Document:

exv10w11

Exhibit 10.11

MEIJI SEIKA KAISHA, LTD. INTERNATIONAL HEADQUARTERS, PHARMACEUTICALS

4-16, Kyobashi 2 chome, Chuo-ku, Tokyo, 104-8002 Japan            TELEPHONE:(03)3272 6511 FAX: (03)3281 • 4058 (03)3278-6551

JOINT DEVELOPMENT AGREEMENT

This Agreement is made as of this 11th day of February, 2008 by and between:

Meiji Seika Kaisha, Ltd., a company organized and existing under the laws of Japan and having its
principal place of business at 4-16, Kyobashi 2-chome, Chuo-ku, Tokyo 104-8002 Japan (hereinafter
referred to as “Meiji Seika”), and

Cornerstone Biopharm Inc., a corporation organized and existing under the laws of the State of
Nevada and having its principal office at 2000 Regency Parkway, Suite 255 Cary, North Carolina,
27518 USA (hereinafter referred to as “Cornerstone”).

WITNESSETH:

WHEREAS, Meiji Seika and Cornerstone entered into the License and Supply Agreement dated October
12, 2006 regarding Cefditoren Pivoxil as amended by the Amendment No. 1 dated July 27, 2007
(“License Agreement”); and

WHEREAS, Meiji Seika and Cornerstone concluded a letter agreement dated July 27, 2007 (“Letter
Agreement”) regarding the development of the Once-Daily Product and the Pediatric Product
(respectively defined below); and

WHEREAS, Meiji Seika and Cornerstone entered into a letter agreement dated January 11, 2008 to
confirm the mechanism and allocation of expenses for formulation of [***] tablet and [***] study as
a part of the development of the Once-Daily Product and scale up manufacture of [***] as a part of
the development of the Pediatric Product (“Formulation Agreement”); and

WHEREAS, Meiji Seika and Cornerstone discussed the mechanism and allocation of expenses for the
remaining part of the development of the Once-Daily Product and the Pediatric Product.

 

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

 

 

MEIJI SEIKA KAISHA, LTD. INTERNATIONAL HEADQUARTERS, PHARMACEUTICALS

4-16, Kyobashi 2 chome, Chuo-ku, Tokyo, 104-8002 Japan            TELEPHONE:(03)3272 6511 FAX: (03)3281 • 4058 (03)3278-6551

NOW, THEREFORE, in consideration of the mutual obligations and promises as set forth herein, the
parties do hereby agree as follows:

Article 1 — Definitions

For the purpose of this Agreement, the following terms shall have the following meanings:

	(1)	 	The capitalized terms not defined herein shall have the meanings ascribed to them in the
License Agreement.

	(2)	 	The term “Development” shall mean the development of the Once-Daily Product and the Pediatric
Product in the Territory to be conducted in accordance with the Development Plan.

	(3)	 	The term “Development Plan” shall mean the plan and schedule for the development of the
Once-Daily Product and the Pediatric Product in the Territory as described in the Annex A
attached hereto and any amendment thereto which may be mutually agreed in writing between both
parties.

	(4)	 	The term “Effective Date” shall mean the date of this Agreement first written above.
	 
	(5)	 	The term “Once-Daily Product” shall mean a once-daily dosage form of the Product.
	 
	(6)	 	The term “Pediatric Product” shall mean a pediatric form of the Product.

Article 2 — Development

	(1)	 	Subject to the terms and conditions set forth in this Agreement, Meiji Seika hereby grants
Cornerstone an exclusive right to conduct the Development.

 

 

MEIJI SEIKA KAISHA, LTD. INTERNATIONAL HEADQUARTERS, PHARMACEUTICALS

4-16, Kyobashi 2 chome, Chuo-ku, Tokyo, 104-8002 Japan            TELEPHONE:(03)3272 6511 FAX: (03)3281 • 4058 (03)3278-6551

	(2)	 	Meiji Seika and Cornerstone agree that the Development has been started and is to be
proceeded with according to the Development Plan. Cornerstone shall, with full consultation
with Meiji Seika, be in charge of the project management for the Development, including but
not limited to filing a submission of the Once-Daily Product and the Pediatric Product to the
health authorities in the Territory for obtaining the Product Registrations. Specific
mechanism and the decision making process/method to proceed with the Development shall be
discussed separately by Meiji Seika and Cornerstone. The important decision such as
continuance or discontinuance of the Development and amendment of the Development Plan shall
be made jointly and unanimously between Meiji Seika and Cornerstone. If either party foresees
a possible risk including occurrence of serious events which would make it impossible or
impracticable to pursue the Development from a reasonable pharmaceutical point of view, such a
party may, with full consultation with the other party, terminate this Agreement upon thirty
(30) day’s written notice.

	(3)	 	Any and all data and results generated from the Development hereunder shall be the property
jointly owned by Meiji Seika and Cornerstone and both party shall have the right to access and
use such data and results solely for the purpose of this Agreement and shall not use such data
and results for any other purpose, provided that (a) Meiji Seika has the right to use such
data and results in order to obtain the product registrations of and to commercialize both the
Once-Daily Product and the Pediatric Product outside the Territory, and (b) notwithstanding
the confidentiality obligations set forth in Article 7, Meiji Seika may disclose such data and
results to its licensees and potential licensees outside the Territory with the binder of
confidentiality obligations not less stringent than those set forth in Article 7 and to the
health authorities outside the Territory for such purpose.

	(4)	 	The total expenses of the Development except for the expenses agreed to be allocated by
Formulation Agreement shall be borne by Cornerstone.

Article 3 — Inclusion in the License Agreement

 

 

MEIJI SEIKA KAISHA, LTD. INTERNATIONAL HEADQUARTERS, PHARMACEUTICALS

4-16, Kyobashi 2 chome, Chuo-ku, Tokyo, 104-8002 Japan            TELEPHONE:(03)3272 6511 FAX: (03)3281 • 4058 (03)3278-6551

Once the Product Registrations have been obtained for the Once-Daily Product and/or the Pediatric
Product as a result of the Development, then the Once-Daily Product and/or the Pediatric Product
shall be automatically added to the Product under the License Agreement, provided that Cornerstone
shall not be required to pay any upfront license fee in respect to the Once-Daily Product and the
Pediatric Product.

Article 4 — Pharmacovigilance

Mechanism, procedures and responsibilities for the exchange of adverse event information regarding
the Development hereunder between the parties shall be agreed in the separate agreement.

Article 5 — Confidentiality

During the term of this Agreement and for a period often (10) years thereafter, each party
(“Receiving Party”) shall keep all technical information, data and know-how (“Confidential
Information”) furnished by the other party (“Disclosing Party”) under this Agreement in strict
confidence and shall not disclose Confidential Information to any third party nor use the same for
any purpose other than the performance of this Agreement without prior written consent of the
Disclosing Party. Provided, however, that disclosure to clinicians and the health authorities in
the Territory shall be allowed insofar as such disclosure is specifically required for the
performance of this Agreement and such disclosure is limited within a reasonable extent.
Confidential Information shall not include any information which:

	(a)	 	is in the public domain at the time of disclosure by the Disclosing Party or subsequently
comes into the public domain-through no fault of the Receiving Party;

	(b)	 	the Receiving Party can prove by documentary evidence was legitimately in its possession at
the time of disclosure by the Disclosing Party or is subsequently developed

 

 

MEIJI SEIKA KAISHA, LTD. INTERNATIONAL HEADQUARTERS, PHARMACEUTICALS

4-16, Kyobashi 2 chome, Chuo-ku, Tokyo, 104-8002 Japan            TELEPHONE:(03)3272 6511 FAX: (03)3281 • 4058 (03)3278-6551

by such of its employees or its affiliate’s employees who had no knowledge of Confidential
Information disclosed by the Disclosing Party; or

	(c)	 	is legitimately obtained by the Receiving Party from a third party without any duty of
confidentiality to the Disclosing Party.

Article 6 — Term and Termination

	(1)	 	The term of this Agreement shall commence on the Effective Date and shall, unless earlier
terminated pursuant to Article 2 or Article 6 or by mutual agreement between the parties,
expire upon the date of the expiration or termination of the License Agreement.

	(2)	 	Either party may, in addition to any other remedies available to it by law, terminate this
Agreement, upon sixty (60) days’ written notice in the event that the other party breaches a
material provision of this Agreement and fails to cure such breach within sixty (60) days of
written notice of the breach.

	(3)	 	Either party may, in addition to any other remedies available to it by law, terminate this
Agreement, upon thirty (30) days’ written notice in the event that the other party shall have
become insolvent or bankrupt, or shall have made an assignment for the benefit of its
creditors, or there shall have been appointed a trustee or receiver of the other party or for
all or substantial part of its property, or any case or proceeding shall have commenced or
other action taken by or against the other party in bankruptcy.

	(4)	 	Termination or expiration of this Agreement shall not relieve the parties of any obligation
accruing prior thereto. The provisions of Paragraph 3 of Article 2 and Article 7 shall survive
termination or expiration of this Agreement.

	(5)	 	If this Agreement is terminated by Cornerstone pursuant to Article 2 or this Agreement is
terminated by Meiji Seika due to the reason attributable to Cornerstone pursuant to Article 6,
any right granted to Cornerstone under this Agreement and the Letter

 

 

MEIJI SEIKA KAISHA, LTD. INTERNATIONAL HEADQUARTERS, PHARMACEUTICALS

4-16, Kyobashi 2 chome, Chuo-ku, Tokyo, 104-8002 Japan            TELEPHONE:(03)3272 6511 FAX: (03)3281 • 4058 (03)3278-6551

Agreement in respect to the Once-Daily Product and the Pediatric Product shall terminate,
and in such a case Cornerstone shall assist and cooperate with Meiji Seika for continuing
the Development if Meiji Seika desires to continue any of the Development even after such
termination.

Article 7 — Non-assignability

This Agreement and any rights and obligations hereunder shall not be assignable or transferable by
either party to any third party without prior written consent of the other party.

Article 8 -Arbitration and Governing Law

All disputes, controversies or differences which may arise between the parties in relation to or in
connection with this Agreement, or the breach thereof, shall be finally settled by arbitration to
be conducted in English in accordance with the Arbitration Rules of the International Chamber of
Commerce by a single arbitrator appointed in accordance with the said Rules. The arbitration shall
be held in Geneva, Switzerland and the governing law shall be the laws of Switzerland. The award
rendered by the arbitrator shall be final and binding upon both parties.

Article 9 — Force Majeure

There shall be no breach or violation of this Agreement if either party is delayed or prevented
from fulfilling its obligations hereunder due to war, revolution, strike, labor conflict, riot,
fire, flood, earthquake, explosion, natural calamity, embargo, compliance with any law or
governmental order, Act of God and any other causes beyond its reasonable control, provided that
such impeded party shall promptly notify the other party of the nature and expected duration of
such force majeure event and shall use its reasonable endeavor to remove such force majeure event.

Article 10 — Severability

 

 

MEIJI SEIKA KAISHA, LTD. INTERNATIONAL HEADQUARTERS, PHARMACEUTICALS

4-16, Kyobashi 2 chome, Chuo-ku, Tokyo, 104-8002 Japan            TELEPHONE:(03)3272 6511 FAX: (03)3281 • 4058 (03)3278-6551

If any provision of this Agreement is held invalid or unenforceable by a court or other
governmental authorities of competent jurisdiction, then such provision shall be construed, to the
extent feasible, so as to render such provision valid and enforceable, and if no feasible
interpretation would save such provision, it will be severed from the remainder of this Agreement.
The remainder of this Agreement shall remain in full force and effect, unless the severed provision
is essential and material to the rights or benefits received by either party. In such event, the
parties shall negotiate, in good faith, and substitute a valid and enforceable provision that most
nearly implements the parties’ intent in entering into this Agreement.

Article 11 — Entire Agreement

This Agreement constitutes the entire agreement of the parties hereto with respect to the subject
matter hereof and supersedes all prior agreements and understandings, either oral or written. This
Agreement may be amended only by a written instrument duly signed by authorized representatives of
both parties.

IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the Effective Date.

	 	 	 	 	 	 	 	 	 
	Meiji Seika Kaisha, Ltd.	 	 	 	Cornerstone Biopharma, Inc.
	 
	 	 	 	 	 	 	 	 
	 

	 	/s/ Ryuzo Asada
	 	 	 	 	 	/s/ Craig Collard
	 	 	 	 	   
	By:

	 	Ryuzo Asada
	 	 	 	By:
	 	Craig Collard
	Title:

	 	Vice President
	 	 	 	Title:
	 	Chief Executive Officer

 

 

MEIJI SEIKA KAISHA, LTD. INTERNATIONAL HEADQUARTERS, PHARMACEUTICALS

4-16, Kyobashi 2 chome, Chuo-ku, Tokyo, 104-8002 Japan            TELEPHONE:(03)3272 6511 FAX: (03)3281 • 4058 (03)3278-6551

Annex A

Development Plan

	 	 	 	 	 	 	 
	A)	 	Spectracef [***] Once Daily Dose	 	Schedule
	 
	 	 	 	 	 	 
	 
	 	1.	 	Complete GMP clinical release batch of new formulation (Patheon)	 	[***]
	 
	 	 	 	 	 	 
	 
	 	2.	 	Submit PK protocol/formulation data to FDA for comments	 	[***]
	 
	 	 	 	 	 	 
	 
	 	3.	 	Submit pivotal clinical protocols (AECB) to FDA for comment	 	[***]
	 
	 	 	 	 	 	 
	 
	 	4.	 	Conduct PK study/food effect	 	[***]
	 
	 	 	 	 	 	 
	 
	 	5.	 	Discuss PK results (Cornerstone/Meiji Seika)	 	[***]
	 
	 	 	 	 	 	 
	 
	 	6.	 	Conduct pivotal clinical studies	 	[***]
	 
	 	 	 	 	 	 
	 
	 	7.	 	Prepare sNDA	 	[***]
	 
	 	 	 	 	 	 
	 
	 	8.	 	sNDA submission	 	[***]
	 
	 	 	 	 	 	 
	 
	 	9.	 	sNDA approval	 	[***]
	 
	 	 	 	 	 	 
	B)	 	Pediatric Suspension Development	 	Schedule
	 
	 	 	 	 	 	 
	 
	 	1.	 	Manufacture GMP validation batches (Patheon)	 	[***]
	 
	 	 	 	 	 	 
	 
	 	2.	 	Prepare NDA for pharyngitis/tonsillitis	 	[***]
	 
	 	 	 	 	 	 
	 
	 	3.	 	Submit NDA for pharyngitis/tonsillitis	 	[***]
	 
	 	 	 	 	 	 
	 
	 	4.	 	Submit Otitis Media protocols to FDA for comment	 	[***]
	 
	 	 	 	 	 	 
	 
	 	5.	 	Conduct Otitis Media clinical studies	 	[***]
	 
	 	 	 	 	 	 
	 
	 	6.	 	Prepare sNDA for Otitis Media	 	[***]
	 
	 	 	 	 	 	 
	 
	 	7.	 	sNDA submission	 	[***]
	 
	 	 	 	 	 	 
	 
	 	8.	 	sNDA approval	 	[***]

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.exv10w12

Exhibit 10.12

CORNERSTONE LICENSE AGREEMENT

     This Agreement (the “Agreement”) is made and entered into effective as of the 31st day of
August, 2006, by and between Pharmaceutical Innovations, LLC. (hereinafter referred to as “PI”) and
Cornerstone Biopharma, Inc. (hereinafter referred to as “Cornerstone”).

RECITALS:

     A. PI is the owner of or otherwise controls certain proprietary PI Patents (as defined below)
and PI Information (as defined below) relating to the Licensed Products (as defined below).

     B. PI desires to grant a license to Cornerstone under the foregoing PI Patents and/or PI
Information with respect to the manufacturing, packaging, marketing, distribution and exploitation
of various prescription day-night products.

     C. Cornerstone desires to secure 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 these various day-night products on a worldwide basis, all in accordance with the terms and
conditions set forth in this Agreement.

     NOW, THEREFORE, in consideration of the mutual promises and covenants as contained herein, the
parties hereto, intending to be legally bound, agree as follows:

Definitions.

     1.01. “Agreement” shall mean this License Agreement.

     1.02. “Article” shall mean each numbered heading used in the Agreement, individually, and all
Sections that are included under each such heading.

     10.3. “Calendar Quarter Year” shall mean either the first, second, third or fourth three-month
period in any Calendar Year.

     1.04. “Calendar Year” shall mean each twelfth month period ending December 31.

     1.05. “Effective Date” is the date of this Agreement appearing in the preamble to this
Agreement.

     1.06. “Exclusive Territory” shall mean the United States and Puerto Rico.

     1.07. Intentionally Omitted.

 

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

1

 

     1.08. “PI Information” shall mean all technical and marketing information, data, know-how, new
concepts and the like relating to Licensed Products in the possession of PI on the date of this
Agreement, including processes and equipment for the production and use of Licensed Products and
new PI information, data, know-how, new concepts and the like acquired or developed by or for PI
after the Effective Date relating to Licensed Products.

     1.09. “PI Patents” shall mean U.S. Patent # 6,843,372 and all corresponding foreign patent
applications and granted foreign patents, and all reissues, divisions, continuations,
continuations-in-part, substitutes, extensions and replacements thereto.

     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 (which may be known as AlleRx CP) consisting of  [***].

     1.11. “Minimum Royalty Payment” shall mean the minimum payment of royalties under Section 4.03
owed in any Calendar Year.

     1.12. “Net Sales” shall mean the gross invoice price of sales by Cornerstone or its
sublicensees from the manufacture, use or sale of the Licensed Products, minus the sum of (i)
freight and other transportation charges (to the extent included in the gross invoice price and
charged to the customer as a separate charge), (ii) applicable excise, sale, use or value-added
taxes and customs duties (to the extent included in the gross invoice price and charged to the
customer as a separate charge), and (iii) credits for returned or defective products, rebates
(including managed care rebates) not funded by third parties, chargebacks and trade discounts.

     1.13. “Nonexclusive Territory” shall mean all countries other than the United States.

     1.14. “Out-of-Pocket Expenses” of a party shall mean and include payments made by such party
to unaffiliated persons, firms, corporations, and the like, and specifically excludes internal
costs and expenses of such party’s own activities and operations, as conducted by its own employees
and agents at its own facilities.

     1.15. “Section” shall mean each separately numbered paragraph of this Agreement, individually.

     1.16. “Seven Year Period” shall mean the seven (7) year period specified in Section 4.03(a).

 

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

2

 

     1.17. “[***] Percent Royalty” shall mean the royalty specified in Section 4.02(a).

2. Disclosure to Cornerstone.

     2.01. As soon as reasonably convenient after the Effective Date (and in any event within
thirty days), PI will submit to Cornerstone in writing the PI Information.

     2.02. In addition, throughout the life of this Agreement, PI will continue to disclose to
Cornerstone on a prompt and regular basis all new PI Information.

3. Grant of License.

     3.01. Subject to the terms and conditions set forth in this Agreement, PI hereby grants an
exclusive right and license (including the right to sublicense others) to use the PI Information to
manufacture, package, market, distribute, use, sell and to otherwise exploit Licensed Products in
the Exclusive Territory and a nonexclusive right and license (including the right-to-sublicense
others) to use the PI Information to manufacture, package, market, distribute, use, sell and to
otherwise exploit Licensed Products in the Nonexclusive Territory.

     3.02. Subject to the terms and conditions set forth in this Agreement, PI hereby grants an
exclusive right and license (including the right to sublicense others) in and under the PI Patents
to manufacture, package, market, distribute, use, sell and to otherwise exploit Licensed Products
in the Exclusive Territory and a nonexclusive right and license (including the right to sublicense
others) to use the PI Patents to manufacture, package, market, distribute, use, sell and to
otherwise exploit the Licensed Products in the Nonexclusive Territory.

4. License Fees; Royalties.

     In full consideration for the rights and licenses herein granted to Cornerstone hereunder,
Cornerstone agrees to pay to PI the following:

     4.01(a). A special royalty shall be payable at the rate of eight and one-half percent (8.5%)
of the Net Sales of Licensed Products until the total royalty paid under this Section 4.01(a)
equals Two Hundred Fifty Thousand Dollars ($250,000). This royalty shall be paid to PI in addition
to the royalty under Section 4.01 (b) hereof. Cornerstone may, at any time, prepay all or any
portion of this special royalty.

     4.01 (b) A royalty payment equal to the percentages of Net Sales of Licensed Products per
Calendar Year according to the following schedule:

	 	(i)	 	[***] percent ([***]%) of the Net Sales of
Licensed Products during each Calendar Year up to and including
$5,000,000 of Net Sales of Licensed Products; and

 

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

3

 

	 	(ii)	 	[***] percent ([***]%) of the Net Sales of
Licensed Products in excess of $5,000,000 during each Calendar Year.

     4.02(a) For a seven (7) year period of time (“Seven Year Period”) commencing on the earlier of
(i) the date all of the PI Patents expire or (ii) the date all of the PI Patents are determined to
be invalid by a court of competent jurisdiction or governmental authority (and such determination
is no longer subject to appeal), Cornerstone shall pay PI for PI Information a royalty equal to
[***] percent ([***]%) of the Net Sales of Licensed Products sold by Cornerstone or its
sublicensees (“[***] Percent Royalty”). When the Seven Year Period has expired, no further [***]
Percent Royalty payments shall be owed PI under this Agreement.

     4.02.(b) At the expiration of the PI Patents, Cornerstone shall have a fully vested right to
continue producing and selling Licensed Products using the technology of U.S. Patent # 6,843,372
subject only to the obligation of Cornerstone to make [***] Percent Royalty payments to PI for the
Seven Year Period specified in Section 4.03(a). Notwithstanding any provision herein to the
contrary, Cornerstone shall be obligated to pay the Section 4.02 royalty on Net Sales of Licensed
Products that is covered by any valid, applicable and pertinent, live issued patent of PI’s.

     4.03. Cornerstone shall pay to PI Minimum Royalty Payments equal to One Hundred Fifty
Thousand Dollars ($150,000) per Calendar Year for each of the three Licensed Products (such
Minimum Royalty Payment to be calculated separately for each Licensed Product) 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.) The Minimum
Royalty Payments mean that if for any Calendar Year commencing with Calendar Year 2007 the
aggregate royalties payable to PI under Section 4.01(b) are less than $450,000 (or a lesser amount
if pro ration applies) for the Licensed Products, 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 per Calendar Year (or a lesser amount if pro ration applies). To clarify
regarding pro ration, by way of example, if the PI Patents expire on August 31 in a particular
Calendar Year, the Minimum Royalty Payment for the Licensed Products for that Calendar Year shall
be 66.2/3% of $450,000 or $300,000.

     4.04. Cornerstone shall keep an accurate account of all Licensed Products sold under the scope
of the license granted hereunder and shall render a statement in writing by Cornerstone or its
sublicensees on which royalties are payable to PI in accordance with this Article. Within
forty-five (45) days after the end of each Calendar Quarter Year during the term of this Agreement,
Cornerstone shall report to PI in writing the amount of royalties due and payable in respect to
sales of Licensed Products during the corresponding Calendar Quarter-Year. Payment of all such
royalties thus shown to be due shall accompany such report. PI shall have the right, on reasonable
prior notice during regular business hours, at its own expense and not more often than once in any
Calendar Year, to have an independent certified public accountant audit the books of

 

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

4

 

     Cornerstone to verify the royalty statements and royalties due pursuant to this Agreement.
Cornerstone shall use good faith efforts to maintain an accurate account of royalties owed on the
books of Cornerstone. PI shall maintain and shall cause its auditors to maintain all records and
information provided by Cornerstone and its sublicensees in strictest confidence.

     4.05. Royalties accruing hereunder on Net Sales of Licensed Products shall, at Cornerstone’s
option, be paid to PI either in United States currency or in the currency of the country of sale.
All royalties converted into currency other than that of the United States shall be converted on
the basis of the simple average of the exchange rates reported in the London Financial Times under
the heading “World Value of the Pound” on the last business day of each month during the Calendar
Quarter Year for which payment is being made. To the extent that Cornerstone elects to pay
royalties on sales of Licensed Products invoiced in a currency other then United States currency,
the royalties payable on such sales shall be expressed in the domestic currency of the sale
together with the United States currency equivalent, calculated using the simple average of the
exchange rates published in the London Financial Times guide as aforesaid.

     4.06. The provisions of Article 4.03 shall have no force or effect with respect to any period
in which (a) operations of Cornerstone have been interrupted or sharply curtailed for reasons of
the type specified in Article 12.14 including any interruption or curtailment of the sale of
Licensed Products by any government or regulation, including but not limited to the FDA (to be
determined on a product by product basis and adjusted accordingly), (b) the PI Patents are all
determined to be invalid by a court of competent jurisdiction or governmental authority (and such
determination is no longer subject to appeal) or (c) any issue with stability, validation or
manufacturing legally prevents Cornerstone from being able to market and sell Licensed Product (to
be determined on a product by product basis and adjusted accordingly). Notwithstanding any
provision herein to the contrary, in the event that the commercialization of any Licensed Product
is delayed, interrupted or sharply curtailed as a result of an action taken by the FDA, or any
issue with stability, validation and manufacturing that would not allow such Licensed Product on
the market and that extends for a period of one (1) year or more, PI shall have the option at any
time thereafter (but only in the event such delay, interruption or curtailment is then continuing)
to terminate this Agreement as to such Licensed Product.

     4.07. All payments to PI required in accordance with this Agreement shall be minus any taxes
required to be deducted or withheld from such payments in accordance with the laws or regulations
of the United States or any political sub-division thereof, provided that Cornerstone shall furnish
PI with written receipts for any such taxes as are actually deducted or withheld.

5. Intentionally Omitted.

6. Term.

     6.01. Subject to the provisions for termination as hereinafter provided, the term of this
Agreement shall commence on the Effective Date and shall continue until the later of the expiration
date of the last to expire patent in the PI Portfolio or the expiration date of the Seven Year
Period specified in Section 4.02(a) (herein referred to as the “Term”). All rights and obligations
of the parties, including any obligation of Cornerstone to make further payments to

5

 

PI hereunder shall cease upon such termination, except (i) to keep confidence obligations of
Article 10 which shall survive such termination for 7 years following the date of termination and
(ii) the license rights and grants to Cornerstone pursuant to Article 3 which shall survive and
vest indefinitely.

     6.02. Notwithstanding any provision herein to the contrary: If the royalty payments to PI are
in arrears for thirty (30) days after the due date (or such longer period, if any, as PI may agree
to in its discretion), or if either party defaults in performing any of the other provisions of
this Agreement and such default continues for a period of thirty (30) days following written notice
thereof, or if either party is adjudicated a bankrupt or becomes insolvent, or enters into a
composition with creditors, or if a receiver is appointed for it, then the non-breaching party
shall thereafter have the right to terminate this Agreement upon giving written notice to the
breaching party and all rights and licenses granted to Cornerstone hereunder shall, at the
non-breaching party’s option, terminate without prejudice to the non-breaching party’s rights under
this Agreement, including, if Cornerstone is the breaching party, PI’s right to collect monies due
or to become due under this Agreement.

7. Promotional, Distribution and Maintenance Covenants. Cornerstone shall use commercially
reasonable diligent efforts to promote the sale and distribution of the Licensed Products in the
Exclusive Territory. PI shall maintain the patents in PI’s Patent Portfolio enforceable by making
timely payment of all appropriate patent office maintenance fees.

8. Patent Marking. During the time that the indicated patents remains in force,
Cornerstone shall mark all Licensed Products sold in the United States with the following legend or
its substantial equivalent:

LICENSED UNDER

U.S. Patent #6,843,372

9. Patents, Trademarks, Licensed Know-How, Confidentiality and Competition.

     9.01. Infringement by Third Parties.

          (a) Nothing in this Agreement shall be construed as a warranty that any PI patent is valid and
enforceable or that its exercise does not infringe any patent rights of any third party. PI has no
knowledge and is unaware of any fact which would adversely affect the validity of any patent or
which could give rise to a claim of third party patent infringement relating to the sale or use of
the Licensed Products.

          (b) If either Cornerstone or PI becomes aware of an infringement of any relevant patent, or
any unfair or illegal competition by others relating to the Licensed Products, it shall give prompt
written notice thereof to the other party. In the event PI deems it necessary after consulting with
Cornerstone to bring an action against a third party for patent infringement of the rights to PI
technology granted Cornerstone under this Agreement, PI shall have the first option to prosecute
such an infringement action and choose its own counsel. PI shall bear the entire cost of such
litigation.

6

 

          (c) PI shall pay all costs and expenses, including attorneys’ fees, for any action prosecuted
by PI pursuant to Section 9.01(b).

          (d) If PI, recovers any damages as a result of an infringement proceeding prosecuted by PI
pursuant to Section 9.01(b), such amounts shall be retained by PI, except that any portion of the
damages attributable to damages suffered by Cornerstone (if any) shall be distributed to
Cornerstone.

          (e) If PI elects not to prosecute an action pursuant to Section 9.01(b), which written
election shall be made within ninety (90) days after notification of an actionable infringement by
a third party, Cornerstone may do so at its sole option and expense and shall have full, sole
control over such action. Unless otherwise agreed upon by the parties, if Cornerstone is successful
in its action, and Cornerstone recovers any damages as a result of such an infringement proceeding,
such amounts shall be retained by Cornerstone, except that any portion of the damages attributable
to damages suffered by PI (if any) shall be distributed to PI.

          (f) PI and Cornerstone agree to cooperate with each other in any proceeding under this
Section 9.01, and each agrees to participate as a party as necessary to any proceeding initiated
under this Section 9.01.

     9.02 Actions for Infringement by Third Parties. Each party shall indemnify and hold the other
harmless from and against any and all claims, judgments, liabilities and damages arising out of any
claim that the technology of the other party infringes any patent, trade secret, or other
intellectual property right of a third party. In the event any such claim is made, the party to be
indemnified (the “Indemnitee”) shall immediately notify the indemnifying party (the “Indemnitor”).
The Indemnitor shall have the right to control the defense of such claim with counsel of its choice
and shall bear all cost and expense of such defense. The Indemnitee shall allow the Indemnitor to
control the defense of such claims, shall cooperate as reasonably necessary in the defense of any
such claim at the expense of the Indemnitor, and may participate in the defense with counsel of its
choice at Indemnitee’s cost. To the extent a claim is based on infringement by the technology of
both parties, each party shall bear the cost and expense of its own defense, and shall indemnify,
reimburse, and hold the other harmless to the extent that it is determined that such infringement
is attributable to such party and its technology.

10. Confidence.

     10.01. Subject to the terms and provisions of this Agreement, the parties hereby agree to
maintain in confidence the confidential information of the other party. To this end, neither party
will disclose confidential information of the other party to third parties, except for
sublicensees, contractors, consultants, and advisors to the receiving party, who have first agreed
in writing to maintain the information of the disclosing party confidential. Notwithstanding the
foregoing or Section 10.02, Cornerstone shall have the right to disclose information licensed
hereunder to regulatory authorities as it deems necessary or appropriate to meet its obligations
under Section 7.

     10.02. For the purpose of this provision, it is agreed that the information disclosed by the
parties to the other party pursuant to Confidential Disclosure Agreement entered into by and

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between the parties dated on the Effective Date, a copy of which is attached hereto as Exhibit
A, remains in full force and effect and shall continue in full force and effect during the Term of
this Agreement.

11. Representation and Warranties.

     11.01. PI represents and warrants that it has the unqualified right and ability to disclose
the PI Information to Cornerstone hereunder and to make the license grants to Cornerstone set forth
herein.

     11.02. PI represents and warrants that it has no prior commitment of any kind which would
interfere with or prevent its providing Cornerstone with the PI Information hereunder or otherwise
from fully and faithfully performing its obligations to Cornerstone pursuant to this Agreement.

     11.03. PI represents and warrants that the PI Patents have been maintained.

     11.04. PI represents and warrants that no challenges of any type have been made to the PI
Patents in the U.S. by any third party.

     11.05. PI represents and warrants that there are no encumbrances upon the PI Patents.

12. Miscellaneous.

     12.01. Amendment. This Agreement may be amended by the parties. No amendment will be
effective unless in writing, and signed by both of the parties.

     12.02. Arbitration.

          (a) The parties will attempt through good faith negotiation to resolve their disputes. The
term “disputes” includes, without limitation, any disagreements between the parties concerning the
existence, formation, interpretation and implementation of this Agreement. If the parties are
unable to resolve their disputes by negotiation, either party may provide written notice that it
intends to commence arbitration within 30 days of the date of the written notice if the dispute is
unable to be resolved by the parties. The notice will state the dispute with particularity. If at
the end of the 30 day period the dispute remains unresolved, either party may commence arbitration
by sending a written notice of arbitration to the other party. The notice will state the dispute
with particularity.

          (b) There shall be one arbitrator. If the parties fail to select a mutually acceptable
arbitrator within ten (10) days after the notice of arbitration, a single arbitrator located in the
State of Maryland shall be appointed as soon as possible on the request of either party by the
American Arbitration Association or a similar body agreed upon by the parties. The fee payable to
the arbitrator shall be based upon the then current fee schedule of the American Arbitration
Association (or the other body selected by the parties) and shall be advanced one half by each
party, upon the written request of the arbitrator or the American Arbitration Association (or the
other body selected by the parties).

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          (c) The parties shall have reasonable rights of discovery.

          (d) Except as set forth in this Section, the arbitrator shall conduct the arbitration
according to the Commercial Arbitration Rules of the American Arbitration Association Arbitration
(or the other body selected by the parties) shall take place in the State of Maryland unless the
parties otherwise agree. The arbitrator shall base the decision on the express language of this
Agreement. Within ten (10) days after the arbitrator is appointed, or as soon thereafter as shall
be reasonably practicable, the arbitrator will conduct a hearing on the dispute. Each party may
make written submissions to the arbitrator, and each party shall have a reasonable opportunity for
rebuttal, but no longer than ten (10) days. As soon as reasonably practicable, but not later than
ten (10) days after the hearing is completed, the arbitrator shall arrive at a final decision,
which shall be reduced to writing, signed by the arbitrator and mailed to each party and its legal
counsel.

          (e) All decisions of the arbitrator shall be final, and binding on all parties, and (except as
provided below) shall constitute the only method of resolving disputes. Judgment may be entered
upon the decision in accordance with applicable law in any court having jurisdiction.

          (f) This arbitration section and all decisions of the arbitrator shall be specifically
enforceable in a court of law, or in the arbitral tribunal.

     12.03 Assignability. Except for assignment to affiliates and successors-in-interest of
the company, neither this Agreement nor any interest therein may be assigned, in whole or in part,
by a party without the prior written consent of the other party, not to be unreasonably withheld or
delayed. In the event of an assignment hereunder, the assignor shall remain liable for the
obligations hereunder.

     12.04 Attorneys’ Fees. If either party institutes litigation or arbitration to
interpret or enforce this Agreement, or to recover damages for breach of this Agreement, the
prevailing party shall be entitled to recover costs of suit or arbitration, and to recover
reasonable attorney fees. A party can be the prevailing party even if the proceedings are not
brought to a final judgment or award.

     12.05 Authority. Any individual signing this Agreement on behalf of an entity hereby
represents and warrants in his/her individual capacity that he/she has full authority to do so on
behalf of that entity.

     12.06 Captions. The titles and captions are included only as a matter of convenience.
They shall not affect the interpretation of any provision.

     12.07 Consents and Approvals. A party shall not unreasonably withhold a consent
provided for in this Agreement, unless the Agreement specially permits otherwise. Consents shall be
effected only by written notice.

     12.08 Construction of Agreement. Both parties and their counsels have participated
fully in the preparation of this Agreement. Any rule of construction to the effect that
ambiguities are to be resolved against the drafting party shall not apply to the interpretation of
this Agreement.

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     12.09 Corporate Assets. If an entity party breaches this Agreement, the non-breaching
party agrees to look solely to the assets of the breaching entity in satisfaction of any damages
incurred or judgment obtained as a result of the breach. The non-breaching party waives any claim
it has against the breaching entity to pierce the entity veil, or to otherwise disregard the
entity. The shareholders, members, officers, managers, directors, employees, attorneys, agents or
affiliates of the breaching party shall not be liable under or with respect to this Agreement.

     12.10 Counterparts. This Agreement may be executed in two counterparts, each of which
shall be deemed an original, but taken together shall constitute one instrument.

     12.11 Cumulative Remedies. The various rights, options, elections, powers, and
remedies under this Agreement, or granted by law (collectively, “Remedies”), shall be construed as
cumulative. No single Remedy is exclusive of any of the other Remedies.

     12.12 Effective Date. This Agreement shall be effective only when signed by both
parties.

     12.13 Expenses. Except as may be specifically provided for in this Agreement, both
parties shall bear their own expenses incurred in connection with this Agreement and the
transactions contemplated in it including, but not limited to, legal and accounting fees.

     12.14 Force Majeure. Neither party will be liable or in default for any delay or
failure in performance under this Agreement, or for any other interruption of service resulting
directly or indirectly from Acts of God, civil authority, including government regulation as
indicated in Section 4.06, or military authority, acts of public enemy, war, accidents, fires,
explosions, earthquakes, floods, failure of transportation, strikes or similar or dissimilar causes
beyond the reasonable control of either party.

     12.15 Further Assurances. Each party will do such further acts, including executing
and delivering additional agreements or instruments as the other may reasonably require, to
consummate, evidence or confirm the agreements contained in this Agreement.

     12.16 Governing Law. This Agreement shall be construed and enforced according to the
laws of the State of Maryland applicable to agreements made and to be performed wholly within the
State of Maryland.

     12.17 Incorporation of Exhibits and Recitals. All exhibits and recitals referred to in
this Agreement are an integral part of this Agreement. They are incorporated in this Agreement by
this reference as though at this point set forth in full.

     12.18 Integration. The making, execution and delivery of this Agreement by the parties
has not been induced by any representations, statements, warranties or agreements other than those
expressed in this Agreement. This Agreement embodies the entire understanding of the parties as to
the License Agreement. Except for a Confidential Disclosure Agreement between the parties dated on
the Effective Date, there are no other agreements or understandings, written or oral, in effect
between the parties relating to the subject matter of this Agreement.

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     12.19 Judicial Remedies. The parties reserve the right to seek a judicial temporary
restraining order, preliminary injunction, or other similar short term equitable relief prior to
the appointment of the arbitrator. The arbitral tribunal will have the right to make a final
determination of the parties’ rights, including whether to make permanent, modify or dissolve the
judicial order.

     12.20 No Third Party Rights. The parties do not intend the benefits of this Agreement
to inure to any person or entity not a party to this Agreement.

     12.21 Notices.

          (a) Written notices. All notices, demands or requests (“Notices”) which are required or
permitted to be given pursuant to this Agreement shall be in writing. Notices shall be delivered
personally, by commercial carrier or by registered or certified mail, postage prepaid, addressed to
a party as stated below.

PI’s address for notices:

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

Washington, D.C. 20016

Facsimile No.: 301-983-0510

Attn: Allan M. Weinstein, M.D.

Cornerstone’s address for notices:

Craig Collard

President and CEO

Cornerstone Biopharma, Inc.

2000 Regency Parkway,

Suite 255

Cary, North Carolina 27511

Facsimile No.: 919-678-6599

          (b) Notice given personally or by commercial carrier is effective upon delivery. Notice given
by United States mail is effective the third (3rd) United States Post Office delivery day after the
date of mailing.

          (c) Change of address. Either party may change his/her/its address for Notices by
Notice given pursuant to this Section.

     12.22 Partial Invalidity. If any provision of this Agreement is found to be invalid or
unenforceable by any court or arbitral tribunal, only that provision will be ineffective, unless
its invalidity or unenforceability will defeat an essential business purpose of this Agreement.

     12.23 Successors and Assigns. This Agreement and the rights and obligations of the
parties shall be binding upon and inure to the benefit of the parties and their respective
successors and permitted assigns.

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     12.24 Survival. Except as otherwise expressly provided in this Agreement, all
covenants, representations and warranties, express or implied, shall survive the execution of this
Agreement.

     12.25 Time of the Essence. Time is of the essence throughout the term of this
Agreement for every provision in which time is an element. No extension of time for performance of
any act shall be deemed an extension of time for the performance of any other acts.

     12.26 Waiver of Right. No waiver of or failure by either party to enforce a provision,
covenant, condition or right under this Agreement (collectively, “Right”) shall be construed as a
subsequent waiver of the same Right, or a, waiver of any other Right. No extension of time for
performance of any obligations or acts shall be deemed an extension of the time for performance of
any other obligations or acts.

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

	 	 	 	 	 	 	 	 	 
	Witness/Attest:	 	 	 	Cornerstone Biopharma, Inc.
	 
	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	By:
	 	/s/ Craig Collard
	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	Craig Collard
	 

	 	 	 	 	 	 	 	President and CEO
	 
	 	 	 	 	 	 	 	 
	Witness/Attest:	 	 	 	Pharmaceutical Innovations, LLC
	 
	 	 	 	 	 	 	 	 
	Porter Fleming	 	 	 	By:	 	/s/ Allan M. Weinstein
	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	Allan M. Weinstein, M.D. President

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Exhibit A

Confidential Disclosure Agreement

Between PI and Cornerstone

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CONFIDENTIAL DISCLOSURE AGREEMENT

     This Confidential Disclosure Agreement (the “Agreement”) is made and entered into as of the
31st day of August, 2006 (the “Effective Date”), by and between Pharmaceutical Innovations, LLC,
3301 New Mexico Avenue, N.W., Suite #302, Washington, D.C. 20016 (“PI”) and Cornerstone Biopharma,
Inc., 2000 Regency Parkway, Suite 255, Cary, North Carolina 27511 (“Cornerstone”).

RECITALS:

     A. Each party to this Agreement possesses certain Confidential Information (as hereinafter
defined) which it is willing to disclose to the other party for the purposes set forth herein and
subject to the terms and conditions set forth herein; and

     B. Each party to this Agreement is willing to receive the other party’s Confidential
Information subject to the terms and conditions set forth herein.

     NOW, THEREFORE, for and in consideration of the premises and the mutual promises and benefits
set forth herein, the parties hereto hereby agree as follows:

1. Definition of Confidential Information

     (a) As used herein, the term “Cornerstone Confidential Information” shall mean any and all
information that is disclosed on or after the Effective Date in accordance with Section 1(d) below
by Cornerstone or any of its Affiliates (as defined herein) to PI, including, but not limited to,
technical, developmental, marketing, packaging, sales, operating, performance, cost, know-how,
business information, computer programming techniques, and all record bearing media containing or
disclosing such information and techniques.

     (b) As used herein, the term “PI Confidential Information” shall mean any and all information
that is disclosed on or after the Effective Date in accordance with Section 1(d) below by PI to
Cornerstone or any of its Affiliates, including, but not limited to, technical, developmental,
marketing, packaging, sales, operating, performance, cost, know-how, business information, computer
programming techniques, and all record bearing media containing or disclosing such information and
techniques.

     (c) Cornerstone Confidential Information and PI Confidential Information are sometimes
hereinafter collectively referred to as the “Confidential Information”.

     (d) All Confidential Information shall be disclosed by the disclosing party in writing or in
any other tangible medium and designated as confidential at the time of disclosure or, if disclosed
orally, shall be identified by the disclosing party as confidential at the time of disclosure and
thereafter summarized in writing or reduced to another tangible medium, designated as confidential,
and submitted to the recipient within thirty (30) days of such disclosure.

     (e) Confidential Information shall not include any portion of the Confidential Information of
the other party hereto which:

 

 

	 	(i)	 	at the time of disclosure hereunder is generally available to
the public;
	 
	 	(ii)	 	after the time of disclosure hereunder becomes generally
available to the public, except through breach of this Agreement by the
recipient;
	 
	 	(iii)	 	the recipient can demonstrate, by reference to its written
records, was in its possession prior to the time of disclosure by the
disclosing party hereunder, and was not acquired directly or indirectly from
the disclosing party or its Affiliates;
	 
	 	(iv)	 	becomes available to the recipient from a third party which is
not legally prohibited from disclosing such Confidential Information, provided
such Confidential Information was not acquired directly or indirectly from the
disclosing party or its Affiliates; or
	 
	 	(v)	 	the recipient can demonstrate, by reference to its written
records, was developed by or for the recipient independently of the disclosure
of Confidential Information by the disclosing part or its Affiliates.

     (f) The proposed recipient of Confidential Information under this Agreement shall have the
right to refuse acceptance of any information under this Agreement and nothing herein shall
obligate the disclosing party to disclose to the recipient any particular information.

     (g) Notwithstanding any provision herein to the contrary, the recipient of Confidential
Information agrees not to challenge any patent which relates to the Confidential Information or act
in contradiction to the validity of any such patent.

2. Purpose of Disclosure. The Confidential Information is being disclosed between the
parties hereto for the purpose of enabling the parties to determine the feasibility of entering
into a mutually attractive business arrangement. The parties shall have no obligation to enter into
any further agreement with each other except as the parties, in their sole judgment, may deem
advisable.

3. Maintenance of Confidentiality; Non-use Obligations.

     (a) The Confidential Information shall be kept strictly confidential by the recipient
and, except as otherwise permitted herein, shall not be disclosed to any third party by the
recipient in any manner whatsoever, in whole or in part, without first obtaining the disclosing
party’s prior written consent to such disclosure. The standard of care required of the recipient in
protecting the confidentiality of the disclosing party’s Confidential Information shall be the same
standard of care that the recipient uses in protecting its own confidential information of a
similar nature, but in no event shall the recipient use less than a reasonable standard of care.
The recipient may disclose the disclosing party’s Confidential Information only to the recipient’s
employees or consultants on a need-to-know basis, provided that the recipient will have executed or
shall execute appropriate written agreements with its employees and applicable consultants
sufficient to enable the recipient to comply with all the provisions of this Agreement.

2

 

     (b) The Confidential Information shall be used by the recipient only for the purposes set
forth herein and shall not be utilized by the recipient for any pecuniary benefit, to interfere in
any manner with the disclosing party’s business relationships or for any purposes whatsoever except
as permitted herein, without first obtaining the disclosing party’s prior written consent to such
utilization or without first entering into a separate written agreement duly executed by authorized
representatives of the parties hereto.

4. Notification of Mandatory Disclosure.

     (a) In the event that either party hereto is required by applicable statute or regulation or
by judicial or administrative process to disclose any part of the Confidential Information which is
disclosed to it hereunder, the recipient shall (i) promptly notify the disclosing party of each
such requirement and identify the documents so required thereby, so that the disclosing party may
seek an appropriate protective order or other remedy and/or waive compliance by the recipient with
the provisions of this Agreement and (ii) consult with the disclosing party on the advisability of
taking legally available steps to resist or narrow the scope of such requirement.

     (b) If, in the absence of such a protective order or such a waiver by the disclosing party of
the provisions of this Agreement, the recipient is nonetheless required by mandatory applicable law
to disclose any part of the Confidential Information which is disclosed to it hereunder, the
recipient may disclose such Confidential Information without liability under this Agreement, except
that the recipient shall furnish only that portion of the Confidential Information which it is
legally required to disclose.

5. Term of Obligations. This Agreement may be terminated with respect to further
disclosures upon written notice by either party to the other party. Otherwise, this Agreement shall
terminate five (5) years after the Effective Date. Notwithstanding the foregoing, the rights and
obligations of the parties accruing prior to termination shall in all events survive the
termination of this Agreement.

6. Ownership; No Licenses. All Cornerstone Confidential Information is and shall remain the
property of Cornerstone. All PI Confidential Information is and shall remain the property of PI.
Neither this Agreement nor any disclosure hereunder shall be deemed, by implication, estoppel or
otherwise, to vest in the recipient any license or other ownership rights to or under any
inventions patents, know-how, trade secrets, trademarks or copyrights owned or controlled by the
disclosing party. The parties agree that no warranties of any kind are given with respect to such
Confidential Information, as well as any use thereof, except as otherwise agreed to in writing.

7. Return of Confidential Information. At any time upon the request of the disclosing
party, the recipient shall promptly return to the disclosing party the disclosing party’s
Confidential Information, including all copies thereof. At the disclosing party’s written request,
the Confidential Information that is otherwise required to be returned to such disclosing party
shall be destroyed and such destruction shall be certified in writing to the disclosing party by an
authorized representative of the recipient. Notwithstanding the foregoing, the recipient may retain
a single archival copy of the disclosing party’s Confidential Information solely for the purpose of
establishing the extent of disclosure of Confidential Information by the disclosing

3

 

party hereunder. The return and/or destruction of such Confidential Information as provided above
shall not relieve the recipient of its other obligations under this Agreement.

8. Affiliates. Notwithstanding the obligations set forth herein regarding confidentiality
and use of Confidential Information, either party hereto may disclose (a) any of its Confidential
Information directly to Affiliates of the other party hereto or (b) any Confidential Information
which is disclosed to it hereunder to any of its Affiliates, in each case provided that such
Affiliate has agreed to be bound by the terms hereof. In the event of such disclosure, the terms
“Cornerstone” and/or “PI,” as applicable shall include any such Affiliate to which (i) the
disclosing party has disclosed its Confidential Information directly or (ii) such party has
disclosed the disclosing party’s Confidential Information. For purposes of this Agreement, the term
“Affiliate” shall mean any corporation or non-corporate entity which controls, is controlled by or
is under common control with a party hereto. A corporation or non-corporate entity, as applicable,
shall be regarded as in control of another corporation if it owns or directly or indirectly
controls at least fifty percent (50%) of the voting stock of the other corporation or (x) in the
absence of the ownership of at least fifty percent (50%) of the voting stock of a corporation or
(y) in the case of a non-corporate entity, if it possesses, directly or indirectly, the power to
direct or cause the direction of the management and policies of such corporation or non-corporate
entity, as applicable.

9. No Other Obligation. This Agreement shall not be construed to create any obligation on
the part of either party hereto or their respective Affiliates to retain the other party’s services
or to compensate the other party in any manner, except as may be set forth by a separate written
agreement duly executed by authorized representatives of the parties hereto.

10. Notices. All notices or other communications required or permitted to be made or given
hereunder shall be deemed so made or given when hand-delivered or sent in writing by registered or
certified mail, postage prepaid and return-receipt requested, or by a nationally-recognized courier
service guaranteeing next-day delivery, charges prepaid, and properly addressed to such other party
as set forth above or at such other address as may be specified by either party hereto by written
notice similarly sent or delivered. Notices or other communications directed to Cornerstone shall
be sent to the attention of Craig Collard, President and CEO. Notices or other communications
directed to PI shall be sent to the attention of Allan M. Weinstein, M.D., President and CEO.

11. Indemnification; Remedies for Breach.

     (a) The recipient shall indemnify the disclosing party and hold the disclosing party harmless
from and against any and all loss, cost, damage, injury or expense (including court costs and
reasonably attorneys fees) which the disclosing party or any of its agents, successors or assigns
may incur as a result of a breach of this Agreement by the recipient (and its directors, officers,
employees, consultants, agents or representatives).

     (b) Both parties hereto agree that should this Agreement be breached, money damages would be
inadequate to remedy any such breach. As a result, the non-breaching party shall be entitled to
seek, and a court of competent jurisdiction may grant, specific performance and injunctive or other
equitable relief as a remedy for any breach of this Agreement. Such

4

 

remedy shall be in addition to all other remedies, including money damages, available to a
non-breaching party at law or in equity.

12. Assignment. This Agreement shall be binding upon and shall inure to the benefit of the
parties hereto and their respective successors, permitted assigns, subsidiaries and Affiliates.
This Agreement shall not be assigned by either party without the prior written consent of the other
party, which consent may be withheld at such party’s sole discretion, and any purported assignment
without such consent shall be void.

13. Severability. If any provision of this Agreement or the application thereof to either
party hereto or circumstance is held illegal, invalid or unenforceable, such illegality, invalidity
or unenforceability shall not affect any other provision hereof. This Agreement shall, in such
circumstances, be deemed modified to the extent necessary to render enforceable the provisions
hereof to the fullest extent permitted by law.

14. Entire Agreement; Amendments; Waiver. This Agreement contains the entire understanding
between the parties hereto with respect to the subject matter contained herein and supersedes all
prior written or oral communications, negotiations, understandings or agreements of any kind with
respect to such subject matter. No amendment or modification of this Agreement shall be effective
unless made or agreed to in writing by authorized representatives of both parties hereto. Failure
by either party hereto to enforce any rights under this Agreement shall not be construed as a
waiver of such rights nor shall a waiver by either party hereto in one or more instances be
construed as constituting a continuing waiver or as a waiver in other instances.

15. Governing Law; Headings; Counterparts. This Agreement shall be governed by and
construed in accordance with the laws of the State of Maryland, without regard to principles of
conflicts of laws applicable in such jurisdiction. Any dispute under this Agreement shall be
decided in the federal or state courts in the State of Maryland. The headings in this Agreement are
for convenience of reference only and shall not affect its interpretation. This Agreement and any
amendment hereto may be executed in counterparts and all of such counterparts taken together shall
be deemed to constitute one and the same instrument.

     IN WITNESS WHEREOF, the parties hereto have duly executed this Agreement as of the Effective
Date by their duly authorized representatives.

	 	 	 	 	 	 	 	 	 	 	 
	Pharmaceutical Innovations, LLC	 	 	 	Cornerstone Biopharma, Inc	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By:

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

	 	 
	 	 	 	 	 	 	 	 
	 

	 	Allan M. Weinstein, M.D.
	 	 	 	 	 	Craig Collard	 	 
	 

	 	President and CEO
	 	 	 	 	 	President and CEO	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Date:

	 	 	 	 	 	Date:
	 	 9/7/06	 	 
	 

	 	 	 	 	 	 	 	 	 	 

5

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