SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
October
12, 2010
Date of
Report (Date of earliest event reported)
Discovery
Laboratories, Inc.
(Exact
name of registrant as specified in its charter)
Delaware
|
000-26422
|
94-3171943
|
(State
or other jurisdiction
of
incorporation)
|
(Commission
File Number)
|
(IRS
Employer
Identification
Number)
|
2600
Kelly Road, Suite 100
Warrington,
Pennsylvania 18976
(Address
of principal executive offices)
(215)
488-9300
(Registrant’s
telephone number, including area code)
(Former
name or former address, if changed since last report)
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
¨
|
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
|
¨
|
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|
¨
|
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
|
¨
|
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
|
Item
1.01. Entry into a Material
Definitive Agreement.
On October 12, 2010, Discovery
Laboratories, Inc. (the “Company”) entered into a securities purchase agreement
(the “Securities Purchase Agreement”) with PharmaBio Development Inc.
(“PharmaBio”), as the sole purchaser, related to an offering of 2,380,952 shares
of the Company’s common stock (the “Common Stock”) and warrants to purchase an
aggregate of 1,190,476 shares of Common Stock (“Warrants”). The
shares of Common Stock and Warrants are being sold as units (“Units”), with each
Unit consisting of (i) one share of Common Stock, and (ii) one Warrant to
purchase one-half of a share of Common Stock, at an offering price of $0.21 per
Unit (the “Offering”). The offering price per Unit was calculated
based on the greater of (a) the volume-weighted average sale price (“VWAP”) per
share of the Common Stock on The Nasdaq Capital Market for 10 consecutive
trading days ending on October 11, 2010 and (b) the VWAP per share of the Common
Stock on October 11, 2010.
Each warrant represents the right to
purchase one-half of a share of Common Stock at an exercise price of $0.273 per
share, which represents 130% of the greater of (a) the VWAP per share of the
Common Stock on The Nasdaq Capital Market for 10 consecutive trading days ending
on October 11, 2010 and (b) the VWAP per share of the Common Stock on October
11, 2010. The Warrants to be issued in the Offering generally will be
exercisable immediately upon issuance for a period of five years from the
original date of issuance. The exercise price and number of shares of
Common Stock issuable on exercise of the Warrants will be subject to adjustment
in the event of any stock split, reverse stock split, stock dividend,
recapitalization, reorganization or similar transaction.
The Company may also redeem any or all
outstanding Warrants at any time within 20 days following the occurrence of a
trading threshold at a per Warrant redemption price of $0.001, upon 20 days’
written notice to the holder of the Warrant. A trading threshold will
be deemed to have occurred on any date that the reported VWAP for any five (5)
out of seven (7) consecutive trading days immediately prior to such date exceeds
$0.45, with a minimum average daily trading volume for such seven (7) day period
of at least 500,000 shares of common stock (with such price and volume criteria
being appropriately adjusted for any share dividend, share split or other
similar transaction that may occur on or after the issuance). Upon
the expiration of the 20-day notice period (as it may be extended if the
registration statement is not effective), all warrants noticed for redemption
that have not been exercised by the holder will, upon payment of the aggregate
redemption price, cease to represent the right to purchase any shares of common
stock and will be deemed cancelled and void and of no further force or effect
without any further act or deed on the Company’s part.
The Offering is expected to close on
October 14, 2010, subject to the satisfaction of customary closing conditions.
Gross proceeds to the Company from the Offering will be $500,000 and the net
proceeds to the Company are expected to be approximately $470,000, after
deducting estimated expenses payable by the Company associated with the
Offering. The Offering is being made by means of a prospectus
supplement dated October 12, 2010 and an accompanying prospectus dated June 11,
2010, pursuant to the Company’s existing shelf registration statement on Form
S-3 (File No. 333-151654).
The Securities Purchase Agreement
contains customary representations, warranties, and agreements by the Company,
and customary conditions to closing.
The agreements and instruments that
have been attached as hereto as exhibits are intended to provide investors and
security holders with information regarding the terms of those agreements and
instruments and are not intended to provide any other factual information about
the Company. The representations, warranties and covenants contained therein
were made only for purposes of such agreements and instruments and as of
specific dates, were solely for the benefit of the parties thereto, and may be
subject to limitations agreed upon by the contracting parties, including being
qualified by confidential disclosures exchanged between the parties in
connection with the execution of such agreements and instruments.
A copy of the Securities Purchase
Agreement and the form of Warrant to be issued in connection with the Offering
are filed herewith as Exhibits 10.1 and 4.1 and are incorporated herein by
reference. The foregoing description of the Offering by the Company and the
documentation related thereto does not purport to be complete and is qualified
in its entirety by reference to such exhibits. A copy of the opinion
of SNR Denton US LLP relating to the legality of the issuance and sale of the
securities in the Offering is attached as Exhibit 5.1 hereto.
Item
8.01. Other
Events.
On October 13, 2010 the Company issued
a press release announcing the entry into the Securities Purchase Agreement. The
full text of the press release is set forth in Exhibit 99.1 to this Current
Report on Form 8-K.
Item
9.01. Financial Statements and
Exhibits.
(d) Exhibits
|
5.1
|
Opinion
of SNR Denton US LLP
|
|
10.1
|
Securities
Purchase Agreement dated October 12, 2010 by and between Discovery
Laboratories, Inc. and PharmaBio Development
Inc.
|
|
23.1
|
Consent
of SNR Denton US LLP (included in its opinion filed as Exhibit 5.1
hereto)
|
|
99.1
|
Press
release dated October 13, 2010
|
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
Discovery
Laboratories, Inc.
|
|
|
By:
|
/s/ John G.
Cooper
|
Name:
|
John
G. Cooper
|
Title:
|
President
and Chief Financial
Officer
|
Date:
October 13, 2010
DISCOVERY
LABORATORIES, INC.
WARRANT
TO PURCHASE COMMON STOCK
Warrant
No.: ___
Number of
Shares of Common Stock: 1,190,476
Date of
Issuance: October 14, 2010 (“Issuance Date”)
Discovery
Laboratories, Inc., a Delaware corporation (the “Company”), hereby certifies
that, for good and valuable consideration, the receipt and sufficiency of which
are hereby acknowledged, PharmaBio Development Inc., a North Carolina
corporation, the registered holder hereof or its permitted assigns (the “Holder”), is entitled, subject
to the terms set forth below, to purchase from the Company, at the Exercise
Price (as defined below) then in effect, upon surrender of this Warrant to
Purchase Common Stock (including any Warrants to Purchase Common Stock issued in
exchange, transfer or replacement hereof, the “Warrant”), at any time or
times on or after the Issuance Date, but not after 11:59 p.m., New York time, on
the Expiration Date (as defined below), 1,190,476 (One
Million, One Hundred and Ninety Thousand, Four Hundred and Seventy-Six) fully paid nonassessable
shares of Common Stock (as defined below) (the “Warrant Shares”). Except
as otherwise defined herein, capitalized terms in this Warrant shall have the
meanings set forth in Section 16. This Warrant is the Warrant to purchase
Common Stock (this “Warrant”) issued pursuant to
(i) Section 2(c) of that certain Securities Purchase Agreement (the “Securities Purchase
Agreement”), dated as of October 12, 2010 (the “Pricing Date”), by and between
the Company and PharmaBio Development Inc. and (ii) the Company’s Registration
Statement on Form S-3 (File number 333-151654) (the “Registration Statement”).
1. EXERCISE
OF WARRANT.
(a) Mechanics
of Exercise. Subject to the terms and conditions hereof, this Warrant may
be exercised by the Holder on any day on or after the Issuance Date, in whole or
in part, by (i) delivery of a written notice, in the form attached hereto
as Exhibit A (the “Exercise Notice”), of the
Holder’s election to exercise this Warrant and (ii) (A) payment to the
Company of an amount equal to the applicable Exercise Price multiplied by the
number of Warrant Shares as to which this Warrant is being exercised (the “Aggregate Exercise Price”) in
cash or by wire transfer of immediately available funds or (B) provided the
conditions for cashless exercise set forth in Section 1(d) are
satisfied, by notifying the Company that this Warrant is being exercised
pursuant to a Cashless Exercise (as defined in Section 1(d)). The
Holder shall not be required to deliver the original Warrant in order to effect
an exercise hereunder. Execution and delivery of the Exercise Notice with
respect to less than all of the Warrant Shares shall have the same effect as
cancellation of the original Warrant and issuance of a new Warrant evidencing
the right to purchase the remaining number of Warrant Shares. On or before
the first (1st ) Business
Day following the date on which the Company has received each of the Exercise
Notice and the Aggregate Exercise Price (or notice of a Cashless Exercise)
(collectively, the “Exercise
Delivery Documents”), the Company shall transmit by facsimile or
electronic mail an acknowledgment of receipt of the Exercise Delivery Documents
to the Holder and Continental Stock Transfer & Trust Company (the Company’s
“Transfer
Agent”). On or before the third (3rd) Business Day following the
date on which the Company has received all of the Exercise Delivery Documents
(the “Share Delivery
Date”), the Company shall (X) provided that the Transfer Agent is
participating in The Depository Trust Company (“DTC”) Fast Automated
Securities Transfer Program, upon the request of the Holder, credit such
aggregate number of Warrant Shares to which the Holder is entitled pursuant to
such exercise to the Holder’s or its designee’s balance account with DTC through
its Deposit/Withdrawal At Custodian (“DWAC”) system, or (Y) if the
Transfer Agent is not participating in the DTC Fast Automated Securities
Transfer Program or the Holder does not request delivery of the Warrant Shares
via DWAC, issue and dispatch by overnight courier to the address as specified in
the Exercise Notice, a certificate, registered in the Company’s share register
in the name of the Holder or its designee, for the number of Warrant Shares to
which the Holder is entitled pursuant to such exercise. Upon delivery of
the Exercise Delivery Documents, the Holder shall be deemed for all corporate
purposes to have become the holder of record of the Warrant Shares with respect
to which this Warrant has been exercised, irrespective of the date such Warrant
Shares are credited to the Holder’s DTC account or the date of delivery of the
certificates evidencing such Warrant Shares, as the case may be. If this
Warrant is submitted in connection with any exercise pursuant to this Section
1(a) and the number of Warrant Shares represented by this Warrant submitted for
exercise is greater than the number of Warrant Shares being acquired upon an
exercise, then the Company shall as soon as practicable and in no event later
than three Business Days after any exercise and at its own expense, issue a new
Warrant (in accordance with Section 7(d)) representing the right to
purchase the number of Warrant Shares purchasable immediately prior to such
exercise under this Warrant, less the number of Warrant Shares with respect to
which this Warrant is exercised. No fractional shares of Common Stock are
to be issued upon the exercise of this Warrant, but rather the number of shares
of Common Stock to be issued shall be rounded down to the nearest whole
number. The Company shall pay any and all taxes which may be payable with
respect to the issuance and delivery of Warrant Shares upon exercise of this
Warrant.
(b) Exercise
Price. For purposes of this Warrant, “Exercise Price” means $0.273
subject to adjustment as provided herein.
(c) Company’s
Failure to Timely Deliver Securities. If the Company shall fail for any
reason or for no reason to issue to the Holder within three (3) Business Days of
receipt of the Exercise Delivery Documents in compliance with the terms of
this Section 1, a certificate for the number of shares of Common Stock to
which the Holder is entitled and register such shares of Common Stock on the
Company’s share register or to credit the Holder’s balance account with DTC for
such number of shares of Common Stock to which the Holder is entitled upon the
Holder’s exercise of this Warrant, and if on or after such Trading Day the
Holder purchases (in an open market transaction or otherwise) shares of Common
Stock to deliver in satisfaction of a sale by the Holder of shares of Common
Stock issuable upon such exercise that the Holder anticipated receiving from the
Company (a “Buy-In”), then the Company
shall, within three (3) Business Days after the Holder’s request and in the
Holder’s discretion, either (i) pay cash to the Holder in an amount equal to the
Holder’s total purchase price (including brokerage commissions, if any) for the
shares of Common Stock so purchased (the “Buy-In Price”), at which point
the Company’s obligation to deliver such certificate (and to issue such Warrant
Shares) shall terminate, or (ii) promptly honor its obligation to deliver to the
Holder a certificate or certificates representing such Warrant Shares and pay
cash to the Holder in an amount equal to the excess (if any) of the Buy-In Price
over the product of (A) such number of shares of Common Stock, times (B) the
Closing Bid Price on the date of exercise.
(d) Cashless
Exercise. Notwithstanding anything
contained herein to the contrary, if, but only if, (i) a registration statement
covering the issuance of the Warrant Shares that are the subject of the Exercise
Notice (the “Unavailable
Warrant Shares”) is not effective and (ii) in the written opinion of
counsel to the Holder addressed to the Company, which is satisfactory in form
and substance to the Company and its counsel, an exemption from registration for
the issuance and resale of such Unavailable Warrant Shares would only be
available if the exercise of the Warrant is effected pursuant to a Cashless
Exercise pursuant to this Section 1(d), then the Holder may exercise this
Warrant in whole or in part and, in lieu of making the cash payment otherwise
contemplated to be made to the Company upon such exercise in payment of the
Aggregate Exercise Price, elect instead to receive upon such exercise the “Net
Number” of shares of Common Stock determined according to the following formula
(a “Cashless
Exercise”):
Net
Number =
|
(A x B) - (A x
C)
|
|
|
B
|
|
For
purposes of the foregoing
formula:
|
A=
|
the
total number of shares with respect to which this Warrant is then being
exercised.
|
B=
|
the
arithmetic average of the Closing Sale Prices of the shares of Common
Stock for the five (5) consecutive Trading Days ending on the Trading Day
immediately preceding the date of the Exercise
Notice.
|
C=
|
the
Exercise Price then in effect for the applicable Warrant Shares at the
time of such exercise.
|
For sake
of clarity, regardless of whether an effective registration statement or an
exemption from registration is or is not available, there is no circumstance
that requires the Company to effect a net cash settlement of the
Warrants.
(e) Rule
144. For purposes of Rule 144(d) promulgated under the Securities Act, as
in effect on the date hereof, it is intended that the Warrant Shares issued in a
Cashless Exercise shall be deemed to have been acquired by the Holder, and the
holding period for the Warrant Shares shall be deemed to have commenced, on the
date this Warrant was originally issued pursuant to the Securities Purchase
Agreement.
(f) Disputes. In
the case of a dispute as to the determination of the Exercise Price or the
arithmetic calculation of the Warrant Shares, the Company shall promptly issue
to the Holder the number of Warrant Shares that are not disputed, and all such
disputes shall be resolved pursuant to Section 13.
(g) Beneficial
Ownership. The Company shall not effect the exercise of this Warrant, and
the Holder shall not have the right to exercise this Warrant, to the extent that
after giving effect to such exercise, such Person (together with such Person’s
affiliates) would beneficially own in excess of 9.99% (the “Maximum Percentage”) of the
shares of Common Stock outstanding immediately after giving effect to such
exercise (including in connection with any Fundamental Transaction (as defined
below)). For purposes of the foregoing sentence, the aggregate number of
shares of Common Stock beneficially owned by such Person and its affiliates
shall include the number of shares of Common Stock issuable upon exercise of
this Warrant with respect to which the determination of such sentence is being
made, but shall exclude shares of Common Stock which would be issuable upon (i)
exercise of the remaining, unexercised portion of this Warrant beneficially
owned by such Person and its affiliates and (ii) exercise or conversion of the
unexercised or unconverted portion of any other securities of the Company
beneficially owned by such Person and its affiliates (including, without
limitation, any convertible notes or convertible preferred stock or warrants)
subject to a limitation on conversion or exercise analogous to the limitation
contained herein. Except as set forth in the preceding sentence, for
purposes of this paragraph, beneficial ownership shall be calculated in
accordance with Section 13(d) of the Securities Exchange Act of 1934, as
amended. For purposes of this Warrant, in determining the number of
outstanding shares of Common Stock, the Holder may rely on the number of
outstanding shares of Common Stock as reflected in (1) the Company’s most recent
Form 10-K, Form 10-Q, Current Report on Form 8-K or other public filing with the
Securities and Exchange Commission, as the case may be, (2) a more recent public
announcement by the Company or (3) any other notice by the Company or the
Transfer Agent setting forth the number of shares of Common Stock outstanding.
To the extent that the limitation contained in this Section
1(g) applies, the determination of whether this Warrant is exercisable (in
relation to other securities owned by such Holder) and of which a portion of
this Warrant is exercisable shall be in the sole discretion of a Holder, and the
submission of an Exercise Notice shall be deemed to be each Holder’s
determination of whether this Warrant is exercisable (in relation to other
securities owned by such Holder) and of which portion of this Warrant is
exercisable, in each case subject to such aggregate percentage limitation, and
the Company shall have no obligation to verify or confirm the accuracy of such
determination. For any reason at any time, upon the written or oral request
of the Holder, the Company shall within two (2) Business Days confirm to the
Holder the number of shares of Common Stock then outstanding. In any case,
the number of outstanding shares of Common Stock shall be determined after
giving effect to the conversion or exercise of securities of the Company,
including this Warrant, by the Holder and its affiliates since the date as of
which such number of outstanding shares of Common Stock was reported. By
written notice to the Company, the Holder may from time to time increase or
decrease the Maximum Percentage to any other percentage not in excess of 9.99%
specified in such notice; provided that (i) any
such increase will not be effective until the sixty-first (61st) day after such notice is
delivered to the Company, and (ii) any such increase or decrease will apply only
to the Holder. The provisions of this paragraph shall be construed and
implemented in a manner otherwise than in strict conformity with the terms of
this Section 1(g) to correct this paragraph (or any portion hereof)
which may be defective or inconsistent with the intended beneficial ownership
limitation herein contained or to make changes or supplements necessary or
desirable to properly give effect to such limitation.
2. ADJUSTMENT
OF EXERCISE PRICE AND NUMBER OF WARRANT SHARES. The Exercise Price and the
number of Warrant Shares shall be adjusted from time to time as
follows:
(a) Adjustment
upon Subdivision or Combination of Common Stock. If the Company at any time
on or after the Pricing Date subdivides (by any stock split, stock dividend,
recapitalization, reorganization, scheme, arrangement or otherwise) one or more
classes of its outstanding shares of Common Stock into a greater number of
shares, the Exercise Price in effect immediately prior to such subdivision will
be proportionately reduced and the number of Warrant Shares will be
proportionately increased. If the Company at any time on or after the
Pricing Date combines (by any stock split, stock dividend, recapitalization,
reorganization, scheme, arrangement or otherwise) one or more classes of its
outstanding shares of Common Stock into a smaller number of shares, the Exercise
Price in effect immediately prior to such combination will be proportionately
increased and the number of Warrant Shares will be proportionately
decreased. Any adjustment under this Section 2(a) shall become
effective at the close of business on the date the subdivision or combination
becomes effective.
(b) Other
Events. If any event occurs of the type contemplated by the provisions of
this Section 2 but not expressly provided for by such provisions (including,
without limitation, the granting of stock appreciation rights, phantom stock
rights or other rights with equity features), then the Company’s Board of
Directors will make an appropriate adjustment in the Exercise Price and the
number of Warrant Shares so as to protect the rights of the Holder; provided
that no such adjustment pursuant to this Section 2(b) will increase
the Exercise Price or decrease the number of Warrant Shares as otherwise
determined pursuant to this Section 2 .
3. RIGHTS
UPON DISTRIBUTION OF ASSETS. If the Company shall declare or make any
dividend or other distribution of its assets (or rights to acquire its assets)
to all holders of shares of Common Stock, by way of return of capital or
otherwise (including, without limitation, any distribution of cash, stock or
other securities, property or options by way of a dividend, spin off,
reclassification, corporate rearrangement, scheme of arrangement or other
similar transaction) (a “Distribution”), at any time
after the issuance of this Warrant, then, in each such case:
(a) any
Exercise Price in effect immediately prior to the close of business on the
record date fixed for the determination of holders of shares of Common Stock
entitled to receive the Distribution shall be reduced, effective as of the close
of business on such record date, to a price determined by multiplying such
Exercise Price by a fraction of which (i) the numerator shall be the Closing Bid
Price of the shares of Common Stock on the Trading Day immediately preceding
such record date minus the value of the Distribution (as determined in good
faith by the Company’s Board of Directors) applicable to one share of Common
Stock, and (ii) the denominator shall be the Closing Bid Price of the shares of
Common Stock on the Trading Day immediately preceding such record date;
and
(b) the
number of Warrant Shares shall be increased to a number of shares equal to the
number of shares of Common Stock obtainable immediately prior to the close of
business on the record date fixed for the determination of holders of shares of
Common Stock entitled to receive the Distribution multiplied by the reciprocal
of the fraction set forth in the immediately preceding paragraph (a); provided that in the
event that the Distribution is of shares of Common Stock (or common stock)
(“Other Shares of Common
Stock”) of a company whose shares of common stock are traded on a
national securities exchange or a national automated quotation system, then the
Holder may elect to receive a warrant to purchase Other Shares of Common Stock
in lieu of an increase in the number of Warrant Shares, the terms of which shall
be identical to those of this Warrant, except that such warrant shall be
exercisable into the number of shares of Other Shares of Common Stock that would
have been payable to the Holder pursuant to the Distribution had the Holder
exercised this Warrant immediately prior to such record date and with an
aggregate exercise price equal to the product of the amount by which the
exercise price of this Warrant was decreased with respect to the Distribution
pursuant to the terms of the immediately preceding paragraph (a) and the number
of Warrant Shares calculated in accordance with the first part of this paragraph
(b).
4. PURCHASE
RIGHTS; FUNDAMENTAL TRANSACTIONS.
(a) Purchase
Rights. In addition to any adjustments pursuant to Section 2 above, if at
any time the Company grants, issues or sells any Options, Convertible Securities
or rights to purchase stock, warrants, securities or other property pro rata to
the record holders of any class of shares of Common Stock (the “Purchase Rights”), then the
Holder will be entitled to acquire, upon the terms applicable to such Purchase
Rights, the aggregate Purchase Rights which the Holder could have acquired if
the Holder had held the number of shares of Common Stock acquirable upon
complete exercise of this Warrant (without regard to any limitations on the
exercise of this Warrant) immediately before the date on which a record is taken
for the grant, issuance or sale of such Purchase Rights, or, if no such record
is taken, the date as of which the record holders of shares of Common Stock are
to be determined for the grant, issue or sale of such Purchase
Rights.
(b) Fundamental
Transactions. The Company shall not enter into or be party to a Fundamental
Transaction unless the Successor Entity assumes this Warrant in accordance with
the provisions of this Section (4)(b), including agreements to deliver to
each holder of Warrants in exchange for such Warrants a security of the
Successor Entity evidenced by a written instrument substantially similar in form
and substance to this Warrant, including, without limitation, an adjusted
exercise price equal to the value for the shares of Common Stock reflected by
the terms of such Fundamental Transaction, and exercisable for a corresponding
number of shares of capital stock equivalent to the shares of Common Stock
acquirable and receivable upon exercise of this Warrant (without regard to any
limitations on the exercise of this Warrant) prior to such Fundamental
Transaction, and satisfactory to the Holder. Upon the occurrence of any
Fundamental Transaction, the Successor Entity shall succeed to, and be
substituted for (so that from and after the date of such Fundamental
Transaction, the provisions of this Warrant referring to the “Company” shall
refer instead to the Successor Entity), and may exercise every right and power
of the Company and shall assume all of the obligations of the Company under this
Warrant with the same effect as if such Successor Entity had been named as the
Company herein. Upon consummation of the Fundamental Transaction, the
Successor Entity shall deliver to the Holder confirmation that there shall be
issued upon exercise of this Warrant at any time after the consummation of the
Fundamental Transaction, in lieu of the shares of the Common Stock (or other
securities, cash, assets or other property) purchasable upon the exercise of the
Warrant prior to such Fundamental Transaction, such shares of stock, securities,
cash, assets or any other property whatsoever (including warrants or other
purchase or subscription rights) which the Holder would have been entitled to
receive upon the happening of such Fundamental Transaction had this Warrant been
converted immediately prior to such Fundamental Transaction, as adjusted in
accordance with the provisions of this Warrant. In addition to and not in
substitution for any other rights hereunder, prior to the consummation of any
Fundamental Transaction pursuant to which holders of shares of Common Stock are
entitled to receive securities or other assets with respect to or in exchange
for shares of Common Stock (a “Corporate Event”), the Company
shall make appropriate provision to insure that the Holder will thereafter have
the right to receive upon an exercise of this Warrant at any time after the
consummation of the Fundamental Transaction but prior to the Expiration Date, in
lieu of the shares of the Common Stock (or other securities, cash, assets or
other property) purchasable upon the exercise of the Warrant prior to such
Fundamental Transaction, such shares of stock, securities, cash, assets or any
other property whatsoever (including warrants or other purchase or subscription
rights) which the Holder would have been entitled to receive upon the happening
of such Fundamental Transaction had the Warrant been exercised immediately prior
to such Fundamental Transaction. If holders of Common Stock are given any
choice as to the securities, cash or property to be received in a Fundamental
Transaction, then the Holder shall be given the same choice as to the
consideration it receives upon any exercise of this Warrant following such
Fundamental Transaction. The provisions of this Section 4 shall
apply similarly and equally to successive Fundamental Transactions and Corporate
Events and shall be applied without regard to any limitations on the exercise of
this Warrant.
5. NONCIRCUMVENTION. The
Company hereby covenants and agrees that the Company will not, by amendment of
its Certificate of Incorporation, Bylaws or through any reorganization, transfer
of assets, consolidation, merger, scheme of arrangement, dissolution, issue or
sale of securities, or any other voluntary action, avoid or seek to avoid the
observance or performance of any of the terms of this Warrant, and will at all
times in good faith carry out all the provisions of this Warrant and take all
action as may be required to protect the rights of the Holder. Without
limiting the generality of the foregoing, the Company (i) shall not
increase the par value of any shares of Common Stock receivable upon the
exercise of this Warrant above the Exercise Price then in effect,
(ii) shall take all such actions as may be necessary or appropriate in
order that the Company may validly and legally issue fully paid and
nonassessable shares of Common Stock upon the exercise of this Warrant, and
(iii) shall, so long as this Warrant is outstanding, take all action necessary
to reserve and keep available out of its authorized and unissued shares of
Common Stock, solely for the purpose of effecting the exercise of this Warrant,
100% of the number of shares of Common Stock issuable upon exercise of this
Warrant then outstanding (without regard to any limitations on
exercise).
6. WARRANT
HOLDER NOT DEEMED A STOCKHOLDER. Except as otherwise specifically provided
herein, the Holder, solely in such Person’s capacity as a holder of this
Warrant, shall not be entitled to vote or receive dividends or be deemed the
holder of share capital of the Company for any purpose, nor shall anything
contained in this Warrant be construed to confer upon the Holder, solely in such
Person’s capacity as the Holder of this Warrant, any of the rights of a
stockholder of the Company or any right to vote, give or withhold consent to any
corporate action (whether any reorganization, issue of stock, reclassification
of stock, consolidation, merger, conveyance or otherwise), receive notice of
meetings, receive dividends or subscription rights, or otherwise, prior to the
issuance to the Holder of the Warrant Shares which such Person is then entitled
to receive upon the due exercise of this Warrant. In addition, nothing
contained in this Warrant shall be construed as imposing any liabilities on the
Holder to purchase any securities (upon exercise of this Warrant or otherwise)
or as a stockholder of the Company, whether such liabilities are asserted by the
Company or by creditors of the Company.
7. REISSUANCE
OF WARRANTS.
(a) Transfer of Warrant. If
this Warrant is to be transferred, the Holder shall surrender this Warrant to
the Company together with a written assignment of this Warrant in the form
attached hereto as Exhibit B duly executed by the Holder or its agent
or attorney, whereupon the Company will forthwith, subject to compliance with
any applicable securities laws, issue and deliver upon the order of the Holder a
new Warrant (in accordance with Section 7(d)), registered as the Holder may
request, representing the right to purchase the number of Warrant Shares being
transferred by the Holder and, if less than the total number of Warrant Shares
then underlying this Warrant is being transferred, a new Warrant (in accordance
with Section 7(d)) to the Holder representing the right to purchase the number
of Warrant Shares not being transferred.
(b) Lost, Stolen or Mutilated
Warrant. Upon receipt by the Company of evidence reasonably satisfactory to
the Company of the loss, theft, destruction or mutilation of this Warrant, and,
in the case of loss, theft or destruction, of any indemnification undertaking by
the Holder to the Company in customary form and, in the case of mutilation, upon
surrender and cancellation of this Warrant, the Company shall execute and
deliver to the Holder a new Warrant (in accordance with Section 7(d))
representing the right to purchase the Warrant Shares then underlying this
Warrant.
(c) Exchangeable for Multiple
Warrants. This Warrant is exchangeable, upon the surrender hereof by the
Holder at the principal office of the Company, for a new Warrant or Warrants (in
accordance with Section 7(d)) representing in the aggregate the right to
purchase the number of Warrant Shares then underlying this Warrant, and each
such new Warrant will represent the right to purchase such portion of such
Warrant Shares as is designated by the Holder at the time of such surrender;
provided, however, that no Warrants for fractional shares of Common Stock shall
be given.
(d) Issuance of New
Warrants. Whenever the Company is required to issue a new Warrant pursuant
to the terms of this Warrant, such new Warrant (i) shall be of like tenor with
this Warrant, (ii) shall represent, as indicated on the face of such new
Warrant, the right to purchase the Warrant Shares then underlying this Warrant
(or in the case of a new Warrant being issued pursuant to Section
7(a) or Section 7(c), the Warrant Shares designated by the Holder
which, when added to the number of shares of Common Stock underlying the other
new Warrants issued in connection with such issuance, does not exceed the number
of Warrant Shares then underlying this Warrant), (iii) shall have an issuance
date, as indicated on the face of such new Warrant, which is the same as the
Issuance Date, and (iv) shall have the same rights and conditions as this
Warrant.
8. OPTIONAL
REDEMPTION. At any time within 20 days following the occurrence of a
Trading Threshold (as defined in Section 16(q)), the Company shall be entitled
to redeem the Warrants, or any of them, at a per Warrant Share redemption price
of $0.001 (the “Redemption
Price”), upon 20 days’ written notice to the Holder. Hereinafter such
20-day period, as it may be extended pursuant to this Section 8, is referred to
as the “Redemption
Period.” Upon the expiration of the Redemption Period (the
“Redemption Date”), all
Warrants noticed for redemption that have not theretofore been exercised by the
Holder shall, upon payment of the aggregate Redemption Price therefor, cease to
represent the right to purchase any shares of Common Stock and shall be deemed
cancelled and void and of no further force or effect without any further act or
deed on the part of the Company. The Holder undertakes to return the
certificate representing any redeemed Warrants to the Company upon their
redemption and to indemnify the Company with respect to any losses, claims,
damages or liabilities arising from the Holder’s failure to return such
certificate. In the event the certificate so returned represents a
number of Warrants in excess of the number being redeemed, the Company shall as
promptly as practicable issue to the Holder a new certificate for the number of
unredeemed Warrants. If at any time during a Redemption Period that
begins prior to the 181st day
that follows the Issuance Date, the prospectus used in connection with the
disposition of the Warrant Shares pursuant to the Registration Statement may not
be used by the Holder for the resale of the Warrant Shares because the
Registration Statement is not effective, then the Redemption Period shall be
extended by the period of time that the Holder may not so use the prospectus
plus 20 days.
9. NOTICES. The
Company shall provide the Holder with prompt written notice of all actions taken
pursuant to this Warrant, including in reasonable detail a description of such
action and the reason therefor. Whenever notice is required to be given
under this Warrant, unless otherwise provided herein, such notice shall be given
in writing, will be mailed (a) if within the domestic United States by
first-class registered or certified mail, or nationally recognized overnight
express courier, postage prepaid, or by facsimile or (b) if delivered from
outside the United States, by International Federal Express or facsimile, and
(c) will be deemed given (i) if delivered by first-class registered or certified
mail domestic, three business days after so mailed, (ii) if delivered by
nationally recognized overnight carrier, one business day after so mailed, (iii)
if delivered by International Federal Express, two business days after so mailed
and (iv) if delivered by facsimile, upon electronic confirmation of receipt, and
will be delivered and addressed as follows:
|
(a)
|
if
to the Company, to:
|
Discovery
Laboratories, Inc.
2600
Kelly Road
Warrington,
Pennsylvania 18976
Attention: John
G. Cooper
Facsimile: 215-488-9301
with
copies to:
SNR
Denton US LLP
Two World
Financial Center
225
Liberty Street
New York,
NY 10281-2699
Attention: Ira
L. Kotel, Esq.
Fax:
212-768-6800
|
(b)
|
if
to the Holder, to:
|
PharmaBio
Development Inc.
c/o
Quintiles Transnational Corp.
4820
Emperor Blvd
Durham,
NC 27703
Attn: President
Facsimile: (919)
998-2090
with
copies to:
Smith,
Anderson, Blount, Dorsett,
Mitchell
& Jernigan, L.L.P.
2500
Wachovia Capitol Center
Raleigh,
NC 27601
Attn:
Christopher B. Capel
Facsimile:
(919) 821-6800,
or to
Holder’s address on any Exercise Notice delivered to the Company in the form
attached as Exhibit A hereto, or at such other address or addresses as may have
been furnished to the Company in writing.
10.
AMENDMENT AND WAIVER. Except as otherwise provided herein, the provisions
of this Warrant may be amended only with the written consent of the Company and
the Holder, and the Company may take any action herein prohibited, or omit to
perform any act herein required to be performed by it, only with the written
consent of the Holder.
11.
GOVERNING LAW. This Warrant shall be governed by and construed and enforced
in accordance with, and all questions concerning the construction, validity,
interpretation and performance of this Warrant shall be governed by, the
internal laws of the State of Delaware, without giving effect to any choice of
law or conflict of law provision or rule (whether of the State of Delaware or
any other jurisdictions) that would cause the application of the laws of any
jurisdictions other than the State of Delaware.
12. CONSTRUCTION;
HEADINGS. This Warrant shall be deemed to be jointly drafted by the Company
and the Holder and shall not be construed against any person as the drafter
hereof. The headings of this Warrant are for convenience of reference and
shall not form part of, or affect the interpretation of, this
Warrant.
13.
DISPUTE RESOLUTION. In the case of a dispute as to the determination of the
Exercise Price or the arithmetic calculation of the Warrant Shares, the Company
shall submit the disputed determinations or arithmetic calculations via
facsimile or electronic mail within two (2) Business Days of receipt of the
Exercise Notice giving rise to such dispute, as the case may be, to the
Holder. If the Holder and the Company are unable to agree upon such
determination or calculation of the Exercise Price or the Warrant Shares within
three Business Days of such disputed determination or arithmetic calculation
being submitted to the Holder, then the Company shall, within two (2) Business
Days submit via facsimile or electronic mail (a) the disputed determination of
the Exercise Price to an independent, reputable investment bank selected by the
Company and approved by the Holder or (b) the disputed arithmetic calculation of
the Warrant Shares to the Company’s independent, outside accountant. The
Company shall cause at its expense the investment bank or the accountant, as the
case may be, to perform the determinations or calculations and notify the
Company and the Holder of the results no later than ten Business Days from the
time it receives the disputed determinations or calculations. Such
investment bank’s or accountant’s determination or calculation, as the case may
be, shall be binding upon all parties absent demonstrable error.
14. REMEDIES,
OTHER OBLIGATIONS, BREACHES AND INJUNCTIVE RELIEF. The remedies provided in
this Warrant shall be cumulative and in addition to all other remedies available
under this Warrant, at law or in equity (including a decree of specific
performance and/or other injunctive relief), and nothing herein shall limit the
right of the Holder to pursue actual damages for any failure by the Company to
comply with the terms of this Warrant.
15. TRANSFER. Subject
to compliance with any applicable securities laws, this Warrant may be offered
for sale, sold, transferred or assigned without the consent of the
Company.
16. CERTAIN
DEFINITIONS. For purposes of this Warrant, the following terms shall have
the following meanings:
(a) “Bloomberg” means Bloomberg
Financial Markets.
(b)
“Business Day” means any
day other than Saturday, Sunday or other day on which commercial banks in The
City of New York are authorized or required by law to remain
closed.
(c)
“Change of Control”
means any Fundamental Transaction other than (A) any reorganization,
recapitalization or reclassification of the Common Stock, in which holders of
the Company’s voting power immediately prior to such reorganization,
recapitalization or reclassification continue after such reorganization,
recapitalization or reclassification to hold publicly traded securities and,
directly or indirectly, the voting power of the surviving entity or entities
necessary to elect a majority of the members of the board of directors (or their
equivalent if other than a corporation) of such entity or entities, or (B)
pursuant to a migratory merger effected solely for the purpose of changing the
jurisdiction of incorporation of the Company.
(d) “Closing Bid Price” and “Closing Sale Price” means, for
any security as of any date, the last closing bid price and last closing trade
price, respectively, for such security on the Principal Market, as reported by
Bloomberg, or, if the Principal Market begins to operate on an extended hours
basis and does not designate the closing bid price or the closing trade price,
as the case may be, then the last bid price or the last trade price,
respectively, of such security prior to 4:00:00 p.m., New York time, as reported
by Bloomberg, or, if the Principal Market is not the principal securities
exchange or trading market for such security, the last closing bid price or last
trade price, respectively, of such security on the principal securities exchange
or trading market where such security is listed or traded as reported by
Bloomberg, or if the foregoing do not apply, the last closing bid price or last
trade price, respectively, of such security in the over-the-counter market on
the electronic bulletin board for such security as reported by Bloomberg, or, if
no closing bid price or last trade price, respectively, is reported for such
security by Bloomberg, the average of the bid prices, or the ask prices,
respectively, of any market makers for such security as reported in the “pink
sheets” by Pink Sheets LLC (formerly the National Quotation Bureau,
Inc.). If the Closing Bid Price or the Closing Sale Price cannot be
calculated for a security on a particular date on any of the foregoing bases,
the Closing Bid Price or the Closing Sale Price, as the case may be, of such
security on such date shall be the fair market value as determined by the Board
of Directors of the Company in the exercise of its good faith judgment. All
such determinations to be appropriately adjusted for any stock dividend, stock
split, stock combination or other similar transaction during the applicable
calculation period.
(e) “Common Stock” means
(i) the Company’s shares of Common Stock, par value $0.001 per share, and
(ii) any share capital into which such Common Stock shall have been changed
or any share capital resulting from a reclassification of such Common
Stock.
(f) RESERVED
(g) “Convertible Securities” means
any stock or securities (other than Options) directly or indirectly convertible
into or exercisable or exchangeable for shares of Common Stock.
(h) “Eligible Market” means the
Principal Market, The New York Stock Exchange, Inc., The American Stock
Exchange, The NASDAQ Global Select Market, The NASDAQ Global Market or OTC
Bulletin Board.
(i)
“Expiration Date”
means the date five (5) years following the Issuance Date or, if such date falls
on a day other than a Business Day or on which trading does not take place on
the Principal Market (a “Holiday”), the next date that
is not a Holiday.
(j)
“Fundamental
Transaction” means that the Company shall, directly or indirectly, in one
or more related transactions, (i) consolidate or merge with or into (whether or
not the Company is the surviving corporation) another Person, or (ii) sell,
assign, transfer, convey or otherwise dispose of all or substantially all of the
properties or assets of the Company to another Person, or (iii) allow another
Person to make a purchase, tender or exchange offer that is accepted by the
holders of more than the 50% of the outstanding shares of Common Stock (not
including any shares of Common Stock held by the Person or Persons making or
party to, or associated or affiliated with the Persons making or party to, such
purchase, tender or exchange offer), or (iv) consummate a stock purchase
agreement or other business combination (including, without limitation, a
reorganization, recapitalization, spin-off or scheme of arrangement) with
another Person whereby such other Person acquires more than the 50% of the
outstanding shares of Common Stock (not including any shares of Common Stock
held by the other Person or other Persons making or party to, or associated or
affiliated with the other Persons making or party to, such stock purchase
agreement or other business combination), (v) reorganize, recapitalize or
reclassify its Common Stock, or (vi) any “person” or “group” (as these terms are
used for purposes of Sections 13(d) and 14(d) of the Exchange Act) is or shall
become the “beneficial owner” (as defined in Rule 13d-3 under the Exchange Act),
directly or indirectly, of 50% of the aggregate ordinary voting power
represented by issued and outstanding Common Stock.
(k) “Options” means any rights,
warrants or options to subscribe for or purchase shares of Common Stock or
Convertible Securities.
(l)
“Parent Entity” of a
Person means an entity that, directly or indirectly, controls the applicable
Person and whose common stock or equivalent equity security is quoted or listed
on an Eligible Market, or, if there is more than one such Person or Parent
Entity, the Person or Parent Entity with the largest public market
capitalization as of the date of consummation of the Fundamental
Transaction.
(m)
“Person” means an
individual, a limited liability company, a partnership, a joint venture, a
corporation, a trust, an unincorporated organization, any other entity and a
government or any department or agency thereof.
(n)
“Principal Market” means
The NASDAQ Capital Market.
(o)
“Successor Entity”
means the Person (or, if so elected by the Holder, the Parent Entity) formed by,
resulting from or surviving any Fundamental Transaction or the Person (or, if so
elected by the Holder, the Parent Entity) with which such Fundamental
Transaction shall have been entered into.
(p)
“Trading Day”
means any day on which shares of Common Stock are traded on the Principal
Market, or, if the Principal Market is not the principal trading market for the
Common Stock, then on the principal securities exchange or securities market or
electronic quotations system on which the shares of Common Stock are then
traded; provided that “Trading
Day” shall not include any day on which the Common Stock is scheduled to trade
on such exchange, market or system for less than 4.5 hours or any day that the
Common Stock is suspended from trading during the final hour of trading on such
exchange, market or system (or if such exchange, market or system does not
designate in advance the closing time of trading on such exchange, market or
system, then during the hour ending at 4:00 p.m., New York time).
(q)
A “Trading Threshold”
shall be deemed to occur on any date that the reported Weighted Average Price
for any five (5) out of seven (7) consecutive Trading Days immediately prior to
such date, exceeds $0.45 with a minimum average daily trading volume for such
seven (7) day period of at least 500,000 shares of Common Stock as reported by
the Principal Market for such period (with such price and volume criteria being
appropriately adjusted for any share dividend, share split or other similar
transaction that may occur on or after the Issuance Date).
(r)
“Weighted Average Price”
means, for any security as of any date, the dollar volume-weighted average price
for such security on the Principal Market (or, if the Principal Market is not
the principal trading market for the Common Stock, then on the principal
securities exchange or securities market or electronic quotations system on
which the shares of Common Stock are then traded) during the period beginning at
9:30:01 a.m., New York City time, and ending at 4:00:00 p.m., New York City
time, as reported by Bloomberg through its “Volume at Price” function or, if the
foregoing does not apply, the dollar volume-weighted average price of such
security in the over-the-counter market on the electronic bulletin board for
such security during the period beginning at 9:30:01 a.m., New York City time,
and ending at 4:00:00 p.m., New York City time, as reported by Bloomberg, or, if
no dollar volume-weighted average price is reported for such security by
Bloomberg for such hours, the average of the highest closing bid price and the
lowest closing ask price of any of the market makers for such security as
reported in the “pink sheets” by Pink Sheets LLC (formerly the National
Quotation Bureau, Inc.). If the Weighted Average Price cannot be calculated
for such security on such date on any of the foregoing bases, the Weighted
Average Price of such security on such date shall be the fair market value as
mutually determined by the Company and the Holder. If the Company and the
Holder are unable to agree upon the fair market value of such security, then
such dispute shall be resolved pursuant to Section 13 with the term
“Weighted Average Price” being substituted for the term “Exercise Price.” All
such determinations shall be appropriately adjusted for any share dividend,
share split or other similar transaction during such period.
[Signature
Page Follows]
IN WITNESS WHEREOF, the
parties have caused this Warrant to Purchase Common Stock to be duly executed
and delivered as of the Issuance Date set out above.
|
DISCOVERY
LABORATORIES, INC.
|
|
|
|
By:
|
|
|
Name: John
G. Cooper
|
|
Title: President
and Chief Financial
Officer
|
|
PHARMABIO
DEVELOPMENT INC.
|
|
|
|
By:
|
|
|
Name: John
L. Bradley, Jr.
|
|
Title: Vice
President
|
EXHIBIT
A
EXERCISE
NOTICE
TO
BE EXECUTED BY THE REGISTERED HOLDER TO EXERCISE THIS
WARRANT
TO PURCHASE COMMON STOCK
DISCOVERY
LABORATORIES, INC.
The
undersigned holder hereby exercises the right to purchase _________________ of
the shares of Common Stock (“Warrant Shares”) of Discovery
Laboratories, Inc, a Delaware corporation (the “Company”), evidenced by the
attached Warrant to Purchase Common Stock (the “Warrant”). Capitalized
terms used herein and not otherwise defined shall have the respective meanings
set forth in the Warrant.
1. Form
of Exercise Price. The Holder intends that payment of the Exercise Price
shall be made as:
|
____________
|
a “Cash
Exercise” with respect to _________________ Warrant Shares;
and/or
|
|
____________
|
a
“Cashless Exercise” with respect to _______________ Warrant Shares
(provided the conditions for cashless exercise set forth in Section
1(d) of the Warrant are satisfied).
|
2. Payment
of Exercise Price. In the event that the holder has elected a Cash Exercise
with respect to some or all of the Warrant Shares to be issued pursuant hereto,
the holder shall pay the Aggregate Exercise Price in the sum of
$___________________ to the Company in accordance with the terms of the
Warrant.
3. Delivery
of Warrant Shares. The Company shall deliver __________ Warrant Shares in
the name of the undersigned holder or in the name of ______________________ in
accordance with the terms of the Warrant to the following DWAC Account Number or
by physical delivery of a certificate to:
_______________________________
_______________________________
_______________________________
Date:
_______________ __, ______
|
|
Name
of Registered Holder
|
ACKNOWLEDGMENT
The
Company hereby acknowledges this Exercise Notice and hereby directs Continental
Stock Transfer & Trust Company to issue the above indicated number of shares
of Common Stock in accordance with the Transfer Agent Instructions dated
[ ], 2010 from the Company and acknowledged and agreed to by Continental
Stock Transfer & Trust Company.
|
DISCOVERY
LABORATORIES, INC
|
|
|
|
By:
|
|
|
|
Name:
|
|
|
Title:
|
EXHIBIT
B
ASSIGNMENT
FORM
(To
assign the foregoing warrant, execute
this form
and supply required information.
Do not
use this form to exercise the warrant.)
FOR VALUE
RECEIVED, all of or [_______] shares of the foregoing Warrant and all rights
evidenced thereby are hereby assigned to
_______________________________________________
whose address is
_______________________________________________________________.
_______________________________________________________________
Dated: ______________,
_______
|
Holder’s
Signature:
|
|
|
|
|
|
|
|
Holder’s
Address:
|
|
|
|
|
|
|
NOTE: The
signature to this Assignment Form must correspond with the name as it appears on
the face of the Warrant, without alteration or enlargement or any change
whatsoever, and must be guaranteed by a bank or trust company. Officers of
corporations and those acting in a fiduciary or other representative capacity
should file proper evidence of authority to assign the foregoing
Warrant.
|
SNR
Denton US LLP
Two
World Financial Center
225
Liberty Street
New
York, NY 10281-2699 USA
|
|
T +1
212 768 6700
F +1
212 768 6800
snrdenton.com
Two
World Financial Center
New
York, NY 10281-1008
212.768.6700
212.768.6800
fax
www.sonnenschein.com
|
October
12, 2010
EXHIBIT
5.1
Board of
Directors
Discovery
Laboratories, Inc.
2600
Kelly Road, Suite 100
Warrington,
Pennsylvania 18976-3622
Re: Sale
of Common Stock and Warrants registered pursuant to
Registration
Statement on Form S-3 (File No. 333-151654)
Ladies
and Gentlemen:
In our
capacity as counsel to Discovery Laboratories, Inc., a Delaware corporation (the
“Company”), we have been
asked to render this opinion in connection with a registration statement on Form
S-3 (the “Registration
Statement”), heretofore filed by the Company with the Securities and
Exchange Commission (the “Commission”) under the
Securities Act of 1933, as amended (the “Act”), the prospectus
supplement filed pursuant to Rule 424(b) under the Act, dated as of October 12,
2010 (the “Prospectus
Supplement”), under which the following securities being sold by the
Company have been registered: (i) 2,380,952 shares (the “Shares”) of common stock, par
value $0.001 per share, of the Company (the “Common Stock”), (ii) warrants to
purchase 1,190,476 shares of Common Stock at an exercise price of $0.273 per
share (each a “Warrant”
and collectively, the “Warrants”) and (iii) 1,190,476
shares (the “Warrant
Shares”) of Common Stock that are issuable upon exercise of the
Warrants. The securities are being sold as units (the “Units”) with each Unit being
comprised of (i) one Share and (ii) one Warrant.
We are
delivering this opinion to you at your request in accordance with the
requirements of Item 601(b)(5) of Regulation S-K under the Act.
In
connection with rendering this opinion, we have examined and are familiar with
(i) the Company’s Amended and Restated Certificate of Incorporation, (ii) the
Company’s By-Laws, (iii) the Registration Statement, including the base
prospectus contained therein and as restated as of June 11, 2010 and filed
pursuant to Rule 424(b) under the Act (such base prospectus, the “Base
Prospectus”), (iv) the Prospectus Supplement (such Base Prospectus and
Prospectus Supplement are collectively referred to herein as the “Prospectus”),
(v) corporate proceedings of the Company relating to the Shares, the Warrants
and the Warrant Shares, and (vi) such other instruments and documents as we have
deemed relevant under the circumstances.
In making
the aforesaid examinations, we have assumed the genuineness of all signatures
and the conformity to original documents of all copies furnished to us as
original or photostatic copies. We have also assumed that the corporate records
furnished to us by the Company include all corporate proceedings taken by the
Company to date.
Based
upon the foregoing and subject to the assumptions and qualifications set forth
herein, we are of the opinion that:
1. The
Shares have been duly authorized by the Company and, when issued in accordance
with the terms set forth in the Registration Statement and the Prospectus, will
be validly issued, fully paid and non-assessable.
2. The
Warrant Shares have been duly authorized by the Company and, when issued in
accordance with the terms set forth in the Registration Statement and the
Prospectus, and, when issued and paid for in accordance with the terms of the
Warrants, will be validly issued, fully paid and non-assessable.
3. The
Warrants have been duly authorized by the Company and, when issued in accordance
with the terms set forth in the Registration Statement and the Prospectus, will
be validly issued.
The
foregoing opinion is limited to the laws of the United States of America and
Delaware corporate law (which includes the Delaware General Corporation Law and
applicable provisions of the Delaware constitution, as well as reported judicial
opinions interpreting same), and we do not purport to express any opinion on the
laws of any other jurisdiction.
We hereby
consent to the use of our opinion as an exhibit to the Registration Statement
and to the reference to this firm and this opinion under the heading “Legal
Matters” in the prospectus comprising a part of the Registration Statement and
any amendment thereto. In giving such consent, we do not hereby admit
that we come within the category of persons whose consent is required under
Section 7 of the Act, or the rules and regulations of the Commission
thereunder.
|
Very
truly yours,
|
|
|
|
/s/
SNR DENTON US LLP
|
|
|
|
SNR
DENTON US LLP
|
EXECUTION
COPY
SECURITIES PURCHASE
AGREEMENT
SECURITIES
PURCHASE AGREEMENT dated as of October 12, 2010 (this “Agreement”), by and
between DISCOVERY LABORATORIES, INC., a Delaware corporation (“Company”), and
PHARMABIO DEVELOPMENT INC., a North Carolina corporation (“Investor”).
The
Investor hereby confirms its agreement with the Company as follows:
1. Offering and sale of the
Units. (a) The
Company has authorized the sale and issuance (the “Unit Purchase”) to
the Investor of 2,380,952 units (the “Units”), at a price
of $0.21 per Unit (the “Unit Price”), with
each Unit consisting of (i) one share (the “Share,” and
collectively, the Shares”) of its
common stock, par value $.001 per share (“Common Stock”), and
(ii) one warrant (the “Warrant,” and
collectively, the “Warrants”) to
purchase one-half of a share of Common Stock in substantially the form attached
hereto as Exhibit A. Each Warrant will represent the right to
purchase one-half of a share of Common Stock at an exercise price of $0.273 per
share of Common Stock (subject to adjustment as set forth in the Warrant). Units
will not be issued or certificated. The Shares and Warrants are immediately
separable and will be issued separately. The shares of Common Stock issuable
upon exercise of the Warrants are referred to herein as the “Warrant Shares” and,
together with the Units, the Shares and the Warrants, are referred to herein as
the “Securities”).
(b) The
offering and sale of the Units (the “Offering”) are being
made pursuant to (a) an effective Registration Statement on Form S-3, No.
333-151654 (the “Registration
Statement”) filed by the Company with the Securities and Exchange
Commission (the “Commission”),
including the Prospectus contained therein and dated June 11, 2010 (the “Base Prospectus”),
(b) if applicable, certain “free writing prospectuses” (as that term is defined
in Rule 405 under the Securities Act of 1933, as amended (the “Act”)), that have
been or will be filed, if required, with the Commission and delivered to the
Investor on or prior to the date hereof (the “Free Writing
Prospectus”), containing certain supplemental information regarding the
Units, the terms of the Offering and the Company and (c) a Prospectus
Supplement (the “Prospectus
Supplement” and, together with the Base Prospectus, the “Prospectus”)
containing only certain supplemental information regarding the Units and terms
of the Offering that will be filed with the Commission and delivered to the
Investor prior to the Closing (or made available to the Investor prior to the
Closing by the filing by the Company of an electronic version thereof with the
Commission).
2. Closing. The
closing of the issuance and sale of the Units (the “Closing”) shall take
place at 10:00 a.m. on October 14, 2010 (the “Closing
Date”). The Closing shall be held at the offices of the
Company, 2600 Kelly Road, Suite 100, Warrington, Pennsylvania. At the Closing,
(a) the Investor shall cause to be delivered to the Company via wire transfer of
immediately available funds the purchase price of $500,000.00 for the Units (the
“Purchase
Price”) to an account specified to the Investor by the Company at least
one business day prior to the Closing, (b) the Company shall cause the
Company’s transfer agent (the “Transfer Agent”) to
credit the Shares to which the Investor is entitled to the Investor’s balance
account (through Merrill Lynch) with Depositary Trust Corporation through its
Deposit/Withdrawal At Custodian (DWAC) system as indicated on Exhibit B, and
(c) the Company shall cause the executed Warrants to be delivered to the
Investor, registered in the name of the Investor or, if so indicated on Exhibit B, in the
name of a nominee designated by the Investor.
3. Conditions to Closing of the
Company. The
Company’s obligations at the Closing are subject to: (i) the receipt by the
Company of the Purchase Price, and (ii) the accuracy as of the Closing of the
representations and warranties made by the Investor and the fulfillment of those
undertakings of the Investor to be fulfilled prior to the Closing
Date.
4. Conditions to Closing of the
Investor. The
Investor’s obligations at the Closing are subject to the accuracy as of the
Closing of the representations and warranties made by the Company and the
fulfillment of those undertakings of the Company to be fulfilled prior to the
Closing Date.
5. Representations of
Investor. The
Investor hereby represents, warrants and agrees that:
(a) The
Investor has full power and authority to enter into, execute, deliver and
perform this Agreement and all other agreements and instruments to be executed
by the Investor in connection herewith. All of such actions have been
duly authorized by all necessary corporate action on the part of the Investor
and no further approval or authorization by Investor’s shareholders or any other
persons or entities are necessary to take such actions. This
Agreement constitutes the legal, valid and binding obligation of the Investor
enforceable against the Investor in accordance with its terms except as such
enforcement may be limited by bankruptcy, insolvency, reorganization or other
laws and subject to general principles of equity.
(b) The
Investor has legally available and sufficient funds to pay the Purchase Price at
Closing.
(c) The
execution and delivery of this Agreement, the consummation of the Unit Purchase
and all of the other transactions contemplated hereby will not
result:
(i) in
a breach of any of the terms and provisions of or constitute a default under
Investor’s articles of incorporation or bylaws, or any indenture, mortgage, deed
or trust, or other agreement or instrument to which the Investor is a party;
or
(ii) in
a violation of or default under any state or federal statute or any of the rules
or regulations applicable to the Investor of any court or of any federal and
state regulatory body or administrative agency.
(d) The
Investor has received (or otherwise had made available to it by the filing by
the Company of an electronic version thereof with the Commission) the
Prospectus, which is a part of the Registration Statement, the documents
incorporated by reference therein, and the Free Writing Prospectus
(collectively, the “Disclosure Package”),
prior to or in connection with the execution of this Agreement. The
Investor acknowledges that, prior to the execution of this Agreement, the
Investor has also received certain additional information regarding the Offering
(the “Offering
Information”) by any means permitted under the Act, including the
Prospectus Supplement, a Free Writing Prospectus and oral
communications. In connection with its decision to purchase the
Shares, the Investor has received, and is not relying upon anything other than,
the Disclosure Package and the documents incorporated by reference therein and
the Offering Information.
(e) The
Investor (i) is knowledgeable, sophisticated and experienced in making, and is
qualified to make decisions with respect to, investments in securities
presenting an investment decision like that involved in the purchase of the
Units, including investments in securities issued by the Company and investments
in comparable companies, and (ii) has provided the required information on Exhibit B and such
information is the true and correct as of the date hereof and will be true and
correct as of the Closing Date. The Investor can afford the financial risk of an
investment in the Securities.
(f) Except
as set forth below, (i) the Investor has had no position, office or other
material undisclosed relationship within the past three years with the Company
or persons known to it to be affiliates of the Company, (ii) the Investor is not
a member of the Financial Industry Regulatory Authority, Inc. or an Associated
Person (as such term is defined under the NASD Membership and Registration Rules
Section 1011) as of the Closing, and (iii) neither the Investor nor any group of
investors (as identified in a public filing made with the Commission) of which
the Investor is a part in connection with the Offering of the Securities,
acquired, or obtained the right to acquire, 20% or more of the Common Stock (or
securities convertible into or exercisable for Common Stock) or the voting power
of the Company on a post-transaction basis.
(g) The
Investor understands that nothing in this Agreement, the Prospectus, the
Disclosure Package, the Offering Information or any other materials presented to
the Investor in connection with the transactions contemplated by this Agreement
constitutes legal, tax or investment advice. The Investor has
consulted such legal, tax and investment advisors and made such investigation as
it, in its sole discretion, has deemed necessary or appropriate in connection
with its purchase of the Securities.
(h) Since
10 days before the date hereof, the Investor has not disclosed any information
regarding the Offering to any third parties (other than its legal, accounting
and other advisors) and has not engaged in any purchases or sales involving the
securities of the Company (including, without limitation, any Short Sales (as
defined below) involving the Company’s securities). The Investor
covenants that it will not engage in any purchases or sales in the securities of
the Company (including Short Sales) prior to the time that the transactions
contemplated by this Agreement are publicly disclosed. The Investor
agrees that it will not cover any short position in the Common Stock if doing so
would be in violation of applicable securities laws. For purposes
hereof, “Short
Sales” include, without limitation, all “short sales” as defined in Rule
200 promulgated under Regulation SHO under the Exchange Act of 1934, as amended
(the “Exchange
Act”), whether or not against the box, and all types of direct and
indirect stock pledges, forward sales contracts, options, puts, calls, short
sales, swaps, “put equivalent positions” (as defined in Rule 16a-1(h) under the
Exchange Act) and similar arrangements (including on a total return basis), and
sales and other transactions through non-US broker dealers or foreign regulated
brokers.
6.
Representations of the
Company. The
Company hereby represents, warrants and agrees that:
(a) The
Company has full power and authority to enter into, execute, deliver and perform
this Agreement and all other agreements and instruments to be executed by the
Company in connection herewith. All of such actions have been duly
authorized by all necessary corporate action on the part of the Company and no
further approval or authorization by the Company’s stockholders or any other
persons or entities are necessary to take such actions. This
Agreement constitutes the legal, valid and binding obligation of the Company,
enforceable against the Company in accordance with its terms except as such
enforcement may be limited by bankruptcy, insolvency, reorganization or other
laws and subject to general principles of equity.
(b) The
execution and delivery of this Agreement, the consummation of the Unit Purchase
and all of the other transactions contemplated hereby will not
result:
(i) in
a breach of any of the terms and provisions of or constitute a default under the
Company’s certificate of incorporation or bylaws;
(ii) in
the creation of any lien, charge, security interest or encumbrance upon any
assets of the Company pursuant to the terms or provisions of, or will not
conflict with, result in the breach or violation of, or constitute, either by
itself or upon notice or the passage of time or both, a default under any
indenture, mortgage, deed or trust, or other agreement or instrument to which
the Company is a party; or
(iii) in
a violation of or default under any state or federal statute or any of the rules
or regulations applicable to the Company of any court or of any federal and
state regulatory body or administrative agency.
(c) Except
for (i) applicable filings, if any, with the Commission pursuant to the Exchange
Act and the Securities Act, (ii) filings with The Nasdaq Capital Market in
connection with the listing of the Shares, and (iii) filings, if any, under
state securities or “blue sky” laws, no consent, authorization or order of, or
filing or registration with, any governmental authority is required to be
obtained or made by the Company for the execution, delivery and performance of
this Agreement or the consummation of the Unit Purchase and all of the other
transactions contemplated hereby.
(d) The
Shares and the Warrants to be issued and sold by the Company to the Investor
hereunder have been duly and validly authorized and, when issued and delivered
against payment therefor as provided herein will be duly and validly issued,
fully paid and non-assessable. The Warrant Shares have been duly and validly
authorized and, when issued and delivered against payment therefor as provided
in the Warrants, will be duly and validly issued, fully paid and non-assessable.
The Company has reserved a reasonably adequate number of authorized but unissued
shares of Common Stock for issuance upon exercise of the Warrants and such
shares shall remain so reserved (subject to reduction from time to time for
Common Stock issued upon the exercise of the Warrants) as long as the Warrants
are exercisable.
(e) The
Company has complied in all material respects with all applicable Laws,
including securities laws, in connection with the offer, issuance and sale of
the Securities hereunder.
(f) The
Registration Statement has been declared effective by the Commission and there
is no stop order suspending the effectiveness of the Registration
Statement. The Company meets the requirements for the use of Form S-3
under the Act in connection with the offer, issuance and sale of the Securities
hereunder. The Registration Statement in the form in which it became
effective and also in such form as it may be when any post-effective amendment
thereto became effective and the Base Prospectus and any supplement or amendment
thereto, including the Prospectus Supplement relating to the Units, when filed
with the Commission under Rule 424(b) under the Act, complied (or will comply)
as to form with the provisions of the Act and did not (or will not) at any such
times contain an untrue statement of a material fact or omit to state a material
fact required to be stated therein or necessary to make the statements therein,
in the light of the circumstances under which they were made, not
misleading. The Commission has not issued any order preventing or
suspending the use of any Prospectus.
(g) As
of the Closing Date, the Registration Statement as supplemented by any
post-effective amendment thereto and any prospectus supplements, including the
Prospectus Supplement relating to the Units, will not contain an untrue
statement of a material fact or omit to state a material fact required to be
stated therein or necessary to make the statements therein, in light of the
circumstances under which they were made, not misleading.
7. Survival. Notwithstanding
any investigation made by any party to this Agreement, all agreements,
representations and warranties made by the Company and the Investor herein will
survive the execution of this Agreement and the delivery to the Investor of the
Shares and the Warrants.
8. Counterparts. This
Agreement may be executed in one or more counterparts, each of which shall be
deemed an original, and all of which together shall constitute one and the same
instrument. The exchange of copies of this Agreement or amendments thereto and
of signature pages by facsimile transmission or by email transmission in
portable document format, or similar format, shall constitute effective
execution and delivery of such instrument(s) as to the parties and may be used
in lieu of the original Agreement or amendment for all
purposes. Signatures of the parties transmitted by facsimile or by
email transmission in portable document format, or similar format, shall be
deemed to be original signatures for all purposes.
9. Notices. All
notices, requests, consents and other communications hereunder will be in
writing, will be mailed (a) if within the domestic United States by first-class
registered or certified mail, or nationally recognized overnight express
courier, postage prepaid, or by facsimile or (b) if delivered from outside the
United States, by International Federal Express or facsimile, and (c) will be
deemed given (i) if delivered by first-class registered or certified mail
domestic, three business days after so mailed, (ii) if delivered by nationally
recognized overnight carrier, one business day after so mailed, (iii) if
delivered by International Federal Express, two business days after so mailed
and (iv) if delivered by facsimile, upon electronic confirmation of receipt and
will be delivered and addressed as follows (or to such other address or
addresses as may have been furnished by notice to the other
party):
if to the
Company, to:
Discovery
Laboratories, Inc.
2600
Kelly Road
Warrington,
PA 18976
Attention: Legal
Department
Facsimile: 215-488-9301
with copies
to:
SNR
Denton US LLP
Two World
Financial Center
225
Liberty Street
New York,
NY 10281-2699
Attention: Ira
L. Kotel, Esq.
Fax:
212-768-6800
if to the
Investor, to:
PharmaBio
Development Inc.
c/o
Quintiles Transnational Corp.
4820
Emperor Blvd
Durham,
NC 27703
Attn: President
Facsimile: (919)
998-2090
with copies
to:
Smith,
Anderson, Blount, Dorsett,
Mitchell
& Jernigan, L.L.P.
2500
Wachovia Capitol Center
Raleigh,
NC 27601
Attn:
Christopher B. Capel
Facsimile:
(919) 821-6800.
10. Applicable
Law. This
Agreement will be governed by, and construed in accordance with, the internal
laws of the State of Delaware, as applied to contracts made and to be performed
entirely within such State, without giving effect to the principles of conflicts
of law that would require the application of the laws of any other
jurisdiction.
11. No Implied Rights or
Remedies. Except
as otherwise expressly provided herein, nothing herein expressed or implied is
intended or shall be construed to confer upon or to give any person, other than
the Company and the Investor, any rights or remedies under or by reason of this
Agreement.
12. No Waiver. No
failure on the part of any of the parties to this Agreement to exercise, no
delay in exercising and no course of dealing with respect to, any right or
remedy under this Agreement will operate as a waiver thereof. No
single or partial exercise of any right or remedy under this Agreement will
preclude any other further exercise thereof or the exercise of any other right
or remedy.
13. Headings. The
headings in this Agreement are inserted for convenience of reference only and
shall not be a part of or control or affect the meaning of this
Agreement.
14. Successors and
Assigns. This
Agreement may not be assigned without the written consent of all of its parties;
provided, however, that Investor may at any time following the Closing assign or
transfer any of its rights or obligations under this Agreement to an
affiliate. This Agreement and all of its provisions shall be binding
upon and inure to the benefit of the parties and their respective successors,
permitted assigns, heirs and legal representatives.
15. Severability. If
any provision of this Agreement shall be invalid or unenforceable, the other
provisions of this Agreement shall continue in full force, and the validity and
enforceability of such other provisions shall not be adversely
affected.
16. Press
Release. The
Company and the Investor agree that the Company shall, prior to the opening of
the financial markets in New York City on the business day immediately after the
date hereof, (i) issue a press release announcing the Offering, and (ii) file a
Current Report on Form 8-K with the Commission, including a form of this
Agreement.
[Remainder
of page intentionally blank]
IN
WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly
executed as of the date first above written.
PHARMABIO
DEVELOPMENT INC.
|
|
|
|
By:
|
/s/ John L. Bradley, Jr.
|
|
Name:
|
John
L. Bradley, Jr.
|
|
Title:
|
Vice
President
|
|
|
|
DISCOVERY
LABORATORIES, INC.
|
|
|
|
By:
|
/s/ John G. Cooper
|
|
Name:
|
John
G. Cooper
|
|
Title:
|
President
and Chief Financial
Officer
|
[Signature
Page to Securities Purchase Agreement]
Exhibit
A
Form of
Warrant
See
Exhibit 4.1 to Form 8-K
Exhibit
B
1.
|
|
The
exact name that your Shares and Warrants are to be registered
in. You may use a nominee name if appropriate:
|
|
PharmaBio
Development Inc.
|
|
|
|
|
|
2.
|
|
The
relationship between the Investor and the registered holder listed in
response to item 1 above:
|
|
Same
|
|
|
|
|
|
3.
|
|
The
mailing address of the registered holder listed in response to item 1
above:
|
|
c/o
Quintiles Transnational Corp.
|
|
|
|
|
4820
Emperor Blvd
|
|
|
|
|
Durham,
NC 27703
|
|
|
|
|
|
4.
|
|
The
Tax Identification Number of the registered holder listed in the response
to item 1 above:
|
|
56-2019326
|
|
|
|
|
|
5.
|
|
Name
of DTC Participant (broker-dealer at which the account or accounts to be
credited with the Shares are maintained):
|
|
Merrill
Lynch
|
|
|
|
|
|
6.
|
|
DTC
Participant Number:
|
|
5198
|
|
|
|
|
|
7.
|
|
Name
of Account at DTC Participant being credited with the
Shares:
|
|
PharmaBio
Development Inc.
|
|
|
|
|
|
8.
|
|
Account
Number at DTC Participant being credited with the Shares:
|
|
8PW-07056
|
Unassociated Document
PharmaBio
Expands Investment in Discovery Labs to Advance Surfaxin LS™ and Aerosurf®
Programs
Warrington, PA —October 13, 2010 —
Discovery Laboratories, Inc. (Nasdaq: DSCO), a biotechnology company
developing its novel synthetic surfactant and aerosol technologies for
respiratory diseases, today announces that it has entered into an agreement for
a new investment of $0.5 million from PharmaBio Development Inc. (PharmaBio),
the former strategic investing subsidiary of Quintiles Transnational Corp.
(Quintiles).
PharmaBio
has agreed to purchase approximately 2.4 million shares of the Company’s common
stock and warrants to purchase approximately 1.2 million shares of common stock
for gross proceeds of $0.5 million. Each common share, together with a
related warrant to purchase one half of a share of common stock, was sold at a
unit price of $0.21. The warrants have a five year term and are exercisable at
an exercise price of $0.273 per share of common stock. Should the
dollar
volume-weighted
average price of the Company’s common stock exceed $0.45 for any five out of
seven consecutive trading days for which stated minimum trading volumes are also
met, the Company is entitled to redeem the warrants upon 20 days written
notice.
“While
our primary focus remains obtaining FDA approval for Surfaxin® for
Respiratory Distress Syndrome in premature infants, this additional funding is
intended to primarily support near-term regulatory and related development
activities to progress Surfaxin LS™ and Aerosurf®” said
John G. Cooper, President and Chief Financial Officer of Discovery
Laboratories.
Discovery
Labs and PharmaBio have a longstanding relationship and PharmaBio, before giving
effect to the offering, owns approximately 5.6 million shares of the Company’s
common stock. In April 2010, Discovery restructured its $10.6 million
loan with PharmaBio, with the final payment of $2.0 million occurring on
September 30, 2010. Additionally, the two companies have agreed to continue
evaluating a potential long-term strategic collaboration focused on the
development of Surfaxin LS and/or Aerosurf, however, there can be no assurances
that any such arrangements will be entered into.
The
offering is being made solely to PharmaBio. The securities will be issued under
a previously filed registration statement that was declared effective by the
Securities and Exchange Commission on June 18, 2008. The transaction is
expected to close on or about October 14, 2010, subject to satisfaction of
customary closing conditions. This press release shall not constitute an offer
to sell or the solicitation of an offer to buy any securities of Discovery
Laboratories, Inc. nor shall there be any sale of the securities in any state or
jurisdiction in which such offer, solicitation or sale would be unlawful prior
to registration or qualification under the securities laws of any such state or
jurisdiction.
The
description of the financing with PharmaBio is subject in its entirety to the
definitive terms of the transaction documents, which are attached as exhibits to
the Form 8-K to be filed by the Company with the Securities and Exchange
Commission (“SEC”).
About
Surfaxin, Surfaxin LS and Aerosurf
Discovery
Labs lead programs, Surfaxin, Surfaxin LS and Aerosurf are being developed with
the potential to greatly improve the management of RDS in premature infants, and
collectively represent the opportunity, over time, to significantly expand the
current RDS worldwide annual market.
The
safety and efficacy of Surfaxin for neonatal RDS has been previously
demonstrated in a large, multinational Phase 3 clinical
program. Discovery Labs believes that to potentially gain FDA
marketing approval for Surfaxin for the prevention of RDS it must satisfy the
FDA as to the final validation of an important quality control release and
stability test for Surfaxin, the fetal rabbit biological activity test
(BAT). Discovery Labs is currently conducting a comprehensive
preclinical program that is intended to satisfy the FDA in this
respect. If approved, Surfaxin would be the first synthetic,
peptide-containing surfactant for commercial use in neonatal
medicine.
Discovery
Labs’ development strategy for Surfaxin LS™
(next-generation, lyophilized formulation of Surfaxin) is to build upon the
Surfaxin clinical experience to create a best-in-class surfactant therapy with
improved preparation and administration flexibility and the potential to further
improve clinical performance. Aerosurf®
(drug/device combination for noninvasive administration of aerosolized KL4 surfactant
to address neonatal RDS) holds the promise to significantly expand the use of
surfactant therapy by providing neonatologists with a less-invasive means of
delivering KL4 surfactant
without the current requirement of invasive endotracheal intubation and
mechanical ventilation.
Surfaxin,
Surfaxin LS and Aerosurf are investigational drug or drug-device combination
products that have not been approved by the U.S. Food and Drug Administration or
any other world health regulatory authority.
About
Discovery Labs
Discovery
Laboratories, Inc. is a biotechnology company developing KL4 surfactant
therapies for respiratory diseases. Surfactants are produced naturally in
the lungs and are essential for breathing. Discovery Labs’ novel
proprietary KL4 surfactant
technology produces a synthetic, peptide-containing surfactant that is
structurally similar to pulmonary surfactant and is being developed in liquid,
aerosol or lyophilized formulations. In addition, Discovery Labs’
proprietary capillary aerosolization technology produces a dense aerosol, with a
defined particle size that is capable of potentially delivering aerosolized
KL4
surfactant to the deep lung without the complications currently associated with
liquid surfactant administration. Discovery Labs believes that its
proprietary technology platform makes it possible, for the first time, to
develop a significant pipeline of surfactant products to address a variety of
respiratory diseases for which there frequently are few or no approved
therapies. For more information, please visit our website at www.Discoverylabs.com.
Forward-Looking
Statements
To the extent that statements in this
press release are not strictly historical, all such statements are
forward-looking, and are made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. These
forward-looking statements are subject to certain risks and uncertainties that
could cause actual results to differ materially from the statements
made. Examples of such risks and uncertainties are: risks relating to
the rigorous regulatory requirements required for approval of any drug or
drug-device combination products that Discovery Labs may develop, including
that: (a) Discovery Labs and the U.S. Food and Drug Administration (FDA) or
other regulatory authorities will not be able to agree on the matters raised
during regulatory reviews, or Discovery Labs may be required to conduct
significant additional activities to potentially gain approval of its product
candidates, if ever, (b) the FDA or other regulatory authorities may not
accept or may withhold or delay consideration of any of Discovery Labs’
applications, or may not approve or may limit approval of Discovery Labs’
products to particular indications or impose unanticipated label
limitations, and (c) changes in the national or
international political and regulatory environment may make it more difficult to
gain FDA or other regulatory approval; risks relating to Discovery Labs’
research and development activities, including (i) time-consuming and
expensive pre-clinical studies, clinical trials and other efforts, which may be
subject to potentially significant delays or regulatory holds, or fail, and (ii)
the need for sophisticated and extensive analytical methodologies, including an
acceptable biological activity test, if required, as well as other quality
control release and stability tests to satisfy the requirements of the
regulatory authorities; risks relating to Discovery Labs’ ability to develop and
manufacture drug products and capillary aerosolization systems for clinical
studies, and, if approved, for commercialization of drug and combination
drug-device products, including risks of technology transfers to contract
manufacturers and problems or delays encountered by Discovery Labs, its contract
manufacturers or suppliers in manufacturing drug products, drug substances and
capillary aerosolization systems on a timely basis or in an amount sufficient to
support Discovery Labs’ development efforts and, if approved, commercialization;
the risk that Discovery Labs may be unable to identify potential strategic
partners or collaborators to develop and commercialize its products, if
approved, in a timely manner, if at all; the risk that Discovery Labs will not
be able in a changing financial market to raise additional capital or enter into
strategic alliances or collaboration agreements, or that the ongoing credit
crisis will adversely affect the ability of Discovery Labs to fund its
activities, or that additional financings could result in substantial equity
dilution; the risk that Discovery Labs will not be able to access credit from
its committed equity financing facilities (CEFFs), or that the minimum share
price at which Discovery Labs may access the CEFFs from time to time will
prevent Discovery Labs from accessing the full dollar amount potentially
available under the CEFFs; the risk that Discovery Labs or its strategic
partners or collaborators will not be able to retain, or attract, qualified
personnel; the risk that Discovery Labs will be unable to regain compliance with
The Nasdaq Capital Market listing requirements prior to the expiration of the
additional grace period currently in effect, which could cause the price of
Discovery Labs’ common stock to decline; the risk that recurring losses,
negative cash flows and the inability to raise additional capital could threaten
Discovery Labs’ ability to continue as a going concern; the risks that Discovery
Labs may be unable to maintain and protect the patents and licenses related to
its products, or other companies may develop competing therapies and/or
technologies, or health care reform may adversely affect Discovery Labs; risks
of legal proceedings, including securities actions and product liability claims;
risks relating to health care reform; and other risks and uncertainties
described in Discovery Labs’ filings with the Securities and Exchange Commission
including the most recent reports on Forms 10-K, 10-Q and 8-K, and any
amendments thereto.
Contact
Information:
Investor
relations:
John G.
Cooper, President and Chief Financial
Officer
215-488-9300
Media:
Michelle
Linn
Linnden
Communications
508-362-3087
linnmich@comcast.net