
and restated as of June 30,
2006, between OrthoLogic Corp.
and PharmaBio Development Inc.
(d/b/a NovaQuest) (asterisks
located within exhibit denote
information that has been
deleted pursuant to a request
for confidential treatment
filed with the Securities and
Exchange Commission)
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X |
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4.7
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Amended and Restated Class D
Warrant Agreement dated
February 24, 2006, and amended
and restated as of June 30,
2006, between OrthoLogic Corp.
and PharmaBio Development Inc.
(d/b/a NovaQuest) (asterisks
located within exhibit denote
information that has been
deleted pursuant
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X |
-2-
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Incorporated Herein |
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Filed |
Exhibit |
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Description |
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By Reference To |
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Herewith |
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to a request
for confidential treatment
filed with the Securities and
Exchange Commission) |
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4.8
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Class A Warrant Agreement dated
June 30, 2006, between
OrthoLogic Corp. and PharmaBio
Development Inc. (d/b/a
NovaQuest)
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Exhibit 4.1 to the Companys Current Report
on Form 8-K, filed with the SEC on July 6,
2006 |
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5.1
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Opinion of Quarles & Brady
Streich Lang LLP*
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10.1
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Common Stock and Warrant
Purchase Agreement dated
February 24, 2006, by and
between the Company and
PharmaBio Development Inc.
(d/b/a NovaQuest)
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Exhibit 10.1 to the Companys Registration
Statement on Form S-3, filed with the SEC on
April 13, 2006 (the April 13th
S-3) |
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10.2
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Registration Rights Agreement
dated February 24, 2006,
between PharmaBio Development
Inc. (d/b/a NovaQuest) and the
Company,
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Exhibit 10.2 to the April 13th S-3 |
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10.3
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Registration Rights Agreement
dated February 27, 2006, by and
among the Company, AzERx, Inc.
and the other shareholders
listed thereon
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Exhibit 10.3 to the April 13th S-3 |
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10.4
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Amendment No.1 to Registration
Rights Agreement dated June 30,
2006, between PharmaBio
Development Inc. (d/b/a
NovaQuest) and the Company
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X |
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23.1
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Consent of Deloitte & Touche LLP
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X |
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23.2
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Consent of Quarles & Brady
Streich Lang LLP*
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24.1
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Powers of Attorney
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Signature page to April 13th S-3 |
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* The opinion and consent of Quarles & Brady Streich Lang will be filed in an amendment to this registration statement.
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-3-