|
<PAGE>
Exhibit 10.5
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote
omissions.
AMENDMENT NO. 1 TO CO-PROMOTION AND MARKETING SERVICES
AGREEMENT
BY AND BETWEEN CRITICAL THERAPEUTICS, INC. AND DEY, L.P.
This Amendment No. 1 to the Co-Promotion and Marketing Services
Agreement
(the "AMENDMENT"), effective as of June 25, 2007 ("AMENDMENT
EFFECTIVE DATE"),
is entered into by and between Critical Therapeutics, Inc., a
Delaware
corporation, having a place of business at 60 Westview Street,
Lexington, MA
02421 ("CRTX") and Dey, L.P., a limited partnership organized
and existing under
the laws of the State of Delaware and having its principal
offices at 2751 Napa
Valley Corporate Drive, Napa, CA 94558 ("DEY").
RECITALS:
A. CRTX and DEY entered into the Co-Promotion and Marketing
Services
Agreement effective March 13, 2007 (the "ORIGINAL
AGREEMENT").
B. CRTX and DEY desire to amend the Original Agreement.
NOW THEREFORE, in consideration of the mutual covenants
contained in the
Original Agreement and in this Amendment No. 1 and other good
and valuable
consideration the receipt of which is hereby acknowledged, the
parties agree
that on the Amendment Effective Date, the Original Agreement is
hereby amended
as follows:
AMENDMENT:
1. All capitalized terms used herein but not otherwise defined
shall have the
meaning set forth in the Original Agreement.
2. Except as modified herein, all terms and conditions of the
Original
Agreement shall remain in full force and effect.
3. Section 1.3 of the Original Agreement shall be deleted in its
entirety and
replaced with the following:
1.3 "Additional Zileuton Products" means any CRTX products with
(i)
Zileuton or (ii) alternative forms of zileuton, such as
salts,
enantiomers, polymorphs, metabolites or prodrugs of
Zileuton,
including, but not limited to, a single isomer of zileuton,
as
one of the active pharmaceutical ingredients in the Territory
for
the treatment of asthma and, subject to FDA approval, other
respiratory conditions but shall not mean or include (i) the
Products or (ii) any product in the Excluded Field.
4. Section 1.4 of the Original Agreement shall be deleted in its
entirety and
replaced with the following:
1 of 5
<PAGE>
1.4 "Adverse Event(s)" means adverse drug experiences, as
defined by
21 CFR 312.32 or 314.80, relating to a Product. "Serious
Adverse
Event(s)" means a serious Adverse Event, as defined by 21
CFR
312.32 or 314.80, relating to a Product. For purposes of
Section
6 of this Agreement, the use of the phrase "Adverse Event"
is
intended to include Serious Adverse Event(s).
5. Article 1 of the Original Agreement shall be amended by the
addition of the
following:
1.5A "Amendment No. 1 Date" means June 25, 2007.
6. Section 4.6(4) of the Original Agreement shall be deleted in
its entirety
and replaced with the following:
(4) In addition to the training referred to above, during the
Term,
each Party shall conduct separate training programs for
their
respective sales force with respect to the Medicare and
Medicaid
Anti-Kickback Statute, as set forth at 42 U.S.C. Section
1320(a)-7b(b)
and the acts prohibited thereunder, PDMA regulations, and all
other
applicable guidances relating to promotion of Product,
including,
without imitation, the PhRMA Code on Interactions with
Healthcare
Professionals. Upon completion of such additional training, each
sales
force member shall be required to sign a certificate
acknowledging
their receipt of such training and certifying and acknowledging
their
attendance at the training.
7. Section 6.5 of the Original Agreement shall be deleted in its
entirety and
replaced with the following:
6.5 Adverse Events. CRTX shall use its established operating
procedures to report Adverse Events to the FDA in accordance
with
Applicable Laws. Such operating procedures shall include any
measures
n
| 
