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.
 
   

 
-1-

 
 

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.
 
 
-3-

 
 

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.
 
 
-8-

 
 

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.
 
 
-12-

 
 

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.
 
-15-