Back to top

LICENSE AND COLLABORATION AGREEMENT

Collaboration Agreement

LICENSE AND COLLABORATION AGREEMENT You are currently viewing:
This Collaboration Agreement involves

ATHEROGENICS INC

. RealDealDocs™ contains millions of easily searchable legal documents and clauses from top law firms. Search for free - click here.
Title: LICENSE AND COLLABORATION AGREEMENT
Governing Law: New York     Date: 3/10/2006
Industry: BIOTRX     Law Firm: Arnold Porter     Sector: HEALTH

Search Collaboration Agreement by:

Document Title:

Entire Document: (optional)

50 of the Top 250 law firms use our Products every day

<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

      &