Blueprint





 






 
Exhibit
10.1


 



SUBLICENSE AGREEMENT

 


This
Agreement is entered into as of August 7, 2017 (“Effective
Date”), by and between TransChem, Inc., a corporation
organized and existing under the laws of the State of Delaware,
having an office and place of business at 6415 Buffalo Speedway,
Houston, Texas 77005 (“Sublicensor”) on one
hand, and AzurRx Biopharma, Inc., a corporation organized and
existing under the laws of Delaware having an office and place of
business at 760 Parkside Avenue, Downstate Biotechnology Incubator,
Suite 217, Brooklyn, New York 11226 (“Sublicensee”) on the
other hand.

 


 

 



S t a t e m e n t

 


Sublicensor holds
a license from Albert Einstein College of Medicine, Inc., a not for
profit corporation organized and existing under the laws of the
State of New York, having an office and place of business at 1300
Morris Park Avenue, Bronx, New York 10461 (“Einstein”),
Victoria Link Limited, a wholly owned subsidiary of Victoria
University of Wellington, a University established under the
Education Act 1989 having its registered offices at Kelburn Parade,
Wellington 6140, New Zealand (“Viclink”) (Einstein and
Viclink shall be referred to collectively as
“Licensors”) to patents and patent applications
relating to Helicobacter pylori 5’-methylthioadenosine
nucleosidase (“MTAN”) inhibitors (the “Master
License”). Sublicensee wishes to acquire an exclusive license
to Sublicensor’s rights in the aforementioned patent rights,
and Sublicensor wishes to grant such license to
Sublicensee.

 


NOW,
THEREFORE, in consideration of the promises and mutual covenants,
conditions and limitations herein contained and other good and
valuable consideration, the receipt and sufficiency of which is
hereby acknowledged, Sublicensor and Sublicensee agree as
follows:

 

1. Definitions

 




1.01

“Agreement Patents” means
the patents and patent applications listed on Appendix A, together
with any and all patents and patent applications which issue from
or are based on such patents and patent applications and from any
and all divisionals, continuations, continuations-in-part (but only
to the extent the claims thereof are enabled by disclosure of the
parent application) and foreign counterparts of such patents and
patent applications, and any and all reissues, renewals and
extensions or the like of such patents and patent applications and
any and all U.S. and foreign patents which are based on such
patents and patent applications. Appendix A shall be updated from
time-to-time by the parties.





 




1.02

"First
Field" means MTAN inhibitors for the treatment and/or
prevention of Helicobacter pylori (H. pylori) infections. [*****].
[*****].





 




1.03

“Second
Field” means MTAN
inhibitors for the treatment and/or prevention of bacterial
infections. [*****]. [*****].





 




1.0

“Field” means collectively,
the First Field and the Second Field.





 




1.05

“First Licensed Product”
means any product or service in the First Field, the development,
manufacture, use, provision or sale of which is covered by a claim
of Agreement Patents, or which cannot be marketed without a license
or sublicense for the use of the Agreement Patents in any
jurisdiction in which such product is approved for sale or is being
manufactured.





 

 



 


*****
AZURRX BIOPHARMA, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF
THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. AZURRX BIOPHARMA, INC. HAS SEPARATELY FILED
THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.







 





 








1.06

 “Second Licensed
Product” means any product or service in the Second
Field, the development, manufacture, use, provision or sale of
which is covered by a claim of Agreement Patents, or which cannot
be marketed without a license or sublicense for the use of the
Agreement Patents in any jurisdiction in which such product is
approved for sale or is being manufactured.





 




1.07

 “Licensed Products” means,
collectively, First Licensed Products and Second Licensed
Products.





 




1.08

Net Sales” means the total
consideration, in any form, received by Sublicensee as
consideration for the sale, lease, provision or other disposition
of Licensed Products by Sublicensee to an independent third party,
less:





 




(a)

customary and
reasonable trade discounts actually taken, refunds, returns and
recalls; and





 




(b)

when included in
gross sales, customary and reasonable freight, shipping, duties,
and sales, V.A.T. and/or use taxes based on sales prices, but not
including taxes when assessed on incomes derived from such
sales.





 


 If
Sublicensee intends to accept from independent third parties any
non-cash consideration as Net Sales, Sublicensee must first obtain
Sublicensor’s written approval. For any non-cash
consideration approved by Sublicensor and received as Net Sales,
the parties will appoint an independent third party to determine,
at Sublicensee’s expense, the present day fair market value
of such consideration and that value shall be added to Net Sales in
place of the non-cash consideration. Net Sales shall exclude any
samples of Licensed Products transferred or disposed of at no cost
for promotional or educational purposes.

 


In the
event that, during a particular calendar quarter, a Licensed
Product is sold in combination with one or more other products,
whether or not such other products are packaged or otherwise
physically combined with such Licensed Product, for a single price
(a “Combination Product”), Net Sales from sales of a
Combination Product, for purposes of calculating royalties due
under this Agreement, shall be calculated by multiplying the Net
Sales of the Combination Product by the fraction A/(A+B), where A
is the average per unit sales price for such calendar quarter of
the Licensed Product sold separately in the country of sale and B
is the average per unit sales price for such calendar quarter of
the other product(s) sold separately in the country of sale. In the
event that no separate sales are made of the Licensed Product
and/or the other product(s) in the country of sale, separate sale
prices in commensurate countries may be used instead. In the event
that no separate sales are made of the Licensed Product and/or the
other product(s), Net Sales from sales of a Combination Product,
for purposes of determining royalty payments on such Combination
Products, shall be calculated using the entire Net Sales of such
Combination Products.

 




1.09

 “Confidential
Information” means any information designated as such
in writing by the disclosing party, whether by letter or by the use
of an appropriate proprietary stamp or legend, prior to or at the
time any such confidential or proprietary materials or information
are disclosed by the disclosing party to the recipient.
Notwithstanding the foregoing, information or materials which are
orally or visually disclosed to the recipient by the disclosing
party, or are disclosed in a writing or other tangible form without
an appropriate letter, proprietary stamp or legend, shall
constitute Confidential Information if the disclosing party, within
thirty (30) days after such disclosure, delivers to the recipient a
written document or documents describing such information or
materials and referencing the place and date of such oral, visual,
written or other tangible disclosure.





 




1.10

 “Marketable
Securities” means shares of the common stock of
Sublicensee that are listed or quoted for trading on the NASDAQ
Global Market, the NASDAQ Global Select Market, the New York Stock
Exchange, or the New York Stock Exchange Amex (each, a
“Trading Market”).





 


 




 


*****
AZURRX BIOPHARMA, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF
THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. AZURRX BIOPHARMA, INC. HAS SEPARATELY FILED
THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.








 






 




1.11

“Volume Weighted Average
Price” means, for the applicable date, the
price determined by the average
of the daily volume weighted average price of the common stock of
Sublicensee for the twenty (20) consecutive trading days ending on
the trading day immediately before the applicable date on the
applicable Trading Market as reported by Bloomberg L.P., based on a
trading day from 9:30 a.m. to 4:02 p.m. (New York City
time).





 




2.


Agreement Patents





 




2.01

Sublicensee will
reimburse Licensors for expenses incurred in connection with the
preparation, filing, prosecution and maintenance of the Agreement
Patents (and not previously reimbursed to Licensors by a third
party) as follows: [*****]. Amounts paid by Sublicensee pursuant to
this Section 2.01 are non-refundable and not creditable against any
other payment due to Sublicensor.





 




2.02

As of and after the
Effective Date, and only to the extent that a third party is not
obligated to do so, Sublicensee will pay the cost of preparing,
filing, prosecuting, maintaining and resisting challenges to the
validity of the Agreement Patents (as well as the cost of
preparing, filing, prosecuting, maintaining and resisting
challenges to the validity of corresponding applications in at
least the United States, [*****], and in such other jurisdictions
as Sublicensee shall determine), using patent counsel selected by
Licensor. Such payments will be due within five (5) days of
Sublicensee’s receipt of a request for upfront payment from
Licensor’s patent counsel relating to said costs. Sublicensee
will pay the cost of defending and/or prosecuting any interference,
reexamination, reissue, opposition, cancellation and nullity
proceedings involving Agreement Patents to the extent that a third
party is not obligated to do so. Sublicensor will keep Sublicensee
fully informed concerning such Sublicensee supported patents and
applications and will consult with Sublicensee concerning the
preparation, filing, prosecution, maintenance and challenges to the
validity of such Sublicensee supported patents and applications.
Sublicensor and Sublicensee shall cooperate with any reasonable
request of the other in connection with any such preparation,
filing, prosecution, maintenance and/or defense. To the extent not
prohibited by law or contractual obligations of Sublicensor,
Sublicensor shall inform Sublicensee with respect to the
preparation, filing, prosecution, maintenance, defense or
enforcement of any patents or applications listed on Appendix A
that are supported by a third party. Notwithstanding anything
contained herein to the contrary, in the event that Sublicensee
elects not to prepare, file, prosecute, maintain, or resist
challenges to the validity of any patent or patent application
within the Agreement Patents, or defend and/or prosecute any
interference, reexamination, reissue, opposition, cancellation and
nullity proceedings involving Agreement Patents, Sublicensee shall
give Sublicensor thirty (30) days prior written notice of such
election. Any patents or patent applications so elected by
Sublicensee shall at the end of the notice period cease to be
considered Agreement Patents, and Sublicensor shall then be free,
at its election, to abandon or maintain the prosecution of such
patent application or issued patent or grant rights to such patent
application or issued patent to third parties.





 




2.03

Amounts paid by
Sublicensee pursuant to Section 2.02 will be non-refundable and not
creditable against any other payment due to
Sublicensor.





 




3.


License Grant





 




3.01

Sublicensor hereby
grants to Sublicensee, subject to the terms and conditions of the
Master License, a worldwide, exclusive license to
Sublicensor’s rights in the Agreement Patents, to make, have
made, use, have used, provide, import, have imported, market,
distribute, offer to sell, sell and have sold First Licensed
Products and Second Licensed Products.





 




3.02

Nothing contained
in this Agreement shall be construed or interpreted as a grant, by
implication or otherwise, of any license except as expressly
specified in Section 3.01 hereof.





 


 




 


*****
AZURRX BIOPHARMA, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF
THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. AZURRX BIOPHARMA, INC. HAS SEPARATELY FILED
THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.








 






 




4.


Confidentiality





 




4.01

Sublicensee will
retain in confidence Confidential Information of Sublicensor
(“Sublicensor Confidential Information”) and
Sublicensee will not disclose any such Sublicensor Confidential
Information to any third party without the prior written consent of
Sublicensor, except that Sublicensee shall have the right to
disclose such Sublicensor Confidential Information to any third
party for commercial or research and development purposes under
written terms of confidentiality and non-disclosure which are
commercially reasonable. Sublicensee will keep confidential all
Sublicensor Confidential Information for a period of five (5) years
after termination or expiration of this Agreement, provided,
however, that the obligation of confidentiality will not apply to
any such information which:





 




(a)

was known to
Sublicensee or generally known to the public prior to its
disclosure hereunder; or





 




(b)

subsequently
becomes known to the public by some means other than a breach of
this Agreement, including but not limited to publication and/or
laying open to inspection of any patent applications or patents;
or





 




(c)

is subsequently
disclosed to Sublicensee by a third party having a lawful right to
make such disclosure; or





 




(d)

is required to be
disclosed by regulation, law or court order to the most limited
extent necessary to comply therewith, provided Sublicensor are
given a fair opportunity to defend against such disclosure;
or





 




(e)

is independently
developed by Sublicensee as evidenced by Sublicensee’s
written records.





 




4.02

During the term of
this Agreement, it is contemplated that Sublicensor may become
aware of Confidential Information of Sublicensee
(“Sublicensee Confidential Information”). Sublicensor
agree to retain such Sublicensee Confidential Information in
confidence and not to disclose any such Sublicensee Confidential
Information to a third party without prior written consent of
Sublicensee for a period ending five (5) years after termination or
expiration of this Agreement, except that such obligations shall
not apply to any information which:





 




(a)

was known to
Sublicensor or generally known to the public prior to their
disclosure hereunder; or





 




(b)

subsequently
becomes known to the public by some means other than a breach of
this Agreement; or





 




(c)

is subsequently
disclosed to Sublicensor by a third party having a lawful right to
make such disclosure; or





 




(d)

is required to be
disclosed by regulation, law or court order to the most limited
extent necessary to comply therewith, provided Sublicensee is given
a fair opportunity to defend against such disclosure;
or





 




(e)

is independently
developed by Sublicensor as evidenced by Sublicensor’s
written records.





 


 




 


*****
AZURRX BIOPHARMA, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF
THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. AZURRX BIOPHARMA, INC. HAS SEPARATELY FILED
THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.








 






 




5.


Royalties and Payments





 




5.01

Sublicensee shall
make the following payments to Sublicensor:





 




(a)

Sublicensee will
pay to Sublicensor [*****] of Net Sales (the
“Royalty”).





 




(b)

Royalty
Offset/Stacking Royalties. In the event that, with respect to Net
Sales of Licensed Products, Sublicensee is required to pay
royalties to unaffiliated third parties for patent rights such that
the practice of the Agreement Patent(s) would infringe such rights,
the amount due and payable to Sublicensor hereunder shall be
proportionally reduced by [*****] due such third party, but in no
event shall the Royalty payable to Sublicensor be less than [*****]
of Net Sales. By example, if the royalty due other third parties
equals [*****] of Net Sales, the Royalty due Sublicensor shall be
[*****]; if the royalty due other third parties equals [*****] of
Net Sales, the Royalty due Sublicensor shall be
[*****].





 




5.02

Sublicensee shall
make the following license signing and license maintenance payments
to Sublicensor:





 




(a)

Upon execution of
this Agreement by the parties, Sublicensee will pay to Sublicensor
[*****] as a sublicense signing fee, which payment is
non-refundable and not creditable against any other payment due to
Sublicensor pursuant to this Agreement.





 




(b)

On each of the
first, second, third and fourth anniversaries of the Effective
Date, Sublicensee will pay to Sublicensor [*****] as a sublicense
maintenance fee. This payment is non-refundable but is creditable
against actual Royalties and payments due to Sublicensor pursuant
to Sections 5.01 and 5.02 during the twelve (12) month period
following each such anniversary.





 




(c)

On the fifth
anniversary of the Effective Date, Sublicensee will pay to
Sublicensor [*****] as a sublicense maintenance fee. This payment
is non-refundable but is creditable against actual Royalties and
payments due to Sublicensor pursuant to Sections 5.01 and 5.02
during the twelve (12) month period following such fifth
anniversary.





 




(d)

On the sixth
anniversary of the Effective Date, Sublicensee will pay to
Sublicensor [*****] as a sublicense maintenance fee. This payment
is non-refundable but is creditable against actual Royalties and
payments due to Sublicensor pursuant to Sections 5.01 and 5.02
during the twelve (12) month period following such sixth
anniversary.





 




(e)

On the seventh
anniversary of the Effective Date and every anniversary of the
Effective Date thereafter, Sublicensee will pay to Sublicensor
[*****] as a sublicense maintenance fee. Each such payment is
non-refundable but is creditable against actual Royalties and other
payments due to Sublicensor pursuant to Sections 5.01 and 5.02
during the twelve (12) month period following each such
anniversary.





 




5.03

Sublicensee shall
make the following milestone payments to Sublicensor:





 




(a)

Upon the initiation
by Sublicensee of the first Phase I clinical trial (or its foreign
equivalent) for each Licensed Product (or each indication for a
Licensed Product) anywhere in the world, Sublicensee shall [*****].
Notwithstanding the foregoing, if no such Phase I clinical trial
has occurred by [*****] from the Effective Date, and no Phase I
clinical trial initiated by a Sublicensee for a Licensed Product
has occurred by [*****] from the Effective Date, then Sublicensee
shall [*****];





 


 




 


*****
AZURRX BIOPHARMA, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF
THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. AZURRX BIOPHARMA, INC. HAS SEPARATELY FILED
THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.








 






 




(b)

Upon the completion
by Sublicensee of the first Phase I clinical trial (or its foreign
equivalent) for each Licensed Product (or each indication for a
Licensed Product) anywhere in the world, Sublicensee shall [*****].
Notwithstanding the foregoing, if no such Phase I clinical trial
has been completed by [*****] from the Effective Date, and no Phase
I clinical trial initiated by a Sublicensee for a Licensed Product
has been completed by [*****] from the Effective Date, then
Sublicensee shall pay to Sublicensor [*****];





 




(c)

Upon the initiation
by Sublicensee of the first Phase II clinical trial (or its foreign
equivalent) for each Licensed Product (or each indication for a
Licensed Product) anywhere in the world, Sublicensee shall [*****].
Notwithstanding the foregoing, if no such Phase II clinical trial
has occurred by [*****] from the Effective Date, and no Phase II
clinical trial initiated by a Sublicensee for a Licensed Product
has occurred by [*****] from the Effective Date, then Sublicensee
shall pay to Sublicensor [*****];





 




(d)

Upon the completion
by Sublicensee of the first Phase II clinical trial (or its foreign
equivalent) for each Licensed Product (or each indication for a
Licensed Product) anywhere in the world, Sublicensee shall [*****].
Notwithstanding the foregoing, if no such Phase II clinical trial
has been completed by [*****] from the Effective Date, and no Phase
II clinical trial initiated by a Sublicensee for a Licensed Product
has been completed by [*****] from the Effective Date, then
Sublicensee shall pay to Sublicensor [*****];





 




(e)

Upon the initiation
by Sublicensee of the first Phase III clinical trial (or its
foreign equivalent) for each Licensed Product (or each indication
for a Licensed Product) anywhere in the world, Sublicensee shall
[*****]. Notwithstanding the foregoing, if no such Phase III
clinical trial has occurred by [*****] from the Effective Date, and
no Phase III clinical trial initiated by a Sublicensee for a
Licensed Product has occurred by [*****] from the Effective Date,
then Sublicensee shall pay to Sublicensor [*****];





 




(f)

Upon the submission
of a new drug application to the FDA (or its foreign equivalent)
for each Licensed Product (or each indication for a Licensed
Product), Sublicensee shall [*****]. Notwithstanding the foregoing,
if no such new drug application has been submitted to the FDA by
[*****] from the Effective Date, and no new drug application was
submitted by a Sublicensee for a Licensed Product by [*****] from
the Effective Date, then Sublicensee shall pay to Sublicensor
[*****];





 




(g)

Upon first
commercial sale of each Licensed Product (or each indication for a
Licensed Product) by Sublicensee, Sublicensee shall [*****];
and





 




(h)

[*****].





 




5.04

[*****].





 




5.05

Sublicensee’s
failure to pay full Royalties, transfer stock or make complete
payments under Sections 5.01, 5.02, 5.03 or 5.04 shall be a breach
of this Agreement.





 




6.


Payment Reports and Records





 




6.01

All cash payments
required to be made by Sublicensee to Sublicensor pursuant to this
Agreement shall be made to Sublicensor in U.S. Dollars by wire
transfer or by check payable to Sublicensor and sent to
Sublicensor’s address set out in Section 12.01. All Shares
and Marketable Securities shall be issued to Sublicensor at
Sublicensor’s address set out in Section 12.01.





 


 




 


*****
AZURRX BIOPHARMA, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF
THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. AZURRX BIOPHARMA, INC. HAS SEPARATELY FILED
THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.








 






 




6.02

All payments
required to be made by Sublicensee to Sublicensor pursuant to this
Agreement shall be subject to a charge of one and one-half percent
(1.5%) per month or Two Hundred and Fifty Dollars (US$250),
whichever is greater, if late. Conversion of foreign currency to
U.S. dollars shall be made at the conversion rate quoted by the
Wall Street Journal, averaged on the last business day of each of
the three (3) consecutive calendar months constituting the calendar
quarter in which the payment was earned. Sublicensee will bear any
loss of exchange or value and pay any expenses incurred in the
transfer or conversion to U.S. dollars.





 




6.03

Payment due from
Sublicensee to Sublicensor pursuant to Section 5.01 will be paid
within thirty (30) days after the end of each calendar year quarter
during which the payment accrued. If no Royalties or other payments
are due for any quarter, Sublicensee will send a statement signed
by an officer of Sublicensee to that effect to Sublicensor. Payment
shall be accompanied by a statement of the number of Licensed
Products and Combination Products sold by Sublicensee in each
country, total billings for such Licensed Products and Combination
Products, the values of A and B used to calculate the Net Sales of
Combination Products, deductions applicable to determine the Net
Sales thereof, the amount of Net Sales realized by Sublicensee, the
amount of any deduction and a detailed listing thereof, and the
total payment due from Sublicensee to Sublicensor (the
“Royalty Report”). Such Royalty Report shall be signed
by an officer of Sublicensee.





 




6.04

Sublicensee shall
maintain complete and accurate books of account and records showing
Net Sales. Such books and records of Sublicensee shall be open to
inspection, in confidence, during usual business hours, upon at
least ten (10) business days prior notice to Sublicensee, by an
independent certified public accountant appointed by Sublicensor on
behalf of Sublicensor, who has entered into a written agreement of
confidentiality with Sublicensor which is no less protective of
Sublicensee’s Confidential Information than the provisions of
Section 4.01 hereof and to whom Sublicensee has no reasonable
objection, for the purpose of verifying the accuracy of the
payments made to Sublicensor by Sublicensee pursuant to this
Agreement. All information, data, documents and materials reviewed
during the course of an audit shall be deemed Sublicensee’s
Confidential Information and subject to the confidentiality
provisions of this Agreement. Any notice by Sublicensor requesting
such inspection will contain detailed information regarding the
records and time periods being audited, which will be no greater
than one year prior to the date of the audit, but no further back
than the Effective Date. Sublicensee shall retain all applicable
records for one year subsequent to the expiration or termination of
this Agreement. Inspection shall be at Sublicensor’s sole
expense and limited to those matters related to Sublicensee’s
payment obligations under this Agreement and shall take place not
more than once per calendar year. Sublicensor will provide to
Sublicensee a complete copy of any audit report generated pursuant
to this Section. Any underpayment revealed by any inspection, plus
interest on the underpayment amount at the rate of one and one-half
percent (1.5%) per month or Two Hundred and Fifty Dollars (US$250),
whichever is greater, shall be promptly paid by Sublicensee to
Sublicensor. Further, if any inspection reveals an underpayment to
Sublicensor of ten percent (10%) or greater, then the cost of the
inspection shall be paid by Sublicensee. No audit may be commenced
until all prior audits are final and closed. Only periods with
amounts paid by Sublicensee with no open dispute may be the subject
of an audit by Sublicensor. No audit results may be extrapolated or
otherwise applied to any period that is not the subject of an
audit. If Sublicensee disagrees in any respect with the results of
the verification provided in this Section, Sublicensor and
Sublicensee shall meet to attempt to resolve the disagreement. If
they are unable within thirty (30) days to reach a resolution,
Sublicensor and Sublicensee shall jointly retain an independent
auditor to review the books and records and calculations hereunder
and the verification conducted under this Section and make a final
determination regarding any disputed item or items (the "Final
Determination"). The decision of such independent auditor with
respect to the payments, if any, to be made pursuant to this
Section shall be final and binding on the parties. The costs of
such independent auditor shall be borne by the non-prevailing
party.





 


 




 


*****
AZURRX BIOPHARMA, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF
THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. AZURRX BIOPHARMA, INC. HAS SEPARATELY FILED
THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.








 






 




7.


Infringement





 




7.01

Each party should
provide timely written notice of any suspected infringement of the
Agreement Patents to the other party and the parties should then
discuss and agree upon a strategy for addressing the infringement
consistent with the terms and conditions of the Master
License.





 




8.


Prohibition on Use of Names; No Publicity





 




8.01

No party to this
Agreement shall use the name of any other party without the prior
written consent of such other party, except if the use of such name
is required by law, regulation, federal securities law, or judicial
order, in which event the party intending to use such name will
promptly inform in writing the relevant other party prior to any
such required use. Additionally, No party to this Agreement shall
use the name of the Licensors without the prior written consent of
the Licensors, except if the use of such name is required by law,
regulation, federal securities law, or judicial order, in which
event the party intending to use such name will promptly inform in
writing the relevant other party prior to any such required use. No
party to this Agreement will make any public announcement regarding
the existence of this Agreement, and/or the Master License, and/or
the collaboration hereunder without obtaining the prior written
consent of the other party, except if such announcement is required
by law, regulation, federal securities law or judicial order, in
which event the party intending to make such announcement will
promptly inform the other party prior to such
announcement.





 




9.


Term and Termination





 




9.01

Unless terminated
earlier under other provisions hereof, this Agreement will expire
upon the expiration of the last Agreement Patent. Upon termination
or expiration of this Agreement for any reason, Sections 4, 8,
9.08, 9.09, 11.01 through 11.09, 11.14 and 12 shall survive and all
undisputed payment obligations under Articles 5 and 6 hereof
accrued as of the termination date shall be paid by Sublicensee
within thirty (30) days of such termination or
expiration.





 




9.02

Sublicensee may
terminate this Agreement and the licenses granted hereunder for any
reason and without further liability, by giving notice to
Sublicensor sixty (60) days prior to such termination. Upon such
termination, Sublicensee shall not use Agreement Patents for any
purpose and all of Sublicensee’s rights in Agreement Patents
shall be terminated.





 




9.03

If Sublicensor or
Sublicensee defaults on or breaches any term or condition of this
Agreement, the aggrieved party may serve notice upon the other
party of the alleged default or breach. If such default or breach
is not remedied within sixty (60) days from the date of such
notice, the aggrieved party may at its election terminate this
Agreement, subject to the conditions set forth in Sections 11.17
and 11.18; provided that if such default cannot reasonably be cured
within such sixty (60)-day period and the defaulting party shall
have commenced to cure such default within such sixty (60)-day
period and thereafter diligently and expeditiously proceeds to cure
the same, such sixty (60)-day period may be extended for so long as
it shall require such defaulting party in the exercise of due
diligence to cure such default, it being agreed that no such
extension shall be for a period in excess of one-hundred twenty
(120) days in the aggregate. Any failure to terminate hereunder
shall not be construed as a waiver by the aggrieved party of its
right to terminate for future defaults or breaches. Upon
termination of this Agreement by Sublicensor pursuant to this
Section 9.03, the licenses granted by Sublicensor to Sublicensee
shall terminate and Sublicensee shall not use Agreement Patents for
any purpose and all of Sublicensee’s rights in Agreement
Patents shall be terminated.





 


 




 


*****
AZURRX BIOPHARMA, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF
THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. AZURRX BIOPHARMA, INC. HAS SEPARATELY FILED
THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.








 






 




9.04

If Sublicensee
makes an assignment for the benefit of creditors or if proceedings
for a voluntary bankruptcy are instituted on behalf of Sublicensee
or if Sublicensee is declared bankrupt or insolvent, Sublicensor
may, at its election, terminate this Agreement by providing notice
to Sublicensee. Upon termination of this Agreement by Sublicensor
pursuant to this Section 9.04, the licenses granted by Sublicensor
to Sublicensee shall terminate and Sublicensee shall not use
Agreement Patents for any purpose and all of Sublicensee’s
rights in Agreement Patents shall be terminated.





 




9.05

If Sublicensee is
convicted of a felony relating to the manufacture, use or sale of
Licensed Products or a felony relating to moral turpitude,
Sublicensor may, at its election, terminate this Agreement by
notice to Sublicensee. Upon termination of this Agreement by
Sublicensor pursuant to this Section 9.05, the licenses granted by
Sublicensor to Sublicensee shall terminate and Sublicensee shall
not use Agreement Patents for any purpose and all of
Sublicensee’s rights in Agreement Patents shall be
terminated.





 




9.06

Notwithstanding the
provisions of Section 9.03 hereof, should Sublicensee fail to pay
Sublicensor any cash, or issue to Sublicensor any Marketable
Securities, as applicable, when due and payable under this
Agreement, then upon thirty (30) days written notice Sublicensor
may, at its election, terminate this Agreement, unless within the
thirty (30) day period all delinquent amounts together with
interest due and unpaid have been paid in cash, or issued in
Marketable Securities (as applicable), by Sublicensee. Upon
termination of this Agreement by Sublicensor pursuant to this
Section 9.06, the licenses granted by Sublicensor to Sublicensee
shall terminate and Sublicensee shall not use Agreement Patents for
any purpose and all of Sublicensee’s rights in Agreement
Patents shall be terminated.





 




9.07

Termination of this
Agreement by Sublicensee or Sublicensor shall not prejudice the
rights of the parties accruing herein.





 




9.08

If Sublicensee
terminates this Agreement pursuant to Section 9.02 or if
Sublicensor terminate this Agreement pursuant to Sections 9.03,
9.04, 9.05 or 9.06, then Sublicensee shall, upon such termination,
assign to Sublicensor all right, title and interest in and to any
Dependent Patents and Dependent Know-How (as defined below)
developed by or for Sublicensee during the term of this Agreement,
and shall, within thirty (30) days of termination, provide copies
of all documents and other materials embodying Dependent Know-How
to Sublicensor. As used in this Section 9.08, the term
“Dependent Patents” means any U.S. or foreign patent
application or patent which claims an invention the practice of
which would infringe a claim of a patent or patent application of
the Agreement Patents or the practice of which results in a product
covered by a claim of a patent or patent application of Agreement
Patents. “Dependent Know-How” means confidential
information, including clinical trial information, the practical
application of which would infringe a claim of a patent or patent
application of Agreement Patents, or which results in a product
covered by a claim of a patent or patent application of Agreement
Patents. Sublicensee agrees to take all actions and execute any and
all documents reasonably requested by Sublicensor to effectuate the
terms of this Section 9.08 at Sublicensor’s expense. During
the time period between notice of termination and the effective
date of termination Sublicensee will take whatever actions are
necessary to prevent any Dependent Patent from becoming abandoned
or canceled at Sublicensor’s expense.





 




9.09

If Sublicensee
terminates this Agreement pursuant to Section 9.02 or if
Sublicensor terminates this Agreement pursuant to Sections 9.03,
9.04, 9.05 or 9.06, Sublicensee shall submit a final Royalty Report
to Sublicensor and any payments and patent costs due to Sublicensor
hereunder as of the date of termination shall be payable within
thirty (30) days of the date of termination. In addition, within
ten (10) days of notice of such termination, Sublicensee shall
provide Sublicensor with a report showing the status of all
Dependent Patents, including, without limitation, a list of all
countries where Dependent Patents have been filed and a list of all
actions which must be taken with respect to the Dependent Patents
and relevant due dates.





 




 


*****
AZURRX BIOPHARMA, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF
THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. AZURRX BIOPHARMA, INC. HAS SEPARATELY FILED
THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.








 






 




10.


Amendment and Assignment





 




10.01

This Agreement sets
forth the entire understanding between Sublicensor and Sublicensee
pertaining to the subject matter hereof.





 




10.02

Except as otherwise
provided herein, this Agreement may not be amended, supplemented or
otherwise modified, except by an instrument in writing signed by
both parties.





 




10.03

Without the prior
written approval of the other party, which approval shall not be
unreasonably withheld, no party may assign this Agreement except
that this Agreement may be assigned without the other party’s
consent as follows: (a) to an entity acquiring substantially all of
such party’s business to which this Agreement relates, (b) in
the event of a merger, consolidation, change in control,
reorganization or other combination or similar transaction of such
party, or (ii) the transfer or assignment to an affiliate, in each
case, pursuant to which the surviving entity or assignee assumes
the assigning or merging party’s obligations hereunder in
writing. Any attempted assignment in contravention of this Section
11.03 shall be null and void.





 




11.


Miscellaneous Provisions





 




11.01

This Agreement
shall be construed and the rights of the parties governed in
accordance with the laws of the State of New York, excluding its
law of conflict of laws. Any dispute or issue arising hereunder,
including any alleged breach by any party, shall be heard,
determined and resolved by an action commenced in the state or
federal courts in New York, New York, which the parties hereby
agree shall have proper jurisdiction and venue over the issues and
the parties. Sublicensor and Sublicensee hereby agree to submit to
the jurisdiction of the state or federal courts in New York and
waive the right to make any objection based on jurisdiction or
venue. The New York courts shall have the right to grant all relief
to which Sublicensor and Sublicensee are or shall be entitled
hereunder, including all equitable relief as the Court may deem
appropriate.





 




11.02

This Agreement has
been prepared jointly.





 




11.03

If any term or
provision of this Agreement or the application thereof to any
person or circumstance shall to any extent be invalid or
unenforceable, the remainder of this Agreement or the application
of such term or provision to persons or circumstances other than
those as to which it is held invalid or unenforceable shall not be
affected thereby and each term and provision of this Agreement
shall be valid and enforced to the fullest extent permitted by
law.





 




11.04

Sublicensee agrees
to indemnify Sublicensor and their current or former directors,
officers, employees, and agents and their respective successors,
heirs and assigns (Sublicensor, and each such person being the
“Sublicensor Indemnified Parties”) for the cost of
defense and for damages awarded and losses and liabilities
incurred, if any, as a result of any third party claims,
liabilities, suits or judgments based on or arising out of the
research, development, marketing, manufacture, sale and/or
provision of Licensed Products by Sublicensee, and/or the licenses
granted under this Agreement, or otherwise related to the conduct
of Sublicensee’s business, so long as such claims,
liabilities, suits, or judgments are not attributable to the
material breach of this Agreement or the grossly negligent or
intentionally wrongful acts or omissions by the Sublicensor
Indemnified Parties.





 


Sublicensor agrees
to indemnify Sublicensee and their respective current or former
directors, officers, employees, representatives and agents and
their respective successors, heirs and assigns (Sublicensee and
each such person being the “Sublicensee Indemnified
Parties”) for the cost of defense and for damages awarded and
losses and liabilities incurred, if any, as a result of any third
party claims, liabilities, suits or judgments based on or arising
out of any breach by Sublicensor of its representations, warranties
and covenants under this Agreement, so long as such claims,
liabilities, suits, or judgments are not attributable to the
material breach of this Agreement or the grossly negligent or
intentionally wrongful acts or omissions by the Sublicensee
Indemnified Parties.

 




 


*****
AZURRX BIOPHARMA, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF
THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. AZURRX BIOPHARMA, INC. HAS SEPARATELY FILED
THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.








 






 


This
indemnity is conditioned upon the indemnified party’s
obligation to: (i) advise indemnifying party of any claim or
lawsuit, in writing promptly after the indemnified party has
received notice of said claim or lawsuit provided however that the failure or
delay to do so shall not relieve the indemnifying party of any
obligation or liability that it may have to the party seeking
indemnity, except to the extent that the ability to defend or
resolve the claim, liability, suit or judgment is adversely
affected thereby, (ii) assist the indemnifying party and its
representatives, at the indemnifying party’s expense, in the
investigation and defense of any lawsuit and/or claim for which
indemnification is provided, and (iii) permit indemnifying party to
control the defense of such claim or lawsuit for which
indemnification is provided. Neither party shall make any
settlement of any claims that may give rise to liability of the
other party hereto without the prior written consent of the other
party.

 




11.05

Sublicensee agrees
to indemnify Licensors and their current or former directors,
governing board members, trustees, officers, faculty, medical and
professional staff, employees, students and agents and their
respective successors, heirs and assigns (Licensors and each such
person being the “Indemnified Parties”) for the cost of
defense and for damages awarded and losses and liabilities
incurred, if any, as a result of any third party claims,
liabilities, suits or judgments based on or arising out of the
research, development, marketing, manufacture, sale and/or
provision of Licensed Products by Sublicensee, and/or the licenses
granted under this Agreement, or otherwise related to the conduct
of Sublicensee’s business, so long as such claims,
liabilities, suits, or judgments are not solely attributable to
grossly negligent or intentionally wrongful acts or omissions by
the Indemnified Parties.





 




1.06

Nothing in this
Agreement is or shall be construed as:





 




(a)

Except as set forth
in Section 11.08, a warranty or representation by Sublicensor that
anything made or used by Sublicensee under any license granted in
this Agreement (including, without limitation, Licensed Products)
is or will be free from infringement of patents, copyrights, and
other rights of third parties; or





 




(b)

Granting by
implication, estoppel, or otherwise any license, right or interest
other than as expressly set forth herein.





 




11.07

Except as expressly
set forth in this Agreement, the parties MAKE NO REPRESENTATIONS
AND EXTEND NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED,
EITHER IN FACT OR BY OPERATION OF LAW, STATUTE OR OTHERWISE, AND
THE PARTIES SPECIFICALLY DISCLAIM ANY IMPLIED WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN ADDITION,
EXCEPT FOR THE PARTIES’ INDEMNIFICATION OBLIGATIONS
HEREUNDER, NO PARTY SHALL BE LIABLE FOR ANY SPECIAL, INDIRECT,
INCIDENTAL OR CONSEQUENTIAL DAMAGES, HOWEVER CAUSED, UNDER ANY
THEORY OF LIABILITY AND WHETHER OR NOT SUCH PARTY HAS BEEN ADVISED
OF THE POSSIBILITY OF SUCH DAMAGES.





 


IN
PARTICULAR, EXCEPT FOR THE PARTIES’ INDEMNIFICATION
OBLIGATIONS HEREUNDER, IN NO EVENT SHALL EITHER PARTY, THEIR
TRUSTEES, DIRECTORS, OFFICERS, EMPLOYEES OR AFFILIATES BE LIABLE
FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND, INCLUDING
ECONOMIC DAMAGES OR INJURY TO PROPERTY AND LOST PROFITS, REGARDLESS
OF WHETHER SUCH PARTY SHALL BE ADVISED, SHALL HAVE OTHER REASON TO
KNOW, OR IN FACT SHALL KNOW OF THE POSSIBILITY OF THE
FOREGOING.

 




 


*****
AZURRX BIOPHARMA, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF
THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. AZURRX BIOPHARMA, INC. HAS SEPARATELY FILED
THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.








 






 




11.08

Each of Sublicensor
and Sublicensee represent and warrant to the other that as of the
Effective Date:





 




(a)

it is a corporation
or entity duly organized and validly existing under the laws of the
state or other jurisdiction of its incorporation or
organization;





 




(b)

they have the legal
right and authority to enter into this Agreement and to perform all
of their obligations hereunder;





 




(c)

when executed by
all parties, this Agreement will constitute a valid and legally
binding obligation and shall be enforceable in accordance with its
terms;





 




(d)

there are no
existing or threatened actions, suits or claims pending or
threatened against them that may affect the performance of their
obligations under the Agreement.





 




(e)

the execution,
delivery and performance by each party of this Agreement and its
compliance with the terms and provisions hereof does not and will
not conflict with or result in a breach of any of the terms and
provisions of or constitute a default under: (i) a loan agreement,
guaranty, financing agreement, agreement affecting a Licensed
Product or other agreement or instrument affecting a Licensed
Product; (ii) the provisions of its charter or other operative
documents or bylaws; or (iii) any order, writ, injunction or decree
of any court or governmental authority entered against it or by
which any of its property is bound; and





 




(f)

it has the full
right, power and authority to grant all of the right, title and
interest in the licenses, if any, granted to the other party under
this Agreement;





 



 

Sublicensor
represents and warrants to Sublicensee that (a) Sublicensor has a
valid license in and to all Agreement Patents (with the right to
sublicense) for use by Sublicensee as contemplated hereunder free
and clear of all liens and encumbrances of any nature whatsoever,
and (b) Sublicensee’s exercise of the license to the
Agreement Patents granted herein will not infringe or
misappropriate the intellectual property rights of any third
party.





 




11.09

Except as expressly
set forth hereunder, Sublicensee represents and warrants that it
has not relied on any information provided by Sublicensor or
Sublicensor’s current or former employees and has conducted
its own due diligence investigation to its own satisfaction prior
to entering into this Agreement.





 




11.10

Sublicensee
represents and warrants that before Sublicensee makes any sales of
Licensed Products or performs or causes any third party to perform
any clinical trials or tests in human subjects involving Licensed
Products, Sublicensee will acquire and maintain in each country in
which Sublicensee shall test or sell Licensed Products, appropriate
insurance coverage reasonably acceptable to Licensors and
Sublicensor, but providing coverage in respect of Licensed Products
in an amount no less than five million (US $5,000,000) per claim.
Sublicensee will not perform, or cause any third party to perform,
any clinical trials or any tests in human subjects involving
Licensed Products unless and until it/they obtain(s) all required
regulatory approvals with respect to Licensed Products in the
applicable countries. Prior to instituting any clinical trials or
any tests in human subjects, or sale of any Licensed Product,
Sublicensee shall provide evidence of such insurance to Licensors
and Sublicensor. If Licensors determine that such insurance is not
reasonably appropriate, it shall so advise Licensee and/or
Sublicensee and Licensee and/or Sublicensee shall delay such
trials, tests or sales until the parties mutually agree that
reasonably appropriate coverage is in place. Licensors shall be
listed as additional insureds in Sublicensee’s insurance
policies. If such insurance is underwritten on a ‘claims
made’ basis, Sublicensee agrees that any change in
underwriters during the term of this Agreement will require the
purchase of ‘prior acts’ coverage to ensure that
coverage will be continuous throughout the term of this
Agreement.





 


 




 


*****
AZURRX BIOPHARMA, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF
THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. AZURRX BIOPHARMA, INC. HAS SEPARATELY FILED
THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.








 






 




11.11

Each of Sublicensor
and Sublicensee shall exercise its rights and perform its
obligations hereunder in compliance with all applicable laws and
regulations. In particular, it is understood and acknowledged that
the transfer of certain commodities and technical data is subject
to United States laws and regulations controlling the export of
such commodities and technical data, including all Export
Administration Regulations of the United States Department of
Commerce. These laws and regulations, among other things, prohibit
or require a license for the export of certain types of technical
data to certain specified countries. Sublicensee hereby agrees and
gives written assurance that Sublicensee will comply with all
United States laws and regulations controlling its export of
commodities and technical data relating to Licensed Products, that
Sublicensee will be solely responsible for any violation of such by
Sublicensee, and that Sublicensee will defend and hold Licensors
and Sublicensor harmless in the event of any legal action of any
nature occasioned by such violation by Sublicensee.





 




11.12

Sublicensee agrees
(i) to obtain all regulatory approvals required for the manufacture
and sale of Licensed Products prior to marketing or selling any
such Licensed Products and (ii) to utilize legally appropriate
patent marking on such Licensed Products. Sublicensee agrees to
register or record this Agreement as is required by law or
regulation in any country where the license is in
effect.





 




11.13

Sublicensee agrees
that it will comply with 35 U.S.C. §204 Preference for United
States Industry. Upon Sublicensee’s reasonable request and
expense, Sublicensor shall request that Licensors seek waiver of
this requirement. Sublicensee will prepare all necessary papers at
its sole cost and expense and will provide same to Licensors
together with detailed instructions as to how to seek waiver of
this requirement.





 




11.14

Any tax required to
be withheld under the laws of any jurisdiction on royalties payable
to Sublicensor by Sublicensee under this Agreement will be promptly
paid by Sublicensee for and on behalf of Sublicensor to the
appropriate governmental authority, and Sublicensee will furnish
Sublicensor with proof of payment of the tax together with official
or other appropriate evidence issued by the competent governmental
authority sufficient to enable Sublicensor to support a claim for
tax credit with respect to any sum so withheld. Any tax required to
be withheld on payments by Sublicensee to Sublicensor will be an
expense of and be borne solely by Sublicensor, and
Sublicensee’s royalty payment(s) to Sublicensor following the
withholding of the tax will be decreased by the amount of such tax
withholding. Sublicensee will cooperate with Sublicensor in the
event Sublicensor elect to assert, at their own expense, exemption
from any tax.





 




11.15

Sublicensee will
meet all of the following due diligence requirements:





 




(a)

[*****]





 




(b)

[*****]





 




(c)

[*****]





 




(d)

[*****]





 




(e)

[*****]





 




(f)

[*****]





 




(g)

[*****]





 




(h)

[*****]





 




(i)

[*****]





 




(j)

[*****]





 




(k)

[*****]





 


 




 


*****
AZURRX BIOPHARMA, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF
THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. AZURRX BIOPHARMA, INC. HAS SEPARATELY FILED
THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.








 






 




(l)

[*****]





 




(m)

[*****]





 




(n)

[*****]





 




(o)

[*****]





 




(p)

[*****]





 




(q)

[*****]





 




(r)

[*****]





 




(s)

[*****]





 




11.16

In the event
Sublicensor determine that Sublicensee has failed to fulfill any of
its obligations under Section 15.15(a) – (d) and 11.15(s),
Sublicensor may treat such failure as breach in accordance with
Section 0.03.





 




11.17

In the event
Sublicensor determine that Sublicensee has failed to fulfill any of
its obligations under Sections 11.15(e)-(k), Sublicensor may treat
such failure as breach in accordance with Section 9.03, except that
Sublicensee may cure such breach within sixty (60) days of
notification of the breach by either:
[*****].[*****].[*****].





 




11.18

In the event
Sublicensor determines that Sublicensee has failed to fulfill any
of its obligations under Section 11.15(l) – (r) for the
Second Licensed Product, Sublicensor may treat such failure as
breach in accordance with Section 9.03, except that Sublicensee may
cure the breach by either: [*****].[*****].[*****].





 




11.19

Sublicensee shall
be entitled to extend the milestone schedule in Section 11.15 for
one additional one year period for either the First Licensed
Product or the Second Licensed Product upon payment of [*****] to
Sublicensor, provided,
however, that the extension
permitted by this Section 11.19 [*****].





 




11.20

In the event
Sublicensee (or any entity acting under Sublicensee’s control
or on its behalf) initiates any proceeding or otherwise asserts any
claim challenging the validity or enforceability of any of the
Agreement Patents in any court, administrative agency or other
forum (“Challenge”), the royalty rates set forth in
Section 5.01 and the license maintenance fees set forth in Section
5.04 shall be automatically doubled on and after the date of such
Challenge for the remaining term of this Agreement. Moreover, to
the extent not already covered by Sections 2.01, 2.02 and 2.03,
Sublicensee agrees to pay all costs and expenses (including actual
attorneys’ fees) incurred by Sublicensor in connection with
defending a Challenge.





 




11.21

Neither party shall
be held liable or responsible to the other party nor be deemed to
have defaulted under or breached this Agreement for failure or
delay in fulfilling or performing any term of this Agreement to the
extent, and for so long as, such failure or delay is caused by or
results from causes beyond the reasonable control of the affected
party; provided, however, that the party affected shall not have
caused or procured such event, shall have used reasonable diligence
to avoid such event or ameliorate its effects, shall give prompt
notice of such event to the other party, and shall continue to take
all reasonable actions within its power to comply as fully as
possible with the terms of this Agreement. Notwithstanding the
foregoing, in the event that any force majeure event shall continue
for more than one hundred eighty (180) days, the party not subject
to such force majeure event may, in its sole discretion, terminate
this Agreement written notice to the other party.





 


 




 


*****
AZURRX BIOPHARMA, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF
THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. AZURRX BIOPHARMA, INC. HAS SEPARATELY FILED
THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.








 






 




12.


Notices





 




12.01

Any notice or
report required or permitted hereunder shall be given in writing,
and shall be deemed to have been properly given and effective upon
delivery, by registered or certified mail, return receipt
requested, or by facsimile with proof of receipt and a confirmation
copy sent by overnight courier, or by overnight courier, to the
following addresses:





 



To Sublicensor:

 


TransChem,
Inc.


6415
Buffalo Speedway


Houston, Texas
77005


Attention: Warren
Lau, CEO

 



With copy to:

 


John W.
Campbell, Ph.D.


Morgan,
Lewis & Bockius LLP


77 West
Wacker Drive, Fifth Floor


Chicago, IL
60601


 



To Sublicensee:

 


AzurRx
Biopharma, Inc.


760
Parkside Avenue,


Downstate
Biotechnology Incubator, Suite 217


Brooklyn, New York
11226


Attention: Thijs
Spoor, President and CEO


 


With
copy to:


 


Y.
Jerry Cohen, Esq.


Cohen
Tauber Spievack & Wagner, PC


420
Lexington Avenue, Suite 2400


New
York, NY 10170

 


 




 


*****
AZURRX BIOPHARMA, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF
THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. AZURRX BIOPHARMA, INC. HAS SEPARATELY FILED
THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.








 






 




13.


Counterpart.





 


This
Agreement may be executed in counterparts, each of which shall be
deemed an original, but all of which shall constitute a single
instrument.


 

 


 

 


SIGNATURE PAGE
FOLLOW

 


 




 


*****
AZURRX BIOPHARMA, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF
THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. AZURRX BIOPHARMA, INC. HAS SEPARATELY FILED
THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.








 






 


IN
WITNESS WHEREOF, the parties have entered into this Agreement
effective as of the day and year first above written.

 


TRANSCHEM,
INC.

 


/s/ Warren C. Lau


Name:
Warren C. Lau


Title:
President & CEO

 

Date:  
July 14,
2017


 

 


AZURRX
BIOPHARMA, INC.


 

 


/s/ Thijs Spoor


Name:
Thijs Spoor


Title:
Chief Executive Officer and President


 

 

Date:   
August 7,
2017


 

 


 

 




 


*****
AZURRX BIOPHARMA, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF
THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. AZURRX BIOPHARMA, INC. HAS SEPARATELY FILED
THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.








 










 


APPENDIX
A - Agreement Patents


 


(List
of Patents Begins on Next Page)

 


 

 




 


*****
AZURRX BIOPHARMA, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF
THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. AZURRX BIOPHARMA, INC. HAS SEPARATELY FILED
THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.








 






 


[*****]


 


 

 




 


*****
AZURRX BIOPHARMA, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF
THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. AZURRX BIOPHARMA, INC. HAS SEPARATELY FILED
THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.








 






 


[*****]


 

 


 




 


*****
AZURRX BIOPHARMA, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF
THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. AZURRX BIOPHARMA, INC. HAS SEPARATELY FILED
THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.








 






 


[*****]


 


 

 




 


*****
AZURRX BIOPHARMA, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF
THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. AZURRX BIOPHARMA, INC. HAS SEPARATELY FILED
THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.








 






 


[*****]


 

 


 




 


*****
AZURRX BIOPHARMA, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF
THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. AZURRX BIOPHARMA, INC. HAS SEPARATELY FILED
THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.








 






 


[*****]


 


 

 


[*****]

 




 


*****
AZURRX BIOPHARMA, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF
THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. AZURRX BIOPHARMA, INC. HAS SEPARATELY FILED
THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.








 






 


[*****]


 


 

 




 


*****
AZURRX BIOPHARMA, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF
THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. AZURRX BIOPHARMA, INC. HAS SEPARATELY FILED
THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.








 






 


[*****]

 


 

 




 


*****
AZURRX BIOPHARMA, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF
THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. AZURRX BIOPHARMA, INC. HAS SEPARATELY FILED
THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.








 






 


[*****]

 


 

 




 


*****
AZURRX BIOPHARMA, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF
THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. AZURRX BIOPHARMA, INC. HAS SEPARATELY FILED
THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.








 






 


[*****]

 


 

 




 


*****
AZURRX BIOPHARMA, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF
THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. AZURRX BIOPHARMA, INC. HAS SEPARATELY FILED
THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.








 










 



Appendix B - Excluded Compound List

 


 

 


[*****]

 


 

 




 


*****
AZURRX BIOPHARMA, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF
THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. AZURRX BIOPHARMA, INC. HAS SEPARATELY FILED
THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.