exv10w1



 





Exhibit 10.1




*Confidential Treatment Requested Under

17 C.F.R. §§ 200.80(b)(4) and 240.24b-2




EXCLUSIVE MEMORANDUM OF UNDERSTANDING





	 	 	This Exclusive Memorandum of Understanding is executed on 24th October 2007 at Pune





by and between





	 	 	Serum lnstitute of India Ltd., a Company having a place of business at 212/2, Hadapsar,
Pune-411 028, India (hereinafter referred to as “Serum”) which expression shall include its
successors and permitted assigns) of the One Part;





AND





	 	 	AKORN INC. a company incorporated under the Laws of State of Louisiana, having place of
business at 2500 Millbrook Drive Buffalo Grove, Illinois 60089-4694 (hereinafter referred
as “AKORN”) which expression shall include its successors and permitted assigns) of the
Other Part;






	 	 	WHEREAS:






	A.	 	AKORN is a leading pharmaceutical company in the United States and is engaged in the business
of marketing pharmaceuticals.






					
	 	 	 	 	 
	/s/ ACP
	 	1
	 	/s/ ASP
	SERUM
	 	 	 	AKORN






*  CONFIDENTIAL TREATMENT REQUESTED — This language has been omitted and filed separately with the
Securities and Exchange Commission.


 









 





*Confidential Treatment Requested Under

17 C.F.R. §§ 200.80(b)(4) and 240.24b-2





	 	B.	SERUM is engaged in the Research and Development, Manufacturing and Marketing of Human
Vaccines, Oncology and Pharmaceutical Products in India and abroad.
	 	 
	 	C.	AKORN is desirous of getting certain Vaccines sourced from SERUM for selling them in the
Territory.
	 	 
	 	 	THE PARTIES THEREFORE HAVE DISCUSSED AND ARRIVED AT THIS UNDERSTANDING, WHICH AT A LATER
DATE IS TO BE CONVERTED INTO AN EXCLUSIVE DEFINITIVE DEVELOPMENT, MANUFACTURING AND SUPPLY
AGREEMENT:






	 	1	 	SCOPE OF THE COLLABORATION






	 	a)	 	SERUM is manufacturing and intends to sell the following vaccines in the
United States of America and its territories on an exclusive basis (the Territory)




Measles Mumps Rubella Vaccine (MMR)

Human Diploid Rabies Vaccine

Recombinant Hepatitis B Vaccine

Onco BCG Vaccine (BCG)





					
	 	 	 	 	 
	/s/ ACP
	 	2
	 	/s/ ASP
	SERUM
	 	 	 	AKORN





* CONFIDENTIAL TREATMENT REQUESTED — This language has been omitted and filed separately with the
Securities and Exchange Commission.



 









 





*Confidential Treatment Requested Under

17 C.F.R. §§ 200.80(b)(4) and 240.24b-2





	 	b)	 	SERUM grants exclusive marketing rights to AKORN for the above listed
products for the Territory for a period of Ten Years from the date of receipt of BLA
Approval for the respective product
	 
	 	c)	 	Both the parties will have a pre IND meeting with CBER, USA to explore
the possibility of registering the above listed Vaccines in USA
	 
	 	d)	 	AKORN shall fund all the clinical trials necessary for securing a BLA
license for each product and agrees to pay for the FDA filing fee for the BLA for
each of the Vaccines listed herein.
	 
	 	e)	 	If AKORN finds that the funding which it is required to make as per the
clause (d) above is prohibitive then in such a case it reserves the right to not
proceed with funding the clinical trials for that particular Vaccine. Consequently,
the exclusive right granted by SERUM to AKORN for that Vaccine shall lapse
immediately. SERUM then is free to formulate the strategy for marketing the Vaccine
in USA on its own or through another company. AKORN has indicated that it is ready
to fund the costs so far as they do not exceed the following amount for each
Vaccine:





	 	 	 	 	 
	Measles Mumps Rubella Vaccine (MMR)
	 	US $[***...***]
	Human Diploid Rabies Vaccine
	 	US $[***...***]
	Recombinant Hepatitis B Vaccine
	 	US $[***...***]
	Onco BCG Vaccine (BCG)
	 	US $[***...***]







					
	 	 	 	 	 
	/s/ ACP
	 	3
	 	/s/ ASP
	SERUM
	 	 	 	AKORN






* CONFIDENTIAL TREATMENT REQUESTED — This language has been omitted and filed separately with the
Securities and Exchange Commission.


 









 





*Confidential Treatment Requested Under

17 C.F.R. §§ 200.80(b)(4) and 240.24b-2





	 	f)	 	SERUM shall provide all the documents necessary for a BLA filing
including but not limited to technical data, manufacturing processes and
intellectual property, previous clinical data and provide assistance as may be
required by AKORN initially for requesting a pre IND Meeting and then subsequently
for obtaining a BLA License. SERUM shall provide Vaccine Products at no cost to
AKORN necessary to conduct the Vaccine clinical trials.
	 
	 	g)	 	In consideration of SERUM granting the Exclusive Marketing Rights to
AKORN, AKORN shall make the following payment to SERUM






	 	*	 	US $[***...***] for each Vaccine listed above immediately after AKORN
decides to proceed and conduct the Clinical Trials based on understanding the
costs associated with commercializing the Vaccine product on the basis of the
feedback from the pre IND meeting






	 	2	 	REVENUE SHARING






	 	 	It is agreed that the Net Revenues shall be split 50-50. SERUM shall bear all the
Manufacturing Costs and AKORN shall bear all the marketing costs. AKORN and SERUM shall
share the FDA Annual Establishment and Product Fee in the ratio of 50-50.






					
	 	 	 	 	 
	/s/ ACP
	 	4
	 	/s/ ASP
	SERUM
	 	 	 	AKORN





* CONFIDENTIAL TREATMENT REQUESTED — This language has been omitted and filed separately with the
Securities and Exchange Commission.



 









 





*Confidential Treatment Requested Under

17 C.F.R. §§ 200.80(b)(4) and 240.24b-2





	 	3	 	INDIVIDUAL ROLES & RESPONSIBILITIES






	 	 	SERUM shall
	 
	 	 	Provide all the data, documents and assistance which AKORN may need for the pre-IND Meeting
and for securing BLA License
	 
	 	 	Manufacture the Products for sale in USA in US FDA approved facilities so as to sell it in
the US markets
	 
	 	 	Provide all the data, information as may be required for filing the relevant applications
with US Authorities for registering the Vaccines
	 
	 	 	Supply these Vaccines to AKORN as per the marketing plan mutually agreed from time to time.
	 
	 	 	AKORN shall
	 
	 	 	Arrange for and co-ordinate the pre IND meeting
	 
	 	 	Conduct and pay for all the clinical trials, tests as may be required by CBER to register
these Vaccines in the Territory
	 
	 	 	Market the Vaccines in the Territory





					
	 	 	 	 	 
	/s/ ACP
	 	5
	 	/s/ ASP
	SERUM
	 	 	 	AKORN






* CONFIDENTIAL TREATMENT REQUESTED — This language has been omitted and filed separately with the
Securities and Exchange Commission.



 









 





*Confidential Treatment Requested Under

17 C.F.R. §§ 200.80(b)(4) and 240.24b-2





	 	 	Shall make appropriate payments to SERUM as per the revenue sharing model agreed upon.
	 
	 	 	Shall file the applications for registering the Products in the Territory.
	 
	 	 	Shall remit the funds to SERUM as per the milestones agreed upon hereinabove






	 	4	 	EQUITY PARTICIPATION
	 
	 	 	 	AKORN shall allot on private placement basis 1 million shares in Common Stock
within 30 days of this MOU at the then current market price and as per the
prevailing securities regulations of the SEC, USA. A separate Securities Purchase
Agreement shall be executed for the purchase of these shares.
	 
	 	5	 	GENERAL TERMS






	 	a)	 	AKORN agrees to hire a medical doctor who shall be an expert in Vaccines
and epidemiology in order to manage the clinical trials for these vaccines
	 
	 	b)	 	Both the parties agree to arrive at AN EXCLUSIVE DEFINITIVE DEVELOPMENT,
MANUFACTURING AND SUPPLY AGREEMENT within a period of 2 months from the date of this
MOU. If there is any delay for executing AN EXCLUSIVE DEFINITIVE DEVELOPMENT,
MANUFACTURING AND SUPPLY AGREEMENT then






					
	 	 	 	 	 
	/s/ ACP
	 	6
	 	/s/ ASP
	SERUM
	 	 	 	AKORN






* CONFIDENTIAL TREATMENT REQUESTED — This language has been omitted and filed separately with the
Securities and Exchange Commission.


 









 





*Confidential Treatment Requested Under

17 C.F.R. §§ 200.80(b)(4) and 240.24b-2





	 	 	 	the parties would discuss a corresponding extension for execution of agreement
between SERUM and AKORN.





	 	 	 
	For Akorn Inc.

	 	For Serum Institute of India Ltd.
	 
	 	 
	/s/ Arthur S. Przybyl

	 	/s/ A C Poonawalla
	Arthur S. Przybyl

	 	Mr. A C Poonawalla
	President & Chief Executive Officer

	 	Executive Director
	Akorn Inc.

	 	Serum Institute Of India Ltd.
	 
	 	 
	Place — PUNE, INDIA
	 	 






	 	 	 
	Witnesses
	 	 
	 
	 	 
	1 /s/ Sam Boddapati

	 	1 /s/ Markarand Kaskere
	Sam Boddapati

	 	Markarand Kaskere
	 
	 	 
	2 /s/ Douglas R. Pinnizel

	 	2 /s/ P.J. Dostooz
	Douglas R. Pinnizel

	 	P.J. Dostooz





					
	 	 	 	 	 
	/s/ ACP
	 	7
	 	/s/ ASP
	SERUM
	 	 	 	AKORN









* CONFIDENTIAL TREATMENT REQUESTED — This language has been omitted and filed separately with the
Securities and Exchange Commission.