0001554795-13-000605.txt : 20131015 0001554795-13-000605.hdr.sgml : 20131014 20131015150423 ACCESSION NUMBER: 0001554795-13-000605 CONFORMED SUBMISSION TYPE: S-1 PUBLIC DOCUMENT COUNT: 34 FILED AS OF DATE: 20131015 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Regen BioPharma Inc CENTRAL INDEX KEY: 0001589150 IRS NUMBER: 455192997 STATE OF INCORPORATION: NV FISCAL YEAR END: 0930 FILING VALUES: FORM TYPE: S-1 SEC ACT: 1933 Act SEC FILE NUMBER: 333-191725 FILM NUMBER: 131151721 BUSINESS ADDRESS: STREET 1: 4700 SPRING ST #304 CITY: LA MESA STATE: CA ZIP: 91942 BUSINESS PHONE: 619-702-1404 MAIL ADDRESS: STREET 1: 4700 SPRING ST #304 CITY: LA MESA STATE: CA ZIP: 91942 S-1 1 regen100913forms1.htm FORM S-1

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington D.C. 20549 

_____________________

  

FORM S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933  

______________________

  REGEN BIOPHARMA, INC.
 (Exact name of registrant as specified in its charter)

 

 

Nevada   7389   45-5192997
(State or other jurisdiction of   (Primary Standard Industrial   (I.R.S. Employer Identification Number)
incorporation or organization)   Classification Code Number)    

   _______________________

 

4700 Spring Street, Suite 304, La Mesa, California, 91942

 

(619) 702-1404

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

     ________________________

 

Attn: David R. Koos

Chief Executive Officer

Bio Matrix Scientific Group,Inc.

4700 Spring Street, Suite 304

La Mesa CA 91942

Tel: 619-702-1404

 

(Name, address, including zip code, and telephone number, including area code, of agent for service)

   _________________________

 

Copies to:

Attn: David R. Koos

Chief Executive Officer

Regen Biopharma, Inc.

4700 Spring Street, Suite 304

La Mesa CA 91942

Tel: 619-702-1404

 

 

CALCULATION OF REGISTRATION FEE

 

Title of Each Class of Securities To Be Registered  

Amount To Be

Registered

 

Proposed Maximum

Offering Price

Per Share(1)

   

Proposed Maximum

Aggregate

Offering Price(1)

   

Aggregate

Amount of

Registration Fee

(1) 
Common Stock, par value $0.0001 per share   20,000,000   $ 0.0001     $ 2,000     $ 0.27  
                             

We are registering 20,000,000 shares of our common stock that will be distributed by Bio Matrix Scientific Group, Inc. as a dividend in kind on a pro rata basis to:

(a)Holders of the outstanding common shares of Bio Matrix Scientific Group Inc, a Delaware corporation, as of the record date
(b)Holders of any outstanding series of the preferred shares of Bio Matrix Scientific Group Inc, a Delaware corporation, as of the record date

(1) Estimated solely for the purpose of calculating the amount of the registration fee pursuant to Rules 457(f) under the Act.

 

If any of the securities being registered on this form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box.  o

 

If this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  o

 

If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o

 

If this form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o

 

Indicated by check mark whether the Registrant is large accelerated filer, an accelerated filer, a non-accelerated filer or a small reporting company as defined in Rule 12b-2 of the Securities Exchange Act of 1934.  (Check one unless a smaller reporting company.)

 

Large Accelerated Filer   o Accelerated Filer   o
Non-accelerated Filer   o Smaller Reporting Company     x

 

The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file an amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

 

The information in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the U.S. Securities and Exchange Commission (“SEC”) is effective. This preliminary prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

 

PROSPECTUS

 

DATED ____, 2013

 

REGEN BIOPHARMA, INC.

 

20,000,000 Shares of Common Stock

 

 

You may only rely on the information contained in this prospectus or that we have referred you to. We have not authorized anyone to provide you with different information. This prospectus does not constitute an offer to sell or a solicitation of an offer to buy any securities other than the common stock offered by this prospectus. This prospectus does not constitute an offer to sell or a solicitation of an offer to buy any common stock in any circumstances in which such offer or solicitation is unlawful. Neither the delivery of this prospectus nor any sale made in connection with this prospectus shall, under any circumstances, create any implication that there has been no change in our affairs since the date of this prospectus is correct as of any time after its date.

 

We are furnishing this prospectus to the common and preferred shareholders of Bio Matrix Scientific Group, Inc. a Delaware corporation. This prospectus relates to the distribution on a pro rata basis as a dividend in kind of 20,000,000 of our common shares, par value $0.0001, currently owned by Bio Matrix Scientific Group, Inc (“BMSN”) to:

 

(a)Holders of record of the outstanding common shares of BMSN as of the record date
(b)Holders of record of the shares of any outstanding series of the preferred shares of BMSN as of the record date.

Shareholders of BMSN will receive a proportionate allocation of the shares to be distributed in relation to the total number of common and or/preferred shares to which they are shareholders of record as of the record date. The record date is anticipated to be the date that the registration statement on Form S-1 of which this prospectus forms a part is declared effective by the United States Securities and Exchange Commission (“Record Date”). The distribution of the 20,000,000 common shares of Regen Biopharma,Inc. to the common and preferred shareholders of BMSN will occur ___ days after the Record Date (“Distribution Date”)


This investment involves a high degree of risk. You should purchase shares only if you can afford a complete loss. See “Risk Factors” beginning on page_.

 

Neither the SEC nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

 

The date of this prospectus is____, 2013.

 

 

1

 

PROSPECTUS SUMMARY 3

ABOUT THIS OFFERING 6

SUMMARY FINANCIAL AND OPERATING INFORMATION 7

RISK FACTORS 8

USE OF PROCEEDS 14

DETERMINATION OF OFFERING PRICE 14

DILUTION 14

DISTRIBUTING SECURITY HOLDER 14

PLAN OF DISTRIBUTION 15

DESCRIPTION OF SECURITIES TO BE REGISTERED 15

INTERESTS OF NAMED EXPERTS AND COUNSEL 16

BUSINESS 16

PROPERTIES 26

LEGAL PROCEEDINGS 26

MARKET PRICE OF AND DIVIDENDS ON THE REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS 26

FINANCIAL STATEMENTS 28

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 47

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 48

DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS 48

TRANSACTIONS WITH RELATED PERSONS 51

CORPORATE GOVERNANCE 51

SUMMARY COMPENSATION TABLES 52

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT 57

AVAILABLE INFORMATION 58

DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT LIABILITIES. 58

 

2

PROSPECTUS SUMMARY

This summary highlights certain information contained elsewhere in this prospectus. Because it is a summary, it may not contain all of the information that is important to you. Before investing in our common stock, you should read this entire prospectus carefully, especially the sections entitled “Risk Factors” beginning on page 8 and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” beginning on page 47, as well our financial statements and related notes included elsewhere in this prospectus. In this prospectus, the terms “Regen Biopharma, Inc” “Regen ” “Company,” “we,” “us” and “our” refer to Regen Biopharma , Inc.. In this prospectus, the terms “Bio Matrix Scientific Group” “Bio Matrix ” and “BMSN” refer to Bio Matrix Scientific Group , Inc..

 

About Us

 

We were incorporated April 24, 2012 under the laws of the State of Nevada. We are a wholly owned subsidiary of Bio Matrix Scientific Group, Inc, a Delaware corporation.

 

We intend to engage primarily in the development of regenerative medical applications which we intend to license from other entities up to the point of successful completion of Phase I and or Phase II clinical trials after which we would either attempt to sell or license those developed applications or, alternatively, advance the application further to Phase III clinical trials.

 

On May 1, 2013 Dr. Wei Ping Min (“Min”) entered into an agreement (“Agreement”) whereby Min assigned to Regen all right, title and interest in US Patent # 8,389,708 as well as all Patent applications from the same family corresponding to numbers PCT/CA2006/000984, CA2612200 and EP1898936.(“Min IP”) US Patent # 8,389,708 was granted to Min with regard to his invention of a method directed to the silencing of immunosuppressive cancer causing genes using short interfering RNA (siRNA) leading to an increase in the immune response, a decrease in tumor-induced immunosuppression and a decrease in in vivo tumor progression.

 

As consideration for the Min IP, Regen is required to:

 

(a) negotiate in good faith with Min with regards to a proposed consulting agreement whereby Min shall perform certain mutually agreed upon tasks for the benefit of Regen for consideration to Min consisting of One Hundred Thousand United States Dollars ($100,000 ) of the common shares of Bio Matrix valued as of the date of issuance and to be paid over a twelve month period in twelve equal installments (“Consulting Shares”) and registered under the Securities Act of 1933 on Form S-8.

 

(b) Cause to be issued to Min 100,000 of Bio Matrix’s preferred shares (“Assignor Preferred Shares”) exchangeable into common shares of Bio Matrix (“Exchange Common Shares”) under the following terms and conditions:

(i) A sufficient number of common shares shall be authorized for issuance by Bio Matrix in order that the required number of Exchange Common Shares may be issued

(ii) Subject to (i) above, upon any date subsequent to the date of the completion of a satisfactory review by the United States Food and Drug Administration (“FDA”) of an Investigational New Drug Application (“IND”) for the Min IP submitted by Regen which shall result in the ability of Regen to lawfully begin clinical testing of the Min IP on human subjects within the United States Min shall be permitted, at his option, to exchange 33,333 of the Assignor Preferred Shares into that number of Exchange Common Shares having a value of Three Hundred Thirty Three Thousand United States Dollars ($333,000) such shares being valued at a price per share equal to the closing price as of the day written notice is given by Min to Regen of Min’s intent to exchange.

(iii) Subject to (i) above, upon any date subsequent to the date that manufacturing procedures for the manufacture of the Min IP have been developed by Regen which comply to the Current Good Manufacturing Practices (“cGMP “) requirements of the Food Drug and Cosmetics Act of 1938 and the rules and regulations promulgated thereunder as they may apply to the manufacture of the Min IP Min shall be permitted, at Min’s option, to exchange 33,333 of the Assignor Preferred Shares into that number of Exchange Common Shares having a value of Three Hundred Thirty Three Thousand United States Dollars ($333,000) such shares being valued at a price per share equal to the closing price as of the day written notice is given by Min to Regen of Min’s intent to exchange.

(iv) Subject to (i) above, upon any date subsequent to the date that, in connection with a lawfully administered Phase I clinical trial of the Min IP being conducted by Regen within the United States on human subjects, both of (1) a clinical trial protocol has been completed and (2) a Principal Investigator has been appointed, Min shall be permitted, at Min’s option, to exchange 33,333 of the Assignor Preferred Shares into that number of Exchange Common Shares having a value of Three Hundred Thirty Three Thousand United States Dollars ($333,000) such shares being valued at a price per share equal to the closing price as of the day written notice is given by Min to Regen of Min’s intent to exchange.

 

(c) Subject to sufficient number of common shares having been authorized for issuance by the Company, Min shall receive, upon successful completion of a lawfully administered Phase I clinical trial of the Min IP being conducted by Regen within the United States on human subjects, the results of which (1) shall indicate that the Min IP can be safely tolerated by human subjects (2) shall not indicate that use of the Min IP in human subjects result in side effects of such severity that commencement of a Phase II clinical trial could not occur, and (3) establishes the optimal dosage and/or method of administration( as applicable )of the Min IP , Min shall receive that number of the common shares of BMSN which, at a price per share equal to the closing price of the shares as of the day of issuance, shall equal One Million United States Dollars ($1,000,000)

 

Pursuant to the Agreement, Min shall be entitled to additional consideration for productivity and deliverables over and above listed items (“”Bonus””). The eligibility of Min to receive a Bonus as well as the nature and amount of any Bonus shall be at the sole discretion and determination of the Chief Executive Officer of the Company.

3

 

 

On August 5, 2013 Regen was granted by Benitec Australia Limited (“Benitec”) an exclusive worldwide right and license to certain patents, patent applications, know-how and other intellectual property relating to RNA interference, a biological mechanism by which double-stranded RNA modifies gene expression (“RNAi”) possessed by Benitec.

 

Pursuant to the agreement between the parties for the grant of the license (“Agreement”) , Regen is obligated to make the following payments to Benitec as consideration for the grant of the license:

 

(1)   a one-time, non-refundable, upfront payment of twenty five thousand US dollars ($25,000) as a license initiation fee on the execution date of the Agreement

 

(2)   a one-time non-refundable payment of twenty five thousand US dollars ($25,000) on the first anniversary of the execution date of the Agreement.

 

(3)   The following milestone payments per each Licensed Product that meets such milestone :

 

Milestone

Amount

 

Start Phase I/II clinical trial – dosing first patient

$100,000 US Dollars

 

Start Phase III clinical trial

$500,000 US Dollars

 

Regulatory Approval for a Licensed Product by first regulatory agency

$1,000,000 US Dollars

 

Regulatory Approval for a Licensed Product by second regulatory agency

$2,000,000.00 US Dollars

 

 

 

As defined by the Agreement, “Licensed Product” shall mean any product sold by or on behalf of Regen, its Affiliates or its sublicensees pursuant to the license granted by the Agreement.

 

 

As further consideration to Benitec, Regen is required to pay:

 

(i)   Royalties equal to the greater of (a) a minimum annual payment of $25,000 per year or (b) four percent (4%) of the Net Sales as defined in the Agreement of any Licensed Products sold pursuant to the license sold within a given year.

 

(ii)   fifty percent (50%) of all consideration (in the case of in-kind consideration, at fair market value as monetary consideration) received by Regen  from sublicensees, excluding royalties from sublicensees based on Net Sales of any Licensed Products for which Benitec receives payment.


 

The term of this Agreement commenced on the date of execution (“Effective Date “) continues in full force and effect on a Licensed Product-by-Licensed Product and country-by-country basis until the expiration or termination of the Benitec’s Patent Rights covering such Licensed Product.

 

 

The Company has begun development of HemaXellerate, a cellular drug designed to heal damaged bone marrow. HemaXellerate I is a patient-specific composition of cells that have been demonstrated to repair damaged bone marrow and stimulate production of blood cells based on previous animal studies. The initial application of HemaXellerate will be the treatment of severe aplastic anemia (AA) which is characterized by immune-mediated bone marrow hypoplasia and pancytopenia. The HemaXellerate treatment consists of the use of autologous stromal vascular fraction(SVF) cells extracted from the patient’s own adipose tissue as a treatment for immune suppressant refractory aplastic anemia. SVF preparations contain significant numbers of cellular populations with therapeutic activity that would be relevant to aplastic anemia; namely, a) mesenchymal stem cells (MSC), which suppress pathological immune responses and accelerate hematopoiesis; b) endothelial cells, which assist in repairing damaged bone marrow hematopoietic microenvironment and stimulate hematopoiesis; and c) T regulatory cells, which possess anti-inflammatory properties.

 

On February 5, 2013 Regen filed an Investigational New Drug (IND) application with the United States Food and Drug Administration to initiate clinical trials assessing the company’s HemaXellerate drug currently in development in patients with drug-refractory aplastic anemia.

 

We generated net losses of $404,363 during the period from April 24, 2012(inception) through June 30, 2013. This condition raises substantial doubt about our ability to continue as a going concern. Our continuation as a going concern is dependent on our ability to meet our obligations, to obtain additional financing as may be required and ultimately to attain profitability. Our auditor's report dated September 19, 2013 expressed substantial doubt about our ability to continue as a going concern.

 

 

4

 

   
    At June 30, 2013    
Selected Balance Sheet Information:   unaudited    
         
Cash   $ 3,653    
Current assets     3,653    
Total assets   $ 3,653    
           
Current liabilities   $ 0    
Total liabilities     0    
Total stockholders' equity (deficit)   $ 3,653    

 

As of June 30, 2013  we had $3,653  cash on hand and current liabilities of $0.

 

We feel we will not be able to satisfy its cash requirements over the next twelve months and shall be required to seek additional financing.

 

We currently plan to raise additional funds primarily by offering securities for cash and applying for grants .

 

From the period beginning July 1, 2013 and ending September 23, 2013 the Company’s activities have been primarily focused upon

 

(a) the development of protocols for pre-clinical research required to be undertaken with regard to the HemaXellerate I product in development in response to the US Food and Drug Administration’s comments on the Company’s submitted IND

 

(b) the development of preclinical research to be undertaken with regard to the development of dCell Vax , a product under development by the Company derived from intellectual property licensed from Benitec. DCell Vax is intended to be a therapy whereby dendritic cells of the cancer patient are harvested from the body , treated with plasmid DNA that has the ability to block the dendritic cell from expressing indoleamine 2,3-dioxygenase (“IDO”) and subsequently reimplanted in the cancer patient.

 

During the six months ending March 31, 2014 the Company anticipates completion of all actions required to be undertaken with regards to addressing comments made by the US Food and Drug Administration with regards to the IND filed by the Company for HemaXellerate I with commencement of the Phase I clinical trial for HemaXellerate I anticipated to begin July 2014. The Company intends, upon satisfaction of all comments, to seek Orphan Drug Designation under the Orphan Drug Act of 1983 from the US Food and Drug Administration for HemaXellerate I. During the six months ended March 31, 2014 the Company also anticipates completion of preclinical testing with regards to dCell Vax as well as submission of an IND to the FDA with regards to dCell Vax.

 

The Company has historically met its cash needs primarily through capital contributions made by BMSN and anticipates continuing to do so for the period beginning July 1, 2013 and ending March 31, 2014. The Company also plans to meet cash needs through applying for governmental and non governmental grants as well as selling its securities for cash. Management has yet to decide what type of offering the Company will use or how much capital the Company will raise. There is no guarantee that the Company will be able to raise any capital through any type of offerings. Management can give no assurance that any governmental or non governmental grant will be obtained by the Company despite the Company’s best efforts.

 

The Company anticipates hiring a Chief Financial Officer and a Project Coordinator as well as retaing the services of Contract Research Organizations (CROs) during the period beginning July 1, 2013 and ending March 31 , 2014. The utilization of CROs is intended to provide significant savings with regard to equipment expenditures and long term fixed research / development overhead. As such, the Company does not currently anticipate material acquisition of plant and equipment to be undertaken over the period beginning July 1, 2013 and ending March 31 , 2014

 

The foregoing statements that are not historical facts, including statements about Regen’s plans, beliefs or expectations, are forward-looking statements. These statements are based on plans, estimates and projections at the time Regen made the original statement, and you should not place undue reliance on them as these plans, estimates and projections may be subject to change .. Forward-looking statements involve inherent risks and uncertainties and Regan cautions you that a number of important factors could cause actual results to differ materially from those contained in any such forward-looking statement.

 

 

5

 

ABOUT THIS OFFERING

 

Shares Issued   BMSN will issue to all BMSN common and preferred  shareholders of record on the Record Date a pro rata distribution of  20,000,000 common shares of Regen Biopharma, Inc. owned by BMSN.
     
Distribution Date  

____ days after the Record Date.

 

 

 

Certain U.S. Federal Income Tax Consequences of the Spin-Off   The spin-off is taxable to the recipient, as with any dividend.
     
Secondary Market   There is currently no existing public market  for the common shares of the Company

 

 

Dividend Policy   The Company does not anticipate payment of dividends to shareholders in the foreseeable future.
     
Appraisal Rights   Holders of BMSN common and preferred shares have no dissenters’ rights of appraisal in connection with this distribution of the Company’s common shares.

 

Relationship between BMSN and the Company subsequent to the Distribution.   BMSN will own approximately 58% of the outstanding shares of the Company following the distribution. The sole officer and director of BMSN, David Koos,  will also be Chairman, CEO, President and  the sole executive officer of the Company following the distribution.

 

 

6

SUMMARY FINANCIAL AND OPERATING INFORMATION

 

The following selected financial information is derived from our  Financial Statements appearing elsewhere in this Prospectus and should be read in conjunction with our  Financial Statements, including the notes thereto, appearing elsewhere in this Prospectus.

 

             
       
    For the period from inception (April 24, 2012) to September 30, 2012      
Selected Statement of Operations Information:          
           
Revenues   $ 0      
Gross profit     0      
Total operating expenses     (167,190 )    
Operating income (loss)     (167,190)      
Net income (loss) to common shareholders   $ (167,190)      
             
Basis and diluted earnings (loss) per common share     $     (16.72)      
             
Weighted average common shares outstanding basic and diluted     10,000      
               

 

 

           
     
    As of September 30, 2012    
Selected Balance Sheet Information:        
         
Cash   $ 923    
Current assets     923    
Total assets   $ 923    
           
Current liabilities   $ 0    
Total liabilities     0    
Total stockholders' equity (deficit)   $ 923    

 

7

 

 

                 
       
       
   

 

For the nine months ended

June 30, 2013

   

For the period from inception (April 24, 2012) to

June 30, 2012

 
Selected Statement of Operations Information:   unaudited     unaudited  
             
Revenues   $ 0       0  
Gross profit     0       0  
Total operating expenses     (237,173)       (18,425)  
Operating income (loss)                
Net income (loss) to common shareholders   $ (237,173)       $             (18,425)  
                 
Basis and diluted earnings (loss) per common share   $ (0.0296)       $              (1.842)  
                 
Weighted average common shares outstanding basic and diluted     8,009,891       10,000  

 

 

   
    At June 30, 2013    
Selected Balance Sheet Information:   unaudited    
         
Cash   $ 3,653    
Current assets     3,653    
Total assets   $ 3,653    
           
Current liabilities   $ 0    
Total liabilities     0    
Total stockholders' equity (deficit)   $ 3,653    

 

RISK FACTORS

 

An investment in our common stock involves a high degree of risk.  You should carefully consider the risks described below as well as other information provided to you in this prospectus, including information in the section of this document entitled “Information Regarding Forward Looking Statements.”  If any of the following risks actually occur, our business, financial condition or results of operations could be materially adversely affected, the value of our common stock could decline, and you may lose all or part of your investment. The following discussion and analysis should be read in conjunction with the other financial information and consolidated financial statements and related notes appearing in this prospectus.

 

8

 

Risks Related to our Business:

 

 

WE HAVE A LIMITED OPERATING HISTORY UPON WHICH AN EVALUATION OF OUR PROSPECTS CAN BE MADE.

 

The Company was incorporated April 24, 2012 and has only been pursuing its current business plan since April 24, 2012. The Company has never generated positive cash flow from operations. Due to the early stage of our development, limited financial and other historical data is available for investors to evaluate whether we will be able to fulfill our business strategy and plans.  Further, financial and other limitations may force us to modify, alter, or significantly delay the implementation of such plans.   We may incur substantial losses in the future, making it extremely difficult to implement our business plans and strategies and sustain our then current level of operations.  Furthermore, no assurances can be given that our strategy will result in an improvement in operating results or that our operations will become profitable.

 

THERE IS SUBSTANTIAL DOUBT ABOUT THE COMPANY’S ABILITY TO CONTINUE AS A GOING CONCERN.

 

Our auditor’s report dated September 19, 2013 expresses an opinion that substantial doubt exists as to whether we can continue as an ongoing concern.  Because obtaining investment capital in not certain, we may not have the funds necessary to continue our operations.   Our ability to meet our operating needs depends in large part on our ability to secure third party financing.  We cannot provide any assurances that we will be able to obtain financing.  

 

 

WE ARE IN THE EARLY STAGES OF DEVELOPING HEMAXELLERATE, THE EFFECTIVENESS OF WHICH IS UNPROVEN. OTHER PRODUCTS IN VARIOUS EARLY STAGES OF DEVELOPMENT ARE ALSO UNPROVEN.

 

The Company is currently in the early stage of developing Hemaxellerate, a cellular drug designed to heal damaged bone marrows. Hemaxellerate is unproven and no assurance can be given that Hemaxellerate will prove effective for its intended purpose.

 

WE WILL NEED TO RAISE ADDITIONAL CAPITAL TO CARRY OUT OUR BUSINESS PLAN.

 

To date, the Company’s operations have not generated cash flow sufficient to fund our capital requirements and there can be no assurance given that the Company’s operations will do so in the future. There is no guarantee that we will be able to access additional capital at rates and on terms which are attractive to us, if at all.  Without the additional funding needed to fund our growth we may not be able to grow as planned.

9

 

 

 

WE RELY ON HIGHLY SKILLED PERSONNEL AND, IF WE ARE UNABLE TO RETAIN OR MOTIVATE KEY PERSONNEL, HIRE QUALIFIED PERSONNEL, WE MAY NOT BE ABLE TO GROW EFFECTIVELY.

 

Our performance largely depends on the talents and efforts of highly skilled individuals.  Our future success depends on our continuing ability to identify, hire, develop, motivate and retain highly skilled personnel for all areas of our organization, particularly sales and marketing.  Competition in our industry for qualified employees is intense.  In addition, our compensation arrangements may not always be successful in attracting new employees and retaining and motivating our existing employees.  Our continued ability to compete effectively depends on our ability to attract new employees and to retain and motivate our existing employees.

 

DEPENDENCE ON DAVID R. KOOS, WITHOUT WHOSE SERVICES COMPANY BUSINESS OPERATIONS COULD CEASE.

 

At this time, the sole officer and director of the Company is David R. Koos, who is wholly responsible for the development and execution of our business. If Mr. Koos should choose to leave us for any reason before we have hired additional personnel our operations may fail. Even if we are able to find additional personnel, it is uncertain whether we could find qualified management who could develop our business along the lines described herein or would be willing to work for compensation the Company could afford. Without such management, the Company could be forced to cease operations and investors in our common stock or other securities could lose their entire investment.

 

THE COMPANY DOES NOT MAINTAIN CERTAIN INSURANCE, INCLUDING ERRORS AND OMISSIONS INSURANCE.

 

The Company has limited capital and, therefore, does not currently have a policy of insurance against liabilities arising out of the negligence of its officers and directors and/or deficiencies in any of its business operations.  Even assuming that the Company obtained insurance, there is no assurance that such insurance coverage would be adequate to satisfy any potential claims made against the Company, its officers and directors, or its business operations or products.  Any such liability which might arise could be substantial and may exceed the assets of the Company.  

 

IN THE FUTURE WE MAY BE SUBJECT TO INTELLECTUAL PROPERTY RIGHTS CLAIMS, WHICH ARE COSTLY TO DEFEND, COULD REQUIRE US TO PAY DAMAGES AND COULD LIMIT OUR ABILITY TO SELL SOME OF OUR PRODUCTS.

 

Although we have not been subject to any intellectual property litigation or infringement claims, we may be in the future, which could cause us to incur significant expenses to defend such claims, divert management’s attention or prevent us from manufacturing, selling or using some aspect of our products.  If we chose or are forced to settle such claims, we may be required to pay for a license to certain rights, paying royalties on both a retrospective and prospective basis, and/or cease our manufacturing and sale of certain products that are alleged to be infringing.  Future infringement claims against us by third parties may adversely impact our business, financial condition and results of operations.

 

WE ARE SUBJECT TO NUMEROUS LAWS AND REGULATIONS, FAILURE TO COMPLY WITH THOSE LAWS AND REGULATIONS MAY ADVERSELY IMPACT OUR BUSINESS.

 

Products we are currently developing and which may be developed by us would be highly regulated. We currently have no products approved for sale and we cannot guarantee that we will ever have marketable products. The development of a product candidate and issues relating to its approval and marketing are subject to extensive regulation by the Food and Drug Administration (FDA) in the United States and regulatory authorities in other countries, with regulations differing from country to country. We are not permitted to market our product candidates in the United States until we receive approval of a New Drug Application (NDA) or a Biologic License Application (BLA), as applicable, from the FDA..

10

In the United States, NDAs and BLAs must include extensive preclinical and clinical data and supporting information to establish the product candidate’s safety and effectiveness for each desired indication. NDAs and BLAs must also include significant information regarding the chemistry, manufacturing and controls for the product. Obtaining approval of a NDA or BLA is a lengthy, expensive and uncertain process, and we may not be successful in obtaining approval. Regulators of other jurisdictions, such as the European Medicines Agency (EMA) , a European Union agency for the evaluation of medicinal products, have their own procedures for approval of product candidates. Even in the event that a product is approved, the FDA or the EMA, as the case may be, may limit the indications for which the product may be marketed, require extensive warnings on the product labeling or require expensive and time-consuming clinical trials or reporting as conditions of approval. Regulatory authorities in countries outside of the United States and Europe also have requirements for approval of drug candidates with which we must comply prior to marketing in those countries. Obtaining regulatory approval for marketing of a product candidate in one country does not ensure that we will be able to obtain regulatory approval in any other country.

 

 

NO APPROVAL HAS BEEN GRANTED BY THE FDA FOR THE MARKETING AND SALE OF HEMAXELLERATE

On February 5, 2013 Regen filed an Investigational New Drug (IND) application with the United States Food and Drug Administration to initiate clinical trials assessing the Company’s HemaXellerate drug currently in development in patients with drug-refractory aplastic anemia. Regen will be required to obtain approval from the US Food and Drug Administration (FDA) in order to market HemaXellerate. No approval has been granted by the FDA for the marketing and sale of HemaXellerate.

 

NO ASSURANCE THAT ANY PRODUCT IN DEVELOPMENT OR WHICH MAY BE PUT INTO DEVELOPMENT WILL SUCCESFULLY COMPLETE ANY CLINICAL TRIALS.

Clinical trials involving new drugs and biologics are commonly classified into three phases. Each phase of the drug approval process is treated as a separate clinical trial and the drug-development process usually advances through all four phases over many years. Each phase exposes greater number of subjects to the drug and each phase builds on existing safety and efficacy information. Phase 1 trials are designed to assess the safety and tolerability of a drug or biologic. Phase II trials are designed to assess how well the drug or biologic works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. Phase III trials are aimed at being the definitive assessment of how effective the drug or biologic is, in comparison with current treatment and to provide an adequate basis for physician labeling. If the drug or biologic successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population.

The Company’s plan is to engage primarily in the development of regenerative medical applications which we intend to license from other entities up to the point of successful completion of Phase I and or Phase II clinical trials after which we would either attempt to sell or license those developed applications or, alternatively, advance the application further to Phase III clinical trials.

We have yet to complete a successful clinical trial of any product under development and no assurance can be made that any product under development will successfully complete a clinical trial.

THE COMPANY CAN PROVIDE NO ASSURANCE THAT IT WILL BE ABLE TO SELL OR LICENSE ANY PRODUCT UNDER DEVELOPMENT OR WHICH WE MAY DEVELOPIN THE FUTURE.

The Company’s current plans include the development of regenerative medical applications up to the point of successful completion of Phase I and/ or Phase II clinical trials after which we would either attempt to sell or license those developed applications or, alternatively, advance the application further to Phase III clinical trials. We can provide no assurance that the Company will be able to sell or license any product or that, if such product is sold or licensed, such sale or license will be on terms favorable to the Company.

WE HAVE NOT OBTAINED PATENT PROTECTION FOR OUR INTELLECTUAL PROPERTY.

 

With the exception of all proprietary rights to US Patent # 8,389,708 (Method of Cancer Treatment using siRNA Silencing ) assigned to the Company on May 1, 2013, the Company has not obtained patent protection on any of its intellectual property.  Although the Company plans on attempting to obtain patents on its products and services, there can be no assurance that the Company can obtain effective protection against unauthorized duplication or the introduction of substantially similar products.

11

 

 

LIABILITY OF DIRECTORS FOR BREACH OF DUTY OF CARE IS LIMITED. OUR BYLAWS INDEMNIFY MEMBERS OF OUR BOARD OF DIRECTORS, OUR OFFICERS, EMPLOYEES, AND AGENTS AND PERSONS WHO FORMERLY HELD SUCH POSITIONS, AND THE LEGAL REPRESENTATIVES OF ANY OF THEM, TO THE FULLEST EXTENT LEGALLY PERMISSIBLE UNDER THE GENERAL CORPORATION LAW OF THE STATE OF NEVADA AGAINST ANY OR ALL EXPENSE, LIABILITY AND LOSS REASONABLY INCURRED IN DEFENDING A CIVIL OR CRIMINAL ACTION, SUIT OR PROCEEDING TO WHICH ANY SUCH PERSON SHALL HAVE BECOME SUBJECT BY REASON OF HIS HAVING HELD SUCH A POSITION OR HAVING ALLEGEDLY TAKEN OR OMITTED TO TAKE ANY ACTION IN CONNECTION WITH SUCH POSITION.

 

According to Nevada law (NRS 78.138(7)), all Nevada corporations limit the liability of directors and officers, including acts not in good faith. Our stockholders’ ability to recover damages for fiduciary breaches may be reduced by this statute. In addition our Bylaws indemnify members of the board of directors, our officers, employees, and agents and persons who formerly held such positions, and the legal representatives of any of them, to the fullest extent legally permissible under the general corporation law of the state of Nevada against any or all expense, liability and loss reasonably incurred in defending a civil or criminal action, suit or proceeding to which any such person shall have become subject by reason of his having held such a position or having allegedly taken or omitted to take any action in connection with such position.

 

Risks Related to an Investment in Our Common Stock

 

WE DO NOT PLANT TO PAY CASH DIVIDENDS IN THE FORESEEABLE FUTURE.

 

We currently intend to retain all future earnings for use in the operation and expansion of our business. We do not intend to pay any cash dividends in the foreseeable future. Unless we pay dividends, our stockholders will not be able to receive a return on their shares unless they sell them.  There is no assurance that stockholders will be able to sell shares when desired.

 

NO PUBLIC MARKET CURRENTLY EXISTS FOR SHARES OF OUR COMMON STOCK, NOR MAY A PUBLIC MARKET EVER EXIST AND OUR SHARES ARE ILLIQUID.

 

There is currently no public market for our securities and you may not be able to liquidate your investment since there is no assurance that a public market will develop for our common stock or that our common stock will ever be approved for trading on a recognized exchange. Our shares are not and have not been listed or quoted on any exchange or quotation system.

 

“PENNY STOCK” RULES MAY MAKE BUYING OR SELLING OUR COMMON STOCK DIFFICULT.

 

Trading in our securities, should a public market develop, will most likely be subject to the “penny stock” rules. The SEC has adopted regulations that generally define a penny stock to be any equity security that has a market price of less than $5.00 per share, subject to certain exceptions. These rules require that any broker-dealer who recommends our securities to persons other than prior customers and accredited investors, must, prior to the sale, make a special written suitability determination for the purchaser and receive the purchaser’s written agreement to execute the transaction. Unless an exception is available, the regulations require the delivery, prior to any transaction involving a penny stock, of a disclosure schedule explaining the penny stock market and the risks associated with trading in the penny stock market. In addition, broker-dealers must disclose commissions payable to both the broker-dealer and the registered representative and current quotations for the securities they offer. The additional burdens imposed upon broker- dealers by such requirements may discourage broker-dealers from effecting transactions in our securities, which could severely limit the market price and liquidity of our securities. Broker-dealers who sell penny stocks to certain types of investors are required to comply with the Commission’s regulations concerning the transfer of penny stocks. These regulations require broker- dealers to:

 

  ¨ Make a suitability determination prior to selling a penny stock to the purchaser;

 

  ¨ Receive the purchaser’s written consent to the transaction; and

 

  ¨ Provide certain written disclosures to the purchaser.

12

 

These requirements may restrict the ability of broker-dealers to sell our common stock and may affect your ability to resell our common stock.

 

CONCENTRATED CONTROL RISKS; SHAREHOLDERS COULD BE UNABLE TO CONTROL OR INFLUENCE KEY CORPORATE ACTIONS OR EFFECT CHANGES IN THE COMPANY’S BOARD OF DIRECTORS OR MANAGEMENT

 

Our sole officer and Chairman of our Board of Directors, David R. Koos, has voting power over 50,010,000,shares of our common stock, representing approximately 97% of the voting control of the Company as of September 22, 2013 . Mr. Koos is also, as of September 22, 2013 the sole executive officer of the Company. Subsequent to the distribution, Mr. Koos is anticipated to have voting power over 30,010,000,shares of our common stock, representing approximately 58% of the voting control. Mr. Koos therefore has the power to make many major decisions regarding our affairs, including decisions regarding whether or not to issue stock and for what consideration. In addition, due to Mr. Koos voting power,  investors in this offering will have limited control over matters requiring approval by our security holders, including the election of directors, whether or not to sell all or substantially all of our assets and for what consideration and whether or not to authorize more stock for issuance or otherwise amend our charter or bylaws.

 

 

FORWARD LOOKING STATEMENTS

 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS AND OTHER INFORMATION CONTAINED IN THIS PROSPECTUS

 

This prospectus contains forward-looking statements. Forward-looking statements give our current expectations or forecasts of future events. You can identify these statements by the fact that they do not relate strictly to historical or current facts. Forward-looking statements involve risks and uncertainties. Forward-looking statements include statements regarding, among other things, (a) our projected sales, profitability, and cash flows, (b) our growth strategies, (c) anticipated trends in our industries, (d) our future financing plans and (e) our anticipated needs for working capital. They are generally identifiable by use of the words “may,” “will,” “should,” “anticipate,” “estimate,” “plans,” “potential,” “projects,” “continuing,” “ongoing,” “expects,” “management believes,” “we believe,” “we intend” or the negative of these words or other variations on these words or comparable terminology. These statements may be found under “Management's Discussion and Analysis of Financial Condition and Results of Operations” and “Business,” as well as in this prospectus generally. In particular, these include statements relating to future actions, prospective products or product approvals, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results.

 

Any or all of our forward-looking statements in this report may turn out to be inaccurate. They can be affected by inaccurate assumptions we might make or by known or unknown risks or uncertainties. Consequently, no forward-looking statement can be guaranteed. Actual future results may vary materially as a result of various factors, including, without limitation, the risks outlined under “Risk Factors” and matters described in this prospectus generally. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements contained in this filing will in fact occur. You should not place undue reliance on these forward-looking statements.

 

The forward-looking statements speak only as of the date on which they are made, and, except to the extent required by federal securities laws, we undertake no obligation to publicly update any forward-looking statements, whether as the result of new information, future events, or otherwise.

 

 

15

USE OF PROCEEDS

 

We will not receive any proceeds from the distribution of our common stock

 

DETERMINATION OF OFFERING PRICE

 

No consideration will be paid for the shares of common stock distributed in the spin-off..  The proposed offering price of the common shares to which this registration statement pertains  is $0.__-  and has been estimated solely for the purpose of computing the amount of the registration fee in accordance with Rule 457(f) of the Securities Act of 1933, on the basis of the book value of such securities computed as of the latest practicable date prior to the date of filing the registration statement

 

DILUTION

 

We have determined that there is no substantial disparity between the public offering price and the effective cash cost to officers, directors, promoters and affiliated persons of common equity in the Company acquired by them in transactions during the past five years, or which they have the right to acquire.

 

DISTRIBUTING SECURITY HOLDER

 

We are furnishing this prospectus to the common and preferred shareholders of Bio Matrix Scientific Group, Inc. a Delaware corporation. This prospectus relates to the distribution on a pro rata basis as a dividend in kind of 20,000,000 of our common shares, par value $0.0001, currently owned by Bio Matrix Scientific Group, Inc (“BMSN”) to:

 

:

(a)Holders of record of the outstanding common shares of BMSN as of the record date
(b)Holders of record of the shares of any outstanding series of the preferred shares of BMSN as of the record date.

Shareholders of BMSN will receive a proportionate allocation of the shares to be distributed in relation to the total number of common and or/preferred shares to which they are shareholders of record as of the record date. The record date is anticipated to be the date that the registration statement on Form S-1 of which this prospectus forms a part is declared effective by the United States Securities and Exchange Commission (“Record Date”). The distribution of the 20,000,000 common shares of Regen Biopharma,Inc. to the common and preferred shareholders of BMSN will occur ___ days after the Record Date (“Distribution Date”)

 

                                 
Name  

Shares

Beneficially

Owned

Prior to

The Distribution

   

Shares to be

Distributed

   

Amount

Beneficially

Owned Before

Distribution

   

Percent

Beneficially

Owned After

Distribution

 
                         
Bio Matrix Scientific Group, Inc.     50,010,000       20,000,000       97%       58%  

 

 

David R. Koos is the sole executive officer and director of BMSN and the sole executive officer and director of the Company.

 

 

14

PLAN OF DISTRIBUTION

 

The distribution will be effected through a pro rata property dividend to common and preferred shareholders of BMSN. The number of shares each BMSN common or preferred shareholder will be entitled to receive in the distribution will depend on how many common and preferred shares are issued and outstanding as of the Record Date which has yet to be determined. Assuming BMSN issues no additional common or preferred shares after September 22, 2013, which cannot be assured, each BMSN common and preferred shareholder of record as of the Record Date will receive one common share of Regen for each 113 common and/or preferred shares of BMSN held of record as of that date. No fractional shares will be distributed. The Distribution Date will be ---- days after the Record Date.

 

BMSN will pay all expenses incident to the registration and distribution of the shares of our common stock to which this prospectus pertains other than:


DESCRIPTION OF SECURITIES TO BE REGISTERED

 

The stockholders' equity section of the Company contains the following classes of capital stock as September 22, 2013:

 

Common stock, $ 0.0001 par value;5,000,000 ,000 shares authorized: 50,010,000 shares issued and outstanding.

With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Common Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Common Stock owned by such holder times one (1).

On any voluntary or involuntary liquidation, dissolution or winding up of the Corporation, the holders of the Common Stock shall receive, out of assets legally available for distribution to the Company's stockholders, a ratable share in the assets of the Corporation.

Preferred Stock, ,$0.0001 par value, 5,000,000 shares authorized: 0 shares issued and outstanding

The abovementioned shares authorized pursuant to the Company’s certificate of incorporation may be issued from time to time without prior approval of the shareholders. The Board of Directors of the Company shall have the full authority permitted by law to establish one or more series and the number of shares constituting each such series and to fix by resolution full or limited, multiple or fractional, or no voting rights, and such designations, preferences, qualifications, restrictions, options, conversion rights and other special or relative rights of any series of the Stock that may be desired.

 

 

This prospectus relates to the distribution on a pro rata basis as a dividend in kind of 20,000,000 of our common shares, par value $0.0001, currently owned by BMSN to:

 

:

(a)Holders of record of the outstanding common shares of BMSN as of the record date
(b)Holders of record of the shares of any outstanding series of the preferred shares of BMSN as of the record date.

Shareholders of BMSN will receive a proportionate allocation of the shares to be distributed in relation to the total number of common and or/preferred shares to which they are shareholders of record as of the record date. The record date is anticipated to be the date that the registration statement on Form S-1 of which this prospectus forms a part is declared effective by the United States Securities and Exchange Commission (“Record Date”). The distribution of the 20,000,000 common shares of Regen Biopharma,Inc. to the common and preferred shareholders of BMSN will occur ___ days after the Record Date (“Distribution Date”).

All shares being registered under this prospectus are common shares. The transfer agent for our common shares is:

Securities Transfer Corporation

2591 Dallas Parkway Suite 102

Frisco, Texas 75034

Phone - 469-633-0101

FAX 469-633-0088

 

15

 

INTERESTS OF NAMED EXPERTS AND COUNSEL

 

No expert or counsel named in this prospectus as having prepared or certified any part of this prospectus or having given an opinion upon the validity of the securities being registered or upon other legal matters in connection with the registration or offering of the common stock was employed on a contingency basis, or had, or is to receive, in connection with the offering, a substantial interest, direct or indirect, in the registrant or any of its parents or subsidiaries. Nor was any such person connected with the registrant or any of its parents or subsidiaries as a promoter, managing or principal underwriter, voting trustee, director, officer, or employee.

 

The audited financial statements of the Company included in this prospectus and in the registration statement have been audited by Seale and Beers, CPAs.

 

Joseph L.. Pittera, our independent legal counsel, has provided an opinion on the validity of our common stock.

 

 

BUSINESS

 

We were incorporated April 24, 2012 under the laws of the State of Nevada. We are a wholly owned subsidiary of Bio Matrix Scientific Group, Inc, a Delaware corporation.

 

We intend to engage primarily in the development of regenerative medical applications which we intend to license from other entities up to the point of successful completion of Phase I and or Phase II clinical trials after which we would either attempt to sell or license those developed applications or, alternatively, advance the application further to Phase III clinical trials.

 

On May 1, 2013 Dr. Wei Ping Min (“Min”) entered into an agreement (“Agreement”) whereby Min assigned to Regen all right, title and interest in US Patent # 8,389,708 as well as all Patent applications from the same family corresponding to numbers PCT/CA2006/000984, CA2612200 and EP1898936.(“Min IP”) US Patent # 8,389,708 was granted to Min with regard to his invention of a method directed to the silencing of immunosuppressive cancer causing genes using short interfering RNA (siRNA) leading to an increase in the immune response, a decrease in tumor-induced immunosuppression and a decrease in in vivo tumor progression.

16

 

 

As consideration for the Min IP, Regen is required to:

 

(a) negotiate in good faith with Min with regards to a proposed consulting agreement whereby Min shall perform certain mutually agreed upon tasks for the benefit of Regen for consideration to Min consisting of One Hundred Thousand United States Dollars ($100,000 ) of the common shares of Bio Matrix valued as of the date of issuance and to be paid over a twelve month period in twelve equal installments (“Consulting Shares”) and registered under the Securities Act of 1933 on Form S-8.

 

(b) Cause to be issued to Min 100,000 of Bio Matrix’s preferred shares (“Assignor Preferred Shares”) exchangeable into common shares of Bio Matrix (“Exchange Common Shares”) under the following terms and conditions:

(i) A sufficient number of common shares shall be authorized for issuance by Bio Matrix in order that the required number of Exchange Common Shares may be issued

(ii) Subject to (i) above, upon any date subsequent to the date of the completion of a satisfactory review by the United States Food and Drug Administration (“FDA”) of an Investigational New Drug Application (“IND”) for the Min IP submitted by Regen which shall result in the ability of Regen to lawfully begin clinical testing of the Min IP on human subjects within the United States Min shall be permitted, at his option, to exchange 33,333 of the Assignor Preferred Shares into that number of Exchange Common Shares having a value of Three Hundred Thirty Three Thousand United States Dollars ($333,000) such shares being valued at a price per share equal to the closing price as of the day written notice is given by Min to Regen of Min’s intent to exchange.

(iii) Subject to (i) above, upon any date subsequent to the date that manufacturing procedures for the manufacture of the Min IP have been developed by Regen which comply to the Current Good Manufacturing Practices (“cGMP “) requirements of the Food Drug and Cosmetics Act of 1938 and the rules and regulations promulgated thereunder as they may apply to the manufacture of the Min IP Min shall be permitted, at Min’s option, to exchange 33,333 of the Assignor Preferred Shares into that number of Exchange Common Shares having a value of Three Hundred Thirty Three Thousand United States Dollars ($333,000) such shares being valued at a price per share equal to the closing price as of the day written notice is given by Min to Regen of Min’s intent to exchange.

(iv) Subject to (i) above, upon any date subsequent to the date that, in connection with a lawfully administered Phase I clinical trial of the Min IP being conducted by Regen within the United States on human subjects, both of (1) a clinical trial protocol has been completed and (2) a Principal Investigator has been appointed, Min shall be permitted, at Min’s option, to exchange 33,333 of the Assignor Preferred Shares into that number of Exchange Common Shares having a value of Three Hundred Thirty Three Thousand United States Dollars ($333,000) such shares being valued at a price per share equal to the closing price as of the day written notice is given by Min to Regen of Min’s intent to exchange.

 

(c) Subject to sufficient number of common shares having been authorized for issuance by the Company, Min shall receive, upon successful completion of a lawfully administered Phase I clinical trial of the Min IP being conducted by Regen within the United States on human subjects, the results of which (1) shall indicate that the Min IP can be safely tolerated by human subjects (2) shall not indicate that use of the Min IP in human subjects result in side effects of such severity that commencement of a Phase II clinical trial could not occur, and (3) establishes the optimal dosage and/or method of administration( as applicable )of the Min IP , Min shall receive that number of the common shares of BMSN which, at a price per share equal to the closing price of the shares as of the day of issuance, shall equal One Million United States Dollars ($1,000,000)

 

Pursuant to the Agreement, Min shall be entitled to additional consideration for productivity and deliverables over and above listed items (“”Bonus””). The eligibility of Min to receive a Bonus as well as the nature and amount of any Bonus shall be at the sole discretion and determination of the Chief Executive Officer of the Company.

 

 

17

 

On August 5, 2013 Regen was granted by Benitec Australia Limited (“Benitec”) an exclusive worldwide right and license to certain patents, patent applications, know-how and other intellectual property relating to RNA interference, a biological mechanism by which double-stranded RNA modifies gene expression (“RNAi”) possessed by Benitec.

 

Pursuant to the agreement between the parties for the grant of the license (“Agreement”) , Regen is obligated to make the following payments to Benitec as consideration for the grant of the license:

 

(1)   a one-time, non-refundable, upfront payment of twenty five thousand US dollars ($25,000) as a license initiation fee on the execution date of the Agreement

 

(2)   a one-time non-refundable payment of twenty five thousand US dollars ($25,000) on the first anniversary of the execution date of the Agreement.

 

(3)   The following milestone payments per each Licensed Product that meets such milestone :

 

Milestone

Amount

 

Start Phase I/II clinical trial – dosing first patient

$100,000 US Dollars

 

Start Phase III clinical trial

$500,000 US Dollars

 

Regulatory Approval for a Licensed Product by first regulatory agency

$1,000,000 US Dollars

 

Regulatory Approval for a Licensed Product by second regulatory agency

$2,000,000.00 US Dollars

 

 

 

As defined by the Agreement, “Licensed Product” shall mean any product sold by or on behalf of Regen, its Affiliates or its sublicensees pursuant to the license granted by the Agreement.

 

 

As further consideration to Benitec, Regen is required to pay:

 

(i)   Royalties equal to the greater of (a) a minimum annual payment of $25,000 per year or (b) four percent (4%) of the Net Sales as defined in the Agreement of any Licensed Products sold pursuant to the license sold within a given year.

 

(ii)   fifty percent (50%) of all consideration (in the case of in-kind consideration, at fair market value as monetary consideration) received by Regen  from sublicensees, excluding royalties from sublicensees based on Net Sales of any Licensed Products for which Benitec receives payment.


The term of this Agreement commenced on the date of execution (“Effective Date “) continues in full force and effect on a Licensed Product-by-Licensed Product and country-by-country basis until the expiration or termination of the Benitec’s Patent Rights covering such Licensed Product.

 

The Company has begun development of HemaXellerate, a cellular drug designed to heal damaged bone marrow. HemaXellerate I(TM) is a patient-specific composition of cells that have been demonstrated to repair damaged bone marrow and stimulate production of blood cells based on previous animal studies. The initial application of HemaXellerate will be the treatment of severe aplastic anemia (AA) which is characterized by immune-mediated bone marrow hypoplasia and pancytopenia. The HemaXellerate treatment consists of the use of autologous stromal vascular fraction(SVF) cells extracted from the patient’s own adipose tissue as a treatment for immune suppressant refractory aplastic anemia. SVF preparations contain significant numbers of cellular populations with therapeutic activity that would be relevant to aplastic anemia; namely, a) mesenchymal stem cells (MSC), which suppress pathological immune responses and accelerate hematopoiesis; b) endothelial cells, which assist in repairing damaged bone marrow hematopoietic microenvironment and stimulate hematopoiesis; and c) T regulatory cells, which possess anti-inflammatory properties.

18

 

 

On February 5, 2013 Regen filed an Investigational New Drug (IND) application with the United States Food and Drug Administration to initiate clinical trials assessing the company’s HemaXellerate drug currently in development in patients with drug-refractory aplastic anemia.

 

 

Principal Products and Services

 

HemaXellarate I

 

The Company has begun development of HemaXellerate I I, a cellular therapy designed to heal damaged bone marrow. HemaXellerate I is a patient-specific composition of cells that have been demonstrated to repair damaged bone marrow and stimulate production of blood cells based on previous animal studies. The initial application of HemaXellerate I will be the treatment of severe aplastic anemia which is characterized by immune-mediated bone marrow hypoplasia and pancytopenia.

 

Adipose tissue is collected from the patient and processed in order to separate , extract and isolate Stromal Vascular Fraction (SVF), a mix of various cell types including mesenchymal stem cells and endothelial cells. The isolated SVF is then intravenously administered to the patient. The Company believes that the isolated SVF will generate growth factors with the ability to repair damaged hematopoietic stem cells. Hematopoietic stem cells are immature cells that can develop into all types of blood cells, including white blood cells, red blood cells, and platelets. Hematopoietic stem cells are found in the peripheral blood and the bone marrow.

 

 

On February 5, 2013 Regen filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (“FDA”) to initiate a Phase I clinical trial assessing HemaXellerate I I in patients with drug-refractory aplastic anemia. The Phase I clinical trial is intended to determine safety and potential efficacy of intravenously administered autologous SVF cells in patients with severe, immune suppressive refractory aplastic anemia with the primary endpoints of safety and feasibility and secondary endpoints of efficacy as determined by patients having complete response, partial response or relapse.

Complete response (CR) will be defined as a neutrophil count greater than 1.5 × 10(9)/L, a platelet count greater than 150 × 10(9)/L, and a hemoglobin level of greater than 110 g/L (11.0 g/dL). Partial response (PR) will be defined by transfusion independence and no longer meeting criteria for severe disease. Relapse is indicated by the requirement for blood transfusion. Toxicity of treatment will be evaluated for the duration of the study and will be graded according to the criteria of the World Health Organization.

It is estimated that the Company will require six to eight months for patient recruitment for the Phase I clinical trial and duration of the Phase I clinical trial is intended to be six months with ten human patients tested. The Phase I clinical trial cannot commence until comments directed to the Company by the FDA with regard to the IND have been addressed by the Company to the FDA’s satisfaction. The total cost to completion of the Phase I clinical trial is estimated by the Company shall be $500,000.

The Company estimates that the total costs for initiating and completing Phase I, Phase II and Phase III clinical trials with regard to the HemaXellerate I product shall be $6,000,000. The Company’s current intention is to initiate and complete Phase I and Phase II clinical trials with regard to HemaXellerate I and, upon successful completion of a Phase II clinical trial, seek to license the product out to one or more licensees.

19

 

Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a previously unapproved drug or biologic intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals annually in the United States. Generally, if a product with an orphan drug designation subsequently receives the first marketing approval for the indication for which it has such designation, the product is entitled to a seven year period of marketing exclusivity, which precludes the FDA from approving another marketing application for the same drug for that time period. The sponsor of the product would also be entitled to a United States federal tax credit equal to 50% of clinical investigation expenses as well as exemptions from certain fees and .

 

The Company believes that this application of HemaXellerate qualifies for Orphan designation under the Orphan Drug Act, and intends to apply to the FDA for Orphan designation for HemaXellerate.

 

HemaXellerate II

 

Also in early stage development by the Company is a version of HemaXellerate called HemaXellerate II.

 

HemaXellerate II is intended to be a universal donor endothelial cell based therapeutic and is intended to be manufactured by obtaining cells from a part of the placenta called the “vascular lobules”. The cells are processed and utilized for the purpose of stimulating bone marrow hematopoetic stem cell repair and proliferation. The mechanism of action for HemaXellerate II is similar to HemaXellerate I whereby the harvested and processed cells would produce growth factors which would mediate the therapeutic effects of the product.

 

The Company estimates that the amount of time required for the initiation and completion of Phase I and Phase II clinical trials for HemaXellerate II to be three years and total cost of Phase I/Phase II clinical trials for HemaXellerate II is estimated to be $4,600,000. Preclinical development is estimated to require five months at an estimated expense of $210,000. The Company has not begun preclinical development of HemaXellerate II as of September 23, 2013.

 

 

DCell  Vax

 

 

DCell Vax is intended to be a therapy whereby dendritic cells of the cancer patient are harvested from the body , treated with plasmid DNA that has the ability to block the dendritic cell from expressing indoleamine 2,3-dioxygenase (“IDO”) and subsequently reimplanted in the cancer patient.

 

The dendritic cells that are treated with the IDO-blocking plasmid become resistant to the influence of tumor cells which produce factors which cause the dendritic cell to express the IDO. Expression of IDO on the dendritic cell halts the dendritic cell from activating T cells and causes the dendritic cell to suppress T cells. T lymphocytes (‘T cells”) are a lymphocyte that play a central role in the human immune system’s attempt to eradicate tumors.

 

The Company is currently in the process of attempting to generate a human equivalent of a mouse plasmid that was successfully used to silence IDO in mice which the Company believes will silence IDO in human cells (“Human Plasmid”) . Upon successful generation of the Human Plasmid, the Company anticipates commencing discussions with the US Food and Drug Administration with regard to the filing of an IND for DCell Vax.

 

The Company estimates that Phase I/Phase II clinical trials for DC Vax would require approximately four years and expenses incurred in connection with Phase I/Phase II clinical trials for DC Vax would be approximately $5,500,000.

 

Preclinical experimentation to be performed in connection with the development of DCell Vax is estimated to cost approximately $100,000 and have a duration of approximately two months.

20

 

 

Distribution methods of the products or services:

 

It is anticipated that Regen will enter into licensing and/or sublicensing agreements with outside entities in order that Regen may obtain royalty income on the products and services which it may develop and commercialize.

 

 

Competitive business conditions and Regen's competitive position in the industry and methods of competition

 

 

We are recently formed and have yet to achieve revenues or profits.  The pharmaceutical and biologics industries in which we intend to compete are highly competitive and characterized by rapid technological advancement. Many of our competitors have greater resources than we do.

 

We intend to be competitive by utilizing the services and advice of individuals that we believe have expertise in their field in order that we can concentrate our resources on projects  in which products and services in which we have the greatest potential to secure a competitive advantage  may be developed and commercialized .

 

To that effect, we have established a Scientific Advisory Board of (the Advisory Board) comprised of individuals who we believe have a high level of expertise in their professional fields and who have agreed to provide counsel and assistance to us in (a) determining the viability of proposed projects (b) obtaining financing for projects and (c) obtaining the resources required to initiate and complete a project in the most cost effective and rapid manner.

 

Members of the Advisory Board include as follows:

 

Dr. Weiping Min, M.D., Phd

 

Dr.  Min is currently a Professor, Department of Surgery at the University of Western Ontario. Dr. Min obtained his MD from Jiangxi Medical University, China, in 1983 and his Ph.D.in Immunology from Kyushu University, Japan. Dr. Min has completed postdoctoral training at the Department of Medical Microbiology and Immunology, University of Alberta and the Department of Immunology, University of Toronto.

 

Dr. Min has served on the Advisory Board since May 20, 2012. As consideration for agreeing to serve as a member of the Scientific Advisory Board of Regen, BMSN has agreed to issue to Dr. Min 200,000 of the common shares of BMSN.

 

 

David James Graham White, M.D., Ph.D.

 

Dr. White currently serves as Novartis/Stiller Professor of Xenotransplantation at the University of Western Ontario ( to which he was appointed in 2000) and is a member of British Transplantation Society, the British Society of Immunologists, the Transplantation Society, the European Society of Organ Transplantation, the Royal College of Pathologists and the Athenaeum. Dr. White obtained a B.Sc. degree from the University of Surrey and M.D. and Ph.D. degrees from Cambridge University.

 

Dr. White has served on the Advisory Board since May 20, 2012. As consideration for agreeing to serve as a member of the Scientific Advisory Board of Regen, BMSN has agreed to issue to Dr. White 200,000 of the common shares of BMSN.

 

21

 

David A. Suhy, PhD

 

Dr. Suhy currently serves as Vice President of Research and Development at Tacere Therapeutics, a position he has held since October 2012. From April 2008 to October 2012 Dr. Suhy served as Director of Research and Development at Tacere Therapeutics. Dr. Suhy was one of the inventors of Tacere Therapeutics’ TT-033 and has directed development of the TT-03x series of compounds which target the Hepatitis C virus (HCV) through to Investigational New Drug enabling studies.

 

Dr. Suhy obtained a Bachelor’s Degree in biochemistry from the University of Pittsburgh in 1990 and a PhD in Biochemistry, Molecular Biology and Cell Biology from Northwestern University in 1996. Dr. Suhy conducted his post-doctoral work at Stanford University (Post Doctoral Fellow, Microbiology & Immunology) between 1996 and 1999.

 

Dr. Suhy has served on the Advisory Board since September 11, 2013. As consideration for agreeing to serve as a member of the Scientific Advisory Board of Regen, BMSN has agreed to issue to Dr. White 500,000 of the common shares of BMSN.

 

 

Sources and availability of raw materials and the names of principal suppliers

 

The supplies and materials required to conduct our operations are available through a wide variety of sources and may be obtained through a wide variety of sources.

 

 

Patents, trademarks, licenses, franchises, concessions, royalty agreements or labor contracts, including duration

 

Other than exclusive worldwide right and license to certain patents, patent applications, know-how and other intellectual property relating to RNA interference granted under the Company’s license agreement with Benitec Australia Limited (“Benitec Agreement”) , the Company has not been granted any license to develop and commercialize any third party intellectual property.

 

Other than all right, title and interest in US Patent # 8,389,708 granted pursuant to that agreement entered into between Regen and Dr. Wei Ping Min the Company has been granted no patents. 

 

 

The following is a list of patents to which a license has been granted to the Company pursuant to the Benitec Agreement:

 

22

 

 

 

Title Inventors Country Number
GENETIC CONSTRUCTS FOR DELAYING OR REPRESSING THE EXPRESSION OF A TARGET GENE (‘099”) Graham, Rice, Waterhouse US 6,573,099

SYNTHETIC GENES AND GENETIC CONSTRUCTS COMPRISING THE SAME

 (Graham Family)

 

Waterhouse, Graham, Wang,

Rice

US 8,067,383 (was 10/346,853)
    US 11/218,999
    US 7754697
    US 8048670 (was 10/759,841)
    US 8053419 (was 10/821,726)
    US 90/007,247

CONTROL OF GENE EXPRESSION WO99/49029

 

 

Graham, Rice, Waterhouse, Wang AU 743316
    AU 2005211538
    AU 2005209648
    AU 2008249157
    BR PI9908967.0
    BR PI9917642.4
    CA 2323726
    CN 200510083325.1
    CN 200910206175
    CZ  295108
    EP  1555317 (formerly patent application no. 04015041.9)
    EP 1624060 (formerly patent application no.05013010.3
    EP 07008204.5
    EP 10183258.2
    UK GB 2353282
    HK 1035742
    HG PO5000631
    HG PO101225
    IN 3901/DELNP/2005
    IN 2000/00169/DE
    JP 2000-537990
    JP 2005-223953
    JP 2007-302237
    JP 2009-161847
    KR

10-2010-7006892

Divisional of 7010419/00

    MX PA/a/2000/008631
    MX PA/a/2005/006838

    NZ 506648
    NZ 547283
    PL P-377017
    SG 75542
    SG 200205122.5
    SG 141233
    SL 287538
    ZA 2000/4507
    SG 141233

 

 

 

23

 

Patent Name Inventors Country Application/ Grant No
METHODS AND MEANS FOR OBTAINING MODIFIED PHENOTYPES Waterhouse, Wang, Graham AU 29514/99 (760041)
    AU 2007201023
    CA 2325344
    CN ZL99805925.0 (CN1202246-C)
    EP 99910592.7 (EP1068311)
    JP 2000-543598
    NZ 507093
    US 09/287632
    US 11/364183
    US 11/841737 US20080104732.

 

 

Title. Inventors Country Number
GENETIC SILENCING Graham, Rice, Murphy, Reed JP 2001-569332
BR PI0109269-3
UK GB2377221
SG 91678
ZA 2002/07428

DOUBLE-STRANDED NUCLEIC ACID

 

(LONG HAIR PIN)

Graham, Rice, Roelvink, Suhy, Kolkykhalov, Harrison, Reed. AU 2004243347
NZ 543815
EP 04735856.9
CA 2527907
JP 2006-508084
ZA 2005/09813
SG 200507474-5
IL 172191
US 12/914893 Continuation of 10/861191

RNAi EXPRESSION CONSTRUCTS (single promoter) 

 

Roelvink, Suhy, Kolykhalov, Couto US 7,803,611
US 11/883645
CN 200680010811.3
HK 08112495.7
EP 09015950.0
CA 2596711
AU 2006210443
IL 185315
NZ 560936

 

 

 

24

 

Other than obligations to make royalty payments pursuant to the Benitec Agreement, the Company is party to no royalty agreements. We have been granted a trademark for the term HEMAXELLERATE for biological tissue, namely, blood, stem cells, umbilical cords and placentas for scientific and medical research use

 

 

Need for any government approval of principal products or services, effect of existing or probable governmental regulations on the business

 

The US Food and Drug Administration (“FDA”) and foreign regulatory authorities will regulate our proposed products as drugs or biologics, , depending upon such factors as the use to which the product will be put, the chemical composition, and the interaction of the product on the human body. In the United States, products that are intended to be introduced into the body will generally be regulated as drugs, while tissues and cells intended for transplant into the human body will be generally be regulated as biologics .

 

Our domestic human drug and biological products will be subject to rigorous FDA review and approval procedures. After testing in animals, an Investigational New Drug Application (“IND”) must be filed with the FDA to obtain authorization for human testing. Extensive clinical testing, which is generally done in three phases, must then be undertaken at a hospital or medical center to demonstrate optimal use, safety, and efficacy of each product in humans. Each clinical study is conducted under the auspices of an independent Institutional Review Board (“IRB”). The IRB will consider, among other things, ethical factors, the safety of human subjects, and the possible liability of the institution. The time and expense required to perform this clinical testing can far exceed the time and expense of the research and development initially required to create the product. No action can be taken to market any therapeutic product in the United States until an appropriate New Drug Application (“NDA”) or Biologic License Application (“BLA”) or has been approved by the FDA. FDA regulations also restrict the export of therapeutic products for clinical use prior to NDA or BLA approval.

 

Even after initial FDA approval has been obtained, further studies may be required to provide additional data on safety or to gain approval for the use of a product as a treatment for clinical indications other than those initially targeted. In addition, use of these products during testing and after marketing could reveal side effects that could delay, impede, or prevent FDA marketing approval, resulting in FDA-ordered product recall, or in FDA-imposed limitations on permissible uses.

 

The FDA regulates the manufacturing process of pharmaceutical products, and human tissue and cell products, requiring that they be produced in compliance with Current Good Manufacturing Practices (“cGMP”) . The FDA also regulates the content of advertisements used to market pharmaceutical products. Generally, claims made in advertisements concerning the safety and efficacy of a product, or any advantages of a product over another product, must be supported by clinical data filed as part of an NDA or an amendment to an NDA, and statements regarding the use of a product must be consistent with the FDA approved labeling and dosage information for that product.

 

Sales of drugs and biologics outside the United States are subject to foreign regulatory requirements that vary widely from country to country. Even if FDA approval has been obtained, approval of a product by comparable regulatory authorities of foreign countries must be obtained prior to the commencement of marketing the product in those countries. The time required to obtain such approval may be longer or shorter than that required for FDA approval.

 

On February 5, 2013 Regen filed an Investigational New Drug (IND) application with the United States Food and Drug Administration to initiate clinical trials assessing the company’s HemaXellerate I drug currently in development in patients with drug-refractory aplastic anemia. Regen is currently in the process of responding to comments made to Regen by the FDA with regard to the IND including the compiling of sufficient preclinical data to allow an adequate assessment of the overall risk/benefit in the proposed population and support the safety and potential activity of the cell dose level proposed for clinical administration. The clinical trial for which the IND was submitted may not commence until all comments are addressed to the satisfaction of the FDA.

 

25

Amount spent during the last fiscal year and first nine months of the current fiscal year on research and development activities

 

During the fiscal year ended September 30, 2012 we expended $17,715 on research and development activities.

 

During the nine months ended June 30, 2013 we expended $8,394 on research and development activities.

 

Costs and effects of compliance with environmental laws (federal, state and local);

 

Regen has not incurred any unusual or significant costs to remain in compliance with any environmental laws and does not expect to incur any unusual or significant costs to remain in compliance with any environmental laws in the foreseeable future.

 

Number of total employees and number of full-time employees

 

As of September 24, 2013, Regen has 3 employees of which 3 are considered by Regen to be full time.

 

PROPERTIES

 

The Company  utilizes approximately 2,300 square feet of office space at 4700 Spring Street, Suite 304, La Mesa California, 91941provided to the Company by Entest BioMedical, Inc. on a month to month basis free of charge. The property is utilized as office space. We believe that the foregoing properties are adequate to meet our current needs for office space.

 

LEGAL PROCEEDINGS

 

 

There are no material pending legal proceedings to which the Company is a party or of which any of the Company’s property is the subject.

 

MARKET PRICE OF AND DIVIDENDS ON THE REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS

 

There has never been and there currently is no public market for our securities. We anticipate applying for trading of our common stock on the over the counter bulletin board (OTC BB) or the OTCQB Tier operated by OTC Markets Group , however, we can provide no assurance that our shares will be traded on the bulletin board or, if traded, that a public market will materialize.

 

The following classes of capital stock of the Company are authorized, issued and outstanding as October 4, 2013:

 

Common stock, $ 0.0001 par value;500,000 ,000 shares authorized: 51,610,000 shares issued and outstanding.

With respect to each matter submitted to a vote of stockholders of the Company, each holder of Common Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Common Stock owned by such holder times one (1).

On any voluntary or involuntary liquidation, dissolution or winding up of the Company, the holders of the Common Stock shall receive, out of assets legally available for distribution to the Company's stockholders, a ratable share in the assets of the Corporation.

Preferred Stock, ,$0.0001 par value, 5,000,000 shares authorized: 0 shares issued and outstanding

26

 

The abovementioned shares authorized pursuant to the Company’s certificate of incorporation may be issued from time to time without prior approval of the shareholders. The Board of Directors of the Company shall have the full authority permitted by law to establish one or more series and the number of shares constituting each such series and to fix by resolution full or limited, multiple or fractional, or no voting rights, and such designations, preferences, qualifications, restrictions, options, conversion rights and other special or relative rights of any series of the Stock that may be desired.

 

Holders

 

As of October 3, 2013 there were 3 holders of our Common Stock .

 

Dividends

 

No cash dividends were paid since our inception. We do not expect to declare cash dividends in the immediate future.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

27

 

FINANCIAL STATEMENTS

REGEN BIOPHARMA , INC.      
(A Development Stage Company)      
BALANCE SHEET      
       
   As of  As of
  

June 30,

2013

  September 30, 2012
   (unaudited)   
ASSETS      
CURRENT ASSETS          
Cash  $3,653   $923 
     Total Current Assets   3,653    923 
           
           
TOTAL ASSETS  $3,653   $923 
           
LIABILITIES AND STOCKHOLDERS' EQUITY          
Total Current Liabilities   0    0 
Total Liabilities   0    0 
           
STOCKHOLDERS' EQUITY (DEFICIT)          
           
Common Stock ($.0001 par value) 500,000,000 shares authorized;          
   10,000 shares issued and outstanding as of          
    September 30, 2012 ($0.001 par value) and 50,010,000 shares issued and outstanding June 30, 2013   5,001    10 
Additional Paid in capital   15,089    80 
Contributed Capital   387,926    168,023 
Retained Earnings (Deficit) accumulated during the development stage   (404,363)   (167,190)
Total Stockholders' Equity (Deficit)   3,653    923 
           
TOTAL LIABILITIES & STOCKHOLDERS' EQUITY (DEFICIT)  $3,653   $923 
           
The Accompanying Notes are an Integral Part of These Financial Statements  

28

       
REGEN BIOPHARMA , INC.            
(A Development Stage Company)            

STATEMENT OF OPERATIONS

            
(Unaudited)            
             
    Three Months Ended    From Inception(April 24, 2012) to    Nine Months Ended    From Inception to 
    30-Jun    30-Jun    30-Jun    6/30/2013 
    2013    2012    2013      
                     
REVENUES   0    0    0    0 
                     
COST AND EXPENSES                    
Research and Development   3,000.00         8,394    26,109 
General and Administrative   71,829.00    16,250    228,779    365,964 
Consulting and Professional Fees        2,175    0    12,290 
Total Costs and Expenses   74,829.00    18,425    237,173    404,363 
                     
OPERATING LOSS   (74,829.00)   (18,425)   (237,173)   (404,363)
                     
OTHER INCOME & (EXPENSES)   0    0    0    0 
NET INCOME (LOSS)   (74,829.00)   (18,425)   (237,173)   (404,363)
BASIC AND FULLY DILUTED                    
EARNINGS (LOSS) PER SHARE   (0.0031)   (1.8100)   (0.0296)     
WEIGHTED AVERAGE NUMBER OF                    
COMMON SHARES OUTSTANDING   24,185,714.00    10,000    8,009,891      
                     
The Accompanying Notes are an Integral Part of These Financial Statements       
                     

29

REGEN BIOPHARMA , INC.                     
(A Development Stage Company)                     
Statement of shareholder's equity                     

For the period from inception (April 24, 2012)

To June 30, 2013

 (Unaudited)
            
                      
               Additional      
    Preferred     Common    Paid-in    Retained    Contributed    
    Shares    Amount    Shares    Amount    Capital    Earnings    Capital   Total
Shares issued to Parent April 25, 2012             10,000    10    80             90
Contributed Capital April 24, 2012 to September 30, 2012                                 168,023   168,023
Net Loss                            (167,190)       (167,190)
Balance September 30, 2012             10,000    10    80    (167,190)   168,023   923
Contributed Capital October 1 2012 to December 31, 2012                                 91,549   91,549
Net Loss October 1, 2012 to December 31 2012                            (91,839)       (91,839)
Balance December 31, 2012             10,000    10    80    (259,029)   259,572   633
Contributed Capital January 1 2013 to March 31, 2013                                 70,500   70,500
Net Loss January 1 2013 to March 31, 2013                            (70,505)       (70,505)
Balance March 31, 2013             10,000    10    80    (329,534)   330,072   628
Change in par value, common stock May 15, 2013                  (9)   9             0
Common Stock issued for Cash May 17, 2013             50,000,000    5,000    15,000             20,000
Contributed Capital April 1, 2013 to June 30, 2013                                 57,854   57,854
Net Loss April 1, 2013 to June 30, 2013                            (74,829)       (74,829)
Balance June 30, 2013             50,010,000    5,001    15,089    (404,363)   387,926   3,653

The Accompanying Notes are an Integral Part of These Financial Statements

 

 

 

30

REGEN BIOPHARMA , INC.         
(A Development Stage Company)         

STATEMENT OF CASH FLOWS

         
(Unaudited)         
          
   Nine Months Ended  From inception(April 24, 2012) to  From inception to June 30
   June 30 2013  June 30 2012  2013
CASH FLOWS FROM OPERATING ACTIVITIES               
                
Net Income (loss)  $(237,173)  $(18,425)  $(404,363)
Adjustments to reconcile net Income to net cash               
    Increase (Decrease) in Accounts Payable               
Net Cash Provided by (Used in) Operating  $(237,173)  $(18,425)  $(404,363)
    Activities                
CASH FLOWS FROM FINANCING ACTIVITIES               
    Common Stock issued for Cash   20,000   90   20,090 
    Increase in Contributed Capital   219,903   43,270   387,926 
Net Cash Provided by (Used in) Financing               
    Activities   239,903   43,360   408,016 
                
Net Increase (Decrease) in Cash  $2,730   $24,935   $3,653 
                
Cash at Beginning of Period   923    0    0 
                
Cash at End of Period  $3,653   $24,935   $3,653 
                
The Accompanying Notes are an Integral Part of These Financial Statements  

 

31

REGEN BIOPHARMA, INC.

Notes to Financial Statements

As of June 30, 2013

 

NOTE 1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

 

Regen Biopharma , Inc. (“Company”) was organized April 24, 2012 under the laws of the State of Nevada. The Company is a wholly owned subsidiary of Bio Matrix Scientific Group, Inc, a Delaware corporation.

 

The Company intends to engage primarily in the development of regenerative medical applications which we intend to license from other entities up to the point of successful completion of Phase I and or Phase II clinical trials after which we would either attempt to sell or license those developed applications or, alternatively, advance the application further to Phase III clinical trials

 

A. BASIS OF ACCOUNTING

 

The financial statements have been prepared using the basis of accounting generally accepted in the United States of America. Under this basis of accounting, revenues are recorded as earned and expenses are recorded at the time liabilities are incurred. The Company has adopted a September 30 year-end.

 

 

B. USE OF ESTIMATES

 

The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

 

C. DEVELOPMENT STAGE

 

The Company is a development stage company devoting substantially all of its efforts to establish a new business.

 

D. CASH EQUIVALENTS

 

The Company considers all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents.

   

E. PROPERTY AND EQUIPMENT

 

Property and equipment are recorded at cost. Maintenance and repairs are expensed in the year in which they are incurred. Expenditures that enhance the value of property and equipment are capitalized.

 

F. FAIR VALUE OF FINANCIAL INSTRUMENTS

 

Fair value is the price that would be received for an asset or the exit price that would be paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants on the measurement date.  A fair value hierarchy requires an entity to maximize the use of observable inputs, where available. The following summarizes the three levels of inputs required by the standard that the Company uses to measure fair value:

 

Level 1:  Quoted prices in active markets for identical assets or liabilities

 

Level 2:  Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities.

 

Level 3:  Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

32

  

G. INCOME TAXES

 

The Company accounts for income taxes using the liability method prescribed by ASC 740, “Income Taxes.” Under this method, deferred tax assets and liabilities are determined based on the difference between the financial reporting and tax bases of assets and liabilities using enacted tax rates that will be in effect in the year in which the differences are expected to reverse. The Company records a valuation allowance to offset deferred tax assets if based on the weight of available evidence, it is more-likely-than-not that some portion, or all, of the deferred tax assets will not be realized. The effect on deferred taxes of a change in tax rates is recognized as income or loss in the period that includes the enactment date.

 

The Company applied the provisions of ASC 740-10-50, “Accounting For Uncertainty In Income Taxes”, which provides clarification related to the process associated with accounting for uncertain tax positions recognized in our financial statements. Audit periods remain open for review until the statute of limitations has passed. The completion of review or the expiration of the statute of limitations for a given audit period could result in an adjustment to the Company’s liability for income taxes. Any such adjustment could be material to the Company’s results of operations for any given quarterly or annual period based, in part, upon the results of operations for the given period. As of December 31 2012 the Company had no uncertain tax positions, and will continue to evaluate for uncertain positions in the future.

 

The Company generated a deferred tax credit through net operating loss carry forward.  However, a valuation allowance of 100% has been established.

 

Interest and penalties on tax deficiencies recognized in accordance with ACS accounting standards are classified as income taxes in accordance with ASC Topic 740-10-50-19.

 

H.  BASIC EARNINGS (LOSS) PER SHARE

 

The Financial Accounting Standards Board (FASB) issued Accounting Standards Codification (ASC) 260, "Earnings Per Share", which specifies the computation, presentation and disclosure requirements for earnings (loss) per share for entities with publicly held common stock. ASC 260 requires the presentation of basic earnings (loss) per share and diluted earnings (loss) per share. The Company has adopted the provisions of ASC 260 effective from inception.

 

Basic net loss per share amounts is computed by dividing the net income by the weighted average number of common shares outstanding.

 

I. ADVERTISING

 

Costs associated with advertising are charged to expense as incurred. Advertising expenses were $0 for the nine months ended June 30 , 2013

 

NOTE 2 .  RECENT ACCOUNTING PRONOUNCEMENTS

 

In May 2011, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2011-04, "Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and IFRSs." The amendments in this update generally represent clarifications of Topic 820, but also include some instances where a particular principle or requirement for measuring fair value or disclosing information about fair value measurements has changed. This update results in common principles and requirements for measuring fair value and for disclosing information about fair value measurements in accordance with U.S. GAAP and IFRS. The amendments in this update are to be applied prospectively. The amendments are effective for interim and annual periods beginning after December 15, 2011. Early application is not permitted. The Company does not expect this guidance to have a significant impact on its consolidated financial position, results of operations or cash flows.

  

33

In June 2011, the FASB issued ASU No. 2011-05, "Presentation of Comprehensive Income." This update was amended in December 2011 by ASU No. 2011-12, "Deferral of the Effective Date for Amendments to the Presentation of Reclassifications of Items Out of Accumulated Other Comprehensive Income in Accounting Standards Update No. 2011-05." This update defers only those changes in update 2011-05 that relate to the presentation of reclassification adjustments. All other requirements in update 2011-05 are not affected by this update, including the requirement to report comprehensive income either in a single continuous financial statement or in two separate but consecutive financial statements. ASU No. 2011-05 and 2011-12 are effective for fiscal years (including interim periods) beginning after December 15, 2011. The Company does not expect this guidance to have a significant impact on its consolidated financial position, results of operations or cash flows.

 

In December 2011, the FASB issued ASU No. 2011-11, "Disclosures about Offsetting Assets and Liabilities." The amendments in this update require enhanced disclosures around financial instruments and derivative instruments that are either (1) offset in accordance with either ASC 210-20-45 or ASC 815-10-45 or (2) subject to an enforceable master netting arrangement or similar agreement, irrespective of whether they are offset in accordance with either ASC 210-20-45 or ASC 815-10-45. An entity should provide the disclosures required by those amendments retrospectively for all comparative periods presented. The amendments are effective during interim and annual periods beginning on or after January 1, 2013. The Company does not expect this guidance to have any impact on its consolidated financial position, results of operations or cash flows.

 

ASU 2011-08,  Intangibles – Goodwill and Other (Topic 350): Testing Goodwill for Impairment  is applicable to fiscal years beginning after December 15, 2011. Early application is permitted. The Company does not expect this ASU has a material impact on its financial position or carrying value of its intangible assets at this time.

 

A variety of proposed or otherwise potential accounting standards are currently under study by standard setting organizations and various regulatory agencies.  Due to the tentative and preliminary nature of those proposed standards, the Company’s management has not determined whether implementation of such standards would be material to its financial statements.

 

NOTE 3. GOING CONCERN

 

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. the Company generated net losses of $ 404,363 during the period from April 24, 2012 (inception) through June 30, 2013. This condition raises substantial doubt about the Company's ability to continue as a going concern. The Company's continuation as a going concern is dependent on its ability to meet its obligations, to obtain additional financing as may be required and ultimately to attain profitability. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

Management plans to raise additional funds by offering securities for cash. Management has yet to decide what type of offering the Company will use or how much capital the Company will raise. There is no guarantee that the Company will be able to raise any capital through any type of offerings.

 

NOTE 4. INCOME TAXES

 

As of June 30, 2013

 

Deferred tax assets:     
Net operating tax carry forwards  $137,483 
Other   -0- 
Gross deferred tax assets   137,483 
Valuation allowance   (137,483))
Net deferred tax assets  $-0- 

 

34

 

As of  June 30 ,  2013 the Company has a  Deferred Tax Asset of  $137,483 completely attributable to net operating loss carry forwards  of approximately $ 404,363  ( which expire 20 years from the date the loss was incurred) ..

 

Realization of deferred tax assets is dependent upon sufficient future taxable income during the period that deductible temporary differences and carry forwards are expected to be available to reduce taxable income. The achievement of required future taxable income is uncertain. As a result, the Company has the Company recorded a valuation allowance reducing all deferred tax assets to 0.

 

Income tax is calculated at the 34% Federal Corporate Rate.

 

 

NOTE 5. RELATED PARTY TRANSACTIONS

 

As of June 30, 2013 the Company has received capital contributions from its parent totaling $387,926 and has issued 50,010, 000 common shares to its parent fro aggregate consideration of $20,090. The Company also utilizes approximately 2,300 square feet of office space at 4700 Spring Street, Suite 304, La Mesa California, 91941provided to the Company by Entest BioMedical, Inc. on a month to month basis free of charge. The Chief Executive Officer of Entest Biomedical Inc. is David R. Koos who also serves as the Chief Executive Officer of the Company’s parent.

 

NOTE6. STOCKHOLDERS' EQUITY

 

The stockholders' equity section of the Company contains the following classes of capital stock as June, 2013:

 

Common stock, $ 0.0001 par value;500,000 ,000 shares authorized: 50,010,000 shares issued and outstanding.

With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Common Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Common Stock owned by such holder times one (1).

On any voluntary or involuntary liquidation, dissolution or winding up of the Corporation, the holders of the Common Stock shall receive, out of assets legally available for distribution to the Company's stockholders, a ratable share in the assets of the Corporation.

Preferred Stock, ,$0.0001 par value, 5,000,000 shares authorized: 0 shares issued and outstanding

The abovementioned shares authorized pursuant to the Company’s certificate of incorporation may be issued from time to time without prior approval of the shareholders. The Board of Directors of the Company shall have the full authority permitted by law to establish one or more series and the number of shares constituting each such series and to fix by resolution full or limited, multiple or fractional, or no voting rights, and such designations, preferences, qualifications, restrictions, options, conversion rights and other special or relative rights of any series of the Stock that may be desired.

 

NOTE 7. STOCK TRANSACTIONS

 

During the quarter ended June 30, 2013 the Company issued 50,000,000 Common Shares to its parent for consideration of $20,000.

 

35

 

NOTE 8. SUBSEQUENT EVENTS

 

On September 9, 2013 the Company issued 1,500,000 common shares to Caven Investments LLC for .

(a)The satisfaction of $70,000 of the outstanding indebtedness owed to Caven Investments LLC by Bio-Matrix Scientific Group Inc
(b)The cancellation of all of Caven Investments LLC’s outstanding warrants to purchase common shares of Bio-Matrix Scientific Group Inc.

 

On September 30, 2013 the Company sold 100,000 of its common shares for consideration of $100,000.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

36

 

SEALE AND BEERS, CPAs

PCAOB & CPAB REGISTERED AUDITORS

www.sealebeers.com

 

 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

 

To the Board of Directors and Stockholders of

Regen BioPharma, Inc.

(A Development Stage Company)

 

We have audited the accompanying balance sheets of Regen BioPharma, Inc.(A Development Stage Company) as of September 30, 2012, and the related statements of income, stockholders’ equity (deficit), and cash flows for the year ended September 30, 2012 and since inception on April 24, 2012 through September 30, 2012. Regen BioPharma, Inc.’s management is responsible for these financial statements. Our responsibility is to express an opinion on these financial statements based on our audits.

 

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. The company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audit included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

 

In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Regen BioPharma, Inc.(A Development Stage Company) as of September 30, 2012, and the related statements of income, stockholders’ equity (deficit), and cash flows for the year ended September 30, 2012 and since inception on April 24, through September 30, 2012 in conformity with accounting principles generally accepted in the United States of America.

 

37

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 3 to the financial statements, the Company has no revenues, has negative working capital at September 30, 2012, has incurred recurring losses and recurring negative cash flow from operating activities, and has an accumulated deficit which raises substantial doubt about its ability to continue as a going concern. Management’s plans concerning these matters are also described in Note 3. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

/s/ Seale and Beers,CPAs

 

Seale and Beers, CPAs

Las Vegas, Nevada

September 19, 2013

 

50 S. Jones Blvd. Suite 202 Las Vegas, NV 89107 Phone: (888)727-8251 Fax: (888)782-2351

 

 

 

 

 

 

 

 

38

REGEN BIOPHARMA , INC.   
(A Development Stage Company)   
BALANCE SHEET   
    
   As of
   September 30, 2012
    
ASSETS   
CURRENT ASSETS     
Cash  $923 
Prepaid Expenses     
     Total Current Assets   923 
      
      
TOTAL ASSETS  $923 
      
LIABILITIES AND STOCKHOLDERS' EQUITY     
      
Total Liabilities   0 
      
STOCKHOLDERS' EQUITY (DEFICIT)     
      
Common Stock ($.001 par value) 10,000 shares authorized;     
   10,000 shares  issued and outstanding as of     
    September 30 , 2012   10 
Additional Paid in capital   80 
Contributed Capital   168,023 
Retained Earnings (Deficit) accumulated during the development stage   (167,190)
Total Stockholders' Equity (Deficit)   923 
      
TOTAL LIABILITIES & STOCKHOLDERS' EQUITY (DEFICIT)  $923 
      
The Accompanying Notes are an Integral Part of These Financial Statements     

 

39

REGEN BIOPHARMA , INC.   
(A Development Stage Company)   
STATEMENT OF OPERATIONS   
    
   From Inception
   (April 24, 2012)
   to
   30-Sep
   2012
    
    
REVENUES  $--  
      
COST AND EXPENSES     
      
Research and Development   17,715 
General and Administrative   137,185 
Consulting and Professional Fees   12,290 
Total Costs and Expenses   167,190 
      
OPERATING LOSS   (167,190)
      
OTHER INCOME & (EXPENSES)     
NET INCOME (LOSS)   (167,190)
BASIC AND FULLY DILUTED     
EARNINGS (LOSS) PER SHARE   (16.72)
WEIGHTED AVERAGE NUMBER OF COMMON     
SHARES OUTSTANDING   10,000 
      
The Accompanying Notes are an Integral Part of These Financial Statements     

 

 

 

 

 

 

 

40

REGEN BIOPHARMA , INC.               
(A Development Stage Company)                 
Statement of shareholder's equity              

For the period from inception (April 24, 2012)

To September 30, 2012

 
             
                      
             Additional       
     Common Paid-in    Retained    Contributed      
            Shares    Amount    Capital   Earnings   Capital   Total
Shares issued to Parent April 25, 2012  10,000    10    80           90
Contributed Capital April 24, 2012 to September 30, 2012                     168,023   168,023
Net Loss                 (167,190)      (167,190)
Balance September 30, 2012   10,000    10    80   (167,190)  168,023   923

 

 

The Accompanying Notes are an Integral Part of These Financial Statements

 

 

 

 

 

 

 

 

41

REGEN BIOPHARMA , INC.   
(A Development Stage Company)   
Statement of Cash Flows   
    
    
   From inception (April 24, 2012) to September 30, 2012
  
CASH FLOWS FROM OPERATING ACTIVITIES     
      
Net Income (loss)  $(167,190)
Adjustments to reconcile net Income to net cash     
Net Cash Provided by (Used in) Operating   (167,190)
  Activities     
CASH FLOWS FROM FINANCING ACTIVITIES     
  Common Stock issued for Cash   90 
  Increase in Contributed Capital   168,023 
Net Cash Provided by (Used in) Financing   168,113 
  Activities     
      
Net Increase (Decrease) in Cash   923 
      
Cash at Beginning of Period   0 
      
Cash at End of Period  $923 
      
      
The Accompanying Notes are an Integral Part of These Financial Statements     

 

 

42

REGEN BIOPHARMA, INC.

Notes to Financial Statements

As of September 30, 2012

 

NOTE 1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Regen Biopharma , Inc. (“Company”) was organized April 24, 2012 under the laws of the State of Nevada. The Company is a wholly owned subsidiary of Bio Matrix Scientific Group, Inc, a Delaware corporation.

 

The Company intends to engage primarily in the development of regenerative medical applications which we intend to license from other entities up to the point of successful completion of Phase I and or Phase II clinical trials after which we would either attempt to sell or license those developed applications or, alternatively, advance the application further to Phase III clinical trials

 

A. BASIS OF ACCOUNTING

 

The financial statements have been prepared using the basis of accounting generally accepted in the United States of America. Under this basis of accounting, revenues are recorded as earned and expenses are recorded at the time liabilities are incurred. The Company has adopted a September 30 year-end.

 

B. USE OF ESTIMATES

 

The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

 

C. DEVELOPMENT STAGE

 

The Company is a development stage company devoting substantially all of its efforts to establish a new business.

 

D. CASH EQUIVALENTS

 

The Company considers all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents.

   

E. PROPERTY AND EQUIPMENT

 

Property and equipment are recorded at cost. Maintenance and repairs are expensed in the year in which they are incurred. Expenditures that enhance the value of property and equipment are capitalized.

 

F. FAIR VALUE OF FINANCIAL INSTRUMENTS

 

Fair value is the price that would be received for an asset or the exit price that would be paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants on the measurement date.  A fair value hierarchy requires an entity to maximize the use of observable inputs, where available. The following summarizes the three levels of inputs required by the standard that the Company uses to measure fair value:

 

Level 1:  Quoted prices in active markets for identical assets or liabilities

 

Level 2:  Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities.

 

Level 3:  Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

 

43

 

G. INCOME TAXES

 

The Company accounts for income taxes using the liability method prescribed by ASC 740, “Income Taxes.” Under this method, deferred tax assets and liabilities are determined based on the difference between the financial reporting and tax bases of assets and liabilities using enacted tax rates that will be in effect in the year in which the differences are expected to reverse. The Company records a valuation allowance to offset deferred tax assets if based on the weight of available evidence, it is more-likely-than-not that some portion, or all, of the deferred tax assets will not be realized. The effect on deferred taxes of a change in tax rates is recognized as income or loss in the period that includes the enactment date.

 

The Company applied the provisions of ASC 740-10-50, “Accounting For Uncertainty In Income Taxes”, which provides clarification related to the process associated with accounting for uncertain tax positions recognized in our financial statements. Audit periods remain open for review until the statute of limitations has passed. The completion of review or the expiration of the statute of limitations for a given audit period could result in an adjustment to the Company’s liability for income taxes. Any such adjustment could be material to the Company’s results of operations for any given quarterly or annual period based, in part, upon the results of operations for the given period. As of September 30, 2012 the Company had no uncertain tax positions, and will continue to evaluate for uncertain positions in the future.

 

The Company generated a deferred tax credit through net operating loss carry forward.  However, a valuation allowance of 100% has been established.

 

Interest and penalties on tax deficiencies recognized in accordance with ACS accounting standards are classified as income taxes in accordance with ASC Topic 740-10-50-19.

 

H.  BASIC EARNINGS (LOSS) PER SHARE

 

The Financial Accounting Standards Board (FASB) issued Accounting Standards Codification (ASC) 260, "Earnings Per Share", which specifies the computation, presentation and disclosure requirements for earnings (loss) per share for entities with publicly held common stock. ASC 260 requires the presentation of basic earnings (loss) per share and diluted earnings (loss) per share. The Company has adopted the provisions of ASC 260 effective from inception.

 

Basic net loss per share amounts is computed by dividing the net income by the weighted average number of common shares outstanding.

 

I. ADVERTISING

 

Costs associated with advertising are charged to expense as incurred. Advertising expenses were $0 for the twelve months ended September 30 , 2012.

 

NOTE 2 .  RECENT ACCOUNTING PRONOUNCEMENTS

 

In May 2011, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2011-04, "Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and IFRSs." The amendments in this update generally represent clarifications of Topic 820, but also include some instances where a particular principle or requirement for measuring fair value or disclosing information about fair value measurements has changed. This update results in common principles and requirements for measuring fair value and for disclosing information about fair value measurements in accordance with U.S. GAAP and IFRS. The amendments in this update are to be applied prospectively. The amendments are effective for interim and annual periods beginning after December 15, 2011. Early application is not permitted. The Company does not expect this guidance to have a significant impact on its consolidated financial position, results of operations or cash flows.

  

44

In June 2011, the FASB issued ASU No. 2011-05, "Presentation of Comprehensive Income." This update was amended in December 2011 by ASU No. 2011-12, "Deferral of the Effective Date for Amendments to the Presentation of Reclassifications of Items Out of Accumulated Other Comprehensive Income in Accounting Standards Update No. 2011-05." This update defers only those changes in update 2011-05 that relate to the presentation of reclassification adjustments. All other requirements in update 2011-05 are not affected by this update, including the requirement to report comprehensive income either in a single continuous financial statement or in two separate but consecutive financial statements. ASU No. 2011-05 and 2011-12 are effective for fiscal years (including interim periods) beginning after December 15, 2011. The Company does not expect this guidance to have a significant impact on its consolidated financial position, results of operations or cash flows.

 

In December 2011, the FASB issued ASU No. 2011-11, "Disclosures about Offsetting Assets and Liabilities." The amendments in this update require enhanced disclosures around financial instruments and derivative instruments that are either (1) offset in accordance with either ASC 210-20-45 or ASC 815-10-45 or (2) subject to an enforceable master netting arrangement or similar agreement, irrespective of whether they are offset in accordance with either ASC 210-20-45 or ASC 815-10-45. An entity should provide the disclosures required by those amendments retrospectively for all comparative periods presented. The amendments are effective during interim and annual periods beginning on or after January 1, 2013. The Company does not expect this guidance to have any impact on its consolidated financial position, results of operations or cash flows.

 

ASU 2011-08,  Intangibles – Goodwill and Other (Topic 350): Testing Goodwill for Impairment  is applicable to fiscal years beginning after December 15, 2011. Early application is permitted. The Company does not expect this ASU has a material impact on its financial position or carrying value of its intangible assets at this time.

 

A variety of proposed or otherwise potential accounting standards are currently under study by standard setting organizations and various regulatory agencies.  Due to the tentative and preliminary nature of those proposed standards, the Company’s management has not determined whether implementation of such standards would be material to its financial statements.

 

NOTE 3. GOING CONCERN

 

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. the Company generated net losses of $ 167,190 during the period from April 24, 2012 (inception) through September 30, 2012. This condition raises substantial doubt about the Company's ability to continue as a going concern. The Company's continuation as a going concern is dependent on its ability to meet its obligations, to obtain additional financing as may be required and ultimately to attain profitability. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

Management plans to raise additional funds by offering securities for cash. Management has yet to decide what type of offering the Company will use or how much capital the Company will raise. There is no guarantee that the Company will be able to raise any capital through any type of offerings.

 

NOTE 4. INCOME TAXES

 

As of September 30, 2012

 

Deferred tax assets:      
Net operating tax carry forwards   $ 56,844  
Other     -0-  
Gross deferred tax assets     56,844  
Valuation allowance     (56,844)
Net deferred tax assets   $ -0-  

45

 

 

As of  June 30 ,  2012 the Company has a  Deferred Tax Asset of  $56,844 completely attributable to net operating loss carry forwards  of approximately $167,190   ( which expire 20 years from the date the loss was incurred) ..

 

Realization of deferred tax assets is dependent upon sufficient future taxable income during the period that deductible temporary differences and carry forwards are expected to be available to reduce taxable income. The achievement of required future taxable income is uncertain. As a result, the Company has the Company recorded a valuation allowance reducing all deferred tax assets to 0.

 

Income tax is calculated at the 34% Federal Corporate Rate.

 

NOTE 5. RELATED PARTY TRANSACTIONS

 

As of September 30, 2012 the Company has received capital contributions from its parent totaling $168,023. The Company also utilizes approximately 2,300 square feet of office space at 4700 Spring Street, Suite 304, La Mesa California, 91941provided to the Company by Entest BioMedical, Inc. on a month to month basis free of charge. The Chief Executive Officer of Entest Biomedical Inc. is David R. Koos who also serves as the Chief Executive Officer of the Company’s parent.

 

NOTE6. STOCKHOLDERS' EQUITY

 

The stockholders' equity section of the Company contains the following classes of capital stock as September 30, 2012:

 

Common stock, $ 0.001 par value;10,000 shares authorized: 10,000 shares issued and outstanding.

With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Common Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Common Stock owned by such holder times one (1).

On any voluntary or involuntary liquidation, dissolution or winding up of the Corporation, the holders of the Common Stock shall receive, out of assets legally available for distribution to the Company's stockholders, a ratable share in the assets of the Corporation.

 

NOTE 7. STOCK TRANSACTIONS

 

During the year ended September 30, 2012 the Company issues 10,000 common shares to its parent for consideration of $90:

 

 

NOTE 8. SUBSEQUENT EVENTS

 

On May 13, 2013 the Company amended Article 3 of its certificate of incorporation to amend the aggregate number of shares which the Company is authorized to issue as follows:

 

500,000,000 Common shares, $0.0001 par value

5,000,000 Preferred Shares,$0.0001 par value

 

The abovementioned shares authorized pursuant to the Company’s certificate of incorporation may be issued from time to time without prior approval of the shareholders. The Board of Directors of the Company shall have the full authority permitted by law to establish one or more series and the number of shares constituting each such series and to fix by resolution full or limited, multiple or fractional, or no voting rights, and such designations, preferences, qualifications, restrictions, options, conversion rights and other special or relative rights of any series of the Stock that may be desired.

 

46

 

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

For the Quarter and Nine Months ended June 30, 2013 and the period from inception to June 30, 2012

Revenues were $0 during the three months ended June 30, 2013. Net Losses were $74,829 for the three months ended June 30, 2013. The largest components of net losses were:

(a)$20,000 in fees to Oregon Health and Sciences University (“OHSU”) pursuant to an option agreement entered into by and between the Company and OHSU on June 5, 2012
(b)$30,000 of compensation expenses resulting to compensation payable to Thomas Ichim
(c)$19,354 of compensation expenses resulting to compensation payable to J. Christopher Mizer

 

Revenues were $0 during the period from inception to June 30, 2012. Net Losses were $18,425 for the period from inception to June 30, 2012. The largest components of net losses were:

a)$5,000 in fees paid pursuant to an option agreement entered into by and between the Company and OHSU on June 5, 2012
b)$3,120 paid for website design
c)$7,200 in compensation expenses related to J. Christopher Mizer

No meaningful comparison can be made between the quarter ended June 30, 2013 and the period from inception to June 30 , 2012 due to the fact that the period from inception to June 30 , 2012 consisted solely of 68 days.

Revenues were $0 during the nine months ended June 30, 2013. Net Losses were $237,173 for the three months ended June 30, 2013. The largest components of net losses were:

(a) $195,799 in compensation expense related to Thomas Ichim and J. Christopher Mizer

(b) $30,000 in fees to Oregon Health and Sciences University (“OHSU”) pursuant to an option agreement entered into by and between the Company and OHSU on June 5, 2012

For the period from inception (April 24, 2012) to September 30, 2012

Revenues were $0 during the period from inception to September 30, 2012. Net Losses were $167,190 for the period from inception to September 30, 2012. The largest components of net losses were:

(a)$124,671 in compensation expense related to Thomas Ichim and J. Christopher Mizer
(b)$17,640 in consulting fees paid to Cascade Life Sciences, Inc., a contract research organization, for preclinical studies conducted
(c)$5,000 in fees to Oregon Health and Sciences University (“OHSU”) pursuant to an option agreement entered into by and between the Company and OHSU on June 5, 2012 .

47

 

Liquidity and Capital Resources

The Company’s cash and liquidity resources have been provided by stock sales to and capital contributions from BMSN, its parent. For the period from inception to June 30, 2013 the Company has sold 50,010,000 common shares to BMSN for total proceeds of $20,090 and for the period from inception to June 30, 2013 BMSN has made capital contributions to the company in the form of cash or expenses paid for or assumed by BMSN on Regen’s behalf in the total amount of $387,926.

On September 30, 2013 the Company sold 100,000 of its common shares for consideration of $100,000.

The Company has historically met its cash needs primarily through capital contributions made by BMSN and anticipates continuing to do so for the period beginning July 1, 2013 and ending March 31, 2014. The Company also plans to meet cash needs through applying for governmental and non governmental grants as well as selling its securities for cash. Management has yet to decide what type of offering the Company will use or how much capital the Company will raise. There is no guarantee that the Company will be able to raise any capital through any type of offerings. Management can give no assurance that any governmental or non governmental grant will be obtained by the Company despite the Company’s best efforts.

 

We cannot assure that we will be successful in obtaining additional financing necessary to implement our business plan.  We have not received any commitment or expression of interest from any financing source that has given us any assurance that we will obtain the amount of additional financing in the future that we currently anticipate.  For these and other reasons, we are not able to assure that we will obtain any additional financing or, if we are successful, that we can obtain any such financing on terms that may be reasonable in light of our current circumstances.

 

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

 

During our most recent fiscal year there have been no changes in or disagreements with our independent registered public accountant.

 

DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS

 

David R. Koos

David R. Koos has served as Chairman of the Board of Directors, Chief Executive Officer, Secretary, Treasurer and Acting Chief Financial Officer of the Company since April 24, 2013. David R. Koos has served as president of the Company since May 29, 2013.

Education:

 

DBA - Finance (December 2003)

Atlantic International University

 

Ph.D. - Sociology (September 2003)

Atlantic International University

 

MA - Sociology (June 1983)

University of California - Riverside, California

 

48

 

 

Five Year Employment History:

 

     
Position: Company Name: Employment Dates:
     
Chairman, President, CEO and Acting CFO

Bio-Matrix Scientific Group, Inc.*

 

June 14, 2006 (Chairman) to Present

June 19, 2006 (President, CEO and Acting CFO)

June 19, 2006 (Secretary) to Present

Chairman, CEO, Secretary & Acting CFO Frezer Inc. May 2, 2005 to February 2007
Chairman, CEO & Acting CFO

BMXP Holdings, Inc.

 

December 6, 2004 to June 2008

 

* As of October 4, 2013 Bio-Matrix Scientific Group, Inc owns 50,010,000 Common Shares of Regen representing 97% of our outstanding share capital as of September 25, 2013.

 

Thomas Ichim

Thomas Ichim has served as our Chief Scientific Officer and Director of Research since June 15, 2012 and has served as a director since July 15, 2013.

Education:

 

1998University of Waterloo, Waterloo, Ontario, Canada
BSc in Biology

 

2003University of Western Ontario, London, Ontario, Canada
MSc Microbiology and Immunology

 

2005Society of Clinical Research Associates, Chalfont, PA
Certified Clinical Research Associate

 

2007University of Sciences Arts and Technology, Olveston Monserrat
Ph.D Immunology

 

49

 

Five Year Employment History:

 

 

2012-PresentPresident and Chief Scientific Officer
Medistem Inc
   
  9255 Towne Centre Drive, Suite 450, San Diego, CA 92121
   

 

2008-2012Chief Technology Officer
Medistem Inc
   
  9255 Towne Centre Drive, Suite 450, San Diego, CA 92121
   

 

2007-2008Chief of Scientific Development

 

Medistem Inc
  
  9255 Towne Centre Drive, Suite 450, San Diego, CA 92121
   

2006-2009Chief Technology Officer

OncoMune LLC


18851 NE 29th Avenue, Suite 500, Aventura, FL 33180 

 

2004-2007Co-Founder and Program Manager
bioRASI LLC

18851 NE 29th Avenue, Suite 500, Aventura, FL 33180 

 

Mr. Ichim has also served as a director at the following entities:

Creative Medical, Phoenix Arizona (2011-present)

Carbon Manna (2010-2011)

Riordan Clinic, Wichita, Kansas (2009-present)

Medistem Inc (2008-present)

 

50

TRANSACTIONS WITH RELATED PERSONS

 

During the period beginning from inception to June 30, 2013 the Company has sold 50,010,000 common shares to BMSN for total consideration of $20,090.

During the period beginning from inception to June 30, 2013 BMSN has made capital contributions to the Company totaling $387,926.

The Company  utilizes approximately 2,300 square feet of office space at 4700 Spring Street, Suite 304, La Mesa California, 91941provided to the Company by Entest BioMedical, Inc. on a month to month basis free of charge. The property is utilized as office space. We believe that the foregoing properties are adequate to meet our current needs for office space. David R. Koos, our Chairman and Chief Executive Officer, serves as Chairman and Chief Executive Officer of Entest BioMedical, Inc.

 

CORPORATE GOVERNANCE

 

Code of Ethics

 

On September 25, 2013 we adopted a Code of Ethics pursuant to Section 406 of the Sarbanes-Oxley Act of 2002.

 

Director Independence

 

Audit Committee and Audit Committee Financial Expert

 

The members of the Company’s board of Directors may not be considered independent. The Company is not a "listed company" under Securities and Exchange Commission (“SEC”) rules and is therefore not required to have an audit committee comprised of independent directors. The Company does not currently have an audit committee, however, for certain purposes of the rules and regulations of the SEC and in accordance with the Sarbanes-Oxley Act of 2002, the Company’s  Board of Directors is deemed to be its  audit committee and as such functions as an audit committee and performs some of the same functions as an audit committee including: (1) selection and oversight of our independent accountant; (2) establishing procedures for the receipt, retention and treatment of complaints regarding accounting, internal controls and auditing matters; and (3) engaging outside advisors. The Board of Directors has determined that its member is  able to read and understand fundamental financial statements and has substantial business experience that results in that member's financial sophistication. Accordingly, the Board of Directors believes that its member has  the sufficient knowledge and experience necessary to fulfill the duties and obligations that an audit committee would have.

 

Nominating and Compensation Committees

 

The Company does not have standing nominating or compensation committees, or committees performing similar functions. The board of directors believes that it is not necessary to have a compensation committee at this time because the functions of such committee are adequately performed by the board of directors. The board of directors also is of the view that it is appropriate for the Company not to have a standing nominating committee because the board of directors has performed and will perform adequately the functions of a nominating committee. The Company is not a "listed company" under SEC rules and is therefore not required to have a compensation committee or a nominating committee.

 

51

Shareholder Communications

 

There has not been any defined policy or procedure requirements for stockholders to submit recommendations or nomination for directors. There are no specific, minimum qualifications that the board of directors believes must be met by a candidate recommended by the board of directors. Currently, the entire board of directors decides on nominees, on the recommendation of any member of the board of directors followed by the board’s review of the candidates’ resumes and interview of candidates. Based on the information gathered, the board of directors then makes a decision on whether to recommend the candidates as nominees for director. The Company does not pay any fee to any third party or parties to identify or evaluate or assist in identifying or evaluating potential nominee.

 

Because the Chief Executive Officer of the Company is also the Chairman of the Board of Directors of the Company, the Board of Directors has determined not to adopt a formal methodology for communications from shareholders on the belief that any communication would be brought to the Board of Directors’ attention by virtue of the co-extensive capacities of the Chairman of the Board of Directors.

 

SUMMARY COMPENSATION TABLES

 

                               
Name and Principal Position  Year  Salary
($)
  Bonus
($)
  Stock
Awards
($)
  Restricted
Stock Awards
 
($)(a)(b)
  Option
Awards
($)
  Non Equity
Incentive
Plan
Compensation
($)
  Nonqualified
Deferred
Compensation
Earnings
($)
  All
Other
Compensation
($)
  Total
($)
                                                   
David Koos
Chairman, and CEO
    From April 24, 2012 to  September 30, 2012   $0    0    0    0    0    0    0    0   $0 
                                                   
Thomas Ichim
Chief Scientific Officer and Director of Research
    From April 24, 2012 to  September 30, 2012   $35,161             $48,000                          
                                                   
J Christopher Mizer,
 President  
(President until May 29,2013)
    From April 24, 2012 to  September 30, 2012   $48,710             $86,400                          

 

For the period from inception (April 24, 2012) to September 30, 2012

Name Restricted Stock awards
Number of shares
acquired on vesting
(#) (a)
Value
realized on
vesting
($)(a)
J. Christopher Mizer 4,000,000 Common shares of BMSN $28,800
Thomas Ichim 3,000,000 Common Shares of BMSN $12,000

 

 

(a)All Restricted Stock Awards represented in the Summary Compensation tables represent common stock of BMSN.
(b)Represents fair Market value of the entire restricted stock award as of the date of the grant

 

52

Employment Agreements

David R. Koos

David Koos is not party to an employment agreement with the Company

Thomas Ichim.

On June 15, 2012 BMSN entered into an employment agreement with Thomas Ichim whereby Mr. Ichim agreed to assume the position of Chief Scientific Officer and Director of Research of Regen BioPharma, Inc. (“Ichim Employment Agreement”).

As consideration for rendering services pursuant to the Ichim Employment Agreement, Mr. Ichim shall receive:

 

(a) Monthly salary of $10,000 payable in cash or common shares of BMSN, at BMSN’s option

 

(b) 12,000,000 common shares of BMSN (“Signing Shares”)

 

Signing Shares may not be sold, transferred, assigned, pledged or otherwise encumbered or disposed of by Mr. Ichim (“ Transfer Restriction”) except as follows:

 

1. Upon the expiration of one month from the date of the grant of the Signing Shares, Transfer Restrictions shall no longer apply to 1,000,000 of the Signing Shares.

 

2. Upon the expiration of two months from the date of the grant of the Signing Shares, Transfer Restrictions shall no longer apply to an additional 1,000,000 of the Signing Shares.

 

3. Upon the expiration of three months from the date of the grant of the Signing Shares, Transfer Restrictions shall no longer apply to an additional 1,000,000 of the Signing Shares.

 

4. Upon the expiration of four months from the date of the grant of the Signing Shares, Transfer Restrictions shall no longer apply to an additional 1,000,000 of the Signing Shares.

 

5. Upon the expiration of five months from the date of the grant of the Signing Shares, Transfer Restrictions shall no longer apply to an additional 1,000,000 of the Signing Shares.

 

6. Upon the expiration of six month from the date of the grant of the Signing Shares, Transfer Restrictions shall no longer apply to an additional 1,000,000 of the Signing Shares.

 

53

Transfer Restrictions shall no longer apply to 6,000,000 of the Signing Shares (“Milestone Shares”) upon the achievement of the following events (“Milestones”) during the course of the Mr. Ichim’s employment

1. Upon the addition to the Scientific Advisory Board of BMSN or any subsidiary of BMSN of five Researchers approved by the CEO of BMSN to act as members of Scientific Advisory Board of BMSN or any subsidiary of BMSN, prior to December 31, 2012, Transfer Restrictions shall no longer apply to 1,000,000 Milestone Shares

 

2. Upon the identification of five separate intellectual properties (“IPs”), prior to May 4, 2013, which are, in the sole discretion of the CEO of BMSN, deemed to be suitable IPs for BMSN or any subsidiary of BMSN to consider licensing for commercial use Transfer Restrictions shall no longer apply to 1,000,000 Milestone Shares.

 

3. Upon execution, prior to May 4, 2013, of binding agreements whereby BMSN or any of its subsidiaries have secured commercial licensing rights to all of the IPs listed above prior to May 4, 2013 Transfer Restrictions shall no longer apply to 1,000,000 Milestone Shares.

 

4. Upon retention by BMSN or any of its subsidiaries , prior to May 4, 2013, of both of appropriate researchers and an appropriate Contract Research Organization , the purpose of such retention being the commencement of clinical trials and the preparation of an Investigational New Drug Application pursuant to applicable law, Transfer Restrictions shall no longer apply to 1,000,000 Milestone Shares.

 

5. Upon commencement, prior to December 31, 2013, of a “Phase I” clinical trial by BMSN or any subsidiary of BMSN, to be performed in connection with an Investigational New Drug Application submitted by BMSN and in accordance with applicable law, Transfer Restrictions shall no longer apply to 2,000,000 Milestone Shares.

 

In the event that Mr. Ichim is no longer employed by BMSN or any subsidiary of BMSN, any Signing Shares (including Milestone Shares) still subject to Transfer Restrictions shall be forfeited by the Mr. Ichim, and ownership of those Signing Shares shall be transferred back to BMSN.

 

54

In the event that any Milestone listed above is not achieved by the date so indicated, those Milestone Shares for which Transfer Restrictions would no longer apply upon achievement of the applicable Milestone shall be forfeited by Mr. Ichim and ownership of the Milestone Shares shall be transferred back to the Company.

 

The term of the Ichim Employment Agreement is from June 15, 2012 to June 14, 2015 and may be extended by mutual agreement between Mr. Ichim and the Company.

On June 21, 2012 the Ichim Employment Agreement was amended so that no salary was due and payable during the month of June 2012 and $15,161 would be due and payable in the month of July 2012.

J. Christopher Mizer

On May 4, 2012 BMSN entered into an employment agreement with J. Christopher Mizer whereby Mr. Mizer agreed to assume the position of President of Regen BioPharma, Inc. (“Mizer Employment Agreement”).

As consideration for rendering services pursuant to the Mizer Employment Agreement, Mr. Mizer shall receive:

 

(a)

Monthly salary of $10,000 payable in cash or common shares of BMSN, at BMSN’s option

(b)

12,000,000 common shares of BMSN (“Signing Shares”)

 

Signing Shares may not be sold, transferred, assigned, pledged or otherwise encumbered or disposed of by Mr. Mizer (“ Transfer Restriction”) except as follows:

 

(1)Upon the expiration of one month from the date of the grant of the Signing Shares, Transfer Restrictions shall no longer apply to 1,000,000 of the Signing Shares.

 

(2)Upon the expiration of two months from the date of the grant of the Signing Shares, Transfer Restrictions shall no longer apply to an additional 1,000,000 of the Signing Shares.

 

(3)Upon the expiration of three months from the date of the grant of the Signing Shares, Transfer Restrictions shall no longer apply to an additional 1,000,000 of the Signing Shares.

 

(4)Upon the expiration of four months from the date of the grant of the Signing Shares, Transfer Restrictions shall no longer apply to an additional 1,000,000 of the Signing Shares.

55

(5).Upon the expiration of five months from the date of the grant of the Signing Shares, Transfer Restrictions shall no longer apply to an additional 1,000,000 of the Signing Shares.

 

(6)Upon the expiration of six month from the date of the grant of the Signing Shares, Transfer Restrictions shall no longer apply to an additional 1,000,000 of the Signing Shares.

 

Transfer Restrictions shall no longer apply to 6,000,000 of the Signing Shares (“Milestone Shares”) upon the achievement of the following events (“Milestones”) during the course of the Mr. Mizer’s employment with BMSN

 

1.Upon the addition to the Scientific Advisory Board of BMSN or any subsidiary of BMSN of five Researchers approved by the CEO of BMSN to act as members of Scientific Advisory Board of BMSN or any subsidiary of BMSN, prior to December 31, 2012, Transfer Restrictions shall no longer apply to 1,000,000 Milestone Shares

 

2.Upon the identification of five separate intellectual properties (“IPs”), prior to May 4, 2013, which are, in the sole discretion of the CEO of BMSN, deemed to be suitable IPs for BMSN or any subsidiary of BMSN to consider licensing for commercial use Transfer Restrictions shall no longer apply to 1,000,000 Milestone Shares.

 

3.Upon execution, prior to May 4, 2013, of binding agreements whereby BMSN or any of its subsidiaries have secured commercial licensing rights to all of the IPs listed above prior to May 4, 2013 Transfer Restrictions shall no longer apply to 1,000,000 Milestone Shares.

 

4.Upon retention by BMSN or any of its subsidiaries , prior to May 4, 2013, of both of appropriate researchers and an appropriate Contract Research Organization , the purpose of such retention being the commencement of clinical trials and the preparation of an Investigational New Drug Application pursuant to applicable law, Transfer Restrictions shall no longer apply to 1,000,000 Milestone Shares.

 

5. Upon commencement, prior to December 31, 2013, of a “Phase I” clinical trial by BMSN or any subsidiary of BMSN, to be performed in connection with an Investigational New Drug Application submitted by BMSN and in accordance with applicable law, Transfer Restrictions shall no longer apply to 2,000,000 Milestone Shares.

 

In the event that Mr. Mizer is no longer employed by BMSN or any subsidiary of BMSN, any Signing Shares (including Milestone Shares) still subject to Transfer Restrictions shall be forfeited by the Mr. Mizer, and ownership of those Signing Shares shall be transferred back to BMSN.

 

56

On May 12, 2012 the Ichim Employment Agreement was amended so that no salary was due and payable during the month of June and May 2012 and $28,710 would be due and payable in the month of July 2012.

On May 29, 2013 J. Christopher Mizer was dismissed from his position as president of Regen BioPharma Inc. The position of president of Regen BioPharma Inc. has been assumed by David R. Koos, the Company’s Chairman and Chief Executive Officer.

In the event that any Milestone listed above is not achieved by the date so indicated, those Milestone Shares for which Transfer Restrictions would no longer apply upon achievement of the applicable Milestone shall be forfeited by Mr. Mizer and ownership of the Milestone Shares shall be transferred back to the Company.

 

The term of the Mizer Employment Agreement is from May 4, 2012 to May 3, 2015 and may be extended by mutual agreement between Mr. Mizer and the Company.

 

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT

 

The following table sets forth information known to the Company with respect to the beneficial ownership of each class of the Company’s capital stock as of September 25, 2013 for (1) each person known by the Company to beneficially own more than 5% of each class of the Company’s voting securities, (2) each executive officer, (3) each of the Company’s directors and (4) all of the Company’s executive officers and directors as a group.

 

As of October 4, 2013 the Company had 51, 610,000 common shares outstanding and no preferred shares outstanding.

 

Based on  51, 610,000 shares issued and outstanding as of October 4, 2013

 

 

57

 

 

          
Title of Class  Name and Address of Beneficial Owner  Amount and Nature
 of Beneficial Owner
  Percent of Class
 Common   David R. Koos*
C/o Regen Biopharma Inc.
4700 SPRING STREET, SUITE 304, LA MESA, CALIFORNIA, 91942
   50,010,000    97%
                
 Common   Bio Matrix Scientific Group Inc.
4700 SPRING STREET, SUITE 304, LA MESA, CALIFORNIA, 91942
   50,010,000    97%
                
 Common   All Officers and Directors As a Group   50,010,000    97%
·Includes 50,010,000 common shares of the Company beneficially owned by Bio Matrix Scientific Group Inc. David R. Koos is the sole officer and director of Bio Matrix Scientific Group Inc.and has voting and dispositive control over common shares of Regen held by Bio Matrix Scientific Group Inc

AVAILABLE INFORMATION

 

We have filed a registration statement on Form S-1 under the Securities Act of 1933 with the Securities and Exchange Commission with respect to the shares of our common stock offered through this prospectus. This prospectus is filed as a part of that registration statement and does not contain all of the information contained in the registration statement and exhibits. We refer you to our registration statement and each exhibit attached to it for a more complete description of matters involving us, and the statements we have made in this prospectus are qualified in their entirety by reference to these additional materials. You may inspect the registration statement and exhibits and schedules filed with the Securities and Exchange Commission at the Commission’s principal office in Washington, D.C. Copies of all or any part of the registration statement may be obtained from the Public Reference Section of the Securities and Exchange Commission, 100 F Street NE, Washington, D.C. 20549. Please call the Commission at 1-800-SEC-0330 for further information on the operation of the public reference rooms. The Securities and Exchange Commission also maintains a web site at http://www.sec.gov that contains reports, proxy statements and information regarding registrants that file electronically with the Commission. In addition, we will file electronic versions of our annual and quarterly reports on the Commission’s Electronic Data Gathering Analysis and Retrieval, or EDGAR System. Our registration statement and the referenced exhibits can also be found on this site as well as our quarterly and annual reports. We will not send the annual report to our shareholders unless requested by the individual shareholders.

DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT LIABILITIES.

 

Under applicable provisions of the Nevada Revised Statutes, we can indemnify our directors and officers against liabilities they may incur in such capacities, including liabilities under the Securities Act of 1933, as amended (the “Securities Act”). Our Bylaws indemnify members of the board of directors, our officers, employees, and agents and persons who formerly held such positions, and the legal representatives of any of them, to the fullest extent legally permissible under the general corporation law of the state of Nevada against any or all expense, liability and loss reasonably incurred in defending a civil or criminal action, suit or proceeding to which any such person shall have become subject by reason of his having held such a position or having allegedly taken or omitted to take any action in connection with such position.

 

Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers or persons controlling the registrant pursuant to the foregoing provisions, the registrant has been informed that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is therefore unenforceable.

 

58

 

20,000,000 Shares of

 

Common Stock

 

REGEN BIOPHARMA, INC.

 

PROSPECTUS

 

______2013

 

 

 

 

No dealer, salesperson or other person has been authorized to give any information or to make any representations other than those contained in this prospectus in connection with the offering made by this prospectus, and, if given or made, such information or representations must not be relied upon as having been authorized by our Company or the Selling Security Holders.  This prospectus does not constitute an offer to sell or a solicitation of an offer to buy any securities other than those specifically offered hereby or an offer to sell or a solicitation of an offer to buy any of these securities in any jurisdiction to any person to whom it is unlawful to make such offer or solicitation.  Except where otherwise indicated, this prospectus speaks as of the effective date of the registration statement.  Neither the delivery of this prospectus nor any sale hereunder shall under any circumstances create any implication that there has been no change in the affairs of our Company since the date hereof.

 

 

 

 

 

 

 

 

PART II

 

INFORMATION NOT REQUIRED IN PROSPECTUS

 

Other Expenses of Issuance and Distribution

 

The estimated expenses of this offering in connection with the issuance and distribution of the securities being registered, all of which are to be paid by the Registrant, are as follows:

 

        
Securities and Exchange Commission Filing Fee   $   
Legal Fees and Expenses   $   
        
Miscellaneous Expenses   $   
Total   $   

 

 

 

INDEMNIFICATION OF DIRECTORS AND OFFICERS

 

Section 78.138 of the Nevada Revised Statutes(“NRS”), provides that a director or officer will not be individually liable unless it is proven that (i) the director’s or officer’s acts or omissions constituted a breach of his or her fiduciary duties, and (ii) such breach involved intentional misconduct, fraud or a knowing violation of the law.

 

Section 78.7502 of NRS permits a company to indemnify its directors and officers against expenses, judgments, fines and amounts paid in settlement actually and reasonably incurred in connection with a threatened, pending or completed action, suit or proceeding if the officer or director (i) is not liable pursuant to NRS 78.138 or (ii) acted in good faith and in a manner the officer or director reasonably believed to be in or not opposed to the best interests of the corporation and, if a criminal action or proceeding, had no reasonable cause to believe the conduct of the officer or director was unlawful.

 

Section 78.751 of NRS permits a Nevada company to indemnify its officers and directors against expenses incurred by them in defending a civil or criminal action, suit or proceeding as they are incurred and in advance of final disposition thereof, upon receipt of an undertaking by or on behalf of the officer or director to repay the amount if it is ultimately determined by a court of competent jurisdiction that such officer or director is not entitled to be indemnified by the company. Section 78.751 of NRS further permits the company to grant its directors and officers additional rights of indemnification under its articles of incorporation or bylaws or otherwise.

 

Section 78.752 of NRS provides that a Nevada company may purchase and maintain insurance or make other financial arrangements on behalf of any person who is or was a director, officer, employee or agent of the company, or is or was serving at the request of the company as a director, officer, employee or agent of another company, partnership, joint venture, trust or other enterprise, for any liability asserted against him and liability and expenses incurred by him in his capacity as a director, officer, employee or agent, or arising out of his status as such, whether or not the company has the authority to indemnify him against such liability and expenses.

 

Our Bylaws indemnify members of the board of directors, our officers, employees, and agents and persons who formerly held such positions, and the legal representatives of any of them, to the fullest extent legally permissible under the general corporation law of the state of Nevada against any or all expense, liability and loss reasonably incurred in defending a civil or criminal action, suit or proceeding to which any such person shall have become subject by reason of his having held such a position or having allegedly taken or omitted to take any action in connection with such position.

 
 

  

RECENT SALES OF UNREGISTERED SECURITIES

 

On April 25, 2012 the Company issued 10,000 common shares (“Shares”) to Bio Matrix Scientific Group, Inc. for consideration of $90.

 

The Shares were issued pursuant to Section 4(a) (2) of the Securities Act of 1933, as amended. No underwriters were retained to serve as placement agents for the sale. The shares were sold directly through our management.  No commission or other consideration was paid in connection with the sale of the shares. There was no advertisement or general solicitation made in connection with this Offer and Sale of Shares.

 

 

On May 17, 2013 the Company issued 50,000,000 common shares (“Shares”) to Bio Matrix Scientific Group, Inc. for consideration of $20,000.

 

The Shares were issued pursuant to Section 4(a) (2) of the Securities Act of 1933, as amended. No underwriters were retained to serve as placement agents for the sale. The shares were sold directly through our management.  No commission or other consideration was paid in connection with the sale of the shares. There was no advertisement or general solicitation made in connection with this Offer and Sale of Shares.

 

 

On September 9, 2013 the Company issued 1,500,000 common shares (“Shares”) to Caven Investments LLC.

(c)The satisfaction of $70,000 of the outstanding indebtedness owed to Caven Investments LLC by Bio-Matrix Scientific Group Inc
(d)The cancellation of all of Caven Investments LLC’s outstanding warrants to purchase common shares of Bio-Matrix Scientific Group Inc.

 

The Shares were issued pursuant to Section 4(a) (2) of the Securities Act of 1933, as amended. No underwriters were retained to serve as placement agents for the sale. The shares were sold directly through our management.  No commission or other consideration was paid in connection with the sale of the shares. There was no advertisement or general solicitation made in connection with this Offer and Sale of Shares.

 

On September 30, 2013 the Company issued 100,000 common shares (“Shares”) to ASC Recap, LLC for consideration of $100,000.

The Shares were issued pursuant to Section 4(a) (2) of the Securities Act of 1933, as amended. Capital Path Securities LLC served as placement agent with regards to the Offer and Sale of the Shares for which they were compensated in the amount of 10% of the proceeds from the sale of the Shares.   There was no advertisement or general solicitation made in connection with this Offer and Sale of Shares.

 

 

 
 

EXHIBITS

 

Exhibit No. Description
3(i) Articles of Incorporation
3(i)(2) Amendment to Articles of incorporation
3(ii) Bylaws of the Registrant
10.1 June 5 2013 Agreement by and between the Company and Oregon Health and Science University
10.2 Termination of June 5 2013 Agreement by and between the Company. and Oregon Health and Science University August 8 2013
10.3 Employment Agreement by and between Biomatrix Scientific Group, Inc. and J. Christopher Mizer
10.4 Amendment to Employment Agreement by and between Biomatrix Scientific Group, inc. and J. Christopher Mizer
10.5 Employment Agreement by and between Biomatrix Scientific Group, Inc. and Thomas Ichim
10.6 Amendment to Employment Agreement by and between Biomatrix Scientific Group, inc. and Thomas Ichim
10.7 May 1 2013 agreement with Dr. Wei Ping Min
10.8   Letter Agreement by and between Wei Ping Min and Bio Matrix Scientific Group Inc dated May 18, 2012
10.9      Option Agreement by and between the Company and Oregon State University June 5 2013
10.10 Letter Agreement by and between James White and Bio Matrix Scientific Group Inc dated May 16, 2012
   
10.11 Letter Agreement by and between David Suhy and Regen dated September 11 2013
   
10.12 Exclusive License Agreement between Regen and Benitec Australia Limited
   
10.13 Service Agreement by and between Regen and Dr. Wei Ping Min July 27,2013
   
5.1     Opinion regarding Legality
   
23.1 Consent of Joseph L. Pittera (Exhibit 5.1)
   
23.2 Consent of Seale and Beers CPAs

 

14.1 Code of Ethics

10.14 Share Purchase Agreement September 30, 2013

 
 


UNDERTAKINGS

The Registrant hereby undertakes the following:

 

(a)(1) To file, during any period in which it offers or sells securities, a post-effective amendment to this registration statement to:

 

(i) include any Prospectus required by Section 10(a)(3) of the Securities Act;

 

(ii) reflect in the Prospectus any facts or events which, individually or together, represent a fundamental change in the information in the registration statement, but notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and

 

(iii) include any additional or changed material information of the plan of distribution.

 

For (2) determining liability under the Securities Act, treat each post-effective amendment as a new registration statement of the securities offered, and the offering of the securities at that time to be the initial bona fide offering.

 

File a (3) post-effective amendment to remove from registration any of the securities that remain unsold at the end of the offering.

 

(b) Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the Registrant pursuant to the provisions described under Item 24 above, or otherwise, the Registrant has been advised that in the opinion of the Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification relative to alleged Securities Act violations (other than the payment by the Registrant of expenses incurred or paid by a director, officer or controlling person in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person, the Registrant will submit to a court of appropriate jurisdiction the question of whether such indemnification is against public policy and will be governed by the final adjudication of such issue.

 

(c) That, for the purpose of determining liability under the Securities Act to any purchaser, each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included in the registration statement as of the date it is first used after effectiveness. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such first use, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such date of first use.

    

 

 
 

 

Pursuant to the requirements of the Securities Act of 1933, the registrant has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized in the City of La Mesa, State of California, on October 9, 2013

 

     
REGEN BIOPHARMA, INC.
     
  By: /s/ David R. Koos
    David R. Koos,
    Chief Executive Officer, Principal Executive Officer
     
  By: /s/ David R. Koos
    David R. Koos,
    Principal Accounting Officer

 

 

 

PURSUANT TO THE REQUIREMENTS OF THE SECURITIES ACT OF 1933, AS AMENDED, THIS REGISTRATION STATEMENT ON FORM S-1HAS BEEN SIGNED BY OR ON BEHALF OF THE FOLLOWING PERSONS IN THE CAPACITIES AND ON THE DATES INDICATED:

 

         
         
Signature   Title   Date
         
/s/ David R. Koos   Principal Executive Officer   October 9, 2013 

David R. Koos        
         
         
/s/ David R. Koos   Principal Accounting Officer   October 9, 2013
David R. Koos        
         
         
/s/ David R. Koos   Director   October 9, 2013
David R. Koos        
         
         
/s/ David R. Koos   Principal Financial Officer   October 9, 2013
David R. Koos        
         
         
/s/ Thomas Ichim    Director    October 9, 2013
Thomas Ichim        
         
         

 

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M]NB_YZ+^=)_:$/\`SU3\ZE\M?[H_*D\E/[J\>U`$0U*`NR^:A90"1FG&]B7& M9%R?>G^2H.=JY^E'E*#G:N?I0!$=2AX_>H<^]']I08)\U./>I?)3&-B\^PH\ ME#U53^%`$0U.W./WR'/O2?VK;Y`\Y.?>IO(3^XOY"CR4P!L7CV%`%<:U;$D& M901Z]_>G#5[8DCSD)'6IO)0]57GVH\E`<[5R?:@"'^U[;&?.0_C1_:MN02)D M./>IA"@(.QFU>?:@"+^T[?:&\Y,'WH;5+=`29EXJ7R5_NK^5'E+_= M7\J`(#J]L.LRTX:I;DX\U2:E\E3U5?RH\E?[J\>U`$)U6W!P9D_.D;5[9 EX-3 10 reg1009forms1ex3_1ii.htm EXHIBIT 3II2

Exhibit No. 3(i)(2)

 

 
 

EX-3 11 reg1009forms1ex3_ii.htm EXHIBIT 3II

Exhibit 3(ii)

BY-LAWS

 

OF

 

REGEN BIOPHARMA INC

 

A NEVADA CORPORATION

 

ARTICLE ONE

 

OFFICES

 

Section 1.1 Registered Office – the registered office of this corporation shall be in the County of Carson City, State of Nevada

 

Section 1.2 Other Offices – The Corporation may also have offices at such other places both within and without the State of Nevada as the Board of Directors may from time to time or the business of the corporation may require.

 

 

ARTICLE TWO

 

MEETINGS OF STOCKHOLDERS

 

Section 2.1 Place – All annual meetings of the stockholders shall be held at registered office of the corporation or at such other place within or without the State of Nevada as the directors shall determine. Special meetings of the stockholders may be held at such time and place within or without the State of Nevada as shall be stated in the notice of the meeting, or in a duly executed waiver of notice thereof.

 

Section 2.2 Annual Meetings – The annual meeting of the stockholders of the corporation shall be held on such date and at such time as designated from time to time for the purpose or electing directors of the corporation and to transact all business as may properly come before the meeting. If the election of the directors is not held on the day designated herein for any annual meeting of the stockholders, or at any adjournment thereof, the president shall cause the election to be held at a special meeting of the stockholders as soon thereafter as is convenient.

 

Section 2.3 Special Meetings – Special meetings of the stockholders, for any purpose or purposes, unless otherwise prescribed by statute or by the Articles of Incorporation, may be called by the CEO or the Secretary by resolution of the Board of Directors or at the request in writing of stockholders owning a majority in amount of the entire capital stock of the corporation issued and outstanding and entitled to vote. Such requests shall state the purpose of the purposed meeting.

 

Section 2.4 Notice of Meetings – Notice of meetings shall be in writing and signed by the President or other officer or by such person or persons as the directors shall designate. Such notice shall state the purpose or purposes of which the meeting is called and the time and place, which may be within or without this state, where it is to be held. A copy of such notice shall either be personally delivered to or shall be mailed to each stockholder of record entitled to vote at such meetings not less than 10 days and not more than 60 days before such meeting. If mailed, it shall be directed to a stockholder as his address as it appears upon the records of the corporation and upon such mailing of any such notice, the service shall be complete and the time of the notice shall begin to run from the date upon which such notice is deposited in the mail for transmission to such stockholder. Personal delivery of any such notice to any officer of a corporation or association or to any member of a partnership shall constitute delivery of such notice of the meeting to the transferee.

 

Section 2.5 Purpose of Meetings – Business transacted at any special meeting of stockholders shall be limited to the purpose stated in the notice.

 

Section 2.6 Quorum – The holders of a majority of the stock issued and outstanding and entitled to vote there at, present in person or represented by proxy, shall constitute a quorum at all meetings of stockholders for the transaction of business except as otherwise provided by statute or by the Articles of Incorporation. If, however, such quorum shall not be present or represented at any meeting of the stockholders, the stockholders entitled to vote there at, present in person or represented by proxy, shall have power to adjourn the meeting from time to time, without notice other than announcement at the , until a quorum shall be present or represented, any business may be transacted which might have been transacted at the meeting as originally notified.

 

Section 2.7 Voting – When a quorum is present or represented at any meeting, the vote of the holders of a majority of the stock having voting power present in person or represented by proxy shall be sufficient to elect directors or to decide any questions brought before such meeting, unless the question is one upon which by express provision of the statutes or of the Articles of Incorporation, a different vote is required in which case such express provision shall govern and control the decision of such question.

 

Section 2.8 Share Voting – Each stockholder of record of the corporation shall be entitled at each meeting of stockholders to one vote for each share of stock standing in his name on the books of the corporation unless such series of stock held by that stockholder shall have been fixed by resolution of the Board of Directors a number of votes per share not equal to one in which case that stockholder shall be entitled to that number of votes so fixed by resolution for each share of stock standing in his name on the books of the corporation .

 

Section 2.9 Proxy – At the meeting of the shareholders any stockholder may be presented and vote by a proxy or proxies appointed by an instrument in writing. In the event that any such instrument in writing shall designate two or more persons to act as proxies, a majority of such persons present at the meeting, or, if only one shall be present, then that one shall have and may exercise all of the powers conferred by such written instrument upon all of the persons so designated unless the instrument shall otherwise provide. No proxy or power of attorney to vote shall be used to vote at a meeting of the stockholders unless it shall have been filed with the secretary of the meeting when required by the inspectors of election. All questions regarding the qualification of voters, the validity of proxies and the acceptance or rejection of votes shall be decided by the inspectors of election who shall be appointed by the Board of Directors, or if not so appointed, then by the presiding officer of the meeting.

 

Section 2.10 Written Consent in Lieu of Meeting – Any action which may be taken by the vote of the stockholders at a meeting may be taken without a meeting if authorized by a written consent of stockholders holding at least a majority of the voting power, unless the provisions of the statutes or of the Articles of Incorporation require a greater proportion of voting power to authorization such action in which case such greater proportion of written consents shall be required.

 

 
 

ARTICLE THREE

 

DIRECTORS

 

Section 3.1 Powers – The business of the corporation shall be managed by its Board of Directors, which may exercise all such powers of the corporation and do all such lawful acts and things as are not by statute or by the Articles of Incorporation or by these Bylaws directed or required to be exercised or done by the stockholders.

 

Section 3.2 Number, Tenure, and Qualification. Except as otherwise provided herein, the Board of Directors of the corporation shall consist of at least one (1) and no more than fifteen (15) persons, who shall be elected at the annual meeting of the stockholders of the corporation and who shall hold office for one (1) year or until his or her successor or successors are elected and qualify.

 

Section 3.3 Resignation. Any director may resign effective upon giving written notice to the Chairman of the Board of Directors, the CEO or the secretary of the corporation, unless the notice specified at a later time for effectiveness of such resignation. If the Board of Directors accepts the resignation of a director tendered to take effect at a future date, the Board of Directors or the stockholders may elect a successor to take office when the resignation becomes effective.

 

Section 3.4 Change in Number. Subject to the limitations of the laws of the State of Nevada or the Articles of Incorporation, the number of directors may be changed from time to time by resolution adopted by the Board of Directors.

 

Section 3.5 Removal.

 

(a) The Board of Directors of the corporation, by majority vote, may declare vacant the office of a director who has been declared incompetent by an order of a court of competent jurisdiction, convicted of a felony, suspected of misfeasance, malfeasance, immoral acts or otherwise brings disrespect or undue negative impact upon the corporation.

 

(b) Any director may be removed from office, with or without cause, by the vote or written consent of stockholders representing not less than fifty percent of the issued and outstanding voting capital stock of the corporation.

 

Section 3.6 Vacancies A vacancy in the Board of Directors because of death, resignation, removal, change in the number of directors, or otherwise may be filled by the stockholders at any regular or special meeting or any adjourned meeting thereof or the remaining director(s) or the affirmative vote of a majority thereof. Each successor so elected shall hold office until the next annual meeting of stockholders or until a successor shall have been duly elected and qualified.

 

Section 3.7 Reduction in Number. No reduction of the number of directors shall have the effect of removing any director prior to the expiration of his term of office.

.

 

ARTICLE FOUR

 

MEETINGS OF THE BOARD OF DIRECTORS

 

Section 4.1 Place – Regular meetings of the Board of Directors shall be held at any place within or without the State which has been designated from time to time be resolution of the Board or by written consent of all members of the Board. In the absence of such designation regular meetings shall be held at the registered office of the corporation. Special meetings of the Board may be held either at a place so designated or at the registered office.

 

Section 4.2 First Meeting – The first meeting of each newly elected Board of Directors shall be immediately following the adjournment of the meeting of stockholders and at the place thereof. No notice of such a meeting shall be necessary to the directors in order legally to constitute the meeting, provided a quorum be present. In the event such meeting is not so held, the meeting may be held at such time and place as shall be specified in a notice given as herein after provided for special meetings of the Board of Directors.

 

Section 4.3 Regular Meetings – Regular meetings of the Board of Directors may be held without call or notice at such a time and at such a place as shall from time to time be fixed and determined by the Board of Directors.

 

Section 4.4 Special Meetings – Special meetings of the Board of Directors may be called by the Chairman or the CEO.

 

Written notice of the time and place of special meetings shall be delivered personally to each director, or sent to each director by mail or by other form of written communication, charges prepaid, addressed to him at his address as it is shown upon the records or if not readily ascertainable, at the place in which the meeting of the directors are regularly held. In case such notice is mailed it shall be deposited in the United States mail at least forty-eight (48) hours prior to the time of the holding of the meeting. In case such notice is delivered as above provided, it shall be so delivered at least at least twenty-four (24) hours prior to the time of holding of the meeting. Such mailing or delivery as above provided shall be due, legal and personal notice to such director.

 

Section 4.5 Notice – Notice of the time and place of holding an adjourned meeting need not be given to the absent directors if the time and place be fixed at the meeting adjourned.

 

Section 4.6 Waiver – The transactions of any meeting of the Board of Directors, however called and noticed or wherever held, shall be as valid as though had a meeting duly held after regular call and notice, if a quorum be present, and if, either before or after the meeting, each of the directors not present signs a written waiver of notice, or a consent to holding such meeting, or an approval of the minutes thereof. All such waivers, consents or approvals shall be filed with the corporate records or made a part of the minutes of the meeting.

 

Section 4.7 Quorum – A Majority of the authorized number of directors shall be necessary to constitute a quorum for the transaction of business, except to adjourn as here in after provided. Every act or decision done or made by a majority of the directors present at a meeting duly held at which a quorum is present shall be regarded as the act of the Board of Directors, unless a greater number is required by law or by the Articles of Incorporation. Any action of a majority, although not a regularly called meeting, and the record thereof, if assented to in writing by all of the other members of the Board shall be as valid and effective in all respects as if passed by the Board in regular meeting.

 

Section 4.8 Adjournment – A quorum of the directors may adjourn any directors meeting to meet again at a stated day and hour; provided, however, that in the absence of a quorum, a majority of the directors present at any directors meeting, either regular or special, may adjourn from time to time until the time fixed for the next regular meeting of the Board.

 

Section 4.9 Meetings of the Board of Directors may be held through the use of a conference telephone or similar communications equipment such as email, instant messaging or similar communication so long as all members participating in such meeting can communicate with one another at the time of such meeting. Participation in such a meeting constitutes presence in person at such meeting. Each person participating in the meeting shall sign the minutes thereof, which may be in counterparts. Approval of said meeting may be accomplished via email or fax.

 

Section 4.10 Board Decisions. The affirmative vote of a majority of the directors present at a meeting at which a quorum is present shall be the act of the Board of Directors.

 

 

 
 

ARTICLE FIVE

 

COMMITTEES OF DIRECTORS

 

Section 5.1 Power to Designate – The Board of Directors may, by resolution adopted by a majority of the whole Board, designate one or more committees of the Board of Directors, each committee to consist of one or more of the directors of the corporation which, to the extent provided in the resolution, shall have and may exercise the power of the Board of Directors in the management of the business and affairs of the corporation and may have power to authorize the seal of the corporation to be affixed to all papers which may require it. Such committees shall have such name or names as may be determined from time to time by the Board of Directors. The members of any such committee present at any meeting and not disqualified from voting may, whether or not they constitute a quorum, unanimously appoint another member of the Board of Directors to act at the meeting in the meeting in the place of any absent or disqualified member. At meetings of such committees, a majority of the members or alternate members shall constitute a quorum for the transaction of business, and the act of a majority of the members or alternate members at any meeting at which there is a quorum shall be the act of the committee.

 

Section 5.2 Regular Minutes – The committees shall keep regular minutes of their proceedings and report the same to the Board of Directors.

 

Section 5.3 Written Consent – Any action required or permitted to be taken at any meeting of the Board of Directors or of any committee thereof may be taken without a meeting if a written consent thereto is signed by all members of the Board of Directors or of such committee, as the case may be, and such written consent is filed with the minutes of proceedings of the Board or committee.

 

 

ARTICLE SIX

 

COMPENSATION OF DIRECTORS

 

Section 6.1 Compensation – The directors may be paid their expenses of attendance at each meeting of the Board of Directors and may be paid a fixed sum for attendance at each meeting of the Board of Directors or a stated salary as director. No such payment shall prelude any director from serving the corporation in any other capacity and receiving compensation therefore. Members of special or standing committees may be allowed like reimbursement and compensation for attending committee meetings.

 

 

ARTICLE SEVEN

 

NOTICES

 

Section 7.1 Notice – Notices to directors and stockholders shall be in writing and delivered personally or mailed to the directors or stockholders at their addresses appearing on the books of the corporation. Notice by mail shall be deemed to be given at the time when the same shall be mailed. Notice to directors may also be given by telegram.

 

Section 7.2 Consent – Whenever all parties entitled to vote at any meeting, whether of directors or stockholders, consent, either by a writing on the records of the meeting or filed with the secretary, or by presence at such meeting and oral consent entered on the minutes, or by taking part in the deliberations at such meeting without objection, the doings of such meetings shall be as valid as if they had occurred at a meeting regularly called and noticed, and at such meeting any business may be transacted which is not excepted from written consent or to the consideration of which no objection for want of notice is made at the time, and if any meeting be irregular for want of notice or of such consent, provided a quorum was present at such a meeting, the proceedings of said meeting may be ratified and approved and rendered likewise valid and the irregularity of defect therein waived by a writing signed by all parties having the right to vote at such meeting; and such consent or approval of stockholders may be proxy or attorney, but all such proxies and powers of attorney must be in writing.

 

Section 7.3 Waiver of Notices – Whenever any notice whatsoever is required to be given under the provisions of the statutes, of the Articles of Incorporation or of these Bylaws, a waiver thereof in writing, signed by the person or persons entitled to said notice, whether before or after the time stated therein, shall be deemed equivalent thereto.

 

 

ARTICLE EIGHT

 

OFFICERS

 

Section 8.1 Appointment of Officers – The officers of the Corporation shall be chosen by the Board of Directors and shall be Chief Executive Officer, a Secretary and a Treasurer. Any person may hold two or more offices.

 

Section 8.2 Time of Appointment – The Board of Directors at its first meeting after each annual meeting of stockholders shall choose a Chairman of the Board who shall be a director, and shall choose a Chief Executive Officer, a Secretary and a Treasurer, none of whom need be directors.

 

Section 8.3 Additional Officers – The Board of Directors may appoint such other officers and agents as it shall deem necessary who shall hold their offices for such terms and shall exercise such powers and perform such duties as shall be determined from time to time by the Board of Directors.

 

Section 8.4 Salaries – The salaries and compensation of all officers of the corporation shall be fixed by the Board of Directors.

 

Section 8.5 Vacancies, Removals, Resignations –Any officer or agent elected or appointed by the Board of Directors may be removed by it with or without cause. Any office may resign at any time upon written notice to the corporation without prejudice to the rights, if any, of the corporation under contract to which the resigning officer is a party. Any vacancy in any office because of death, resignation, removal or otherwise may be filled by the Board of Directors for the unexpired term or such office.

 

Section 8.6 Chairman of the Board – The Chairman of the Board shall preside at meetings of the stockholders and the Board of Directors, and shall see that orders and resolutions of the Board of Directors are carried into effect.

 

Section 8.7 Vice-Chairman of the Board – The Vice-Chairman shall, in the absence or disability of the Chairman of the Board, perform the duties and exercise the powers of Chairman of the Board and shall perform such other duties as the Board of Directors may from time to time prescribe.

 

Section 8.8 Chief Executive Officer – The Chief Executive Officer (also referred to in these Bylaws as the CEO) of the corporation shall be deemed the general manager and executive officer of the corporation subject to the supervision and control of the Board of Directors, and shall direct the corporate affairs, with full power to execute all resolutions and orders of the Board of Directors not especially entrusted to some other officer of the corporation. The CEO, or his designee, shall perform such other duties as shall be prescribed by the Board of Directors. Unless otherwise ordered by the Board of Directors, the CEO, or his designee shall have the full power and authority on behalf of the corporation to attend, act and vote at meetings of the stockholders of any corporation in which the corporation may hold stock and, at such meetings, shall possess and may exercise any and all rights and powers incident to the ownership of such stock. The Board of Directors, by resolution from time to time, may confer like powers on any person or persons in place of the CEO to represent the corporation for these purposes.

 

Section 8.9 Secretary – The Secretary shall act under the direction of the CEO. Subject to the direction of the CEO he shall attend all meetings of the Board of Directors and all meetings of the stockholders and record the proceedings. He shall perform like duties for the standing committees when required. He shall give, or cause to be given, notice of all meetings of the stockholders and special meetings of the Board of Directors, and shall perform such other duties as may be required by the CEO or the Board of Directors.

 

Section 8.10 Treasurer – The Treasurer shall act under the direction of the CEO. Subject to the direction of the CEO he shall have custody of the corporate funds and securities and shall keep full and accurate accounts of receipts and disbursements in books belonging to the corporation and shall deposit all monies and other valuable effects in the name and to the credit of the corporation in such depositories as may be designated by the Board of Directors. He shall disburse the funds as may be ordered by the CEO or the Board of Directors, taking proper vouchers for such disbursements, and shall render to the CEO and the Board of Directors, at its regular meetings, or when the Board of Directors so requires, an account of all his transactions as Treasurer and of the financial condition of the corporation.

 

Section 8.11 Surety – If required by the Board of directors, he shall give the corporation a bond in such sum surety or sureties as shall be satisfactory to the Board of Directors for the faithful performance of the duties of his office and for the restoration to the corporation, in case of his death, resignation, retirement or removal from office, of all books, papers, vouchers, money and other property of whatever kind in his possession or under his control belonging to the corporation.

 

 
 

ARTICLE NINE

 

CERTIFICATES OF STOCK

 

Section 9.1 Share Certificates – Every stockholder shall be entitled to have a certificate signed by the President or a Vice-President and the Treasurer or an Assistant Treasurer, or the Secretary of the corporation, certifying the number of shares owned by him in the corporation. If the corporation shall be authorized to issue more than one class of stock or more than one series of any class, the designations, preferences and relative participating, optional or other special restrictions of such rights, shall be set forth in full or summarized on the face or back of the Certificate which the corporation shall issue to represent such stock.

 

Section 9.2 Transfer Agents – if a certificate is signed (a) by a transfer agent other than the corporation or its employees or (b) by a registrar other than the corporation or its employees, the signatures of the officers of the corporation may be facsimiles. In case any officers who has signed or who’s facsimile signature has been placed upon a certificate shall cease to be such officer before such certificate is issued, such certificate may be issued with the same effect as though the person had not ceased to be such officer. The seal of the corporation, or a facsimile thereof, may, but need not be, affixed to the certificate of stock.

 

Section 9.3 Lost or Stolen Certificates – The Board of Directors may direct a new certificate or certificates to be issued in place of any certificate theretofore issued by the corporation alleged to have been lost or destroyed upon the making of an affidavit to the fact by the person claiming the certificate of stock to be lost or destroyed. When authorizing such issue of a new certificate or certificates, the Board of Directors may, in its discretion and as a condition precedent to the issue thereof, require the owner of such lost or destroyed certificate or certificates or his legal representative, to advertise the same in such a manner as it shall require and/or give the corporation a bond in such sum as it may direct as indemnity against any claim that may be made against the corporation with respect to the certificate alleged to have been lost or destroyed.

 

Section 9.4 Share Transfers – upon surrender to the corporation or the transfer agent of the corporation of a certificate for shares duly endorsed or accompanied by a proper evidence of succession, assignment or authority to transfer, it shall be the duty of the corporation, if it is satisfied that all provisions of the laws and regulations applicable to the corporation regarding transfer and ownership of shares have been complied with, to issue a new certificate to the person entitled thereto, cancel the old certificate and record the transaction upon its books.

 

Section 9.5 Voting Shareholder – The Board of Directors may fix in advance a date not exceeding sixty (60) days nor less than ten (10) days preceding the date of any meeting of stockholders, or the date for the payment of any dividend, or date for the allotment of rights, or the date when any change or conversion or exchange of capital stock shall go into effect, or a date in connection with obtaining the consent of stockholders for any purpose, as a record date for determination of the stockholders entitled to receive payment of any such meeting, and any adjournment thereof, or entitlement to receive payment of any such dividend, or to give such consent, and in such case, such stockholders, and only such stockholders as shall be stockholder of record on the date so fixed, shall be entitled to notice of and to vote at such a meeting, or any adjournment thereof, or to receive payment of such dividend, or to receive such allotment of rights, or to exercise such rights, or to give such consent, as the case may be, notwithstanding any transfer of any stock on the books of the corporation after any such record date fixed as foresaid.

 

Section 9.6 Shareholders Record – The corporation shall be entitled to recognize the person registered on its books as the owner of shares to be the exclusive owner for all purposes including voting and dividends, and the corporation shall not be bound to recognize any equitable or other claim to or interest in such share or shares on the part of any other person, whether or not it shall have expressed or other notice thereof, except as otherwise provided by the laws of Nevada.

 

Section 9.7 Notwithstanding any other provision in these By-Laws, the Corporation may adopt a system of issuance, recordation and transfer of its shares by electronic or other means not involving any issuance of certificates, including provisions for notice to purchasers in substitution for any required statements on certificates.”

 

ARTICLE TEN

 

GENERAL PROVISIONS

 

Section 10.1 Dividends – Dividends upon the capital stock of the corporation, subject to the provisions of the Articles of Incorporation, if any, may be declared by the Board of Directors at any regular or special meeting, pursuant to law. Dividends may be paid in cash, in property or in shares of the capital stock, subject to the provisions of the Articles of Incorporation.

 

Section 10.2 Reserves – Before payment of any divided, there may be set aside out of any funds of the corporation available for dividends such sum or sums as the directors from time to time, in their absolute discretion, think proper as a reserve or reserves to meet contingencies, or for equalizing dividends or for repairing or maintaining any property of the corporation or for such other purpose as the directors shall think conductive to the interest of the corporation, and the directors may modify or abolish any such reserve in the manner in which it was created.

 

Section 10.3 Checks – All checks or demands for money and notes of the corporation shall be signed by such officer or officers or such other person or persons as the Board of Directors may from time to time designate.

 

Section 10.4 Fiscal Year – The fiscal year end of the corporation shall beSeptember 30.

 

Section 10.5 Corporate Seal – The Corporation may or may not have a corporate seal, as may from time to time be determined by resolution of the Board of Directors. If a corporate seal is adopted, it shall have inscribed thereon the name of the Corporation and the words “Corporate Seal” and “Nevada”. The seal may be used by causing it or a facsimile thereof to be impressed or affixed or in any manner reproduced.

 

 
 

ARTICLE ELEVEN

 

INDEMNIFICATION

 

Every person who was or is a party or is threatened to be made party to or is involved in any action, suit or proceeding, whether civil, criminal, administrative or investigative, by reason of the fact that he or a person of whom he is the legal representative is or was a director or officer of the corporation or is or was serving at the request of the corporation or for its benefit as a director or officer of another corporation, or as its representative in a partnership, joint venture, trust or other enterprise, shall be indemnified and held harmless to the fullest extent legally permissible under the General Corporation Law of the State of Nevada from time to time against all expense, liability and loss (including attorney’s fees, judgments, fines and amounts paid or to be paid in settlement) reasonably incurred in defending a civil or criminal action, suit or proceeding must be paid by the corporation as they are incurred and in advance of the final disposition of the action, suit or proceeding upon receipt of an undertaking by or on behalf of the director or officer to repay the amount if it is ultimately determined by a court of competent jurisdiction that he is not entitled to be indemnified by the corporation. Such a right of indemnification shall be a contract right which may be enforced in any manner desired by such person. Such right of indemnification shall not be exclusive of any other right which such directors, officers or representatives may have or hereafter acquire and, without limiting the generality of such statement, they shall be entitled to their respective rights of indemnification under any bylaw, agreement, vote of stockholders, provision of law or otherwise, as well as their rights under this Article.

 

The Board of Directors may cause the corporation to purchase and maintain insurance on behalf of any person who is or was a director or officer of the corporation, or is or was serving at the request of the corporation as a director or officer of another corporation, or as its representative in a partnership, joint venture, trust or other enterprise against any liability asserted against such person and incurred in any such capacity or arising out of such status, whether or not the corporation would have the power to indemnify such person.

 

The Board of Directors may from time to time adopt further Bylaws with respect to indemnification and may amend these and such Bylaws to provide at all times the fullest indemnification permitted by the General Corporate Law of the State of Nevada.

 

 

ARTICLE TWELVE

 

AMENDMENTS

 

 

Section 12.1 By Shareholder – The Bylaws may be amended by a majority vote of all the stock issued and outstanding and entitled to vote at any annual or special meeting of the stockholders, provided notice of intention to amend shall have been contained in the notice of the meeting.

 

Section 12.2 By Board of Directors – The Board of Directors by a majority vote of the whole Board at any meeting may amend these Bylaws, including Bylaws adopted by the stockholders, but the stockholders may from time to time specify particular provisions of the Bylaws which shall not be amended by the Board of Directors.

 

 

APPROVED AND ADOPTED this 1st day of May, 2012.

 

 

 

 _/s/ David Koos__________________________

Secretary

 

 
 

CERTIFICATE OF SECRETARY

 

 

I hereby certify that I am the Secretary of Regen Biopharma Inc and that the foregoing Bylaws, consisting of 14 pages, constitute the code of Bylaws of Regen Biopharma Inc, as duly adopted at a regular meeting of the Board of Directors of the corporation held May 1, 2012.

 

IN WITNESS WHEREOF, I have hereunto subscribed my name this 1st day of May, 2012.

 

 

 

 _/s/ David Koos__________________________

Secretary 

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Exhibit 10.1

Exclusive License Agreement

Between OHSU and Regen BioPharma, INC

For Invention Disclosure 0472

 

 

 

 

 

 1.

BACKGROUND

 

 2
 2.

DEFINITIONS

 

 2
 3.

GRANT OF RIGHTS

 

 5
 4.

PAYMENTS

 

 6
 5.

SUBLICENSING

 

 8
 6.

COMMERCIALIZATION

 

 9
 7.

RESTRICTIONS

 

10
 8.

BOOKS, RECORDS AND REPORTS

 

11
 9.

CONFIDENTIAL INFORMATION

 

12
 10.

PROSECUTION, DEFENSE AND MAINTENANCE OF PATENTS

 

11
 11.

PATENT ENFORCEMENT

 

13
 12.

REPRESENTATIONS, WARRANTIES AND DISCLAIMERS

 

14
 13.

INSURANCE

 

15
 14.

INDEMNIFICATION

 

15
 15.

TERM AND TERMINATION

 

16
 16.

GENERAL PROVISIONS

 

17

APPENDIX A: PATENT RIGHTS AND KNOW HOW

 

21

APPENDIX B: COMMERCIAL DEVELOPMENT PROGRESS REPORT

 

22

APPENDIX C: FORM OF QUARTERLY REPORT

 

23

 

 

1
 

 
 

EXCLUSIVE LICENSE AGREEMENT

 

This Exclusive License Agreement (this "Agreement"), dated and effective as of June 5, 2013 (the "Effective Date"), is between the Oregon Health & Science University, having offices at 0690 SW Bancroft Street, L106TT,  Portland, Oregon 97239 ("OHSU"), and Regen BioPharma, Inc., having offices at 4700 Spring St # 304, La Mesa, CA 91942 ("Licensee").  OHSU and Licensee are herein referred to each as a "Party" and collectively as the "Parties."

 

1.   BACKGROUND

 

1.1   OHSU has certain inventions and discoveries generally described in OHSU Invention Disclosure ##0472 entitled “Method for enhancing hematopoiesis” (the "Invention").

 

1.2   OHSU desires the Invention to be utilized for the public benefit to the fullest extent possible.

 

1.3   Licensee intends to bring together the scientific and business talent, facilities and capital to develop and market products and processes based upon the Invention.

 

1.4   Licensee wishes to obtain from OHSU, and OHSU is willing to grant to Licensee, a license to exploit the Invention subject to the terms and conditions set forth below.

 

2.   DEFINITIONS

 

2.1   "Affiliate" means any entity that controls, is controlled by or is under common control with Licensee, where "control" means beneficial ownership of more than 50% of the outstanding voting securities of an entity, the right to receive 50% or more of the profits or earnings, or the ability otherwise to elect a majority of the board of directors or other managing authority.

 

2.2   "Change of Control" means (a) the acquisition, either directly or indirectly, through one or a series of transactions by any third party of more than fifty one percent (51%) of the assets of Licensee; (b) any merger or consolidation involving Licensee that  either directly or indirectly, through one or a series of transactions by which any third party acquires more than fifty one percent (51%) of the voting stock of Optionee; or (c) the transfer to any third party of all or substantially all the assets of Licensee relating to the subject matter of this Agreement.

 

2.3   "Clinician Sublicensees" means any person or entity that directly or indirectly obtains any rights in or to Licensed Technology from Licensee to use the Licensed Technology in a clinical setting, including the purchase of Licensed Product.  Any remuneration received by Licensee from Clinician Sublicensees to use the Licensed Technology in a clinical setting will be subject to the Royalty Payments as set forth in Section 4.3.

 

2.4   "Commercial Development Progress Report" means a written plan submitted by Licensee describing the details of how and when Licensee intends to commercially develop and exploit the Licensed Technology, attached hereto in Appendix B, and as updated pursuant to Section 6.2.

 

 

2
 

 

2.5    "Confidential Information" means all information and materials provided by one Party ("Disclosing Party") to the other ("Recipient") and designated as confidential by Disclosing Party when provided.  The term "Confidential Information" does not include any information or materials that the Recipient demonstrates (a) is or becomes part of the public domain through no fault of the Recipient or anyone receiving the Confidential Information from Recipient; (b) was already known to Recipient prior to disclosure as demonstrated through adequate written records; (c) is disclosed to Recipient by a third party who has the right to make such disclosure; or (d) through adequate written records to have been developed independently of knowledge of or access to the Confidential Information. The specific terms and conditions of this Agreement are Confidential Information, but the existence of the Agreement and Field of Use are not.

 

2.6   "Field of Use" means all therapeutic uses related to treatment of diseases in humans and/or animals.

 

2.7   "Inventors" means the individuals listed as inventors on any patent application or issued patent included within the Patent Rights.

 

2.8   "Know-How" means all information, including Confidential Information, related to the Invention provided by the Inventors, as set forth in Appendix A.

 

2.9   "Least Developed Countries" means each country identified as a low-income economy by the World Bank Group and by the United Nations on their respective websites at the time the Licensed Product is transferred, and all other countries mutually agreed to in writing by OHSU and Licensee.

 

2.10   "Licensed Product" means (a) any method, procedure, service or process that incorporates, uses, used, is covered by, infringes or would infringe any of the Licensed Technology but for the exception in 35 U.S.C. §271(e)(1), or similar exception in the U.S. or foreign jurisdictions; and (b) any apparatus, material, equipment, machine or other product that incorporates, uses, used, is covered by, infringes or would infringe any of the Licensed Technology but for the exception in 35 U.S.C. §271(e)(1), or similar exception in the U.S. or foreign jurisdictions.

 

2.11   "Licensed Technology" means (a) a pending or issued claim of the Patent Rights; and/or (b) the Know-How.

 

2.12   "Net Sales" means the gross invoiced amount, and/or the monetary equivalent of any other consideration actually received by Licensee and/or its Sublicensees, for the transfer of a Licensed Product, less any of the following items that are itemized on the relevant invoice or which Licensee can demonstrate have been actually paid or credited with respect to such transfer:

 

(a)   outbound shipping, storage, packing and insurance expenses;

 

(b)   distributor discounts;

 

3
 

 

(c)   allowance for doubtful accounts or uncollectible accounts receivable;

 

(d)   amounts repaid or credited as a result of rejections, defects, or returns, provided that such rejected, defective or returned Licensed Products are not re-transferred; and

 

(e)   sales and other excise taxes (excluding VAT), tariffs, export license fees and duties paid to a governmental entity.

 

Sales commissions are not deductible.  If Licensee or Sublicensee determines the resale price for subsequent transfers of Licensed Product, then Net Sales will be calculated based on the resale invoiced amount. If Licensee or Sublicensees sell the Licensed Products with any other goods or services, Net Sales will be calculated based on the mutually agreeable fair market value of the Licensed Products.  Net Sales accrue at the first of delivery or invoice.

 

 

2.13   "Patent Costs" means all out-of-pocket costs and expenses incurred by OHSU in connection with the preparation, filing, prosecution, defense, including interference and opposition proceedings, and maintenance of the Patent Rights.

 

2.14   "Patent Rights" means the patents and patent applications listed on Appendix A to this Agreement, PCT, U.S. and foreign applications thereon, including continuations, continuations-in-part (but only to the extent of subject matter therein that is described sufficiently in the patents and patent applications listed on Appendix A to satisfy the requirements of 35 U.S.C. §112) and divisionals, patents issuing from any of the foregoing, and reissues, extensions, supplementary protection certificates, substitute applications, and reexaminations of any of the foregoing.

 

2.15   Technology Sublicensees” means any person or entity that directly or indirectly obtains any rights in or to the Licensed Technology from Licensee to use the Licensed Technology to further develop or modify the Licensed Technology or to incorporate the Licensed Technology into such Sublicensee’s products or services.  Any remuneration received by Licensee from Technology Sublicensees will be subject to the Technology Sublicensee Payments set forth in Section 4.6.

 

2.16   "Sublicensees" means any person or entity including an Affiliate that directly or indirectly obtains any rights in or to Licensed Technology from Licensee, including by an agreement not to assert rights, other than solely from the purchase of Licensed Product, including Clinician Sublicensees and Technology Sublicensees.

 

2.17   "Term" means the period beginning on the Effective Date and ending on the date when (a) the last patent and patent application included within the Patent Rights have expired, been abandoned, or been finally adjudicated as invalid or unenforceable by a non-appealable order; or (b) 10 years, whichever is later.

 

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3.   GRANT OF RIGHTS

 

3.1   Licenses

 

(a)   Exclusive Patent License. Subject to the terms and conditions of this Agreement and Licensee’s compliance therewith, OHSU grants to Licensee an exclusive, worldwide and nontransferable (except as provided below) license in the Field of Use under the Patent Rights, to make, have made, use, offer to sell, sell and import Licensed Products for the Field of Use.

 

(b)   Non-Exclusive Know-How License. Subject to the terms and conditions of this Agreement and Licensee’s compliance therewith, OHSU grants to Licensee a nonexclusive and nontransferable (except as provided below) license in the Field of Use to use the Know-How to make, have made, offer to sell, sell and import Licensed Products for the Field of Use.  OHSU has made the Know-How reasonably available to Licensee on an "AS IS, WHERE IS" basis and will transfer materials, if any, that are included within the Know-How on the same basis within 90 days of receipt of the payment required by Section 4.1.  OHSU has no other obligation with respect to the Know-How.

 

(c)   Sublicense.  Licensee will have the right to grant sublicenses under the rights conveyed in Sections 3.1(a) and (b) as set forth in Section 5 to Clinician Sublicensees and to Technology Sublicensees.  If an Affiliate of Licensee desires to practice the Licensed Technology, such Affiliate must become either a Clinician Sublicensee or a Technology Sublicensee hereunder.

 

(d)   Limited License.  OHSU has not authorized  any products or processes other than Licensed Products made, used, sold and imported in compliance with this Agreement and Licensee agrees not to practice or have practiced OHSU’s rights in contravention therewith.  All conveyances of the rights licensed in this Section 3.1, including sublicenses, assignments and transfers will be consistent with the terms and conditions of this Agreement or will be null and void.

 

3.2   Retained Rights.

 

(a)   OHSU reserves the right to (i) practice and have practiced the Licensed Technology for research, education and/or non-profit patient care purposes, and publishing any scientific findings or other information relating to or including the Licensed Technology; and (ii) all right, title and interest in and to the Licensed Technology not expressly granted in Section 3.1.

 

(b)   This Agreement does not confer any right, title or interest, including any license or rights by implication, estoppel or otherwise, in tangible or intangible property rights, including any patents, know-how or other inventions or discoveries, that are not explicitly granted to Licensee in Section 3.1, and OHSU expressly retains those rights.

 

(c)   Patent exhaustion will not apply for any unauthorized sale, and Licensee will provide notice of the Field of Use restrictions to all entities, including Sublicensees and customers to prevent exhaustion of the Patent Rights and any implied license.

 

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4.   PAYMENTS

 

As partial consideration for the rights granted to Licensee under this Agreement, Licensee will pay OHSU the following:

 

4.1   License Issue Payment.  Licensee will pay OHSU a license issue payment of Thirty-five Thousand Dollars ($35,000) within 30 days after the Effective Date. Option fees may be credited towards this license fee.

 

4.2   Milestone Payments.  Licensee will pay OHSU the following amounts within 30 days of Licensee or any Sublicensee achieving each of the following milestones:

 

4.2.1   Twenty-five Thousand Dollars ($25,000) on the enrollment of the first patient in a Phase I clinical trial anywhere in the world for each Licensed Product.

 

4.2.2   One Hundred Fifty Thousand Dollars ($150,000) on the enrollment of the first patient in a Phase III clinical trial anywhere in the world for each Licensed Product.

 

4.2.3   Two Hundred Fifty Thousand Dollars ($250,000) on the first regulatory approval anywhere in the world for each Licensed Product.

 

4.3   Royalty Payments.  Licensee will pay OHSU a continuing royalty as set forth below.  No multiple royalty payments will be payable to OHSU because a Licensed Product may be covered by more than one patent or patent application included within the Patent Rights or may embody the use of both Patent Rights and Know-How.  Royalty payments are due and payable within 30 days after the end of the calendar quarter in which the Net Sale occurred and must be accompanied by a Quarterly Report as more fully described in Section 8.2 below.

 

4.3.1   2% Of Net Sales outside the Least Developed Countries; which percentage may be reduced in half where the Licensed Product embodies solely the Know-How and not the Patent Rights.

 

4.3.2   0% Of Net Sales solely within any of the Least Developed Countries, so long as the Net Sales received by Licensee and/or Sublicensees solely cover Licensee's or Sublicensees' reasonable and documented direct costs to manufacture the Licensed Products ("Costs").

 

4.3.3   1% Of Net Sales solely within any of the Least Developed Countries that exceed Costs.

 

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4.4   License Maintenance Payments.  For the first four (4) years until the first Net Sale, Licensee will pay OHSU a license maintenance payment of One Thousand Dollars ($1,000) by each anniversary of the Effective Date. Beginning in year 5 until the first Net Sale, Licensee will pay OHSU a license maintenance payment of then Five Thousand Dollars ($5,000) by each anniversary of the Effective Date.

 

4.5   Minimum Royalty Payments.  Commencing on the first January 1 to occur after the first Net Sale, and for each year thereafter, Licensee will pay to OHSU minimum annual royalty of Ten Thousand Dollars ($10,000).  OHSU will credit payment of minimum royalties received against any subsequent royalty payments made by Licensee, but only for the year in which the minimum annual royalty was received.

 

4.6   Technology Sublicensee Payments.  Licensee will pay OHSU the percentage set forth below of all remuneration received from a Technology Sublicensee, whether in the form of money, equipment, property, equity, debt financing or any other cash or noncash consideration, other than sales generating royalty payments to OHSU pursuant to Section 4.3.  The Parties will negotiate in good faith to determine the fair market value of all noncash remuneration within 30 days of receipt, and Licensee will pay OHSU such amount by the end of such 30 day period.

 

4.6.1   30% in the 1st year.

 

4.6.2   25% in the 2nd year.

 

4.6.3   20% in the 3rd year.

 

4.6.4   15% in the 4th year and thereafter.

 

4.7   Reimbursement of Patent Costs.  Within 30 days after the Effective Date, Licensee will pay OHSU the sum of $9,167.12, which represents Patent Costs incurred by OHSU as of April 30, 2012.  Licensee will also reimburse OHSU for all Patent Costs occurring thereafter pursuant to Section 10.2.

 

4.8   Payment Terms.

 

(a)   Except as expressly provided in Section 4.5, all payments are nonrefundable and noncreditable, and due and payable to OHSU by Licensee on the date specified in this Agreement.  In the event no date is specified, payment is due within 30 days from the date of the invoice.

 

(b)   Any unpaid invoices or payments will incur a late fee of 1.0% per month (12% per annum) until paid.  Acceptance of late payments does not negate or waive OHSU's right to seek any other remedy in law, equity or otherwise.

 

(c)   All amounts payable to OHSU under this Agreement are payable in United States dollars, including royalties based on Net Sales in foreign countries and sublicensee payments payable by Sublicensees located in foreign countries.

 

(d)   United States dollar amounts will be calculated using the foreign exchange rate published in The Wall Street Journal in effect for that foreign currency on the last business day of the reporting period to which the payment relates, and all fees in connection with making the payment will be borne by Licensee.

 

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(e)   Licensee will bear all credit risks associated with its Sublicensees and is responsible for making all payments of all royalties, sublicensee payments and other sums required under this Agreement by Licensee and Sublicensees.

 

(f)   All amounts payable to OHSU under this Agreement are net of all taxes and other charges, and Licensee will be responsible for paying all taxes, fees and other charges levied by any taxing authority on account of license payments, royalties or any other sums payable under this Agreement.  Licensee will deliver copies of all official tax receipts.

 

(g)   All payments required under this Agreement will be delivered by hand, by overnight courier, or by first class, registered or certified mail, properly addressed to OHSU at the address listed in Section 16.1 below.

 

4.9   Third Party Royalties.  If Licensee is required to pay royalties to a third party in order to sell Licensed Products as a result of (a) governmental laws; (b) settlement agreements; (c) a final nonappealable judgment in an infringement action; or (d) good faith determination by Licensee that infringement will occur without a license, and OHSU concurs, the Parties will negotiate a reduction in the percentage used to calculate royalties for the period of time such third party payments are made  However, in no event shall the royalties due OHSU be reduced by more than fifty percent (50%)]

 

4.10   Combination Products.  If the Parties agree the Licensed Products should be sold in combination with other products or processes ("Other Products"), then Net Sales shall be calculated on the following basis

 

4.10.1   if Licensed Product and Other Products have each been sold separately, the total price of the combination multiplied by the ratio of the separate prices of the Licensed Product over the Other Products;

 

4.10.2   if Licensed Product has been sold separately but the Other Products have not, the price of the combination multiplied by the ratio of the separate price of the Licensed Product to the price of the combination; or

 

4.10.3   if the Licensed Product has not been sold separately, then the parties agree to negotiate a reduction in the royalty to reflect the fair value of the Licensed Product to the combination.

 

4.10.4   However, in no event shall the royalties due OHSU be reduced by more than fifty percent (50%).

 

5.   SUBLICENSING

 

5.1   Method of Granting a Sublicense.  Subject to the terms and conditions of this Agreement and Licensee’s compliance therewith, Licensee may grant sublicenses under this Agreement to Clinician Sublicensees and to Technology Sublicensses by entering into a written sublicense agreement (a) that names OHSU as a third party beneficiary; (b) is consistent with all terms and conditions of this Agreement, including Sections 7 (Restrictions), 8 (Books, Records and Reports), 9 (Confidential Information), 12 (Representations, Warranties and Disclaimers) and 14 (Indemnification); and (c) provides that it will terminate upon the earlier of the termination or expiration of this Agreement.

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5.2   Duty to Deliver a Copy of the Sublicense Agreement to OHSU.  Within 30 days after the execution of each sublicense agreement and any amendment thereof, Licensee will deliver to OHSU a copy of that sublicense agreement and/or amendment to OHSU.

 

5.3   Liability.  Licensee remains liable for Sublicensee's compliance with the terms and conditions of this Agreement, and OHSU has the right to audit Sublicensee's compliance.

 

6.   COMMERCIALIZATION

 

6.1   Diligence.  Licensee will use its reasonable best efforts to develop, manufacture or have manufactured, market and sell Licensed Products as soon as practicable consistent with reasonable business practices and judgment and any obligations to the U.S. government specified in Section 3.3 including::

 

6.1.1   Identification of optimum embodiment of patent claims for clinical development (e.g.: utilization of endothelial cells from bone marrow versus placenta, versus adipose stromal vascular fraction) by August 2013

 

6.1.2   Creation of white paper in peer reviewed journal comparing hematopoietic stimulatory activity of endothelial cells from different tissues of the body. This puts forth the scientific rationale for the project by September 2013

 

6.1.3   Selection of manufacturing facility and development of Good Manufacturing Practice (GMP) protocol for creation of preclinical samples for experimentation by October 2013.

 

6.1.4   Establishment of preclinical animal model to replicate patient data using cells produced according to Regen standard operating  procedures by December 2013

 

6.1.5   Recruitment of Principal Investigator for Clinical Trial by February 2014.

 

6.1.6   Compilation of preclinical efficacy and safety data for IND generation by April 2014

 

6.1.7   Submission of IND application to FDA by May 2014

 

7.   Commercial Development Progress Report.    Furthermore, Licensee will provide a Commercial Development Progress Report to OHSU within 60 days after the end of each calendar year that includes the following information substantially in the form attached as Appendix B.

 

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8.   RESTRICTIONS

 

8.1   Use Restrictions.  Neither Licensee nor Sublicensees will use the Licensed Products without paying a royalty, except to (a) obtain regulatory approval of Licensed Products; (b) demonstrate the Licensed Products to potential customers or partners; or (c) as provided for herein.

 

8.2   Sales, Transfer and Encumbrance Restrictions.  Neither Licensee nor Sublicensees will sell, lease, license, import, transfer or otherwise dispose of any Licensed Products other than in a manner that supports commercialization of the Licensed Products.

 

8.3   Compliance with Laws.

 

(a)   Licensee is subject to all United States laws and regulations, including the Export Administration Act of 1979 and the Arms Export Control Act (collectively, the "Export Acts") that control the export of technical data, computer software, laboratory prototypes, biological material and other commodities.  The transfer of those items may require a license from the U.S. Government or written assurances by Licensee that it will not export such items to certain foreign countries without prior approval from the U.S. Government.  OHSU neither represents that a license is required, nor that if required, it will be issued.

 

(b)   Licensee will at all times and at its expense (i) comply with the Export Acts and obtain all required export licenses and approvals necessary; (ii) register and give the required notice of this Agreement in each country where an obligation exists; and (iii) be solely responsible for ensuring that Licensee's performance, the Licensed Technology and the Licensed Products comply with all applicable laws, rules, regulations, orders, decrees, judgments and other governmental acts of any foreign governmental authorities having jurisdiction over Licensee or any Sublicensee (including any health and safety rules and regulations and any patent, copyright, trademark or other infringement laws).

 

8.4   No Endorsement/Use of OHSU's Name.

 

  (a)        At Licensee's request, Licensee and OHSU will issue a joint press release regarding the existence of this Agreement in a form acceptable to both Parties.  Neither Party will use the name, image, trade or service marks, landmarks, monuments, likeness, logos or any other distinguishing feature of the other Party or any employee of the other Party in any press release, general publication, advertising, marketing, promotional or sales literature (“Releases”), in each case without the prior written consent of the other Party, which consent shall not be unreasonably withheld.  Once such consent has been made, the Parties agree that each shall have the right to use any information contained therein for future Releases.  OHSU has the right to state that Licensee and Sublicensees are licensed under the Licensed Technology.

 

  (b)       Notwithstanding anything to the contrary, OHSU does not directly or indirectly endorse any product or service provided, or to be provided, by Licensee and/or Sublicensees including the Licensed Product. Licensee will not state or imply any endorsement by OHSU or any of its employees.

 

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8.5   Marking.  Licensee will mark, and cause each Sublicensee to mark, all Licensed Products with notices of the Patent Rights and of the license that will enable the Patent Rights to be enforced to their full extent in any country where the Licensed Products are made, used, sold or imported.  Licensee will provide evidence of proper marking upon request by OHSU.

 

9.   BOOKS, RECORDS AND REPORTS

 

9.1   Notice of First Commercial Transfer.  Licensee will notify OHSU of the first transfer for commercial purposes of each Licensed Product in each country in the world within 30 days of each such date.

 

9.2   Quarterly Reports.  Commencing on first commercial transfer of Licensed Product, Licensee will deliver to OHSU within 30 days after the end of each calendar quarter (each, a "Reporting Period") a written report substantially in the form attached as Appendix C that has been signed by an authorized official of Licensee.  Each report will set forth a full accounting of any amounts due OHSU, including the information necessary or desirable to calculate the amount of (a) the continuing royalty payments due under Section 4.3 above for the Reporting Period on a country-by-country basis; (b) the licensing remuneration received during the Reporting Period, or if there were no gross sales/Net Sales or licensing revenue, Licensee will provide a short written statement to OHSU stating that fact; (c) any minimum royalties available as a credit for the Reporting Period; and (d) either the amount due to OHSU for the Reporting Period or the amount of any prepaid minimum royalties that remain available as a credit to Licensee and that will be carried forward to the next Reporting Period.   Licensee will also deliver to OHSU a written report for any payment due under Section 10.2 within 30 days after the end of each calendar quarter.

 

9.3   Books and Records.  Licensee will keep proper, continuous and complete books and records of account in accordance with accounting practices generally accepted in the United States. Those books and records will accurately reflect the sales upon which the continuing royalty payments are based and all other information necessary for the accurate determination of all payments required under this Agreement.  Licensee will retain those books and records for at least five years following their creation.

 

9.4   Audits.  Upon reasonable written notice, OHSU will have the right to copy, inspect and audit the records and books of Licensee and Sublicensees at least once each calendar year during normal business hours for the purpose of verifying the correctness of the payments required under this Agreement.  Examination of the books and records for any Reporting Period will not take place more than two years following the end of that Reporting Period.  Licensee will, within thirty days of the date Licensee receives notice of the amount of any shortfall, pay OHSU that shortfall, plus all applicable late fee charges as described in Section 4.8The costs and expense of any such audit will be borne by OHSU unless the audit discloses that Licensee underpaid by 5% or more during any Reporting Period, in which case, Licensee will pay the costs and expense of the audit.

 

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10.   CONFIDENTIAL INFORMATION

 

10.1   If Licensee provides Confidential Information to OHSU, it must do so solely through Dr. W. H. Fleming as well as the authorized representative of OHSU designated in Section 16.1. Recipient of Confidential Information will protect and keep that Confidential Information secret and will not (a) disclose that Confidential Information to any person other than to Recipient's and Sublicensee's employees, agents and independent contractors with a need to know the Confidential Information to exercise its rights and/or perform its obligations hereunder, and who have agreed to an obligation of confidentiality and prohibition on use at least as protective of the Confidential Information as this Section 9; or (b) use that Confidential Information for any purpose other than to exercise its rights and perform its obligations under this Agreement. Recipient's obligations under Section 9 expire five years following the later of the expiration or termination of this Agreement.

 

10.2   If Recipient is required by law, including Oregon Public Records Law, regulation or court order to disclose any of the Confidential Information, it will: (a) promptly notify the Disclosing Party; (b) reasonably assist the Disclosing Party to obtain a protective order or other remedy of Disclosing Party's election; (c) make reasonable efforts to provide Disclosing Party prior review of any disclosure; (d) only provide that portion of the Confidential Information that is legally required; and (e) make reasonable efforts to obtain reliable assurance that the Confidential Information will be maintained in confidence.

 

10.3   Given the nature of the Confidential Information and the damage that would result to the Disclosing Party upon unauthorized disclosure, use or transfer of their Confidential Information to any third party, the Parties agree that monetary damages would not be a sufficient remedy for any breach or threatened breach of this Section 9.  In addition to all other remedies, Disclosing Party will be entitled to seek specific performance and injunctive and other equitable relief as a remedy for any breach or threatened breach of this Section 9. The breaching Party agrees to waive any requirement for the securing or posting of any bond or the showing of actual monetary damages in connection with such remedy hereunder.

 

11.   PROSECUTION, DEFENSE AND MAINTENANCE OF PATENTS

 

11.1   Prosecution and Maintenance. OHSU agrees to take responsibility for, but OHSU will consult with Licensee, all material patent matters regarding the Patent Rights within the Field of Use, and use reasonable good faith efforts to implement all reasonable requests made by Licensee with regard to such matters.  Further, OHSU will provide Licensee with copies of all material written communications to and from any patent office with respect to the patent applications and patents contained in the Patent Rights regarding the Field of Use.  OHSU will endeavor to give Licensee at least 30 days' prior written notice of its intent to abandon the prosecution of any patent application or to discontinue the maintenance of any patent or patent application included in the Patent Rights in the Field of Use. In which case, Licensee shall have the right, but not the obligation, to maintain the Patent Rights at its own expense.

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11.2   Reimbursement of Ongoing Patent Costs.  Licensee agrees to reimburse OHSU for Patent Costs within 30 days of invoice unless Licensee has surrendered its rights under Section 10.4 below.

 

11.3   Cooperation and Disclosure.  Licensee will promptly inform OHSU of all matters that come to its attention that may affect the preparation, filing, prosecution, defense or maintenance of the Patent Rights.  Licensee has a continuing responsibility to keep OHSU informed of its and all Sublicensees' entity status, including any change from "small" to "large" entity (as defined by the United States Patent and Trademark Office).

 

11.4   Loss of Rights.  If Licensee elects to discontinue payment for the filing, prosecution, defense and/or maintenance of any patent or patent application within the Patent Rights or fails to pay any invoice submitted by OHSU for those Patent Costs within 30 days after the date of that invoice, the jurisdiction described in that invoice will be excluded from the license and the patent or patent application described in that invoice will be excluded from the term "Patent Rights" and all rights relating to those patent applications and patents will revert to OHSU without further obligation to Licensee and may be freely licensed by OHSU to others.  If Licensee elects not to pay the Patent Costs for the filing, prosecution, defense and/or maintenance of any patent application or patent in any country or for any patent or patent application, and OHSU acting in reliance on that election ceases to prosecute or defend that patent application or maintain or defend that patent in that country, then Licensee will not sell any product or provide any processes covered by the claims of that patent as issued, or in the case of an application, covered in the claims as written at the time Licensee notifies OHSU of its decision not to support the application, unless Licensee pays royalties under this Agreement on sales in that country as set forth in Section 4.3.

 

11.5   Patent Term Extension. The Parties will cooperate in selecting a patent within the Patent Rights to seek a term extension for or supplementary protection certificate under in accordance with the applicable laws of any country.  Each Party agrees to execute any documents and to take any additional actions as the other Party may reasonably request in connection therewith.

 

11.6   Challenge.  In the event Licensee intends to challenge the validity or enforceability of any of the Patent Rights, Licensee will (a) give OHSU 90 days' prior written notice; and (b) continue to make all payments required hereunder directly to OHSU without the right to pay into escrow or other account any such amounts; (c) reimburse all otherwise unreimbursed costs and expenses of OHSU regarding such challenge including attorneys’ fees; and (d) from the date of the decision by the District Court upholding all or part of  claims within Patent Rights, until the end of the Term, make payments under Section 4.3 at double the royalty rate otherwise required in Section 4.3.  For purposes of clarity, Licensee agrees that no payment made to OHSU is refundable or may be offset, including any amounts paid under this Agreement prior to or during the period of the challenge, even if the challenge is successful or it is otherwise determined that the Patent Rights do not include valid claims.

 

12.   PATENT ENFORCEMENT

 

12.1   Enforcement Rights.  If either OHSU or Licensee becomes aware of any actual or threatened infringement of the Licensed Technology, that Party will promptly notify the other of each infringement or possible infringement, as well as any facts that may affect the validity, scope or enforceability of the Patent Rights (the "Infringement Notice").  The Parties will reasonably cooperate with each other to abate that infringement without litigation.

 

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(a)   If within 120 days after the date of the Infringement Notice, attempts to abate such infringement are unsuccessful, then Licensee may bring an action to enforce the Patent Rights in the Field of Use at its own expense, provided Licensee first notifies OHSU and carefully considers OHSU's views before initiating and throughout that suit.  In that case, OHSU will cooperate with Licensee as reasonably requested, at Licensee's expense.  OHSU may at any time, solely on its own initiative, join in that suit.

 

(b)   If Licensee fails to bring an action within 180 days after the date the Infringement Notice, OHSU may bring an action at its own expense, in which case Licensee will cooperate with OHSU, including joining the suit as reasonably requested, at OHSU's expense.

 

The Party initiating and maintaining the action will keep the other Party reasonably apprised of the status and progress of the litigation.

 

 

12.2   Fees and Costs.  In any infringement action brought under Section 11.1(a), Licensee will pay all expenses including costs, fees, expenses, experts' and attorneys' fees and disbursements of OHSU.

 

12.3   Settlement and Recovery.

 

(a)   Licensee agrees OHSU owns the Licensed Technology, and Licensee will not settle any action or other proceeding in any manner that includes an admission of fault and/or is prejudicial to OHSU, including any of the rights regarding the Licensed Technology, without OHSU's prior written approval.

 

(b)   Any recovery made by Licensee, through court judgment or settlement, will be applied first to reimburse Licensee for its reasonable out-of-pocket litigation expenses, and second, to reimburse OHSU for royalties that it would have received had the actions taken by the defendant occurred in compliance with this Agreement generating a Net Sale. Any remaining recoveries will be shared equally between Licensee and OHSU.  Should OHSU be made a Party to any suit described in this Section 11, Licensee will reimburse OHSU for any costs, fees and expenses, including experts' and attorneys' fees OHSU incurs as a result of and in opposing that action.

 

13.   REPRESENTATIONS, WARRANTIES AND DISCLAIMERS

 

13.1   Mutual Representations and Warranties.  Each Party represents and warrants to the other that (a) it is and will be at all times during the Term a valid legal entity existing under the law of its state of incorporation with the power to own all of its properties and assets and to carry on its business as it is currently being conducted; and (b) the execution and delivery of this Agreement has been duly authorized and no further approval, corporate or otherwise, is required in order to execute this binding Agreement.

 

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13.2   Disclaimers. NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY NOT EXPRESSLY SET FORTH IN SECTION 12.1, AND EXPRESSLY DISCLAIMS ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE, INCLUDING MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, COURSE OF DEALING, USAGE, AND TRADE PRACTICE, WITH RESPECT TO THE SCOPE, VALIDITY OR ENFORCEABILITY OF THE LICENSED TECHNOLOGY; THAT ANY PATENT WILL ISSUE BASED UPON ANY OF THE PENDING PATENT RIGHTS; OR THAT THE MANUFACTURE, USE, SALE, OFFER FOR SALE OR IMPORTATION OF THE LICENSED PRODUCTS WILL NOT INFRINGE PROPERTY RIGHTS. IN NO EVENT WILL OHSU BE LIABLE FOR LOSS OF PROFITS, LOSS OF USE, OR ANY OTHER CONSEQUENTIAL, INCIDENTAL, SPECIAL OR PUNITIVE DAMAGES.  NOTHING WILL LIMIT OHSU'S REMEDIES OR ABILITY TO RECOVER DAMAGES IN THE EVENT OHSU ASSERTS ITS INTELLECTUAL PROPERTY RIGHTS, INCLUDING INCREASED DAMAGES FOR WILLFUL INFRINGEMENT.

 

13.3   Prohibition Against Inconsistent Representations. Licensee will not make any statements, representations or warranties, or accept any liabilities or responsibilities whatsoever which are inconsistent with any term or condition of this Agreement.  

 

14.   INSURANCE

 

14.1   Licensee will maintain general and product liability insurance with deductibles and minimum limits of liability in amounts commensurate with industry standards and sufficient to satisfy its obligation hereunder, including Section 14.1.  Evidence of insurance will be provided to OHSU upon request.

 

15.   INDEMNIFICATION

 

14.1  Licensee will indemnify, defend and hold harmless OHSU, its directors, trustees, officers, employees, students, fellows, agents, consultants, the sponsors of the research that led to the Licensed Technology and the Inventors ("OHSU Indemnitees") from and against all claims, liabilities, demands, damages, costs, expenses (including attorney fees and costs) and losses, including (a) for death, personal injury, illness and property damage arising from or relating in any way to this Agreement, including the Licensed Products; (b) the use or misuse of the Licensed Technology and/or Licensed Products by or on behalf of Licensee, Sublicensees, their customers, suppliers, independent contractors and other third persons; (c) the design, manufacture, distribution, storage, sale, import and/or use of any Licensed Products or other products or processes developed in connection with or arising out of the Licensed Technology; and (d) Licensee's and/or Sublicensees' negligence and willful malfeasance.  OHSU will reasonably cooperate with Licensee, at Licensee's expense, in the defense of such action; provided that under no circumstances will Licensee or any party acting on its behalf make any admissions of fault or impose any material obligation on OHSU Indemnitees, including with respect to the Licensed Technology.

 

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14.2  To the extent necessary to satisfy its obligations to OHSU under Section 14.1, Licensee hereby waives any immunity or exemption from liability for the personal injury or death of its employees that may exist under, or any right to receive contribution from OHSU created by, the workers' compensation laws of the state where the injury occurs or the employee is located.

 

16.     TERM AND TERMINATION

 

16.1   Expiration.  This Agreement is effective as of the Effective Date and unless sooner terminated under this Section 15, will expire at the end of the Term.

 

16.2   Termination by Either Party.

 

  (a) Either Party may terminate this Agreement if the other Party commits a breach and fails to remedy such breach within 30 days after receiving written notice. If OHSU is unable to determine Licensee's and its Sublicensee's compliance with the terms and conditions of this Agreement because Licensee has not provided sufficient communications required by this Agreement, the Parties agree that such failure to provide will also be deemed evidence of Licensee's failure to perform activities to which were to be reported in such communications.

 

 

  (b) This Agreement will terminate if the other Party enters liquidation, has a receiver or administrator appointed over any assets related to this Agreement, makes any voluntary arrangement with any of its creditors, or ceases to carry on business, or any similar event under the law of any foreign jurisdiction.

 

 

16.3   Licensee's Termination Rights.  At any time following the first anniversary of the Effective Date, Licensee may terminate this Agreement by giving OHSU 60 days' written notice, paying OHSU all sums then due and payable, and making a termination payment of Five Thousand Dollars ($5,000), except in the case where diligent scientific and clinical development leads to the conclusion that the efficacy or safety of the Licensed Product do not justify further development.

 

16.4   Termination by OHSU. OHSU does not license its rights to entities that bring suit against it and as such, OHSU may immediately terminate this Agreement if Licensee or any Sublicensees directly or indirectly bring any action or proceeding against OHSU, including any pertaining to tangible or intellectual property owned by OHSU unless (a) such suit is for an uncured material breach of this Agreement by OHSU, (b) such suit is for an uncured material breach of this Agreement by Licensee and Licensee has attempted reasonably and in good faith to resolve the subject matter of such suit through discussion and mediation as described in Section 16.7, or (c) the suit relates to an uncured material breach of this Agreement or another agreement by OHSU that has not been resolved in accordance with this Agreement..

 

16
 

16.5   Consequences of Expiration/Termination.  Upon expiration or earlier termination of this Agreement for any reason whatsoever:

 

(a)   Licensee will immediately discontinue, and will cause its Sublicensees to immediately discontinue, the manufacture, use, marketing, importation and sale of the Licensed Products, except that after termination of this Agreement under Section 15.3, if Licensee or Sublicensees then possess, have started the manufacture of or have accepted binding orders for Licensed Products, then Licensee or such Sublicensee may sell their inventories, complete the manufacture of, and market and sell the finished Licensed Products to the extent necessary to dispose of those inventories and fill those orders, subject at all times to Licensee's obligation to comply with the terms and conditions of this Agreement, including to pay OHSU the payments under Section 4 and to deliver the reports required in Section 8.2;

 

(b)   Licensee will not be discharged from any liability or obligation to OHSU that arose, accrued or became due before the effective date of expiration or termination;

 

(c)   Within 90 days after the expiration or earlier termination of this Agreement for any reason, Licensee will submit a final report in form and content similar to the Quarterly Report and pay all amounts required to be paid to OHSU under this Agreement, including the prorated minimum annual license maintenance payment and minimum annual royalty payments;

 

(d)   Sections that by their nature prescribe continuing rights and obligations will survive until their purposes are fulfilled, including Section 7 (Restrictions), 8 (Books, Records and Reports), 9 (Confidential Information), 12 (Representations, Warranties and Disclaimers), 13 (Insurance), 14 (Indemnification) and 16 (General Provisions);

 

(e)   Each Party will promptly return or destroy the Confidential Information of the other Party (except that OHSU may retain one copy of Licensee's Confidential Information solely for archival purposes), and will deliver a certificate signed by one of its authorized officers that it has done so; and

 

(f)   All rights licensed or transferred by OHSU to Licensee under this Agreement will revert to OHSU, all sublicenses will terminate, and Licensee agrees to execute and deliver all instruments necessary or desirable to effectuate the foregoing.

 

17.   GENERAL PROVISIONS

 

17.1   Notices.  All notices or other communications given hereunder shall be in writing, shall be signed by an officer of the Party sending such notice or other communication, and shall be delivered by hand, by overnight courier, by electronic mail or by facsimile with all delivery charges prepaid and addressed to the Parties as follows:

 

17
 

 

If to OHSU:            Attention:  Director

 

Technology Transfer & Business Development,

 

Oregon Health & Science University

 

0690 SW Bancroft Street L106TT

 

Portland, OR 97239

 

Phone: 503-494-8200

 

Fax: 503-494-4729

 

 

 

 

 

If to Licensee:        David Koos

 

Chairman & CEO

 

Regen BioPharma, Inc.

 

4700 Spring St # 304

 

La Mesa, CA 91942

 

Phone: 619-702-1404

 

Communications under Sections 10 and 11 may also be made by verbal disclosure in person and/or telephonically.  All such notices and communications will be effective on the date delivered, if in person or telephonically, on the date of the postmark of that notice or communication if by courier, and on the date of the date stamp of that notice or communication if by electronic mail or facsimile.  Either Party may change its address by giving notice of that change to the other Party.

 

17.2   Waivers.  Neither Party will be deemed to have waived any of its rights under this Agreement until it has signed a written waiver of those rights.  Without limiting the preceding, no failure or delay by either Party in exercising any rights, powers or remedies under this Agreement will operate as a waiver of any such right, power or remedy, and no waiver will constitute a waiver of any other provision, breach, right or remedy, nor will any waiver constitute a continuing waiver or be effective except for the specific instance and for the specific purpose given.

 

17.3   Amendments.  If either Party wishes to modify this Agreement, the Parties will confer in good faith to determine the desirability of such modification.  No modification will be effective until a written amendment is signed by both Parties.  

 

18
 

17.4   Assignment.  Licensee will not assign or transfer its interests in nor delegate its obligations under this Agreement, whether by transfer, merger, operation of law or otherwise without OHSU's written consent, which will not be unreasonably withheld.  A Change of Control of Licensee (voting or otherwise) will be deemed an assignment for purposes of Sections 4.2 and 16.4. This Agreement will be binding on and inure to a Party's successors and assigns.  OHSU has the right to assign its Licensed Technology and this Agreement to any successor or assign.

 

17.5   Governing Law; Jurisdiction and Venue.  This Agreement will be governed by and construed in accordance with the laws of the State of Oregon without reference to any choice of law provisions, the Uniform Commercial Code or the International Convention on the Sale of Goods.  Subject to Section 16.7, any claim, action or suit between OHSU and Licensee and/or Sublicensee that arise out of or relate to this Agreement and that is not barred by sovereign immunity will be brought and conducted solely and exclusively within the Circuit Court for Multnomah County, Oregon, provided however, if any such claim, action or suit may be brought only in a federal forum or pertains to the enforcement of the Patent Rights, and does not waive sovereign immunity on behalf of OHSU unless OHSU so elects at that time, such claim, action or suit will be brought and conducted solely and exclusively within the United States District Court of Oregon and Licensee and/or Sublicensee consents to the jurisdiction of and venue in those courts.  Nothing herein will be construed as a waiver of sovereign immunity.

 

17.6   Severability.  The terms and conditions of this Agreement are severable.  If any term or condition of this Agreement is rendered invalid or unenforceable by any law or regulation, or declared null and void by any court of competent jurisdiction, that part will be reformed, if possible, to conform to law, and if reformation is not possible, that part will be deleted in such jurisdiction only and the remainder of the terms and conditions of this Agreement as well as the invalid or unenforceable term or condition in all jurisdictions where valid and enforceable will remain in full force and effect, unless enforcement of this Agreement without the invalid or unenforceable term or condition would be grossly inequitable under the circumstances or would frustrate the primary purpose of this Agreement.

 

17.7   Dispute Resolution.  The Parties agree to first attempt to settle amicably any controversy or claim arising out of or relating to this Agreement by providing copies of documents reasonably requested to enable a Party to evaluate its position. If the Parties are unable to settle amicably any controversy or claim then both Parties agree that all disputes between them arising out of or relating to this Agreement will be submitted to non-binding mediation unless the Parties mutually agree otherwise in writing.  Licensee further agrees to include a similar provision in all agreements with Sublicensees thereby providing for mediation as the first and primary method for dispute resolution between the parties to those agreements.  All parties agree to exercise their best effort in good faith to resolve all disputes in mediation provided, however, nothing will limit OHSU's remedies or ability to enforce its rights in the Licensed Technology in any jurisdiction or manner.  In the event of a dispute between the Parties, neither Party shall make any public statements to the press.

 

19
 

17.8   Independent Contractor; No Agency.  Neither Party will be deemed to be the employee, representative, agent, joint venturer or partner of the other Party for any purpose.  Neither Party has the authority to obligate or bind the other, or to incur any liability on behalf of the other, nor to direct the employees of the other.

 

17.9   Interpretation.  Both Parties have had the opportunity to have this Agreement reviewed by their attorneys.  Therefore, no rule of construction or interpretation that favors or disfavors either Party will apply to the interpretation of this Agreement.  Instead, this Agreement will be interpreted according to the fair meaning of its terms.  The captions or headings of this Agreement are for convenience of reference only.  They will not limit or otherwise affect the meaning or interpretation of any provision of this Agreement.  The words "includes" and "including" are not limited in any way and mean "includes or including without limitation."  The word "person" includes individuals, corporations, partnerships, limited liability companies, co-operatives, associations and other natural and legal persons.  The term "and/or" means each and all of the persons, words, provisions or items connected by that term; i.e., it has a joint and several meaning. The word "will" is a synonym for the word "shall".  All attachments to this Agreement are a part of and are incorporated in this Agreement.

 

17.10   Counterparts; Facsimile Delivery.  This Agreement may be executed in one or more counterparts, each of which will be deemed an original and all of which together will constitute one and the same Agreement.  This Agreement may be delivered by facsimile, and when so delivered will have the same force and effect as delivery of an original signature.

 

17.11   Attorneys' Fees.  In any legal action or proceeding arising out of or related to this Agreement, the Prevailing Party will be entitled to recover all reasonable attorneys’ fees incurred at trial, on appeal, or on any petition for review, together with other costs allowed by law.  For purposes of this Agreement, "Prevailing Party" means the Party that prevails either affirmatively or by means of a successful defense with respect to claims having the greatest value or importance as reasonably determined by the mediator or court with jurisdiction over the matter, as applicable and after taking into consideration any settlement offers made by the Parties.

 

17.12   Entire Agreement.  With respect to the Licensed Technology, this Agreement, including its Appendices which are incorporated herein by reference, is the entire agreement between the Parties and supersedes all prior discussions, representations, warranties and agreements, both written and oral between the Parties.

 

 

OHSU: OREGON HEALTH & SCIENCE UNIVERSITY

 

 

 /s/Andrew O Watson     June 5, 3013
   
   
 __________________________________    _______________
   
 Andrew O. Watson   Date
   
Interim Director, Technology Transfer & Business Development  


 

 

 LICENSEE:  REGEN BIOPHARMA, INC.  
   
   
 /s/David Koos   June 5, 2013
   
 ___________________________________    _______________
   
 David Koos   Date
   
 Chairman & CEO  

 

 

20
 

  APPENDIX A: PATENT RIGHTS and KNOW HOW

 

 

 

Patent Rights:

 

 

US patent No. 6,821,513 “Method for enhancing hematopoiesis” issued Nov. 23, 2004.


 

 

Know-How:


 

 

Know-how includes technical data, specifications, methods, laboratory notebooks, grant applications, publications or verbal discussions with Licensee; and all inventions that are the subject of the invention disclosure giving rise to, or that are described in, patent applications included in the Patent Rights that do not issue into patents.

 

21
 

 

  APPENDIX B: COMMERCIAL DEVELOPMENT PROGRESS REPORT

 

 

 

1.   Funding information of Licensee (VC, STTR, etc.) and Sublicensees (if any).

 

2.   Information on Licensee's and Sublicensees' key individuals who are involved in the  research, development and commercialization of the Licensed Technology.

 

Research and development milestones, including the timeline and budget of each,.

 

Identification of optimum embodiment of patent claims for clinical development (e.g.: utilization of endothelial cells from bone marrow versus placenta, versus adipose stromal vascular fraction) by August 2013

 

Creation of white paper in peer reviewed journal comparing hematopoietic stimulatory activity of endothelial cells from different tissues of the body. This puts forth the scientific rationale for the project by

September 2013

 

Selection of manufacturing facility and development of Good Manufacturing Practice (GMP) protocol for creation of preclinical samples for experimentation by October 2013.

 

Establishment of preclinical animal model to replicate patient data using cells produced according to Regen standard operating  procedures by December 2013

 

Recruitment of Principal Investigator for Clinical Trial by February 2014.

 

Compilation of preclinical efficacy and safety data for IND generation by April 2014

 

Submission of IND application to FDA by May 2014

 

3.   Regulatory approval processes for each Licensed Product including a schedule for each stage of the process.

 

4.   Status of first transfer for commercial purposes be made for each Licensed Product.

 

5.   Status of commercialization relationships that are intended to generate Net Sales.

 

22
 

 

 

  APPENDIX C: FORM OF QUARTERLY REPORT

 

Name of Licensee:                                                     Invention Disclosure #                                                               

 

 

Reporting Period:                                                     

 

A.           Royalties

 

1.   Detailed sales invoice records used to calculate royalties during the Reporting Period

 

2.   Quantity of Licensed Products transferred by Licensee and/or all Sublicensees during the Reporting Period on a country-by-country basis listing each patent or patent application relating to the Licensed Product on a Licensed Product-by-Licensed Product basis

 

3.   Gross invoiced amounts, monetary equivalents and any other consideration received for Licensed Products during the Reporting Period

 

4.   Net Sales calculations made during the Reporting Period, including applicable deductions, foreign exchange rates, allowances and other charges, or if there were no gross sales/Net Sales, Licensee will provide a short written statement to OHSU stating that fact

 

5.   Any minimum royalties available as a credit for the Reporting Period

 

6.   Either the amount of royalties required to be paid to OHSU for the Reporting Period or the amount of any prepaid minimum royalties that remain available as a credit to Licensee and that will be carried forward to the next Reporting Period in such year

 

B.          Milestone payments

 

C.          License maintenance payments

 

D.          Sublicensee payments

 

  1. List of Sublicensees

 

  2. Amount and type of compensation received by Licensee under Section 4.6 of the Agreement (other than royalty payments covered by Section 4.3 of the Agreement), as well as the Sublicensing rate set forth in Section 4.6 of the Agreement

 

  4. The amount of sublicense payments required to be paid to OHSU for the Reporting Period.

 

THE INFORMATION IN THIS REPORT IS TRUE, ACCURATE AND COMPLETE FOR THE REPORTING PERIOD SPECIFIED ABOVE.

 

23
 

 

 

LICENSEE:                                                                

 

By:___________________________________                                                                                           _______________

 

     Signature of Authorized Official                                                                                                                     Date

 

Printed Name___________________________

 

 

Title__________________________________

 

 

 

 

24

 

 

EX-10.2 15 reg1009forms1ex10_2.htm EXHIBIT 10.2

Exhibit 10.2

 

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Exhibit 10.3

 

EMPLOYMENT AGREEMENT BETWEEN

BIO-MATRIX SIENTIFIC GROUP, INC.

AND

J. CHRISTOPHER MIZER

 

THIS EMPLOYMENT AGREEMENT (the "Agreement") dated as of May 4, 2012

is entered into between Bio-Matrix Scientific Group, Inc., a Delaware corporation, (the "Company") and J. Christopher Mizer ("Employee").

 

WITNESSETH:

WHEREAS, Employee and the Company desire to enter into an agreement providing for the employment by the Company of Employee uponthe terms provided herein.

REPRESENTATIONS AND WARRANTIES

(A) Company hereby represents and warrants to Employee as follows;

(i) Corporate Existence of Company. Company:

(a)

is a corporation duly formed, validly existing and in good standing under the laws of the State of Delaware and

(b) has all requisite power and authority, and has all governmental licenses, authorizations, consents and approvals necessary to execute and deliver this Agreement and to consummate the transactions contemplated by this Agreement.

(ii) No Conflicts. None of the execution, delivery and performance of this Agreement by Company, or the consummation or the transactions contemplated hereby and thereby

(a) constitute or will constitute a violation of the organizational documents of Company,

(b) constitutes or will constitute a breach or violation of, or a default (or an event which, with notice or lapse of time or both, would constitute such a default) under, any indenture, mortgage, deed of Company, loan agreement, lease or other agreement or instrument to which Company is a party or by which Company or any of its properties may be bound,

(c) violates or will violate any statute, law or regulation or any order, judgment, decree or injunction of any court or Governmental Authority directed to Company or any of its properties in a proceeding to which its property is or was a party.

 

(B) Employee hereby represents and warrant to Company as follows:

(i) No Conflicts. None of the execution, delivery and performance of this Agreement by Employee, or the consummation of the transactions contemplated hereby and thereby

1
 

(a) constitutes or will constitute a breach or violation of, or a default (or an event which, with notice or lapse of time or both, would constitute such adefault) under, any indenture, mortgage, deed of Trust, loan agreement, lease or other agreement or instrument to which Employee is a party or by which Employee or any of its properties may be bound,

(b) violates or will violate any statute, law or regulation or any order, judgment, decree or injunction of any court or Governmental Authority directed to Employee or any of their properties in a proceeding to which its property is or was a party.

 

AGREEMENT:

NOW, THEREFORE, in consideration of the foregoing and the mutual promises and agreements set forth herein, the parties hereto, intending to be legally bound, hereby agree as follows:

1. Employment. During the Employment Period (as defined in Section 2), the Company hereby employs Employee and Employee hereby accepts employment.

2. Term. The Term of this Agreement shall commence on May 4, 2012 and shall expire on May 3, 2015 unless sooner terminated in accordance with the provisions of Section 6 hereof; provided, however, that the term of this Agreement may be extended by mutual agreement. The period from thecommencement of the term of this Agreement to the date of its expiration or sooner termination shall be considered to be the “Employment Period" hereunder.

 

3. Duties. Employee shall be granted the title of President with the Company’s wholly owned subsidiary, Regen BioPharma Inc. Subject to the authority of the Board of Directors of the Company (the "Board") and the Company's Chief Executive Officer (the "CEO"), Employee shall perform such duties commensurate with his offices and as directed by the Board and/or the CEO such duties to include, but not be limited to:

See Schedule 1.

During the Employment Period, Employee shall perform his duties hereunder in a diligent manner, subject to the provisions of Schedule 1 of this Agreement;devoting such amount of his business time, attention and efforts to the affairs of the Company within the scope of his employment as is necessary for the proper rendition of such service and shall use his best efforts to promote the best interests of the Company. Employee's services shall be rendered when and as required by the Board and/or the CEO and in accordance with its and/or their instructions, direction and control.

 

2
 

It is agreed that Employee will only devote such time as to effectively conduct duties and responsibilities associated with this position pursuant to thisagreement.  

 

4. Compensation Salary. During the Employment Period, Company shall pay Employee salary at the rate of (i) $10,000 per month prorated for any partial employment month ("Salary"). Salary shall be paid on a monthly basis (“Payday”) or, in the event that Payday falls on a Saturday, Sunday or holiday, on the next business day. Salary may be paid, at the Company’s sole discretion, either in

 

(a)

cash, or

(b)

shares of the Company’s common stock (“Stock Payment”)

 

Employee acknowledges that any Stock Payments  issued pursuant to this Agreement that are not registered pursuant to the Securities Act of 1933 shall constitute “restricted securities” as that term is defined in Rule 144 promulgated under the Securities Act of 1933, and shall contain the following restrictive legend:

 

THESE SECURITIES HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”), OR SECURITIES LAWS OF ANY STATE AND MAY NOT BE OFFERED, SOLD, ASSIGNED, PLEDGED, TRANSFERRED OR OTHERWISE DISPOSED OF IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT UNDER THE ACT AND APPLICABLE STATE SECURITIES LAWS OR PURSUANT TO AN AVAILABLE EXEMPTION FROM REGISTRATION UNDER THE ACT OR SUCH LAWS AND, IF REQUESTED BY THE COMPANY, UPON DELIVERY OF AN OPINION OF COUNSEL REASONABLY SATISFACTORY TO THE COMPANY THAT THE PROPOSED TRANSFER IS EXEMPT FROM THE ACT OR SUCH LAWS.

 

The Company may register any Stock Payment pursuant to the Securities Act of 1933, but is not obligated to do so pursuant to this Agreement.

 

5. Benefits.

a.

During the Employment Period, Employee shall be entitled to participation in any profit sharing plan, retirement plan, group life insurance plan or other insurance plan, medical expense plan, medical and dental insurance and other benefit arrangements maintained by the Company for its employees generally and, if applicable, their family members. In addition, Employee shall be entitled to two weeks paid vacation (“Vacation”) subject to (i) the completion of 12 full months of employment pursuant to this Agreement and (ii) having given fourteen days prior notice to the Company of Employee’s intent to Vacation.

b.   Stock Compensation.  Employee shall receive 12 million newly issued common shares of the Company upon execution of this agreement (“Signing Shares”).  The shares shall be subject to a vesting schedule (see Schedule 2.).

3
 

Employee acknowledges that any Signing Shares  issued pursuant to this Agreement will not be  registered pursuant to the Securities Act of 1933 , shall constitute “restricted securities” as that term is defined in Rule 144 promulgated under the Securities Act of 1933 and shall contain the following restrictive legend:

 

THESE SECURITIES HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”), OR SECURITIES LAWS OF ANY STATE AND MAY NOT BE OFFERED, SOLD, ASSIGNED, PLEDGED, TRANSFERRED OR OTHERWISE DISPOSED OF IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT UNDER THE ACT AND APPLICABLE STATE SECURITIES LAWS OR PURSUANT TO AN AVAILABLE EXEMPTION FROM REGISTRATION UNDER THE ACT OR SUCH LAWS AND, IF REQUESTED BY THE COMPANY, UPON DELIVERY OF AN OPINION OF COUNSEL REASONABLY SATISFACTORY TO THE COMPANY THAT THE PROPOSED TRANSFER IS EXEMPT FROM THE ACT OR SUCH LAWS.

 

6. Termination.

 

a.

Employee's employment hereunder shall terminate upon the earlier of:

(i) the expiration of the Employment Period,

(ii) the death of Employee,

(iii) the expiration of a continuous period of thirty (30) calendar days during which Employee is unable to perform his material duties due to physical or mental incapacity,

(iv) termination by the Company due to “just cause,”

(v) termination by Employee due to a material breach of this Agreement by the Company ("good reason”). The exercise of the right of theCompany or Employee to terminate this Agreement pursuant to clauses (iv) or (v) hereof, as the case may be, shall not abrogate the rights and remedies of the terminating party in respect of the breach giving rise to such termination.

 

b.

"Just cause" hereunder shall be defined and limited to mean:

(i) Employee's failure or refusal, as determined by either the CEO and/or the Board in his or their sole discretion, to perform specificdirectives of the Board which are consistent with the scope and nature of Employee's duties and responsibilities as set forth herein (including the duties described in Section 3), which failure or refusal continues after notice thereof and a reasonable time to cure; such reasonable time to be determined by either the CEO or the Board.

(ii) Employee's conviction for a felony or any crime involving moral turpitude, fraud, or misrepresentation, or the presentation of proofsatisfactory to the Board in the exercise of its reasonable judgment of Employee's misappropriation or embezzlement of funds or assets from the Company;   

 

4
 

(iii) any intentional act having the purpose and effect of injuring the reputation, business or business relationships of the Company in any material respect; and

(iv) any breach by Employee of any material provision of this Agreement, including, without limitation, the restrictive covenants contained in Section 7 hereof.

c.

In the event of any dispute regarding the existence of Employee's incapacity hereunder, the matter wil1 be resolved by the determination of aphysician qualified to practice medicine in California selected by the CEO or the Board. For this purpose, Employee will submit to appropriate medical examinations.

d.

If Employee's employment hereunder is terminated pursuant to Section

6, the Company shall have no further obligations or liabilities hereunder.

 

7. Restrictive Covenant.

 

a.

Nondisclosure. Employee has, and during the Employment Period will have, access to confidential information and trade secrets of theCompany and its subsidiaries (the "Confidential Information") that may include, among other things: 

(i)

Financial information

(ii)

Supply and services information

(iii)

Marketing information

(iv)

Personnel information

(v)

Customer information

(vi)

Product information

(vii)

The Company’s procedures, systems, policies and processes of operation.

5
 

Employee shall at all times during his employment by the Company and thereafter hold in strictest confidence any and all Confidential Information that may have come or may come into Employee's possession or within Employee's knowledge. Employee agrees that neither he nor any person or entity,directly or indirectly, controlled by or under common control with the Employee (an "Affiliate") will for any reason, except in the course of performing his duties hereunder, for himself or any other person, use or disclose to anyone, exclusive of Company employees, agents, representatives, or independent consultants to the Company or any of its subsidiaries or Affiliates of the Company, any Confidential Information; provided, however,that Employee may disclose Confidential Information which (i) has become generally available to the public other than as a result of a breach of this Agreement by Employee or (ii) Employee is compelled to disclose pursuant to subpoena or an order by a court competent jurisdiction; provided that, if Employee is so required to disclose any Confidential Information pursuant to the foregoing clause (ii), Employee shall provide advance written notice to the Company, to the extent possible, to allow the Company to seek an appropriate protective order therefore (iii) Potential advisors, employees, or investors of the Company where there is a reasonable expectation of confidentiality. All Confidential Information shall remain the Company's property and shall be returned (or, at the Company's option, destroyed) upon the Company's written request.

 

b.

Non-Solicitation of Employees. Employee agrees that from the date hereof and continuing for a period of three years following the termination of this Agreement for whatever reason (the "Non-Compete Period"), neither Employee nor any Affiliate of Employee will solicit or hire for employment any officer, director or employee of the Company who was employed by the Company at any time within twelve months prior to the act of solicitation.

c.

Non-Competition. Employee agrees that, other than with the approval of the Board, which approval shall not be unreasonably withheld, during the Employment Period, neither Employee nor any Affiliate of Employee will, directly or indirectly, become a shareholder, director, officer, agent, partner or employee of, or otherwise hold any ownership interest in, any person, firm or entity engaged in any Competitive Business (asdefined below), engage as a sole proprietor in any Competitive Business, act as a consultant to or assist any of the foregoing or otherwise engage or participate in any Competitive Business; provided, however, that the foregoing shall not prohibit the ownership by Employee of less than ten  percent (10%) of the outstanding shares of the stock of any corporation engaged in any Competitive Business, which shares are regularly traded on a national securities exchange or in any over-the-counter market. For the purpose hereof, "Competitive Business" means the ownership, operation, development, marketing of the services related to, or management of cellular storage facilities within the United States.

6
 

d.

Consideration, Relief, Reformation; Severability. The Company has specifically bargained for the covenants set forth in this Section 6 inconsideration for the compensation, experience, and information that Employee will gain or receive in connection with his employment by theCompany. Employee agrees that the covenants set forth herein will not preclude Employee from engaging in any lawful profession, trade or businessor from being gainfully employed necessary to provide Employee, his family members and dependents a standard of living to which he and they havebeen accustomed and may expect. Employee acknowledges and agrees that the restrictive covenants in this Section 6 have been specificallynegotiated, are reasonable in all respects, including, without limitation, their geographic scope and duration, and may be enforced by specificperformance or otherwise. Employee shall not raise any issue of reasonableness as a defense in any proceeding to enforce any of such covenants. Notwithstanding the foregoing, in the event that a covenant included in this Agreement shall be deemed by any court to be unreasonably broad in any respect, it shall be modified or limited in its geographic scope, duration or otherwise to the extent necessary to make it reasonable while preserving its restrictive nature to the maximum degree possible and shall be enforced accordingly; provided however, that if, notwithstanding the foregoing, a courtof competent jurisdiction shall hold any of the covenants contained in Sections 7 (a), (b) or (c) to be unenforceable (as so modified), then the unenforceable covenant shall be deemed eliminated from the provisions of this Agreement for the purpose of those proceedings to the extentnecessary to permit the remaining covenants to be enforced so that the validity, legality or enforceability of the remaining provisions of this Agreement shall not be affected thereby.

 

8. Developments.

 

Employee hereby assigns to the Company his entire right, title and interest in all know how, discoveries and improvements, customer lists, trade secrets and ideas, writings and copyrightable material, which may be conceived by Employee or developed or acquired by him during the term of this Agreement, which may pertain directly to the Company's business and were developed with Company resources. Employee agrees to promptly and fully disclose in writing allsuch developments. Employee will, upon the Company's request, execute, acknowledge and deliver to the Company all instruments and do all other actswhich are necessary or desirable to entitle the Company to all rights in the foregoing and enable the Company to file and prosecute applications for, and to acquire, maintain and enforce all letters, trademark registrations or copyrights with respect to the foregoing in all countries.

7
 

9. Remedies.

 

Employee acknowledges that any material breach of this Agreement will cause irreparable harm to the Company, that such harm will be difficult if not impossible to ascertain, and that the Company shall be entitled to equitable relief, including injunction, against any actual or threatened breach hereof, without bond and without liability should such relief be denied, modified or vacated. Neither the right to obtain such relief nor the obtaining of such relief shall be exclusive of or preclude the Company from any other remedy.

 

10. Legal Counsel.

 

Employee acknowledges that Employee has carefully read this Agreement and understands all of the terms hereof and that Employee has been given theopportunity to discuss this Agreement with Employee's private legal counsel and has availed himself of that opportunity to the extent Employee wishes to do so.

 

11. Notices.

 

All notices, requests and other communications under this Agreement shall be in writing and shall be deemed to have been received five business days after having been deposited in the United States Mail and enclosed in a registered or certified post-paid envelope; one day after having been sent by overnight courier on a business day or otherwise at the open of business on the next succeeding business day; when personally delivered or sent by facsimile communications equipment of the sending party on a business day or otherwise at the open of business on the next succeeding business day; and, in each case, addressed to the respective parties at the addresses stated below or to such other changed addresses that the parties may have fixed by notice in accordance herewith.

If to the Company:

Bio-Matrix Scientific Group, Inc.

4700 Sprint Street, Suite 304

La Mesa, CA 91942

 

Attn: David Koos, CEO

 

 

If to Employee:

J. Christopher Mizer

7141 Fay Avenue

La Jolla, CA 92037

8
 

 

12. Waiver of Breach.

A waiver by the Company or Employee of a breach of any provision of this Agreement by the other party shall not operate or be construed as a waiver of any subsequent breach by the other party.

13. Entire Agreement.

 

This instrument contains the entire agreement of the parties with respect to the subject matter hereof and supersedes any prior agreements of the parties with respect to the subject matter hereof. It may be changed only by an agreement in writing signed by a party against whom enforcement of any waiver, change, modification, extension or discharge is sought.

 

14. Applicable Law.

 

The terms and conditions of this Agreement shall be governed by and construed in accordance with the laws of the State or California. Any action to enforce this Agreement shall be brought in the state courts located in San Diego County, State of California.

IN WHITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year first above written.

 

 

By: /s/David R. Koos

David R. Koos

Chief Executive Officer

 

 

 

By: /s/J. Christopher Mizer

J. Christopher Mizer

 

9
 

 

Schedule 1.

 

Employer: Regen BioPharma, Inc.

 

Location: Company Headquarters and Contracted Research Facilities

 

Description:

 

The President is responsible for the overall operation, leadership, direction, and administration of the Company’s business affairs including regulatory compliance with various Federal and State Regulatory agencies. This position has responsibility for intellectual property acquisition and development, business model implementation, regulatory compliance including validation and review,  supervision of clinical trials, and management of commercialization opportunities.

 

Position Responsibilities:

1.

Plan, develop, organize, implement, direct and evaluate the organization's targeted intellectual properties for acquisition / license / option by the company with final approval of the terms and conditions of any acquisition, license or option to be granted by the Company’s CEO in his sole discretion.

2.

Coordinate all aspects of the company’s commercialization activities.

3.

Source outside researchers, partners and facilities in order to conduct the company’s business with final approval regarding the retention of researchers ,  entry into agreements with partners, or purchase or lease of facilities to be granted by the Company’s CEO in his sole discretion.   

4.

Participate in the development and implementation of operations budget to ensure compliance with organizational expenditure requirements.

5.

Advise, negotiate, manage and administer contracts in which the company may enter.

6.

Lead and direct the development, communication and implementation of effective growth strategies and processes.

7.

Perform other duties as required. Perform other responsibilities as mandated by and any other pertinent local, state or federal regulations.

10
 

Schedule 2.

 

 

VESTING SCHEDULE FOR SIGNING SHARES

 

Signing Shares may not be sold, transferred, assigned, pledged or otherwise encumbered or disposed of by Employee (“ Transfer Restriction”) except as follows:

 

(a)

Monthly vesting of shares:

 

Upon the expiration of one month from the date of the grant of the Signing Shares, Transfer Restrictions shall no longer apply to 1,000,000 of the Signing Shares.

 

Upon the expiration of two months from the date of the grant of the Signing Shares, Transfer Restrictions shall no longer apply to an additional 1,000,000 of the Signing Shares.

 

Upon the expiration of three months from the date of the grant of the Signing Shares, Transfer Restrictions shall no longer apply to an additional 1,000,000 of the Signing Shares.

 

Upon the expiration of four months  from the date of the grant of the Signing Shares, Transfer Restrictions shall no longer apply to an additional 1,000,000 of the Signing Shares.

 

Upon the expiration of five months from the date of the grant of the Signing Shares, Transfer Restrictions shall no longer apply to an additional 1,000,000 of the Signing Shares.

 

Upon the expiration of six month from the date of the grant of the Signing Shares, Transfer Restrictions shall no longer apply to an additional 1,000,000 of the Signing Shares.

 

(b)

Milestone Vesting of shares:   Transfer Restrictions shall no longer apply to 6,000,000 of the Signing Shares (“Milestone Shares”) upon the achievement of the following events (“Milestones”) during the course of the Employee’s employment with the Company

 

(1)

Upon the addition to the Scientific Advisory Board of the Company or any subsidiary of the Company  of five Researchers approved by the CEO of the Company to act as members of Scientific Advisory Board of the Company or any subsidiary of the Company, prior to December 31, 2012, Transfer Restrictions shall no longer apply to 1,000,000  Milestone Shares

 

11
 

(2)

Upon the identification of five separate intellectual properties (“IPs”) , prior to May 4, 2013, which are, in the sole discretion of the CEO of the Company, deemed to be suitable IPs for the Company or any subsidiary of the Company to consider licensing for commercial use Transfer Restrictions shall no longer apply to 1,000,000 Milestone Shares.

(3)

Upon execution, prior to May 4, 2013, of binding agreements whereby the Company or any of its subsidiaries have secured commercial licensing rights to all of the IPs listed above prior to May 4, 2013Transfer Restrictions shall no longer apply to 1,000,000 Milestone Shares.

(4)

Upon retention by the Company or any of its subsidiaries , prior to May 4, 2013,  of both of appropriate researchers and an appropriate Contract Research Organization  , the purpose of such retention being the commencement of clinical trials and  the preparation of an Investigational New Drug Application pursuant to applicable law, Transfer Restrictions shall no longer apply to 1,000,000 Milestone Shares.

(5)

Upon commencement, prior to December 31, 2013,  of a “Phase I” clinical trial by the Company or any subsidiary of the Company, to be performed in connection with an Investigational New Drug Application submitted by the Company and in accordance with applicable law,  Transfer Restrictions shall no longer apply to 2,000,000 Milestone Shares.

 

In the event that Employee is no longer employed by the Company or any subsidiary of the Company, any Signing Shares (including Milestone Shares) still subject to Transfer Restrictions shall be forfeited by the Employee, and ownership of those Signing Shares shall be transferred back to the Company.

 

In the event that any Milestone listed above is not achieved by the date so indicated, those Milestone Shares for which Transfer Restrictions would no longer apply upon achievement of the applicable Milestone shall be forfeited by the Employee, and ownership of the Milestone Shares shall be transferred back to the Company.

 

 

 

 

 

 

12 

EX-10.4 18 reg1009forms1ex10_4.htm EXHIBIT 10.4

Exhibit 10.4

 

 

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M'/'(!;?:F"3(?+DVP?O,J3\F&Z$&N*TG_@GSX4\.SPW.G:OK]KJ`OM&U&YN< MV[F]GTQ(8XG9#%L1I8[:T28Q*GF"UA^Z5S67??\`!.'2-5T*'3;OQKXLN;:T M\.1^&+,R1632:=;Q_.'@S!L61ITMYI"482M9P*X:-/+(!Z]X4_:$\#>.O%X\ M/:/XM\/ZGKQMGNSIMO?1R7:1)*\+NT0.]0LLRM;2,"VN;^Y$JI;QQHK/)J$^X*H&%CP,AF;T MJ@`HI"V"!R<^U+0`44B%BHW<'VYI:`"BBB@`HHHH`****`"BBB@`!SSG-%`& M.**`"BBB@`HHHH`****`"BBB@`HHHH`****`"BBB@`HHHH`****`"BBB@`HI M&;:!P3DXXI:`"BAFV@GDX_6@'(!YYH`****``'.1Z4444`%`&,^]%)@[LYX] M*`%HHHH`****`"BBB@`HHHH``,9]Z***`"BBB@`HHHH`****`"BBB@`H4DYR M,8-%%`!1103M!)/2@`HH!R`>N:*`"BBB@`HHHH`3=\Q7/(YI:**``\\'O111 M0`4444`%%%%`!1110`4444`%%%%`!0#G/7BBB@`HHHH`****`"BBB@`HHHH` M**.=V<\>E%`",VT`G/)QTS2T44`%%%%`!1110`#.XYZ=O6BBB@`HHHH`**** M`"BBB@`HHHH`****`"BBB@`HHHH`****`"BBB@`HHHH`****`"BBB@`HILJ- M)$RJY1F&`P`)7WYIPS@9Y-`` EX-10.5 20 reg1009forms1ex10_5.htm EXHIBIT 10.5

Exhibit 10.5

EMPLOYMENT AGREEMENT BETWEEN

BIO-MATRIX SCIENTIFIC GROUP, INC.

AND

THOMAS ICHIM

 

THIS EMPLOYMENT AGREEMENT (the "Agreement") dated as of June 15, 2012 is entered into between Bio-Matrix Scientific Group,Inc., a Delaware corporation, (the "Company") and Thomas Ichim ("Employee").

 

WITNESSETH:

WHEREAS, Employee and the Company desire to enter into an agreement providing for the employment by the Company of Employee upon the terms provided herein.

REPRESENTATIONS AND WARRANTIES

 

(A) Company hereby represents and warrants to Employee as follows;

(i) Corporate Existence of Company. Company:

(a)

is a corporation duly formed, validly existing and in good standing under the laws of the State of Delaware and

(b) has all requisite power and authority, and has all governmental licenses, authorizations, consents and approvals necessary to execute and deliver this Agreement and to consummate the transactions contemplated by this Agreement.

(ii) No Conflicts. None of the execution, delivery and performance of this Agreement by Company, or the consummation or the transactions contemplated hereby and thereby

(a) constitute or will constitute a violation of the organizational documents of Company,

(b) constitutes or will constitute a breach or violation of, or a default (or an event which, with notice or lapse of time or both, would constitute such a default) under, any indenture, mortgage, deed of Company, loan agreement, lease or other agreement or instrument to which Company is a party or by which Company or any of its properties may be bound,

(c) violates or will violate any statute, law or regulation or any order, judgment, decree or injunction of any court or Governmental Authority directed to Company or any of its properties in a proceeding to which its property is or was a party.

 

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(B) Employee hereby represents and warrant to Company as follows:

(i) No Conflicts. None of the execution, delivery and performance of this Agreement by Employee, or the consummation of the transactions contemplated hereby and thereby

(a) constitutes or will constitute a breach or violation of, or a default (or an event which, with notice or lapse of time or both, would constitute such a default) under, any indenture, mortgage, deed of Trust, loan agreement, lease or other agreement or instrument to which Employee is a party or by which Employee or any of its properties may be bound,

(b) violates or will violate any statute, law or regulation or any order, judgment, decree or injunction of any court or Governmental Authority directed to Employee or any of their properties in a proceeding to which its property is or was a party.

 

AGREEMENT:

NOW, THEREFORE, in consideration of the foregoing and the mutual promises and agreements set forth herein, the parties hereto, intending to be legally bound, hereby agree as follows:

1. Employment. During the Employment Period (as defined in Section 2), the Company hereby employs Employee and Employee hereby accepts employment.

2. Term. The Term of this Agreement shall commence on June 15, 2012 and shall expire on June 14, 2015 unless sooner terminated in accordance with the provisions of Section 6 hereof; provided, however, that the term of this Agreement may be extended by mutual agreement. The period from the commencement of the term of this Agreement to the date of its expiration or sooner termination shall be considered to be the “Employment Period" hereunder.

 

3. Duties. Employee shall be granted the title of Chief Scientific Officer and Director of Research With the Company’s wholly owned subsidiary, Regen BioPharma Inc. Subject to the authority of the Board of Directors of the Company (the "Board") and the Company's Chief Executive Officer (the "CEO"), Employee shall perform such duties commensurate with his offices and as directed by the Board and/or the CEO such duties to include, but not be limited to:

See Schedule 1.

During the Employment Period, Employee shall perform his duties hereunder in a diligent manner, subject to the provisions of Schedule 1 of this Agreement; devoting such amount of his business time, attention and efforts to the affairs of the Company within the scope of his employment as is necessary for the proper rendition of such service and shall use his best efforts to promote the best interests of the Company. Employee's services shall be rendered when and as

2
 

required by the Board and/or the CEO and in accordance with its and/or their instructions, direction and control.

 

It is agreed that Employee will only devote such time as to effectively conduct duties and responsibilities associated with this position pursuant to this agreement.  

 

4. Compensation Salary. During the Employment Period, Company shall pay Employee salary at the rate of (i) $10,000 per month prorated for any partial employment month ("Salary"). Salary shall be paid on a monthly basis (“Payday”) or, in the event that Payday falls on a Saturday, Sunday or holiday, on the next business day. Salary may be paid, at the Company’s sole discretion, either in

 

(a)        cash, or

(b)        shares of the Company’s common stock (“Stock Payment”)

 

Employee acknowledges that any Stock Payments  issued pursuant to this Agreement that are not registered pursuant to the Securities Act of 1933 shall constitute “restricted securities” as that term is defined in Rule 144 promulgated under the Securities Act of 1933, and shall contain the following restrictive legend:

 

THESE SECURITIES HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”), OR SECURITIES LAWS OF ANY STATE AND MAY NOT BE OFFERED, SOLD, ASSIGNED, PLEDGED, TRANSFERRED OR OTHERWISE DISPOSED OF IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT UNDER THE ACT AND APPLICABLE STATE SECURITIES LAWS OR PURSUANT TO AN AVAILABLE EXEMPTION FROM REGISTRATION UNDER THE ACT OR SUCH LAWS AND, IF REQUESTED BY THE COMPANY, UPON DELIVERY OF AN OPINION OF COUNSEL REASONABLY SATISFACTORY TO THE COMPANY THAT THE PROPOSED TRANSFER IS EXEMPT FROM THE ACT OR SUCH LAWS.

 

The Company may register any Stock Payment pursuant to the Securities Act of 1933, but is not obligated to do so pursuant to this Agreement.

 

 

3
 

5. Benefits.

 

a.

During the Employment Period, Employee shall be entitled to participation in any profit sharing plan, retirement plan, group life insurance plan or other insurance plan, medical expense plan, medical and dental insurance and other benefit arrangements maintained by the Company for its employees generally and, if applicable, their family members. In addition, Employee shall be entitled to two weeks paid vacation (“Vacation”) subject to (i) the completion of 12 full months of employment pursuant to this Agreement and (ii) having given fourteen days prior notice to the Company of Employee’s intent to Vacation.

b.   Stock Compensation.  Employee shall receive 12 million newly issued common shares of the Company upon execution of this agreement (“Signing Shares”).  The shares shall be subject to a vesting schedule (see Schedule 2.).

 

Employee acknowledges that any Signing Shares  issued pursuant to this Agreement will not be  registered pursuant to the Securities Act of 1933 , shall constitute “restricted securities” as that term is defined in Rule 144 promulgated under the Securities Act of 1933 and shall contain the following restrictive legend:

 

THESE SECURITIES HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”), OR SECURITIES LAWS OF ANY STATE AND MAY NOT BE OFFERED, SOLD, ASSIGNED, PLEDGED, TRANSFERRED OR OTHERWISE DISPOSED OF IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT UNDER THE ACT AND APPLICABLE STATE SECURITIES LAWS OR PURSUANT TO AN AVAILABLE EXEMPTION FROM REGISTRATION UNDER THE ACT OR SUCH LAWS AND, IF REQUESTED BY THE COMPANY, UPON DELIVERY OF AN OPINION OF COUNSEL REASONABLY SATISFACTORY TO THE COMPANY THAT THE PROPOSED TRANSFER IS EXEMPT FROM THE ACT OR SUCH LAWS.

 

6. Termination.

 

a.

Employee's employment hereunder shall terminate upon the earlier of:

(i) the expiration of the Employment Period,

(ii) the death of Employee,

(iii) the expiration of a continuous period of thirty (30) calendar days during which Employee is unable to perform his material duties due to physical or mental incapacity,

(iv) termination by the Company due to “just cause,”

(v) termination by Employee due to a material breach of this Agreement by the Company ("good reason”). The exercise of the

 

4
 

right of the Company or Employee to terminate this Agreement pursuant to clauses (iv) or (v) hereof, as the case may be, shall not abrogate the rights and remedies of the terminating party in respect of the breach giving rise to such termination.

 

b.

"Just cause" hereunder shall be defined and limited to mean:

(i) Employee's failure or refusal, as determined by either the CEO and/or the Board in his or their sole discretion, to perform specific directives of the Board which are consistent with the scope and nature of Employee's duties and responsibilities as set forth herein (including the duties described in Section 3), which failure or refusal continues after notice thereof and a reasonable time to cure; such reasonable time to be determined by either the CEO or the Board.

(ii) Employee's conviction for a felony or any crime involving moral turpitude, fraud, or misrepresentation, or the presentation of proof satisfactory to the Board in the exercise of its reasonable judgment of Employee's misappropriation or embezzlement of funds or assets from the Company;   

(iii) any intentional act having the purpose and effect of injuring the reputation, business or business relationships of the Company in any material respect; and

(iv) any breach by Employee of any material provision of this Agreement, including, without limitation, the restrictive covenants contained in Section 7 hereof. 

c.

In the event of any dispute regarding the existence of Employee's incapacity hereunder, the matter wil1 be resolved by the determination of a physician qualified to practice medicine in California selected by the CEO or the Board. For this purpose,Employee will submit to appropriate medical examinations.

d.

If Employee's employment hereunder is terminated pursuant to Section

5, the Company shall have no further obligations or liabilities hereunder.

7. Restrictive Covenant.

 

a.

Non-disclosure. Employee has, and during the Employment Period will have, access to confidential information and trade secrets of the Company and its subsidiaries (the "Confidential Information") that may include, among other things: 

(i)

Financial information

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(ii)

Supply and services information

(iii)

Marketing information

(iv)

Personnel information

(v)

Customer information

(vi)

Product information

(vii)

The Company’s procedures, systems, policies and processes of operation.

Employee shall at all times during his employment by the Company and thereafter hold in strictest confidence any and all Confidential Information that may have come or may come into Employee's possession or within Employee's knowledge. Employee agrees that neither he nor any person or entity, directly or indirectly, controlled by or under common control with the Employee (an "Affiliate")will for any reason, except in the course of performing his duties hereunder, for himself or any other person, use or disclose to anyone, exclusive of Company employees, agents, representatives, or independent consultants to the Company or any of its subsidiaries or Affiliates of the Company, any Confidential Information; provided, however, that Employee may disclose Confidential Information which (i) has become generally available to the public other than as a result of a breach of this Agreement by Employee or (ii) Employee is compelled to disclose pursuant to subpoena or an order by a court competent jurisdiction; provided that, if Employee is so required to disclose any Confidential Information pursuant to the foregoing clause (ii), Employee shall provide advance written notice to the Company, to the extent possible, to allow the Company to seek an appropriate protective order therefore (iii) Potential advisors, employees, or investors of the Company where there is a reasonable expectation of confidentiality. All Confidential Information shall remain the Company's property and shall be returned (or, at the Company's option, destroyed) upon the Company's written request.

b.

Non-Solicitation of Employees. Employee agrees that from the date hereof and continuing for a period of three years following the termination of this Agreement for whatever reason (the "Non-Compete Period"), neither Employee nor any Affiliate of Employee will solicit or hire for employment any officer, director or employee of the Company who was employed by the Company at any time within twelve months prior to the act of solicitation.

c.

Non-Competition. Employee agrees that, other than with the

6
 

 approval of the Board, which approval shall not be unreasonably withheld, during the Employment Period, neither Employee nor any Affiliate of Employee will, directly or indirectly, become a shareholder, director, officer, agent, partner or employee of, or otherwise hold any ownership interest in, any person, firm or entity engaged in any Competitive Business (as defined below), engage as a soleproprietor in any Competitive Business, act as a consultant to or assist any of the foregoing or otherwise engage or participate in any Competitive Business; provided, however, that the foregoing shall not prohibit the ownership by Employee of less than ten  percent (10%) of the outstanding shares of the stock of any corporation engaged in any Competitive Business, which shares are regularly traded on a national securities exchange or in any over-the-counter market. For the purpose hereof, "Competitive Business" means the ownership, operation, development, marketing of the services related to, or management of cellular therapeutics within the United States. 

d.

Consideration, Relief, Reformation; Severability. The Company has specifically bargained for the covenants set forth in this Section 6 in consideration for the compensation, experience, and information that Employee will gain or receive in connection with his employment by the Company. Employee agrees that the covenants set forth herein will not preclude Employee from engaging in any lawful profession, trade or business or from being gainfully employed necessary to provide Employee, his family members and dependents a standard of living to which he and they have been accustomed and may expect. Employee acknowledges and agrees that the restrictive covenants in this Section 6 have been specifically negotiated, are reasonable in all respects, including, without limitation, their geographic scope and duration, and may be enforced by specific performance or otherwise. Employee shall not raise any issue of reasonableness as a defense in any proceeding to enforce any of such covenants. Notwithstanding the foregoing, in the event that a covenant included in this Agreement shall be deemed by any court to be unreasonably broad in any respect, it shall be modified or limited in its geographic scope, duration or otherwise to the extent necessary to make it reasonable while preserving its restrictive nature to the maximum degree possible and shall be enforced accordingly; provided however, that if, notwithstanding the foregoing, a court of competent jurisdiction shall hold any of the covenants contained in Sections 6 (a), (b) or (c) to be unenforceable (as so modified), then the unenforceable covenant shall be deemed eliminated from the provisions of this Agreement for the purpose of those proceedings to the extent necessary to permit the remaining covenants to be enforced so that the validity,legality or enforceability of the remaining provisions of this Agreement shall not be affected thereby.

 

8. Developments.

7
 

 

 Employee hereby assigns to the Company his entire right, title and interest in all know how, discoveries and improvements, customer lists,trade secrets and ideas, writings and copyrightable material, which may be conceived by Employee or developed or acquired by him during the term of this Agreement, which may pertain directly to the Company's business and were developed with Company resources. Employee agrees to promptly and fully disclose in writing all such developments. Employee will, upon the Company's request, execute, acknowledge and deliver to the Company all instruments and do all other acts which are necessary or desirable to entitle the Company to all rights in the foregoing and enable the Company to file and prosecute applications for, and to acquire, maintain and enforce all letters, trademark registrations or copyrights with respect to the foregoing in all countries.

 

9. Remedies.

Employee acknowledges that any material breach of this Agreement will cause irreparable harm to the Company, that such harm will be difficult if not impossible to ascertain, and that the Company shall be entitled to equitable relief, including injunction, against any actual or threatened breach hereof, without bond and without liability should such relief be denied, modified or vacated. Neither the right to obtain such relief nor the obtaining of such relief shall be exclusive of or preclude the Company from any other remedy.

 

10. Legal Counsel.

Employee acknowledges that Employee has carefully read this Agreement and understands all of the terms hereof and that Employee has been given the opportunity to discuss this Agreement with Employee's private legal counsel and has availed himself of that opportunity to the extent Employee wishes to do so.

 

11. Notices.

All notices, requests and other communications under this Agreement shall be in writing and shall be deemed to have been received five business days after having been deposited in the United States Mail and enclosed in a registered or certified post-paid envelope; one day after having been sent by overnight courier on a business day or otherwise at the open of business on the next succeeding business day; when personally delivered or sent by facsimile communications equipment of the sending party on a business day or otherwise at the open of business on the next succeeding business day; and, in each case, addressed to the respective parties at the addresses stated below or to such other changed addresses that the parties may have fixed by notice in accordance herewith.

If to the Company:

Bio-Matrix Scientific Group, Inc.

4700 Sprint Street, Suite 304

 

8
 

La Mesa, CA 91942

 

Attn: David Koos, CEO

 

 

If to Employee:

Thomas Ichim

5350 Toscana Way, #E410

San Diego, CA 92122

 

12. Waiver of Breach.

A waiver by the Company or Employee of a breach of any provision of this Agreement by the other party shall not operate or be construed as a waiver of any subsequent breach by the other party.

13. Entire Agreement.

 

This instrument contains the entire agreement of the parties with respect to the subject matter hereof and supersedes any prior agreements ofthe parties with respect to the subject matter hereof. It may be changed only by an agreement in writing signed by a party against whom enforcement of any waiver, change, modification, extension or discharge is sought.

 

14. Applicable Law.

 

The terms and conditions of this Agreement shall be governed by and construed in accordance with the laws of the State or California. Anyaction to enforce this Agreement shall be brought in the state courts located in San Diego County, State of California.

IN WHITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year first above written.

 

 

By: /s/David R. Koos

David R. Koos

Chief Executive Officer

 

 

By: /s/ Thomas Ichim

Thomas Ichim, PhD

 

9
 

 

Schedule 1.

 

Employer: Regen BioPharma, Inc.

 

Location: Company Headquarters and Contracted Research Facilities

 

Description:

 

The Director of Scientific Research day to day duties include:

·

Coordinating the company’s research projects;

·

Sourcing Principal Researchers;

·

Identifying intellectual property relevant to the company’s interests;

·

Identifying research facilities and negotiating contracts with contract research organizations;

·

Analyzing Scientific Data;

·

Writing reports of Scientific Experiments;

·

Submitting grant proposals and presenting findings to various governmental agencies, including but not limited to the FDA

Position Responsibilities:

 

1.

Plan, develop, organize, implement, direct and evaluate intellectual property for Company in-licensing.

 

2.

Coordinate all aspects of the company’s research activities.

 

3.

Source outside researchers, partners and facilities in order to conduct the company’s business with final approval regarding the retention of researchers, entry into agreements with partners, or purchase or lease of facilities to be granted by the Company’s CEO in his sole discretion.    .

 

4.

Advise, negotiate, manage and administer research contracts in which the company may enter.

 

5.

Lead and direct the development, communication and implementation of research related effective growth strategies and processes.

 

6.

Perform other duties as required. Perform other responsibilities as mandated by and any other pertinent local, state or federal regulations.

 

10
 

Schedule 2.

 

 

VESTING SCHEDULE FOR SIGNING SHARES

 

Signing Shares may not be sold, transferred, assigned, pledged or otherwise encumbered or disposed of by Employee (“ Transfer Restriction”) except as follows:

 

(a)

Monthly vesting of shares:

 

 

Upon the expiration of one month from the date of the grant of the Signing Shares, Transfer Restrictions shall no longer apply to 1,000,000 of the Signing Shares.

 

Upon the expiration of two months from the date of the grant of the Signing Shares, Transfer Restrictions shall no longer apply to an additional 1,000,000 of the Signing Shares.

 

Upon the expiration of three months from the date of the grant of the Signing Shares, Transfer Restrictions shall no longer apply to an additional 1,000,000 of the Signing Shares.

 

Upon the expiration of four months from the date of the grant of the Signing Shares, Transfer Restrictions shall no longer apply to an additional 1,000,000 of the Signing Shares.

 

Upon the expiration of five months from the date of the grant of the Signing Shares, Transfer Restrictions shall no longer apply to an additional 1,000,000 of the Signing Shares.

 

Upon the expiration of six month from the date of the grant of the Signing Shares, Transfer Restrictions shall no longer apply to an additional 1,000,000 of the Signing Shares.

 

(b)

Milestone Vesting of shares:   Transfer Restrictions shall no longer apply to 6,000,000 of the Signing Shares (“Milestone Shares”) upon the achievement of the following events (“Milestones”) during the course of the Employee’s employment with the Company:

(1)

Upon the addition to the Scientific Advisory Board of the Company or any subsidiary of the Company  of five Researchers approved by the CEO of the Company to act as members of Scientific Advisory Board of the Company or any subsidiary of the Company, prior to December 31, 2012, Transfer Restrictions shall no longer apply to 1,000,000 shares Milestone Shares

(2)

Upon the identification of five separate intellectual properties (“IPs”),

 

11
 

 

prior to May 4, 2013, which are, in the sole discretion of the CEO of the Company, deemed to be suitable IPs for the Company or any subsidiary of the Company to consider licensing for commercial use Transfer Restrictions shall no longer apply to 1,000,000 Milestone Shares.

(3)

Upon execution, prior to May 4, 2013, of binding agreements whereby the Company or any of its subsidiaries have secured commercial licensing rights to all of the IPs listed above prior to May 4, 2013, Transfer Restrictions shall no longer apply to 1,000,000 Milestone Shares.

(4)

Upon retention by the Company or any of its subsidiaries, prior to May 4, 2013,  of both of appropriate researchers and an appropriate Contract Research Organization, the purpose of such retention being the commencement of clinical trials and  the preparation of an Investigational New Drug Application pursuant to applicable law, Transfer Restrictions shall no longer apply to 1,000,000 Milestone Shares.

(5)

Upon commencement, prior to December 31, 2013, of a “Phase I” clinical trial by the Company or any subsidiary of the Company, to be performed in connection with an Investigational New Drug Application submitted by the Company and in accordance with applicable law, Transfer Restrictions shall no longer apply to 2,000,000 Milestone Shares.

 

 

In the event that Employee is no longer employed by the Company or any subsidiary of the Company, any Signing Shares (including Milestone Shares) still subject to Transfer Restrictions shall be forfeited by the Employee, and ownership of those Signing Shares shall be transferred back to the Company.

 

In the event that any Milestone listed above is not achieved by the date so indicated, those Milestone Shares for which Transfer Restrictions would no longer apply upon achievement of the applicable Milestone shall be forfeited by the Employee, and ownership of the Milestone Shares shall be transferred back to the Company.

 

 

 

 

 

12

EX-10.6 21 reg1009forms1ex10_6.htm EXHIBIT 10.6

Exhibit 10.6

 

 

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Exhibit 10.7

WORLDWIDE INTELLECTUAL PROPERTY ASSIGNMENT AGREEMENT

DATED May 1, 2013

This Intellectual Property Assignment Agreement (“Agreement”) is entered into on

May 1, 2013 by and between Dr. Wei Ping Min (“Assignor”), an individual

residing at 84 Hesketh St, London, Ontario, N6G 5H5, Canada, and Regen

BioPharma Inc. (“Assignee”), a fully owned subsidiary of Bio-Matrix Scientific

Group, Inc. having offices at 4700 Spring St # 304, La Mesa, CA 91942

 

WHEREAS, Assignor is the owner of all proprietary and intellectual property

rights, including but not limited to trade secrets, patent applications and patents, in

the concepts and technologies specifically described in Attachment A (“Min IP”)

 

WHERAS, Assignee desires to acquire the ownership of all proprietary rights,

including, but not limited to, the copyrights, trade secrets, trademarks and

associated good will and patent rights in the Min IP

 

THEREFORE, IT IS AGREED AS FOLLOWS:

1. ASSIGNMENT OF RIGHTS:

As consideration to Assignee for entering into this Agreement and agreeing to

comply with the terms and conditions of this Agreement, Assignor hereby assigns,

transfers, and conveys to Assignee 100% of Assignor’s right, title and interest in

the Min IP, including:

(1) all copyrights, trade secrets, trademarks and associated good will and all

patents anywhere in the world which are granted and which may be granted on the

Min IP;

(2) all applications for patents (including divisions, continuations in whole or

part or substitute applications) in the United States or any foreign countries whose

duty it is to issue such patents;

(3) any reissues and extensions of such patents; and

(4) all priority rights under the International Convention for the Protection of

Industrial Property for every member country.

 

 

 

 

2. WARRANTIES AND REPRESENTATIONS OF ASSIGNOR

(a)Assignor is sole and rightful owner of any and all rights, title and interest in

the Min IP

(b)The Min IP has not been sold or transferred to any third party nor has any

third party been granted the right to acquire or license any of the Min IP

(c) The execution, delivery and performance of this Agreement by Assignor

does not and shall not constitute Assignor’s breach of any statute or

regulation or ordinance of any governmental authority, and shall not conflict

with or result in a breach of or default under any of the terms, conditions, or

provisions of any order, writ, injunction, decree, contract, agreement, or

instrument to which the Assignor is a party, or by which Assignor is or may

be bound.

 

3. WARRANTIES AND REPRESENTATIONS OF ASSIGNEE

(a)Assignee is a corporation duly organized, validly existing and in good

standing under the laws of the state its incorporation and has the requisite

corporate power and authority to enter into and perform its obligations under

this Agreement without the consent, approval or authorization of, or

obligation to notify, any person, entity or governmental agency which

consent has not been obtained.

(b)The execution, delivery and performance of this Agreement by Assignee

does not and shall not constitute Assignee’s breach of any statute or

regulation or ordinance of any governmental authority, and shall not conflict

with or result in a breach of or default under any of the terms, conditions, or

provisions of any order, writ, injunction, decree, contract, agreement, or

instrument to which the Assignee is a party, or by which Assignee is or may

be bound.

 

 

 

 

(c)Assignee shall cause Bio-Matrix Scientific Group, Inc. (.BMSN.) to

perform any and all actions required in order that BMSN shall authorized

have a sufficient number of common shares that consideration may be

rendered to Assignor in accordance with the terms and conditions of this

Agreement ..

 

4. CONSIDERATION TO ASSIGNOR

(1)Assignee agrees to negotiate in good faith with Assignor with regards to a

proposed consulting agreement whereby the Assignor shall perform certain

 

agreed upon tasks for the benefit of Assignee for consideration to

the Assignor consisting of One Hundred Thousand United States Dollars

($100,000 ) of the common shares of BMSN valued as of the date of

issuance and to be paid over a twelve month period in twelve equal

installments (“Consulting Shares”) and registered under the Securities Act of

1933 on Form S-8.

 

(2)

(i) Assignor shall receive 100,000 of the preferred shares of BMSN within 10

days of execution of this document (.Assignor Preferred Shares.).

(ii)Assignor preferred Shares may be exchanged by Assignor for newly issued

common shares of BMSN (“Exchange Common Shares”) at Assignor’s

option subject to the following conditions:

 

(a)A sufficient number of common shares shall be authorized for issuance by

BMSN in order that the required number of Exchange Common Shares may

be issued

(b)Subject to (2)(ii)(a) above, upon any date subsequent to the date of the

completion of a satisfactory review by the United States Food and Drug

Administration (“FDA”) of an Investigational New Drug Application

(“IND”) for the Min IP submitted by the Assignee which shall result in the

ability of the Assignee to lawfully begin clinical testing of the Min IP on

human subjects within the United States the Assignee shall be permitted, at

Assignee’s option, to exchange 33,333 of the Assignor Preferred Shares into

that number of Exchange Common Shares having a value of Three Hundred

Thirty Three Thousand United States Dollars ($333,000) such shares being

valued at a price per share equal to the closing price as of the day written

notice is given by Assignor to Assignee of Assignor’s intent to exchange.

 

 

 

 

(c) Subject to (2)(ii)(a) above, upon any date subsequent to the date that

manufacturing procedures for the manufacture of the Min IP have been

developed by the Assignee which comply to the Current Good

Manufacturing Practices (“cGMP “) requirements of the Food Drug and

Cosmetics Act of 1938 and the rules and regulations promulgated thereunder

as they may apply to the manufacture of the Min IP the Assignor shall be

permitted, at Assignor’s option, to exchange 33,333 of the Assignor

Preferred Shares into that number of Exchange Common Shares having a

value of Three Hundred Thirty Three Thousand United States Dollars

($333,000) such shares being valued at a price per share equal to the closing

price as of the day written notice is given by Assignor to Assignee of

Assignor’s intent to exchange.

(d)Subject to (2)(ii)(a) above, upon any date subsequent to the date that, in

connection with a lawfully administered Phase I clinical trial of the Min IP

being conducted by the Assignee within the United States on human

subjects, both of (1) a clinical trial protocol has been completed and (2) a

Principal Investigator has been appointed, the Assignor shall be permitted,

at Assignor’s option, to exchange 33,333 of the Assignor Preferred Shares

into that number of Exchange Common Shares having a value of Three

Hundred Thirty Three Thousand United States Dollars ($333,000) such

shares being valued at a price per share equal to the closing price as of the

day written notice is given by Assignor to Assignee of Assignor’s intent to

exchange.

(e) Subject to sufficient number of common shares having been authorized for

issuance by BMSN, Assignor shall receive, upon successful completion of a

lawfully administered Phase I clinical trial of the Min IP being conducted by

the Assignee within the United States on human subjects, the results of

which (1) shall indicate that the Min IP can be safely tolerated by human

subjects (2) shall not indicate that use of the Min IP in human subjects result

in side effects of such severity that commencement of a Phase II clinical

trial could not occur, and (3) establishes the optimal dosage and/or method

of administration( as applicable )of the Min IP the Assignor shall receive

that number of the common shares of BMSN which, at a price per share

equal to the closing price of the shares as of the day of issuance, shall equal

One Million United States Dollars ($1,000,000)

(f) For purposes of this Section 4, the term “closing price” with regards to any

common shares of BMSN issued to the Assignor shall mean the last sale

price as reported by the principal securities exchange or trading market

where the common shares of BMSN are listed or traded. In the event that the

common shares of BMSN are not be traded publicly on a securities

exchange or trading market as of the date of required issuance the common

shares shall be valued at fair value as determined by a third party who shall

be approved by both Assignor and Assignee.

 

 

 

 

(g)Assignor shall be entitled to additional consideration for productivity and

deliverables over and above listed items (“Bonus”) The eligibility of the

Assignor to receive a Bonus as well as the nature and amount of any Bonus

shall be at the sole discretion and determination of the CEO of BMSN on

behalf of Assignee.

 

5. NO REGISTRATION UNDER THE SECURITIES ACT OF 1933 OR THE

SECURIES LAWS OF ANY STATE

Assignor acknowledges that any securities issued pursuant to this Agreement that

are not registered pursuant to the Securities Act of 1933 shall constitute “restricted

 

securities” as that term is defined in Rule 144 promulgated under the Securities Act of

1933, and shall contain the following restrictive legend:

 

THESE SECURITIES HAVE NOT BEEN REGISTERED UNDER THE

SECURITIES ACT OF 1933, AS AMENDED (THE .ACT.), OR SECURITIES

LAWS OF ANY STATE AND MAY NOT BE OFFERED, SOLD, ASSIGNED,

PLEDGED, TRANSFERRED OR OTHERWISE DISPOSED OF IN THE

ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT UNDER THE

ACT AND APPLICABLE STATE SECURITIES LAWS OR PURSUANT TO

AN AVAILABLE EXEMPTION FROM REGISTRATION UNDER THE ACT

OR SUCH LAWS AND, IF REQUESTED BY THE COMPANY, UPON

DELIVERY OF AN OPINION OF COUNSEL REASONABLY

SATISFACTORY TO THE COMPANY THAT THE PROPOSED TRANSFER

IS EXEMPT FROM THE ACT OR SUCH LAWS.

 

6. COOPERATION BY ASSIGNOR. Assignor agrees to cooperate with

Assignee and to execute and deliver all papers, instruments and assignments

as may be necessary to vest all right, title and interest in and to the Min IP to

Assignee. Assignor further agrees to testify in any legal proceeding, sign all

lawful papers and applications and make all rightful oaths and generally do

everything possible to aid Assignee to obtain and enforce proper protection

for the Min IP in all countries.

 

7. This Agreement embodies all of the representations, warranties and

agreements of the parties hereto with respect to the subject matter hereof,

and all prior understandings, representations, and warranties (whether oral or

written) with respect to such matters are superseded and may not be

amended, modified, waived, discharged, or orally terminated except by the

mutual written consent of the parties.

 

 

 


 

8. The invalidity or unenforceability of any particular provision of this

Agreement shall not affect the other provisions hereof, and this Agreement

shall be construed in all respects as if such invalid or unenforceable

provisions were omitted. Furthermore, in lieu of such illegal, invalid, or

unenforceable provision there shall be added automatically as a part of this

Agreement a provision as similar in terms to such illegal, invalid, or

unenforceable provision as may be possible and be legal, valid and

enforceable.

 

9. The parties each shall bear their own legal and other expenses incurred in

connection with the preparation, execution and performance of this

Agreement.

 

10. The terms and conditions of this Agreement shall be governed by and

construed in accordance with the laws of the State of California, without

reference to its choice of law rules. Any action arising as a result of this

Agreement shall be brought in the state courts located in San Diego County,

State of California.

 

11. This agreement may be signed in two or more counterparts each of which

may be a facsimile copy and which shall be deemed to be an original, but

together shall constitute the same instrument and shall be binding on the

parties.

 

IN WITNESS WHEREOF, the parties have executed this Agreement as of the date

first above written.

 

"ASSIGNOR"

By:   /s/Wei Ping Min                

Date: May 1, 2013

 

"ASSIGNEE"

By:   /s/David R. Koos               

Title: Chairman & CEO

Date: May 1, 2013

 

 

 

 

APPENDIX A

- Method of Cancer Treatment using siRNA Silencing US Patent # 8,389,708

- Patent applications from the same family corresponding to numbers PCT/CA2006/000984,

CA2612200 and EP1898936

EX-10.8 24 reg1009forms1ex10_8.htm EXHIBIT 10.8

Exhibit 10.8


Regen BioPharma Inc.

A wholly owned subsidiary of Bio-Matrix Scientific Group Inc.

May 18, 2012

 

Wei-Ping Min, MD, PhD

Professor, Department of Surgery

University of Western Ontario

339 Windermere Road

LHSC-UC, C9-136

London, Ontario

N6A 5A5

Canada

 

Dear Dr. Wei-Ping Min:

 

This letter is a follow up to our previous discussion about the Scientific Advisory Board for Regen BioPharma Inc. (a wholly owned subsidiary of Bio-Matrix Scientific Group Inc.).  The function of the Scientific Advisory Board is to review research directions that Regen BioPharma Inc. may undertake, determining those projects which may lead to future developments / advancements in the field of stem cell therapy.  Other areas may be pursued as well, with advice from this advisory board.

 

You will receive 200,000 shares of Bio-Matrix Common stock as consideration for participating in telephonic calls / conference calls and serving on Regen BioPharma Inc.’s Scientific Advisory Board.  The frequency and timing of such calls will be established on a mutually agreeable basis.

 

It is anticipated that members of the Scientific Advisory Board will potentially serve as primary research consultants to the Company as such projects are undertaken.  Compensation for such projects will be either at a rate of $500 per hour or negotiated separately on a case-by-case basis between the Company and the researcher.

 

Thank you for your consideration,

 

/s/ David R. Koos                   

Chairman & CEO

 

P.S.: Please sign the bottom of this letter in your acceptance and fax back to me at 619.330.2328.  Also, please email me a copy of your curriculum vitae in word format.  Any usage of your name in any press releases will be submitted to you for review and comment before being released to the public.

 

 

/s/Wei Ping Min                      

Wei-Ping Min, MD, PhD

(date: May 26, 2012)

EX-10.9 25 reg1009forms1ex10_9.htm EXHIBIT 10.9

Exhibit 10.9

Exclusive Option to Negotiate an Exclusive License

Between

Oregon Health & Science University

and

Regen BioPharma, Inc.

 

This Exclusive Option to Negotiate an Exclusive License (this “Agreement”), dated and effective as of June 5, 2012 (the “Effective Date”), is between the Oregon Health & Science University, having offices at 0690 SW Bancroft Street, L106TT,  Portland, Oregon 97239 (“OHSU”), and Regen BioPharma, Inc., having offices at 4700 Spring St # 304, La Mesa, CA 91942 (“Optionee”).  OHSU and Optionee are herein referred to each as a “Party” and collectively as the “Parties.”

1.

BACKGROUND

1.01

OHSU has certain inventions and discoveries generally described in OHSU Invention Disclosure #0472 entitled “Method for enhancing hematopoiesis” (the “Invention”).  

1.02

OHSU desires the Invention to be utilized for the public benefit to the fullest extent possible.

1.03

Optionee wishes to obtain from OHSU, and OHSU is willing to grant to Optionee, an exclusive option for an exclusive, worldwide, royalty bearing license to the Patent Rights and a non-exclusive, worldwide, royalty bearing license to the Know-How described in this Agreement, subject to the terms and conditions set forth below.

 

2.

DEFINITIONS

2.1

Change of Control” means (a) the acquisition, either directly or indirectly, through one or a series of transactions by any third party of more than fifty one percent (51%) of the assets of Optionee; (b) any merger or consolidation involving Optionee that either directly or indirectly, through one or a series of transactions by which any third party acquires more than fifty one percent (51%) of the voting stock of Optionee; or (c) the transfer to any third party of all or substantially all the assets of Optionee relating to the subject matter of this Agreement

2.2

Confidential Information” means all information and materials provided by one Party (“Disclosing Party”) to the other (“Recipient”) and designated as confidential by Disclosing Party when provided.  The term "Confidential Information" does not include any information or materials that the Recipient demonstrates (a) is or becomes part of the public domain through no fault of the Recipient or anyone receiving the Confidential Information from Recipient; (b) was already known to Recipient prior to disclosure as demonstrated through adequate written records; (c) is disclosed to Recipient by a third party who has the right to make such disclosure; or (d) through adequate written records to have been developed independently of knowledge of or access to the Confidential Information. The specific terms and conditions of this Agreement are Confidential Information, but the existence of the Agreement and Field of Use are not.

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2.3

 “Field of Use” means all therapeutic uses related to treatment of diseases in humans.

2.4

 “Inventors” means the individuals listed as inventors on any patent application or issued patent included within the Patent Rights.

2.5

 “Know-How” means information, including Confidential Information, provided by the Inventors at their sole election, as set forth in Appendix A, and materials transferred to Optionee in amounts determined solely by Inventors.

2.6

 “Licensed Product” means (a) any method, procedure, service or process that incorporates, uses, used, is covered by, infringes or would infringe any of the Optioned Technology but for the exception in 35 U.S.C. §271(e)(1), or similar exception in the U.S. or foreign jurisdictions; and (b) any apparatus, material, equipment, machine or other product that incorporates, uses, used, is covered by, infringes or would infringe any of the Optioned Technology but for the exception in 35 U.S.C. §271(e)(1), or similar exception in the U.S. or foreign jurisdictions.

2.7

 “Optioned Technology” means (a) a pending or issued claim of the Patent Rights; and/or (b) the Know-How.

2.8

 “Patent Costs” means all out of pocket costs incurred by OHSU in connection with the preparation, filing, prosecution, defense, including interference and opposition proceedings, and maintenance of the Patent Rights.  

2.9

 “Patent Rights” means the patents and patent applications listed on Appendix A to this Agreement, PCT, U.S. and foreign applications thereon, including continuations, continuations-in-part (but only to the extent of subject matter therein that is described sufficiently in the patents and patent applications listed on Appendix A to satisfy the requirements of 35 U.S.C. §112) and divisionals, patents issuing from any of the foregoing, and reissues, extensions, supplementary protection certificates, substitute applications, and reexaminations of any of the foregoing.

2.10

 “Term” means the period beginning on the Effective Date and terminating on the day which is six (6) months after the Effective Date. This Term is extendable by mutual written agreement of the Parties.

 

3.

GRANT OF RIGHTS

3.1

Option.

3.1.1

Subject to the terms and conditions of this Agreement and Optionee’s compliance therewith, OHSU grants to Optionee an exclusive option during the Term to evaluate the technology and execute an exclusive, worldwide, royalty bearing license in the Field of Use under the Patent Rights and a non-exclusive, royalty bearing license in the Field of Use to use the Know-How to make, have made, offer to sell, sell and import Licensed Products for the Field of Use substantially similar to the form of which is attached hereto as Appendix B.  

3.1.2

Optionee shall diligently evaluate the Optioned Technology and may exercise this option at any time during the Term by notifying OHSU in writing of its intent to exercise this option.

3.1.3

OHSU and Optionee shall negotiate in good faith towards the execution of an exclusive license agreement  with the terms and conditions substantially similar to those described in Appendix B.  

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3.2

Retained Rights.

3.2.1

OHSU reserves the right to (i) practice and have practiced the Optioned Technology for research, education and/or non-profit patient care purposes and publishing any scientific findings or other information relating to or including the Optioned Technology; and (ii) all right, title and interest in and to the Optioned Technology not expressly granted in Section 3.1.

3.2.2

This Agreement does not confer any right, title or interest, including any license or rights by implication, estoppel or otherwise, in tangible or intangible property rights, including any patents, know-how or other inventions or discoveries, that are not explicitly granted to Optionee in Section 3.1, and OHSU expressly retains those rights.

 

4.

PAYMENTS

 

As partial consideration for the rights granted to Optionee under this Agreement, Optionee will pay OHSU the following:

4.1

Option Issue Payment.  Optionee will pay OHSU an option issue payment of Five Thousand U.S. Dollars (US$5,000) within 30 days after the Effective Date. The aforesaid payment shall be credited towards satisfaction of the upfront license issue payment payable provided Optionee exercises the option granted herein and executes a license agreement within the Term.  This Agreement may be extended by mutual agreement for an additional six (6) months for an additional option issue payment of Ten Thousand U.S. Dollars (US$10,000). The option issue payment(s) may be credited towards the exclusive license upfront payment.

4.2

Reimbursement of Patent Costs.  Optionee will reimburse OHSU for all Patent Costs occurring during the Term..    

4.3

Payment Terms.  

4.3.1

Except as expressly provided in Section 4.1, all payments are nonrefundable and noncreditable, and due and payable to OHSU by Optionee on the date specified in this Agreement.  In the event no date is specified, payment is due within 30 days from the date of invoice.  

4.3.2

Any unpaid invoices or payments will incur a late fee of 1.0% per month (12% per annum) until paid.  Acceptance of late payments does not negate or waive OHSU's right to seek any other remedy in law, equity or otherwise.

4.3.3

All amounts payable to OHSU under this Agreement are payable in United States dollars.

4.3.4

All amounts payable to OHSU under this Agreement are net of all taxes and other charges, and Optionee will be responsible for paying all taxes, fees and other charges levied by any taxing authority on account of any sums payable under this Agreement.  Optionee will deliver copies of all official tax receipts.

4.3.5

All payments required under this Agreement will be delivered by hand, by overnight courier, or by first class, registered or certified mail, properly addressed to OHSU at the address listed in Section 7.1 below.

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5.

CONFIDENTIAL INFORMATION

5.1

If Optionee provides Confidential Information to the Fleming Laboratory at OHSU, it must do so through Dr. W. H. Fleming as well as the authorized representative of OHSU designated in Section 7.1.  Recipient of Confidential Information will protect and keep that Confidential Information secret and will not (a) disclose that Confidential Information to any person other than to Recipient's employees, agents and independent contractors with a need to know the Confidential Information to exercise its rights and/or perform its obligations hereunder, and who have agreed to an obligation of confidentiality and prohibition on use at least as protective of the Confidential Information as this Section 5; or (b) use that Confidential Information for any purpose other than to exercise its rights and perform its obligations under this Agreement. Recipient's obligations under Section 5 expire five years following the later of the expiration or termination of this Agreement.

5.2

If Recipient is required by law, including Oregon Public Records Law, regulation or court order to disclose any of the Confidential Information, it will: (a) promptly notify the Disclosing Party; (b) reasonably assist the Disclosing Party to obtain a protective order or other remedy of Disclosing Party's election; (c) provide Disclosing Party prior review of any disclosure; (d) only provide that portion of the Confidential Information that is legally required; and (e) make reasonable efforts to obtain reliable assurance that the Confidential Information will be maintained in confidence.

5.3

Given the nature of the Confidential Information and the damage that would result to the Disclosing Party upon unauthorized disclosure, use or transfer of their Confidential Information to any third party, the Parties agree that monetary damages would not be a sufficient remedy for any breach or threatened breach of this Section 5.  In addition to all other remedies, Disclosing Party will be entitled to seek specific performance and injunctive and other equitable relief as a remedy for any breach or threatened breach of this Section 5. The breaching Party agrees to waive any requirement for the securing or posting of any bond or the showing of actual monetary damages in connection with such remedy hereunder.  

 

6.

TERMINATION

6.1

Optionee may terminate this Agreement for any reason by giving thirty (30) days advance written notice to OHSU and paying OHSU all sums then due and payable.

6.2

If Optionee breaches this Agreement or defaults on its payment obligations, OHSU may terminate this Agreement by giving thirty (30) days advance written notice to Optionee specifying the breach or default under this Agreement, unless before the end of the 30-day period Optionee has cured the breach or default to the satisfaction of OHSU.

 

7.

GENERAL PROVISIONS

7.1

Notices.  All notices or other communications given hereunder shall be in writing, shall be signed by an officer of the Party sending such notice or other communication, and shall be delivered by hand, by overnight courier, by electronic mail or by facsimile with all delivery charges prepaid and addressed to the Parties as follows:

4
 

If to OHSU:

Attention:  Director

Technology Transfer & Business Development

Oregon Health & Science University

0690 SW Bancroft Street, L10TT

Portland, OR 97239

Phone: 503-494-8200

Fax: 503-494-4729

 

 

If to Optionee:

 

J. Christopher Mizer

President

Regen BioPharma, Inc.

4700 Spring St # 304

 La Mesa, CA 91942

Phone: 619-702-1404

 

All notices and communications will be effective on the delivered date if in person, or on the date of the postmark of that notice or communication if by courier, and on the date of the date stamp of that notice or communication if by electronic mail or facsimile.  Either Party may change its address by giving notice of that change to the other Party.

7.2

Waivers.  Neither Party will be deemed to have waived any of its rights under this Agreement until it has signed a written waiver of those rights.  Without limiting the preceding, no failure or delay by either Party in exercising any rights, powers or remedies under this Agreement will operate as a waiver of any such right, power or remedy, and no waiver will constitute a waiver of any other provision, breach, right or remedy, nor will any waiver constitute a continuing waiver or be effective except for the specific instance and for the specific purpose given.

7.3

Amendments.  If either Party wishes to modify this Agreement, the Parties will confer in good faith to determine the desirability of such modification.  No modification will be effective until a written amendment is signed by both Parties.

7.4

Assignment.  Optionee will not assign or transfer its interests in nor delegate its obligations under this Agreement, whether by transfer, merger, operation of law or otherwise without OHSU's written consent, which will not be unreasonably withheld.  A Change of Control of Optionee (voting or otherwise) will be deemed an assignment for purposes of this Section 7.4. An assignment among entities under common control of Optionee shall not be deemed a Change in Control.  This Agreement will be binding on and inure to a Party's successors and assigns.  OHSU has the right to assign its Optioned Technology and this

5
 

Agreement to any successor or assign.

7.5

Governing Law; Jurisdiction and Venue.  This Agreement will be governed by and construed in accordance with the laws of the State of Oregon without reference to any choice of law provisions, the Uniform Commercial Code or the International Convention on the Sale of Goods.  Subject to Section 7.7, any claim, action or suit between OHSU and Optionee that arise out of or relate to this Agreement and that is not barred by sovereign immunity will be brought and conducted solely and exclusively within the Circuit Court for Multnomah County, Oregon, provided however, if any such claim, action or suit may be brought only in a federal forum or pertains to the enforcement of the Patent Rights, and does not waive sovereign immunity on behalf of OHSU unless OHSU so elects at that time, such claim, action or suit will be brought and conducted solely and exclusively within the United States District Court of Oregon and Optionee consents to the jurisdiction of and venue in those courts.  Nothing herein will be construed as a waiver of sovereign immunity.

7.6

Severability.  The terms and conditions of this Agreement are severable.  If any term or condition of this Agreement is rendered invalid or unenforceable by any law or regulation, or declared null and void by any court of competent jurisdiction, that part will be reformed, if possible, to conform to law, and if reformation is not possible, that part will be deleted in such jurisdiction only and the remainder of the terms and conditions of this Agreement as well as the invalid or unenforceable term or condition in all jurisdictions where valid and enforceable will remain in full force and effect, unless enforcement of this Agreement without the invalid or unenforceable term or condition would be grossly inequitable under the circumstances or would frustrate the primary purpose of this Agreement.

7.7

Dispute Resolution.  The Parties agree to first attempt to settle amicably any controversy or claim arising out of or relating to this Agreement by providing copies of documents reasonably requested to enable a Party to evaluate its position. If the Parties are unable to settle amicably any controversy or claim then both Parties agree that all disputes between them arising out of or relating to this Agreement will be submitted to non-binding mediation unless the Parties mutually agree otherwise in writing.  Both Parties agree to exercise their best effort in good faith to resolve all disputes in mediation provided, however, nothing will limit OHSU's remedies or ability to enforce its rights in the Optioned Technology in any jurisdiction or manner.

7.8

Independent Contractor; No Agency.  Neither Party will be deemed to be the employee, representative, agent, joint venturer or partner of the other Party for any purpose.  Neither Party has the authority to obligate or bind the other, or to incur any liability on behalf of the other, nor to direct the employees of the other.

7.9

Interpretation.  Both Parties have had the opportunity to have this Agreement reviewed by their attorneys.  Therefore, no rule of construction or interpretation that favors or disfavors either Party will apply to the interpretation of this Agreement.  Instead, this Agreement will be interpreted according to the fair meaning of its terms.  The captions or headings of this Agreement are for convenience of reference only.  They will not limit or otherwise affect the meaning or interpretation of any provision of this Agreement.  The words "includes" and "including" are not limited in any way and mean "includes or including without limitation."  The word "person" includes individuals, corporations, partnerships, limited liability companies, co-operatives, associations and other natural and legal persons.  The term "and/or" means each and all of the persons, words, provisions or items connected by that term; i.e., it has a joint and several meaning. The word "will" is a synonym for the word "shall".  All attachments to this Agreement are a part of and are incorporated in this Agreement.

7.10

Counterparts; Facsimile Delivery.  This Agreement may be executed in one or more counterparts, each of which will be deemed an original and all of which together will constitute one and the same Agreement.  This Agreement may be delivered by facsimile, and when so delivered will have the same force and effect as delivery of an original signature.

6
 

 

7.11

Attorneys' Fees.  In any legal action or proceeding arising out of or related to this Agreement, the Prevailing Party will be entitled to recover all reasonable attorneys’ fees incurred at trial, on appeal, and on any petition for review, together with other costs allowed by law.  For purposes of this Agreement, "Prevailing Party" means the Party that prevails either affirmatively or by means of a successful defense with respect to claims having the greatest value or importance as reasonably determined by the mediator or court with jurisdiction over the matter, as applicable and after taking into consideration any settlement offers made by the Parties.

7.12

ENTIRE AGREEMENT.  With respect to the Optioned Technology, this Agreement, including its Appendices which are incorporated herein by reference, is the entire agreement between the Parties and supersedes all prior discussions, representations, warranties and agreements, both written and oral between the Parties.

 

OHSU:   OREGON HEALTH & SCIENCE UNIVERSITY

 

 

/s/Andrew O. Watson

June 6, 2012

 

Andrew O. Watson

Date

 

Interim Director, Technology Transfer & Business Development

 

 

OPTIONEE:

REGEN BIOPHARMA, INC.

 

/s/ J. Christopher Mizer

June 6, 2012

     

J. Christopher Mizer

Date

 

 

 

7

EX-10.10 26 reg1009forms1ex10_10.htm EXHIBIT 10.10

Exhibit 10.10

REGEN BIO PHARMA INC.

A wholly owned subsidiary of Bio matrix Scientific Group, Inc.

 

 

May 16, 2012

 

Dr. David James Graham White

The Schulic School of Medicine

University of Western Ontario

The Siebens Drake Centre

1400 Western Road

London Ontario

Canada N6G 2V4

 

Dear Dr. White

 

This letter is a follow up to our previous discussion about the Scientific Advisory Board for Regen BioPharma, Inc (a wholly owned subsidiary of Bio Matrix Scientific Group, Inc.).

 

The function of the Scientific Advisory Board is to review research directions that Regen BioPharma, Inc.  may undertake, determining those projects which may lead to future developments/advancements in the field of stem cell therapy. Other areas may be pursued as well, with advice from this advisory board.

 

You will receive 200,000 shares of Bio Matrix Common Stock as consideration for participating in telephonic calls/conference calls and serving on Regen BioPharma, Inc.’s Scientific Advisory Board. The frequency and timing of such calls will be established on a mutually agreeable basis.

 

It is anticipated that members of the Scientific Advisory Board will potentially serve as primary research consultants to the Company as such projects are undertaken. Compensation for such projects will be either at the rate of $500 per hour or negotiated separately on a case-by-case basis between the Company and the researcher.

 

Thank You for your consideration

 

   /s/ David R. Koos                                      

David R. Koos

Chairman and CEO

 


 

P.S.: Please sign this letter in your acceptance and fax back to me at 619-330-2328. Any usage of your name in any press releases will be submitted to you for review and comment before being released to the public.

 

   /s/ Dr. David James Graham White          

Dr. David James Graham White

(date: 5/20/2012)

 

 

 

EX-10.11 27 reg1009forms1ex10_11.htm EXHIBIT 10.11

Exhibit 10.11

 

 

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MB1XFGMM%D0Y1[6%]0,<#(0-IC52N/EQ7U;10!Y5_PQOX1_Z#'Q5_\.?XE_\` MD^C_`(8W\(_]!CXJ_P#AS_$O_P`GUZK10!Y2W[&WA%@0=8^*W/I\3_$H_P#; M^MKP-^SGX7^'OB6SUFSCU^_U;3H+NUM;S6?$6HZS<6T5RULT\:/>3RE5 EX-10.12 29 reg1009forms1ex10_12.htm EXHIBIT 10.12

Exhibit 10.12  

 

LICENSE AGREEMENT - EXECUTION

 

 

THIS LICENSE AGREEMENT, including the exhibits referred to herein and attached hereto (the “Agreement”), effective as of August 5, 2013 (the “Effective Date”), is made and entered into by and between Benitec Australia Limited, an Australian corporation (ACN 080 299 645) having its registered office at 1-15 Barr Street, Balmain, NSW, Australia 2041, (“Benitec Australia”) and Regen BioPharma, Inc., a United States company having its registered office at 4700 Spring Street, Suite 304, La Mesa, CA 91942 USA, (“Regen BioPharma”).  Benitec Australia and Regen BioPharma may be referred to in this Agreement each as a “Party” or collectively as the “Parties.”

 

 

RECITALS

A.   Benitec Australia owns or has the right from CSIRO pursuant to the CSIRO License to grant rights and licenses under certain patents, patent applications, know-how and other intellectual property relating to RNA interference, a biological mechanism by which double-stranded RNA modifies gene expression (“RNAi”);

 

B.   Regen BioPharma desires to obtain from Benitec Australia an exclusive right and license under such patents, patent applications, know-how and other intellectual property for development and commercialization of RNAi for use to silence indoleamine 2, 3 – doxygenase (IDO) in Dendritic Cells for human therapeutic use; and

 

C.   Benitec Australia is willing to grant such right and license to Regen BioPharma.

 

NOW, THEREFORE, in consideration of the mutual covenants and obligations set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, Benitec Australia and Regen BioPharma hereby agree as follows:

 

1.  

DEFINITIONS

 

As used in this Agreement, the following terms shall have the meanings indicated:

 

1.1.   Affiliate” shall mean any entity that is controlled by, controls, or is under common control with Benitec Australia or Regen BioPharma, as the case may be, at any time during the Term.  For such purpose the term “control” means (a) direct or indirect ownership of more than fifty percent (50%) of the voting interest in the entity in question, or more than fifty percent (50%) interest in the income of the entity in question; provided, however, that if local law requires a minimum percentage of local ownership of greater than fifty percent (50%), control will be established by direct or indirect beneficial ownership of one hundred percent (100%) of the maximum ownership percentage that may, under such local law, be owned by foreign interests; or (b) possession, directly or indirectly, of the power to direct or cause the direction of management or policies of the entity in question (whether through ownership of securities or other ownership interests, by contract or otherwise).

 

 

 

 

1.2.   Benitec Australia Know-How” shall mean any and all technical and scientific information, owned or controlled by Benitec Australia as of the Effective Date and at any time during the Term to the extent that such information relates to RNAi as applicable to the Field, including, for example, ideas, discoveries, knowledge, know-how, data processes, procedures, methods, techniques, protocols, formulae, trade secrets, inventions (whether or not patentable), research tools, formulations, other physical, chemical or biological information, including without limitation improvements to such information.

 

1.3.   Clinical Trial” means an investigation in human subjects and/or patients intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of a Licensed Product, and/or to identify any adverse reactions to a Licensed Product, and/or to study absorption, distribution, metabolism, and/or excretion of a Licensed Product with the objective of ascertaining its safety, activity and/or efficacy.

 

1.4.   Commercialization” or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

 

1.5.   Commercially Reasonable Efforts” means those commercial reasonable efforts and resources, consistent with the practice of comparable pharmaceutical companies of a similar size and resources, both financial and otherwise, to Licensee, that would reasonably be used by such companies were they developing or commercializing a pharmaceutical product of comparable market potential and risk profile.

 

1.6.   Confidential Information” shall have the meaning set forth in Section 9.1 (Confidential Information).

 

1.7.   CSIRO shall mean the Commonwealth Scientific and Industrial Research Organisation of Australia.

 

1.8.   CSIRO License” means the Agreement dated 23rd December 2009, as amended on 28th May 2012 pursuant to a Deed of Amendment, entered into by and between CSIRO and Benitec Australia Limited ACN 080 299 645 and Benitec Limited ACN 068 945 662 (as it then was, now Benitec Australia Limited).

 

1.9.   Develop” or “Developments” shall mean pre-clinical and clinical research and development activities, including toxicology and other pre-clinical development efforts, stability testing, process development, pre-formulation, formulation development, delivery system development, quality assurance and quality control development, statistical analysis, clinical pharmacology, clinical studies (including without limitation Clinical Trials), regulatory affairs, and regulatory approval and clinical study regulatory activities.

 

1.10.   Field” shall mean the use of RNAi in the Human Field (as “Human Field” is defined in the CSIRO License – the definition and supporting definitions are set out in Schedule 1) for the silencing of indoleamine 2, 3 – doxygenase (IDO) in Dendritic Cells for human therapeutic use in.

 

  

 

 

1.11.   First Commercial Sale” shall mean, with respect to each Licensed Product, the first sale of such Licensed Product by Regen BioPharma or its Affiliates or sublicensees to a third party for which payment has been received in any country in the Territory after all applicable required regulatory approvals have been granted by the applicable regulatory authority in such country.

 

1.12.   “Improvements” shall mean any development, discovery or invention that is conceived, reduced to practice or otherwise developed by or on behalf of a Party, whether or not patentable, that is a modification, improvement or enhancement to, and is dominated by the claims of, the Patent Rights.

 

1.13.   Licensed Product” shall mean any product sold by or on behalf of Regen BioPharma, its Affiliates or its sublicensees under the applicable sublicense agreement, the manufacture, use or sale of which would infringe a Valid Claim within the Patent Rights in the country of such manufacture, use or sale but for the license granted herein.

 

1.14.   Licensed Technology” shall mean the Benitec Australia Know-How, the Patent Rights and any Improvements developed by or on behalf of Benitec Australia.

 

1.15.   Net Sales” shall mean the gross amount billed or invoiced by Regen BioPharma, its Affiliate, or its sublicensees (“Seller”) in U.S. dollars for the final end-user sale or other disposition of Licensed Products, less the following deductions (to the extent such deductions are not already deducted from the amount billed or invoiced and to the extent such deductions are not otherwise recovered or reimbursed):

 

  (a) actual amounts, net of recoveries, of any discounts, chargebacks, rebates, allowances for bad debts or uncollectible amounts (provided that such amounts have been formally designated as such in accordance with Seller’s internal accounting procedures, consistently applied), Medicaid/Medicare rebates (other than as described in (d) below) and allowances actually taken;

 

  (b) sales, use, value added and excise taxes, import and customs duties, tariffs, and any other similar government charges, taxes, duties or tariffs, directly imposed against gross sales and to the extent actually paid by or charged to the account of the Seller;

 

  (c) freight, insurance, packaging and insurance costs and other transportation charges to the extent included in the sales price;

 

  (d) amounts corresponding to usual and customary retroactive price reductions actually taken, and

 

  (e) amounts corresponding to credits, allowances or deductions for returns, or rejected or damaged goods, defects, recalls,  commissions, stocking allowances, or marketing and promotional expenses.

 

 

 

 

Notwithstanding the foregoing, “Net Sales” shall not include amounts (i) for any Licensed Product furnished to a third party for which payment (other than the cost of the Licensed Product) is not intended to be received, including, but not limited to, Licensed Products used in Clinical Trials and Licensed Products distributed as promotional and free goods or (ii) from sales or other dispositions of Licensed Products between Regen BioPharma and any of its Affiliates or between Regen BioPharma or any of its Affiliates and a sublicensee, unless such Affiliate or sublicensee, as the case may be, is an end-user of such Licensed Product.

 

1.16.   Patent Rights” shall mean any and all (a) rights under all Patents listed in Exhibit A, including any Patents which issue on the applications listed in Exhibit A, and all Patents owned or controlled by Benitec Australia that describe and claim inventions set forth in the invention disclosures listed on Exhibit A; and (b) all Patents hereafter filed, owned or controlled by Benitec Australia that claim an Improvement dominated by the claims of one or more of the patent rights described in (a) above, each to the extent that they are applicable to the Field.

 

1.17.   Patents” shall mean all: (a) United States and foreign patents, re-examinations, reissues, renewals, extensions and term restorations, inventors’ certificates and counterparts thereof; and (b) pending applications for United States and foreign patents, including, without limitation, provisional applications, continuations, continued prosecution, divisional and substitute applications, and counterparts thereof.

 

1.18.   Phase I” shall mean dosing of the first subject in a Phase I clinical trial (i.e., a clinical trial generally consistent with U.S. 21 C.F.R. 312.21(a) or any other country’s counterpart thereof), initiated by or on behalf of Regen BioPharma, its Affiliates or sublicensee anywhere in the world.

 

1.19.   Phase II” shall mean dosing of the first subject in a Phase II clinical trial (i.e., a clinical trial generally consistent with U.S. 21 C.F.R. 312.21(b) or any other country’s counterpart thereof, including a Phase IIa study), initiated by or on behalf of Regen BioPharma, its Affiliates or sublicensee anywhere in the world.

 

1.20.   Phase III” shall mean dosing of the first subject in a Phase III clinical trial (i.e., a clinical trial generally consistent with U.S. 21 C.F.R. 312.21(c) or any other country’s counterpart thereof, including a Phase II/III study), initiated by or on behalf of Regen BioPharma, its Affiliates or sublicensee anywhere in the world.

 

1.21.   Prosecute” or “Prosecution” shall mean, with respect to Patents, the filing for, prosecuting, responding to oppositions, nullity actions, re-examinations, revocation actions and similar proceedings (including without limitation conducting or participating in interference proceedings and oppositions) filed by third parties against, and maintaining, the Patents.

 

1.22.   “Quarter” means each of the four (4) thirteen (13) week periods; (i) commencing on January 1 of any calendar year.

 

1.23.   Regen BioPharma Improvement” shall have the meaning set forth in Section 2.3 (Rights to Regen BioPharma Improvements).

 

 

 

 

1.24.   Regulatory Approval” shall mean the final approval to market a Licensed Product in any country of the Territory, and any other approval which is required to launch the Licensed Product in the normal course of business.

 

1.25.   Research Plan” shall have the meaning set forth in Section 4.1.1.

 

1.26.   RNAi” shall have the meaning set forth in the Recitals.

 

1.27.    “Term shall have the meaning set forth in Section 8.1 (Term).

 

1.28.   Territory shall mean worldwide.

 

1.29.   Valid Claim” shall mean any claim in any (i) issued and unexpired patent that has not been held unenforceable or invalid by a court or other governmental agency of competent jurisdiction in an unappealed or unappealable decision, and which has not been disclaimed or admitted to be invalid or unenforceable through reissue, reexamination, opposition, interference or otherwise or (ii) any composition of matter, article of manufacture, or method of use claim contained in a patent application that has been pending for no more than seven (7) years from the first priority date claimed in such patent application.

 

1.30.   $” shall mean US Dollars.

 

2.   LICENSES

 

2.1.   Grant of Rights.  Subject to the terms and conditions of this Agreement, Benitec Australia hereby grants to Regen BioPharma an exclusive, royalty-bearing right and license, in the Field in the Territory, including the right to grant sublicenses, under the Licensed Technology, to Develop, make, have made, use, Commercialize, offer for sale, have sold, and import Licensed Products.

 

2.2.   Sublicense Rights.  Regen BioPharma shall have the right, subject to Benitec Australia’s prior written consent, such consent not to be unreasonably withheld, delayed or conditioned, to sublicense the rights granted under Section 2.1 (Grant of Rights) to an Affiliate or a third party pursuant to a written sublicense agreement; PROVIDED, in the event of any sublicense of rights by Regen BioPharma hereunder, (i) full copies of the final sublicense are provided to Benitec Australia, (ii) such sublicense shall be subject to the terms and conditions of this Agreement that, by their terms, are applicable to such sublicense, (iii) the sublicense by Regen BioPharma hereunder shall not relieve Regen BioPharma of its obligations under this Agreement, and (iv) Regen BioPharma shall remain responsible to Benitec Australia for the performance or nonperformance of any such sublicensee hereunder.

 

2.3.   Rights to Benitec Australia Improvements. Any Improvement made by or on behalf of Benitec Australia after the Effective Date which is available to be licensed shall be automatically included in the Licensed Technology licensed to Regen BioPharma in Section 2.1 (Grant of Rights).

 

 

 

 

2.4.   Rights to Regen BioPharma Improvements.  Any Improvement made by or on behalf of Regen BioPharma after the Effective Date (“Regen BioPharma Improvement”) shall be owned by Regen BioPharma.  Regen BioPharma hereby grants Benitec first right of refusal on any intellectual property developed from this license agreement.

 

2.5.   No Other Rights.  Except as expressly provided herein, no right, title, or interest is granted whether by implication, estoppel, reliance, or otherwise, by Benitec Australia to Regen BioPharma in, to or under the Licensed Technology.  All rights with respect to technology, patents or other intellectual property rights that are not specifically granted herein are reserved; in particular, the use of the Patent Rights in plants is reserved to CSIRO in the entirety and the use of the Patent Rights in non-human animals is reserved to Benitec Australia and/or CSIRO and sublicensees, OTHER THAN in relation to Regen BioPharma’s right to Develop Licensed Products in non-human animals and to manufacture Licensed Products in isolated animal cells in accordance with Section 2.1 (and for the purpose of clarity, only for Developments in the Human Field) (Grant of Rights).

 

2.6.   Bankruptcy.  All rights and licenses granted under or pursuant to this Agreement, including amendments hereto, are, for all purposes of 11 U.S.C. § 365(n), licenses of rights to intellectual property as defined in the United States Bankruptcy Code.  Each Party may elect to retain and may fully exercise all of its rights and elections under 11 U.S.C. § 365(n).

 

3.   PAYMENTS AND RELATED OBLIGATIONS

 

3.1.   License Fees.  In partial consideration for the rights and license granted pursuant to Section 2.1 (Grant of Rights), Regen BioPharma shall pay to Benitec Australia:

 

3.1.1.    a one-time, non-refundable, upfront payment of twenty five thousand US dollars ($25,000) as a license initiation fee on the Effective Date (which is defined as the execution date of this agreement); and

 

3.1.2.   a one-time non-refundable payment of twenty five thousand US dollars ($25,000) on the first anniversary of the Effective Date.

 

The payments specified in Section 3.1 may be paid in cash or common stock in accordance with Section 3.3.

 

3.2.   Milestone Payments.  In partial consideration for the rights and license granted pursuant to Section 2.1 (Grant of Rights), Regen BioPharma shall make the following milestone payments to Benitec Australia within sixty (60) days after the first achievement by Regen BioPharma, its Affiliates, or sublicensees of the corresponding events in the Territory.  For the avoidance of doubt, each milestone payment below will be paid once per Licensed Product that meets such milestone.

 

 

  

 

Milestone

 

Amount
Start Phase I/II clinical trial – dosing first patient

$100,000 US Dollars*

 

Start Phase III clinical trial

$500,000 US Dollars

 

Regulatory Approval for a Licensed Product by first regulatory agency

$1,000,000 US Dollars

 

Regulatory Approval for a Licensed Product by second regulatory agency

$2,000,000.00 US Dollars

 

 

*The payment of $100,000 specified in Section 3.2 for “Start Phase I/II clinical trial – dosing first patient” may be paid in cash or common stock in accordance with Section 3.3.

 

3.3.  

BMSN Issue of Common Stock Equivalent to Cash.  The payments identified in Sections 3.1 and 3.2 as payable in cash or common stock may be paid in cash or fully paid common stock (restricted for up to six (6) months) in Regen’s parent company Bio-Matrix Scientific Group (OTCQB: BMSN - “BMSN” – such common stock would be issued at BMSN’s discretion and, in the event that BMSN doesn’t have enough authorized shares available to issue, BMSN may increase the authorized shares so as to allow payment to Benitec Australia).  If common stock in BMSN has not been calculated (in accordance with the following) and issued to Benitec Australia within six (6) months of the Effective Date, then Regen BioPharma will pay to Benitec Australia the full cash amount upon that date.

 

If BMSN determines to issue common stock to Benitec Australia in accordance with this Section 3.3 then it will calculate the number of shares to be issued in accordance with the following:

 

(1)   BMSN will determine the 30 day VWAP (Volume-Weighted Average Price, as determined by BMSN share volumes and prices reported by the OTC Markets Group) of its common stock immediately prior to the date the payment is due; and

 

(2)   BMSN will issue to Benitec that number of shares which is equal to the amount of the payment divided by the 30 day VWAP (step (1) above) rounded up to the nearest whole share.

 

3.4.   Minimum Annual Royalties. In partial consideration for the rights and licenses granted pursuant to Section 2.1 (Grant of Rights), Regen BioPharma shall pay to Benitec Australia minimum annual royalties of twenty five thousand US dollars ($25,000) payable per year on each anniversary of the Effective Date, commencing on the second anniversary of the Effective Date.  This minimum annual royalty is only payable to the extent that royalty payments made during the preceding 12-month period pursuant to Clause 3.4 below do not exceed twenty five thousand US dollars ($25,000).

 

3.5.   Royalty Payments.

 

3.5.1.   In partial consideration for the rights and licenses granted pursuant to Section 2.1 (Grant of Rights), Regen BioPharma shall pay to Benitec Australia royalties equal to four percent (4%) of the Net Sales of any Licensed Products sold within the scope of a Valid Claim of the Licensed Technology in a Quarter.

 

 

 

 

3.5.2.   Royalty Term.  The obligation of Regen BioPharma to pay royalties to Benitec Australia pursuant to Section 3.5.1 shall commence on the date of the First Commercial Sale of a Licensed Product and continue, on a country-by-country basis and on a Licensed Product-by-Licensed Product basis, until expiration or termination of the Patent Rights covering such Licensed Product.  Thereafter, Regen BioPharma shall have an irrevocable perpetual, fully paid up, sub-licensable, royalty-free license of the Licensed Technology with respect to such Licensed Product in such country in which the Patent Rights have expired or permanently terminated.

 

3.5.3.   Sublicensee Payments. Regen BioPharma will pay Benitec BioPharma fifty percent (50%) of all consideration (in the case of in-kind consideration, at fair market value as monetary consideration) received by Regen BioPharma from sublicensees, excluding royalties from sublicensees based on Net Sales of any Licensed Products for which Benitec receives payment in accordance with Section 3.5.1.

 

3.6.   Payment Terms.

 

3.6.1.   No multiple royalties or milestones, pursuant to Sections 3.2 (Milestone Payments) and 3.5 (Royalty Payments), respectively, shall be due or payable because the Development, manufacture, use, offer for sale, sale or import of any Licensed Product is or shall be covered by more than one Valid Claim within the Patent Rights.

 

3.6.2.   Regen BioPharma shall pay all royalties due and payable on Net Sales in each Quarter pursuant to Section 3.4 (Royalty Payments) (i) within sixty (60) days after the last day of each Quarter in which the applicable Net Sales underlying such royalties were billed or invoiced by Regen BioPharma or (ii) in the case of a sublicensee, within thirty (30) days after the sublicensee or its Affiliate remits payment to Regen BioPharma.

 

3.6.3.   All payments made by Regen BioPharma under this Agreement shall be made in US dollars, and such payments shall be made by check or wire transfer to one bank account to be designated in writing by Benitec Australia.  In the event that Licensed Products are sold in currencies other than US dollars, Net Sales shall be calculated by Regen BioPharma in accordance with United States of America generally accepted accounting principles, consistently applied.  Net Sales in currencies other than US dollars shall be converted into US dollars using the average official rate of exchange for such currencies published in The Wall Street Journal on the first and last days of the calendar quarter period in which such Net Sales accrued (or, if not published on such days, the first and last publication days for The Wall Street Journal during such calendar quarter period) and subsequently converted into US dollars also using the Wall Street Journal, before payment into the Benitec Australia account.  If an exchange rate for any particular currency is not published in The Wall Street Journal, the rate of exchange to be used for such currency shall be determined using average conversion rates that generally are accepted in the industry on the first and last days of the calendar quarter period in which such Net Sales accrued.  Royalty payments due to Benitec Australia pursuant to Section 3.5 (Royalty Payments) shall be calculated based on the Net Sales in US dollars as calculated above.  In the event that restrictions or prohibitions imposed by a national or international government authority preclude conversion of a national or international currency into US dollars, the Parties shall consult to find a prompt and acceptable solution.

 

 

 

 

3.7.   Late Payment Interest.  Any payment due and payable to Benitec Australia under the terms and conditions of this Agreement, including, without limitation, any royalty payment, made by Regen BioPharma after the date such payment is due and payable shall bear interest as of the day after the date such payment was due and payable and shall continue to accrue such interest until such payment is made at a rate equal to the lesser of either (a) one percent (1%) above the prime rate as reported by Citibank, New York, New York, as of the date such payment was due and payable, or (b) the maximum rate permitted by applicable law.

 

3.8.   Taxes.  To the extent a withholding tax obligation is imposed by a governmental authority upon a royalty or other payment due and payable by Regen BioPharma to Benitec Australia, Regen BioPharma or a sublicensee, as the case may be, shall be entitled to withhold from such payment the amount, if any, of any tax assessed against Benitec Australia and to be withheld, provided that such tax is only for the account of Benitec Australia and evidence of the payment of such tax is promptly provided to Benitec Australia.  Regen BioPharma, or the sublicensee, as the case may be, shall pay the amount of such tax to the proper taxing authority as required and shall be entitled to deduct the amount of such tax from the payment to be made by Regen BioPharma to Benitec Australia.  Regen BioPharma shall advise Benitec Australia of any tax payment made for the benefit of Benitec Australia pursuant to this Section 3.8 (Taxes) and provide, or request a sublicensee to provide, Benitec Australia copies of tax receipts for all taxes paid and deducted from the payment due and payable to Benitec Australia, together with copies of all pertinent communications from or with governmental authorities with respect thereto.  At Benitec Australia’s reasonable request and at Benitec Australia’s reasonable expense, Regen BioPharma shall reasonably assist Benitec Australia in any effort by Benitec Australia in claiming any exemption from such deductions or withholdings under any double taxation or similar agreement or treaty from time to time in force, and in minimizing the amount required to be so withheld or deducted.

 

3.9.   Records and Reports.  All payments made to Benitec Australia hereunder shall be accompanied by a written statement setting forth in reasonable detail the calculation thereof, including, for example, in the case of royalty payments, the gross amount billed or invoiced by Regen BioPharma, its Affiliates or its sublicensees for sale or other disposition of Licensed Products on a country-by-country basis in the local currency, itemized deductions against such gross amount in accordance with Section 1.16 (Net Sales), Net Sales on a country-by-country basis, and, if applicable, the exchange rate utilized to convert a local currency to US dollars and these reports are due within 30 days of each Quarter.  Regen BioPharma shall maintain complete and accurate records sufficient to enable accurate calculation of royalties and other payments due Benitec Australia hereunder.  Such records and books of account shall be preserved by Regen BioPharma for a period of seven (7) years after the end of the period covered by such records and books of account, which obligation shall survive expiration or termination of this Agreement.  Regen BioPharma shall use commercially reasonable efforts to ensure that its sublicensees provide reports and keep records in a manner consistent with this Section 3.9.  Regen BioPharma shall provide reports received from sublicensees to Benitec Australia with the applicable payment and such reports shall be deemed Confidential Information of Regen BioPharma and shall be subject to Section 9 (Confidentiality).

 

 

 

 

3.10.   Audit Rights.  Regen BioPharma shall permit an independent public accountant designated by Benitec Australia and reasonably acceptable to Regen BioPharma, to have access, no more than once in each calendar year during the Term and no more than twice during the three (3) calendar years following the expiration or termination of this Agreement, during regular business hours and upon at least sixty (60) days written notice, to Regen BioPharma’s records and books to the extent necessary to determine the accuracy of Net Sales reported, and payments made, by Regen BioPharma to Benitec Australia within the three (3) year period immediately preceding such an audit.  The independent public accountant shall be under a confidentiality obligation to Regen BioPharma to disclose to Benitec Australia only (a) the accuracy of Net Sales reported and the basis for royalty and other payments made to Benitec Australia under this Agreement and (b) the difference, if any, such reported and paid amounts vary from amounts determined as a result of the audit.  If such examination results in a determination that Net Sales or payments have been misstated, over or under paid amounts due shall be paid promptly to the appropriate Party.  If Net Sales are understated by greater than five percent (5%), the fees and expenses of such accountant shall be paid by Regen BioPharma; otherwise the fees and expenses of such accountant shall be paid by Benitec.  All matters reviewed by such independent public accountant shall be deemed Confidential Information of Regen BioPharma and shall be subject to Section 9 (Confidentiality).  Regen BioPharma shall use commercially reasonable efforts to reserve the right to conduct audits of its sublicensees in a comparable manner to this Section 3.10 and if requested by Benitec Australia shall appoint an independent public accountant to conduct such audit, at Benitec Australia’s expense, unless the Net Sale of sublicensee are understated by greater than five percent (5%), in which case Regen BioPharma shall ensure that the fees and expenses of such accountant shall be paid by the sublicensee.  Regen BioPharma shall provide Benitec Australia with a copy of all audit reports of sublicensees under this Section 3.10, such reports shall be deemed Confidential Information of Regen BioPharma and shall be subject to Section 9(Confidentiality).

 

4.   PRODUCT DEVELOPMENT

 

4.1.   Research Plan & Progress Reports.

 

4.1.1.   Regen BioPharma, either directly or through a sublicensee, will develop a research plan summarizing the work it will perform and associated indicative timelines to Develop, obtain Regulatory Approval for and sell Licensed Products (the “Research Plan”).  Regen BioPharma will provide a copy of the Research Plan to Benitec Australia within ninety (90) days of the Effective Date.

 

 

 

 

4.1.2.   By September 1 of each calendar year, Regen BioPharma, either directly or through a sublicensee, will submit a written report to Benitec Australia covering the preceding twelve (12) month period.  Each report will describe: Regen BioPharma’s progress, either directly or through a sublicensee, in accordance with the Research Plan and towards commercialization of Licensed Product, including work completed, key scientific discoveries, summary of work-in-progress, current schedules or anticipated events or milestones, market plans for introduction of Licensed Product, and significant corporate transaction(s) involving Licensed Product.

 

4.2.   Timelines. The Research Plan shall, inter alia, identify milestones and proposed timelines in relation to Development and Commercialization of Licensed Products. Timelines proposed by Regen BioPharma are subject to agreement by Benitec Australia who shall not unreasonably refuse or withhold approval. Agreed times can be varied by agreement in writing by the Parties

 

4.3.   Diligence. Consistent with the Research Plan, Regen BioPharma will use Commercially Reasonable Efforts to diligently Develop, manufacture, and sell Licensed Products and will use Commercially Reasonable Efforts to develop markets for Licensed Products, in both cases either directly or through a sublicensee.  Regen BioPharma, either directly or through a sublicensee, will use Commercially Reasonable Efforts to obtain all necessary governmental approvals for the sale of Licensed Products in the United States of America and in the European Union.  Regen BioPharma will ensure that it has obtained all necessary governmental approval in each country where Licensed Products are Developed, made, used, Commercialized, sold, offered for sale or imported.

 

5.   PATENT MAINTENANCE AND ENFORCEMENT

 

5.1.1.   Patent Maintenance and Prosecution.  Benitec Australia has provided a copy of the CSIRO License to Regen BioPharma. This Section 5 (Patent Maintenance and Prosecution) is subject at all times to and does not operate to fetter or derogate from the rights of CSIRO under the CSIRO License.

 

5.1.2.   Patent Rights.  Benitec Australia, or CSIRO to the extent applicable and permissible under the CSIRO License, shall have the right and the obligation to Prosecute all Patents included within the Patent Rights at its cost and expense.  Benitec Australia shall keep Regen BioPharma reasonably apprised of all relevant actions regarding the status of such Patent Rights to the extent reasonably possible pursuant to the CSIRO License.

 

5.2.   Patent Enforcement and Defense.

 

5.2.1.   Each Party shall notify the other Party of any infringement of any of the Patent Rights by a third party in the Field which becomes known to such Party, and of any claim of infringement by a third party that the activities of a Party infringe patent rights of such third party.

 

 

 

 

5.2.2.   Regen BioPharma acknowledges that pursuant to Section 15.2 of the CSIRO License, CSIRO has sole responsibility and control of legal action relating to the Patent Rights licensed from CSIRO to Benitec.  Subject to the foregoing, as between the Parties:

 

(a)        Benitec Australia shall have the first right, but not an obligation, to initiate, maintain and control, at Benitec Australia’s expense, legal action against any infringement of the Patent Rights by a third party in the Field;

 

(b)        in the event that Benitec Australia initiates legal action against infringement of the Patent Rights (including by CSIRO) by a third party in the Field, Benitec Australia shall notify Regen BioPharma in writing prior to initiating such legal action.  Thereafter, Benitec Australia will keep Regen BioPharma fully informed as to any proceedings and Regen BioPharma shall have a right to comment on and have input prior to any legal actions to the extent that they relate to the Patent Rights in the Field, and Benitec must reasonably consider (including through CSIRO) all of Regen BioPharma's relevant proposals.

 

5.2.3.   Regen BioPharma acknowledges that it may not commence suit under the Patent Rights without seeking and obtaining the prior written consent of Benitec Australia (or CSIRO, as the case may be).  If such consent is given then:

 

(a)        it may be given conditionally, including on condition that Regen BioPharma indemnify Benitec Australia and/or CSIRO against all costs and expenses associated with the litigation regardless of whether Benitec Australia and/or CSIRO are joined in the litigation voluntarily or involuntarily; and

 

(b)        Benitec Australia and/or CSIRO shall, if necessary and at the cost of Regen BioPharma, lend their name/s to such proceedings and provide all other reasonable assistance to Regen BioPharma in commencing and undertaking the proceedings.

 

5.3.   Cooperation.  In any suit, proceeding or dispute involving the infringement of any of the Patent Rights in the Field, the Parties shall provide each other with reasonable cooperation, and, upon the request and at the expense of the Party bringing suit, the other Party shall make available to the Party bringing suit, at reasonable times and under appropriate conditions, all relevant personnel, records, papers, information, samples, specimens, and the like in its possession. Notwithstanding any other provision of this Section 5 (Patent Maintenance and Enforcement) but subject always to CSIRO’s rights pursuant to the CSIRO License, neither Party shall make any settlements of any suit, proceeding or action relating to an infringement of the Patent Rights in the Field underSection 5.2 (Patent Enforcement and Defense) that would adversely affect the other Party or materially affect the rights and licenses granted hereunder without first obtaining such other Party’s prior written consent, such consent not to be unreasonably withheld or delayed.

 

6.   REPRESENTATIONS AND WARRANTIES

 

6.1.   Representations and Warranties of Benitec Australia.  Benitec Australia represents and warrants that, as of the Effective Date:

 

 

 

 

6.1.1.   Benitec Australia is a corporation, duly organized, validly existing and in good standing under the laws of Australia;

 

6.1.2.   This Agreement is permitted under and in full compliance with and will not conflict with or violate any term, condition, or obligation of any third party agreement to which Benitec Australia or any Affiliate, officer, or board member of Benitec Australia or its Affiliates is a party to, including, but not limited to, any agreement with CSIRO.

 

6.1.3.   Benitec Australia owns or controls all right and interest in, to and under the Licensed Technology, subject to the terms and conditions of any agreement with CSIRO.

 

6.1.4.   Benitec Australia has the sole, exclusive and unencumbered right and authority to grant the rights and licenses granted pursuant to the terms and conditions set forth in this Agreement;

 

6.1.5.   The Licensed Technology is free and clear of any lien, encumbrance, security interest and restriction;

 

6.1.6.   Benitec Australia has not granted any right, license or interest in, to or under the Licensed Technology in the Field to any other party;

 

6.1.7.   Other than standard patent office actions in the examination of pending applications, there are no legal actions, re-examinations, oppositions, interferences, suits, investigations, legal claims or proceedings pending or threatened relating to the Patent Rights;

 

6.1.8.   The execution, delivery and performance of this Agreement has been duly authorized by all necessary corporate action on the part of Benitec Australia;

 

6.1.9.   The CSIRO License is valid and in full force and effect and constitutes the entire agreement with CSIRO in relation to Benitec Australia’s rights to license the Licensed Technology to Licensee pursuant to this Agreement; and

 

6.1.10.  There are no existing or claimed defaults by Benitec Australia, and to Benitec Australia’s knowledge, by CSIRO under the CSIRO License.

 

6.2.   Warranties of Regen BioPharma.  Regen BioPharma warrants that as of the Effective Date:

 

6.2.1.   Regen BioPharma is a corporation, duly organized validly existing and in good standing under the laws of Nevada, USA; and

 

6.2.2.   The execution, delivery and performance of this Agreement has been duly authorized by all necessary corporate action on the part of Regen BioPharma.

 

6.3.   Disclaimer.  EXCEPT AS EXPRESSLY PROVIDED FOR IN THIS AGREEMENT, NEITHER PARTY MAKES ANY, AND HEREBY DISCLAIMS TO THE FULLEST EXTENT ALLOWED BY APPLICABLE LAW, ANY AND ALL, REPRESENTATIONS AND WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, WITH RESPECT TO WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT OF ANY THIRD PARTY’S PROPRIETARY RIGHTS.

 

 

 

 

7.   INDEMNIFICATION AND INSURANCE

 

7.1.   Benitec Australia Indemnification.  Benitec Australia shall indemnify, defend and hold Regen BioPharma, its directors, officers, employees, agents, and Affiliates harmless from and against all claims, demands, damages, liabilities, losses, costs and expenses, including without limitation attorney’s fees (collectively, “Claims”) resulting from or arising out of (a) any breach by Benitec Australia of any of Benitec Australia’s representations or, warranties or covenants delivered to Regen BioPharma hereunder; or (b) the Development (whether preclinical or clinical), testing, manufacture, use, sale, offer for sale, importation, exportation, storage, handling, transportation, distribution or any other disposition of any product by Benitec Australia or any Benitec Australia Affiliate or sublicensee (other than Regen BioPharma or any Regen BioPharma Affiliate or sublicensee) in fields other than the Field; provided, however, that Benitec Australia’s indemnification obligations under this Section 7.1 (Benitec Australia Information) shall not apply (i) to the extent that any such Claim arises out of any breach by Regen BioPharma of any of Regen BioPharma’s representations, warranties or covenants hereunder, or (ii) to any claim arising out of Regen BioPharma’s gross negligence or willful misconduct.

 

7.2.   Regen BioPharma Indemnification.  Regen BioPharma shall indemnify, defend and hold Benitec Australia, its directors, officers, employees, agents, and Affiliates, including CSIRO, harmless from and against all Claims resulting from or arising out of (a) any breach by Regen BioPharma of any of Regen BioPharma’s representations, warranties or covenants delivered to Benitec Australia hereunder; or (b) the Development (whether preclinical or clinical), testing, manufacture, use, sale, offer for sale, importation, exportation, storage, handling, transportation, distribution or any other disposition of any Licensed Product by Regen BioPharma in the Field; provided, however, that Regen BioPharma’s indemnification obligations under this Section 7.2 (Regen BioPharma Indemnification) shall not apply (i) to the extent that any such Claim arises out of any breach by Benitec Australia of any of Benitec Australia’s representations, warranties or covenants hereunder, or (ii) to any claim arising out of Benitec Australia and/or CISIRO’s gross negligence or willful misconduct.

 

7.3.   Procedure.  For purposes of Section 7.1 (Benitec Australia Indemnification) and Section 7.2 (Regen BioPharma Indemnification), the indemnified Party shall give prompt written notice to the indemnifying Party of any suits, claims or demands by third parties or the indemnified Party which may give rise to any Claim for which indemnification may be required under this Section 7 (Indemnification and Insurance); provided, however, that failure to give such notice shall not relieve the indemnifying Party of its obligation to provide indemnification hereunder except, if and to the extent that such failure materially affects the ability of the indemnifying Party to defend the applicable suit, claim or demand.  The indemnifying Party shall be entitled to assume the defense and control of any such suit, claim or demand of any third party at its own cost and expense; provided, however, that the other party shall have the right to be represented by its own counsel at its own cost in such matters.  In the event that the indemnifying Party declines to or fails to timely assume control of any such suit, claim or demand, the Party entitled to indemnification shall be entitled to assume such control, conduct the defense of, and settle such suit, claim or action, all at the sole cost and expense of the indemnifying Party.  Neither the indemnifying Party nor the indemnified Party shall settle or dispose of any such matter in any manner which would adversely affect the rights or interests of the other Party without the prior written consent of the indemnified Party, which shall not be unreasonably withheld or delayed.  Each Party shall cooperate with the other Party and its counsel in the course of the defense of any such suit, claim or demand, such cooperation to include without limitation using reasonable efforts to provide or make available documents, information and witnesses.

 

 

  

 

8.   TERM AND TERMINATION

 

8.1.   Term.  The term of this Agreement shall commence on the Effective Date and continue in full force and effect on a Licensed Product-by-Licensed Product and country-by-country basis until expiration of Licensee’s payment obligations under Section 3 (Payments and Related Obligations), unless and until terminated at an earlier date in accordance with Section 8.2 (Termination by Benitec Australia) (the “Term”).

 

8.2.   Termination

 

8.2.1.   If Regen BioPharma fails to make any uncontested payment due to Benitec Australia under Section 3 (Payments and Related Obligations), Benitec Australia may notify Regen BioPharma in writing of such failure to pay.  If Regen BioPharma does not either make a written objection as to whether such payment is due or fails to cure such failure to pay within sixty (60) days of the receipt of the foregoing notice from Benitec Australia, then, subject to the terms of this Section 8.2 (Termination by Benitec Australia), the license granted by Benitec Australia to Regen BioPharma under Section 2.1 (Grant of Rights), and any concomitant Improvements, shall terminate, effective upon receipt by Regen BioPharma of a second written notice from Benitec Australia.  If Regen BioPharma disputes the amount or that a payment is due under Benitec Australia’s written notice of non-payment above, such dispute will be subject to the dispute resolution provisions of Section 10 (Dispute Resolution).

 

8.2.2.   If a Party commits a material breach of this Agreement (“Defaulting Party”), the other Party may notify the Defaulting Party in writing of such failure.  If the Defaulting Party does not make a written objection as to whether a material breach has occurred or fails to cure such material breach within ninety (90) days of the receipt of the foregoing notice from the other Party, or, for material breaches that are not curable within ninety (90) days, within such time as reasonably practical to cure with diligent effort, then, subject to the terms of this Section 8.2 (Termination),  the other Party may terminate this Agreement, effective upon receipt by the Defaulting Party of a second written notice from the other Party.  If the Defaulting Party disputes the material breach under the other Party’s written notice of breach above, such dispute will be subject to the dispute resolution provisions of Section 10 (Dispute Resolution).

 

 

 

 

8.2.3.   If Regen BioPharma or its Affiliate commences an action or proceeding, including without limitation by reexamination, opposition, interference, declaratory judgment proceeding, or invalidity or nullity proceeding alleging that a Patent Right is invalid, unenforceable or not infringed by the Development, manufacture, use, sale or importation of a Licensed Product then Benitec Australia may terminate this Agreement by thirty (30) days written notice to Regen BioPharma.  Regen BioPharma shall use commercially reasonable efforts to reserve a comparable right of termination in all sublicenses which right will be exercised by Regen BioPharma if requested in writing by Benitec Australia.

 

8.2.4.   Regen BioPharma shall have the option, at its sole discretion, to terminate this Agreement either in full, or on a Licensed Product-by-Licensed Product and country-by-country basis, at any point in time during the Term, on thirty (30) days prior written notice to Benitec Australia.

 

8.2.5.   Benitec Australia may terminate this Agreement if Regen BioPharma, its Affiliate, or its sublicensee, has not sold Licensed Product anywhere in the Territory for any twelve (12) month period after Regen BioPharma’s, its Affiliate’s, or its sublicensee’s First Commercial Sale of a Licensed Product, unless (i) such failure to sell Licensed Product is the result of (a) a recall, suspension of regulatory approval or clinical hold by a regulatory authority such as the U.S. Food and Drug Administration or foreign equivalent in the Territory, (b) a voluntary recall and/or suspension of Licensed Product sales by Regen BioPharma, its Affiliate, or its sublicensee, based on reasonable concerns for patient safety, (c) sale by a third party of a product covered by the Patent Rights, or (d) a force majeure under Section 11.5 (Force Majeure); or (ii) Regen BioPharma, its Affiliate, or its sublicensee is actively developing one or more additional Licensed Products in the Field.

 

8.2.6.   Benitec Australia may terminate this Agreement after 12 months’ notice in writing if Regen BioPharma, in the opinion of Benitec Australia at its absolute discretion, abandons the Development of Licensed Products or has not used Commercially Reasonable Efforts to Commercialize the Licensed Products.

 

8.3.   Effect of Expiration or Termination.  Upon natural expiration of this Agreement in accordance with Section 8.1 (Term), the rights and licenses granted by Benitec Australia to Regen BioPharma under this Agreement shall become fully paid-up, sub-licensable, perpetual, royalty-free and irrevocable.  Upon termination of this Agreement pursuant to Section 8.2 (Termination), subject to Section 8.5 (Survival), (i) if terminated in its entirety, this Agreement, including, but not limited to, all payment obligations of Regen BioPharma (other than payment obligations due, but not paid, prior to the date of such termination) and all rights and licenses under this Agreement granted to Regen BioPharma shall immediately terminate or (ii) if the license under Section 2.1 (Grant of Rights) is terminated in a given country pursuant to Section 8.2.4 (Termination), all rights and obligations with respect to such license in such country, including all payment obligations (other than payment obligations due, but not paid, prior to the date of such termination), shall immediately terminate, but the remainder of the Agreement shall remain in full force and effect, including the remaining license Section 2.1 (Grant of Rights) in non-terminated countries, as the case may be.

 

 

 

 

8.4.   Effect of Early Termination.

 

8.4.1.   In the event of early termination of this Agreement, each Party shall promptly return, or at the other Party’s written request destroy, any Confidential Information of the other Party in such Party’s possession or control at the time of termination.

 

8.4.2.   In the event of early termination of this Agreement, each Party shall retain any and all rights or remedies such Party may have in law or in equity, provided that neither Party may claim compensation for lost opportunity or consequential damages arising out of the fact of such early termination.

 

8.5.   Survival.  Notwithstanding anything to the contrary in this Agreement, Sections 1 (Definitions), 2.4 (Regen BioPharma Improvements), 6 (Representations and Warranties), 7 (Indemnification and Insurance), 8.3 (Effect of Expiration or Termination), 8.4 (Effect of Early Termination), 8.5 (Survival), 9 (Confidentiality), 10(Dispute Resolution) and 11 (Miscellaneous) shall survive expiration or termination of this Agreement for any reason.

 

9.   CONFIDENTIALITY

 

9.1.   Confidential Information.  The Parties may provide Confidential information to each other, including but not limited to each Party’s know-how, invention disclosures, proprietary materials and/or technologies, economic information, business or research strategies, trade secrets and material embodiments thereof.  As used herein, “Confidential Information” means any information of a confidential and proprietary nature disclosed by a Party to this Agreement to the other Party (i) in written form marked “confidential” or (ii) in oral form if summarized in a writing marked “confidential” delivered to the receiving Party within thirty (30) days after the oral disclosure.

 

9.2.   Confidentiality and Non-Use.  The recipient of a disclosing Party’s Confidential Information shall maintain such Confidential Information in confidence, and shall disclose such Confidential Information only to its employees, agents, consultants, Affiliates, licensors, sublicensees, attorneys, accountants, investors, potential acquirors and advisors who have a reasonable need to know such Confidential Information and who are bound by obligations of confidentiality and non-use no less restrictive than those set forth herein and for whom each Party shall be responsible for any breach of this Section 9. The recipient of the disclosing Party’s Confidential Information shall use such Confidential Information solely to exercise its rights and perform its obligations under this Agreement (including, without limitation, the right to use and disclose such Confidential Information in regulatory applications and filings), unless otherwise mutually agreed in writing.  The recipient of the other Party’s Confidential Information shall take the same degree of care that it uses to protect its own confidential and proprietary information of a similar nature and importance (but in any event no less than reasonable care).

 

 

 

 

9.3.   Exclusions.  Confidential Information shall not include information that: (a) is in the recipient’s possession prior to receipt from the disclosing Party as established by documentary proof; (b) is or becomes, through no fault of the recipient or its Affiliates or sublicensees hereunder, publicly known (as shown by the recipient’s written record); (c) is furnished to the recipient by a third party without breach of a duty to the disclosing Party; (d) is independently developed by the recipient without use of, application of or access to the disclosing Party’s Confidential Information; or (e) is required to be disclosed under applicable law, but only for the sole purpose of and solely to the extent required by such law, and provided that the recipient, to the extent possible, shall give the disclosing Party prior written notice of the proposed disclosure and cooperate fully with the disclosing Party to minimize the scope of any such required disclosure, to the extent possible and in accordance with applicable law.

 

9.4.   Terms of Agreement.  The terms of this Agreement shall be Confidential Information of both Parties, and subject to the terms of this Section9 (Confidentiality).  Notwithstanding the foregoing, either Party may make a disclosure of terms of this Agreement (i) to any financial advisors, accountants, potential sublicensees, investors, or potential acquirers, (ii) if required by applicable law, or (iii) as otherwise permitted pursuant to Section 12.1 (Public Announcements).  Except as otherwise permitted for disclosures pursuant to Section 12.1 (Public Announcements), the disclosing Party shall use commercially reasonable efforts to preserve the confidentiality of this Agreement and the terms thereof notwithstanding any required disclosure.  A Party will give the other Party written notice of any required disclosure under (ii) above, which notice shall, to the extent reasonably practicable, be given a reasonable period of time in advance of such required disclosure.  In the event either Party is required to file this Agreement with the U.S. Securities and Exchange Commission or any comparable Australian or other non-U.S. regulatory agency, such Party shall apply for confidential treatment of this Agreement to the fullest extent permitted by applicable law, shall provide the other Party a copy of the confidential treatment request far enough in advance of its filing to give the other Party a meaningful opportunity to comment thereon, and shall incorporate in such confidential treatment request any reasonable comments of the other Party.

 

9.5.   Termination.  All obligations of confidentiality and non-use imposed under this Section 9 (Confidentiality) shall expire ten (10) years after the date of disclosure of such information under this Agreement.

 

10.   DISPUTE RESOLUTION

 

10.1.   Exclusive Dispute Resolution Mechanism.  The Parties agree the procedures set forth in this Section 10 (Dispute Resolution) shall be the exclusive mechanism for resolving any bona fide disputes, controversies or claims (collectively, “Disputes”) between the Parties that arise from time to time pursuant to this Agreement relating to any Party’s rights and/or obligations hereunder that cannot be resolved through good faith negotiation between the Parties.

 

 

  

 

10.2.   Executive Mediation.

 

10.2.1.   Any Dispute must first be submitted to the officers designated below, or their appointed representatives, for attempted resolution by good faith negotiations for a period of at least thirty (30) days.

     

  For Benitec Australia - Peter French, CEO

 

  For Regen BioPharma - David R. Koos, Chairman and CEO

 

In the event that the representatives of the Parties designated in accordance with the above are not able to resolve any Dispute within such thirty (30) day period, either Party may invoke the provisions set forth in Section 10.3 (Arbitration).

 

10.3.   Arbitration.

 

10.3.1.   Any and all unresolved Disputes, and any and all unresolved issues remaining after consideration of a Dispute in accordance with Section 10.2 (Executive Mediation), except as set forth in Sections 10.4 (Preliminary Injunctions) or 10.5 (Patent Disputes), shall be exclusively and finally resolved by binding arbitration.

 

10.3.2.   Any arbitration concerning a Dispute shall be conducted in Sydney, New South Wales, Australia; unless otherwise agreed to by Benitec Australia and Regen BioPharma in writing.  Each and any arbitration shall be administered by the International Center For Dispute Resolution (“ICDR”), and shall be conducted in accordance with the International Arbitration Rules of the ICDR (the “Rules”), as such Rules may be amended from time to time.

 

10.3.3.   Within ten (10) days after receipt of an arbitration notice from a Party, the Parties shall attempt in good faith to agree on a single neutral arbitrator with pharmaceutical or biotechnology industry experience to conduct the arbitration.  If the Parties do not agree on a single neutral arbitrator within thirty (30) days after receipt of an arbitration notice, each Party shall select one (1) arbitrator and the two (2) Party-selected arbitrators shall select a third arbitrator with pharmaceutical or biotechnology industry experience to constitute a panel of three (3) arbitrators to conduct the arbitration in accordance with the Rules.  In the event that only one of the Parties selects an arbitrator, then such arbitrator shall be entitled to act as the sole arbitrator to resolve the Dispute or any or all unresolved issues subject to the arbitration.  Each and all arbitrator(s) of the arbitration panel conducting the arbitration must and shall agree to render an opinion within twenty (20) days after the final hearing before the panel.

 

10.3.4.   Except in the case of manifest error or fraud, the decision or award of the arbitrator(s) shall be final, binding and incontestable and may be used as a basis for judgment thereon in any jurisdiction.  Subject to the foregoing, the Parties hereby expressly agree to waive the right to appeal from the decision of the arbitrator(s).  Accordingly, there shall be no appeal to any court or other authority (government or private) from the decision of the arbitrator(s), and the Parties shall not dispute nor question the validity of such decision or award before any regulatory or other authority in any jurisdiction where enforcement action is taken by the Party in whose favor the decision or award is rendered, except in the case of manifest error and/or fraud.  The arbitrator(s) shall, upon the request of either Party, issue a written opinion of the findings of fact and conclusions of law and shall deliver a copy to each of the Parties.  Each Party shall bear its own costs and attorneys’ fees, and the Parties shall equally bear the fees, costs, and expenses of the arbitrator(s) and the arbitration proceedings; provided, however, that the arbitrator(s) may exercise discretion to award costs, including attorneys’ fees, to the prevailing Party.  Without limiting any other remedies that may be available under applicable law, the arbitrator(s) shall have no authority to award provisional remedies of any nature whatsoever, injunctive relief, or punitive, special, consequential or any other similar form of damages.

 

 

 

 

10.4.   Preliminary Injunctions.  Notwithstanding anything to the contrary, a Party may seek a temporary restraining order or a preliminary injunction from any court of competent jurisdiction in order to prevent immediate and irreparable injury, loss, or damage on a provisional basis, pending the decision of the arbitrator(s) on the ultimate merits of any Dispute.

 

10.5.   Patent Disputes.  Notwithstanding anything to the contrary, any and all issues regarding the scope, construction, validity and enforceability of one or more Patents shall be determined in a court of competent jurisdiction under the local patent laws of the jurisdictions having issued the Patent or Patents in question.

 

10.6.   Confidentiality. All proceedings and decisions of the arbitrator(s) shall be deemed Confidential Information of each of the Parties, and shall be subject to Section9 (Confidentiality).

 

 

 

 

 

 

11.   MISCELLANEOUS

 

11.1.   Public Announcements.  The Parties will mutually agree on a press release to be issued upon execution of this Agreement or reasonably soon thereafter.  Neither Party shall make any subsequent public announcement concerning the terms of this Agreement not previously made public without the prior written approval of the other Party with regard to the form, content, and precise timing of such announcement, except such as may be required to be made by either Party in order to comply with applicable law, regulations, court orders, or tax, securities filings, financing arrangements, acquisitions, or sublicenses.  Such consent shall not be unreasonably withheld or delayed by such other Party.  Prior to any such public announcement, the Party wishing to make the announcement will submit a draft of the proposed announcement to the other Party in sufficient time to enable such other Party to consider and comment thereon. The Parties will agree to the form of public announcement about this license prior to the Effective Date.

 

11.2.   Governing Law.  This Agreement shall be governed by, and construed and interpreted, in accordance with the internal laws of the State of New South Wales, Australia without giving effect to any choice of law rule that would cause the application of the laws of any jurisdiction other than the internal laws of the State of New South Wales to the rights and duties of the Parties.

 

11.3.   Further Assurances.  From time to time on and after the Effective Date, each Party shall at the reasonable request of the other Party (a) deliver to such other Party such records, data or other documents consistent with the provisions of this Agreement, (b) execute, and deliver or cause to be delivered, all such assignments, consents, documents or further instruments of transfer or license, and (c) take or cause to be taken all such other actions, as such other Party may reasonably deem necessary or desirable in order for such Party to obtain the full benefits of this Agreement and the transactions contemplated thereby.

 

11.4.   Limitation of Liability.  NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR INCIDENTAL, CONSEQUENTIAL, INDIRECT, PUNITIVE OR SPECIAL DAMAGES (WHETHER FOR LOSS OF PROFITS OR OTHERWISE) ARISING OUT OF OR RELATED TO THIS AGREEMENT, HOWEVER CAUSED, UNDER ANY THEORY OF LIABILITY.

 

11.5.   Force Majeure.  Neither Party shall be held responsible for any delay or failure in performance hereunder caused by strikes, embargoes, unexpected government requirements, including clinical holds, civil or military authorities, acts of God, earthquake, or by the public enemy or other causes reasonably beyond such Party’s control and without such Party’s fault or negligence; provided that the affected Party notifies the unaffected Party as soon as reasonably possible, and resumes performance hereunder as soon as reasonably possible following cessation of such force majeure event; and provided further that no such delay or failure in performance shall continue for more than twelve (12) months.  In the event that a delay or failure in performance by Regen BioPharma under this Section11.5 (Force Majeure) continues longer than twelve (12) months, then Benitec Australia may terminate this Agreement in accordance with the terms and conditions of Section 8.2 (Termination for Cause).

 

 

 

 

11.6.   Independent Contractors.  The relationship of the Parties established by this Agreement is that of independent contractors.  Nothing in this Agreement shall be constructed to create any other relationship between the Parties.  Neither Party shall have any right, power or authority to bind the other or assume, create or incur any expense, liability or obligation, express or implied, on behalf of the other Party.

 

11.7.   Assignment.  The Parties agree that their rights and obligations under this Agreement may not be transferred or assigned to a third party without the prior written consent of the other Party, such consent not to be withheld unreasonably.  Notwithstanding the foregoing, a Party may transfer or assign its rights and obligations under this Agreement, without consent, to an Affiliate or a successor to all or substantially all of its business or assets relating to this Agreement whether by sale, merger, operation of law or otherwise.  This Agreement shall be binding upon successors and permitted assigns of the Parties.  Any assignment not in conformance with this Section 11.7 (Assignment) shall be null, void and of no legal effect.

 

11.8.   No Use of Names.  Except as otherwise required under applicable law, or as otherwise permitted under Section 11.1 (Public Announcements), neither Party will use the name of the other Party in its advertising, press releases or promotional materials without the prior written consent of such other Party.

 

11.9.   Notices.  Any notice, report, communication or consent required or permitted by this Agreement shall be in writing and shall be sent (a) by prepaid registered or certified mail, return receipt requested, (b) by overnight express delivery service by a nationally recognized courier, or (c) via confirmed facsimile or telecopy, followed within five (5) days by a copy mailed in the preceding manner, addressed to the other Party at the address shown below or at such other address for which such Party gives notice hereunder.  Such notice will be deemed to have been given when delivered or, if delivery is not accomplished by some fault of the addressee, when tendered.

 

 

If to Benitec Australia:

Benitec Australia Limited

1-15 Barr Street

BALMAIN  NSW  2041

AUSTRALIA

Attn: Peter French, CEO

Facsimile: +61 (0) 3 8678 1342

 

 

  

 

If to Regen BioPharma:

Regen BioPharma,

4700 Spring Street

Suite 304

La Mesa CA 91942

USA

Attn: David R. Koos, CEO

Facsimile: + 1 (619) 330-2328

 

 

11.10.   Modification; Waiver.  This Agreement may not be altered, amended or modified in any way except by a writing signed by both Parties.  The failure of a Party to enforce any rights or provisions of the Agreement shall not be construed to be a waiver of such rights or provisions, or a waiver by such Party to thereafter enforce such rights or provision or any other rights or provisions hereunder.  No waiver shall be effective unless made in writing and signed by the waiving Party.

 

11.11.   Severability.  If any provision of this Agreement shall be found by a court to be void, invalid or unenforceable, the same shall be reformed to comply with applicable law or stricken if not so conformable, so as not to affect the validity or enforceability of this Agreement; provided that no such reformation or striking shall be effective if the result materially changes the economic benefit of this Agreement to either Party.  In the event that any provision of this Agreement becomes or is declared by a court of competent jurisdiction to be void, invalid or unenforceable, and reformation or striking of such provision would materially change the economic benefit of this Agreement to either Party, the Parties shall modify such provision in accordance with Section 12.10 (Modification; Waiver) to obtain a legal, valid and enforceable provision and provide an economic benefit to the Parties that most nearly effects the Parties’ intent on entering into this Agreement.

 

11.12.   Entire Agreement.  The Parties acknowledge that this Agreement, together with the exhibits attached hereto, sets forth the entire agreement and understanding of the Parties as to the subject matter hereof, and supersedes all prior and contemporaneous discussions, agreements and writings in respect hereto.

 

11.13.   Ambiguities.  Ambiguities, if any, in this Agreement shall not be construed against any Party, regardless of which Party may be deemed to have authored the ambiguous provision.

 

11.14.   Headings.  The article, section and subsection headings contained herein are for the purposes of convenience only and are not intended to define or limit the contents of the articles, sections or subsections to which such headings apply.

 

11.15.   Counterparts.  This Agreement may be executed in two or more counterparts, each of which shall be deemed an original and all of which together shall constitute one instrument.

 

 

  

 

EXECUTED BY THE PARTIES AS AN AGREEMENT

 

Benitec Australia Limited by  )  
     
   )  
     
Peter French  )  /s/: Peter French
     
[insert name]  )  [signature]
     
CEP  )  8/6/2013
     
[insert title]  )  [date]
     
     
     

 

 

 

Signed for and on behalf of  )  
     
Regen BioPharma, Inc.  )  
     
by  )  
     
   )  
     
David R. Koos  )  /s/: David R. Koos
     
[name]  )  [signature]
     
Chairman & CEO  )  8/5/2013
     
[title]  )  [date]
     

 

 

  

 

Schedule 1 – CSIRO License Definitions

 

[Note: Below are pre-existing definitions which cannot be amended.]

 

Definitions

 

Animal shall mean any species of the Kingdom Animalia, according to the Linnaean System of Taxonomy, and cells, tissues and organs isolated therefrom, but excluding Humans.

 

Delivery Agent means any agent (including a construct, vector, molecule or complex) engineered to deliver an RNAi Molecule into a cell, including:

 

(a)   an agent engineered to deliver into the cell an RNAi Molecule synthesised outside the cell;

 

(b)   a DNA molecule from which an RNAi Molecule may be transcribed in the cell;

 

(c)   a viral vector from which an RNAi Molecule may be produced in the cell through:

 

(i)   replication of the vector; and/or

 

(ii)   in the case of a DNA virus, transcription of the vector; and/or

 

(iii)   in the case of an RNA virus that utilises reverse transcription, transcription of a reverse transcription product of the vector,

 

and may be a DNA virus or an RNA virus or an agent derived from or incorporated in such a virus (and may, but need not, be an RNA virus that involves reverse transcription), and includes a formulated pharmaceutical product for administration to an organism that incorporates the subject matter of paragraph (a), (b) or (c).

 

Food Additive means a substance which when combined with other ingredients has a tradition of use as a food in the form in which it is consumed.

 

Foodstuff means a substance ingested orally which has a tradition of use as a food in the form in which it is consumed.

 

Fungus shall mean any species of the Kingdom Fungi, according to the Linnaean System of Taxonomy, and cells, tissues and organs isolated therefrom, and ‘Fungi’ shall be similarly construed.

 

Human or Humans shall mean Homo sapiens, and cells, tissues and organs isolated therefrom.

 

Human Field:

 

(a)   shall mean all Uses of the Technology:

 

(i)   in Humans and Animals for research to understand the role of Human genes in Human biology, physiology and metabolism;

 

 

 

 

(ii)   in Humans and Animals for studying and understanding diseases, disease states and disorders of Humans;

 

(iii)   in Humans and Animals for development and validation of RNAi Human Therapeutics, including:

 

(A)   development and validation of Delivery Agents to assess potential for use as an RNAi Human Therapeutic; and

 

(B)   the use of Transgenic Animals in experiments that Use the Technology in those Animals for the sole purpose of such development or validation;

 

(iv)   in Humans and isolated Animal cells (but not otherwise involving the use of Animals) for development, validation and manufacture of Non-RNAi Human Therapeutics;

 

(v)   in Humans, Protista, Fungi and isolated Animal cells (but not otherwise involving the use of Animals) for the manufacture of RNAi Human Therapeutics;

 

(vi)   in Humans, and in isolated Animal cells in diagnostic kits for use in conjunction with testing Human cells, for diagnosing and monitoring diseases, disease states and disorders of Humans;

 

(vii)   in Humans for:

 

i.   preventing and treating diseases, disease states and disorders in Humans (including those caused by Pathogens and Parasites of Humans);

 

ii.   preventing and treating Pathogens and Parasites of Humans;

 

(viii)   in Animals (including Transgenic Animals) for the sole purpose of preparing Animal organs, tissues and cells for xenotransplantation into Humans;

 

(ix)   in Humans for treating a xenotransplant in a Human;

 

(b)   also includes manufacturing an RNAi Molecule or a Delivery Agent outside a cell (including acellular or synthetic manufacture), or in bacteria or otherwise in a cell in a manner that does not Use the Technology in the cell, solely for the purpose of carrying out the activities set out in paragraph (a), provided always that the Delivery Agent is engineered for delivery or administration to the relevant organism or cell type as set out in paragraph (a) to cause Use of the Technology in the organism or cell type;

 

(c)   excludes all Uses of the Technology in Plants;

 

 

  

 

(d)   excludes all Uses of the Technology to make Foodstuffs, Food Additives and Nutraceuticals that do not rely upon the Use of the Technology in Humans;

 

(e)   excludes making, using and selling Research Tool Products and providing Research Tool Services.

 

Human Therapeutics shall mean any application of the subject matter of the Patents and Patent Applications that comprises a therapeutic agent or method for the treatment or prevention of a disease, disease state or disorder, or for the maintenance of health, in Humans (including in relation to Pathogens and Parasites of Humans), other than for purely diagnostic ex vivo purposes relating solely to Humans and excludes all Foodstuffs, Food Additives and Nutraceuticals that do not Use the Technology in Humans.

 

Non-RNAi Human Therapeutic means a Human Therapeutic the manufacture of which involves use of an RNAi Molecule to induce downregulation of target gene expression in a cell used in the manufacture of the Non-RNAi Human Therapeutic and which is not an RNAi Human Therapeutic or an RNAi Molecule.

 

Nutraceutical means a substance that is a cosmetic or that has drug-like properties but is not legally recognised as a therapeutic agent by the Australian Therapeutic Goods Agency or the US Food and Drug Administration.

 

Parasite shall mean any organism living in, with or on another organism, to the detriment of that host organism.

 

Pathogen shall mean any specific causative agent of disease, such as a virus, bacterium or Fungus.

 

Plant shall mean any species being a member of the Kingdom Plantae according to the Linnaean System of Taxonomy and cells, tissues and organs isolated therefrom.

 

Protista shall mean any species being a member of the Kingdom of Protista according to the Linnaean System of Taxonomy.

 

Research Tool Products means any product, including a Transgenic Animal, the manufacture, use or sale of which would Use the Technology, that is sold for use in Research and Development within the Human Field, but does not include a product the manufacture, use or sale of which is for, or comprises:

 

(a)   Use of the Technology in Plants; or

 

(b)   a therapeutic agent or method of treatment, prevention, monitoring or diagnosis of a disease, disease state or disorder, or for the maintenance of health, in Humans.

 

 

 

 

RNAi Human Therapeutic means a Human Therapeutic comprising a Delivery Agent engineered for the sole purpose of administration to a Human so as to Use the Technology in a Human and excludes all Foodstuffs, Food Additives and Nutraceuticals that do not rely upon the Use of the Technology in Humans.

 

RNAi Molecule means a double stranded RNA molecule that induces sequence specific downregulation of target gene expression in a cell, where the double stranded RNA molecule has two separate complementary strands or a single strand having two complementary parts that hybridise.

 

Transgenic Animal means an Animal whose genome has been modified by introduction and integration of exogenous DNA.

 

Use of the Technology in an organism or cell type, means inducing downregulation of target gene expression in a cell of the organism or cell type (where the target gene may be endogenous or exogenous), such downregulation being induced by an RNAi Molecule that is introduced into the cell by any means.

 

In the case of Use of the Technology for preventing and treating Pathogens and Parasites of an organism, Use of the Technology in the organism also includes downregulation of target gene expression in a cell of a Parasite or Pathogen that is in, on or otherwise in contact with the organism, being downregulation induced by an RNAi Molecule introduced into a cell of the organism.

 

Non-limiting examples of means of introducing an RNAi Molecule into a cell include:

 

(a)   by direct introduction into the cell of an RNAi Molecule synthesised outside the cell;

 

(b)   by transcription from a DNA molecule introduced into the cell or a proximate cell, whether the DNA molecule is introduced directly (such as via a DNA virus) or indirectly (such as through reverse transcription from an RNA virus)); or

 

(c)   by replication and/or transcription of a viral vector introduced into the cell or a proximate cell, whether a DNA virus or an RNA virus (whether or not involving reverse transcription),

 

where ‘proximate cell’ means a cell within the same organism or cell culture as the cell into which the DNA molecule or viral vector is introduced.

 

Where the expression “Use of the Technology” does not refer to an organism or cell type, the expression will mean any use of the subject matter of the Patents and Patent Applications.

 

The expressions “Use the Technology” and “application of the Technology” shall be similarly construed.

 

 

  

 

Exhibit A

 

 

Patents

 

 

Graham family ddRNAi patents – Benitec has an exclusive, irrevocable worldwide license from CSIRO for human therapeutics

 

Title Inventors Country Number
GENETIC CONSTRUCTS FOR DELAYING OR REPRESSING THE EXPRESSION OF A TARGET GENE (‘099”) Graham, Rice, Waterhouse US 6,573,099

SYNTHETIC GENES AND GENETIC CONSTRUCTS COMPRISING THE SAME

 (Graham Family)

 

Waterhouse, Graham, Wang,

Rice

US 8,067,383 (was 10/346,853)
    US 11/218,999
    US 7754697
    US 8048670 (was 10/759,841)
    US 8053419 (was 10/821,726)
    US 90/007,247

CONTROL OF GENE EXPRESSION WO99/49029

 

Graham, Rice, Waterhouse, Wang AU 743316
    AU 2005211538
    AU 2005209648
    AU 2008249157
    BR PI9908967.0
    BR PI9917642.4
    CA 2323726
    CN 200510083325.1
    CN 200910206175
    CZ  295108
    EP  1555317 (formerly patent application no. 04015041.9)
    EP 1624060 (formerly patent application no.05013010.3
    EP 07008204.5
    EP 10183258.2
    UK GB 2353282
    HK 1035742
    HG PO5000631
    HG PO101225
    IN 3901/DELNP/2005
    IN 2000/00169/DE
    JP 2000-537990
    JP 2005-223953
    JP 2007-302237
    JP 2009-161847
    KR

10-2010-7006892

Divisional of 7010419/00

    MX PA/a/2000/008631
    MX PA/a/2005/006838
    NZ 506648
    NZ 547283
    PL P-377017
    SG 75542
    SG 200205122.5
    SG 141233
    SL 287538
    ZA 2000/4507
    SG 141233

 

 

  

 

Waterhouse Family (Benitec has an exclusive worldwide license for human therapeutics from CSIRO)

 

Patent Name Inventors Country Application/ Grant No
METHODS AND MEANS FOR OBTAINING MODIFIED PHENOTYPES Waterhouse, Wang, Graham AU 29514/99 (760041)
    AU 2007201023
    CA 2325344
    CN ZL99805925.0 (CN1202246-C)
    EP 99910592.7 (EP1068311)
    JP 2000-543598
    NZ 507093
    US 09/287632
    US 11/364183
    US 11/841737 US20080104732.

 

Benitec Australia Owned Patents/Applications

 

Title and Benitec Ref No. Inventors Country Number
GENETIC SILENCING (106) Graham, Rice, Murphy, Reed JP 2001-569332
BR PI0109269-3
UK GB2377221
SG 91678
ZA 2002/07428

DOUBLE-STRANDED NUCLEIC ACID (107)

 

(LONG HAIR PIN)

Graham, Rice, Roelvink, Suhy, Kolkykhalov, Harrison, Reed. AU 2004243347
NZ 543815
EP 04735856.9
CA 2527907
JP 2006-508084
ZA 2005/09813
SG 200507474-5
IL 172191
US 12/914893 Continuation of 10/861191

RNAi EXPRESSION CONSTRUCTS (single promoter) (114)

 

 

Roelvink, Suhy, Kolykhalov, Couto US 7,803,611
US 11/883645
CN 200680010811.3
HK 08112495.7
EP 09015950.0
CA 2596711
AU 2006210443
IL 185315
NZ 560936

EX-10.13 30 reg1009forms1ex10_13.htm EXHIBIT 10.13

Exhibit 10.13

 

SERVICE AGREEMENT

 

 

 

This Independent Contractor Agreement (“Agreement”) is entered into this 27th day of July 2013 between Dr. Wei Ping Min (“Min”), a research scientist (hereinafter referred to as “Contractor”) whose address is 84 Hesketh Street, London Ontario N6G5H5, Canada and Regen BioPharma, Inc. (hereinafter referred to as “Client”), a Nevada corporation with offices at 4700 Spring Street, Suite 304, La Mesa, CA 91942.

 

WHEREAS:

 

A.   Contractor is a scientific researcher in the area of biological sciences.

 

B.   Contractor is experienced and knowledgeable with regard to the conducting scientific research in the area of aplastic anemia.

 

NOW THEREFORE, in consideration of the mutual promises and conditions contained herein, the parties agree as follows:

 

ARTICLE 1

 

Duration of Contract

 

Section 1.1   This Agreement is effective July 27, 2013 and will continue in effect until June 30, 2014, unless terminated in accordance with the provisions of Article 7 of this Agreement.

 

Section 1.2   This Agreement may be extended by mutual consent of said parties.

 

ARTICLE 2

 

Independent Contractor Status

 

Section 2.1   It is the express intention of the parties that Contractor is an independent contractor and not an employee, agent, joint venture participant, or partner of Client.

 

Nothing in this Agreement shall be interpreted or construed as creating or establishing the relationship of employer and employee between Client and Contractor or any employee or agent of Contractor. Both parties acknowledge that Contractor is not an employee for state or federal tax purposes. Contractor shall retain the right to perform services for others during the term of this Agreement.

 

Section 2.2.  Client acknowledges and agrees that Contractor shall have the right to engage in other independent scientific activities.

 

 

 

 

ARTICLE 3

 

Services Performed by Contractor

 

Section 3.1 Participate in discussions with FDA and provide experimental support.

 

Section 3.2 Execution of FDA suggested additional experiment:

 

(a)   8-12 week female B6 mice will be treated with interperitoneal injection of 150mg/kg 5-FU

 

(b)   Groups of mice (10 mice per group) will consist of 1) control PBS; 2) 15000 stromal vascular fraction cells; 3) 30000 stromal vascular fraction cells; or 4) 60000 stromal vascular fraction cells.

 

(c)   Injection of stromal vascular fraction cells will be performed intravenously 24 hours after administration of 5-FU

 

(d)   Stromal vascular fraction cells will either be provided by Regen BioPharma Inc. or isolated according to the protocol Rodriguez et al. Int Arch Med. 2012 Feb 8;5: 5

 

(e)   Survival and complete blood counts will be evaluated every second day over the period of two weeks.

 

(f)   Blood Samples (20 UL) will be taken retro-orbitally or by tail vein in a vial containing 1 UL of 0.5 M EDTA and white and red cells will be calculated.

 

(g)   Two weeks after injection, animals will be assessed for macroscopic organ changes, and microscopic  histology. Organs analyzed will be heart, lung, liver, spleen, kidney and intestine.

 

(h)   Histological assessment of human Stromal vascular fraction in major organs.

 

Section 3.3 Participate in/perform other experiments that may be requested by FDA for HemaXellerate IND

 

Section 3.4 In vitro development of human dendritic cells and silencing by IDO shRNA

 

(a)   Peripheral blood mononuclear cells (PBMCs) are isolated as described in the previous Example. A total of 2 X 10(7) PBMCs are cultured in 10ml medium per 75cm2 flask (Corning). After 2 hours or overnight the cells are gently agitated and the adherent cells are collected. Monocytes (more than 85% CD14+) will be purified from adherent cells by using MACS Monocyte Isolation Kit (Miltenyl Biotec, Bergisch Gladbach, Germany), and 1 X 106 cells per millimeter are cultured in 2 ML RPMI 1640, 10% FBS, recombinant GM-CSF (rGM-CSF)(10 ng/mL), rlL-4 (500 U/mL) in 6 well flat- bottomed plates.

 

(b)   In some experiments, tumor necrosis factor-a (TNF-a)(20 ng/mL) is added at the initial culture.

 

(c)   IDO targeting shRNA will be developed and transfected into generated dendritic cells, control shRNA using scrambled IDO sequences will be used.

 

(d)   Ability of cells to mature will be assessed by flow cytometry for expression of CD83, 80,86, while immaturity as determined by non-differentiation will be assessed by the CD14 monocyte marker. In some experiments maturation will be assessed functionally by production of IL-10/IL-12 in response to LPS, as well as ability to stimulate allogeneic mixed lymphocyte reaction.

 

 

 

 

(e)   Assessment of IDO Inhibition will be assessed at the transcript level

 

(f)   Standard Operating Procedures (SOPs) will be generated for DC maturation and silencing.

 

Section 3.5 Contractor may perform services under this Agreement using Contractor’s own supplies, tools, and instrumentalities or supplies, tools, and instrumentalities normally provided for on Client’s premises at Contractor’s discretion and expense.

 

ARTICLE 4

 

Compensation

 

Section 4.1 In consideration for services to be performed by Contractor, Client agrees to pay Contractor $100,000 during the 12 month duration of this contract. There will be 12 total payments made to the contractor ( one twelfth of the $100,000 per month with the total number of payments aggregating to $100,000)  these payments will be made in Bio-Matrix Scientific Group Inc.’s common stock (the parent of Regen BioPharma) and will be valued at the closing price on the day before issuance. In the event of a shortage of available stock to issue for payments owed to Contractor, the amount owed will accrue until the authorized shares are available to issue to Contractor. These payments will continue for the duration of this contract unless the contract is terminated under Article 7 of this agreement. All intellectual property developed from this agreement is owned by Regen BioPharma Inc.

 

Section 4.2 The aforementioned common stock in Bio-matrix Scientific Group, Inc. may be issued either as restricted shares or registered shares at the Company’s discretion.

 

ARTICLE 5

 

Obligations of Contractor

 

Section 5.1 Contractor agrees to comply with all reasonable requests of Client necessary to the performance of Client’s duties under this Agreement.  Contractor also agrees to provide access to all pertinent information and documentation necessary to the performance of his/her services.

 

Section 5.2 Contractor is responsible for his/her own business expenses, including, but not limited to, expenses for travel meals, clothing, personal equipment and tools, insurance, accounting, etc., that Contractor may incur as a result of performing her services.

 

Section 5.3 Neither this Agreement nor any duties or obligations under this Agreement may be assigned by Contractor without prior consent of Client.

 

ARTICLE 6

 

Obligations of Client

 

Section 6.1 Client agrees to comply with all reasonable requests of Contractor necessary to the performance of Contractor’s duties under this Agreement. Client also agrees to provide access to all pertinent information and documentation necessary to the performance of his/her services.

 

 

 

 

Section 6.2 Neither this Agreement nor any duties or obligations under this Agreement may be assigned by Client without prior written consent of Contractor.

 

ARTICLE 7

 

Termination of Contract

 

Section 7.1 this Agreement shall automatically terminate on the occurrence of any of the following”

 

A.   Bankruptcy or insolvency of Client

 

B.   Sale of intellectual property to another entity

 

C.   Death or incapacitation of Contractor

 

D.   Mutual written consent of both parties

 

E.   In the sole determination of the Client, the failure of Contractor to provide any of the duties agreed upon in a skillful, professional and workmanlike manner.

 

F.   Failure of Client to remit payment as agreed herein.

 

G.   Regen BioPharma ceases to be in the business of biotechnology research and development.

 

Section 8.1 Any notices to be given hereunder by either party to the other party may be effected either by personal delivery in writing or by mail, registered or certified, postage prepaid with return receipt requested. Mailed notices shall be addressed to the parties at the addresses appearing in the introductory paragraph of this Agreement, but each party may change the address by written notice in accordance with this paragraph. Notices delivered personally will be deemed communicated as of actual receipt; mailed notices will be deemed communicated as of three days after mailing.

 

Section 8.2 This Agreement supersedes any and all agreements , either oral or written, between the parties hereto with respect to the rendering of services by Contractor to Client and contains all the covenants and agreements between the parties with respect to the rendering of such services in any manner whatsoever. Each party to this Agreement acknowledges that no promises, or agreement, orally or otherwise, have been made by any party, or anyone acting on behalf of any party, that are not embodied herein, and that no agreement, statement or promise not contained in this Agreement shall be valid or binding. Any modification to this Agreement will be effective only if it is in writing signed by the parties hereto.

 

Section 8.3 if any provision of this Agreement is held by a court of competent jurisdiction to be invalid, void, or unenforceable, the remaining provisions will nevertheless continue in full force without being impaired or invalidated in any way.

 

Section 8.4 If any action at law or inequity, including an action for declaratory relief, is brought to enforce or interpret the provisions of this Agreement, the prevailing party will be entitled to reasonable attorney’s fees, which may be set by the court in the same action or in a separate action brought for that purpose, in addition to any other relief to which the party may be entitled.

 

Section 8.5 This Agreement will be governed by the laws of the State of California.

 

 

 

 

IN WITNESS WHEREOF, this contract is executed in the City of San Diego, County of San Diego, State of California, on the date and year first above written.

 

  

CONTRACTOR

 

/s/Wei Ping Min                        

Wei Ping Min, MD, PhD

Independent Contractor

 

  

CLIENT

 

/s/David R. Koos                       

By: David R Koos

Its: Chairman and CEO

Regen BioPharma Inc.

EX-10.14 31 reg1009forms1ex10_14.htm EXHIBIT 10.14

Exhibit 10.14

 

This SECURITIES PURCHASE AGREEMENT (the “Agreement”), dated as of , by and between Regen Biopharma, Inc. , a Nevada corporation, with headquarters located at 4700 Spring Street, Suite 304,La Mesa California, 91942, (the “Company”), and ASC Recap LLC, a Connecticut Limited Liability Company, with its address at 90 Grove Street, Suite 108, Ridgefield CT 06877(the “Buyer”).

 

WHEREAS:

 

A. The Company and the Buyer are executing and delivering this Agreement in reliance upon the exemption from securities registration afforded by Section 4(a)(2) of the Securities Act of 1933, as amended (the “1933 Act”);

B. Buyer desires to purchase and the Company desires to issue and sell, upon the terms and conditions set forth in this Agreement 100,000 shares of common stock, $0.0001 par value per share, of the Company (the “Common Stock”).

NOW THEREFORE, the Company and the Buyer hereby agree as follows:

 

1.Purchase and Sale of the Common Stock.

a. Purchase of the Common Stock. On the Closing Date (as defined below), the Company shall issue and sell to the Buyer and the Buyer agrees to purchase from the Company the Common Stock

b. Form of Payment. On the Closing Date (as defined below), (i) the Buyer shall pay the amount of $ 100,000 USD for the Common Stock to be issued and sold to it at the Closing (as defined below) (the “Purchase Price”) by wire transfer of immediately available funds to the Company, in accordance with the Company’s written wiring instructions and (ii) the Company shall deliver the Common Stock to the Buyer, against delivery of such Purchase Price.

c. Closing Date. The date and time of the issuance and sale of the Common Stock pursuant to this Agreement (the “Closing Date”) shall be September 30, 2013 , or such other mutually agreed upon time. The closing of the transactions contemplated by this Agreement (the “Closing”) shall occur on the Closing Date at such location as may be agreed to by the parties.

 

2. Buyer’s Representations and Warranties. The Buyer represents and warrants to the Company that:

a. Investment Purpose. As of the date hereof, the Buyer is purchasing the shares of Common Stock for its own account and not with a present view towards the public sale or distribution thereof, except pursuant to sales registered or exempted from registration under the 1933 Act

b. Accredited Investor Status. The Buyer is an “accredited investor” as that term is defined in Rule 501(a) of Regulation D (an “Accredited Investor”).

c. Reliance on Exemptions. The Buyer understands that the Common Stock is being offered and sold to it in reliance upon specific exemptions from the registration requirements of United States federal and state securities laws and that the Company is relying upon the truth and accuracy of, and the Buyer’s compliance with, the representations, warranties, agreements, acknowledgments and understandings of the Buyer set forth herein in order to determine the availability of such exemptions and the eligibility of the Buyer to acquire the Common Stock.

d. Information .The Buyer and its advisors, if any, have been furnished with all materials relating to the business, finances and operations of the Company and materials relating to the offer and sale of the Common Stock which have been requested by the Buyer or its advisors. The Buyer and its advisors, if any, have been afforded the opportunity to ask questions of the Company. Notwithstanding the foregoing, the Company has not disclosed to the Buyer any material nonpublic information and will not disclose such information unless such information is disclosed to the public prior to or promptly following such disclosure to the Buyer.

e. Transfer or Re-sale. The Buyer understands that sale or re-sale of the Common Stock has not been and is not being registered under the 1933 Act or any applicable state securities laws, and the Common Stock may not be offered, sold, transferred, pledged, hypothecated or otherwise disposed of except pursuant to an effective registration statement under the 1933 Act and applicable state securities laws or any other applicable securities laws or pursuant to an applicable exemption from the registration requirements of such 1933 Act and such laws;

f. Legends. The Buyer understands that the Common Stock will bear a restrictive legend in substantially the following form:

THESE SECURITIES HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”), OR SECURITIES LAWS OF ANY STATE AND MAY NOT BE OFFERED, SOLD, ASSIGNED, PLEDGED, TRANSFERRED OR OTHERWISE DISPOSED OF IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT UNDER THE ACT AND APPLICABLE STATE SECURITIES LAWS OR PURSUANT TO AN AVAILABLE EXEMPTION FROM REGISTRATION UNDER THE ACT OR SUCH LAWS AND, IF REQUESTED BY THE COMPANY, UPON DELIVERY OF AN OPINION OF COUNSEL REASONABLY SATISFACTORY TO THE COMPANY THAT THE PROPOSED TRANSFER IS EXEMPT FROM THE ACT OR SUCH LAWS.

g. Authorization; Enforcement. This Agreement has been duly and validly authorized. This Agreement has been duly executed and delivered on behalf of the Buyer, and this Agreement constitutes a valid and binding agreement of the Buyer enforceable in accordance with its terms.

 

3. Company’s Representations and Warranties. The Company represents and warrants to the Buyer that:

a. Organization. Company is a corporation duly organized, validly existing and in good standing under the laws of the State of Nevada and has the corporate power and authority to carry on its business as it is now being conducted.

b. Authorization; Enforcement. This Agreement has been duly and validly authorized. This Agreement has been duly executed and delivered on behalf of the Company, and this Agreement constitutes a valid and binding agreement of the Company enforceable in accordance with its terms.

 

4. General Provisions.

a. Entire Agreement. This Agreement constitutes the entire Agreement and supersedes all prior agreements and understandings, oral and written, between the parties hereto with respect to the subject matter hereof.

b. Governing Law. This Agreement, and all transactions contemplated hereby, shall be governed by, construed and enforced in accordance with the laws of the State of California. In the event that litigation results from or arises out of this Agreement or the performance thereof, the parties agree to reimburse the prevailing party's reasonable attorney's fees, court costs, and all other expenses, whether or not taxable by the court as costs, in addition to any other relief to which the prevailing party may be entitled.

 

 

IN WITNESS WHEREOF, this Agreement has been executed by each of the individual parties hereto on the date first above written.

 

Signed, sealed and delivered in the presence of:

 

COMPANY:

By:    /s/David R. Koos                                           Date signed:9/30/2013

David R. Koos, Chairman and CEO

 

BUYER

By:    Stephen Hicks                                                Date signed: 9/30/2013

Stephen Hicks, Managing Partner

EX-14.1 32 reg1009forms1ex14_1.htm EXHIBIT 14.1

Exhibit 14.1

 

POLICY ON ETHICS AND BUSINESS CONDUCT

 

Regen Biopharma Inc. , Inc. is committed to always doing the right thing. This is why we have an ethics and compliance program and why we publish this Code of Ethics. The Code is specifically designated to be a part of an effective program to prevent and detect violations of law and moral values.

 

The values embodied by the Regen Biopharma , Inc. Code of Ethics are meant to guide the business decisions of the Company.

 

This Code of Ethics will apply to all officers, directors, and employees of the Company.

 

Code Of Ethics

 

1. We will always be honest and truthful.
2. We will adhere to the letter and spirit of all applicable laws, rules, and regulations.
3. We will handle all actual and apparent conflicts of interest between personal and professional dealings in an ethical manner.
4. All public filings will contain full, fair, accurate, timely, and understandable disclosure.
5. All public communications will include full, fair, accurate, timely, and understandable disclosure.
6. All employees will promptly report to the Board of Directors any violations of this Code.
7. All employees will be held accountable for adherence to this Code. We will protect employees who report violations of this Code from unfair and undue repercussion by those accused.
8. We will promote and sustain a work environment that fosters mutual respect, openness, and individual integrity.
9. We will provide high quality products and services.

 

 

Adopted September 25, 2013

/s/David Koos                           

David Koos

Chairman and CEO

/s/Thomas Ichim                        

Thomas Ichim

Director

EX-23.2 33 reg1009forms1ex23_2.htm EXHIBIT 23.2

Exhibit 23.2

 

SEALE AND BEERS, CPAs

PCAOB & CPAB REGISTERED AUDITORS

www.sealebeers.com

 

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

We consent to the use, in the statement on the S-1 of Regen Biopharma, Inc., of our report dated September 19, 2013 on our audit of the financial statements of Regen Biopharma, Inc. as of September 30, 2012 and the related statements of operations, stockholders’ equity and cash flow for the inception period ended September 30, 2012, and the reference to us under the caption “Experts”.

 

/s/Seale and Beers, CPAs

Seale and Beers, CPAs

Las Vegas, Nevada

September 19, 2013

EX-99.C6 OTHER OPIN 34 reg1009forms1legal.htm LEGAL OPINION

Law Offices of Joseph L. Pittera

2214 Torrance Boulevard

Suite 101

Torrance, California 90501

Telephone (310) 328-3588

Facsimile (310) 328-3063

E-mail: jpitteralaw@gmail.com

 

October 7, 2013

 

Board of Directors

Regen BioPharma, Inc.

4700 Spring Street, Suite 304

La Mesa, California, 91942

 

Re: Opinion of Counsel for Registration Statement on Form S-1

 

To Whom It May Concern:

 

I  have acted as counsel to, Regen Biopharma, Inc., a Nevada corporation (the “Registrant”), in connection with the preparation and filing by the Registrant of a registration statement on Form S-1 (the “Registration Statement”) with the U.S. Securities and Exchange Commission (the “Commission”) under the Securities Act of 1933, as amended (the “Securities Act”), with respect to the registration of 20,000,000 shares of the Registrant’s common stock, par value $0.0001 per share, (“the Dividend Shares”) being distributed pursuant to the Registration Statement to shareholders of Bio-Matrix Scientific Group, Inc., the parent of the Registrant. Such Dividend Shares are, as described in the Registration Statement filed on Form S-1 with the Securities and Exchange Commission under the Securities Act of 1933, as amended (together with all amendments thereto) (the “Registration Statement”), proposed to be distributed by the Registrant pursuant to the referenced Registration Statement.

 

In connection with this opinion, I have examined and relied upon the originals or copies of such documents, corporate records, and other instruments as I have deemed necessary or appropriate for the purpose of this opinion.

 

In my examination, I have assumed the genuineness of all signatures, the legal capacity of all natural persons, the authenticity of all documents submitted to us as originals, the conformity to original documents of all documents submitted to us as certified or photostatic copies and the authenticity of the originals of such documents, and the accuracy and completeness of the corporate records made available to us by the Registrant

 

Based upon the foregoing, and in reliance thereon, I am of the opinion that the Dividend Shares have been duly authorized, and when distributed will be legally issued, fully paid and non-assessable.

 

I hereby consent in writing to the reference to my name under the caption "Interests of Named Experts and Counsel" in the Prospectus included in the Registration Statement and the use of my opinion as an exhibit to the Registration Statement and any amendment thereto.

 

 

Yours Truly,

 

/S/ Joseph L. Pittera

 

Joseph L. Pittera, Esq.

 

 

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ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) (USD $)
5 Months Ended 9 Months Ended
Sep. 30, 2012
Jun. 30, 2013
Accounting Policies [Abstract]    
Valuation allowance 100.00% 100.00%
Incurred advertising expenses $ 0 $ 0
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STATEMENT OF OPERATIONS (Unaudited) (USD $)
2 Months Ended 3 Months Ended 5 Months Ended 9 Months Ended 15 Months Ended
Jun. 30, 2012
Jun. 30, 2013
Sep. 30, 2012
Jun. 30, 2013
Jun. 30, 2013
Income Statement [Abstract]          
REVENUES $ 0 $ 0    $ 0 $ 0
COST AND EXPENSES          
Research and Development   3,000 17,715 8,394 26,109
General and Administrative 16,250 71,829 137,185 228,779 365,964
Consulting and Professional Fees 2,175   12,290 0 12,290
Total Costs and Expenses 18,425 74,829 167,190 237,173 404,363
OPERATING LOSS (18,425) (74,829) (167,190) (237,173) (404,363)
OTHER INCOME & (EXPENSES)          
NET INCOME (LOSS) $ (18,425) $ (74,829) $ (167,190) $ (237,173) $ (404,363)
BASIC AND FULLY DILUTED EARNINGS (LOSS) PER SHARE $ (1.8100) $ (0.0031) $ (16.72) $ (0.0296)  
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING 10,000 24,185,714.00 10,000 8,009,891  
XML 38 R10.htm IDEA: XBRL DOCUMENT v2.4.0.8
INCOME TAXES
5 Months Ended 9 Months Ended
Sep. 30, 2012
Jun. 30, 2013
Income Tax Disclosure [Abstract]    
INCOME TAXES

NOTE 4. INCOME TAXES

 

As of September 30, 2012

 

Deferred tax assets:      
Net operating tax carry forwards   $ 56,844  
Other     -0-  
Gross deferred tax assets     56,844  
Valuation allowance     (56,844)  
Net deferred tax assets   $ -0-  

 

 

As of  June 30 ,  2012 the Company has a  Deferred Tax Asset of  $56,844 completely attributable to net operating loss carry forwards  of approximately $167,190   ( which expire 20 years from the date the loss was incurred) .

 

Realization of deferred tax assets is dependent upon sufficient future taxable income during the period that deductible temporary differences and carry forwards are expected to be available to reduce taxable income. The achievement of required future taxable income is uncertain. As a result, the Company has the Company recorded a valuation allowance reducing all deferred tax assets to 0.

 

Income tax is calculated at the 34% Federal Corporate Rate.

NOTE 4. INCOME TAXES

 

As of June 30, 2013

 

Deferred tax assets:        
Net operating tax carry forwards   $ 137,483  
Other     -0-  
Gross deferred tax assets     137,483  
Valuation allowance     (137,483 ))
Net deferred tax assets   $ -0-  

 

 

As of  June 30 ,  2013 the Company has a  Deferred Tax Asset of  $137,483 completely attributable to net operating loss carry forwards  of approximately $ 404,363  ( which expire 20 years from the date the loss was incurred) .

 

Realization of deferred tax assets is dependent upon sufficient future taxable income during the period that deductible temporary differences and carry forwards are expected to be available to reduce taxable income. The achievement of required future taxable income is uncertain. As a result, the Company has the Company recorded a valuation allowance reducing all deferred tax assets to 0.

 

Income tax is calculated at the 34% Federal Corporate Rate.

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SUBSEQUENT EVENTS (Details Narrative) (USD $)
1 Months Ended
Sep. 30, 2013
Sep. 09, 2013
Jun. 30, 2013
May 13, 2013
Sep. 30, 2012
Subsequent Events [Abstract]          
Common shares issued to Caven Investments for satisfaction of debt   1,500,000      
Satisfaction of outstanding indebtedness to Caven Investments $ 70,000        
Common shares sold for consideration 100,000        
Common shares issued for consideration $ 100,000        
Common stock, par value (in dollars per share)     $ 0.0001 $ 0.0001 $ 0.001
Common stock, shares authorized     500,000,000 500,000,000 500,000,000
Preferred stock, par value (in dollars per share)     $ 0.0001 $ 0.0001  
Preferred stock, shares authorized     5,000,000 5,000,000  
XML 41 R18.htm IDEA: XBRL DOCUMENT v2.4.0.8
GOING CONCERN (Details Narrative) (USD $)
2 Months Ended 3 Months Ended 5 Months Ended 9 Months Ended 15 Months Ended
Jun. 30, 2012
Jun. 30, 2013
Mar. 31, 2013
Dec. 31, 2012
Sep. 30, 2012
Jun. 30, 2013
Jun. 30, 2013
Organization, Consolidation and Presentation of Financial Statements [Abstract]              
Net losses $ (18,425) $ (74,829) $ (70,505) $ (91,839) $ (167,190) $ (237,173) $ (404,363)
XML 42 R6.htm IDEA: XBRL DOCUMENT v2.4.0.8
STATEMENT OF CASH FLOWS (Unaudited) (USD $)
2 Months Ended 3 Months Ended 5 Months Ended 9 Months Ended 15 Months Ended
Jun. 30, 2012
Jun. 30, 2013
Dec. 31, 2012
Sep. 30, 2012
Jun. 30, 2013
Jun. 30, 2013
CASH FLOWS FROM OPERATING ACTIVITIES            
Net Income (loss) $ (18,425)     $ (167,190) $ (237,173) $ (404,363)
Adjustments to reconcile net Income to net cash Increase (Decrease) in Accounts Payable            
Net Cash Provided by (Used in) Operating Activities (18,425)     (167,190) (237,173) (404,363)
CASH FLOWS FROM FINANCING ACTIVITIES            
Common Stock issued for Cash 90 20,000     20,000 20,090
Increase in Contributed Capital 43,270 57,854 91,549 168,023 219,903 387,926
Net Cash Provided by (Used in) Financing Activities 43,360     168,113 239,903 408,016
Net Increase (Decrease) in Cash 24,935     923 2,730 3,653
Cash at Beginning of Period 0   923 0 923 0
Cash at End of Period $ 24,935 $ 3,653   $ 923 $ 3,653 $ 3,653
XML 43 R8.htm IDEA: XBRL DOCUMENT v2.4.0.8
RECENT ACCOUNTING PRONOUNCEMENTS
5 Months Ended 9 Months Ended
Sep. 30, 2012
Jun. 30, 2013
Accounting Changes and Error Corrections [Abstract]    
RECENT ACCOUNTING PRONOUNCEMENTS

NOTE 2 .  RECENT ACCOUNTING PRONOUNCEMENTS

 

In May 2011, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2011-04, "Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and IFRSs." The amendments in this update generally represent clarifications of Topic 820, but also include some instances where a particular principle or requirement for measuring fair value or disclosing information about fair value measurements has changed. This update results in common principles and requirements for measuring fair value and for disclosing information about fair value measurements in accordance with U.S. GAAP and IFRS. The amendments in this update are to be applied prospectively. The amendments are effective for interim and annual periods beginning after December 15, 2011. Early application is not permitted. The Company does not expect this guidance to have a significant impact on its consolidated financial position, results of operations or cash flows.

  

In June 2011, the FASB issued ASU No. 2011-05, "Presentation of Comprehensive Income." This update was amended in December 2011 by ASU No. 2011-12, "Deferral of the Effective Date for Amendments to the Presentation of Reclassifications of Items Out of Accumulated Other Comprehensive Income in Accounting Standards Update No. 2011-05." This update defers only those changes in update 2011-05 that relate to the presentation of reclassification adjustments. All other requirements in update 2011-05 are not affected by this update, including the requirement to report comprehensive income either in a single continuous financial statement or in two separate but consecutive financial statements. ASU No. 2011-05 and 2011-12 are effective for fiscal years (including interim periods) beginning after December 15, 2011. The Company does not expect this guidance to have a significant impact on its consolidated financial position, results of operations or cash flows.

 

In December 2011, the FASB issued ASU No. 2011-11, "Disclosures about Offsetting Assets and Liabilities." The amendments in this update require enhanced disclosures around financial instruments and derivative instruments that are either (1) offset in accordance with either ASC 210-20-45 or ASC 815-10-45 or (2) subject to an enforceable master netting arrangement or similar agreement, irrespective of whether they are offset in accordance with either ASC 210-20-45 or ASC 815-10-45. An entity should provide the disclosures required by those amendments retrospectively for all comparative periods presented. The amendments are effective during interim and annual periods beginning on or after January 1, 2013. The Company does not expect this guidance to have any impact on its consolidated financial position, results of operations or cash flows.

 

ASU 2011-08,  Intangibles – Goodwill and Other (Topic 350): Testing Goodwill for Impairment  is applicable to fiscal years beginning after December 15, 2011. Early application is permitted. The Company does not expect this ASU has a material impact on its financial position or carrying value of its intangible assets at this time.

 

A variety of proposed or otherwise potential accounting standards are currently under study by standard setting organizations and various regulatory agencies.  Due to the tentative and preliminary nature of those proposed standards, the Company’s management has not determined whether implementation of such standards would be material to its financial statements.

NOTE 2 .  RECENT ACCOUNTING PRONOUNCEMENTS

 

In May 2011, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2011-04, "Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and IFRSs." The amendments in this update generally represent clarifications of Topic 820, but also include some instances where a particular principle or requirement for measuring fair value or disclosing information about fair value measurements has changed. This update results in common principles and requirements for measuring fair value and for disclosing information about fair value measurements in accordance with U.S. GAAP and IFRS. The amendments in this update are to be applied prospectively. The amendments are effective for interim and annual periods beginning after December 15, 2011. Early application is not permitted. The Company does not expect this guidance to have a significant impact on its consolidated financial position, results of operations or cash flows.

  

In June 2011, the FASB issued ASU No. 2011-05, "Presentation of Comprehensive Income." This update was amended in December 2011 by ASU No. 2011-12, "Deferral of the Effective Date for Amendments to the Presentation of Reclassifications of Items Out of Accumulated Other Comprehensive Income in Accounting Standards Update No. 2011-05." This update defers only those changes in update 2011-05 that relate to the presentation of reclassification adjustments. All other requirements in update 2011-05 are not affected by this update, including the requirement to report comprehensive income either in a single continuous financial statement or in two separate but consecutive financial statements. ASU No. 2011-05 and 2011-12 are effective for fiscal years (including interim periods) beginning after December 15, 2011. The Company does not expect this guidance to have a significant impact on its consolidated financial position, results of operations or cash flows.

 

In December 2011, the FASB issued ASU No. 2011-11, "Disclosures about Offsetting Assets and Liabilities." The amendments in this update require enhanced disclosures around financial instruments and derivative instruments that are either (1) offset in accordance with either ASC 210-20-45 or ASC 815-10-45 or (2) subject to an enforceable master netting arrangement or similar agreement, irrespective of whether they are offset in accordance with either ASC 210-20-45 or ASC 815-10-45. An entity should provide the disclosures required by those amendments retrospectively for all comparative periods presented. The amendments are effective during interim and annual periods beginning on or after January 1, 2013. The Company does not expect this guidance to have any impact on its consolidated financial position, results of operations or cash flows.

 

ASU 2011-08,  Intangibles – Goodwill and Other (Topic 350): Testing Goodwill for Impairment  is applicable to fiscal years beginning after December 15, 2011. Early application is permitted. The Company does not expect this ASU has a material impact on its financial position or carrying value of its intangible assets at this time.

 

A variety of proposed or otherwise potential accounting standards are currently under study by standard setting organizations and various regulatory agencies.  Due to the tentative and preliminary nature of those proposed standards, the Company’s management has not determined whether implementation of such standards would be material to its financial statements.

XML 44 R11.htm IDEA: XBRL DOCUMENT v2.4.0.8
RELATED PARTY TRANSACTIONS
5 Months Ended 9 Months Ended
Sep. 30, 2012
Jun. 30, 2013
Related Party Transactions [Abstract]    
RELATED PARTY TRANSACTIONS

NOTE 5. RELATED PARTY TRANSACTIONS

 

As of September 30, 2012 the Company has received capital contributions from its parent totaling $168,023. The Company also utilizes approximately 2,300 square feet of office space at 4700 Spring Street, Suite 304, La Mesa California, 91941provided to the Company by Entest BioMedical, Inc. on a month to month basis free of charge. The Chief Executive Officer of Entest Biomedical Inc. is David R. Koos who also serves as the Chief Executive Officer of the Company’s parent.

NOTE 5. RELATED PARTY TRANSACTIONS

 

As of June 30, 2013 the Company has received capital contributions from its parent totaling $387,926 and has issued 50,010, 000 common shares to its parent fro aggregate consideration of $20,090. The Company also utilizes approximately 2,300 square feet of office space at 4700 Spring Street, Suite 304, La Mesa California, 91941 provided to the Company by Entest BioMedical, Inc. on a month to month basis free of charge. The Chief Executive Officer of Entest Biomedical Inc. is David R. Koos who also serves as the Chief Executive Officer of the Company’s parent.

XML 45 R9.htm IDEA: XBRL DOCUMENT v2.4.0.8
GOING CONCERN
5 Months Ended 9 Months Ended
Sep. 30, 2012
Jun. 30, 2013
Organization, Consolidation and Presentation of Financial Statements [Abstract]    
GOING CONCERN

NOTE 3. GOING CONCERN

 

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. the Company generated net losses of $ 167,190 during the period from April 24, 2012 (inception) through September 30, 2012. This condition raises substantial doubt about the Company's ability to continue as a going concern. The Company's continuation as a going concern is dependent on its ability to meet its obligations, to obtain additional financing as may be required and ultimately to attain profitability. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

Management plans to raise additional funds by offering securities for cash. Management has yet to decide what type of offering the Company will use or how much capital the Company will raise. There is no guarantee that the Company will be able to raise any capital through any type of offerings.

NOTE 3. GOING CONCERN

 

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. the Company generated net losses of $ 404,363 during the period from April 24, 2012 (inception) through June 30, 2013. This condition raises substantial doubt about the Company's ability to continue as a going concern. The Company's continuation as a going concern is dependent on its ability to meet its obligations, to obtain additional financing as may be required and ultimately to attain profitability. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

Management plans to raise additional funds by offering securities for cash. Management has yet to decide what type of offering the Company will use or how much capital the Company will raise. There is no guarantee that the Company will be able to raise any capital through any type of offerings.

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BALANCE SHEET (Parenthetical) (USD $)
Jun. 30, 2013
May 13, 2013
Sep. 30, 2012
Statement of Financial Position [Abstract]      
Common stock, par value (in dollars per share) $ 0.0001 $ 0.0001 $ 0.001
Common stock, shares authorized 500,000,000 500,000,000 500,000,000
Common stock, shares issued 50,010,000   10,000
Common stock, shares outstanding 50,010,000   10,000
XML 49 R14.htm IDEA: XBRL DOCUMENT v2.4.0.8
SUBSEQUENT EVENTS
5 Months Ended 9 Months Ended
Sep. 30, 2012
Jun. 30, 2013
Subsequent Events [Abstract]    
SUBSEQUENT EVENTS

NOTE 8. SUBSEQUENT EVENTS

 

On May 13, 2013 the Company amended Article 3 of its certificate of incorporation to amend the aggregate number of shares which the Company is authorized to issue as follows:

 

500,000,000 Common shares, $0.0001 par value

5,000,000 Preferred Shares,$0.0001 par value

 

The abovementioned shares authorized pursuant to the Company’s certificate of incorporation may be issued from time to time without prior approval of the shareholders. The Board of Directors of the Company shall have the full authority permitted by law to establish one or more series and the number of shares constituting each such series and to fix by resolution full or limited, multiple or fractional, or no voting rights, and such designations, preferences, qualifications, restrictions, options, conversion rights and other special or relative rights of any series of the Stock that may be desired.

NOTE 8. SUBSEQUENT EVENTS

 

On September 9, 2013 the Company issued 1,500,000 common shares to Caven Investments LLC for .

  (a) The satisfaction of $70,000 of the outstanding indebtedness owed to Caven Investments LLC by Bio-Matrix Scientific Group Inc

 

  (b) The cancellation of all of Caven Investments LLC’s outstanding warrants to purchase common shares of Bio-Matrix Scientific Group Inc.

 

On September 30, 2013 the Company sold 100,000 of its common shares for consideration of $100,000.

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Statement of shareholder's equity (Unaudited) (USD $)
Common Stock
Additional Paid-in Capital
Retained Earnings
Contributed Capital
Total
Beginning Balance, Amount at Apr. 23, 2012          
Shares issued to Parent, Shares 10,000        
Shares issued to Parent, Amount $ 10 $ 80     $ 90
Contributed Capital       168,023 168,023
Net Loss     (167,190)   (167,190)
Ending Balance, Amount at Sep. 30, 2012 10 80 (167,190) 168,023 923
Ending Balance, Shares at Sep. 30, 2012 10,000        
Contributed Capital       91,549 91,549
Net Loss     (91,839)   (91,839)
Ending Balance, Amount at Dec. 31, 2012 10 80 (259,029) 259,572 633
Ending Balance, Shares at Dec. 31, 2012 10,000        
Contributed Capital       70,500 70,500
Net Loss     (70,505)   (70,505)
Ending Balance, Amount at Mar. 31, 2013 10 80 (329,534) 330,072 628
Beginning Balance, Shares at Mar. 31, 2013 10,000        
Contributed Capital       57,854 57,854
Change in par value, common stock (9) 9     0
Common Stock issued for Cash, Shares 50,000,000        
Common Stock issued for Cash, Amount 5,000 15,000     20,000
Net Loss     (74,829)   (74,829)
Ending Balance, Amount at Jun. 30, 2013 $ 5,001 $ 15,089 $ (404,363) $ 387,926 $ 3,653
Ending Balance, Shares at Jun. 30, 2013 50,010,000        
XML 51 R2.htm IDEA: XBRL DOCUMENT v2.4.0.8
BALANCE SHEET (Unaudited) (USD $)
Jun. 30, 2013
Sep. 30, 2012
CURRENT ASSETS    
Cash $ 3,653 $ 923
Total Current Assets 3,653 923
TOTAL ASSETS 3,653 923
LIABILITIES AND STOCKHOLDERS EQUITY    
Total Current Liabilities 0 0
Total Liabilities 0 0
STOCKHOLDERS EQUITY (DEFICIT)    
Common Stock ($.0001 par value) 500,000,000 shares authorized; 10,000 shares issued and outstanding as of September 30, 2012 ($0.001 par value) and 50,010,000 shares authorized and outstanding June 30, 2013 5,001 10
Additional Paid in capital 15,089 80
Contributed Capital 387,926 168,023
Retained Earnings (Deficit) accumulated during the development stage (404,363) (167,190)
Total Stockholders' Equity (Deficit) 3,653 923
TOTAL LIABILITIES & STOCKHOLDERS' EQUITY (DEFICIT) $ 3,653 $ 923
XML 52 R23.htm IDEA: XBRL DOCUMENT v2.4.0.8
STOCK TRANSACTIONS (Details Narrative) (USD $)
3 Months Ended 5 Months Ended
Jun. 30, 2013
Sep. 30, 2012
Equity [Abstract]    
Shares issued to Parent for consideration 50,000,000  
Shares issued to Parent for consideration, Amount $ 20,000 $ 90
XML 53 R13.htm IDEA: XBRL DOCUMENT v2.4.0.8
STOCK TRANSACTIONS
5 Months Ended 9 Months Ended
Sep. 30, 2012
Jun. 30, 2013
Equity [Abstract]    
STOCK TRANSACTIONS

NOTE 7. STOCK TRANSACTIONS

 

During the year ended September 30, 2012 the Company issues 10,000 common shares to its parent for consideration of $90.

NOTE 7. STOCK TRANSACTIONS

 

During the quarter ended June 30, 2013 the Company issued 50,000,000 Common Shares to its parent for consideration of $20,000.

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INCOME TAXES (Tables)
5 Months Ended 9 Months Ended
Sep. 30, 2012
Jun. 30, 2013
Income Tax Disclosure [Abstract]    
Deferred tax assets
Deferred tax assets:      
Net operating tax carry forwards   $ 56,844  
Other     -0-  
Gross deferred tax assets     56,844  
Valuation allowance     (56,844)  
Net deferred tax assets   $ -0-  
Deferred tax assets:        
Net operating tax carry forwards   $ 137,483  
Other     -0-  
Gross deferred tax assets     137,483  
Valuation allowance     (137,483 ))
Net deferred tax assets   $ -0-  
XML 56 R12.htm IDEA: XBRL DOCUMENT v2.4.0.8
STOCKHOLDERS' EQUITY
5 Months Ended 9 Months Ended
Sep. 30, 2012
Jun. 30, 2013
Equity [Abstract]    
STOCKHOLDERS' EQUITY

NOTE6. STOCKHOLDERS' EQUITY

 

The stockholders' equity section of the Company contains the following classes of capital stock as September 30, 2012:

 

Common stock, $ 0.001 par value;10,000 shares authorized: 10,000 shares issued and outstanding.

With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Common Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Common Stock owned by such holder times one (1).

On any voluntary or involuntary liquidation, dissolution or winding up of the Corporation, the holders of the Common Stock shall receive, out of assets legally available for distribution to the Company's stockholders, a ratable share in the assets of the Corporation.

NOTE6. STOCKHOLDERS' EQUITY

 

The stockholders' equity section of the Company contains the following classes of capital stock as June, 2013:

 

Common stock, $ 0.0001 par value;500,000 ,000 shares authorized: 50,010,000 shares issued and outstanding.

With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Common Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Common Stock owned by such holder times one (1).

On any voluntary or involuntary liquidation, dissolution or winding up of the Corporation, the holders of the Common Stock shall receive, out of assets legally available for distribution to the Company's stockholders, a ratable share in the assets of the Corporation.

Preferred Stock, ,$0.0001 par value, 5,000,000 shares authorized: 0 shares issued and outstanding

The abovementioned shares authorized pursuant to the Company’s certificate of incorporation may be issued from time to time without prior approval of the shareholders. The Board of Directors of the Company shall have the full authority permitted by law to establish one or more series and the number of shares constituting each such series and to fix by resolution full or limited, multiple or fractional, or no voting rights, and such designations, preferences, qualifications, restrictions, options, conversion rights and other special or relative rights of any series of the Stock that may be desired.

XML 57 R7.htm IDEA: XBRL DOCUMENT v2.4.0.8
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
5 Months Ended 9 Months Ended
Sep. 30, 2012
Jun. 30, 2013
Accounting Policies [Abstract]    
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

NOTE 1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Regen Biopharma , Inc. (“Company”) was organized April 24, 2012 under the laws of the State of Nevada. The Company is a wholly owned subsidiary of Bio Matrix Scientific Group, Inc, a Delaware corporation.

 

The Company intends to engage primarily in the development of regenerative medical applications which we intend to license from other entities up to the point of successful completion of Phase I and or Phase II clinical trials after which we would either attempt to sell or license those developed applications or, alternatively, advance the application further to Phase III clinical trials

 

A. BASIS OF ACCOUNTING

 

The financial statements have been prepared using the basis of accounting generally accepted in the United States of America. Under this basis of accounting, revenues are recorded as earned and expenses are recorded at the time liabilities are incurred. The Company has adopted a September 30 year-end.

 

B. USE OF ESTIMATES

 

The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

 

C. DEVELOPMENT STAGE

 

The Company is a development stage company devoting substantially all of its efforts to establish a new business.

 

D. CASH EQUIVALENTS

 

The Company considers all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents.

   

E. PROPERTY AND EQUIPMENT

 

Property and equipment are recorded at cost. Maintenance and repairs are expensed in the year in which they are incurred. Expenditures that enhance the value of property and equipment are capitalized.

 

F. FAIR VALUE OF FINANCIAL INSTRUMENTS

 

Fair value is the price that would be received for an asset or the exit price that would be paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants on the measurement date.  A fair value hierarchy requires an entity to maximize the use of observable inputs, where available. The following summarizes the three levels of inputs required by the standard that the Company uses to measure fair value:

 

Level 1:  Quoted prices in active markets for identical assets or liabilities

 

Level 2:  Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities.

 

Level 3:  Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

 

 

G. INCOME TAXES

 

The Company accounts for income taxes using the liability method prescribed by ASC 740, “Income Taxes.” Under this method, deferred tax assets and liabilities are determined based on the difference between the financial reporting and tax bases of assets and liabilities using enacted tax rates that will be in effect in the year in which the differences are expected to reverse. The Company records a valuation allowance to offset deferred tax assets if based on the weight of available evidence, it is more-likely-than-not that some portion, or all, of the deferred tax assets will not be realized. The effect on deferred taxes of a change in tax rates is recognized as income or loss in the period that includes the enactment date.

 

The Company applied the provisions of ASC 740-10-50, “Accounting For Uncertainty In Income Taxes”, which provides clarification related to the process associated with accounting for uncertain tax positions recognized in our financial statements. Audit periods remain open for review until the statute of limitations has passed. The completion of review or the expiration of the statute of limitations for a given audit period could result in an adjustment to the Company’s liability for income taxes. Any such adjustment could be material to the Company’s results of operations for any given quarterly or annual period based, in part, upon the results of operations for the given period. As of September 30, 2012 the Company had no uncertain tax positions, and will continue to evaluate for uncertain positions in the future.

 

The Company generated a deferred tax credit through net operating loss carry forward.  However, a valuation allowance of 100% has been established.

 

Interest and penalties on tax deficiencies recognized in accordance with ACS accounting standards are classified as income taxes in accordance with ASC Topic 740-10-50-19.

 

H.  BASIC EARNINGS (LOSS) PER SHARE

 

The Financial Accounting Standards Board (FASB) issued Accounting Standards Codification (ASC) 260, "Earnings Per Share", which specifies the computation, presentation and disclosure requirements for earnings (loss) per share for entities with publicly held common stock. ASC 260 requires the presentation of basic earnings (loss) per share and diluted earnings (loss) per share. The Company has adopted the provisions of ASC 260 effective from inception.

 

Basic net loss per share amounts is computed by dividing the net income by the weighted average number of common shares outstanding.

 

I. ADVERTISING

 

Costs associated with advertising are charged to expense as incurred. Advertising expenses were $0 for the twelve months ended September 30 , 2012.

NOTE 1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

 

Regen Biopharma , Inc. (“Company”) was organized April 24, 2012 under the laws of the State of Nevada. The Company is a wholly owned subsidiary of Bio Matrix Scientific Group, Inc, a Delaware corporation.

 

The Company intends to engage primarily in the development of regenerative medical applications which we intend to license from other entities up to the point of successful completion of Phase I and or Phase II clinical trials after which we would either attempt to sell or license those developed applications or, alternatively, advance the application further to Phase III clinical trials

 

A. BASIS OF ACCOUNTING

 

The financial statements have been prepared using the basis of accounting generally accepted in the United States of America. Under this basis of accounting, revenues are recorded as earned and expenses are recorded at the time liabilities are incurred. The Company has adopted a September 30 year-end.

 

 

B. USE OF ESTIMATES

 

The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

 

C. DEVELOPMENT STAGE

 

The Company is a development stage company devoting substantially all of its efforts to establish a new business.

 

D. CASH EQUIVALENTS

 

The Company considers all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents.

   

E. PROPERTY AND EQUIPMENT

 

Property and equipment are recorded at cost. Maintenance and repairs are expensed in the year in which they are incurred. Expenditures that enhance the value of property and equipment are capitalized.

 

F. FAIR VALUE OF FINANCIAL INSTRUMENTS

 

Fair value is the price that would be received for an asset or the exit price that would be paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants on the measurement date.  A fair value hierarchy requires an entity to maximize the use of observable inputs, where available. The following summarizes the three levels of inputs required by the standard that the Company uses to measure fair value:

 

Level 1:  Quoted prices in active markets for identical assets or liabilities

 

Level 2:  Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities.

 

Level 3:  Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

  

G. INCOME TAXES

 

The Company accounts for income taxes using the liability method prescribed by ASC 740, “Income Taxes.” Under this method, deferred tax assets and liabilities are determined based on the difference between the financial reporting and tax bases of assets and liabilities using enacted tax rates that will be in effect in the year in which the differences are expected to reverse. The Company records a valuation allowance to offset deferred tax assets if based on the weight of available evidence, it is more-likely-than-not that some portion, or all, of the deferred tax assets will not be realized. The effect on deferred taxes of a change in tax rates is recognized as income or loss in the period that includes the enactment date.

 

The Company applied the provisions of ASC 740-10-50, “Accounting For Uncertainty In Income Taxes”, which provides clarification related to the process associated with accounting for uncertain tax positions recognized in our financial statements. Audit periods remain open for review until the statute of limitations has passed. The completion of review or the expiration of the statute of limitations for a given audit period could result in an adjustment to the Company’s liability for income taxes. Any such adjustment could be material to the Company’s results of operations for any given quarterly or annual period based, in part, upon the results of operations for the given period. As of December 31 2012 the Company had no uncertain tax positions, and will continue to evaluate for uncertain positions in the future.

 

The Company generated a deferred tax credit through net operating loss carry forward.  However, a valuation allowance of 100% has been established.

 

Interest and penalties on tax deficiencies recognized in accordance with ACS accounting standards are classified as income taxes in accordance with ASC Topic 740-10-50-19.

 

H.  BASIC EARNINGS (LOSS) PER SHARE

 

The Financial Accounting Standards Board (FASB) issued Accounting Standards Codification (ASC) 260, "Earnings Per Share", which specifies the computation, presentation and disclosure requirements for earnings (loss) per share for entities with publicly held common stock. ASC 260 requires the presentation of basic earnings (loss) per share and diluted earnings (loss) per share. The Company has adopted the provisions of ASC 260 effective from inception.

 

Basic net loss per share amounts is computed by dividing the net income by the weighted average number of common shares outstanding.

 

I. ADVERTISING

 

Costs associated with advertising are charged to expense as incurred. Advertising expenses were $0 for the nine months ended June 30 , 2013

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INCOME TAXES - Deferred tax assets (Details) (USD $)
Jun. 30, 2013
Sep. 30, 2012
Deferred tax assets:    
Net operating tax carry forwards $ 137,483 $ 56,844
Other 0 0
Gross deferred tax assets 137,483 56,844
Valuation allowance (137,483) (56,844)
Net deferred tax assets $ 0 $ 0
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ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
5 Months Ended 9 Months Ended
Sep. 30, 2012
Jun. 30, 2013
Accounting Policies [Abstract]    
BASIS OF ACCOUNTING

A. BASIS OF ACCOUNTING

 

The financial statements have been prepared using the basis of accounting generally accepted in the United States of America. Under this basis of accounting, revenues are recorded as earned and expenses are recorded at the time liabilities are incurred. The Company has adopted a September 30 year-end.

A. BASIS OF ACCOUNTING

 

The financial statements have been prepared using the basis of accounting generally accepted in the United States of America. Under this basis of accounting, revenues are recorded as earned and expenses are recorded at the time liabilities are incurred. The Company has adopted a September 30 year-end.

USE OF ESTIMATES

B. USE OF ESTIMATES

 

The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

B. USE OF ESTIMATES

 

The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

DEVELOPMENT STAGE

C. DEVELOPMENT STAGE

 

The Company is a development stage company devoting substantially all of its efforts to establish a new business.

C. DEVELOPMENT STAGE

 

The Company is a development stage company devoting substantially all of its efforts to establish a new business.

CASH EQUIVALENTS

D. CASH EQUIVALENTS

 

The Company considers all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents.

D. CASH EQUIVALENTS

 

The Company considers all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents.

PROPERTY AND EQUIPMENT

E. PROPERTY AND EQUIPMENT

 

Property and equipment are recorded at cost. Maintenance and repairs are expensed in the year in which they are incurred. Expenditures that enhance the value of property and equipment are capitalized.

E. PROPERTY AND EQUIPMENT

 

Property and equipment are recorded at cost. Maintenance and repairs are expensed in the year in which they are incurred. Expenditures that enhance the value of property and equipment are capitalized.

FAIR VALUE OF FINANCIAL INSTRUMENTS

F. FAIR VALUE OF FINANCIAL INSTRUMENTS

 

Fair value is the price that would be received for an asset or the exit price that would be paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants on the measurement date.  A fair value hierarchy requires an entity to maximize the use of observable inputs, where available. The following summarizes the three levels of inputs required by the standard that the Company uses to measure fair value:

 

Level 1:  Quoted prices in active markets for identical assets or liabilities

 

Level 2:  Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities.

 

Level 3:  Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

F. FAIR VALUE OF FINANCIAL INSTRUMENTS

 

Fair value is the price that would be received for an asset or the exit price that would be paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants on the measurement date.  A fair value hierarchy requires an entity to maximize the use of observable inputs, where available. The following summarizes the three levels of inputs required by the standard that the Company uses to measure fair value:

 

Level 1:  Quoted prices in active markets for identical assets or liabilities

 

Level 2:  Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities.

 

Level 3:  Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

INCOME TAXES

G. INCOME TAXES

 

The Company accounts for income taxes using the liability method prescribed by ASC 740, “Income Taxes.” Under this method, deferred tax assets and liabilities are determined based on the difference between the financial reporting and tax bases of assets and liabilities using enacted tax rates that will be in effect in the year in which the differences are expected to reverse. The Company records a valuation allowance to offset deferred tax assets if based on the weight of available evidence, it is more-likely-than-not that some portion, or all, of the deferred tax assets will not be realized. The effect on deferred taxes of a change in tax rates is recognized as income or loss in the period that includes the enactment date.

 

The Company applied the provisions of ASC 740-10-50, “Accounting For Uncertainty In Income Taxes”, which provides clarification related to the process associated with accounting for uncertain tax positions recognized in our financial statements. Audit periods remain open for review until the statute of limitations has passed. The completion of review or the expiration of the statute of limitations for a given audit period could result in an adjustment to the Company’s liability for income taxes. Any such adjustment could be material to the Company’s results of operations for any given quarterly or annual period based, in part, upon the results of operations for the given period. As of September 30, 2012 the Company had no uncertain tax positions, and will continue to evaluate for uncertain positions in the future.

 

The Company generated a deferred tax credit through net operating loss carry forward.  However, a valuation allowance of 100% has been established.

 

Interest and penalties on tax deficiencies recognized in accordance with ACS accounting standards are classified as income taxes in accordance with ASC Topic 740-10-50-19.

G. INCOME TAXES

 

The Company accounts for income taxes using the liability method prescribed by ASC 740, “Income Taxes.” Under this method, deferred tax assets and liabilities are determined based on the difference between the financial reporting and tax bases of assets and liabilities using enacted tax rates that will be in effect in the year in which the differences are expected to reverse. The Company records a valuation allowance to offset deferred tax assets if based on the weight of available evidence, it is more-likely-than-not that some portion, or all, of the deferred tax assets will not be realized. The effect on deferred taxes of a change in tax rates is recognized as income or loss in the period that includes the enactment date.

 

The Company applied the provisions of ASC 740-10-50, “Accounting For Uncertainty In Income Taxes”, which provides clarification related to the process associated with accounting for uncertain tax positions recognized in our financial statements. Audit periods remain open for review until the statute of limitations has passed. The completion of review or the expiration of the statute of limitations for a given audit period could result in an adjustment to the Company’s liability for income taxes. Any such adjustment could be material to the Company’s results of operations for any given quarterly or annual period based, in part, upon the results of operations for the given period. As of December 31 2012 the Company had no uncertain tax positions, and will continue to evaluate for uncertain positions in the future.

 

The Company generated a deferred tax credit through net operating loss carry forward.  However, a valuation allowance of 100% has been established.

 

Interest and penalties on tax deficiencies recognized in accordance with ACS accounting standards are classified as income taxes in accordance with ASC Topic 740-10-50-19.

BASIC EARNINGS (LOSS) PER SHARE

H.  BASIC EARNINGS (LOSS) PER SHARE

 

The Financial Accounting Standards Board (FASB) issued Accounting Standards Codification (ASC) 260, "Earnings Per Share", which specifies the computation, presentation and disclosure requirements for earnings (loss) per share for entities with publicly held common stock. ASC 260 requires the presentation of basic earnings (loss) per share and diluted earnings (loss) per share. The Company has adopted the provisions of ASC 260 effective from inception.

 

Basic net loss per share amounts is computed by dividing the net income by the weighted average number of common shares outstanding.

H.  BASIC EARNINGS (LOSS) PER SHARE

 

The Financial Accounting Standards Board (FASB) issued Accounting Standards Codification (ASC) 260, "Earnings Per Share", which specifies the computation, presentation and disclosure requirements for earnings (loss) per share for entities with publicly held common stock. ASC 260 requires the presentation of basic earnings (loss) per share and diluted earnings (loss) per share. The Company has adopted the provisions of ASC 260 effective from inception.

 

Basic net loss per share amounts is computed by dividing the net income by the weighted average number of common shares outstanding.

ADVERTISING

I. ADVERTISING

 

Costs associated with advertising are charged to expense as incurred. Advertising expenses were $0 for the twelve months ended September 30 , 2012.

I. ADVERTISING

 

Costs associated with advertising are charged to expense as incurred. Advertising expenses were $0 for the nine months ended June 30 , 2013

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STOCKHOLDERS' EQUITY (Details Narrative) (USD $)
Jun. 30, 2013
May 13, 2013
Sep. 30, 2012
Equity [Abstract]      
Common stock, par value (in dollars per share) $ 0.0001 $ 0.0001 $ 0.001
Common stock, shares authorized 500,000,000 500,000,000 500,000,000
Common stock, shares issued 50,010,000   10,000
Common stock, shares outstanding 50,010,000   10,000
Preferred stock, par value (in dollars per share) $ 0.0001 $ 0.0001  
Preferred stock, shares authorized 5,000,000 5,000,000  
Preferred stock, shares issued 0    
Preferred stock, shares outstanding 0    
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INCOME TAXES (Details Narrative) (USD $)
15 Months Ended
Jun. 30, 2013
Sep. 30, 2012
Income Tax Disclosure [Abstract]    
Deferred tax asset $ 137,483 $ 56,844
Net loss carryforwards 404,363 167,190
Deferred tax assets, net valuation allowance $ 0 $ 0
Income tax, Federal rate 34.00%  
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Document and Entity Information
15 Months Ended
Jun. 30, 2013
Document And Entity Information  
Entity Registrant Name Regen BioPharma Inc
Entity Central Index Key 0001589150
Document Type S-1
Document Period End Date Jun. 30, 2013
Amendment Flag false
Current Fiscal Year End Date --09-30
Is Entity a Well-known Seasoned Issuer? No
Is Entity a Voluntary Filer? No
Is Entity's Reporting Status Current? No
Entity Filer Category Smaller Reporting Company
Document Fiscal Year Focus 2013
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RELATED PARTY TRANSACTIONS (Details Narrative) (USD $)
5 Months Ended 9 Months Ended
Sep. 30, 2012
Jun. 30, 2013
Related Party Transactions [Abstract]    
Contributions from parent $ 168,023 $ 387,926
Shares issued to Parent for aggregate consideration   50,010,000
Shares issued to Parent for aggregate consideration, Amount $ 90 $ 20,090