Blueprint





 


 





 



Exhibit 10.5






 CERTAIN IDENTIFIED INFORMATION HAS BEEN
EXCLUDED FROM THE EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD
LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY
DISCLOSED.


 

 


EXCLUSIVE
LICENSE AGREEMENT

 


by
and between


 





CIPHER
PHARMACEUTICALS INC.


 





and


 





EDESA
BIOTECH INC.


 





June
15, 2016


 




 




 








 





 






TABLE OF CONTENTS


 





	
 

	

Page


	

ARTICLE
1 DEFINITIONS

	

1


	

ARTICLE
2 SCOPE AND GOVERNANCE

	

7


	

2.1 General.

	

7


	

2.2 Joint Steering Committee

	

7


	

2.3 JSC Meetings

	

8


	

ARTICLE
3 PRODUCT DEVELOPMENT AND COMMERCIALIZATION

	

8


	

3.1 Overview

	

8


	

3.2 Conduct of Development and
Commercialization

	

9


	

3.3 Rights to Engage
Subcontractors

	

9


	

ARTICLE
4 MANUFACTURE AND SUPPLY

	

10


	

ARTICLE
5 RECORDS

	

10


	

ARTICLE
6 REGULATORY

	

10


	

6.1 Regulatory Obligations

	

10


	

6.2 Safety Reporting

	


11


	

6.3 Recalls

	

11


	

6.4 Pricing and Reimbursement.

	

12


	

ARTICLE
7 PAYMENTS

	

12


	

7.1 Milestone Payments

	

12


	

7.2 Product Royalties

	

13


	

7.3 Royalty Stacking

	

13


	

7.4 Reports; Payment of Royalty

	

13


	

7.5 Audits

	

14


	

7.6 Payment Exchange Rate

	

14


	

7.7 Tax Withholding

	

15


	

7.8 Late Payments

	

15


	

ARTICLE
8 LICENSES; EXCLUSIVITY

	

15


	

8.1 License to Licensee

	

15


	

8.2 Sublicensing

	

15


	

8.3 License to Cipher.

	

15


	

8.4 No Implied Licenses

	

16


	

8.5 Registration and Recordation of
License

	

16


	

8.6  Non-Compete

	

16


	

ARTICLE
9 CONFIDENTIALITY; PUBLICATION

	

16







 







 

i








 





 



TABLE OF CONTENTS



(Continued)


 


	

9.1 Nondisclosure
Obligation

	

16


	

9.2 Publicity; Use of Names

	

18


	


ARTICLE 10 REPRESENTATIONS AND WARRANTIES

	


19


	

10.1 Representations and Warranties of
Cipher.

	

19


	

10.2 Representations and Warranties and Covenants of
Licensee

	

20


	

10.3 Representations and Covenants of Both
Parties

	

20


	

10.4  No Other Representations or
Warranties

	

20


	


ARTICLE 11 INDEMNIFICATION

	


21


	

11.1 General Indemnity By Licensee

	

21


	

11.2 General Indemnity By Cipher.

	

21


	

11.3 Defined Indemnification Terms

	

21


	

11.4 Defense

	

21


	

11.5 Settlement.

	

22


	

11.6 Notice

	

22


	

11.7 Permission by Indemnifying
Party

	

22


	

11.8 Limitation of Liability

	

22


	

11.9  Insurance

	

22


	


ARTICLE 12 INVENTIONS; PATENT PROVISIONS

	


23


	

12.1 Ownership of Intellectual
Property

	

23


	

12.2  Improvements

	

23


	

12.3 Enforcement.

	

23


	

12.4 Defense

	

24


	


ARTICLE 13 TERM AND TERMINATION

	


25


	

13.1 Term and Expiration

	

25


	

13.2 Termination for Cause

	

25


	

13.3 Termination Without Cause

	

26


	

13.4 Effect of Termination

	

26


	

13.5  Survival.

	

27


	


ARTICLE 14 MISCELLANEOUS

	


27


	

14.1 Force Majeure

	

27


	

14.2 Assignment.

	

27


	

14.3 Severability

	

27


	

14.4 Notices

	

27


	

14.5 Applicable Law and Litigation

	

28


	

14.6 Entire Agreement; Amendments

	

28


	

14.7 Independent Contractors

	

29


	

14.8  Waiver.

	

29






  





 

ii







 





 





TABLE OF CONTENTS



(Continued)

   



	

14.9 Cumulative Remedies

	

29


	

14.10 Waiver of Rule of Construction

	

29


	

14.11 Counterparts

	

29


	

14.12 Further Assurances

	

29


	

14.13 Construction

	

29


	

14.14 Currency

	

30


	

14.15 Use of Third Parties

	

30


	

14.16 Dispute Resolutions

	

30


	

14.17 Statute of Limitations

	

32


	

14.18 Injunctive and Other Interim
Relief

	

32


	

14.19 Time of the Essence

	

32


	

14.20 Execution in Counterparts; Facsimile
Signatures

	

32


	

14.20
Performance by Affiliates

	


32







 




iii








 





 


EXCLUSIVE
LICENSE AGREEMENT


 





This
Agreement (the "Agreement"),
effective as of June 15, 2016 (the "Effective Date"), is entered into by
and between Cipher Pharmaceuticals Inc., an Ontario corporation
with its principal office at 2345 Argentia Road, Suite 100A,
Mississauga, Ontario, L5N 8K4 ("Cipher"), and Edesa Biotech Inc., an
Ontario corporation with its principal office at 100 Spy Court,
Markham, Ontario, L3R 5H6 ("Licensee"). Cipher and Licensee may be
referred to herein individually as a "Party" or collectively as the
"Parties". Reference to a
Paity shall be deemed to include that Party's
Affiliates.


 





RECITALS:

 







A.

Cipher owns Cipher
IP relating to ASF-1096 (Levo-salbutamol and/or R-salbutamol) as
further described in Schedule "A".






 







B.

Licensee is a
pharmaceutical company having expertise in the discovery,
development, manufacturing and commercialization of innovative
human pharmaceutical products.





 







C.

Licensee wishes to
develop, manufacture, and commercialize a pharmaceutical product or
products that may Cover Cipher IP.






 







D.

Licensee and Cipher
desire to enter into an agreement under which Licensee would obtain
exclusive rights to the Cipher IP for therapeutic, prophylactic and
diagnostic applications of the Product in human and veterinary
medicine for Anorectal Disorders (as defined below) (collectively,
the "Field").






 





In
consideration of the foregoing premises and the mutual covenants
herein contained, the Parties hereby agree as follows:


 





ARTICLE
1


DEFINITIONS


 





Unless
specifically set forth to the contrary herein, the following terms,
whether used in the singular or plural, shall have the respective
meanings set forth below:


 








1.1.

"Adverse Event" shall
mean any undesirable medical occurrence in a patient or clinical
investigation subject administered the Product and which does not
necessarily have to have a causal relationship with the
Product.





 








1.2.

"ADRC" has the meaning
set forth in Section 14.16.






 








1.3.

"Affiliate" means with
respect to any Party, any person or entity controlling, controlled
by or under common control with such Party. For purposes of this
Section 1.3, "control" shall
mean: (a) in the case of a corporate entity, direct or indirect
ownership of fifty percent (50%) or more of the stock or shares
having the right to vote for the election of directors of such
corporate entity; and (b} in the case of an entity that is not a
corporate entity, the possession, directly or indirectly, of the
power to direct, or cause the direction of, the management or
policies of such entity, whether through the ownership of voting
securities, by contract or otherwise.






 








1.4.

"Anorectal Disorders"
means any condition that affects the anal region, including but not
limited to hemorrhoids, tears, fistulas and abscesses.





  



 

1







 





 








1.5.

"Arbitration Panel
Finalization" has the meaning set forth in Section
14.16.






 








1.6.

"Biologics License
Application" means the request for permission to
introduce, or deliver for introduction a biologic product into
interstate commerce.in the US, which request is filed with the
FDA.






 








1.7.

"Calendar Quarter" means
the respective periods of three (3) consecutive calendar months
ending on March 31, June 30, September 30 and December
31.






 








1.8.

"Calendar Year" means the
respective periods of twelve (12) months commencing on January I
and ending on December 31.






 








1.9.

"cGMP" means current good
manufacturing practices as promulgated under the United States
Federal Food, Drug, and Cosmetic Act, as amended, the Food and Drugs Act (Canada), and
similar requirements of jurisdictions outside the United States and
Canada applicable to manufacture of Clinical Materials or
Product.





 








1.10.

"Cipher Data" has the
meaning ascribed to it in Section 6.l(b).






 








1.11.

"Cipher Field" means the
dermatological field and dermatological indications.






 








1.12.

"Cipher Indemnitee(s)"
has the meaning ascribed to it in Section I I.
I.






 








1.13.

"Cipher IP" means Cipher
Licensed Patents and Cipher Licensed Know-How.






 








1.14.

"Cipher Licensed
Know-How" means all information and Know-How owned or
Controlled by Cipher as of the Effective Date or at any time during
the Term, that is necessary or useful for Licensee to exercise the
rights licensed to it under this Agreement or to perform its
obligations under this Agreement. Such Cipher Licensed Know-How
shall include, in particular, all pre-clinical data, clinical data,
formulation data (including batch records), chemistry,
manufacturing and controls data and regulatory data including the
Dossiers.






 








1.15.

"Cipher Licensed Patents"
means all:





 







(a)

Patent rights owned
by Cipher as of the Effective Date or at any time during the Term
as further described in Schedule "A", including the Patent rights
that, from time to time, the Parties identify as, and agree in
writing are, Cipher Licensed Patents;






 







(b)

continuations,
divisionals, renewals, continuations-in-part, and Patents of
addition claiming priority to the Cipher Licensed Patents described
in the foregoing subsection (a),






 







(c)

restorations,
extensions, supplementary protection certificates, reissues and
re-examinations of the Cipher Licensed Patents described in the
foregoing subsections (a) and (b),







 












and foreign equivalents
of the Cipher Licensed Patents described in the foregoing
subsections (a), (b) and (c).





 





(NaN.

"Claimant" has the
meaning set forth in Section 14.16.







 






 

2







 






 







1.17.

"Clinical Material(s)"
means the Product formulated in accordance with the Specifications
and applicable Canadian, United States and/or foreign laws, rules
and regulations: (a) for preclinical activities; and (b) for
administration to subjects in clinical trials.






 








1.18.

"Clinical Trial(s)" means
all pre-clinical trials and activities, clinical trials and
toxicology studies, in each with respect to the Product in the
Field.






 








1.19.

"Commercialization" or
"Commercialize" means ac11v1t1es undertaken after
obtaining Regulatory Approval relating specifically to the
pre-launch, launch, promotion, marketing, sales force recruitment,
pricing determination, sale, use and distribution (including
importation and exportation) of a pharmaceutical product and
post-launch medical activities, including without limitation: (a)
manufacturing and distribution for commercial sale, (b) strategic
marketing, sales force detailing, advertising, and market and
product support; (c) medical education and liaison; (d) all
customer support and product distribution, invoicing and sales
activities; (e) all post-approval regulatory activities, including
those necessary to maintain Regulatory Approvals; (f) target product profile, pricing,
formulary and reimbursement related activities including pricing
and reimbursement approvals; and (g) organizing formulary access
and drug distribution.






 





1.20.

"Confidential
Information" has the
meaning set forth in Section 9.1.






 








1.21.

"Control,"
"Controls" or "Controlled by" means
(except as used in Section 1.3), with respect to any item of or
right under Patents or Know-How, the ability of a Party (whether
through ownership or license, other than pursuant to this
Agreement) to grant access to, or a license or sublicense of, such
item or right as provided for herein without violating the terms of
any agreement or other arrangement with any Third Party existing at
the time such Party would be required hereunder to grant the other
Party such access or license or sublicense.






 








1.22.

"Cover" or "Covered"
means, with respect to Patents subject to this Agreement, in the
absence of a license to an unexpired, valid claim thereof, the
research, development, manufacture, use, sale, offer for sale, or
importation of the applicable invention, discovery, process, or
product would infringe such a claim (or, in the case of a claim
that has not yet issued, would infringe such a claim if it were to
issue).






 








1.23.

"Demand for Arbitration"
has the meaning set forth in
Section 14.16.






 








1.24.

"Develop" or "Development" or
"Developing" means research, discovery, process
development, manufacturing for preclinical and clinical uses,
preparation for drug reimbursement, preparation and initiation of
medical education and liaison activities and preclinical and
clinical drug or biological development activities, including,
without limitation, test method development and stability testing,
toxicology, formulation, quality assurance/quality control
development, statistical analysis, preclinical and clinical studies
and regulatory affairs, approval and registration, in each case, of
a Product for use in the Field.






 








1.25.

"Diligent Efforts" means
those efforts and resources commonly associated with the
commercially­ reasonable business practices and standards in
the research-based pharmaceutical industry to research, develop,
manufacture or commercialize (as appropriate) a product or compound
of similar market potential at a similar stage in its
product.











 

3







 






 





1.26.

"Dossiers" means any and
all product registration and NDA applications, including all
pre­ investigational new drug application consultations, and
all supporting files, writings, data, studies, and reports,
manufacturing information and clinical protocols and investigator
information, in draft and compiled in final form and submitted to
the competent local authorities for obtention of a product
registration or NDA approval.






 





1.27.

"EMEA" means the European
Medicines Evaluation Agency or any successor agency
thereto.






 








1.28.

"FDA" means the United
States Food and Drug Administration or any successor agency
thereto.






 








1.29.

"Field" has the meaning
ascribed to it in the recitals.






 








1.30.

"First
Commercial Sale" means, with respect to the Product
in the Field, the first sale to a Third Party for end use or
consumption of the Product in the Field in a country in the Territory after
Regulatory Approval of the Product in the Field has been granted by
the Regulatory Authority of such country.






 








1.31.

"Good
Clinical Practice" means the current good clinical
practice applicable to the clinical Development of the Product
under applicable law, to the extent such standards are not less
stringent than the U.S. current good clinical practice, including
the ICH guidelines.






 








1.32.

"Good
Laboratory Practice" means the current good
laboratory practice applicable to the Development of the Product
under applicable law, to the extent such standards are not less
stringent than the U.S. current good laboratory practice, including
21 C.F.R. Part 58.






 








1.33.

"ICH" means the
International Conference on Harmonization of Technical Requirements
for Registration of Pharmaceuticals for Human Use.





 








1.34.

"IFRS" means
International Financial Reporting Standards as the same may be in
effect from time to time.






 








1.35.

"IND" means an
Investigational New Drug application in the United States, a
Clinical Trial Application in Canada, or a foreign equivalent
application or submission for approval to conduct human clinical
investigations filed with or submitted to a Regulatory Authority in
conformance with the requirements of such Regulatory
Authority.






 








1.36.

"Indication" means any
separate and distinct disease (or stage of disease), disorder or
medical condition in humans or non-human animals which a Product is
intended to treat, prevent, diagnose, monitor or ameliorate and
which, for a Product candidate, is intended to be reflected in the
labeling for such Product as an approved indication, and which, for
an approved Product, is reflected in the labeling for such
Product.






 








1.37.

"Indemnifying Party" has
the meaning ascribed to it in Section 11.3.





 








1.38.

"Indemnitee" has the
meaning ascribed to it in Section 11.3.






 








1.39.

"Information" means any
and all scientific, pre-clinical, clinical, regulatory,
manufacturing, marketing, financial and commercial information and
data, in any tangible or intangible form, including all
Know-How.







 

4







 






 







1.40.

"Know-How" means (a) any
proprietary scientific or technical information, results and data
of any type whatsoever, in any tangible or intangible form
whatsoever, including databases, safety information, practices,
methods, techniques, specifications, formulations, formulae,
knowledge, know-how, skill, experience, test data including
pharmacological, medicinal chemistry, biological, chemical,
biochemical, toxicological and clinical test data, analytical and
quality control data, stability data, studies and procedures, and
manufacturing process and development information, results and data
and (b) any proprietary biological, chemical or physical
materials.






 








1.41.

"Knowledge" shall mean
actual knowledge of any of the current officers of the
Party.





 








1.42.

"Licensee Data" has the
meaning ascribed to it in Section 6.l(b).






 








1.43.

"Licensee Indemnitee(s)"
has the meaning ascribed to it in Section 11.2.






 








1.44.

"Licensee Licensed
Know-How" means all Know-How (excluding any Patents)
Controlled by Licensee as of the Effective Date or at any time
during the Term, that is: (a) related to the Product (or a
composition containing the Product, or the manufacturing or use of
the Product); and (b) reasonably necessary for Cipher to exercise
the rights licensed to it under this Agreement or to perform its
obligations under this Agreement, or to continue Development or
Commercialization of the Product for use in the Cipher
Field.






 





1.45.

"Licensee Licensed
Patents" means any and all Patents owned by Licensee
at any time during the Term, that are necessary or reasonably
useful for Cipher to exercise the rights licensed to it under this
Agreement or to perform its obligations under this Agreement or to
continue Development or Commercialization of the Product for use in
the Cipher Field.






 








1.46.

"Licensee Trademarks"
means any and all Trademarks Controlled by Licensee at any time
during the Term that are registered for or apply to the
Product.






 








1.47.

"NDA" or
"New Drug
Application" means an
application submitted to FDA pursuant to 21 U.S.C. § 505(b) or a Canadian or foreign
equivalent application or submission to a Regulatory Authority
which contains complete details of the manufacture and testing of a
new drug, for purposes of obtaining Regulatory Approval for such
new drug in the applicable jurisdiction, for a particular
Indication, and also includes a Biologics License
Application.





 








1.48.

"Net
Sales" means the gross amount invoiced by Licensee or
its Affiliates to unrelated Third Parties (excluding any
Sublicensee) for sales of the Product in the Field in the
Territory, less:






 







(a)

Trade, quantity and
cash discounts actually allowed or paid;





 







(b)

Commissions,
discounts, refunds, rebates (including but not limited to
wholesaler fees), chargebacks, retroactive price adjustments, and
any other allowances which effectively reduce the net selling
price;






 







(c)

Actual Product
returns and allowances;





 







(d)

Any sales, use,
excise, value added taxes or similar taxes measured by the billing
amount, when included in billing;






  






 

5







 





 







(e)

Any freight,
postage, shipping, and insurance charges related to delivery of the
Product from applicable warehouse all to the extent included in the
third pa1ty invoices; and






 







(f)

custom, import and
export duties actually paid.






 





Any
refund or reimbursement of any of the foregoing amounts previously
deducted from Net Sales shall be appropriately credited to Net
Sales, or adjusted through allowances, upon receipt
thereof.


 





For
greater certainty "Net Sales" shall not include sales or transfers
between members of the group comprised of Licensee, Sublicensees,
and their Affiliates.

 





For
greater certainty, provision of Product for the purpose of
conducting Clinical Trials in order to obtain Regulatory Approvals
shall not be deemed to be a sale.


 





Such
amounts shall be determined from the books and records of Licensee
or its Affiliates, as applicable, maintained in accordance with
IFRS, consistently applied. Licensee further agrees that in
determining such amounts, it will use Licensee's then current
standard procedures and methodology, including Licensee's then
current standard exchange rate methodology for the translation of
foreign currency sales into U.S. Dollars, consistently
applied.


 








1.49.

"Patent(s)" means: (a)
all patents and patent applications in any country or supranational
jurisdiction; and (b) any provisionals, substitutions, divisions,
continuations, continuations in part, reissues, renewals,
registrations, confirmations, reexaminations, extensions,
supplementary protection certificates and the like, of any such
patents or patent applications.





 








1.50.

"Phase
III Clinical Study" means a human clinical study to
confirm with statistical significance the efficacy and safety of
the Product in the Field performed to obtain Regulatory Approval
for the Product in any country.






 








1.51.

"Product" means ASF-1096
(Levo-salbutamol and/or R-salbutamol) and any product that is
Covered by Cipher Licensed Patents.






 








1.52.

"Regulatory Approval(s)"
means all approvals or authorizations by Regulatory Authorities
necessary to market and sell the Product in the Field in the
applicable jurisdiction.






 








1.53.

"Regulatory Authority"
means any applicable government regulatory authority involved in
granting approvals for the conduct of clinical trials or the
manufacturing, marketing, reimbursement or pricing of a Product in
the Territory, including in the United States the FDA, and in
Canada, Health Canada.






 








1.54.

"Respondent" has the
meaning set faith in Section 14.16.






 








1.55.

"Specifications" means
the Licensee's specifications for the Product.





 








1.56.

"Subcontractors" has the
meaning set forth in Section 3.3.





 





1.57.

"Sublicensee" means a Third Party that
is granted a sublicense under the licenses granted to a Party under
this Agreement.









 

6







 






  






1.58.

"Sublicensing Fees" has
the meaning set forth in Section 7.2.






 








1.59.

"Sublicensing Revenue"
means the net amount of all revenues, royalties, receipts, and
monies, including, without limitation, upfront payments, milestone
payments, and license fees, earned or received by Licensee and its
Affiliate(s) from Sublicensee(s) with respect to the
Product.






 





1.60.

"Technology Transfer" has
the meaning set forth in Article 4.





 








1.61.

"Term" has the meaning
set forth in Section 13.1.






 








1.62.

"Territory" means the
entire world.






 








1.63.

"Third
Party" means an entity other than: (a) Licensee and
its Affiliates; and (b) Cipher and its Affiliates.






 








1.64.

"Trademark(s)" means all
granted trademarks and all trademark applications in any country or
supranational jurisdiction and/or any other trademark used for the
promotion, marketing, distribution, use and/or sale of
Product.






 








1.65.

"United States" or
"US" means the United
States of America and its territories and possessions, including
the Commonwealth of Puerto Rico and the U.S. Virgin
Islands.






 





ARTICLE
2


SCOPE
AND GOVERNANCE


 








2.1.

General.






 







(a)

Scope. Pursuant to and subject to the
terms of this Agreement: (a) Licensee will be responsible for the
Development and Commercialization of the Product in the Territory
in the Field with the goal of obtaining Regulatory Approval for the
Product, as soon as commercially reasonable; (b) Licensee will have
exclusive rights to Commercialize the Product as further set forth
in Section 8.1 in exchange for royalty and other payments to be
made to Cipher as described in Article 7; and (c) responsibility
for manufacture of Clinical Materials and Product shall be as
detailed in Article 4.






 







(b)

Guiding Principles. The committee set
forth in this Article 2 shall perform its responsibilities under
this Agreement based on the principles of good faith, prudence and
good scientific and business judgment. The committee shall not have
any power to amend, modify or waive compliance under this
Agreement. Notwithstanding anything to the contrary in this
Agreement, no decision by either Party, or any committee set forth
in this Article 2, will be effective if such decision requires the
other Party to breach any obligation under this Agreement or to
perform any activities that are materially different or greater in
scope than those provided for specifically under this
Agreement.





 








2.2.

Joint
Steering Committee.






 







(a)

Membership. The Parties hereby establish
a Joint Steering Committee, or JSC, to coordinate and oversee
activities of the Parties under this Agreement. The JSC shall
consist of two (2) representatives from each Party although the JSC
may change the size of the JSC from time to time by mutual consent
of the members of the JSC. Each Party shall notify the other of
its representatives to the JSC within thirty (30) days of the
Effective Date. Each Party may replace its JSC representatives at
any time upon written notice to the other Party. The JSC shall be
chaired first by a representative of Licensee from the period from
the Effective Date through July 1,
2017 and thereafter the chairperson position shall rotate
annually on July 1, with
Cipher to appoint the chairperson for the second annual term, and
so forth thereafter. The chairperson shall be responsible for
calling meetings, preparing and circulating an agenda in advance of
each meeting, and preparing and issuing minutes of each meeting
within thirty (30) days thereafter. Each Party may replace any of
its appointed JSC representatives, including a chairperson, at any
time upon five (5) days' prior written notice to the other
Party.





 






 

7







 





 







(b)

Responsibilities. The
responsibilities of the JSC shall be:






 







(i)

to provide a
vehicle by which the Parties may provide to each other information
regarding the Development of the Product in their respective
Field;






 







(ii)

to provide a
vehicle by which Licensee and Cipher can share and discuss the
data, results and intellectual property generated by, on behalf of
or under the direction of, Cipher, Licensee or their respective
Affiliates with respect to the Product and by which Licensee and
Cipher can provide input regarding the Parties' intellectual
property strategies in respect of the Product;





 







(iii)

to facilitate the
exchange of Information between the Parties with respect to the
Development activities hereunder and to establish procedures for
the efficient sharing of Information necessary for the Parties to
fulfill their respective responsibilities with respect to the
Development of the Product hereunder;






 







(iv)

to discuss
collaborative approaches to ensure commercial viability of the
Product both within and outside of the Field;





 







(v)

to perform such
other functions as appropriate to further the purposes of this
Agreement, as determined by the Parties.






 








2.3.

JSC
Meetings.






 





JSC
meetings shall be held quarterly, or on any other schedule agreed
upon by the Parties. With the consent of the representatives of
each Party serving on the JSC, other representatives of each Party
may attend meetings as non-voting observers (provided such
non-voting observers have confidentiality obligations to such Party
that are at least as stringent as those set forth in this
Agreement). A JSC meeting may be held by audio, video or other
electronic means with the consent of each Party, but at least one
meeting per year shall be held in person. Each Party shall be
responsible for all of its own expenses of participating in the JSC
meetings.

 


ARTICLE
3


PRODUCT
DEVELOPMENT AND COMMERCIALIZATION.


 







3.1.

Overview.





 


From
and after the Effective Date, Licensee shall have full
responsibility and authority, at its sole cost and expense, for the
conduct of all Clinical Trials and for the Development and
Commercialization of the Product in the
Field in the Territory. Responsibility for regulatory matters will
be as set forth in Article 6.


 



 

8







 






 







3.2.

Conduct
of Development and Commercialization.






 





Licensee shall use
Diligent Efforts to Develop and Commercialize the Product in the
Field in the Territory, in compliance with the terms and conditions
of this Agreement and with a goal to maximize profits from Net
Sales of the Product in the Field in the Territory. As between
Licensee and Cipher, Licensee shall have the sole right and
obligation to determine all pricing of the Product in the Field. In
addition, each Party and any Affiliate(s), contractor(s) or
Sublicensee(s) performing activities in connection with the
Development and Commercialization of the Product shall comply with:
(i) all applicable Good Laboratory Practices, Good Clinical
Practices and applicable cGMP requirements; and (ii) all applicable
laws and regulations. Licensee shall report to the JSC at each JSC
meeting as to the status of Development and Commercialization of
the Product in the Field.


 





Without
limiting the foregoing:

 







(a)

Licensee shall, at
its own cost, use Diligent Efforts to complete a proof of concept
study with respect to the Product in the Field;






 







(b)

Development and
Commercialization of the Product in the Field shall be carried out
by Licensee so as to not actively unreasonably hinder, impede or
impair the Commercialization of the Product for use in the Cipher
Field by Cipher, its Affiliates or Third Parties contracting with
Cipher. The Parties agree that any pricing decisions by Licensee
for Product in the Field shall not constitute an active
unreasonable hindrance, impediment, or impairment of the
Commercialization of the Product for use in the Cipher Field by
Cipher, its Affiliates or Third Parties contracting with Cipher.
Except as otherwise stated in this paragraph, any dispute
associated with or related to the determination of whether
Development and/or Commercialization of the Product by Licensee in
the Field actively hinders, impedes or impairs Commercialization of
the Product for use in the Cipher Field by Cipher, its Affiliates
or Third Parties contracting with Cipher shall be addressed in
accordance with Section 14.15; and






 







(c)

Licensee shall not
apply to register and/or use in connection with the Development and
Commercialization of Product any Trademarks owned by
Cipher.






 







3.3.

Rights
to Engage Subcontractors.





 


 


Except
as set forth below, Licensee shall have the right to engage Third
Party contractors to perform any of its activities or obligations
hereunder, provided that Licensee shall be responsible for ensuring
that, prior to any such engagement, any subcontractors are subject
to written agreements containing terms and conditions: (i)
consistent with the relevant terms and conditions of this Agreement
protecting the rights of Cipher under this Agreement including
imposing obligations of confidentiality on each such
subcontractor; (ii) that vests ownership of any and all
inventions developed by such subcontractor that is Covered by the
Products in the course of performing such subcontracted work in
Licensee; and (iii) that does not impose any payment obligations or
liability on Cipher without the prior written consent of Cipher,
(such subcontractor, a "Subcontractor").

 






 




 

9







 





 





ARTICLE
4


MANUFACTURE
AND SUPPLY


 


The
Parties will negotiate, in good faith, determining which Party or
Third Party will manufacture and supply Product and Clinical
Materials to Licensee. If the Parties determine that
Cipher is not responsible for the manufacture and supply of Product
for Licensee, Cipher shall provide to the manufacturer access to
all Product Information, manufacturing Know-How, and any and all
original processes, records, and any other Information reasonably
necessary to have the Product and Clinical Materials manufactured
in accordance with the applicable Specifications ("Technology
Transfer"), provided that such manufacturer agrees to keep
any Confidential Information confidential in accordance with the
provisions set out in this Agreement. In the event the Parties
agree that Cipher will be responsible for the manufacture and
supply of Product and Clinical Materials to Licensee, the Parties
shall negotiate the terms and conditions (including as to pricing)
of a manufacturing agreement pursuant to which Cipher shall
manufacture and supply Product or Clinical Materials for
Licensee.

 


ARTICLE
5



RECORDS


 


Each
Party shall maintain appropriate records of: (a) all significant
Development, manufacturing and Commercialization events and
activities conducted by it or on its behalf related to the Product;
and (b) all significant Information generated by it or on its
behalf in connection with research and Development of Products
under this Agreement, in each case in accordance with such Party's
usual documentation and record retention practices. Such records
shall be in sufficient detail to properly reflect, in good
scientific manner, all significant work done and results of studies
and trials undertaken, and further shall be at a level of detail
appropriate for patent and regulatory purposes. If reasonably necessary for a
Party to perform its work under this Agreement or to exercise its
rights under this Agreement, that Party may request that, and the
other Party shall provide within a reasonable time frame, such
information and data regarding its activities hereunder as is
reasonably available and reasonably related to the activities under
this Agreement. Neither Party is required to generate additional
data or prepare additional reports to comply with the foregoing
obligation. All such repo1ts, Information and data provided shall
be subject to the provisions of Article 9.

 


ARTICLE
6


REGULATORY

 







6.1.

Regulatory
Obligations.





 


 




(a)

Licensee shall be
responsible for and shall have the sole right to control, all
regulatory activities and strategy associated with IND, NDA and all
other regulatory submissions, all Regulatory Approvals, and the
maintenance of such submissions and Regulatory Approvals, in each
case with respect to the Product in the Field, including
communicating and preparing and filing all reports including all
INDs and NDAs with the applicable Regulatory Authorities. Cipher
shall cooperate with Licensee as requested in preparing and filing
all such reports, and Cipher shall provide Licensee with all
available information, including regulatory, technical and clinical
data concerning the Product, and any Dossiers related to the
Product, to enable Licensee to prepare and file such reports.
Licensee shall pay all governmental fees associated with obtaining
and maintaining any and all Regulatory Approvals including any
establishment license fees of Licensee or Third Parties which must
be paid with respect to facilities used in the manufacture of the
Product by or on behalf of Licensee in the Field.





 






 

10







 





 







(b)

Cipher shall have
the right to access and use in a timely manner any and all data and
results related to the Product that is generated by, on behalf of
or under the direction of, Licensee or its Affiliates with respect
to the Product (including all data or results contained or
referenced in Licensee's submissions or applications for Regulatory
Approvals with respect to the Product, including all reports,
correspondence and conversation logs) (the "Licensee Data"), for
the purpose of Development and Commercialization of the Product in
the Cipher Field, and Cipher may cross reference all such data in
Cipher's submissions or applications for Regulatory
Approvals.






 







(c)

Licensee shall have
access and the right to use, in a timely manner any and all data
and results related to the Product that is generated by, on behalf
of or under the direction of, Cipher or its Affiliates with respect
to the Product (including all data or results contained or
referenced in Cipher's submissions or applications for Regulatory
Approvals with respect to the Product, including without
limitation, all reports, correspondence and conversation logs) (the
"Cipher
Data"), for the purpose of Development and Commercialization
of the Product within the Field, and Licensee may cross reference
all such data in Licensee's submissions or applications for
Regulatory Approvals.






 







(d)

As between the
Parties, and excluding any Cipher Data, Licensee shall own all
right, title and interest in Licensee Data. As between the Parties,
and excluding any Licensee Data, Cipher shall own all right, title
and interest in Cipher Data.






 







6.2.

Safety
Reporting.





 







(a)

Adverse Event
Procedures. Licensee shall be responsible for all regulatory
activities including: (i) management and monitoring of safety and
Adverse Event/experience information for the Product in the Field;
(ii) regulatory reporting; (iii) managing the global safety data
base; and (iv) reviewing and approving of safety information for
inclusion in the Product label in the Territory, in each case with
respect to the Product in the Field.






 







(b)

Safety Agreement.
Representatives of each Party from the affected areas will begin
meeting as soon as possible but no later than sixty (60) days after
the Effective Date of this Agreement and will work in good faith
together to develop a Safety Agreement within an agreed reasonable
time to describe safety data transfers, and Adverse Event handling
and reporting to Regulatory Authorities, which shall include timely
reporting to the other Party of Adverse Events and access to any
relevant safety data by each Party.





 







(c)

Third Parties. Each
Party agrees that if it contracts with a Third Party for clinical
research to be performed by such Third Party relating to the
Product, that Party agrees to require such Third Party to report to
the contracting Party the information set forth above.






 







6.3.

Recalls.





 





Licensee shall be
responsible for any recall decision and the conduct of any recall
in respect of the Product in the Field, including the costs and
expenses thereof. If Licensee recalls, detains
or retains such Product (voluntarily, or by order of a Regulatory
Authority), Cipher shall reasonably cooperate in such actions, at
Licensee's sole expense. Cipher shall be responsible for any recall
decision and the conduct of any recall in respect of the Product in
the Cipher Field, including the costs and expenses thereof.
If Cipher
recalls, detains or retains such Product (voluntarily, by order of
a Regulatory Authority), Licensee shall reasonably cooperate in
such actions, at Cipher's sole expense


 



 

11







 





  







6.4.

Pricing
and Reimbursement.






 





Licensee shall be
solely responsible for setting the price for Product in the Field
to be sold by Licensee, and shall do so without discussion or
consultation with Cipher. Cipher may provide to Licensee, in
writing, suggested resale prices or price ranges and any lawfully
derived market studies or data, provided, however, that no such
data is obtained from another Cipher collaborator and, provided,
further, however, that Licensee shall determine its selling price
in its sole discretion without discussion or consultation with
Cipher regarding such suggested prices, price levels, market
studies or data. Cipher shall be solely responsible for setting the
price for Product in the Cipher Field to be sold by Cipher, and
shall do so without discussion or consultation with Licensee.
Licensee may provide to Cipher, in writing, any lawfully derived
market studies or data, provided, however, that Cipher shall
determine its selling price in its sole discretion without
discussion or consultation with Licensee regarding such market
studies or data. The foregoing shall not apply with regard to
Product to be sold from one Party to the other, which price shall
be established by agreement.


 





ARTICLE
7


PAYMENTS


 







7.1.

Milestone
Payments.






 





Licensee shall
immediately notify Cipher of the achievement of any of the
following development and commercial milestones, all for the
Product in the Field. Licensee shall pay to Cipher the milestone
payments listed below which shall be non-refundable and
non-creditable and are due and payable within thirty (30) days of the receipt by Licensee of an
invoice for payment from Cipher:


 


	
Upon enrollment of
the first study subject in a Phase III Clinical Study

	
  [  ] 


	
Upon receipt of
Regulatory Approval from the FDA

	
  [  ] 


	
First Commercial
Sale

	
  [  ] 


	
First occurrence of
$[  ] million in aggregate Net Sales in a Calendar Year in
those countries in which the Licensee directly
Commercializes

	
  [  ] 


	
First occurrence of
$[  ] million in aggregate Net Sales in a Calendar Year in
those countries in which the Licensee directly
Commercializes

	
  [  ] 


	
First occurrence of
$[  ] million in aggregate Net Sales in a Calendar Year in
those countries in which the Licensee directly
Commercialize

	
  [  ] 






 





Upon
the first occurrence of each $[  ] million incremental
increase in aggregate Net Sales in a Calendar Year beyond $[ 
] million in countries in which the Licensee directly
Commercializes, Licensee shall pay Cipher a milestone payment
equivalent to [  ]% of the value of the aggregate Net Sales in
such Calendar Year. For example, upon the first occurrence of
aggregate Net Sales in a Calendar Year reaching $[  ] million,
Licensee shall pay Cipher $[  ] million.


 



 

12







 





 




7.2.

Product
Royalties.






 





Licensee shall pay
to Cipher a royalty of [  ]% of Net Sales of the Product in
the Field in the countries in the Territory where it directly
Commercializes the Product. Licensee shall pay to Cipher an amount
equal to [  ]% of Sublicensing Revenue received by Licensee
and its Affiliates ("Sublicensing Fees")
in the countries in the Territory where it does not directly
Commercialize the Product.

 







7.3.

Royalty
Stacking.






 





The
parties recognize and agree that, in order to Develop and
Commercialize the Product in the Field, it may be necessary for
Licensee and/or its Sublicensees to make use of and/or incorporate
multiple elements of intellectual property from multiple sources.
Licensee and/or its Sublicensees will determine, in their sole
judgment, which elements of intellectual property are necessary
and/or desirable for the Development and/or Commercialization of
the Product. Royalty payments or license fees to third parties may
occur if intellectual property owned by a third party is required
or desirable for the Commercialization of the Product in the Field
and Territory. All types of payments to third parties that Licensee
and/or its Sublicensees have determined and/or may determine are
necessary or desirable to obtain licenses or other rights to use or
incorporate intellectual property or products other than the
Products in the Field and Territory, will be creditable against
royalties otherwise owed to Cipher hereunder, provided that such
payments must have been made in good faith. Notwithstanding the
foregoing, at no point shall Cipher's [  ]% royalty on Net
Sales, nor Cipher's [  ]% share of the Sublicensing Revenue be
reduced by more than [  ]% due to payments to third parties in
respect of other licenses required to Develop and Commercialize the
Product in the Field in the Territory.

 







7.4.

Reports;
Payment of Royalty.






 







(a)

During the Term,
following the First Commercial Sale of the Product, Licensee shall
furnish to Cipher a quarterly written report for the Calendar
Quarter showing: (i) the Net Sales of the Product in the Field in
countries in which the Licensee directly commercializes as well as
on a country-by-country basis (in countries in which the Licensee
directly commercializes) during the reporting period and the
royalties payable under this Agreement in respect thereof; and (ii)
Sublicensing Revenues during the reporting period and the
Sublicensing Fees payable under this Agreement in respect thereof
on a country­ by-country basis.






 







(b)

Reports shall be
due on the thirtieth (30th) day following the close of each
Calendar Quarter. Royalties and Sublicensing Fees shown to have
accrued by each royalty report shall be due and payable in
accordance with Section 7.1. Licensee shall keep complete and
accurate records in sufficient detail to enable the royalties and
Sublicensing Fees payable hereunder to be determined. The quarterly
written reports contemplated by this Section 7.3 shall include, at
a minimum, the total sales units showing the number of doses sold
and Net Sales on a country-by-country basis, where available, as
well as a breakdown of all Sublicensing Revenues (broken down by
upfront, milestone, royalty, license and other payments) on a
country-by-country basis. For each country, the total gross sales,
all deductions (broken down separately by each of the categories
set out in clauses (a) to (f) of the
definition of "Net Sales" and separately setting forth any
adjustments thereto due to refunds or reimbursements of deducted
amounts) and total Net Sales of Product for the quarter shall also
be provided.





 






 

13







 






 






7.5.

Audits.






 







(a)

Licensee will keep
and maintain (and to the extent applicable, will cause its
Affiliates, and their respective sub-licensees, distributors,
assignees and transferees to keep and maintain) proper and complete
records and books of account in such form and detail as is
necessary for the determination of the amounts payable by Licensee
(on behalf of itself and its Affiliates and their respective
sub-licensees, distributors, assignees and transferees) to Cipher
under this Agreement and for the purposes of this
Agreement.






 




(b)

Upon the written
request of Cipher and not more than once in each Calendar Year,
Licensee shall permit an independent certified public accounting
firm of nationally recognized standing (that has been retained on
an hourly or flat fee basis and receives no contingency fee or
other bounty or bonus fee) selected by Cipher and reasonably
acceptable to Licensee, at Cipher's expense, to have access during
normal business hours to such of the records of Licensee as may be
reasonably necessary solely to verify the accuracy of the royalty
reports hereunder for any Calendar Year ending not more than
thirty-six (36) months prior to the date of such request. This
right to audit shall remain in effect throughout the life of this
Agreement and for a period of thirty-six (36) months after the
termination of this Agreement.






 







(c)

Cipher shall share
the accounting firm's written report with Licensee within five (5)
days of its receipt by Cipher. If such accounting firm identifies a
discrepancy made during such period, the appropriate Party shall
pay the other Party the amount of the discrepancy within thirty
(30) days of the date Cipher delivers to Licensee such accounting
firm's written report so concluding, or as otherwise agreed upon by
the Parties. The fees charged by such accounting firm shall be paid
by Cipher unless the underpayment exceeded the greater of: A)
ten
percent (10%) of the amount owed by Licensee to Cipher for such
Calendar Year; or BJ $25,000.00,
in which case, Licensee shall pay to Cipher the reasonable fees
charged by such accounting firm, which fees shall not exceed
$40,000 CAD. Licensee shall pay interest on the amounts owed to
Cipher, said interest shall be calculated as being 2% greater than
the U.S. commercial prime rate as published by the Wall Street
Journal on the date of the first discrepancy identified in the
audit, and shall accrue from the date payments should have been
made.










(d)

Licensee shall
include in each sublicense granted by it pursuant to this Agreement
a provision requiring the Sublicensee to make reports to Licensee,
to keep and maintain records of sales made pursuant to such
sublicense and to grant access to such records by an independent
certified public accountant selected by Licensee to the same extent
required of Licensee under this Agreement.






 







(e)

Cipher shall treat
all financial information subject to review in accordance with the
confidentiality and non-use provisions of this Agreement, and shall
cause its accounting firm to enter into an acceptable
confidentiality agreement with Licensee or its Related Parties
obligating it to retain all such information in confidence pursuant
to such confidentiality agreement.






 







7.6.

Payment
Exchange Rate.






 





All
payments to be made by one Party to the other under this Agreement
shall be made in United States dollars by bank wire transfer in
immediately available funds to a bank account designated in writing
by the Party receiving the payment. In the case of sales outside
the United States, royalty payments by Licensee to Cipher
shall be converted to United States Dollars in accordance with the
following: the rate of currency conversion shall be calculated
using a simple average of mid-month and month-end rates as provided
by the spot rate as published by The Wall Street Journal, New York
City Edition for such accounting period.


 



 

14







 






 







7.7.

Tax
Withholding.






 





The
Parties will withhold taxes with respect to payments under this
Agreement under applicable law. Each Party will provide
documentation to the other Party as evidence of the accuracy and
payment of any such withholding tax, as applicable.

 







7.8.

Late
Payments.






 





The
paying Party shall pay interest to the receiving Party on the
aggregate amount of any undisputed invoices that are not paid on or
before the date the payment of such invoices are due under this
Agreement at a rate per annum equal to the lesser of one percent
(I%) per month or the highest rate permitted by applicable law,
calculated on the number of days such payments are paid after the
date payment of such invoices is due and compounded
monthly.

 


ARTICLE
8


LICENSES;
EXCLUSIVITY


 







8.1.

License
to Licensee.






 







(a)

Exclusive License and
Sublicenses. Subject to the terms and conditions of this
Agreement, Cipher hereby grants to Licensee and its Affiliates an
exclusive (except with respect any rights retained by Cipher under
Section 8.l(b)), royalty-bearing license in the Territory in the
Field, with the right to grant sublicenses, under the Cipher IP and
the Cipher Data, as necessary for the Development and
Commercialization of the Product in the Field.





 







(b)

Cipher Retained Rights.
Notwithstanding the rights granted to Licensee in Section 8. l(a),
Cipher retains the following: (i) the right to manufacture or have
manufactured Product or Clinical Materials for use pursuant to this
Agreement as provided in and in accordance with Article 4;and (ii)
the right to Develop or Commercialize or conduct any other
activities involving the Product in the Cipher Field.






 







8.2.

Sublicensing.





 





Licensee shall have
the right to grant Sublicenses under the Cipher IP to Sublicensees
on terms that are consistent with those granted to Licensee
pursuant to this Agreement.


 







8.3.

License
to Cipher.






 







(a)

Licensee hereby
grants Cipher an exclusive, royalty-free license, with the right to
grant sublicenses to Third Parties in accordance with this Section
8.3(b), under the Licensee Licensed Patents, Licensee Licensed
Know-How and Licensee Data solely (i) to manufacture Clinical
Materials or the Product to the extent contemplated by Article 4,
and (ii) to make or Develop, manufacture or
Commercialize Products in the Cipher Field as contemplated by
Section 8.l(b) of this Agreement.









 

15







 





 







(b)

Cipher shall only
have the right to grant a sublicense to a Third Party pursuant to
Section 8.3(a) if (i) Cipher has provided Licensee with reasonable
written notice prior to granting any such sublicense to a Third
Party and such written notice identifies the applicable
Sublicensee; and (ii) Cipher causes each Sublicensee to enter into
an agreement with Cipher. Each sublicense agreement shall
(1) be in
writing; (2) be subject to and consistent with, the terms of this
Agreement; (3) preclude assignment of such sublicense agreement and
sublicensing of the licenses granted under such sublicense
agreement to any Third Parties without Licensee's prior written
consent, such consent not to be unreasonably withheld or delayed
(4) terminate upon the termination of this Agreement in accordance
with the terms hereof, and (5) include Licensee as an intended
third party beneficiary with the right to enforce the terms of such
sublicense agreement.






 







8.4.

No
Implied Licenses.






 





Except
as explicitly set forth in this Agreement, neither Party nor its
Affiliates grants any license, express or implied, under its
intellectual property rights to the other Party. Without limiting
the foregoing, this Agreement and the licenses and rights granted
herein do not and shall not be construed to confer any rights upon
either Party or its Affiliates by implication, estoppel, or
otherwise as to any of the other Party's or its Affiliates'
intellectual property, except as otherwise expressly set forth
herein.


 







8.5.

Registration
and Recordation of License.






 





If this Agreement or any license herein
granted is required to be registered with or reported to a national
or supranational agency of any country in which Licensee would do
business, Licensee shall, at its expense, undertake such
registration or report, and provide prompt notice and appropriate
verification of the act or registration, report or any agency
ruling resulting from such registration to Cipher. Any formal
recordation of this Agreement or any license herein granted which
is required by the law of any country, as a prerequisite to
enforceability of the Agreement or license in the courts of any
such country or for other reasons, shall be carried out by Licensee
at its expense, and appropriately verified proof of such
recordation shall be promptly provided to Cipher.


 







8.6.

Non-Compete.






 





Licensee agrees
that neither it nor any of its Affiliates shall, at any time during
the Term, Develop or Commercialize the Product for use in the
Cipher Field, nor will Licensee Develop or Commercialize any
product that could act as a substitute for the Product in the
Cipher Field. Cipher agrees that neither it nor any of its
Affiliates shall, at any time during the Term, Develop or
Commercialize the Product in the Field nor will Cipher Develop or
Commercialize any product that could act as a substitute for the
Product in the Field. The Parties agree that the Development and
Commercialization of the Product by Cipher in the Cipher Field and
the Development and Commercialization of the Product by Licensee in
the Field are in compliance with this Section 8.6.

 


ARTICLE
9


CONFIDENTIALITY;
PUBLICATION


 







9.1.

Nondisclosure
Obligation.





 







(a)

Except as provided
in this Section 9.1, all Information and any other confidential or
proprietary information disclosed by one Party or any of its
Affiliates to the other Party or any of its Affiliates hereunder in
connection with this Agreement, whether disclosed or provided prior
to or after the Effective Date and whether provided orally,
visually, electronically or
in writing, shall be maintained in confidence by the receiving
Party and shall not be disclosed to any Third Party or used for any
purpose except as set forth herein without the prior written
consent of the disclosing Party, until ten (10) years following the
Term of this Agreement, except to the extent that such
Information:





 


 

16







 





 



(i)

is known by the receiving Party at the time of
its receipt, and not through a prior disclosure by the disclosing
Party, as documented by the receiving Party's business
records;






 







(ii)

is or becomes part
of the public domain through no fault of the receiving
Party;






 







(iii)

is subsequently
disclosed to the receiving Party by a Third Party who may lawfully
do so and is not under an obligation of confidentiality to the
disclosing Party; or






 







(iv)

is developed by the
receiving Party independently of Information received from the
disclosing Party, as documented by the receiving Party's business
records.





 





All
information disclosed by one Party to the other hereunder, other
than described in Subsections (i) through (iv) above, is
hereinafter referred to as "Confidential Information".


 







(b)

Each Party may
disclose Confidential Information of the other Party, without such
other Party's prior written consent, to its Affiliates' directors,
employees, agents, consultants, Sublicensees, suppliers, and other
persons or entities who:






 







(i)

need to know such
Confidential Information to assist the Party in fulfilling its
obligations hereunder;






 







(ii)

need to know such
Confidential Information to assist Cipher or Licensee, as the case
may be, in the Development or Commercialization of the Product for
use in the Cipher Field or the Field, respectively;
and






 







(iii)

are bound by
written confidentiality and non-use obligations consistent with
those the Party uses to protect its own Confidential
Information.





 







(c)

Each Party shall
promptly disclose to the other Party the nature and scope of any
breach of this provision by it, or its Affiliates, directors,
officers, employees, agents, consultants, Sublicensees, suppliers,
or other persons or entities permitted hereunder and the steps
taken to contain and address the breach.






 







(d)

Each Party may also
disclose the Confidential Information of the other Party, without
such other Party's prior written consent, to any person, entity, or
government or regulatory authority to the extent that the law
requires such disclosure, including filings pursuant to applicable
securities or tax laws and regulations. The Party disclosing such
Confidential Information shall take such actions as are reasonable
to preserve the confidentiality of such Confidential Information,
such as requesting confidential treatment. In addition, it may also
disclose the other Party's Confidential Information, without the
other Party's prior written consent, to any person, entity, or
government or Regulatory Authority to the extent that such
disclosure is necessary for obtaining, maintaining, or amending any
Regulatory Approvals or satisfying any other regulatory obligation
regarding the Product. Each party may also disclose the
Confidential Information of the other Party, without such other
Party's
prior written consent, pursuant to an order of a Regulatory
Authority or court of competent jurisdiction, provided that it: (i)
promptly notifies the other Party of the required disclosure in
order to provide such Party an opportunity to take legal action to
prevent or limit such disclosure and, if asked, reasonably assists
the other Party in pursuing such action; and (ii) shall only
disclose the Confidential Information to the minimum extent
required by law.






   




 

17







 





 



9.2.

Publicity;
Use of Names.






 







(a)

The Parties shall
issue a mutually acceptable press release announcing the execution
of this Agreement. A Party may issue any subsequent press release
relating to this Agreement or activities conducted hereunder upon
prior written approval of the other Party, such approval not to be
unreasonably withheld or delayed; provided, however, that no
approval of the other Party shall be required if a subsequent press
release solely discloses the information that: (1) a milestone
under this Agreement has been achieved and/or any payments
associated therewith have been received; (2) the filing and/or
approval of the NDA with the FDA or the EMEA generally has occurred
(provided, however, that specific dates of filing shall not be
disclosed); (3) commercial launch of the Product in any country or
any information that has previously been approved and disclosed as
permitted by this Section 9.2. In the case of items (1)-(3) of the
preceding sentence, the disclosing Party shall provide the other
Party a copy of such proposed disclosures prior to the proposed
release and consider in good faith any comments the other Party may
make, where practicable, and in light of any reporting obligations
of such disclosing Party under applicable laws, rules or
regulations, including without limitation, applicable securities
law. Except as otherwise provided in this Section 9.2(a), neither
Party shall use the name, trademark, trade name or logo of the
other Party or its employees in any publicity or news release
relating to this Agreement or its subject matter, without the prior
express written permission of the other Party.






 







(b)

Notwithstanding the
terms of this Article 9, either Party shall be permitted to
disclose the existence and terms of this Agreement, to the extent
required, in the reasonable opinion of such Party's legal counsel,
to comply with applicable laws, rules or regulations, including
without limitation the rules and regulations promulgated by
securities law regulatory agencies or any other governmental
agency. Notwithstanding the foregoing, before disclosing this
Agreement or any of the terms hereof pursuant to this Section
9.2(b), the Parties shall consult with one another on the terms of
this Agreement for which confidential treatment will be sought in
making any such disclosure. If
a Party wishes to disclose this Agreement or any of the terms
hereof in accordance with this Section 9.2(b), such Party agrees,
at its own expense, to seek confidential treatment of the portions
of this Agreement or such terms as may be reasonably requested by
the other Party, provided that the disclosing Party shall always be
entitled to comply with legal requirements.






 







(c)

Either Party may
also disclose the existence and terms of this Agreement to its
legal counsel, investment bankers, accountants and advisors, and to
potential Sublicensees, Third Party contractors, investors, lenders
or acquirers, and their legal counsel, investment bankers,
accountants and advisors, in each case under an agreement or in the
case of legal counsel, a professional obligation, to keep the terms
of this Agreement confidential under terms of confidentiality and
non-use substantially similar to the terms contained in this
Agreement and to use such Confidential Information solely for the
purpose permitted pursuant to this Section 9.2(c).






   




 

18







 





 





ARTICLE
10


REPRESENTATIONS
AND WARRANTIES

 







10.1.

Representations
and Warranties of Cipher.






 


Cipher
represents and warrants to Licensee that as of the Effective
Date:


 







(a)

To Cipher's
knowledge of Cipher, Schedule "A" is a true and complete list of
all of the Cipher Licensed Patents existing in the Territory and
that it owns or controls all right, title and interest in and to
the Cipher Licensed Patents and to the Cipher Licensed
Know-How;






 







(b)

it has the full
right, power and authority to enter into this Agreement, to perform
its obligations under this Agreement, and to grant the licenses
granted under Section 8.1, and the fulfillment of its obligations
and performance of its activities hereunder do not materially
conflict with, violate, or breach or constitute a default under any
material contractual obligation or court or administrative order by
which Cipher is bound;





 







(c)

to the knowledge of
Cipher, there are no legal claims, judgments or settlements against
or owed by Cipher or pending legal claims or litigation, in each
case relating to the Product, the Cipher Licensed Patents or the
Cipher Licensed Know-How;






 






(d)

subject to Section
14.11, all necessary consents, approvals and authorizations of all
government authorities and other persons required to be obtained by
Cipher as of the Effective Date in connection with the execution,
delivery and performance of this Agreement have been
obtained;






 







(e)

it Controls the
right, title and interest in and to the Cipher Licensed Patents and
the Cipher Licensed Know-How, and has the right to grant to
Licensee the licenses that it purports to grant hereunder and has
not granted any Third Party rights that would interfere or be
inconsistent with Licensee's rights hereunder;






 







(f)

it is not aware of
any other Patents, Know How or other intellectual property right
Controlled by Cipher or its Affiliates, other than that which is
licensed hereunder to Licensee, which the Development, manufacture,
use and/or Commercialization of the Product as contemplated
hereunder would infringe;






 







(g)

it is not aware of
any other Patents, Know How or other intellectual property right
which the Development, manufacture, use and/or Commercialization of
the Product as contemplated hereunder would infringe;






 







(h)

to the knowledge of
Cipher, there is no action, suit, inquiry, investigation or other
proceeding threatened, pending or ongoing brought by any Third
Party that alleges the use of the Cipher Licensed Patents, Cipher
Licensed Know-How or the Development, manufacture,
Commercialization and/or use of the Product would infringe or
misappropriate the intellectual property or intellectual property
rights of any Third Party (and it has not received any notice
alleging such an infringement or misappropriation). In the event
that Cipher becomes aware of any such action or proceeding, it
shall promptly notify Licensee in writing;





 






 

19







 





 







(i)

to the knowledge of
Cipher, neither Cipher nor any of its Affiliates, nor any of its
employees or agents: (i) is debarred, excluded, suspended, proposed
for debarment or otherwise ineligible for participation in any
federal, state or provincial health care program;("Debarred");
and





 




(j)


Cipher
does not have any current knowledge that would cause any of its
representations or warranties to Licensee to be incorrect or
untrue.






 







10.2.

Representations
and Warranties and Covenants of Licensee.





 





Licensee represents
and warrants to Cipher that as of the Effective Date:


 







(a)

it has the full
right, power and authority to enter into this Agreement, to perform
its obligations under this Agreement, to grant the licenses granted
under Section 8.2, and the fulfillment of its obligations and
performance of its activities hereunder do not materially conflict
with, violate, or breach or constitute a default under any material
contractual obligation or court or administrative order by which
Licensee is bound;






 







(b)

subject to Section
14.11 all necessary consents, approvals and authorizations of all
government authorities and other persons required to be obtained by
Licensee as of the Effective Date in connection with the execution,
delivery and performance of this Agreement have been
obtained;





  







(c)

Licensee does not
have any current knowledge that would cause any of its
representations or warranties to Cipher to be incorrect or
untrue;






 







(d)

it has no products
that could be used as a substitute for the Product in the
Field;






 








(e)

To the knowledge of
Licensee, neither Licensee nor any of its Affiliates, nor any of
its employees or agents, (i) is debarred, excluded, suspended,
proposed for debarment or otherwise ineligible for participation in
any federal, state or provincial health care program ("Debarred").






 







10.3.

Representations
and Covenants of Both Parties.






 





Each
Party shall, and shall cause its Affiliates and agents to, comply
with applicable laws, rules, regulations and guidelines of health
regulatory authorities having jurisdiction in the Territory and
related to the performance of its obligations hereunder, including
the United States Food, Drug and Cosmetics Act and the Food and Drugs Act
(Canada) and the regulations promulgated thereunder, and their
foreign counterparts; all applicable federal, provincial, state and
foreign laws and regulations applicable to health care fraud and
abuse, kickbacks, physician self-referral and false claims; and
local laws and regulations regarding the advertisement, sale and
promotion of pharmaceutical products, in each case as amended from
time to time.


 







10.4.

No
Other Representations or Warranties.






 





EXCEPT
AS EXPRESSLY STATED IN THIS AGREEMENT, NO REPRESENTATIONS OR
WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING,
WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF
THIRD PARTY INTELLECTUAL
PROPERTY RIGHTS, ARE MADE OR GIVEN BY OR ON BEHALF OF A PARTY. ALL
REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW
OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.


 



 

20







 





 


ARTICLE
11


INDEMNIFICATION

 







11.1.

General
Indemnity By Licensee.






 





   
        Licensee shall indemnify and
hold harmless Cipher, its Affiliates, and their directors,
officers, employees and agents (individually and collectively, the
"Cipher Indemnitee(s)") from
and against all losses, liabilities, damages and expenses
(including reasonable legal fees and costs) incurred in connection
with any claims, demands, actions or other proceedings by any Third
Party (individually and collectively, "Losses") first arising after the
Effective Date to the extent arising from: (a) the Development or
Commercialization of the Product in the Field by Licensee or any of
its Related Parties or Subcontractors; (b) the use of the Product
in the Field manufactured or sold by Licensee or any of its Related
Parties or Subcontractors by
any purchasers thereof including, without limitation, any product
liability claim; (c) the use by Licensee or any of its Related
Parties or Subcontractors of the Cipher Licensed Patents and the
Cipher Licensed Know-How in accordance with this Agreement; (d) the
negligence, fraud or willful misconduct of Licensee in the
performance of this Agreement; or (e) Licensee's material breach of
this Agreement, except to the extent such Losses arise out of any
of Cipher Indemnitee's negligence, illegal conduct or fraud,
willful misconduct, or breach of this Agreement.


  







11.2.

General
Indemnity By Cipher.





 





Cipher
shall indemnify and hold harmless Licensee, its Affiliates, and
their directors, officers, employees and agents (individually and
collectively, the "Licensee
Indemnitee(s)") from and against all losses, liabilities,
damages and expenses (including reasonable legal fees and costs)
incurred in connection with any claims, demands, actions or other
proceedings by any Third Party (individually and collectively,
"Losses") first arising
after the Effective Date to the extent arising from: (a) the
Development or Commercialization of the Product in the Cipher Field
by Cipher or any of its Related Parties or Subcontractors; (b) the
use of the Product in the Cipher Field manufactured or sold by
Cipher or any of its Related Parties or Subcontractors by any
purchasers thereof including any product liability claim; (c) the
use by Cipher or any of its Related Parties or Subcontractors of
the Licensee Licensed Know-How and Licensee Data in accordance with
this Agreement; (c) the negligence, fraud or willful misconduct of
Cipher in the performance of this Agreement; or (e) Cipher's
material breach of this Agreement, except to the extent such Losses
arise out of any of Licensee Indemnitee's negligence, fraud,
willful misconduct, or breach of this Agreement.


 







11.3.

Defined
Indemnification Terms.






 





Either
of the Licensee Indemnitee or the Cipher Indemnitee shall be an
"Indemnitee" for the purpose
of this Article 11 and Article 12, and the Party that is obligated
to indemnify the lndemnitee under Section 11.1 or Section 11.2 or
Section 12.4 shall be the "Indemnifying Party".


 







11.4.

Defense.






 





If any
such claims or actions are made, the Indemnitee shall be defended
at the Indemnifying Party's sole expense by counsel selected by
Indemnifying Party and reasonably acceptable to the Indemnitee,
provided that the Indemnitee may, at its own expense, also be
represented by counsel of its own choosing. The
Indemnifying Party shall have the sole right to control the defense
of any such claim or action, subject to the terms of this Article
11.

 






 

21







 





 







11.5.

Settlement.






 





The
Indemnifying Party may settle any such claim, demand, action or
other proceeding or otherwise consent to an adverse judgment: (a)
with prior written notice to the Indemnitee but without the consent
of the Indemnitee, where the only liability to the Indemnitee is
the payment of money and the Indemnifying Party makes such payment;
or (b) in all other cases, only with the prior written consent of
the Indemnitee, such consent not to be unreasonably withheld.
Notwithstanding the foregoing, the Indemnifying Party shall not
consent to entry of any judgment or enter into any settlement of a
Third Party claim without the consent of the Indemnitee if the
effect thereof is (a) to permit any injunction, declaratory
judgement, other order or other non-monetary relief to be entered,
directly or indirectly, against any Indemnitee; or (b) to ascribe
any fault on any Indemnitee in connection with such
defense.


 







11.6.

Notice.





 





The
Indemnitee shall notify the Indemnifying Party promptly of any
claim, demand, action or other proceeding under Section 11.1 or
Section 11.2 and shall reasonably cooperate with all reasonable
requests of the Indemnifying Party with respect
thereto.


 







11.7.

Permission
by Indemnifying Party.






 





The
Indemnitee may not settle any such claim, demand, action or other
proceeding or otherwise consent to an adverse judgment in any such
action or other proceeding or make any admission as to liability or
fault without the express written permission of the Indemnifying
Party.


 







11.8.

Limitation
of Liability.





 





NEITHER
PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, CONSEQUENTIAL,
INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES OR FOR LOST PROFITS
ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT,
REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES.
NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 11.8 IS
INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS
OR OBLIGATIONS OF EITHER PARTY UNDER ARTICLE 11 OR ARTICLE 12.4, OR
DAMAGES AVAILABLE FOR A PARTY'S BREACH OF CONFIDENTIALITY
OBLIGATIONS IN ARTICLE 9.


 







11.9.

Insurance.





 





Each
Party shall maintain in good standing throughout the Term of this
Agreement and for a period of seven (7) years thereafter, product
liability insurance policies in respect of the Product with an
internationally recognized insurer or insurers licensed to do
business in the Territory in an amount of not less than $5 million
per occurrence, and not less than $5 million in the aggregate, on
such terms and conditions as are customary in the industry. Each
Party shall provide proof of such insurance to the other Patty
within thirty (30) days of the Effective Date and thereafter from
time to time within thirty (30) days of request of proof of such
insurance.


 



 

22







 






 




ARTICLE
12


INVENTIONS;
PATENT PROVISIONS


 







12.1.

Ownership
of Intellectual Property.






 





As
between the Parties, Cipher shall remain the sole and exclusive
owner of all Cipher Licensed Patents, Cipher Licensed Know-How,
Trademarks owned by Cipher and Cipher Data, and Licensee shall
remain the sole and exclusive owner of all Licensee Licensed
Patents, Licensee Trademarks, Licensee Licensed Know-How and
Licensee Data. Each Party shall own all data, results and
inventions, whether patentable or not, conceived or reduced to
practice by or on behalf of such Party, together with all
intellectual property rights therein.


 







12.2.

Improvements





 





For
greater certainty, as between Licensee and Cipher, Licensee shall
own all right, title and interest in and to any improvements to the
Cipher Licensed Patents developed by Licensee.

 







12.3.

Enforcement.






 







(a)

Notice. Each Party
shall promptly provide, but in no event later than forty five (45)
days, the other with written notice reasonably detailing any known
or alleged infringement, misappropriation or other violation or
challenge to the validity, scope or enforceability of any Patent or
Trademark, or misappropriation or other violation of Know-How or
Confidential Information, in each case owned or Controlled by the
other Party with respect to the Product.





 







(b)

Enforcement of Intellectual
Property Rights. The sole owner or Party Controlling
Patents, Trademarks, Know-How or Confidential Information shall
have, except as set out to the contrary in this subsection, the
exclusive right to institute and direct legal proceedings against
any Third Party believed to be misappropriating or otherwise
violating such Patents, Trademarks, Know-How or Confidential
Information. For clarity, Cipher shall have the first right to
initiate a lawsuit against a person accused of misappropriating or
otherwise violating Cipher Licensed Know-How and/or Cipher Licensed
Patents. If Cipher does not cause the accused person to cease
misappropriating or otherwise violating Cipher Licensed Know-How or
Cipher Licensed Patents, or commence a lawsuit against the accused
person if necessary, within forty-five (45) days after notice of
violation of such Cipher Licensed Know-How and/or Cipher Licensed
Patents, then Licensee shall be entitled (but shall not be
obligated) to take all actions reasonably necessary to cause the
accused person to cease misappropriating or otherwise violating
Cipher Licensed Patents or Cipher Licensed Know-How, including
commencement of a lawsuit against the accused person if necessary;
provided, however, that Licensee shall consult in advance with
Cipher regarding such action and may not undertake any enforcement
action without the prior approval of the JSC, such approval not to
be unreasonably withheld. The primary objective of any enforcement
action shall be to preserve exclusivity for the Product and uses
thereof in the major pharmaceutical markets. Other objectives shall
be subservient to this primary objective. All amounts recovered
from enforcement of any such rights by either Party relating to the
intellectual property licensed under this Agreement shall be first
used to reimburse each Party's costs and expenses incurred in
connection with such action, and any remainder of such recovery
shall be retained by the Party instituting the action, provided
that any remainder retained by Licensee with respect to the
enforcement of Cipher Licensed Know-How and/or Cipher Licensed
Patents shall be treated as Net Sales and shall be subject to
Licensee's royalty payment obligations at the applicable rate
specified in Section 7.2.






 



 

23







 






 







(c)

Cooperation in Enforcement
Proceedings. For any action by a Patty pursuant to
subsection 12.2(b), in the event that such Patty is unable to
initiate or prosecute such action solely in its own name, the other
Party will join such action voluntarily and will execute all
documents necessary for such Party to initiate, prosecute and
maintain such action. If either Party initiates an
enforcement action pursuant to subsection 12.3(b), then the other
Party shall cooperate to the extent reasonably necessary and at the
first Parties' sole expense (except for the expenses of the
non-controlling Party's counsel, if any). Upon the reasonable
request of the Party instituting any such action, such other Party
shall join the suit and can be represented in any such legal
proceedings using counsel of its own choice. Each Party shall
assert and not waive the joint defense privilege with respect to
all communications between the Parties reasonably the subject
thereof.






 







(d)

Settlement. The Parties
shall keep each other informed of the status of and of their
respective activities regarding any enforcement action pursuant to
subsection 12.3(b). Neither Party shall settle any litigation or
legal proceeding to enforce Cipher Licensed Patent without the
other Party's written authorization, not to be unreasonably
withheld.






 







12.4.

Defense.





 







(a)

Each Party shall
notify the other in writing of any allegations it receives from a
Third Party that the Development, Commercialization, manufacture or
use of the Product or any technology or intellectual property
licensed by a Party under this Agreement infringes, misappropriates
or otherwise violates the intellectual property rights of such
Third Party. Such notice shall be provided promptly, but in no
event after more than thirty (30) business days, following receipt
of such allegations.






 







(b)

In the event that a
Party receives notice that it or any of its Affiliates have been
individually named as a defendant in a legal proceeding by a Third
Party alleging infringement, misappropriation or violation of a
Third Party's Patents or other intellectual property right as a
result of the Development, Commercialization, manufacture or use of
the Product or any technology or intellectual property licensed by
a Party under this Agreement, such Party shall immediately notify
the other Party in writing and in no event notify such other Party
later than thirty (30) business days after the receipt of such
notice. The Parties agree that Licensee shall assume the primary
responsibility for the conduct of the defense of any such claim
that is specific to the Field, at Licensee's expense, and Cipher
shall assume the primary responsibility for the conduct of the
defense of any other such claim, at Cipher's expense. The Party
that does not assume primary responsibility for the conduct of the
defense shall have the right, but not the obligation, to
participate and be separately represented in any such suit at its
sole option and at its own expense. Each Party shall reasonably
cooperate with the Party conducting the defense of the claim.
If a Party or any
of its Affiliates have been individually named as a defendant in a
legal proceeding relating to the alleged infringement,
misappropriation or violation of a Third Party's Patents or other
intellectual property right as a result of the manufacture,
production, use, development, sale or distribution of Products, the
other Party shall be allowed to join in such action, at its own
expense.






 







(c)

Status; Settlement. The
Parties shall keep each other reasonably informed of the status of
and of their respective activities regarding any litigation or
settlement thereof initiated by a Third Party
concerning a Party's Development, Commercialization, manufacture or
use of the Product or any technology or intellectual property
licensed by a Party under this Agreement; provided, however, that
no settlement or consent judgment or other voluntary final
disposition of a suit under this subsection 12.4(c) may be
undertaken by a Party without the consent of the other Party which
consent shall not be unreasonably withheld or delayed; provided
that such consent shall not be required to the extent that the
settlement does not (a) adversely affect the validity,
enforceability or scope of, or admit non­ infringement of any
of a Party's Patents, Know-How or other intellectual property
rights; (b) give rise to liability of such other Party or its
Sublicensees; or (c) grant to a Third Party a license or covenant
not to sue under, or with respect to, any intellectual property
that the other Party owns or to which the other Party otherwise has
exclusive rights.






 



 

24







 





 


ARTICLE
13


TERM
AND TERMINATION


 








13.1.

Term
and Expiration.





 


The
term of this Agreement (the "Term") shall expire upon the
20th anniversary of the First
Commercial Sale, unless terminated earlier pursuant to Sections
13.2, 13.3 or the launch of the first generic entrant. The Term
shall be automatically renewed for additional successive one
(I) year periods.

 








13.2.

Termination
for Cause.





 


This
Agreement may be terminated at any time during the Term upon
written notice by either Party if the other Party is (i) in breach of its payment obligations
under this Agreement (ii) is in violation of its obligation to
maintain insurance pursuant to 11.9; or (iii) in material breach of
its other obligations under this Agreement and, in each case, has
not cured such breach within forth-five (45) days after notice
requesting cure of the breach (where reasonable steps have been
taken to address non-payment within forty­ five (45) days);
provided, however, that if such breach is not reasonably subject to
cure within forty-five (45)
days,
subject to reasonably diligent efforts being undertaken within
forty-five (45) days, the breaching Party shall not be deemed in
breach provided it uses reasonable best efforts to cure such breach
as promptly as possible. In addition, either Party may, at its
option, terminate this Agreement, and all rights granted herein
upon the occurrence of any of the following events of
default:


 





(a)

the filing by the
other Party of any petition or any application seeking
reorganization, readjustment or rearrangement of the business of
Licensee under any federal or provincial law relating to bankruptcy
or insolvency;






 







(b)

the making by the
other Party of any assignment or attempted assignment for the
benefit of creditors;






 







(c)

the other Party
becoming insolvent, as evidenced, for example (without limitation)
by (i) the appointment of a receiver or a receiver manager for all
or substantially all of the property of the other Party, (ii) the
inability of the other Party to pay its liabilities generally as
they become due, (iii) the termination of a majority of the other
Party's employees, or (iv) the other
Party ceasing, or imminently ceasing by way of a third party
petition remaining in place for 30 days, to carry on
business;








 





 

25







 






 



(d)          

any resolution
passed, order made, or other steps taken by the other Party for the
winding up, liquidation or other termination of the existence of
the other Party; or





 




(e)


if the
other Patty assigns or attempts to assign this Agreement or any
rights hereunder contrary to this Agreement without the prior
written notification of the Party.





 







13.3


Termination
Without Cause.





 





Upon
sixty (60) days prior written notice to Cipher, Licensee may
terminate this Agreement in its entirety without
cause.


 








13.4.

Effect
of Termination.






 







(a)

Upon the
termination of this Agreement:






 







(i)

Within sixty (60)
days of expiration of termination of this Agreement (or such later
date with respect to those costs that are incurred but cannot be
reported as of such date), Licensee shall pay Cipher all undisputed
amounts due to Cipher under this Agreement as of the effective date
of such expiration or termination.





 







(ii)

Notwithstanding
anything to the contrary in this Section 13.4, if this Agreement
terminates pursuant to Section 13.2 or 13.3 at the request of
Licensee, Licensee shall have the right to sell its remaining
inventory of Product(s) so long as Licensee has fully paid, and
continues to pay fully when due, any and all undisputed invoiced
amounts corresponding to Royalties and Sublicensee Revenues owed to
Cipher hereunder based on such sales.






 







(iii)

Notwithstanding
Section 13.4, Licensee will not terminate the license granted to
Cipher pursuant to Section 8.3 of this Agreement under the Licensee
Licensed Patents, the Licensee Licensed Know-How, and Licensee
Data, regulatory materials and other information related to the
Product solely to manufacture clinical Materials or to make,
Develop, manufacture or Commercialize Products within the Cipher
Field.






 




(iv)

The license granted
to Licensee under Section 8.1 and any sublicenses that have been
granted to a Sublicensee with respect to Cipher IP shall
terminate.






 







(v)

Except as otherwise
provided under this Agreement or otherwise agreed by the Parties,
all activities underway at the time of termination shall be
terminated as soon as possible except that all costs of continuing
studies or Clinical Trials or winding down activities shall
continue to be borne by the Parties as provided in this Agreement
until completion of such activities in the normal course. For the
sake of clarity the costs of winding down activities shall include
any incurred costs or otherwise unavoidable wind down costs that
would otherwise have been payable by Licensee.






 







(b)

If either Party has
the right to terminate this Agreement under Section 13.2, it may at
its sole option, elect either to: (i) terminate this Agreement and
pursue any legal or equitable remedy available to it; or (ii)
maintain this Agreement in effect and pursue any legal or equitable
remedy available to it.






 



 

26







 






 







13,5            

Survival.






 





Any
undisputed payments accruing hereunder shall continue to be due and
owing following termination of this Agreement. In addition, the
following provisions shall survive the termination of this
Agreement for any reason: Articles 1, 5, 6.l(b), 7.5, 8.2, 9, 10,
11, 12, 13 and 14.


 





ARTICLE
14


MISCELLANEOUS


 








14.1.

Force
Majeure.






 





Neither
Party shall be held liable to the other Party nor be deemed to have
defaulted under or breached this Agreement for failure or delay in
performing any obligation under this Agreement to the extent such
failure or delay is caused by or results from causes beyond the
reasonable control of the affected Party including, but not limited
to, embargoes, war, acts of war (whether war be declared or not),
insurrections, riots, civil commotions, strikes, lockouts or other
labour disturbances, fire, floods, or other acts of God, or acts,
omissions or delays in acting by any governmental authority or the
other Party. The affected Party shall notify the other Party of
such force majeure circumstances as soon as reasonably practical,
and shall promptly undertake reasonable efforts necessary to
mitigate such force majeure circumstances.


 








14.2.

Assignment.






 


Neither
Party may assign its rights or obligations under this Agreement
without providing prior written notice to the other
Party.


 








14.3.

Severability.





 





If any
one or more of the provisions contained in this Agreement is held
invalid, illegal or unenforceable in any respect, the validity,
legality and enforceability of the remaining provisions contained
herein shall not in any way be affected or impaired thereby, unless
the absence of the invalidated provision(s) adversely affects the
substantive rights of the Parties. The Parties shall in such an
instance use their commercially reasonable efforts to replace the
invalid, illegal or unenforceable provision(s) with valid, legal
and enforceable provision(s) which, insofar as practical, implement
the purposes of this Agreement.


 








14.4.

Notices.






 





All
notices which are required or permitted hereunder shall be in
writing and sufficient if delivered personally, sent by email (and
promptly confirmed by personal delivery, registered or certified
mail or overnight courier), sent by nationally-recognized overnight
courier or sent by registered or certified mail, postage prepaid,
return receipt requested, addressed as follows:

 


	
if
to Cipher, to:  


	
Cipher
Pharmaceuticals Inc.


	
 

	
Attn: Shawn Patrick
O'Brien, President & CEO


	
 

	
2345 Argentia Road,
Suite lO0A


	
 

	
Mississauga,
Ontario


	
 

	
L5N
8K4


	
 

	
Email:






 



 

27







 





 


	
with a copy (which
shall not constitute notice) to:

	
Torys
LLP


	
 

	
79
Wellington Street West


	
 

	
Box 270, TD
Centre



	
 

	
Toronto,
ON


	
 

	
Attn: Cheryl
Reicin, Esq.


	
 

	
Email: creicin@torys.com


	
 

	
 


	
if
to Licensee, to:


	
Edesa Biotech
Inc.


	
 

	
Attn: Pardeep
Nijhawan, Director


	
 

	
l00 Spy
Court


	
 

	
Markham,
Ontario


	
 

	
L3R5H6


	
 

	
Email: par@exzell.com


	
 

	
 


	
with a copy (which
shall not constitute notice) to: 


	
Borden Ladner
Gervais LLP


	
 

	
Scotia Plaza, 40
King Street W.


	
 

	
Toronto,
ON


	
 

	
M5H3Y4


	
 

	
Attn: Lydia
Wakulowsky


	
 

	
Email: lwakulowsky@blg.com







   




or to
such other address as the Party to whom notice is to be given may
have furnished to the other Party in writing in accordance
herewith. Any such notice shall be deemed to have been given: (a)
when delivered if personally delivered or sent by email on a
business day; (b) on the business day after dispatch if sent by
nationally-recognized overnight courier; or (c) on the fifth
business day following the date of mailing if sent by
mail.

 








14.5.

Applicable
Law and Litigation.





 





This
Agreement shall be governed by and construed in accordance with the
laws of the Province of Ontario and the laws of Canada applicable
therein, without reference to any rules of conflict of laws. For
controversies, claims and disputes not covered by the arbitration
provisions pursuant to Section 14.16, and for injunctive or other
equitable interim relief in relation to all controversies, claims
and disputes arising out of or relating to this Agreement, the
Parties irrevocably and unconditionally: (a) consent to the
exclusive jurisdiction of the courts of the Province of Ontario,
Canada for any action, suit or proceeding and relating to
injunctive or other equitable relief, and agree not to commence any
action, suit or proceeding related thereto except in such courts;
and (b) waive any objection to the laying of venue of any action,
suit or proceeding in the courts of the Province of Ontario, Canada
and waive and agree not to plead or claim in any such court that
any such action, suit or proceeding brought in any such court has
been brought in an inconvenient forum.


 








14.6.

Entire
Agreement; Amendments.






 





This
Agreement contains the entire understanding of the Parties with
respect to the subject matter hereof. All express or implied
agreements and understandings, either oral or written, with regard
to the subject matter hereof are superseded by the terms of this
Agreement. On the Effective Date, the confidentiality agreement
between the Parties effective November 25, 2015 shall terminate and
all Confidential Information exchanged thereunder shall be deemed
Confidential Information of the Party disclosing such information
and protected under this Agreement. This Agreement may be amended,
or any term hereof
modified, only by a written instrument duly executed by authorized
representatives of both Parties.

 






 

28







 





 








14.7.

Independent
Contractors.





 





The
Parties shall be independent contractors and the relationship
between the Parties shall not constitute a partnership, joint
venture or agency. Neither Party shall have the authority to make
any statements, representations or commitments of any kind, or to
take any action, which shall be binding on the other Party, without
the prior written consent of the other Party.


 








14.8.

Waiver.





 


The
waiver by either Party of any right hereunder, or the failure of
the other Party to perform, or a breach by the other Party, shall
not be deemed a waiver of any other right hereunder or of any other
breach or failure by such other Party whether of a similar nature
or otherwise.


 








14.9.

Cumulative
Remedies.






 





No
remedy referred to in this Agreement is intended to be exclusive,
but each shall be cumulative and in addition to any other remedy
referred to in this Agreement or otherwise available under
law.


 








14.10.

Waiver
of Rule of Construction.






 





Each
Party has had the opportunity to consult with legal counsel in
connection with the review, drafting and negotiation of this
Agreement. Accordingly, the rule of construction that any ambiguity
in this Agreement shall be construed against the drafting Party
shall not apply.

 








14.11.

Counterparts.






 





The
Agreement may be executed in two or more counterparts, each of
which shall be deemed an original, but all of which together shall
constitute one and the same instrument. Each Party shall be
entitled to rely on the delivery of executed facsimile copies of
counterpart execution pages of this Agreement and such facsimile
copies shall be legally effective to create a valid and binding
agreement among the parties.


 





14.12.

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, or to better assure and confirm unto such
other Party its rights and remedies under this Agreement. Each
Party shall use its commercially reasonable efforts to take all
actions necessary or advisable under applicable laws to consummate
and make effective the transactions contemplated by this Agreement
including the taking of such reasonable actions as are necessary to
obtain any requisite approvals, consents, orders, exemptions or
waivers by any governmental authority.


 








14.13.

Construction.






 



 

29







 






 





Except
where the context otherwise requires, wherever used, the singular
will include the plural, the plural the singular, the use of any
gender will be applicable to all genders, and the word "or" is used
in the inclusive sense (and/or). 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. The term "including"
as used herein means including, without limiting the generality of
any description preceding such term. References to "Section" or
"Sections" are references to the numbered sections of this
Agreement, unless expressly stated otherwise.


 








14.14.

Currency.






 


All
payments under this Agreement shall be made in United States
Dollars. All references to "dollars" or"$" in this Agreement are to
United States Dollars.


 





14.15.

Use
of Third Parties.






 





It is understood that when a Party engages
any Third Patty to manufacture the Product, that engagement may
require a limited license or limited sublicense of rights obtained
from the other Party under this Agreement. The Party engaging such
Third Party (or non-licensed Affiliate) may disclose Confidential
Information of the other Party solely as necessary to fulfill the
business purposes of the engagement, and then only pursuant to
terms and conditions that are substantially as protective of that
Confidential Information as the terms and conditions of this
Agreement. Notwithstanding any delegation of obligations under this
Agreement by a Party to its Affiliates or to a Third Party, whether
related to manufacturer of the Product or otherwise, the Party
shall remain primarily liable and responsible for the performance
of all of its obligations under this Agreement and for causing such
Affiliates or Third Parties to act in a manner consistent herewith.
In addition, such Party shall assure that any intellectual property
developed by its Affiliates or such Third Parties shall be
Controlled by that Party. The Party contracting with such Third
Party shall not agree to any term that would make it unable to
comply with its obligations under this Agreement. Cipher shall not
engage any Third Party manufacturer without the prior written
consent of Licensee, not to be unreasonably withheld.

 








14.16.

Dispute
Resolutions.






 







(a)

Any controversy,
claim or dispute arising out of or relating to this Agreement shall
first be submitted to the CEO of each Party for attempted
resolution. If the CEOs of the
Parties do not resolve such matter within thirty (30) days of the
matter being submitted to them, then such matter shall be resolved
through binding arbitration as follows. For the sake of clarity,
this Section 14.16 is not intended to alter the rights of the
Parties as established by Article 2, Governance, herein. The
dispute shall be resolved by final and binding arbitration. The
place of arbitration shall be the City of Toronto, Ontario, Canada.
The arbitration shall be in accordance with the rules of
ADRChambers ("ADRC") except
as modified herein. The number of arbitrators shall be three. The
language of the arbitration shall be English.






 







(b)

The Patty wishing
to commence an arbitration ("Claimant") shall notify the other
party ("Respondent") in
writing of its decision to commence arbitration hereunder
(sometimes referred to in this Agreement as its "demand for arbitration"), setting out
briefly its claims in its notice, and with its notice, name the
arbitrator it is appointing.






 







(c)

The Respondent
shall, within thirty (30) days of receipt of a demand for
arbitration, notify the Claimant in writing of the name of the
arbitrator it is appointing.






 



 

30







 






 







(d)

The third
arbitrator shall be chosen by the first two arbitrators within
twenty (20) days after the second of such arbitrators was
appointed.






 








(e)

All arbitrators
shall be chosen taking into account the type of issues to be
addressed in the arbitration, whether legal, business, scientific,
or a combination thereof, and having regard to their availability
to conduct the arbitration within the times provided below. (The
date on which the third arbitrator is appointed is the "Arbitration Panel
Finalization").






 







(f)

Within thirty (30)
days of completion of the hearing, the arbitrators shall render a
reasoned arbitration award describing, in writing, the essential
finding and conclusions on which the decision is based, including
the calculation of any damages awarded. Any monetary award shall be
made within thirty (30) days of the rendering of such
award.






 







(g)

All information and
documents in relation to the arbitration shall be deemed
Confidential Information to the full extent permitted by law. No
individual shall be appointed as an arbitrator unless the
individual first agrees in writing to be bound by this subsection
and to conduct the arbitration in a manner that in his/her judgment
is most likely to maintain the confidentiality of Confidential
Information. Neither Party may retain any expert in connection with
the arbitration unless the expert first agrees in writing to be
bound by this subsection, as applicable. The fact of and subject
matter of the arbitration, including the fact that any dispute has
been submitted to arbitration, and all evidence given and
submissions made in connection with any arbitration, shall be
Confidential Information, and shall be treated as such by the
Parties and all persons employed by or contracted to them. Any
meetings, conferences or hearings in connection with or during the
arbitration may be attended only by those individual persons whose
presence, in the opinion of the arbitral tribunal, is reasonably
necessary for the determination or other resolution of the dispute
and such person first agrees in writing to be bound by the
provisions of these sections, as applicable. The obligations under
this subsection continue notwithstanding any determination or other
resolution of the arbitration.






 




(h)

The arbitrators
shall be paid reasonable fees plus expenses. These fees and
expenses, along with the reasonable legal fees and expenses of the
prevailing Party (including all expert witness fees and expenses),
the fees and expenses of a court reporter, and any expenses for a
hearing room, shall be paid as follows:






 







(i)

If the
arbitrators rule in favour of one Party on all disputed issues in
the arbitration, the losing Party shall pay 100% of such fees and
expenses.






 







(ii)

If the
arbitrators rule in favour of one Party on some issues and the
other Party on other issues, the arbitrators shall issue with the
ruling a written determination as to how such fees and expenses
shall be allocated between the Parties. The arbitrators shall
allocate fees and expenses in a way that bears a reasonable
relationship to the outcome of the arbitration, with the Party
prevailing on more issues, or on issues of greater value or
gravity, recovering a relatively larger share of its legal fees and
expenses.






 







(i)

Any final award of
the arbitrators shall be final, conclusive and binding on the
Parties, and judgment may be entered in any court of competent
jurisdiction. To the extent lawful, the Parties exclude any right
of review or appeal to Canadian, United States or other courts,
including in connection with any question of law arising in the
arbitration or in connection with any award or
decision made by the arbitrators, except as is necessary to
recognize or enforce such award or decision.






 



 

31







 






 








14.17.

Statute
of Limitations.






 





In no
event will a demand for arbitration be made after the date when
institution of a legal or equitable proceeding based upon such a
dispute between the Parties would otherwise be barred by the
applicable statute of limitations.


 








14.18.

Injunctive
and Other Interim Relief.






 





Nothing
in this Agreement shall be construed as limiting in any way the
right of a Party to seek injunctive or other interim relief from a
court of competent jurisdiction with respect to any actual or
threatened breach of this Agreement, or to preserve or protect any
property or assets pending an arbitral award, or otherwise in
support of the contemplated or pending arbitration. No such court
application shall be taken as a waiver or impairment of
arbitration.

 








14.19.

Time
of the Essence.






 





Time
shall be of the essence with respect to any payment owed or any
other obligation of a Party hereunder.

 








14.20.

Execution
in Counterparts; Facsimile Signatures.






 





This
Agreement may be executed in counterparts, each of which
counterpart, when so executed and delivered, shall be deemed to be
an original, and all of which counterparts, taken together, shall
constitute one and the same instrument even if both Parties have
not executed the same counterpart. Signatures provided by facsimile
transmission or scanned and emailed copies shall be deemed to be
original signatures.


 








14.21.

Performance
by Affiliates.






 





To the
extent that this Agreement imposes obligations on Affiliates of a
Party, such Party shall cause its Affiliates to perform such
obligations. Either Party may use one or more of its Affiliates to
perform its obligations and duties hereunder; provided, however the
Parties shall remain liable hereunder for the prompt payment and
performance of all their respective obligations
hereunder.

 



[Remainder of the Page Intentionally Left Blank]


 




 

32








 





  





The
Parties have executed this Agreement as of the Effective
Date.


 




	

 

	
CIPHER PHARMACEUTICALS
INC.


	

 


	

 

	

 

	

 

	

 


	

	
By:  

	
/s/ Shawn Patrick
O'Brien 

	

 


	

 

	

 

	
Name: Shawn Patrick
O'Brien  

	

 


	

 

	

 

	

Title:
President & CEO 

	

 


	

 

	

 

	

 

	

 


	

 

	

By:

	

/s/
Norm Evans


	

 


	

 

	

 

	

Name:
Norm
Evans

	

 


	

 

	

 

	

Title:
CFO


	

 







 




	

 

	
EDESA BIOTECH INC.


	

 


	

 

	

 

	

 

	

 


	

	
By:  

	
/s/ Pardeep
Nijhawan 

	

 


	

 

	

 

	
Name: Pardeep
Nijhawan

	

 


	

 

	

 

	

Title:
Director 

	

 






 




	

	
By:  

	
/s/ Michael
Brooks 

	

 


	

 

	

 

	
Name: Michael
Brooks  

	

 


	

 

	

 

	

Title:
Vice President 

	

 






 

 


 




 

33








 






 





Schedule
"A"


 




	

Country

	

Registration
No. or Application No.


	

Australia

	

2006233502


	

Belgium

	

1719507


	

Brazil

	

PI609361-2


	

Canada

	

2604758


	

China

	

ZL
2006800165347


	

EU

	

1719507


	

Israel

	

186491


	

Japan

	

5021621


	

South
Korea

	

10-1355422


	

Mexico

	

281857


	

Norway

	

331211


	

New
Zealand

	

562940


	

Poland

	

1719507


	

Russian
Federation

	

016082


	

Thailand

	

0601001702


	

Taiwan

	

1366457


	

USA

	

8,426,475







 


 




 

34