Document:

exv10w13

Exhibit 10.13

First Amendment to Cornerstone License Agreement

     This First Amendment to Cornerstone License Agreement (“Amendment”) is made and entered into
on August, 10, 2007 (“Effective Date”), by and between Pharmaceutical Innovations, LLC (hereinafter
referred to as “PI”) and Cornerstone Biopharma, Inc. (hereinafter referred to as “Cornerstone”).

Recitals:

     A. PI and Cornerstone entered into that certain Cornerstone License Agreement dated August 31,
2006 (“Agreement”), whereby Cornerstone secured from PI an exclusive license in the United States
and a nonexclusive license in all other markets to manufacture, package, market, distribute and
otherwise exploit the Licensed Products (as defined in the Agreement) on a worldwide basis.

     B. The parties desire to amend the Agreement as set forth in this Amendment.

NOW, THEREFORE, the undersigned hereby agree as follows:

	 	     1.	 	The effective date of this Amendment shall be the Effective
Date.
	 
	 	     2.	 	Section 1.10 of the Agreement is hereby deleted in its entirety
and replaced with the following:
	 
	 	 	 	“1.10. “Licensed Products” shall mean the following prescription day-night
products which fall within the scope of one or more valid claims of any PI
Patent: (i) a product (which may be known as AlleRx PE) consisting of 40 mg.
phenylephrine/2.5 mg. methscopolamine nitrate, for daytime use and 10 mg.
phenylephrine/8 mg. chlorpheniramine maleate/2.5 mg. methscopolamine nitrate
for nighttime use; (ii) a product (which may be known as AlleRx HC)
consisting of [***] and (iii) a product consisting of
120 mg. pseudoephedrine/2.5 mg. methscopolamine nitrate, for daytime use and
8mg. chlorpheniramine maleate/2.5 mg. methscopolamine nitrate/an attenuated
dose of pseudoephedrine or phenylephrine for nighttime use HCL for nighttime use.”

 

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

 

	 	3.	 	Section 4.03 of the Agreement is hereby deleted in its
entirety and replaced with the following:
	 
	 	 	 	“4.03.(a) With respect to the License Product referenced in Section 1.10(i)
hereof, Cornerstone shall pay to PI Minimum Royalty Payments equal to One
Hundred Fifty Thousand Dollars ($150,000) per Calendar Year for the term of
this Agreement beginning with Calendar Year 2007 and ending at the beginning
of the Seven Year Period (such Minimum Royalty Payments to be pro rated for
periods of less than twelve months.)
	 
	 	 	 	4.03(b) With respect to the Licensed Products referenced in Section
1.10(ii) and Section 1.10(iii) hereof, Cornerstone shall
pay to PI (A) no Minimum Royalty Payments for Calendar Year 2007, and (B)
Minimum Royalty Payments equal to One Hundred Fifty Thousand Dollars
($150,000) per Calendar Year for each of those Licensed Products for the
term of this Agreement beginning with Calendar Year 2008 and ending at the
beginning of the Seven Year Period.
	 
	 	 	 	4.03(c) The Minimum Royalty Payments for Calendar Year 2007 mean that if the
aggregate royalties payable to PI under Section 4.01 (b) are less than
$150,000 (or a lesser amount if pro ration applies) for the Licensed Product
referenced in Section 1.10(i) hereof, Cornerstone shall, within 30 days
after the end of such Calendar Year, make-up the difference with
supplemental payments to PI such that PI is paid a total of $150,000 for
such Calendar Year (or a lesser amount if pro ration applies). The Minimum
Royalty Payments for Calendar Year 2008 and each Calendar Year
thereafter until the beginning of the Seven Year Period means that if the aggregate royalties payable to PI under Section 4.01 (b) are
less than $450,000 for any Calendar Year (or a lesser amount if pro ration applies or if Cornerstone exercises its right under Section 6.3),
Cornerstone shall, within 30 days after the end of each
such Calendar Year, make-up the difference with supplemental payments to PI
such that PI is paid a total of $450,000 for such
Calendar Year (or a lesser amount if pro ration applies or if Cornerstone exercises its right under Section 6.3). To clarify
regarding pro ration, by way of example, if a Minimum Royalty Payment is due
with respect to all three (3) of the Licensed Products set forth in Section
1.10 and the PI Patents expire on August 31, 2011, the Minimum Royalty
Payment for that Calendar Year shall be
66.2/3% of $450,000 or $300,000 determined on an aggregated basis for the three (3)
Licensed Products.”
	 
	 	4.	 	The following new Section 6.03 is hereby added to the
Agreement:

2

 

	 	 	 	“6.03 Cornerstone shall have a one-time right to terminate this Agreement
with respect to any or all of the Licensed Products referenced in Section
1.10(ii) and/or Section 1.10(iii) only by providing
written notice to PI on or before December 31, 2007. In the event Cornerstone
exercises its right under this Section 6.03, (A) all other terms and
conditions of this Agreement shall remain in full force and effect with
respect to the Licensed Products which were not terminated under this
Section 6.03, and (B) any such Licensed Products terminated under this
Section 6.03 shall no longer be considered a “Licensed Product for all
purposes of this Agreement, including, without limitation, Sections 1.10, 3,
and 4.”
	 
	 	5.	 	Discontinued Product. The parties hereby terminate their respective rights and obligations
under the Agreement with respect to the Licensed Product
(tentatively known as AlleRx CP) consisting of [***] (the “Discontinued Product”). The Discontinued Product shall no longer be considered
a “Licensed Product” for all purposes of the Agreement, including without limitation, Section 1.10, 3 and 4.
	 
	 	6.	 	All capitalized terms in this Amendment shall have the meaning
given to such terms in the Agreement, unless otherwise defined herein.
	 
	 	7.	 	Except as specifically set forth herein, the Agreement remains
unmodified and in full force and effect.
	 
	 	8.	 	This Amendment may be executed in any number of counterparts,
each of which when so executed and delivered shall be deemed to be an original
and all of which taken together shall constitute but one and the same
instrument. A facsimile or similar transmission of a counterpart signed by a
party hereto shall be regarded as signed by such party for purposes hereof.

     IN WITNESS WHEREOF, the undersigned have executed this Amendment on the day and year first
above written.

	 	 	 	 	 	 	 
	Witness/Attest:	 	 	 	Cornerstone Biopharma, Inc.
	 
	 	 	 	 	 	 
	 

	 	 	 	By:
	 	/s/ Craig Collard
	 

	 	 	 	 	 	 
	 

	 	 	 	 	 	Craig Collard
	 

	 	 	 	 	 	President and CEO
	 
	 	 	 	 	 	 
	Witness/Attest:

	 	 	 	Pharmaceutical
Innovations, LLC
	 
	 	 	 	 	 	 
	 

	 	 	 	By:
	 	/s/ Allan M. Weinstein
	 

	 	 	 	 	 	 
	 

	 	 	 	 	 	Allan M. Weinstein, M.D.
	 

	 	 	 	 	 	President

 

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

3exv10w14

Exhibit 10.14

Cornerstone Biopharma, Inc.

2000 Regency Parkway, Suite 244

Cary, NC 275l8

February 15, 2008

Allan M. Weinstein, M.D.

Pharmaceutical Innovations, LLC

3301 New Mexico Avenue, N.W., Suite 302

Washington, D.C. 20016

Re: Cornerstone License Agreement dated August 31, 2006, as amended — Second Amendment

Dear Allan:

This letter will serve to reflect our agreement regarding an amendment of the above-referenced
license agreement (the “Agreement”). As you know, Cornerstone Biopharma, Inc. (“Cornerstone”)
exercised its right under Section 6.03 of the Agreement to terminate the Agreement with respect to
the Licensed Product referenced in Section 1.10(ii) (Allerx HC) by providing written notice to
Pharmaceutical Innovations, LLC on December 22, 2007 of such intent. The parties wish to amend the
Agreement to reflect such partial termination as well as make other modifications to the Agreement.

Section 1.10 of the Agreement is hereby deleted in its entirety and replaced with the following.

“1.10. Licensed Products” shall mean the following prescription day-night
products which fall within the scope of one or more valid claims of any PI
Patent: (i) a product (which may be known as AlleRx PE) consisting of 40 mg.
phenylephrine/2.5 mg. methscopolamine nitrate, for daytime use and 10 mg.
phenylephrine/8 mg. chlorpheniramine maleate/2.5 mg. methscopolamine nitrate
for nighttime use; and (ii) a product consisting of 120 mg.
pseudoephedrine/2.5 mg. methscopolamine nitrate, for daytime use and 8 mg.
chlorpheniramine maleate/2.5 mg. methscopolamine nitrate/an attenuated dose
of pseudoephedrine or phenylephrine for nighttime use.

Section 4.03 of the Agreement is hereby deleted in its entirety and replaced with the following:

“4.03 With respect to the Licensed Products referenced in Section 1.10
hereof, Cornerstone shall pay to PI Minimum Royalty Payments equal to Three
Hundred Thousand Dollars ($300,000) per Calendar Year for the term of this
Agreement beginning with Calendar Year 2007 and ending at the beginning of
the Seven Year Period (such Minimum Royalty Payments to be pro rated for
periods of less than twelve months); provided, however, that the Minimum
Royalty Payments for Calendar Year 2007 shall be One Hundred Fifty Thousand
Dollars ($150,000). To clarify regarding pro

 

ration, by way of example, if the PI Patents expire on August 31, 2011, the
Minimum Royalty Payment for that Calendar Year shall be 66 2/3% of $300,000
or $200,000.”

Please sign where indicated below to confirm that this letter constitutes the Second Amendment to
the Agreement and that Sections 1.10 and 4.03 now read as shown above.

	 	 	 	 	 
	 	Very truly yours,

 	 
	 	/s/ Craig Collard
 	 
	 	Craig Collard/President & Chief Executive Officer 	 
	 	 	 
	 

	 	 	 
	Acknowledged and agreed:

	 	 
	 
	 	 
	Pharmaceutical Innovations, LLC
	 	 
	 
	 	 
	/s/ Allan Weinstein
	 	 
	 
	 	 
	Name: Allan Weinstein, M.D.
	 	 
	Title: President
	 	 
	Date: 2-15-2008
	 	 

 

Termination and Mutual Release Agreement

     This Termination and Mutual Release Agreement (this “Agreement”) is made and entered into
effective as of February 15, 2008, by and between (i) Pharmaceutical Innovations, LLC (“PI”) and
(ii) Cornerstone BioPharma, Inc. (“Cornerstone”).

RECITALS:

     R-1. PI and Cornerstone are parties to a certain Cornerstone License Agreement dated August
31, 2006 (the “License Agreement”) relating to the commercialization of a product with amoxicillin
clavulante and a decongestant expectorant or another anti-infective and decongestant expectorant.

     R-2. PI and Cornerstone desire to terminate the License Agreement, and to settle all claims
and obligations, known and unknown, related to the Agreement and the Licensed Product.

     NOW THEREFORE, in consideration of the mutual promises set forth herein, and other good and
valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties
hereto agree as follows:

     1. Incorporation of Recitals. The preambles set forth above are incorporated herein
and made a substantive part of this Agreement.

     2. Definitions.

     (a) References in this Agreement to PI and to Cornerstone shall mean those entities and their
respective owners, employees, principals, partners, members, managers, directors, officers,
affiliates, parent or subsidiary companies, predecessors, successors, assigns, designees,
subcontractors or consultants, attorneys and insurers, whether past, present or future.

     (b) As used herein, “Claims” means any and all claims, cross-claims, demands, actions, causes
of action, rights, suits, judgments, liens, damages, attorneys’ fees, interest, losses of service,
expenses, costs and compensation of any nature whatsoever accruing through the date of this
Agreement, known or unknown, disclosed or undisclosed, whether in law or equity or otherwise,
liquidated or contingent, and relating to or arising out of or based upon any act, condition,
occurrence or transaction relating to the License Agreement or the Licensed Product, except for any
claims arising from the terms of this Agreement.

     3. Mutual Releases.

     (a) Release by PI. In consideration of the terms of this Agreement, PI hereby fully
and forever releases, acquits, and discharges Cornerstone from any and all Claims.

     (b) Release by Cornerstone. In consideration of the terms of this Agreement,
Cornerstone hereby fully and forever releases, acquits, and discharges PI from any and all Claims.

 

     4. Termination of License Agreement. The parties acknowledge and agree that the
License Agreement is hereby terminated and shall be deemed null and void and of no further effect.

     5. Miscellaneous.

     (a) Cooperation. The parties hereto hereby agree to execute and deliver any and all
other instruments or documents necessary to carry out this Agreement. The parties shall cooperate
fully with each other and with their respective counsel in connection with any steps required to be
taken as part of their respective obligations under this Agreement. Except as otherwise provided
herein, each party shall bear its own costs and expenses incurred in connection with such
cooperation.

     (b) Entire Agreement; No Oral Modification. This writing constitutes the entire
agreement of the parties with respect to the subject matter hereof and may not be modified, amended
or terminated except by a written agreement specifically referring to this Agreement and signed by
the parties hereto prior to the effective date of any such modification, amendment or termination.

     (c) Governing Law. This Agreement shall be governed by and interpreted in accordance
with the laws of the State of Maryland.

     (d) Counterparts. This Agreement may be executed in one or more counterparts, and
shall be effective when all parties have signed a counterpart hereof.

     IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first above
written.

	 	 	 	 	 	 	 	 	 
	Pharmaceutical Innovations, LLC	 	 	 	Cornerstone BioPharma, Inc.
	 
	 	 	 	 	 	 	 	 
	By:

	 	/s/ Allan M. Weinstein
	 	 	 	By:
	 	/s/ Craig Collard
	 

	 	 
	 	 	 	 	 	 
	Allan M. Weinstein, M.D.	 	 	 	Craig Collard
	President	 	 	 	President and CEO

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