Document:

Ex 10.144 Mesh Settlement Agreement

Exhibit 10.144
CONFIDENTIAL

The confidential portions of this exhibit have been filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request in accordance with Rule 24b-2 of the Securities and Exchange Act of 1934, as amended.  REDACTED PORTIONS OF THIS EXHIBIT ARE MARKED BY AN ***.

MASTER SETTLEMENT AGREEMENT 
 
Freese & Goss, PLLC/Matthews & Associates 
 
and 
 
American Medical Systems, Inc.

CONFIDENTIAL

Exhibit 10.144
CONFIDENTIAL

TABLE OF CONTENTS
	
				
	I.
	INTRODUCTION
	1
	

	II.
	RECITALS
	1
	

	III.
	DEFINITIONS
	3
	

	IV.
	AGREEMENT
	6
	

	 
	 
	 

	A.
	NO OBJECTION BY INSURERS AS A CONDITION PRECEDENT TO AGREEMENT
	6
	

	B.
	AUTHORITY OF COUNSEL
	6
	

	C.
	BASIC AGREEMENT
	6
	

	D.
	TOLLING OF STATUTE OF LIMITATIONS
	6
	

	E.
	RELEASE OF CLAIMS
	7
	

	 
	1. Release, Indemnity and Assignment
	7
	

	 
	2. Execution by Spouses and Former Spouses
	7
	

	 
	3. Released Parties
	8
	

	 
	4. Released Claims
	8
	

	F.
	COURT APPROVAL AND OTHER DOCUMENTATION
	9
	

	 
	1. Survival and Wrongful Death Claims
	9
	

	 
	2. Claims Involving a Minor
	8
	

	 
	3. Other Documents
	9
	

	G.
	SETTLEMENT FUND
	10
	

	H.
	MINIMUM NUMBER OF EXECUTED RELEASES
	10
	

	I.
	WITHDRAWAL OF COUNSEL
	11
	

	J.
	ACKNOWLEDGMENTS REGARDING CLAIMANTS RIGHT TO PAYMENT
	11
	

	K.
	ACKNOWLEDGMENT OF MEDICAL CONDITION OF THE SUBMITTED INVENTORY
	12
	

	L.
	ALLOCATION OF FUNDS TO CLAIMANTS
	12
	

	M.
	RELEASE OF FUNDS FROM THE SETTLEMENT FUND
	13
	

	N.
	RELEASES, WAIVERS, AND DISMISSALS
	14
	

	 
	1. Dismissal of Claims
	14
	

	 
	2. Release Provisions
	15
	

	O.
	LIENS, ASSIGNMENT RIGHTS, AND OTHER THIRD PARTY PAYOR CLAIMS
	15
	

	P.
	NO ADMISSION OF LIABILITY
	17
	

	Q.
	CONFIDENTIALITY
	17
	

	 
	1. Confidentiality Agreement
	17
	

	 
	2. Inadmissibility of Settlement and Related Documents
	19
	

	 
	3. Joint Messaging
	19
	

	 
	4. Return of Confidential and Privileged Information
	20
	

	R.
	PUBLICITY
	20
	

	S.
	PRESENT INTENTIONS
	20
	

	T.
	SUCCESSORS AND ASSIGNS
	21
	

	U.
	DEADLINES
	21
	

	V.
	GOVERNING LAW
	21
	

	W.
	CHALLENGES TO OR DISPUTES INVOLVING THIS AGREEMENT
	21
	

	X.
	ATTORNEYS’ FEES
	22
	

	Y.
	EXECUTION IN COUNTERPARTS
	22
	

	Z.
	MERGER AND INTEGRATION
	22
	

	AA.
	NO PRESUMPTION
	23
	

CONFIDENTIAL

Exhibit 10.144
CONFIDENTIAL

	
				
	BB.
	INCORPORATION BY REFERENCE
	23
	

	CC.
	NOTICE
	23
	

CONFIDENTIAL

Exhibit 10.144
CONFIDENTIAL

MASTER SETTLEMENT AGREEMENT
		
	I.
	INTRODUCTION

American Medical Systems, Inc. (hereinafter defined in Paragraph III(a) as “AMS”), on the one hand, and Freese & Goss, PLLC and Matthews & Associates (hereinafter defined in Paragraph III(e) as “Claimants Counsel”) acting on their own behalf and on behalf of  all Claimants (hereinafter defined in Paragraph III(e) as “Claimants”), on the other hand, have reached a confidential settlement of all claims arising out of the implantation of pelvic mesh products manufactured, marketed, and distributed by AMS, subject to the terms and conditions set forth in this document.  
The terms and conditions of this Master Settlement Agreement (the “Agreement”) are as follows:
		
	II.
	RECITALS

WHEREAS, Claimants have alleged Claims against AMS arising out of medical complications following the implantation of AMS Mesh Products (hereinafter defined in Paragraph III(b)) and have asserted AMS Mesh Product-Related Injuries (hereinafter defined in Paragraph III(c));
WHEREAS, AMS and its affiliates have denied any and all liability for the claims alleged by Claimants;
WHEREAS, the Parties believe it would be in their respective best interest to settle all Claims, differences and controversies that Claimants, as well as Claimants’ dependents, family members, domestic companions, heirs, beneficiaries, executors, successors, administrators, agents and assigns, if any now or in the future, may have against AMS and its affiliates related to AMS Mesh Products and avoid the risk, expense, inconvenience, and distraction of continued litigation;

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WHEREAS, Claimants Counsel on April 29, 2013, submitted to AMS a matrix reflecting a list of *** total clients, which was comprehensive of all Claimants represented by Claimants Counsel and identified by Claimants Counsel as having an AMS Mesh Product-Related Injury (hereinafter the “Submitted Inventory List”, attached at Exhibit “A”).  The medical conditions on the Submitted Inventory List included designations for “***” and “***.”  Those individuals categorized as “***” are reflected on Exhibit “B” (hereinafter the “***”) and those individuals categorized as “***” are reflected on Exhibit “C” (hereinafter the “***”).  The Parties also categorized certain individuals’ medical conditions as “***” during their negotiations.  Those individuals categorized as “***” are reflected on Exhibit “D” (hereinafter the “***”);
WHEREAS, at the time of its submission to AMS, Claimants Counsel acknowledged that the Submitted Inventory List reflected the medical condition(s) for each individual based upon Claimants Counsel’s review of the pertinent information, medical records, and other documentation in Claimants Counsel’s possession at the time of submission;
WHEREAS, on or about April 30, 2013, the Parties executed a Memorandum of Understanding reflecting the Parties’ agreement relating to the terms for settling all actual and potential Claims that have arisen between AMS and Claimants, including derivative and/or assigned Claims, whether known or unknown, asserted or unasserted, existing now or arising in the future, relating to AMS Mesh Products and AMS Mesh Product-Related Injuries.  The Memorandum of Understanding provided that if certain conditions precedent were satisfied by the Parties that the Parties would execute this binding Master Settlement Agreement.  The condition precedent to the execution of this Agreement has been satisfied. 

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NOW THEREFORE, for the good and valuable consideration described below, the sufficiency of which is hereby acknowledged, the Parties stipulate and agree as follows:
		
	III.
	DEFINITIONS

For the purpose of this Agreement the following terms (designated by initial capitalization throughout this Agreement) shall have the meaning set forth below:
(a)    “AMS” means American Medical Systems, Inc.; American Medical Systems Holdings, Inc.; Endo Pharmaceuticals Inc.; and Endo Health Solutions Inc., formerly known as Endo Pharmaceuticals Holdings Inc., their (i) past, present and future entire companies, affiliates, respective officers, directors, employees, contractors, and shareholders, (ii) their respective past, present, and future related entities, parents,  subsidiaries, affiliates, controlling persons, suppliers, distributors, contractors, agents, assigns, servants, counsel, sureties, service providers and insurers, (iii) all of their past, present and future officers, directors, affiliates, employees, shareholders, contractors, predecessors, successors, trustees, beneficiaries, agents, assigns, heirs, executors, estate administrators, and personal representatives (or the equivalent thereto), and (iv) any and all other persons, corporations, and legal entities which might be in privity with any of these entities.
(b)    “AMS Mesh Product”  or “AMS Mesh Products” means those pelvic mesh product(s) manufactured, marketed, sold and distributed by AMS and its affiliates known as:  Apogee® System with IntePro® LiteTM, Apogee® System with InteXen®  LPTM, Perigee® System with IntePro® LiteTM, Perigee® System with InteXen®  LPTM,   Elevate® Apical and Posterior Prolapse Repair System with IntePro® LiteTM, Elevate® Apical and Posterior Prolapse Repair System with InteXen® LP, Elevate® Anterior & Apical Prolapse Repair System with IntePro® LiteTM, Elevate® Anterior & Apical Prolapse Repair System with InteXen® LP, Straight-InTM Sacralcolpopexy System, IntePro® Y-Mesh, InteXen® LP Porcine Dermal Matrix, SPARC® Sling System, Monarc® Subfascial Hammock, BioArc® SP System with InteXen® LP, BioArc® TO System with InteXen® LP, MiniArc® Single-Incision Sling System, MiniArc PreciseTM Single-Incision Sling System, In-Fast Ultra®,  as well as any variations of said Products, past, present or future. 
(c)    “AMS Mesh Product-Related Injuries” means injuries, conditions, complications and damages of whatever kind and character, existing in the past, now or arising in the future, whether known or unknown, alleged to be related to the manufacture, distribution, promotion, marketing, testing, labeling, sale, purchase, implant, use, removal, explant, excision, extraction or revision of AMS Mesh Products, including, but not limited to:  mesh erosion; mesh extrusion; mesh rejection; mesh contraction or “shrinkage”; mesh encapsulation; any and all types of infection; fistula formation; inflammation; scar tissue formation; organ perforation 

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or other organ damage; dyspareunia (pain during sexual intercourse); loss of intimacy or sexual relations, loss of desire for intimacy or sexual relations, and/or inability to engage in sexual activity for any reason; blood loss; vaginal bleeding; neuropathic and other acute and chronic nerve damage and pain, including but not limited to pudendal nerve damage; pelvic floor damage; chronic pelvic pain; de novo urinary and/or fecal incontinence and other de novo urinary and/or intestinal problems; worsening urinary and/or fecal incontinence and other worsening urinary and/or intestinal problems; de novo, continuing, worsening or recurrent pelvic organ prolapse; emotional or mental harm or suffering; loss of enjoyment of life; economic losses, including but not limited to, medical bills and expenses; and/or any other complications, conditions, damages or injuries not heretofore described, existing in the past, now or arising in the future, whether known or unknown.
(d)     “Claims” means of and from any and all claims, demands, actions, causes or action, losses, damages or suits whatsoever, whether past or future, known or unknown, regardless of the kind or nature thereto, including but not limited to, claims for pain and suffering, disability, mental anguish, punitive damages, common law or statutory penalties of recompense, impairment, loss of consortium, loss of society, loss of service, lost wages (past and future), diminished earning capacity (past and future), loss of income (past and future), medical and hospital expenses, and, specifically, including future claims for wrongful death and all claims arising out of alleged wrongful death, including loss of financial support, loss of love  and affection, loss of consortium, service and society and funeral expenses, or any other loss or damage of whatever kind or nature, which is related to, results from, arises out of AMS Mesh Product Related Injuries regardless as to whether such has resulted in a Filed Case or could have resulted in a case filed in a state or federal jurisdiction.
(e)     “Claimants” means those individuals or groups of individuals, or persons representing the interests of those individuals, on Exhibit “A” , and their respective dependents, family members, domestic companions, heirs, beneficiaries, executors, successors, administrators, agents, servants and assigns, if any now or in the future.      
(f)    “Claimants Counsel” means Freese & Goss, PLLC and Matthews & Associates, including all attorney members of or affiliated with each firm, that represent or otherwise have any financial interest in the Claims of those Claimants whose Filed Cases and/or Claims are the subject of this Agreement.  
(g)    “Filed Case” means any Claim brought by a Claimant relating to an AMS Mesh Product, including any derivative and/or assigned Claim, which has been filed with any Court.
(h)     “Effective Date” means the date this “Master Settlement Agreement” is signed on behalf of Claimants Counsel and AMS.

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(i)    “Release” means a standard form confidential release and indemnity agreement whereby AMS is released by settling Claimant from any and all Claims in a form substantially similar to that attached as Exhibit E.  

(j)    “Master Settlement Agreement” and “Release of All Claims” means this Agreement which constitutes the final and more complete settlement and release documents to be executed by the Parties consistent with, incorporating, and reflecting the terms of the Memorandum of Understanding.

(k)    “Parties” means AMS, Claimants and Claimants Counsel.

(l)    “Required Release Filed Case” means the state cases with a trial setting and/or the state cases with an upcoming trial scheduling conference, and includes the Filed Cases styled as follows:

***

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	IV.
	AGREEMENT 

		
	A.
	SATISFACTION OF CONDITION PRECEDENT TO AGREEMENT 

AMS represents that the previous condition precedent in the MOU requiring that AMS’s insurers  not object to this Agreement has been satisfied or is waived by AMS for the purposes of proceeding with the execution of the MSA.  Nothing in this paragraph should be interpreted as a waiver of any and all coverage available to AMS and/or its affiliates.  
		
	B.
	AUTHORITY OF COUNSEL

Claimants Counsel represent and warrant that they have reviewed the provisions of this Agreement, have concluded that it is in the best interests of the Claimants and any interests represented by them.  The Claimants Counsel, therefore, represent and warrant that they will recommend to each of the Claimants that they settle their AMS Mesh Products Claims under the terms of this Agreement.
		
	C.
	BASIC AGREEMENT

For and in consideration of a release of all past, existing, and future Claims relating to AMS Mesh Products, whether known or unknown, asserted or unasserted, and other agreements as set forth herein, and in complete settlement of the Claimants’ cases and/or Claims, including derivative and/or assigned Claims, AMS will make payment on behalf of settling Claimants as described below.
		
	D.
	TOLLING OF STATUTE OF LIMITATIONS

To avoid the necessity of filing or pursuing an AMS Mesh Products-Related Injury claim, action or lawsuit, and subject to the conditions described below, AMS agrees, with respect to each Claimant, to the tolling of the running of the applicable statutes of limitations against any such Claimant for a time commencing from the Effective Date.  In the event that the conditions of the Master Settlement 

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Agreement are not met or a Claimant does not resolve his or her case and/or claim under the Master Settlement Agreement, then the period of tolling shall expire thirty (30) days after notice that the conditions of the Master Settlement Agreement have not been met, or thirty (30) days after notice that the Claimant’s Claim has not been resolved under the Master Settlement Agreement, whichever event occurs later.  
In no event does the above tolling provision revive or renew any limitations or repose period that may have already expired prior to the Effective Date.
Claimants Counsel agree not to set a previously tolled case for a trial prior to (1) year from the Effective Date. 
		
	E.
	RELEASE OF CLAIMS

1.    Release, Indemnity and Assignment.  A “Release of All Claims” (hereinafter “Release”) will be appropriately executed for or by each Claimant participating in the settlement.  Claimants Counsel will provide AMS with (1) full name(s); (2) Social Security number(s); and (3) current address(es) for the Claimants executing a Release.  Claimants Counsel will provide to Claimants full disclosure of the terms of this Master Settlement Agreement as required by applicable state ethics rules corresponding to Rule 1.8(g) of the ABA Model Rules of Professional Conduct.
2.    Execution by Spouses and Former Spouses. 
a.    Any spouse, former or current, who was not married to Claimant during the time Claimant alleges she suffered injury shall not be required to execute a Release. 

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b.    Any person who was married to Claimant during the time she alleges she suffered injury shall be required to execute a Release, so long as that person continues to be married to Claimant and resides with Claimant;
c.    A former spouse who was married to Claimant during the time she alleges she suffered injury shall be required to sign a Release if the former spouse brought a Claim or lawsuit against AMS;
d.    With respect to the above, AMS recognizes there may be circumstances making it impractical to obtain spousal execution and will work cooperatively and in good faith with Claimants Counsel to reach a resolution permitting the Claimant’s settlement to be finalized, including agreeing when appropriate that the spouse need not execute the Release;
3.    Released Parties.  The Release shall provide that each Claimant fully release AMS and any other entities or persons as required by AMS.
4.    Released Claims.  The Release fully sets forth the Claims to be released by the settling Claimant pursuant to this settlement and the terms for indemnification and contribution.  
5.    Medical Bills, Liens, and Other Potential Rights for Reimbursement.  The Release and Paragraph IV.O below fully sets forth the terms for satisfaction of all past, present and/or future bills, costs or liens resulting from or arising out of Claimant’s alleged medical complications following implantation of the AMS Mesh Product/s, including the procedure if Claimant has received payments from Medicare and/or Medicaid, a Medicare and/or Medicaid intermediary or carrier, or any other federal or state government, agency or entity.   Additionally, the Release for each Claimant will contain the representations, warranties and indemnification provisions contained in Exhibit E.

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	F.
	COURT APPROVAL AND OTHER DOCUMENTATION

1.Survival and Wrongful Death Claims.  If required by applicable state law, Claimants Counsel or a party authorized by Claimants Counsel will seek court approval of the settlement of a claim brought on behalf of a decedent or others authorized under applicable state law to advance survival or wrongful death claims.  Such approval will not unnecessarily delay payment to the remaining Claimants, provided all other conditions of the settlement have been met.  Any properly executed Release awaiting Court approval will be counted as an executed and received Release for purpose of determining whether the Minimum Threshold has been satisfied. 
2.Claims Involving a Minor.  If required by applicable state law, Claimants Counsel or a party authorized by Claimants Counsel will seek court approval of the settlement of a claim brought on behalf of a minor.  Such approval will not unnecessarily delay payment to the remaining Claimants, provided all other conditions of the settlement have been met.  Any properly executed Release awaiting Court approval will be counted as an executed and received Release for purpose of determining whether the Minimum Threshold has been satisfied.    
3.Other Documents.  AMS and Claimants Counsel agree to cooperate in acquiring and/or executing any other documents necessary to finalize an individual Claimant’s settlement.  AMS and Claimants Counsel further agree that, if requested by AMS, any application, petition, or filing in any court related to obtaining the necessary court approval or any other documents necessary to finalize an individual Claimant’s settlement shall be filed or submitted under seal, unless prohibited by the rules of the court in which they must be filed.  AMS and Claimants Counsel agree to request that any and all such documents, records, files, hearings and hearing transcripts remain confidential and, if filed under seal, remain under seal.  AMS and Claimants Counsel specifically agree to work together to obtain and 

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maintain the confidentiality or sealing of any such documents and to oppose any motion to intervene or other effort to unseal or make public such documents.
		
	G.
	SETTLEMENT FUND

No sooner than thirty (30) days after the Master Settlement Agreement is signed and an escrow agent mutually agreed upon by the Parties (the “Escrow Agent”), AMS will pay the total sum of Fifty-Four Million, Five Hundred Thousand Dollars ($54,500,000.00) (the “Settlement Amount”) into a settlement fund (the “Settlement Fund”) held in escrow by the Escrow Agent, provided that mutually agreeable escrow arrangements are made with a financial institution (chosen by Claimants Counsel and subject to approval by AMS, which will not be unreasonably withheld) and an Order is entered by a District Court of Dallas County, Texas, or some other mutually agreeable jurisdiction establishing such fund as a Qualified Settlement Fund within the meaning of Treasury Regulation Section 1.468B-1.
The Settlement Fund shall be held at a mutually agreed upon Bank (the “Bank”).  Said financial institution shall be responsible for any and all investment-related decisions, following the Settlement Fund Administrator’s investment policy for fiduciaries, which is based on safety of principal, no bank balance sheet exposure and zero sweep accounts for distributions to Claimants once authorized.  The Settlement Fund Administrator shall not authorize any distributions of income or principal from the Settlement Fund except pursuant to joint instruction to the Settlement Fund Administrator by AMS, or its counsel, and Claimants Counsel.  No other person or entity is permitted to authorize or make any withdrawals from the Settlement Fund.  
		
	H.
	 MINIMUM NUMBER OF EXECUTED RELEASES

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Claimants Counsel agree to obtain an executed Release from a minimum of ninety-five percent (95%) of all Claimants which shall include one hundred percent (100%) of the Required Release Filed Cases (the “Distribution Threshold”). 
In the event Claimants Counsel meet the Distribution Threshold within one hundred twenty (120) days after the Effective Date, AMS will not receive the return of any Individual Allocated Amount (as defined in Paragraph IV.L.).  Claimants Counsel will continue to employ their best efforts to obtain an executed Release from 100% of Claimants following expiration of the 120-day period.  
 In the event Claimants Counsel fails to meet the Distribution Threshold, within the earlier of the date Claimant’s Counsel declares all potential Releases have been received or one hundred twenty (120) days after the Effective Date, then AMS shall have the option of (i) voiding the entire Agreement and receiving in return all money deposited in the Settlement Fund, along with all accrued interest, within fifteen (15) days after such deadline or (ii) accepting the Releases provided and receiving the return of the Individual Allocated Amount (defined in Paragraph IV.L.) for only those Claimants below the ninety-five percent (95%) Distribution Threshold, plus the pro rata share of any accrued interest, within fifteen (15) days after such deadline.
		
	I.
	WITHDRAWAL OF COUNSEL

To the extent permitted by the rules of professional conduct in any jurisdiction in which the firm may practice, Claimants Counsel agree to take all necessary steps to disengage and withdraw from the representation of any Claimant who declines a settlement offer under this Master Settlement Agreement or who fails to provide an executed Release. 
		
	J.
	ACKNOWLEDGMENTS REGARDING CLAIMANTS’ RIGHT TO PAYMENT

 

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The Parties acknowledge that Claimants Counsel have previously provided to AMS satisfactory medical or other records or information for all Claimants establishing their respective entitlement to participate and be paid in this settlement upon the satisfaction of the other terms of this Agreement.
		
	K.
	ACKNOWLEDGMENT OF MEDICAL CONDITION OF THE SUBMITTED INVENTORY

Claimants Counsel acknowledge that the medical condition reflected in the Submitted Inventory matrix, as revised, reflects the medical condition reasonably believed by Claimants Counsel to be the respective Claimant’s medical condition as of that date.  This acknowledgment is based upon a review of all the medical records or other documentation in Claimants Counsel’s possession at the time of this Master Settlement Agreement.  Claimants Counsel agrees to provide medical records to AMS that substantiate the categorization for each Claimant in the *** Category upon request.  If records are not provided, the Claimant will be placed into the “***” category. 
		
	L.
	ALLOCATION OF FUNDS TO CLAIMANTS

The Parties acknowledge that the Settlement Fund provided by AMS to resolve the Claims of Claimants is being paid to resolve the categories for Claimants as follows:
		
	(1)
	***            $***    

		
	(2)
	***            $***

		
	(3)
	***            $***

Total            $54,500,000.00 
Each Claimant will participate in the funds designated for that Claimants respective category, which will be based on the medical condition known from the medical records received by counsel as of May 31, 2013.  The Parties understand that it may be necessary for Claimants to participate in varying amounts within their respective categories.  However, there will not be any substantial deviation from the total category allocated amounts and total Claimants within each category, and specifically, the    

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***.  The amount of each Claimant’s participation may be determined by Claimant’s Counsel, any Settlement Administrator appointed under Treasury Regulation Section 1.468B, a special master, or any other qualified individual.  The Claimants respective participation amount is that Claimant’s “Individual Allocated Amount”.  Claimants Counsel will provide AMS with documentation stating the Individual Allocated Amount disbursed to each Claimant.
The Parties acknowledge and agree that the settlement payments hereunder are exclusively for alleged bodily injury -- meaning actual physical injury to the body of a person resulting in sickness, disease, disability, or death -- and no payment hereunder is, or shall be deemed to be, attributable to any other damage claim, including without limitation any claim for lost wages, lost income, diminished earning capacity, or punitive damages, notwithstanding that such additional damage Claims are within the scope of the Release, and accordingly zero dollars ($0) is placed on such Claims.  The Parties expressly disclaim that AMS has any responsibility or liability for any allocations or any distributions of the Settlement Fund or for reporting requirements related thereto that are imposed on Claimants or Claimants Counsel by applicable state or federal laws.  
		
	M.
	RELEASE OF FUNDS FROM THE SETTLEMENT FUND

The payment of Claimant’s Individual Allocated amount from the Settlement Fund in resolution and satisfaction of their Claims shall only be released by the Escrow Agent pursuant to written escrow instructions to be provided by AMS and Claimants Counsel and subject to the following:
(1)    Subject to an obligation on the part of Claimants Counsel to assure that:  (a) all Medicare liens have been fully satisfied in accordance with Section O herewith; and (b) AMS is repaid any funds released from escrow in the event the Master Settlement Agreement is voided, AMS will, following transfer of the Settlement Amount to the Settlement Fund, direct the Escrow Agent to make payments to

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Claimants Counsel in such amounts as may be requested by Claimants Counsel to pay timely any reasonable charges by the Escrow Agent, any Settlement Administrator appointed under Treasury Regulation Section 1.468B, and any special master engaged to determine the Individual Allocated Amount(s), and any other reasonable and necessary charges associated with the administration of the Settlement Fund.
(2)    Within three (3) business days after receipt of the minimum number of Releases from Claimants Counsel, AMS shall direct the Escrow Agent to make a payment or payments of the remaining Settlement Fund to Claimants Counsel or at Claimants Counsel’s direction, subject to the requirements of Paragraph IV.H. above.
(3)    The payment or payments to Claimants where court approval of a settlement is required by law, including but not limited to Claims on behalf of or by a decedent, shall be released by the Escrow Agent only upon proof of written court approval satisfactory to AMS.  
(4)    AMS shall have no further responsibility for the payment of any funds other than as stated in this Paragraph IV.M, and in no event will AMS be responsible for paying any additional amount to the Settlement Fund.
		
	N.
	RELEASES, WAIVERS, AND DISMISSALS

		
	1.
	Dismissal of Claims.

This Master Settlement Agreement and the distribution of funds to Claimants are conditioned upon AMS receiving releases and waivers from Claimants for all past, present, and future AMS Mesh Products related Claims in the form attached hereto as Exhibit E.  The Parties agree that before any individual Claimant receives a settlement payment, such Claimant must either dismiss with prejudice his or her Filed Case, including derivative Claims, and provide a Release or if no lawsuit has been 

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commenced, provide AMS with a Release of all AMS Mesh Products Claims, whether or not asserted by the Claimant.  Such dismissals and waivers shall terminate the subject lawsuit or released Claim as to all AMS named parties, including affiliates, in their entirety and provide that AMS and Claimants each
shall be responsible for their own costs and fees.  Dismissals shall be effective as to all AMS named parties and affiliates, but shall not constitute a release or satisfaction of Claims against any non-AMS party.
		
	2.
	Release Provisions.

A Release of liability must be provided to AMS by any Claimant who is to receive payment.  The releases from all Claimants shall release all AMS Mesh Product-related Claims that each individual Claimant ever had, or now has, or hereafter can, shall, or may have in the future against AMS arising out of, relating to, resulting from, or which are in any way connected to an AMS Mesh Product-related claim, including those Claims and damages of which the Claimant is not aware and/or that Claimant has not yet anticipated, as described more fully in the “Release of All Claims” form, the content of which is incorporated herein and made part of this Master Settlement Agreement.  The Release shall be effective as to all AMS parties and affiliates, but shall not constitute a release of any non-AMS party or other mesh product manufacturers or distributors.
		
	O.
	LIENS, ASSIGNMENT RIGHTS, AND OTHER THIRD PARTY PAYOR CLAIMS

Claimants Counsel shall appoint a Lien Resolution Administrator (“LRA”) to perform certain functions in connection with liens and/or reimbursement Claims, including, but not limited to, those that may be asserted with respect to federal Medicare (Part A and B) benefits (“Medicare”) as contemplated by the Medicare Secondary Payer Act, 42 U.S.C. §1395y; Medicaid liens; and certain other governmental health care programs with statutory reimbursement or subrogation rights (specifically, TRICARE, VA, and Indian Health Services benefits).  Each settling Claimant shall be required to 

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cooperate with the procedures and protocols established by the LRA and approved by AMS, including but not limited to providing a fully executed Medicare Form B prior to release of any funds.  The LRA’s fees and expenses may be paid out of the Settlement Fund as a reasonable expense. 
Regardless of any limitation as to the scope of the LRA’s responsibilities described above, as to any right or claim to any portion of any settlement proceeds hereunder, including without limitation any right or claim based on payment for or reimbursement of any injury-related medical expenses alleged to be caused or arise from medical complications following implantation of an AMS Mesh Product, which include, but are not limited to, drug costs, hospital expenses, medical expenses, physician expenses, or any other health care provider expenses arising from or based upon the provision of medical care or treatment to settling Claimants or interests they represent, each settling Claimant shall identify (i) all statutory claim or lien holders, including government payors such as Medicare and Medicaid; (ii) any other holders of claims or liens as to which the Claimant or Claimants Counsel has received notice; and (iii) any parties to lawsuits or interventions, including by subrogation, possessing any right or making any claim.  Prior to distribution of any funds from escrow or similar settlement account for a settling Claimant, such settling Claimant and Claimants Counsel (whether through the LRA or otherwise) shall have provided (through the LRA or otherwise) all information that AMS may need to comply with reporting requirements applicable to it, including under Section 111 of the Medicare, Medicaid and SCHIP Extension Act of 2007 (“MMSEA”) (P.L. 110-173), codified at 42 U.S.C. § 1395y(b)(8), and shall authorize AMS to report such information to applicable authorities.  In addition, prior to distribution of any funds from escrow or similar settlement account for a settling Claimant, such settling Claimant and Claimants Counsel shall have represented and warranted that any and all liens, assignment rights, and other claims for a Claimant, where Claimant or Claimant’s Counsel have been put on notice for a specific Claimant, have been or will be satisfied or otherwise resolved by the settling Claimant 

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CONFIDENTIAL

(whether through the LRA, in a global or traditional resolution program, or otherwise).  Satisfaction of any and all liens, assignments, and other claims is the sole responsibility of the settling Claimant, and AMS shall not pay any amounts that result therefrom. 
The settling Claimants shall agree that they are releasing AMS from all medical expenses, including, but not limited to, drug costs, hospital, medical, physician, and health care provider expenses relating to any past, present, or future medical care or treatment, arising from or in connection with alleged medical complications following implantation of an AMS Mesh Product.  Nothing in this Master Settlement Agreement will be construed as expanding the legal rights of any claim or lien holder for reimbursement of any lien, assignment, or claim or any portion of same thereof asserted against a settling Claimant and Claimants Counsel beyond those rights currently provided under applicable law, including the expenses of any lien or other claims or rights to include a lien or other claims or rights to withhold attorneys’ fees and expenses of Claimant’s Counsel.
		
	P.
	NO ADMISSION OF LIABILITY

This Master Settlement Agreement is entered into solely by way of compromise and settlement and shall not be construed as an admission of liability, responsibility, or fault of or by AMS.  AMS expressly denies any liability or wrongdoing to Claimants on the part of itself, including its officers, employees, parents, subsidiaries, related entities, affiliates, contractors, distributors, agents and assigns.
		
	Q.
	CONFIDENTIALITY

		
	1.
	Confidentiality Agreement.

The terms of the MOU the Master Settlement Agreement, and the amount of settlement payments made to Claimants are strictly confidential, except as may be required by law or an Order of a Court and then only to the extent necessary.  Any and all evaluation processes and procedures utilized in 

-17-

Exhibit 10.144
CONFIDENTIAL

conjunction with the claims administration or payment distribution process shall also be kept strictly confidential among the Claimants and the Claimants Counsel.
Agreement to, and maintenance of, confidentiality are material terms of this Master Settlement Agreement.  The Parties agree that the following language shall be included in each individual settlement Releases and is incorporated in this Master Settlement Agreement:
Claimant and his/her attorneys shall keep strictly confidential and agree not to publicize, disclose or characterize to any third party, person or entity, at any time, the following information, except as it may otherwise appear in the public domain: the MOU, this Master Settlement Agreement and any Addendums or exhibits hereto, and Claimant’s Releases, and any of the terms and conditions of this settlement, the amount of this settlement including the Claimant’s Individual Allocated Amount, the history, background and/or substance of the negotiations, directly or indirectly, leading up to the MOU A and Master Settlement Agreement, or any other information which would assist a third party in receiving or otherwise learning about the MOU, Master Settlement Agreement, and Claimant’s Releases, and such terms, conditions, amounts, history, background and/or the substance of any negotiations (all which shall be and is “Confidential Information”), except as required by law or an Order of a Court or necessary for any required probate or other Court approval of the Claimant’s Claims.  In that event, only the Claimant’s Release and the amount of Claimant’s settlement may be disclosed.  Claimant and his/her attorneys may also make disclosure of the money received by Claimant to their accountants and/or financial advisors who shall, however, upon such disclosure, be instructed to maintain and honor the confidentiality of such information.  If inquiry is made by any third person concerning the status of Claimant’s lawsuit, other than as identified above and as necessary to resolve the liens identified above, Claimant and his/her attorneys shall respond only that the suit has been resolved, and make no further comments.  Claimant represents and warrants that any unauthorized disclosure of Confidential Information is a material breach of the settlement, and further that AMS is entitled to compensation from Claimant, as well as all other relief as justice so requires, for any injury, loss or detriment suffered as a result of an unauthorized disclosure of Confidential Information by Claimant, whether the disclosure was made through Claimant’s own actions or through the actions of his or her agents, attorneys, representatives, heirs, servants, beneficiaries or family members.
The Parties agree that any violations of the confidentiality provisions shall entitle the non-
breaching Party to bring an action against the breaching party to seek and recover immediate 
relief, redress and damages associated with such breach, including injunctive relief, without the 

-18-

Exhibit 10.144
CONFIDENTIAL

need to establish actual damages suffered by AMS as a result of the breach.  Because it may be impossible or impractical to determine the actual damages suffered by AMS as a result of 
Claimant’s breach, and because the time and expense involved in proving the actual damage or 
loss suffered by AMS for such a breach make liquidated damages appropriate, if Claimant 
breaches her obligations to maintain and secure confidentiality pursuant to this Confidentiality Agreement, Claimant shall pay to AMS, as liquidated damages, ten percent (10%) of the amount paid to her by AMS under the Settlement Agreement.  
		
	2.
	Inadmissibility of Settlement and Related Documents.

Claimants Counsel and Claimants who receive payments pursuant to this Master Settlement Agreement, shall not offer in evidence or in any way refer to in any civil, criminal, administrative, or other related action or proceeding, the MOU, this Master Settlement Agreement and any Addendums hereto, other than as may be necessary to consummate or enforce this Master Settlement Agreement.  If the subject of this Master Settlement Agreement shall rise in any such legal proceedings, Claimants and Claimants Counsel shall give AMS notice and opportunity to intervene and oppose disclosure and take reasonable measures to ensure that this Master Settlement Agreement and/or its terms are kept confidential.  In the event that there is a proceeding to consummate or enforce this Master Settlement Agreement, including but not limited to any proceeding involving a minor’s compromise, death compromise, divorce, or any other judicial proceeding, Claimant will file under seal any documents which disclose or refer to this Master Settlement Agreement and/or its terms and will take reasonable measures to ensure that this Master Settlement Agreement and/or its terms are kept confidential. 
		
	3.
	Joint Messaging.

The Parties will agree upon a joint message, if any.

-19-

Exhibit 10.144
CONFIDENTIAL

		
	4.
	Return of Confidential and Privileged Information.

Claimant and Claimants Counsel will comply with the terms of any Protective Order and/or Confidentiality Order applicable in the Claimant’s case.  Further, to the extent not otherwise governed by an existing Protective Order and/or Confidentiality Order, Claimant and Claimants Counsel will return all originals and all copies of documents that contain information provided by AMS in any Civil Action involving pelvic mesh products that were in their respective possession, custody or control at the time of the Effective Date.  This includes but is not limited to all documents (copies, originals, electronic files) that AMS produced during discovery in connection with any such Civil Action, and the deposition transcripts and exhibits of AMS company witnesses and/or past or current AMS employees and expert witnesses.  Claimant and Claimants Counsel shall permanently delete and destroy all such information in their possession that is electronically stored.  Claimant and Claimants Counsel will provide certification that they have complied fully with the terms of this Paragraph.
		
	R.
	PUBLICITY

The Claimants Counsel agree not to represent publicly that the MOU, Release, or Master Settlement Agreement in any way embodies, reflects, implies, or can be used to infer any culpable or harmful act by AMS.
		
	S.
	PRESENT INTENTIONS

The Parties agree that while nothing in the MOU or this Master Settlement Agreement is intended to operate as a restriction on the right of the Claimants Counsel to practice law within the meaning of Rule 5.6(b) of the ABA Model Rules of Professional Conduct in any jurisdiction in which the firm may practice or whose rules may otherwise apply, the Claimants Counsel represent that they have no present intent to solicit or represent new clients for the purpose of bringing Claims against AMS in connection with AMS Mesh Products or AMS Mesh Product Injuries.  Claimants Counsel further 

-20-

Exhibit 10.144
CONFIDENTIAL

represent that they will not actively solicit prospective Pelvic Mesh clients via television, radio, or website advertisement or other public or professional media outlets, either directly or indirectly through affiliates.  Claimants Counsel represent and warrant that the Submitted Inventory List accurately reflects all known or knowable claims involving an AMS Mesh Product in which Claimants Counsel has or may have a financial stake or interest.
		
	T.
	SUCCESSORS AND ASSIGNS

The terms and conditions of this Master Settlement Agreement shall inure to the benefit of and be binding upon the respective successors and assigns of each party hereto.
		
	U.
	DEADLINES

Whenever a deadline (i.e., the last day in the period during which an act required by the MOU or this Master Settlement Agreement may be performed) is a Saturday, a Sunday, or a federal holiday, such deadline shall be extended to the next day that is not a Saturday, a Sunday, or a federal holiday.  AMS and the Claimants Counsel may, by written agreement, extend any of the deadlines contained herein and agree that any requested reasonable extension of any deadline will not be unreasonably withheld.
		
	V.
	GOVERNING LAW

This Master Settlement Agreement shall be governed by and construed in accordance with the laws of the State of Delaware, without giving effect to any choice or conflict of law principles, provision or rule (whether of the State of Delaware or any other jurisdiction) that would cause the application of the laws of any other jurisdiction other than the State of Delaware.
		
	W.
	CHALLENGES TO OR DISPUTES INVOLVING THIS AGREEMENT

Any challenges to or disputes arising out of or relating to an alleged violation of the MOU or Master Settlement Agreement, including but not limited to disputes between AMS and Claimants 

-21-

Exhibit 10.144
CONFIDENTIAL

Counsel and/or Claimants and disputes between or among Claimants Counsel and/or members of Claimants Counsel arising out of or in connection with this Master Settlement Agreement, shall be referred for binding determination to Judicial Arbitration Mediation Services (“JAMS”) for resolution, with all costs to be shared equally.  The Parties shall work together to agree on a binding neutral arbitrator to resolve any and all disputes, and if an agreed upon arbitrator cannot be selected, JAMS’ complex resolution procedures shall control the selection of a neutral arbitrator.
		
	X.
	ATTORNEYS’ FEES

Nothing in this Master Settlement Agreement or any agreement shall affect the obligation of any Claimant to pay attorneys’ fees and costs pursuant to any agreement such Claimant may have with his or her counsel.  AMS shall have no responsibility whatsoever for the payment of Claimants’ attorneys’ fees.  Any division of the Settlement Amount is to be determined by Claimant and the Claimants Counsel and shall in no way affect the validity of this Master Settlement Agreement or the Confidential Release executed by any Claimant.
		
	Y.
	EXECUTION IN COUNTERPARTS

The signatories to this Master Settlement Agreement may execute this Master Settlement Agreement in counterparts, and the execution of counterparts shall have the same effect as if all counsel had signed the same instrument.  Facsimile signatures shall be considered as valid signatures as of the date hereof, but the original signature pages shall thereafter be appended to this Master Settlement Agreement; provided, however, that the failure to so append them shall not affect the validity of such facsimile signatures.
		
	Z.
	MERGER AND INTEGRATION

This Master Settlement Agreement (with its expressly incorporated documents) supersedes and replaces the MOU and any prior agreement, tolling agreement, or writing between the Parties and 

-22-

Exhibit 10.144
CONFIDENTIAL

constitutes the entire agreement between AMS, Claimants Counsel, and the Claimants.  Each of the Parties hereby acknowledges and represents that such Party has not relied on any representation, assertion, guarantee, warranty, collateral contract or other assurance, except those set out in this Settlement Agreement, made by or on behalf of any other party or any other person or entity whatsoever, prior to the execution of this Settlement Agreement.  The Parties agree that this Master Settlement Agreement may not be modified, altered or changed except by a written agreement signed by the Parties, and that if any provision of this Master Settlement Agreement is held to be invalid, the remaining provisions shall remain in full force and effect.    
AA.  NO PRESUMPTION                                                                                                                                                         This Master Settlement Agreement is the product of arm’s length negotiations between the  Parties.  No Party shall be deemed the drafter of this Master Settlement Agreement or any provision thereof.  No presumption shall be deemed to exist in favor of or against any Party as a result of the preparation or negotiation of this Master Settlement Agreement. 
BB.    INCORPORATION BY REFERENCE 
All exhibits referenced and attached hereto shall be treated as if they are fully incorporated and set out fully herein.  The exhibits attached are:

Exhibit A:    Submitted Inventory List
Exhibit B:    ***
Exhibit C:    ***
Exhibit D:    ***
Exhibit E:    Form of Release

CC.    NOTICE
Any notices required under this Master Settlement Agreement shall be provided as follows:
For Claimants Counsel, notice shall be provided to:

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Exhibit 10.144
CONFIDENTIAL

Tim K. Goss, Esquire                        David Matthews
Freese & Goss, PLLC                        Matthews & Associates
3031 Allen Street, Suite 200                     2905 Sackett
Dallas, Texas 75204                         Houston, Texas 77098
(214) 761-6610 (phone)                    (713) 222-8080 (phone)
(214) 761-6688 (fax)                         (713) 535-7184 (fax)
tim@freeseandgoss.com                    dmatthews@thematthewslawfirm.com

For AMS, notice shall be provided to:
Barbara R. Binis, Esquire
Reed Smith LLP
2500 One Liberty Place
1650 Market St.
Philadelphia, PA 19103
Office Phone: 214-851-8100
Fax: 215-851-1420
BBinis@ReedSmith.com

-1-

Exhibit 10.144
CONFIDENTIAL

Executed on this 14th day of June 2013.

So Agreed On Behalf Of Claimants And Claimants Counsel:
	
	
	/s/ Tim K. Goss
______________________________________
Tim K. Goss, Esquire
Freese & Goss, PLLC
3031 Allen Street
Suite 200
Dallas, TX 75204

	
	
	/s/ David P. Matthews
______________________________________
David P. Matthews
Matthews & Associates
2905 Sackett
Houston, Texas 77098

So Agreed On Behalf Of American Medical Systems, Inc.
	
	
	American Medical Systems, Inc.

By: /s/ Caroline B. Manogue
______________________________________
Caroline B. Manogue | Executive Vice President, Chief Legal Officer & Secretary
Endo 
1400 Atwater Drive
Malvern,  PA 19355

	
	
	/s/ Barbara R. Binis
_____________________________________  
Barbara R. Binis, Esquire
Reed Smith LLP
2500 One Liberty Place
1650 Market St.
Philadelphia, PA 19103

-2-

Exhibit 10.144
CONFIDENTIAL

Exhibit A

Submitted Inventory List

***

Freese & Goss
Master Settlement Agreement

Exhibit 10.144
CONFIDENTIAL

Exhibit B

***

Freese & Goss
Master Settlement Agreement

Exhibit 10.144
CONFIDENTIAL

Exhibit C

***

Freese & Goss
Master Settlement Agreement

Exhibit 10.144
CONFIDENTIAL

Exhibit D

***

Freese & Goss
Master Settlement Agreement

Exhibit 10.144
CONFIDENTIAL

Exhibit E

Form of Release

(see attached)

Freese & Goss
Master Settlement Agreement

Exhibit 10.144
CONFIDENTIAL

RELEASE AND CONFIDENTIALITY AGREEMENT 
 

I, ____________________________ (hereinafter “Claimant”), represent that I have relied upon the advice of my attorneys, who are the attorneys of my choosing, concerning the legal consequences of this Release and Confidentiality Agreement and that the terms of this Release and Confidentiality Agreement are fully understood and voluntarily accepted by me.

Claimant has either stated his/her intention to commence a lawsuit, or has commenced a lawsuit against AMS1 (such intended or commenced lawsuit referred to herein as the “Action”); and
Claimant has asserted, could assert, or has reserved the right to assert, personal injury claims, and, if spouses, or others are signatories to this Agreement and Release, then such claims as such spouses, children and others have asserted, could assert or have reserved the right to assert for personal injury, loss of companionship, consortium, support, society, affection, love, and comfort (collectively for all releasors, the “Claim”) arising out of or in connection with Claimant’s AMS Mesh Products 
Claimant hereby represents that he/she is authorized under applicable law to represent and bind all other relevant parties who are not signatories to this Agreement and Release and by signing this Agreement and Release does so bind; 

Releasors (as defined below) and AMS believe it would be in their respective best interests to settle the Claim and avoid the risk, expense, inconvenience, and distraction of continued litigation; and
Undersigned counsel has explained to Claimant, and Claimant understands, (i) the terms of this Agreement and Release and (ii) the conditions set forth in the Confidential Master Settlement Agreement (“Confidential Settlement Agreement”) that must be satisfied before Claimant or anyone on Claimant’s behalf can receive the settlement funds;

In consideration for the releases, understandings, warranties, and representations made by Claimant/Releasors in this Release and Confidential Settlement Agreement, Claimant/Releasors will be paid the “Individual Allocated Amount” defined below;

In consideration of the obligations of AMS under the Confidential Settlement Agreement and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, each party hereto, intending to be legally bound, hereby stipulate and agree as follows:

Defined Terms
___________________________
1 “AMS” means American Medical Systems, Inc.; American Medical Systems Holdings, Inc.; Endo Pharmaceuticals Inc.;  and Endo Health Solutions Inc., formerly known as Endo Pharmaceuticals Holdings Inc., their (i) past, present and future entire companies, affiliates, respective officers, directors, employees, contractors, and shareholders, (ii) their respective past, present, and future related entities, parents,  subsidiaries, affiliates, controlling persons, suppliers, distributors, contractors, agents, assigns, servants, counsel, and insurers, and (iii) all of their past, present and future officers, directors, affiliates, employees, shareholders, contractors, predecessors, successors, agents, assigns, heirs, executors, estate administrators, and personal representatives (or the equivalent thereto).

Exhibit 10.144
CONFIDENTIAL

1.As used herein, the term “Claimant” encompasses the Claimant on his/her own behalf and where the Recipient is not the Claimant, the Recipient on whose behalf the Claimant has commenced or stated his/her intent to commence the Action and on whose behalf the Claimant is acting with respect to the provisions of this Agreement and Release.
2.As used herein, the term “Releasors” encompasses the Claimant/Recipient and all other signatories to this  Agreement and Release (individually and collectively), including any and all of their spouses, domestic companions, representatives, agents, successors, assigns, beneficiaries, heirs, or executors of any of them or their estates, except counsel.
3.As used herein, the term “Master Settlement Agreement” means the Confidential Master Settlement Agreement, dated June 7, 2013, by and between AMS, on the one hand, and Freese & Goss, PLLC and Matthews & Associates, acting on their own behalf and on behalf of all Claimants, on the other hand.
4.As used herein, the term “Claim” means of and from any and all claims, demands, actions, causes of action, losses, damages or suits whatsoever, whether past or future, known or unknown, regardless of the kind or nature thereof, including but not limited to, claims for pain and suffering, disability, mental anguish, punitive damages, common law or statutory penalties of recompense, impairment, loss of consortium, loss of society, loss of service, lost wages (past and future), diminished earning capacity (past and future), loss of income (past and future), medical and hospital expenses, future medical expenses, workmen’s compensation claims, interest, attorney’s fees, legal expenses, and, specifically, including future claims for wrongful death and all claims arising out of alleged wrongful death, including loss of financial support, loss of love and affection, loss of consortium, service and society and funeral expenses, or any other loss or damage of whatever kind or nature, which is related to, results from, arises out of AMS Mesh Product Related Injuries regardless as to whether such has resulted in a Filed Case or could have resulted in a case filed in a state or federal jurisdiction.
5.As used herein, the term “Individual Allocated Amount” refers to the Claimant’s respective settlement participation amount, as described in Section L, “Allocation of Funds to Claimants”, of the Master Settlement Agreement.
Release
6.Claimant, in exchange for good and valuable consideration, does hereby completely release and forever discharge AMS from any and all past, present or future claims arising directly or indirectly out of or in any manner related to the injuries or damages that were or could have been alleged by Claimant/Releasor as related to an AMS Mesh Product2 and/or or its manufacture, design, distribution,
___________________________
2 “AMS Mesh Product”  or “AMS Mesh Products” means those pelvic mesh product(s) manufactured, marketed, sold and distributed by AMS and its affiliates known as:  Apogee® System with IntePro® LiteTM, Apogee® System with InteXen®  LPTM, Perigee® System with IntePro® LiteTM, Perigee® System with InteXen®  LPTM,  Elevate® Apical and Posterior Prolapse Repair System with IntePro® LiteTM, Elevate® Apical and Posterior Prolapse Repair System with InteXen® LP, Elevate® Anterior & Apical Prolapse Repair System with IntePro® LiteTM, Elevate® Anterior & Apical Prolapse Repair System with InteXen® LP, Straight-InTM Sacralcolpopexy System, IntePro® Y-Mesh, InteXen® LP Porcine Dermal Matrix, SPARC® Sling System, Monarc® Subfascial Hammock, BioArc® SP System with InteXen® LP, BioArc® TO System with InteXen® LP, MiniArc® Single-Incision Sling System, MiniArc PreciseTM Single-Incision Sling System, In-Fast Ultra®,  as well as any variations of said AMS Mesh Products, past, present or future.

Exhibit 10.144
CONFIDENTIAL

testing, efficacy, labeling, advertising, regulatory certification and approval, warnings, sale, warranties, promises or condition at any time or times whatsoever,  including, without limitation, injuries, conditions, complications and damages of whatever kind and character, existing in the past, now or arising in the future, whether known or unknown, alleged to be related to the manufacture, distribution, promotion, marketing, testing, labeling, sale, purchase, implant, use, removal, explant, excision, extraction or revision of AMS Mesh Products, including, but not limited to:  mesh erosion; mesh extrusion; mesh rejection; mesh contraction or “shrinkage”; mesh encapsulation; any and all types of infection; fistula formation; inflammation; scar tissue formation; organ perforation or other organ damage; dyspareunia (pain during sexual intercourse); loss of consortium; loss of intimacy or sexual relations, loss of desire for intimacy or sexual relations, and/or inability to engage in sexual activity for any reason; blood loss; vaginal bleeding; neuropathic and other acute and chronic nerve damage and pain, including but not limited to pudendal nerve damage; pelvic floor damage; chronic pelvic pain; de novo urinary and/or fecal incontinence and other de novo urinary and/or intestinal problems; worsening urinary and/or fecal incontinence and other worsening urinary and/or intestinal problems; de novo, continuing, worsening or recurrent pelvic organ prolapse; emotional or mental harm or suffering; loss of enjoyment of life; economic losses, including but not limited to, medical bills and expenses; and/or any other complications, conditions, damages or injuries not heretofore described, existing in the past, now or arising in the future, whether known or unknown, and that he/she will not seek anything further, including any other payment, from AMS in regard to such Claim.  

7.No portion of such settlement amount represents the payment of punitive or exemplary damages but in consideration for the satisfaction of Claimant’s Claim for compensatory damages, Claimant/Releasors release Claims for punitive or exemplary damages as described below.  

8.Claimant/Releasor acknowledges that the undersigned counsel settled his/her case with AMS as part of a combined settlement of Claims against AMS, and acknowledges and understands that other claimants may have received different amounts depending upon the circumstances of each claimant’s case.

9.Claimant/Releasors agree that in exchange for the consideration provided herein, Releasors will dismiss with prejudice any Claims alleged against AMS in any Action.

10.Claimant/Releasor represents that s/he has consented to the jurisdiction of the Court where the action is filed for purpose of establishing the Qualified Settlement Fund described in the Master Settlement Agreement.

11.To the extent that any law, statute, ordinance, rule, regulation, case or other such legal provision or authority may purport to preserve Claimant’s and/or Recipient’s and/or other Releasors’ right hereafter to assert presently existing but unknown, unasserted, unsuspected, or undiscovered causes of

Exhibit 10.144
CONFIDENTIAL

action and/or claims, including without limitation such causes of action and/or which would otherwise be foreclosed by the terms of this Agreement and Release, Claimant/Recipient and other Releasors hereby specifically and expressly waive their rights under such law, statute, ordinance, rule, regulation, case or other such legal provision or authority.  

12.Claimant/Releasors understand and acknowledge the significance and consequence of releasing all of Claimant’s AMS causes of action and/or Claims, including presently existing, but unknown, unasserted, unsuspected, or undiscovered causes of action and/or claims, and hereby assume full risk and responsibility for any and all injuries, losses, damages, assessments, penalties, charges, expenses, costs, and/or liabilities that Claimant and/or other Releasors may hereinafter incur or discover that in any way arise out of or relate to such causes of action and/or claims.  

13.This Release and Confidentiality Agreement specifically EXCLUDES any claims or causes of action that Claimant/Releasors may have, including presently existing, but unknown, unasserted, unsuspected, or undiscovered causes of action and/or claims, related to a pelvic mesh product(s) manufactured, marketed, sold and/or distributed by any other entity other than AMS or its affiliates.

Indemnification, Contribution and Other Third Party Claims
14. Claimant agrees to indemnify and defend AMS against and hold AMS harmless from any and all damages or losses AMS may incur, including attorneys’ fees and costs, in connection with claims, by and through Claimant, alleging:  (i) claims seeking damages for or attributable to the personal injuries of Claimant, or seeking any other damages, indemnity or contribution, including Claimant’s  heirs, next of kin, successors, assigns, agents, representatives, guardians, duly-appointed trustees, executors, estate administrators or personal representatives (or equivalent thereto) or any medical institution, health care provider or other pelvic mesh product manufacturer or distributor asserting a claim by cross-complaint, counterclaim or third party claim or in a separate claim for indemnity or contribution; (ii) liens, subrogated interests, or encumbrances pertaining to Claimant’s claims including, but not limited to, medical expenses, physicians’ expenses, or other health care provider expenses, including any claims asserted by private or government health insurers, including but not limited to Medicare or Medicaid, arising from or based upon the provision of past, present or future medical care and treatment of Claimant; and (iii) any tax liability associated with this Agreement and/or the Confidential Settlement Agreement.

Confidentiality
15.Claimant/Releasors and the undersigned counsel, and every person employed or retained by them who has any knowledge of any term of this Agreement and Release or of any settlement or release referred to herein (the "Restricted Persons"), shall keep STRICTLY CONFIDENTIAL and agree not to disclose to any other party, person or entity the amount of this settlement, any of the terms of this Agreement and Release, the Confidential Settlement Agreement, or the amount received by any Claimant, or the amounts of money offered, demanded or discussed during the course of settlement negotiations (the "Confidential Information").

Exhibit 10.144
CONFIDENTIAL

 
16.Claimant/Releasors and the undersigned counsel shall keep strictly confidential and agree not to publicize, disclose or characterize to any third party, person or entity, at any time, the following information, except as it may otherwise appear in the public domain:  the Memorandum of Understanding, the Master Settlement Agreement and any Addendums or exhibits hereto, and Claimant’s Releases, and any of the terms and conditions of this settlement, the amount of this settlement including the Claimant’s Individual Allocated Amount, the history, background and/or substance of the negotiations, directly or indirectly, leading up to the Memorandum of Understanding and Master Settlement Agreement, or any other information which would assist a third party in receiving or otherwise learning about the Memorandum of Understanding, Master Settlement Agreement, and Claimant’s Releases, and such terms, conditions, amounts, history, background and/or the substance of any negotiations (all which shall be and is “Confidential Information”), except as required by law or an Order of a Court or necessary for any required probate or other Court approval of the Claimant’s claims.  In that event, only the Claimant’s Release and the amount of Claimant’s settlement may be disclosed.  Claimant and his/her attorneys may also make disclosure of the money received by Claimant to their accountants and/or financial advisors who shall, however, upon such disclosure, be instructed to maintain and honor the confidentiality of such information.  If inquiry is made by any third person concerning the status of Claimant’s lawsuit, other than as identified above and as necessary to resolve the liens identified above, Claimant and his/her attorneys shall respond only that the suit has been resolved, and make no further comments.  

17.Claimant/Releasors represent and warrant that any unauthorized disclosure of Confidential Information is a material breach of the settlement, and further that AMS is entitled to compensation from Claimant/Releasors, as well as all other relief as justice so requires, for any injury, loss or detriment suffered as a result of an unauthorized disclosure of Confidential Information by Claimant/Releasors, whether the disclosure was made through Claimant’s/Releasor’s own actions or through the actions of his or her agents, attorneys, representatives, heirs, servants, beneficiaries or family members.

18.No Restricted Person shall offer in evidence or in any civil, criminal, administrative or other action or proceeding, refer to any of the Confidential Information other than as may be necessary to consummate or enforce this Agreement and Release or as may be compelled by legal process.  If the subject of such information should arise in any legal proceedings, other than a proceeding to consummate or enforce this Agreement and Release, the Restricted Persons will, to the extent possible, give AMS reasonable notice practicable in the circumstances and an opportunity to intervene and oppose, file under seal any documents disclosing the information and take all reasonable measures to ensure that it is kept confidential and that any disclosure thereof takes place in camera.  

19.No Restricted Person will rely on or attempt to rely on this Agreement and Release or the Master Settlement Agreement, or any portion of the contents thereof, or any amount provided herein, or any amount received by any claimant and/or recipient, in any proceeding other than a proceeding to consummate or enforce this Agreement and Release.  No Restricted Person will attempt to lift, or to cause any court or other body to lift, the confidentiality provisions of this Agreement and Release for any purpose.

Exhibit 10.144
CONFIDENTIAL

Effect Of Breach Of Confidentiality
20.In the event of any such breach by Claimant/Releasors or his/her attorneys, AMS shall be entitled to equitable relief from the breaching party by way of a temporary restraining order, preliminary injunction and permanent injunction, as appropriate, and such further and other relief as any court of competent jurisdiction may deem proper, including any damages that are proximately caused by a breach thereof.  

21.In the event of any such breach by Claimant/Releasors or his/her attorneys, AMS shall be entitled to recover liquidated damages from the breaching party of ten percent (10%) of the amount of the Claimant’s disbursement of the good and valuable consideration identified in the “Release” section.  All parties agree that said percentage is reasonable in light of the likely difficulty and impracticability of ascertaining actual damages upon such a breach.  All parties further agree that if said percentage should be determined to be a penalty or otherwise unenforceable or not collectible for any reason, AMS shall be entitled to recover such lesser amount as the court may determine to be the greatest amount of liquidated damages permitted by law.  

22.Claimant/Releasors are bound by this Agreement and Release.  Anyone who succeeds to the rights and responsibilities of any Releasor, including any and all representatives, agents, successors, assigns, beneficiaries, heirs, or executors of any of them or their estates, is also bound.  This Agreement and Release is made for the benefit of Claimant, other Releasors, and AMS.
Governmental Liens
23.Claimant/Releasors and the undersigned counsel represent and affirm that any and all medical liens and/or claims from medical expenses, past, present and/or future incurred by Medicare or Medicaid, which were incurred as a result of a Claimant’s AMS injuries, will be resolved by holdback, payment or otherwise in accordance with LRA established provisions for each Claimant prior to the distribution of any of the Individual Allocated Amount that has been deposited into the Qualified Settlement Fund as described in the Confidential Master Settlement Agreement.  Claimant agrees to cooperate with counsel to satisfy any such liens and/or claims and to provide proof of such satisfaction to AMS, as set forth in the Confidential Master Settlement Agreement.

24.In further consideration of the foregoing, Claimant agrees and covenants to forever defend, indemnify and hold harmless AMS from any reimbursement claims that Medicare, any other government program or any other government entity, federal or state or local, may have as to Claimant.  
Medicare
25.Representations and Warranties.  Claimant/Releasors, Claimants Counsel and AMS agree that all Representations and Warranties made herein shall survive settlement.
		
	a.
	Medicare Secondary Payer.  Claimant/Releasors and Claimants Counsel acknowledge and agree that the Parties hereto have taken or will take reasonable steps to comply with the requirements of 42 U.S.C. §1395y and the related rules and regulations (hereinafter 

Exhibit 10.144
CONFIDENTIAL

collectively “MSP”).  
		
	b.
	MSP applicability.

		
	i.
	Claimant/Releasors and Claimants Counsel are aware of Medicare’s potential interest in this settlement to the extent Medicare has made any conditional payments for medical services or items received by Claimant pursuant to MSP, and related to Claims or AMS Mesh Product Injuries;

		
	ii.
	Claimant/Releasors and Claimants Counsel represent and warrant that they have provided the information to AMS necessary to comply with the reporting of this settlement to Medicare;

		
	c.
	Claimant/Releasors’ responsibility for reimbursement of Medicare claims.

		
	i.
	Claimant/Releasors and Claimants Counsel represent and warrant that they or their agent have notified, or prior to distributing any settlement funds will notify Medicare of the claim giving rise to this settlement.

		
	ii.
	Claimant/Releasors and Claimants Counsel represent and warrant that in exchange for payment of the Individual Allocated Amount by AMS to Claimants Counsel, they shall reimburse Medicare for any claims related to this settlement and/or arising from or related to the matters forming the basis of the claims asserted by Claimant/Releasors up to the amount of the consideration paid for the settlement.  Claimant/Releasors and Claimants Counsel represent and warrant that it is their responsibility, and not AMS’ responsibility, to reimburse Medicare.

		
	iii.
	Claimant/Releasors and Claimants Counsel represent and warrant that in exchange for payment of the Individual Allocated Amount by AMS, Claimant’s Counsel shall hold funds in an escrow account or client trust account equal to the total medical costs related to the AMS Mesh Product Injury up to the amount of consideration paid until a conditional payment letter or other documentation is received from Medicare identifying a lien, if any, at which time funds in excess of the amount provided in the conditional payment letter, if any, may be released. The funds remaining in trust (“Held Settlement Funds”) will not be distributed to Claimant/Releasors or any other person or entity aside from Medicare until the Medicare claims, if any, arising from or related to this settlement have been satisfied, waived or otherwise resolved.  Claimant/Releasors and Claimants Counsel will provide AMS any and all written documentation from Medicare, if any, proving waiver or satisfaction and release of Medicare Claims, if any, arising from or related to matters forming the basis of Claimant’s claim.

26.Reliance on Representations and Warranties.  In agreeing to the Release and funding the settlement, AMS is relying on the representations and warranties of Claimant/Releasors and Claimant’s Counsel regarding Claimant’s Medicare status and the actions Claimant/Releasors and Claimant’s Counsel have represented they have taken and/or will take to satisfy any and all Medicare claims pertaining to the matters forming the basis of Claimant’s claims.

Exhibit 10.144
CONFIDENTIAL

Governing Law
27.Claimant/Releasors understand and agree that this Agreement and Release will be governed by and construed under the laws of Delaware, irrespective of choice of law principles.

No Admissions of Fault
28.Claimant/Releasors acknowledge that neither this Agreement and Release nor the payment of the Settlement Amount shall constitute any admission of liability or fault of any kind on the part of the AMS, who expressly deny any liability to Claimant or other Releasors.  This Agreement and Release is entered into to avoid the uncertainty and expense of litigation.  This Agreement and Release shall not be admissible in evidence in any proceeding except in an action arising out of or in connection with this Agreement and Release.

29.No portion of such settlement represents the payment of punitive or exemplary damages but in consideration for the satisfaction of Claimant’s/Recipient’s claim for compensatory damages Claimant releases claims for punitive or exemplary damages.

30.Costs and attorney’s fees will be borne by the party incurring same. 
Warranty of Capacity to Execute Agreement
31.Claimant hereby represents that he/she is authorized under applicable law to represent and bind all other relevant parties who are not signatories to this Agreement and Release and by signing this Agreement and Release does so bind.
Return of Confidential and Privileged Information
32.Claimant and Claimants Counsel will comply with the terms of any Protective Order and/or Confidentiality Order applicable in the Claimant’s case.  Further, to the extent not otherwise governed by an existing Protective Order and/or Confidentiality Order, Claimant and Claimants Counsel will return all originals and all copies of documents that contain information provided by AMS in any Civil Action involving pelvic mesh products that were in their respective possession, custody or control at the time of the Effective Date.  This includes but is not limited to all documents (copies, originals, electronic files) that AMS produced during discovery in connection with any such Civil Action, and the deposition transcripts and exhibits of AMS company witnesses and/or past or current AMS employees and expert witnesses.  Claimant and Claimants Counsel shall permanently delete and destroy all such information in their possession that is electronically stored.  By executing this Release, Claimant and Claimants Counsel certify that they have complied fully with the terms of this Paragraph.
Acknowledgements
33.CLAIMANT/RELEASORS DECLARE AND ACKNOWLEDGE THAT THEY HAVE READ AND UNDERSTAND THE TERMS OF THIS AGREEMENT, THAT THEY HAVE BEEN REPRESENTED BY ATTORNEYS WITH REGARD TO THE EXECUTION OF THIS AGREEMENT, AND THAT THEY EXECUTE THIS AGREEMENT VOLUNTARILY AFTER 

Exhibit 10.144
CONFIDENTIAL

CONSULTATION WITH THEIR ATTORNEYS AND WITHOUT BEING PRESSURED OR INFLUENCED BY ANY STATEMENT OR REPRESENTATION MADE BY ANY PERSON ACTING ON BEHALF OF AMS AND/OR THE RELEASED PARTIES.  CLAIMANTS FURTHER DECLARE AND ACKNOWLEDGE THAT THEY FULLY UNDERSTAND THE NATURE AND VALUE OF THE CONSIDERATION, AND AGREE TO ACCEPT THAT AMOUNT FOR THE RELEASES GRANTED HEREIN.
Signatures
Claimant:
I, ____________________, the undersigned, have read the foregoing RELEASE AND CONFIDENTIALITY AGREEMENT; I have had an opportunity to confer with my attorney concerning its terms, conditions and effects; and I fully understand the terms, conditions and effects of this agreement.

DATED: ____________________, 2013.    

                                                            
Claimant Signature 

Witness:
I declare under penalty of perjury that, on the date indicated above, Claimant 
__________________________, who I know and recognize, came before me and I witnessed him/her personally signing this document.

DATED: ____________________, 2013.    

		
	                                                     
	    __________________            

Witness Signature                     Witness Print Name    
Spouse/Releasor:
The following Releasor agrees that, if not represented by the undersigned counsel, that they have had the opportunity to consult with independent counsel prior to signing this RELEASE AND CONFIDENTIALITY AGREEMENT; that they fully understand its terms and conditions, as well as the consequences of signing it; and that they agree to be bound by all of its terms.  Sworn to and signed under penalty of perjury.
DATED: ____________________, 2013.    

                                                                    
Spouse/Releasor Signature 
Witness:

Exhibit 10.144
CONFIDENTIAL

I declare under penalty of perjury that, on the date indicated above, ________________________  (Spouse/Releasor), who I know and recognize, came before me and I witnessed him/her personally signing this document.

DATED: ____________________, 2013.    

		
	                                                     
	    ___________________________        

Witness Signature                     Witness Print Name

Claimant’s Attorney:
I, _________________, one of the attorneys  for the above-signed Claimant, declare that I have reviewed the foregoing Release and Confidentiality Agreement, and approved the execution of this document by the above-signed Claimant, and agree to the confidentiality agreement provisions contained therein.

DATED: ____________________, 2013.                                                        

_____________________________
Attorney for Claimantexh10_1.htm

 

Ex. 10.1  LICENSE AGREEMENT

 

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 under Section 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 Section 9 (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 Section 9 (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 Section 11.5 (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

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