LICENSE AGREEMENT
Exhibit
10.35
This
License Agreement (this “Agreement”) dated as of
February 14, 2019 (the “Effective Date”), by and
between Augusta University Research Institute, Inc., having an
office at 0000 00xx Xxxxxx, Xxxxxxx, Xxxxxxx 00000
(“AURI”) and Cellular Biomedicine Group HK
Ltd., a Hong Kong corporation, and its Affiliates, as defined
herein, with its principal place of business at Xxxx 000, 0xx
Xxxxx, Xxxxxxxx House, No. 0 Xxxxxx Xxxx Xxxxx, Xxxxxxxxx, Xxxx
Xxxx ("XXXX"). AURI and CBMG are sometimes referred to herein
individually as a “Party” and collectively as the
“Parties”.
1 BACKGROUND
WHEREAS, AURI is
the assignee of invention " Human Alpha Fetoprotein-Specific T
Cell Receptors and Uses Thereof" invented in the laboratory of
Augusta University faculty, Dr. Yukai He, and described in in US
patent application #15/969,211 and PCT patent application
#PCT/US2018/030637; and
WHEREAS, CBMG
desires to obtain, and AURI is willing to grant, an exclusive
license in the Field (as defined below) under AURI’s rights
in the Licensed Patent Rights (as defined below) to develop and
commercialize according to the terms and conditions of this
Agreement.
NOW,
THEREFORE, in consideration of the foregoing premises and the
mutual covenants herein contained, the Parties hereby agree as
follows:
2 DEFINITIONS
For
purposes of this Agreement, the terms defined in this Section shall
have the respective meanings set forth below:
2.1
“Affiliate” shall mean, with respect to any Person, any
other Person which directly or indirectly controls, is controlled
by, or is under common control with, such Person. A Person shall be
regarded as in control of another Person if it directly or
indirectly possesses the power to direct or cause the direction of
the management and policies of the other Person by any means
whatsoever.
2.2
“Commercially Reasonable Efforts” means, with respect
to the efforts to be expended to research, develop, and
commercialize the Licensed Product in the Field in at least one
country in a Major Market, such efforts materially consistent with
the efforts and resources normally used by a prudent company in the
biopharmaceutical industry of a size comparable to CBMG, with
respect to a biopharmaceutical product for which the same
regulatory approval is held as the Licensed Product, which
biopharmaceutical product is owned or licensed in the same manner
as the Licensed Product, which biopharmaceutical product is at a
similar stage in its product life and of similar market and profit
potential as the Licensed Product, taking into account intellectual
property protection, efficacy, safety, approved labeling, the
competitiveness of the market, the proprietary position of the
biopharmaceutical product, the regulatory requirements involved,
pricing / reimbursement for the biopharmaceutical product, the
profitability of the biopharmaceutical product, and other relevant
factors, all as measured by the facts and circumstances in
existence at the time such efforts are due.
2.3
“Field” shall mean all commercial research,
development, fields, applications, and uses.
2.4
“First Commercial Sale” shall mean, with respect to any
Licensed Product, the earliest date of sale of a Licensed Product
by CBMG, its Affiliates or any of its Sublicensees. Any first sale
of a Licensed Product shall only qualify as a First Commercial Sale
if the Licensed Product has been approved for commercialization in
the applicable jurisdiction. The transfer of Licensed Products by
CBMG, its Affiliates or its Sublicensees strictly for internal
purposes, testing, expanded access programs or compassionate use
does not constitute a First Commercial Sale.
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2.5
“Licensed Patent Rights” shall mean (a) US patent
application #15/969,211 and PCT patent application
#PCT/US2018/030637, all patent applications generated thereon, and
all foreign counterparts thereto; (b) all patents that have
issued or in the future shall issue therefrom, including utility,
model and design patents and certificates of invention; and
(c) all divisionals, continuations, continuations-in-part,
reissues, renewals, reexaminations, extensions or additions to any
such patent applications and patents.
2.6
“Licensed Product” shall mean a product in the Field,
which, if made, used, offered for sale, sold or imported in any
country, would infringe a Valid Patent Claim in such country, but
for the license granted by this Agreement.
2.7
“Major Market” shall mean the United States of America,
the European Union, the Middle East, the United Kingdom, Canada,
Australia, Japan, South Korea, China, Taiwan, and
India.
2.8
“Net Sales” shall mean the gross amount billed by CBMG
and its Affiliates and Sublicensees for the sale of Licensed
Products to a third party, less the following:
(a)
customary trade, quantity, prompt payment or cash rebates or other
discounts, incentives or adjustments to the extent actually allowed
and taken;
(b)
amounts repaid or credited by reason of rejection, claim, refund,
allowance, damaged goods, retroactive price reduction, trade, or
return;
(c) to
the extent separately stated on purchase orders, invoices, or other
documents of sale, any taxes or other governmental charges levied
on the production, sale, transportation, delivery, or use of a
Licensed Product which is paid by or on behalf of CBMG;
and
(d)
outbound transportation, postage, shipping, packing, storage, and
delivery costs, and costs of insurance in transit;
(e)
non-affiliated brokers’ or agents’ commissions actually
allowed;
(f)
rebates and chargebacks provided to managed health care
organizations, international organizations or federal, state, local
or other governments, including, in the United States, Medicare and
Medicaid; and
(g)
actual uncollectable accounts receivables determined in accordance
with GAAP, consistently applied.
No
deductions shall be made for commissions paid to individuals who
are regularly employed by CBMG and on its payroll, or for cost of
collections. Net Sales shall occur on the date of billing for a
Licensed Product. If a Licensed Product is distributed at a
discounted price that is substantially lower than the customary
price charged by CBMG, or distributed for non-cash consideration
(whether or not at a discount), Net Sales shall be calculated based
on the non-discounted (other than discounts allowed pursuant to
clause (a) above) amount of the Licensed Product charged to an
independent third party during the same Reporting Period in the
same country or, in the absence of such sales, on the fair market
value of the Licensed Product.
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If
CBMG, any Affiliate, or any Sublicensee sells any Licensed Products
with any other goods or services, Net Sales will be calculated
based on the fair market value of the Licensed
Product.
2.9
“Person” shall mean an individual, corporation,
partnership, limited liability company, trust, business trust,
association, joint stock company, joint venture, pool, syndicate,
sole proprietorship, unincorporated organization, governmental
authority or any other form of entity not specifically listed
herein.
2.10
“Royalty Term” shall mean, with respect to each
Licensed Product in each country, the term for which a Valid Patent
Claim in such country remains in effect and would, if in an issued
patent, be infringed by the manufacture, use, offer for sale, sale
or import of such Licensed Product in such country but for the
license granted by this Agreement.
2.11
“Third Party” shall mean any Person other than AURI,
CBMG and their respective Affiliates.
2.12
“Valid Patent Claim” shall mean either (a) a claim
of an issued and unexpired patent included within the Licensed
Patent Rights, which has not been canceled, abandoned, held
permanently revoked, unenforceable or invalid by a decision of a
court or other governmental agency of competent jurisdiction,
unappealable or unappealed within the time allowed for appeal, and
which has not been admitted to be invalid or unenforceable through
reissue or disclaimer or otherwise or (b) a claim of a pending
patent application included within the Licensed Patent Rights,
which claim was filed in good faith and has not been abandoned or
finally disallowed without the possibility of appeal or refiling of
such application, and which claim has not been pending for more
than eight (8) years from the earliest claimed priority
date.
3 REPRESENTATIONS AND WARRANTIES
AURI
hereby represents and warrants to CBMG as follows:
3.1
AURI (a) is a 501 (c) (3) not-for-profit duly organized,
validly existing and in good standing under the laws of the State
of Georgia; (b) has the corporate power and authority and the
legal right to own and operate its property and assets, to lease
the property and assets it operates under lease, and to carry on
its business as it is now being conducted and (c) is in
compliance with all requirements of applicable law, except to the
extent that any noncompliance would not have a material adverse
effect on the properties, business, financial or other condition of
it and would not materially adversely affect its ability to perform
its obligations under this Agreement.
3.2
AURI (a) has the corporate power and authority and the legal
right to enter into this Agreement and to perform its obligations
hereunder and (b) has taken all necessary corporate action on
its part to authorize the execution and delivery of this Agreement
and the performance of its obligations hereunder. This Agreement
has been duly executed and delivered on behalf of AURI, and
constitutes a legal, valid, binding obligation, enforceable against
AURI in accordance with its terms.
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3.3 All
necessary consents, approvals and authorizations of all
governmental authorities and other Persons required to be obtained
by AURI in connection with this Agreement have been
obtained.
3.4
AURI is the legal and beneficial owner of all right, title and
interest in and to the Licensed Patent Rights, having good title
thereto, free and clear of any and all mortgages, liens, security
interest and charges, and no Person has or shall have any claim of
ownership with respect to the Licensed Patent Rights. Except as
otherwise set forth in this Agreement, AURI has not sold, assigned,
conveyed, mortgaged, encumbered, transferred or granted any license
or other right under the Licensed Patent Rights to any Person to
develop, make, have made, use and sell Licensed Products for use in
the Field.
3.5 To
the best of AURI’s knowledge, neither the use of the Licensed
Patent Rights nor the granting of this license to practice under
the Licensed Patent Rights violates, infringes or otherwise
conflicts or interferes with any patent or any other intellectual
property or proprietary right of any Third Party. To the best of
AURI’s knowledge, no Third Party is currently infringing upon
the Licensed Patent Rights.
CBMG
hereby represents and warrants to AURI as follows:
3.6
CBMG (a) has the corporate power and authority and the legal
right to enter into this Agreement and to perform its obligations
hereunder and (b) has taken all necessary corporate action on
its part to authorize the execution and delivery of this Agreement
and the performance of its obligations hereunder. This Agreement
has been duly executed and delivered on behalf of CBMG, and
constitutes a legal, valid, binding obligation, enforceable against
CBMG in accordance with its terms.
3.7
CBMG (a) is a corporation duly organized, validly existing and
in good standing under the laws of Hong Kong; (b) has the
corporate power and authority and the legal right to own and
operate its property and assets, to lease the property and assets
it operates under lease, and to carry on its business as it is now
being conducted and (c) is in compliance with all requirements
of applicable law, except to the extent that any noncompliance
would not have a material adverse effect on the properties,
business, financial or other condition of it and would not
materially adversely affect its ability to perform its obligations
under this Agreement.
3.9 All
necessary consents, approvals and authorizations of all
governmental authorities and other Persons required to be obtained
by CBMG in connection with this Agreement have been
obtained.
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4 LICENSE GRANT
4.1
AURI hereby grants to CBMG and its Affiliates an exclusive
worldwide license (with the right to grant sublicenses) under the
Licensed Patent Rights to make, have made, use, research, develop,
have used, sell, have sold, offer for sale and import Licensed
Products in the Field.
4.2
CBMG shall deliver to AURI a copy of each sublicense, with
appropriate redactions as determined solely by CBMG, under this
Agreement promptly after execution of the same. Each sublicense
shall be subject to the terms and conditions of this Agreement.
Sublicense agreements shall automatically terminate upon
termination of this license. Any Third Party to which CBMG or its
Affiliates granted a sublicense under the Licensed Patent Rights
(each, a “Sublicensee”) not then in default shall have
the right to seek a license from AURI. AURI agrees to negotiate
such licenses in good faith under reasonable terms and
conditions.
4.3 It
is expressly agreed that, notwithstanding any provisions herein,
AURI and Augusta University retains the right on behalf of itself
and all other non-profit research institutions to practice under
the Licensed Patent Rights for non-commercial research, teaching,
and educational purposes. Should AURI or Augusta University grant
any Licensed Patent Rights to a Third Party for non-commercial
research, teaching, and educational purposes, AURI shall promptly
notify CBMG. Furthermore, AURI and Augusta University shall be free
to publish data from Licensed Patent Rights, as they see fit,
provided such data does not include CBMG Confidential Information
(defined in Section 9.1). AURI and Augusta University shall
disclose any publication materials related to the Licensed Patent
Rights to CBMG prior to publication so that CBMG will have at least
thirty (30) days prior to publication to review and provide
comments and/or to request edits regarding intellectual property.
Further, upon CBMG’s reasonable request, AURI and Augusta
University will delay publication for no more than 45 additional
days to permit patent filing on such intellectual property. CBMG
acknowledges that the U.S. federal government retains a
royalty-free, non-exclusive, non-transferable license to practice
any government-funded invention claimed in any Licensed Patent
Rights as set forth in 35 U.S.C. §§ 201-211, and the
regulations promulgated thereunder, as amended, or any successor
statutes or regulations.
5 ROYALTIES, LICENSE FEES
5.1 In
consideration for the license granted hereunder, within thirty (30)
days of execution of this Agreement, CBMG shall pay to AURI a
one-time, non-refundable, non-creditable license fee in an amount
equal to [***].
5.2 In
consideration for the license granted hereunder, until the end of
the Royalty Term or earlier termination thereof, CBMG shall pay to
AURI running royalties on Net Sales of Licensed Products by CBMG,
its Affiliates and Sublicensees as follows:
a.
[***] beginning on the Effective Date;
b.
Royalties shall be due and payable on a quarterly basis and shall
be submitted by CBMG along with the report as specified in Section
6.1 below.
5.3 If
CBMG is required to take a license under any Third Party patents to
use the Licensed Patent Rights, then [***].
5.4 For
any non-royalty consideration that is comprised of either monetary
instruments or quantifiable in-kind remuneration received by CBMG
by sublicense agreement from Sublicensees, [***].
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6 ROYALTY REPORTS AND ACCOUNTING
6.1
During the term of this Agreement following the First Commercial
Sale of a Licensed Product, CBMG shall furnish to AURI a quarterly
written report showing in reasonably specific detail, on a country
by country basis, (a) the Net Sales of each Licensed Product
sold by CBMG, its Affiliates and its Sublicensees during the
reporting period; (b) the royalties payable in United States
dollars, if any, which shall have accrued hereunder based upon Net
Sales of each Licensed Product; (c) the withholding taxes, if
any, required by law to be deducted in respect of such sales;
(d) the date of the First Commercial Sales of each Licensed
Product in each country during the reporting period; and
(e) the exchange rates used in determining the amount of
United States dollars.
With
respect to sales of Licensed Products invoiced in United States
dollars, Net Sales and royalties payable shall be expressed in
United States dollars. With respect to sales of Licensed Products
invoiced in a currency other than United States dollars, Net Sales
and royalties payable shall be expressed in the domestic currency
of the Person making the sale together with the United States
dollar equivalent of the royalty payable, calculated using the
average closing buying rate for such currency quoted in the
continental terms method of quoting exchange rates (local currency
per US$1) by the Wall Street Journal on the last business day of
each month in the calendar quarter prior to the date of
payment.
CBMG
may withhold taxes on the amounts otherwise payable to AURI
under this agreement as required by applicable
law. The Parties agree to cooperate in good faith to reduce or
eliminate the amount of any such withholding taxes under the
provisions of applicable law, including the provisions of any
applicable income tax treaty. As may be
required under applicable law in order to reduce or eliminate
the amount of any withholding tax, AURI shall be entitled to timely
provide to CBMG a duly and properly executed certificate of
exemption from withholding tax or certificate of reduced
withholding tax, or such other forms as may be required under
applicable law to reduce or eliminate the amount of withholding
tax, and CBMG shall withhold taxes in accordance with such
duly and properly executed certificate or forms. CBMG shall remit
any withheld taxes to the relevant authorities on behalf
of AURI and upon request of AURI, CBMG shall provide to AURI
appropriate evidence of the payment to the relevant authorities of
the amounts withheld and remitted to the relevant authorities on
behalf of AURI.
Reports
shall be due on the sixtieth (60th) day following the close of each
reporting period. CBMG shall keep complete and accurate records in
sufficient detail to properly reflect Net Sales and to enable the
royalties payable hereunder to be determined.
6.2
Upon the written request of AURI and not more than once in each
calendar year, CBMG shall permit an independent certified public
accounting firm of nationally recognized standing, selected by AURI
and reasonably acceptable to CBMG, at AURI’s expense, to have
access during normal business hours to such of the records of CBMG
as may be reasonably necessary to verify the accuracy of the
royalty reports hereunder for any year ending not more than
thirty-six (36) months prior to the date of such request. The
accounting firm shall disclose to AURI only whether the records are
correct or not and the details concerning any specific
discrepancies. No other information shall be shared.
If such
accounting firm concludes that additional royalties were owed
during such period, CBMG shall pay the additional royalties within
thirty (30) days of the date AURI delivers to CBMG such accounting
firm’s written report documenting the royalty underpayment.
The fees charged by such accounting firm shall be paid by AURI;
provided, however, if the audit discloses that the royalties
payable by CBMG for the audited period are more than [***] of the
royalties actually paid for such period, and the difference between
royalties payable and royalties paid is greater than [***], then
CBMG shall pay the reasonable fees and expenses charged by such
accounting firm.
6.3
CBMG shall include in each sublicense granted by it pursuant to
this Agreement a provision requiring the Sublicensee to make
reports to CBMG, to keep and maintain records of sales made
pursuant to such sublicense and to grant AURI’s independent
accountant access to such records to the same extent required of
CBMG under this Agreement.
6.4
AURI shall treat all financial information subject to review under
this Section 6 or under any sublicense agreement as
Confidential Information pursuant to Section 9 below, and shall
cause its accounting firm to retain all such financial information
in confidence.
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7 PAYMENTS
7.1
Royalties shown to have accrued in the quarter covered by each
royalty report provided for under Section 6 of this Agreement
shall be due and payable on the date such royalty report is due.
Payment of royalties in whole or in part may be made in advance of
such due date.
7.2 All
payments by CBMG to AURI under this Agreement shall be paid in
United States dollars, and all such payments shall be made by bank
wire transfer in immediately available funds to such account as
AURI shall designate before such payment is due. CBMG shall be
responsible for any foreign transaction fees.
7.3 If
at any time legal restrictions prevent the prompt remittance of
part or all royalties with respect to any country where the
Licensed Product is sold, payment shall be made through such lawful
means or methods as AURI reasonably shall determine.
8 RESEARCH AND DEVELOPMENT OBLIGATIONS
8.1
CBMG (a) shall use its Commercially Reasonable Efforts to
develop and conduct such research, development and validation
studies as necessary or desirable to obtain all regulatory
approvals to manufacture and market such Licensed Products in the
Field in at least one country in a Major Market, and (b) upon
receipt of such approvals, to use Commercially Reasonable Efforts
to market, each such Licensed Product in the Field in such country.
CBMG, at its sole expense, shall fund the costs of all research,
development, preclinical and clinical trials, regulatory approval
and commercialization of the Licensed Products.
8.2
CBMG shall maintain records, in sufficient detail and in good
scientific manner appropriate for patent purposes, which shall
reflect all work done and results achieved in the performance of
its research and development regarding the Licensed Patent Rights
and the Licensed Products (including all data in the form required
under all applicable laws and regulations).
8.3
Within ninety (90) days following the end of each calendar year
during the term of this Agreement, CBMG shall prepare and deliver
to AURI a written report which shall describe, in reasonably
sufficient detail, (a) the research performed to date employing the
Licensed Patent Rights, (b) the progress of the development,
and testing of Licensed Products, and (c) the status of obtaining
the necessary approvals to market Licensed Products. In addition,
CBMG shall provide AURI with written notice of all material
regulatory filings and submissions prior to the date of such
submissions, and written notice of all approvals obtained promptly
after obtaining such approvals.
9 CONFIDENTIALITY
9.1
During the term of this Agreement, and for a period of three (3)
years following the expiration or earlier termination hereof, each
Party shall maintain in confidence all written information and data
provided by one Party to the other hereunder and marked
“Confidential” or, if information disclosed orally,
visually or in some other form, which is summarized in writing, is
confirmed in writing as “Confidential” to the other
Party within thirty (30) days of such disclosure, or, if not marked
“Confidential or summarized in writing as
“Confidential,” any information exchanged between the
Parties under this Agreement that should reasonably be regarded as
“Confidential” (collectively, the “Confidential
Information”), and shall not use, disclose or grant the use
of the Confidential Information except on a need-to-know basis to
those directors, officers, employees, agents, sublicensees and
permitted assignees, to the extent such disclosure is reasonably
necessary in connection with such Party’s activities as
expressly authorized by this Agreement. To the extent that
disclosure is authorized by this Agreement, prior to disclosure,
each Party hereto shall obtain agreement of any such Person to hold
in confidence and not make use of the Confidential Information for
any purpose other than those permitted by this
Agreement.
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9.2 The
confidentiality obligations contained in Section 9.1 of this
Agreement shall not apply to the extent that (a) (i) any
receiving Party (the “Recipient”) is required to
disclose information by law, order or regulation of a governmental
agency or a court of competent jurisdiction, provided that the
Recipient shall provide written notice thereof to the other Party
and sufficient opportunity to object to any such disclosure or to
request confidential treatment thereof at such other Party’s
sole expense, or (ii) to the extent CBMG is required to disclose
information to any governmental agency for purposes of obtaining
approval to test or market a product or to show to a potential
Sublicensee or contractor subject to appropriate confidentiality
agreement; or (b) the Recipient can demonstrate that
(i) the disclosed information was public knowledge at the time
of such disclosure to the Recipient, or thereafter became public
knowledge, other than as a result of actions of the Recipient in
violation hereof; (ii) the disclosed information was
rightfully known by the Recipient (as shown by its written records)
prior to the date of disclosure to the Recipient by the other Party
hereunder; or (iii) the disclosed information was disclosed to
the Recipient on an unrestricted basis from a source unrelated to
any Party to this Agreement and not under a duty of confidentiality
to the other Party.
9.3
Each Party hereby acknowledges and agrees that, in the event of any
breach or threatened breach of this Agreement by the Recipient, the
disclosing Party may suffer irreparable injury for which damages at
law may not be an adequate remedy. Accordingly, without prejudice
to any other rights and remedies otherwise available to the
disclosing Party, the disclosing Party shall be entitled to seek
equitable relief, including injunctive relief and specific
performance, for any breach or threatened breach of this Agreement
by the Recipient, its Affiliates, or any of its or their employees,
directors, officers, members, agents, or
representatives.
9.4
Neither Party shall make any public announcement, issue any press
release or publish any study (collectively, all such
communications, “Publication”) concerning the
transactions contemplated herein, or make any Publication which
includes the name of the other Party or any of its Affiliates, or
otherwise use the name or names of the other Party or any of their
employees or any adaptation, abbreviation or derivative of any of
them, whether oral or written, related to the terms, conditions or
subject matter of this Agreement, without the prior written
permission of such other Party, except as needed for the United
States Securities and Exchange Commission or the Nasdaq Global
Market or as may be required by law, regulation or judicial order.
Consistent with the foregoing, each party may state that CBMG
licensed from AURI and Augusta University the Licensed Patent
Rights, and describe the type and extent of the
License.
10 PATENTS
10.1
CBMG shall be responsible for paying past patent costs not to
exceed [***]. During the term of this Agreement, CBMG shall be
responsible for and shall have the right to advise the preparation,
filing, prosecution and maintenance of the Licensed Patent Rights,
and shall be responsible for paying all reasonable out-of-pocket
costs thereof. AURI shall cooperate with CBMG, execute all lawful
papers and instruments and make all rightful oaths and declarations
as may be necessary in the preparation, prosecution and maintenance
of all patents and other filings referred to in this Section
10.1.
10.2 If
CBMG decides not to continue prosecution of a patent application to
issuance or maintain any United States or foreign patent
application or patent on technology within the Licensed Patent
Rights, CBMG shall timely notify AURI in writing, and such patent
shall be excluded from the definition of Licensed Patent Rights
upon AURI assuming such costs.
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10.3 If
CBMG or AURI has actual notice of infringement of the Licensed
Patent Rights, the Parties shall confer to determine in good faith
an appropriate course of action to enforce the Licensed Patent
Rights or otherwise xxxxx the infringement thereof, to take (or
refrain from taking) appropriate action to enforce Licensed Patent
Rights, to control any litigation or other enforcement action and
to enter into, or permit, the settlement of any such litigation or
other enforcement action with respect to Licensed Patent Rights.
Such right shall include the right to recover any damages awarded
in consequence of any actual or alleged infringement of the
Licensed Patent Rights, which, after recuperation of all expenses
and costs, shall be treated as Net Sales hereunder. AURI shall join
any litigation or other enforcement action to the extent required
by a court in order for CBMG to exercise the rights granted by this
Section 10.3.
If CBMG
does not file suit to enforce the Licensed Patent Rights against at
least one (1) infringing party, AURI shall have the right at its
sole expense to take (or refrain from taking) appropriate action to
enforce the Licensed Patent Rights, to initiate and control any
litigation or other enforcement action and to enter into, or
permit, the settlement of any such litigation or other enforcement
action regarding the Licensed Patent Rights, and shall consider, in
good faith, the interests of CBMG in so doing. CBMG shall reimburse
AURI for any applicable out of pocket expenses and
costs.
To
AURI’s actual knowledge, neither the use of the Licensed
Patent Rights nor the granting of this license to practice under
the Licensed Patent Rights violates, infringes or otherwise
conflicts or interferes with any patent or any other intellectual
property or proprietary right of any Third Party. To
AURI’s actual knowledge, no Third Party is currently
infringing upon the Licensed Patent Rights in the
Field.
11 TERMINATION
11.1
Subject to the provisions of Sections 11.2 and 11.3 of this
Agreement, this Agreement shall expire on the termination of
CBMG’s obligation to pay royalties to AURI under Section 5 of
this Agreement. Upon expiration of the Royalty Term, the license
granted to CBMG in Section 4.1 shall survive such expiration of
this Agreement, and shall be converted to a perpetual, fully paid
up license.
11.2
CBMG may terminate this Agreement, in its sole discretion, upon
thirty (30) days prior written notice to AURI.
11.3
Except as otherwise provided in Section 13 of this Agreement,
a Party may terminate this Agreement upon or after the breach of
any material provision of this Agreement by the other Party if the
other Party has not cured such breach within forty five (45) days
after notice thereof by the non-breaching Party.
11.4
Expiration or termination of this Agreement shall not relieve the
Parties of any obligation accruing prior to such expiration or
termination, and the provisions of Sections 9, 10, 12, 14 and
15 shall survive the expiration or termination of this
Agreement.
12 INDEMNIFICATION AND INSURANCE
12.1
CBMG shall indemnify and hold AURI, the Board of Regents of the
University System of Georgia on behalf of Augusta University, and
both of their respective employees, officers, board members and
agents (hereinafter “Indemnitees”) harmless from all
losses, liabilities, damages and expenses (including reasonable
attorneys’ fees and costs) incurred by AURI as a result of
any Third Party claim, demand, action or other proceeding arising
directly out of the manufacture, use or sale of any Licensed
Product by CBMG, its Affiliates or Sublicensees, or their
respective distributors, customers or end-users. AURI will be
liable for its own acts and omissions to the extent permitted by
law.
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12.2
CBMG shall maintain liability insurance, or self-insurance,
including product liability insurance with respect to the research,
development, manufacture and sales of Licensed Products by CBMG in
such amount as CBMG customarily maintains with respect to the
research, development, manufacture and sales of its other products
that are at a similar stage of development. CBMG shall maintain
such insurance (or self-insurance) for so long as it continues to
manufacture or sell any Licensed Products, and thereafter for so
long as CBMG customarily maintains insurance (or self-insurance)
for itself covering the research, development, manufacture or sales
of its other products that it no longer manufactures or
sells.
13 FORCE MAJEURE
Neither
Party shall be held liable or responsible to the other Party nor be
deemed to have defaulted under or breached this Agreement for
failure or delay in fulfilling or performing any term of this
Agreement to the extent, and for so long as, such failure or delay
is caused by or results from causes beyond the reasonable control
of the affected Party including but not limited to fire, floods,
embargoes, war, acts of terror, acts of war (whether war be
declared or not), insurrections, riots, civil commotions, strikes,
lockouts or other labor disturbances, acts of God or acts,
omissions or delays in acting by any governmental authority or
other Party.
14 LIMITATION OF LIABILITY
EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, IN NO
EVENT SHALL EITHER PARTY BE LIABLE FOR ANY INDIRECT, INCIDENTAL,
SPECIAL OR CONSEQUENTIAL DAMAGES, OR DAMAGES FOR LOSS OF PROFITS,
REVENUE, DATA OR USE, INCURRED BY EITHER PARTY OR ANY THIRD PARTY,
WHETHER IN AN ACTION IN CONTRACT OR TORT, EVEN IF THE OTHER PARTY
HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. EACH
PARTY’S LIABILITY FOR DAMAGES HEREUNDER SHALL IN NO EVENT
EXCEED THE AMOUNT OF FEES PAID (OR PAYABLE) BY CBMG UNDER THIS
AGREEMENT.
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15 MISCELLANEOUS
15.1
Any consent, notice or report required or permitted to be given or
made under this Agreement by one of the Parties hereto to the other
Party shall be in writing, delivered by any lawful means, and
addressed to such other Party at its address indicated below, or to
such other address as the addressee shall have last furnished in
writing to the addressor and (except as otherwise provided in this
Agreement) shall be effective upon receipt by the
addressee.
If to
AURI:
Augusta
University Research Institute
0000
00xx Xxxxxx
Xxxxxxx, Xxxxxxx
00000
Attn:
Executive Director
If to
CBMG:
Cellular
Biomedicine Group HK, Ltd.
Xxxx
000, 0xx Xxxxx, Xxxxxxxx Xxxxx
Xxxxxxxxx, Xxxx
Xxxx
Attn:
General Counsel
15.2
This Agreement shall be governed by the laws of the State of
Georgia.
15.3
Neither Party shall assign its rights or obligations under this
Agreement, in whole or in part, by operation of law or otherwise,
without the prior written consent of the other Party, which consent
shall not be unreasonably withheld; provided, however, that either
Party may assign its rights to the successor to all or
substantially all of its assets or business to which this Agreement
relates without the other Party’s prior written consent. Any
purported assignment in violation of this Section 15.3 shall be
void.
15.4 No
change, modification, extension, termination or waiver of this
Agreement, or any of the provisions herein contained, shall be
valid unless made in writing and signed by duly authorized
representatives of the Parties hereto.
15.5
This Agreement embodies the entire understanding between the
Parties and supersedes any prior understanding and agreements
between and among them respecting the subject matter hereof. There
are no representations, agreements, arrangements or understandings,
oral or written, between the Parties hereto relating to the subject
matter of this Agreement which are not fully expressed
herein.
15.6
Any of the provisions of this Agreement which are determined to be
invalid or unenforceable in any jurisdiction shall be ineffective
to the extent of such invalidity or unenforceability in such
jurisdiction, without rendering invalid or unenforceable the
remaining provisions hereof and without affecting the validity or
enforceability of any of the terms of this Agreement in any other
jurisdiction.
15.7
The waiver by either Party hereto of any right hereunder or the
failure to perform or of a breach by the other Party shall not be
deemed a waiver of any other right hereunder or of any other breach
or failure by said other Party whether of a similar nature or
otherwise.
15.8
This Agreement may be executed in two or more counterparts, each of
which shall be deemed an original, but all of which together shall
constitute one and the same instrument.
15.9
Nothing in this Agreement or in the course of business between AURI
and CBMG shall make or constitute either Party a partner, employee
or agent of the other and the relationship between the Parties is
not a partnership, joint venture or agency. Neither Party shall
have any right or authority to commit or legally bind the other in
any way whatsoever including, without limitation, the making of any
agreement, representation or warranty.
[SIGNATURE
PAGE FOLLOWS]
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IN
WITNESS WHEREOF, the Parties have executed this Agreement as of the
date first set forth above.
AUGUSTA
UNIVERSITY RESEARCH INSTITUTE, INC.
By /s/ Xxxxx
Xxxxxxx
Xxxxx
Xxxxxxx
Executive
Director
CELLULAR
BIOMEDICINE GROUP HK LTD.
By /s/ Xxxxxx
Xxxx
Xxxxxx
Xxxx
Director
12
