<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
<TABLE>
<CAPTION>
Page
----
<S>
<C>
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
<PAGE>
<TABLE>
<S>
<C>
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
</TABLE>
ii
<PAGE>
<TABLE>
<S>
<C>
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>
<TABLE>
<S>
<C>
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
10
<PAGE>
Executive Officer of AGIX and, with respect to intellectual
property matters,
the Director of Legal Affairs and Intellectual Property, and, in
the case of
each such officer, such additional knowledge as could be obtained
upon
reasonable inquiry of AGIX employees and AGIX records.
"Licensed
Patents" means AGIX Compound Patents and Other AGIX Patents.
"Licensed
Probucol Analog" has the meaning provided in Section 7.4(b)
hereof.
"Major
Market" means any of the following jurisdictions: [****].
"Manufacture" and "Manufacturing" means, with respect to a Product
or
Compound, the synthesis, manufacturing, processing, formulating,
packaging,
labeling, holding and quality control testing of such Product or
Compound.
"Material
Restructuring" means the transfer to any Third Party by either
Party of more than fifty percent (50%) of its fixed (tangible and
intangible)
assets as shown on the balance sheet of the Party at December 31,
2005.
"Mixed
Issue" means an issue relating to a Licensed Patent that is not
a
Compound-Only Issue.
"NDA"
means the single application or set of applications (and any
other
required registrations, notifications, forms or supplements) for a
Product
and/or pre-market approval to make and sell commercially a Product,
filed with
the FDA or with a Regulatory Authority anywhere in the
Territory.
"NDA
Acceptance" means the acceptance in writing for regulatory filing
of
a NDA by the FDA.
"Net
Sales" means the gross invoiced amount on sales of Products to
Third
Parties by AstraZeneca, its Affiliates, distributors and
Sublicensees (except
for sales by Sublicensees who are parties to Compulsory Sublicenses
and for
sales by AstraZeneca to Sublicensees), after deduction of the
following items:
(a) discounts or rebates given that are consistent with
AstraZeneca's group accounting (except for bundled Products as
provided below);
(b) amounts repaid or credited because of rejections, returns,
refunds, recalls and the like;
(c) rebates and similar payments made with respect to sales paid
for
by any government or Regulatory Authority (except for bundled
Products);
-------
[****] 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.
11
<PAGE>
(d) [****] net of the amounts described in clauses (a), (b),
(c)
and (e) in this definition, for transportation costs, distribution
expenses,
special packaging and related insurance charges;
(e) taxes, excise taxes, Indirect Taxes, customs duties,
customs
levies and import fees paid on the sale, importation, use or
distribution of a
Licensed Product; and
(f) bad debts actually incurred.
Net Sales
shall be calculated (i) using AstraZeneca's internal audited
systems used to report gross invoiced sales as adjusted for any of
the items in
clauses (a) through (f) of the preceding sentence, and (ii)
consistent with
GAAP, with the exception of bundled Products in clauses (a) and
(c), and bad
debts in clause (f), of the preceding sentence. Where any discount
or rebate
(including rebates or payments described in clause (a) or (c) of
the first
sentence of this definition) is based on sales of a bundled set of
products in
which a Product is included, the discount or rebate would be
allocated as
actually credited unless the Product receives a higher than pro
rata share of
the discount or rebate then the bundled product receives. In such
case, the
Product discount or rebate shall be allocated to such Product on no
greater than
a pro rata basis based on the sales value (i.e., the unit average
selling price
multiplied by the unit volume) of the Product relative to the sales
value
contributed by the other products in the bundled set with respect
to such sale.
The calculation
of Net Sales for Combination Products is set forth in
Section 8.4(f) hereof and shall be the sole method for calculating
Net Sales for
such Combination Products.
"Noncompulsory Sublicense" means any sublicense of the rights
granted in
this Agreement entered into by AstraZeneca or an AstraZeneca
Affiliate, other
than a Compulsory Sublicense.
"Non-Exclusive Market Product" means a product sold or offered for
sale by
a person other than AGIX in a country that is not the subject of
any Valid
Patent Claim directed to the composition of matter or use of such
product in
such country.
"Other
AGIX Patents" means any Patents, other than AGIX Compound
Patents,
Controlled by AGIX 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
Products in the
Field, including those Patents listed in Exhibit 1C and all foreign
counterparts
thereof, as supplemented and updated from time to time pursuant to
Section
9.1(d) hereof.
"Party" or
"Parties" means AGIX and/or AstraZeneca.
-------
[****] 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.
12
<PAGE>
"Patent"
or "Patents" means (a) United States and non-United States
patent
applications (including provisional applications, continuation
applications,
continued prosecution applications, continuation-in-part
applications,
divisional applications, substitute applications, or abandoned
applications and
applications for certificates of invention), including without
limitation patent
applications under the International Treaties and Conventions,
including the
Patent Cooperation Treaty and the European Patent Convention; (b)
any patents
issued or issuing from such patent applications (including
certificates of
invention); (c) all patents and patent applications based on,
corresponding to,
or claiming the priority date(s) of any of the foregoing; (d) any
reissues,
substitutions, confirmations, registrations, renewals, patents of
addition,
validations, re-examinations, additions, continuations, continued
prosecution
applications, continuations-in-part, or divisionals of or claiming
priority to
any of the foregoing; and (e) term extensions, supplementary
protection
certificates and other governmental action which provide exclusive
rights to a
product beyond the original patent expiration date.
"Person"
means a natural person, a corporation, a partnership, a trust,
a
joint venture, a limited liability company, any Governmental
Authority or any
other entity or organization.
"Plaque
Regression Claim" means the date that AstraZeneca or its
Affiliates (a) may through its sales representatives promote
atherosclerotic
plaque regression in connection with the promotion of a Product in
the United
States consistent and in accordance with the FD&C Act and (b)
actually
authorizes its sales force to engage in such promotion.
"Pre-Existing Third Party Licenses" means the Patent Purchase
Agreement
between Sampath Parthasarathy, Ph.D. and AtheroGenics, Inc., dated
April 26,
1995 and the License Agreement between Emory University and
AtheroGenics, Inc.,
dated January 23, 1995, as amended August 3, 2005, as attached
hereto as Exhibit
1D.
"Probucol
Analog" has the meaning set forth in Exhibit 1E.
"Probucol
Analog Fee" has the meaning provided in Section 7.4(b) hereof.
"Probucol
Analog Information" has the meaning provided in Section 7.4(b)
hereof.
"Product"
means a pharmaceutical product that contains or incorporates
the
Compound, whether in development or approved by any Regulatory
Authority,
including all formulations, line extensions and modes of
administration
(including, without limitation, all delivery devices, dosage forms
or other
peripherals and consumables), including, without limitation,
Combination
Products.
13
<PAGE>
"Product
Complaint" means any written, verbal, or electronic expression
of
dissatisfaction regarding a Product including, but not limited to,
actual or
suspected product tampering, contamination, mislabeling, or wrong
ingredients.
"Product
Launch" shall mean the date on which the First Product is first
shipped in commercial quantities by AstraZeneca, its Affiliate or
Sublicensee
for commercial sale to Third Persons in the Territory (not
Affiliates or
Sublicensees) following Regulatory Approval of such Product.
"Product
Trademarks" means (i) the Trademarks for or relating to any
Products and the registrations thereof, (ii) any pending or future
Trademark
registration applications relating to the Products, (iii) any
unregistered
Trademark rights relating to the Products as may exist through use
prior to or
as of the date hereof, (iv) any current or future modifications or
variants of
any of the foregoing rights, and (v) any future Trademarks adopted
by
AstraZeneca or its Affiliates for use in connection with the
Products.
"Promotable Diabetes Claim" means that AstraZeneca or its
Affiliates (a)
may through its sales representatives promote treatment or
prevention of
Diabetes in the United States consistent and in accordance with the
FD&C Act and
(b) actually authorizes its sales force to engage in such
promotion.
"Promotion" means those activities normally undertaken by a
pharmaceutical
company's sales force to implement marketing plans and strategies
aimed at
encouraging the appropriate use of a particular prescription or
other
pharmaceutical product, including detailing. When used as a verb,
"Promote"
means to engage in such activities.
"Promotional Materials" means any printed or other materials
bearing a
Product name (trade name or generic name) used to promote Product,
(examples
include, but are not limited to, all promotional brochures, journal
ads,
brochures, selling aids, posters, reprints, video or audio tapes,
press
releases, service items, managed care pull through sheets,
formulary
presentations, price lists, monographs, Internet pages and
websites, and
telephone, radio or television advertisements) and materials
produced by outside
sources (examples include, but are not limited to, medical
reprints, textbooks
and CME materials) to the extent funded by, created in cooperation
with,
reviewed by or distributed by a Party, and any other items defined
as labeling
or advertising in Section 201(m) of the FD&C Act or 21 C.F.R.
Section
202.1(l)(1) (as such sections may be amended from time to time).
"Promotional
Materials" shall also be deemed to include any advertising and
promotional
labeling bearing the Parties' names but not bearing a Product name
(examples
include "coming soon" or "reminder" advertisements) that may be
used prior to
obtaining Regulatory Approval to market, sell and distribute a
Product to
promote only the Indications of the Product.
"Prosecution" has the meaning provided in Section 9.3(a)
hereof.
14
<PAGE>
"Recent
Monthly Net Sales" means an amount equal to the aggregate
monthly
Net Sales of the Products during the last twelve (12) months
preceding the date
that notice of termination is provided by AstraZeneca to AGIX,
divided by twelve
(12).
"Regulatory Approval" means any and all approvals (including, to
the
extent necessary, pricing approvals), licenses, registrations or
authorizations
of any Regulatory Authority, necessary for the Development,
Manufacture or
Commercialization of a Product.
"Regulatory Authority" means, in a particular country or
jurisdiction, any
applicable government regulatory authorities involved in granting
Regulatory
Approval of Product in such country or jurisdiction, including
without
limitation, (a) in the United States, the FDA, and any other
applicable
governmental or regulatory authority in the United States having
jurisdiction
over Product, and any successor government authority having
substantially the
same function, and (b) any non-United States equivalent
thereof.
"Regulatory Materials" means any regulatory submissions,
notifications,
registrations, approvals and/or other filings and correspondence
made to or with
a Regulatory Authority, and any other records required to be
maintained for
possible audit by a Regulatory Authority, that may be necessary or
reasonably
desirable to Develop, Manufacture, market, sell or otherwise
Commercialize
Products in the Territory.
"Related
Agreements" means the Co-Promotion Agreement and Transition
Services Agreement entered into by the Parties contemporaneously
with this
Agreement.
"Representatives" shall be deemed to include each Person that is
or
becomes (i) an Affiliate of AstraZeneca, or (ii) an officer,
director, employee,
attorney, advisor, accountant, agent or representative of
AstraZeneca or of any
of AstraZeneca's subsidiaries or other Affiliates, providing such
person is
acting on behalf of AstraZeneca.
"Royalty"
or "Royalties" means the running royalties paid pursuant to
Section 8.3.
"Royalty
Term" means, with respect to each Product, for each country in
the Territory, the period of time commencing on the First
Commercial Sale of
such Product in any country and ending upon the expiration of the
later of: (a)
the last Valid Patent Claim of a Licensed Patent, a Joint Patent or
an
AstraZeneca Patent that would preclude a Third Party from
developing, making,
using, selling or importing such Product in such country; and (b)
ten (10) years
from the First Commercial Sale of such Product.
"Secondary
Market" means the following countries: [****].
"Standard
Sales Price" means the published sales price for the Product in
the relevant country.
-------
[****] 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.
15
<PAGE>
"Sublicensee" means any Third Person (including, without
limitation, a
distributor) to which a Party or any of its Affiliates grants any
right to make,
use, market, or import and sell a Product in accordance with
Section 7.1(c).
Notwithstanding the foregoing, a Third Person who is granted only
the right to
distribute or promote a Product (such as a contract sales
organization) shall
not be considered a Sublicensee.
"Successor" has the meaning provided in the definition of
Business
Combination.
"Term" has
the meaning provided in Section 13.1 hereof.
"Territory" shall mean all countries of the world.
"Third
Party" or "Third Person" means any Person other than AGIX or
AstraZeneca and their respective Affiliates.
"Third
Party Royalties" means upfront, milestone, royalty and any
other
similar payments paid by AstraZeneca or any AstraZeneca Affiliate
to any Third
Party for any Blocking Patent for the Development or
Commercialization of
Compounds or Products, other than pursuant to a Pre-Existing Third
Party
License.
"Trademark" means any trademark, trade dress, brand mark, trade
name,
brand name, corporate name, logo or business symbol.
"Transition Services Agreement" means the Transition Services
Agreement
between the Parties, dated as of the Execution Date and attached
hereto as
Exhibit 1F.
"U.S."
means the United States of America, including its territories
and
possessions.
"U.S.
Commercialization Team" means AstraZeneca's and its Affiliates'
team
responsible for the commercialization of Products in the United
States.
"U.S. NDA
Approval" means approval by the FDA of the NDA filed with the
FDA relating to a Product.
"Valid
Patent Claim" means a claim of an issued and unexpired Patent,
together with any patent term extension, supplementary protection
certificate,
and/or regulatory approved period of exclusivity which has not been
revoked or
held unenforceable or invalid by a decision of a court or other
governmental
agency of competent jurisdiction, and which is not appealable or
has not been
appealed within the time allowed for appeal, and which has not been
disclaimed,
denied or admitted to be invalid or unenforceable through
reissue,
re-examination, opposition, disclaimer or otherwise.
16
<PAGE>
2. PRODUCT DEVELOPMENT
2.1
Development Plan
(a) Contents of the Development Plan. The Development Plan shall,
to
the extent applicable, (i) identify the Product(s) to be Developed
by the
Parties, including any Combination Product(s), Coated Stent(s) and
other Drug
Devices; (ii) describe the overall program of Development for each
such Product
through Regulatory Approval (A) in all Major Markets; (B) in the
Secondary
Market taken as a whole; and (C) in other countries; (iii) describe
the
Development activities of the Parties, including preclinical
studies,
pharmacology, toxicology, ADME, formulation, Manufacturing of
clinical supply,
clinical pharmacology studies, clinical studies and regulatory
plans and other
key elements necessary to obtain Regulatory Approval for each such
Product; (iv)
specify plans and protocols for clinical studies (including
protocol outlines
for Phase IIIb and Phase IV clinical studies for label indication);
and (v)
establish a schedule for all such activities. In addition, the
Development Plan
shall include a detailed Development Budget that shall specify the
Development
Costs for all Development activities covered by the Development
Plan supported
by a financial business case.
(b) Initial Development. The Initial Development Plan is
contained
in a letter delivered by AGIX to AstraZeneca on the date
hereof.
(c) Additional Development . The Parties shall, within one
hundred
eighty (180) days of the Effective Date, prepare a Development
Plan, which shall
describe the Development activities in addition to those activities
described in
the Initial Development Plan which will include additional
Development
activities both before and after submission of the NDA for the
First Product,
and an anticipated schedule for such activities. Such additional
Development
Plan shall comply with Section 2.1(a) and shall be consistent with
the
Development Plan Outline. The amendment shall become effective upon
approval by
the JMC.
(d) Further Amendments to the Development Plan
(i) The JDC shall prepare for approval by the JMC amendments
and updates to the Development Plan at least once each Calendar
Year.
(ii) Prior to the Assumption Date, notwithstanding anything
else in this Agreement to the contrary, no Development Plan or
amendment to a
Development Plan shall be inconsistent with or contradict the
Initial
Development Plan or Development Plan Outline; provided, however,
that
AstraZeneca shall remain subject to the obligations set forth in
Section
2.2(c)(i). In addition, no Development Plan shall obligate a Party
to undertake
Development activities or expenditures beyond those
17
<PAGE>
contemplated by the Initial Development Plan or Development Plan
Outline without
the written agreement of such Party.
2.2
Development Activities of the Parties
(a) Compliance with the Development Plan. The Parties agree to
use
Commercially Diligent Efforts to carry out Development of
Product(s) in
accordance with the Development Plan under the direction and
oversight of the
JDC; provided, however, that:
(i) Neither Party shall be obligated to incur Development
Costs in excess of the amounts allocated to such Party as specified
in the
Development Plan;
(ii) The JMC shall be responsible for strategic planning
regarding Development of Products, and shall have the authority to
approve the
Development of Coated Stent(s), identify Combination Products for
which
Regulatory Approval will be sought, and identify any other
potential Indications
or Products. The JMC shall be responsible for approval of
amendments to and
updates of the Development Plan to provide for any such additional
Products and
to oversee Development of any such Products; and
(iii) In no event shall the JDC or the JMC be authorized to
take any action, including approving any amendment to the
Development Plan, that
would cause either Party to increase its Development Costs in
excess of those
expressly contemplated by the Agreement or the then approved
Development Plan
without the approval of such Party.
(b) AGIX Development Activities
(i) AGIX shall have responsibility, at its sole cost and at
the direction of the JDC, for Development, including without
limitation
conducting and managing clinical studies, for those Development
activities
described in the Initial Development Plan.
(ii) AGIX shall sponsor, prepare and submit, at its sole cost
and at the direction of the JDC, the U.S. NDA with respect to such
First
Product; provided, however, that AstraZeneca shall cooperate and
assist AGIX
with such filing.
(iii) AGIX may, at any time prior to the Assumption Date, in
its discretion and at its own expense, elect to sponsor and conduct
a FOCUS
Study (Further Follow up Of AGI-1067 in ARISE Continuation as an
Unblinded
Study) and/or a LOCATE Study (Limited Outcome Collection following
ARISE for
Terminal Endpoints), unless the Parties otherwise agree to include
either or
both such studies in the Development Plan, in which case
AstraZeneca shall pay
the cost of such study or studies.
18
<PAGE>
If AGIX elects to
sponsor and conduct either such study or both studies, and if
AstraZeneca does not terminate the Agreement pursuant to Section
13.3(a), then
AstraZeneca shall thereafter be responsible for [****] of such
Studies
(including costs incurred by AGIX prior to and subsequent to the
date when
AstraZeneca elects not to terminate the Agreement pursuant to
Section 13.3(a)).
(iv) AGIX shall have the right to Manufacture clinical
supplies of the Compound for its own Development activities
pursuant to the
Development Plan.
(c) AstraZeneca Development Activities
(i) Except as set forth in Section 3.2(c), AstraZeneca shall
have responsibility, at its sole cost and at the direction of the
JDC, for all
Development activities described in the Development Plan associated
with the
Products that are not described in the Initial Development Plan,
which shall
include conducting and managing a Carotid Intima Medial Thickness
(CIMT) Study
(unless AstraZeneca can demonstrate that it would be commercially
unreasonable
to do so).
(ii) Except as set forth in Section 3.2(c), AstraZeneca shall
have responsibility, at its sole cost and at the direction of the
JDC, for all
Development activities described in the Development Plan necessary
to seek
Regulatory Approval for the Products in the Territory outside the
United States,
including without limitation conducting and managing clinical
studies required
for Regulatory Approval in such countries.
(iii) The JDC shall identify, and the JMC shall have the
authority to approve as a part of the Development Plan, potential
post-marketing
clinical studies, and AstraZeneca shall be responsible for
conducting and
managing such post-marketing Clinical Studies, with AGIX assisting
in such
management to the extent mutually agreed by the Parties.
(d) Cooperation
(i) Each Party shall assist the other Party in all Development
activities to the extent reasonably requested and mutually agreed
to by the
Parties.
(ii) AstraZeneca shall be entitled, but not required, to have
three (3) representatives designated by AstraZeneca participate on
AGIX's
Development team prior to U.S. NDA Approval. AGIX shall provide
space at its
facility for such representatives to facilitate such
participation.
(iii) AGIX shall be entitled, but not required, to have three
(3) representatives designated by AGIX participate on AstraZeneca's
Development
team after U.S. NDA Approval. AstraZeneca shall provide space at
its facility
for such representatives to facilitate such participation.
-------
[****] 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.
19
<PAGE>
(e) Costs. Unless otherwise indicated in this Agreement or as
otherwise agreed to by the Parties, each Party shall bear its own
costs in
connection with its activities under this Section.
3. REGULATORY MATTERS
3.1
Regulatory Strategy. The Parties shall work together through the
JDC
and the JMC to determine regulatory strategy in the Territory.
3.2
Regulatory Responsibility in General
(a) AGIX's Responsibilities
(i) AGIX shall be responsible for the preparation, submission,
and maintenance of Regulatory Materials, including without
limitation the NDA,
for the First Product in the United States prior to the Assumption
Date;
provided, however, that AstraZeneca shall cooperate and assist AGIX
as
reasonably requested by AGIX.
(ii) Promptly after the Assumption Date, AGIX shall assign to
AstraZeneca all of AGIX's rights in and to all Regulatory Materials
relating to
the First Product, and shall take all other necessary actions
required to allow
AstraZeneca to assume ownership, possession and control of such
Regulatory
Materials.
(b) AstraZeneca's Responsibilities
(i) After the date of assignment described in Section
3.2(a)(ii), AstraZeneca shall be responsible for the preparation,
submission and
maintenance of Regulatory Materials for the First Product in the
United States.
(ii) AstraZeneca shall, to the extent set forth in the
Development Plan, be responsible for the preparation, submission
and maintenance
of Regulatory Materials for the First Product in all countries
outside of the
United States.
(iii) AstraZeneca shall, to the extent set forth in the
Development Plan, be responsible for the preparation, submission
and maintenance
of Regulatory Materials for all other Products in the
Territory.
(c) Accelerated Assumption Payment
(i) Notwithstanding anything herein to the contrary, at any
time following payment by AstraZeneca to AGIX of the ARISE
Milestone and the NDA
Acceptance Milestone and prior to U.S. NDA Approval for the First
Product,
AstraZeneca may elect to pay to AGIX a nonrefundable, noncreditable
payment of
U.S. [****] (the "ACCELERATED ASSUMPTION PAYMENT"), and thereby (A)
become the
owner of
-------
[****] 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.
20
<PAGE>
the Regulatory Materials in the United States for the First Product
in lieu of
AGIX, and (B) assume decision-making authority and responsibility
for the
preparation, submission and maintenance of Regulatory Materials and
for
interaction with Regulatory Authorities, with the JDC oversight as
set forth in
Section 6.3(b) and in accordance with the Development Plan, for any
decisions
concerning the First Product. Notwithstanding the foregoing, if
Regulatory
Approval for the First Product has not occurred within one hundred
eighty (180)
days of the Accelerated Assumption Payment, the Parties shall
accept the label
then proposed by the FDA for Regulatory Approval, so as to allow
the Parties to
promptly obtain U.S. NDA Approval for the First Product.
(ii) If AstraZeneca makes the Accelerated Assumption Payment,
AstraZeneca shall not be obligated to pay the U.S. NDA Approval
Milestone.
(d) Expenses
(i) AGIX's Expenses. Prior to the Assumption Date, AGIX shall
be responsible for the cost of preparing, submitting and
maintaining the
Regulatory Materials for the First Product in the United
States.
(ii) AstraZeneca's Expenses. AstraZeneca shall be responsible
for the cost of preparing, submitting and maintaining the
Regulatory Materials
for (i) the First Product (a) in the United States after the
Assumption Date,
and (b) in all of the other countries other than the United States
in the
Territory and (ii) for all other Product(s) in the Territory.
(iii) Cooperation Expenses. Each Party shall bear its own
expenses incurred in cooperating with the owner of the Regulatory
Materials or
participating in the preparation, submission and maintenance of
Regulatory
Materials pursuant to this Section 3.2.
(e) Ownership
(i) Prior to the Assumption Date, AGIX shall own all
Regulatory Materials and any applications and other filings made
with the FDA
relating to the First Product.
(ii) Promptly after the Assumption Date as the Parties agree
is appropriate, but no later than promptly after the date of U.S.
NDA Approval,
AstraZeneca shall own all Regulatory Materials and any applications
and other
filings made with the FDA relating to the First Product.
(iii) AstraZeneca shall own all Regulatory Materials and any
applications and other filings made with a Regulatory Authority
relating to the
First Product in all countries other than the United States in the
Territory.
Prior to the transfer of ownership of the Regulatory Materials to
AstraZeneca as
described in
21
<PAGE>
Section 3.2(e)(ii), AGIX shall provide a right of reference to the
Regulatory
Materials and shall take all action necessary to effect such right
of reference,
to the extent necessary or useful for AstraZeneca to pursue
Regulatory Approval
of Products in countries other than the United States.
(iv) AstraZeneca shall own all Regulatory Materials and any
applications and other filings made with a Regulatory Authority
relating to any
other Product(s) in the Territory.
(v) Notwithstanding anything in this Agreement to the
contrary:
(A) AGIX may keep
archival copies of all Regulatory
Materials
that AGIX creates or receives during the Term;
(B) AstraZeneca shall provide to AGIX promptly after
their
creation, and AGIX may keep, archival copies of any material
Regulatory
Materials (as agreed upon by the Parties) created subsequent to
the
Assumption Date, or in connection with Regulatory Materials created
or
received
by or on behalf of AstraZeneca pursuant to this Agreement at
any
time during the Term,
including without limitation Section 3.2(e)(i)-(iv);
(C) AGIX shall have the right to use Regulatory
Materials
(including study protocols, study results, analytical
methodologies, bulk and final product manufacturing process
descriptions,
batch
records, vendor qualifications, validation documentation, and
regulatory
documentation) for its own internal use in connection with its
research,
development and commercialization activities consistent with
the
requirements of this Agreement but shall remain obligated under
Section 10
with
respect to such Regulatory Materials.
(f) Periodic Updates. The owner of the Regulatory Materials shall
be
exclusively responsible (with reasonable cooperation from the other
Party as may
be requested by the owner of the Regulatory Materials from time to
time) for all
post-approval updates to Regulatory Materials, such as annual
updates,
supplements and amendments and routine maintenance of the
submissions of the
Regulatory Materials that must be provided on a Product at periodic
intervals to
the Regulatory Authorities. In addition, the owner of the
Regulatory Materials
shall be the sponsor of all filings for Indications.
(g)
Relationship with Regulatory Authorities. The Party who owns
the
Regulatory Materials shall have primary responsibility for
interacting with
Regulatory Authorities, chairing meetings with such Regulatory
Authorities,
responding to inquiries of such Regulatory Authorities, and other
communications
with such Regulatory Authorities, with regard to such Regulatory
Materials or a
Product, including but not
22
<PAGE>
limited to, Regulatory Materials related to Indications and Drug
Devices. Each
Party shall provide to the other Party copies of any material
Regulatory
Materials (and any updates thereto and any other Regulatory
Materials reasonably
requested by a Party) submitted to Regulatory Authorities, within
five (5) days
of such Party's submission thereof to such Regulatory Authorities
.
3.3 Regulatory
Authority Communications and Cooperation Between the Parties
(a) General. Each Party shall provide the other Party with a copy
of
all material correspondence received from a Regulatory Authority
(and any other
correspondence reasonably requested by a Party). Each Party shall
consult and
cooperate with the other Party in the preparation of its Regulatory
Materials
and any meetings or other correspondence with a Regulatory
Authority. Each Party
shall further consult with and keep the other Party regularly and
fully informed
of, the preparation, Regulatory Authority review and approval of
NDA filings for
which such Party is responsible. Each Party agrees to consider in
good faith any
comments or suggestions made by the other Party in relation to any
Regulatory
Materials, but the Party responsible for submitting such Regulatory
Materials
shall have the final authority to determine the content of such
Regulatory
Materials. In the event a Party is meeting in person or by
telephone with or has
a hearing before any Regulatory Authority, such Party shall provide
the other
Party with reasonable advance notice of the time and date of such
meeting or
hearing and any preparatory material for use in such meeting or
hearing and a
reasonable number of representatives of the other Party shall have
the right to
attend such hearing or meeting.
(b) Communications With Regulatory Authorities. Except as
otherwise
provided in the Development Plan, the Party that does not own any
particular
Regulatory Materials shall not, without the prior consultation
with, and
agreement of the owner of the Regulatory Materials, or unless so
required by
law, correspond or communicate with Regulatory Authorities
concerning a Product
covered by such Regulatory Materials or any Regulatory Materials
related
thereto. Each Party shall keep the other Party informed of
notification of any
action by, or notification or other information which it receives
(directly or
indirectly) from any Regulatory Authority which: (i) raises any
material
concerns regarding the safety or efficacy of a Product; (ii)
indicates or
suggests a potential material liability for either Party to third
parties
arising in connection with a Product; (iii) is reasonably likely to
lead to a
recall or market withdrawal of a Product; (iv) relates to a
Product, Regulatory
Materials, Promotional Materials, samples, package inserts, the
Indications,
labeling, expedited and periodic Adverse Event Reports, medical
inquiries,
Product Complaints, this Agreement or the Related Agreements, or
(v) is
otherwise important to the Development and/or Commercialization of
the Product.
(c) Communications from Regulatory Authorities. In the event that
a
Party receives any communication or questions from any Regulatory
Authority,
such
23
<PAGE>
Party shall promptly notify the other Party. The owner of the
Regulatory
Materials shall then prepare the response to the communication
(except for
responses to FDA communications regarding a loss, theft, or
significant loss of
the other Party's Product samples). Before submitting a response to
a Regulatory
Authority regarding correspondence received by a Party, the owner
of the
Regulatory Materials shall give the other Party a reasonable and
timely
opportunity to comment on the response to the extent such response
may affect
the other Party's rights or obligations under this Agreement. If it
is necessary
for such other Party to respond to the FDA or any other Regulatory
Authority,
such Party shall seek the input and approval of the owner of the
Regulatory
Materials before responding.
(d) Audit by Regulatory Authority. If a Regulatory Authority
desires
to conduct an inspection or audit of AstraZeneca or AGIX with
regard to a
Product or this Agreement, AstraZeneca and AGIX each agrees to
cooperate with
the Regulatory Authority and the other Party during such inspection
or audit,
including by allowing, to the extent practicable, a representative
of the other
Party to be present during the applicable portions of such
inspection or audit.
In the event a Party receives notice that a Regulatory Authority
intends to
conduct such an inspection or audit, such Party shall promptly
notify the other
Party of receipt of such notice.
3.4
Communications Concerning Product. The Parties shall mutually
agree
upon procedures for communication and handling of Product
Complaints and medical
inquiries concerning a Product. All Product Complaints concerning
suspected or
actual Product tampering, contamination or mix-up (e.g. wrong
ingredients) shall
be notified to the owner of the Regulatory Materials by telephone
immediately
and delivered in writing within twenty-four (24) hours of receipt
of the same.
Except as mutually agreed, the other Party shall not take any other
action in
connection with any such Product Complaint without the consent of
the owner of
the Regulatory Materials.
3.5
Records. Each Party shall maintain records, in sufficient detail
and
in appropriate good scientific manner, that shall fully and
properly reflect all
work done and results achieved in the performance of its activities
under the
Development Plan and the Commercialization Plan. Each Party shall
have the
right, during normal business hours and upon reasonable prior
notice, to inspect
those records of the other Party referred to herein that are
necessary or useful
to the inspecting Party for any appropriate purpose under this
Agreement,
including for the purposes of making any required filings with
Regulatory
Authorities in order to obtain Manufacturing approvals and/or
Regulatory
Approvals. Each Party shall have the right to copy any such records
to the
extent such Party is required to have a copy to comply with
Applicable Laws.
Each Party shall maintain such records and the information
disclosed therein in
confidence in accordance with Section 10.1.
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<PAGE>
3.6 Safety
Matters
(a) Information. Until the Assumption Date, AGIX shall provide
AstraZeneca with all information necessary or desirable for
AstraZeneca to
comply with all Applicable Laws with respect to the Compounds and
the Products,
as the case may be. In furtherance thereof, AGIX shall (a) develop
appropriate
adverse experience reporting procedures, (b) provide to AstraZeneca
any material
information on the Compounds or Products from preclinical or
clinical
laboratory, animal toxicology and pharmacology studies, as well as
serious or
unexpected adverse experience reports from clinical trials and
commercial
experiences with the Compounds or Products, and (c) report and
provide such
information to AstraZeneca in such a manner and time so as to
enable AstraZeneca
to comply with all Applicable Law in countries for which Regulatory
Approval is
or will be sought or in which the Product is being developed,
marketed or sold.
(b) Records and Notice. Until the Assumption Date, AGIX shall
(a)
maintain a record of any and all complaints it receives with
respect to the
Compounds of the Products, (b) notify AstraZeneca in reasonable
detail or any
complaint received by it within ten (10) days after the event, and
in any event
in sufficient time to allow AstraZeneca to comply with all
Applicable Law in any
country in which the Product is being developed, marketed or
sold.
(c) Safety Agreement. The Parties shall, unless both Parties
otherwise agree, after the Execution Date but before the Assumption
Date,
negotiate and execute a Safety Agreement containing appropriate
provisions
addressing safety issues relating to Products which is consistent
with the terms
of this Agreement and the Related Agreements.
4. COMMERCIALIZATION
4.1 Global
Commercialization Team and U.S. Commercialization Team. So long
as AGIX is not Developing, Commercializing or Promoting a Competing
1067
Product, AGIX shall be entitled to have up to three (3)
representatives
designated by AGIX, at AGIX's expense, attend, observe and
participate in
meetings of each of the Global Commercialization Team and U.S.
Commercialization
Team having the relevant experience and skill appropriate for
service on such
Teams. Such representatives shall be regular working members of the
Global
Commercialization Team and U.S. Commercialization Team. AstraZeneca
shall
provide AGIX office space at its facilities for such
representatives to
facilitate such participation; provided that such representatives
shall comply
with all policies and reasonable restrictions imposed by
AstraZeneca.
4.2
Commercially Diligent Efforts. AstraZeneca shall use
Commercially
Diligent Efforts to Commercialize Product(s) in the Territory as
set forth in
Section 5.
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<PAGE>
4.3
Commercialization Plan
(a) Commercialization Plan. Within ninety (90) days after the
Effective Date, the Global Commercialization Team shall prepare and
provide to
the JMC for the JMC's approval an initial commercialization plan
summarizing the
plan for Commercializing the Product given the stage of the Product
at the time
of such plan (as such plan may be updated pursuant to Section
4.3(c), the
"COMMERCIALIZATION PLAN"). Promptly following such approval,
AstraZeneca shall
implement the activities described in the Commercialization Plan,
including, to
the extent set forth in the Commercialization Plan, pre-launch
market
development, market research and activities to increase scientific
awareness of
the Product.
(b) Content of the Commercialization Plan. An outline of the
anticipated principal components of the Commercialization Plan is
included in a
letter delivered by AGIX to AstraZeneca on the date hereof. The
Commercialization Plan as approved by the JMC pursuant to Section
4.3(a), and as
updated from time to time pursuant to Section 4.3(c), shall
include, at a
minimum, the items listed in such Commercialization Plan outline,
unless the
Parties otherwise agree. Upon adoption, the Commercialization Plan
shall
describe the overall plan for Commercializing each Product during
the first
three years after Product Launch of such Product in (i) each of the
countries in
the Major Markets, (ii) the Secondary Market, and (iii) other
countries in the
Territory to the extent applicable. The Commercialization Plan
shall include for
each Product, without limitation, (A) a comprehensive marketing,
sales, pricing,
distribution and licensing strategy for such Product, including
market research
and activities to increase scientific awareness of the Product
and
pharmacoeconomic activities and programs to support pricing of the
Product; (B)
estimated date of Product Launch, market and sales forecasts, in
numbers of
patients and local currency, and competitive analysis for such
Product; and (C)
production and inventory forecasts. The Commercialization Plan
shall include a
budget which shall detail the levels of spending for all
Commercialization
activities covered by the Commercialization Plan and the allocation
of projected
sales support and time such sales support shall be spending on
the
Commercialization of each such Product.
(c) Updates to the Commercialization Plan. At least once per
Calendar Year, the Global Commercialization Team shall prepare an
updated
Commercialization Plan, which shall cover the ensuing three
Calendar Years. The
Global Commercialization Team shall provide all such updated
Commercialization
Plans to the JMC for review and approval.
4.4
Commercialization Activities of the Parties
(a) Compliance with the Commercialization Plan. The Parties agree
to
carry out their activities under the Commercialization Plan.
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<PAGE>
(b) AstraZeneca Activities. AstraZeneca shall be responsible for
the
distribution and Commercialization of each Product in the
Territory, subject to
the terms and conditions of the Co-Promotion Agreement which
provides for AGIX's
rights to co-promote Product(s) in the United States.
(c) AGIX Co-Promotion Activities. AGIX shall have the right to
co-promote Product(s) and certain other products in the United
States in
accordance with the Co-Promotion Agreement; provided, however, that
AGIX shall
only use Promotional Materials supplied to AGIX by AstraZeneca to
promote
Product(s).
(d) Commercialization Costs. Except as provided in the
Co-Promotion
Agreement, AstraZeneca shall bear all costs for the
Commercialization of
Product(s) in the Territory, including pre-approval and market
development
activities.
(e)
Pricing Decisions. AstraZeneca shall have sole responsibility
for setting pricing for all Product(s), provided that the initial
pricing for
any Product(s) shall be subject to JMC approval.
(f) Booking Sales. AstraZeneca (and, as appropriate, its
Affiliates
and Sublicensees) shall record on its books all sales of Products
worldwide.
4.5
Commercial Manufacturing and Supply of Products
(a) Supply of Compound in Spray Dried Form. The Manufacture and
supply of the active pharmaceutical ingredient in a spray dried
form shall be
effected in accordance with the Transition Services Agreement.
(b) Management. Subject to the terms of the Transition Services
Agreement, the JMC shall oversee Manufacturing pursuant to the
Development Plan
and the Commercialization Plan.
(c) Product Packaging, Labeling and Formulation. AstraZeneca
shall
be solely responsible, at its sole cost, for supplying all of the
requirements
of Product formulation, packaging and labeling. AGIX shall use
Commercially
Diligent Efforts to facilitate any necessary transfer of technology
to
AstraZeneca or a Third Party chosen by AstraZeneca for Product
formulation,
packaging and labeling.
5. DILIGENCE AND COOPERATION
5.1
Information Sharing
(a) Cooperation. The Parties agree to fully cooperate in
sharing
information regarding Development and Commercialization,
including
Manufacturing, of Products in order to keep each Party informed of
material
developments and to provide
27
<PAGE>
each Party with necessary information (including without limitation
any decision
not to pursue Commercialization of Products in a particular country
as
contemplated by the Commercialization Plan) for each Party to make
decisions in
the manner set forth in this Agreement on material issues as they
arise.
(b) Technology Transfer. Each Party agrees to use Commercially
Diligent Efforts to facilitate any necessary transfer of technology
to the other
Party, as reasonably requested by such other Party, to support the
Development
and Commercialization of Products as contemplated by this
Agreement.
5.2
Diligence Requirements
(a) Product Development. Each Party shall use Commercially
Diligent
Efforts to conduct Development of Product(s) in accordance with the
Development
Plan. Each Party shall conduct its portion of the Development
Program, in a good
scientific manner and in compliance in all material respects with
all
requirements of Applicable Laws, including cGCPs, cGLPs and cGMPs,
to Develop
Products as provided in the Development Plan. Each Party shall use
Commercially
Diligent Efforts to provide the other Party with all reasonable
assistance and
take all actions reasonably requested by that Party, without
changing the
allocation of responsibilities assigned in the Development Plan or
this
Agreement, that are necessary or desirable to enable each Party to
comply with
the terms and intent of this Agreement. Each Party shall use
Commercially
Diligent Efforts to assist the other Party, as provided in the
Development Plan,
to conduct Development of and obtain Regulatory Approvals of
Products.
(b) Commercialization
(i) AstraZeneca shall, itself or through its permitted
Sublicensees, use Commercially Diligent Efforts to Commercialize
Products in
each Major Market.
(ii) AstraZeneca shall, itself or through its Sublicensees,
use Commercially Diligent Efforts to Commercialize Products in the
Secondary
Market. All of the countries comprising the Secondary Market shall
for this
purpose be considered together as one market as a whole. The level
of
Commercially Diligent Efforts made in the Secondary Market shall
take into
consideration the total commercial potential of Products in the
Secondary Market
taken as a whole.
(iii) Each Party shall conduct its portion of the
Commercialization Plan in compliance in all material respects with
all
requirements of Applicable Laws.
(c)
Coated Stents. AstraZeneca shall, itself or through its
permitted Sublicensees, use Commercially Diligent Efforts to
Develop and
Commercialize a
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<PAGE>
Coated Stent in the United States if, after the first U.S. NDA
Approval, the JMC
approves Development of a Coated Stent. AstraZeneca shall not have
any other
obligation to use Commercially Diligent Efforts (or any other level
of efforts)
to Develop or Commercialize a Coated Stent prior to any such
approval, or in any
jurisdiction outside the United States.
5.3
Failure To Use Diligence
(a) Notice of Failure. If AGIX believes that AstraZeneca is
failing
to satisfy its obligations to use Commercially Diligent Efforts in
accordance
with this Section 5, AGIX may give AstraZeneca notice of such
alleged failure,
which notice shall describe such failure with reasonable
specificity.
(b) AstraZeneca Response. Within thirty (30) days following
AstraZeneca's receipt of any such notice from AGIX, AstraZeneca
shall provide
AGIX with a written response specifying, in reasonable detail,
whether or not it
agrees with AGIX's belief and the reasons for its disagreement, if
applicable.
(c) Disputes. In the event of a dispute between the Parties
with
respect to whether AstraZeneca is using its Commercially Diligent
Efforts in
accordance with Section 5, as evidenced by notice from AstraZeneca
of a
disagreement pursuant to Section 5.3(b), such dispute shall be
resolved in
accordance with Section 14. Neither Party may initiate dispute
resolution under
Section 14 until sixty (60) days after receipt by AGIX of a notice
of
disagreement described in Section 5.3(b).
6. GOVERNANCE
6.1
General. The activities of the Parties pursuant to this
Agreement
shall be governed by the Alliance Managers, the JMC, the JDC, the
IPC and such
additional committees as established by the JMC, as provided in
this Section 6.
6.2
Alliance Managers
(a) Appointment and Roles. Promptly after the Effective Date,
each
of the Parties shall appoint a single individual to act as that
Party's alliance
manager (the "ALLIANCE MANAGER"). The role of the Alliance Managers
is to
facilitate the relationship between the Parties. Alliance Managers
may attend
JMC meetings, JDC meetings and any other meetings of additional
committees or
subgroups established by the JMC pursuant to Section 6.1 and shall
support the
chairpersons of each such committee and group in the discharge of
their
responsibilities. Alliance Managers shall be nonvoting participants
in such
Committee meetings, unless they are also appointed members of such
Committee.
Each Party's Alliance Manager shall alternate serving as the
secretary to the
JMC on an annual basis, starting with AGIX.
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<PAGE>
(b) Availability of Facilities. Each Party shall allow the
other
Party's Alliance Manager to spend any amount of time at the other
Party's
offices as is necessary for the other Party to perform its
activities under this
Agreement; provided that, each Alliance Manager shall comply with
all policies
and reasonable restrictions imposed by the Party hosting such
Alliance Manager.
(c) Changes in Alliance Managers. Each Party may change its
designated Alliance Manager from time to time upon written notice
to the other
Party.
6.3
Committees
(a) JMC
(i) Formation and Duration. No later than thirty (30) days
after the Effective Date, the Parties shall establish a Joint
Management
Committee ("JMC").
(ii) Activities of the JMC. The JMC shall be responsible for
overall strategic and operational direction of the Collaboration,
including
without limitation:
(A) developing and implementing accountability
mechanisms
for the JDC, IPC and any other committees formed under this
Agreement;
(B) overseeing the Manufacture of Product for commercial
sales;
(C) reviewing and approving the Commercialization Plan
and
Development Plan and any amendments thereto;
(D) making decisions regarding Development for
Indications and Combination Products and any Coated Stent or other
Drug
Device following
the first Regulatory Approval of the first Product
(however,
the JMC will consider and plan, but not decide, such activities
prior to
such Regulatory Approval); provided that, the JMC shall have no
obligation
to approve Development for Combination Products that include
Exclusive
Market Products;
(E) establishing additional committees or subgroups as
the JMC
deems necessary or appropriate; and
(F) Product life cycle management relating to the
Products.
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<PAGE>
(iii) Composition. Each Party shall designate up to four (4)
representatives and a nonvoting Alliance Manager for membership on
the JMC
having the relevant experience and skill appropriate for service on
the JMC.
(iv) Meetings. During the Term and unless otherwise agreed to
by the Parties, the JMC shall meet a minimum of four times each
Calendar Year in
accordance with a schedule determined by the Parties and to be held
in Atlanta,
Georgia or Puerto Rico, unless the Parties otherwise mutually
agree. Additional
ad hoc meetings of the JMC may be called by either Party upon
reasonable advance
notice to the other Party. A Party may attend any meeting of the
JMC by
teleconference, video or Webex.
(b) JDC
(i) Formation and Duration. No later than thirty (30) days
after the Effective Date, the Parties shall establish a Joint
Development
Committee ("JDC").
(ii) Activities of the JDC. The JDC shall be responsible for
oversight of all Development, including without limitation the
following:
(A) clinical trials (including Phase IV trials) of a
Product;
(B) preparing for approval by the JMC the Development
Plans and
the budgets of Development Costs and overseeing the
implementation thereof ;
(C) proposing updates and amendments to the Development
Plan for
approval by the JMC;
(D) reviewing protocols for clinical studies of a
Product;
(E) reviewing and overseeing regulatory strategies for
each
Product
(F) reviewing and approving the final Statistical
Analysis
Plan; and
(G) reviewing, prior to its submission to the Third
Party
statistician of the ARISE Study, the ARISE Results.
(iii) Composition. AGIX shall designate three (3)
representatives and AstraZeneca shall designate three (3)
representatives for
membership on the JDC having the relevant experience and skill
appropriate for
service on the JDC.
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<PAGE>
(iv) Meetings. Prior to U.S. NDA Approval for the First
Product, the JDC shall meet at least once a month. After U.S. NDA
Approval and
unless otherwise agreed to by the Parties, the JDC shall meet at
least four
times each Calendar Year. Such meetings shall be in accordance with
a schedule
and at a location mutually determined by the Parties. Ad hoc
meetings of the JDC
may be called by either Party upon reasonable advance notice to the
other Party.
Upon mutual agreement, such ad hoc meetings may be face-to-face or
by
teleconference, video or Webex.
(c) Representatives. The Parties, through the committee
structure,
may establish and later change the number of representatives on the
JMC or JDC
committee as long as an equal number of representatives from each
of AstraZeneca
and AGIX are maintained. Each Party may change its representatives
to the JDC or
JMC at any time by written notice to the other Party.
(d) Committee Chairs. The JMC shall be co-chaired by AstraZeneca
and
AGIX. Prior to the earlier of (a) the date U.S. NDA Approval is
received and (b)
the date that AstraZeneca makes an Accelerated Assumption Payment,
the JDC shall
be chaired by a representative of AGIX. After such date, the JDC
shall each be
chaired by a representative of AstraZeneca.
(e) Expenses. Each Party shall bear the expense of the
participation
of its respective members and the Alliance Managers in the JMC and
JDC meetings.
(f) Agenda and Minutes. At least five (5) Business Days prior
to
each JDC or JMC meeting, each Party shall provide written notice to
the other
Party of agenda items proposed by such Party for discussion or
decision at such
meeting, together with appropriate information related thereto. At
least two (2)
Business Days prior to each JDC or JMC meeting, each Party shall
provide written
copies to the other Party of all presentations to be made at such
meeting.
Reasonably detailed written minutes shall be kept of all JDC and
JMC meetings
and shall reflect, without limitation, material decisions made at
such meeting.
Responsibility for keeping the JMC minutes shall alternate between
the co-chairs
of each Party, beginning with AstraZeneca. The chairperson of the
JDC shall be
responsible for keeping the JDC minutes. Meeting minutes shall be
sent to each
committee member for review and approval within five (5) Business
Days after
such meeting. Minutes shall be deemed approved unless a committee
member objects
to the accuracy of such minutes within ten (10) Business Days of
receipt.
(g) Decision-making
(i) Decisions. The Parties' representatives on the JMC and JDC
shall use all reasonable efforts, acting in good faith, to resolve
all issues
presented to them as expeditiously as possible. Each Party's
representatives on
the JMC and JDC shall make decisions by consensus. All JMC and JDC
decisions
shall be made by unanimous vote, and each Party's representatives
shall
collectively have one vote.
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(ii) Decision-making Authority. Notwithstanding anything to
the contrary, neither the JDC or the JMC shall have the authority
to determine
any of the matters for which (i) one or more of the Parties is
allocated
decision-making authority elsewhere in this Agreement or (ii) the
Agreement
provides that the matter in question is explicitly a matter
requiring the mutual
or joint agreement of the Parties. Each of the JDC and JMC shall be
deemed to
have a quorum if they have at least two (2) designated
representatives from each
Party. A quorum shall also be deemed to have been achieved if at
least ten (10)
Business Days written notice of a meeting, including a proposed
agenda, has been
provided for a meeting held by telephone conference or in Atlanta,
Georgia or
Puerto Rico.
(iii) Disputes
(A) JDC Disputes. The JDC, or either Party, may, after
thirty
(30) days (or such other period as the Parties otherwise agree)
of
good faith
efforts to reach a unanimous decision on an issue, refer any
unresolved
issue to the respective heads of the appropriate department for
each
Party. If the department heads can not resolve such issue within
ten
(10) days,
then such issue shall be referred to the JMC.
(B) JMC Disputes. The JMC or either Party may, after
thirty
(30) days (or such other period as the Parties may otherwise
agree)
of good
faith efforts to reach a unanimous decision on an issue refer
such
issue to
the officers set forth in Section 14.1(b), or their designee.
Such
officers of the Parties shall meet promptly thereafter and
shall
negotiate
in good faith to resolve the issues. If the issues were raised
by the JDC
and if they cannot resolve the issue within thirty (30) days of
commencing
negotiations, prior to the earlier of (i) the date U.S. NDA
Approval
is received and (ii) the date upon which AstraZeneca makes an
Accelerated Assumption Payment, the resolution of such issue shall
be
determined
by AGIX. For all other JMC issues, the resolution of any such
issue
shall be determined by AstraZeneca.
(iv) Decisions Affecting Development and Commercialization
Plans. Notwithstanding anything in this Section 6 to the
contrary:
(A) no decision by the JDC or the JMC shall affect
AstraZeneca's control of all aspects regarding the
Commercialization of
Products;
(B) neither Party's rights and obligations as contained
in this
Agreement can be amended without such Party's consent;
(C) prior to the Assumption Date, no decision by the JDC
or the JMC
shall increase AstraZeneca's development obligations as set
forth in
the Development Plan Outline or AstraZeneca's commercialization
obligations
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<PAGE>
as set
forth in the Commercialization Plan outline included in a
letter
delivered
by AGIX to AstraZeneca on the date hereof, without the consent
of
AstraZeneca; and
(D) after the Assumption Date, AstraZeneca shall have
authority
to determine the resolution of any disagreement in the JMC with
respect to the
approval of the Development Plan governing activities
following
U.S. NDA Approval, even if such Development Plan was approved
prior to
U.S. NDA Approval.
(h) IPC. No later than thirty (30) days after the Effective
Date,
the Parties shall establish an Intellectual Property Committee
("IPC"). The IPC
shall be responsible for overseeing all intellectual property
matters as further
described in Section 9. The IPC shall be governed by the rules and
procedures
set forth in Section 9.2.
7. LICENSES AND COVENANTS
7.1
License Grants to AstraZeneca
(a) License to AGIX IP. Subject to the terms of this Agreement,
including Section 7.1(b) and Section 7.1(c), and AGIX's retained
rights solely
to the extent necessary to perform it obligations under the
Transition Services
Agreement, AGIX hereby grants to AstraZeneca an exclusive license,
with the
right to sublicense, under the AGIX Compound Patents, Other AGIX
Patents and
AGIX Know-How (other than as set forth in Exhibit 11.5), to
research, develop,
make, have made, use, sell, have sold, offer for sale and import
the Compound
and Products in the Field in the Territory.
(b) Distribution and Co-Promotion
(i) Neither AstraZeneca nor its Affiliates shall be permitted
to appoint distributors to distribute, market or sell Products in
any Major
Market [****] without the prior approval of AGIX.
(ii) AstraZeneca and its Affiliates shall have the right, in
their sole discretion, to appoint distributors to distribute,
market and sell
the Products [****] and in any other countries in the Territory
that are not
part of the Major Market.
(iii) AstraZeneca and its Affiliates shall have the right, in
their sole discretion, to co-promote the Products with Third
Parties in
countries other than the Major Market and to appoint Third Parties
to promote
the Products in such countries.
(iv) Notwithstanding the foregoing, AstraZeneca may appoint
any Affiliate to distribute, market or sell Products without
restriction.
-------
[****] 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.
34
<PAGE>
(v) Notwithstanding anything herein to the contrary,
AstraZeneca may engage contract sales organizations to Promote
Products,
provided that any sales of Products effected by any such
organization are booked
by AstraZeneca.
(c) Sublicenses
(i) Neither AstraZeneca nor its Affiliates shall be permitted
to enter into any Noncompulsory Sublicenses in any Major Market
[****] without
the prior approval of AGIX.
(ii) AstraZeneca and its Affiliates shall be permitted to
enter into Compulsory Sublicenses and Noncompulsory Sublicenses in
any country
in the Territory other than a Major Market on the terms set forth
in this
Section 7.1(c).
(iii) AstraZeneca and its Affiliates shall not enter into any
Noncompulsory Sublicense of the rights granted in this Agreement
with a
Sublicensee to the extent permitted in this Section 7.1(c) unless
the
Sublicensee agrees to all applicable terms of this Agreement.
(iv) No Compulsory Sublicenses or Noncompulsory Sublicense
shall relieve AstraZeneca of any obligations it has under this
Agreement.
(v) AstraZeneca shall promptly notify AGIX upon entering into
any Compulsory Sublicense and any Noncompulsory Sublicense.
(vi) Notwithstanding the foregoing, AstraZeneca may enter into
any Sublicense with any Affiliate without restriction, except as
described in
clauses (iii) and (iv) of this Section 7.1(c).
(vii) All Sublicensees shall be bound by the provisions of
Section 10 of this Agreement.
7.2
License Grants to AGIX. Subject to the terms and conditi
