As filed with the Securities and Exchange Commission
on April 11, 2006
Registration No. 333-
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
AVI
BIOPHARMA, INC.
(Exact name of registrant as
specified in its charter)
Oregon
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93-0797222
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.)
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One S.W. Columbia St., Suite 1105
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Portland, OR 97258
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(503) 227-0554
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(Address, including zip code, and telephone number, including area
code,
of registrants principal executive offices)
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Alan P. Timmins
President and Chief Operating Officer
AVI BioPharma, Inc.
One S.W. Columbia, Suite 1105, Portland, OR 97258
(503) 227-0554
(Name, address, including zip
code, and telephone number,
including area code, of agent for service)
Copies to:
Michael
C. Phillips, Esq.
Davis Wright Tremaine LLP
23rd Floor
1300 S.W. Fifth Avenue
Portland, Oregon 97201
(503) 241-2300
Approximate date of proposed sale to the public: From time to time after the effective date
of this Registration Statement.
If
the only securities being registered on this Form are being offered
pursuant to dividend or interest reinvestment plans, please check the following
box. o
If
any of the securities being registered on this Form are to be offered on a
delayed or continuous basis pursuant to Rule 415 under the Securities Act
of 1933, other than securities offered only in connection with dividend or
interest reinvestment plans, check the following box. ý
If
this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, please check the
following box and list the Securities Act registration statement number of the
earlier effective registration statement for the same offering. o
If
this Form is filed as a post-effective amendment filed pursuant to Rule 462(c) under
the Securities Act, please check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. o
If
this Form is a registration statement pursuant to General
Instruction I.D. or a post-effective amendment thereto that shall become
effective upon filing with the Commission pursuant to Rule 462(e) under
the Securities Act, check the following box. o
If
this Form is a post-effective amendment to a registration statement filed
pursuant to General Instruction I.D. filed to register additional
securities or additional classes of securities pursuant to Rule 413(b) under
the Securities Act, check the following box. o
CALCULATION OF REGISTRATION FEE
Title of Class of
Securities to be
Registered
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Amount to be
Registered (1)
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Proposed Maximum
Aggregate Offering
Price per share (2)
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Proposed Maximum
Aggregate Offering
Price (2)
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Amount of
Registration
Fee (2)
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Common Stock, par value $.0001 per share
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692,003
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$
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7.13
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$
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4,933,981.30
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$
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527.94
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(1) Pursuant to Rule 416 under the Securities
Act, includes such indeterminate amounts and numbers of common stock as may be
issued upon a stock split, stock dividend or similar transaction.
(2) Fee calculated pursuant to Rule 457(o)
and Section 6(b) of the Securities Act of 1933 using the average of
the high and low prices of the registrants common stock as reported on The
Nasdaq National Market on April 7, 2006.
The registrant hereby amends this registration
statement on such date or dates as may be necessary to delay its effective
date until the registrant shall file a further amendment which
specifically states that this registration statement shall thereafter become
effective in accordance with Section 8(a) of the Securities Act of
1933 or until the registration statement shall become effective on such date as
the Securities and Exchange Commission, acting pursuant to said Section 8(a),
may determine.
The information in this prospectus is not complete and may be
changed. The selling shareholder named in this prospectus may not sell
these securities until the registration statement filed with the Securities and
Exchange Commission is effective. This prospectus is not an offer to sell these
securities and the selling shareholder named in this prospectus are not
soliciting offers to buy these securities in any jurisdiction where the offer
and sale is not permitted.
SUBJECT TO COMPLETION, DATED APRIL 11, 2006
PROSPECTUS
AVI BIOPHARMA, INC.
692,003 Shares of Common Stock
This
prospectus relates to the offer and sale from time to time by the selling shareholder
identified in this prospectus, and its pledgees, assignees and
successors-in-interest, of 692,003 shares of our common stock. We are filing
the registration statement of which this prospectus is a part in order to
fulfill contractual obligations with the selling shareholder.
The
prices at which such shareholder may sell the shares in this offering will
be determined by the prevailing market price for the shares or in negotiated
transactions. We will not receive any of the proceeds from the sale of the
shares.
Our
common stock is quoted on the Nasdaq National Market under the symbol AVII.
The closing sales price of our common stock on the Nasdaq National Market on April 7,
2006 was $ 7.05 per share.
Investing in our common stock involves a high degree
of risk. See Risk Factors beginning on page 3.
Neither the Securities and Exchange Commission nor any
state securities commission has approved or disapproved of these securities or
passed upon the adequacy or accuracy of this prospectus. Any representation to
the contrary is a criminal offense.
The date of this prospectus is April 11, 2006.
TABLE OF CONTENTS
Our
executive offices are located at One S.W. Columbia, Suite 1105, Portland,
OR 97258. Our telephone number is (503) 227-0554, fax number is (503)
227-0751, and our website address is www.avibio.com. The information on our
website is not incorporated by reference into this prospectus.
You
should rely only on the information contained in this prospectus, including
information incorporated by reference in this prospectus, or any supplement to
which we have referred you. We have not authorized anyone else to provide you
with different information. You should not assume that the information in this
prospectus or any supplement is accurate as of any date other than the date on
the front of those documents or that any document incorporated by reference is
accurate as of any date other than its filing date. You should not consider
this prospectus to be an offer or solicitation relating to the securities in
any jurisdiction in which such an offer or solicitation relating to the
securities is not authorized. Furthermore, you should not consider this
prospectus to be an offer or solicitation relating to the securities if the
person making the offer or solicitation is not qualified to do so, or if it is
unlawful for you to receive such an offer or solicitation.
NEUGENE®, Resten-NG® and AVICINE® are
registered trademarks of AVI. Resten-MP and Oncomyc-NGTM are
trademarks of AVI. All other trademarks, service marks or trade names referred
to in this prospectus are the property of their respective owners.
PROSPECTUS SUMMARY
This summary highlights important features of this
offering and the information included or incorporated by reference in this
prospectus. This summary does not contain all of the information that you
should consider before investing in our common stock. You should read this
prospectus and the information and documents incorporated by reference
carefully. Such documents contain important information you should consider
when making your investment decision. See Incorporation of Certain Documents
by Reference on page 13.
Unless the context otherwise requires, all references
to we, our, our company, or the Company in this prospectus refer to AVI
BioPharma, Inc., an Oregon corporation.
About AVI BioPharma, Inc.
We are a biopharmaceutical
company developing therapeutic products principally based on third-generation NEUGENE®
antisense technology. Our principal products in development target
life-threatening diseases, including cardiovascular disease and infectious
disease. Currently approved drugs or other therapies for these diseases often
prove to be ineffective or produce undesirable side effects. Our pre-clinical
and clinical studies indicate that our technology may produce drugs that
we believe offer more effective treatment options with fewer side effects than
currently approved products. A patent estate including 172 patents (foreign and
domestic) issued or licensed to us and 151 pending patent applications
(domestic and foreign) protects our technologies. Our lead product candidate,
Resten-NG®, targets a market we believe may exceed $3 billion worldwide.
The Offering
Common
stock offered by selling shareholder
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692,003
shares
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Use
of proceeds
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We
will not receive any proceeds from the sale of shares in this offering.
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Nasdaq
National Market symbol
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AVII
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2
RISK FACTORS THAT MAY AFFECT FUTURE RESULTS
The following factors should be considered in
evaluating our outlook. If the possibilities described as risks below actually
occur, our operating results and financial condition would likely suffer and
the trading price of our common stock may fall, causing a loss of some or
all of an investment in our common stock.
Our products are in an early stage
of research and development and may not be determined to be safe or
effective.
We are only in the early stages of research and
clinical development with respect to our NEUGENE antisense pharmaceutical
products. We have devoted almost all of our time to research and development of
our technology and products, protecting our proprietary rights and establishing
strategic alliances. Our potential products are in the pre-clinical or clinical
stages of research and development and will require significant further
research, development, clinical testing and regulatory clearances. We have no
products available for sale and we do not expect to have any products available
for sale for several years. Our proposed products are subject to development
risks. These risks include the possibilities that any of the products could be
found to be ineffective or toxic, or could fail to receive necessary regulatory
clearances. We have not received any significant revenues from the sale of
products and we may not successfully develop marketable products that will
increase sales and, given adequate margins, make us profitable. Third parties may develop
superior or equivalent, but less expensive, products.
We have incurred net losses since
our inception and we may not achieve or sustain profitability.
We incurred a net loss of $24.8 million in 2004 and
$16.7 million in 2005. As of December 31, 2005, our accumulated deficit
was $173.0 million. Our losses have resulted principally from expenses incurred
in research and development of our technology and products and from selling,
general and administrative expenses that we have incurred while building our
business infrastructure. We expect to continue to incur significant operating
losses in the future as we continue our research and development efforts and
seek to obtain regulatory approval of our products. Our ability to achieve
profitability depends on our ability to raise additional capital, complete
development of our products, obtain regulatory approvals and market our
products. It is uncertain when, if ever, we will become profitable.
If we fail to attract significant
additional capital, we may be unable to continue to successfully develop
our products.
Since we began operations, we have obtained
operating funds primarily by selling shares of our common stock. Based on our
current plans, we believe that current cash balances will be sufficient to meet
our operating needs for the current fiscal year. Furthermore, the actual amount
of funds that we will need will be determined by many factors, some of which
are beyond our control. These factors include the success of our research and
development efforts, the status of our pre-clinical and clinical testing, costs
relating to securing regulatory approvals and the costs and timing of obtaining
new patent rights, regulatory changes, competition and technological
developments in the market. We may need funds sooner than currently
anticipated.
If necessary, potential sources of additional
funding could include strategic relationships, public or private sales of
shares of our common stock or debt or other arrangements. We may not be
able to obtain additional funding when we need it on terms that will be
acceptable to us or at all. If we raise funds by selling additional shares of
our common stock or securities convertible into our common stock, the ownership
interest of our existing shareholders will be diluted. If we are unable to
obtain financing when needed, our business and future prospects would be
materially adversely affected.
3
If we fail to receive necessary
regulatory approvals, we will be unable to commercialize our products.
All of our products are subject to extensive
regulation by the United States Food and Drug Administration, or FDA, and by
comparable agencies in other countries. The FDA and these agencies require new
pharmaceutical products to undergo lengthy and detailed clinical testing
procedures and other costly and time-consuming compliance procedures. We do not
know when or if we will be able to submit our products for regulatory review.
Even if we submit a new drug application, there may be delays in obtaining
regulatory approvals, if we obtain them at all. Sales of our products outside
the United States will also be subject to regulatory requirements governing
clinical trials and product approval. These requirements vary from country to
country and could delay introduction of our products in those countries. We
cannot assure you that any of our products will receive marketing approval from
the FDA or comparable foreign agencies.
We may fail to compete
effectively, particularly against larger, more established pharmaceutical
companies, causing our business to suffer.
The biotechnology industry is highly competitive. We
compete with companies in the United States and abroad that are engaged in the
development of pharmaceutical technologies and products. They include
biotechnology, pharmaceutical, chemical and other companies; academic and
scientific institutions; governmental agencies; and public and private research
organizations.
The financial and technical resources and production
and marketing capabilities of many of these entities, some of which are our
competitors, exceed our resources and capabilities. Our industry is
characterized by extensive research and development and rapid technological
progress. Competitors may successfully develop and market superior or less
expensive products which render our products less valuable or unmarketable.
We have limited operating experience.
We have engaged solely in the research and
development of pharmaceutical technology. Although some members of our
management team have experience in biotechnology company operations, we have
limited experience in manufacturing or selling pharmaceutical products. We also
have only limited experience in negotiating and maintaining strategic relationships
and in conducting clinical trials and other later-stage phases of the
regulatory approval process. We may not successfully engage in some or all
of these activities.
We have limited manufacturing capacity.
While we believe that we can produce materials for
clinical trials and produce products for human use at our recently completed
GMP manufacturing facility, we may need to expand our commercial
manufacturing capabilities for products in the future if we elect not to or
cannot contract with others to manufacture our products. This expansion may occur
in stages, each of which would require regulatory approval, and product demand
could at times exceed supply capacity. We have not selected a site for any
expanded facilities and do not know what the construction cost will be for such
facilities and whether we will have the financing needed for such construction.
We do not know if or when the FDA will determine that such facilities comply
with Good Manufacturing Practices. The projected location and construction of
any facilities will depend on regulatory approvals, product development,
pharmaceutical partners and capital resources, among other factors. We have not
obtained regulatory approvals for any productions facilities for our products,
nor can we assure investors that we will be able to do so.
4
If we lose key personnel or are
unable to attract and retain additional, highly skilled personnel required for
our activities, our business will suffer.
Our success will depend to a large extent on the
abilities and continued service of several key employees, including Drs. Denis
Burger, Patrick Iversen, and Dwight Weller. We maintain key man life insurance
in the amount of $1,000,000 for Dr. Burger and $500,000 for each of Drs. Iversen
and Weller. The loss of any of these key employees could significantly delay
the achievement of our goals. Competition for qualified personnel in our
industry is intense, and our success will depend on our ability to attract and
retain highly skilled personnel. To date, we have been successful in attracting
and retaining key personnel. We are not aware of any key personnel who plan to
retire or otherwise leave the Company in the near future.
Asserting, defending and
maintaining our intellectual property rights could be difficult and costly, and
our failure to do so will harm our ability to compete and the results of our
operations.
Our success will depend on our existing patents and
licenses and our ability to obtain additional patents in the future. A patent
estate including 172 patents (domestic and foreign) issued or licensed to us,
and 151 pending patent applications (domestic and foreign) protects our
technologies. We license the composition, manufacturing and use of AVICINE in all
fields, except fertility regulation, from The Ohio State University. We license
other patents for certain complementary technologies from others.
Some of our patents on core technologies expire as
early as 2008, including for NEUGENES. Based on patented improvements and
additions to such core patents, however, we believe our patent protection for
those products and other products extend beyond 2020.
We cannot assure you that our pending patent
applications will result in patents being issued in the United States or
foreign countries. In addition, the patents which have been or will be issued may not
afford meaningful protection for our technology and products. Competitors may develop
products similar to ours which do not conflict with our patents. Others may challenge
our patents and, as a result, our patents could be narrowed or invalidated. The
patent position of biotechnology firms generally is highly uncertain, involves
complex legal and factual questions, and has recently been the subject of much
litigation. No consistent policy has emerged from the United States Patent and
Trademark Office (USPTO), or the courts regarding the breadth of claims allowed
or the degree of protection afforded under biotechnology patents. In addition,
there is a substantial backlog of biotechnology patent applications at the
USPTO and the approval or rejection of patents may take several years.
Our success will also depend partly on our ability
to operate without infringing upon the proprietary rights of others, as well as
our ability to prevent others from infringing on our proprietary rights. We may be
required at times to take legal action to protect our proprietary rights and,
despite our best efforts, we may be sued for infringing on the patent
rights of others. We have not received any communications or other indications
from owners of related patents or others that such persons believe our products
or technology may infringe their patents. Patent litigation is costly and,
even if we prevail, the cost of such litigation could adversely affect our
financial condition. If we do not prevail, in addition to any damages we might
have to pay, we could be required to stop the infringing activity or obtain a
license. Any required license may not be available to us on acceptable
terms, or at all. If we fail to obtain a license, our business might be
materially adversely affected.
To help protect our proprietary rights in unpatented
trade secrets, we require our employees, consultants and advisors to execute
confidentiality agreements. However, such agreements may not provide us
with adequate protection if confidential information is used or disclosed
improperly. In addition, in some situations, these agreements may conflict
with, or be subject to, the rights of third parties with whom our employees,
consultants or advisors have prior employment or consulting relationships.
Further, others may independently develop substantially equivalent
proprietary information and techniques, or otherwise gain access to our trade
secrets.
5
If our strategic relationships are unsuccessful, our
business could be harmed.
Our strategic relationship with Exelixis and others
are important to our success. The development, improvement and marketing of many
of our key therapeutic products are or will be dependent on the efforts of our
strategic partners. The transactions contemplated by our agreements with
strategic partners, including the equity purchases and cash payments, are
subject to numerous risks and conditions. The occurrence of any of these events
could severely harm our business.
Our near-term strategy is to co-develop products
with strategic partners or to license the marketing rights for our products to
pharmaceutical partners after we complete one or more Phase II clinical trials.
In this manner, the extensive costs associated with late-stage clinical
development and marketing will be shared with, or the responsibility of, our
strategic partners.
To fully realize the potential of our products,
including development, production and marketing, we may need to establish
other strategic relationships.
We may be subject to product
liability lawsuits and our insurance may not be adequate to cover damages.
We believe we carry adequate insurance for the
product development research we currently conduct. In the future, when we have
products available for commercial sale and use, the use of our products will
expose us to the risk of product liability claims. Although we intend to obtain
product liability insurance coverage, product liability insurance may not
continue to be available to us on acceptable terms and our coverage may not
be sufficient to cover all claims against us. A product liability claim, even
one without merit or for which we have substantial coverage, could result in
significant legal defense costs, thereby increasing our expenses, lowering our
earnings and, depending on revenues, potentially resulting in additional
losses.
Continuing efforts of government
and third party payers to contain or reduce the costs of health care may adversely
affect our revenues and future profitability.
In addition to obtaining regulatory approval, the
successful commercialization of our products will depend on the ability to
obtain reimbursement for the cost of the product and treatment from the
consumers of or third-party payors for such products. Government authorities,
private health insurers and other organizations, such as health maintenance
organizations are increasingly challenging the prices charged for medical
products and services. Also, the trend toward managed health care in the United
States, the growth of healthcare organizations such as HMOs, and legislative
proposals to reform healthcare and government insurance programs could
significantly influence the purchase of healthcare services and products,
resulting in lower prices and reducing demand for our products. The cost
containment measures that healthcare providers are instituting and any
healthcare reform could affect our or our marketing partners ability to
sell our products and may have a material adverse effect on our financial
results from operations. Reimbursement in the United States or foreign
countries may not be available for any of our products, any reimbursement
granted may be reduced or discontinued, and limits on reimbursement
available from third-party payors may reduce the demand for, or the price
of, our products. The lack or inadequacy of third-party reimbursements for our
products would have a material adverse effect on our operations. Additional
legislation or regulation relating to the healthcare industry or third-party
coverage and reimbursement may be enacted in the future that adversely
affects our products and our business.
6
If we fail to establish strategic
relationships with larger pharmaceutical partners, our business may suffer.
We do not intend to conduct late-stage (Phase III)
human clinical trials ourselves. We anticipate entering into relationships with
larger pharmaceutical companies to conduct these and later pharmaceutical
trials and to market our products. We also plan to continue to use contract
manufacturing for late stage clinical and commercial quantities of our
products. We may be unable to enter into partnerships or other
relationships, which could impede our ability to bring our products to market. Any such partnerships, if entered into at
all, maybe on less than favorable terms and may not result in the
successful development or marketing of our products. If we are unsuccessful in
establishing advantageous clinical testing, manufacturing and marketing
relationships, we are not likely to generate significant revenues and become
profitable.
We use hazardous substances in our
research activities.
We use organic and inorganic solvents and reagents
in our clinical development that are customarily used in pharmaceutical
development and synthesis. Some of these chemicals, such as methylene chloride,
isopropyl alcohol, ethyl acetate and acetane, may be classified as
hazardous substances, are flammable and, if exposed to human skin can cause
anything from irritation to severe burns. We receive, store, use and dispose of
such chemicals in compliance with all applicable laws with containment storage
facilities and contained handling and disposal safeguards and procedures. We
are routinely inspected by federal, state and local governmental and public
safety agencies regarding our storage, use and disposal of such chemicals,
including the federal Occupational, Safety and Health Agency (OSHA), the
Oregon Department of Environmental Quality (DEQ) and local fire departments,
without any material noncompliance issues in such inspections to date. Further,
our usage of such chemicals is limited and falls below the reporting thresholds under federal law. Based on
our limited use of such chemicals, the nature of such chemicals and the
safeguards undertaken by the Company for storage, use and disposal, we believe
we do not have any material exposure for toxic tort liability. Further, the
cost of such compliance is not a material cost in our operating budget. While
we do not have toxic tort liability insurance at this time, we believe our
current insurance coverage is adequate to cover most liabilities that may arise
from our use of such substances. If we are wrong in any of our beliefs, we
could incur a liability in certain circumstances that would be material to our
finances and the value of an investment in our securities.
Risks Related to Share Ownership
Our right to issue preferred
stock, our classified Board of Directors and Oregon Anti-Takeover laws may delay
a takeover attempt and prevent or frustrate any attempt to replace or remove
the then current management of the Company by shareholders.
Our authorized capital consists of 200,000,000
shares of common stock and 20,000,000 shares of preferred stock. Our Board of
Directors, without any further vote by the shareholders, has the authority to
issue preferred shares and to determine the price, preferences, rights and
restrictions, including voting and dividend rights, of these shares. The rights
of the holders of shares of common stock may be affected by the rights of
holders of any preferred shares that our board of directors may issue in
the future. For example, our Board of Directors may allow the issuance of
preferred shares with more voting rights, higher dividend payments or more
favorable rights upon dissolution, than the shares of common stock or special
rights to elect directors.
In addition, we have a classified Board of
Directors, which means that only one-half of our directors are eligible for
election each year. Therefore, if shareholders wish to change the composition
of our Board of Directors, it could take at least two years to remove a
majority of the existing directors or to change all directors. Having a
classified Board of Directors may, in some cases, delay mergers, tender offers
or other possible transactions which may be favored by some or a majority
of our shareholders and may delay or frustrate action by shareholders to
change the then current Board of Directors and management.
7
The Oregon Control Share Act and Business
Combination Act may limit parties who acquire a significant amount of voting
shares from exercising control over us for specific periods of time. These acts
may lengthen the period for a proxy contest or for a person to vote their
shares to elect the majority of our Board and change management.
Our stock price is volatile and may fluctuate
due to factors beyond our control.
Historically, the market price of our stock has been
highly volatile. The following types of announcements could have a significant
impact on the price of our common stock: positive or negative results of testing
and clinical trials by ourselves, strategic partners, or competitors; delays in
entering into corporate partnerships; technological innovations or commercial
product introductions by ourselves or competitors; changes in government
regulations; developments concerning proprietary rights, including patents and
litigation matters; public concern relating to the commercial value or safety
of any of our products; financing or other corporate transactions; or general
stock market conditions.
The significant number of our
shares of common stock eligible for future sale may cause the price of our
common stock to fall.
We have outstanding 52,925,682 shares of common
stock as of April 3, 2006, and all are eligible for sale under Rule 144
or are otherwise freely tradeable. In addition:
Our employees and others hold options to buy
a total of 5,706,382 shares of common stock, of which 3,735,497 shares were
exercisable at April 3, 2006. The options outstanding have exercise prices
between $1.76 to $8.13 per share. The shares of common stock to be issued upon
exercise of these options have been registered, and, therefore, may be
freely sold when issued;
There are outstanding warrants to buy 11,508,103
shares of common stock at April 3, 2006 with exercise prices ranging from
$.0003 to $35.63 per share. All of these shares of common stock are registered
for resale and may be freely sold when issued;
We may issue options to purchase up to
an additional 1,704,011 shares of common stock at April 3, 2006 under our stock
option plans, which also will be fully saleable when issued except to the
extent limited under Rule 144 for resales by our officers and directors;
We are authorized to sell up to 39,807 shares
of common stock under our Employee Stock Purchase Plan to our full-time
employees, nearly all of whom are eligible to participate;
We have also granted certain contractual
rights to purchase (i) an additional 352,113 shares of our common stock at
a price of $7.10 per share and (ii) the right to purchase up to $7,500,000
of our common stock based on the average closing sales price for the five days
preceding the commitment to purchase. If we meet certain technological
milestones, the holder of these rights is obligated to purchase shares of
common stock from us. The holder of these rights may require us to
register the shares issued upon the exercise of such purchase rights.
Sales of substantial amounts of shares into the
public market could lower the market price of our common stock.
We do not expect to pay dividends
in the foreseeable future.
We have never paid dividends on our shares of common
stock and do not intend to pay dividends in the foreseeable future. Therefore,
you should only invest in our common stock with the expectation of realizing a
return through capital appreciation on your investment. You should not invest
in our common stock if you are seeking dividend income.
8
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus and the documents incorporated by reference contain, in addition to
historical information, forward-looking statements regarding our plans,
expectations, estimates and beliefs. Our actual results could differ materially
from those discussed in, or implied by, these forward-looking statements.
Forward-looking statements are identified by words such as believe, anticipate,
expect, intend, plan, will, may, and other similar expressions. In
addition, any statements that refer to expectations, projections or other
characterizations of future events or circumstances are forward-looking
statements. We have based these forward-looking statements largely on our
expectations. Forward-looking statements in this report include, but are not
necessarily limited to, those relating to:
our intention to introduce new products,
receipt of any required FDA or other
regulatory approval for our products,
our expectations about the markets for our
products,
acceptance of our products, when introduced,
in the marketplace,
our future capital needs,
results of our research and development
efforts, and
success of our patent applications.
Forward-looking
statements are subject to risks and uncertainties, certain of which are beyond
our control. Actual results could differ materially from those anticipated as a
result of the factors described in the Risk Factors and detailed herein and
in our other Securities and Exchange Commission filings, including among
others:
the effect of regulation by the FDA and other
governmental agencies,
delays in obtaining, or our inability to
obtain, approval by the FDA or other regulatory authorities for our products,
research and development efforts, including
delays in developing, or the failure to develop, our products,
the development of competing or more
effective products by other parties,
the results of pre-clinical and clinical
testing,
uncertainty of market acceptance of our
products,
problems that we may face in
manufacturing, marketing, and distributing our products,
our inability to raise additional capital
when needed,
delays in the issuance of, or the failure to
obtain, patents for certain of our products and technologies, and
problems with important suppliers and
business partners.
Because
of these risks and uncertainties, the forward-looking events and circumstances
discussed in this report or incorporated by reference might not occur. Factors
that cause actual results or conditions to differ from those anticipated by
these and other forward-looking statements include those more fully described
in the Risk Factors section and elsewhere in this prospectus.
USE OF PROCEEDS
The proceeds from the sale of the selling
shareholders shares of common stock will belong to the selling shareholder. We
will not receive any proceeds from those sales.
9
DESCRIPTION OF TRANSACTION
On March 10, 2006, we entered into a
transaction with Cook Group Incorporated (Cook) for Cooks development and
commercialization of products for vascular diseases. We entered into a license
agreement with Cook with respect to our NEUGENE® antisense technology in
certain applications. In connection with that license, Cook will take over
clinical development of our devicerelated programs for cardiovascular
restenosis, including our RestenNG® drugeluting stent (DES) program, RestenMP
microparticle delivery program and our new program for catheter delivery
of RestenNG.
Cook will fully fund the development,
clinical and regulatory costs of these programs in the U.S. and Europe leading
to commercialization. This funding is expected to result in expenditures by
Cook that could reach $100 million.
We also entered into a supply agreement with
Cook to sell to Cook the drugs for development, clinical studies and
commercialization. Cook will take over our facilities and personnel at our
Colorado site.
Finally, we entered into a stock purchase
agreement under which Cook acquired 692,003 shares of our common stock for $5
million and we agreed to register those shares for resale by Cook.
SELLING SHAREHOLDER
This prospectus relates to the resale from time
to time of up to a total of 692,003 shares of our common stock by the selling shareholder.
The shares were issued in a private placement exempt from registration
requirements under the Securities Act of 1933, as amended. Under the stock
purchase agreement pursuant to which we sold the shares, we agreed to file a
registration statement, of which this prospectus is a part, with the SEC to
register the resale of these shares and to keep the registration statement
effective until the earlier of the date when all of the shares registered
hereunder are sold, or the date on which the shares registered hereunder can be
sold without registration as to the number of shares sold or March 13,
2009.
The following table, based upon information
currently known by us, sets forth as of April 3, 2006: (i) the number
of shares held of record or beneficially by the selling shareholder as of such
date and (ii) the number of shares that may be offered under this
prospectus. Beneficial ownership includes shares of common stock plus any
securities held by the holder exercisable for or convertible into shares of
common stock within sixty (60) days after April 3, 2006, in accordance
with Rule 13d-3(d)(1) under the Securities Exchange Act of 1934, as
amended. The selling shareholder is not a broker-dealer or an affiliate of a
broker-dealer.
Name of Selling
Shareholder
|
|
Common Stock
Beneficially owned
prior to the offering
|
|
Common stock
owned upon
completion of the
offering(1)
|
|
Percentage of
common stock
owned upon
completion of this
offering(1)
|
|
|
|
|
|
|
|
Cook Group Incorporated, an Indiana
corporation(2)
|
|
692,003
|
|
0
|
|
Less than 1%
|
(1) The table
assumes the sale of the selling shareholder of all of its shares of common
stock available for resale under this prospectus. Percent calculations are
based on 52,925,682 shares of our common stock issued and outstanding as of April 3,
2006.
(2) M.
Kem Hawkins, Executive Vice President and Chief Financial Officer holds voting
and investment power over the shares held by Cook Group Incorporated.
Accordingly, he may be deemed to be the beneficial owner of such shares. Mr.
Hawkins disclaims beneficial ownership of such shares except to the extent of
his pecuniary interest.
10
PLAN OF
DISTRIBUTION
The selling shareholder of
our common stock and any of its pledgees, assignees and successors-in-interest
may, from time to time, sell any or all of its shares of common stock on the Nasdaq
Stock Market or any other stock exchange, market or trading facility on which
the shares are traded or in private transactions. These sales may be at
fixed or negotiated prices. The selling shareholder may use any one or
more of the following methods when selling shares:
ordinary brokerage transactions and
transactions in which the broker-dealer solicits purchasers,
block trades in which the broker-dealer will
attempt to sell the shares as agent but may position and resell a portion
of the block as principal to facilitate the transaction,
purchases by a broker-dealer as principal and
resale by the broker-dealer for its account,
an exchange distribution in accordance with
the rules of the applicable exchange,
privately- negotiated transactions,
settlement of short sales entered into after
the effective date of the registration statement of which this prospectus is a
part,
broker-dealers may agree with the
selling shareholder to sell a specified number of such shares at a stipulated
price per share,
through the writing or settlement of options
or other hedging transactions, whether through an options exchange or otherwise,
a combination of any such methods of sale, or
any other method permitted pursuant to
applicable law.
The selling shareholder may also
sell shares under Rule 144 under the Securities Act of 1933, as amended
(the Securities Act), if available, rather than under this prospectus.
Broker-dealers engaged by
the selling shareholder may arrange for other broker-dealers to
participate in sales. Broker-dealers may receive commissions or discounts
from the selling shareholder (or, if any broker-dealer acts as agent for the
purchaser of shares, from the purchaser) in amounts to be negotiated, but,
except as set forth in a supplement to this prospectus, in the case of an agency
transaction not in excess of a customary brokerage commission in compliance
with NASDR Rule 2440; and in the case of a principal transaction a markup
or markdown in compliance with NASDR IM-2440.
In connection with the sale
of the common stock or interests therein, the selling shareholder may enter
into hedging transactions with broker-dealers or other financial institutions,
which may in turn engage in short sales of the common stock in the course
of hedging the positions they assume. The selling shareholder may also
sell shares of the common stock short and deliver these securities to close out
its short positions, or loan or pledge the common stock to broker-dealers that
in turn may sell these securities. The selling shareholder may also
enter into option or other transactions with broker-dealers or other financial
institutions or the creation of one or more derivative securities which require
the delivery to such broker-dealer or other financial institution of shares
offered by this prospectus, which shares such broker-dealer or other financial
institution may resell pursuant to this prospectus (as supplemented or
amended to reflect such transaction).
The selling shareholder and
any broker-dealers or agents that are involved in selling the shares may be
deemed to be underwriters within the meaning of the Securities Act in
connection with such sales. In such event, any commissions received by such
broker-dealers or agents and any profit on the resale of the shares purchased
by them may be deemed to be underwriting commissions or discounts under
the Securities Act. The selling shareholder has informed us that it does not
have any written or oral agreement or understanding, directly or indirectly,
with any person to distribute the common stock. In no event shall any
broker-dealer receive fees, commissions and markups which, in the aggregate,
would exceed eight percent (8%).
11
We are required to pay
certain fees and expenses incurred by us incident to the registration of the
shares. We have agreed to indemnify the selling shareholder against certain
losses, claims, damages and liabilities, including liabilities under the Securities
Act.
Because the selling shareholder
may be deemed to be an underwriter
within the meaning of the Securities Act, it will be subject to the prospectus
delivery requirements of the Securities Act including Rule 172 thereunder.
In addition, any securities covered by this prospectus which qualify for sale
pursuant to Rule 144 under the Securities Act may be sold under Rule 144
rather than under this prospectus. There is no underwriter or coordinating
broker acting in connection with the proposed sale of the resale shares by the
selling shareholder.
We agreed to keep this
prospectus effective until the earlier of (i) the date on which the shares
may be resold by the selling shareholder without registration and without
regard to any volume limitations by reason of Rule 144(k) under the
Securities Act or any other rule of similar effect or (ii) all of the
shares have been sold pursuant to this prospectus or Rule 144 under the
Securities Act or any other rule of similar effect or (iii) March 13,
2009. The resale shares will be sold only through registered or licensed
brokers or dealers if required under applicable state securities laws. In
addition, in certain states, the resale shares may not be sold unless they
have been registered or qualified for sale in the applicable state or an
exemption from the registration or qualification requirement is available and
is complied with.
Under applicable rules and
regulations under the Securities Exchange Act of 1934, as amended (the Exchange
Act), any person engaged in the distribution of the resale shares may not
simultaneously engage in market making activities with respect to the common
stock for the applicable restricted period, as defined in Regulation M, prior
to the commencement of the distribution. In addition, the selling shareholder
will be subject to applicable provisions of the Exchange Act and the rules and
regulations thereunder, including Regulation M, which may limit the timing
of purchases and sales of shares of the common stock by the selling shareholder
or any other person. We will make copies of this prospectus available to the
selling shareholder and have informed it of the need to deliver a copy of this
prospectus to each purchaser at or prior to the time of the sale (including by
compliance with Rule 172 under the Securities Act).
LEGAL
MATTERS
The validity of the shares
of common stock being offered hereby has been passed upon for AVI BioPharma, Inc.
by Davis Wright Tremaine LLP of Portland, Oregon.
EXPERTS
The financial statements of
AVI BioPharma, Inc. as of December 31, 2005 and 2004, and for each of
the years in the three-year period ended December 31, 2005, and managements
assessment of the effectiveness of internal control over financial reporting as
of December 31, 2005, have been incorporated by reference herein and in
the registration statement in reliance upon the reports of KPMG LLP,
independent registered public accounting firm, incorporated by reference
herein, and upon the authority of said firm as experts in accounting and auditing.
12
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and current reports, proxy statements and
other information with the SEC. Our SEC filings are available to the public
from the SECs web site at http://www.sec.gov. You may also read and copy any
document we file at the SECs public reference room in
Washington, D.C. located at 100 F Street, N.E., Room 1580,
Washington, D.C. 20549. You may also obtain copies of any document we
file at prescribed rates by writing to the Public Reference Section of the
Securities Exchange Commission at that address. Please call the SEC at
1-800-SEC-0330 for further information on the public reference room.
Information about us, including our SEC filings, is also available on our
website at http://www.avibio.com; however, that information is not a part of
this prospectus or any accompanying prospectus supplement.
INFORMATION INCORPORATED BY REFERENCE
The SEC allows us to incorporate by reference in this prospectus the
information in other documents that we file with it, which means that we can
disclose important information to you by referring you to those documents. The
information incorporated by reference is considered to be a part of this
prospectus, and information in documents that we file later with the SEC will
automatically update and supersede information contained in documents filed
earlier with the SEC or contained in this prospectus or a prospectus
supplement. We incorporate by reference in this prospectus the documents listed
below and any future filings that we may make with the SEC under
Sections 13(a), 13(c), 14, or 15(d) of the Securities Exchange
Act of 1934, as amended, prior to the termination of the offering under this
prospectus:
Annual
Report on Form 10-K for the year ended December 31, 2005;
Current
Report on Form 8-K filed on March 28, 2006; and
The
description of our common stock contained in our registration statement on Form 8-A
filed on May 29, 1997.
Notwithstanding the foregoing, we are not incorporating any document or
information deemed to have been furnished and not filed in accordance with SEC
rules. You may obtain a copy of any or all of the documents referred to
above which may have been or may be incorporated by reference into
this prospectus (excluding certain exhibits to the documents) at no cost to you
by writing or telephoning us at the following address:
AVI BioPharma, Inc.
Investor Relations
One S.W. Columbia
Suite 1105
Portland, OR 97258
Attn: Michael C. Hubbard
(503) 227-0554
The
mailing address of our principal executive offices is AVI BioPharma, Inc.,
One S.W. Columbia Suite 1105 Portland, OR 97258, and our telephone number
at that location is (503) 227-0554.
13
PART II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item 14. Other
expenses of issuance and distribution.
The
following is a statement of the estimated expenses (other than underwriting
compensation) to be incurred by the Registrant in connection with registration
of 692,003 shares of its common stock for resale hereunder.
SEC registration fee
|
|
$
|
527.94
|
|
Printing and engraving fees*
|
|
3,000
|
|
Legal expenses*
|
|
30,000
|
|
Accounting fees and expenses*
|
|
15,000
|
|
NASD, Nasdaq and blue sky expenses*
|
|
0
|
|
Transfer Agent fees and expenses*
|
|
500
|
|
Miscellaneous*
|
|
972.06
|
|
Total
|
|
$
|
50,000
|
|
(*)
The amounts marked with a * above are estimates.
Item 15. Indemnification
of directors and officers.
Our
Amended and Restated Articles of Incorporation provide for indemnification by
us or our directors and former directors, and for advancement of reasonable
expenses incurred by each such person upon an undertaking by such person to
repay such amount if it is ultimately determined that he or she is not entitled
to indemnification. Our Bylaws also provide that we shall have the power to
indemnify our directors and officers pursuant to applicable law. Such
indemnification does not cover matters involving (i) the breach of a
directors duty of loyalty, (ii) actions or omissions not in good faith,
intentional misconduct or knowing violations of law, (iii) the unlawful
payment of dividends, stock purchases or redemptions or (iv) any
transaction from which a director derives an improper personal benefit.
We
have entered into indemnification agreements with each of our directors. These
agreements, among other things, indemnify our directors and officers for
certain expenses (including attorneys fees), judgments, fines and settlement
amounts incurred by any such director or officer in any action or proceeding,
including any action by or in our right, arising out of such persons services
as one of our directors or officers, to any of our subsidiaries or to any other
company or enterprise to which the director or officer provides services at our
request. We believe that these provisions and agreements are necessary to
attract and retain qualified persons as directors and officers.
14
Item 16. Exhibits
Exhibit
Number*
|
|
Exhibit Description
|
|
Incorporated by Reference to Filings Indicated
|
|
Filed
Herewith
|
Form
|
|
File No.
|
|
Exhibit
|
|
Filing Date
|
4.1
|
|
Third
Restated Articles of Incorporation of AntiVirals Inc.
|
|
SB-2
|
|
333-20513
|
|
3.1
|
|
May 29, 1997
|
|
|
4.2
|
|
First
Amendment to Third Restated Articles of Incorporation.
|
|
8-K
|
|
0-22613
|
|
3.3
|
|
September 30, 1998
|
|
|
4.3
|
|
Amendment
to Article 2 of the Companys Third Restated Articles of Incorporation.
|
|
DEF 14A
|
|
1-14895
|
|
N/A
|
|
April 11, 2002
|
|
|
4.4
|
|
Bylaws
of AntiVirals Inc.
|
|
SB-2
|
|
333-20513
|
|
3.2
|
|
May 29, 1997
|
|
|
5.1
|
|
Opinion
of Davis Wright Tremaine LLP (contained in Exhibit 23.2).
|
|
|
|
|
|
|
|
|
|
X
|
10.50+
|
|
Supply
Agreement, dated March 10, 2006, by and between Cook Group Incorporated
and AVI BioPharma, Inc.
|
|
|
|
|
|
|
|
|
|
X
|
10.51+
|
|
License
and Development Agreement, dated March 10, 2006, by and between Cook
Group Incorporated and AVI BioPharma, Inc.
|
|
|
|
|
|
|
|
|
|
X
|
10.52
|
|
Investment
Agreement, dated March 10, 2006, by and between Cook Group Incorporated
and AVI BioPharma, Inc.
|
|
|
|
|
|
|
|
|
|
X
|
23.1
|
|
Consent
of KPMG LLP, Independent Registered Public Accounting Firm.
|
|
|
|
|
|
|
|
|
|
X
|
23.2
|
|
Consent
of Davis Wright Tremaine LLP.
|
|
|
|
|
|
|
|
|
|
X
|
24.1
|
|
Power
of Attorney (contained on page 19).
|
|
|
|
|
|
|
|
|
|
X
|
(*) Materials in the exhibit marked with a +
have been omitted pursuant to a request for confidential treatment filed with
the Securities and Exchange Commission. Omitted portions have been filed
separately with the Securities and Exchange Commission.
15
Item 17. Undertakings.
(a) The undersigned Registrant hereby undertakes:
(1) to file, during any period in which offers or sales are being
made, a post-effective amendment to this Registration Statement: (i) to
include any prospectus required by Section 10(a)(3) of the Securities
Act; (ii) to reflect in the prospectus any facts or events arising after
the effective date of the Registration Statement (or the most recent
post-effective amendment thereof) which, individually or in the aggregate,
represent a fundamental change in the information set forth in the Registration
Statement. Notwithstanding the foregoing, any increase or decrease in volume of
securities offered (if the total dollar value of securities offered would not
exceed that which was registered) and any deviation from the low or high end of
the estimated maximum offering range may be reflected in the form of
prospectus filed with the Commission pursuant to Rule 424(b) if, in
the aggregate, the changes in volume and price represent no more than a 20%
change in the maximum aggregate offering price set forth in the Calculation of
Registration Fee table in the effective Registration Statement; and (iii) to
include any material information with respect to the plan of distribution not
previously disclosed in the Registration Statement or any material change to
such information in the Registration Statement;
provided, however, that paragraphs (i), (ii) and (iii) do
not apply if the Registration Statement is on Form S-3 and the information
required to be included in a post-effective amendment by those paragraphs is
contained in reports filed with or furnished to the Commission by the
Registrant pursuant to Section 13 or Section 15(d) of the
Securities Exchange Act of 1934 that are incorporated by reference in the Registration
Statement, or is contained in a form of prospectus filed pursuant to Rule 424(b) that
is part of the Registration Statement;
(2) that, for the purpose of determining any liability under the
Securities Act of 1933, each such post-effective amendment shall be deemed to
be a new registration statement relating to the securities offered therein, and
the offering of such securities at that time shall be deemed to be the initial
bona fide offering thereof;
(3) to remove from registration by means of a post-effective
amendment any of the securities being registered which remain unsold at the
termination of the offering;
(4) that, for the purpose of determining liability under the
Securities Act of 1933 to any purchaser:
(A) Each prospectus
filed by the Registrant pursuant to Rule 424(b)(3) shall be deemed to
be part of the Registration Statement as of the date the filed prospectus
was deemed part of and included in the Registration Statement; and
(B) Each prospectus
required to be filed pursuant to Rule 424(b)(2), (b)(5) or (b)(7) as
part of a registration statement in reliance on Rule 430B relating to
an offering made pursuant to Rule 415(a)(1)(i), (vii) or (x) for
the purpose of providing the information required by section 10(a) of
the Securities Act of 1933 shall be deemed to be part of and included in
the Registration Statement as of the earlier of the date such form of
prospectus is first used after effectiveness or the date of the first contract
of sale of securities in the offering described in the prospectus. As provided
in Rule 430B, for liability purposes of the issuer and any person that is
at that date an underwriter, such date shall be deemed to be a new effective
date of the registration statement relating to the securities in the Registration
Statement to which that prospectus relates, and the offering of such securities
at that time shall be deemed to be the initial bona
fide offering thereof. Provided,
however, that no statement made in a Registration Statement or
prospectus that is part of the Registration Statement or made in a
document incorporated or deemed incorporated by reference into the Registration
Statement or prospectus that is part of the registration statement will,
as to a purchaser with a time of contract of sale prior to such effective date,
supersede or modify any statement that was
16
made in the Registration Statement or prospectus that was part of
the Registration Statement or made in any such document immediately prior to
such effective date; and
(5) that, for the purpose of determining liability of the
Registrant under the Securities Act of 1933 to any purchaser in the initial
distribution of the securities, the undersigned Registrant undertakes that in a
primary offering of securities of the undersigned Registrant pursuant to this
Registration Statement, regardless of the underwriting method used to sell the
securities to the purchaser, if the securities are offered or sold to such
purchaser by means of any of the following communications, the undersigned
Registrant will be a seller to the purchaser and will be considered to offer or
sell such securities to such purchaser:
(A) Any preliminary
prospectus or prospectus of the undersigned Registrant relating to the offering
required to be filed pursuant to Rule 424;
(B) Any free writing
prospectus relating to the offering prepared by or on behalf of the undersigned
Registrant or used or referred to by the undersigned Registrant;
(C) The portion of any
other free writing prospectus relating to the offering containing material
information about the undersigned Registrant or its securities provided by or
on behalf of the undersigned Registrant; and
(D) Any other
communication that is an offer in the offering made by the undersigned
Registrant to the purchaser.
(b) The undersigned Registrant hereby undertakes that, for
purposes of determining any liability under the Securities Act, each filing of
Registrants annual report pursuant to Section 13(a) or Section 15(d) of
the Securities Exchange Act that is incorporated by reference in this
Registration Statement shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering thereof.
(c) Insofar as indemnification for liabilities arising under the
Securities Act of 1933 may be permitted to directors, officers and
controlling persons of the Registrant pursuant to the provisions described
under Item 15 above, or otherwise, the Registrant has been advised that in
the opinion of the Securities and Exchange Commission such indemnification is
against public policy as expressed in the Act and is, therefore, unenforceable.
In the event that a claim for indemnification against such liabilities (other
than the payment by the Registrant of expenses incurred or paid by a director,
officer or controlling person of the Registrant in the successful defense of
any action, suit or proceeding) is asserted by such director, officer or
controlling person in connection with the securities being registered, the
Registrant will, unless in the opinion of its counsel the matter has been
settled by controlling precedent, submit to a court of appropriate jurisdiction
the question whether such indemnification by it is against public policy as
expressed in the Act and will be governed by the final adjudication of such
issue.
17
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the
registrant certifies that it has reasonable grounds to believe that it meets
all of the requirements for filing on Form S-3 and has duly caused this
Registration Statement to be signed on its behalf by the undersigned, thereunto
duly authorized, in Portland, Oregon on April 11, 2006.
AVI
BIOPHARMA, INC.
|
|
|
By:
|
/s/ DENIS R. BURGER, PH.D.
|
|
Denis R. Burger, Ph.D.
Chief Executive Officer and
Chairman of the Board
|
18
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature
appears below constitutes and appoints Denis R. Burger, Alan P. Timmins and
Mark M. Webber, and each of them, as his true and lawful attorneys-in-fact and
agents, with full power of substitution and resubstitution, for the undersigned
and in his or her name, place and stead, in any and all capacities, to sign any
or all amendments (including post-effective amendments and registration
statements filed pursuant to Rule 462(b) under the Securities Act) to
the Registration Statement and to file the same, with all exhibits thereto, and
all documents in connection therewith, with the Securities and Exchange
Commission, granting unto said attorneys-in-fact and agents, full power and
authority to do and perform each and every act and thing requisite and
necessary to be done in connection therewith, as fully to all intents and
purposes as he or she might or could do in person, hereby ratifying and
confirming all that said attorneys-in-fact and agents, or any of them or their
or his substitute or 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 below by the following persons in
the capacities and on the dates indicated.
SIGNATURE
|
|
TITLE
|
|
DATE
|
|
|
|
/s/ DENIS
R. BURGER, PH.D.
|
|
Chairman
of the Board and Chief
Executive Officer (Principal Executive
Officer)
|
|
April 11,
2006
|
Denis
R. Burger, Ph.D.
|
|
|
|
/s/ ALAN
P. TIMMINS
|
|
President,
Chief Operating Officer,
and Director
|
|
April 11,
2006
|
Alan
P. Timmins
|
|
|
|
/s/ MARK
M. WEBBER
|
|
Chief
Financial Officer and Chief
Information Officer (Principal
Financial and Accounting Officer)
|
|
April 11,
2006
|
Mark
M. Webber
|
|
|
|
/s/ DWIGHT
D. WELLER, PH.D.
|
|
Senior
Vice President of Chemistry
and Manufacturing and Director
|
|
April 11,
2006
|
Dwight
D. Weller, Ph.D.
|
|
|
|
/s/ JOHN
W. FARA, PH.D.
|
|
Director
|
|
April 11,
2006
|
John
W. Fara, Ph.D.
|
|
|
|
/s/ JAMES
B. HICKS, PH.D.
|
|
Director
|
|
April 11,
2006
|
James
B. Hicks, Ph.D.
|
|
|
|
/s/ JACK
L. BOWMAN
|
|
Director
|
|
April 11,
2006
|
Jack
L. Bowman
|
|
|
|
/s/ K.
MICHAEL FORREST
|
|
Director
|
|
April 11,
2006
|
K.
Michael Forrest
|
|
|
|
/s/ JOHN
C. HODGMAN
|
|
Director
|
|
April 11,
2006
|
John
C. Hodgman
|
19
INDEX TO EXHIBITS
Exhibit
Number*
|
|
Exhibit Description
|
|
Incorporated by Reference to Filings Indicated
|
|
Filed
Herewith
|
Form
|
|
File No.
|
|
Exhibit
|
|
Filing Date
|
4.1
|
|
Third Restated Articles of Incorporation of AntiVirals Inc.
|
|
SB-2
|
|
333-20513
|
|
3.1
|
|
May 29, 1997
|
|
|
4.2
|
|
First Amendment to Third Restated Articles of Incorporation.
|
|
8-K
|
|
0-22613
|
|
3.3
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September 30, 1998
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4.3
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Amendment to Article 2 of the Companys Third Restated Articles
of Incorporation.
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DEF 14A
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1-14895
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N/A
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|
April 11, 2002
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4.4
|
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Bylaws of AntiVirals Inc.
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|
SB-2
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|
333-20513
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3.2
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|
May 29, 1997
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5.1
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Opinion of Davis Wright Tremaine LLP (contained in Exhibit 23.2).
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|
|
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X
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10.50+
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|
Supply Agreement, dated March 10, 2006, by and between Cook
Group Incorporated and AVI BioPharma, Inc.
|
|
|
|
|
|
|
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X
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10.51+
|
|
License and Development Agreement, dated March 10, 2006, by and
between Cook Group Incorporated and AVI BioPharma, Inc.
|
|
|
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|
|
|
|
|
|
X
|
10.52
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|
Investment Agreement, dated March 10, 2006, by and between Cook
Group Incorporated and AVI BioPharma, Inc.
|
|
|
|
|
|
|
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|
|
X
|
23.1
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|
Consent of KPMG LLP, Independent Registered Public Accounting Firm.
|
|
|
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|
|
|
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|
|
X
|
23.2
|
|
Consent of Davis Wright Tremaine LLP.
|
|
|
|
|
|
|
|
|
|
X
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24.1
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Power of Attorney (contained on page 19).
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|
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X
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(*) Materials
in the exhibit marked with a + have been omitted pursuant to a request
for confidential treatment filed with the Securities and Exchange Commission.
Omitted portions have been filed separately with the Securities and Exchange
Commission.
20
Exhibit 10.50
NOTE: Portions of this document marked *** have
been omitted and filed separately with the Securities and Exchange Commission
pursuant to a request for confidential treatment of the omitted and separately
filed portions.
SUPPLY
AGREEMENT
THIS SUPPLY AGREEMENT (the Agreement) is made and
entered into as of March 10, 2006, (the Effective Date) between AVI
BIOPHARMA, INC. (as defined below, Supplier), an Oregon corporation, and
COOK GROUP INCORPORATED (as defined below, Company), an Indiana corporation.
WITNESSETH:
WHEREAS, Supplier is establishing manufacturing
facilities to manufacture drugs such as the Drug (as defined below);
WHEREAS, Company and Supplier have entered into a
License and Development Agreement of even date herewith with respect to the
Drug (the License and Development Agreement);
WHEREAS, Company and Supplier have entered into an
Investment Agreement of even date herewith with respect to the Drug (the Investment
Agreement);
WHEREAS, Supplier and Company wish to enter into this
Agreement regarding Suppliers supplying the Drug (as defined below) to
Company;
AGREEMENTS:
NOW THEREFORE, in consideration of the
representations, warranties, covenants and agreements contained herein, and for
other valuable consideration, the receipt and adequacy of which is hereby
acknowledged, the parties mutually agree as follows:
ARTICLE 1.
DEFINITIONS
1.1. Specific
Definitions. As used in this Agreement, the following terms shall have the
meanings set forth or as referenced below:
Actual Cost means the cost of
non-manufacturing activities performed by AVI personnel pursuant to this
Agreement, including direct labor, materials, travel, and allocated overhead
costs.
Affiliate of a
specified person (natural or juridical) means a person that directly, or
indirectly through one or
more intermediaries, controls, or is controlled by, or is under common control
with, the person specified. Control shall mean ownership of more than
50% of the shares of stock entitled to vote for the election of directors in
the case of a corporation, and more than 50% of the voting power in the case of
a business entity other than a corporation.
Agreement means
this Agreement and all Exhibits and Schedules hereto.
Company means
Cook Group Incorporated and its Affiliates.
Confidential
Information means know-how, trade secrets, and unpublished information
disclosed (whether before or during the term of this Agreement) by one of the
parties (the disclosing party) to the other party (the receiving party) or
generated under this Agreement, excluding information which:
(a) was
already in the possession of receiving party prior to its receipt from the
disclosing party (provided that the receiving party is able to provide the
disclosing party with reasonable documentary proof thereof and, if received
from a third party, that such information was acquired without any partys
breach of a confidentiality or non-disclosure obligation to the disclosing
party related to such information);
(b) is
or becomes part of the public domain by reason of acts not attributable to
the receiving party;
(c) is
or becomes available to receiving party from a source other than the disclosing
party which source, has rightfully obtained such information and has no
obligation of non-disclosure or confidentiality to the disclosing party with
respect thereto; or
(d) has
been independently developed by the receiving party without breach of this
Agreement or use of any Confidential Information of the other party.
Drug has the
meaning given such term in the License and Development Agreement.
Effective Date
has the meaning set forth in the recitals hereto.
FDA means the
United States Food and Drug Administration.
Force Majeure
means any event or condition, not existing as of the date of this Agreement,
not reasonably foreseeable as of such date and not reasonably within the
control of either party, which prevents in whole or in material part the
performance by one of the parties of its obligations hereunder, such as an act
of government, war or related actions, civil insurrection, act of terrorism,
riot, sabotage, strike, epidemic, fire, flood, windstorm, and similar events.
GMP means Good
Manufacturing Practices as defined in 21 CFR Parts 210 through 226 and Parts
600 through 680 and any successor provisions thereof that apply to production
of the Drug under this Agreement.
Intellectual Property
means U.S. and foreign patents and patent applications, trademarks, service
marks and registrations thereof and applications therefor, copyrights and
2
copyright registrations
and applications, mask works and registrations thereof, know-how, trade
secrets, inventions, discoveries, ideas, technology, data, information,
processes, drawings, designs, licenses, computer programs and software, and
technical information including but not limited to information embodied in
material specifications, processing instructions, equipment specifications,
product specifications, confidential data, electronic files, research
notebooks, invention disclosures, research and development reports and the like
related thereto and all amendments, modifications, and improvements to any of
the foregoing.
Indemnifiable Losses
has the meaning set forth in Section 7.1.
Indemnitee has
the meaning set forth in Section 7.3.
Indemnitor has
the meaning set forth in Section 7.3.
Investment Agreement
has the meaning set forth in the recitals hereto.
License and
Development Agreement has the meaning set forth in the recitals hereto.
Product Liability
Damages means any liability, claim or expense, including but not limited
to reasonable attorneys fees and medical expenses, arising in whole or in part out
of claims of third parties for personal injury or loss of or damage to property
relating to or arising out of the Products, whether based on strict liability
in tort, negligent manufacture of product, or any other allegation of liability
arising from the design, testing, manufacture, packaging, labeling (including
instructions for use), or sale of the Products.
Product means
the final formulation or configuration of the Drug with or without a device or
delivery mechanism such as a stent, catheter, or microbubble formulation.
Specifications
means the specifications and formulations for the Products as agreed to by the
parties. Within sixty (60) days of the Effective Date, the parties will agree
in writing to initial Specifications for each Product to be developed. Thereafter,
Specifications for a particular Product may be amended from time to time
upon mutual agreement of the parties. Specifications specifically developed by
Company or included in any FDA approval of the Drug, but excluding in either
case Supplier Specifications (as defined herein), shall be referred to as Company
Specifications. Supplier Specifications shall mean
specifications developed by Supplier and incorporated into the Specifications
without modification by Company.
Supplier means
AVI BioPharma, Inc. and its Affiliates.
Term has the
meaning set forth in Section 8.1.
Warranty Exclusions
has the meaning set forth in Section 5.1.
1.2. Other
Terms. Other terms may be defined elsewhere in the text of this
Agreement and shall have the meaning indicated throughout this Agreement.
3
1.3. Definitional
Provisions.
(a) The
words hereof, herein, and hereunder and words of similar import, when
used in this Agreement, shall refer to this Agreement as a whole and not to any
particular provisions of this Agreement.
(b) The
terms defined in the singular shall have a comparable meaning when used in the
plural, and vice versa.
(c) References
to an Exhibit or to a Schedule are, unless otherwise specified, to one of
the Exhibits or Schedules attached to or referenced in this Agreement, and
references to an Article or a Section are, unless otherwise specified, to
one of the Articles or Sections of this Agreement.
(d) The
term person includes any individual, partnership, joint venture, corporation,
trust, unincorporated organization or government or any department or agency
thereof.
ARTICLE 2.
SUPPLY
2.1. Supply
of Drug. Commencing upon the closing of transactions contemplated by the
Investment Agreement, Supplier
shall manufacture, or have manufactured, and supply to Company all of Companys
orders for Drug made under Article 3, in accordance with the
Specifications in effect at the time of order for each Product and with Companys
schedule for deliveries. In the event of any Drug or material shortages or
temporary or long-term production capacity restraints or Force Majeure events,
Supplier may allocate production capacity among customers, but, in all
events will supply Company on a priority basis over supplying any other
customers.
2.2. Promotion
and Training. Upon a reasonable request by Company and subject to staff and
support availability, Supplier will assist Company in preparing promotional,
marketing and training literature and instructions for the Products, including
any artwork, will conduct training courses and seminars to educate
medical professionals on the use of Products and their use in connection with
Companys medical devices and for training its marketing, sales, and
distribution groups, and will provide Company with training related to the sale
of Products. Company shall reimburse Suppliers Actual Costs in providing all
services and support pursuant to this Section 2.2. Within thirty (30) days
of the end of each calendar quarter in which costs were incurred, Supplier will
send Company an invoice specifying the Actual Cost of services and support
provided in the just-ended quarter and the payment due. Within thirty (30) days
of receiving each such invoice, Company will make a payment to Supplier for the
full amount due.
2.3. Packaging
and Labeling. Supplier shall package and label the Drug in accordance with
packaging and labeling specifications to be mutually agreed upon by Company and
Supplier and approved by the FDA.
4
2.4. Compliance
With Laws and Regulations.
(a) Supplier
shall be responsible for compliance with present and future applicable
statutes, laws, ordinances and regulations of national, federal, state and
local governments now or hereafter in effect materially relating to its
manufacture of the Drug. If required or necessary in connection with sales of
Products by Company, Supplier shall have its manufacturing facilities become
ISO 9001 certified. Without limitation of the foregoing, Supplier represents
and warrants to Company that all Drugs sold and delivered to Company under this
Agreement will have been manufactured, labeled and packaged in accordance with
applicable FDA GMP requirements and, if applicable, Suppliers ISO 9001
certifications, and that continually during the term of this Agreement no Drugs
delivered by Supplier to Company shall be adulterated or misbranded at the time
of delivery within the meaning of the U.S. Food, Drug and Cosmetic Act and
regulations thereunder or any similar law or regulation. Supplier shall cause
Companys regulatory personnel to be provided with reasonable access from time
to time to the facilities and records of Supplier for the purpose of confirming
Suppliers compliance with any applicable FDA GMP and all other applicable
requirements noted in this Article 2. Supplier agrees to provide
Company with reasonable prior written notice of any FDA inspection of Suppliers
facilities or records prior to such FDA inspection, or if such prior written
notice is not feasible, then within three business days thereafter. Supplier
also agrees to provide Company with written notice of its receipt of any claim
by the FDA or other governmental agency of any actual or alleged violation by
Supplier of any GMP or other applicable requirements as soon as practicable
following receipt of such notice (but in no event more than 5 business days
thereafter). Company shall have the right, at any time and from time-to-time
upon not less than 72 hours prior notice to the Supplier, to inspect Suppliers
manufacturing facilities in order to examine all phases of the manufacturing
process and inspect or audit any or all of the Suppliers data and records
related thereto and the Products compliance with the terms and conditions
hereunder or with respect to any applicable law, rule or regulation. In
the event Supplier uses a sub-contractor or third party to perform any part of
the manufacturing, Supplier shall obtain the agreement of such sub-contractor
or third party that Company shall have similar inspection rights.
(b) Company and
Supplier (except where Supplier has the responsibility under Section 2.4(a) or
elsewhere herein) shall comply with all applicable laws, rules, regulations,
codes, and standards of all federal, state, local and municipal government
agencies which affect their respective performance and activities under this
Agreement. Notwithstanding anything contained herein, Company shall be
responsible for compliance with present and future applicable statutes, laws,
ordinances and regulations of national, federal, state and local governments
now or hereafter in effect including applicable import and export laws
materially relating to its purchase, distribution or sale of the Products.
2.5. Exclusivity.
During the term of this Agreement, or if longer, the term of the License and
Development Agreement, (a) Supplier shall not promote, make, have made,
market or sell the Drug for use in the Field (as defined in the License and
Development Agreement) to any person or entity other than Company, and (b) Company
shall purchase 100% of its requirements for the Drug for use in the Field from
Supplier. Prior to any sale, transfer or other disposition to any third party
of Drug for use outside the Field, Supplier shall obtain the agreement of such
third party that it will not use, promote, market or sell the Drug in the Field
or resell the Drug for use in the Field.
5
2.6. Complaints
and Adverse Events. Each party agrees to inform the other party
promptly (but in no event no later than forty-eight (48) hours after becoming
aware of same) of any information concerning any complaint involving the
Products or that might be applicable to the Products or adverse drug experience
(as defined in 21 C.F.R. § 314.80), injury, toxicity, or sensitivity
reaction associated with the use of the Products or that might be applicable to
the Products, provided that:
(a) if the
adverse drug experience is serious, as defined in 21 C.F.R. § 314.80
(including any adverse drug reaction that is fatal or life-threatening, is
permanently disabling, requires inpatient hospitalization, or is a congenital
anomaly, cancer or overdose), then each party shall notify the other party
within twenty-four (24) hours;
(b) all
notifications to Company shall be by facsimile and on Companys designated
adverse event forms; and
(c) all
notifications to Supplier shall be by facsimile and on Suppliers designated
adverse event forms.
2.7. Records
and Recall. Company shall maintain complete and accurate records of all
Products sold by Company in sufficient detail to enable Supplier to conduct an
effective recall of Drugs purchased by Company under this Agreement if Supplier
determines that such a recall is required or otherwise necessary or appropriate.
In the event of a recall of any of the Drugs by Supplier, Company will
cooperate with and assist Supplier in effecting such recall, including promptly
contacting any purchasers that Supplier reasonably desires to be contacted and
promptly communicating to such purchasers the information or instructions
Supplier reasonably desires to be transmitted relating to such recall. Company
shall be responsible for all costs of effecting such recall of Products,
including any shipping costs related to returning recalled Drugs to Supplier
and replacing such recalled Drugs with new Drugs, except, such costs shall
instead be paid by Supplier (directly or through reimbursement of Company for
costs reasonably incurred by Company) where the recall relates to a matter for
which Supplier would be required to indemnify Company under Article 7
of this Agreement. Notwithstanding the foregoing, Company shall control any
recall of any products sold by Company to third parties that may incorporate
the Drug.
2.8. Certain
Responsibilities. Notwithstanding anything contained herein, Supplier shall
not be responsible for any loss or damage,
including Products Liability Damages, from the use or performance of the Drugs
manufactured under this Agreement where (a) such use or performance did
not result from a breach of this Agreement by Supplier, including, without
limitation, Suppliers warranties, (b) the Drugs complied with the
description and form described in any documents used for all governmental
approvals, applications, submissions, and approvals filed by Company with the
FDA, or given to Company by the FDA, and (c) the Drugs complied with the
packaging, shipping, and labeling for the Drugs. Company further agrees that no
Products will be released for public use or consumption until all requisite
governmental approvals therefore have been obtained for such use and
consumption.
6
2.9. Supply.
Supplier agrees: (i) to have in
place prior to the first regulatory approval of the commercial sale of the
Product an agreed upon reserve supply of the Drug to support the Product and
maintain during the term of this Agreement a commercially reasonable supply for
the Drug and (ii) to produce commercially reasonable quantities of the
Drug in compliance with FDA GMP requirements and other regulatory requirements.
The Company agrees to pay for the agreed upon reserve supply of Drug prior to
the first regulatory approval. Supplier agrees to store in a safe and secure
off-site location a reserve supply of the Drug and Supplier agrees to exercise
commercially reasonable efforts to replenish such supply if it is used. The
Drugs shall be stored in compliance with the Specifications and any applicable
law or regulation.
ARTICLE 3.
ORDERS
AND DELIVERY
3.1. Purchase
Orders. To assist the Supplier in determining the reserve supply of Drug to
be maintained, the Company will make its commercially reasonable efforts to
forecast its requirements for Drugs six (6) months in advance of ordering
Drugs and updating a rolling forecast at three (3) month intervals. Such
rolling forecasts by Company shall be used for purposes of facilitating Companys
clinical, sales and marketing plans and meeting the lead times required by
certain of Suppliers suppliers, but they are not legally binding on Company in
any manner. Company shall submit purchase orders for the Drugs to Supplier in
writing, whether by mail, facsimile, email or otherwise, which shall, at a
minimum, set forth the product numbers, quantities, delivery dates, and
shipping instructions and shipping addresses for all Drugs ordered. Each
purchase order shall constitute a contract between Company and Supplier for the
sale of the Drugs ordered and shall be subject to and governed by the terms of
this Agreement. The terms and conditions of this Agreement shall so govern and
supersede any additional or contrary terms set forth in Companys purchase
order or any Supplier or Company acceptance, confirmation, invoice or other
document unless duly signed by an officer of Company and an executive officer
of Supplier and expressly stating and identifying which specific additional or
contrary terms shall supersede the terms and conditions of this Agreement. With
respect to all purchase orders submitted at least sixty (60) days in advance of
the earliest scheduled delivery date set forth in such order, Supplier shall
fill such orders in accordance with the scheduled delivery dates set forth
therein, and with respect to all other purchase orders, Supplier shall exercise
commercially reasonable efforts to fill such orders in accordance with the
scheduled delivery dates set forth therein.
3.2. Modification
of Orders. No purchase order shall be modified or canceled except upon the
mutual agreement of the parties; provided, however, that Company may cancel
a purchase order based upon actions of a regulatory authority and Company may make
changes to a purchase order in quantities that do not exceed ten (10) percent
of such outstanding order, provided that Company will reimburse Supplier for
costs incurred on any such cancelled orders to the extent Supplier is not able,
after reasonable effort, to recover its costs in connection therewith. Mutually
agreed change orders shall be subject to all provisions of this Agreement,
whether or not the change order so states. Notwithstanding the foregoing, any
purchase order may be cancelled by Company, without any liability to
7
Company, as to any Drug that is not delivered within sixty (60) days
after the delivery date requested by Company, and any such cancellation shall
not limit or affect any contract remedies available to Company with respect
thereto. Any such cancellation by Company must be by written notice to Supplier
given within sixty-five (65) days after the delivery date requested by Company.
3.3. Delivery
Terms. All deliveries of Drugs shall be F.O.B. Suppliers manufacturing
facility. Supplier shall have no further responsibility for risk of damage to
or loss or delay of Drugs upon delivery by Supplier at the F.O.B. location to
the common carrier specified by Company or, in the event that no carrier shall
have been specified by Company on or before the date fifteen (15) days prior to
the requested shipment date, a common carrier reasonably selected by Supplier. Company
shall be responsible for all shipping, handling, and insurance costs.
3.4. Product
Changes. Supplier shall not, without Companys prior written consent,
materially alter the Specifications for Drugs. Supplier shall not, without
Companys prior written consent, modify the manufacturing processes, methods or
procedures for the Drug in any manner that increases the manufacturing costs. Such
consent will not be unreasonably withheld by Company if specifications,
processes, methods, or procedures must be changed based upon demands by a
regulatory authority or changes in applicable law.
ARTICLE 4.
PRICES
AND PAYMENTS
4.1. Prices.
Unless and until otherwise mutually agreed by the parties in writing, the
purchase price for Drugs manufactured by Supplier for Company under this
Agreement shall be determined under Exhibit A.
4.2. Payment
Terms. Payments made by Company for Drugs purchased hereunder shall be due
and payable in full within thirty (30) days after the date the invoice is
received by Company.
ARTICLE 5.
WARRANTY
AND SERVICE
5.1. Warranty.
(a) Supplier
represents and warrants to Company that all Drugs sold under this Agreement
will have been manufactured, labeled and packaged in accordance with all
applicable laws and regulations, including (as applicable) FDA GMP requirements
and, if applicable, ISO 9001 certifications, or successor requirements, and all
other applicable manufacturing requirements, as well as the Specifications. Supplier
represents, warrants and covenants that it will have, or will contract for, the
facilities, equipment, licenses, permits and personnel to manufacture and
supply the Drugs in accordance with the current forecasted requirements of
Company.
8
(b) Supplier
represents and warrants to Company that Drugs shall, when delivered to Company,
meet the Specifications and warranties set forth herein and shall be free from
defects in materials and workmanship. Company shall invoice Supplier for, and
Supplier shall promptly pay, all shipping, transportation, insurance and other
expenses actually incurred in replacing defective Drugs where either the defect
arises from a breach of any representation or warranty of Supplier herein or
from a matter for which Supplier would be required to indemnify Company
hereunder. Supplier will, at Companys option, replace or credit Companys
account for any Drug that Company reasonably determines, in accordance with Section 5.3,
was defective at the time of shipment to Company or that does not conform to
the express warranties of Supplier herein; provided, however, that Supplier
shall have no obligation under this warranty to make replacements or grant
credits necessitated in whole or in part by accidents; failure to maintain
in accordance with any transportation, storage, handling, or maintenance
instructions supplied by Supplier; damage due to Company Specifications where
Supplier followed such specifications and the damage was due to defects in such
Company Specifications; where Company is specifically liable for such damages
or defect under the terms of Article 7; damage by acts of nature,
vandalism, burglary neglect or misuse; or other fault or negligence of Company
or (except for any strict liability of Supplier) the customer or user
(collectively, Warranty Exclusions).
5.2. Limited
Warranty. THE EXPRESS WARRANTIES SET FORTH ABOVE ARE IN LIEU OF ALL OTHER
WARRANTIES, EXPRESS OR IMPLIED, WHICH ARE HEREBY SPECIFICALLY DISCLAIMED, INCLUDING
WITHOUT LIMITATION THE IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE OR USE.
5.3. Inspection
of Drug. In the event of any shortage, damage or discrepancy in or to a
shipment of Drug or in the event any shipment of Drug fails to comply with the
then current Specifications (excluding Warranty Exclusions) or Supplier
warranties for the Drugs, Company shall report the same to Supplier within
thirty (30) days after its discovery and in no event more than three (3) months
after receipt of the Drug after delivery thereof to Company and, if requested
in writing by Supplier, furnish such written evidence or other documentation
and such samples of the Drug deemed to be nonconforming as Supplier reasonably may deem
appropriate in connection therewith. If Supplier agrees that the shipment of
Drug is nonconforming, or if the Drug is not delivered within the time periods
required, Company may reject the Drugs and return the Drugs to Supplier,
at Suppliers expense (including handling, insurance and shipping charges),
unless the Products defect results from matters that are Companys
responsibility under Article 7 or constitute Warranty Exclusions. Should
the parties disagree as to whether or not a Drug shipment meets Specifications,
a sample of such shipment will be sent for analysis to an independent
laboratory mutually agreeable to the parties. If the independent laboratory
determines that the Drug shipment meets Specifications, Company will accept the
Drug shipment, pay Supplier pursuant to the payment terms herein, and shall pay
the cost of testing by the independent laboratory. If the independent
laboratory determines the Drug shipment to be out of Specification, Supplier
will replace the nonconforming Drug shipment at its cost as soon as practicable
and shall pay the cost of testing by the independent laboratory. Following acceptance of a Drug shipment by
Company, the sole remedies of Company with respect to damage to or defects in
the Drugs shall be those set forth in Sections 5.1 and 7.1.
9
Company shall not be obligated to conduct any tests or inspections of
the Drugs prior to or after its acceptance. Supplier shall promptly notify
Company in writing if it has reason to believe that any delivery of the Drug
fails to meet the Specifications, fails to satisfy the representations and
warranties made under this Article 5, or is otherwise not free from
defects in material and workmanship.
ARTICLE 6.
CERTAIN
REPRESENTATIONS AND WARRANTIES
6.1. Representations
and Warranties.
(a) Supplier
represents and warrants to Company that the execution and delivery by Supplier
of this Agreement and the performance by Supplier of its obligations hereunder
have been duly authorized by all requisite corporate action and will not
violate any provision of law, any order of any court or other agency of
government, the Articles of Incorporation or Bylaws of Supplier, as amended, or
any provision of any indenture, agreement or other instrument to which Supplier
or any of its properties or assets is bound, or conflict with, result in a
breach of or constitute (with due notice or lapse of time or both) a default
under any such indenture, agreement or other instrument, or result in the
creation or imposition of any lien, charge, restriction, claim or encumbrance
of any nature whatsoever upon any of the properties or assets of Supplier. This
Agreement has been duly executed and delivered by Supplier and constitutes the
legal, valid and binding obligation of Supplier, enforceable in accordance with
its terms, subject, as to the enforcement of remedies, to the discretion of the
courts in awarding equitable relief and to applicable bankruptcy,
reorganization, insolvency, moratorium and similar laws affecting the rights of
creditors generally.
(b) Company
represents and warrants to Supplier that the execution and delivery by Company
of this Agreement and the performance by Company of its obligations hereunder
have been duly authorized by all requisite corporate action and will not
violate any provision of law, any order of any court or other agency of
government, the Articles of Incorporation or Bylaws of Company, as amended, or
any provision of any indenture, agreement or other instrument to which Company
or any of its properties or assets is bound, or conflict with, result in a
breach of or constitute (with due notice or lapse of time or both) a default
under any such indenture, agreement or other instrument, or result in the
creation or imposition of any lien, charge, restriction, claim or encumbrance
of any nature whatsoever upon any of the properties or assets of Company. This
Agreement has been duly executed and delivered by Company and constitutes the
legal, valid and binding obligation of Company, enforceable in accordance with
its terms, subject, as to the enforcement of remedies, to the discretion of the
courts in awarding equitable relief and to applicable bankruptcy,
reorganization, insolvency, moratorium and similar laws affecting the rights of
creditors generally.
10
ARTICLE 7.
INDEMNIFICATION
7.1. Suppliers
Liability.
(a) Supplier shall
indemnify, defend and hold harmless Company and its subsidiaries, and their
respective officers, directors, employees, shareholders and distributors from
and against and in respect of any and all demands, claims, actions or causes of
action, assessments, losses, damages, liabilities, interest and penalties,
costs and expenses (including, without limitation, reasonable legal fees and
disbursements incurred in connection therewith and in seeking indemnification
therefor, and any amounts or expenses required to be paid or incurred in
connection with any action, suit, proceeding, claim, appeal, demand, assessment
or judgment) finally awarded (Indemnifiable Losses), resulting from, arising
out of, or imposed upon or incurred by any person to be indemnified hereunder
by reason of: (i) any breach of representation, warranty or
agreement on the part of Supplier under this Agreement (collectively, Supplier
Breach); (ii) Product Liability Damages with respect to the Drugs arising
from or related to a Supplier Breach; (iii) any charges of patent or other
intellectual property infringement due to the manufacture of the Drugs, the sale
of the Drugs for use in the Field (as defined in the License and Development
Agreement) or the formulation of the Drug, except to the extent such
formulation is required specifically for the Company Specifications, and such
infringement would have been avoided by compliance with Supplier Specifications
(which indemnity shall be in addition to, and not in lieu of, Suppliers
indemnity made in the License and Development Agreement), or (iv) other
negligence or intentional misconduct of Supplier; provided that in no event
shall Supplier be liable for matters for which Company is responsible under Section 7.2
below or for punitive or exemplary damages.
(b) During the term
of this Agreement, Supplier shall maintain, at its expense, a policy of
comprehensive general liability insurance sufficient to honor the indemnity
made herein, with products liability endorsement, but in no event less than
Seven Million Five Hundred Thousand U.S. Dollars ($7,500,000) in the aggregate
with a maximum deductible per occurrence of not more than One Million U.S.
Dollars ($1,000,000) per occurrence and in the annual aggregate. Said policy
shall name Company and its Affiliates as additional beneficiaries. Supplier
shall furnish Company with a certificate of insurance evidencing such coverage
within thirty (30) days of the execution of this Agreement, which certificate
shall provide for not less than thirty (30) days notice to Company prior to
material change in coverage or policy cancellation.
7.2. Companys
Liability. Company shall indemnify, defend and hold harmless Supplier and
its subsidiaries and their respective officers, directors, employees,
shareholders and suppliers from and against and in respect of any and all
Indemnifiable Losses resulting from, arising out of, or imposed upon or
incurred by any person to be indemnified hereunder by reason of: (a) any
breach of representation, warranty or agreement on the part of Company
under this Agreement; (b) Product Liability Damages with respect to the
Products other than those arising from or related to a Supplier Breach; (c) any
charges of patent or other intellectual property infringement that does not
relate to a claim described in
11
Section 7.1(a)(iii) and
involves the marketing, distribution and sale of the Product by Company; or (d)
negligent handling by Company of the Drugs or changes, additions or
modifications to the Drugs by Company (other than changes, additions or
modifications made to the Products by Company in connection with or related to
the incorporation of the Drugs into or onto, or the utilization of the Drugs in
connection with, a medical device, such as a balloon, catheter or stent), or (e) other
negligent or intentional misconduct of Company; provided that in no event shall
Company be liable for matters for which Supplier is responsible under Section 7.1
above or under the License and Development Agreement, or for punitive or
exemplary damages.
7.3. Procedure.
If a claim by a third party is made and a party (the Indemnitee) intends to
claim indemnification under this Article 7, the Indemnitee shall
promptly notify the other party (the Indemnitor) in writing of any claim in
respect of which the Indemnitee or any of its subsidiaries, directors,
officers, employees, shareholders, suppliers or distributors intends to claim
such indemnification. If the Indemnitor accepts liability for indemnifying
Indemnitee hereunder, Indemnitor shall have sole control of the defense and/or
settlement thereof; provided that the Indemnitee may participate in any
such proceeding with counsel of its choice at its own expense. The indemnity
agreement in this Article 7 shall not apply to amounts paid in
settlement of any Indemnifiable Losses if such settlement is effected without
the consent of the Indemnitor, which consent shall not be withheld unreasonably.
The failure to deliver written notice to the Indemnitor within a reasonable
time after the commencement of any such action, if adversely prejudicial to its
ability to defend such action, shall relieve such Indemnitor of any liability
to the Indemnitee under this Article 7 but the omission to so
deliver written notice to the Indemnitor shall not relieve the Indemnitor of
any liability that it may otherwise have to any Indemnitee other than
under this Article 7. If the Indemnitor fails to provide defense of
the claim, and diligently defend or settle the same after receipt of notice
from Indemnitee of, and a reasonable opportunity to cure, such failure, the
Indemnitee may defend or settle the claim without prejudice to its rights
to indemnification hereunder, provided that the Indemnitee does so diligently
and in good faith and further does not enter into any settlement or agree to
any stipulation that would adversely affect the rights of the Indemnitor or
impose any additional obligation on the Indemnitor without the Indemnitors
prior written consent (which consent will not be unreasonably withheld). The
Indemnitee under this Article 7, its employees and agents, shall
cooperate fully with the Indemnitor and its legal representatives and provide
full information in the investigation of any Indemnifiable Losses covered by
this indemnification.
ARTICLE 8.
TERM
AND TERMINATION
8.1. Term.
This Agreement shall take effect as of the date hereof and shall continue in
force until the earlier of (a) the date on which this Agreement is
terminated pursuant to Section 8.2, or (b) the date of termination of
the License and Development Agreement (the Term). Nothing contained in this
Agreement will be interpreted as
12
requiring either party to renew or extend this Agreement beyond the
initial term or any renewal term hereof.
8.2. Termination.
Notwithstanding the provisions of Section 8.1 above, this Agreement
may be terminated in accordance with the following provisions:
(a) A party may terminate
this Agreement by giving notice in writing to the other party if the other
party is in material breach of any representation, warranty or covenant of this
Agreement and, except as otherwise provided herein, shall have failed to cure
such breach within thirty (30) days after receipt of written notice thereof
from the first party;
(b) Either party may terminate
this Agreement at any time by giving notice in writing to the other party,
which notice shall be effective upon dispatch, if the other party (i) becomes
insolvent; (ii) commences any action or proceeding under any bankruptcy or
insolvency law for the reorganization, arrangement, composition or similar relief,
(iii) has commenced against it any action or proceeding under any
bankruptcy or insolvency law, or (iv) makes an assignment for the benefit
of creditors, goes into liquidation or receivership or otherwise loses legal
control of its business; or
(c) Company may terminate
this Agreement upon sixty (60) days prior written notice to Supplier if
Supplier has been in material breach of any of the representations, warranties
or covenants contained herein on three or more occasions within any three
hundred sixty (360) day period. In order to exercise such termination right,
Company must provide Supplier with written notice of such termination within
sixty (60) days after the end of any applicable three hundred sixty (360) day
period.
(d) Company may terminate
this Agreement upon sixty (60) days prior written notice to Supplier if
Supplier is unable to produce sufficient quantities of Drug to fulfill Companys
purchase orders on a timely basis.
(e) Supplier shall
have the right to terminate this Agreement upon sixty (60) days prior written
notice if, following an assignment of Companys rights under the License and
Development Agreement pursuant to Section 10.13(b)(iv) or (v) thereof,
the permitted assignee terminates its development efforts under the License and
Development Agreement or it fails to meet the Performance Standards contained
in Exhibit C of the License and Development Agreement.
8.3. Rights
and Obligations on Termination. In the event of termination of this
Agreement for any reason, the parties shall have the following rights and
obligations:
(a) Termination of
this Agreement shall not release either party from the obligation to make
payment of all amounts previously due and payable.
(b) The terminating
party shall have the right, at its option, to cancel any or all purchase orders
that provide for delivery after the effective date of termination.
(c) Nothing herein
shall be construed to release either party from any obligation that matured
prior to the effective date of such termination.
13
(d) The parties will
return and deliver to the other party all of such partys materials and
documents developed during the performance of this Agreement provided that a
party may retain one copy of such materials and documents for legal
purposes.
(e) The parties
obligations pursuant to Articles 5, 6, 7 and 8 and Sections
2.5, 2.6 and 2.7 hereof and any and all other terms and
provisions hereof intended to be observed and performed by the parties after
the termination hereof, shall survive termination of this Agreement. All other
provisions of this Agreement shall terminate upon termination of this
Agreement.
ARTICLE 9.
FORCE
MAJEURE
9.1. Notice
of Force Majeure. Upon giving notice to the other party, a party affected
by an event of Force Majeure shall be released without any liability on its part from
the performance of its obligations under this Agreement, except for the
obligation to pay any amounts due and owing hereunder, but only to the extent
and only for the period that its performance of such obligations is prevented
by the event of Force Majeure.
9.2. Suspension
of Performance. During the period that the performance by one of the
parties of its obligations under this Agreement has been suspended by reason of
an event of Force Majeure, the other party may likewise suspend the
performance of all or part of its obligations hereunder (except for the
obligation to pay any amounts due and owing hereunder) to the extent that such
suspension is commercially reasonable.
ARTICLE 10.
MISCELLANEOUS
10.1. Nondisclosure.
The parties agree not to disclose or use (except as permitted or required for
performance by the party receiving such Confidential Information of its rights
or duties hereunder or under other agreement between the parties or their
Affiliates) any Confidential Information of the other party obtained during the
term of this Agreement until the expiration of any and all Patents. Each party
further agrees to take appropriate measures to prevent any such prohibited
disclosure of Confidential Information by its present and future employees,
officers, agents, subsidiaries, or consultants during such period.
10.2. Successors
and Assigns. This Agreement shall be binding upon and inure to the benefit
of the parties hereto and the successors or assigns of the parties hereto;
provided, that (a) the rights and obligations of Supplier herein may not
be assigned except to any person who succeeds to substantially all of the
assets and business of Supplier to which this Agreement relates, and (b) the
rights and obligations of Company herein may not be assigned except that
Company may assign any or all of its rights, interests and obligations
hereunder without Suppliers consent (i) to Companys direct or indirect
parent, (ii) to any
14
subsidiary of
Company at least 50% of the voting power of which is owned, directly or
indirectly, by Company or its Affiliates, (iii) to a wholly-owned, direct
or indirect subsidiary of Company, (iv) to an entity that acquires the
entire equity interest or substantially all of the assets of Company or Companys
parent, or (v) to any person who acquires the product line to which this
Agreement pertains; provided that any assignee under this clause (b) shall
expressly agree to be bound by all of the provisions of this Agreement,
including Section 4.3, and (c) the Company may collaterally
assign its rights under this Agreement to parties providing financing in
connection with the transactions contemplated hereby. The Supplier may enter
into agreements with third parties to provide for performance by third parties
of any or all of its obligations to manufacture and supply the Drugs; provided
that such agreement is consistent with this Agreement in all material respects.
Notwithstanding the provisions of any such agreement, the Supplier shall remain
obligated and liable to Company for the performance of its obligations and
duties hereunder.
10.3. Complete
Agreement. This Agreement and the License and Development Agreement, and
the Schedules and Exhibits hereto and thereto, constitute the entire agreement
between the parties hereto with respect to the subject matter hereof and
supersede all prior agreements whether written or oral relating hereto.
10.4. Governing
Law. The formation, legality, validity, enforceability and interpretation
of this Agreement shall be governed by the laws of the State of Oregon, without
giving effect to the principles of conflict of laws.
10.5. Waiver,
Discharge, Amendment, Etc. The failure of any party hereto to enforce at
any time any of the provisions of this Agreement shall not, absent an express
written waiver signed by the party making such waiver specifying the provision
being waived, be construed to be a waiver of any such provision, nor in any way
to affect the validity of this Agreement or any part thereof or the right
of the party thereafter to enforce each and every such provision. No waiver of
any breach of this Agreement shall be held to be a waiver of any other or
subsequent breach. Any amendment to this Agreement shall be in writing and
signed by the parties hereto.
10.6. Notices.
All notices or other communications to a party required or permitted hereunder
shall be in writing and shall be delivered personally or by facsimile (receipt
confirmed electronically) to such party (or, in the case of an entity, to an
executive officer of such party) or shall be sent by a reputable express
delivery service or by certified mail, postage prepaid with return receipt
requested, addressed as follows:
If to Company, to:
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Cook Group Incorporated
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750 Daniels Way
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Bloomington, Indiana
47204
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Attn: Pete Yonkman
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Facsimile:
(812)-339-5369
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with a copy to:
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Ice Miller LLP
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One American Square, Suite 3100
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Indianapolis, Indiana
46282
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Attn: Stephen J.
Hackman
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Facsimile: (317)
592-4666
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If to Supplier, to:
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AVI BioPharma, Inc.
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One SW Columbia, Suite 1105
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Portland OR 97258
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Attn: Alan Timmins
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Facsimile: (503)
227-0554
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with a copy to:
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Davis Wright Tremaine
LLP
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1300 SW Fifth Avenue, Suite 2300
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Portland OR 97201-5682
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Attn: Michael Phillips
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Facsimile: (503)
778-5299
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Any party may change the abovespecified recipient and/or mailing
address by notice to all other parties given in the manner herein prescribed. All
notices shall be deemed given on the day when actually delivered as provided
above (if delivered personally or by facsimile) or on the day shown on the
return receipt (if delivered by mail or delivery service).
10.7. Expenses.
Except as expressly provided herein, Supplier and Company shall each pay their
own expenses incident to this Agreement and the preparation for, and
consummation of, the transactions provided for herein.
10.8. Titles
and Headings; Construction. The titles and headings to the Articles and
Sections herein are inserted for the convenience of reference only and are not
intended to be a part of or to affect the meaning or interpretation of
this Agreement. This Agreement shall be construed without regard to any
presumption or other rule requiring construction hereof against the party
causing this Agreement to be drafted.
10.9. Severability.
If any provision of this Agreement is held invalid, illegal or unenforceable,
such provision shall be enforced to the maximum extent permissible and the
remaining provisions shall nonetheless be enforceable according to their terms.
10.10. Relationship.
This Agreement does not make either party the employee, agent or legal
representative of the other for any purpose whatsoever. Neither party is
granted any right or authority to assume or to create any obligation or
responsibility, express or implied, on behalf of or in the name of the other
party. In fulfilling its obligations pursuant to this Agreement, each party
shall be acting as an independent contractor.
10.11. Benefit.
Nothing in this Agreement, expressed or implied, is intended to confer on any
person other than the parties hereto or their respective successors or assigns,
any rights, remedies, obligations or liabilities under or by reason of this
Agreement.
16
10.12. Survival.
All of the representations, warranties, and covenants made in this Agreement,
and all terms and provisions hereof intended to be observed and performed by
the parties after the termination hereof, shall survive such termination and
continue thereafter in full force and effect, subject to applicable statutes of
limitations.
10.13. Counterparts.
This Agreement may be executed in any number of counterparts, each of
which shall be deemed as original and all of which together shall constitute
one instrument.
10.14. Execution
of Further Documents. Each party agrees to execute and deliver without
further consideration any further applications, licenses, assignments or other
documents, and to perform such other lawful acts as the other party may reasonably
require to fully secure and/or evidence the rights or interests herein.
10.15. Public
Announcement. In the event any party proposes to issue any press release or
public announcement concerning any provisions of this Agreement or the
transactions contemplated hereby, such party shall so advise the other parties
hereto, and the parties shall thereafter use their best efforts to cause a
mutually agreeable release or announcement to be issued. Neither party will
publicly disclose or divulge any provisions of this Agreement nor the
transactions contemplated hereby without the other partys written consent,
except as may be required by applicable law or stock exchange regulation,
and except for communications to such partys employees or customers or
investors or prospective investors (subject to appropriate confidentiality
obligations); provided that, prior to disclosure of any provision of this
Agreement that either party considers particularly sensitive or confidential to
any governmental agency or stock exchange, the parties shall cooperate to seek
confidential treatment or other applicable limitations on the public
availability of such information. In particular, prior to such disclosure, each
party shall use its best efforts to redact the payment terms specified herein
and each party shall provide the other the opportunity to redact other
information and seek confidential treatment of any such disclosure.
[SIGNATURE PAGE FOLLOWS]
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IN WITNESS WHEREOF, each of the parties has caused
this Supply Agreement to be executed in the manner appropriate to each, as of
the date first above written.
COOK GROUP INCORPORATED
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AVI BIOPHARMA, INC.
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By:
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By:
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Printed:
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Printed:
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Title:
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Title:
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18
EXHIBIT A
Pricing
For the first three grams of the Drug purchased by
Company hereunder, the price shall be: ***
per mg.
For all subsequent purchases of the Drug hereunder,
the price shall be: *** per mg.
As a reference point:
It is anticipated that the weight of
drug on a stent platform will be approximately *** mg;
For the AVAIL clinical trial, the
weight of drug used for catheter delivery was *** mg;
For AVIs ongoing APRAISAL trial in
Germany for systemic delivery, the weight of drug used in the microbubble
formulation is *** mg.
19
Exhibit 10.51
NOTE: Portions of this document marked *** have
been omitted and filed separately with the Securities and Exchange Commission
pursuant to a request for confidential treatment of the omitted and separately
filed portions.
LICENSE
AND DEVELOPMENT AGREEMENT
THIS LICENSE AND DEVELOPMENT AGREEMENT (this Agreement) is made and
entered into as of March 10, 2006 between AVI BIOPHARMA, INC. (AVI),
an Oregon corporation, and COOK GROUP INCORPORATED (Company), an Indiana
corporation.
RECITALS
WHEREAS, AVI has developed technology relating to antisense compounds
which may have applications in the treatment of coronary artery and
peripheral vascular disease;
WHEREAS, Company makes and sells medical devices relating to the
treatment of vascular disease;
WHEREAS, AVI desires to grant, and Company desires to obtain, the
rights set forth herein;
WHEREAS, AVI and Company are entering into a Supply Agreement (the Supply
Agreement) and an Investment Agreement (the Investment Agreement) both of even
date herewith regarding AVIs supplying Companys requirements for the Drug (as
defined below); and
WHEREAS, the parties desire that Company attempt to develop products
using the Technology (as defined below) for the treatment of coronary artery
and peripheral vascular disease through certain systemic and non-systemic
applications.
AGREEMENT
NOW, THEREFORE, in consideration of the respective representations,
warranties, covenants and agreements contained herein, and for other valuable
consideration, the receipt and adequacy of which is hereby acknowledged, the
parties hereto agree as follows:
ARTICLE 1.
DEFINITIONS
1.1. Specific
Definitions. As used in this
Agreement, the following terms shall have the meanings set forth or as
referenced below:
Actual Cost means the cost of
activities performed by AVI personnel pursuant to this Agreement, including
direct labor and materials and allocated overhead costs.
Affiliate of a specified person (natural or juridical) means a
person that directly, or indirectly through one or more intermediaries,
controls, or is controlled by, or is under common control with, the person
specified. Control shall mean ownership of more than 50% of the shares of
stock entitled to vote for the election of directors in the case of a
corporation, and more than 50% of the voting power in the case of a business
entity other than a corporation.
Agreement means this Agreement and
all Exhibits and Schedules hereto.
AVI has the meaning set forth in the
recitals hereto.
Company has the meaning set forth in
the recitals hereto.
Drug means any phosphorodiamidate
morpholino oligomers, with or without attachments to enhance efficacy, that
inhibit translation of the human protein, c-myc. Included in this definition
are the compounds known as AVI-4126 and AVI-5126.
Expiration or Expired
means, with respect to a particular patent, the patents expiration,
abandonment, cancellation, disclaimer, award to another party other than AVI in
an interference proceeding, or declaration of invalidity or unenforceability by
a court or other authority of competent jurisdiction (including final rejection
in a re-examination or re-issue proceeding).
FDA means the U.S. Food and Drug
Administration.
Field means the treatment of coronary
artery and peripheral vascular diseases and conditions by administration of a
drug or drug-containing device that inhibits the production or function of the
human protein, c-myc. Specifically excluded from the Field are treatment of
coronary artery bypass grafts, congestive heart failure, and malignancies.
Intellectual Property means U.S. and
foreign patents and patent applications, trademarks, service marks and
registrations thereof and applications therefor, copyrights and copyright
registrations and applications, mask works and registrations thereof, know-how,
trade secrets, inventions, discoveries, ideas, technology, data, information,
processes, drawings, designs, licenses, computer programs and software, and
technical information including but not limited to information embodied in
material specifications, processing instructions, equipment specifications,
product specifications, confidential data, electronic files, research
notebooks, invention disclosures, research and development reports and the like
related thereto, and all amendments, modifications, and improvements to any of
the foregoing.
Invention means any invention,
discovery, know-how, trade secret, data, information, technology, process or
concept, whether or not patented or patentable, and whether or not memorialized
in writing.
Investment Agreement means the
Investment Agreement of even date herewith by
2
and between AVI and Company.
Joint Inventions is defined in Section 6.3.
Know-How means all know-how, trade
secrets, expertise, Inventions, discoveries and technical information other
than Patents (as defined below) now or hereafter owned by, licensed to,
possessed by, or under the control of, AVI which are necessary, appropriate or
useful for designing, developing, processing, manufacturing, using, selling or
delivering the Drug within the Field, including but not limited to information
embodied in drawings, designs, copyrights, copyright registrations and applications,
trademarks, service marks and registrations thereof and applications therefor,
material specifications, processing instructions, formulas, equipment
specifications, product specifications, confidential data, computer software,
electronic files, research notebooks, invention disclosures, research and
development reports and the like related thereto, and all amendments,
modifications, upgrades and improvements to any of the foregoing, occurring
before or during the term of this Agreement.
Liens means liens, mortgages,
charges, security interests, claims, voting trusts, pledges, encumbrances,
options, assessments, restrictions, licenses, sublicenses, or third party or
spousal interests of any nature.
Milestone Event has the meaning set
forth in Section 3.2.
Milestone Payment has the meaning
set forth in Section 3.2.
Net Sales of Products with respect
to a particular period means the gross amount billed with respect to Products
sold by Company, its Affiliates and sublicensees, less (to the extent included
in the gross amount and to the extent not for promotional purposes):
(a) cash
discounts actually given;
(b) credits
or allowances actually given or made on account of price adjustments, rebates
(including Medicaid or other government programs, chargebacks, and contractual
agreements), or volume reimbursements;
(c) separately
stated (on customer invoice) taxes on sales (such as sales and use taxes); and
(d) separately
stated (on customer invoice) delivery charges actually paid to third party carriers
(including transportation and insurance costs); all as determined in accordance
with generally accepted accounting principles; provided, however, that bona
fide sample units and clinical trial units of Products will not be included in
any calculation of Net Sales.
NIH
License means the exclusive license granted by the NIH Public Health
Service to Lynx Therapeutics, Inc. on September 17, 1996 and assigned
to AVI on May 18, 2001 to patents covering Inhibition of Cell
Proliferation Using Antisense Oligonucleotides.
Patents
means (a) the patents and patent applications, together with any patents
that
3
may issue based thereon, set forth on Exhibit A; (b) any
other patents or patent applications now or hereafter owned by or licensed to
AVI that are necessary, appropriate or useful for designing, developing,
processing, manufacturing, using, selling or delivering the Drug within the
Field; including but not limited to, any patents or patent applications
covering any sole or joint Inventions of AVI made or conceived during the Term
of this Agreement and any improvements thereof; (c) all continuation,
divisional, re-issue, re-examination and substitution applications that may be
filed, before or during the term of this Agreement, by or for the benefit of
AVI based on the foregoing referenced patents or patent application, together
with any patents that may issue based thereon; and (d) all foreign
applications that may be filed, before or during the term of this
Agreement, by or for the benefit of AVI based on the foregoing referenced
patents and patent applications, together with all patents which may issue
based thereon.
Performance
Standards has the meaning set forth in Section 10.13.
Product
means the Drug and any product or device sold by Company or its Affiliate that
incorporates or includes the Drug. No more than one (1) payment calculated
in accordance with Section 3.1 shall be paid on any single product
covered by the Patents even though such product, including its manufacture,
sale or use may be covered by Valid Claims of more than one patent
included in the Patents.
Resten-MP
means the product candidate currently in Phase II clinical development by AVI
for prevention of coronary artery restenosis which consists of AVI-4126
formulated in a microbubble formulation for systemic administration to
patients.
Summerton
Agreement means the Technology Transfer Agreement between AVI and Dr. James
Summerton (on behalf of Anti-Gene Development Group, an Oregon limited
partnership) dated February 9, 1992, as amended.
Supply
Agreement means the Supply Agreement of even date herewith by and between
AVI and Company.
Technology
means the Patents and the Know-How.
Term
has the meaning set forth in Section 9.1.
Unexpired
shall mean a patent that has not Expired.
Valid
Claim means a claim in an Unexpired patent included with the Patents which
has not been held unenforceable, unpatentable or invalid by a decision of a
court or other governmental agency of competent jurisdiction, unappealable or
unappealed within the time allowed for appeal and which has not been admitted to
be invalid or unenforceable through reissue or disclaimer.
UNeMed
License means the license obtained by AVI from UNeMed Corporation pursuant
to an agreement dated June 1, 1998 to microbubble technology for use in
the delivery of therapeutic compounds.
4
1.2. Definitional
Provisions.
(a) The
words hereof, herein, and hereunder and words of similar import, when
used in this Agreement, shall refer to this Agreement as a whole and not to any
particular provisions of this Agreement.
(b) Terms
defined in the singular shall have a comparable meaning when used in the
plural, and vice-versa.
(c) References
to an Exhibit or to a Schedule are, unless otherwise specified, to one of
the Exhibits or Schedules attached to or referenced in this Agreement, and
references to an Article or a Section are, unless otherwise specified, to
one of the Articles or Sections of this Agreement.
(d) The
term person includes any individual, partnership, joint venture, corporation,
trust, unincorporated organization or government or any department or agency
thereof.
(e) The
terms including and includes and words of similar import mean including,
but not limited to.
ARTICLE 2.
LICENSE TO COMPANY
2.1. Grant
of License. In consideration for the
payments set forth in the Investment Agreement and this Agreement and subject
to the terms and conditions of this Agreement, AVI hereby grants to Company a
worldwide, sublicensable, exclusive license to the Technology to use, import,
export, sell, and offer to sell the Drug in the Field and to make, have made,
use, import, sell and offer to sell Products incorporating or utilizing the
Drug and/or the Technology in the Field, practice methods covered thereby, and
otherwise to commercialize and exploit, the Drug and/or the Technology in the
Field. For clarity, AVI grants the foregoing exclusive license to the fullest
extent of AVIs rights in the Technology within the Field, retaining only
rights in the Technology outside the Field.
2.2. Technology
Transfer. AVI shall, upon Companys
reasonable request from time to time, provide to Company at AVIs Actual Cost
available drawings, specifications, processes, materials, and any manufacturing
procedures and such other documentation and Know-How as is reasonably necessary
or useful to enable Company to fully utilize the license granted to Company
under this Agreement. In addition, AVI will make available personnel as
requested by Company, to provide such individual training to Company technical
and manufacturing personnel as is necessary to enable Company to fully utilize
the license granted to Company under this Agreement, at such reasonable times
and places as Company may request from time to time, including, without
limitation, to complete any development of the Technology in the Field, and to
assist in the transfer of any manufacturing and regulatory submissions
(including raw and compiled clinical data), certificates or other documents or
approvals.
5
ARTICLE 3.
FEES, ROYALTIES AND REPORTS
3.1. Royalty
Payments.
(a) Subject
to the terms of this Agreement, Company shall pay to AVI a royalty equal to ***
of (i) Net Sales of Products by Company, Affiliates, and sublicensees; and
(ii) any other payments or consideration paid to Company by sublicensees
who are not Affiliates of the Company in consideration of the grant of such
sublicense, including but not limited to upfront payments, stock payments, and
milestone payments.
3.2. Milestone
Payment. Company shall pay AVI a
one-time milestone payment of *** (the Milestone Payment) within
thirty (30) days after the date upon which Companys cumulative Net Sales of
Products reaches *** (the Milestone Event).
3.3. Third
Party Patent Rights. Notwithstanding
any other provision of this Agreement to the contrary, Company shall not be
liable for any royalties, payments or other amount due or to become due to
third parties under any license or other agreement with respect to the Drug or
the Technology that is in effect as of the date of this Agreement (including
any such royalties, payments or other amounts payable under the NIH License,
the Summerton Agreement or the UNeMed License), all of which royalties,
payments and other amounts shall be borne by AVI. After the date hereof, if the
parties agree that AVI needs to obtain rights to a third party patent that it
does not have rights to on the date hereof to commercialize the Drug within the
Field, then the parties shall agree on the allocation between the parties of
the cost of obtaining such rights (including any royalties that may be
payable).
3.4. Reports
and Payments. Within thirty (30)
days after the end of each calendar quarter, Company shall provide AVI with a
written report indicating the amount of Net Sales of Products during such
preceding period and the amount of the royalties due for such period. Simultaneous
with making such report, Company shall pay to AVI the amount of royalties then
due. With respect to sales of Products outside the United States on which any
earned royalties are payable hereunder, conversions to U.S. dollars, shall be
made by based on interbank (official) rates as reported on www.oanda.com as of
the first Business Day of the month in which the payment is to be made. Notwithstanding
anything to the contrary contained in this Agreement, Company shall be entitled
to withhold, from earned royalties payable hereunder, all taxes thereon
required, by competent governmental authorities, to be withheld.
3.5. Records. Company agrees to keep accurate written
records sufficient in detail to enable the royalties payable under this
Agreement by Company to be determined and verified for a period of one (1) year after the delivery of any royalty report.
3.6. Audit
of Records. Upon reasonable notice
and during regular business hours, Company shall from time to time, but no more
frequently than once annually, make available the records referred to in Section 3.5
for audit at AVIs expense by independent representatives selected by AVI and
reasonably acceptable to Company to verify the accuracy of the reports provided
to AVI. Such representatives shall execute a suitable confidentiality agreement
6
reasonably
acceptable to Company prior to conducting such audit. Such representatives may disclose
to AVI only their conclusions regarding the accuracy of royalty payments and of
records related thereto, and shall not disclose Companys information to AVI
without the prior written consent of Company. No claim may be asserted by
AVI against Company for any errors unless made within thirty (30) days following completion of
such examination or audit made pursuant to this Section 3.6. The
right to audit shall extend through one (1) year following the delivery of
the last royalty report of a calendar year and thereafter any royalty report
shall be deemed complete and accurate. Each royalty report shall be subject to
only one such examination and audit. The party benefiting from any discrepancy
will promptly pay the amount of such discrepancy to the other.
ARTICLE 4.
DEVELOPMENT PROJECT
4.1. Development
Efforts.
(a) During
the Term of this Agreement, Company will control any regulatory and clinical
programs for the Drug in the Field as Company deems appropriate (including the
clinical trials set forth in the Article 4) and obtain in Companys
name any necessary device or medical regulatory approvals from the FDA, and any
applicable regulatory agencies of such other countries as Company deems
appropriate, prerequisite to the commercial sale of products for their intended
uses. AVI will supply Company with all available documents, instruments,
information and reports reasonably necessary or convenient as requested by
Company in connection with such regulatory approval efforts and in connection
with pre-clinical efforts. During the Term of this Agreement, AVI will assist
and cooperate with the development of the Drug in the Field, including, without
limitation, supplying the Drug to Company and advising and participating in
product scientific research and development proceedings and all governmental
actions, including filings, proceedings and meetings, as requested by Company.
AVI will also assist and cooperate with Company in Companys development of
coating technology and processes necessary or convenient for the use of the
Drug in the Field. In connection with the foregoing and at Companys reasonable
request, AVI shall make available senior AVI personnel responsible for and
knowledgeable about the Drug and the Technology. AVI grants to Company the
right of reference to AVIs regulatory files with the FDA or other appropriate
government agencies as necessary or helpful for support of Companys regulatory
submissions with respect to the Drug in the Field. All regulatory approvals
funded by Company and all related studies, documents, instruments, information
and reports, will be in Company name and owned by Company. Company grants to
AVI the right of reference to Companys regulatory files relating to the Drug
with the FDA or other appropriate governmental agencies as necessary for
support of AVIs current or future regulatory submissions outside the Field;
provided that AVI shall not be entitled to utilize such right in connection
with any commercialization efforts involving a medical device company for use
in the Field. AVI shall provide prior written notice to Company of any exercise
of such right of reference specifying the time of such exercise, the type of
filing, the regulatory files to be referenced and such other circumstances as may be
appropriate for Company to determine AVIs compliance with the exercise of such
right. AVIs sole remedy for any breach of Companys obligations under this Section 4.1
shall be as set forth in Section 9.2.
7
(b) Payments
to AVI for Development Support. Except
for the supply of clinical and commercial supplies of Drug, the terms of which
are included in the Supply Agreement, Company will reimburse AVIs Actual Costs
in providing all services and support provided by AVI pursuant to this
Agreement. Within thirty (30) days of the end of each calendar quarter, AVI
will send Company an invoice specifying the Actual Cost of services and support
provided in the just-ended quarter and the payment due. Within thirty (30) days
of receiving each such invoice, Company will make a payment to AVI for the full
amount due.
(c) AVI
shall supply to Company on payment terms specified in the Supply Agreement such
quantities of the Drug as are reasonably required by Company in connection with
pre-clinical and clinical trials and in connection with obtaining regulatory
approvals. AVI represents and warrants to Company that all Drugs supplied to
Company hereunder will have been manufactured, labeled and packaged in
accordance with all applicable laws and regulations, including (as applicable)
FDA GMP requirements and all other manufacturing requirements that are
applicable for the intended uses of Drug that have been communicated to AVI by
Company.
4.2. Non-Compete.
AVI shall not directly or indirectly
market or sell, or directly or indirectly encourage or solicit the submission
of, or entertain inquiries, proposals or offers from any person or entity
(other than Company or its Affiliates), or otherwise provide information to or
engage in discussions with any other person or entity, in any way relating to
the sale, licensing, distribution or other disposition of any compound for use
or application in the Field or any Intellectual Property relating to the
compound for use or application in the Field.
4.3. Resten-MP.
Company agrees to complete the
multicenter Phase II clinical trial of Resten-MP currently underway in Germany
to assess the safety and efficacy of Resten-MP in preventing coronary artery
restenosis (German Study). Company may elect to have AVI complete the
German Study and in such case will pay AVIs Actual Costs incurred in doing so.
Completion of the German Study is defined as completing 6-month follow-up
assessments, per the study protocol, of at least thirty-five (35) evaluable
patients. Within sixty (60) days of obtaining the final data from the German
Study, Company will inform AVI of its decision whether or not to continue
product development of Resten-MP. In the event that Company decides to continue
development, it will share with AVI its plans for development of the final
commercial formulation of drug and its Phase III clinical strategy for
Resten-MP. If Company decides not to continue development of Resten-MP or a
similar microparticle delivery Product (for example based on AVI-5126)
following completion of the German study, AVI may on thirty (30) days
written notice reacquire all rights specific to microparticle delivery
Products. AVI may also reacquire all rights specific to microparticle delivery
Products, on thirty (30) days written notice if at any time in the further
development program for Resten MP or a similar microparticle delivery
Product: a) Company informs AVI that it has decided to discontinue development
of Resten-MP or a similar microparticle delivery Product; or b) six (6) months
elapse during which no development work on Resten-MP or a similar microparticle delivery
Product is ongoing by Company, in which case the development program will be
deemed to be discontinued. In any such case, upon written notice by AVI to
Company, the definition of Field will be amended to exclude all rights specific
to microparticle delivery of Drugs.
4.4. Product
Development Committee. Company
agrees to use commercially reasonable efforts to commercialize the Technology
in the Field. AVI and Company
8
acknowledge
that the development process for new technologies is uncertain and that
unforeseen issues may arise. In order to ensure that Company is pursuing
the Technology and to accommodate the uncertainty of product development, the
parties agree to the following:
(a) Company
and AVI shall each appoint a representative to a Product Development Committee.
The Product Development Committee will be primarily responsible for monitoring
Companys efforts to develop and commercialize the Technology in the Field and
for monitoring and promoting cooperation in those efforts between and among the
parties and their representatives. The Product Development Committee shall meet
no less frequently than every other month during the Term at times and places
to be determined by agreement of the members thereof.
(b) If
either member of the Product Development Committee is dissatisfied with the
nature or extent of the progress being made with respect to the
commercialization of the Technology, that member may request a meeting of
one or more members of senior management of each party to discuss and attempt
to resolve the issue. The first such meeting of the parties representatives
shall take place within thirty (30) days of the request. Each party shall cause
its representatives to negotiate in good faith to attempt to reach a mutually
acceptable resolution of any issue referred to its senior management.
ARTICLE 5.
AVIS OBLIGATIONS
5.1. Maintain
Licenses in Force. AVI shall comply
with all of the provisions of, and shall maintain in full force and effect
(including the timely payment of all royalties, payments and other amounts due
thereunder), all license agreements with third parties, including,
specifically, the NIH License and UNeMed License, pursuant to which AVI is
licensee of Intellectual Property included in the Technology. AVI shall
promptly notify Company if any such third party alleges any breach, default, or
event that, with the passage of time or giving of notice could become a
default, by AVI of any such license agreement. Company shall be entitled, but
not obligated, to cure any alleged breach or default by AVI of such license
agreement and set-off the cost of such cure against amounts otherwise owed to
AVI hereunder.
5.2. Company
Exclusivity. AVI will not, without
the prior written consent of Company, supply, sell, transfer or otherwise
dispose of the Drug or any products or components utilizing the Drug or the
Technology or any Joint Invention to any third party if AVI should have known
after making reasonable inquiry or has actual knowledge (including the actual
knowledge of any of AVIs executive officers) that such third party intends or
is likely to use, sell, supply, transfer or otherwise dispose of the Drug or
any such products, components, Technology or any Joint Inventions in the Field.
Prior to any sale, supply, transfer or other disposition to any third party of the
Drug or any products or components utilizing the Drug or any such products,
components, Technology or any Joint Invention, AVI shall obtain the agreement
of such third party that it will not use, sell, supply, transfer or otherwise
dispose of the Drug or any such products, components, Technology or any Joint
Inventions in the Field. AVI shall obtain the agreement of such third party
that Company will be an express third party beneficiary of such agreement. The
restrictions set forth in this Section 5.2 shall not apply to
transfers of the Drug to
9
consultants or
agents of AVI who are performing research or consulting services on behalf of
AVI in connection with such transfer.
5.3. No
Amendments With Adverse Effects to Company. AVI agrees not to modify, waive or amend any
provision of any agreement in effect as of the date hereof that would adversely
affect Companys obligations under Article 3 without the prior
written consent of Company, including any modification, waiver or amendment to
any agreement in effect as of the date hereof that could have the effect of
increasing the amount payable to the licensor.
ARTICLE 6.
INTELLECTUAL PROPERTY
6.1. Protect
Know-How. AVI and Company agree to
maintain the confidentiality of all Confidential Information (as such term is
defined in the Investment Agreement), including but not limited to the status
of any patent applications included in the Patents, to the extent such patent
applications relate solely to the Field. Each party agrees not to disclose or
use (except as permitted or required for performance by the party receiving
such Confidential Information of its rights or duties hereunder) any
Confidential Information of the other party obtained during the term of this
Agreement. Each party further agrees to take appropriate measures to prevent
any such prohibited disclosure by its present and future employees, officers,
agents, subsidiaries, or consultants during the term of this Agreement and
shall be liable for any breach of this Article 6 by and such
person.
6.2. Protection
of Technology. During the term of
this Agreement, each party shall promptly inform the other of any
Invention, improvement, amendment, upgrading or modification relating to the
Drug or the Technology which may be applicable or useful in the Field. AVI
agrees to protect the Technology by obtaining and maintaining appropriate
patent rights as recommended by reputable patent counsel; provided, however,
that Company shall have the right to review and approve any filings or other
correspondence with the appropriate patenting authority relating to the
Technology or the Drug in the Field. Company shall not unreasonably withhold
such approval. If Company determines, in its sole discretion, that any
Technology conceived, reduced to practice or otherwise made, developed or
acquired by one or more employees or agents of AVI is not being adequately
protected by patents, Company may so inform AVI. If Company decides
that AVIs response has been inadequate, Company may take whatever action
it deems necessary at its expense to protect such Technology. All patents and
copyright registrations shall be applied for in the names of the actual
inventors or authors and shall be assigned to AVI, subject to Companys rights
and license therein; each party shall execute and deliver such forms of
assignment, power of attorney and other documents which are necessary to give
effect to the provisions hereof.
6.3. Ownership
of Intellectual Property. Subject to
the rights and licenses granted to Company by this Agreement, (a) any
Intellectual Property conceived, reduced to practice or otherwise made,
developed or acquired by one or more employees or agents of AVI shall be the
property of AVI, (b) any Intellectual Property conceived, reduced to
practice or otherwise made, developed or acquired by one or more employees or
agents of Company shall be the property of
10
Company, and (c) AVI
and Company shall each have an undivided one-half interest in any Intellectual
Property jointly conceived, reduced to practice or otherwise made, developed or
acquired by one or more employees or agents of AVI and one or more employees or
agents of Company (Joint Inventions). For purposes of this Section 6.3,
Intellectual Property which is the subject of a patent application shall be
deemed to have been developed jointly by employees or agents of Company and
AVI, and thus be a Joint Invention, if at least one employee or agent of each
of Company and AVI is required to be named as an inventor in such application
in order for such patent to be valid.
6.4. Prosecution
of Patents on Joint Inventions. If
either AVI or Company proposes to file an application for any U.S or foreign
patents, copyright registration, or any continuation or modification thereof,
with respect to any Joint Invention, then such party proposing such
registration (the first party) shall notify the other party (the second
party) in writing and the second party shall have option of joining in such
action. If the second party elects to join in such action, the second party
shall pay one-half of the total expenses incurred by Company and AVI therein
and be entitled to participate in all material steps in such action. If the second
party elects not to join in such action, the first party shall be entitled to
control such action, but such failure to participate shall not affect the
second partys ownership interest in the Joint Inventions or in any
Intellectual Property rights therein. Whether or not the second party elects to
join in such action, the second party shall, upon the request of the first
party, cooperate with and assist the first party in such action to the extent
required by statute, regulation or government agency, including without
limitation, executing and delivering all documents in connection therewith and
using its reasonable efforts to obtain such executions from all appropriate
employees and agents of the second party at the second partys cost. Each party
will treat Joint Inventions as Confidential Information.
6.5. License
Grant to AVI. Company hereby grants
AVI (for all applications outside the Field) a worldwide, royalty-free,
nonexclusive license, with the right to sublicense, to any Intellectual Property
that is based upon AVIs Technology and is invented by employees of Company
working on the development of Products pursuant to this Agreement.
6.6. Prosecution
of Infringement of Technology.
(a) Each
of Company and AVI shall promptly notify the other if it knows or has reason to
believe that any of the rights to the Technology in the Field are being
infringed or misappropriated by a third party or that such infringement or
misappropriation is threatened. The parties shall consult with each other as promptly
as reasonably practicable to review actions to be taken in connection with such
alleged infringement or misappropriation. The parties acknowledge that many of
the patents licensed by Company hereunder contain claims that bear on other
therapeutic fields and applications in addition to the Field. Company shall
have the right to institute and control the prosecution of any alleged
infringement or misappropriation of the Technology in the Field, provided
however, that Company shall not enter into any settlement without AVIs written
consent that could impact AVIs or AVIs licensees ability to develop or
commercialize products outside the Field.
(b) Company
shall be solely responsible for payment of all costs and expenses it incurs in
the prosecution and/or a negotiation of a settlement. Company shall have the
right to
11
act in the name of, or on behalf of AVI, and
join AVI as a party plaintiff to any such proceeding if Company believes it is
necessary or advisable to successfully prosecute such infringement or
misappropriation. AVI shall cooperate in connection with the initiation and
prosecution by Company of such suit or action. The proceeds from any judgment,
decision or settlement shall first be used to reimburse Company for all costs
and expenses it incurred relating to prosecution and settlement of any action;
second, be allocated equally between Company and AVI.
(c) If
Company fails to initiate the prosecution of any alleged infringement or misappropriation
of the Technology in the Field within six (6) months of receiving written
notice from AVI or providing notice to AVI of any commercially significant
infringement or misappropriation, AVI shall have the right to institute and
control the prosecution of any such alleged infringement or misappropriation. AVI
shall be solely responsible for the payment of all costs and expenses it incurs
in the prosecution and/or a negotiation of a settlement. AVI may request
from Company the right to act in the name of, or on behalf of Company, and to
join Company as a party plaintiff to any such proceeding that AVI believes it
is necessary or advisable to successfully prosecute such infringement or
misappropriation, such request not to be unreasonably withheld or delayed by
Company. If such right is granted to AVI, Company shall cooperate in connection
with the initiation and prosecution by AVI of such suit or action. The proceeds
from any judgment, decision or settlement shall first be used to reimburse AVI
for all costs and expenses it incurred relating to prosecution and settlement
of any action; second, be allocated on an equal basis between Company and AVI.
ARTICLE 7.
REPRESENTATIONS AND WARRANTIES
7.1. Representations
of AVI. AVI represents, warrants and
covenants to Company that:
(a) AVI
is a corporation duly organized, validly existing, and in good standing under
the laws of the State of Oregon and has full corporate power to conduct the
business in which it is presently engaged and to enter into and perform its
obligations under this Agreement.
(b) AVI
has taken all necessary corporate action under the laws of the state of its
incorporation and its certificate of incorporation and by-laws to authorize the
execution and consummation of this Agreement and, when executed and delivered
by AVI, this Agreement shall constitute the valid and legally binding agreement
of AVI enforceable against AVI in accordance with the terms hereof, subject to
bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium and
similar laws of general applicability relating to or affecting creditors
rights and to general equity principles.
(c) Neither
the execution and delivery of this Agreement nor the consummation of the
transactions contemplated herein will violate any provision of the certificate
of incorporation or bylaws of AVI or any law, rule, regulation, writ, judgment,
injunction, decree, determination, award or other order of any court or
governmental agency or instrumentality, domestic or foreign, or conflict with
or result in any breach of any of the terms of or constitute a default under or
result in termination of or the creation or imposition of any Lien pursuant to
the terms
12
of any contract or agreement to which AVI is
a party or by which AVI or any of its assets is bound.
(d) AVI
exclusively owns, or has valid and subsisting exclusive license rights (with
the right to sublicense) to, all of the Technology within the Field, subject to
no Lien whatsoever. Other than payment obligations under the NIH License, the
UNeMed License, and the Summerton Agreement, AVI is not subject to any
obligation to any person or entity for royalties, fees or commissions in
respect of the Technology within the Field. No current or former stockholder,
employee, officer, agent or consultant of AVI has any rights in or to any of
the Technology for use within the Field. The Technology is valid and
enforceable and has not been challenged in any judicial or administrative
proceeding and AVI has not received and is not aware of any claim or notice of
any person that such person is contemplating such action. AVIs execution and
performance of this Agreement, the transactions contemplated herein and Companys
use of the Technology within the Field will not infringe, misappropriate,
misuse or conflict with the rights, including patent and other Intellectual
Property or contractual rights, of third parties. AVI has the right and
authority to enter into this Agreement and to grant the license granted herein.
To AVIs knowledge, no person or entity nor such persons or entitys business
or products has infringed, misused, misappropriated or conflicted with the
Technology within the Field or currently is infringing, misusing,
misappropriating or conflicting with such Technology within the Field.
(e) There
are no actions, suits, claims, disputes or proceedings or governmental
investigations pending or, to AVIs knowledge, threatened against AVI or any of
its Affiliates with respect to the Technology or the use thereof by AVI, either
at law or in equity, before any court or administrative agency or before any
governmental department, commission, board, bureau, agency or instrumentality,
or before any arbitration board or panel whether located in the United States
or a foreign country. AVI has not failed to comply with any law, rule,
regulation, writ, judgment, injunction, decree, determination, award or other
order of any court or other governmental department, commission, board, bureau,
agency or instrumentality, or before any arbitration board or panel whether
located in the United States or a foreign country, which failure in any case
would in any material respect impair any rights of Company under this
Agreement.
(f) All
Patents identified in Exhibit A have the status indicated therein and all
applications are still pending in good standing and have not been withdrawn or
abandoned. The Patents identified in Exhibit A constitute all of the
current patents and patent applications of AVI having applicability to the
Technology or the Drug within the Field. AVI has made all statutorily required
filings, if any, to record its interest in the Patents.
(g) No
representation or warranty made by AVI herein and no information disclosed by
AVI to Company contains any untrue statement of a material fact or omits to
state a material fact necessary to make the statement made herein or therein
not misleading.
(h) The
NIH License and the UNeMed License are in full force and effect and there are
no existing defaults, or events, which, with the passage of time or giving of
notice, would become defaults thereunder. AVI is the sole and exclusive owner
of the licensees interest in the NIH License and the UNeMed License, free and
clear of any Liens. The execution and delivery by AVI of this Agreement and its
performance hereunder will not constitute a default (or an
13
event which, with the passage of time or
giving of notice, would constitute a default) under the NIH License or the
UNeMed License. AVI has not received notice, nor is AVI otherwise aware, that
the licensor under the NIH License or the UNeMed License intends to cancel or
terminate the corresponding license or provide notice of a default (or an event
which, with the passage of time or giving of notice, would constitute a
default) thereunder. None of the terms of the NIH License or the UNeMed License
has been impaired, waived, altered, amended or modified in any respect) prior
to the date hereof. AVI has previously delivered to Company true and correct
copies of the NIH License and the UNeMed License.
(i) AVI
has made no public disclosure of any non-patented Technology in the Field and
shall make no public disclosure of any such Technology in the Field or any such
Technology in the Field which may come into existence during the term of
this Agreement, except to the extent required by law or to obtain patent
protection therefore. AVI has otherwise taken reasonable steps to protect its
rights in the Technology.
(j) As
of the date hereof, the protein referred to in the definition of Drug set
forth in Section 1.1 constitutes ***.
7.2. Representations
of Company. Company represents,
warrants and covenants to AVI that:
(a) Company
is a corporation duly organized, validly existing, and in good standing under
the laws of the State of Indiana and has full corporate power to conduct the
business in which it is presently engaged and to enter into and perform its
obligations under this Agreement.
(b) Company
has taken all necessary corporate action under the laws of the state of its
incorporation and its Articles of Incorporation and bylaws to authorize the
execution and consummation of this Agreement and, when executed and delivered
by Company, this Agreement shall constitute the valid and legally binding
agreement of Company enforceable against Company in accordance with the terms
hereof, subject to bankruptcy, insolvency, fraudulent transfer, reorganization,
moratorium and similar laws of general applicability relating to or affecting
creditors rights and to general equity principles.
(c) Neither
the execution and delivery of this Agreement nor the consummation of the
transactions contemplated herein will violate any provision of the Articles of
Incorporation and bylaws of Company or any law, rule, regulation, writ,
judgment, injunction, decree, determination, award or other order of any court
or governmental agency or instrumentality, domestic or foreign, or conflict
with or result in any breach of any of the terms of or constitute a default
under or result in termination of or the creation or imposition of any Lien
pursuant to the terms of any contract or agreement to which Company is a party
or by which Company or any of its assets is bound.
ARTICLE 8.
INDEMNIFICATION
8.1. Indemnification
by AVI. AVI shall indemnify, defend
and hold harmless Company and each of its subsidiaries, officers, directors,
shareholder, employees, agents and
14
affiliates
(collectively, all such indemnities are referred to in this Section as Company)
against and in respect of any and all claims, demands, losses, obligations,
liabilities, damages (and including without limitation, compensatory and
punitive damages), deficiencies, actions, settlements, judgments, costs and
expenses which Company may incur or suffer or with which it may be
faced (including reasonable costs and legal fees incident thereto or in seeking
indemnification therefor), (referred to as Costs) arising out of or based
upon the breach by AVI of any of its representations, warranties, covenants or
agreements contained or incorporated in this Agreement or any agreement,
certificate or document executed and delivered to Company by AVI in connection
with the transactions hereunder. An amount for which Company is entitled to
indemnification pursuant hereto is referred to as an Indemnified Amount.
During the term of this Agreement, AVI shall maintain, at its expense, a policy
of comprehensive general liability insurance sufficient to honor the indemnity
made herein, with products liability endorsement, but in no event less than
Seven Million Five Hundred Thousand U.S. Dollars ($7,500,000) in the aggregate
with a maximum deductible per occurrence of not more than One Million U.S.
Dollars ($1,000,000). Such policy shall name Company and its Affiliates as
additional insureds. AVI shall furnish Company with a certificate of insurance
evidencing such coverage within thirty (30) days of the execution of this
Agreement, which certificate shall provide for not less than thirty (30) days
notice to Company prior to material change in coverage or policy cancellation.
8.2. Indemnification
by Company. Company shall indemnify,
defend and hold harmless AVI and each of its subsidiaries, officers, directors,
shareholder, employees, agents and affiliates (collectively, all such
indemnities are referred to in this Section as AVI) against and in
respect of any and all claims, demands, losses, obligations, liabilities,
damages (and including without limitation, compensatory and punitive damages),
deficiencies, actions, settlements, judgments, costs and expenses which AVI may incur
or suffer or with which it may be faced (including reasonable costs and
legal fees incident thereto or in seeking indemnification therefor), (referred
to as Costs) arising out of or based upon the breach by Company of any of its
representations, warranties, covenants or agreements contained or incorporated
in this Agreement or any agreement, certificate or document executed and
delivered to AVI by Company in connection with the transactions hereunder. An
amount for which AVI is entitled to indemnification pursuant hereto is referred
to as an Indemnified Amount. During the term of this Agreement, Company
shall maintain, at its expense, a policy of comprehensive general liability
insurance sufficient to honor the indemnity made herein, with products
liability endorsement, but in no event less than Seven Million Five Hundred
Thousand U.S. Dollars ($7,500,000) in the aggregate with a maximum deductible
per occurrence of not more than One Million U.S. Dollars ($1,000,000)). Such
policy shall name AVI and its Affiliates as additional insureds. Company shall
furnish AVI with a certificate of insurance (or a self-insurance letter (if
Company is self-insured)) evidencing such coverage within thirty (30) days of
the execution of this Agreement, which certificate shall provide for not less
than thirty (30) days notice to Company prior to material change in coverage or
policy cancellation.
8.3. Third
Party Claims. If a claim by a third
party is made against any indemnified party, and if the indemnified party
intends to seek indemnity with respect thereto under this Article 8,
such indemnified party shall promptly notify the indemnifying party of such
claim; provided, however, that failure to give timely notice shall not affect
the rights of the indemnified party so long as the failure to give timely
notice does not adversely affect the indemnifying partys ability to defend such
claim against a third party. The indemnifying party shall be entitled
15
to settle or
assume the defense of such claim, including the employment of counsel
reasonably satisfactory to the indemnified party. If the indemnifying party
elects to settle or defend such claim, the indemnifying party shall notify the
indemnified party within thirty (30) days (but in no event less than twenty
(20) days before any pleading, filing or response on behalf of the indemnified
party is due) of the indemnifying partys intent to do so. If the indemnifying
party elects not to settle or defend such claim or fails to notify the
indemnified party of the election within thirty (30) days (or such shorter
period provided above) after receipt of the indemnified partys notice of a
claim of indemnity hereunder, the indemnified party shall have the right to
contest, settle or compromise the claim without prejudice to any rights to
indemnification hereunder. Regardless of which party is controlling the
settlement of defense of any claim, (a) both the indemnified party and
indemnifying party shall act in good faith, (b) the indemnifying party
shall not thereby permit to exist any Lien, encumbrance or other adverse charge
upon any asset of any indemnified party or of its subsidiaries, (c) the
indemnifying party shall permit the indemnified party to participate in such
settlement or defense through counsel chosen by the indemnified party, with all
fees, costs and expenses of such counsel borne by the indemnified party, (d) no
entry of judgment or settlement of a claim may be agreed to without the
written consent of the indemnified party, and (e) the indemnifying party
shall promptly reimburse the indemnified party for the full amount of such
claim and the related expenses as incurred by the indemnified party pursuant to
this Article 8. So long as the indemnifying party is reasonably
contesting any such third party claim in good faith and the foregoing clause (b) is
being complied with, the indemnified party shall not pay or settle any such
claim. The controlling party shall upon request deliver, or cause to be
delivered, to the other party copies of all correspondence, pleadings, motions,
briefs, appeals or other written statements relating to or submitted in
connection with the settlement or defense of any such claim, and timely notices
of any hearing or other court proceeding relating to such claim.
8.4. Set-Off.
In the event Company is entitled to
indemnification under this Article 8, Company shall be entitled in
its discretion, without limitation of any other rights or remedies of Company,
to set-off all or any part of the Indemnified Amount against any amounts
which are then owed or thereafter become owed by Company to AVI. Company shall
be entitled to set-off an Indemnified Amount when such Costs are threatened,
whether or not yet incurred and whether or not the amount thereof has been
finally determined. If Company defers payment of any amount to AVI past the
scheduled payment date because there exists a pending indemnification claim by
Company pursuant to this Article 8 the amount of which has not then
been finally determined, the excess, if any, of such deferred amount over the
finally determined amount of the indemnification claim shall be promptly paid
upon such final determination, together with simple interest at the rate of
eight percent (8%) per annum on such excess accrued from the originally
scheduled payment date for such deferred amount.
ARTICLE 9.
TERM AND TERMINATION
9.1. Term
of License. Unless otherwise
terminated under provisions of Section 9.2, Section 10.13 or
extended by mutual agreement of the parties, this Agreement and the license
granted under Section 2.1 shall terminate upon the expiration of
the last to expire Valid Claim (Term).
16
9.2. Termination.
(a) If
either party is in material breach of the terms, conditions or agreements of
this Agreement, then the other party may terminate this Agreement, at its
option and without prejudice to any of its other legal and equitable rights and
remedies, by giving the breaching party thirty (30) days notice in writing,
particularly specifying the breach. Such notice of termination shall not be
effective if the breaching party cures the specified breach within such thirty
(30) days period. Each party shall have the
right to suspend payment of any amount due to the other hereunder during the
time that the breach of the other party remains uncured.
(b) Company
shall have the right, in its sole discretion, to terminate this Agreement at
any time on ninety (90) days written notice to AVI.
(c) AVI
shall have the right to terminate this Agreement upon sixty (60) days prior
written notice if, following an assignment of Companys rights under this
Agreement pursuant to Section 10.13(b)(iv) or (v), the permitted
assignee terminates its development efforts under this Agreement.
9.3. Effect
of Termination.
(a) In
the event of termination of this Agreement, Company shall be entitled to
complete all work-in-process and sell its remaining inventory of Products,
subject to the payment of royalties pursuant to Section 3.1 on such
Net Sales.
Upon
termination of this Agreement, each party will within thirty (30) days return
to the other all tangible Confidential Information of the other party (except
one copy which may be retained by legal counsel solely for evidentiary
purposes in the event of a dispute), and each party will deliver to the other a
copy of any documentation in its possession or control specifically relating to
the Joint Inventions.
ARTICLE 10.
MISCELLANEOUS
10.1. Further
Assurances. Each party agrees to
execute and deliver without further consideration any further applications,
licenses, assignments or other documents, and to perform such other lawful
acts as the other party may reasonably request to fully secure and/or
evidence the rights or interests herein.
10.2. Complete
Agreement. This Agreement, the
Investment Agreement and the Supply Agreement (including all schedules and
exhibits hereto and thereto for such agreements) constitutes the entire
agreement among the parties hereto with respect to the subject matter hereof
and thereof. There are no restrictions, promises, warranties or undertakings,
other than those set forth or referred to herein or therein, with respect to
the subject matter hereof and thereof. This Agreement supersedes all prior
agreements and understandings among the parties hereto with respect to the
subject matter hereof.
17
10.3. Survival
of Representations, Warranties and Agreements. The representations, warranties, covenants and
agreements contained in and Articles 7 and 8 of this Agreement
shall survive termination of this Agreement and remain in full force and effect.
No independent investigation of AVI by Company, its counsel, or any of its
agents or employees shall in any way limit or restrict the scope of the
representations and warranties made by AVI in this Agreement.
10.4. Waiver,
Discharge, Amendment, Etc. The
failure of any party hereto to enforce at any time any of the provisions of
this Agreement shall not, absent an express written waiver signed by the party
making such waiver specifying the provision being waived, be construed to be a
waiver of any such provision, nor in any way to affect the validity of this
Agreement or any part thereof or the right of the party thereafter to
enforce each and every such provision. No waiver of any breach of this
Agreement shall be held to be a waiver of any other or subsequent breach. Any
amendment to this Agreement shall be in writing and signed by AVI and Company.
10.5. Notices. All notices or other communications to a
party required or permitted hereunder shall be in writing and shall be delivered
personally or by telecopy (receipt confirmed) to an executive officer of such
party or shall be sent by a reputable express delivery service or by certified
mail, postage prepaid with return receipt requested, addressed as follows:
if to
Company to:
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Cook Group
Incorporated
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750 Daniels Way
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Bloomington, Indiana 47204
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Attn: Pete Yonkman
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Facsimile: (812) 339-5369
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With a copy to:
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Ice Miller LLP
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One American Square, Suite 3100
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Indianapolis, Indiana 46282
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Attention: Stephen J. Hackman
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Facsimile: (317) 592-4666
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if to AVI to:
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AVI BioPharma, Inc.
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One SW Columbia Street, Suite 1105
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Portland, OR 97225
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Attn:
Alan Timmins
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Facsimile: (503) 227-0751
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With a copy to:
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Davis Wright Tremaine LLP
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1300 SW Fifth Avenue, Suite 2300
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Portland, OR 97201-5682
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Attn: Michael Phillips
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Facsimile: (503 778-5299)
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Any party may change the above-specified recipient and/or mailing
address by notice to the other party given in the manner herein prescribed. All
notices shall be deemed given on the day when
18
actually delivered as provided above (if delivered personally or by
telecopy) or on the day shown on the return receipt (if delivered by mail or
delivery service).
10.6. Public
Announcement. In the event any party
proposes to issue any press release or public announcement concerning any
provisions of this Agreement or the transactions contemplated hereby, such
party shall so advise the other party hereto, and the parties shall thereafter
use their best efforts to cause a mutually agreeable release or announcement to
be issued. Neither party will publicly or privately disclose or divulge any
provisions of this Agreement or the transactions contemplated hereby without
the other parties written consent, except as may be required by
applicable law, rule, regulation, order or stock exchange regulation, and
except for communications to employees; provided that, prior to disclosure of
any provision of this Agreement that either party considers particularly
sensitive or confidential to any governmental agency or stock exchange, the
parties shall cooperate to seek confidential treatment or other applicable
limitations on the public availability of such information. In particular,
prior to such disclosure, each party shall use its best efforts to redact the
royalty rates and payment terms specified herein and each party shall provide
the other the opportunity to redact other information and seek confidential
treatment of any such disclosure.
10.7. Expenses.
Except as expressly provided herein, AVI
and Company shall each pay their own expenses incident to this Agreement and
the preparation for, and consummation of, the transactions provided for herein.
10.8. Governing
Law. This Agreement shall be
governed by and construed in accordance with the Laws of the State of Indiana
applicable to a contract executed and performed in such State, without giving
effect to the conflicts of laws principles thereof.
10.9. Titles
and Headings; Construction. The
titles and headings to the Articles and Sections herein are inserted for the
convenience of reference only and are not intended to be a part of or to
affect the meaning or interpretation of this Agreement. This Agreement shall be
construed without regard to any presumption or other rule requiring
construction hereof against the party causing this Agreement to be drafted.
10.10. Benefit.
Nothing in this Agreement, expressed or
implied, is intended to confer on any person other than the parties hereto or
their respective successors or assigns, any rights, remedies, obligations or
liabilities under or by reason of this Agreement.
10.11. Counterparts.
This Agreement may be executed in
any number of counterparts, each of which shall be deemed as original and all
of which together shall constitute one instrument.
10.12. Force
Majeure. Neither party shall be in
default because of any failure to perform this Agreement if such failure
arises from causes beyond the control of such party (the first party) and
without the fault or negligence of such first party, including without
limitation, acts of God or of the public enemy, acts of the Government in
either its sovereign or contractual capacity, fires, floods, earthquakes,
epidemics, quarantine restrictions, strikes, freight embargoes or unusually
severe weather. In each instance, the failure to perform must be beyond
the reasonable control and without the fault or negligence of the first party. If
it appears that
19
performance
under this Agreement may be delayed by an event of Force Majeure, the
first party will immediately notify the other party as soon as practicable in
writing at the address specified in this Agreement. During the period that the
performance by one of the parties of its obligations under this Agreement has
been suspended by reason of an event of Force Majeure, the other party may likewise
suspend the performance of all or part of its obligations hereunder to the
extent that such suspension is commercially reasonable.
10.13. Assignment. Neither this Agreement nor any right,
interest or obligation hereunder may be assigned by any party hereto
without the prior written consent of the other party hereto and any attempt to
do so will be void, except (a) for assignments and transfers by operation
of Law; (b) that Company may assign any or all of its rights,
interests and obligations hereunder without AVIs consent (i) to Companys
direct or indirect parent, (ii) to any subsidiary of Company at least 50%
of the voting power of which is owned, directly or indirectly, by Company or
its Affiliates, (iii) to a wholly-owned, direct or indirect subsidiary of
Company, (iv) to an entity (other than an Affiliate of the Company) that
acquires the entire equity interest or substantially all of the assets of
Company or Companys parent, or (v) to any entity (other than an Affiliate
of the Company) that acquires the product line to which this Agreement
pertains; provided that any assignee under this clause (b) shall expressly
agree to be bound by all of the provisions of this Agreement, including Section 4.3,
(c) that Company may collaterally assign its rights under this
Agreement to parties providing financing in connection with the transactions
contemplated hereby. In the case of any assignment under Subsections 10.13 (b) (iv) or
(v), the acquiring party will also be bound by the performance standards listed
in Exhibit C (Performance Standards). Should such acquiring
entity fail to meet any of the Performance Standards, AVI may, on thirty (30)
days written notice, terminate this Agreement. This Agreement is otherwise
binding upon, inures to the benefit of and is enforceable by the parties hereto
and their respective successors and assigns.
10.14. NIH
License. Company agrees to be bound
by the provisions of paragraphs 5.01-5.04, 8.01, 10.01, 10.02, 12.05, and
13.07-13.09 of the NIH License (a copy of which is attached hereto as Exhibit B)
as if Company were a party to the NIH License.
[SIGNATURE PAGE FOLLOWS]
20
IN WITNESS WHEREOF, each of the parties has
caused this License and Development Agreement to be executed in the manner
appropriate for each, and to be dated as of the date first above-written.
COOK GROUP INCORPORATED
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AVI BIOPHARMA, INC.
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By:
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By:
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Printed:
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Printed:
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Title:
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Title:
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Date:
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Date:
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21
EXHIBIT A
AVI
BioPharma Intellectual Property
Morpholino Backbone Patents
1. Attorney Docket No. 50450-8003.US02 (.23) entitled UNCHARGED
POLYNUCLEOTIDE-BINDING POLYMERS - U.S. Patent No. 5142047
2. Attorney Docket No. 50450-8003.US04 (.28) entitled UNCHARGED
MORPHOLINO-BASED POLYMERS HAVING PHOSPHOROUS LINKED CHIRAL INTERSUBUNIT
LINKAGES U.S. Patent No. 5185444
3. Attorney Docket No. 50450-8003.US05 (.29) entitled
ALPHA-MORPHOLINO RIBONUCLEOSIDE DERIVATIVES AND POLYMERS THEREOF U.S. Patent No. 5235033
4. Attorney Docket No. 50450-8009 entitled ALPHA-MORPHOLINO
RIBONUCLEOSIDE DERIVATIVES AND POLYMERS THEREOF U.S. Patent No. 5378841
5. Attorney Docket No. 50450-8015 entitled POLYNUCLEOTIDE REAGENT
CONTAINING CHIRAL SUBUNITS AND METHOD OF USE CA 2069869, JP 3398378, AU
655164, EP 962463, KR 167574
6. Attorney Docket No. 50450-8015 (.43) entitled POLYNUCLEOTIDE
REAGENT CONTAINING CHIRAL SUBUNITS AND METHOD OF USE EP 0506830
Resten-NG Patents
7. Attorney Docket No. 50450-8025.US00 entitled ANTISENSE
RESTENOSIS COMPOSITION AND METHOD U.S. application pending; corresponding CA,
JP, AU, EP, KR applications
8-9. Attorney Docket Nos. 50450-8318 and -8318.US00 entitled DELIVERY
OF MICROPARTICLE-CONJUGATED DRUGS FOR INHIBITION OF STENOSIS U.S.
applications pending; corresponding CA, JP, AU, EP, KR applications
10. Attorney Docket No. 50450.8060
entitled DELIVERY OF THERAPEUTIC COMPOUNDS VIA MICROPARTICLES OR MICROBUBBLES -
U.S. application pending; corresponding PCT application
11. Attorney Docket No. 50450.8067
entitled PEPTIDE CONJUGATED, INOSINE SUBSTITUED ANTISENSE OLIGOMER COMPOUND AND
METHOD U.S. application pending; corresponding PCT application
22
12. Attorney Docket No. 50450.8050 entitled COMPOSITIONS FOR
ENHANCING TRANSPORT OF MOLECULES INTO CELLS U.S. application pending;
corresponding CA, AU, EP applications
Licensed
Intellectual Property
13-14. Attorney Docket No. 50450-8302 entitled COMPOSITION AND
METHODS FOR ALTERING THE BIODISTRIBUTION OF BIOLOGICAL AGENTS U.S. Patent
Nos. 5,849,727, 6,117,858 and 6,537,814; EP Patent No. 938341;
corresponding CA, JP applications (Licensed from UNeMed)
15. Attorney Docket No. 50450-8302.US02 (.31) MICROBUBBLE
COMPOSITIONS AND METHODS FOR OLIGONUCLEOTIDE DELIVERY U.S. application
pending (UNeMed)
16. Attorney Docket No. 50450-8310.US00 (.31) entitled TARGETED
SITE SPECIFIC ANTISENSE OLIGODEOXYNUCLEOTIDE DELIVERY METHOD - U.S. Patent No. 6,245,747;
AU Patent No. 743695; EP Patent No. 1094843 (UNeMed)
17. Attorney Docket No. 50450-8305.30 entitled ULTRASOUND CONTRAST
AGENT AND METHODS FOR THEIR MANUFACTURE AND USE U.S. Patent No. 5,567,415
(UNeMed)
18. Attorney Docket No. 50450-8305.31 entitled PERFLUOROBUTANE
ULTRASOUND CONTRAST AGENT COMPRISING MICROBUBBLES CONTAINING A FILMOGENIC
PROTEIN AND A CACCHARIDE U.S. Patent No. 5,695,740 (UNeMed)
19. INHIBITION OF CELL PROLIFERATION USING ANTISENSE OLIGONUCLEOTIDES
U.S. Patent No. 5,756,476 (Licensed from The U.S. Department of
Health and Human Services, National Institutes of Health)
23
EXHIBIT B
NIH License Agreement
24
EXHIBIT C
Performance
Standards for Acquiring Entity
For Drug-Eluting Stents:
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No Later Than
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Complete
Product Design/Preclinical testing
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***
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Commence
First in Man Pilot Study
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***
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Commence
European Clinical Trial
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***
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Apply for CE
Mark Approval
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***
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Apply for
IDE in U.S.
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***
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Complete
enrollment of first patients approved by FDA in IDE
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*** from
approval of IDE
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Complete enrollment
of remaining approved patients in IDE
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*** from
approval by FDA to begin enrolling remaining patients
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First U.S.
Commercial Sale
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Within ***
of FDA approval
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For Infusion Catheter:
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No Later Than
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Complete
Product Development
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***
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Complete Preclinical
Testing
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***
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Submission
for U.S. Clinical Trial (Phase III)
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***
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First U.S.
Commercial Sale
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Within *** of FDA approval
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For Microbubbles:
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No Later Than
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Complete
Enrollment of European (Phase II) Clinical Trial
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***
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Complete
Preclinical Testing (U.S.)
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***
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Commence
U.S. Pilot Study (Phase I)
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***
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Commence
U.S. Clinical Trial (Phase II)
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*** from the date of completion of FIM
Pilot Study
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Commence
U.S. Clinical Trial (Phase III)
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*** from the date of completion of Phase II
Clinical Trial
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First U.S.
Commercial Sale
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Within *** of FDA approval
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So long as the Acquiring Entity is using commercially reasonable
efforts to pursue the development of a Product, each of the foregoing
Performance Standards for the relevant category of Product shall be
automatically extended if, during any phase of the development process for that
particular Product, the Acquiring Entity determines, based on clinical or other
data, that it is necessary to suspend work on that phase in the development
process (the Suspended Phase)
25
and return to or repeat one or more previous phases in the development
process (each, a Prior Phase) in order to enhance the likelihood of producing
a commercially-viable Product. In the case of any such determination, the
Acquiring Entity will promptly provide AVI with documentation, including Gantt
charts (or similar project management tools), budgets, spending records
(subject to audit by AVI), and the like, that shows that the necessary
development, as agreed by the Product Development Committee, in each of the
specific product applications is moving forward.
The applicable Performance Standard for the Suspended Phase and for
phases following the Suspended Phase for the relevant category of Product shall
be extended by the number of days that the Acquiring Entity works in any Prior
Phase(s) to resolve the issue(s) that resulted in the suspension of work in the
Suspended Phase. Once a Performance Standard for a particular phase of the
development process has been achieved, it shall be deemed achieved for all
purposes of this Agreement.
The parties acknowledge the necessity for the Acquiring Entity to meet
all applicable regulatory requirements in the major markets of the world (e.g.
U.S. and Europe). The parties also acknowledge the uncertain regulatory
requirements for a combination device product. If regulatory requirements
create significantly longer timelines than currently anticipated to receive
regulatory approval for Products, the Performance Standards for the relevant
category of Product will be extended by the time required to complete the
additional regulatory requirements, so long as the delay in obtaining
regulatory approval is not the result of the Acquiring Entity failing to adhere
to relevant regulatory guidelines or to use commercially reasonable diligence
in the development of the particular Product.
26
Exhibit 10.52
INVESTMENT
AGREEMENT
THIS INVESTMENT AGREEMENT (this Agreement) is made and entered into
effective the 10th day of March, 2006 (the Effective Date) by between AVI
BIOPHARMA, INC. (AVI), an Oregon corporation, and Cook Group Incorporated
(Investor), an Indiana corporation.
RECITALS:
WHEREAS, AVI desires to issue and sell to Investor, and Investor
desires to purchase on the terms and subject to the conditions set forth in
this Agreement, certain shares of AVI Common Stock, $0.0001 par value (Common
Stock);
WHEREAS, Investor and AVI are entering into a License and Development
Agreement (the License and Development Agreement) and a Supply Agreement (the
Supply Agreement) both of even date herewith; and
NOW, THEREFORE, in consideration of the respective representations,
warranties, covenants and agreements contained herein, and for other valuable
consideration, the receipt and adequacy of which is hereby acknowledged, the
parties hereto agree as follows:
AGREEMENT
1. DEFINITIONS
(a) Specific
Definitions. As used in this
Agreement, the following terms shall have the meanings set forth or as
referenced below:
Affiliate of a specified person (natural or juridical) means a
person that directly, or indirectly through one or more intermediaries,
controls, or is controlled by, or is under common control with, the person
specified. Control shall mean ownership of more than 50% of the shares of
stock entitled to vote for the election of directors in the case of a
corporation, and more than 50% of the voting power in the case of a business
entity other than a corporation.
Agreement means this Agreement and all Exhibits and Schedules
hereto.
AVI has the meaning defined in the recitals hereto.
AVI Subsidiaries means all subsidiaries of AVI, including but
not limited to the subsidiaries identified in the Disclosure Schedule.
Change of Control with respect to AVI means the occurrence of
any of the following:
(i) a
sale of assets representing fifty percent (50%) or more of the net book value
and of the fair market value of AVIs consolidated assets (in a single
transaction or in a series of related transactions);
(ii) a
liquidation or dissolution of AVI;
(iii) a
merger or consolidation involving AVI or any subsidiary of AVI after the
completion of which: (i) in the case of a merger (other than a
triangular merger) or a consolidation involving AVI, the shareholders of AVI
immediately prior to the completion of such merger or consolidation
beneficially own (within the meaning of Rule 13d-3 promulgated under the
Exchange Act or comparable successor rules), directly or indirectly,
outstanding voting securities representing less than fifty percent (50%) of the
combined voting power of the surviving entity in such merger or consolidation,
and (ii) in the case of a triangular merger involving AVI or a subsidiary
of AVI, the shareholders of AVI immediately prior to the completion of such
merger beneficially own (within the meaning of Rule 13d-3 promulgated
under the Exchange Act, or comparable successor rules), directly or indirectly,
outstanding voting securities representing less than fifty percent (50%) of the
combined voting power of the surviving entity in such merger and less than
fifty percent (50%) of the combined voting power of the parent of the surviving
entity in such merger;
(iv) an
acquisition by any person, entity or group (within the meaning of Section 13(d) or
14(d) of the Exchange Act or any comparable successor provisions), other
than any employee benefit plan, or related trust, sponsored or maintained by
AVI or an affiliate of AVI and other than in a merger or consolidation of the
type referred to in clause (c) of this definition of Change of Control, of
beneficial ownership (within the meaning of Rule 13d-3 promulgated under
the Exchange Act, or comparable successor rules) of outstanding voting
securities of AVI representing more than thirty-three and 1/3 percent (33-1/3%)
of the combined voting power of AVI (in a single transaction or series of
related transactions); or
(v) individuals
who, as of the date hereof or replacements therefore who have been initially
nominated by the then current members of the AVI Board of Directors, are
members of the AVI Board of Directors (the Incumbent Board), cease for any
reason to constitute at least sixty percent (60%) of the AVI Board of
Directors, provided that if election, or nomination for election by AVIs
shareholders, of any new member of the AVI Board of Directors is approved by a
vote of at least sixty percent (60%) of the Incumbent Board, such new member of
the Board shall be considered as a member of the Incumbent Board.
Closing means the later to occur of the payment for Purchased
Shares by Investor and the delivery by AVI to Investor of a stock certificate
for Purchased Shares as provided in Section 2. Closing Date shall
be the date on which the stock certificate for Purchased Shares is delivered to
Investor.
Code means the United States Internal Revenue Code of 1986, as
amended.
Common Stock means shares of Common Stock of AVI, par value
$0.0001 per share.
Confidential Information means know-how, trade secrets,
unpublished information, scientific and technical information, inventions,
methods, plans, processes, characteristics, data, business plans and the like
disclosed (whether before or during the term of this Agreement) by one of the
parties (the disclosing party) to the other party (the receiving party) or
generated under this Agreement or the other Transaction Documents, excluding
information which: (i) was
2
already in the possession of receiving party
prior to its receipt from the disclosing party (provided that the receiving
party is able to provide the disclosing party with reasonable documentary proof
thereof and, if received from a third party, that such information was acquired
without any partys breach of a confidentiality or non-disclosure obligation to
the disclosing party related to such information ); (ii) is or becomes part of
the public domain by reason of acts not attributable to the receiving
party; (iii) is or becomes
available to receiving party from a source other than the disclosing party
which source, has rightfully obtained such information and has no obligation of
non-disclosure or confidentiality to the disclosing party with respect thereto;
or (iv) has been independently developed by the receiving party without
breach of this Agreement or use of any Confidential Information of the other
party.
Disclosure Schedule has the meaning given in Section 3.
Drug has the meaning defined in the License and Development
Agreement.
Environmental Laws or Regulations means any one or more of the
following: the Comprehensive Environmental Response Compensation and Liability
Act (CERCLA) as amended by the Superfund Amendments and Reauthorization Act
of 1986 (SARA), 42 U.S.C. § 9601 et seq.; the Federal Resource
Conservation and Recovery Act of 1976 (RCRA), 42 U.S.C. § 6921 et seq.;
the Clean Water Act, 33 U.S.C. § 1321 et seq.; the Clean Air Act, 42
U.S.C. § 7401 et seq.; any other federal, state, county, municipal, local,
foreign or other statute, law, ordinance or regulation which may relate to
pesticides, agricultural or industrial chemicals, wastes, Hazardous Substances,
or the environment; and all regulations promulgated by a regulatory body
pursuant to any of the foregoing statutes, laws, regulations, or ordinances.
Exchange Act means the Securities Exchange Act of 1934, as
amended, and all rules and regulations promulgated thereunder.
FDA means the U.S. Food and Drug Administration.
Field has the meaning defined in the License and Development
Agreement.
Financial Statements means AVIs financial statements included
in SEC Documents.
Hazardous Substance means asbestos, urea formaldehyde,
polychlorinated biphenyls, nuclear fuel or materials, chemical waste,
radioactive materials, explosives, known carcinogens, petroleum products,
pesticides, fertilizers, or other substance which is dangerous, toxic, or
hazardous, or which is a pollutant, contaminant, chemical, material or
substance defined as hazardous or as a pollutant or contaminant in, or the use,
transportation, storage, release or disposal of which is regulated by, any
Environmental Laws or Regulations.
Initial Market Price means the average (rounded to the nearest
full cent, with the cents rounded up if the third decimal place is 5 or more)
of the volume weighted closing sale prices of a share of Common Stock as
reported on the Nasdaq Stock Market as of the end of the regular trading
session, as reported in The Wall Street Journal, for the twenty (20)
consecutive Nasdaq trading days ending on and including the Nasdaq trading day
immediately preceding the Effective Date of this Agreement.
3
Intellectual Property means letters patent and patent
applications; trademarks, service marks and registrations thereof and
applications therefor; copyrights and copyright registrations and applications;
all discoveries, ideas, technology, knowhow, trade secrets, processes,
formulas, drawings and designs, computer programs or software; and all
amendments, modifications, and improvements to any of the foregoing.
Investor has the meaning defined in the recitals hereto.
Knowledge or knowledge means actual knowledge of a
fact or the knowledge which such person could reasonably be expected to have
based on reasonable inquiry and consistent with such persons duties and
responsibilities. The knowledge of AVI shall include only the knowledge of AVIs
directors and/or officers.
License and Development Agreement has the meaning defined in
the recitals hereto.
Liens means liens, mortgages, charges, security interests,
claims, voting trusts, pledges, encumbrances, options, assessments,
restrictions, or third-party or spousal interests of any nature.
Material Adverse Effect means a material adverse effect on (a) the
business, operations, results of operations, assets (including intangible
assets), liabilities, prospects, or condition (financial or otherwise) of AVI
and the AVI Subsidiaries, taken as a whole, or (b) the ability of AVI to
perform its obligations under this Agreement or any of the Transaction
Documents or any other agreement or instrument to be entered into in connection
with this Agreement.
Purchase Election has the meaning defined in the License and
Development Agreement.
Purchased Shares means the shares of Common Stock purchased by
Investor pursuant to Section 2.
SEC means the Securities and Exchange Commission or any other
federal agency at the time administering the Securities Act or the Exchange
Act.
SEC Documents means all documents filed by AVI with the SEC
after December 31, 2000.
Securities Act means the Securities Act of 1933, as amended,
and all rules and regulations promulgated thereunder.
Supply Agreement has the meaning defined in the recitals
hereto.
Transaction Documents means the License and Development
Agreement and the Supply Agreement.
4
(b) Definitional
Provisions.
(i) The
words hereof, herein, and hereunder and words of similar import, when
used in this Agreement, shall refer to this Agreement as a whole and not to any
particular provisions of this Agreement.
(ii) Terms
defined in the singular shall have a comparable meaning when used in the
plural, and viceversa.
(iii) Reference
to an Exhibit or to a Schedule are, unless otherwise specified, to one of
the Exhibits or Schedules attached to or referenced in this Agreement, and
references to a Section are, unless otherwise specified, to one of the
Sections of this Agreement.
(iv) The
term person includes any individual, partnership, joint venture, corporation,
trust, unincorporated organization or government or any department or agency
thereof.
2. PURCHASE
OF COMMON STOCK
AVI shall sell, issue and deliver to
Investor, and Investor shall purchase from AVI, such number of shares of Common
Stock (rounded to the nearest whole share) which shall equal five million
dollars ($5,000,000) divided by the Initial Market Price (the Purchased Shares).
The purchase price for the Purchased Shares shall be payable by wire transfer
of funds to AVIs account within one (1) day of the Effective Date as
follows:
AVI BioPharma, Inc.
4575 SW Research Way, Suite 200
Corvallis, OR
97333
Account # 153591259962
US Bank
1607 Main Street
Vancouver, WA
98660-2975
US Bank contact: Erik Bjorvik (503) 275-5879
Transmit No. 125000105
A certificate representing Purchased Shares
shall be issued by AVI in a form acceptable to Investor and its counsel
within one (1) day of receipt by AVI of payment for the Purchased Shares.
3. REPRESENTATIONS
AND WARRANTIES OF AVI
Except as set forth in the Disclosure Schedule attached
hereto as Schedule A, AVI hereby makes the following
representations and warranties to the Investor:
(a) Authorization;
Enforcement; No Conflicts. AVI is duly organized and validly
exists under the laws of the State of Oregon and has the requisite
corporate power and authority to enter into and to consummate the transactions
contemplated hereby and otherwise to carry out
5
its
obligations hereunder. The execution and delivery of this Agreement by AVI and
the consummation by it of the transactions contemplated hereby have been duly
authorized by all necessary action on the part of AVI and no further
consent or action is required by AVI, its Board of Directors or its
stockholders. This Agreement has been (or upon delivery will be) duly executed
by AVI and is, or when delivered in accordance with the terms hereof, will
constitute, the valid and binding obligation of AVI enforceable against AVI in
accordance with its terms, subject to bankruptcy, insolvency, and other similar
laws affecting the rights of creditors generally and subject to the exercise of
judicial discretion in accordance with principles of equity. The execution,
delivery and performance of this Agreement by AVI and the consummation by AVI
of the transactions contemplated hereby do not and will not: (i) conflict
with or violate any provision of AVIs certificate or articles of
incorporation, bylaws or other organizational or charter documents, or (ii) subject
to obtaining the Required Approvals (as defined below), conflict with, or
constitute a default (or an event that with notice or lapse of time or both
would become a default) under, or give to others any rights of termination,
amendment, acceleration or cancellation (with or without notice, lapse of time
or both) of, any agreement, credit facility, debt or other instrument
(evidencing an AVI debt or otherwise) or other understanding to which AVI is a
party or by which any property or asset of AVI is bound or affected, or (iii) result
in a violation of any law, rule, regulation, order, judgment, injunction,
decree or other restriction of any court or governmental authority to which AVI
is subject (including federal and state securities laws and regulations), or by
which any property or asset of AVI is bound or affected; except in the case of
each of clauses (i), (ii) and (iii), such as could not, individually or in
the aggregate: (x) materially and adversely affect the legality, validity or
enforceability of this Agreement, (y) have or result in a materially
detrimental effect on the results of operations, assets, business or financial
condition of AVI, or (z) adversely impair AVIs ability to perform fully
on a timely basis its obligations under the Agreement (any of (x), (y) or (z),
a Material Adverse Effect).
(b) Filings,
Consents and Approvals; Issuance of Securities. AVI is not required to obtain any consent,
waiver, authorization or order of, give any notice to, or make any filing or
registration with, any court or other federal, state, local or other
governmental authority or other Person in connection with the execution,
delivery and performance by AVI of this Agreement, other than (i) the
filings of a Form 8-K disclosing the transaction contemplated hereby, (ii) the
application(s) to The Nasdaq National Market (the Principal
Market) for the listing of the Purchased Shares for trading thereon
in the time and manner required thereby, and (iii) applicable filings
under federal and applicable state blue sky laws (collectively, the Required Approvals). Person means an individual or corporation,
partnership, trust, incorporated or unincorporated association, joint venture,
limited liability company, joint stock company, government (or an agency or
subdivision thereof) or other entity of any kind. The Purchased Shares are duly
authorized and, when issued and paid for in accordance with this Agreement will
be duly and validly issued, fully paid and nonassessable, and free and clear of
all Liens. The issuance by AVI of the Purchased Shares has not been registered
under the Securities Act and, accordingly, the Purchased Shares may not
be, sold, assigned or transferred without registration unless the Purchased
Shares are subsequently registered or are exempt under applicable exemptions from
registration under the Securities Act.
(c) SEC
Reports; Financial Statements. AVI
has filed all reports required to be filed by it under the Securities Act and
the Securities Exchange Act of 1934, as amended (the 1934
6
Act),
including pursuant to Section 13(a) or 15(d) thereof, for the
two (2) years preceding the date hereof (the foregoing materials being
collectively referred to herein as the SEC
Reports) on a timely basis or has received a valid extension of
such time of filing and has filed any such SEC Reports prior to the expiration
of any such extension. As of their respective dates, the SEC Reports complied
in all material respects with the requirements of the Securities Act and the
1934 Act and the rules and regulations of the SEC promulgated thereunder,
and none of the SEC Reports, when filed, contained any untrue statement of a
material fact or omitted to state a material fact required to be stated therein
or necessary in order to make the statements therein, in the light of the
circumstances under which they were made, not misleading. The financial
statements of AVI included in the SEC Reports comply in all material respects
with applicable accounting requirements and the rules and regulations of
the SEC with respect thereto as in effect at the time of filing. Such financial
statements have been prepared in accordance with generally accepted accounting
principles applied on a consistent basis during the periods involved (GAAP), except as may be otherwise
specified in such financial statements or the notes thereto, and fairly present
in all material respects the financial position of AVI as of and for the dates
thereof and the results of operations and cash flows for the periods then
ended, subject, in the case of unaudited statements, to normal, immaterial,
year-end audit adjustments.
(d) Material
Changes. Since the date of the
latest audited financial statements included within the SEC Reports, except as
specifically disclosed in the SEC Reports: (i) there has been no event,
occurrence or development that, individually or in the aggregate, has had or
that could reasonably be expected to result in a Material Adverse Effect, (ii) AVI
has not incurred any liabilities (contingent or otherwise) other than (A) trade
payables and accrued expenses incurred in the ordinary course of business
consistent with past practice and (B) liabilities not required to be
reflected in AVIs financial statements pursuant to GAAP or required to be
disclosed in filings made with the SEC, (iii) AVI has not altered its
method of accounting or the identity of its auditors, (iv) AVI has not
declared or made any dividend or distribution of cash or other property to its
stockholders or purchased, redeemed or made any agreements to purchase or
redeem any shares of its capital stock, and (v) AVI has not issued any
equity securities to any officer, director or Affiliate, except pursuant to
existing AVI stock option and purchase plans.
(e) Disclosure.
All disclosures provided to the Investor
regarding AVI, its business and the transactions contemplated hereby, furnished
by or on behalf of AVI are true and correct and do not contain any untrue
statement of a material fact or omit to state any material fact necessary in
order to make the statements made therein, in the light of the circumstances
under which they were made, not misleading. None of the statements, documents,
certificates or other items prepared or supplied by AVI with respect to the
transactions contemplated hereby, including, without limitation, reports, data,
analyses and correspondence relating to the Drug, contains an untrue statement
of a material fact or omits a material fact necessary to make the statements
contained therein not misleading. There is no fact which AVI has not disclosed
to Investor and its counsel in writing and of which AVI is aware which could
have a Material Adverse Effect.
(f) Nasdaq;
Etc. AVI is in compliance with all
applicable Nasdaq continued listing requirements for the Nasdaq Stock Market
and is listed in good standing on the Nasdaq Stock Market. There are no
proceedings pending or, to AVIs knowledge, threatened against AVI
7
relating to
the continued listing of AVIs Common Stock on the Nasdaq National Market and
AVI has not received any notice of, nor to the knowledge of AVI is there any
basis for, the delisting of the Common Stock from the Nasdaq National Market.
4. REPRESENTATIONS
AND WARRANTIES OF INVESTOR
(a) Investor
hereby makes the following representations and warranties to AVI:
(i) Investor
is a corporation duly organized, validly existing and in good standing under
the laws of the State of Indiana.
(ii) Investor
has the requisite corporate (or other entity) power and authority to enter into
and perform this Agreement and to purchase the Common Stock in accordance
with the terms hereof.
(iii) In
making its investment decision in this offering, Investor and its advisors, if
any, have relied solely on AVIs public filings as filed with the Securities
and Exchange Commission and on the representations and warranties of AVI in
this Agreement.
(iv) Investor
is an accredited investor as such term is defined under the Securities Act and
Investor is purchasing the Purchased Shares for its own account as principal,
and not with a view towards distribution of such securities.
(v) Investor
understands that the Purchased Shares have not been registered under the
Securities Act or applicable state securities laws. Investor also understands
that the Purchased Shares are being offered and sold pursuant to exemptions
from registration contained in the Securities Act and applicable state
securities laws in part upon Investors representations contained in this
Agreement.
5. COVENANTS
(a) Best
Efforts. AVI will use its best
efforts to satisfy in a timely fashion each of the conditions to be satisfied
under Section 6 of this Agreement.
(b) Compliance
With Nasdaq Listing Requirements. AVI
will comply with all applicable Nasdaq continued listing requirements for the
Nasdaq Stock Market and shall remain in good standing on the Nasdaq Stock
Market so long as the Investor holds any of the Purchased Shares.
(c) Regulatory
Approvals.
(i) Cooperation. AVI and Investor shall each use
commercially reasonable efforts to take, or cause to be taken, all appropriate
action, and do, or cause to be done, all things as may be necessary or
appropriate under any applicable law, and will file and, if appropriate, use
commercially reasonable efforts to have declared effective or approved all
documents and notifications with any governmental or regulatory bodies that
they deem necessary or appropriate for, the issuance of the Purchased Shares
and each party shall give the other information
8
reasonably
requested by such other party pertaining to it and its Affiliates to enable
such other party to take such actions. The parties agree to make any such
required filing a reasonable period of time prior to the anticipated date of
the occurrence of any closing hereunder that gives rise to such required filing.
It shall be a condition to the occurrence of any closing hereunder that any
such actions or approvals required under any such law be declared effective or
approved, or that any waiting periods (or extensions thereof) expire or
terminate.
(ii) No
Divestiture Required of Investor. Notwithstanding
the foregoing or anything herein to the contrary, nothing shall require
Investor to make or agree to make, any divestiture of any portion of any
business or assets of Investor or its Affiliates to make arrangements for or to
effect the cessation, sale, or other disposition of particular assets or
categories of assets or businesses of Investor or its Affiliates in order to
obtain any waiver, consent or approval, and neither Investor nor its Affiliate
shall be required to take or commit to take any action that limits its freedom
of action or rights with respect to AVI or the Purchased Shares.
(d) Exclusivity.
AVI agrees that for a period commencing
upon execution of this Agreement until the earlier of the Closing or
termination of this Agreement in accordance with Section 8, AVI will not
directly or indirectly encourage or solicit the submission of, or entertain
inquiries, proposals or offers from any person or entity (other than Investor
or its Affiliates), or otherwise provide information to or engage in
discussions with any other Person, in any way relating to the sale, licensing,
distribution or other disposition of the Drug in the Field, except as may otherwise
be required under applicable fiduciary duties applicable to the AVI Board of
Directors.
(e) Registration
of Purchased Shares. AVI agrees to
file a registration statement for the Purchased Shares under the Securities Act
(the Registration Statement) within thirty (30) days of the Closing
Date and to use its best efforts to cause the registration statement to become
effective as soon as practicable thereafter. Once the Registration Statement is
declared effective by the SEC, AVI will cause the Registration Statement to
remain continuously effective until the earlier of (i) the date on which
all of the Purchased Shares have been sold by Investor or (ii) the first
date on which all the Purchased Shares (in the opinion of AVIs counsel, which
opinion is reasonably acceptable to Investor and its counsel) may be
immediately sold by Investor without registration and without restriction
(including without limitation as to volume by each holder thereof) as to the
number of Purchased Shares to be sold, pursuant to Rule 144(k) under the
Securities Act or any successor rule, or (iii) March ,
2009. AVI will also use its best efforts to register and qualify the Purchased
Shares under such other securities or blue sky laws of such jurisdictions as
Investor reasonably requests and to cause such registrations and qualifications
to remain effective for the same period of time that the registration with the
SEC remains effective. AVI will bear all expenses, other than underwriting
discounts and commissions and transfer taxes, if any, incurred in connection
with the registration or qualification of the Purchased Shares as provided
herein. AVI shall indemnify and hold harmless Investor and its officers,
directors, shareholders, and controlling persons within the meaning of the
Securities Act and the Exchange Act, from and against any loss damage, claim,
expense or liability arising or alleged to arise under the Securities Act or
the Exchange Act or otherwise as a result of any untrue statement or alleged
untrue statement of material fact contained in the Registration Statement or
any document filed with any state securities administrator in connection with
the registration or
9
qualification
of the Purchased Shares or any amendment or supplement to the Registration
Statement or any such document or the omission or alleged omission to state
therein a material fact required to be stated therein or necessary to make the
statements therein not misleading; provided however, AVI shall have no
obligation or liability under the foregoing with respect to any claims made
with respect to information contained in the Registration Statement that is
provided by Investor and, further, AVIs liability hereunder shall be limited
to $5 million.
6. CONDITIONS
TO CLOSING
(a) Conditions
to Investors Obligations. The
obligations of Investor to purchase and pay for the Purchased Shares pursuant
to Section 2 at the Closing are subject to the satisfaction or waiver of
the conditions set forth below:
(i) Representations
and Warranties to be True and Correct. The representations and warranties contained
in Section 3 shall be true, complete and correct in all material respects
on and as of the Closing Date with the same effect as though such
representations and warranties had been made on and as of such date, and the
President and Chief Financial Officer of AVI shall have certified to such
effect to Investor in writing.
(ii) Performance.
AVI shall have performed and complied
with all terms and conditions contained in this Agreement and the Transaction
Documents which are required to be performed or complied with by AVI prior to
or at such Closing Date, and the President and Chief Financial Officer of AVI
shall have certified to Investor in writing to such effect and to the further
effect that all of the conditions set forth in this Section 6 have been
satisfied.
(iii) Execution
and Delivery of Transaction Documents. AVI shall have executed and delivered the
Transaction Documents.
(iv) All
Proceedings to be Satisfactory. All
corporate and other proceedings to be taken by AVI in connection with the
transactions contemplated hereby and all documents incident thereto shall be
satisfactory in form and substance to Investor and its counsel, and
Investor and its counsel shall have received all such counterpart originals
or certified or other copies of such documents as they reasonably may request.
(v) Required
Consents. AVI shall have obtained the
written consent or approval of each Person whose consent or approval is
required in connection with this Agreement and the Transaction Documents,
including but not limited to expiration or termination of any waiting periods
(and any extension thereof) under all applicable laws and all applicable
consents and approvals, in form and content satisfactory to Investor, from
the National Institute of Health with respect to the assignment of the NIH
License (as defined in the License and Development Agreement) to AVI, the grant
of a sublicense by AVI to Investor with respect thereto and the modification of
the benchmarks set forth in the NIH License in a manner acceptable to Investor.
(vi) Litigation
Affecting Closing. No suit, action
or other proceeding shall be pending or threatened by any third party or by or
before any court or governmental agency in which it is sought to restrain or
prohibit or to obtain damages or other relief in connection with this Agreement
or the Transaction Documents, or the consummation of the transactions
10
contemplated
hereby or thereby, and no investigation that might result in any such suit,
action or other proceeding shall be pending or threatened.
(vii) Legislation.
No statute, rule, regulation, order, or
interpretation shall have been proposed, enacted, entered or deemed applicable
by any domestic or foreign government or governmental or administrative agency
or court which would make the transactions contemplated by this Agreement or
the Transaction Documents illegal.
(viii) No
Change of Control. Since the date
hereof, there shall not have been any Change of Control.
(ix) No
Material Adverse Changes. Since the
date hereof, no event shall have occurred which may be reasonably expected
to result in a Material Adverse Effect.
(x) No
Default. Since the date hereof, no
default (or event which, with the passage of time and/or the giving of notice,
would constitute a default) of AVI shall have occurred under this Agreement or
the Transaction Documents.
(xi) Opinion
of AVIs Counsel. Investor shall
have received from Davis Wright Tremaine LLP, counsel for AVI, an opinion dated
as of such Closing Date in form and scope satisfactory to Investor and its
counsel, substantially as set for in Exhibit A.
(b) Conditions
to AVIs Obligations. The
obligations of AVI to issue, sell and deliver certificates representing the
Purchased Shares pursuant to Section 2 are subject to the satisfaction or
waiver, on or before the Closing Date of the conditions set forth below:
(i) Execution
of Transaction Documents. Investor
shall have executed and delivered the Transaction Documents.
(ii) Representations
and Warranties to be True and Correct. The representations and warranties contained
in Section 4 shall be true, complete and correct in all material respects
on and as of the Closing Date.
(iii) Performance.
Investor shall have performed and
complied with all terms and conditions contained in this Agreement and the
Transaction Documents which are required to be performed or complied with by
Investor prior to or at such Closing Date.
(iv) Proceedings
to be Satisfactory. All corporate
and other proceedings to be taken by Investor in connection with the
transactions contemplated hereby and all documents incident thereto shall be
satisfactory in form and substance to AVI and its counsel, and AVI and its
counsel shall have received all such counterpart originals or certified or
other copies of such documents as they reasonably may request.
(v) Required
Consents. Investor shall have
obtained the written consent or approval of each Person whose consent or
approval is required in connection with this Agreement and the Transaction
Documents.
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(vi) Litigation
Affecting Closing. No suit, action
or other proceeding shall be pending or threatened by any third party or by or
before any court or governmental agency in which it is sought to restrain or
prohibit or to obtain damages or other relief in connection with this Agreement
or the Transaction Documents, or the consummation of the transactions
contemplated hereby or thereby, and no investigation that might result in any
such suit, action or other proceeding shall be pending or threatened.
(vii) Legislation.
No statute, rule, regulation, order, or
interpretation shall have been proposed, enacted, entered or deemed applicable
by any domestic or foreign government or governmental or administrative agency
or court which would make the transactions contemplated by this Agreement or
the Transaction Documents illegal.
(viii) No
Change of Control. Since the date
hereof, there shall not have been any Change of Control of Investor.
(ix) No
Default. Since the date hereof, no
default (or event which, with the passage of time and/or the giving of notice,
would constitute a default) of Investor shall have occurred under this
Agreement or the Transaction Documents.
7. INDEMNIFICATION
(a) Indemnification
of Investor. AVI shall indemnify,
defend and hold harmless Investor and each of its Affiliates, and their
respective officers, directors and shareholders from and against and in respect
of any and all demands, claims, actions or causes of action, assessments,
losses, damages, liabilities, interest and penalties, costs and expenses
(including, without limitation, reasonable legal fees and disbursements
incurred in connection therewith and in seeking indemnification therefor, and
any amounts or expenses required to be paid or incurred in connection with any action,
suit, proceeding, claim, appeal, demand, assessment or judgment) (Indemnifiable
Losses), resulting from, arising out of, or imposed upon or incurred by any
Person to be indemnified hereunder by reason of any breach of any
representation, warranty, covenant or agreement of AVI contained in this
Agreement or any agreement, certificate or document executed and delivered by
AVI pursuant hereto.
(b) Indemnification
of AVI. Investor shall indemnify,
defend and hold harmless AVI and each of its Affiliates, and their respective
officers, directors and shareholders from and against and in respect of any and
all Indemnifiable Losses resulting from, arising out of, or imposed upon or
incurred by any Person to be indemnified hereunder by reason of any breach of
any representation, warranty, covenant or agreement of Investor contained in
this Agreement or any agreement, certificate or document executed and delivered
by Investor pursuant hereto.
(c) Third-Party
Claims. If a claim by a third party
is made against Investor or AVI as the case may be and such claim does or may constitute
an Indemnifiable Loss (an Indemnified Party)and if the other party (the Indemnifying
Party) intends to seek indemnity with respect thereto under this Section 7,
the Indemnified Party shall promptly notify Indemnifying Party of such claim;
provided, however, that failure to give timely notice shall not affect the
rights of the Indemnified Party so long as the failure to give timely notice
does not materially and adversely affect the Indemnifying Partys ability to
defend such claim against a third party. The
12
Indemnified
Party shall not settle such claim without the consent of the Indemnifying Party.
If the Indemnifying Party acknowledges in writing its indemnity obligations for
Indemnifiable Losses resulting therefrom, the Indemnifying Party shall control
all settlement discussions and litigation proceedings and the Indemnified Party
may participate at its own cost and expense in such discussions or
proceedings so long as such participation does not interfere with the
reasonable judgment of the Indemnifying Party with respect to such discussions
and proceedings.
(d) Cooperation
as to Indemnified Liability. Each
party hereto shall cooperate fully with the other party with respect to access
to books, records, or other documentation within such partys control, if
deemed reasonably necessary or appropriate by either party in the defense of
any claim which may give rise to indemnification hereunder.
(e) Brokerage.
AVI will indemnify and hold harmless
Investor against and in respect of any claim for brokerage or other commissions
relative to this Agreement or to the transactions contemplated hereby, based in
any way on agreements, arrangements or understandings made or claimed to have
been made by AVI with any third party.
(f) Limitation
on Certain Claims. To the extent any
Indemnified Party wishes to make a claim for indemnification under Section 7
with respect to the breach of an Indemnifying Partys representations and
warranties deemed made as of the Closing Date, such claim for indemnification
shall be made within one hundred and eighty (180) days after the Closing Date. However,
the foregoing one hundred and eighty (180) day limitation shall not apply to
any claim for indemnification arising out of any third party claim made against
an Indemnified Party.
8. TERMINATION
AND DEFAULT
(a) Termination.
The obligation of the parties hereto to
consummate the remaining transactions contemplated hereby may be
terminated and abandoned at any time at or before the Closing if any of the
following events occurs:
(i) by
and at the option of Investor or AVI, if the Closing does not occur within five
(5) days from the date hereof, provided that Investor or AVI, as the case may be,
is not then in material default under this Agreement; or
(ii) by
and at the option of Investor, if the Investor terminates the License and
Development Agreement pursuant to Section 9.2(b) thereof; or
(iii) by
and at the option of Investor, if AVI is in default under this Agreement or the
Transaction Documents, and does not cure such default within thirty (30) days
after having received a written notice from Investor regarding such default; or
(iv) by
and at the option of AVI, if Investor is in default under this Agreement or the
Transaction Documents, and does not cure such default within thirty (30) days
after having received a written notice from AVI regarding such default; or
(v) by
and at the option of Investor, if any event or circumstance occurs or exists
that renders any condition to Investors obligations set forth in Section 6
incapable of being satisfied; or
13
(vi) by
and at the option of Investor if a Material Adverse Effect with respect to AVI
shall have occurred; or
(vii) by
the mutual written consent of the parties; or
(viii) by
and at the option of either Investor or AVI if any governmental authority shall
have issued an order, decree, or ruling or taken any other action restraining,
enjoining or otherwise prohibiting in any material respects the transactions
contemplated hereby and such order, decree, ruling or other action shall have
become final and nonappealable.
(b) Effect.
Termination of this Agreement by a party
shall not relieve the other parties hereto of any liability for breach of
representation, warranty, covenant or agreement by such other parties including
liability for monetary damages and/or specific performance. Investors rights
pursuant to the Transaction Documents shall survive any termination of this
Agreement.
9. OTHER
PROVISIONS
(a) Further
Assurances. At such time and from
time to time on and after the Closing Date, upon request by the other party,
Investor and AVI will execute, acknowledge and deliver, or will cause to be
done, executed, acknowledged and delivered, all such further acts, deeds,
assignments, transfers, conveyances, powers of attorney and assurances that may be
required for the better conveying, transferring, assigning, delivering,
assuring and confirming to Investor, or to its respective successors and
assigns, all of the Purchased Shares or to otherwise carry out the purposes of
this Agreement.
(b) Complete
Agreement. This Agreement and the
Transaction Documents (including all schedules and exhibits hereto and thereto)
constitute the entire agreement among the parties hereto with respect to the
subject matter hereof and thereof. There are no restrictions, promises,
warranties or undertakings, other than those set forth or referred to herein or
therein, with respect to the subject matter hereof and thereof. This Agreement
supersedes all prior agreements and understandings among the parties hereto
with respect to the subject matter hereof.
(c) Survival
of Representations, Warranties and Agreements. The representations, warranties, covenants and
agreements contained in Sections 3 and 4 of this Agreement shall survive the
Closing and remain in full force and effect. No independent investigation of
AVI by Investor, its counsel, or any of its agents or employees shall in any
way limit or restrict the scope of the representations and warranties made by
AVI in this Agreement.
(d) Waiver,
Discharge, Amendment, Etc. The
failure of any party hereto to enforce at any time any of the provisions of
this Agreement shall not, absent an express written waiver signed by the party
making such waiver specifying the provision being waived, be construed to be a
waiver of any such provision, nor in any way to affect the validity of this
Agreement or any part thereof or the right of the party thereafter to
enforce each and every such provision. No waiver of any breach of this
Agreement shall be held to be a waiver of any other or subsequent breach. This
Agreement may be amended by AVI and Investor, by mutual action approved by
their respective Boards of Directors or their respective officers authorized by
such Board of
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Directors, at
any time. Any amendment to this Agreement shall be in writing and signed by AVI
and Investor.
(e) Notices. All notices or other communications to a
party required or permitted hereunder shall be in writing and shall be
delivered personally or by telecopy (receipt confirmed) to an executive officer
of such party or shall be sent by a reputable express delivery service or by
certified mail, postage prepaid with return receipt requested, addressed as
follows:
if to
Investor to:
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Cook Group
Incorporated
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750 Daniels Way
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Bloomington, Indiana 47402
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Attn: Pete Yonkman
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Facsimile: (812) 339-5369
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With a copy to:
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Stephen J. Hackman
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Ice Miller LLP
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One American Square, Suite 3100
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Indianapolis, Indiana 46282
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Facsimile: (317) 592-4666
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if to AVI to:
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AVI BioPharma Inc.
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One SW Columbia, Suite 1105
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Portland OR 97258
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Attn: Alan Timmins
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Facsimile: (503) 227-0554
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With a copy to:
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Michael Phillips
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Davis Wright Tremaine LLP
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1300 SW Fifth Avenue, Suite 2300
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Portland OR 97201-5682
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Facsimile: (503) 778-5299
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Any party may change the abovespecified recipient and/or mailing
address by notice to the other party given in the manner herein prescribed. All
notices shall be deemed given on the day when actually delivered as provided
above (if delivered personally or by telecopy) or on the day shown on the
return receipt (if delivered by mail or delivery service).
(f) Public
Announcement. In the event either
party proposes to issue any press release or public announcement concerning the
existence of the terms and conditions of or the negotiations of the parties
with respect to this Agreement or any of the Transaction Documents, such party
shall so advise the other party hereto, and the parties shall thereafter use
their best efforts to cause a mutually agreeable release or announcement to be
issued; provided that neither party shall issue any such press release or
public announcement if AVI notifies the Investor that it has been advised by
counsel that the issuance of the proposed press release or the making of the proposed
public announcement, under the circumstances existing at the time of the
proposed disclosure, would result in a violation of applicable federal
securities laws or require AVI to disclose material non-public information
involving AVI that, in the good faith judgment of AVIs
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Board of
Directors, would be inadvisable or would be likely to materially and adversely
affect AVIs business. If any press release or other public announcement is
delayed under this Section 9(f), AVI shall notify the Investor as soon as
the condition entitling AVI to delay disclosure is resolved and Investor shall
thereafter be entitled to make such press release or public announcement in a form that
is mutually agreeable to the parties.
(g) Expenses.
AVI and Investor shall each pay their
own expenses incident to this Agreement and the preparation for, and
consummation of, the transactions provided for herein.
(h) Governing
Law. This Agreement shall be
governed by and construed in accordance with the Laws of the State of Oregon
applicable to a contract executed and performed in such State, without giving
effect to the conflicts of laws principles thereof.
(i) Titles
and Headings; Construction. The
titles and headings to the Sections herein are inserted for the convenience of
reference only and are not intended to be a part of or to affect the
meaning or interpretation of this Agreement. This Agreement shall be construed
without regard to any presumption or other rule requiring construction
hereof against the party causing this Agreement to be drafted.
(j) Benefit.
Nothing in this Agreement, expressed or
implied, is intended to confer on any person other than the parties hereto or
their respective successors or assigns, any rights, remedies, obligations or
liabilities under or by reason of this Agreement.
(k) Counterparts.
This Agreement may be executed in
any number of counterparts, each of which shall be deemed as original and all
of which together shall constitute one instrument.
(l) Assignment. Neither this Agreement nor any right, interest
or obligation hereunder may be assigned by any party hereto without the
prior written consent of the other party hereto and any attempt to do so will
be void, except (a) for assignments and transfers by operation of Law; (b) that
Investor may assign any or all of its rights, interests and obligations
hereunder without the AVIs consent (i) to Investors direct or indirect
parent, (ii) to any subsidiary of Investor at least 50% of the voting
power of which is owned, directly or indirectly, by Investor or its Affiliates,
(iii) to a wholly-owned, direct or indirect subsidiary of Investor, (iv) to
an entity that acquires the entire equity interest or substantially all of the
assets of Investor or Investors parent, or (v) to any person who acquires
the product line to which this Agreement and the Transaction Documents pertain,
(c) that Investor may collaterally assign its rights under this
Agreement to parties providing financing in connection with the transactions
contemplated hereby. This Agreement is binding upon, inures to the benefit of
and is enforceable by the parties hereto and their respective successors and
assigns. Notwithstanding and in addition to the foregoing, Investor may separately
assign its rights and indemnities under Section 5(d) to any Person
who acquires at least 10,000 Purchased Shares from Investor.
(m) Jurisdiction;
Venue. AVI consents to the
jurisdiction of, and venue in, any state or federal court located within Marion
County, Indiana, and waives personal service of any and all process made upon
AVI. AVI waives any objection, which it may have to any proceeding
commenced in a federal or state court located within Marion County, Indiana. Any
judicial
16
proceeding by
AVI against Investor involving, directly or indirectly, any matter or claim in
any way arising out of, related to or connected herewith shall be brought only
in the federal or state courts of the State of Indiana, situated in Marion
County, Indiana.
(n) Non-Disclosure. Each party agrees not to disclose or use
(except as permitted or required for performance by the party receiving such
Confidential Information of its rights or duties hereunder or under the
Transaction Documents) any Confidential Information of the other party obtained
during the term of this Agreement until the expiration of three (3) years
after the earlier of the Closing or the termination of this Agreement. Each
party further agrees to take appropriate measures to prevent any such
prohibited disclosure by its present and future employees, officers, agents,
subsidiaries, or consultants during such term.
[SIGNATURE PAGE FOLLOWS]
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IN WITNESS WHEREOF, each of the parties has caused this Investment
Agreement to be executed in the manner appropriate for each, and to be dated as
of the date first above-written.
COOK GROUP INCORPORATED
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AVI BIOPHARMA, INC.
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By:
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By:
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Printed:
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Printed:
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Alan P. Timmins
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Title:
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Title:
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President
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Date:
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Date:
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18
EXHIBITS AND SCHEDULES:
Schedule A Disclosure Schedule
19
EXHIBIT A
LEGAL OPINION OF AVIS COUNSEL
(a) AVI
is a corporation duly incorporated and validly existing under the laws of the
state of Oregon. AVI has the corporate power and authority to execute, deliver
and perform this Agreement and the Transaction Documents and to issue,
sell and deliver the Purchased Shares.
(b) All
necessary corporate action on the part of AVI and of its officers,
directors and shareholders has been taken for the valid execution and delivery
of this Agreement, the Transaction Documents, and the performance of the
obligations of AVI hereunder and thereunder. This Agreement and the Transaction
Documents have been validly executed and delivered and are legal, valid and
binding obligations of AVI, enforceable against AVI in accordance with their respective
terms, subject in each case to bankruptcy, insolvency, and other similar laws
affecting the rights of creditors generally and subject to the exercise of
judicial discretion in accordance with principles of equity. The execution and
delivery of this Agreement and the Transaction Documents and the performance by
AVI of its obligations hereunder and thereunder do not conflict with or result
in the violation of AVIs Articles of Incorporation or Bylaws; or order, writ,
judgment or decree known to such counsel to which AVI is a party or by which it
is bound, or to such counsels knowledge, violate any existing law or
regulation.
(c) The
Purchased Shares have been duly authorized by all necessary corporate action on
the part of AVI and, upon delivery by AVI in accordance with the terms of
this Agreement, will be duly and validly issued, fully paid and nonassessable.
(d) All
consents, approvals, orders, authorizations or registrations, qualifications,
designations, declarations or filings of or with any federal or state
governmental authority on the part of AVI required in connection with the
consummation of the transactions contemplated by this Agreement and the
Transaction Documents have been made, obtained or effected (provided, however,
that filings under applicable state securities laws may be made promptly
after the Closing to the extent such filings are permitted to be made after the
sale of the Purchased Shares). Based in part on the representations of
Investor in Section 4 of this Agreement, the offer, sale and issuance by
AVI of the Purchased Shares, all in conformity with the terms of this
Agreement, do not require registration under Section 5 of the Securities
Act of 1933, as amended.
20
Exhibit 23.1
Consent
of Independent Registered Public Accounting Firm
The Board of Directors
AVI
BioPharma, Inc.:
We consent to the use of our reports dated March 15,
2006, with respect to the balance sheets of AVI BioPharma, Inc. as of December
31, 2005 and 2004, and the related statements of operations, shareholders
equity and comprehensive income (loss), and cash flows for each of the years in
the three-year period ended December 31, 2005, managements assessment of the
effectiveness of internal control over financial reporting as of December 31,
2005, and the effectiveness of internal control over financial reporting as of
December 31, 2005, incorporated herein by reference and to the reference to our
firm under the heading Experts in the prospectus.
Portland, Oregon
April 7,
2006
Exhibit 23.2
April 7, 2006
AVI BioPharma, Inc.
One S.W. Columbia Street,
Suite 1105
Portland, Oregon 97258
Dear Ladies and Gentlemen:
We have acted as counsel to AVI BioPharma, Inc. (the Company) in connection with the registration
statement on Form S-3 to be filed by the Company with the Securities and
Exchange Commission on April 11, 2006 (the Registration Statement), relating
to the registration under the Securities Act of 1933, as amended, of 692,003
shares of the Companys Common Stock, par value $0.0001 per share (the Shares).
Capitalized terms used herein that are not otherwise defined have the meanings
ascribed thereto as set forth in the Registration Statement and the exhibits
thereto.
We have examined such documents, papers, statutes and authorities as we
have deemed necessary to form a basis for the opinions hereinafter expressed.
This opinion letter is to be interpreted in accordance with the Guidelines for
the Preparation of Closing Opinions issued by the Committee on Legal Opinions of
the American Bar Associations Business Law Section as published in 57 Business
Lawyer 875 (February 2002).
Based upon the foregoing, we are of the opinion that the Shares have
been duly authorized for issuance by Company, and when issued and sold in the
manner described in the Registration Statement, the Shares will be validly
issued, fully paid and nonassessable.
This opinion is limited to the Oregon Business Corporation Act. We
express no opinion with respect to the laws of any other country, state or
jurisdiction.
This opinion letter is limited to the matters stated herein and no
opinion is implied or may be inferred beyond the matters expressly stated. This
letter speaks only as of the date hereof and is limited to present statutes,
regulations and administrative and judicial interpretations. We undertake no
responsibility to update or supplement this letter after the date hereof.
We consent to the use of this opinion as an exhibit to the Registration
Statement, and further consent to all references to us in the Registration
Statement and any amendment thereto.
Very truly yours,
Davis Wright Tremaine LLP
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