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Loan Agreement

 

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Title:

Loan Agreement

Entities:

Discovery Laboratories Inc.; First Union National Bank; Johnson & Johnson; Dickstein Shapiro Morin & Oshinsky

Date:

2002

Size:

Preview shows 9KB of 59KB total

Price:

$42

ID:

#283694

 

 

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                                 LOAN AGREEMENT


THIS LOAN AGREEMENT (this "Agreement") is dated and entered into as of
December 10, 2001 (the "Effective Date") by and between DISCOVERY LABORATORIES,
INC., a Delaware corporation ("Borrower"), and PHARMABIO DEVELOPMENT INC., a
North Carolina corporation ("Lender").

WHEREAS, Borrower and Lender are parties to the Common Stock and Warrant
Purchase Agreement dated as of the date hereof (the "Purchase Agreement") and
the Investment and Commission Agreement dated as of the date hereof (the
"Investment and Commission Agreement");

WHEREAS, Borrower and Quintiles Transnational Corp., an Affiliate of
Lender ("Quintiles"), are parties to a Commercialization Agreement (the
"Commercialization Agreement"), dated as of the date hereof;

WHEREAS, in connection with the Purchase Agreement, Investment and
Royalty, and Commercialization Agreement, Lender is willing to extend certain
credit facilities to Borrower, subject to and upon the terms and conditions of
this Agreement; and

NOW, THEREFORE, for good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged by the parties, the parties hereby
agree as follows:

ARTICLE I
DEFINITIONS

1.01 Definitions. Capitalized terms used but not defined in the text of
this Agreement shall have the meanings ascribed to them on Exhibit A attached
hereto and incorporated herein by reference.

ARTICLE II
Amount and Terms of Loan

2.01 Advances.

(a) Subject to and upon the terms and conditions set forth herein,
Lender agrees, at any time and from time to time, from and after the occurrence
of Milestone One (as defined below) and prior to December 10, 2004 (the
"Maturity Date"), to make advances (each an


1
{PAGE}

"Advance" and collectively the "Advances") to Borrower at such times and in such
amounts as Borrower shall request pursuant to this Agreement, up to an aggregate
principal amount of Eight Million, Five Hundred Thousand Dollars ($8,500,000)
(as adjusted and subject to the satisfaction of certain milestones in accordance
with this Section 2.01, the "Commitment") in lawful money of the United States
of America in immediately available funds. The Commitment shall become available
to Borrower as follows:

(i) Upon the occurrence of Milestone One (as defined below),
one third (1/3) of the Commitment shall be available. "Milestone
One" shall mean the later to occur of (i) the completion by The
Lewin Group of a market opportunity assessment and report in
customary form regarding the Product, which shall include without
limitation an assessment and report as to pre-launch
commercialization requirements and sales forecasts, and (ii)
Borrower shall have obtained a valid and binding extension of the
deadline for the filing of the NDA referred to in Section 6 of the
License Agreement until at least October 28, 2003.

(ii) Upon the occurrence of Milestone One and Milestone Two
(as defined below), two thirds (2/3) of the Commitment shall be
available. "Milestone Two" shall mean the earlier to occur of (i)
the sale after the date of this Agreement by Borrower of shares of
its capital stock for cash proceeds with an aggregate purchase price
of at least $10,000,000 in one or more capital financing
transactions or pursuant to the exercise of options, warrants or
rights to purchase its capital stock, and in each case the proceeds
of which may be used for general corporate purposes or (ii) the
public disclosure by Borrower of Phase III clinical trial data
regarding the indication for the Product known as idiopathic
respiratory distress syndrome ("IRDS"), and the completion by
Quintiles or an appropriate Affiliate of a written assessment and
report indicating that such data is favorable and that such data
substantially enhances the Company's prospects with respect to its
ability to repay the Commitment as increased by such Milestone Two.

(iii) Upon the occurrence of Milestone One, Milestone Two, and
Milestone Three (as defined below), the full Commitment shall be
available. "Milestone Three" shall mean the earlier to occur of (i)
the completion by Quintiles or an appropriate Affiliate of a written
assessment and report in customary form indicating the
"approvability" by the FDA of Borrower's NDA for the Product for
either the IRDS indication or the indication known as meconium
aspiration syndrome ("MAS"), which shall include without limitation
an assessment and report as to the quality of the documentation
comprising such NDA and the clinical data included in such NDA, or
(ii) the issuance by the FDA of a letter in customary form
indicating that Borrower's NDA for the Product is "approvable" with
respect to Borrower's NDA for either the IRDS indication or the MAS
indication.

(b) Notwithstanding anything to the contrary in this Agreement, upon
the occurrence of the "First Milestone" (as defined in the Investment and
Commission Agreement),


2
{PAGE}

Borrower shall prepay Advances as described in Section 2.05(b), and the
Commitment shall be automatically reduced by the amount of such required
prepayment.

(c) Notwithstanding anything to the contrary in this Agreement, upon
the occurrence of the "Second Milestone" (as defined in the Investment and
Commission Agreement), Borrower shall prepay the aggregate outstanding amount of
all Advances and the Commitment shall be automatically terminated.

(d) As contemplated by the Commercialization Agreement, the JCC (as
defined therein) may authorize expenditures for pre-Launch Marketing Services in
excess of $8,500,000 up to $10,000,000 (without the consent of Lender). In the
event that the JCC authorizes such expenditures in excess of $8,500,000 (but not
in excess of $10,000,000), (i) the Commitment shall be deemed increased by a
commensurate amount, but in any event not in excess of a maximum Commitment of
$10,000,000 in the aggregate, and (ii) Borrower shall execute a new promissory
note as described in Section 3.02(e).

(e) In the event that the parties mutually agree to authorize
expenditures for pre-Launch Marketing Services in excess of $10,000,000 (but not
in excess of $15,000,000), (i) the Commitment shall be deemed increased by a
commensurate amount, and (ii) Borrower shall execute a new promissory note as
described in Section 3.02 (e). Notwithstanding anything in this Agreement to the
contrary, any increase in the Commitment in excess of $10,000,000 shall require
the express written agreement of Lender in the sole discretion of Lender, and
this subsection (e) shall not imply that Lender is willing, or obligate Lender
in any manner, to agree to any such increase or to agree to any increase in
Lender's obligations under the Investment and Commission Agreement, with any
such increase in Lender's obligations being required to be set forth in an
express written agreement referring to the Investment and Commission Agreement.

(f) Borrower may use the Commitment, as in effect from time to time,
on a revolving basis by borrowing, repaying the Advances in whole or in part,
and reborrowing, all in accordance with the terms and conditions of this

 

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