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style+AD0-'font-size:10.0pt+ADs-color:black'+AD4APA-o:p+AD4AJg-nbsp+ADsAPA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
+ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4APA-o:p+AD4AJg-nbsp+ADsAPA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
+ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4gHA-Affiliate+IB0-
+ADw-/span+AD4APA-/b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-of any person
means a corporation or other entity, which, directly or indirectly,
is controlled by, controls or is under direct or indirect common
control with such person. +ACY-nbsp+ADs-For the purposes of this
Section, +IBw-control+IB0- shall mean possession, directly or
indirectly, of the power to direct or cause the direction of the
management and policies of a person or entity, whether through the
ownership of voting securities, by agreement or
otherwise+ADsAPA-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4APA-o:p+AD4AJg-nbsp+ADsAPA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
+ADw-p
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style+AD0-'font-size:10.0pt+ADs-color:black'+AD4gHA-Agency+IB0APA-/span+AD4APA-/b+AD4APA-span
style+AD0-'font-size: 10.0pt+ADs-color:black'+AD4- means any
governmental regulatory authority responsible for granting
Regulatory Approvals for the sale of the Product in the
Territory+ADsAPA-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
style+AD0-'margin-top:0in+ADs-margin-right:0in+ADs-margin-bottom:12.0pt+ADs-margin-left:
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style+AD0-'font-size:10.0pt+ADs-color:black'+AD4APA-o:p+AD4AJg-nbsp+ADsAPA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
+ADw-p align+AD0-center
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-text-align:center+ADs-
line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-1+ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
+ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-Watson License
December 06+ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4APA-o:p+AD4AJg-nbsp+ADsAPA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
+ADw-div class+AD0-MsoNormal align+AD0-center
style+AD0-'margin-top:.1in+ADs-margin-right:0in+ADs-
margin-bottom:.1in+ADs-margin-left:0in+ADs-text-align:center+ADs-line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4- +ADw-hr
size+AD0-1 width+AD0AIg-100+ACUAIg- noshade
color+AD0AIgAj-004080+ACI- align+AD0-center+AD4-
+ADw-/span+AD4APA-/div+AD4- +ADw-span
style+AD0-'font-size:10.0pt+ADs-font-family:+ACI-Times New
Roman+ACIAOw-mso-fareast-font-family: +ACI-Times New
Roman+ACIAOw-color:black+ADs-mso-ansi-language:EN-US+ADs-mso-fareast-language:
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style+AD0-'mso-special-character:line-break+ADs-
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style+AD0-'font-size:10.0pt+ADs-color:black'+AD4gHA-Business
Day+IB0- +ADw-/span+AD4APA-/b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-shall mean means a
day other than a Saturday, Sunday or any other day on which the
principal chartered banks located in London, Ontario or in the
United States are not open for
business+ADsAPA-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-span
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+ADw-p
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style+AD0-'font-size:10.0pt+ADs-color:black'+AD4gHA-CDN+IB0APA-/span+AD4APA-/b+AD4APA-span
style+AD0-'font-size: 10.0pt+ADs-color:black'+AD4- means Canadian
dollars+ADsAPA-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4APA-o:p+AD4AJg-nbsp+ADsAPA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
+ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4gHA-Commercialization
Committee+IB0APA-/span+AD4APA-/b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4- means the
committee constituted and operating as specified in Section
6+ADsAPA-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4-+ADw-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4APA-o:p+AD4AJg-nbsp+ADsAPA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
+ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4gHA-Commercially
Reasonable Efforts+IB0APA-/span+AD4APA-/b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4- means
commercially reasonable efforts in accordance with such Party+IBk-s
business, legal, medical, and scientific judgment and with the
efforts and resources such Party would use for a product owned by
it, or to which it otherwise has rights, which is of similar market
potential, at a similar stage in its product life, taking into
account the competitiveness of the market place, the proprietary
position of the product, the regulatory structure involved and
other relevant
factors+ADsAPA-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4APA-o:p+AD4AJg-nbsp+ADsAPA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
+ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4gHA-Competing
Product+IB0APA-/span+AD4APA-/b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4- means any branded
or generic medical device or pharmaceutical product (other than the
Product), containing chondroitin sulphate for instillation into the
bladder, and capable of being substituted for Product, that is
marketed in the Territory for the treatment of interstitial
cystitis+ADs- +ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
+ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4APA-o:p+AD4AJg-nbsp+ADsAPA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
+ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4AJg-quot+ADs-Documents+ACY-quot+ADsAPA-/span+AD4APA-/b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4- means,
collectively, all books, pamphlets, bulletins, memoranda, letters,
notices, reports, manufacturing records or other publications or
documents prepared by or on behalf of Stellar setting forth
information, formulae, production specifications, advice,
standards, requirements, operating procedures, instructions or
policies relating to the Products including the
+ACY-quot+ADs-Technical Documentation+IB0- per Appendix
1+ADsAPA-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4APA-o:p+AD4AJg-nbsp+ADsAPA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
+ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4AJg-quot+ADs-Effective
Date+ACY-quot+ADsAPA-/span+AD4APA-/b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4- means the date on
which this Licence Agreement was
executed+ADsAPA-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4APA-o:p+AD4AJg-nbsp+ADsAPA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
+ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4AJg-quot+ADs-FDA+ACY-quot+ADs-
+ADw-/span+AD4APA-/b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-means the United
States Food and Drug Administration or any successor
entity+ADsAPA-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4APA-o:p+AD4AJg-nbsp+ADsAPA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
+ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4AJg-quot+ADs-FOB+ACY-quot+ADsAPA-/span+AD4APA-/b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4- means Free on
Board+ADsAPA-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4APA-o:p+AD4AJg-nbsp+ADsAPA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
+ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4AJg-quot+ADs-Field+ACY-quot+ADsAPA-/span+AD4APA-/b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4- means the
treatment of all human bladder conditions in the
Territory+ADsAPA-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4APA-o:p+AD4AJg-nbsp+ADsAPA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
+ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4gHA-Gross
Sales+IB0APA-/span+AD4APA-/b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4- means the gross
amount invoiced by Watson, its Affiliates (excluding any Affiliate
primarily engaged in the distribution of pharmaceutical products to
whom Watson, its Affiliates or its sub-licensees provide Products
for further distribution, any such Affiliate being referred to
herein as a +IBw-Distribution Affiliate+IB0-) and its sub-licensees
on sales of the Products in the Territory and all other receipts or
receivables whatsoever generated from or arising directly from the
marketing or sale of the Products. +ACY-nbsp+ADs-For any sales by
Watson, its Affiliates or its sub-licensees to a Distribution
Affiliate, Gross Sales shall mean the gross amount invoiced by
Watson on its sales to such Distribution Affiliate, provided that
the effective price for such sales shall be deemed to be the
greater of (i) the actual price charged to such Distribution
Affiliate and (ii) the average price charged for Products to
arm+IBk-s length third parties during the fiscal quarter in which
the sale to the Distribution Affiliate took
place.+ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4APA-o:p+AD4AJg-nbsp+ADsAPA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
+ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4gHA-Improvements+IB0APA-/span+AD4APA-/b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4- means any future
innovations, inventions, designs, plans, drawings, Specifications,
techniques, formulations, intellectual property, data and technical
information relevant to the Product licensed hereunder with respect
to new or improved methods of manufacture, formulas, method of
delivery, dosage and uses thereof as well as the addition of other
active
ingredients+ADsAPA-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
+ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4APA-o:p+AD4AJg-nbsp+ADsAPA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
+ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4AJg-quot+ADs-Interest
Rate+ACY-quot+ADsAPA-/span+AD4APA-/b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4- means the
commercial lending rate of two percent (2+ACU-) above the U.S.
dollar prime or equivalent rate quoted by Citibank N.A. or another
mutually acceptable bank, as in effect during the period from the
date due until
payment+ADsAPA-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4APA-o:p+AD4AJg-nbsp+ADsAPA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
+ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4AJg-quot+ADs-Methods
and Technical Know-How+ACY-quot+ADsAPA-/span+AD4APA-/b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4- means all
information, knowledge and experience of a technical and/or
commercial nature, including, but not limited to, trade secrets,
know-how, intellectual property, the Specifications, the Documents,
information and data relating to techniques for, methods of or
practices in the manufacturing, use and sale of the Products+ADs-
+ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
style+AD0-'margin-top:0in+ADs-margin-right:0in+ADs-margin-bottom:12.0pt+ADs-margin-left:
0in+ADs-line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4APA-o:p+AD4AJg-nbsp+ADsAPA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
+ADw-p align+AD0-center
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-text-align:center+ADs-
line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-2+ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
+ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-Watson License
December 06+ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4APA-o:p+AD4AJg-nbsp+ADsAPA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
+ADw-div class+AD0-MsoNormal align+AD0-center
style+AD0-'margin-top:.1in+ADs-margin-right:0in+ADs-
margin-bottom:.1in+ADs-margin-left:0in+ADs-text-align:center+ADs-line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4- +ADw-hr
size+AD0-1 width+AD0AIg-100+ACUAIg- noshade
color+AD0AIgAj-004080+ACI- align+AD0-center+AD4-
+ADw-/span+AD4APA-/div+AD4- +ADw-span
style+AD0-'font-size:10.0pt+ADs-font-family:+ACI-Times New
Roman+ACIAOw-mso-fareast-font-family: +ACI-Times New
Roman+ACIAOw-color:black+ADs-mso-ansi-language:EN-US+ADs-mso-fareast-language:
EN-US+ADs-mso-bidi-language:AR-SA'+AD4APA-br clear+AD0-all
style+AD0-'mso-special-character:line-break+ADs-
page-break-before:always'+AD4- +ADw-/span+AD4- +ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt+ADs-page-break-before:
always'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4APA-o:p+AD4AJg-nbsp+ADsAPA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
+ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-a
name+AD0AIg-OLE+AF8-LINK1+ACIAPgA8-/a+AD4APA-b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4AJg-quot+ADs-Net
Sales+ACY-quot+ADsAPA-/span+AD4APA-/b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4- means Gross
Sales, less (a) returns, discounts, rebates, chargebacks,
+ACY-nbsp+ADs-allowances and all other similar or related items
customarily deducted from gross sales in arriving at a net sales
figure+ADs- (b) amounts repaid or credited by reasons of
rejections, recalls or returns of goods+ADs- (c) bad debts actually
incurred (not to exceed 0.5+ACU- of gross sales). +ACY-nbsp+ADs-All
deductions shall be made on an accrual basis in a manner consistent
with Watson+IBk-s business, in accordance with United States GAAP.
+ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
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outside of the Field, whereby the Product must be unique in formula
and strength as to in no way be substitutable or interchangeable
with the Product for the Field in the
Territory+ADsAPA-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
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collectively, Stellar and Watson or their successors or permitted
assigns, as applicable and individually a
+ACY-quot+ADs-Party+ACY-quot+ADs- shall mean either Stellar or
Watson, as
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and patent applications, including provisional and priority
filings, utility models, and their applications and which
specifically or generally claim the Product, claim a method of
treatment for the Product, claim a method of making the Product or
otherwise covers the Product, including but not limited to the
patent grants and applications listed in Appendix 2 as amended,
together in all cases with any continuations,
continuations-in-part, divisions, patents of additions,
re-examinations, reissues, renewals as well as extensions,
supplementary protection certificates and any other patent term
extensions of any of the
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collectively, Uracyst+ADw-sup+AD4ArgA8-/sup+AD4-, a sterile sodium
chondroitin sulphate solution marketed at 2.0+ACU- in a 20 mL vial
for human use in the Field, and such related products as stipulated
in Improvements (including but not limited to various strengths of
chondroitin sulphate solution)+ADs-
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trade marks, trade names and other commercial symbols and related
logos relating to the Products as set forth in Appendix 3, together
with such other trade names, trademarks, symbols, logos,
distinctive names, service marks, marks, logo designs, insignia or
otherwise which may be designated by Stellar+ADs-
+ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
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Territory+ADs-
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all specifications, tests, methods, applications, criteria,
qualities, requirements and all other information in connection
with the manufacture, testing, use, handling, distribution,
marketing and/or sale of the Products in any manner whatsoever,
including any manual, specification booklet, letter, notice,
memorandum or other written
form+ADsAPA-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
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Agreement dated as of December 13, 2006 herewith by and between the
Parties in which Stellar exclusively supplies the Product to Watson
in the Territory+ADs-
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meaning ascribed thereto in Section 11.1 of this License
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Grant:+ADw-/span+AD4APA-/b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4- Subject to the
provisions of this License Agreement and for the Term hereinafter
specified, Stellar hereby grants to Watson the exclusive right and
license, even as to Stellar, to market, promote, offer to sell,
sell, have sold, distribute, import, grant sublicenses, or
otherwise dispose of Products in the Field in the
Territory.+ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
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style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-Watson License
December 06+ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
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style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-Watson may grant
sublicenses to Third Parties in order to import, market, promote,
distribute and sell the Products in the Territory, provided that
Stellar shall have the right to reasonably object to said
sublicensee and provided further that the licenses granted to such
sub-licensees are not inconsistent with the licenses granted to
Watson. +ACY-nbsp+ADs-Watson shall provide Stellar with prior
written notice of any prospective sub-license together with a
summary of the terms of such sub-licenses and other information
Stellar may reasonably request in order to make a determination as
to whether it objects to such
sub-license.+ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
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style+AD0-'font-size:10.0pt+ADs-font-family:+ACI-CG Times
12pt+ACIAOw- color:black'+AD4- Subject to the provisions of this
License Agreement and for the Term hereinafter specified, Stellar
hereby grants to Watson the exclusive right and license,
+ADw-/span+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-even as to
Stellar, to any and all Patents, Proprietary Marks, Methods and
Technical Know-How, trade secrets, and proprietary information
related to the Products in the Field in the
Territory.+ADw-/span+AD4APA-span
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consultants, and/or the FDA shall have rights of access to any and
all information, including, but not limited to, trade secrets and
Methods and Technical Know-How necessary to secure regulatory
approvals of the
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style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-Subject to the
provisions of this License Agreement and for the Term hereinafter
specified, Stellar hereby covenants and agrees to provide Watson
with the Methods and Technical Know-How to be used by Watson to
obtain Regulatory Approval of the Products in the Territory and
Watson hereby covenants and agrees to use Commercially Reasonable
Efforts to obtain all Regulatory Approvals in the Territory
required to market, promote, offer to sell, sell or distribute the
Products in the Territory. +ACY-nbsp+ADs-All costs and activities
related to such Regulatory Approval shall be the obligation of
Watson. +ACY-nbsp+ADs-Methods and Technical Know-How materials,
methods and other regulatory documents will be supplied at
Stellar+IBk-s cost as per Appendix 1.
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reasonably cooperate and assist Watson, if and as requested by
Watson, in connection with any regulatory activities (including
with respect to any of the foregoing regulatory activities set out
above in Sections 2.3.1 and 2.3.3 below, provided that Stellar is
reimbursed for any reasonable out of pocket expenses, said expenses
to include the reimbursement of salaries of those Stellar employees
or consultants utilized by Watson on a pro rata basis, based on the
portion of their time allocated to said regulatory activities.
+ACY-nbsp+ADs-Notwithstanding the foregoing, Stellar shall not be
obligated to perform any studies related to the Product.
+ACY-nbsp+ADs-Should Watson be required by a governmental authority
to perform studies, Watson shall be responsible for all costs
associated with those studies which are required.
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scientific data and documentation currently in Stellar+IBk-s
possession as of the date of the signing of this License Agreement
not be sufficient to gain Regulatory Approvals from the FDA, Watson
shall bear the cost of any and all development programs necessary
to gain said
approvals.+ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
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style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-All data generated
on or on behalf of Watson for the approval of the Products in the
Territory shall be shared with Stellar in its entirety for
Stellar+IBk-s exclusive use outside the Territory. All data
generated on or on behalf of Stellar for the approval of the
Products outside the Territory shall be shared with Watson in its
entirety for Watson+IBk-s exclusive use inside the
Territory.+ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
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Regulatory Approval, Watson shall maintain all necessary and
desirable approvals for the sale of the Products in the Territory
and/or any supplements to such authorizations. +ACY-nbsp+ADs-If any
other government or other regulatory submissions or agreements in
the Territory are required for Watson to import the Products for
sale and distribution in the Territory, Watson shall be responsible
for completing such submissions and Stellar shall be responsible
for the completion of all Canadian documents necessary to export
the Products into the Territory.
+ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
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style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-Each Party shall
provide the other Party with all reasonable assistance and take all
actions reasonably requested by the other Party that are necessary
or desirable to enable such Party to comply with any law, rule or
regulation applicable to the Product in the Territory.
+ACY-nbsp+ADs-Such assistance and actions shall include (a) keeping
the other Party informed (as applicable to the role of such Party
relative to the Product) within three (3) Business Days (or sooner
if necessary to permit the other Party a reasonable and sufficient
amount +ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
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December 06+ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-span
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style+AD0-'font-size:10.0pt+ADs-color:black'+AD4- +ADw-hr
size+AD0-1 width+AD0AIg-100+ACUAIg- noshade
color+AD0AIgAj-004080+ACI- align+AD0-center+AD4-
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always'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-of time to respond
or take action to comply with applicable laws, rules, and
regulations) and as may be required by applicable laws, rules, and
regulations, of notification of any action by, or notification or
other information which it receives (directly or indirectly), from
any Agency, and (b) immediately providing copies of any written
communications which (i) raise any concerns regarding the safety or
efficacy of the Product in the Territory, (ii) indicate or suggest
a potential liability for either Party to a Third Party arising in
connection with the Product in the Territory, or (iii) is
reasonably likely to lead to a recall or withdrawal of the Product
in the Territory+ADs- provided that neither Party shall be required
to disclose information in breach of any contractual restriction
regarding confidentiality. +ACY-nbsp+ADs-The following types of
information shall be deemed to be included in categories (i), (ii)
and (iii) above: +ACY-nbsp+ADs-(1) inspections by an Agency of
manufacturing, distribution or other facilities related to the
Product which have arisen solely because of that Party+IBk-s
dealings with the Product+ADs- (2) inquiries by an Agency
concerning clinical investigation activities in relation to the
Product (including inquiries of investigators, clinical monitoring
organizations and other related Persons)+ADs- (3) any communication
from an Agency involving the manufacture, sale, promotion,
marketing, use or distribution of the Product or any other Agency
reviews or inquiries relating to the Product+ADs- (4) an initiation
of an Agency investigation, detention, seizure or injunction
concerning the Product+ADs- or (5) any other regulatory action
(e.g., proposed labeling or other registrational dossier changes
and recalls) that would affect the Product in the
Territory.+ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
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style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-Notwithstanding
anything in this Agreement to the contrary, Watson shall have no
obligation to continue pursuing Regulatory Approval if the FDA
notifies Watson that it will be required to file a New Drug
Application to obtain Regulatory Approval. +ACY-nbsp+ADs-If, after
such notice Watson determines that it will not continue pursuing
Regulatory Approval, it shall immediately notify Stellar of such
determination and this Agreement shall be terminated with the
effect set forth in Section 11. +ACY-nbsp+ADs-If Watson does not
provide such notice to Stellar within ten (10) business days of
such FDA notice, Watson shall be obligated to continue pursuit of
Regulatory
Approval.+ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
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Names and Trademarks:+ADw-/span+AD4APA-/b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4APA-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
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style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-Watson shall have
the right during the Term to use the Proprietary Marks for the
Products, as further defined in Appendix 2, for use in the
Territory. +ACY-nbsp+ADs-Stellar shall retain the rights to such
Proprietary Marks outside the Territory.
+ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
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that as of the Effective Date the trademark
+ACY-quot+ADsAPA-b+AD4-URACYST+ADw-sup+AD4ArgA8-/sup+AD4APA-/b+AD4AJg-quot+ADs-
has been registered in Canada and the U.S.A. +ACY-nbsp+ADs-Stellar
confirms that Canadian patent +ACM- 2,269,260 and U.S.A. Patent
+ACM-6,083,933 have been issued and that Stellar has international
patents pending. +ACY-nbsp+ADs-Watson confirms that all right,
title and interest in the Patents and Propriety Marks is the sole
property of Stellar and this License Agreement shall not operate to
convey any ownership interest in the Patents or Proprietary Marks
to Watson, save and except the license rights granted in this
License Agreement. +ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
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style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-Any Improvements
resulting solely from the activities undertaken by Stellar or its
Affiliates pursuant to this License Agreement (each, a +IBw-Stellar
Improvement+IB0-), whether patentable or non-patentable, shall be
owned by Stellar or its Affiliates and any related patent
applications shall be filed under the name of Stellar or its
Affiliates and at Stellar+IBk-s or its Affiliates+IBk- expense.
+ACY-nbsp+ADs-Any Stellar Improvement shall be included without
limitation in the grant of license rights under Section 2.1 of this
License Agreement.
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exclusive license in the Territory to any and all products
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definitive agreement. +ACY-nbsp+ADs-This right of first refusal
must be exercised by Watson within 90 days of Stellar making the
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+ACQ-2,200,000.00 by wire transfer, within two (2) Business Days of
the signing of this License Agreement, (2) USD +ACQ-1,300,000.00
within thirty (30) days of the issuance of a second patent in the
United States containing at least one valid claim protecting the
Product and which claims are based on PCT publication W02004073584,
and (3) USD +ACQ-4,500,000.00 within thirty (30) days of
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December 06+ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
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style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-Invalid or
Unenforceable Patent: in the event that the last Valid Claim
relating to the Product in the Territory is declared invalid or
unenforceable by a court of competent jurisdiction and such
decision is final and not appealable, Watson shall thereafter pay a
royalty of five percent (5+ACU-) of annual Net Sales for use of
Stellar+IBk-s trademark and know
how.+ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
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style+AD0-'font-size:10.0pt+ADs-color:black'+AD4APA-o:p+AD4AJg-nbsp+ADsAPA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
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style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-3.3.1+ADw-/span+AD4APA-/b+AD4APA-span
style+AD0-'font-size:
10.0pt+ADs-color:black'+AD4APA-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
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style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-The Royalty
payments set forth under this License Agreement shall be paid by
Watson on a quarterly basis on or before forty-five (45) days
following the end of each fiscal quarter of Watson and within sixty
(60) days after the termination of the License Agreement.
+ACY-nbsp+ADs-Watson shall deliver to Stellar a written statement,
on or before forty-five (45) days following the end of each fiscal
quarter, signed by Watson and certified by it to be true and
correct and in such detail and form as Stellar reasonably
determines, showing the amount and calculation of Net Sales for the
current quarter and of Net Sales for such preceding quarter (and
partial quarter, if any, at the beginning or end of the Term).
+ACY-nbsp+ADs-Any changes to this procedure relating to reporting
of Net Sales and the calculation of Net Sales shall be mutually
agreed to by the Parties.
+ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
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style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-Expenses:
+ACY-nbsp+ADsAPA-/span+AD4APA-/b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-All expenses
incurred by Watson in the handling, distribution, marketing and
sale of the Products and in carrying out its obligations under this
License Agreement shall be paid by or on behalf of Watson.
+ACY-nbsp+ADs-All expenses incurred by Stellar in connection with
the supply of ongoing Methods and Technical Know-How and in
carrying out its obligations under this License Agreement shall be
paid by Stellar.+ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
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style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-Reports, Audits
and Inspection+ADw-/span+AD4APA-/b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4APA-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
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style+AD0-'font-size:10.0pt+ADs-color:black'+AD4APA-o:p+AD4AJg-nbsp+ADsAPA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
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style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-Watson shall
prepare and keep at its principal office for at least three (3)
years following the end of each year, adequate books and records
which shall show inventories and receipts of merchandise, and daily
receipts from all sales, charges, and other transactions of Watson
with respect to the sale of the Products, as well as sales tax
returns, all pertinent original sales records, and such other
supporting records as Stellar reasonably determines pursuant to
generally accepted accounting principals, regarding Net Sales and
the calculation of Net Sales and the royalties herein. Watson shall
record at the time of sale, all receipts from sales, charges or
other transactions, whether for cash or
credit.+ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
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style+AD0-'font-size:10.0pt+ADs-color:black'+AD4APA-o:p+AD4AJg-nbsp+ADsAPA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
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style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-Stellar may, at
its own expense and upon thirty (30) days prior written notice to
Watson, cause a complete audit during normal business hours to be
made of Watson+IBk-s business and records relating to the
calculation of Net Sales for the Product and the royalties
therefrom, using an independent representative acceptable to
Watson. Such audits will be limited to one per calendar year during
the Term. +ACY-nbsp+ADs-If the independent representative reports
that there is a deficiency or overpayment in any payments made by
Watson to Stellar pursuant to this Agreement, then Watson shall,
within thirty (30) days, correct such deficiency, or Stellar shall,
within thirty (30) days correct such overpayment, by paying the
amount of such deficiency or overpayment, as applicable, to the
other Party, and such payment shall be the sole remedy related
thereto. If any payments owing to Stellar pursuant to this License
Agreement are understated by five percent (5+ACU-) or more, Watson
shall in addition pay to Stellar the amount of the cost of the
audit. +ACY-nbsp+ADs-The report of the independent representative
is final and binding on the Parties hereto.
+ACY-nbsp+ADsAPA-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4APA-o:p+AD4AJg-nbsp+ADsAPA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
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style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-All amounts due
and payable by Watson or Stellar pursuant to this License Agreement
or as otherwise agreed shall bear interest after the due date at
the Interest Rate, calculated and payable monthly, not in advance,
both before and after default or expiration or termination of this
License Agreement for any reason whatsoever. +ACY-nbsp+ADs-The
acceptance of any interest payment shall not be construed as a
waiver by either party of its rights in respect of the default
giving rise to such payment.
+ACY-nbsp+ADsAPA-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4APA-o:p+AD4AJg-nbsp+ADsAPA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
+ADw-p
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style+AD0-'font-size:10.0pt+ADs-color:black'+AD4Apw-5+ADw-/span+AD4APA-/b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-
color:black'+AD4APA-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
+ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-text-indent:.5in+ADs-line-height:12.0pt'+AD4APA-b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-Representations
and Warrants+ADw-/span+AD4APA-/b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4APA-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
+ADw-p
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style+AD0-'font-size:10.0pt+ADs-color:black'+AD4APA-o:p+AD4AJg-nbsp+ADsAPA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
+ADw-p
style+AD0-'margin-top:0in+ADs-margin-right:0in+ADs-margin-bottom:0in+ADs-margin-left:.5in+ADs-
margin-bottom:.0001pt+ADs-text-indent:-.5in+ADs-line-height:12.0pt'+AD4APA-b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-5.1+ADw-/span+AD4APA-/b+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-
color:black'+AD4APA-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
+ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-Stellar hereby
represents and warrants to and in favour of Watson as
follows:+ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4APA-o:p+AD4AJg-nbsp+ADsAPA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
+ADw-p
style+AD0-'margin-top:0in+ADs-margin-right:0in+ADs-margin-bottom:0in+ADs-margin-left:.5in+ADs-
margin-bottom:.0001pt+ADs-text-indent:-.5in+ADs-line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-a)+ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
+ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-Stellar is a
corporation duly incorporated validly subsisting under the laws of
the Province of Ontario, Canada and has the corporate power to
enter into this License Agreement and to perform its obligations
hereunder+ADsAPA-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
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style+AD0-'font-size:10.0pt+ADs-color:black'+AD4APA-o:p+AD4AJg-nbsp+ADsAPA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
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style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-Watson License
December 06+ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
style+AD0-'margin:0in+ADs-margin-bottom:.0001pt+ADs-line-height:12.0pt'+AD4-+ADw-span
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margin-bottom:.1in+ADs-margin-left:0in+ADs-text-align:center+ADs-line-height:12.0pt'+AD4APA-span
style+AD0-'font-size:10.0pt+ADs-color:black'+AD4- +ADw-hr
size+AD0-1 width+AD0AIg-100+ACUAIg- noshade
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style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-b)+ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
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style+AD0-'font-size:10.0pt+ADs-color:black'+AD4-This License
Agreement has been duly authorized, executed and delivered by
Stellar and is a legal, valid and binding obligation of
Stellar+ADs- +ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
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Commercialization Committee comprised of two senior managers
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Commercially Reasonable Efforts in the marketing and selling of the
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refrain from knowingly directly or indirectly selling the Products
outside the Territory during the Term of this License
Agreement.+ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4- +ADw-p
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Watson such continuing technical assistance and guidance as is from
time to time reasonably required by Watson+ADs- however, in no
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knowingly directly or indirectly selling the Products in the
Territory during the Term of this License Agreement and shall cause
its sub-licensees, designates, importers, promoters and agents to
refrain from knowingly, directly or indirectly, selling the
Products inside the Territory during the Term of this License
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or assist in the defence of such patent challenge but any such
costs incurred in connection with Watson+IBk-s election to
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Efforts to investigate the suspected diversion of the Products in
contravention of this Agreement. Each Party agrees to meet with the
other Party at its request to discuss matters relating to the
unauthorized importation and or sale into the Territory or outside
the Territory.+ADw-o:p+AD4APA-/o:p+AD4APA-/span+AD4APA-/p+AD4-
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medical event reporting recommendations and requirements in all
countries where the Parties carry out clinical studies and/or
market the Product. +ACY-nbsp+ADs-The Parties agree to exchange
such information as may be necessary to fulfill mandatory
regulatory obligations, including single case reports, together
with appropriate medical evaluations if requested by the regulatory
agency in any country, as well as aggregate data, such as periodic
reports required by the Party+IBk-s respective regulatory
authorities. +ACY-nbsp+ADs-Watson shall be solely responsible for
reporting to regulatory authorities in the Territory.
+ACY-nbsp+ADs-Stellar shall cooperate with and assist Watson in
such reporting, including by immediately notifying Watson of all
adverse reactions of which Stellar becomes aware. +ACY-nbsp+ADs-The
Parties shall follow the specific procedures as outlined further in
Appendix 4+ADw-i+AD4-,+ADw-/i+AD4- as such may be updated from time
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requirements of pharmacovigilance related to the Product.
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limiting the generality of its generally
|