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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form S-8
REGISTRATION STATEMENT
UNDER THE SECURITIES ACT OF 1933
ORTHOLOGIC CORP.
(Exact name of Registrant as specified in charter)
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Delaware
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86-0585310 |
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(State or other jurisdiction of
incorporation or organization)
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(IRS Employer
Identification No.) |
1275 West Washington Street, Tempe, AZ 85281
(602) 286-5520
(Address, including zip code, and telephone number, including
area code, of registrants principal executive offices)
ORTHOLOGIC CORP.
Letter of Stock Option Grant, OrthoLogic Corp., dated March 3, 2005
(Dr. James M. Pusey)
Letter of Restricted Stock Grant, OrthoLogic Corp., dated March 3, 2005
(Dr. James M. Pusey)
(Full Title of the Plans)
Dr. James M. Pusey, Chief 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)
The Commission is requested to send copies of all communications to:
Steven P. Emerick
Quarles & Brady Streich Lang LLP
One Renaissance Square
Two North Central Avenue
Phoenix, Arizona 85004-2391
(602) 229-5200
CALCULATION OF REGISTRATION FEE
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Title of securities to be registered |
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Amount to be |
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Proposed maximum |
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Proposed maximum |
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Amount of |
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registered |
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offering price per |
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aggregate offering |
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registration fee |
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share |
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price |
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Common Stock, $.0005 par value per share |
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300,000 shares (1) |
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$5.88(2) |
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$1,764,000(2) |
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$207.63 |
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Common Stock, $.0005 par value per share |
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200,000 shares (3) |
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$4.13(4) |
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$826,000(4) |
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$97.23 |
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(1) |
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Shares of OrthoLogic common stock issuable upon the exercise by Dr. James M. Pusey of an
option to purchase such shares pursuant to a Letter of Stock Option Grant, dated March 3,
2005. The grant letter provides for the possible adjustment of the number, price and kind of
shares covered by options granted or to be granted in the event of certain capital or other
changes affecting Registrants Common Stock. Pursuant to Rule 416(a) of the Securities Act of
1933, this Registration Statement therefore covers, in addition to the above-stated shares, an
indeterminate number of shares that may become subject to the grant letter by means of stock
splits, stock dividends or similar transactions. |
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Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(h)
under the Securities Act of 1933, based on the exercise price of the option. |
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Shares of OrthoLogic common stock previously issued to Dr. James M. Pusey pursuant to a
Letter of Restricted Stock Grant, dated March 3, 2005. The grant letter provides for the
possible adjustment of the number, price and kind of shares covered thereby in the event of
certain capital or other changes affecting Registrants Common Stock. Pursuant to Rule 416(a)
of the Securities Act of 1933, this Registration Statement therefore covers, in addition to
the above-stated shares, an indeterminate number of shares that may become subject to the
grant letter by means of stock splits, stock dividends or similar transactions. |
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(4) |
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Estimated solely for the purpose of calculating the amount of the registration fee, pursuant to
Rule 457(c) under the Securities Act of 1933, on the basis of the average of the high and low sales
prices as reported on the Nasdaq National Market on August 5, 2005, for shares of the Registrants
Common Stock. |
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EXPLANATORY NOTE
The Registrant has prepared this Registration Statement in accordance with the requirements of
Form S-8 under the Securities Act of 1933, as amended (the Securities Act), to register (i) the
issuance of up to 300,000 shares of OrthoLogic common stock upon the exercise of an option to
purchase such shares granted to Dr. James M. Pusey under a Letter of Stock Option Grant dated March
3, 2005 (the Option Grant Letter), and (ii) resales of 200,000 shares of OrthoLogic common stock
previously issued to Dr. James M. Pusey (the Selling Stockholder) under a Letter of Restricted
Stock Grant dated March 3, 2005 (the Restricted Stock Grant Letter). Accordingly, this
Registration Statement also includes a reoffer prospectus that has been prepared in accordance with
the requirements of Part I of Form S-3 and, pursuant to General Instruction C of Form S-8, may be
used for reofferings and resales on a continuous or delayed basis of 200,000 shares of OrthoLogic
common stock that have been issued to the Selling Stockholder under the Restricted Stock Grant
Letter.
PART I
INFORMATION REQUIRED IN THE SECTION 10(a) PROSPECTUS
The documents containing the information required by Part I of Form S-8 will be sent or given
to the Selling Stockholder as specified by Rule 428(b)(1) promulgated under the Securities Act.
Such documents are not required to be and are not filed with the Securities and Exchange Commission
(the SEC) either as part of this Registration Statement or as prospectuses or prospectus
supplements pursuant to Rule 424 promulgated under the Securities Act. These documents and the
documents incorporated by reference in this Registration Statement pursuant to Item 3 of Part II of
this Form S-8, taken together, constitute a prospectus that meets the requirements of Section 10(a)
of the Securities Act.
Under the cover of this Form S-8 is a reoffer prospectus prepared in accordance with the
requirements of Part I of Form S-3. The reoffer prospectus may be used for reofferings and resales
on a continuous or delayed basis of 200,000 shares of OrthoLogic common stock that have been issued
to the Selling Stockholder under the Restricted Stock Grant Letter.
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REOFFER PROSPECTUS
200,000 Shares
OrthoLogic
Corp.
Common Stock
This reoffer prospectus is being used in connection with the offering from time to time
by Dr. James M. Pusey (the Selling Stockholder) of an aggregate of 200,000 shares of our common
stock that have been issued to him pursuant to a Letter of Restricted Stock Grant dated March 3,
2005 (the Restricted Stock Grant Letter). We will not receive any of the proceeds from any such
offering.
The Selling Stockholder may offer the shares issued pursuant to the Restricted Stock Grant
Letter (the Restricted Stock) from time to time through public or private transactions at
prevailing market prices, at prices related to prevailing market prices or at other negotiated
prices. The Selling Stockholder may sell none, some or all of the shares of Restricted Stock
offered by this reoffer prospectus.
Our common stock is quoted on The Nasdaq National Market under the symbol OLGC. The last
reported sale price of our common stock on August 5, 2005 on The Nasdaq National Market was $4.15
per share. The mailing address of our principal executive office is 1275 West Washington Street,
Tempe, Arizona, 85281. Our telephone number is (602) 286-5520.
INVESTING IN OUR COMMON STOCK INVOLVES RISKS. CONSIDER CAREFULLY THE RISK FACTORS BEGINNING
ON PAGE P-7 OF THIS REOFFER PROSPECTUS.
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined if this reoffer prospectus is truthful or
complete. Any representation to the contrary is a criminal offense.
The
date of this reoffer prospectus is August 9, 2005.
P-1
You should rely only on the information contained or incorporated by reference in this reoffer
prospectus. We have not authorized anyone to provide you with additional information or
information different from that contained or incorporated by reference in this reoffer prospectus.
This reoffer prospectus is not an offer to sell or solicitation of an offer to buy these shares of
common stock in any circumstance under which the offer or solicitation is unlawful. You should
assume that the information in this reoffer prospectus is accurate only as of the date on the front
of the document and that any information we have incorporated by reference is accurate only as of
the date of the document incorporated by reference, regardless of the time of delivery of this
reoffer prospectus or of any sale of our common stock. Unless the context otherwise requires,
references to OrthoLogic, Company, we, our and us in this reoffer prospectus refer to
OrthoLogic Corp.
TABLE
OF CONTENTS
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EX-5.1 |
EX-23.1 |
We own or have rights to use trademarks or trade names that we use in conjunction with the
operation of our business. All other trademarks, service marks and trade names referred to in this
reoffer prospectus are the property of their respective owners.
P-2
THE COMPANY
OrthoLogic is a drug development company focused on the healing of musculoskeletal,
orthopedic, dermal and cardiovascular tissue through therapeutic biopharmaceutical approaches. Our
research and clinical trials are focused on the potential commercialization of several
therapeutics comprising the Chrysalin® Product Platform, a series of product candidates aimed at
treating both traumatic and chronic indications. 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, and has the potential to accelerate the natural cascade of healing
events in tissue repair. We continue to explore other biopharmaceutical compounds that can
complement our research activity internally and broaden our potential pipeline for successful
products.
On August 5, 2004, we purchased substantially all of the assets and intellectual property of
Chrysalis Biotechnology, Inc. (CBI), including its exclusive worldwide license for Chrysalin for
all medical indications, for $2.5 million in cash and $25.0 million in OrthoLogic common stock plus
an additional $7.0 million in OrthoLogic common stock upon the occurrence of certain triggering
events. We became a development stage entity commensurate with the acquisition.
The Chrysalin technology represents the ability to potentially accelerate tissue repair by the
initiation of the bodys entire natural healing cascade. Chrysalin has been shown to recruit cells
to the site of tissue injury, turn on the synthesis of specific growth factors known to be crucial
for tissue healing, and stimulate revascularization of damaged tissue.
OrthoLogic owns the exclusive worldwide license for Chrysalin for all medical indications. We
are pursuing the following potential medical applications for Chrysalin:
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fracture repair; |
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diabetic ulcer healing; and |
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cartilage defect repair. |
Preclinical research, as well as a Phase 1/2 pilot clinical safety study has been conducted in
the following indications:
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spine fusion; |
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cardiovascular repair, and |
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ligament and tendon repair. |
We continue to explore other biopharmaceutical or peptide-based compounds that can complement
the research activities internally and broaden the potential pipeline for successful products.
OUR LEAD PRODUCT CANDIDATES
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.
P-3
Chrysalin is a substance that, when injected through the skin into the fracture site at the
time of fracture reduction, has been shown in preliminary clinical trials 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.
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.
To date, there have been no adverse events related to Chrysalin reported in this Phase 3 trial. We
are currently collecting the data for the Phase 3 study and, data permitting, expect to release
initial efficacy results in the first half of 2006.
We are also conducting a Phase 2b human clinical trial to establish the lower dose range of
Chrysalin versus a placebo control, as well as provide information to support our potential future
fracture repair new drug application (NDA). Enrollment is proceeding in the study with a goal of
500 patients in approximately 60 sites. Currently, there are more than 40 sites that are actively
enrolling patients and several additional sites are seeking approval from their respective
Institutional Review Boards (IRBs) to conduct the Phase 2b trial.
Diabetic Ulcer Healing
Our diabetic ulcer 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 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 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 result in amputation of the affected limb.
We believe topical treatment of the wound with Chrysalin will promote new tissue growth
necessary for healing. In 2001, CBI conducted a multicenter Phase 1/2 double blind human clinical
trial with 60 patients, the results of which were presented at the Wound Healing Society in May of
2002. CBI 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.
Our preclinical studies and initial Phase 1/2 human clinical trial evaluated Chrysalin as a
potential product for diabetic ulcer healing in a saline formulation. We are currently developing a
gel formulation for a Chrysalin-based product candidate for diabetic ulcer healing. The start date
for our next human clinical trial for this indication will depend on successful completion of the
gel formulation work and formulation-bridging preclinical studies, as
well as the submission of a formulation amendment and clinical trial protocol to the existing
and active Investigational New Drug (IND) application for this indication.
P-4
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. We have
completed several steps necessary to submit an IND application for a Chrysalin-based product
candidate for cartilage defect repair. Data permitting, we plan to submit an IND to the U.S. Food
and Drug Administration (FDA) to begin a human clinical trial for this indication.
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. 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. Recently, a new alternative, bone morphegenic protein (BMP), which does have bioactive
properties, has become commercially available as an alternative to autograft bone. While BMP
appears to be as effective as autograft in fusing bone, BMP is expensive because it requires
recombinant DNA technology to manufacture and currently costs up to $5,000 per dose. Recombinant
DNA technology is a complex, multi-step process that requires growing the BMP proteins in cells in
a laboratory, extracting the BMP proteins from the host cells and processing them for distribution
to the patient.
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 recently 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 spine fusion tests.
Our preclinical studies on spine fusion address questions of safety when the Chrysalin peptide
is used for spine fusion surgeries. We are currently collecting data from our pilot Phase 1/2
clinical trial for spine fusion, which completed enrollment in the spring of 2004. We expect to
have preliminary results late this summer. To date, there have been no adverse events in this trial
that were reported to be related to Chrysalin and patient follow-up has been excellent.
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 pharmaceuticals that
reduce the patients cholesterol (slowing the buildup of deposits along artery walls) and surgical
procedures to
P-5
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 over the last two years, 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. We are evaluating various delivery mechanisms for a Chrysalin
product candidate for myocardial revascularization, as well as completing a series of preclinical
studies to support clinical development for this indication.
Dental Bone Repair
We have 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 bonegraft
material into the space above a rabbits 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.
Based on CBIs 2004 pre-clinical study, we are evaluating the use of Chrysalin with synthetic
bone graft material on maxillo-facial defects to increase bone formation following maxillo-facial
reconstruction surgery. Maxillo-facial reconstruction is a surgical procedure to reconstruct the
face or head after a traumatic event. We do not have additional studies ongoing at this time.
Ligament and Tendon Repair
Ligaments are the soft tissues that connect bone to bone. Tendons are the soft tissue that
connects muscles to bone. Ligaments and tendons are crucial to the biomechanical functions of the
body. Injuries to ligaments and 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. Our research is focused on determining if
Chrysalin accelerates ligament and tendon tissue repair, resulting in better restoration of
function. We are currently completing our first pre-clinical study of Chrysalin for tendon repair
in collaboration with an academic institution.
P-6
FORWARD-LOOKING STATEMENTS AND RISK FACTORS
All statements other than statements of historical facts included or incorporated by reference
into this reoffer 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
reoffer 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 elsewhere
in this reoffer prospectus and documents incorporated by
reference into this reoffer 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 below for a more
complete discussion of the risks of an investment in our securities. The forward-looking statements
included in this reoffer prospectus or incorporated by reference into
this reoffer prospectus are made only as of
the date of this reoffer prospectus or the date of the incorporated document, and we undertake no
obligation to publicly update these statements to reflect subsequent events or circumstances.
Risks of 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. In November 2003,
we sold our bone growth stimulation device business, which was our revenue generating operation.
We are now focused solely on developing and testing the product candidates in our Chrysalin Product
Platform. We currently have no pharmaceutical products being sold or ready for sale and do not
expect to be able to market 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 are the primary source of our working capital. At the end of 2004, our cash and
investments were approximately $103.6 million. At June 30, 2005, our cash and investments were
$91.1 million. Based on current research and development plans, we anticipate that 2005 cash
expenditures will be approximately $26.0 to $28.0 million, which we expect will be offset by the receipt of
$7.0 million in cash from an indemnity escrow established in connection with the sale of our bone
growth stimulation device business in November 2003. As we accelerate our development work,
particularly for indications other than our most advanced indication, fracture repair, we will need
additional funding to continue our development program, through the sale of equity or debt
securities, joint ventures, licensing agreements, or other sources of funding.
P-7
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
repeat 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 human clinical trials |
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Dermal Wound Healing
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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 and Ligament 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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Spine Fusion
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Phase 1/2 human clinical trials |
We are subject to the risk that:
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some or all of our product candidates are determined to be 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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patients, health insurance and/or physicians do 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.
Our product candidates are all based on the same peptide, Chrysalin. If one of our product
candidates reveals safety or fundamental inefficacy issues in clinical trials, it could impact the
development path for all our other current 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 thrombin molecule contributes to tissue repair.
While there are important differences in each of the product candidates in terms of their purpose
(fracture repair, diabetic ulcer healing, cartilage repair, etc.), each product candidate is
focused on accelerating tissue repair and is based on the ability of
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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. If one of the product candidates has negative
clinical trial results or is shown to be ineffective, it could impact the development path or
future development of the other product candidates in the platform. If we find that one of the
biopharmaceutical product candidates is unsafe, it could impact the development of our other
product candidates in clinical trials.
A portion of our rights to Chrysalin are sublicensed and if the license is invalid or
unenforceable, we may lose our rights to use the Chrysalin technology, which would ultimately
prevent us from commercializing and selling any Chrysalin-based products.
We co-own the principal patents underlying Chrysalin and indirectly license all other rights to the
patents from the other co-owner through a license with the University of Texas, the licensee from
the co-owner. If we lose our rights to Chrysalin under the license agreement, we would be unable
to continue our product development programs and our business and prospects would be materially
harmed.
If we cannot protect the Chrysalin 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 each product resulting from Chrysalin. 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 is patented and there have been no successful challenges to the Chrysalin patent.
However, if there were to be a challenge to the patent 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. To the extent that consultants, key employees or
other third parties apply technological information independently developed by them or by others to
our proposed products, disputes may arise as to the proprietary rights to such information, which
may not be resolved in our favor. 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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pay substantial damages; |
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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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The loss of our key management and scientific personnel may hinder our ability to execute our
business plan.
As a small company with 40 employees, 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. We are most
highly dependent on the services of Dr. James Ryaby, our Senior Vice-President and Chief Scientific
Officer, whom we consider our key scientific employee. A long time employee of OrthoLogic, Dr.
Ryaby oversees all of our clinical trials. Like all companies in our field, we face intense
competition in our hiring efforts with other pharmaceutical and biotechnology companies, as well as
universities and nonprofit research organizations, and we may have to pay higher salaries to
attract and retain qualified personnel. The loss of one or more members of our current management
team or any of our scientific personnel, could delay our business plan. The loss of Dr. Ryaby
could cause a substantial delay in implementing our business plan. We do not maintain key man
insurance on Dr. Ryaby.
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.
Our stock price is volatile and fluctuates due to a variety of factors.
Our stock price has varied significantly in the past (from a low of $3.28 to a high of $8.96
since January 1, 2003) 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, 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.
Risks of our Industry
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.
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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.
We also currently and in the future will depend upon third party manufacturers of our
products, who are required to maintain compliance with the applicable FDA Good Manufacturing
Practice regulations. We cannot be certain that our present or future manufacturers and suppliers
will continue to comply with these regulations. 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. We endeavor to
monitor compliance by conducting periodic audits using independent third party vendors.
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 New Drug Application (NDA) necessary to receive approval from the
FDA to commercialize that product.
We are currently conducting a Phase 3 human clinical trial on Chrysalin for fracture repair
indications. If we fail to achieve the primary endpoint in this Phase 3 clinical trial or the
results are ambiguous, 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 could be extremely costly and time-consuming. 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.
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
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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. |
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 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, diabetic ulcer healing, cartilage defect
repair, cardiovascular repair and ligament and tendon repair. 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. We are
currently aware of the following development efforts by our competitors:
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Acceleration of Fracture Repair: While there is currently no drug product approved by
the FDA for acceleration of fracture repair, at least one large pharmaceutical company,
Pfizer, Inc., received FDA clearance to begin human clinical trials in the United States
for this indication. |
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Diabetic Ulcer Healing: To our knowledge, there are two corporate sponsored clinical
trials underway on new drug substances for diabetic ulcer healing. These early stage
clinical trials are being conducted by Genentech on recombinant human vascular endothelial
growth factor, and by King Pharmaceuticals on an adenosine A2A receptor agonist. One gene
therapy company, Selective Genetics, has initiated an early stage human clinical trial on
platelet derived growth factors in the United States for the diabetic ulcer indication. |
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Cartilage Defect Repair: Several products with bioactive components are in the
development stage for this indication, including Bone Morphegenic Proteins (BMPs).
However, we believe no company has yet received FDA authorization to begin human clinical
trials in the United States for this indication. |
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.
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 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.
We caution that the foregoing list of important factors is not exclusive. We do not undertake
to update any forward-looking statement that may be made from time to time by or on behalf of us.
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.
P-13
USE OF PROCEEDS
We will not receive any proceeds from the sale of the common stock pursuant to this reoffer
prospectus. All proceeds from the sale of the common stock pursuant to this reoffer prospectus
will be made for the account of the Selling Stockholder, as described below.
SELLING STOCKHOLDER
The following table sets forth information as of August 5, 2005 with respect to the beneficial
ownership of our common stock both before and immediately following the offering by Dr. James M.
Pusey (the Selling Stockholder identified and referred to throughout this reoffer prospectus).
Beneficial ownership includes shares which may be acquired upon exercise of options that are
exercisable within sixty days of the date as of which such beneficial ownership is determined. For
purposes of the table below, we have assumed that after completion of the offering none of the
shares covered by this reoffer prospectus will be held by the Selling Stockholder. All of the
shares being offered under this reoffer prospectus were issued under the terms of a Letter of
Restricted Stock Grant, dated March 3, 2005 between us and the Selling Stockholder.
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NAME AND ADDRESS |
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RELATIONSHIP TO |
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NUMBER OF SHARES |
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NUMBER OF SHARES |
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OF SELLING |
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ORTHOLOGIC |
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OWNED PRIOR TO |
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BEING OFFERED |
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OWNED AFTER THE |
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STOCKHOLDER |
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THE OFFERING |
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OFFERING |
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Dr. James M. Pusey |
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President, Chief |
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700,000(1) |
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200,000 |
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500,000(1) |
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1275 West Washington St. |
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Executive Officer |
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Tempe, Arizona 85281 |
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and Director |
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Includes 500,000 shares Dr. Pusey has a
right to acquire upon exercise of stock options granted to him in
March 2005, 10% of which vested immediately upon effectiveness of the
grants, and the remainder of which vest monthly in equal amounts over
a period of 48 months, subject to his continued employment with
OrthoLogic. |
Pursuant to Rule 416 promulgated under the Securities Act of 1933, as amended, the
registration statement of which this reoffer prospectus is a part also covers any additional shares
of common stock which become issuable in connection with the shares identified in the table above
through any stock split, stock dividend, or similar transaction effected without the receipt of
consideration, which results in an increase in the number of outstanding shares of common stock.
PLAN OF DISTRIBUTION
We will not receive any of the proceeds from the sale of the common stock by the Selling
Stockholder pursuant to this reoffer prospectus. The aggregate proceeds to the Selling Stockholder
from the sale of the common stock will be the purchase price of the common stock less any discounts
and commissions. The Selling Stockholder reserves the right to accept and, together with his
agents, to reject, any proposed purchase of common stock to be made directly or through agents.
This reoffer prospectus covers the resale of shares of our common stock by the Selling Stockholder.
As used in this reoffer prospectus, Selling Stockholder includes holders of shares of our common
stock received from the Selling Stockholder after the date of this reoffer prospectus and who
received such shares by gift or by other transfer by the Selling Stockholder 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 Stockholder and his successors, which includes his 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 Stockholder 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 Stockholder 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
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amended. As a result, any profits on the sale of the common stock by the Selling Stockholder 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
Stockholder is deemed to be an underwriter, the Selling Stockholder 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 Stockholder will
be responsible for underwriting discounts or commissions or agents commissions.
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 Stockholder 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 Stockholder 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 Stockholder may arrange for other brokers-dealers to
participate in sales. Broker-dealers may receive commissions or discounts from the Selling
Stockholder (or, if any broker-dealer acts as agent for the purchaser of shares, from the
purchaser) in amounts to be negotiated. The Selling Stockholder does not expect these commissions
and discounts to exceed what is customary in the types of transactions involved.
The Selling Stockholder may from time to time pledge or grant a security interest in some or
all of the shares of common stock owned by him and, if he defaults in the performance of his
secured obligations, the pledgees or secured parties may offer and sell the shares of common stock
from time to time under this reoffer prospectus, or under an amendment to this reoffer prospectus
under Rule 424(b)(3) or other applicable provision of
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the Securities Act amending the list of selling stockholders to include the pledgee, transferee or
other successors in interest as selling stockholders under this reoffer prospectus.
We understand that the Selling Stockholder has entered into an agreement with a broker-dealer
pursuant to Rule 10b5-1 under the Securities Exchange Act of 1934, as amended, pursuant to which
the broker-dealer is obligated, upon the lapsing of the restrictions on shares covered by this
reoffer prospectus from time to time, to sell a specified percentage of such shares within a
specified time following such lapse. This arrangement is subject to change or termination by the
Selling Stockholder as permitted under Rule 10b5-1 and other applicable law and regulation.
At the time a particular offering is made, if required, a reoffer prospectus supplement will
be distributed, which will set forth the name of the Selling Stockholder, the aggregate amount and
type of securities being offered, the price at which the securities are being sold and other
material terms of the offering, including the name or names of any underwriters, broker-dealers or
agents, any discounts, commissions and other terms constituting compensation from the Selling
Stockholder and any discounts, commissions or concessions allowed or reallowed to broker-dealers.
We cannot be certain that the Selling Stockholder will sell any or all of the common stock
pursuant to this reoffer prospectus. Further, we cannot assure you that the Selling Stockholder
will not transfer, devise or gift the common stock by other means not described in this reoffer
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 Stockholder and any other person participating in the sale of the common stock
will be subject to 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
Stockholder and any other such person. 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.
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.
WHERE YOU CAN FIND MORE INFORMATION
REGISTRATION STATEMENT
We have filed with the Securities and Exchange Commission a registration statement on Form S-8
under the Securities Act with respect to our common stock offered in this reoffer prospectus. This
reoffer 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 reoffer 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. The registration statement, including
exhibits to the registration statement, may be inspected and copied at the public reference
facilities maintained by the SEC at its Public Reference Room at 450 Fifth Street, N.W.,
Washington, D.C. 20549 at prescribed rates. You should call 1-800-SEC-0330, for more information on
the public reference room. The SEC also maintains a website (http://www.sec.gov) that contains
reports, proxy and information statements and other information regarding registrants, including
us, which file electronically with the SEC. The registration statement, including all exhibits and
amendments to the registration statement, is available on that
website.
OTHER INFORMATION
Government Filings
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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 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., 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 (202) 551-8090 for further information on its public reference facilities.
In addition, the SEC 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. Information contained on the SEC website is not part of this
reoffer prospectus.
Nasdaq
Our common stock is listed on The Nasdaq National 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 reoffer 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 reoffer prospectus or the registration statement (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 reoffer prospectus certain information
we file with the SEC, which means that:
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incorporated documents are considered a part of this reoffer 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 reoffer prospectus with the SEC
will automatically update and supersede information contained in this reoffer prospectus
and the registration statement. |
We incorporate by reference into this reoffer 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 reoffer 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, 2004; |
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Our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2005 and June 30, 2005; |
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Our Current Reports on Form 8-K filed with the SEC on January 4, 2005, February 11,
2005, February 22, 2005, March 4, 2005, April 15, 2005, April 21, 2005, June 16, 2005
and July 8, 2005; and |
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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. |
P-17
LEGAL MATTERS
Certain legal matters in connection with the OrthoLogic common stock offered by this reoffer
prospectus have been passed upon for us by 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 the Companys Annual Report on Form 10-K 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 include an explanatory paragraph
relating to the sale of our bone stimulation device business in 2003 for which the gain on the
sale, the results of operations prior to the sale, and any subsequent income recognized related to
the sale are included in income from discontinued operations,
(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 report of such firm given upon their
authority as experts in accounting and auditing.
INDEMNIFICATION
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 or
enterprises 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 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 to the
fullest extent permitted by the DGCL for all current or former directors or officers.
Insofar as indemnification for liabilities arising under the Securities Act of 1933, as
amended, may be permitted to directors, officers and controlling persons of the Registrant pursuant
to the foregoing provisions, or
P-18
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 Securities Act of
1933, as amended, and is, therefore, unenforceable. In the event that a claim for indemnification
against such liabilities (other than the payment by the Registrant of expenses incurred or paid by
a director, officer or controlling person of the Registrant in the successful defense of any
action, suit or proceeding) is asserted by such director, officer or controlling person in
connection with the securities being registered, the Registrant will, unless in the opinion of its
counsel the matter has been settled by controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is against public policy as expressed
in the Securities Act of 1933, as amended, and will be governed by the final adjudication of such
issue.
P-19
PART II
INFORMATION REQUIRED IN THE REGISTRATION STATEMENT
Item 3. Incorporation of Documents by Reference.
The
SEC allows us to incorporate by reference in this reoffer prospectus certain information we file
with the SEC, which means that:
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incorporated documents are considered a part of this reoffer 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
reoffer prospectus with the SEC will
automatically update and supersede information contained in this
reoffer prospectus and the
registration statement. |
We
incorporate by reference into this reoffer 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 reoffer 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, 2004; |
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Our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2005 and June 30, 2005; |
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Our Current Reports on Form 8-K filed with the SEC on January 4, 2005, February 11,
2005, February 22, 2005, March 4, 2005, April 15, 2005, April 21, 2005, June 16, 2005
and July 8, 2005; and |
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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. |
Item 4. Description of Securities.
Not applicable.
Item 5. Interests of Named Experts and Counsel.
Not applicable.
Item 6. 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
II-1
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 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 to the
fullest extent permitted by the DGCL for all current or former directors or officers.
Item 7. Exemption from Registration Claimed.
Exemption from the registration provisions of the Securities Act of 1933, as amended, for the
issuance of the shares being offered pursuant to the prospectus contained in this registration
statement is claimed under Section 4(2) of the Securities Act of 1933, as amended, among others, on
the basis that such transactions did not involve any public offering and the purchaser was
sophisticated with access to the kind of information registration would provide.
Item 8. Exhibits.
See the Exhibit Index which is incorporated herein by reference.
Item 9. Undertakings.
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 of 1933, as
amended;
(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;
(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 paragraphs (1)(i) and (1)(ii) do not apply if the
registration statement is on Form S-3, Form S-8 or Form F-3, and the information
required to be included in a
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post-effective amendment by those paragraphs is contained in periodic reports filed with
or furnished to the Securities and Exchange Commission by the Registrant pursuant to
section 13 or section 15(d) of the Securities Exchange Act of 1934, as amended, that
are incorporated by reference in the registration statement;
(2) That, for the purpose of determining any liability under the Securities Act of 1933, as
amended, 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; and
(4) That, for purposes of determining any liability under the Securities Act of 1933, as
amended, each filing of the Registrants annual report pursuant to section 13(a) or section 15(d)
of the Securities Exchange Act of 1934, as amended, that is incorporated by reference in the
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.
Insofar as indemnification for liabilities arising under the Securities Act of 1933, as
amended, may be permitted to directors, officers and controlling persons of the Registrant pursuant
to the foregoing provisions, 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 Securities Act of 1933, as amended, and is, therefore, unenforceable. In the event that a
claim for indemnification against such liabilities (other than the payment by the Registrant of
expenses incurred or paid by a director, officer or controlling person of the Registrant in the
successful defense of any action, suit or proceeding) is asserted by such director, officer or
controlling person in connection with the securities being registered, the Registrant will, unless
in the opinion of its counsel the matter has been settled by controlling precedent, submit to a
court of appropriate jurisdiction the question whether such indemnification by it is against public
policy as expressed in the Securities Act of 1933, as amended, and will be governed by the final
adjudication of such issue.
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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-8 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
August 9, 2005.
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ORTHOLOGIC CORP.
(Registrant)
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By: |
/s/ James M. Pusey
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James M. Pusey |
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Chief Executive Officer |
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POWER OF ATTORNEY
KNOW ALL MEN BY THESE PRESENTS, that each person whose signature appears below constitutes and
appoints James M. Pusey and Sherry A. Sturman and each of them, his true and lawful
attorneys-in-fact and agents, with full power of substitution and resubstitution, for him and in
his name, place and stead, in any and all capacities, to sign any and all amendments (including
post-effective amendments) to this Registration Statement, and to file the same, with all exhibits
thereto, and other documents in connection therewith, with the Securities and Exchange Commission,
and any other regulatory authority, granting unto said attorneys-in-fact and agents, and each of
them, full power and authority to do and perform each and every act and thing requisite and
necessary to be done in and about the premises, as fully to all intents and purposes as he might or
could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents or
any of them, or their substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, this Registration Statement has
been signed by the following persons in the capacities and on the dates indicated.
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Person |
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Title |
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Date |
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/s/ James. M. Pusey
James M. Pusey
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President, Chief
Executive Officer and
Director (Principal
Executive Officer)
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August 9, 2005 |
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/s/ John M. Holliman, III
John M. Holliman, III
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Chairman of the Board
of Directors and
Director
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August 9, 2005 |
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/s/ Fredric J. Feldman
Fredric J. Feldman
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Director
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August 9, 2005 |
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/s/ Elwood D. Howse, Jr.
Elwood D. Howse, Jr.
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Director
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August 9, 2005 |
S-1
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Person |
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Title |
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Date |
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/s/ Augustus A. White, III
Augustus A. White, III
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Director
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August 9, 2005 |
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/s/ Stuart H. Altman, Ph.D.
Stuart H. Altman, Ph.D.
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Director
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August 9, 2005 |
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/s/ Michael D. Casey
Michael D. Casey
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Director
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August 9, 2005 |
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/s/ Sherry A. Sturman
Sherry A. Sturman
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Senior Vice President
and Chief Financial
Officer (Principal
Financial and
Accounting Officer)
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August 9, 2005 |
S-2
ORTHOLOGIC CORP.
EXHIBIT INDEX
TO
FORM S-8 REGISTRATION STATEMENT
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Exhibit |
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Description |
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Incorporated Herein by |
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Filed Herewith |
Number |
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Reference To |
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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
Securities and
Exchange Commission
on March 6, 1997 |
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4.2
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1987 Stock Option
Plan of the
Company, as amended
and approved by
stockholders
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Exhibit 4.4 to the
Companys Form 10-Q
for the quarter ended
June 30, 1997 (June
1997 10-Q) |
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4.3
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1997 Stock Option
Plan of the Company
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Exhibit 4.3 to the
Companys
Registration
Statement on Form S-8
filed March 2, 2005 |
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4.4
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First Amendatory
Agreement to March
4, 1997 Rights
Agreement
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Exhibit 10.1 to the
Companys Form 8-K
filed August 24, 1999 |
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4.5
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Amendment No. 2 to
March 4, 1997
Rights Agreement
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Exhibit 4.1 to the
Companys Form 8-K
filed October 20,
2003 |
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5.1
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Opinion of Quarles
& Brady Streich
Lang LLP
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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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Included in Exhibit 5.1 |
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24.1
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Powers of Attorney
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See signature page |