Document:

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

 

 

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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.

 

 

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	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;

 

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	(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.

 

    	13

    	 

    

	(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.

 

    	14

    	 

    

	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.

 

    	15

    	 

    

	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__________________________________

 

 

 

 

24Exhibit
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

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