AMENDMENT NO. 2 TO CO-PROMOTION
AND MARKETING SERVICES
AGREEMENT
This Amendment
No. 2 to Co-Promotion and Marketing Services Agreement (this
“Amendment”) is dated May 4, 2009 (the
“Amendment Execution Date”), by and between
Cornerstone Therapeutics Inc. (formerly known as Critical
Therapeutics, Inc.), a Delaware corporation with its principal
offices located at 1255 Crescent Green Drive, Suite 250, Cary,
NC 27518 (“CRTX”) and Dey, L.P. , a Delaware
limited partnership with its principal offices located at 2751 Napa
Valley Corporate Drive, Napa, CA 94558
(“DEY”).
WHEREAS, the
Parties entered into that certain Co-Promotion and Marketing
Services Agreement dated as of March 13, 2007 (the
“Co-Promotion Agreement”);
WHEREAS, the
Parties entered into that certain Amendment No. 1 to the
Co-Promotion Agreement dated as of June 25, 2007 (hereinafter,
the Co-Promotion Agreement, as amended by Amendment No. 1,
shall be referred to as the “Agreement”);
and
WHEREAS, the
Parties desire to amend certain terms of the Agreement by way of
this Amendment.
NOW, THEREFORE, in
consideration of the promises made herein and other good and
valuable consideration, the receipt and sufficiency of all of which
are hereby acknowledged, the Parties, intending to be legally
bound, agree as follows:
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1.
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All
capitalized terms used in this Amendment and not otherwise defined
herein shall have the meanings given to them in the
Agreement.
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2.
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Section 1.22 of the Agreement
is hereby deleted in its entirety and replaced with the
following:
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“Detail
Targets” means, for the Pre-Launch and Launch Period, the
Detail Targets will be those who the JCC agrees qualify as
potential targets for the Products, and, thereafter, the Detail
Targets shall include the PUDs and all other office based
physicians and other health care professionals in the Territory
that significantly influence use with respect to any Product in the
Territory as mutually agreed upon by the Parties.
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3.
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A
new Section 1.23(a) is added to the Agreement as
follows:
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1.23(a)
“Amendment No. 2 Effective Date” means
January 1, 2009.
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4.
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Section 1.28 of the Agreement
is hereby deleted in its entirety and replaced with the
following:
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“Forecast(s)” means a twelve month
rolling forecast provided by DEY to CRTX on a calendar quarterly
basis listing DEY’s monthly requirements for Samples. Such
forecast shall be provided to CRTX at least six (6) months in
advance of the first applicable Calendar Quarter in such
forecast.
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[***]
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Confidential
portions of the exhibit have been omitted and filed separately with
the Securities and Exchange Commission.
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5.
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Section 1.44 of the Agreement
is hereby deleted in its entirety and replaced with the
following:
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“Promotional Materials” means all
written, printed or graphic material provided by CRTX and intended
for use by a Party’s Sales Representatives during a Call, or
during marketing sponsored speaker programs including, but not
limited to, visual aids, file cards, premium items, clinical
studies, reprints, drug information updates and any other
promotional support items or advertising that CRTX (following
consultation with (i) the Committee during the Pre-Launch
Period and the Launch Period or (ii) DEY in accordance with
Section 4.4(8) thereafter), deems necessary or appropriate in
connection with the Promotion of Product. Promotional Materials
shall include only those materials describing FDA-approved
indicated uses, safety, effectiveness, contraindications, side
effects, warnings and other relevant characteristics of a Product
that meet the regulations as outlined in the Code of Federal
Regulations. Promotional Materials shall not include any Product
packaging, Product labeling or Sample labeling.
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6.
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Section 1.47 of the Agreement
is hereby deleted in its entirety and replaced with the
following:
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“Promotion Plan” means a plan
relating to the Promotion of a Product. During the Pre-Launch
Period and the Launch Period, the Promotion Plan will be as
established by the Committee. Thereafter, the Promotion Plan will
be established by the individual Parties in their sole discretion,
subject to the terms of the Agreement, as amended
herein.
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7.
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Section 1.50 of the Agreement
is hereby deleted in its entirety and replaced with the
following:
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“Samples” means Products provided
primarily to Detail Targets for no consideration in accordance with
PDMA guidelines.
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8.
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A
new Section 1.60 is added to the Agreement as
follows:
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“Non-personal Promotion Expenses”
mean those Promotion Expenses not associated with Details. Together
Non-personal and Personal Promotion Expenses equal the Promotion
Expenses.
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9.
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A
new Section 1.61 is added to the Agreement as
follows:
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“Personal
Promotion Expenses” mean those Promotion Expenses associated
with Details.
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10.
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A
new Section 1.62 is added to the Agreement as
follows:
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“PUD(s)” means, for any particular
date, the pulmonary specialists identified and defined by IMS
Health (or by mutual written consent of the Parties another Third
Party data vendor such as Wolters Kluwer) as either Pulmonary
Critical Care Medicine or Pulmonary Disease Specialists during the
period
Page 2 of 14
beginning on
the Amendment No. 2 Effective Date and ending on such
particular date. Any doctor identified as a PUD at any time during
the Term of this Agreement, based upon the definition above, shall
remain a PUD throughout the remainder of the Term for purposes of
this Agreement.
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11.
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A
new Section 1.63 is added to the Agreement as
follows:
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“PUD
Prescription Ratio” means, for any particular Calendar
Quarter, the ratio of total prescriptions written for the Products
by PUDs to the total prescriptions written for the Products, based
upon data published by IMS Health for such period. If IMS Health
data is not available, Wolters Kluwer prescription data will be
used by the Parties. If neither IMS Health nor Wolters Kluwer data
is available, the last available PUD Prescription Ratio will be
used for the remainder of the Term. For example, in order to
calculate the PUD Prescription Ratio for the third calendar quarter
of 2008 (July 1, 2008 through September 30, 2008), the
total number of prescriptions written by PUDs for the Products
([***]) is divided by the number of total prescriptions written for
the Products ([***]) to arrive at the PUD Prescription Ratio, which
is [***]% (actual data from IMS Health NPA, including LTC, used for
this example). For comparison, PUD Prescription Ratio using Wolters
Kluwer data for this same quarter was [***]% ([***] divided by
[***]).
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12.
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The
following new language is added to Section 3.1 of the
Agreement following the heading “Joint Commercial
Committee” (before subsections (1) through
(7)):
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For the
Pre-Launch Period and the Launch Period, the Parties shall
establish a Joint Commercial Committee on the following terms and
conditions. As of January 1, 2009, the Joint Commercial
Committee shall be disbanded and this Section 3.1 shall be of
no further effect.
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13.
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Section 4.3(3) of the Agreement
is hereby deleted in its entirety and replaced with the
following:
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During the
Post-Launch Period and the Post-Exclusivity Period, and as long as
no generic competition for Zileuton XR has entered the market in
the Territory, DEY shall deliver at least [***] Details per full
calendar month to PUDs for Zileuton XR in the second position. DEY
shall have no obligation to deliver Details during any Calendar
Quarter for which CRTX is unable to deliver to DEY (i) at
least seventy-five percent (75%) of the Samples forecast by DEY for
such quarter or (ii) a reasonably adequate supply of
Promotional Materials. Once a Third Party AB-rated generic product
to Zileuton XR has entered the market in the Territory, [***];
provided, however, each of DEY and Mylan Inc. (“Mylan”)
covenant and agree that, during the Term, neither DEY, Mylan nor
any of their Affiliates will introduce in the Territory the first
AB-rated generic product to either (i) Zileuton XR or
(ii) Zileuton IR.
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[***]
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Confidential
portions of the exhibit have been omitted and filed separately with
the Securities and Exchange Commission.
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Page 3 of 14
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14.
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Section 4.3(4) of the Agreement
is hereby deleted in its entirety and replaced with the
following:
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15.
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Section 4.3(5) of the Agreement
is hereby deleted in its entirety and replaced with the
following:
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For Details
described in Subsections 4.3(1) through (2), DEY shall provide
Details to Detail Targets who the JCC agrees qualify as potential
targets for the Products, and the JCC also will determine an
optimal level of Detail frequency for all targeted
physicians.
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16.
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Section 4.3(6) of the Agreement
is hereby deleted in its entirety and replaced with the
following:
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In Year 2008,
DEY will contribute fifty percent (50%) of the docu

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