exv10w1






EXHIBIT 10.1




TRIPLICATE ORIGINAL




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:




	 	1.	 	
All capitalized terms used in this Amendment and not otherwise defined herein shall have
the meanings given to them in the Agreement.







	 	2.	 	

Section 1.22 of the Agreement is hereby deleted in its entirety and replaced with the
following:






“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.



	 	3.	 	

A new Section 1.23(a) is added to the Agreement as follows:






1.23(a) “Amendment No. 2 Effective Date” means January 1, 2009.



	 	4.	 	

Section 1.28 of the Agreement is hereby deleted in its entirety and replaced with
the following:






“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.





 




			
	[***]	 	Confidential portions of the exhibit have been omitted and filed separately with the Securities and Exchange Commission.





 









 






	 	5.	 	
Section 1.44 of the Agreement is hereby deleted in its entirety and replaced with the
following:






“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.



	 	6.	 	
Section 1.47 of the Agreement is hereby deleted in its entirety and replaced with the
following:






“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.




	 	7.	 	
Section 1.50 of the Agreement is hereby deleted in its entirety and replaced with the
following:






“Samples” means Products provided primarily to Detail Targets for no
consideration in accordance with PDMA guidelines.




	 	8.	 	
A new Section 1.60 is added to the Agreement as follows:






“Non-personal Promotion Expenses” mean those Promotion Expenses not
associated with Details. Together Non-personal and Personal Promotion
Expenses equal the Promotion Expenses.




	 	9.	 	
A new Section 1.61 is added to the Agreement as follows:






“Personal Promotion Expenses” mean those Promotion Expenses associated with
Details.




	 	10.	 	
A new Section 1.62 is added to the Agreement as follows:






“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



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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.




	 	11.	 	
A new Section 1.63 is added to the Agreement as follows:






“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 [***]).




	 	12.	 	
The following new language is added to Section 3.1 of the Agreement following the heading
“Joint Commercial Committee” (before subsections (1) through (7)):






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.




	 	13.	 	
Section 4.3(3) of the Agreement is hereby deleted in its entirety and replaced with the
following:






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.





 




			
	[***]	 	Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.




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	 	14.	 	
Section 4.3(4) of the Agreement is hereby deleted in its entirety and replaced with the
following:






Intentionally Omitted.


 
	 	15.	 	
Section 4.3(5) of the Agreement is hereby deleted in its entirety and replaced with the
following:






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.




	 	16.	 	
Section 4.3(6) of the Agreement is hereby deleted in its entirety and replaced with the
following:






In Year 2008, DEY will contribute fifty percent (50%) of the documented
total Zileuton XR Promotion Expenses that are developed and approved by the
JCC. During the Term of the Agreement, DEY also is responsible for salaries
for its own employees performing marketing functions, which shall be
separate from and in addition to the required Zileuton XR Promotion Expenses
for Year 2008. DEY shall bear its Sales Representative expenses and Sample
expenses, which shall also be separate from and in addition to the required
Zileuton XR Promotion Expenses for Year 2008. DEY shall bear its Sales
Representative expenses and Sample expenses for the remainder of the Term.




	 	17.	 	
Section 4.3(10) of the Agreement is hereby deleted in its entirety and replaced with the
following:






Intentionally Omitted.



	 	18.	 	

Section 4.3(11) of the Agreement is hereby deleted in its entirety and replaced with the
following:






(11) (a) Neither DEY nor Mylan Inc. (“Mylan”) shall directly or indirectly,
manufacture, Detail, sell, market or promote any product (except for
Products during the Term of this Agreement) containing Zileuton as one of
the active pharmaceutical ingredients for sale in the Territory during the
Term. If this Agreement expires or terminates for any reason, neither DEY
nor Mylan shall directly or indirectly, manufacture, Detail, sell, market or
promote any product containing Zileuton as one of the active
pharmaceutical ingredients for sale in the Territory until the later of
(i) one year after such expiration or termination or (ii) March 31, 2012
(the “Post-Termination Non-Compete Period”); provided, however, if: (x) a
Third Party AB-rated generic product to Zileuton XR not expressly
authorized by CRTX enters the Territory during this Post-Termination
Non-Compete Period, DEY and Mylan will no longer



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be held to the Post-Termination Non-Compete Period; or (y) a Third Party
AB-rated generic product to Zileuton IR not expressly authorized by CRTX
enters the Territory during this Post-Termination Non-Compete Period,
DEY and Mylan will no longer be held to the Post-Termination
Non-Compete Period with respect to such a product. Nothing set forth in
this Agreement is intended to prevent DEY and/or Mylan from being able to
take any and all actions necessary to be ready to launch a product
containing Zileuton as one of the active pharmaceutical ingredients for sale
in the Territory simultaneously with the market entry of a Third Party
AB-rated generic product to Zileuton XR and/or Zileuton IR not expressly
authorized by CRTX. Notwithstanding the foregoing, if this Agreement is
terminated by DEY pursuant to Section 12.2(4) or by DEY pursuant to Section
12.2(6), the Post-Termination Non-Compete Period in this Section 4.3(11)
shall be void; provided, however, DEY and CRTX shall continue to abide by
the provisions of Section 9 of this Agreement after such termination.




(b) If at any time CRTX decides in its sole discretion to launch an
authorized generic of Zileuton XR and/or Zileuton IR in the Territory, DEY
and/or Mylan shall have the exclusive right to be CRTX’s exclusive
authorized generic distributor in the Territory. DEY and/or Mylan shall
have thirty (30) days after CRTX’s written notice of its decision to launch
such authorized generic(s) in the Territory to elect in writing to exercise
its right to commercialize such authorized generic(s) in the Territory.
CRTX’s written notice to DEY shall include DEY’s Transfer Cost (as defined
below), CRTX’s manufacturing lead times and the applicable CRTX Royalty (as
defined below). To the extent DEY and/or Mylan do not timely make such
election, CRTX shall be free to commercialize such authorized generic(s) on
its own or through a Third Party on terms no more favorable than the terms
offered to DEY and/or Mylan. To the extent DEY and/or Mylan timely make
such election, CRTX shall exclusively supply DEY and/or Mylan with such
authorized generic at [***] (“DEY’s Transfer Cost”) and upon such other
terms and conditions mutually agreed to in good faith by the Parties. If
DEY and/or Mylan elects to order inventory of the authorized generic in
anticipation of the potential launch of a generic by a Third Party (the
“Pre-launch Inventory”) and the Pre-launch Inventory is not sold, DEY shall,
at CRTX’s option, either: (i) sell back to CRTX at DEY’s Transfer Cost all
of the Pre-launch Inventory, or (ii) destroy the Pre-Launch Inventory. If
the Pre-Launch Inventory is destroyed as a result of such product not being
commercially launched by DEY and/or Mylan because the potential launch of a
generic by a Third Party does not actually occur, the parties shall divide
the transfer and destruction costs of the Pre-launch Inventory eighty
percent to be paid by CRTX and twenty percent to be paid by DEY and/or
Mylan; provided, however, CRTX shall have no obligation to share such costs
if the applicable inventory has more than twelve (12) months of remaining
shelf life on the actual launch date of a generic by a Third Party. DEY
and/or Mylan shall sell and distribute the authorized generic in the
Territory using commercially reasonable efforts to maximize profitability.
Within thirty (30) days following the end of each Calendar Quarter, DEY
and/or Mylan shall





 




			
	[***]	 	Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.




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calculate the net revenue realized from the sale of the authorized generic
product. For purposes of this Section, “net revenue” shall mean the
invoiced sales price to a customer by DEY for the authorized generic less:
(i) any applicable taxes, (ii) returned goods credits, (iii) any discounts,
in amounts customary in the trade, for quantity purchases or cash or prompt
payment, (iv) retroactive price reductions, including chargebacks and
administrative fees, in amounts customary in the trade. DEY and/or Mylan
shall subtract from net revenue the following to arrive at “Net Profits”:
(i) DEY’s Transfer Cost, (ii) any royalty due and payable by CRTX to Third
Parties pursuant to agreement(s) existing as of the Amendment No. 2
Effective Date (“CRTX Royalty”), and (iii) a [***] percent ([***]%)
distribution allowance for DEY and/or Mylan. Within thirty (30) days after
the end of each Calendar Quarter, DEY and/or Mylan shall pay CRTX the CRTX
Royalty and an additional royalty equal to [***] percent
([***]%) of the Net
Profits realized from the sale of the authorized generic. If at any time
after the launch of the authorized generic it becomes commercially
unreasonable for DEY and/or Mylan to continue selling the authorized
generic, DEY and/or Mylan may cease selling the authorized generic upon
ninety (90) days prior written notice to CRTX. Upon DEY and/or Mylan’s
ceasing to sell the authorized generic, it shall, at CRTX’s option, either:
(i) sell back to CRTX at DEY’s Transfer Cost all inventory of the authorized
generic, or (ii) destroy all inventory of the authorized generic at DEY
and/or Mylan’s expense.




	 	19.	 	
Section 4.4(2) of the Agreement is hereby deleted in its entirety and replaced with the
following:






During the Launch Period, CRTX shall deliver at least [***] Details per full
calendar month in the first position for Zileuton XR.



	 	20.	 	

Section 4.4(3) of the Agreement is hereby deleted in its entirety.





	 	21.	 	

Section 4.4(4) of the Agreement is hereby deleted in its entirety and replaced with the
following:






(a) CRTX is responsible for all Promotion Expenses for the Products in Year
2007, which shall be a minimum of US $3.0 million, excluding salaries for
its own employees performing marketing functions (as well as any expenses
for detail aids, promotional items, market research) and Sample expenses.




(b) In Year 2008, CRTX will contribute fifty percent (50%) of the Zileuton
XR Promotion Expenses, which are developed and approved by the JCC. These
expenses shall not include salaries for CRTX’s employees performing
marketing functions (as well as any expenses for detail aids, promotional
items, market research) and Sample expenses, the expenses of which shall be
borne by CRTX.




(c) Beginning in Year 2009 and continuing throughout the Term, CRTX shall be
responsible for all Promotion Expenses. Beginning in Year 2009 and





 




			
	[***]	 	Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.




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continuing throughout the Term until any generic competition for Zileuton XR
enters the market in the Territory, at least [***] percent
([***]%) of the
total Non-personal Promotion Expenses incurred by CRTX must be directed to
the PUDs. Until any generic competition for Zileuton XR enters the market
in the Territory, Promotion Expenses include, but are not limited to, all of
the costs for the following: (1) the Promotional Materials for biannual
Plans of Action to commence March 1 and September 1 of each calendar year
(i.e. Plan of Action 1 (“POA1”) and Plan of Action 2 (“POA2”), (2) on a
calendar quarterly basis promotional mailings to the PUDs identified by DEY
and provided to CRTX, (3) trade show booth panels for the annual meetings of
the American Thoracic Society and American College of Chest Physicians, and
(4) if journal advertising is done for Zileuton XR, the media will include
an appropriate selection of Pulmonology-specific medical journals (e.g.,
CHEST and the American Journal of Respiratory and Critical Care Medicine).
In addition, CRTX shall provide DEY Sales Representatives with quantities of
promotional materials (i.e. Master Sales Aids, Leave Behind Sales Aids,
Clinical Reprints, Reprint Carriers, etc.) commensurate with the quantities
of promotional materials provided to CRTX Sales Representatives (to be
adjusted on a per-target and Call frequency basis taking into account
differences in the number of targets and Call frequency). CRTX will not
offer any promotions to other physician specialties or healthcare providers
that are not also made available to the PUDs. On a calendar quarterly
basis, CRTX will provide DEY with a twenty four (24) month rolling forecast
for sales of the Products.



	 	22.	 	

Section 4.4(5) of the Agreement is hereby deleted in its entirety and replaced with the
following:






Intentionally omitted.



	 	23.	 	

A new Section 4.4(6) will be added to the Agreement as follows:






Intentionally omitted.



	 	24.	 	

Section 4.4(7) of the Agreement is hereby deleted in its entirety and replaced with the
following:





Intentionally omitted.




	 	25.	 	
Section 4.4(8) of the Agreement is hereby deleted in its entirety and replaced with the
following:






CRTX, at its sole expense, will be responsible for obtaining and maintaining
all applicable regulatory approvals for Products and approving and
submitting all Promotional Materials in the Territory to the regulatory
authorities, all as according to Applicable Laws. A minimum of forty-five
(45) business days prior to the date of disk release to its printer for
printed Promotional Materials or the date on which CRTX intends to finalize
the document for non-printed Promotional Materials (such as slides,
teleconferences, MedEd programs,





 




			
	[***]	 	Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.




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etc.), CRTX will submit all draft Promotion Materials to DEY for legal,
medical and regulatory review. DEY will provide its comments to CRTX within
ten (10) business days of its receipt thereof. Following CRTX’s receipt of
DEY’s comments, the Parties shall discuss and CRTX shall use commercially
reasonable efforts to address DEY’s comments in the Promotion Materials.
The revised Promotion Materials will be resubmitted by CRTX to DEY for final
review at least five (5) business days prior to the date of disk release to
its printer or the date on which CRTX intends to finalize the document,
respectively. If a dispute arises between the Parties concerning the content
of any Promotion Material, CRTX will provide copies of the Promotional
Materials that have been revised to remove the disputed section if there is
a documented legal, medical or regulatory concern raised by DEY; provided,
however, in such case, CRTX and DEY shall each pay fifty percent (50%) of
the additional, incremental costs of such Promotional Material. For
example, if the Parties plan to print 1,000 copies of a promotional piece at
a cost of $10,000 but they cannot agree on content and two versions (500
copies each) of the piece must be printed at a cost of $14,000, DEY would
pay CRTX $2,000 ($14,000-$10,000/2). In any case where a dispute between
the Parties results in the creation of two versions of certain Promotional
Material(s), DEY’s name and logo shall appear only on the Promotional
Material(s) in which the disputed section(s) have been removed. The Parties
shall comply with the terms of Section 9.4 of the Agreement regarding press
releases or other public announcements.




	 	26.	 	
Section 4.4(9)(e) of the Agreement is hereby deleted in its entirety and replaced with the
following:






Using Commercially Reasonable Efforts to supply and ship to DEY (at DEY’s
facility in Allen, TX) the number of GMP-compliant commercial Zileuton XR
Samples identified by DEY in each Forecast for the upcoming Calendar
Quarter. CRTX shall invoice DEY for the Samples at [***], provided,
however, that CRTX shall pay for all shipping charges. CRTX shall use
Commercially Reasonable Efforts to supply DEY no later than the
15th of January, April, July and October of each calendar year
with the Samples identified by DEY in each Forecast for the upcoming
Calendar Quarter. Throughout the Term, CRTX shall use Commercially
Reasonable Efforts to reduce the cost of the Samples. If at any time for
any reason CRTX is unable to supply DEY in any Calendar Quarter with the
number of Samples set forth in the applicable Forecast, CRTX shall allocate
[***] percent ([***]%) of any available Samples to DEY until DEY has
received the number of Samples set forth in the applicable Forecast for such
quarter.




	 	27.	 	
The first sentence of Section 4.4(10) of the Agreement is hereby deleted in its entirety
and replaced with the following:






CRTX shall use Commercially Reasonable Efforts to provide DEY with final
draft Promotional Materials updated as agreed by the Parties pursuant to
Sections 4.4(4) and (8), including, but not limited to, training materials
for the performance and supervision of Calls by no later than April 6,
2007, which





 




			
	[***]	 	Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.




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the Parties agree is necessary in order for DEY to meet the Detail
Commencement Date. Such Promotional Materials shall be provided without
cost to DEY and the cost shall be part of the Annual Promotion Budget for
the Year ending December 31, 2008.




	 	28.	 	
Section 4.6(2) of the Agreement is hereby deleted in its entirety and replaced with the
following:






During the Term, CRTX shall provide DEY with sufficient quantities of
training materials relating to the Products in order to meet the Projected
Detail Commencement Date, including an up-to-date programmed learning unit
for “at home” study. Such materials shall be provided to DEY free of charge
for distribution to the DEY sales force and the cost shall be part of the
Annual Promotion Budget for the Year ending December 31, 2008.




	 	29.	 	
Section 4.7(1) of the Agreement is hereby deleted in its entirety and replaced with the
following:






Intentionally deleted.




	 	30.	 	
Section 4.7(4) of the Agreement is hereby deleted in its entirety and replaced with the
following:






In addition to any other reports required by this Agreement, CRTX shall
provide to DEY at no cost to DEY (i) on a quarterly basis, within
[***] business days after the end of each quarter beginning or ending during
the Term, reports of Net Sales, including any Standard Deductions from the
gross amount invoiced for the immediately preceding month; (ii) on a
quarterly basis, the number of Units of each Product sold in the Territory
by customer account; and (iii) such other reports as may be reasonably
requested by DEY in connection with the performance of the Parties’
obligations hereunder.




	 	31.	 	
Section 5.2(c) of the Agreement is hereby deleted in its entirety and replaced with the
following:






Amounts owed by DEY for its portion of (i) Zileuton XR Promotion Expenses
pursuant to Section 4.3(6) of this Agreement for the Year ending December
31, 2008, (ii) Sample costs pursuant Section 4.3(7) of this Agreement, or
(iii) Sample costs pursuant to Section 4.3(8) of this Agreement; each within
thirty (30) days after receipt of invoice from CRTX.




	 	32.	 	
Section 5.6 of the Agreement is hereby deleted in its entirety and replaced with the
following:






CRTX will pay DEY a Co-Promotion Fee for the Post-Launch Period, which shall
be calculated and paid as follows:





 




			
	[***]	 	Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.




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a) The Co-Promotion Fee shall be [***] percent ([***]%) multiplied by the
Products’ total Quarterly NSMR multiplied by the applicable PUD Prescription
Ratio from the immediately prior Calendar Quarter (i.e., the PUD
Prescription Ratio for Q1 will be used to calculate Q2 Co-Promotion Fee),
calculated on a quarterly basis. If the PUD Prescription Ratio for the
current Calendar Quarter differs from the prior Calendar Quarter’s PUD
Prescription Ratio by more than five percent (5%) (i.e., the PUD
Prescription Ratio for Q2 differs by more than five percent (5%) from Q1),
the Parties shall true up the Co-Promotion Fee using the current PUD
Prescription Ratio. For example, if the PUD Prescription Ratio for the
prior Calendar Quarter is twenty-seven percent (27%), a true up would be
paid if the current Calendar Quarter’s PUD Prescription Ratio is less than
25.65 or greater than 28.35.




b) Subject to Section 5.8(3), the Co-Promotion Fee will be paid by CRTX
quarterly within thirty (30) days after the end of the applicable Calendar
Quarter. Subject to Section 5.8(3), the applicable Party shall pay the
other Party the true up amount required by Section 5.6(a) within sixty (60)
days after the end of the applicable Calendar Quarter.




c) Each Party shall have the right to offset amounts due to the other under
the Agreement for Samples and Co-Promotion Fees against any amounts due from
the other Party under the Agreement.




	 	33.	 	
Section 5.7 of the Agreement is hereby deleted in its entirety and replaced with the
following:






CRTX will pay DEY a Co-Promotion Fee for the Post-Exclusivity Period, which
shall be calculated and paid as follows:




a) The Co-Promotion Fee shall be [***] percent ([***]%) multiplied by the
Products’ total Quarterly NSMR multiplied by the applicable PUD Prescription
Ratio from the immediately prior Calendar Quarter (i.e., the PUD
Prescription Ratio for Q1 will be used to calculate Q2 Co-Promotion Fee),
calculated on a quarterly basis. If the PUD Prescription Ratio for the
current Calendar Quarter differs from the prior Calendar Quarter’s PUD
Prescription Ratio by more than five percent (5%) (i.e., the PUD
Prescription Ratio for Q2 differs by more than five percent (5%) from Q1),
the Parties shall true up the Co-Promotion Fee using the current PUD
Prescription Ratio. For example, if the PUD Prescription Ratio for the
prior Calendar Quarter is twenty-seven percent (27%), a true up would be
paid if the current Calendar Quarter’s PUD Prescription Ratio is less than
25.65 or greater than 28.35.




b) Subject to Section 5.8(3), the Co-Promotion Fee will be paid by CRTX
quarterly within thirty (30) days after the end of the applicable Calendar
Quarter. Subject to Section 5.8(3), the applicable Party shall pay the
other Party the true up amount required by Section 5.7(a) within sixty (60)
days after the end of the applicable Calendar Quarter.





 




			
	[***]	 	Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.




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c) If, pursuant to Section 12.2(1), CRTX terminates this Agreement, CRTX
will be obligated to pay DEY until the end of the Term, as follows: [***]
percent ([***]%) of the amount due DEY under Section 5.7(a), above, for up
to four (4) subsequent Calendar Quarters after the effective date of such
termination and, for any additional Calendar Quarters until the end of the
Term, if any, [***] percent ([***]%) of the amount due DEY under Section
5.7(a), above.




	 	34.	 	
Section 5.8(1) of the Agreement is hereby deleted in its entirety and replaced with the
following:






Intentionally Omitted.




	 	35.	 	
A new Section 5.11 is added to the Agreement as follows:






Notwithstanding any other provision of this Agreement, each of the Parties
acknowledges and agrees that as of January 1, 2009 that there exists neither any
failure to perform by the other Party under this Agreement relating to the Covered
Sections (as defined below) nor any breach by the other Party under the Agreement
relating to the Covered Sections and that any failure to perform by the other Party
of any nature under this Agreement relating to the Covered Sections existing or
arising prior to January 1, 2009 is and shall be deemed waived for all purposes
pursuant to Section 13.9. For purposes of this Agreement, “Covered Sections” means
any obligations of either Party relating to details, samples, JCC Meetings, or
clinical trials under the Agreement, including, but not limited to any such
obligations contained in the following sections of this Agreement: (i) Section 3.1;
(ii) Section 4.1; (iii) Section 4.2; (iv) Section 4.3(1); (v) Section 4.3(2); (vi)
Section 4.3(3); (vii) Section 4.3(4); (viii) Section 4.3(6); (ix) Section 4.3(9);
(x) Section 4.3(10); (xi) Section 4.4(1), (xii) Section 4.4(2); (xiii) Section
4.4(3); (xiv) Section 4.4(4); (xv) Section 4.4(5); (xvi) Section 4.4(7); (xvii)
Section 4.4(9)(d); and (xviii) Section 4.4(9)(e). Each of the Parties acknowledges
and agrees that the purpose of this Section 5.11 is to reset the Parties’
relationship with respect to the Covered Sections by forgiving and waiving any
failures to perform or breaches with respect to the Covered Sections that occurred
prior to January 1, 2009 but that this Section 5.11 shall not be deemed a waiver of
any other right hereunder or of any other breach or failure by a Party whether of a
similar nature or otherwise, including, without limitation, any breach or failure of
a Covered Section that occurs on or after January 1, 2009.



	 	36.	 	

Section 6.7 of the Agreement is hereby deleted in its entirety and replaced with the
following:






Safety Contacts. All safety related reports and correspondence shall be
addressed to: Brian Dickson, M.D., Chief Medical Officer, Cornerstone
Therapeutics Inc. by fax, (919) 678-6599 and by telephone, (919) 678-6524,
or such safety representative as may be designated by CRTX.





 




			
	[***]	 	Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.




Page 11 of 14









 











	 	37.	 	
Section 6.8 of the Agreement is hereby deleted in its entirety and replaced with the
following:






Intentionally Omitted.




	 	38.	 	
Section 12.2(1) of the Agreement is hereby deleted in its entirety and replaced with the
following:






This Agreement may be terminated by either Party by providing the other
Party a minimum of six (6) months prior written notice of termination at any
time after March 31, 2012 (i.e. the earliest permissible termination date
pursuant to this provision would be October 1, 2012). DEY shall have the
right to terminate this Agreement by providing a minimum of two (2) months
prior written notice to CRTX if: (i) in any two consecutive Calendar
Quarters CRTX is unable to deliver to DEY at least seventy-five percent
(75%) of the Zileuton XR Samples forecast by DEY for such quarters; or (ii)
at any time commercial supplies of the Zileuton XR remain on back order for
more than one Calendar Quarter.




	 	39.	 	
Section 12.2(6) of the Agreement is hereby deleted in its entirety and replaced with the
following:






DEY has the right to terminate this Agreement if after January 1, 2010 Net Sales of
Zileuton XR for any four consecutive Calendar Quarters for Zileuton XR are below US
$20 million; provided, however, that this termination right must be exercised
providing at least two (2) months prior written notice to CRTX and the first of such
consecutive Calendar Quarters must arise on or after January 1, 2009.



	 	40.	 	

All references in the Agreement to “Schedule 1.22” (DEY Trademarks) shall be changed to
“Schedule 1.23”.






	 	41.	 	
Schedule1.17 to the Agreement is hereby deleted in its entirety and replaced with the
following:





SCHEDULE 1.17




CRTX TRADEMARKS



ZYFLO®

ZYFLO CR®

www.zyflo.com

www.zyflocr.com





	 	42.	 	
The addresses for notices set forth in Section 13.4 are hereby deleted and replaced with
the following:





	 	 	 	 	 	 	 
	 

	 	If to CRTX:
	 	CORNERSTONE THERAPEUTICS INC.
1255
Crescent Green Drive, Suite 250

Cary, NC 27518

Attention: President and Chief Executive Officer
	 	 






Page 12 of 14









 






	 	 	 	 	 	 	 
	 

	 	 	 	With a required copy to:

CORNERSTONE THERAPEUTICS INC.
1255
Crescent Green Drive, Suite 250

Cary, NC 27518

Attention: General Counsel
	 	 
	 
	 	 	 	 	 	 
	 

	 	If to DEY:
	 	DEY, L.P.
2751
Napa Valley Corporate Drive

Napa, CA 94558

Attention: President
	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	With a required copy to:

Mylan Inc.
1500
Corporate Drive, Suite 400

Canonsburg, PA 15317

Attention: Global General Counsel	 	 






	 	43.	 	
Except as specifically amended herein, all other terms and conditions of the Agreement are
in full force and effect.






	 	44.	 	
This Amendment shall be governed by the laws of the State of New York without reference to
any rules of conflict of laws. Any dispute arising in relation to this Amendment shall be resolved
in the same manner as a dispute under the Agreement.





[THE REMAINDER OF THIS PAGE INTENTIONALLY LEFT BLANK]




Page 13 of 14









 





SIGNATURE PAGE TO AMENDMENT NO. 2


TO CO-PROMOTION AND MARKETING SERVICES AGREEMENT




     IN WITNESS of the agreement to the terms and conditions contained herein, the Parties have
caused the following signatures to be affixed hereto to become effective as of the Amendment No. 2
Effective Date:



	 	 	 	 	 	 	 	 	 	 	 
	CORNERSTONE THERAPEUTICS INC.	 	 	 	DEY, L.P.,

by DEY, INC., its General Partner	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	BY:    /s/ Craig A. Collard

	 	 	 	BY:    /s/ Carolyn Myers
	 	 
	 

	 	 	 	 

	 	 
	PRINT NAME:

	 	Craig A. Collard
	 	 	 	PRINT NAME:
	 	Carolyn Myers	 	 
	TITLE: President and Chief Executive Officer

	 	 	 	TITLE: President
	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	DATE: May 4, 2009

	 	 	 	DATE: April 30, 2009
	 	 






Acknowledged and agreed to with respect to Sections 13 and 18 only:




MYLAN INC.




	 	 	 	 	 
	BY:    /s/ Daniel M. P. Caron

	 	 
	 

	 	 
	PRINT NAME:

	 	Daniel M. P. Caron	 	 
	TITLE: Vice President

	 	 
	 
	 	 	 	 
	DATE: April 30, 2009

	 	 







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