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.