-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, G6v2X7WAdNKTC3RIy82eFv0690kw36rDQhLSQVigEjSF3uMrC4vjqeVTlvv9Q9bZ Yr/UliCYzcDhqUnUi9ZKlQ== 0000950137-07-016195.txt : 20071030 0000950137-07-016195.hdr.sgml : 20071030 20071030130225 ACCESSION NUMBER: 0000950137-07-016195 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20071024 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20071030 DATE AS OF CHANGE: 20071030 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AKORN INC CENTRAL INDEX KEY: 0000003116 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 720717400 STATE OF INCORPORATION: LA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-32360 FILM NUMBER: 071198717 BUSINESS ADDRESS: STREET 1: 2500 MILLBROOK DRIVE CITY: BUFFALO GROVE STATE: IL ZIP: 60089 BUSINESS PHONE: 8472796100 MAIL ADDRESS: STREET 1: 2500 MILLBROOK DRIVE CITY: BUFFALO GROVE STATE: IL ZIP: 60089 8-K 1 c21046e8vk.htm CURRENT REPORT e8vk
 

 
 
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act
Date of Report: October 24, 2007
(Date of Earliest Event Reported)
Akorn, Inc.
(Exact Name of Registrant as Specified in its Charter)
         
Louisiana   0-13976   72-0717400
(State or other   (Commission   (I.R.S. Employer
Jurisdiction of   File Number)   Identification No.)
Incorporation)        
2500 MILLBROOK DRIVE
BUFFALO GROVE, ILLINOIS

(Address of principal executive offices)
(847) 279-6100
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (See General Instruction A.2. below):
o Written communication pursuant to Rule 425 under the Securities Ac (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240. 13e-4(c))
 
 

 


 

Item 1.01 Entry into a Material Definitive Agreement.
     On October 24, 2007, Akorn, Inc. (“Akorn”) executed an Exclusive Memorandum of Understanding (“MOU”) with the Serum Institute of India, Ltd. (“Serum”), a vaccine and pharmaceutical manufacturer based in India. The MOU provides the terms of a collaboration between the parties which shall be converted into definitive agreements at a future date. Pursuant to the MOU, Serum will manufacture certain vaccines and grant Akorn exclusive marketing rights for the vaccines in the United States of America and its territories (the “Territory”) for a period of ten (10) years from the date of receipt of biologics license application (“BLA”) approval.
     Akorn shall pay Serum a fee for each of the vaccines for which it decides to conduct clinical trials and shall fund such clinical trials necessary for securing BLA licenses for the vaccines, as well as pay the U.S. Food and Drug Administration (the “FDA”) filing fee for each vaccine’s BLA. Akorn may stop funding the clinical trials for any vaccine if it finds that the clinical trials are cost prohibitive, but upon doing so, the exclusive right granted by Serum to Akorn for that vaccine will lapse immediately and Serum will be free to formulate its own strategy for marketing the vaccine in the Territory.
     The MOU further provides that net revenues will be split equally between Akorn and Serum with Serum bearing all manufacturing costs and Akorn bearing all marketing costs. Akorn and Serum will also share the FDA annual establishment fee and product fee equally.
     Within thirty (30) days of the MOU, Akorn shall sell 1,000,000 shares of common stock to Serum at the then current market price in a private placement pursuant to a separate securities purchase agreement to be executed between the parties. Akorn and Serum also agreed to enter into at a definitive Exclusive Definitive Development, Manufacturing and Supply Agreement (the “Development Agreement”) within two (2) months of the execution of the MOU. If for any reason there is a delay in executing the Development Agreement, Akorn and Serum will discuss a corresponding extension for execution of the Development Agreement.
     The description of the MOU herein is only a summary and is qualified in its entirety by the full text of such document, which is filed as an exhibit hereto and is incorporated by reference herein.
Item 9.01 Financial Statements and Exhibits.
     (d) Exhibits.
     10.1 Exclusive Memorandum of Understanding dated October 24, 2007 between Serum and Akorn. *
 
*   Confidential Treatment Requested for portions of this exhibit Under 17 C.F.R. §§ 200.80(b)(4), 200.83 and 240.24b-2.

 


 

SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Current Report on Form 8-K to be signed on its behalf by the undersigned hereunto duly authorized.
         
  Akorn, Inc.
 
 
  By:   /s/ Jeffrey A. Whitnell    
    Jeffrey A. Whitnell   
    Chief Financial Officer, Treasurer
and Secretary 
 
 
     
Date: October 30, 2007     
     
     
 

 

EX-10.1 2 c21046exv10w1.htm EXCLUSIVE MEMORANDUM OF UNDERSTANDING 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.

 

-----END PRIVACY-ENHANCED MESSAGE-----