Blueprint






Exhibit 10.26


 



CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY [*****], HAS BEEN OMITTED BECAUSE AZURRX BIOPHARMA, INC. HAS
DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD
LIKELY CAUSE COMPETITIVE HARM TO AZURRX BIOPHARMA, INC.
IF PUBLICLY DISCLOSED.






 


 



PATENT LICENSE AGREEMENT


 


THIS PATENT LICENSE AGREEMENT (this
“Agreement”) is
entered into effective as of the 27 day of March, 2019 (the
“Effective
Date”) by and between AzurRx BioPharma, Inc., a
Delaware corporation (“Licensor”) and Laboratoires Mayoly
Spindler SAS, a corporation created and organized under French laws
(“Licensee”)
(collectively, the “Parties” and each, a
“Party”).
Capitalized terms in this Agreement not otherwise defined will have
the meaning set forth in Section 1.

 


WHEREAS, pursuant to that certain Asset
Purchase Agreement by and between Licensor and Licensee dated as of
the Effective Date (the “Asset Purchase Agreement”),
Licensee is assigning to Licensor all of Licensee’s, right,
title and interest in and to, among other things, the Licensed
Patent Rights; and

 


WHEREAS, subject to the terms and
conditions of this Agreement, Licensor wishes to grant, and
Licensee wishes to receive, an exclusive, royalty-bearing license
under the Licensed Patent Rights to Exploit the Licensed Products
solely for sale and use in the Territory; and

 


NOW, THEREFORE, in consideration of the
mutual promises and for other good and valuable consideration, the
receipt of which is hereby acknowledged, the Parties agree as
follows:

 





1.

DEFINITIONS





 



The
following definitions will control the construction of each of the
following items wherever they appear in this
Agreement.

 


1.1 “Affiliate”
means, 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 corporation or other entity shall be
regarded as in control of another corporation or entity if it owns
or directly or indirectly controls more than 50% of the voting
securities or other ownership interest of the other corporation or
entity, or if it possesses, directly or indirectly, the power to
direct or cause the direction of the management and policies of the
corporation or other entity.

 

1.2 “Applicable
Law” means any laws, treaties, statutes, ordinances,
judgments, decrees, directives, rules, injunctions, writs,
regulations, binding arbitration rulings, orders, judicial or
administrative interpretations or authorization of any Governmental
Authority applicable to the manufacture, distribution, promotion,
marketing, handling, storage and/or sale of and/or sale of any
Licensed Product or the performance of either Party’s
obligations under this Agreement, in each case to the extent
applicable and relevant to such Party.

 

1.3 “Commercially
Reasonable Efforts” means, with respect to activities
that Licensee is required to perform hereunder with respect to
Licensed Products, the level of effort that would generally be used
by a similarly-situated company to conduct such activities for any
product owned by it or to which it has rights, which is of
comparable market potential, profit potential or strategic value to
such party and is at a similar stage in its development or product
life, taking into account, without limitation, issues of safety and
efficacy, product profile, the proprietary position, the
then-current competitive environment for such product, the likely
timing of the product’s entry into the market, the then
current market penetration, the return on investment potential of
such product, the regulatory environment and status of the product,
and other relevant scientific, technical and commercial factors, in
each case as measured by the facts and circumstances at the time
such efforts are due.


 


   







 

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1.4 “Exploit”
means to register, manufacture or have manufactured, sell, offer
for sale, and “Exploitation” has a correlative
meaning.

 

1.5 “Governmental
Authority” means any court, governmental agency,
department or commission or other governmental authority or
instrumentality, including, but not limited to, the United States
Food and Drug Administration.

 

1.6 “IFRS” shall mean
International Financial Reporting Standards applied on a consistent
basis.

 

1.7 “License
Term” means the period that begins on the Effective
Date and ends, on a country-by-country basis with respect to the
countries in the Territory, on the date on which all Valid Claims
applicable to Licensed Products that are sold or sued in such
country have expired, have been held unenforceable or invalid
and/or have been abandoned.

 

1.8 “Licensed
Patent Rights” means: (i) the patents and patent
applications in the Territory that are set forth on Appendix A hereto, (ii) any divisional,
continuation and continuation-in-part (excluding new matter)
applications in the Territory that claim priority based on any of
the patents and patent applications set forth on Appendix A and (iii) any patents in the
Territory that may issue from any of the foregoing, and any
reexamination certificates, corrections, extensions, renewals and
reissues with respect to any of the foregoing (in each case, solely
within the Territory).

 

1.9 “Licensed
Product” means any product or service or component of
either of the foregoing, the Exploitation of which would, in the
absence of the license granted to Licensee hereunder, infringe at
least one Valid Claim (whether such Valid Claim is in an issued
patent or a pending patent application).

 

1.10 “Net
Sales” means the gross amounts invoiced by Licensee,
any of its Affiliates or any Sublicensee for sales of a Licensed
Product for use in a given country during the License Term that
applies to such country to customers who are not Affiliates of
Licensee or Sublicensees, less the following deductions
determined in accordance with IFRS, as consistently applied by
Licensee (or, if applicable, its Affiliate or a Sublicensee), to
the extent such deduction is for an amount that was included in the
invoiced amount of Licensed Product sales:

 






(i) 

trade, quantity and
cash discounts, coupons, rebates and other price reductions for the
Licensed Product;





 



(ii) 

credits and
allowances for rejection or return of Licensed Products previously
sold;





 



(iii) 

amounts written off
as bad debt; and





 



(iv) 

sales and
value-added taxes and other taxes and governmental charges related
to sale of the Licensed Product (but not including taxes assessed
against the net income derived from such sale).





 


1.11 “Person”
means an individual, corporation, partnership, limited liability
company, trust, business trust, association, joint venture,
non-profit organization, pool, syndicate, sole proprietorship,
unincorporated organization, university, Governmental Authority or
any other form of entity not specifically listed
herein.

 


 




 



CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY [*****], HAS BEEN OMITTED BECAUSE AZURRX BIOPHARMA, INC. HAS
DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD
LIKELY CAUSE COMPETITIVE HARM TO AZURRX BIOPHARMA, INC.
IF PUBLICLY DISCLOSED.


 


 

-2-








 





  



1.12 “Sublicensee”
means: (i) any Third Party that has entered into an agreement with
Licensee or any of its Affiliates sublicensing to such Third Party
any of the rights granted to Licensee by Licensor pursuant to
Section 2.1 and
(ii) any other Third Party that has entered into a license
agreement with any other Sublicensee sublicensing to such Third
Party the rights granted to such Sublicensee.

 

1.13 “Territory”
means [*****].

 

1.14 “Third
Party” mean any Person other than Licensee, Licensor
or any of their respective Affiliates.

 

1.15 “Valid
Claim” means a claim of: (i) an issued and
unexpired patent that is included in the Licensed Patent Rights,
which claim has not been revoked or held unenforceable or invalid
by a decision of a court of governmental agency of competent
jurisdiction from which no further appeal can be taken or has been
taken within the time allowed for appeal or (ii) a pending patent
application that is included in the Licensed Patent Rights which
was filed and is being prosecuted in good faith and has not been
abandoned or finally disallowed without the possibility of appeal
or re-filing of the application (provided that such prosecution has
not been ongoing for more than seven (7) years from the date of
entry into the national stage or request for reexamination,
whichever is later, with respect to such claim in such
country).

 

1.16 Additional
Definitions. Each of the following terms is defined in the
Section set forth opposite such term:

 





	


Term

	


Section


	

Agreement

	

Preamble


	

Asset
Purchase Agreement

	

Recitals


	

Applicable
Infringement

	

6.2


	

Effective
Date

	

Preamble


	

Invalidity
Claim

	

6.4


	

Licensee

	

Preamble


	

Licensor

	

Preamble


	

Licensor
Indemnitees

	

8.1


	

Losses

	

8.1


	

Parties

	

Preamble


	

Party

	

Preamble


	

Remaining
Funds

	

6.2(ii)


	

Royalty
Statement

	

4.3


	

Royalties

	

4.1


	

Sell-Off
Period

	

5.3.2


	

Sublicense
Income

	

4.2


	

Sublicense
Income Payments

	

4.2


	

Term

	

5.1


	

Third
Party Claims

	

8.1






 




2.

LICENSE
GRANT






 








 



CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY [*****], HAS BEEN OMITTED BECAUSE AZURRX BIOPHARMA, INC. HAS
DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD
LIKELY CAUSE COMPETITIVE HARM TO AZURRX BIOPHARMA, INC.
IF PUBLICLY DISCLOSED.


 


 

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2.1 License
Grant. Licensor hereby grants to Licensee, during the
License Term, an exclusive (subject to Section 2.2),
sub-licensable, royalty-bearing (as provided in Section 4), non-transferable
(except as permitted under Section 10.7) license under the
Licensed Patent Rights, to Exploit any Licensed Products, solely
for sale and use in the Territory.

 

2.2 Exclusivity. During
the Term, Licensor shall not itself market, sell, offer for sale,
and shall not grant any right to any of its Affiliates or to any
Third Party to market, sell, offer for sale, any Licensed Product
in the Territory. For the avoidance of doubt, during the Term,
Licensor shall refrain from using the right to Exploit (and to
license any Third Party to use and/or to Exploit) any and all
Licensed Patent Rights that it has in connection with any Licensed
Product to sell or commercialize Licensed Products in the
Territory. This Section 2.2 shall not apply to a country in the
Territory to the extent that the license granted under this
Agreement has expired with respect to such country. It shall not be
a breach of this Section 2.2 or of Section 2.1 for Licensor to
develop, use, import or manufacture Licensed Products or to use any
Licensed Patent Rights, in each case, in the Territory solely in
connection with the development of a Licensed Product and/or for
commercialization of a Licensed Product outside of the
Territory.

 

2.3 Sublicenses.
Licensee will notify Licensor in writing of each proposed
Sublicensee and will provide Licensor with a copy of the applicable
sublicense agreement promptly after the execution of the sublicense
agreement. Licensee will ensure that the rights granted to each
Sublicensee do not conflict with the provisions of this Agreement,
and will be responsible to Licensor for the performance of each
Sublicensee.

 

2.4 Reservation
of Rights. Licensor reserves all rights not expressly
granted to Licensee hereunder. Without limiting the foregoing,
Licensor reserves the right to use (and to license any Third Party
to use) any and all Licensed Patent Rights in connection with any
Licensed Product for sale or use outside the
Territory.

 




3.

DEVELOPMENT,
MANUFACTURING AND COMMERCIALIZATION





 


3.1 Generally.
Licensee (itself or through Sublicensees) will use Commercially
Reasonable Efforts to Exploit one or more Licensed Products for
sale in the Territory. Licensee shall be solely responsible, at its
expense, for all regulatory, marketing, promotional and pricing
activities in connection with the Licensed Products for sale in the
Territory. Licensee shall be responsible for obtaining marketing
authorization in each country in the Territory at its sole cost and
expense. At Licensor’s request, Licensee will, or will cause
its Sublicensee to, enter into a pharmacovigilance agreement and
any other reasonable or customary agreement that would be necessary
to ensure the safe administration of the Licensed
Product.

 

3.2 Minimum
Sales Milestone. Licensee will use Commercially Reasonable
Efforts to achieve [*****].

 

3.3 No
Sales Outside Territory. Licensee will (and will require
each Sublicensee to) use its best efforts to ensure that no
Licensed Products manufactured or distributed by or on behalf of
Licensee or any Sublicensee are introduced into any market outside
the Territory. If Licensee becomes aware that any such Licensed
Products are introduced to any market outside the Territory,
Licensee will promptly notify Licensor and will reasonably
cooperate with Licensor to stop the distribution and sale of such
Licensed Products outside the Territory.


 


 




 



CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY [*****], HAS BEEN OMITTED BECAUSE AZURRX BIOPHARMA, INC. HAS
DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD
LIKELY CAUSE COMPETITIVE HARM TO AZURRX BIOPHARMA, INC.
IF PUBLICLY DISCLOSED.


 


 

-4-








 





   


3.4 Manufacturing.
Licensee shall have the sole responsibility for, subject to
compliance with this Agreement and at its sole cost and expense,
all manufacturing-related activities (including, but not limited
to, all activities required to qualify a manufacturer and/or to
enable the manufacture of Licensed Product) related to the sale of
commercial Licensed Product in the Territory. Licensee will ensure
that Licensed Product manufactured by or on behalf of it or
Sublicensee will be manufactured in accordance with all Applicable
Laws, including, but not limited to, current good manufacturing
practices. Should Licensor establish manufacturing operations
through a Third Party manufacturer for the sale of Licensed Product
outside of the Territory, Licensor shall, at Licensee’s
request, agree to negotiate in good faith a supply agreement (that,
if it is receiving supply from a Third Party, substantially
reflects its general supply terms) with Licensee for the Territory
on a cost plus basis. Should Licensee decide to manufacture or have
manufactured Licensed Product itself, Licensor shall reasonably
assist Licensee, at Licensee’s expense (at a rate to be
agreed between the parties in good faith) with its efforts to
enable the manufacture of Licensed Product for use in the
Territory.

 




4.

FINANCIAL
TERMS





 

 

4.1 Royalties.
Licensee shall pay Licensor royalties equal to [*****] of Net Sales
(the “Royalties”). For the avoidance of
doubt, the definition of Net Sales includes sales of Licensed
Product by any Sublicensee (as well as sales by Licensee and its
Affiliates).

 

4.2 Sublicense
Income Payments. Licensee will pay Licensor [*****] of any
up-front fees, milestone payments and other amounts (other than
amounts included in Net Sales for which Royalties shall be payable
as set forth in Section 4.1) received by Licensee or any of its
Affiliates from any Sublicensee in consideration of the
sublicensing of any Licensed Patent Rights (the “Sublicense Income”) within
forty-five (45) days of the Sublicensee’s payment of such
Sublicense Income to Licensee or its Affiliate. Such payments to
Licensor are referred to herein as “Sublicense Income
Payments”.

 

4.3 Royalty
Statements: Within thirty (30) days after the end of each
calendar quarter during the License Term during which any Net Sales
are earned, Licensee will deliver to Licensor a complete and
accurate report, giving such particulars of the business conducted
during the preceding quarter under this Agreement as are pertinent
to an accounting of Royalties that may be due to Licensor under
this Agreement (the “Royalty
Statement”). The Royalty Statement will include the
following information:

 








(a)

the
units of Licensed Product sold by Licensee, its Affiliates and any
Sublicensees during such quarter;





 





(b)

gross
sales for the Licensed Product by Licensee and any Sublicensees for
such calendar quarter;





 





(c)

a
detailed breakdown by category of deduction of the deductions taken
from such gross sales amounts and the calculation of Net Sales for
such calendar quarter;





 





(d)

a
breakdown of Royalties due based on such Net Sales;





 





(e)

any
Sublicense Income payments received from any Sublicensee;
and





 

 




 



CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY [*****], HAS BEEN OMITTED BECAUSE AZURRX BIOPHARMA, INC. HAS
DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD
LIKELY CAUSE COMPETITIVE HARM TO AZURRX BIOPHARMA, INC.
IF PUBLICLY DISCLOSED.


 


 

-5-








 





 








(f)

a
copy of each report from each Sublicensee as may be pertinent to an
accounting of royalties and other payments that are due to
Licensor.





 


4.4 Records
and Audits. Licensee and its Affiliates will keep (and
Licensee will cause any Sublicensees to keep) such books of account
containing such particulars as may be reasonably necessary for the
purpose of showing the amounts payable to Licensor under this
Agreement during the most recent three (3) year period. During the
License Term and for one (1) year thereafter, Licensee and its
Affiliates will make (and Licensee will cause any Sublicensees to
make) such books of account available (no more than once per year
upon reasonable prior, written notice to Licensee) for inspection
by Licensor and/or its designated accounting firm, for the purpose
of verifying Licensee’s Royalty Statements. Licensor will be
responsible for the cost of any such inspection; provided, however, that if an inspection
shows for any year an underpayment in excess of [*****] of
Royalties and Sublicense Income Payments payable with respect to
any calendar year, then Licensee will reimburse Licensor for the
reasonable, documented out-of-pocket expenses incurred by Licensor
to conduct the inspection. In the event that any such inspection
reveals an underpayment in the amount of Royalties and/or
Sublicense Income Payments that should have been paid by Licensee
to Licensor, then the underpaid amount will be paid within ten (10)
business days after Licensor makes a demand therefor. Licensor will
cause its accounting firm to retain all information subject to
review under this Section in strict confidence. In addition,
Licensee will have the right to require that such accounting firm,
prior to conducting such inspection, enter into a reasonable
non-disclosure agreement with Licensee regarding such
information.

 

4.5 Form
of Payment; Currency Conversions. All payments under this
Agreement will be non-refundable and non-creditable, and will be
paid in United States dollars by wire transfer or electronic funds
transfer to such bank account as Licensor may from time-to-time
designate by notice. For the purposes of determining Royalties and
Sublicense Income Payments, Net Sales or Sublicense Income (as
applicable) shall first be determined in the currency in which such
Net Sales or Sublicense Income are earned and then converted to its
equivalent in United States currency. The buying rates of exchange
for the currencies involved into the currency of the United States
quoted by Citibank (or its successor in interest) in New York, New
York or any source of information agreed to by the Parties in
writing, at the close of business on the last business day of the
quarterly period in which the Net Sales were earned shall be used
to determine any such conversion.

 

4.6 Late
Payments. Interest will accrue on payments that are not
disputed in good faith or paid when due from the date such payments
are due at the prime rate of interest, as published in The Wall
Street Journal (Eastern United States Edition) (or if such rate
exceeds the maximum rate permitted by Applicable Law, the such
lesser rate as is the maximum rate allowed pursuant to Applicable
Law).

 

4.7 Taxes.
Licensee will be responsible for all sales, use, value-added and
other taxes, customs duties and other governmental charges with
respect to the transactions contemplated by this Agreement, other
than any income taxes of Licensor. The amounts payable by Licensee
to Licensor pursuant to this Agreement will not be reduced on
account of any taxes unless required by Applicable Law. Any taxes,
duties, or other levies which Licensee is required by Applicable
Law to withhold on remittance of any payment(s) due under this
Agreement will be deducted from such payment(s) to Licensor and
timely paid to the appropriate taxing authority. Licensee will
secure and send to Licensor proof of any such taxes, duties or
other levies withheld and paid by Licensee for the benefit of
Licensor, and cooperate, at Licensor’s expense, with any
reasonable request to help ensure that amounts withheld and/or paid
are reduced and/or recovered to the extent permitted by the
relevant jurisdiction.

 





 




 



CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY [*****], HAS BEEN OMITTED BECAUSE AZURRX BIOPHARMA, INC. HAS
DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD
LIKELY CAUSE COMPETITIVE HARM TO AZURRX BIOPHARMA, INC.
IF PUBLICLY DISCLOSED.


 


 

-6-








 





 




5.

TERM
AND TERMINATION





 


5.1 Term.
This Agreement will become effective on the Effective Date and will
remain in effect until the end of the License Term, unless and
until terminated pursuant to Section 5.2 (the “Term”).

 

5.2 Termination.

 




5.2.1

Termination for Convenience by Licensee.
Licensee may terminate this Agreement at any time upon three (3)
months prior, written notice to Licensor.





 




5.2.2

Termination for Material Breach. This
Agreement may be terminated upon ninety (90) days prior written
notice by either Party if the other Party materially breaches any
of the terms, conditions or provisions of this Agreement and fails
to remedy the breach within such ninety (90) day
period.





 




5.2.3

Termination for Challenge to Licensed Patent
Rights. If Licensee, its Affiliate or Sublicensee challenges
the validity or enforceability of any of the Licensed Patent Rights
in any forum through any means, or otherwise indicate the payment
of any royalty due under this Agreement is made under protest or
with any objection on account of a claim by Licensee, its Affiliate
or Sublicensee that any of the Licensed Patent Rights are invalid
or unenforceable, Licensee agrees that Licensor shall have the
right, but not the obligation, in addition to any other remedy it
may have available to it at law and/or in equity, to terminate this
Agreement immediately upon providing written notice of the same to
Licensee.





 

5.3 Effect
of Expiration or Termination. In the event of any expiration
or termination of this Agreement:

 




5.3.1

Upon any
termination of this Agreement, the license granted to Licensee
under Section 2.1
shall terminate, subject to Section 5.3.2
below.





 




5.3.2

Notwithstanding
anything to the contrary, for one hundred eighty (180) days
following the effective date of any termination of this Agreement
(the “Sell-Off
Period”), Licensee (and its Affiliates and any
Sublicensees) shall have the right, but not the obligation, to
sell-off any excess Licensed Product that was manufactured or on
order prior to the effective date of termination. Any revenues
during the Sell-Off Period in connection with the sale of Licensed
Products shall be subject to the Royalty payment provisions set
forth herein.





 

5.4 Survival.
The following provisions shall survive any expiration or
termination of this Agreement: Section 1
(“Definitions”), Section 4.1
(“Royalties”) (to the extent provided in Section 5.3), Section 4.4 (“Records and
Audits”), Section
4.5 (“Form of Payment; Currency Conversions”),
Section 4.6
(“Late Payments”), Section 4.7
(“Taxes”), Section 5.3 (“Effect of
Expiration or Termination”), this Section 5.4
(“Survival”), Section 7.2
(“Disclaimer”), Section 8
(“Indemnification”), Section 9
(“Liability”) and Section 10
(“Miscellaneous Provisions”).

 







6.

PROSECUTION,
MAINTENANCE, ENFORCEMENT AND DEFENSE OF LICENSED INTELLECTUAL
PROPERTY





 

 




 



CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY [*****], HAS BEEN OMITTED BECAUSE AZURRX BIOPHARMA, INC. HAS
DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD
LIKELY CAUSE COMPETITIVE HARM TO AZURRX BIOPHARMA, INC.
IF PUBLICLY DISCLOSED.


 


 

-7-








 





 





6.1 Prosecution
and Maintenance. Licensor shall be responsible for, and
shall use its commercially reasonable efforts in connection with,
the prosecution and maintenance of any patent applications and
patents included in the Licensed Patent Rights in each country in
the Territory (to the extent such Licensed Patent Rights are
currently registered in such country in the Territory). Licensor
shall bear all fees, costs or expenses incurred in connection with
its obligations under the prior sentence. In the event that the
Licensor cannot afford or does not want to assume the prosecution
or maintenance fees, costs and expenses, it may ask the Licensee to
reimburse it for such fees, costs and expenses and Licensee shall
reimburse such amounts within thirty (30) days of the relevant
request; provided that, the Licensee shall be entitled to offset
the amount reimbursed by Licensee to Licensor from the Royalties
paid by Licensee to Licensor as set forth in Article
4.

 

6.2 Notice
and Prosecution of Applicable Infringements. During the
Term, if either Party learns of any potential infringement of the
Licensed Patent Rights in the Territory (an “Applicable Infringement”), such
Party shall promptly notify the other Party in writing and shall
promptly provide such other Party with available evidence of such
Applicable Infringement. Licensee shall have the first right, but
not the obligation, to attempt to resolve such alleged Applicable
Infringement at its own expense, including without limitation the
filing of an infringement suit using counsel of its own choice. If
Licensee does not secure cessation of such Applicable Infringement
nor institute an infringement proceeding against an offending Third
Party within one-hundred and eighty (180) days of learning of such
Infringement (or if Licensee earlier determines that it does not
wish to take action with respect to such Applicable Infringement
and notifies Licensor of such), then Licensor may at its option and
cost institute and control proceedings relating to such Applicable
Infringement. Each Party shall execute all necessary and proper
documents, take such actions as shall be appropriate to allow the
other Party to institute and prosecute such Applicable Infringement
actions and shall otherwise cooperate in the institution and
prosecution of such actions (including, without limitation,
consenting to being named as a party thereto). Any award paid by
Third Parties as a result of an Applicable Infringement action
undertaken pursuant to Section 6.2 (whether by
way of settlement or otherwise) shall be allocated as
follows:

 







(i)

the
Party that has instituted and maintained such action, shall be
entitled first to deduct all costs and expenses incurred by such
party with respect to such action and from any remainder shall
reimburse the other Party for any costs and expenses incurred by
such other Party with respect to such action; and





 




(ii)

if after such deduction, reimbursement and payment
any funds remain (the “Remaining
Funds”), such Remaining
Funds will be shared fifty percent (50%) to Licensee and fifty
percent (50%) to Licensor.





 


6.3 Acknowledgement.
For the avoidance of doubt, Licensor shall have the sole right, but
not the obligation, in Licensor’s sole and absolute
discretion, to attempt to resolve any potential infringement of the
Licensed Patent Rights that is not covered by the definition of
Applicable Infringement.

 

6.4 Invalidity
Claims. If a Third Party at any time asserts a claim that
any of the Licensed Patent Rights is invalid or otherwise
unenforceable (an “Invalidity
Claim”), whether as a defense in an infringement
action brought by either Party pursuant to Section 6.2 or otherwise, the
Parties shall cooperate with respect to such Invalidity Claim, and
Licensor shall, in consultation with Licensee (but subject to
Licensor’s final decision on all matters) and at
Licensor’s cost, use Commercially Reasonable Efforts to
contest, and if necessary settle such Invalidity
Claim.


 


 




 



CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY [*****], HAS BEEN OMITTED BECAUSE AZURRX BIOPHARMA, INC. HAS
DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD
LIKELY CAUSE COMPETITIVE HARM TO AZURRX BIOPHARMA, INC.
IF PUBLICLY DISCLOSED.


 


 

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7.

REPRESENTATIONS
AND WARRANTIES; DISCLAIMER





 


7.1 Mutual
Representations and Warranties. Each Party makes the
following representations and warranties to the other Party as of
the Effective Date:

 




7.1.1

Organization. Such Party (i) is a
company validly existing and in good standing under the laws of the
jurisdiction where such company was formed or incorporated, and
(ii) has all necessary company power and authority to own its
properties and to conduct its business, as currently
conducted.





 




7.1.2

Authorization. The execution and
delivery of this Agreement and the consummation of the transactions
contemplated hereby are within the company power of such Party,
have been duly authorized by all necessary company proceedings of
such Party, and this Agreement has been duly executed and delivered
by such Party.





 




7.1.3

No Conflict. The execution and delivery
of this Agreement and the consummation of the transactions
contemplated hereby do not: (i) conflict with or result in a
breach of any provision of such Party’s organizational
documents; (ii) result in a material breach of any material
agreement to which such Party is bound; (iii) result in a
violation of any order to which such Party is subject;
(iv) require such Party to obtain any material approval or
consent from any governmental authority or other Third Party other
than those consents and approvals which have been obtained prior to
the date hereof; or (v) violate any Applicable Law applicable
to such Party in any material respect.





 




7.1.4

Enforceability. This Agreement
constitutes the valid and binding obligation of such Party,
enforceable against such Party in accordance with its terms,
subject to bankruptcy, reorganization, insolvency and other similar
laws affecting the enforcement of creditors’ rights in
general and to general principles of equity (regardless of whether
considered in a proceeding in equity or an action at
law).





 

7.2 Disclaimer.
EXCEPT AS SET FORTH IN THIS SECTION 7 AND WITHOUT LIMITING
ANY REPRESENTATIONS AND WARRANTIES MADE BY LICENSEE IN THE ASSET
PURCHASE AGREEMENT, NEITHER PARTY MAKES, AND EACH HEREBY EXPRESSLY
DISCLAIMS, ANY AND ALL REPRESENTATIONS AND WARRANTIES OF ANY KIND
ARISING FROM OR RELATING TO THIS AGREEMENT OR SUCH PARTY’S
PERFORMANCE HEREUNDER, OR THE LICENSED PATENT RIGHTS OR ANY
LICENSED PRODUCT, EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT
LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR
A PARTICULAR PURPOSE, NON-INFRINGEMENT AND ANY REPRESENTATIONS OR
WARRANTIES ARISING FROM A COURSE OF DEALING, COURSE OF PERFORMANCE
OR USAGE OF TRADE.

 




8.

INDEMNIFICATION





 


8.1 Indemnity
by Licensee. Licensee shall defend, at its cost, indemnify
and hold harmless Licensor and its Affiliates, and their respective
members, managers, directors, employees, officers and agents
(collectively, the “Licensor
Indemnitees”) from and against any and all liability,
demands,


 




 



CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY [*****], HAS BEEN OMITTED BECAUSE AZURRX BIOPHARMA, INC. HAS
DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD
LIKELY CAUSE COMPETITIVE HARM TO AZURRX BIOPHARMA, INC.
IF PUBLICLY DISCLOSED.


 


 

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damages, fines,
costs and expenses (including, without limitation reasonable legal
fees and expenses) and losses (including, without limitation, with
respect to death, personal injury, illness or property damage)
(collectively, “Losses”), in connection with any
Third Party claim, complaint, demand, suit, action, investigation
or proceeding (collectively, “Third Party Claims”) to the extent
arising from (i) the Exploitation of any Licensed Product by or on
behalf of Licensee, any of its Affiliates or any Sublicensee or
(ii) breach by Licensee of any representation, warranty, covenant
or other provision set forth in this Agreement.

 

8.2 Indemnity
Procedures. In the event that Licensor intends to seek
indemnification for any Third Party Claim under Section 8.1, Licensor shall
inform Licensee of the Third Party Claim promptly after receiving
notice of the Third Party Claim; provided, however, that any failure to
provide such notice shall not relieve Licensee of its obligations
under this Section
8.1 except to the extent the Licensee is materially
prejudiced by such failure. Licensor shall permit Licensee to
direct and control the defense of such Third Party Claim and shall
provide such reasonable assistance as is reasonably requested by
Licensee (at Licensee’s cost) in the defense of the Third
Party Claim, provided that nothing in this Section 8.2 shall permit
Licensee to make any admission on behalf of any Licensor
Indemnitee, or to settle any claim or litigation which would impose
any financial obligations on any Licensor Indemnitee without the
prior, written consent of Licensor, such consent not to be
unreasonably withheld or delayed.

   





9.

LIABILITY





 


9.1 Liability
Exclusion. NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY
FOR ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT, SPECIAL, PUNITIVE OR
EXEMPLARY DAMAGES (INCLUDING DAMAGES FOR LOSS OF BUSINESS, LOSS OF
PROFITS OR THE LIKE) ARISING OUT OF OR RELATING TO THIS AGREEMENT
OR SUCH PARTY’S PERFORMANCE HEREUNDER, EVEN IF SUCH PARTY HAS
BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES AND REGARDLESS OF
THE CAUSE OF ACTION (WHETHER IN CONTRACT, TORT, BREACH OF WARRANTY
OR OTHERWISE), AND NOTWITHSTANDING ANY FAILURE OF THE ESSENTIAL
PURPOSE OF ANY LIMITED REMEDY PROVIDED HEREIN.

 

9.2 Limitation
on Damages. EACH PARTY’S MAXIMUM CUMULATIVE LIABILITY
ARISING OUT OF OR RELATING TO THIS AGREEMENT OR SUCH PARTY’S
PERFORMANCE HEREUNDER, REGARDLESS OF THE CAUSE OF ACTION (WHETHER
IN CONTRACT, TORT, BREACH OF WARRANTY OR OTHERWISE), WILL NOT
EXCEED THE AGGREGATE AMOUNTS PAID TO LICENSOR BY LICENSEE UNDER
THIS AGREEMENT DURING THE ONE (1) YEAR PERIOD PRECEDING THE DATE ON
WHICH SUCH CLAIM ARISES.

 

9.3 Exceptions. Notwithstanding anything to
the contrary, the exclusions and limitations of liability set forth
in Section 9.1 and
Section 9.2 will
not apply: (i) to the extent that acts or omissions of a Party
constitute fraud, willful misconduct, or the infringement or
misappropriation of the other Party’s intellectual property
rights, (ii) Licensee’s indemnity and defense obligations
under Section 8.1
with respect to Third Party Claims or (iii) Licensee’s
payment obligations under this Agreement.

 




10.

MISCELLANEOUS





 


 




 



CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY [*****], HAS BEEN OMITTED BECAUSE AZURRX BIOPHARMA, INC. HAS
DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD
LIKELY CAUSE COMPETITIVE HARM TO AZURRX BIOPHARMA, INC.
IF PUBLICLY DISCLOSED.


 


 

-10-








 





   


10.1 Compliance
with Applicable Laws. Each Party agrees that it will comply
with all Applicable Laws in carrying out its responsibilities under
this Agreement.

 

10.2 Publicity.
Any press releases regarding the relationship contemplated by this
Agreement will be mutually agreed upon by the Parties (such
agreement not to be unreasonably withheld or delayed by either
Party); provided, however, that notwithstanding the foregoing (a)
either Party may disclose to Third Parties or otherwise publicize
the fact that Licensor has granted Licensee a license to Exploit
the Licensed Patent Rights for the Licensed Product in the
Territory and (b) nothing in this Agreement will prohibit a Party
from disclosing this Agreement or the relationship contemplated by
this Agreement to the extent required under applicable federal or
state securities laws or any rule or regulation of any nationally
recognized securities exchange.

 

10.3 Relationship
of the Parties. The Parties are and will be independent
contractors and neither Party has any right, power or authority to
act or create any obligation on behalf of the other
Party.

 

10.4 Notices.
All notices and other communications required or permitted to be
given or made pursuant to this Agreement shall be in writing signed
by the sender and shall be deemed duly given: (a) on the date
delivered, if personally delivered, (b) on the date sent by
facsimile with automatic confirmation by the transmitting machine
showing the proper number of pages were transmitted without error,
(c) on the Business Day after being sent by Federal Express or
another recognized overnight mail service which utilizes a written
form of receipt for next day or next business day delivery, or (d)
upon receipt after mailing, if mailed by United States
postage-prepaid certified or registered mail, return receipt
requested, in each case addressed to the applicable party at the
address set forth below; provided that a Party may change its
address for receiving notice by the proper giving of notice
hereunder:

 


if
to Licensor, to:


 


AzurRx
Biopharma, Inc.


760
Parkside Avenue


Downstate
Biotechnology Incubator


Suite
304


Brooklyn, NY
11226


Tel:
646-699-7855


info@azurrx.com



 


with
a copy to:


 


Lowenstein Sandler
LLP


One
Lowenstein Drive


Roseland, New
Jersey 07068


Facsimile: (973)
597-2400


Attn:
Michael J. Lerner, Esq.

 


if
Licensee, to:


 


 




 



CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY [*****], HAS BEEN OMITTED BECAUSE AZURRX BIOPHARMA, INC. HAS
DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD
LIKELY CAUSE COMPETITIVE HARM TO AZURRX BIOPHARMA, INC.
IF PUBLICLY DISCLOSED.


 


 

-11-








 






 


Laboratoires Mayoly
Spindler


6 avenue de
l'Europe,


78401
Chatou, France


Attention:
President


 


with a
copy to:


 


Laboratoires Mayoly
Spindler


6 avenue de
l'Europe,


78401
Chatou, France


Attention: Legal
Department

 

10.5 Unenforceable
Provisions. If any provision of this Agreement is held
invalid or unenforceable by any court of competent jurisdiction,
the other provisions of this Agreement will remain in full force
and effect, and, if legally permitted, such offending provision
shall be replaced with an enforceable provision that as nearly as
possible effects the Parties’ intent.

 

10.6 Waiver
and Amendment. No amendment or modification of
any provision hereof will be effective unless in writing and signed
by both Parties. No failure or delay by either Party in exercising
any right, power, or remedy hereunder will operate as a waiver of
any such right, power or remedy nor create an expectation of
non-enforcement of that or any other provision or right. No waiver
of any provision hereof will be effective unless in a signed
writing by the person charged with making such waiver.

 

10.7 Assignment. Neither
Party may transfer or assign this Agreement or assign any rights
hereunder or delegate any duties hereunder without the other
Party’s prior, written consent, such consent not to be
unreasonably withheld. Notwithstanding the foregoing, (A) either
Party may transfer or assign this Agreement, without any
requirement to obtain the other Party’s consent: (i) to any
of its Affiliates or (ii) in connection with any merger,
consolidation, sale of all or substantially all assets, sale of
equity interests or other change of control transaction involving
such Party or such Party’s line of business to which this
Agreement relates and (B) Licensor shall be entitled to assign the
right to receive Royalties to any Third Party. Subject to the
foregoing, this Agreement will bind and inure to the benefit of the
Parties and their respective successors and permitted
assigns.

 

10.8 Governing
Law. This Agreement and all matters arising directly or
indirectly herefrom shall be governed by and construed and enforced
in accordance with the laws of the State of New York, U.S.A.
applicable to agreements made and to be performed entirely in such
state, without giving effect to the conflict of law principles
thereof.

 

10.9 Jurisdiction;
Venue, Service of Process. Licensor and Licensee each agrees
to irrevocably submit to the sole and exclusive jurisdiction of the
state and federal courts located in New York County, New York,
U.S.A. for any suit, action or other proceeding arising out of this
Agreement or any transaction contemplated hereby, and hereby waives
any objection to the laying of venue in such courts. Each Party
agrees that service of any process, summons, notice or document by
U.S. registered mail or recognized international courier service to
such Party’s address set forth in this Agreement shall be
effective service of process.

 

10.10 Entire
Agreement. This Agreement constitutes the
final, complete and exclusive agreement of the Parties concerning
the subject matter hereof, and supersedes all previous
agreements,


 




 



CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY [*****], HAS BEEN OMITTED BECAUSE AZURRX BIOPHARMA, INC. HAS
DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD
LIKELY CAUSE COMPETITIVE HARM TO AZURRX BIOPHARMA, INC.
IF PUBLICLY DISCLOSED.


 


 

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communications,
representations and understandings, either oral or written, between
the Parties relating to the subject matter hereof.

 

10.11 Headings.
The headings of the several articles are inserted for convenience
of reference only and are not intended to be a part of or to affect
the meaning or interpretation of this Agreement.

 

10.12 Counterparts.
This Agreement may be executed in two or more counterparts (which
may be exchanged by facsimile or via email .pdf copies), each of
which shall be deemed an original, but all of which together shall
constitute one and the same instrument.

 



(signature page follows)

 

 


 

 




 



CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY [*****], HAS BEEN OMITTED BECAUSE AZURRX BIOPHARMA, INC. HAS
DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD
LIKELY CAUSE COMPETITIVE HARM TO AZURRX BIOPHARMA, INC.
IF PUBLICLY DISCLOSED.


 


 

-13-








 





 






IN WITNESS WHEREOF, the Parties have executed this Agreement
by their duly authorized representatives.

 


	


AZURRX BIOPHARMA, INC.

	


LABORATOIRES MAYOLY SPINDLER SAS


	

 



By: /s/ Thijs
Spoor

	

 



By: /s/ Claude
Brunet

	
 


	


Name: Thijs Spoor

	


Name: Claude Brunet

	
 


	


Title: President & CEO

	


Title: Chief Executive Officer

	
 














 


 


 



[signature page to Patent License Agreement]


 





CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY [*****], HAS BEEN OMITTED BECAUSE AZURRX BIOPHARMA, INC. HAS
DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD
LIKELY CAUSE COMPETITIVE HARM TO AZURRX BIOPHARMA, INC.
IF PUBLICLY DISCLOSED.


 

-14-








 






 



Appendix A






 



Certain Licensed Patent Rights


 



[*****]


 


 


 


 





CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY [*****], HAS BEEN OMITTED BECAUSE AZURRX BIOPHARMA, INC. HAS
DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD
LIKELY CAUSE COMPETITIVE HARM TO AZURRX BIOPHARMA, INC.
IF PUBLICLY DISCLOSED.


 

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