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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).

 
 
 
 

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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.

 
 
 
 

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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.

 
 
 
 

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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).

 
 
 
 

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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).

 
 
 
 

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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.

 
 
 
 

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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.

 
 
 
 

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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.

 
 
 
 

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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).

 
 
 
 

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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.

 
 
 

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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.

 
 
 
 

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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:

 
 
 
 

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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.

 
 
 
 

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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.

 
 
 
 

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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).

 
 
 
 

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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.

 
 
 
 

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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).

 
 
 
 

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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.

 
 
 
 

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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.

 
 
 
 

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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).

 
 
 
 
 
 
 
 

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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

 
 
 
 

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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.

 
 
 
 

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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;

 
 
 
 

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(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;

 
 
 
 

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(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.
 
 
 

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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

 
 
 
 

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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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