GridAI Technologies Corp 8-K/A, filed Jan 13, 2021
GridAI Technologies Corp. (GRDX)
8-K/A
2021-01-13
For: 2020-12-31
View Original
Added on
April 11, 2026
About this 8-K/A
GridAI Technologies Corp filed this 8-K/A on January 13, 2021, reporting on events of December 31, 2020.
Items reported
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K/A
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported):
December 31,
2020
Commission
File Number: 001-37853
AzurRx BioPharma, Inc.
(Exact
name of registrant as specified in its charter.)
|
Delaware
(State or other
jurisdiction of incorporation or organization)
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46-4993860
(IRS Employer
Identification No.)
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1615 South Congress Avenue, Suite 103
Delray Beach, Florida 33445
(Address
of principal executive offices)
646-699-7855
(Registrant's
Telephone number)
Not Applicable
(Former
Name or Former Address, if Changed Since Last Report)
Check
the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant
under any of the following provisions:
[ ]
Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425)
[ ]
Soliciting material pursuant to Rule 14a-12 under the Exchange Act
(17 CFR 240.14a-12)
[ ]
Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
[ ]
Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
Indicate
by check mark whether the registrant is an emerging growth company
as defined in Rule 405 of the Securities Act of 1933 (17 CFR
230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17
CFR 240.12b-2)
Emerging
growth company [X]
If an
emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act. [ ]
Securities
registered pursuant to Section 12(b) of the Act:
|
Title of each class
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Trading Symbol(s)
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Name of exchange on which registered
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Common
Stock, par value $0.0001 per share
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AZRX
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Nasdaq
Capital Market
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Explanatory Note
On
January 4, 2021, AzurRx BioPharma, Inc. (the “Company”)
filed a Current Report on
Form 8-K (the “Prior 8-K”) to report the
Company’s entrance into a license agreement (the
“License Agreement”), dated December 31, 2020, by and
between the Company and First Wave Bio, Inc., a privately-held
Delaware corporation. The Company is filing this amendment to the
Prior 8-K in order to file herewith, as Exhibit 10.1, the License
Agreement. The Prior 8-K otherwise remains unchanged.
Item 9.01 Financial Statements and
Exhibits.
|
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(d)
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Exhibits.
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Exhibit No.
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Description
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License
Agreement, dated December 31, 2020, by and between the Company and
First Wave Bio, Inc.
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* Certain portions of this exhibit (indicated by
“[*****]”) have been omitted as we have determined (1)
it is not material and (2) is the type that the Company treats
as private or confidential.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
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AzurRx BioPharma, Inc.
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Date:
January 13, 2021
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By:
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/s/ James Sapirstein
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Name:
James Sapirstein
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|
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Title:
President and Chief Executive Officer
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CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT
BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE
COMPANY TREATS AS PRIVATE OR CONFIDENTIAL. THE REDACTED TERMS HAVE
BEEN MARKED WITH THREE ASTERISKS [***]
LICENSE AGREEMENT
by and between
FIRST WAVE BIO INC.
and
AZURRX BIOPHARMA INC.
Dated as of December 31, 2020
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Article I.
DEFINITIONS
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1
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Article II.
GOVERNANCE
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13
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Section 2.1
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Formation of the Joint Steering
Committee
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13
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Section 2.2
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Specific Responsibilities of the
JSC
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13
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Section 2.3
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Meetings and
Minutes
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14
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Section 2.4
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Procedural
Rules
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14
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Section 2.5
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Decision-Making
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14
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Section 2.6
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Limitations on
Authority
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15
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Section 2.7
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Expenses
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15
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Section 2.8
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Disbandment
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15
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Article III.
DEVELOPMENT
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15
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Section 3.1
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Development in the Field in the
Territory.
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15
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Section 3.2
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Clinical Trials
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16
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Section 3.3
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Performance
Obligations.
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16
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Section 3.4
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Records and Reports;
Inspections
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16
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Article IV. REGULATORY MATTERS AND
DATA PRIVACY
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17
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|
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Section 4.1
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Regulatory
Activities.
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17
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Section 4.2
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Interactions with Regulatory
Authorities.
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17
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Section 4.3
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Product Withdrawals and
Recalls
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17
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Section 4.4
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Global Safety Database;
Pharmacovigilance Agreement.
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18
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Section 4.5
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FWB’s Right of
Reference
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18
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Section 4.6
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Data Privacy.
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18
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Article V.
COMMERCIALIZATION
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18
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|
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Section 5.1
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Overview.
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18
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Section 5.2
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Commercialization Conduct and
Diligence.
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19
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Section 5.3
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Records
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19
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Section 5.4
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Reports
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19
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Section 5.5
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Booking of Sales; Title;
Distribution
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19
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Article VI.
PAYMENTS
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19
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|
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Section 6.1
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Upfront Cash
Payment
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19
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Section 6.2
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Equity
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20
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Section 6.3
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Milestones
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20
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Section 6.4
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Royalties.
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21
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Section
6.5
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Payment Dates and
Reports
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22
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Section
6.6
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Mode
of Payment
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22
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Section
6.7
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Taxes
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23
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Section
6.8
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Interest on Late
Payments
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23
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Section
6.9
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Financial
Records
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23
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Section
6.10
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Audit
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23
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Section
6.11
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Audit
Dispute
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24
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Section
6.12
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Confidentiality
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24
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Article VII.
SUPPLY OF PRODUCT
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24
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Section
7.1
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Supply
Obligations
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24
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Section
7.2
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Transfer of
Inventory
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25
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Article VIII.
GRANT OF RIGHTS
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25
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Section
8.1
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Rights
Granted to AzurRx.
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25
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Section
8.2
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Rights
Granted to FWB.
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25
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Section
8.3
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Retention of
Rights; No Implied Rights.
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26
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Section
8.4
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Third
Party Licenses.
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26
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Article IX.
INTELLECTUAL PROPERTY
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27
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Section
9.1
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Ownership of
Intellectual Property.
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27
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Section
9.2
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Prosecution and
Maintenance of Patents.
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27
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Section
9.3
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Enforcement of
Patents.
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29
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Section
9.4
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Infringement
Claims by Third Parties.
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30
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Section
9.5
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Invalidity or
Unenforceability Defenses or Actions.
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31
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Article X.
CONFIDENTIALITY
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32
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Section
10.1
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Obligations
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32
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Section
10.2
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Authorized
Disclosure of Confidential Information.
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33
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Section
10.3
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Use of
Name
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34
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Section
10.4
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Press
Releases
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34
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Article XI.
REPRESENTATIONS, WARRANTIES AND COVENANTS
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34
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Section
11.1
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Mutual
Representations and Warranties
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34
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Section
11.2
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Additional
Representations and Warranties of FWB
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35
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Section
11.3
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DISCLAIMER OF
WARRANTIES
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37
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Article XII.
INDEMNIFICATION
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38
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Section
12.1
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Indemnification by
FWB
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38
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Section
12.2
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Indemnification by
AzurRx
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38
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Section
12.3
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Indemnification
Procedures
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38
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Section
12.4
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Special, Indirect,
Consequential and Other Losses.
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40
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Section
12.5
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Insurance
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41
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Article XIII. TERM
AND TERMINATION
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41
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Section
13.1
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Term
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41
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Section
13.2
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Termination by
Either Party for Breach or Insolvency.
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41
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Section
13.3
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Termination by FWB
for Patent Challenge.
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42
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Section
13.4
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Effect
of Termination in Entirety.
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43
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Section
13.5
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Surviving
Obligations.
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45
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Article XIV.
NON-COMPETITION
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45
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Section
14.1
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Non-Competition
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45
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Section
14.2
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Right
of First Refusal
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45
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Section
14.2
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Reformation.
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46
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Article XV.
GOVERNING LAW; DISPUTE RESOLUTION
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46
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Section
15.1
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Governing
Law
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46
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Section
15.2
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Dispute
Resolution.
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46
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Article XVI.
MISCELLANEOUS
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47
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Section
16.1
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Force
Majeure
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47
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Section
16.2
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Successors and
Assigns
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48
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Section
16.3
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Export
Control
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48
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Section
16.4
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Independent
Contractors
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48
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Section
16.5
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Delegation and
Subcontracting of Obligations.
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49
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Section
16.6
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Compliance with
Applicable Law.
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49
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Section
16.7
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Additional AzurRx
Covenants.
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50
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Section
16.8
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Amendment
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50
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Section
16.9
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Notices.
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50
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Section
16.10
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Entire
Agreement
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51
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Section
16.11
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Interpretation
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51
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Section
16.12
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Severability
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52
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Section
16.13
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Waivers
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52
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Section
16.14
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Equitable
Relief
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53
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Section
16.15
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Further
Assurances
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53
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Section
16.16
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Counterparts
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53
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Section
16.17
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No
Third Party Beneficiaries
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53
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Section
16.18
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Costs
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53
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EXHIBITS
Exhibit
1.14
AzurRx
Background Patents as of the Effective Date
Exhibit
1.33
Compound
Exhibit
1.60
FWB
Background Patents as of the Effective Date
Exhibit
2.1
JSC
Representatives
Exhibit
3.4.2
Form
of Development Activities Report
Exhibit
7.1.2
Form
of Manufacturing Report
Exhibit
11.2.8
Known
Researchers Working in the Field as of the Effective
Date
This
LICENSE AGREEMENT (this
“Agreement”) is
made and entered into as of December 31, 2020 (the
“Effective
Date”) by and between First Wave Bio, Inc., a
biopharmaceutical company, having a principal place of business at
First Wave Bio, Inc., P.O. Box 7805, Ann Arbor, MI 48107
(“FWB”), and
AzurRx Biopharma, Inc., a biopharmaceutical company, having a
principal place of business at 1615 South Congress Avenue, Suite
103, Delray Beach, Florida 33445 (“AzurRx”). Each of FWB and AzurRx is
referred to individually as a “Party” and collectively as the
“Parties.”
Recital
WHEREAS, FWB has under development
precision therapies containing the Compound (as defined below) that
are intended to be used in the Immune Checkpoint
Inhibitor-Associated Colitis (“ICI-AC”) Field and the Severe
Acute Respiratory Syndrome Coronavirus 2 (“COVID”) Field (as defined
below);
WHEREAS, AzurRx, either directly or with
or through its Affiliates, has the capability to further develop,
manufacture and commercialize the Product (as defined
below);
WHEREAS, both FWB and AzurRx desire to
enter into an agreement for AzurRx to have exclusive development,
manufacture and commercialization rights for the Product in the
Territory (as defined below), subject to the terms and conditions
of this Agreement.
NOW, THEREFORE, in
consideration of the premises and the mutual promises and
conditions hereinafter set forth, and other good and valuable
consideration, the receipt and sufficiency of which are hereby
acknowledged, the Parties hereby agree as
follows:
ARTICLE I.
DEFINITIONS
Unless
otherwise specifically provided herein, the following terms shall
have the following meanings:
Section
1.1 “AAA” shall have the meaning set
forth in Section
15.2.1(b).
Section
1.2 “AAA Rules” shall have the meaning
set forth in Section 15.2.1(b).
Section
1.3 “Accountant” shall have the meaning
set forth in Section 6.11.
Section
1.4 “Acquisition” shall have the
meaning set forth in Section 14.2.
Section
1.5 “Adverse Event” shall mean (a) any
finding from tests of the applicable Product in laboratory animals
or in vitro that suggests a significant risk for human subjects
including reports of mutagenicity, teratogenicity or
carcinogenicity or (b) any undesirable, untoward or noxious event
or experience associated with the clinical, commercial or other use
or occurring following administration of the applicable Product in
humans, occurring at any dose, whether expected or not, and whether
considered related to or caused by the applicable Product or not,
including such an event or experience as occurs in the course of
the use of the applicable Product in professional practice, in a
Clinical Trial, from overdose, whether accidental or intentional,
from abuse, from withdrawal, or from a failure of expected
pharmacological or biological therapeutic action of the applicable
Product, and including those events or experiences that are
required to be reported to the FDA under 21 C.F.R.
Sections
-1-
312.32
or 314.80 or to foreign Regulatory Authorities under corresponding
Applicable Law outside the United States.
Section
1.6 “Affiliate” shall mean, with
respect to a particular person or entity, a Person that controls,
is controlled by, or is under common control with such person or
entity. For the purposes of this definition, the word
“control” (including, with correlative meaning, the
terms “controlled by” or “under common control
with”) means the actual power, either directly or indirectly
through one or more intermediaries, to direct or cause the
direction of the management and policies of such entity, whether by
the ownership of fifty percent (50%) or more of the voting stock of
such entity, or by contract or otherwise. For clarity, this
definition is intended to cover Persons who may become Affiliates
after the Effective Date.
Section
1.7 “Agreement” shall have the meaning
set forth in the preamble hereto.
Section
1.8 “ANDA Act” shall have the meaning
set forth in Section 9.3.1.
Section
1.9 “Applicable Law” shall mean all
statutes, ordinances, regulations, rules or orders of any kind
whatsoever of any Governmental Authority that may be in effect from
time to time and applicable to the activities contemplated by this
Agreement.
Section
1.10 “Arbitration Notice” shall have the
meaning set forth in Section 15.2.1(a).
Section
1.11 “Arbitrators” shall have the
meaning set forth in Section 15.2.1(b).
Section
1.12 “AzurRx” have the meaning set forth
in the preamble hereto.
Section
1.13 “AzurRx Background IP” shall mean
any and all Know-How or Patents that are (a) Controlled by AzurRx
or its Affiliates as of the Effective Date or independent of this
Agreement during the Term, and (b) necessary or reasonably useful
to Exploit any Product.
Section
1.14
“AzurRx
Background Patents” shall mean Patents within the
AzurRx Background IP. AzurRx Background Patents existing as of the
Effective Date are listed in Exhibit 1.14.
Section
1.15 “AzurRx Program Patent” shall mean
any and all Patents filed based on inventions, discoveries or other
know-how that are invented, conceived, discovered, developed or
otherwise made, whether independently or jointly, by or on behalf
of AzurRx (or its Affiliates or its or their Sublicensees) in
connection with activities conducted under this Agreement and any
Related Agreements.
Section
1.16 “AzurRx Regulatory Documentation” shall
have the meaning set forth in Section 4.5.
Section
1.17 “Background IP” shall mean FWB
Background IP or AzurRx Background IP, as applicable.
Section
1.18 “Background Patents” shall mean FWB
Background Patents and AzurRx Background Patents.
Section
1.19 “Breaching Party” shall have the
meaning set forth in Section 13.2.1.
-2-
Section
1.20 “Business Day” shall mean a day
other than (a) a Saturday or Sunday, or (b) a bank or other public
or federal holiday in San Francisco, California, United States or
New York, State of New York, United States.
Section
1.21 “Calendar Quarter” shall mean each
of the successive three (3)-month periods ending on March 31, June
30, September 30 and December 31 of any given Calendar Year, except
that the first Calendar Quarter of the Term shall commence on the
Effective Date and end on the first to occur of March 31, June 30,
September 30 and December 31 after the Effective Date and the last
Calendar Quarter of the Term shall end on the last day of the
Term.
Section
1.22 “Calendar Year” shall mean any
period beginning on January 1 and ending on the immediately
following December 31, except that the first Calendar Year of the
Term shall commence on the Effective Date and end on the December
31 of the year in which the Effective Date occurs and the last
Calendar Year of the Term shall commence on the January 1 of the
year in which the Term ends and the end on the last day of the
Term.
Section
1.23 “cGCP” shall mean the then current
Good Clinical Practice requirements promulgated or endorsed for the
United States by the FDA and its equivalent in other countries or
regulatory jurisdictions, each as may be amended from time to
time.
Section
1.24 “cGLP” shall mean the then current
Good Laboratory Practice requirements promulgated or endorsed for
the United States by the FDA and its equivalent in other countries
or regulatory jurisdictions, each as may be amended from time to
time.
Section
1.25 “cGMP” shall mean the then current
Good Manufacturing Practice requirements promulgated or endorsed
for the United States by the FDA and its equivalent in other
countries or regulatory jurisdictions, each as may be amended from
time to time.
Section
1.26 “Challenge” shall mean any request
for, or filing or declaration of, or commencement or maintenance of
any action involving any interference, opposition, challenges as to
ownership, assertions of invalidity, unenforceability, or
unpatentability, revocation or reexamination or cancellation,
nullity or similar proceeding relating to any of FWB’s
Patents, or based on any of the foregoing, challenging or
withholding any payment under this Agreement, in each case of the
foregoing in any lawsuit or any other civil or administrative
proceeding, or in connection with making of any claim or
counterclaim, before any court, tribunal, agency or Governmental
Authority anywhere in the world, including citing prior art
pursuant to 35 U.S.C. §122 or §301, filing a request for
re-examination of any of FWB’s Patents pursuant to 35 U.S.C.
§302 or §311, filing a petition to request an inter
partes review of FWB’s Patents pursuant to 35 U.S.C.
§311, or filing a petition to request a post-grant review of
FWB’s Patents pursuant to 35 U.S.C. §321, in each case
except as asserted (i) in response to, or (ii) as a
defense or counterclaim in, an action for infringement of such FWB
Patent brought by or on behalf of FWB, its Affiliates, or a Third
Party licensee of either of the foregoing.
Section
1.27 “Clinical Trials” shall mean any
tests and studies of pharmaceutical products in human subjects or
that constitute observational clinical studies.
Section
1.28 “CMC” shall mean Chemistry and
Manufacturing Controls.
Section
1.29 “Code” shall mean the Internal
Revenue Code of 1986, as amended.
-3-
Section
1.30 “Commercialization” shall mean any
and all activities directed to the preparation for sale of, the
offering for sale of, or sale of the Products in the Field in the
Territory, including activities related to marketing, promoting,
distributing, importing and establishing pricing and reimbursement
with respect to the Products, as well as interacting with
Regulatory Authorities regarding any of the foregoing, but
excluding Development and Manufacturing. When used as a verb,
“to
Commercialize” and “Commercializing” shall mean to
engage in Commercialization, and “Commercialized” shall have a
corresponding meaning.
Section
1.31 “Commercialization Plan and Budget”
shall have the meaning set forth in Section
5.1.
Section
1.32 “Commercially Reasonable Efforts”
shall mean, with respect to the efforts to be expended, or
considerations to be undertaken, by AzurRx with respect to any
objective, activity or decision to be undertaken under this
Agreement with respect to a Product, the level of efforts and
resources commonly dedicated with the usual practices of a
similarly situated biopharmaceutical company in the development,
manufacture, and commercialization of a pharmaceutical product
controlled by it, which is at a similar stage of research,
development, or commercialization, is in a similar therapeutic and
disease area, and is of similar market potential, taking into
account such Product’s: (i) profile of efficacy and safety;
(ii) regulatory status, including anticipated or approved labeling
and anticipated or approved post-approval requirements; (iii)
present and future market and commercial potential, including
competitive market conditions and the expected and actual
profitability and return on investment; and (iv) the expected and
actual competitiveness of alternative products (including generic
or biosimilar products) under development or sold in the
marketplace.
Section
1.33
“Compound” shall mean FWB’s
proprietary formulations of niclosamide as set forth in
Exhibit 1.33.
Section
1.34 “Compulsory Sublicense” means, with
respect to a Product in a country, a license or sublicense granted
to a Third Party (a “Compulsory Licensee”) through the
order, decree, or grant of a Governmental Authority in such
country, authorizing such Compulsory Licensee to make, use, sell,
offer for sale, import, or otherwise Commercialize such Product in
such country. A Compulsory Licensee shall not be deemed to be a
Sublicensee.
Section
1.35
“Confidential Information” shall
mean, all non-public or proprietary Information disclosed by a
Party (“Disclosing
Party”) to the other Party (“Receiving Party”) under this
Agreement, which may include ideas, inventions, discoveries,
concepts, compounds, compositions, formulations, formulas,
practices, procedures, processes, methods, knowledge, know-how,
trade secrets, technology, inventories, machines, techniques,
development, designs, drawings, computer programs, skill,
experience, documents, apparatus, results, clinical and regulatory
strategies, regulatory documentation, information and submissions
pertaining to or made in association with Regulatory Materials,
data (including pharmacological, toxicological, and clinical data,
raw data, analytical and quality control data, manufacturing data
and descriptions, patent and legal data, market data, financial
data or descriptions), devices, assays, chemical formulations,
specifications, material, product samples and other samples,
physical, chemical and biological materials and compounds, and the
like, without regard as to whether any of the foregoing is marked
“confidential” or “proprietary,” or
disclosed in oral, written, graphic, or electronic form; provided,
however, “Confidential Information” shall not include
any information that (1) can be demonstrated by documentation or
other competent proof to
-4-
have
been in the Receiving Party’s or its Affiliates’
possession prior to disclosure by the Disclosing Party without any
obligation of confidentiality with respect to such information;
(2) is or becomes part of the public domain through no fault,
wrongful act or negligence of the Receiving Party or its
Affiliates; (3) can be demonstrated by documentation or other
competent proof to have been independently developed by or for the
Receiving Party or its Affiliates without use of, reliance on or
reference to the Disclosing Party’s Confidential Information;
or (4) the Receiving Party or its Affiliate subsequently obtains
from a Third Party that is not bound by any confidentiality
obligation with respect to such information. Confidential
Information will include derivative information prepared by or on
behalf of Receiving Party (such as notes, drawings, plans,
projections, analyses, records and materials) that incorporates or
reflects and also include the terms and conditions of this
Agreement.
Section
1.36 “Control” or “Controlled” shall mean, with
respect to any item of Know-How, Regulatory Materials, material,
Patent or other intellectual property right, possession of the
right, directly or indirectly, and whether by ownership, license,
covenant or otherwise (other than by operation of the licenses and
other rights granted in Section 4.5, Section
8.1 and Section 8.2), to grant a
license, sublicense, covenant or other right to or under such item
of Know-How, Regulatory Materials, material, Patent or other
intellectual property right as provided for herein without
violating an agreement with a Third Party.
Section
1.37 “Cover” or “Covered” or “Covering” shall mean, with respect
to a particular subject matter at issue and a relevant Patent, that
the manufacture, use, sale, offer for sale, or importation of the
subject matter would fall within the scope of a claim in such
Patent.
Section
1.38 “COVID Field” means the diagnosis,
prevention or treatment of Severe Acute Respiratory Syndrome
Coronavirus 2 in humans.
Section
1.39 “Development” shall mean, with
respect to the Compound or the Products, any and all activities,
whether before, on or after First Commercial Sale of the Products,
directed to research, pre-clinical and other non-clinical testing,
test method development and stability testing, toxicology,
formulation, Manufacturing process development, Manufacturing
scale-up, qualification and validation, quality assurance/quality
control development, Clinical Trials, statistical analysis and
report writing, the preparation and submission of Drug Approval
Applications, regulatory affairs with respect to the foregoing and
all other activities necessary or reasonably useful for, or
otherwise requested, required or recommended by a Regulatory
Authority, Governmental Authority or other payor as a condition or
in support of obtaining, maintaining or expanding Regulatory
Approval. When used as a verb, “Develop” shall mean to engage in
Development.
Section
1.40 “Disclosing Party” shall have the
meaning set forth in Section 1.35.
Section
1.41 “Dispute” shall have the meaning
set forth in Section
15.2.
Section
1.42 “Dollars” or “$” shall mean U.S.
Dollars.
Section
1.43 “Drug Approval Application” shall
mean a New Drug Application as defined in the FFDCA, or any
corresponding foreign application in the Territory, including with
respect to the European Union, a Marketing Authorization
Application filed with the EMA pursuant to the centralized approval
procedure or with the applicable Regulatory Authority of a country
in the European Union with respect to the mutual recognition or any
other national approval procedure.
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Section
1.44 “Effective Date” shall have the
meaning set forth in the preamble hereto.
Section
1.45 “EMA” shall mean the European
Medicines Agency or any successor agency thereto.
Section
1.46 “Emergency Use Authorization” shall
mean the FDA’s Regulatory Approval of the use of a Product
for an emergency indication in the US and any analogous provisions
in any other Major Country.
Section
1.47 “EU Big 4” shall mean France,
Italy, Spain and Germany.
Section
1.48 “European Union” or
“EU” shall mean
the countries that are the member states of the European Union as
constituted from time to time.
Section
1.49 “Excluded Claim” shall have the
meaning set forth in Section 15.2.1(a).
Section
1.50 “Existing Product” shall have the
meaning set forth in Section 1.91.
Section
1.51 “Exploit” shall mean to make, have
made, import, use, sell or offer for sale, including to Develop,
Commercialize, Manufacture, register, hold or keep (whether for
disposal or otherwise), have used, export, transport, distribute,
have distributed, promote, market or have sold or otherwise dispose
of a product or a process, and “Exploitation” means the
act of Exploiting a product or process.
Section
1.52 “FCPA” shall have the meaning set
forth in Section 16.6.
Section
1.53 “FDA” shall mean the United States
Food and Drug Administration, or any successor agency
thereto.
Section
1.54 “FFDCA” shall mean the United
States Food, Drug, and Cosmetic Act, as amended from time to time,
together with any rules, regulations and requirements promulgated
thereunder (including all additions, supplements, extensions and
modifications thereto).
Section
1.55 “Field” shall mean the ICI-AC Field
and the COVID Field.
Section
1.56 “First Commercial Sale” shall mean,
with respect to a country in the Territory and a Product, the first
sale of such Product for use or consumption by the general public
(and excluding research or educational use, charitable or
compassionate use, and indigent care) by a Party or its Affiliate
or Sublicensee to a Third Party in such country after all
Regulatory Approvals have been obtained in such
country.
Section
1.57 “Force Majeure” shall have the
meaning set forth in Section 16.1.
Section
1.58 “FWB” shall have the meaning set
forth in the preamble hereto.
Section
1.59 “FWB Background IP” shall mean any
and all Know-How or Patents that are (a) related to the Compound in
the Field in the Territory, (b) Controlled by FWB or its Affiliates
as of the Effective Date or developed independent of this Agreement
during the Term, and (c) necessary or reasonably useful to Exploit
the Existing Product in the Field in the Territory.
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Section
1.60 “FWB Background Patents” shall mean
Patents within the FWB Background IP. FWB Background Patents
existing as of the Effective Date are listed in Exhibit 1.60.
Section
1.61 “FWB Program Patents” shall mean
any and all Patents filed based on inventions, discoveries or other
know-how that are invented, conceived, discovered, developed or
otherwise made, whether independently or jointly, by or on behalf
of FWB (or its Affiliates or its or their Sublicensees) in
connection with activities conducted under this Agreement and any
Related Agreements.
Section
1.62 “FWB Retained Rights” shall have
the meaning set forth in Section 8.3.1.
Section
1.63 “Good Practices” shall mean cGCP,
cGLP and cGMP.
Section
1.64 “Governmental
Authority” shall
mean any multi-national, national, federal, state, local,
provincial, municipal, or other government authority of any nature
(including any governmental division, subdivision, department,
agency, bureau, branch, office, commission, council, court, or
other tribunal).
Section
1.65 “ICI-AC Field” shall mean the
diagnosis, prevention or treatment of ICI-AC in
humans.
Section
1.66 “Indemnification Claim Notice”
shall have the meaning set forth in Section 12.3.1.
Section
1.67 “Indemnified Party” shall have the
meaning set forth in Section 12.3.1.
Section
1.68 “Indemnitees” shall mean FWB
Indemnitees or AzurRx Indemnitees.
Section
1.69 “Infringement” shall have the
meaning set forth in Section 9.3.1.
Section
1.70 “Infringement Notice” shall have
the meaning set forth in Section 9.3.1.
Section
1.71 “Insolvency Event” shall mean, with
respect to a Party, any one of the following: (a) a case is
commenced by or against either Party under Title 11, United States
Code, as amended, or analogous provisions of Applicable Law outside
the United States (the “Bankruptcy Code”) and, in the
event of an involuntary case under the Bankruptcy Code, such case
is not dismissed within sixty (60) days after the commencement
thereof, (ii) either Party files for or is subject to the
institution of bankruptcy, liquidation or receivership proceedings
(other than a case under the Bankruptcy Code or any voluntary
solvent restructuring), (iii) either Party assigns all or a
substantial portion of its assets for the benefit of creditors (for
clarity, excluding the grant of any security interest under such
assets under a loan agreement or similar agreement), (iv) a
receiver or custodian is appointed for either Party’s
business, or (v) a substantial portion of either Party’s
business is subject to attachment or similar process; then, in any
such case ((i), (ii), (iii), (iv) or (v)), the other Party may
terminate this Agreement upon written notice to the extent
permitted under Applicable Law.
Section
1.72 “Joint Program IP” shall have the
meaning set forth in Section 9.1.2(b).
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Section
1.73 “Joint Program Patents” shall mean
the Patents that Cover the Joint Program IP.
Section
1.74 “Joint Steering Committee” or
“JSC” shall have
the meaning set forth in Section 2.1.
Section
1.75 “Know-How” shall mean all
technical, scientific and other know-how and information, trade
secrets, knowledge, technology, means, methods, discoveries,
compounds, compositions, formulations, processes, correspondence,
computer programs, documents, apparatus, strategies, processes,
practices, formulae, instructions, skills, techniques, procedures,
experiences, ideas, technical assistance, designs, drawings,
assembly procedures, computer programs, apparatuses,
specifications, data, results, regulatory documentation,
information and submissions pertaining to, or made in association
with, filings with any Governmental Authority or Patent Office,
data in written, electronic, oral or other tangible or intangible
form, and other material, including: biological, chemical,
pharmacological, toxicological, pharmaceutical, physical and
analytical, pre-clinical, clinical, safety, manufacturing and
quality control data and information, including study designs and
protocols, assays and biological methodology, and any inventions,
improvements, discoveries, and developments included therein, in
each case (whether or not confidential, proprietary, patented or
patentable) in written, electronic or any other form now known or
hereafter developed, but excluding in any event any published
Patents.
Section
1.76 “Knowledge” with respect to a
Party, means the actual knowledge of such Party after diligent
inquiry.
Section
1.77 “Losses” shall have the meaning set
forth in Section 12.1.
Section
1.78 “Major Country” shall mean the EU Big 4 and the
United Kingdom.
Section
1.79 “Manufacture” and
“Manufacturing”
shall mean any and all activities directed to the formulation
development, production, manufacture, processing, filling,
finishing, packaging, labeling, shipping, holding and disposing of
the Compound or the Products, or any intermediate thereof,
including stability testing, quality assurance, and quality control
and interacting with Regulatory Authorities regarding any of the
foregoing.
Section
1.80 “NDA” shall mean means a New Drug
Application filed with the FDA in conformance with Applicable Law,
or the foreign equivalent of any such application in any other
country filed with a Regulatory Authority to obtain marketing
approval for a pharmaceutical product.
Section
1.81 “Net Sales” shall mean, with
respect to any Product, the gross amounts invoiced for sales or
other dispositions of such Product by or on behalf of AzurRx or its
Affiliates or Sublicensees to Third Parties in the Territory, less
the following deductions to the extent included in the gross
invoiced sales price for such Product and determined in each case
in accordance with generally accepted accounting principles in the
U.S. (“U.S.
GAAP”) or otherwise directly paid or incurred by
AzurRx or its Affiliates or Sublicensees, as applicable, with
respect to the sale or other disposition of such
Product:
1.81.1 normal
and customary trade and quantity discounts actually allowed and
properly taken directly with respect to sales of such
Product;
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1.81.2 credits
or allowances given or made for rejection or return of previously
sold Products or for retroactive price reductions and billing
errors;
1.81.3 rebates
and chargeback payments granted to managed health care
organizations, pharmacy benefit managers (or equivalents thereof),
national, state/provincial, local, and other Government Authorities
including, their agencies and purchasers and reimbursers, or to
trade customers;
1.81.4 taxes,
duties, or other governmental charges (including any tax such as a
value added or similar tax, other than any taxes based on income)
directly levied on or measured by the billing amount for such
Product, as adjusted for rebates and refunds;
1.81.5 amounts
repaid or credited by reason of rejections, defects, return goods
allowance, recalls or returns, or because of retroactive price
reductions, including rebates or wholesaler charge
backs;
1.81.6 the
portion of administrative fees paid during the relevant time period
to group purchasing organizations or pharmaceutical benefit
managers relating to such Product;
1.81.7 gross
sales offsets provided to specialty pharmacies, warehousing chains
or distributors for their services provided; and
1.81.8 freight,
insurance, and other transportation charges to the extent added to
the sale price and set forth separately as such in the total amount
invoiced.
Net
Sales shall not include transfers or dispositions for charitable,
promotional, pre-clinical, clinical, regulatory, or governmental
purposes. Subject to the above, Net Sales shall be calculated in
accordance with the standard internal policies and procedures of
AzurRx, its Affiliates, or Sublicensees, which must be in
accordance with U.S. GAAP. For purposes of determining Net Sales, a
Product will be deemed to be sold when invoiced. A particular
deduction may only be accounted for once in the calculation of Net
Sales. Net Sales will exclude any samples of a Product transferred
or disposed of at no cost, or cost below AzurRx’s cost of
goods for such Product, for promotional, Development, or
educational purposes.
In
the event a Product is sold as part of a Combination Product in a
country, the Parties will negotiate, reasonably and in good faith,
an adjustment to Net Sales with respect to the Combination Product
in such country to account for any value attributable to active
ingredients included in the Combination Product other than the
Compound.
For
clarity, Net Sales will be calculated on an accrual basis, in a
manner consistent with AzurRx’s internal accounting policies,
as consistently applied. To the extent any accrued amounts used in
the calculation of Net Sales are estimates, such estimates shall be
trued-up in accordance with AzurRx’s internal accounting
policies, consistently applied, and Net Sales and related payments
under this Agreement shall be reconciled as
appropriate.
Section
1.82 “Non-Breaching Party” shall have
the meaning set forth in Section 13.2.1.
Section
1.83 “Party(ies)” shall have the meaning
set forth in the preamble hereto.
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Section
1.84 “Patents” shall mean: (a) patents,
including any utility or design patent, utility models or petty
patents; (b) patent applications, including provisionals,
non-provisionals, substitutions, divisionals, continuations,
continuations in-part or renewals; (c) patents of addition,
restorations, extensions, supplementary protection certificates,
registration or confirmation patents, patents resulting from
post-grant proceedings, re-issues, and re-examinations; (d) other
patents or patent applications claiming priority directly or
indirectly to: (i) any such specified patent or patent application
specified in (a) through (c), or (ii) any patent or patent
application from which a patent or patent application specified in
(a) through (c) claim direct or indirect priority; (e)
inventor’s certificates; (f) other rights issued from a
Governmental Authority similar to any of the foregoing specified in
(a) through (e); and (g) in each of (a) through (f), whether such
patent, patent application or other right arises in the U.S. or any
other jurisdiction in the world.
Section
1.85 “Patent Office” shall mean a
Governmental Authority that administers and regulates patents, such
as the United States Patent and Trademark Office, or other similar
Governmental Authority.
Section
1.86 “Patent Term Extension” shall have
the meaning set forth in Section 9.2.4.
Section
1.87 “Person” shall mean any natural
person, corporation, partnership, trust, joint venture, limited
liability company, Governmental Authority or any other entity or
organization.
Section
1.88 “Pharmacovigilance Agreement” shall
have the meaning set forth in Section 4.4.
Section
1.89 “Phase 2 Clinical Trial” shall mean
a Clinical Trial of a Product conducted by or on behalf of AzurRx,
its Affiliates or Sublicensees on a sufficient number of subjects
for making (and the principal purpose of which is to make) a
preliminary determination as to whether a pharmaceutical product is
safe for its intended use and obtaining (and to obtain) sufficient
information about such product’s efficacy, in a manner that
is generally consistent with 21 C.F.R. § 312.21(b), as amended
(or its successor regulation), or a similar clinical study
prescribed by the Regulatory Authorities in a country or
jurisdiction outside the United States, to permit the design of
further Clinical Trials of such Product.
Section
1.90 “Phase 3 Clinical Trial” shall mean
a Clinical Trial of a Product with a defined dose or a set of
defined doses of such Product and conducted by or on behalf of
AzurRx, its Affiliates or Sublicensees on a sufficient number of
subjects for ascertaining (and that is designed to ascertain) the
overall risk-benefit relationship of the Product for its intended
use and determining (and to determine) warnings, precautions, and
adverse reactions that are associated with such Product in the
dosage range to be prescribed, in a manner that is generally
consistent with 21 C.F.R. § 312.21(c), as amended (or its
successor regulation), or a similar clinical study prescribed by
the Regulatory Authorities in a country or jurisdiction outside the
United States, to permit the design of further Clinical Trials of
such Product.
Section
1.91
“Product” shall mean any product
for use in the Field that constitutes, incorporates, comprises or
contains (a) the Compound, whether or not as the sole active
ingredient in the formulations existing as of the Effective Date
(the “Existing
Product”) or (b) any other formulations of niclosamide
developed by AzurRx during the Term in the Field in the
Territory.
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Section
1.92 “Product Labeling” shall mean, with
respect to the applicable Product in a country in the Territory,
(a) the Regulatory Authority approved full prescribing information
for such Product for such country, including any required patient
information, and (b) all labels and other written, printed, or
graphic matter upon a container, wrapper, or any package insert
utilized with or for such Product in such country.
Section
1.93 “Program IP” shall mean the Program
Know-How and the Program Patents.
Section
1.94 “Program Know-How” shall mean any
and all Know-How, whether or not patentable, that is invented,
conceived, discovered, developed or otherwise made, whether
independently or jointly, by or on behalf of FWB (or its Affiliates
or its or their Sublicensees) or AzurRx (or its Affiliates or its
or their Sublicensees) in connection with activities conducted
under this Agreement and any Related Agreements. For clarity,
Program Know-How excludes any Program Patents.
Section
1.95 “Program Patents” shall mean the
FWB Program Patents and the AzurRx Program Patents.
Section
1.96 “Receiving Party” shall have the
meaning set forth in Section 1.35.
Section
1.97 “Registrational Trial” shall mean,
with respect to a Product, either (a) a Phase 3 Clinical Trial for
such Product or (b) Phase 2 Clinical Trial, in each case that, at
the time of commencement or thereafter, is expected to provide an
adequate basis for the preparation and submission of an NDA to
obtain Marketing Approval of such Product in a Major
Country.
Section
1.98 “Regulatory Approval” shall mean,
with respect to a country in the Territory, the grant of any and
all approvals (including approval of Drug Approval Applications),
licenses, registrations or authorizations of any Regulatory
Authority necessary for the commercial distribution, marketing or
sale of any Product for one or more indications in such country,
including, where applicable, (a) pre- and post-approval marketing
authorizations (including any prerequisite Manufacturing approval
or authorization related thereto), (b) labeling approval, (c) with
respect to the United States, scheduling by the Drug Enforcement
Administration, and (d) the satisfaction of all applicable
regulatory and notification requirements, but excluding pricing or
reimbursement approval in such country.
Section
1.99 “Regulatory Authority” shall mean
any applicable supra-national, federal, national, regional, state,
provincial or local regulatory agencies, departments, bureaus,
commissions, councils or other government entities regulating or
otherwise exercising authority with respect to any Product or the
Exploitation thereof in the Territory, including the FDA in the
United States and the EMA in the European Union, but excluding any
government entities responsible for pricing and
reimbursement.
Section
1.100 “Regulatory Exclusivity Period”
shall mean, with respect to a country in the Territory, a period of
exclusivity granted or afforded by Applicable Law or by a
Regulatory Authority in such country that confers data, marketing,
or other exclusivity with respect to the applicable Product in such
country.
Section
1.101 “Regulatory Materials” shall mean
all (a) regulatory submissions, notifications, registrations,
licenses, authorizations, applications (including all INDs and
Drug
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Approval
Applications) and approvals (including any Regulatory Approval) and
all amendments and supplements to any of the foregoing and (b)
correspondence and reports submitted to or received from Regulatory
Authorities and all supporting documents with respect thereto,
including drug lists, advertising and promotion documents, adverse
event files, and complaint files, in each case ((a) and (b))
relating to the Compound or a Product.
Section
1.102 “Regulatory Party” shall mean
AzurRx except as may otherwise be agreed in writing by the
Parties.
Section
1.103 “Related Agreements” shall mean any
other written agreements between the Parties with respect to the
Development, Manufacturing, supply or Commercialization of the
Compound or the Product, as such agreements may be amended by the
Parties from time to time.
Section
1.104 “ROFR Notice” shall have the
meaning set forth in Section 14.2.
Section
1.105 “Royalty Term” shall have the
meaning set forth in Section 6.4.2.
Section
1.106 “Sublicensee” shall mean, with
respect to a Party, any Person, other than an Affiliate, that is
granted a sublicense by such Party under the grants in Section
4.5, Section 8.1 or Section
8.2, as applicable.
Section
1.107 “Successful Completion” with
respect to a Clinical Trial shall mean achievement of the primary
endpoint for such Clinical Trial as determined by consensus of the
JSC (or through escalation to arbitration).
Section
1.108 “Sunshine Act” shall have the meaning set forth
in Section 16.6.
Section
1.109 “Term” shall have the meaning set
forth in Section 13.1.1.
Section
1.110 “Termination Notice” shall have the
meaning set forth in Section 13.2.1.
Section
1.111 “Termination Notice Period” shall
have the meaning set forth in Section 13.2.1.
Section
1.112 “Territory” shall mean the
world.
Section
1.113 “Third Party” shall mean any Person
other than FWB, AzurRx and their respective
Affiliates.
Section
1.114 “Third Party Claims” shall have the
meaning set forth in Section 12.1.
Section
1.115 “Third Party Distributor” shall
mean the Third Party distributor to which AzurRx for such country
delegates primary responsibility for Commercializing the applicable
Product in such country and which purchases such Product from such
selling party (or its Affiliate) for resale in such
country.
Section
1.116 “Third Party Infringement Claim”
shall have the meaning set forth in Section
9.4.
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Section
1.117 “Third Party License” shall mean a
license with a Third Party entered into by AzurRx or any of its
Affiliates on or after the Effective Date in accordance with the
terms of this Agreement in consideration of any rights necessary
for the Exploitation of any Compound or Product in the Field in the
Territory.
Section
1.118 “Third Party Royalties” shall mean
royalties payable to a Third Party under a Third Party
License.
Section
1.119 “Trigger Event” shall have the
meaning set forth in Section 14.2.
Section
1.120 “U.S. GAAP” shall mean generally
accepted accounting principles current in the United States, as
consistently applied.
Section
1.121 “United States” shall mean the
United States of America and its territories and possessions,
including the District of Columbia and Puerto Rico.
Section
1.122 “Valid Claim” shall mean, with
respect to a particular country in the Territory, a claim of an
unexpired FWB Background Patent or any Program Patent in such
country Covering the applicable Product or its Exploitation that
has not been: (i) revoked or held unenforceable, unpatentable
or invalid by a decision of a court or other Governmental Authority
of competent jurisdiction, which decision is unappealable or
unappealed within the time allowed for appeal, or (ii) pending
without being allowed for greater than seven (7) years from the
filing date or (iii) abandoned, disclaimed, denied or admitted to
be invalid or unenforceable through reissue, re-examination or
disclaimer or otherwise.
Section
1.123 “VWAP” shall mean the
volume-weighted average price of a share of AzurRx Common Stock on the Nasdaq Capital Market or, if
no longer traded on the Nasdaq Capital Market, such other market on
which the AzurRx Common Stock is then
traded.
ARTICLE
II.
GOVERNANCE
Section
2.1 Formation of the Joint Steering Committee.
On the
Effective Date, the Parties shall establish a joint steering
committee (the “JSC”), which shall consist of up
to two (2) representatives from each of the Parties, each with the
requisite experience and seniority to enable such person to make
decisions on behalf of the Party appointing him or her with respect
to the issues falling within the jurisdiction of the JSC. As of the
Effective Date, each Party’s representatives to the JSC are
set forth on Exhibit 2.1 hereto. From time to
time, each Party may substitute one or more of its representatives
to the JSC on written notice to the other Party. FWB shall select
from its representatives the initial chairperson for the JSC, and
every twelve (12) months thereafter, the Party for which the
then-current chairperson is not a representative shall select from
its representatives the new chairperson for the JSC. The Party with
the right to appoint the chairperson may, at any time, change the
representative who will serve as chairperson, on written notice to
the other Party.
Section
2.2 Specific Responsibilities of the
JSC. Subject to the dispute resolution provision of
Section 15.2 and
AzurRx’s final decision-making right as set forth in Section
2.5, the JSC shall have overall responsibility for
monitoring and providing general operational oversight with respect
to the Parties’ activities under this Agreement. In
particular, the JSC
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shall
oversee the Development, Manufacture and Commercialization of the
Product in the Field and Territory; review for approval by the JSC
the initial Development Plan (as defined below) and the
Commercialization Plan and Budget (as defined below) and, at least
once annually; consider any amendments thereto; review reports of
Development and Commercialization activities; and perform such
other functions as are assigned to the JSC herein or in any Related
Agreement or as the Parties may mutually agree in
writing.
Section
2.3 Meetings and Minutes. The JSC
shall meet quarterly or at such higher frequency as otherwise
agreed by the Parties, with the location of such meetings, if not
virtual, alternating between locations designated by FWB and
locations designated by AzurRx. Representatives of the Parties on
the JSC may attend a meeting either in person or by telephone,
video conference or similar means in which each participant can
hear what is said by, and be heard by, the other participants. The
chairperson of the JSC shall be responsible for calling meetings on
no less than ten (10) Business Days’ notice (unless the
Parties consent in writing to a shorter notice period); provided
that either Party can call a meeting of the JSC in the event the
chairperson of the JSC fails to call a meeting following request
from a Party. At AzurRx's request in writing at least twenty (20)
Business Days prior to a scheduled JSC meeting, but not more than
two times per year, FWB shall present to the JSC its high-level
plans for the Development and Commercialization of the Product
outside the Field in the Territory. Each Party shall make all
proposals for agenda items and shall provide all appropriate
information with respect to such proposed items at least five (5)
Business Days in advance of the applicable meeting; provided that under exigent circumstances
requiring input by the JSC, a Party may provide its agenda items to
the other Party within a shorter period of time in advance of the
meeting or may propose that there not be a specific agenda for a
particular meeting, so long as the other Party consents to such
later addition of such agenda items or the absence of a specific
agenda for such meeting, such consent not to be unreasonably
withheld, conditioned or delayed. The chairperson of the JSC shall
prepare and circulate for review and approval of the Parties
minutes of each meeting within thirty (30) days after the meeting.
The Parties shall agree on the minutes of each meeting promptly,
but in no event later than the next meeting of the
JSC.
Section
2.4 Procedural Rules. The JSC shall
have the right to adopt such standing rules as shall be necessary
for its work, to the extent that such rules are not inconsistent
with this Agreement. A quorum of the JSC shall exist whenever there
is present at a meeting at least one (1) representative appointed
by each Party. Directors, officers, employees and agents (including
consultants) of each Party (or its Affiliates) that are not
representatives of such Party on the JSC may attend meetings of the
JSC with prior written notice to the other Party; provided, however, that such attendees (a) shall
not vote or otherwise participate in the decision-making process of
the JSC, and (b) are bound by obligations of confidentiality
and non-disclosure equivalent to those set forth in Article
X.
Section
2.5 Decision-Making. Decisions
shall be made by consensus and AzurRx shall have final
decision-making authority with respect to any dispute regarding the
Product in the Field, the Development Plan, the Commercialization
Plan, and the Exploitation of the Product in the Field;
provided that AzurRx shall make all final
decisions in good faith after consideration of FWB’s comments
and shall exercise its decision-making right in a manner that is
consistent with the Parties’ rights and obligations hereunder
with respect to the Product in the Field; and provided further, that (a) consensus is
required regarding the primary endpoint for the applicable Clinical
Trial, and (b) to the extent AzurRx’s final decision solely
related to preclinical Development or the design of the protocol
for the applicable Clinical Trial may, in
-14-
the
reasonable judgment of FWB, negatively impact the Exploitation of
the Product outside the Field in the Territory, such decision shall
require FWB’s consent not to be unreasonably withheld or
delayed; provided however if the JSC fails to reach consensus under
2.5(a) or AzurRx disagrees with the determination of FWB in regards
to 2.5(b), such disagreements may be escalated to arbitration. For
clarity, AzurRx shall not have final decision-making authority with
respect to disputes about the interpretation or termination of this
Agreement. Any final decision made by AzurRx pursuant to this
Section 2.5 shall be deemed
to be a decision by the JSC for the purposes of this Agreement. For
clarity, FWB shall have sole authority and decision-making with
respect to the Product outside the Field.
Section
2.6 Limitations on Authority. Each
Party shall retain the rights, powers, and discretion granted to it
under this Agreement and no such rights, powers, or discretion
shall be delegated to or vested in the JSC unless such delegation
or vesting of rights is expressly provided for in this Agreement or
the Parties expressly so agree in writing. The JSC shall not have
the power to amend, modify, or waive compliance with any provision
of this Agreement, which may only be amended or modified as
provided in Section 16.5 or compliance with which
may only be waived as provided in Section
16.13.
Section
2.7 Expenses. Each Party shall bear
its own costs, including travel costs and taxes (whether imposed on
the personnel or the Party), for personnel serving on the JSC,
except as otherwise explicitly agreed herein.
Section
2.8 Disbandment. Notwithstanding
anything to the contrary herein, the JSC may be dissolved upon the
mutual written agreement of the Parties or at the request of FWB.
In the event of disbandment of the JSC, all responsibilities and
decisions allocated to the JSC shall be deemed allocated to the
Parties, provided
that the final
decision-making authority shall remain in accordance with Section
2.5.
ARTICLE
III.
DEVELOPMENT
Section
3.1 Development in the Field in the
Territory. Unless otherwise agreed in writing between the
Parties, AzurRx shall conduct the Development of the Product in the
Field for the Territory at AzurRx’s sole cost and solely
pursuant to a development plan and budget approved by the JSC,
subject to Section 2.5 (the
“Development
Plan”). The Development Plan shall: (a) set forth in
reasonable detail the Clinical Trials and Development activities to
be conducted by AzurRx relating to the Compound or any Product,
including the specific Clinical Trials and Development activities
required for obtaining and maintaining Regulatory Approval in the
Field in the Territory and anticipated timelines with respect
thereto, and (b) set forth the regulatory strategy for obtaining
and maintaining Regulatory Approvals for the Product(s) in each
country in the Territory. The initial Development Plan shall be
provided to the JSC within ninety (90) days of the Effective Date.
The Development Plan shall be the Confidential Information of
AzurRx, provided that the
non-use restrictions set forth in Section
10.1 shall not apply to such information.
Notwithstanding the foregoing, the Development Plan may not be
shared with any sublicensees of FWB without the consent of AzurRx
not to be unreasonably withheld or delayed. FWB, directly or
through its representatives on the JSC, may provide comments on the
Development Plan from time to time as appropriate, including
proposals to add Clinical Trials and other Development activities
in support of obtaining Regulatory Approval in the Field for the
applicable jurisdiction which proposals are subject to
AzurRx’s decision-making authority set forth in Section
2.5. AzurRx shall use Commercially
Reasonable
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Efforts
to Develop the Product(s) in the US and the European Union or in
three of the five Major Countries, and to achieve the milestones
set forth herein with respect to: (i) at least one Product in the
COVID Field and (ii) at least one Product in the ICI-AC Field.
Operational or tactical level decisions necessary to execute
Development activities pursuant to the Development Plan shall be
within the decision-making authority of AzurRx; provided that all such decisions shall
be consistent with the terms of this Agreement, Applicable Law, the
Development Plan and the decisions of the JSC, subject to Section
2.5. Within thirty (30) days of the Effective Date, FWB
shall deliver and provide to AzurRx such manufacturing process
information Controlled by FWB with respect to the Product, to the
extent not already provided to or otherwise in the possession or
Control of AzurRx as necessary in order to enable AzurRx to
replicate the manufacturing process for the Product, as such
process and Product exist as of the Effective Date without charge
to AzurRx. In the event AzurRx needs additional support from FWB,
AzurRx shall reimburse FWB for FWB’s personnel costs measured
at a reasonable FTE rate and the out-of-pocket costs incurred by
FWB or its Affiliates in connection with the provision of such
assistance. In addition, within ten (10) days following the
Effective Date, FWB shall transfer to AzurRx the applicable IND(s)
and shall also provide copies of Regulatory Materials for the
Development, Commercialization and other Exploitation of the
Products, in each case in the Field in the Territory.
Section
3.2 Clinical Trials. AzurRx shall
be solely responsible for any clinical trial activities carried out
as part of its Development and Commercialization of the Products in
the Field in the Territory.
Section
3.3 Performance Obligations. AzurRx
shall perform, or cause to be performed, any and all of its
Development activities in a good scientific manner and in
compliance with all Applicable Law, including applicable Good
Practices.
3.4.1 AzurRx shall, and shall cause
its Affiliates and Third Party subcontractors to, maintain, in good
scientific manner, complete and accurate written records, accounts, notes, reports, and
data pertaining to its Development activities hereunder and
all Program Know-How resulting from such activities in sufficient
detail to verify compliance with its obligations under this
Agreement, in conformity with standard pharmaceutical practices and
the terms of this Agreement. Such books and records shall (a) be
appropriate for patent and regulatory purposes, (b) be in
compliance with Applicable Law, (c) properly reflect all work done
and results achieved in the performance of the Development
activities, and (d) be retained by AzurRx for at least seven (7)
years after the expiration or termination of this Agreement in its
entirety or for such longer period as may be required by Applicable
Law. FWB shall have the right, during normal business hours and
upon reasonable notice, to inspect and copy all such books and
records maintained by AzurRx or AzurRx’s Third Party
subcontractors pursuant to this Section 3.4.1 for any reasonable
purpose; provided
that FWB shall maintain
such books and records and information disclosed therein in strict
confidence in accordance with Article X. In addition,
upon a FWB’s written request, AzurRx shall send to FWB
legible copies of the aforesaid, throughout the Term and for a
minimum of twelve (12) months following the Term. In the event that
AzurRx intends to delete any such records, it shall notify FWB and
FWB shall notify AzurRx within 30 days whether it wishes to receive
such records in lieu of destruction, in which case AzurRx shall
transfer such records to FWB.
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3.4.2 Without
limiting Section 3.4.1, within forty-five (45) days
following the end of each Calendar Year during which AzurRx is
conducting any Development activities hereunder, AzurRx shall
provide the JSC with a reasonably detailed report of the
Development activities it has performed, or caused to be performed,
since the preceding report (or with respect to the first such
report, since the Effective Date) and its Development activities in
process, and the future activities it expects to initiate. Each
such report shall contain the details as set out in Exhibit 3.4.2.
ARTICLE
IV.
Section
4.1 Regulatory Activities. The
Development Plan shall include the regulatory strategy for
obtaining and maintaining Regulatory Approvals for the Product(s)
in the Field in the Territory. AzurRx shall be responsible for and
shall have the sole right with respect to (a) the preparation,
submission, and maintenance of all Regulatory Materials (including
Drug Approval Applications), and (b) conducting communications with
the applicable Regulatory Authorities (the “Regulatory Activities”), in each
case, with respect to the Products in the Territory, provided that FWB shall receive copies
of such filings and may provide input thereon. AzurRx shall
consider such input from FWB in good faith. AzurRx shall ensure
that the Regulatory Materials (including Product Labeling) and
communications, are consistent with the Development Plan for the
applicable Product. Any Regulatory Materials received by FWB shall
be deemed to be Confidential Information of AzurRx, provided that the non-use restrictions
set forth in Section 10.1 shall not
apply to such Regulatory Materials. Notwithstanding the foregoing,
the Regulatory Materials may not be shared with any sublicensees of
FWB without the consent of AzurRx.
Section
4.2 Interactions with Regulatory
Authorities. AzurRx shall have the sole right to interact
with Regulatory Authorities, respond to inquiries of such
Regulatory Authorities with regard to the Regulatory Materials for
the Product in the Field and in the Territory and file all
post-approval updates to Regulatory Materials, such as periodic or
ad-hoc safety update reports, supplements and amendments, as well
as routine maintenance of the submissions of the Regulatory
Materials that must be provided with respect to such Product at
periodic intervals to such Regulatory Authorities. FWB shall be
permitted to have up to two (2) of its representatives attend all
in-person or other meetings with Regulatory Authorities with regard
to the Product in the Field in the Territory, notice of which shall
be given by AzurRx to FWB sufficiently in advance thereof to allow
FWB to prepare for and participate meaningfully in such meeting;
provided, however, that if
prior to such meeting, AzurRx cannot reasonably provide notice to
FWB because the meeting must take place immediately, AzurRx may act
on its own consistent with the Development Plan.
Section
4.3 Product Withdrawals and
Recalls. If (a) any Regulatory Authority threatens,
initiates or advises any action to remove a Product from the market
in any country in the Territory or requires or advises AzurRx or
any of its respective Affiliates or Sublicensees to distribute a
“Dear Doctor” letter or its equivalent regarding use of
such Product, or (b) either Party determines that an event,
incident or circumstance has occurred that may result in the need
for a recall or market withdrawal of such Product or distribution
of a “Dear Doctor” letter or its equivalent regarding
use of the Product, then in each case ((a) or (b)) FWB or AzurRx,
as applicable, shall notify the other Party of such event or
determination immediately, and in any event within twenty-four (24)
hours (or sooner if required by Applicable Law) after such Party
becomes aware of the event or makes such determination. The JSC
shall discuss and
-17-
agree
upon whether to recall or withdraw such Product or distribute such
“Dear Doctor” letter, provided that AzurRx shall have the
final decision-making authority with respect to such recall,
withdrawal or distribution. AzurRx shall bear the expenses incurred
by the Parties as a result of such withdrawal and recall to the
extent it is determined that the recall is due solely to the
actions of AzurRx. If the recall is due solely to the actions of
FWB then the cost of recall shall be borne by FWB. If the cause of
the recall cannot be determined the cost of the recall shall be
shared equally by the Parties.
Section
4.4 Global Safety Database;
Pharmacovigilance Agreement. AzurRx shall be solely
responsible for, and have the right with respect to, establishing
(if applicable), holding and maintaining the global safety
database(s) for each Product in the Field in the Territory. At the
request of either Party, the Parties shall enter into a reasonable
and customary written pharmacovigilance agreement (the
“Pharmacovigilance
Agreement”) governing each Party’s obligations
with respect to reporting to the other Party and appropriate
Regulatory Authorities Adverse Events, complaints, and other
safety-related matters with respect to the applicable Product as
required by law. The Parties shall cooperate across their
respective fields regarding the reciprocal exchange of
safety-related Regulatory Materials about the Product, and shall
each assist the other Party with the Regulatory Activities for such
Product inside or outside the Field, as applicable, in the
Territory, and at the cost and expense of the Party responsible for
such Regulatory Activities.
Section
4.5 FWB’s Right of Reference.
Subject to the terms and conditions of this Agreement, AzurRx
hereby grants, on behalf of itself and its Affiliates, and shall
cause any Sublicensees to grant, to FWB a non-exclusive right of
reference access to, and a right of reference with respect to, any
and all Regulatory Materials and corresponding documentation to the
extent Controlled by AzurRx or its Affiliates with respect to any
Product in any country in the Territory for use outside the Field
or in any Field following the termination of this Agreement (the
“AzurRx Regulatory Documentation”). Such
right of reference shall be sublicensable through multiple tiers
with the consent of AzurRx not to be unreasonably withheld or
delayed.
Section
4.6 Data Privacy. Each Party shall comply at all times
with Applicable Laws, including those regarding data
privacy.
ARTICLE
V.
Section
5.1 Overview. Subject to the terms
and conditions of this Agreement, AzurRx shall be responsible for
the performance of the activities in relation to the
Commercialization of the Product in the Field in the Territory as
stated under this Article V, subject to
oversight by the JSC and according to a JSC-approved (subject to
Section 2.5)
commercialization plan and budget (the “Commercialization Plan and
Budget”). Such Commercialization Plan and Budget shall
be prepared and delivered within six (6) months before the date of
anticipated Regulatory Approval in the Territory. The
Commercialization Plan and Budget shall describe in reasonable
detail, the pre-launch, launch and subsequent Commercialization of
the Product(s) in the Field in the Territory, including the
following components: (i) overall goals and metrics with regard to
the Commercialization of the Product(s), which will be tracked and
recorded; (ii) general strategies for Commercialization activities
in the Territory; (iii) the material activities to be conducted by
AzurRx in connection with the Commercialization of the Product(s)
in the Territory, including the nature of the marketing and
promotional activities to
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be
conducted for the Product(s); (iv) the pricing, rebating and
contracting strategy for the Product(s) in the Territory; (v) a
non-binding summary-level market and sales forecasts for the
Product(s) in each country in the Territory; (vi) patient
assistance and indigent/expanded access programs in each country in
the Territory; and (vii) a budget for all such Commercialization
activities set forth therein. The Commercialization Plan and Budget
shall be the Confidential Information of AzurRx, provided that the non-use restrictions
set forth in Section 10.1 shall not
apply to such plan and budget. Notwithstanding the foregoing, the
Commercialization Plan and Budget may not be shared with
sublicensees of FWB without the consent of AzurRx not to be
unreasonably withheld or delayed.
Section
5.2 Commercialization Conduct and
Diligence. AzurRx shall use Commercially Reasonable Efforts
(i) to Commercialize in the US and in either the European Union or
in three of the five Major Countries, and (ii) to achieve the
milestones set forth herein with respect to: (A) at least one
Product in the COVID Field and (B) at least one Product in the
ICI-AC Field.
Section
5.3 Records. AzurRx shall maintain
complete and accurate books and records pertaining to its
Commercialization activities hereunder, in sufficient detail to
verify compliance with its obligations under this Agreement and
with Applicable Law. Such records shall properly reflect all work
done and results achieved in the performance of AzurRx’s
Commercialization activities and shall be retained by AzurRx for at
least three (3) years after the expiration or termination of this
Agreement in its entirety or for such longer period as may be
required by Applicable Law. FWB shall have the right, during normal
business hours and upon reasonable notice, to inspect and copy all
such books and records maintained by AzurRx pursuant to this
Section 5.3; provided that FWB shall maintain such records
and information disclosed therein in confidence accordance with
Article X.
Section
5.4 Reports. At least once every
Calendar Quarter during the period in which AzurRx is conducting
Commercialization activities hereunder, AzurRx shall provide to the
JSC reasonably detailed written reports of the Commercialization
activities it has performed, or caused to be performed, since the
preceding report (or with respect to the first such report, since
the Effective Date) and the future activities it expects to
initiate during the then-current Calendar Year. Each such report
shall contain sufficient detail to enable FWB to assess
AzurRx’s compliance with its obligations set forth in this
Article V, including, with
respect to each country in the Territory, the nature of the
Commercialization activities conducted.
Section
5.5 Booking of Sales; Title;
Distribution. AzurRx (or its Affiliate or any Sublicensee)
shall have the sole and exclusive right to sell, distribute and
otherwise commercialize the Products in the Field in the Territory.
AzurRx shall not, and shall cause its Affiliates not to, directly
or indirectly, promote, market or sell the Product(s) for any use
or indication outside the Field or for any indication in the Field
that is not approved by the applicable Regulatory Authority in the
applicable country in the Territory. Nothing herein shall be
construed as a restriction on FWB’s rights outside the
Field.
PAYMENTS
Section
6.1 Upfront Cash Payment. In
partial consideration of the rights granted by FWB to AzurRx
hereunder, (a) within ten (10) days of the Effective Date, AzurRx
shall pay FWB an upfront amount of nine million Dollars
($9,000,000), and (b) on June 30, 2020,
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AzurRx
shall pay FWB the amount of one million two hundred and fifty
Dollars ($1,250,000). Neither of the foregoing amounts shall be
refundable or creditable against any other payments due
hereunder.
Section
6.2 Equity. Within ten (10) days of
the Effective Date of the License Agreement, AzurRx shall issue to
FWB a number of shares of Convertible Preferred Stock (the
“Preferred
Stock”) with an aggregate stated value of $3,000,000.
The Preferred Stock shall accrue dividends at the rate of eight
percent (8%) per annum payable quarterly in cash or in kind until
converted. The issue price, initial stated value and initial
conversion price for the Preferred Stock shall equal the VWAP for
the five-day period immediately preceding the date of execution of
this Agreement by the Parties (provided, that if, for any reason,
information regarding this Agreement becomes publicly available
prior to the execution of this Agreement, the VWAP shall be
determined based on the five-day period immediately preceding the
date on which such information became publicly available). The
Preferred Stock shall convert automatically to common stock on a
1-1 basis immediately following the close of business on the date
on which AzurRx obtains stockholder approval for issuance of all
shares of common stock issuable upon conversion of the Preferred
Stock in accordance with the rules of the NASDAQ Stock Market (the
“Stockholder
Approval”). The Preferred Stock shall be junior in
right to payment to the Company’s Series B Convertible
Preferred Stock. All of the foregoing shall be documented in a
stock purchase agreement between the Parties, reflecting the terms
set forth in this Section 6.2 and including
customary terms, including demand and piggyback registration
rights.
Section
6.3 Milestones. In partial
consideration of the rights granted by FWB to AzurRx hereunder,
AzurRx shall pay to FWB the following non-refundable,
non-creditable milestone amounts set forth below in connection with
achievement of the applicable milestone events set forth below for
(a) the ICI-AC Field and (b) the COVID Field. FWB shall notify
AzurRx promptly of the achievement of each such milestone. Each
such milestone payment shall be due within ninety (90) days after
the achievement of the applicable milestone. Each such milestone
payment shall be payable only once, in each case upon the first
achievement of the applicable milestone, and no amounts shall be
due for subsequent or repeated achievements of such milestone.
[***].
|
Milestone Event
|
Milestone Payment
|
|
ICI-AC Field
|
|
|
1. [***]
|
[***]
|
|
2. [***]
|
[***]
|
|
3. [***]
|
[***]
|
|
4. [***]
|
[***]
|
|
5. [***]
|
[***]
|
|
6. [***]
|
[***]
|
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|
6. Upon First Commercial Sale in the US or EU (or
3/5 EU Big 4 + UK) of the Product for the ICI-AC
Field
|
[***]
|
The
possible aggregated amount of all such milestones for a given
Product in the ICI-AC Field is $37 million.
|
Milestone Event
|
Milestone Payment
|
|
COVID Field
|
|
|
1. [***]
|
[***]
|
|
2. [***]
|
[***]
|
|
3. [***]
|
[***]
|
|
4. [***]
|
[***]
|
|
5. [***]
|
[***]
|
|
6. [***]
|
[***]
|
|
7. [***]
|
[***]
|
The
possible aggregated amount of all such milestones for a given
Product in the COVID Field is $37 million.
6.4.1 Royalty Rate. During each
Calendar Quarter of the Royalty Term, AzurRx shall pay to FWB a
non-refundable, non-creditable royalty on a product-by-product,
country-by-country basis on the Net Sales of the Product(s) for
such Calendar Quarter in the Territory, which royalty shall be
[***].
6.4.2 Royalty Term. AzurRx shall pay
to FWB the royalties set forth in Section 6.4.1 commencing on the
First Commercial Sale of the applicable Product in such country and
expiring on the date that is the later of: (a) the last to expire
Valid Claim in such country, (b) expiration of regulatory
exclusivity for the applicable Product in the applicable country
and (c) the ten (10) year anniversary of the First Commercial Sale
of such Product in such country (the “Royalty Term”).
-21-
6.4.3.1
Third Party
Licenses. If and for so long as AzurRx pays Third Party
Royalties in consideration for a Third Party License necessary to
the Product in its current form, which license has been obtained in
accordance with Section 8.4, on a country-by-country
basis, AzurRx may reduce the royalty payments, otherwise due as set
forth in Section
6.4.1 by up to [***] of the
amount paid to the Third Party; provided, however, that such
reductions, in the aggregate, may not reduce the average effective
royalty rate for a given period by more than [***] points of such
rate.
6.4.3.2
Compulsory
Licenses. If AzurRx or its Affiliates or Sublicensees is
required in a given country in the Territory to issue a Compulsory
Sublicense to one or more Compulsory Licensees for the sale of
Products in such country, then the sales of such Compulsory
Sublicensee shall be excluded from Net Sales, but AzurRx or its
Affiliates shall pay to FWB an amount equal to [***] of the amounts
that AzurRx or its Affiliates or Sublicensees receive from such
Compulsory Sublicensees for such Compulsory
Sublicense.
Section
6.5 Payment Dates and Reports.
Within ninety (90) days after the end of each Calendar Quarter
after the First Commercial Sale of a Product in the Territory,
AzurRx shall submit to FWB a report setting forth its reasonably
good faith estimates of the number of Product units sold. AzurRx
shall pay to FWB the amounts due under Section 6.4.1 with respect to each
Calendar Quarter within ninety (90) days after the end of such
Calendar Quarter. Each such payment shall be accompanied by a
statement including (a) the amount of gross sales of the Product in
Territory, (b) an itemized calculation of Net Sales in the
Territory showing deductions, to the extent practicable, provided
for in the definition of “Net Sales”, (c) a calculation
of the royalty payment due on such Net Sales, (d) an accounting of
the number of units and prices for the Product sold and (e) any
additional Information reasonably required by FWB for the purpose
of calculating royalties payable under Section 6.4.1.
Section
6.6 Mode of Payment. All payments
to either Party under this Agreement shall be made by deposit of
Dollars in the requisite amount to such bank account as the
receiving Party may from time to time designate by notice to the
paying Party. For the purpose of calculating any sums payable under
this Agreement (including the calculation of Net Sales expressed in
a currency other than Dollars), a Party shall convert any amount
expressed in a foreign currency into Dollar equivalents using the
rate of exchange which corresponds to the rate published in The
Wall Street Journal, Eastern Edition.
6.7.1 Each
Party shall be solely responsible for the payment of any tax
imposed on its share of income arising directly or indirectly from
the activities of, or the receipt of any payment by, such Party
pursuant to this Agreement. If any taxes are required to be
withheld by a Party with respect to an amount payable to the other
Party, such Party will: (a) withhold such taxes from the
payment made to the other Party; (b) timely pay the withheld
taxes to the proper taxing authority; (c) send proof of
payment to the other Party; and (d) reasonably assist the
other Party in its efforts to obtain a refund of or credit for such
tax payment in accordance with Section 6.7.2. Any amount actually
withheld and remitted by a Party to a taxing authority pursuant to
this
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6.7.2 Section
6.7 will be treated for all purposes of this Agreement
as paid to the other Party. If a Party makes a payment without
deduction for tax withholding and an amount of tax should have been
withheld from such payment, the Party that made such payment shall
be entitled to recover the underwithheld tax by an additional
withholding from any amount payable to the other Party under this
Agreement. No amount shall be withheld, or a reduced amount shall
be withheld, as applicable, if a Party that is entitled to a
payment timely furnishes the other Party with the necessary tax
forms and other documents prescribed by Applicable Law, which shall
be in a form reasonably satisfactory to the Party receiving the
documents, identifying that the relevant payment is exempt from tax
or subject to a reduced tax rate. On or before the Effective Date,
each Party shall provide to the other a complete, accurate and
properly executed Internal Revenue Service Form W-9 establishing
that the amounts payable by such Party to the other under this
Agreement are exempt from withtholding of United States income
tax.
6.7.3 Each Party agrees to reasonably
assist the other Party in lawfully claiming tax exemptions or
minimizing tax withholdings under double taxation laws or pursuant
to other Applicable Law. Each Party will provide timely and
accurate documentation to the other Party upon request that shall
enable the requesting Party to determine if a payment made
hereunder is subject to withholding, or entitled to reduced
withholding, under an income tax treaty or other Applicable
Laws.
Section
6.8 Interest on Late Payments. If a
Party does not receive payment of any undisputed sum due to it on
or before the due date therefor, simple interest shall thereafter
accrue on the unpaid and undisputed sum due to such Party from the
due date until the date of payment at a per-annum rate equal to the
prime rate as reported in The Wall Street Journal, Eastern Edition,
or the maximum rate allowable by Applicable Law, whichever is
less.
Section
6.9 Financial Records. AzurRx shall
keep or cause to be kept complete and accurate books and records
pertaining to Net Sales in sufficient detail to calculate all
amounts payable hereunder. Such books and records shall be retained
until the later of (a) three (3) years after the end of the
period to which such books and records pertain and (b) the
expiration of the applicable tax statute of limitations (or any
extensions thereof) or for such longer period as may be required by
Applicable Law.
Section
6.10 Audit. At the request of FWB,
AzurRx shall, and shall cause its Affiliates who have performed
activities under this Agreement, to permit an independent auditor
designated by FWB and reasonably acceptable to AzurRx, at
reasonable times and upon reasonable notice and subject to Section
6.12 below to audit the books and records maintained by
AzurRx pursuant to Section 6.9 to ensure the
accuracy of all reports and payments made hereunder, provided, however, that AzurRx shall not be
required to provide, and neither the independent auditor, nor the
Accountant nor FWB shall be entitled to review or examine, the tax
returns or tax records of AzurRx or any of its Affiliates. Such
examinations may not (a) be conducted for any Calendar Quarter more
than two (2) years after the end of such Calendar Quarter, (b) be
conducted more than once in any twelve (12) month period (unless a
previous audit during such twelve (12)-month period revealed an
underpayment with respect to such period) or (c) be repeated for
any Calendar Quarter. Except as provided below, the cost of such
audit shall be borne by FWB, unless the audit reveals an
underpayment by AzurRx or any overpayment by FWB of more than five
percent (5%) for the period that is the subject of the audit, in
which case AzurRx shall bear the cost of the audit. Unless disputed
pursuant to Section 6.11 below, if such
audit concludes that (x) an underpayment was made by AzurRx
or
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an
overpayment was made by FWB, AzurRx shall pay to FWB the amount of
such underpayment or overpayment, as the case may be, with interest
from the date originally due as provided in Section
6.8, or (y) an overpayment was made by AzurRx or an
underpayment was made by FWB, FWB shall pay to the AzurRx the
amount of such overpayment or underpayment, as the case may be, in
either case ((x) or (y)), within sixty (60) days after the date on
which such audit is completed by FWB.
Section
6.11 Audit Dispute. In the event of
a dispute with respect to any audit under Section
6.10, the Parties shall work in good faith to resolve
the disagreement. If the Parties are unable to reach a mutually
acceptable resolution of any such dispute within thirty (30) days,
the dispute shall be submitted for resolution to a certified public
accounting firm jointly selected in writing by each Party’s
certified public accountants or to such other Person as the Parties
shall mutually agree (the “Accountant”). The decision of the
Accountant shall be final and the costs of the Accountant shall be
borne between the Parties in such manner as the Accountant shall
determine. Not later than ten (10) days after such decision and in
accordance with such decision, the audited Party shall pay the
underpayment or overpayment, as the case may be, with interest from
the date originally due as provided in Section
6.8, or the auditing Party shall pay the overpayment or
underpayment, as the case may be, in each case, as described in
Section 6.10, as
applicable.
Section
6.12 Confidentiality. The receiving
Party shall treat all information subject to review under this
Article VI in accordance
with the confidentiality provisions of Article
X, and the Parties shall cause the Accountant to enter
into a reasonably acceptable confidentiality agreement with the
audited Party obligating such firm to retain all such financial
information in confidence pursuant to such confidentiality
agreement.
ARTICLE
VII.
SUPPLY
OF PRODUCT
Section
7.1 Supply
Obligations.
7.1.1 Products.
AzurRx shall be responsible at its sole expense for the Manufacture
of each Product in the Field in the Territory.
7.1.2 Reports. Within twenty (20)
days following the end of each Calendar Quarter during which AzurRx
is performing any material Manufacturing activities, AzurRx shall
provide the JSC with a reasonable written report of the material
Manufacturing activities it has performed, or caused to perform,
since the preceding report (or with respect to the first such
report, since the Effective Date) and its material Manufacturing
activities in process, and the future activities it expects to
initiate. Each such report shall be in the format and shall contain
the details as set out in Exhibit 7.1.2.
Section
7.2 Transfer of Inventory. Within
thirty (30) days after the Effective Date, FWB shall transfer
without charge to AzurRx, at AzurRx’s sole expense, any
inventory of the finished Product in possession or control of FWB
and existing as of the Effective Date.
ARTICLE
VIII.
GRANT
OF RIGHTS
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Section
8.2
8.2.1 License Grant. Subject to the
terms and conditions of this Agreement, including Section
8.3, FWB hereby grants to AzurRx an exclusive (even as
to FWB and its Affiliates), non-transferable (except as permitted
under Section
16.2), sublicensable through multiple tiers (solely in
accordance with Section 8.1.2) license under: (i) the FWB
Background IP, (ii) FWB’s rights to any Program IP, and (iii)
any other intellectual property Controlled by FWB as of the
Effective Date or at any time during the Term and necessary or
reasonably useful to Exploit the Existing Product (collectively the
“Licensed IP”),
in each case ((i) - (iii)), to Develop and have Developed, make,
have made, use, sell, have sold, import, export and Exploit the
Product in the Field in the Territory.
8.2.2 Sublicense Rights. Subject to
the terms and conditions of this Agreement, AzurRx shall have the
right to sublicense the licenses granted to it by FWB under
Section 8.1.1 to Affiliates of
AzurRx and to Third Parties; provided that AzurRx provide notice to FWB and
any such sublicenses shall be consistent with, and expressly made
subject to, the terms and conditions of this Agreement. AzurRx
shall cause each of its Affiliates and Sublicensees to comply with
the applicable terms and conditions of this Agreement. AzurRx
hereby guarantees the performance of its Affiliates and permitted
Sublicensees and the grant of any such sublicense shall not relieve
AzurRx of its obligations under this Agreement, except to the
extent they are satisfactorily performed by such Affiliate or
Sublicensee. A copy of any sublicense agreement executed by AzurRx
or any of its Affiliates with a Third Party shall be provided to
FWB within ten (10) days after its execution; provided that the financial terms, other
confidential business terms, and confidential information of the
Sublicensee of any such sublicense agreement to the extent not
pertinent to an understanding of a Party’s obligations or
benefits under this Agreement may be redacted.
8.3.1 License Grant. Subject to the
terms and conditions of this Agreement, including Section
8.3, AzurRx hereby grants to FWB a worldwide,
non-exclusive, royalty-free, perpetual, irrevocable license under
the Program IP and any other intellectual property owned by AzurRx
and incorporated into the Product for the Exploitation of such
Product during the Term, solely for use outside the Field in the
Territory, and if this Agreement is terminated rather than expires,
then such license shall be for the Exploitation of the Product both
inside and outside the Field, in the Territory.
8.3.2 Sublicense Rights. Subject to
the terms and conditions of this Agreement, FWB shall have the
right to sublicense the license granted to it by AzurRx under this
Agreement to Affiliates of FWB or Third Parties; provided that (a) FWB shall provide written
notice to AzurRx of any such sublicenses to a Third Party; and (b)
such sublicenses shall be consistent with, and expressly made
subject to, the terms and conditions of this Agreement. FWB shall
cause each of its Affiliates and Sublicensees to comply with the
applicable terms and conditions of this Agreement. FWB hereby
guarantees the performance of its Affiliates and permitted
Sublicensees and the grant of any such sublicense shall not relieve
FWB of its obligations under this Agreement, except to the extent
they are satisfactorily performed by such Affiliate or Sublicensee.
A copy of any sublicense agreement executed by FWB or any of its
Affiliates with a Third Party shall be provided to AzurRx within
ten (10) days after its execution;
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provided that the financial terms, other
confidential business terms, and confidential information of the
Sublicensee of any such sublicense agreement to the extent not
pertinent to an understanding of a Party’s obligations or
benefits under this Agreement may be redacted.
8.4.1 Retained Rights of FWB.
Notwithstanding Section 8.1 above, FWB
expressly retains the right on behalf of itself, its Affiliates and
its and their Sublicensees, including the right to license and
grant rights of reference to its Affiliates and its and their
(sub)licensees, to (a) perform its and their obligations and
exercise its and their rights under this Agreement; (b) Develop,
obtain and maintain Regulatory Approvals for and to Manufacture,
Commercialize and otherwise Exploit any compound or product other
than the Compound, Products or any other pharmaceutical product
containing any Compound (alone or in combination with one or more
other active pharmaceutical ingredients), in any field (including
the Field) anywhere in the world; and (c) Develop, obtain and
maintain Regulatory Approvals for, and to Manufacture,
Commercialize and to otherwise Exploit any products, including the
Compound and Products, outside the Field (such rights, (a)-(c), the
“FWB Retained
Rights”); provided, however, that in no event will FWB or
its Affiliates during the term of this Agreement intentionally
Exploit (or license any Third Party to Exploit) any product
containing niclosamide for any indication in the
Field.
8.4.2 No
Implied Licenses. Except as expressly set forth in this
Agreement, neither Party grants to the other Party any right or
license, express or implied, under any of its intellectual property
rights.
Section
8.5 Third Party Licenses. If the
Development, Commercialization, Manufacture or other Exploitation
of the Product by AzurRx as contemplated herein would necessarily
infringe any Third Party Patent right (other than a Patent to which
a Party is already granted a license or sublicense as of the
Effective Date), or the JSC subject to Section
2.5 determines it otherwise necessary to obtain a
license under a Third Party’s Patent rights to avoid any
claims or litigation concerning any such infringement with respect
to one or more countries in the Field in the Territory, then AzurRx
shall have the right to take such Third Party License and may
deduct such royalties to the extent set forth in Section 6.4.3.
ARTICLE
IX.
Section
9.1 Ownership of Intellectual
Property.
9.1.1 Ownership
of Background IP. Each Party shall retain all right, title
and interest to its Background IP, and, except as expressly set
forth in this Agreement, no right or license to such Patents,
Know-How and other intellectual property rights included in such
Background IP is granted by either Party to the other
Party.
9.1.2 Ownership
of Program IP.
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(a) For the purposes of
this Agreement, the determination of inventorship of any Know-How,
whether or not patentable, first invented, discovered, created or
developed in the course of performing activities under this
Agreement, and whether solely or jointly by or on behalf of a Party
including by its employees, Affiliates, agents or independent
contractors, shall be made in accordance with United States patent
law.
(b) As between the
Parties, (i) all patentable inventions within the Program IP and
all Patents claiming such inventions, and (ii) all other Program IP
and other Intellectual Property rights in such Program IP, in each
case ((i) and (ii)) discovered, created or developed solely by its
employees, Affiliates, agents or independent contractors in
connection with their activities under this Agreement, shall be
owned solely by the inventing, discovering, creating or developing
Party(ies), and if discovered, created or developed jointly by any
of one Party’s employees, Affiliates, agents or independent
contractors, on the one hand, and the other Party’s
employees, Affiliates, agents or independent contractors, shall be
owned jointly by the Parties (“Joint Program IP”).
9.1.3 Assignment
Obligation. AzurRx shall cause all Persons who perform
Development, Commercialization, Manufacturing or other activities
for or on behalf of AzurRx under this Agreement or who invent,
conceive, discover, develop or otherwise make any Program Know-How
or Program Patents by or on behalf of AzurRx or its Affiliates or
its or their Sublicensees under or in connection with this
Agreement to assign (or, if AzurRx is unable to cause such Person
to assign, to provide an exclusive license under) their rights in
any such Program Know-How or Program Patents resulting therefrom to
AzurRx, except where Applicable Law requires otherwise and except
in the case of governmental, not-for-profit, academic and public
institutions that have standard policies against such an assignment
(in which case a suitable exclusive license with the right to
sublicense or right to obtain such a license shall be
obtained).
Section
9.2 Prosecution and Maintenance
of
Patents.
9.2.1 Background Patents. As between
the Parties, for any Background Patents, the Party that owns (or
has in-licensed such Patent from a Third Party) the applicable
Background Patent, shall control the preparation, filing,
prosecution and maintenance of such Background Patent, using
counsel of its choice, and at AzurRx’s sole expense,
provided that such
prosecution and maintenance expenses shall be shared between the
Parties if the given patent or patent application is relevant to
both Parties’ development programs. A Party shall keep the other
Party reasonably informed of all material steps with regard to the
preparation, filing, prosecution, and maintenance of such
Background Patents, and shall provide the other Party with a copy
of material communications to and from the patent authorities
regarding such Background Patents, including drafts of any material
filings or responses to be made to such patent authorities
sufficiently in advance of submitting such filings or responses so
as to allow the other Party a reasonable opportunity to review and
comment thereon. The Party shall reasonably consider, but shall
have no obligation, to incorporate the other Party’s requests
and suggestions with respect to such drafts and with respect to
strategies for filing and prosecuting such Background patents.
Except as set forth in this Section 9.2.1, if a Party, during
the Term, determines in its sole discretion to abandon or not
maintain a given patent or patent application within such
Background Patents, then the Party shall provide the other Party
with prior written notice sufficiently in advance of
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any
abandonment to enable the other Party, at its sole discretion, to
maintain such Background Patents and assume the prosecution in the
joint names of the Parties, at its sole cost and expense, and on
receipt of such notice, the Party shall transfer such prosecution
to the other Party.
9.2.2 Program Patents. Each Party
shall have the first right, through using counsel of its own
choice, and at AzurRx’s sole expense, to prepare, file,
prosecute and maintain its solely-owned Program Patents in the
Territory, and to be responsible for any related interference,
re-issuance, re-examination and post grant review, including any
inter partes review and opposition proceedings, provided that such prosecution and
maintenance expenses shall be shared equally between the Parties if
the given patent or patent application is relevant to both
Parties’ development programs. A Party shall keep the other
Party reasonably informed of all material steps with regard to the
preparation, filing, prosecution, and maintenance of such Program
Patents, and shall provide the other Party with a copy of material
communications to and from the patent authorities regarding such
Program Patents, including drafts of any material filings or
responses to be made to such patent authorities sufficiently in
advance of submitting such filings or responses so as to allow the
other Party a reasonable opportunity to review and comment thereon.
The Party shall reasonably consider, but shall have no obligation
to incorporate, the other Party’s requests and suggestions
with respect to such drafts and with respect to strategies for
filing and prosecuting such Program Patents. Except as set forth in
this Section
9.2.2, if a Party, during
the Term, determines in its sole discretion to abandon or not
maintain a given patent or patent application within such Program
Patents, then the Party shall provide the other Party with prior
written notice sufficiently in advance of any abandonment to enable
the other Party, at its sole discretion, to maintain such Program
Patents and assume the prosecution in the joint names of the
Parties, at its sole cost and expense, and on receipt of such
notice, the Party shall transfer such prosecution to the other
Party. The
Parties shall jointly control the preparation, filing, prosecution,
maintenance and defense of any Joint Program Patents within the
Program IP in the Territory, at equally shared expenses, using
counsel mutually acceptable to both Parties.
9.2.3 Cooperation.
Each Party shall, and shall cause its Affiliates to, assist and
cooperate with the other Party, in the preparation, filing,
prosecution and maintenance of the Program Patents under this
Agreement, including that each Party shall, and shall ensure that
its Affiliates, provide access to relevant documents and other
evidence and make its employees available at reasonable business
hours.
(a) The Regulatory
Party shall have the sole right to make decisions regarding, and
shall have the right to apply for, patent term extensions
worldwide, including in the United States with respect to
extensions pursuant to 35 U.S.C. §156 et. seq. and in other
jurisdictions pursuant to supplementary protection certificates,
and in all jurisdictions with respect to any other extensions that
are now available or become available in the future
(“Patent Term
Extensions”), wherever applicable, for Background
Patents and Program Patents, including whether or not to do so;
provided that in the case of Program Patents, a
Party shall consult with the other to determine the course of
action with respect to such filings.
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(b) Common Ownership Under Joint Research
Agreements. Notwithstanding anything to the contrary in this
Article IX, neither Party
shall have the right to make an election under 35 U.S.C. 102(c)
when exercising its rights under this Article
IX without the prior written consent of the other Party.
With respect to any such permitted election, the Parties shall
coordinate their activities with respect to any submissions,
filings or other activities in support thereof. The Parties
acknowledge and agree that this Agreement is a “joint
research agreement” as defined in 35 U.S.C.
100(h).
9.2.5 Patent
Listings. As between the Parties, and subject to Section
4.1, the Regulatory Party shall have the sole right to
make decisions regarding and shall have the right to make all
patent listing filings with Regulatory Authorities in the Territory
with respect to its Background Patents and Program Patents,
including as required or allowed (a) in the United States, in the
FDA’s Orange Book, (b) the European Union, under the national
implementations of Article 10.1(a)(iii) of Directive 2001/EC/83,
and (c) under other international equivalents.
9.3.1 Notice. If either Party becomes
aware of (a) any suspected infringement of a Background Patent or
Program Patent in the Territory or (b) any certification filed in
the United States under the “Drug Price Competition and
Patent Term Restoration Act of 1984” (21 United States Code
§355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV)) (“ANDA Act”) or similar provisions
in other jurisdictions (each of clauses (a) and (b), an
“Infringement”),
such Party shall promptly notify the other Party and provide it
with all details of such Infringement of which it is aware (each,
an “Infringement
Notice”); provided, that each Party shall give
the other Party an Infringement Notice not later than three (3)
Business Days after it becomes aware of any Infringement described
in clause (b) above.
9.3.2 Enforcement
of Background Patents and Program Patents. As between the Parties, for any
Background Patents or Program Patents, the Party that owns (or has
in-licensed from a Third Party) the applicable Background Patent or
Program Patent, shall have the first right, but not the obligation,
to prosecute any Infringement with respect to or otherwise enforce
such Patents in the Field in the Territory, including as a defense
or counterclaim in connection with any Third Party Infringement
Claim, at the Party’s sole cost and expense, using counsel of
the Party’s choice, except
that AzurRx shall have the obligation to prosecute any
Infringement in the Field in the Territory with respect to or
otherwise enforce any Background Patent or Program Patent, in each
case, used for the Exploitation of the Product in the Field in the
Territory. The Prosecuting Party shall notify the other Party of
such Prosecuting Party’s decision as to whether to take any
action at least thirty (30) days before any time limit set forth in
an Applicable Law or within sixty (60) days after receiving the
Infringement Notice, whichever is shorter. If the Prosecuting Party
chooses not to exercise its right to prosecute such alleged or
threatened infringement in the Field in the Territory, the other
Party may step in at such other Party’s sole cost and
expense, using counsel of such other Party’s choice, hence
becoming the new Prosecuting Party. The Parties shall jointly
control enforcement of any Joint Program Patents within the Program
IP in the Territory, at equally shared expenses, using counsel
mutually acceptable to both Parties.
9.3.3 Cooperation.
The Parties agree to cooperate fully in any Infringement action
pursuant to this Section 9.3, including by
making the inventors,
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applicable records
and documents (including laboratory notebooks) of the relevant
Patents available to the controlling Party upon such Party’s
request. Where a Party controls such an action, the other Party
shall, and shall cause its Affiliates to, assist and cooperate with
the controlling Party, as such controlling Party may reasonably
request from time to time, in connection with its activities set
forth in this Section 9.3, including
where necessary, furnishing a power of attorney solely for such
purpose or joining in, or being named as a necessary party to, such
action, providing access to relevant documents and other evidence
and making its employees available at reasonable business hours.
Unless otherwise set forth herein, the Party entitled to bring any
patent infringement litigation in accordance with this Section
9.3 shall have the right to settle such claim;
provided that neither Party shall have the right
to settle any Infringement litigation under this Section
9.3 in a manner that has a material adverse effect on
the rights or interest of the other Party or in a manner that
imposes any costs or liability on or involves any admission by, the
other Party, without the express written consent of such other
Party (which consent shall not be unreasonably withheld,
conditioned or delayed). In connection with any activities with
respect to an Infringement action prosecuted by a Party pursuant to
this Section 9.3, the
Prosecuting Party shall (a) consult with the other Party as to the
strategy for the prosecution of such claim, suit or proceeding, (b)
consider in good faith any comments from the other Party with
respect thereto and (c) keep the other Party reasonably informed of
any material steps taken and provide copies of all material
documents filed, in connection with such action.
9.3.4 Recovery.
Any recovery realized as a result of such litigation described
above in this Section 9.3 (whether by way
of settlement or otherwise) shall be first, allocated to reimburse
the Parties for their costs and expenses in making such recovery
(which amounts shall be allocated pro rata if insufficient to cover
the totality of such expenses) with any remainder being shared as
follows: (i) if AzurRx is the Prosecuting Party then any remaining
amount attributable to recovery for lost sales or profits shall be
deemed “Net Sales” in the Calendar Quarter in which the
money is actually received and AzurRx shall pay the corresponding
Royalty to FWB in accordance with Section 6.4.1 and (ii) if FWB is
the Prosecuting Party then the remaining amount shall be shared
equally (50%/50%) by the Parties (including any treble, punitive or
other multiplier of damages and interest awarded with respect
thereto).
Section
9.4 Infringement Claims by Third
Parties. If the Exploitation of any Product in the Field in
the Territory pursuant to this Agreement results in, or is
reasonably expected to result in, any claim, suit or proceeding by
a Third Party alleging infringement by a Party or any of its
Affiliates or its or their Sublicensees or customers (a
“Third Party Infringement
Claim”), including any defense or counterclaim in
connection with an Infringement action initiated pursuant to
Section 9.3, the Party
first becoming aware of such alleged infringement shall promptly
notify the other Party thereof in writing and the Parties shall
promptly meet to consider the claim or assertion and the
appropriate course of action and may, if appropriate agree on and
enter into a “common interest agreement” wherein the
Parties agree to their shared mutual interest in the outcome of
such potential dispute. Absent any agreement to the contrary and
subject to claims for indemnification under Article
XII, as between the Parties, AzurRx shall have the first
right and obligation to defend and control the defense of any such
claim, suit or proceeding at its cost and expense, using counsel of
AzurRx’s choice. FWB may participate in any such claim, suit
or proceeding with counsel of its choice at its sole cost and
expense. If AzurRx fails to initiate and maintain the defense of,
any such claim, suit or proceeding in which AzurRx is named as a
defendant, within such time periods so that FWB
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is not
prejudiced by any delays, FWB may conduct and control the defense
of any such claim, suit or proceeding at FWB’s sole cost and
expense. Where a Party controls such an action, the other Party
shall, and shall cause its Affiliates to, assist and cooperate with
the controlling Party, as such controlling Party may reasonably
request from time to time, in connection with its activities set
forth in this Section 9.4, including
where necessary, furnishing a power of attorney solely for such
purpose or joining in, or being named as a necessary party to, such
action, providing access to relevant documents and other evidence
and making its employees available at reasonable business hours.
Each Party shall keep the other Party reasonably informed of all
material developments in connection with any such claim, suit or
proceeding. Each Party agrees to provide the other Party with
copies of all material pleadings filed in such action and to allow
the other Party reasonable opportunity to participate in the
defense of the claims. Any recoveries awarded to a Party in
connection with any Third Party Infringement Claim defended under
this Section 9.4 shall be
applied first to reimburse such Party for its reasonable
out-of-pocket costs of defending such claim, suit or proceedings,
with the balance of any such recoveries being shared equally
(50%/50%) by the Parties (subject however to any indemnity claim by
AzurRx under Section 12.1). The Party
entitled to control the defense of a claim, suit or proceeding
under this Section 9.4 shall have the
right to settle such claim, suit or proceeding; provided that neither Party shall have the right
to settle any claim, suit or proceeding under this Section
9.4 in a manner that has a material adverse effect on
the rights or interest of the other Party or in a manner that
imposes any costs or liability on or involves any admission by, the
other Party, without the express written consent of such other
Party (which consent shall not be unreasonably withheld,
conditioned or delayed). Notwithstanding anything contained herein
to the contrary, if AzurRx defends itself against a Third Party
Infringement Claim for which it is entitled to be indemnified by
FWB under Section 12.1, AzurRx shall
be entitled to deduct from milestone payments payable to FWB under
Section 6.3 or royalties
payable to FWB under Section 6.4 the amount of
Losses incurred by AzurRx, its Affiliate or Sublicensees in
connection with such Third Party Infringement Claim to the extent
such Losses are reasonably allocable to the Third Party Claim for
which FWB is obligated to indemnify AzurRx or such Affiliate or
Sublicensee under Section 12.1.
9.5.1 Background Patents and Program
Patents. As between the Parties, each Party shall have the
first right, but not the obligation, to defend and control the
defense of the validity and enforceability of its Background
Patents and Program Patents at its expense, using counsel of such
Party’s choice, including when such invalidity or
unenforceability is raised as a defense or counterclaim in
connection with an Infringement action initiated pursuant to
Section 9.3. The other
Party may participate in any such claim, suit or proceeding in the
Territory with counsel of its choice at its sole cost and expense;
provided that the Party owning the Patents at
issue shall retain control of the defense in such claim, suit or
proceeding. If the Party owning the Patents at issue elects not to
defend or control the defense of such Patents in a suit brought in
the Territory, then such Party shall notify the other Party of its
election by written notice and the other Party may conduct and
control the defense of any such claim, suit or proceeding at the
Parties’ shared (50%/50%) cost and expense. Notwithstanding
the foregoing, if AzurRx defends a claim arising under this
Section 9.5.1 for which it is
entitled to be indemnified by FWB under Section
12.1, AzurRx shall be entitled to deduct from milestone
payments payable to FWB under Section 6.3 or royalties
payable to FWB under Section 6.4 the amount of
Losses incurred by AzurRx, its Affiliate or Sublicensees in
connection with such action to the extent such Losses are
reasonably
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allocable to the
Third Party Claim for which FWB is obligated to indemnify AzurRx or
such Affiliate or Sublicensee under Section
12.1.
9.5.2 Procedure.
Each Party shall promptly notify the other Party in writing of any
alleged or threatened assertion of invalidity or unenforceability
of any of the Background Patents or Program Patents by a Third
Party and of which such Party becomes aware. Where a Party controls
the defense of the validity and enforceability of Background
Patents or Program Patents, the other Party shall, and shall cause
its Affiliates to, assist and cooperate with the controlling Party,
as such controlling Party may reasonably request from time to time
in connection with its activities set forth in this Section
9.5, including, where necessary, furnishing a power of
attorney solely for such purpose or joining in, or being named as a
necessary party to, such action, providing access to relevant
documents and other evidence and making its employees available at
reasonable business hours. In connection with any activities with
respect to a defense, claim or counterclaim relating to the
Background Patents or Program Patents pursuant to this Section
9.5, the controlling Party shall (x) consult with the
other Party as to the strategy for such activities, (y) consider in
good faith any comments from the other Party and (z) keep the other
Party reasonably informed of any material steps taken and provide
copies of all material documents filed, in connection with such
defense, claim or counterclaim. The Party entitled to control the
defense of a claim, suit or proceeding under this Section
9.5 shall have the right to settle such claim, suit or
proceeding; provided
that neither Party shall
have the right to settle any claim, suit or proceeding under this
Section 9.5 in a manner
that has a material adverse effect on the rights or interest of the
other Party or in a manner that imposes any costs or liability on
or involves any admission by, the other Party, without the express
written consent of such other Party (which consent shall not be
unreasonably withheld, conditioned or delayed).
ARTICLE X.
CONFIDENTIALITY
Section
10.1 Obligations. Except upon
obtaining the other Party’s prior written consent to the
contrary or, in the case of disclosures, to the extent expressly
permitted under this Article X, each Party
agrees that, at all times during the Term and for a period of five
(5) years thereafter, it shall, and shall cause its officers,
directors, employees and agents to: (a) maintain in confidence, and
not disclose to any Third Party (except as provided in Section
10.2), the other Party’s Confidential Information
and (b) not use the other Party’s Confidential Information,
directly or indirectly, for any purpose except as contemplated in
this Agreement and the Related Agreements or as reasonably
necessary for the performance of, or the exercise of such
Party’s rights under, this Agreement or a Related Agreement.
The Parties acknowledge that this Agreement and all of the
respective terms of this Agreement will be treated as Confidential
Information of both Parties.
10.2.1 Authorized
Disclosure. Each Receiving Party may disclose the Disclosing
Party’s Confidential Information, without the Disclosing
Party’s prior written consent, only to the extent necessary
or useful in connection with the performance of its obligations or
exercise of its rights as contemplated by this
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Agreement or a
Related Agreement, including (a) filing or prosecution of Patents
as permitted by this Agreement; (b) filing of Regulatory Materials
in order to obtain or maintain Regulatory Approvals, further
subject to Section
10.2.3; (c) complying with
Applicable Law or regulation or order of any court or Governmental
Authority; (d) prosecuting or defending litigation as
contemplated by this Agreement, further subject to Section 10.2.2; and (e) to its
Affiliates’ or actual or potential Sublicensees, and such
Party’s and their Affiliates’ respective directors,
employees, agents, advisers, attorneys, consultants, contractors,
lenders, insurers, prospective settlement parties, and other Third
Parties on a “need-to-know” basis in order for the
Receiving Party to exercise its rights or fulfill its obligations
under this Agreement or, if applicable, any Existing FWB Third
Party Agreement; provided
that in the case of clause
(e), such Persons shall be bound by confidentiality and non-use
obligations that are substantially similar to those set forth in
this Article X.
10.2.2 Disclosure Pursuant to Legal
Process. Each Receiving Party may disclose the Disclosing
Party’s Confidential Information, without the Disclosing
Party’s prior written consent, to any Person, or Governmental
Authority to the extent made in response to a valid order of a
court of competent jurisdiction or other supra-national, federal,
national, regional, state, provincial and local governmental or
regulatory body of competent jurisdiction or that, in the
reasonable opinion of the Receiving Party’s legal counsel,
Applicable Law require such disclosure; provided that the Receiving Party, to the extent
reasonably practicable, promptly notifies the Disclosing Party of
the required disclosure in order to provide the Disclosing Party an
opportunity to take legal action to prevent or limit such
disclosure and, if asked, reasonably assists the Disclosing Party
in pursuing such action; provided,
further that the Receiving Party requests such court of
competent jurisdiction or other supra-national, federal, national,
regional, state, provincial and local governmental or regulatory
body of competent jurisdiction to afford such Confidential
Information confidential protection; and provided, further that the Confidential
Information disclosed in response to such court or governmental
order or requirement shall be limited to that information that is
legally required to be disclosed in response to such court or
governmental order or requirement and shall be disclosed under any
confidentiality provisions available under Applicable Law. For the
avoidance of doubt, the disclosures of this Agreement by reason of
compliance with applicable securities law shall be governed by
Section 10.2.4.
10.2.3 Disclosure to Regulatory
Authorities. The Regulatory Party may disclose the
Disclosing Party’s Confidential Information, without the
Disclosing Party’s prior written consent, to any Governmental
Authority in connection with any filing, application or request for
Regulatory Approval with respect to any Product in the Territory,
to the extent that such disclosure is necessary for obtaining or
maintaining any Regulatory Approval or submitting or amending any
Regulatory Materials with respect to such Product in the Territory
or to the extent such disclosure is required to satisfy any other
regulatory obligation with respect to such Product in the
Territory; provided
that reasonable measures
shall be taken to assure confidential treatment of such information
to the extent practicable and consistent with Applicable
Law.
10.2.4 Securities Filings.
Notwithstanding anything to the contrary in this Article
X, each Party acknowledges and agrees that the other
Party may submit this Agreement to, or file this Agreement with,
the securities regulators or to other Persons
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as may
be required by Applicable Law. If either Party believes in good faith and based on reasonable
advice of counsel is required by Applicable Law of any stock
exchange on which such Party or its Affiliates, listed or trades
securities and proposes to file this Agreement with the
Securities and Exchange Commission or the securities regulators of
any state or other jurisdiction (including the NASDAQ and the
NYSE), then such Party will advise the other Party before making
such disclosure and provide such other party a reasonable
opportunity to review and comment on such filing and consider in
good faith any comments with respect thereto.
Section
10.3 Use of Name. Each Party shall
have the right to use the other Party’s name and logo in
presentations, such Party’s website, collateral materials,
corporate overviews, and other public disclosures (a) describing
the licensing relationship, (b) in connection with exercising its
rights or performing its obligations under this Agreement, or (c)
or making any disclosure identifying the other Party or its
Affiliates that is required by Applicable Law.
Section
10.4 Press Releases. The Parties
have agreed upon the content of press releases that shall be issued
substantially in the forms attached hereto as Exhibit 10.4 the release of which
the Parties shall coordinate in order to accomplish such release
promptly upon execution of this Agreement. Subject to Section 10.2.4, neither Party nor
any of their Affiliates shall issue any other public announcement,
press release or other public disclosure regarding this Agreement
or its subject matter without the other Party’s prior written
consent, except as expressly permitted hereunder or under a Related
Agreement. Neither Party nor its Affiliates shall be required to
seek the permission of the other Party to repeat any information
regarding the terms of this Agreement or any amendment thereto that
has already been publicly disclosed by either Party or its
Affiliates in accordance with this Article
X; provided
that such information
remains accurate as of such time and provided the frequency and
form of such disclosure are reasonable. Notwithstanding the
foregoing, each Party shall have the right to discuss and promote
the Products in terms that do not disclose any Confidential
Information of the other Party or the terms of this Agreement
(except to the extent already disclosed in the initial press
release).
ARTICLE
XI.
Section
11.1 Mutual Representations and Warranties.
Each Party hereby represents and warrants to the other Party as of
the Effective Date, and covenants, that:
11.1.1 Such
Party is a company or corporation duly organized, validly existing,
and in good standing under the laws of the jurisdiction in which it
is incorporated or formed.
11.1.2 Such
Party: (a) has the power and authority and the legal right to enter
into this Agreement and perform its obligations hereunder; (b) has
taken all necessary corporate action on its part required to
authorize the execution and delivery of this Agreement and the
performance of its obligations hereunder; and (c) this Agreement
has been duly executed and delivered on behalf of such Party, and
constitutes a legal, valid, and binding obligation of such Party
that is enforceable against it in accordance with its terms, and,
in all material respects, does not conflict with any agreement,
written or oral, between such Party and any Affiliate or Third
Party.
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11.1.3 Such
Party and its Affiliates have not, at any time prior to the
Effective Date, been prosecuted or convicted of any violation of
any Applicable Law, has not been and is not a party to any deferred
prosecution agreement or similar agreement with respect to any
violation or alleged violation of any Applicable Law, and has no
Knowledge of any investigation being conducted by any government
authority, or by such Party or its Affiliates, with respect to such
potential violations. In exercising its rights and performing its
obligations under this Agreement, each Party shall, and shall cause
its Affiliates to, comply with all Applicable Law in all material
respects.
11.1.4 Each Party represents and
warrants as of the Effective Date, and covenants during the Term as
to any provision of this Section 11.1.4 that relates to any
period after the Effective Date, that:
(a) neither it nor any
of its Affiliates has been debarred by the FDA, is not subject to
any similar sanction of other Regulatory Authorities, and neither
such Party nor any of its Affiliates has used, or will engage, in
any capacity, in connection with this Agreement, any Person who
either has been debarred by such a Regulatory Authority, or is the
subject of a conviction described in Section 306 of the
FFDCA;
(b) such Party shall
inform the other Party in writing promptly if it or any Person
engaged by it or any of its Affiliates who is performing services
under this Agreement is debarred or is the subject of a conviction
described in Section 306 of the FFDCA, or if any action, suit,
claim, investigation or legal or administrative proceeding is
pending or, to such Party's Knowledge, is threatened, relating to
the debarment or conviction of such Party, any of its Affiliates or
any such Person performing services hereunder or thereunder;
and
(c) neither such Party,
nor any of its Affiliates, has made an untrue statement of a
material fact or fraudulent statement to the FDA or other
Governmental Authority, failed to disclose a material fact required
to be disclosed to the FDA or any other Governmental Authority, or
committed any act, made any statement, or failed to make any
statement that, at the time such disclosure was made, would
reasonably be expected to provide a basis for the FDA or any other
Governmental Authority to invoke its policy respecting
“Fraud, Untrue Statements of Material Facts, Bribery, and
Illegal Gratuities” set forth in 56 Fed. Reg. 46191
(September 10, 1991) or any similar policy.
Section
11.2 Additional Representations and
Warranties of FWB. FWB hereby represents and warrants to
AzurRx as of the Effective Date (and where applicable, covenants
during the Term):
11.2.1 to
FWB’s Knowledge, neither the Product, nor the use of the
Product in the Field in accordance with this Agreement, infringes
any Patent rights of any Third Party in the Territory;
11.2.2 FWB
solely owns and Controls the FWB Background Patents set out in
Exhibit
1.60 and has the
right to grant licenses to the FWB Background Patents under
Section 8.1 and, to
FWB’s Knowledge, FWB solely owns and Controls all other
Licensed IP and has the right to grant the licenses to such other
Licensed IP to AzurRx under Section 8.1;
11.2.3 FWB’s
ownership of the FWB Background Patents and Licensed IP (with the
exception of Know-How) is free and clear of any
encumbrance,
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lien,
or claim of ownership by any Third Party other than encumbrances
outside the Field and to FWB’s Knowledge, FWB’s
ownership of all other Licensed IP is free and clear of any
encumbrance, lien, or claim of ownership by any Third Party other
than encumbrances outside the Field;
11.2.4 to
FWB’s Knowledge, each of the FWB Background Patents properly
identifies each and every inventor of the claims thereof as
determined in accordance with the laws of the jurisdiction in which
such Patent is issued or such application is pending;
11.2.5 all
such inventors have assigned their entire right, title, and
interest in and to such inventions to FWB and all such assignments
have been duly recorded and are enforceable in accordance with
Applicable Law; and there are no claims or assertions in writing
received by FWB regarding the inventorship of any FWB Background
Patent alleging that additional or alternative inventors should be
listed;
11.2.6 all
filing, application and renewal fees with respect to the FWB
Background Patents have been duly paid, and FWB has taken all
material steps required for the maintenance and prosecution of the
FWB Background Patents in accordance with Applicable
Law;
11.2.7 FWB
has not as of the Effective Date, and will not during the Term,
grant to any Third Party any right under the FWB Background IP or
Licensed IP that would conflict with the rights granted to AzurRx
hereunder in the Field in the Territory;
11.2.8 FWB has no Knowledge, of any
actual infringement or threatened infringement of any FWB
Background Patent by any Person other than as disclosed to AzurRx
in connection with the execution of this Agreement in Exhibit 11.2.8;
11.2.9 FWB
has not received any written communication from, or written demand
of, any claims or litigation that has been brought or threatened by
any Person alleging that any FWB Background Patent is invalid or
unenforceable;
11.2.10 FWB
has not, prior to the Effective Date, received any written
communication from, or written demand of, any Third Party that the
Development, Manufacture, use or Commercialization of the Products
infringed or misappropriated any intellectual property rights of
such Third Party.
11.2.11 to
FWB’s Knowledge, all FWB Products that are subject to the
jurisdiction of the FDA or a similar Governmental Authority have
been and are currently being Developed or Manufactured in
compliance in all material respects with all Applicable Laws,
including the FFDCA, the Public Health Service Act, and their
applicable implementing regulations and guidance documents, and all
comparable state and foreign Applicable Laws in those jurisdictions
outside the United States in which either (i) Clinical Trials
involving a Company Product have been or are being conducted by FWB
or (ii) any Product has been or is being Developed or Manufactured
by or for FWB.
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11.2.12 FWB
has not received any written notice that the FDA or any other
Governmental Authority has initiated, or threatened to initiate,
any action to suspend any clinical trial, impose a clinical hold,
or suspend or terminate any IND or any comparable foreign
regulatory application, in each case sponsored by FWB with respect
to any Product.
11.2.13 to
FWB’s Knowledge, all ongoing and completed non-clinical
studies and clinical trials conducted by FWB, or by third-party
vendors on FWB’s behalf, in the Field in the Territory, have
been conducted in all material respects in accordance with
applicable Good Clinical Practice regulations described in 21 CFR
Parts 50, 54, 56 and 312 (including study protocols, informed
consent obligations, and institutional review board approvals), and
applicable Good Laboratory Practice regulations as described in 21
CFR Part 58 or comparable applicable foreign Laws. FWB has in its
possession or subject to retrieval or control copies of all the
material documentation in existence on or prior to the date hereof
in each case which was required to be filed with the FDA or
equivalent Governmental Authority as of the Effective Date for the
development or registration of the Products. FWB has made available
to AzurRx Buyer complete and accurate copies of (i) all material
filings with the FDA or equivalent Governmental Authority relating
to the Products, (ii) all material correspondence with the FDA or
equivalent Governmental Authority relating to the Products, and
(iii) all material data, information, results, analyses,
publications, and reports relating to the Products, including all
clinical trial protocols, trial statistical analysis plans and
published trial results.
11.2.14 FWB
has not received from any Governmental Authority any (i) inspection
reports or observations, (ii) notices of adverse findings, warning
or untitled letters, minutes of meetings or (iii) other
correspondence concerning the Products, in each case, in which any
Governmental Entity asserted in writing that the operations of the
Company may not be in compliance with Applicable Laws;
and
11.2.15 to
FWB’s Knowledge, FWB has complied in all material respects
with all applicable security and privacy standards regarding
protected health information under Applicable Laws.
Section
11.3 DISCLAIMER OF WARRANTIES.
EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH HEREIN, NEITHER PARTY
MAKES ANY REPRESENTATIONS OR GRANTS ANY WARRANTIES, EXPRESS OR
IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR
OTHERWISE, AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER
WARRANTIES, WHETHER WRITTEN OR ORAL OR EXPRESS OR IMPLIED,
INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A
PARTICULAR USE OR PURPOSE OR ANY WARRANTY AS TO THE VALIDITY OF ANY
PATENTS OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS
OF THIRD PARTIES.
INDEMNIFICATION
Section
12.1 Indemnification by FWB. FWB
shall indemnify AzurRx, its Affiliates, and its and their
respective directors, officers, employees and agents (the
“AzurRx
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Indemnitees”) and defend and save
each of them harmless, from and against any and all losses,
damages, liabilities, taxes, costs and expenses (including
reasonable attorneys’ fees and expenses) (collectively,
“Losses”) in
connection with (a) any and all suits, investigations, claims,
actions, demands or other proceedings by any Third Parties
(collectively, “Third Party
Claims”) to the extent arising from or occurring as a
result of (i) the gross negligence or willful misconduct on the
part of any FWB Indemnitee in performing its or their obligations
under this Agreement; (ii) the infringement or misappropriation by
FWB or any of its Affiliates of any Third Party intellectual
property rights resulting from its use or practice of any FWB
Background IP; or (iii) the breach by FWB of any warranty,
representation, covenant or agreement made by FWB in this
Agreement, except, in each case ((i) - (iii)), for those Losses for
which AzurRx has an obligation to indemnify an FWB Indemnitee
pursuant to Section 12.2, and (b) the successful
enforcement of AzurRx’s rights under this Section
12.1; provided
that if AzurRx asserts against FWB any claim for
indemnification under this Section 12.1 and it is
determined pursuant to Section 16.2 that FWB is not to
be obligated to provide such indemnification under this Section
12.1, then AzurRx promptly shall reimburse FWB for all
Losses incurred by FWB in defending such claim for
indemnification.
Section
12.2 Indemnification by AzurRx.
AzurRx shall indemnify FWB, its Affiliates, and its and their
respective directors, officers, employees and agents (the
“FWB
Indemnitees”) and defend and hold each of them
harmless, from and against any and all Losses in connection with
(a) any and all Third Party Claims arising from or occurring as a
result of (i) the Exploitation of the Products in the Field in the
Territory, (ii) gross negligence or willful misconduct on the part
of any AzurRx Indemnitee in exercising its rights or performing its
or their obligations under this Agreement; (iii) the infringement
or misappropriation by AzurRx or any of its Affiliates of any Third
Party intellectual property rights; or (iv) the breach by AzurRx of
any warranty, representation, covenant or agreement made by FWB in
this Agreement, except in each case ((i) - (iv)), for those Losses
for which FWB has an obligation to indemnify an AzurRx Indemnitee
pursuant to Section 12.1, or (b) the
successful enforcement of FWB’s rights under this Section
12.2; provided
that if FWB asserts against AzurRx any claim for
indemnification under this Section 12.2 and it is
determined pursuant to Section 15.2 that AzurRx is
not to be obligated to provide such indemnification under this
Section 12.2, then FWB
promptly shall reimburse AzurRx for all Losses incurred by AzurRx
in defending such claim for indemnification.
Section
12.3 Indemnification
Procedures.
12.3.1 Notice of Claim. All indemnification claims in
respect of a Party and its Indemnitees shall be made solely by such
Party (the “Indemnified Party”). The Indemnified Party
shall give the indemnifying Party prompt written notice (an
“Indemnification
Claim Notice”) of any Losses or
discovery of fact upon which such Indemnified Party intends to base
a request for indemnification under this Article
XII, but in no event shall the indemnifying Party be
liable for any Losses that result from any delay in providing such
notice. Each Indemnification Claim Notice must contain a
description of the claim and the nature and amount of such Loss (to
the extent that the nature and amount of such Loss is known at such
time). The Indemnified Party shall furnish promptly to the
indemnifying Party copies of all papers and official documents
received in respect of any Losses and Third Party
Claims.
12.3.2 Control of Defense.
At its option, the
indemnifying Party may assume the defense of any Third Party Claim
by giving written notice to the Indemnified
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Party
within thirty (30) days after the indemnifying Party’s
receipt of an Indemnification Claim Notice. The assumption of the
defense of a Third Party Claim by the indemnifying Party shall not
be construed as an acknowledgment that the indemnifying Party is
liable to indemnify the Indemnified Party or its Indemnitees in
respect of such Third Party Claim, nor shall it constitute a waiver
by the indemnifying Party of any defenses it may assert against the
Indemnified Party’s or its Indemnitees’ claim for
indemnification. Upon assuming the defense of a Third Party Claim,
the indemnifying Party may appoint as lead counsel in the defense
of such Third Party Claim any legal counsel selected by the
indemnifying Party; provided that it obtains the prior written
consent of the Indemnified Party (which consent shall not be
unreasonably withheld, conditioned or delayed). In the event the
indemnifying Party assumes the defense of a Third Party Claim, the
Indemnified Party shall immediately deliver to the indemnifying
Party all original notices and documents (including court papers)
received by the Indemnified Party or any of its Indemnitees in
connection with such Third Party Claim. If the indemnifying Party
assumes the defense of a Third Party Claim, except as provided in
Section 12.3.3, the Indemnifying
Party shall not be liable to the Indemnified Party for any legal
expenses subsequently incurred by such Indemnified Party or any of
its Indemnitees in connection with the analysis, defense or
settlement of such Third Party Claim unless the expenses were
incurred by the Indemnified Party at the request of the
indemnifying Party. In the event that it is ultimately determined
that the indemnifying Party is not obligated to indemnify, defend
or hold harmless the Indemnified Party or its Indemnitees from and
against the Third Party Claim, the Indemnified Party shall
reimburse the indemnifying Party for any and all costs and expenses
(including attorneys’ fees and costs of suit) and any Losses
incurred by the indemnifying Party in its defense of the Third
Party Claim.
12.3.3 Right to Participate in
Defense. Any Indemnified Party shall be entitled to
participate in, but not control, the defense of such Third Party
Claim and to employ counsel of its choice for such purpose;
provided that such employment shall be at the
Indemnified Party’s sole cost and expense unless (a) the
employment thereof has been specifically authorized by the
indemnifying Party in advance in writing, (b) the indemnifying
Party has notified the Indemnified Party is not going to assume or
failed to assume the defense and employ counsel in accordance with
Section 12.3.2 (in which case the
Indemnified Party shall control the defense) or (c) the
interests of the applicable Indemnitees and the indemnifying Party
with respect to such Third Party Claim are sufficiently adverse to
prohibit the representation by the same counsel of both Parties
under Applicable Law, ethical rules or equitable
principles.
12.3.4 Settlement.
With respect to any Losses relating solely to the payment of money
damages in connection with a Third Party Claim and that shall not
result in the applicable Indemnitee’s becoming subject to
injunctive or other relief or otherwise adversely affecting the
business of the applicable Indemnitee in any manner or the
admission or attribution of liability by or to the Indemnified
Party or any Indemnitee and as to which the Indemnifying Party
shall have acknowledged in writing the obligation to indemnify the
applicable Indemnitee hereunder, the Indemnifying Party shall have
the sole right to consent to the entry of any judgment, enter into
any settlement or otherwise dispose of such Loss, on such terms as
the indemnifying Party, in its sole discretion, shall deem
appropriate. With respect to all other Losses in connection with
Third Party Claims, where the indemnifying Party has assumed the
defense of the Third Party Claim in accordance with Section 12.3.2, the Indemnifying
Party shall have
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authority to
consent to the entry of any judgment, enter into any settlement or
otherwise dispose of such Loss; provided that it obtains the prior written
consent of the Indemnified Party (which consent shall not be
unreasonably withheld, conditioned or delayed). If the Indemnifying
Party does not assume and conduct the defense of a Third Party
Claim as provided above, the Indemnified Party may defend against
such Third Party Claim; provided,
further, that the Indemnified Party shall not settle any
Third Party Claim without the prior written consent of the
Indemnifying Party (which consent shall not be unreasonably
withheld, conditioned or delayed).
12.3.5 Cooperation.
Regardless of whether the Indemnifying Party chooses to defend or
prosecute any Third Party Claim, the Indemnified Party shall and
shall cause each Indemnitee to, cooperate in the defense or
prosecution thereof and shall furnish such records, information and
testimony, provide such witnesses and attend such conferences,
discovery proceedings, hearings, trials and appeals as may be
reasonably requested in connection therewith. Such cooperation
shall include access during normal business hours afforded to the
indemnifying Party to and reasonable retention by the Indemnified
Party and Indemnitees of, records and information that are
reasonably relevant to such Third Party Claim and making
Indemnitees and other employees and agents available on a mutually
convenient basis to provide additional information and explanation
of any material provided hereunder, and the indemnifying Party
shall reimburse the Indemnified Party for all its reasonable and
verifiable out-of-pocket expenses in connection therewith.
Notwithstanding the foregoing, the Indemnified Party shall not be
required to provide the tax returns or tax records of such
Indemnified Party or its Affiliates unless and to the extent that
the Indemnifying Party can reasonably demonstrate that such tax
returns or tax records are essential to defending a Third Party
Claim.
12.3.6 Expenses.
Except as provided above, the reasonable costs and expenses,
including reasonable fees and disbursements of counsel, incurred by
the Indemnified Party in connection with any claim shall be
reimbursed on a Calendar Quarter basis by the Indemnifying Party,
without prejudice to the indemnifying Party’s right to
contest the Indemnified Party’s right to indemnification and
subject to refund in the event the Indemnifying Party is ultimately
held not to be obligated to indemnify the Indemnified
Party.
Section
12.4 Special, Indirect, Consequential and
Other Losses. EXCEPT IN CIRCUMSTANCES OF GROSS NEGLIGENCE OR
WILLFUL MISCONDUCT BY A PARTY OR ITS AFFILIATES, OR WITH RESPECT TO
A BREACH OF Article X, Article XIV OR Article
XI, NEITHER PARTY NOR ANY OF THEIR RESPECTIVE
AFFILIATES, SHALL BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL OR
CONSEQUENTIAL DAMAGES, OR LOST PROFITS, WHETHER IN CONTRACT,
WARRANTY, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE, ARISING
OUT OF ANY BREACH OF OR FAILURE TO PERFORM ANY OF THE PROVISIONS OF
THIS AGREEMENT. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS
SECTION 12.4 LIMITS OR
RESTRICTS THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY
PURSUANT TO SECTION 12.1 AND SECTION
12.2 WITH RESPECT TO LOSSES PAYABLE TO THIRD PARTIES
ASSERTING CLAIMS SUBJECT TO SUCH RIGHTS OR
OBLIGATIONS.
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Section
12.5 Insurance. Each Party shall, and shall cause
its Affiliates to, have and maintain such types and amounts of
liability insurance (or self-insurance) to cover liabilities
related to its activities under this Agreement as is normal and
customary in the pharmaceutical industry generally for Persons
similarly situated, and shall upon request provide to the other
Party evidence of its insurance coverage. Such policies shall
remain in effect throughout the Term and for a period of three (3)
years thereafter.
TERM
AND TERMINATION
Section
13.1 Term.
13.1.1 Term. The term of this
Agreement shall commence on the Effective Date and, unless earlier
terminated in accordance with the terms hereof, shall expire on the
date of expiration of the last to expire Royalty Term with respect
to a country in the Territory (for each such portion of the
Territory, the “Term”).
13.1.2 Effect
of Expiration of Royalty Term.
(a) After expiration of
the Royalty Term (but not after early termination of this Agreement
by (i) either Party pursuant to Section 13.2.1 or (ii) AzurRx pursuant to Section
13.2.2) with respect to any country
within the Territory, with respect to any Product, AzurRx shall
have a non-exclusive, fully-paid, perpetual, royalty-free right and
irrevocable license, with the right to grant sublicenses through
multiple tiers, under the FWB Background IP and Program IP to
Exploit such Product in the Field in such country.
(b) For clarity, except
if this Agreement is terminated by AzurRx pursuant to Section 13.2.1, the license granted
to FWB under Section 8.2.1 shall survive any
expiration of the Royalty Term.
Section
13.2 Termination by Either Party for Breach
or Insolvency.
13.2.1 Breach. In the event that either Party
(the “Breaching
Party”) materially breaches this Agreement, in
addition to any other right or remedy the other Party (the
“Non-Breaching
Party”) may have, the Non-Breaching Party may
terminate this Agreement in its entirety by providing sixty (60)
days’ prior written notice or (except as specified in the
last sentence of this Section 13.2.1) by providing thirty (30)
days’ prior written notice with respect to any breach of any
payment obligation hereunder (the
“Termination Notice
Period”) to the Breaching Party specifying the nature
of the breach and stating its intention to terminate this Agreement
if such breach is not cured (the “Termination Notice”); provided that (i) the termination shall not
become effective at the end of the Termination Notice Period if the
Breaching Party cures the breach specified in the Termination
Notice during the Termination Notice Period (or, if such breach
(other than a payment breach) cannot be cured within the
Termination Notice Period, if the Breaching Party commences actions
to cure such breach within the Termination Notice Period and
thereafter diligently continues such actions; provided further that such breach is
cured within one (1) year after the receipt of the Termination
Notice); (ii) in the event of a good faith dispute as to whether
performance has been made by either Party pursuant to this
Agreement, including any good faith dispute as to payments due
under this Agreement (other than the payment required pursuant to
Section 6.1), the relevant
cure period with respect thereto will be tolled from the
date
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the
Breaching Party notifies the Non-Breaching Party of such good faith
dispute and through the resolution of such dispute in accordance
with the applicable provisions of this Agreement (provided, that if such dispute relates
to payment, the cure period will only apply with respect to payment
of disputed amounts, and not with respect to undisputed amounts);
and (iii) it is understood and agreed that during the pendency of
such dispute, all of the terms and conditions of this Agreement
shall remain in effect and the Parties shall continue to perform
all of their respective obligations hereunder. For clarity, the
Termination Notice Period with respect to any payment breach (other
than under Section 6.1(a)(ii)) shall be thirty (30) days and the
Breaching Party shall have the right to cure a payment breach only
within the applicable Termination Notice Period, subject to the
tolling provision of this Section 13.2.1; provided that the tolling provision of this
Section 13.2.1 shall not apply to
any breach of Section 6.1. There shall be
no Termination Notice Period with respect to any payment breach
under Section 6.1(a)(ii).
13.2.2 Voluntary Termination. AzurRx
shall have the right to terminate this Agreement in its entirety at
any time by providing sixty (60) days’ prior written notice
to FWB.
13.2.3 Insolvency.
Each of FWB and AzurRx may terminate this Agreement in its entirety
immediately upon notice if an Insolvency Event occurs in relation
to the other Party. In any event, when a Party first becomes aware
of the likely occurrence of any Insolvency Event with respect to
such Party, such Party shall promptly notify the other Party in
sufficient time to give the other Party sufficient notice to
protect such other Party’s interests under this
Agreement.
13.2.4 Safety
Reasons. AzurRx shall have the right to terminate this
Agreement immediately upon written notice to FWB if AzurRx
reasonably determines based upon additional information that become
available or an analysis of the existing information at any time
that the medical risk/benefit of the Product is so unfavorable that
it would be incompatible with the welfare of patients to Develop or
Commercialize or to continue to Develop or Commercialize the
Product.
Section
13.3 Termination by FWB for Patent
Challenge. Except to the extent the following is
unenforceable under the Applicable Law of a particular jurisdiction
where a Patent application within FWB’s Patents is pending or
a Patent within FWB’s Patents is issued, if AzurRx, its
Affiliates or Sublicensees initiates a Challenge or, other than as
may be required under Applicable Law, materially induces or assists
a Third Party in initiating or prosecuting a Challenge, FWB shall
have the right to terminate this Agreement in its entirety
effective upon thirty (30)-day written notice to
AzurRx.
Section
13.4 Effect of Termination
in Entirety. In the
event this Agreement is terminated in its entirety for any reason,
then:
13.4.1 All
rights and licenses granted by each Party hereunder, other than the
licenses granted in or stated to survive such termination under
this Article XIII, shall
immediately terminate, including, for clarity, any sublicenses
granted pursuant to Section 8.1.2.
13.4.2 The
license granted by AzurRx to FWB under Section 8.2.1 shall survive such
termination, including any sublicenses granted pursuant to
Section 8.2.2.
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13.4.3 AzurRx
shall transfer to FWB the entirety of AzurRx’s right, title
and interest in and to the Program IP.
(a) With respect to any
Clinical Trial being performed by or on behalf of AzurRx under any
Development Plan as of the effective date of such termination,
unless expressly prohibited by any Regulatory Authority, at
FWB’s written request, AzurRx shall and hereby does, and
shall cause its Affiliates to, at FWB’s discretion, (i)
wind-down such Clinical Trial in an orderly fashion; or
(ii) continue to conduct such Clinical Trial to completion, in
each case (i) and (ii), in accordance with all Applicable Law and
the applicable Development Plan.
(b) With respect to any
Clinical Trial being performed by or on behalf of AzurRx under the
Development Plan as of the effective date of such termination, at
FWB’s written request, AzurRx shall and hereby does, and
shall cause its Affiliates to, at FWB’s discretion, (i)
unless expressly prohibited by any Regulatory Authority, transfer
control to FWB (or its designee) of such Clinical Trial being
conducted by or on behalf of AzurRx under the Development Plan or
(ii) if such transfer is prohibited by any Regulatory Authority,
AzurRx shall continue to conduct such Clinical Trial to completion,
in each case (i) and (ii), in accordance with all Applicable Law
and the Development Plan.
13.4.5 At
FWB’s written request, AzurRx shall, and shall cause its
Affiliates to, assign to FWB (and FWB shall assume all obligations
under) any or all Third Party agreements for services or supplies
used in connection with the Development, Manufacturing or
Commercialization of any Product by or on behalf of AzurRx,
including any contract research organization agreements, Clinical
Trial agreements and contract manufacturing agreements, unless any
such agreement expressly prohibits such assignment or also pertains
to activities other than the Development, Manufacturing or
Commercialization of such Product, in which case, AzurRx shall, and
shall cause its Affiliates to, obtain for FWB substantially all of
the practical benefit and burden under such agreement, including by
(i) entering into appropriate and reasonable alternative
arrangements on terms mutually agreeable to FWB and AzurRx (or such
Affiliate) and (ii) subject to the consent and control of FWB,
enforcing, at FWB’s cost and expense and for the account of
FWB, any and all rights of AzurRx (or such Affiliate) against the
other Party thereto arising out of the breach or cancellation
thereof by such other party or otherwise.
13.4.6 Upon
completion pursuant or wind-down pursuant to Section 13.4.4 of the Clinical
Trials ongoing as of the effective date of such termination, as
soon as reasonably practical after the effective date of such
termination AzurRx will provide to FWB, as applicable and to the
extent permitted under any applicable Third Party contract (i) any
Information, including copies of all Clinical Trial data and
results, developed by or for the benefit of FWB relating to the
Products and (ii) other documents to the extent relating to the
Products that are necessary in the continued Exploitation of a
Product (including material documents and agreements relating to
the sourcing and Manufacture of a Product for sale, promotion,
distribution, or use of such Product) throughout the
Territory.
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13.4.7 Upon
request of FWB, AzurRx will and will cause its Affiliates and its
Sublicensees to, (i) effective as of the effective date of
termination, assign to FWB all of its rights, title, and interests
in and to all INDs, Regulatory Approvals, and other Regulatory
Materials for each Product in the Territory, to the extent allowed
under Applicable Law and (ii) to the extent assignment pursuant to
clause (i) is delayed or not permitted by the applicable Regulatory
Authority, permit FWB, its Affiliates or licensees to
cross-reference and rely upon any Regulatory Materials and
Regulatory Approvals filed by AzurRx with respect to any Product.
As soon as practicable after such transfer, AzurRx will take all
steps necessary to transfer ownership of all such assigned
Regulatory Materials and Regulatory Approvals to FWB, including
submitting to each applicable Regulatory Authority a letter or
other necessary documentation (with a copy to FWB) notifying such
Regulatory Authority of the transfer of such ownership of each
Regulatory Approval, including by making such filings as may be
required with Regulatory Authorities and other Governmental
Authorities in the Territory that may be necessary to record such
assignment or effect such transfer.
13.4.8 If
the Product is being Commercialized as of the effective date of
termination, FWB shall either (i) acquire from AzurRx at cost all
inventory of Product or (ii) grant AzurRx and its Affiliates a
license to sell the remaining inventory of Product for a period of
twelve (12) months from the effective date subject to payment of
any royalties or other amounts due to FWB hereunder.
13.4.9 AzurRx
shall use good faith efforts to transition on a seamless and timely
basis to FWB of all Development and Commercialization activities
and responsibilities for the Products under this Agreement. AzurRx
shall provide such transitional services with respect to the
Products as is reasonably requested by FWB to enable such seamless
transition.
Section
13.5 Confidential Information. Upon
expiration or termination of this Agreement in its entirety, each
Party shall promptly return to the other Party, or delete or
destroy, all relevant records and materials in such Party’s
possession or control containing Confidential Information of the
other Party; provided that a Party may keep one copy of such
materials for legal archival purposes subject to continuing
confidentiality obligations.
Section
13.6 Rights in Bankruptcy. All
rights and licenses granted under or pursuant to this Agreement by
one Party to the other Party are, and otherwise will be deemed to
be, for purposes of Section 365(n) of the U.S. Bankruptcy Code
or comparable provision of applicable bankruptcy or insolvency
laws, licenses of right to “intellectual property” as
defined under Section 101 of the U.S. Bankruptcy Code or
comparable provision of applicable bankruptcy or insolvency laws.
The Parties agree that a Party that is a licensee of such rights
under this Agreement will retain and may fully exercise all of its
rights and elections under the U.S. Bankruptcy Code or comparable
provision of applicable bankruptcy or insolvency laws. The Parties
further agree that, in the event of the commencement of a
bankruptcy proceeding by or against a Party to this Agreement under
the U.S. Bankruptcy Code or comparable provision of applicable
bankruptcy or insolvency laws, the other Party will be entitled to
a complete duplicate of (or complete access to, as appropriate) any
such intellectual property and all embodiments of such intellectual
property, and same, if not already in its possession, will be
promptly delivered to it (a) upon any such commencement of a
bankruptcy or insolvency proceeding upon its written request
therefor, unless the bankrupt Party elects to continue to perform
all of its obligations under this Agreement, or (b) if not
delivered under (a) above,
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following the
rejection of this Agreement by or on behalf of the bankrupt Party
upon written request therefor by the other Party.
Section
13.7 Surviving
Obligations.
Expiration or
termination of this Agreement for any reason shall be without
prejudice to any rights that shall have accrued to the benefit of a
Party prior to such expiration or termination. Such expiration or
termination shall not relieve a Party from obligations that are
expressly indicated to survive the expiration or termination of
this Agreement. Without limiting the foregoing, Section
2.5, Section 3.4, Section
4.5, Section 5.3, Section
6.5, Section 6.9, Article X and Article
XIII of this Agreement shall survive the expiration or
termination of this Agreement for any reason.
NON-COMPETITION
Section 14.1 Non-Competition.
During the Term, AzurRx shall not, and shall cause its controlled
Affiliates not to, either directly or indirectly, Develop, use,
market, sell, detail, promote, distribute, import or otherwise
Commercialize any products containing niclosamide, other than the
Product(s), in the Field in the Territory. A breach of this
provision by AzurRx or any of its Affiliates shall be deemed to
constitute a material breach of AzurRx’s obligations under
this Agreement and FWB shall have the right to terminate this
Agreement in its entirety pursuant to Section 13.2.1.
Section 14.2 Right of First Refusal. In the
event that, on or before April 30, 2021, FWB seeks to outlicense,
sell to or otherwise grant rights to a Third Party related to the
Compound or any products containing niclosamide for use outside the
Field to Develop or Commercialize the Product or a product
containing niclosamide for use outside of the Field (including by
way of a merger or sale of its outstanding equity) (or to enter
into discussions with respect to any of the foregoing) (a
“Trigger
Event”), then in such instance, FWB shall provide to
AzurRx written notice of such proposal, in reasonable detail (the
“ROFR Notice”)
and AzurRx shall have the right and option to negotiate with FWB
with respect to a definitive agreement for the acquisition of FWB
(by way of a merger or the acquisition of 100% of the outstanding
equity of FWB, as determined by the Parties) (the
“Acquisition”).
If within fifteen (15) days of receipt of the ROFR Notice, AzurRx
notifies FWB that it desires to enter into negotiations with
respect to the Acquisition, then the Parties shall engage in good
faith negotiations for a period of thirty (30) days to try and
reach agreement on the terms of the Acquisition. In the event the
Parties fail to reach agreement, then in such instance FWB shall be
free to negotiate the Trigger Event transaction or any other
transaction and this Right of First Refusal shall be of no further
force or effect.
Section
14.3 Reformation. Each of the
Parties acknowledges and agrees that (a) the above Section
14.1 has been negotiated by the Parties, (b) the
geographical and time limitations on activities, are reasonable,
valid and necessary in light of the circumstances pertaining to the
Parties and necessary for the adequate protection of the Products,
and (c) neither Party would have entered in this Agreement without
the protection afforded it by Section 14.1. If, however,
a court of competent jurisdiction determines that the restrictions
set forth in Section 14.1 are
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too
broad or otherwise unreasonable under Applicable Law, including
with respect to duration, geographic scope or space, the court is
hereby requested and authorized by the Parties to revise the
foregoing restrictions to include the maximum restrictions
allowable under Applicable Law.
ARTICLE
XV.
Section
15.1 Governing Law. This Agreement
shall be governed by and construed and enforced under the
substantive laws of the State of New York, without giving effect to
any choice of law rules that might otherwise refer construction or
interpretation of this Agreement to the substantive law of another
jurisdiction. The United Nations Convention on Contracts for the
International Sale of Goods (1980) shall not apply to this
Agreement.
15.2.1 Arbitration.
(a) In the event of
any controversy or claim arising out of or relating to this
Agreement, or the rights or obligations of the Parties hereunder
(collectively, a “Dispute”), either Party shall be
free to institute binding arbitration in accordance with this
Section
15.2 upon written
notice to the other Party (an “Arbitration Notice”) and seek such
remedies as may be available. As used in this Section
15.2, the term
“Excluded Claim”
means a dispute, controversy or claim that concerns (i) the
validity or infringement of a Patent, trademark or copyright; or
(ii) any antitrust, anti-monopoly or competition law or regulation,
whether or not statutory.
(b) Upon receipt of
an Arbitration Notice by a Party, the applicable Dispute shall be
resolved by final and binding arbitration before a panel of three
(3) experts with relevant industry experience (the
“Arbitrators”).
Each of AzurRx and FWB shall promptly appoint one (1) Arbitrator
each, which selections shall in no event be made later than thirty
(30) days after the notice of initiation of arbitration. The third
Arbitrator shall be chosen promptly by mutual agreement of the
Arbitrator chosen by AzurRx and the Arbitrator chosen by FWB, but
in no event later than thirty (30) days after the date that the
last of such Arbitrators was appointed. The arbitration shall be
administered by the American Arbitration Association
(“AAA”) (or its
successor entity) in accordance with the then current Commercial
Rules of the American Arbitration Association including the
Procedures for Large, Complex Commercial Disputes (including the
Optional Rules for Emergency Measures of Protection), except as
modified in this Agreement (the “AAA Rules”). The arbitration shall
be held in New York, New York and shall be conducted in the English
language, and the Parties shall use reasonable efforts to expedite
the arbitration if requested by either Party. The Arbitrators
shall, within fifteen (15) days after the conclusion of the
arbitration hearing, issue a written award and statement of
decision describing the essential findings and conclusions on which
the award is based, including the calculation of any damages
awarded. The decision or award rendered by the Arbitrators shall be
final and non-appealable, and judgment may be entered upon it in
accordance with Applicable Law in any court of competent
jurisdiction. The Arbitrators shall be authorized to grant legal
and equitable remedies that would be available in any judicial
proceeding instituted to resolve a disputed matter under the
substantive laws of New York, but shall not be
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authorized to
reform, modify or materially change this Agreement or any other
agreements contemplated hereunder.
(c) Neither Party shall
be required to produce documents or provide information reflecting
communications between the Party and its attorney(s) for the
purpose of seeking or providing legal advice or prepared by the
Party or its attorney(s) (or retained experts or consultants) in
anticipation of litigation or arbitration, the Parties will make
their respective employees available for depositions and hearing
testimony as reasonably requested by the other Party. Judgment on
any arbitral award issued by the Arbitrators may be entered in any
court having competent jurisdiction.
(d) The Parties may
agree to additional appropriate restrictions or procedures that
shall apply to any arbitration under this Section 15.2.
15.2.2 Arbitration
Costs; Confidentiality. Each Party shall bear its own
counsel fees, costs, and disbursements arising out of the dispute
resolution procedures described in this Section
15.2, and shall pay an equal share of the fees and costs
of the Arbitrators and all other general fees related to any
arbitration described in Section 15.2; provided that the Arbitrators shall be
authorized to determine whether a Party is the prevailing Party,
and if so, to award to that prevailing Party reimbursement for its
reasonable counsel fees, costs and disbursements (including expert
witness fees and expenses, photocopy charges, and travel expenses),
or the fees and costs of the Arbitrators. Unless the Parties
otherwise agree in writing, during the period of time that any
arbitration proceeding described in Section 15.2 is pending under
this Agreement, the Parties shall continue to comply with all those
terms and provisions of this Agreement that are not the subject of
such pending arbitration proceeding. All arbitration proceedings
and decisions of the Arbitrators under Section 15.2 shall be deemed
Confidential Information of both Parties under Article
X.
15.2.3 Excluded
Claims. Either Party may initiate litigation in any court of
competent jurisdiction to resolve any Excluded Claim.
ARTICLE
XVI.
Section
16.1 Force Majeure. Neither Party
shall be held liable or responsible to the other Party or 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 that such failure or delay is caused by an event of
Force Majeure. “Force
Majeure” means an event that is beyond a
non-performing Party’s reasonable control, including an act
of God, act of the other Party, strike, lock-out or other
industrial/labor dispute, war, acts of war (whether war be declared
or not) riot, civil commotion, terrorist act, malicious damage,
epidemic, pandemic quarantine, fire, flood, storm, or natural
disaster. The non-performing Party shall promptly after the
occurrence of the Force Majeure event give written notice to the
other Party stating the nature of the Force Majeure event, its
anticipated duration and any action being taken to avoid or
minimize its effect. Any suspension of performance shall be of no
greater scope and of no longer duration than is reasonably required
and the non-performing Party shall use Commercially Reasonable
Efforts to remedy its inability to perform; provided, however, if the suspension of
performance continues for sixty (60) days after the date of the
occurrence and such failure to perform would constitute a material
breach of this Agreement in the absence of such event of Force
Majeure, the Parties shall meet and discuss in good faith an
appropriate course of action.
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Section
16.2 Successors and Assigns. Except
as expressly provided hereunder, neither this Agreement nor any
rights or obligations hereunder may be assigned or otherwise
transferred by either Party without the prior written consent of
the other Party (which consent shall not be unreasonably withheld).
The Parties may assign or otherwise transfer this Agreement and its
rights and obligations hereunder without the other Party’s
consent as follows:
16.2.1 by
AzurRx, in connection with the transfer or sale of all or
substantially all of the business or assets of AzurRx relating to
the Products to a Third Party, whether by merger, consolidation,
divesture, restructure, sale of stock, sale of assets, or
otherwise, provided that in the event of any such transaction
(whether this Agreement is actually assigned or is assumed by the
acquiring party by operation of law (e.g., in the context of a
reverse triangular merger)), intellectual property rights of the
acquiring party to such transaction (if other than AzurRx) shall
not be included in the technology licensed or assigned hereunder;
or
16.2.2 by
FWB in connection with a change of control of FWB.
16.2.3 by
either Party, to an Affiliate, provided that if the entity to which
this Agreement is assigned ceases to be an Affiliate of the
assigning Party, the Agreement shall be automatically assigned back
to the assigning Party or its successor.
The
rights and obligations of the Parties under this Agreement shall be
binding upon and inure to the benefit of the successors and
permitted assigns of the Parties specified above, and the name of a
Party appearing herein will be deemed to include the name of such
Party’s successors and permitted assigns to the extent
necessary to carry out the intent of this Section 16.2. Any assignment
not in accordance with this Section 16.2 shall be null and
void and of no legal force or effect.
Section
16.3 Export Control. This Agreement
is made subject to any restrictions concerning the export of
products or technical information from the United States or other
countries that may be imposed on the Parties from time to time.
Each Party agrees that it shall not export, directly or indirectly,
any technical information acquired from the other Party under this
Agreement or any products using such technical information to a
location or in a manner that at the time of export requires an
export license or other governmental approval, without first
obtaining the written consent to do so from the appropriate agency
or other Governmental Authority in accordance with Applicable
Law.
Section
16.4 Independent Contractors. It is
the express intention of FWB and AzurRx that each Party and its
Affiliates perform its responsibilities under this Agreement as an
independent contractor of the other Party. Nothing contained in
this Agreement shall be construed to create a relationship of
partners, principal and agent, employer and employee or joint
venturers between FWB and AzurRx or their respective Affiliates or
employees. Nothing contained in this Agreement and the Related
Agreements shall be construed to create a “separate
entity” or “business entity” within the meaning
of the Code or the regulations thereunder and any foreign
equivalents thereto. Neither Party, nor its Affiliates or
employees, shall have the power or right to bind or obligate the
other Party, without the other Party’s prior written consent
to do so, nor shall either Party or its Affiliates or employees
hold itself out as having such authority except as otherwise
specified herein or in any Related Agreement.
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Section
16.5 Delegation and Subcontracting of
Obligations to Third Parties. AzurRx (and its Affiliates)
shall have the right to subcontract its Development, Manufacturing
and Commercialization obligations under this Agreement to
one (1) or more Third Parties; provided that neither AzurRx (nor its
Affiliates) may subcontract (a) the conduct of any Clinical Trial
to any contract research organization, (b) the performance of any
Commercialization activity or (c) any Manufacturing obligation to
any Third Party manufacturer, except in each case as determined by
the JSC pursuant to Section 2.5. AzurRx shall
remain responsible for the management of its subcontractor, liable
for the performance of such subcontractor and shall ensure that
such subcontractor complies with the terms of this Agreement and
the Related Agreements in the same manner and to the same extent as
if such activity were performed directly by AzurRx and any action
or omission of such subcontractor shall be deemed an action or
omission of AzurRx for all purposes of this Agreement and the
Related Agreements. All compensation, reimbursement of costs and
other payments to be made to any such Third Party subcontractor
shall be determined solely by AzurRx and such Third Party
subcontractor.
Section
16.6 Compliance with Applicable Law.
Each of the Parties shall, and shall cause its Affiliates to, in
all respects, comply with all Applicable Law in Developing and
Commercializing the Products in the Field in the Territory and
performing its other obligations under this Agreement, including
the Foreign Corrupt Practices Act of 1977, as amended
(“FCPA”); the
FFDCA; the Public Health Service Act, as amended; the Prescription
Drug Marketing Act of 1987, as amended; the Federal Health Care
Program Anti-Kickback Law (42 U.S.C. §§ 1320a-7b),
as amended; the Health Insurance Portability and Accountability Act
of 1996, as amended; the FDA Guidance for Industry-Supported
Scientific and Educational Activities; all federal, state and local
“fraud and abuse,” consumer protection and false claims
statutes and regulations, including the Medicare and State Health
Programs Anti-Fraud and Abuse Amendments of the Social Security Act
and the “Safe Harbor Regulations” found at 42 C.F.R.
§1001.952 et seq.; the Office of the Inspector General’s
Compliance Guidance Program, 42 U.S.C. 1320a-7h and its
implementing regulations (also known as the National Physician
Payment Transparency Program and the Open Payments Program)
(“Sunshine
Act”); and all foreign equivalents in the Territory of
any of the foregoing; provided that with respect to the Sunshine Act,
each Party shall be responsible for reporting in connection with
payments or other transfers of value actually made by such Party or
its Affiliates, and each Party shall use Commercially Reasonable
Efforts to cooperate with the other Party to coordinate such
disclosure. Each Party represents and warrants to the other
Party that, as of the Effective Date, such Party and its Affiliates
have adequate procedures in place to support their compliance with
the FCPA. Each Party and its Affiliates shall maintain such
procedures throughout the Term and shall promptly notify the other
Party in writing with respect to any material non-compliance with
any Applicable Law regarding the Development or Commercialization
of the Products in the Field in the Territory or the performance of
its other obligations under this Agreement. In addition, each of
the Parties shall, and shall cause its Affiliates to, comply with
the Pharmaceutical Research and Manufacturers of America Code on
Interactions with Healthcare Professionals, as hereafter amended
from time to time; and the standards set forth by the Accreditation
Council for Continuing Medical Education relating to educating the
medical community in the Territory, in Developing and
Commercializing the Products in the Field in the Territory and
performing its other obligations under this Agreement.
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16.7.1 Neither
AzurRx or FWB nor any of their Affiliates or Sublicensees has made
or will make, directly or indirectly, any offer, payment, promise
to pay, loan, or gift of anything of value to a Government Official
(defined below), to an immediate relative of a Government Official,
or to any other person while knowing or having reasons to suspect
that any part of such offer, payment, loan or gift will be given or
promised to a Government Official, for the purpose of obtaining or
retaining business on behalf of or for the benefit of AzurRx or FWB
or any of their Affiliates, or where the offer, payment, loan or
gift of which would violate any Applicable Law, including
Anti-Corruption Laws, in each case with respect to activities under
this Agreement. As used in this Section
16.7, “Government Official” means: (i) any
official, employee, agent, advisor or consultant of a non-U.S.
government or any federal, regional or local department, agency,
state-owned enterprise or corporation or any other instrumentality
thereof; (ii) any official or employee or agent of a public
international organization; or (iii) any official or employee or
agent of a political party or candidate for political
office.
16.7.2 An officer of AzurRx shall, on
the date hereof, and on each anniversary of the date hereof,
deliver to FWB an annual certification of Anti-Bribery and
Corruption compliance substantially similar to the certificate
attached hereto as Schedule 16.7.2.
16.7.3 Upon reasonable prior written
notice and for reasonable good cause (including the failure to
timely provide all required certifications in accordance with
Section 16.7.2), each Party or
their designated agents shall be permitted access to all books and
records of the other Party reasonably related to compliance with
this Section
16.7.3 any payment made in
connection with such Party’s under this Agreement, including
for the purpose of auditing such books and records, all at the
expense of the Party performing the audit.
16.7.4 Each Party shall comply with the
other Party’s reasonable requests for information related to
evaluating their compliance with the provisions of this
Section 16.7.4 (including without
limitation completing forms provided by the other
Party).
Section
16.8 Amendment. Any amendment,
change, supplement to or other variation of this Agreement shall be
valid only if made in writing, mutually agreed to by the Parties
and duly executed by authorized representatives of both
Parties.
Section
16.9 Notices.
16.9.1 Requirements. All notices under
or in connection with this Agreement shall be in writing (which
requirement shall also be deemed fulfilled by a facsimile
transmission, but not exclusively via electronic communication or
electronic transmission), shall refer specifically to this
Agreement and shall be deemed given only if delivered by hand or
sent by facsimile transmission (with transmission confirmed) or by
internationally recognized overnight delivery service that
maintains records of delivery, addressed to the Parties at their
respective addresses specified in Section 16.9.2 or to such other
address as the Party to whom notice is to be given may have
provided to the other Party in accordance with this Section 16.9.1. Such notice shall
be deemed to have been given as of the date delivered by hand or
transmitted by facsimile (with
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transmission
confirmed) or on the second Business Day (at the place of delivery)
after deposit with an internationally recognized overnight delivery
service. Any notice delivered by facsimile shall be confirmed by a
hard copy delivered as soon as practicable thereafter. This
Section 16.9.1 is not intended to
govern the day-to-day business communications necessary between the
Parties in performing their obligations under the terms of this
Agreement.
If to FWB,
to:
First
Wave Bio, Inc.
P.O.
Box 7805
Ann
Arbor, MI 48107
Attn:
Gary Glick, President & CEO
Email:
gary@firstwavebio.com
If to AzurRx, to:
AzurRx
Biopharma, Inc.
1615
South Congress Avenue
Suite
103
Delray
Beach FL. 33445
Attn.
James Sapirstein, CEO
Email:
jsapirstein@azurrx.com
Section
16.10 Entire Agreement. This
Agreement and the Related Agreements, together with the Schedules,
Exhibits and Appendices attached hereto and thereto, set forth and
constitute the entire agreement and understanding between the
Parties with respect to the subject matter hereof and all prior
agreements, understandings, promises, and representations, whether
written or oral, with respect thereto are superseded hereby and
thereby, including that certain Confidential Disclosure Agreement
between AzurRx and FWB, effective as of May 13. 2020. Except for
the Related Agreements, there are no ancillary or side agreements,
whether written, oral, or otherwise. Each Party confirms that in
entering into this Agreement it is not relying on any
representations or warranties of the other Party, except as
specifically set forth in this Agreement.
Section
16.11 Interpretation. This Agreement
shall be construed and interpreted in accordance with the following
rules except as expressly otherwise provided herein and except as
the context otherwise requires:
16.11.1 Wherever
used, the singular shall include the plural, the plural the
singular, the use of any gender shall be applicable to all genders
and the word “or” is used in the inclusive sense
(and/or). Whenever this Agreement refers to a number of days,
unless otherwise specified, such number refers to calendar days.
The captions of this Agreement are for convenience of reference
only and in no way define, describe, extend, or limit the scope or
intent of this Agreement or the intent of any provision contained
in this Agreement. In the case of a defined term, any grammatical
form thereof shall have a corresponding meaning. The term
“including,” “include,” or
“includes” as used herein shall mean including, without
limiting the generality of any description preceding such term. The
language of this Agreement shall be deemed to be the
-51-
language mutually
chosen by the Parties and no rule of strict construction shall be
applied against either Party hereto.
16.11.2 Unless
specifically stated otherwise, any reference (a) to any Section,
Article or Exhibit shall be references to such Section or Article
of or Exhibit to this Agreement, (b) in any Section to any clause
shall be a reference to such clause of such Section and (c) to any
agreement, instrument, or other document in this Agreement shall
refer to such agreement, instrument, or other document as
originally executed or, if subsequently amended, replaced, or
supplemented from time to time, as so amended, replaced, or
supplemented and in effect at the relevant time of reference
thereto.
16.11.3 A
reference to a law, ruling, agreement or other legal instrument
shall include all changes, amendments or supplements to such law,
agreement or other legal instrument regardless of whether such
change, amendment or supplement has occurred prior to, on or after
the Effective Date.
16.11.4 In
the event of any inconsistency between a Related Agreement and this
Agreement, the terms of this Agreement shall govern unless such
Related Agreement specifically references a Section of this
Agreement and expressly states that such Section is intended to be
amended by such Related Agreement.
16.11.5 This
Agreement shall be written and executed in, and all other
communications under or in connection with this Agreement shall be
in, the English language. Any translation into any other language
shall not be an official version thereof, and in the event of any
conflict in interpretation between the English version and such
translation, the English version shall control.
Section
16.12 Severability. In the event that
any provision of this Agreement is held to be invalid, illegal or
unenforceable, and if the rights or obligations of either Party
under this Agreement will not be materially and adversely affected
thereby, (a) such provision shall be fully severable, (b) this
Agreement shall be construed and enforced as if such invalid,
illegal or unenforceable provision had never comprised a part
hereof, (c) the validity, legality and enforceability of the
remaining provisions hereof shall not be affected or impaired
thereby and (c) in lieu of such invalid, illegal or unenforceable
provision, there shall be added automatically as a part of this
Agreement a valid, legal and enforceable provision that (x)
achieves, to the maximum extent possible, the Parties’
original intent and commercial objectives and (y) is reasonably
acceptable to the Parties. It is understood that in any case where
a provision is void or unenforceable only in some respects
(e.g., only with respect to
certain countries) such provision shall continue to be applied in
all other respects. To the fullest extent permitted by Applicable
Law, each Party hereby waives any provision of law that would
render any provision hereof illegal, invalid, or unenforceable in
any respect.
Section
16.13 Waivers. Any term or condition
of this Agreement may be waived at any time by the Party that is
entitled to the benefit thereof, but no such waiver (a) shall be
effective unless set forth in a written instrument duly executed by
or on behalf of the Party waiving such term or condition and (b) in
any one instance shall be construed to be a waiver of such term or
provision or any other term or provision in any other instance. All
rights, remedies, undertakings and obligations contained herein
shall be cumulative, and none of them shall be construed to be a
limitation of any other right, remedy, undertaking or
obligation.
-52-
Section
16.14 Equitable Relief. Each Party
acknowledges and agrees that the restrictions set forth
in Article
X and Article XIV are reasonable
and necessary to protect the legitimate interests of the other
Party and that such other Party would not have entered into this
Agreement in the absence of such restrictions, and that any breach
or threatened breach of any provision of such Section or Articles
may result in irreparable injury to such other Party for which
there will be no adequate remedy at law. In the event of a breach
or threatened breach of any provision of such Section or Articles,
the non-breaching Party shall be authorized and entitled to seek
from any court of competent jurisdiction injunctive relief, whether
preliminary or permanent, specific performance, and an equitable
accounting of all earnings, profits, and other benefits arising
from such breach, which rights shall be cumulative and in addition
to any other rights or remedies to which such non-breaching Party
may be entitled in law or equity. Both Parties agree to waive any
requirement that the other (a) post a bond or other security as a
condition for obtaining any such relief and (b) show irreparable
harm, balancing of harms, consideration of the public interest, or
inadequacy of monetary damages as a remedy. Nothing in this
Section 16.14 is
intended, or should be construed, to limit either Party’s
right to equitable relief or any other remedy for a breach of any
other provision of this Agreement.
Section
16.15 Further Assurances. Each Party
shall duly execute and deliver, or cause to be duly executed and
delivered, such further instruments and do and cause to be done
such further acts and things, including the filing of such
assignments, agreements, documents, and instruments, as may be
necessary or as the other Party may reasonably request in
connection with this Agreement or to carry out more effectively the
provisions and purposes hereof, or to better assure and confirm
unto such other Party its rights and remedies under this
Agreement.
Section
16.16 Counterparts. This Agreement
may be executed in any number of counterparts and on a separate
counterpart by each Party. Each of such counterparts shall, when
executed, be deemed to be an original hereof, and all such
counterparts together shall be deemed to constitute one and the
same document. This Agreement may be executed by facsimile or
electronically transmitted signatures and such signatures shall be
deemed to bind each Party hereto as if they were original
signatures.
Section
16.17 No Third Party Beneficiaries.
It is acknowledged and mutually agreed that no provision of this
Agreement shall be for the benefit of, or shall be enforceable by,
any Third Party, including any creditor of either
Party.
Section
16.18 Costs. Except as otherwise set
forth herein, each Party shall bear its own costs and expenses in
connection with the preparation, execution and implementation of
this Agreement.
[Signature page follows]
-53-
IN WITNESS WHEREOF, the Parties have
executed this Agreement by their duly authorized officers as of the
Effective Date.
|
FIRST WAVE BIO INC.
|
AZURRX BIOPHARMA INC.
|
||
|
By:
|
/s/
Gary Glick
|
By:
|
/s/
James Sapirstein
|
|
Name:
|
Gary Glick
|
Name:
|
James Sapirstein
|
|
Title:
|
President & Chief Executive Officer
|
Title:
|
Chief Executive Officer
|
-54-
EXHIBIT 1.14
AzurRx Background Patents as of the Effective Date
None.
-55-
EXHIBIT 1.33
Compound
1. Enema formulation
2. Immediate release formulation
-56-
EXHIBIT 1.60
FWB Background Patents as of the Effective Date
|
Matterid
|
Title
|
Filed
|
Appln
|
Publ Date
|
Publ. No.
|
Issue
|
Patent No.
|
Country
|
Inventors
|
Status
|
|
42152-0002001
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
15/255,102
|
3/2/2017
|
US-2017-0056347-A1
|
5/21/2019
|
10,292,951
|
UNITED
STATES
|
Gary D. Glick,
Luigi Franchi, GIancarlo Santus
|
ISSUED
|
|
42152-0002002
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
10/29/2018
|
16/173,667
|
10/3/2019
|
US-2019-0298670-A1
|
9/15/2020
|
10,772,854
|
UNITED
STATES
|
Gary D. Glick,
Luigi Franchi, GIancarlo Santus
|
ISSUED
|
|
42152-0002003
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
1/9/2020
|
16/738,618
|
5/14/2020
|
US-2020-0147012-A1
|
8/18/2020
|
10,744,103
|
UNITED
STATES
|
Gary D. Glick,
Luigi Franchi
|
ISSUED
|
|
42152-0002004
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
1/9/2020
|
16/738,695
|
5/14/2020
|
US-2020-0147013-A1
|
10/13/2020
|
10,799,468
|
UNITED
STATES
|
Gary D. Glick,
Luigi Franchi
|
ISSUED
|
|
42152-0002005
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSE
|
2/28/2020
|
16/805,245
|
6/25/2020
|
US-2020-0197339-A1
|
|
|
UNITED
STATES
|
Gary D. Glick,
Luigi Franchi
|
ALLOWED
|
|
42152-0002006
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSE
|
2/28/2020
|
16/805,393
|
6/25/2020
|
US-2020-0197340-A1
|
|
|
UNITED
STATES
|
Gary D. Glick,
Luigi Franchi
|
ALLOWED
|
|
42152-0002007
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
5/11/2020
|
16/871,717
|
8/27/2020
|
US-2020-0268694-A1
|
12/1/2020
|
10,849,867
|
UNITED
STATES
|
Gary D. Glick,
Luigi Franchi
|
ISSUED
|
|
42152-0002008
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
5/13/2020
|
15/931,320
|
9/3/2020
|
US-2020-0276140-A1
|
|
|
UNITED
STATES
|
Gary D. Glick,
Luigi Franchi
|
PUBLISHED
|
|
42152-0002AP1
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
AP/P/2018/010627
|
|
|
|
|
ARIPO
|
Gary D. Glick,
Luigi Franchi
|
PENDING
|
|
Matterid
|
Title
|
Filed
|
Appln
|
Publ Date
|
Publ. No.
|
Issue
|
Patent No.
|
Country
|
Inventors
|
Status
|
|
42152-0002AU1
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
2016315852
|
|
|
|
|
AUSTRALIA
|
Gary D. Glick,
Luigi Franchi, GIancarlo Santus
|
PENDING
|
|
42152-0002BR1
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
BR112018004069-0
|
10/2/2018
|
BR112018004069-0
|
|
|
BRAZIL
|
Gary D. Glick,
Luigi Franchi
|
PUBLISHED
|
|
42152-0002CA1
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
2997136
|
|
|
|
|
CANADA
|
Gary D. Glick,
Luigi Franchi
|
PENDING
|
|
42152-0002CL1
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
2018-00559
|
8/17/2018
|
|
|
|
CHILE
|
Gary D. Glick,
Luigi Franchi
|
PUBLISHED
|
|
42152-0002CN1
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
201680063216.X
|
4/2/2019
|
109562137
|
|
|
CHINA
|
Gary D. Glick,
Luigi Franchi
|
PUBLISHED
|
|
42152-0002CO1
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
NC2018/0003465
|
8/31/2018
|
|
|
|
COLOMBIA
|
Gary D. Glick,
Luigi Franchi
|
PUBLISHED
|
|
42152-0002CR1
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
2018-185
|
|
|
|
|
COSTA
RICA
|
Gary D. Glick,
Luigi Franchi
|
PENDING
|
|
42152-0002CR2
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
2020-575
|
|
|
|
|
COSTA
RICA
|
Gary D. Glick,
Luigi Franchi
|
PENDING
|
|
42152-0002DZ1
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
180161
|
|
|
|
|
ALGERIA
|
Gary D. Glick,
Luigi Franchi
|
PENDING
|
|
Matterid
|
Title
|
Filed
|
Appln
|
Publ Date
|
Publ. No.
|
Issue
|
Patent No.
|
Country
|
Inventors
|
Status
|
|
42152-0002EA1
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
201890618
|
10/31/2018
|
201890618
|
|
|
EURASIA
|
Gary D. Glick,
Luigi Franchi
|
PUBLISHED
|
|
42152-0002EG1
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
355/2018
|
|
|
|
|
EGYPT
|
Gary D. Glick,
Luigi Franchi
|
PENDING
|
|
42152-0002EP1
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
16843029.6
|
7/11/2018
|
3344274
|
|
|
EUROPEAN
PATENT CONVENTION
|
Gary D. Glick,
Luigi Franchi, GIancarlo Santus
|
PUBLISHED
|
|
42152-0002HK1
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
19100425.4
|
11/1/2019
|
1258048A
|
|
|
HONG
KONG
|
Gary D. Glick,
Luigi Franchi, GIancarlo Santus
|
PUBLISHED
|
|
42152-0002ID1
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
PID201802181
|
10/12/2018
|
2018/11182
|
|
|
INDONESIA
|
Gary D. Glick,
Luigi Franchi
|
PUBLISHED
|
|
42152-0002ID2
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
P00202007634
|
|
|
|
|
INDONESIA
|
Gary D. Glick,
Luigi Franchi
|
PENDING
|
|
42152-0002IL1
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
257801
|
|
|
|
|
ISRAEL
|
Gary D. Glick,
Luigi Franchi, GIancarlo Santus
|
PENDING
|
|
42152-0002IN1
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
201837009430
|
|
|
|
|
INDIA
|
Gary D. Glick,
Luigi Franchi, GIancarlo Santus
|
PENDING
|
|
42152-0002JP1
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
2018-530676
|
10/11/2018
|
2018-529762
|
|
|
JAPAN
|
Gary D. Glick,
Luigi Franchi, GIancarlo Santus
|
PUBLISHED
|
|
Matterid
|
Title
|
Filed
|
Appln
|
Publ Date
|
Publ. No.
|
Issue
|
Patent No.
|
Country
|
Inventors
|
Status
|
|
42152-0002KR1
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
10-2018-7009287
|
|
|
|
|
SOUTH
KOREA
|
Gary D. Glick,
Luigi Franchi, GIancarlo Santus
|
PENDING
|
|
42152-0002LY1
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
5308/2018
|
|
|
|
|
LIBYA
|
Gary D. Glick,
Luigi Franchi, GIancarlo Santus
|
PENDING
|
|
42152-0002MA1
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
PV/42207
|
|
|
|
|
MOROCCO
|
Gary D. Glick,
Luigi Franchi
|
ABANDONED
|
|
42152-0002MA2
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
48155
|
|
|
|
|
MOROCCO
|
Gary D. Glick,
Luigi Franchi
|
PENDING
|
|
42152-0002MX1
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
MX/a/2018/002586
|
|
|
|
|
MEXICO
|
Gary D. Glick,
Luigi Franchi, GIancarlo Santus
|
PENDING
|
|
42152-0002MY1
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
PI2018000306
|
|
|
|
|
MALAYSIA
|
Gary D. Glick,
Luigi Franchi, GIancarlo Santus
|
PENDING
|
|
42152-0002NZ1
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
740372
|
|
|
|
|
NEW
ZEALAND
|
Gary D. Glick,
Luigi Franchi, GIancarlo Santus
|
PENDING
|
|
42152-0002P01
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2015
|
62/213,016
|
|
|
|
|
UNITED
STATES
|
Gary D. Glick,
Luigi Franchi
|
EXPIRED
|
|
42152-0002P02
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
10/14/2015
|
62/241,508
|
|
|
|
|
UNITED
STATES
|
Gary D. Glick,
Luigi Franchi
|
EXPIRED
|
|
42152-0002PA1
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
92022
|
7/18/2019
|
367
|
|
|
PANAMA
|
Gary D. Glick,
Luigi Franchi, GIancarlo Santus
|
PUBLISHED
|
|
Matterid
|
Title
|
Filed
|
Appln
|
Publ Date
|
Publ. No.
|
Issue
|
Patent No.
|
Country
|
Inventors
|
Status
|
|
42152-0002PE1
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
000333-2018/DIN
|
8/7/2018
|
000333-2018/DIN
|
|
|
PERU
|
Gary D. Glick,
Luigi Franchi, GIancarlo Santus
|
PUBLISHED
|
|
42152-0002PH1
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
1-2018-500448
|
|
|
|
|
PHILIPPINES
|
Gary D. Glick,
Luigi Franchi, GIancarlo Santus
|
PENDING
|
|
42152-0002SG1
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
11201801672S
|
|
|
|
|
SINGAPORE
|
Gary D. Glick,
Luigi Franchi, GIancarlo Santus
|
ALLOWED
|
|
42152-0002SG2
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
10201914118S
|
2/27/2020
|
10201914118S
|
|
|
SINGAPORE
|
Gary D. Glick,
Luigi Franchi
|
PUBLISHED
|
|
42152-0002TH1
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
1801001322
|
|
|
|
|
THAILAND
|
Gary D. Glick,
Luigi Franchi, GIancarlo Santus
|
PENDING
|
|
42152-0002TN1
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
TN2018/0069
|
7/8/2019
|
TN2018/0069
|
9/10/2019
|
25982
|
TUNISIA
|
Gary D. Glick,
Luigi Franchi
|
ISSUED
|
|
42152-0002UA1
|
METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
|
a 2018
02287
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UKRAINE
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Gary D. Glick,
Luigi Franchi, GIancarlo Santus
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PENDING
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42152-0002VN1
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METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
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9/1/2016
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1-2018-01351
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10/25/2018
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59684
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VIET
NAM
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Gary D. Glick,
Luigi Franchi, GIancarlo Santus
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PUBLISHED
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42152-0002WO1
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METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
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9/1/2016
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PCT/US2016/050012
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3/9/2017
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WO
2017/040864
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WIPO
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Gary D. Glick,
Luigi Franchi
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NAT PHASE
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Matterid
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Title
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Filed
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Appln
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Publ Date
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Publ. No.
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Issue
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Patent No.
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Country
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Inventors
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Status
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42152-0002ZA1
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METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
|
9/1/2016
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2018/02084
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|
|
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SOUTH
AFRICA
|
Gary D. Glick,
Luigi Franchi, GIancarlo Santus
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PENDING
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42152-0002ZA2
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METHODS AND
COMPOSITIONS FOR TREATING CONDITIONS ASSOCIATED WITH AN ABNORMAL
INFLAMMATORY RESPONSES
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9/1/2016
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UNKNOWN
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|
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SOUTH
AFRICA
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Gary D. Glick,
Luigi Franchi, GIancarlo Santus
|
PENDING
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-57-
EXHIBIT 2.1
JSC Representatives
AzurRx Representatives
James Sapirstein
Jim Pennington
First Wave Bio Representatives
Gary Glick
Tony Opipari
-58-
EXHIBIT 3.4.2
Form of Development Activities Report
1.
ICI-AC
2.
COVID
|
Description
|
Goal
|
Projected Timeline
(Date/Time)
|
Current Status
|
|
Clinical Trial Phase
|
|
|
|
|
IND Application Status
|
|
|
|
|
Clinical Research Organization (CRO)
|
|
|
|
|
# Patients
|
|
|
|
|
Study Design/Dosing Regimen
|
|
|
|
|
Drug Product
|
|
|
|
|
# Sites/
Countries
|
|
|
|
|
Enrollment Status
Expected to Date/Actual
|
|
|
|
|
Primary Endpoint
|
|
|
|
|
Secondary Endpoints
|
|
|
|
|
Exploratory Endpoints
|
|
|
|
|
Inclusion Criteria
|
|
|
|
-59-
|
Exclusion Criteria
|
|
|
|
|
Projected First Subject Enrolled Date
|
|
|
|
|
Projected Last Subject Enrolled Date
|
|
|
|
|
Projected Last Subject Last Visit
|
|
|
|
|
Database Lock
|
|
|
|
|
Topline Data
|
|
|
|
|
Clinical Study Report (CSR)
|
|
|
|
Other information:
-60-
EXHIBIT 7.1.2
Form of Manufacturing Report
1.
ICI-AC
2.
COVID
|
Description
|
Goal
|
Projected Timeline
(Date/Time)
|
Current Status
|
|
Clinical Trial Phase
|
|
|
|
|
Formulation Development
|
|
|
|
|
IMP Manufacturing
|
|
|
|
|
Clinical Supply
|
|
|
|
|
Stability
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vendor Audits
|
|
|
|
|
Commercial Readiness
|
|
|
|
Other information:
-61-
EXHIBIT 10.4
Press Release
-62-
EXHIBIT 11.2.8
Known Researchers Working in the Field as of the Effective
Date
[***]
-63-