Exhibit 4.24


 


EXECUTION
COPY


 


 


***Text
Omitted and Filed Separately





with
the Securities and Exchange Commission.





Confidential
Treatment Requested





Under
Rule 24b-2 under the Securities





Exchange
Act of 1934


 


PATENT
LICENSE AND SETTLEMENT AGREEMENT


 


This
PATENT LICENSE AND SETTLEMENT AGREEMENT is entered into as of December 14, 2017 (the “Effective Date”) by and
between, on the one hand, Mesoblast Inc., a Delaware corporation, with a place of business at 505 Fifth Avenue, New York, New
York 10017 U.S.A. (“Mesoblast Inc.”) and Mesoblast International Sàrl, a Swiss societé à
responsibilité limitée, with a place of business located at Route de Pre-Bois 20, c/o Accounting & Management
Service SA, 1217 Meyrin, Switzerland (“Mesoblast Sàrl,” and together with Mesoblast Inc., “MSB”)
and, on the other hand, TiGenix S.A.U., a Spanish corporation, with a place of business at Calle Marconi 1, Parque Tecnológico
de Madrid, 28760 Tres Cantos (Madrid), Spain (“TiGenix”); each of MSB and TiGenix may be hereinafter referred
to together as the “Parties” and individually as a “Party” when convenient.


 


BACKGROUND


 


A.       MSB
owns and/or controls certain Licensed Patents (as defined below in Section 1);


 


B.       TiGenix
is a stock-listed innovative company currently focusing on exploiting its stem
cell technology, in particular the product called Cx 601. TiGenix owns certain
Intellectual Property Rights, including Patents, in relation to Cx 601 (each, as defined below in Section 1).


 


C.       MSB
wishes to grant to TiGenix, and TiGenix wishes to receive from MSB an exclusive license under the Licensed Patents with respect
to Royalty Product for the Field in the Territory (each, as defined below in Section 1); and


 


D.       The
Parties further desire to explore other opportunities and have agreed to establish a joint oversight/cooperation committee (as
further described in Section 8), all on the terms and conditions set forth below.


 


NOW,
THEREFORE, in consideration of the terms and provisions contained herein and other good and valuable consideration, the receipt,
adequacy, and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:


 




    1 


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1.                 
DEFINITIONS; INTERPRETATION


 


(a)              
The following capitalized terms shall have the meanings given in this Section 1 or elsewhere in this Agreement when used
in this Agreement:


 


“Accounting
Standards” means, with respect to an Entity, (i) Generally Accepted Accounting Principles of the United States (GAAP)
or (ii) International Financial Reporting Standards (IFRS), in each case (i) or (ii) as consistently applied by such Entity across
its operations.


 


“Affiliate”
means, with respect to an Entity, any other Entity in whatever country organized, that controls, is controlled by, or is under
common control of such first Entity. The term “control” for the purpose of this definition means possession, direct
or indirect, of the power to direct or cause the direction of the management and policies of an Entity, whether through the ownership
of voting securities, by contract, or otherwise, which control shall be presumed with respect to an Entity by another Entity when
such other Entity owns more than fifty percent (50%) of the first Entity’s voting securities.


 


“Agreement”
means this Patent license and settlement agreement, including its Exhibits which are an integral part thereof.


 


“Anti-Corruption
Laws” means the U.S. Foreign Corrupt Practices Act, as amended, the UK Bribery Act 2010, as amended, the Organization
for Economic Co-operation and Development (OECD) Convention on combating bribery of foreign public officials in international
business transactions, and any other applicable anti-corruption law.


 


“Applicable
Law” means any and all laws, ordinances, orders, rules, rulings, directives and regulations of any kind whatsoever of
any Regulatory Authority or other governmental authority within the applicable jurisdiction applicable to a Party’s activities
under this Agreement.


 


“Business
Day” means any day except a Saturday, Sunday or any other day on which commercial banks in Melbourne, Australia or Brussels,
Belgium are authorized or required by Applicable Law to remain closed.


 


“Cover”
means, with respect to any subject matter, that the manufacture, use, sale, offer for sale, storage, import, development or other
exploitation of such subject matter would infringe (whether direct or contributorily) or induce the infringement of a Valid Claim
(in the absence of a license under or ownership of such claim) at the time thereof. This applies to Patents if and to the extent
they are Prosecuted and Maintained in good faith. For the purpose of this definition, “Covered” or “Covering”
have their correlative meanings.


 


“Cx
601 Product” means a locally-administered cell therapy product comprising a composition of allogeneic adipose-derived
MSCs as of the Effective Date known as Cx 601, either fresh or frozen, and irrespective of the form, dose, formulation, component,
agent, delivery


 




    
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device
or dispensing device in or with which said composition is delivered. Cx 601 Product shall exclude any product that would require
the exploitation of any Patent owned or controlled by MSB in relation to proprietary small molecules or biologics, genetic modification
technologies, delivery technologies/devices or other cell types ([***]).


 


“Entity”
means any person, corporation, partnership, limited liability company, association, joint stock company, trust, joint venture,
unincorporated organization, governmental entity (or any department, agency, or political subdivision thereof), or any other legal
entity.


 


“Euro”
means a European Euro, and “€” has the corresponding meaning.


 


“Field”
means the treatment of fistulas.


 


“Intellectual
Property Rights” means any and all know-how, patents, utility models, supplementary protection certificates, patent
term extensions, copyrights and related rights, database rights, trade mark rights, trade and business names, domain names, trade
secrets, rights on unpatented know-how, registered or unregistered designs and any other intellectual or industrial property rights
of any nature including all applications for and reissues, renewals, reexaminations, divisionals, continuations, continuations-in-part,
substitutions or extensions thereof, and including any other rights, titles and interests held therein.


 


“Knowledge”
means, with respect to a Party, the actual knowledge of the Party. For clarity, any representation or warranty to a Party’s
Knowledge regarding any Patents (including the non-existence or non-infringement thereof) shall not imply any obligation for such
Party to conduct, or be construed that such Party has conducted, any search for Patents or other freedom to operate analysis specifically
for the purposes of this Agreement.


 


“Licensed
Patents” means, individually and collectively, any and all Patents which, absent the consent of MSB, its Affiliates
as of the Effective Date and/or any of their legal successors, would be infringed by the manufacture, use, sale, offer for sale,
storage, import, development or other exploitation of the Cx 601 Product for the Field in the Territory. Those Patents reasonably
believed, by the Parties, as of the Effective Date to be Licensed Patents (i.e., that Cover the Cx 601 Product) are listed on
Exhibit A and Exhibit B (which shall be updated from time to time as set forth in Section 4(b) and which are not
exhaustive). To avoid doubt, (i) Licensed Patents include any and all such Patents owned or controlled by MSB or its Affiliates
or to which MSB or its Affiliates has a licensable or sublicensable interest as of the Effective Date, (ii) Licensed Patents include
any and all substitutions, continuations, continuations-in-part, divisions, renewals, reissues, reexaminations, extensions, or
registrations of the Patents in (i) filed or granted before or after the Effective Date and (iii) the Licensed Patents exclude
any Patent owned or controlled by Entities which become an Affiliate of MSB through a share acquisition, merger or similar transaction
after the Effective Date, unless such Patent was a Licensed Patent prior to such transaction.


 


“Marketing
Approval” means, with respect to a product in a particular jurisdiction, approval (whether accelerated, conditional
or unconditional) or other permission by the


 




    
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applicable
Regulatory Authorities sufficient to initiate marketing and sales of such product, including, if necessary to initiate such marketing
and sales, approval, agreement, determination or governmental decision establishing the commercial price for such product.


 


“MSCs”
(mesenchymal stem cells) means a population of ex-vivo culture-expanded human mesenchymal stem cells.


 


“Net
Sales” means, for any period, the amount of “gross sales” (whereby “gross sales” equals the
ex-manufacturer price of Royalty Product, applicable for sales by or on behalf of TiGenix, its Affiliates and their Sublicensees
(each, a “Selling Party”) to an unconnected Third Party in an arm’s length sale times number of units
of Royalty Product sold) in the applicable country in the Territory by a Selling Party, less the following deductions (specifically
excluding any payments made by TiGenix to MSB pursuant to this Agreement), in each case related specifically to Royalty Product
in such country in the Territory and actually allowed and taken by such Third Parties and, in the case of items (i), (ii) and
(v) only, not otherwise recovered by or reimbursed to the Selling Party:


 


(i)                
trade, cash and quantity discounts, including in relation to any offering for sale of more than one product from the Selling
Party’s products, whether owned or licensed-in products (any, a “Portfolio Offering”) (other than price
discounts granted at the time of invoicing and already included in the gross amount invoiced), albeit capped at a maximum of 1%
of Net Sales per calendar year;


 


(ii)             
price reductions or rebates, retroactive or otherwise, imposed by, negotiated with or otherwise paid to Regulatory Authorities
or national or federal institutions, including, without limitation, private health insurance companies, having jurisdiction or
influence over the pricing, market access, funding reimbursement or usage restrictions of Royalty Product in the Field in the
applicable country in the Territory;


 


(iii)           
taxes on sales (such as business tax and VAT), but not including (a) taxes assessed against the income derived from such
sales, and (b) import and customs duties;


 


(iv)            
freight, insurance and other transportation and handling charges to the extent added to the sale price and set forth separately
as such in the total amount invoiced; and


 


(v)              
amounts repaid or credited by reason of rejections, defects, one percent (1%) return credits, recalls or returns or because
of retroactive price reductions (including rebates or wholesaler charge backs).


 


Where
any reduction in the amount of Net Sales is based on sales of a Portfolio Offering of products in which Royalty Product for use
in such country in the Territory is included, the reduction in price or deduction therefrom would be allocated as actually credited
unless such Royalty Product receives a higher than pro rata share of any reduction or deduction that the set of products pertaining
to the Portfolio Offering of products receives. In such case, the reduction or deduction therefrom shall be allocated to such
Product on a no greater than a pro rata basis based


 




    
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on
the sales value (i.e., the stock keeping unit average selling price multiplied by the number of stock keeping units) of such Royalty
Product relative to the sales value contributed by the other products included in the Portfolio Offering of products with respect
to such sale;


 


Subject
to the above, Net Sales shall be calculated in accordance with the Selling Party’s standard internal policies and procedures,
which must be in accordance with Accounting Standards;


 


Net
Sales shall not include (I) sales, transfers or dispositions between or among TiGenix, its Affiliates and their Sublicensees,
unless the purchasing Entity is an end-user, but shall include the subsequent final sales to non-Affiliate Third Parties by any
Selling Party, or (II) up to a maximum of one percent (1%) of the cumulative Net Sales during the applicable calendar year, sampling
for preclinical, clinical, promotional or educational purposes conducted by or on behalf of the Selling Party for Royalty Product
in the Field in such country in the Territory in accordance with the Selling Party’s usual and customary business practices;


 


All
Net Sales will be calculated in Euros; and


 


If
a Selling Party appoints a distributor for Royalty Product in the Field in one or more countries in the Territory, Net Sales will
include the Net Sales invoiced by the Selling Party to such distributor, but it will not include any sales of Royalty Product
in the Field in such countries in the Territory made by any such distributors.


 


“Patent”
means any of the following, whether existing now or in the future anywhere in the Territory: (i) any issued patent (whether utility
models, design patents or the like), including inventor’s certificates, substitutions, extensions, confirmations, reissues,
re-examination, renewal, supplemental protection certificates, any counterparts claiming priority therefrom, or any like governmental
grant for protection of inventions, and any patent resulting from any post-grant proceeding involving any of the foregoing; (ii)
any pending patent application (or application for any of the foregoing), including any continuation, divisional, substitution,
continuation-in-part, provisional and converted provisional applications; and (iii) any applicable pediatric exclusivity period.


 


“Prosecution
and Maintenance” means, with respect to a Patent, (i) the preparing, filing, prosecuting and maintenance of such Patent
(including conducting all correspondence and interactions with any government office or court having jurisdiction over the same),
including the right to apply for Patents pursuant to the International Convention for the Protection of Industrial Property or
pursuant to any other convention, treaty, agreement or understanding and (ii) seeking, conducting or defending re-examinations,
reissues, requests for Patent term extensions and the like with respect to such Patent, together with the conduct of interferences,
inter partes reviews, post-grant reviews, the defense of oppositions and other similar proceedings with respect to the particular
Patent (whether before or after issuance); and “Prosecute and Maintain” and “Prosecuting and Maintaining”
have their correlative meanings.


 




    
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“Regulatory
Authority” means any federal, national, multinational, state, provincial or local regulatory agency, department, bureau
or other governmental entity with authority over the development, manufacture or commercialization or other use or exploitation
(including the granting of Marketing Approvals) of the Product in any jurisdiction, including the United States Food and Drug
Administration and the European Medicines Agency.


 


“Royalty
Product” means any Cx 601 Product Covered in the applicable country in the Territory by a Valid Claim together with
any component, agent, delivery device, or dispensing device explicitly required by the applicable Marketing Approval therefor.
Furthermore, with respect to the U.S. only, if the Cx 601 Product is Covered by a Valid Claim during the Term in the U.S., and
for so long as the Cx 601 Product is subject to any regulatory exclusivity in the U.S. (i.e., for so long as the Regulatory Authority
in the U.S. may not grant a Marketing Approval in the U.S. for a product that is identical or substantially identical to the Cx
601 Product) (such period, the “Regulatory Exclusivity Period”) then it shall be deemed to be a Royalty Product
in the U.S. for an additional period of up to three (3) years as from the expiry date of the last Valid Claim in the U.S. Covering
the Cx 601 Product.


 


“Sublicensee”
means any Third Party to whom a sublicense under the Licensed Patents has been granted, whether directly or indirectly.


 


“Takeda”
means Takeda Pharmaceuticals International AG together with its Affiliates.


 


“Territory”
means all of the countries and territories in the world.


 


“Third
Party” means any Entity that is not a Party or an Affiliate of a Party (and in the case of Net Sales, any Entity that
is not a Selling Party).


 


“U.S.”
means the United States of America, together with its territories and protectorates including the Commonwealth of Puerto Rico.


 


“Valid
Claim” means any issued claim of any Licensed Patent that has not expired, lapsed, or been cancelled or abandoned, and
that has not been dedicated to the public, disclaimed, or been held unenforceable, invalid, or been cancelled by a court or administrative
agency of competent jurisdiction in an order or decision from which no appeal has been or can be taken, through opposition, re-examination,
reissue or disclaimer or the like. A claim of any Licensed Patent that is pending and not issued does not qualify as a Valid Claim;
provided, however, that if such pending and not issued claim issues during the course of this Agreement, it shall qualify as a
Valid Claim retroactively and shall, to the extent the issued claim Covers Royalty Product, trigger royalties in arrears on Net
Sales made as from the application date of the relevant Licensed Patent.


 


(b)              
Additional Definitions. Each of the following definitions shall have the meanings defined in the corresponding Sections
of this Agreement indicated below:


 




    
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	Defined
    Term	Section
	8(b)
    Expiration Date	8(b)
	Assertion
    Notice	8(c)
	Challenge	8(c)
	Challenge
    Notice	8
	Competing
    Enforcement Action	4(d)(ii)(1)
	Competing
    Infringement	4(d)(i)
	Competing
    Product	4(d)(i)
	Confidential
    Information	7(a)
	Denial
    Notice	8(b)
	Dispute	10(b)
	Double
    Tax	3(d)
	Enforcing
    Party	4(d)(iii)
	Financial
    Exhibit	3(a)
	Indemnified
    Party	6(a)
	Indemnifying
    Party	6(a)
	JOCC	8(a)
	MSB
    Indemnified Party	6(a)(ii)
	MSB
    Liability	6(a)(ii)
	MSB
    Oppositions	4(h)(i)
	Negotiation
    Request	8(b)
	New
    Indication	8(b)
	New
    Product	8(b)
	Other
    Party	9(c)(i)
	Portfolio
    Offering	Definition
    of “Net Sales”
	Pre-Issued
    MSB Patent	8(b)
	Reactive
    Challenge	8
	Regulatory
    Exclusivity Period	Definition
    of “Royalty Product”
	Royalty
    Term	Exhibit
    C, II.b)
	Rules	10(b)(ii)
	Selling
    Party	Definition
    of “Net Sales”
	Term	9(a)
	TiGenix
    Indemnified Party	6(a)(i)
	TiGenix
    Liability	6(a)(i)
	TiGenix/Takeda
    Oppositions	4(h)(ii)
	Third
    Party Claim	6(a)(i)


 


(c)              
Interpretation. The captions and headings to this Agreement are for convenience only, and are to be of no force
or effect in construing or interpreting any of the provisions of this Agreement. Unless specified to the contrary, references
to Sections or Exhibits mean the particular Sections or Exhibits to this Agreement and references to this Agreement
include all Exhibits hereto. Unless context otherwise clearly requires, whenever used in this Agreement: (i) the words “include”
or “including” shall be construed as incorporating, also, “but not limited to” or “without limitation”;
(ii) the word “will” shall be construed in the imperative having the same meaning as the word “shall”;
(iii) the word “day” or “year” means a calendar


 




    
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day
or year; (iv) the word “notice” requires notice in writing (whether or not specifically stated) and shall include
notices, consents, approvals and other written communications contemplated under this Agreement; (v) the words “hereof,”
“herein,” “hereby” and derivative or similar words refer to this Agreement (including any Exhibit); (vi)
provisions that require that a Party or the Parties “agree,” “consent” or “approve” or the
like shall require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter,
approved minutes or otherwise; (vii) words of any gender include the other gender; (viii) words using the singular or
plural number also include the plural or singular number, respectively; (ix) references to any specific law, rule or regulation,
or article, section or other division thereof, shall be deemed to include the then-current amendments thereto or any replacement
law, rule or regulation thereof; (x) neither Party nor its Affiliates shall be deemed to be acting “on behalf of”
or “under authority of” the other Party hereunder, and (xi) each Sublicensee shall be deemed to act with consent of
TiGenix.


 


2.                 
LICENSE


 


(a)                    
Exclusive License. From and after the Effective Date and subject to the terms and conditions of this Agreement,
MSB hereby grants to TiGenix, who accepts, an exclusive license under the Licensed Patents to (either by itself, by or on behalf
of an Affiliate, or by a Third Party on its behalf) use, develop, manufacture, sell, offer for sale, store and import Royalty
Product in each case solely for the Field in the Territory. For purposes of this Section 2(a), the term “exclusive”
means that during the Term MSB, its Affiliates and any of their legal successors shall not (i) exercise the Licensed Patents with
respect to the use, development, manufacture, sale, offer for sale, storage or importation of Royalty Product for the Field in
the Territory or (ii) grant any Third Party any right under the Licensed Patents for any such purpose. From and after the Effective
Date the foregoing license shall apply to the use, development, manufacture, sale, offer for sale, storage and importation of
Royalty Product for the Field in the Territory prior to the Effective Date, without any additional consideration for any such
activity prior to the Effective Date.


 


(b)                    
Sublicenses. The license granted to TiGenix in Section 2(a) includes the right to grant sublicenses to (i) Affiliates
and (ii) Third Parties (through multiple tiers); provided that all such sublicenses shall be (A) subject to and consistent with
such license and this Agreement and (B) with respect to Third Parties that have been approved in writing by MSB, such approval
not to be unreasonably withheld, conditioned or delayed. The Parties acknowledge that as of the Effective Date Takeda is a Sublicensee
of TiGenix and is deemed approved for such purposes.


 


(c)                    
Settlement Relating to the Cx 601 Product and Release of Claims. This Agreement, through mutual concessions, puts
a final and definitive end to any claims, liabilities or causes of action that the Parties, their Affiliates or any of their legal
successors could have or make in relation to the Cx 601 Product for the Field in the Territory as of the Effective Date, provided
with respect to each Party, that Party fulfills its obligations under Section 4(h) and without prejudice to TiGenix’s right
to conduct a Challenge in accordance with Section 8(c). Subject to the same limitations and conditions, MSB releases TiGenix,
its Affiliates and their


 




    
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Sublicensees
or any of their legal successors from any and all claims of any nature that it had as of the Effective Date, whether known, unknown,
or suspected to exist, to the extent related to the Cx 601 Product for the Field in the Territory. Without prejudice to any remedies
available under this Agreement or at law or equity, any proceedings brought in breach of this settlement shall be withdrawn at
the costs of the breaching Party.


 


(d)                    
No Recognition. By entering into this Agreement, neither Party acknowledges any infringement to or validity/invalidity
of the other Party’s Intellectual Property Rights and nothing in this Agreement shall be interpreted as such acknowledgment.


 


(e)                    
No Other Rights. Each Party acknowledges that the rights under this Section 2 and elsewhere in this Agreement are
limited to the express scope thereof. Accordingly, (i) the license granted in Section 2(a) is limited to Royalty Product solely
for the Field in the Territory and (ii) except for the rights expressly granted under this Agreement, no right, title, or interest
of any nature whatsoever is granted, whether by implication, estoppel, reliance, or otherwise, by either Party to the other Party.


 


3.                 
PAYMENTS. 


 


(a)                    
Effective Date Payment. As partial consideration of the license and other rights granted to TiGenix and obligations
of MSB hereunder, TiGenix shall pay to Mesoblast Sàrl five million Euros within three (3) Business Days of the Effective
Date, which payment, once paid, shall be non-refundable, and shall not be creditable against any other amount due hereunder.


 


(b)                    
Other Payments. TiGenix shall make the other payments to Mesoblast Sàrl as set forth in Exhibit C
(the “Financial Exhibit”).


 


(c)                    
Payment Method. All payments due under this Agreement shall be made by bank wire transfer in immediately available
funds to an account designated by Mesoblast Sàrl. All payments hereunder shall be made in Euros.


 


(d)                    
Withholding Taxes. All amounts payable by TiGenix to Mesoblast Sàrl under this Agreement shall be subject
to a five percent (5%) withholding in accordance with article 12.2 of the 1966 Convention between the Swiss Confederation and
Spain for the avoidance of double taxation with respect to taxes on income and fortune, as amended by a Protocol signed 29 June
2006 and as further amended by a Protocol signed 27 July 2011 (the “Double Tax Treaty”), provided that Mesoblast
Sàrl annually and timely provides TiGenix with a tax residency certificate as in Exhibit F (duly executed by the
Swiss tax authorities), attesting that Mesoblast Sàrl is a tax resident in Switzerland for purposes of the Double Tax Treaty.
Provided that Mesoblast Sàrl provides TiGenix with the afore-mentioned tax residency certificate, the amounts payable by
TiGenix to Mesoblast Sàrl under this Agreement will not be subject to a twenty-four percent (24%) withholding in accordance
with applicable Spanish legislation.


 


(e)                    
Acknowledgement. The Parties acknowledge that the economic terms and conditions set forth herein were negotiated
and agreed to at arms-length and represent a fair and


 




    
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equitable
valuation of the license for the benefit of TiGenix, its Affiliates and Sublicensees and the obligations of MSB hereunder. No
other payment or compensation of any type shall be due in consideration of the license in Section 2(a).


 


4.                 
PATENT MATTERS


 


(a)                    
Prosecution and Maintenance. Subject to the provisions of this Section 4(a), MSB (itself or through one or more
other Entities acting under its authority) shall perform and control the Prosecution and Maintenance of the Licensed Patents at
its own expense, using patent counsel of its choice. MSB shall keep TiGenix reasonably informed regarding material matters related
to the Prosecution and Maintenance of each Patent within the Licensed Patents to the extent relevant to Royalty Product. In the
event that MSB elects to abandon any Licensed Patent, it shall notify TiGenix at least sixty (60) days in advance, in which case
TiGenix shall have the right to perform and control the Prosecution and Maintenance of such Licensed Patent, at its sole expense
in the name of MSB, except that TiGenix shall have the right to credit the amounts incurred with respect to the Prosecution and
Maintenance of such Licensed Patent against the amounts due pursuant to Paragraph II(a) of the Financial Exhibit with respect
to Royalty Products Covered by such Licensed Patent.


 


(b)                    
Update of Exhibits A and B. If a Party reasonably believes that either Exhibit A (Issued Licensed Patents)
or Exhibit B (Pending Licensed Patents) should be updated to include one or more additional Patents, then such Party shall
provide the other Party notice setting out for the basis for such belief and, subject to the Parties agreeing in writing, Exhibit
A and/or Exhibit B, as applicable shall be appropriately updated.


 


(c)                    
Future Inventions. For the avoidance of any doubt, each Party is and remains free to Prosecute and Maintain Patents
or other Intellectual Property Rights that it owns or otherwise has the appropriate rights to, including but not limited to independent
developments and improvements of the Licensed Patents.


 


(d)                    
Enforcement.


 


(i)                    
Notice. Subject to the provisions of this Section 4(d), in the event that either Party reasonably believes that
any Licensed Patent (A) is being infringed by a Third Party’s product or process comprising allogenic adipose-derived MSCs
for the Field in the Territory that is Covered by a Valid Claim (such product, a “Competing Product” and such
infringement, a “Competing Infringement”) or (B) is subject to a declaratory judgment action arising from Competing
Infringement, such Party shall promptly notify the other Party.


 


(ii)                  
Enforcement Actions.


 


(1)              
As between the Parties, MSB (itself or through one or more other Entities acting under its authority) shall have the right
(but not the obligation) to initiate and control at its expense an action alleging infringement of a Licensed Patent with respect
to any Competing Infringement (any, a “Competing Enforcement Action”).


 




    
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(2)              
TiGenix shall have the right (but not the obligation) to initiate and control at its expense a Competing Enforcement Action
in the event that (A) MSB fails to commence any Competing Enforcement Action within sixty (60) days after the notice described
in Section 4(d)(i) (or within such shorter period as may be necessary to initiate and maintain full enforcement rights under such
Competing Enforcement Action within the statutory or other binding time limitations), (B) there are no Patents (other than Licensed
Patents) that TiGenix, its Affiliate or Sublicensee could reasonably enforce against such Competing Product, and (C) there is
a reasonable likelihood that a court establishes the Competing Infringement; provided that “a reasonable likelihood”
in this context means that it is more likely than not that a court deciding on the merits would establish a Competing Infringement
without materially adversely affecting the License Patent; and provided that, in the event the Parties fail to agree amongst themselves
on whether there is such reasonable likelihood within a period of thirty (30) days after the notice described in Section 4(d)(i)
(or within such shorter period as may be necessary to initiate and maintain full enforcement rights under such an action within
the statutory or other binding time limitations), such matter shall be referred for resolution to one (or three) independent patent
attorney(s) practicing in a country where the Competing Infringement is occurring, who should provide a reasoned opinion on the
issue as a matter of urgency, and in any event no later than thirty (30) days after such referral (or within such shorter period
as may be necessary to initiate and maintain full enforcement rights under such an action within the statutory or other binding
time limitations). TiGenix shall provide MSB with an opportunity to make suggestions and comments with regard to such a Competing
Enforcement Action controlled by TiGenix and shall consider and incorporate, in its reasonable discretion, such suggestions and
comments.


 


(iii)                 
Cooperation. The Party controlling any Competing Enforcement Action in accordance with this Section 4(d) (the “Enforcing
Party”) shall keep the other Party reasonably informed of the progress of any such Competing Enforcement Action, and
such other Party shall have the right to participate with counsel of its own choice at its own expense without prejudice to Section
4(c)(iv) but will not be an Enforcing Party. In any event, the other Party shall reasonably cooperate with the Enforcing Party,
including providing information and materials, at the Enforcing Party’s request and expense. If TiGenix is the Enforcing
Party, MSB shall join any Competing Enforcement Action as a party-plaintiff, upon TiGenix’s request and expense, if and
to the extent such joinder is necessary to fully enforce rights under, and obtain remedies in respect of, the Competing Infringement.
The Enforcing Party shall also have the right to control settlement of the Competing Enforcement Action; provided, however, no
settlement shall be entered into without the consent of the other Party if such settlement would have a material adverse effect
on the interests of the other Party, which consent shall not be unreasonably withheld.


 


(iv)            
Costs and Recoveries. Any recovery received as a result of any Competing Enforcement Action pursuant to this Section
4(d) shall be used first to reimburse the Enforcing Party for the costs and expenses (including court, attorneys’ and professional
fees) incurred in connection with such Competing Enforcement Action. The remainder of the recovery attributable to the Competing
Infringement shall be paid as follows: (A) if MSB is the Enforcing Party: [***]% of such remainder of the recovery shall be paid
to TiGenix and [***]% shall be


 




    
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paid
to MSB or (B) if TiGenix is the Enforcing Party: [***]% of such remainder of the recovery shall be paid to TiGenix and [***]%
shall be paid to MSB.


 


(e)              
Patent Marking. TiGenix shall mark (or cause to be marked) Royalty Product sold or offered for sale with appropriate
Licensed Patent numbers or indicia at MSB’s request, to the extent permitted by Applicable Law, it being understood that
(i) TiGenix shall only be required to do so in those countries in which such notices impact recoveries of damages or remedies
available with respect to infringements of Licensed Patents and (ii) in no event TiGenix shall have to mark (or cause to be marked)
more than what is necessary and customary for achieving said purpose in such country.


 


(f)               
Patent Assignment. In the event that MSB elects to assign or transfer any rights to or under any Licensed Patent,
MSB shall ensure that each assignment or other transfer of any Licensed Patent shall be expressly subject to the terms and conditions
of this Agreement, such that the rights and obligations (including the license) under this Agreement are opposable towards any
Third Party to whom such Licensed Patent is assigned or transferred.


 


(g)              
Registration of the License. TiGenix shall have the right (but not the obligation), at its cost, to record with
any and all of the relevant intellectual property (including, patent) offices, TiGenix deems appropriate, throughout the Territory,
the rights and obligations under this Agreement, and MSB shall reasonably assist TiGenix in connection therewith, at TiGenix’s
cost; for the avoidance of doubt, nothing in this Section 4.(g) alters MSB’s obligations under Section 4.(f).


 


(h)              
[***]


 


5.                 
REPRESENTATIONS AND WARRANTIES


 


(a)                
Representations and Warranties By MSB. MSB hereby represents and warrants to TiGenix as follows that, as of
the Effective Date:


 


(i)                
Organization and Good Standing. Each of Mesoblast Inc. and Mesoblast Sàrl is a corporation duly formed, validly
existing, and in good standing under the laws of the jurisdiction of its formation;


 


(ii)             
Authority. MSB has the full power and authority and has obtained all consents, approvals, or other authorizations
required to enter into this Agreement and to grant the rights granted for the benefit of TiGenix, its Affiliates and Sublicensees
hereunder;


 


(iii)           
Valid and Binding Agreement. This Agreement has been duly executed and delivered by MSB and constitutes the legal,
valid and binding obligation of MSB and its Affiliates, enforceable against MSB in accordance with its terms;


 


(iv)            
Non-Contravention. MSB and its Affiliates have not entered into any license, covenant not to sue or other agreement,
written or oral, with any other Entity which (A)


 




    
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would
conflict with or otherwise limit MSB’s ability to grant the rights hereunder for the benefit of TiGenix, its Affiliates
and Sublicensees or (B) would prevent MSB from carrying out any of its obligations hereunder;


 


(v)              
Title and Contest.


 


(1)              
MSB owns and/or possesses such right, title, and interest to the Licensed Patents, whether by ownership, license or otherwise,
as are necessary (A) to grant the rights for the benefit of TiGenix, its Affiliates and Sublicensees hereunder, in particular
the license, and (B) to carry out all of the respective obligations of MSB (on behalf of itself and its Affiliates and their legal
successors hereunder), without giving rise to any violation of the rights of any Third Party and without breaching the terms of
any agreement with any Third Party;


 


(2)              
To MSB’s Knowledge (A) there are no actions, suits, investigations, claims, or proceedings (including reexamination,
reissue, interference proceeding, or any similar proceeding) threatened, pending, or in progress relating in any way to the Licensed
Patents other than those set forth on Exhibit D, provided TiGenix complies with its obligations in Section 4(h) and (B)
no Competing Infringement exists;


 


(3)              
Neither MSB nor any of its Affiliates has received any notice of a claim of another Entity that such other Entity has an
ownership interest in the Licensed Patents;


 


(4)              
To MSB’s Knowledge, (A)(I) the Patents listed on Exhibit A are all issued Patents and (II) the Patents listed
on Exhibit B are all pending Patents, in each case (I) and (II) owned or controlled by MSB or its Affiliates that
Cover the Cx 601 Product for the Field in the Territory; and (B) except for the Licensed Patents, there are no other Intellectual
Property Rights owned or controlled (whether by ownership, license or otherwise) by MSB or its Affiliates that Cover, or are used
for, the Cx 601 Product for the Field in the Territory; and (C) MSB has not assigned prior to the Effective Date any Patent
or other Intellectual Property Right Covering, or used for, the Cx 601 Product for the Field in the Territory;


 


(vi)            
Validity. The Licensed Patents have not been declared abandoned, or been found invalid, unpatentable, or unenforceable
for any reason including in a final decision in any administrative, arbitration, judicial, or other proceeding. Further, the Licensed
Patents (A) that are issued have, to MSB’s Knowledge, been validly granted and (B) have been, to MSB’s Knowledge,
Prosecuted and Maintained in the period since MSB owned or controlled such Licensed Patent, with an objectively reasonable belief
(but no guarantee) that the claimed subject matter is adequately described and enabled, novel, non-obvious and otherwise meets
all patentability requirements;


 


(vii)         
Fees. No failure to timely pay maintenance fees, annuities, and the like due or payable with respect to the Licensed
Patents has occurred that has or would have a material adverse effect on the Licensed Patents; and


 




    
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(viii)       
Non-infringement of Third Party Patents. To the Knowledge of MSB, there are no Patents that will necessarily be
infringed by the exercise of the Licensed Patents in accordance with this Agreement.


 


(b)                    
Representations and Warranties By TiGenix. TiGenix hereby represents and warrants to MSB as follows that, as of
the Effective Date:


 


(i)                
Organization and Good Standing. TiGenix is a corporation duly formed, validly existing, and in good standing under
the laws of the jurisdiction of its formation;


 


(ii)             
Authority. TiGenix has the full power and authority and has obtained all consents, approvals, and/or other authorizations
required to enter into this Agreement and to carry out its obligations hereunder; and


 


(iii)           
Valid and Binding Agreement. This Agreement has been duly executed and delivered by TiGenix and constitutes the
legal, valid and binding obligation of TiGenix enforceable against TiGenix in accordance with its terms.


 


(c)                    
Disclaimer of Representations and Warranties. NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY EXCEPT FOR THEIR
RESPECTIVE REPRESENTATIONS AND WARRANTIES SET FORTH IN THIS SECTION 5, AND OTHERWISE EACH PARTY DISCLAIMS ALL IMPLIED WARRANTIES,
INCLUDING ANY IMPLIED WARRANTIES OF MERCHANTABILITY, NONINFRINGEMENT AND FITNESS FOR A PARTICULAR PURPOSE.


 


6.                 
INDEMNIFICATION; LIMITATIONS.


 


(a)              
Indemnification.


 


(i)                
MSB shall indemnify and hold harmless TiGenix and its Affiliates, principals, employees, officers, directors, stockholders,
successors, assigns (each, a “TiGenix Indemnified Party”) from and against all claims, disputes, controversies,
demands, causes of action in each case of the foregoing brought by a Third Party (any, a “Third Party Claim”)
and debts, obligations, judgments, liens, liability, damages, costs and expenses (including reasonable attorneys’ fees and
expenses of litigation) from a Third Party Claim (collectively, “TiGenix Liability”) which a TiGenix Indemnified
Party may incur, suffer, or be required to pay resulting from or arising in connection with any Third Party Claim arising out
of or relating to any breach of any representation or warranty of MSB set forth in this Agreement;


 


(ii)             
TiGenix shall indemnify and hold harmless MSB and its Affiliates, principals, employees, officers, directors, stockholders,
successors and assigns (a “MSB Indemnified Party”) from and against all Third Party Claims and debts, obligations,
judgments, liens, liability, damages, costs and expenses (including reasonable attorneys’ fees and expenses of litigation)
from a Third Party Claim (collectively, “MSB Liability”) which a MSB Indemnified Party may incur, suffer, or
be required to pay resulting from or arising in connection


 




    
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with
any Third Party Claims arising out of or relating to (A) any breach of any representation or warranty of TiGenix set forth in
this Agreement or (B) any exercise of the license under Section 2(a) by or under authority of TiGenix, its Affiliates or Sublicensees;


 


To
be eligible to be indemnified hereunder, the TiGenix Indemnified Party or MSB Indemnified Party, as applicable (the “Indemnified
Party”) shall provide the Party obligated to indemnify (the “Indemnifying Party”) with prompt notice
of the Third Party Claim, giving rise to the indemnification obligation pursuant to this Section 6(a). The Indemnifying Party
shall take all appropriate actions, including actions in court, in order to preserve the Indemnified Party’s rights under
this Agreement, and shall voluntarily intervene in any proceedings brought in that context against the Indemnified Party, upon
its first request. The Indemnified Party shall have the right to participate at its own expense, with counsel of its choice, in
the defense of any action that has been assumed by the Indemnifying Party. The Indemnifying Party shall bear all the costs and
expenses (including court, attorneys’ and professional fees) related to its defense of the Third Party Claim. The Indemnifying
Party shall not enter into any settlement that admits fault, wrongdoing or damages without the Indemnified Party’s written
consent, such consent not to be unreasonably withheld, conditioned or delayed. The Indemnifying Party shall have no obligations
with respect to any TiGenix Liability or MSB Liability (as applicable) resulting from the Indemnified Party’s admission,
settlement or other communication without the prior written consent of the Indemnifying Party.


 


(b)                    
Limitation on Consequential Damages. OTHER THAN DIRECT CONTRACTUAL DAMAGES AND WITHOUT LIMITING EITHER PARTY’S
OBLIGATIONS UNDER SECTION 4(e) OR SECTION 6(a), NEITHER PARTY WILL HAVE ANY OBLIGATION OR LIABILITY (WHETHER IN CONTRACT, WARRANTY,
TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, AND NOTWITHSTANDING ANY FAULT, NEGLIGENCE (WHETHER ACTIVE, PASSIVE, OR IMPUTED), REPRESENTATION,
STRICT LIABILITY, OR ROYALTY PRODUCT LIABILITY), FOR COVER OR FOR ANY INCIDENTAL, INDIRECT, CONSEQUENTIAL, MULTIPLIED, PUNITIVE,
SPECIAL, OR EXEMPLARY DAMAGES OR LOSS OF REVENUE, PROFIT, SAVINGS OR BUSINESS ARISING FROM OR OTHERWISE RELATED TO THIS AGREEMENT,
EVEN IF A PARTY OR ITS REPRESENTATIVES HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THE PARTIES ACKNOWLEDGE THAT THESE
EXCLUSIONS OF POTENTIAL DAMAGES WERE AN ESSENTIAL ELEMENT IN SETTING CONSIDERATION UNDER THIS AGREEMENT.


 


7.                 
CONFIDENTIALITY; PRESS RELEASE.


 


(a)                    
Confidentiality; Exceptions. Except to the extent expressly authorized by this Agreement or otherwise agreed by
the Parties in writing, the Parties agree that the receiving Party shall keep confidential and shall not publish or otherwise
disclose or use for any purpose other than as provided for in this Agreement any confidential or proprietary information or materials
furnished to it by the other Party pursuant to this Agreement (collectively, “Confidential Information”). Notwithstanding
the foregoing, Confidential Information shall


 




    
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not
be deemed to include information or materials to the extent that it can be established by written documentation by the receiving
Party that such information or material:


 


(i)                
was already known to or possessed by the receiving Party without any obligation of confidentiality, at the time of its
disclosure to the receiving Party hereunder;


 


(ii)             
was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving
Party hereunder;


 


(iii)           
became generally available to the public or otherwise part of the public domain after its disclosure hereunder other than
through any act or omission of the receiving Party in breach of this Agreement;


 


(iv)            
was independently developed by the receiving Party without use of or reference to the other Party’s Confidential
Information as demonstrated by documented evidence prepared by the receiving Party contemporaneously with such independent development;
or


 


(v)              
was disclosed to the receiving Party, other than under an obligation of confidentiality, by a Third Party not known by
the receiving Party to have an obligation to the disclosing Party not to disclose such information to others.


 


(b)              
Authorized Use and Disclosure. Each Party may disclose Confidential Information of the other Party, but only to
the extent such disclosure is absolutely necessary and limited to the furthest extent possible, in the following situations:


 


(i)                
enforcing its rights or the obligations of the other Party under, or arising out of, this Agreement, in accordance with
Section 10(b) of this Agreement;


 


(ii)             
complying with Applicable Laws and regulations promulgated by security exchanges, court order or administrative subpoenas
or orders or otherwise submitting information to tax or other governmental authorities; provided that the receiving Party has
provided prior notice of such disclosure to the disclosing Party (unless prohibited by Applicable Law) and afforded the disclosing
Party the opportunity to resist or obtain protections in respect of such disclosure;


 


(iii)           
disclosure to its or its Affiliates’ employees, consultants, advisors (including financial advisors, lawyers and
accountants) and others on a need–to-know basis, for the sole purpose of performing its or its Affiliates’ obligations
or exercising its or its Affiliates’ rights under this Agreement, provided that in each case the recipients of such Confidential
Information are bound by written obligations of confidentiality and non-use at least as equivalent in scope as those set forth
in this Section 7 prior to any such disclosure; and


 


(iv)            
disclosure to existing and potential merger partners, acquirers or licensees/Sublicensees (including in the case of TiGenix,
Takeda), including their respective consultants and professional advisors (including financial advisors, lawyers and accounts),
solely


 




    
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on
a need-to-know basis in order to evaluate an actual or potential investment, acquisition or business transactions; and provided
that in connection with such disclosure, the disclosing Party shall inform each disclosee of the confidential nature of such information
and cause each disclosee to treat such information as confidential consistent with the nature of the Confidential Information
so disclosed, which will in any event not be less strict than the provisions set out in this Section 7.


 


(c)              
Publicity.


 


(i)                
Agreement Terms. Each Party agrees not to disclose to any Third Party the terms and conditions of this Agreement
without the prior approval of the other Party, except as provided for in Section 4(g), or to consultants, advisors, and existing
and potential merger partners, acquirers or licensees/Sublicensees (including in the case of TiGenix, Takeda) (including their
respective consultants, financial advisors, lawyers and accountants) and others on a need to know basis, in each case under circumstances
that reasonably protect the confidentiality thereof, or to the extent necessary to comply with the terms of agreements with Third
Parties, or to the extent required by Applicable Law or the rules of any applicable securities exchange. Notwithstanding the foregoing,
the Parties agree to issue the joint press release attached hereto as Exhibit E announcing the execution and the material
terms of this Agreement on the Effective Date ([***]); thereafter, MSB and TiGenix may each disclose to Third Parties the information
contained in such press release without the need for further approval by the other.


 


(ii)             
Publicity Review. To the extent that any other disclosure with respect to matters within the scope of this Agreement
is required by Applicable Law or the rules of recognized stock exchanges with respect to a Party, such Party shall provide the
other Party with at least 72 hours advanced written notice to review and comment on such statement.


 


8.                 
JOCC / NEGOTIATIONS FOR OTHER RIGHTS / NO CHALLENGE.


 


(a)                    
Joint Oversight/Cooperation Committee. Promptly after the Effective Date, TiGenix and MSB shall establish a joint
oversight/cooperation committee (the “JOCC”) to (i) oversee the interactions of the Parties under this Agreement,
(ii) cooperate to avoid disputes between the Parties under this Agreement, (iii) in the event that a Licensed Patent is infringed
by a product for the Field in the Territory, which product is not comprised of allogenic adipose-derived MSCs and if requested
by TiGenix, discuss the possibility of MSB enforcing such Licensed Patent against such infringement, and (iv) discuss those certain
matters described in this Section 8. The JOCC shall consist of an equal number of representatives from each of MSB and TiGenix,
and unless otherwise agreed such number shall be two (2) representatives appointed by each of MSB and TiGenix. Either Party may
replace its respective representative(s) to the JOCC at any time with prior notice to the other Party, provided that such replacement
is of comparable authority and scope of responsibility within that Party’s organization as the individual he or she is replacing,
but may have different area of responsibility. The JOCC shall meet at least once every six (6) months or more often as either
Party may reasonably request at which meetings the JOCC shall discuss the interactions between the Parties hereunder and


 




    
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attempt
to address any concerns of either Party within the context of the terms and conditions of this Agreement.


 


(b)                    
Other Rights to the Licensed Patents. If TiGenix (or any Entity under authority of TiGenix) has (i) filed investigational
drug application (IND) or equivalent filing necessary to initiate a phase three (3) or equivalent pivotal human clinical trial
with the applicable Regulatory Authority, which IND or filing is effective, for (A) the Cx 601 Product for any indication outside
of the Field (each, a “New Indication”) or (B) another product (other than the Cx 601 Product) comprising allogeneic
adipose-derived MSCs for treatment of any indication (any, a “New Product”), (ii) received a term sheet from
a Third Party for the development or commercialization of (A) the Cx 601 Product for a New Indication in the Territory or (B)
a New Product, or (iii) with respect to any Patent owned or controlled by MSB, the period to conduct a Challenge (as defined in
Section (c)), including oppose, file an interference or conduct any pre-issuance challenge, with respect to such Patent has started
running (each, a “Pre-Issued MSB Patent”), then TiGenix has the right (but not the obligation) to notify a
written request to the JOCC (which request shall identify the particular product, the indication and the corresponding Patent(s)
owned or controlled by MSB that TiGenix would like to obtain a license for (any, a “Negotiation Request”) and
which request shall have to be treated with outmost confidentiality by MSB and its Affiliates and the contents of which shall
not be published or otherwise disclosed by MSB and its Affiliates, nor used by MSB and its Affiliates for any purpose other than
the assessment of TiGenix’s New Indication or New Product under this Section 8(b)), and unless MSB notifies TiGenix within
thirty (30) days of the Negotiation Request that MSB has determined in good faith that the proposed grant would compete with any
product then planned, under development or being marketed by or under authority of MSB or its Affiliate, or is of future commercial
interest to MSB or its Affiliate, or is otherwise prohibited from making such a grant (any a “Denial Notice”),
the JOCC shall discuss in good faith (including meeting at least one time specifically for such discussions) the possibility that
MSB would grant appropriate licenses/covenants not to sue under the Licensed Patents and/or other MSB Patents, including Pre-Issued
MSB Patent and the terms and conditions of such grant. If MSB provides a Denial Notice or the Parties do not enter into a definitive
agreement (whether as an amendment to this Agreement or otherwise) for any reason within sixty (60) days of the Negotiation Request
(this period being extendable upon the written agreement of the Parties), then neither Party shall have any further obligation
or liability with respect to such Negotiation Request (the date thereof, the “8(b) Expiration Date”). To avoid
any doubt, a decision by TiGenix not to make a Negotiation Request shall not constitute a breach under this Agreement.


 


(c)                    
Limited cause for termination due to a Challenge. During the term of this Agreement and with respect to the Licensed
Patents, TiGenix agrees (and shall cause each of its Affiliate and Sublicensees to agree) (A) absent a Negotiation Request with
respect to a particular Patent pursuant to Section 8(b) not to (i) challenge in any court action or proceeding, or before any
patent office, the validity, patentability, enforceability, scope or non-infringement of such Patent, (ii) initiate a reexamination
of such Patent or otherwise submit any materials for such purposes, or (iii) assist any Third Party to conduct any of the foregoing
activities (each, a “Challenge”) or (B) in the case of a Negotiation Request with respect to a particular Patent


 




    
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pursuant
to Section 8(b), not to conduct a Challenge at any time prior to the 8(b) Expiration Date, unless the time limitations in Section
8(b) would result in TiGenix being time barred for conducting a Challenge, including in particular an opposition, interference
or other challenge, with respect to such Patent.


 


Notwithstanding
these limited exceptions (A) and (B), TiGenix (or its Affiliate or Sublicensee) shall have and retain any and all right to conduct
a Challenge, including with respect to Licensed Patents and Pre-Issued MSB Patents, by way of a Reactive Challenge. “Reactive
Challenge” means a Challenge of a Patent that MSB has asserted or threatened in writing to assert (either itself, an
Affiliate or via a Third Party) against any product of TiGenix, its Affiliate or Sublicensee.


 


Nothing
in this Section 8(c) shall prohibit nor limit in any way TiGenix’s right to conduct a Challenge against a Patent of MSB
other than a Licensed Patent, provided that TiGenix has provided the Challenge Notice (as defined below) with respect thereto.


 


TiGenix
and MSB agree that the end result of any Challenge, other than a Reactive Challenge, shall not affect the payments to Mesoblast
Sàrl as set forth in Exhibit C, including the payment of royalties for Royalty Product under this Agreement, to the extent
that there is still a Valid Claim Covering said Royalty Product.


 


Except
in case of a Reactive Challenge, TiGenix shall notify MSB at least thirty (30) days prior to initiating a Challenge (each, a “Challenge
Notice”) whereby TiGenix, its Affiliate and Sublicensees shall not initiate a Challenge until each of the 8(b) Expiration
Date, if applicable, and the Challenge Notice have occurred.


 


MSB
shall notify TiGenix at least thirty (30) days prior to asserting a Patent against TiGenix, its Affiliates and/or its Sublicensees
(each, an “Assertion Notice”) and MSB (itself, an Affiliate or a Third Party on behalf thereof) shall not assert
such Patent until the Assertion Notice has occurred.


 


9.                 
TERM AND TERMINATION.


 


(a)                    
Term. This Agreement shall become effective as of the Effective Date and, unless earlier terminated pursuant to
the other provisions of this Section 9, shall continue in full force from and after the Effective Date until the expiration of
the Royalty Term as set forth in the Financial Exhibit (the “Term”).


 


(b)                    
[Left intentionally blank].


 


(c)                    
Termination.


 


(i)                
(A) Either Party may terminate this Agreement in the event the other Party (the “Other Party”) or its Affiliates
(or any Entity acting on behalf of the Other Party or its Affiliate) materially breaches this Agreement, including any breach
of the representations and


 




    
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warranties
under Section 5, and such breach shall have continued for ninety (90) days after notice thereof was provided to the Other Party.
Any such termination shall become effective upon notice thereof at the end of such ninety (90) day period unless the Other Party
has cured any such breach prior to the expiration of the ninety (90) day period; (B) In case TiGenix is of the opinion that there
is no Valid Claim Covering the Cx 601 Product in a given country at a given time as a result of the fact that the only Valid Claims
then Covering the Cx 601 Product (W) have been invalidated as a result of a Challenge in accordance with Section 8(c), (X) have
been invalidated by a Third Party, (Y) were previously pending Licensed Patents which when issued, issued more narrowly than prosecuted,
or (Z) have been abandoned by MSB and not Prosecuted and Maintained by TiGenix pursuant to Section 4(a), and on that basis it
is not obligated to pay royalties for the Net Sales in that country, it may notify MSB and if MSB disagrees, the Parties shall
refer the matter to the JOCC for resolution first. If the JOCC does not succeed in resolving the disagreement within three (3)
months, the Parties shall refer their dispute for resolution pursuant to Section 10(b). MSB shall not have the right to terminate
the Agreement in the case of (B) as long as (I) the matter is pending before the JOCC and/or pursuant to Section 10(b) and (II) TiGenix
pays into an escrow account the amount that would have otherwise been payable to MSB for such Cx 601 Product had it been a Royalty
Product. In such event, if the matter is resolved in the favor of TiGenix, then TiGenix shall receive the amounts set forth in
such escrow account or if the matter is resolved in the favor of MSB, then MSB shall receive the amounts set forth in such escrow
account (in each case together with any interest at the rate set forth in Exhibit C, Paragraph II(f)). Any termination based on
the situation in this Section 9(c)(i)(B), for breach or otherwise, shall in any event be limited to the country in question
and not affect the license in the remainder of the Territory.


 


(ii)             
MSB may terminate this Agreement upon delivery of written notice to TiGenix in the event that (A) TiGenix files in any
court or agency pursuant to any statute or regulation of any jurisdiction a petition in bankruptcy or insolvency or for reorganization
or similar arrangement for the benefit of creditors or for the appointment of a receiver or trustee of such other Party or its
assets, or (B) TiGenix makes an assignment of substantially all of its assets for the benefit of its creditors.


 


(d)                    
Termination for Failure under Section 4(h). Either Party may terminate this Agreement in its entirety immediately
upon notice if the other Party does not fulfill its obligations under Section 4(h) in its entirety.


 


(e)                    
General Effects of Expiration or Termination.


 


(i)                
Expiration or termination of this Agreement for any reason shall not release either Party of any obligation or liability
which, at the time of such expiration or termination, has already accrued to the other Party or which is attributable to a period
prior to such expiration or termination.


 


(ii)             
Notwithstanding anything herein to the contrary, termination of this Agreement by a Party shall be without prejudice to
other remedies such Party may have at law or equity.


 




    
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(f)                     
Surviving Sections. The following Sections shall survive expiration or termination of this Agreement for any reason:
Sections 1, 2(d), 2(e), 6, 7 and 8(b) (the latter only with respect to MSB’s restricted use and confidentiality obligations
regarding the contents of a Negotiation Request) (both for seven (7) years after termination or expiration) 9(e), 9(f), 10, and
Financial Exhibit Paragraphs II(c), (d), (e) and (f) (each for three (3) years after termination or expiration). Except as otherwise
expressly provided in this Section 9, all other rights, obligations and provisions shall expire upon the expiration or termination
of this Agreement.


 


10.             
MISCELLANEOUS


 


(a)                    
Governing Law. This Agreement will be interpreted, construed,
and enforced in all respects in accordance with the laws of the State of New York, without reference to its choice of law principles
to the contrary.


 


(b)                    
Dispute Resolution. Any dispute arising out of or related to this Agreement (any, a “Dispute”)
shall be resolved through binding arbitration, which arbitration may be initiated by either Party by written notice to the other
Party referencing the particular Dispute and this Section 10(b), on the following basis:


 


(i)                
The place of arbitration shall be New York City, New York, and all proceedings and communications shall be in English.


 


(ii)             
The arbitration shall be administered in accordance with UNCITRAL Arbitration Rules then in effect (the “Rules”).


 


(iii)           
The arbitration shall be conducted by a single arbitrator mutually agreed by the Parties, or if the Parties are unable
to agree on a single arbitrator, then a panel of three arbitrators. In each case, the arbitrators shall be neutral, independent
individuals with experience in the biopharmaceutical business related to the matter of the Dispute. Within thirty (30) days after
the notice initiating the arbitration, each Party shall appoint one arbitrator meeting the foregoing criteria by written notice
to the other Party and the two Party-appointed arbitrators shall select the third arbitrator within thirty (30) days of their
appointment. If the Party-appointed arbitrators are unable to agree upon the third arbitrator, the third arbitrator shall be appointed
in accordance with the Rules.


 


(iv)            
Judgment upon the award rendered by such arbitrator(s) shall be binding on the Parties and may be entered by any court
or forum having jurisdiction.


 


(v)              
Either Party may apply to the arbitrator(s) for interim injunctive relief until the arbitration award is rendered or the
controversy is otherwise resolved. Further, either Party also may, without waiving any remedy under this Agreement, seek from
any court having jurisdiction any injunctive or provisional relief necessary to protect the rights or property of such Party pending
the arbitration award.


 




    
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(vi)            
The arbitrator(s) shall have no authority to award punitive or any other type of damages not measured by a Party’s
compensatory damages.


 


(vii)         
Each Party shall bear its own costs and expenses and attorneys’ fees and an equal share of the arbitrator(s)’
and any administrative fees of arbitration, unless the arbitrator(s) determine that a Party has incurred unreasonable expenses
due to vexatious or bad faith position taken by the other Party, in which event, the arbitrator may make an award of all or any
portion of such expense so incurred.


 


(viii)       
Reasons for the arbitrators’ decision should be complete and explicit, including determinations of law and fact.
The written reasons should also include the basis for any damages awarded and a statement of how the damages were calculated.
Such written decision should be rendered by the arbitrator(s) following a full comprehensive hearing, as soon as practicable but
in no event later than six (6) months following the selection of the arbitrator(s) under Section 10(b)(iii).


 


(ix)            
Except to the extent necessary to confirm an award or as may be required by Applicable Law, neither Party nor any arbitrator
may disclose the existence, content, or results of an arbitration without the prior written consent of both Parties.


 


(x)              
In no event shall an arbitration be initiated after the date when commencement of a legal or equitable proceeding based
on the dispute, controversy or claim would be barred by the applicable statute of limitations; provided that such limitation shall
be tolled as of the date a Party notifies the other Party of such Dispute pursuant to this Section 10(b).


 


(c)                    
Notices. Any notice, request, delivery, approval or consent required or permitted to be given under this Agreement
shall be in writing and shall be deemed to have been sufficiently given if delivered in person, transmitted by email (receipt
confirmed) or by express courier service (signature required) or five (5) days after it was sent by registered letter, return
receipt requested (or its equivalent) two (2) days after such mailing, to the Party to which it is directed at its address shown
below or such other address as such Party will have last given by notice to the other Party. Email notice shall be provided for
any postal or certified mailing.


 





	If
    to MSB:	Mesoblast
    Limited
	 	55
    Collins Street, Level 38
	 	Melbourne
    3000
	 	Victoria
    Australia 
	 	Attention:
    Peter T. Howard, General Counsel
	 	Email:
    peter.howard@mesoblast.com
	 	Telephone:
    +61 3 8662 1710
	 	Facsimile:
    +61 3 9639 6030
	 	 
	With
    a copy to:	Wilson
    Sonsini Goodrich & Rosati, P.C.
	 	650
    Page Mill Road



 


 






    
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	 	Palo
    Alto, CA  94304-1050
	 	United
    States
	Attention:
    	Ian
    B. Edvalson, Esq.
	 	Email:
    iedvalson@wsgr.com
	 	Telephone:
    (650) 493-9300
	 	Facsimile:  (650)
    493-6811
	 	 
	If to TiGenix:	TiGenix, S.A.U.
	 	Calle Marconi 1
	 	Parque Tecnológico de
    Madrid
	 	28760 Tres Cantos (Madrid)
	 	Spain
	 	Attention: An Moonen, General
    Counsel
	 	Email: an.moonen@tigenix.com
	 	Telephone: +32 (0)16 39 79 37
	 	 
	With
    a copy to:	Bird
    & Bird LLP
	 	Avenue
    Louise 235, box 1 
	 	1050
    Brussels 
	 	Belgium
	 	Attention:
    Jean-Christophe Troussel
	 	Email:
    jtr@twobirds.com
	 	Telephone:
    +32(0)2 282 60 00
	 	Facsimile:
    +32 (0) 2 282 60 11




 



 


(d)               
Relationship of Parties. The Parties hereto are independent contractors. Nothing in this Agreement will be construed
to create a partnership, joint venture, franchise, fiduciary, employment, or agency relationship between the Parties. Neither
Party has any express or implied authority to assume or create any obligations on behalf of the other or to bind the other to
any contract, agreement, or undertaking with any Third Party.


 


(e)                
Severability. If any provision of this Agreement is found to be invalid or unenforceable, then the remainder of
this Agreement will have full force and effect, and the invalid or unenforceable provision will be modified, or partially enforced,
to the maximum extent permitted to effectuate the original objective.


 


(f)                 
Waiver. Failure or delay by either Party to enforce any term of this Agreement will not be deemed a waiver of future
enforcement of that or any other term in this Agreement or any other agreement that may be in place between the Parties. All waivers
shall be obtained in writing signed by an authorized representative of the Party granting the waiver.


 


(g)               
Assignment. This Agreement shall not be assignable by either Party to any Third Party without the written consent
of the other Party. Notwithstanding the foregoing, (i) either Party may assign this Agreement, without the written consent of
the other Party, (A) to an Affiliate of such Party or (B) to a Third Party that acquires all or substantially all of the business


 




    
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or
assets of such Party to which this Agreement pertains (whether by merger, reorganization, acquisition, sale, operation of law
or otherwise), which in the case of TiGenix would include a Third Party (including a Sublicensee) to which TiGenix has made a
global assignment of the Cx 601 Product and all of the activities and assets related thereto, and (ii) MSB has the right to assign
its right to collect payments under this Agreement, without the written consent of TiGenix, to a Third Party. No assignment or
transfer of this Agreement shall be valid and effective unless and until the assignee/transferee agrees in writing to be bound
by the provisions of this Agreement. Except as expressly provided in this Section 10(g), any attempted assignment or transfer
of this Agreement shall be null and void. Subject to the foregoing, the terms and conditions of this Agreement shall be binding
on and inure to the benefit of the permitted successors and assigns of either Party.


 


(h)               
Third Party Beneficiaries. Except as expressly provided in Section 6(a), this Agreement is not intended to confer
any right or benefit on any Third Party (including, but not limited to, any employee or beneficiary of any Party), and no action
may be commenced or prosecuted against a Party by any Third Party claiming as a third-party beneficiary of this Agreement or any
of the transactions contemplated by this Agreement. Only the Parties hereto and their permitted heirs, successors, and assigns
shall have any rights hereunder.


 


(i)                
Compliance with Applicable Law; Anti-Corruption.


 


(i)                
General. Notwithstanding anything to the contrary contained herein, all rights and obligations of MSB and TiGenix
are subject to prior compliance with, and each Party shall comply with, all Applicable Law, including obtaining all necessary
approvals required by the applicable agencies of the governments of each jurisdiction in which it operates. In addition, each
Party shall conduct, and shall require Entities acting on its behalf or under its authority to conduct, activities under this
Agreement in accordance with good scientific and business practices and Applicable Law.


 


(ii)             
Anti-Corruption. Each Party represents, warrants and covenants that (a) it has complied and will comply with Anti-Corruption
Laws, in all material respects; (b) it has not permitted and will not knowingly permit any Person acting on its behalf to violate
any Anti-Corruption Law; and (c) it and its Affiliates and their employees, agents and contractors will not make any payments
or transfer of value which have the purpose or effect of public or commercial bribery, acceptance of or acquiescence in extortion,
kickbacks, or other unlawful or improper means of obtaining or retaining business or any other improper advantage. Each Party
will promptly report to the other Party if there is a government or judicial determination of a violation of Anti-Corruption Laws
by such Party.


 


(j)                      
Entire Agreement. This Agreement, including its Exhibits, constitutes the entire agreement between the Parties with
respect to the subject matter hereof and merges and supersedes all prior agreements, understandings, negotiations, and discussions.
Neither Party will be bound by any conditions, definitions, warranties, understandings or representations with respect to the
subject matter hereof other than as expressly provided herein.


 




    
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(k)                    
Counterparts. This Agreement may be executed in counterparts, each of which will be deemed an original, and all
of which together constitute one and the same instrument.


 


[SIGNATURES
ON FOLLOWING PAGE]


 




    
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IN
WITNESS WHEREOF, the Parties have caused their duly authorized representatives to execute this Agreement as of the Effective Date.


 


 


 





	MESOBLAST, Inc.	 	MESOBLAST INTERNATIONAL SÀRL
	 	 	 	 	 
	 	 	 	 	 
	By: 	 	 	By: 	 
	Name: 	 	 	Name: 	 
	Title: 	 	 	Title: 	 
	 	 	 	 	 
	 	 	 	 	 
	TIGENIX S.A.U.	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	By: 	 	 	 	 
	Name: 	 	 	 	 
	Title: 	 	 	 	 







 




    
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EXHIBIT
A

ISSUED LICENSED PATENTS 


 


[***]


 




    
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EXHIBIT
B

PENDING LICENSED PATENTS 


 


[***]


 




    
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EXHIBIT
C

FINANCIAL EXHIBIT


 


I.                   
Milestone Payments.


 


		a)	[***].
                                         TiGenix shall pay to Mesoblast Sàrl [***] Euros per individual country (i.e.,
                                         a total maximum of five (5) million Euros) upon the earlier of (i) thirty (30) days of
                                         approval, agreement, determination or governmental decision establishing the commercial
                                         price for Royalty Product in [***] and (ii) twelve (12) months from the Effective Date.



 


		b)	[***].
                                         TiGenix shall pay to Mesoblast Sàrl [***] Euros per individual country (i.e.,
                                         a total maximum of two (2) million Euros) within thirty (30) days of the receipt of the
                                         first Marketing Approval by or on behalf of TiGenix, its Affiliate or Sublicensee for
                                         Royalty Product in [***].



 


		c)	[***].
                                         TiGenix shall pay to Mesoblast Sàrl eight (8) million Euros within thirty (30)
                                         days of the receipt of the first Marketing Approval by or on behalf of TiGenix, its Affiliate
                                         or Sublicensee for Royalty Product in [***].



 


		d)	Notice.
                                         TiGenix shall promptly notify Mesoblast Sàrl of the accomplishment of each milestone
                                         set forth in paragraph I a) – c), inclusive. The payments under this Paragraph
                                         I shall be non-refundable and non-creditable, unless provided otherwise under this Agreement.



 


II.                
Royalty Payments.


 


		a)	Royalty
                                         Payments. TiGenix shall pay to Mesoblast Sàrl quarterly royalty payments of
                                         (i) [***] percent ([***]%) of Net Sales of Royalty Product in the United States and (ii)
                                         [***] percent ([***]%) of Net Sales of Royalty Product in all other jurisdictions throughout
                                         the Territory.



 


		b)	Royalty
                                         Term. TiGenix’s royalty obligations shall commence on the Effective Date and
                                         continue in a given country for the Royalty Product until the date upon which the last
                                         Valid Claim Covering the Cx 601 Product expires in such country or, only with respect
                                         to the U.S., until the later of (i) the date upon which the last Valid Claim Covering
                                         the Cx601 Product in the U.S. expires or (ii) expiration of the Regulatory Exclusivity
                                         Period in the U.S.; provided that the period described in this clause (ii) shall not
                                         extend more than [***] after the expiration of the period in clause (i) (the “Royalty
                                         Term”). For the avoidance of doubt, and without prejudice to the above exception
                                         regarding the U.S., no royalty shall be due in any such country where there is no Valid
                                         Claim Covering the Cx 601 Product.



 


		c)	Payment/Reports.
                                         All payments under this Paragraph II shall be due and payable within thirty (30) days
                                         after receipt of a proper invoice therefor from Mesoblast Sàrl. To that effect,
                                         TiGenix shall deliver to Mesoblast Sàrl, within thirty (30) days after the last
                                         day of



 




    
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the
calendar quarter during which the corresponding Net Sales accrue (including with respect to Sublicensees) an overview of Net Sales
on a country by country basis.


 


		d)	Inspection
                                         of Records. TiGenix shall keep full and accurate books and records setting forth
                                         gross invoiced amounts for Royalty Product, Net Sales, itemized deductions from gross
                                         invoiced amounts taken to calculate Net Sales and other amounts payable hereunder to
                                         Mesoblast Sàrl under this Paragraph II. TiGenix shall permit MSB, by independent
                                         qualified public accountants (which shall not be compensated on a contingent fee basis)
                                         engaged by MSB and reasonably acceptable to TiGenix, to examine such books and records
                                         at any reasonable time and on a thirty (30) day advance notice, to the extent necessary
                                         to verify any payment or report required under this Agreement. Accountants may be required
                                         by TiGenix to enter into a reasonably acceptable confidentiality agreement. MSB shall
                                         bear the out of pocket cost of any such examination and review; provided that if the
                                         inspection and audit shows an underpayment of more than five percent (5%) of the amount
                                         due for the applicable period, then TiGenix shall promptly reimburse MSB for all costs
                                         incurred in connection with such examination and review. TiGenix shall promptly pay to
                                         Mesoblast Sàrl the amount of any underpayment revealed by an examination and review.
                                         Any overpayment by TiGenix revealed by an examination and review shall be fully-creditable
                                         against any future payment owed by TiGenix to Mesoblast Sàrl under this Paragraph
                                         II.



 


		e)	TiGenix
                                         shall also cause each Selling Party to keep full and accurate books and records so as
                                         to allow TiGenix to comply with the terms and conditions of this Agreement. For each
                                         Selling Party, TiGenix shall obtain audit rights and perform (or have performed) audits
                                         at the Selling Parties. If MSB has substantiated reasons to believe that a Selling Party
                                         is not accurately reporting Net Sales to TiGenix, it shall be entitled to ask TiGenix
                                         to perform an audit of the Selling Party’s books and records. TiGenix shall provide
                                         MSB with a copy of the findings of such audit. If the inspection and audit shows no underpayment
                                         of more than ten percent (10%) of the amount due for the applicable period, the costs
                                         of such audit shall be borne entirely by MSB. If it does, TiGenix shall pay the cost
                                         of such audit. TiGenix shall promptly pay to Mesoblast Sàrl the amount of any
                                         underpayment revealed by an examination and review. No more than one audit of a Selling
                                         Party per calendar year shall be conducted under this Agreement.



 


		f)	Late
                                         Payment. Any payments or portions thereof due hereunder which are not paid when due
                                         shall bear interest equal to the lesser of (i) the rate equal to the thirty (30) day
                                         bank lending rate effective for the date that payment was due, as published by The Wall
                                         Street Journal, Internet Edition at www.wsj.com in the “Money Rates” column,
                                         on the date such payment was due, plus an additional three hundred (300) basis points,
                                         or (ii) the maximum rate permitted by Applicable Law, calculated on the number of days
                                         such payment is delinquent. This Paragraph II(f) shall in no way limit any other remedy
                                         available to MSB.



 




    
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EXHIBIT
D


 


OPPOSITIONS
RELATING TO LICENSED PATENTS


 


[***]


 




    
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EXHIBIT
E


 


PRESS
RELEASE


 


 


 







    
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EXHIBIT
F


 


TAX
CERTIFICATE


 


[Attached
behind]


 




    
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