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<PAGE>
EXHIBIT 10.35
CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS
OF THIS DOCUMENT MARKED [****] HAVE BEEN REDACTED AND HAVE BEEN
FILED SEPARATELY WITH THE U.S. SECURITIES AND EXCHANGE
COMMISSION
LICENSE AND COLLABORATION AGREEMENT
BETWEEN
ATHEROGENICS, INC.
AND
IPR PHARMACEUTICALS, INC.
DECEMBER 22, 2005
THIS CONFIDENTIAL DOCUMENT IS SUBJECT TO A NONDISCLOSURE
AGREEMENT
BETWEEN THE PARTIES HERETO AND MAY NOT BE VIEWED BY, COPIED FOR
OR
DISTRIBUTED TO ANY PERSON NOT SUBJECT TO SUCH NONDISCLOSURE
AGREEMENT OR NOT AUTHORIZED BY THE PARTIES HERETO.
<PAGE>
TABLE OF CONTENTS
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Page
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1.
DEFINITIONS....................................................................................
1
2.
PRODUCT
DEVELOPMENT............................................................................
17
2.1
Development Plan
17
2.2
Development Activities of the Parties
18
3.
REGULATORY
MATTERS.............................................................................
20
3.1
Regulatory Strategy
20
3.2
Regulatory Responsibility in General
20
3.3
Regulatory Authority Communications and Cooperation Between the
Parties
23
3.4
Communications Concerning Product
24
3.5
Records
24
3.6
Safety Matters
25
4.
COMMERCIALIZATION..............................................................................
25
4.1
Global Commercialization Team and U.S. Commercialization Team
25
4.2
Commercially Diligent Efforts
25
4.3
Commercialization Plan
26
4.4 Commercialization Activities
of the Parties
26
4.5
Commercial Manufacturing and Supply of Products
27
5.
DILIGENCE AND
COOPERATION......................................................................
27
5.1
Information Sharing
27
5.2
Diligence Requirements
28
5.3
Failure To Use Diligence
29
6.
GOVERNANCE.....................................................................................
29
6.1
General
29
6.2
Alliance Managers
29
6.3
Committees
30
7.
LICENSES AND
COVENANTS.........................................................................
34
7.1
License Grants to AstraZeneca
34
7.2
License Grants to AGIX
35
7.3
Rights Acquired from Third Parties
35
7.4
Covenants Concerning the Products, the Compound and the Field
36
8.
PAYMENTS AND
REPORTS...........................................................................
39
8.1
Upfront Payment
39
8.2
Milestone Payments
39
8.3
Royalties
41
8.4
Adjustments and Changes to Royalty Rates in Certain Circumstances
44
</TABLE>
i
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8.5
Payment; Report
48
8.6
Exchange Rate; Manner and Place of Payment
48
8.7
Representations and Covenants Concerning Certain Matters
51
9.
INTELLECTUAL
PROPERTY..........................................................................
51
9.1
Ownership of Inventions; Obligation to Update
51
9.2
IPC53
52
9.3
Patent Prosecution
55
9.4
Patent Marking
57
9.5
Infringement by Third Parties
57
9.6
Infringement of Third Party Rights
59
9.7
Cooperation
59
9.8
Awards and Recovery
60
9.9
Costs
60
9.10
Trademarks
61
10.
CONFIDENTIALITY................................................................................
62
10.1
Nondisclosure Obligation
62
10.2
Permitted Disclosures
63
10.3
Use of Name
64
10.4
Publicity
64
10.5
Publications
65
11.
REPRESENTATIONS AND
WARRANTIES.................................................................
65
11.1
Corporate Existence and Authority
65
11.2
Authorized Execution; Binding Obligation
65
11.3
No Conflicts
65
11.4
All Consents and Approvals Obtained
66
11.5
AGIX Representations and Warranties. AGIX represents and warrants
to AstraZeneca as
follows:
66
11.6
Other Agreements
68
11.7
Debarment
68
11.8
Knowledge of Pending or Threatened Litigation
69
11.9
Pre-Existing Third Party Licenses
69
11.10
Disclaimer of Implied Warranties
70
11.11
Limitation of Liability
70
11.12
Guarantee of Performance of Affiliates
70
12.
INDEMNIFICATION................................................................................
71
12.1
AstraZeneca Indemnification
71
12.2
AGIX Indemnification
71
12.3
Indemnification Procedures
72
12.4
Indemnification Payment Adjustments
73
12.5
Indemnification Payment
74
12.6
Survival
74
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ii
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13. TERM AND
TERMINATION...........................................................................
74
13.1
Term
74
13.2
Condition Precedent
74
13.3
Termination by AstraZeneca
75
13.4
Termination for Material Breach or Bankruptcy
76
13.5
Effects of Termination
77
13.6
Non-Exclusive Rights
81
13.7
Rights in Bankruptcy
81
13.8
Accrued Rights and Obligations; Survival
81
14. DISPUTE
RESOLUTION.............................................................................
82
14.1
Procedure
82
14.2
Alternative Dispute Resolution
82
14.3
Arbitration Procedure
83
14.4
Special Rules for Disputes Concerning Diligence Covenant
84
15.
MISCELLANEOUS..................................................................................
84
15.1
Standstill
84
15.2
Termination of Certain Rights Upon AGIX Change of Corporate Control
84
15.3
Assignment
85
15.4
Force Majeure
86
15.5
Further Assurances
86
15.6
Severability
86
15.7
Notices
86
15.8
Jurisdiction and Venue
87
15.9
Affiliates
87
15.10
Entire Agreement
87
15.11
Headings
87
15.12
Independent Contractors
87
15.13
Waiver
88
15.14
No
Third Party Beneficiaries
88
15.15
Cumulative Remedies
88
15.16
Counterparts
88
15.17
Waiver of Rule of Construction
88
</TABLE>
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Exhibit 1A .......
AGIX Compound Patents
Exhibit 1B .......
Co-Promotion Agreement
Exhibit 1C .......
Other AGIX Patents
Exhibit 1D .......
Pre-Existing Third Party Licenses
Exhibit 1E .......
Probucol Analog
Exhibit 1F .......
Transition Services Agreement
Exhibit 11.5 .....
Disclosure Concerning AGIX Representations and Warranties
</TABLE>
iii
<PAGE>
LICENSE AND COLLABORATION AGREEMENT
This
LICENSE AND COLLABORATION AGREEMENT (the "AGREEMENT") is made and
is
effective as of December 21, 2005 (the "EXECUTION DATE") by and
between
ATHEROGENICS, INC., a corporation organized and existing under the
laws of the
State of Georgia ("AGIX"), and IPR PHARMACEUTICALS, INC., a
corporation
organized and existing under the laws of Puerto Rico
("ASTRAZENECA").
RECITALS
A. AGIX is
engaged in manufacturing, research and development of
pharmaceutical products and is currently engaged in the development
of AGI-1067.
B.
AstraZeneca is engaged in the research, development, manufacture
and
marketing of pharmaceutical products. AGIX and AstraZeneca wish to
collaborate
in the further clinical development and marketing of the Compound,
upon the
terms described in this Agreement and the Related Agreements (as
defined
herein).
NOW,
THEREFORE, in consideration of the foregoing premises and the
mutual
covenants herein contained, the Parties hereby agree as
follows:
1. DEFINITIONS
When used
and capitalized in this Agreement (other than the headings of
the Sections and subsections), including the foregoing recitals,
the following
terms shall have the meanings assigned to them in this Section and
include the
plural as well as the singular. All financial and accounting terms
not otherwise
defined in this Agreement, whether capitalized or not, shall have
the meanings
assigned to them in accordance with generally accepted accounting
principles
based on International Accounting Standards/International Financial
Reporting
Standards as in effect from time to time ("GAAP").
"Accelerated Assumption Payment" has the meaning provided in
Section
3.2(c)(i) hereof.
"Action"
has the meaning provided in Section 12.3(a) hereof.
"ADR" has
the meaning provided in Section 14.2 hereof.
"ADR
Request" has the meaning provided in Section 14.2(a) hereof.
<PAGE>
"Adverse
Event" means any adverse medical occurrence in a patient or
clinical investigation subject administered a pharmaceutical
product and that
does not necessarily have to have a causal relationship with any
treatment,
including as designated under 21 C.F.R. Section 312.32 and any
other Applicable
Laws.
"Adverse
Event Report" means any oral, written or electronically
transmitted report of any Adverse Event.
"Affiliate" means any Person that directly (or indirectly through
one or
more intermediaries) controls, is controlled by, or is under common
control with
a Party. For purposes of this definition only, the terms
"controls,"
"controlled," and "control" means (i) the direct or indirect
ability or power to
direct or cause the direction of the management and policies of an
entity or
otherwise direct the affairs of such entity, whether through
ownership of
equity, voting securities, or beneficial interest, by contract, or
otherwise, or
(ii) the ownership, directly or indirectly, of at least 50% of the
voting
securities (or other comparable ownership interest for an entity
other than a
corporation) of a Party.
"AGIX
Compound Patents" mean those Patents listed in Exhibit 1A,
including
all foreign counterparts thereof, as supplemented and updated from
time to time
pursuant to Section 9.1(c) hereof.
"AGIX
Indemnitees" has the meaning provided in Section 12.1 hereof.
"AGIX IP"
means the Licensed Patents and AGIX Know-How.
"AGIX
Know-How" means Know-How Controlled by AGIX or any of its
Affiliates
on or after the Effective Date that is necessary or useful for the
research,
Development, Manufacture, Commercialization, use, sale, offer for
sale or
importation of the Compound and Products in the Field.
"AGIX
Losses" has the meaning provided in Section 12.1 hereof.
"Alliance Manager" has
the meaning provided in Section 6.2 hereof.
"Annualized Quarterly Net Sales" means the Net Sales for a given
Calendar
Quarter multiplied by four (4).
"Applicable Laws" means all applicable statutes, ordinances,
regulations,
rules, or orders of any kind whatsoever of any Governmental
Authority,
including, without limitation, the FD&C Act, Prescription Drug
Marketing Act,
Generic Drug Enforcement Act of 1992 (21 U.S.C. Section 335a et
seq.), and
Anti-Kickback Statute (42 U.S.C. Section 1320a-7b et seq.), all as
amended from
time to time in the Territory.
2
<PAGE>
"Approvable Letter" means a written communication from the FDA to
the
owner of the application for Regulatory Approval stating that the
FDA will not
approve the application, or that the FDA will approve the
application if
additional information is submitted or specific conditions are met,
pursuant to
21 C.F.R. Section 314.3(b).
"Arbitration Panel" has the meaning provided in Section 14.3(a)
hereof.
"ARISE
Results" means the statistical summary tables for efficacy and
safety of the unblinded efficacy and safety results from the ARISE
Study, which
summary tables are determined by a Third Party statistician,
mutually agreed to
by the Parties in advance, to be complete and final, analyzed in
accordance with
the last Statistical Analysis Plan submitted to the FDA before
locking the
database of the ARISE Study for unblinding.
"ARISE
Study" means the pivotal Phase III Study being conducted by
AGIX
known as ARISE.
"AstraZeneca Indemnitees" has the meaning provided in Section 12.2
hereof.
"AstraZeneca IP" means AstraZeneca Patents and AstraZeneca
Know-How.
"AstraZeneca Know-How" means Know-How Controlled by AstraZeneca or
any of
its Affiliates that is necessary or useful for the research,
Development,
Manufacture, Commercialization, use, sale, offer for sale or
importation of the
Compound and Products in the Field.
"AstraZeneca Losses" has the meaning provided in Section 12.2
hereof.
"AstraZeneca Patents" means any Patents Controlled by AstraZeneca
or any
of its Affiliates on or after the Effective Date that are necessary
or useful
for the Development, Manufacture, Commercialization, use, sale,
offer for sale
or importation of the Compound or any Product in the Field.
"Assumption Date" means the earlier of (i) the date of receipt of
U.S. NDA
Approval for the First Product and (ii) the date AstraZeneca pays
to AGIX the
Accelerated Assumption Payment.
"Blocking
Patent" means a patent owned or controlled by a Third Party
that
contains a Valid Patent Claim that (a) is necessary for the
Manufacture or sale
of a Compound or Product; and (b) the Development, use,
Manufacture, sale, offer
for sale or importation of such Compound or Product would infringe
such Third
Party's patent rights but for the grant of a license to such rights
by such
Third Party.
"Business
Combination" means any merger, consolidation, sale or transfer
of all or substantially all of the assets, or other similar
transaction to which
AGIX is a party unless, following such transaction or transactions,
(i) the
individuals and entities who
3
<PAGE>
were the beneficial owners of the outstanding voting securities of
AGIX
immediately prior to such transaction beneficially own, directly or
indirectly,
more than fifty percent (50%) of the combined voting power of the
then
outstanding voting securities entitled to vote generally in the
election of
directors or similar governing persons of the corporation or other
entity
resulting from such transaction ("SUCCESSOR") in substantially the
same
proportions as their ownership immediately prior to such
transaction of such
outstanding voting securities, and (ii) at least fifty percent
(50%) of the
members of the Board of Directors or similar governing body of the
Successor
were members of the Board of Directors of AGIX at the time of the
execution of
the initial agreement, or the action of the Board of Directors of
AGIX,
providing for such transaction.
"Business
Day" means any day other than a Saturday, Sunday or any day
that
is a banking holiday in the United States, United Kingdom or Puerto
Rico.
"Calendar
Quarter" means the respective periods of three (3) consecutive
calendar months ending on March 31, June 30, September 30 and
December 31.
"Calendar
Year" means each successive period of twelve (12) months
commencing on January 1 and ending on December 31.
"cGCP"
means the then current good clinical practices as defined in
U.S.
Regulations 21 C.F.R. Sections 50, 54, 56, 312 and 314, (or in the
case of
foreign jurisdictions, comparable regulatory standards), the
International
Conference of Harmonization (ICH) E6 "Good Clinical Practice:
Consolidated
Guidance," and in any successor regulation or any official guidance
documents
issued by a Regulatory Authority.
"cGLP"
means the then current good laboratory practice standards as
defined by the FDA pursuant to 21 C.F.R. Part 58 (or in the case of
foreign
jurisdictions, comparable regulatory standards), and in any
successor regulation
or any official guidance documents issued by a Regulatory
Authority.
"cGMP"
means the then-current good manufacturing practices as defined
by
the FDA pursuant to 21 C.F.R. Sections 210 and 211 and/or the
current
EC-GMP-Directives and relevant EC guidelines and the ECC-GMP-Guide
and in any
successor regulation or any official guidance documents issued by a
Regulatory
Authority.
"Change of
Corporate Control" means the occurrence of either of the
following:
(a) a Business Combination involving AGIX; or
(b) a change in the beneficial ownership of fifty percent (50%)
or
more of
AGIX's voting securities (whether in a single transaction or
series of
related transactions) where, immediately after giving effect to
such
change, the legal or beneficial owner of more than fifty
percent
(50%) of
AGIX's voting securities is a Third Party or Group, excluding
any
equity
investments by venture capitalists or
4
<PAGE>
investment
banks or other non-strategic investors, who alone or with their
Affiliates, are not themselves in the business of developing
and
commercializing pharmaceutical products.
"Coated
Stent" means a stent coated with a Product for use in the
Field.
"Combination Product" means a Product in final form that includes
one or
more pharmaceutically active ingredients other than the Compound,
in combination
with the Compound that are sold as a fixed dose or separate doses
in a single
package and priced as one item. All references to Product in this
Agreement
shall be deemed to include Combination Product(s).
"Commercialization" means all appropriate activities undertaken
before and
after Regulatory Approval pursuant to an approved Commercialization
Plan for a
Product or otherwise relating specifically to the marketing, sale
and
distribution of Products including, without limitation, (i) sales
force
detailing, advertising, education, planning, marketing, sales force
training and
distribution, and (ii) scientific and medical affairs.
"Commercialization Plan" has the meaning provided in Section
4.3(a)
hereof.
"Commercially Diligent Efforts" means, with respect to the
research,
Development, Manufacture or Commercialization by a Party of a
Compound or
Product, as the case may be, efforts and resources reasonably used
by an entity
of similar resources and expertise as such Party (and in the case
of
AstraZeneca, AstraZeneca or its Affiliates), for such similar
entity's own
compounds or products (including internally developed, acquired and
in-licensed
compounds or products) with similar commercial potential at a
similar stage in
their lifecycle (assuming continuing development of such product),
taking into
consideration their safety, tolerability and efficacy, the
competitiveness of
alternative products, the likelihood of Regulatory Approval, their
profitability
(taking into account any payments payable under this Agreement),
the extent of
market exclusivity, cost to develop the Compound or Product, health
economic
claims, and other similar factors reasonably determined by
AstraZeneca to be
relevant. If, at the time of measurement of Commercially Diligent
Efforts, the
efforts and resources used by AGIX or AstraZeneca and their
Affiliates, as the
case may be, for such entity's own similar compounds and products
(other than
the Compound and the Product(s)) are greater than those used by an
entity of
similar resources and expertise, then "Commercially Diligent
Efforts" shall mean
such entity's level of effort and resources, rather than the
efforts and
resources used by an entity with similar resources and
expertise.
"Compete"
means, with respect to a pharmaceutical product, that such
product is in the same Uniform System of Classification (USC) class
as another
product, as reported by IMS or any comparable successor agency.
5
<PAGE>
"Competing
Generic Product" means, with respect to a Product, a product
(i) having the same active pharmaceutical ingredient as the
Compound, and (ii)
that has been approved by applicable Regulatory Authorities for
sale in the
Field; provided, however, that a Competing Generic Product shall
not include any
product being sold or offered for sale by AstraZeneca or any
AstraZeneca
Affiliate.
"Competing
1067 Product" means any pharmaceutical product that Competes
with the Product.
"Compound"
means AGI-1067, which is [****]; including its
pharmacologically acceptable salts, solvates, hydrates,
hemihydrates,
polymorphs, metabolites, free base forms, pro-drugs, esters,
tautomers and if
applicable, any isomers, stereoisomers, racemates, enantiomers and
all optically
active forms thereof.
"Compound-Only Issue" means an issue relating to an AGIX Compound
Patent
or a claim included within an AGIX Compound Patent that in either
case claims,
or is directed to, solely the Compound or solely a Product.
"Compulsory Sublicense" means a sublicense of the rights granted in
this
Agreement entered into by AstraZeneca or an AstraZeneca Affiliate
because a
court or other governmental agency of competent jurisdiction has
required
AstraZeneca or an AstraZeneca Affiliate to grant to a Third Party
rights to
make, have made, use sell, offer to sell or import the Product in a
country in
the Territory; provided, however, that any such requirement shall
not include a
requirement by a court or other governmental agency of competent
jurisdiction
resulting from a merger with or acquisition of or by another
company or entity
involving AstraZeneca, or the acquisition by AstraZeneca of other
products.
"Confidential Information" has the meaning provided in Section
10.1
hereof.
"Control"
or "Controlled" means, with respect to any intellectual
property
right, that the Party or its Affiliate owns or has a license to
such
intellectual property right and has the ability to grant access, a
license, or a
sublicense to such intellectual property right to the other Party
as provided
for in this Agreement without violating an agreement with, or
infringing any
rights of, a Third Person.
"Co-Promotion Agreement" means the Co-Promotion Agreement
between
AstraZeneca Pharmaceuticals LP and AGIX dated as of the Execution
Date and
attached hereto as Exhibit 1B.
"De
Minimis Amount" has the meaning provided in Section 15.1
hereof.
"Development" means the conduct of all activities that are
reasonably
required to obtain Regulatory Approval or create other Indications
for a
Product, including, without limitation: (i) toxicology, in vitro
testing, in
vivo testing, in silico testing, stability testing,
-------
[****] indicates that certain confidential information contained in
this
document has been omitted pursuant to a request for confidential
treatment and
filed separately with the Securities and Exchange Commission.
6
<PAGE>
statistical analysis and report writing, packaging and regulatory
affairs,
pre-clinical studies and clinical trials in accordance with, to the
extent
applicable, the cGLPs, cGCPs and cGMPs or other designated quality
standards and
Applicable Laws; (ii) all activities relating to developing the
ability to
Manufacture the Compound and Product, including, without
limitation,
formulation, delivery technologies and devices, bulk production,
fill/finish,
Manufacturing process development, and Manufacturing and quality
assurance
technical support; (iii) Manufacture of clinical supplies of the
Compound; and
(iv) all interactions with any Regulatory Authority regarding the
foregoing.
"Development Budget" means the budget for Development activities
that is
included within each Development Plan, as such budget may be
amended or updated
from time to time in accordance with Section 2.1(d).
"Development Costs" means the reasonable costs incurred by a Party
or its
Affiliates for Development of Product(s), as in accordance with the
Development
Plan, including without limitation (to the extent included in the
Development
Plan): (a) all out-of-pocket costs and expenses, including without
limitation
payments to investigators and contract research organizations, data
management,
statistical design and analysis, and document preparation; (b) fees
incurred in
connection with filings related to Regulatory Approvals; (c) the
costs and
expenses of clinical supplies for such efforts as set forth in the
Development
Plan, including the cost of clinical supplies of Products, costs
and expenses
incurred to purchase or package combination drugs or devices, and
costs and
expenses of disposal of clinical samples; (d) the costs of internal
scientific,
medical, technical or managerial personnel necessary to conduct the
activities
set forth in the Development Plan; and (e) any other costs
necessary to conduct
the activities described in the Development Plan.
"Development Plan Outline" means the outline of the minimum items
to be
included in the Development Plan, which outline is contained in a
letter
delivered by AGIX to AstraZeneca on the date hereof.
"Development Plan" means a written rolling three-year plan for
the
Development of Product(s), including, without limitation, a budget
for such
activities, as such plan may be amended or updated from time to
time in
accordance with Section 2.1(d). The Initial Development Plan has
been agreed
upon by the Parties and is included in a letter delivered by AGIX
to AstraZeneca
on the date hereof.
"Development Program" means the activities undertaken by AGIX
and
AstraZeneca as set forth in the Development Plan.
"Diabetes"
means diabetes mellitus, insulin resistance, and complications
of diabetes, excluding the treatment of diabetic retinopathy using
nonsystemic
preparations (such as eyedrops, intraocular injections or local
ointments or
creams or eye patches).
"Dispute"
has the meaning provided in Section 14.1(a) hereof.
-------
[****] indicates that certain confidential information contained in
this
document has been omitted pursuant to a request for confidential
treatment and
filed separately with the Securities and Exchange Commission.
7
<PAGE>
"Drug
Device" means a combination of the Product and a therapeutic
device
and/or a device used to deliver the Compound.
"Effective
Date" has the meaning provided in Section 13.2(a) hereof.
"Exchange
Act" has the meaning provided in Section 15.1 hereof.
"Exclusive
Market Product" means a product (other than a Product) sold or
offered for sale by a person other than AGIX in a country that is
the subject of
a Valid Patent Claim directed to the composition of matter or use
of such
product in such country.
"Expanded
Field Indication" has the meaning provided in Section 7.4(a)
hereof.
"FDA"
means the U.S. Food and Drug Administration, or any successor
federal agency having responsibility over U.S. Regulatory
Approvals.
"FD&C
Act" means the U.S. Federal Food, Drug, and Cosmetic Act, as
amended
from time to time (21 U.S.C. Section 301 et seq.), together with
any rules and
regulations promulgated thereunder.
"Field"
means intravenous , injectable, solid and all other dosage or
delivery and therapeutic forms (oral and otherwise, and Drug
Devices, such as
Coated Stents) to treat, prevent or control atherosclerosis and
related
cardiovascular, renovascular, and cerebrovascular indications,
including but not
limited to peripheral vascular disease, post- coronary artery
by-pass graft
patency, restenosis following percutaneous coronary intervention,
carotid artery
disease, acute coronary syndrome, heart failure, stroke, impaired
renal
functions and Diabetes. "Field" shall not include any other
indications not
described in the preceding sentence, including, without limitation,
other
inflammatory and autoimmune diseases such as rheumatoid arthritis,
asthma,
chronic obstructive pulmonary disease, psoriasis, inflammatory
bowel disease,
and transplant vasculopathy, central nervous system diseases and
other
ophthalmic diseases and conditions not expressly included in the
Field, such as
treatment of diabetic retinopathy using nonsystemic preparations
(such as
eyedrops, intraocular injections or local ointments or creams or
eye patches).
"Final
ARISE Results" has the meaning provided in Section 13.3(a).
"First
Commercial Sale" means the date on which a Product is first
shipped
in commercial quantities by AstraZeneca, its Affiliates, or
Sublicensees, as the
case may be, for commercial sale to Third Persons (other than
AstraZeneca's
Sublicensees) in a country in the Territory following Regulatory
Approval of
such Product in such country.
"First
Product" means the Product contemplated by the Initial
Development
Plan.
8
<PAGE>
"GAAP" has
the meaning provided in the first paragraph of this Section 1.
"Generic
Competition" means, for a Product sold in a country, a
situation
where the following three conditions exist and continue:
(i) a court or agency of competent jurisdiction has cancelled
or
held
invalid or unenforceable claims under the Licensed Patents,
AstraZeneca Patents or Joint Patents prior to the expiration of
the
Royalty
Term for such country, such that a Third Party may, without
infringing
any Licensed Patents, AstraZeneca Patents or Joint Patents and
without a
license from or other agreement from AstraZeneca, sell a
Competing
Generic Product in such country; provided, however, that
Generic
Competition shall be considered to no longer be in effect if such
decision
is
reversed or modified such that any such claim in such Licensed
Patent,
AstraZeneca Patent or Joint Patent is reinstated or revalidated on
appeal;
(ii) a Competing Generic Product is being sold to the public in
such
country
pursuant to required approvals from applicable Regulatory
Authorities; and
(iii) the Net Sales of the Product in such country are reduced by
at
least
[****] compared with such Net Sales in such country immediately
preceding
the sale of such Competing Generic Product in such country.
The comparison in clause (iii) above shall be measured for a given
Calendar
Quarter by comparing Net Sales in such country for (A) the
twelve-month period
immediately preceding and including the three months in such
Calendar Quarter,
with (B) the twelve month period preceding and including the month
immediately
preceding the month containing the date that AstraZeneca reasonably
determines
as the date the Competing Generic Product was first offered for
sale to the
public in such country, or was first shipped in such country in
commercial
quantities following receipt for such Competing Generic Product of
required
regulatory approvals from applicable Regulatory Authorities. Where
less than
twelve (12) months of Net Sales for the Product has occurred prior
to the first
sale of the Competing Generic Product, Net Sales shall be
determined on an
annualized basis.
"Global
Commercialization Team" means AstraZeneca's and its Affiliates'
team responsible for the commercialization of Products throughout
the world.
"Governmental Authority" means any court tribunal, arbitrator,
agency,
commission, official or other instrumentality of any federal,
state, or other
political subdivision, or supranational body, domestic or
foreign.
"Group"
means a group of related Persons deemed a "person" for purposes
of
Section 13(d) of the Securities Exchange Act of 1934, as
amended.
-------
[****] indicates that certain confidential information contained in
this
document has been omitted pursuant to a request for confidential
treatment and
filed separately with the Securities and Exchange Commission.
9
<PAGE>
"HSR"
means the Hart-Scott-Rodino Antitrust Improvements Act of 1976,
as
amended.
"Indemnifying Party" means the Party to whom the Indemnitee is
entitled to
look for indemnification, pursuant to Section 12.3(a) hereto.
"Indication" means any use of the Product in the Field as approved
by
Regulatory Authorities.
"Indication Fee" has the meaning provided in Section 7.4(a)
hereof.
"Indication Information" has the meaning provided in Section
7.4(a)
hereof.
"Indirect
Taxes" means value added taxes, sales taxes, consumption taxes
and other similar taxes.
"Initial
Development Plan" means that development plan which AGIX has
previously agreed with the FDA will be completed prior to
submission by AGIX of
an NDA for the Product, and which is contained in a letter
delivered by AGIX to
AstraZeneca on the date hereof.
"IPC
Patent Counsel" has the meaning provided in Section 9.2(b)(iv)
hereof.
"IPC" has
the meaning provided in Section 6.3(h) hereof.
"JDC" has
the meaning provided in Section 6.3(b) hereof.
"JMC" has
the meaning provided in Section 6.3(a) hereof.
"Joint
Inventions" has the meaning provided in Section 9.1(d) hereof.
"Joint
Patents" has the meaning provided in Section 9.1(e) hereof.
"Know-How"
means all tangible and intangible: (a) techniques, technology,
practices, trade secrets, discoveries, inventions, methods,
formulas, knowledge,
know-how, skill, experience, tests, assays, test data and results
(including
pharmacological, toxicological, pre-clinical and clinical test data
and
results), technical, non-technical, analytical and quality control
data, results
or descriptions, drawings, plans, diagrams, software and
algorithms; and (b)
compounds, compositions of matter, cells, cell lines, assays,
animal models and
physical, biological or chemical material that, in either case, is
Controlled by
a Party or the Parties, or Affiliates of a Party on or after the
Effective Date
and that is necessary or useful for the Development, Manufacture
or
Commercialization of a Compound or Product.
"Knowledge
of AGIX" means the actual knowledge of the following AGIX
employees: any Vice-President or Senior Vice-President of AGIX or
higher, the
Chief
&