EXHIBIT 10.13
DEVELOPMENT, LICENSE AND MARKETING AGREEMENT
BY AND BETWEEN
ASTRA AB
AND
CENTAUR PHARMACEUTICALS, INC.
DATED JUNE 26, 1995
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[*] - Confidential treatment is being sought with respect to this portion of
this agreement. This portion has been omitted from this filing and has
been filed separately with the Securities and Exchange Commission.
1. DEFINITIONS................................................ -2-
2. GRANT...................................................... -7-
2.1 License Grant to ASTRA - ASTRA License..................... -7-
(a) Exclusive License.......................................... -8-
(b) Co-Exclusive License....................................... -8-
2.2 ASTRA Affiliates........................................... -8-
2.3 License Grant to CENTAUR - CENTAUR Grant................... -8-
2.4 CENTAUR Co-Promote Rights.................................. -8-
2.5 Oklahoma/Kentucky License.................................. -9-
2.6 Access to CENTAUR Technology............................... -9-
3. STEERING COMMITTEE AND DAY TO DAY
MANAGEMENT OF THE PROJECT WORK............................. -9-
3.1 Formation of Steering Committee............................ -9-
3.2 Meetings of the Steering Committee......................... -9-
3.3 Steering Committee Review of Project Work.................. -9-
3.4 Steering Committee - Dispute Resolution.................... -10-
3.5 Project Groups............................................. -10-
3.6 Third Persons.............................................. -10-
4. RESEARCH WORK.............................................. -10-
4.1 Commencement and Completion of Research Work............... -10-
4.2 R&D Plans.................................................. -10-
4.3 R&D Period................................................. -11-
5. FUNDING OF RESEARCH WORK................................... -11-
5.1 Budgets.................................................... -11-
5.2 CENTAUR FTE................................................ -11-
5.3 ASTRA Payments of Annual Funding/Out-Of-Pocket
Research Costs............................................. -11-
5.4 Funding of R&D Periods - Annual Maximum.................... -12-
5.5 CENTAUR's Records.......................................... -12-
6. DEVELOPMENT WORK........................................... -12-
6.1 Development Work - ASTRA................................... -12-
6.2 Development Work - CENTAUR................................. -12-
6.3 Regulatory Approvals....................................... -12-
6.4 Development of Licensed Product - Major Markets............ -13-
(a) NDA Approval............................................... -13-
(b) First Commercial Sale...................................... -13-
6.5 Development of Licensed Product - Other Than
Major Markets.............................................. -13-
6.6 ASTRA Non-Compliance....................................... -13-
6.7 Notification of Development Work........................... -14-
7. REMUNERATION TO CENTAUR.................................... -14-
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7.1 Total Compensation to CENTAUR.............................. -14-
7.2 Payments................................................... -14-
(a) Effective Date............................................. -14-
(b) Selection of First CD of SP................................ -14-
(c) Selection of First CD of AP................................ -14-
(d) First SP IND in U.S........................................ -15-
(e) First SP IND in EC Major Market or Japan................... -15-
(f) First AP IND in U.S........................................ -15-
(g) First AP IND in EC Major Market or Japan................... -15-
(h) First SP Phase III Trial in U.S............................ -15-
(i) First AP Phase III Trial in EC Major Markets or Japan...... -15-
(j) First AP Phase III Trial in U.S............................ -15-
(k) First AP Phase III Trial in EC Major Markets or Japan...... -15-
(l) First SP NDA Filing in U.S................................. -15-
(m) First SP NDA Filing in EC Major Market or Japan............ -16-
(n) First AP NDA Filing in U.S................................. -16-
(o) First AP NDA Filing in EC Major Market or Japan............ -16-
(p) First SP NDA Approval in U.S............................... -16-
(q) First SP NDA Approval in EC Major Market or Japan.......... -16-
(r) First AP NDA Approval in U.S............................... -16-
(s) First AP NDA Approval in EC Major Market or Japan.......... -16-
7.3 Net Sales Royalty.......................................... -16-
(a) Countries Where CENTAUR Patents are Effective.............. -16-
(b) Countries Where CENTAUR Patents Inapplicable............... -17-
7.4 CENTAUR Default/Bankruptcy................................. -17-
7.5 Termination of CENTAUR Royalty - ASTRA Paid Up License..... -17-
7.6 Third Party Royalties on Sales of Licensed Product......... -17-
7.7 Computation and Payment of Royalty to CENTAUR.............. -17-
7.8 ASTRA Records.............................................. -18-
7.9 CENTAUR Audit.............................................. -18-
8. OPTION TO CO-PROMOTE IN THE U.S............................ -18-
8.1 Notification to Co-Promote................................. -18-
8.2 Election of Co-Promotion Rights............................ -18-
(a) Co-Promote Market Plan..................................... -18-
(b) CENTAUR Medical Representatives............................ -19-
(c) Co-Promote Profits......................................... -19-
8.3 Co-Promote Term............................................ -20-
9. EXCHANGE OF INFORMATION.................................... -20-
9.1 Communication of Information............................... -20-
10. REPRESENTATIONS AND WARRANTIES............................. -20-
10.1 General Representations.................................... -20-
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(a) Duly Organized............................................. -20-
(b) Due Execution.............................................. -20-
(c) No Third Party Approval.................................... -21-
(d) Binding Agreement.......................................... -21-
(e) Governmental Status........................................ -21-
(f) Full Disclosure............................................ -21-
10.2 CENTAUR Representations.................................... -21-
11. PUBLICATIONS............................................... -22-
11.1 Disclosure of Know-How..................................... -22-
11.2 Use of Other Party's Name.................................. -22-
12. MARKETING OF LICENSED PRODUCT.............................. -22-
12.1 ASTRA's Commercialization of Licensed Product.............. -22-
12.2 Labeling................................................... -22-
13. INVENTION, IMPROVEMENTS AND DISCOVERIES.................... -23-
13.1 Ownership of Technology.................................... -23-
14. PATENTS AND PATENT APPLICATIONS............................ -23-
14.1 Maintenance of CENTAUR Patents............................. -23-
14.2 CENTAUR New Inventions Patents............................. -23-
14.3 Joint Patents.............................................. -24-
(a) Joint Patent - ASTRA Default or Bankruptcy................. -24-
(b) Joint Patent - CENTAUR Default or Bankruptcy............... -24-
14.4 Notification With Respect to Patents....................... -25-
14.5 CENTAUR's Election......................................... -25-
14.6 ASTRA's Election........................................... -25-
14.7 Minimum Patent Protection.................................. -25-
15. PATENT INFRINGEMENTS....................................... -26-
15.1 Notification of Alleged Patent Infringement................ -26-
15.2 Third Party Claims......................................... -26-
15.3 Payment of Additional Third Party Royalties................ -26-
15.4 Infringement of CENTAUR Patents/Joint Patents/
New Inventions Patents..................................... -26-
15.5 Monetary Recovery - ASTRA Prosecution...................... -27-
15.6 Monetary Recovery - CENTAUR Prosecution.................... -27-
16. CONFIDENTIALITY............................................ -27-
16.1 Treatment of Confidentiality............................... -27-
16.2 Release from Restrictions.................................. -27-
17. TRADEMARK.................................................. -28-
18. EXCLUSIVITY AND OPTION TO EXTEND THE LICENSE............... -28-
18.1 Restrictions............................................... -28-
18.2 ASTRA Right of First Negotiation........................... -28-
19. WARRANTY DISCLAIMER........................................ -29-
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19.1 Disclaimer by Parties...................................... -29-
(a) CENTAUR Technology/Product Know-How........................ -29-
(b) Third Party Infringement................................... -29-
(c) Prosecution................................................ -29-
(d) Use of Name/Trademark...................................... -29-
(e) CENTAUR Limitation......................................... -29-
(f) ASTRA Limitation........................................... -29-
20. TERM AND TERMINATION....................................... -30-
20.1 Term....................................................... -30-
20.2 Default.................................................... -30-
20.3 Insolvency or Bankruptcy................................... -30-
20.4 Special Termination Provisions............................. -31-
20.5 Effect of Termination of License Agreement................. -31-
(a) Existing Obligations....................................... -31-
(b) Expiration of Term or CENTAUR Default or Bankruptcy........ -31-
(c) Expiration of Term or ASTRA Default or Breach.............. -31-
21. MISCELLANEOUS PROVISIONS................................... -32-
21.1 No Partnership............................................. -32-
21.2 Assignments................................................ -32-
21.3 Force Majeure.............................................. -32-
21.4 No Trademark Rights........................................ -33-
21.5 Public Announcements....................................... -33-
21.6 Entire Agreement of the Parties and Amendment.............. -33-
21.7 Severability............................................... -33-
21.8 Captions................................................... -34-
21.9 Notice and Delivery........................................ -34-
21.10 Limitation of Liability.................................... -34-
21.11 ASTRA Indemnification...................................... -34-
21.12 CENTAUR Indemnification.................................... -35-
21.13 Remedies Cumulative........................................ -35-
21.14 Governing Law.............................................. -35-
22. RESOLUTION OF DISPUTES..................................... -35-
22.1 General.................................................... -35-
22.2 Dispute Resolution Process................................. -35-
(a) Selection of Arbitrators................................... -35-
(b) Written Proposals.......................................... -36-
(c) Hearing.................................................... -36-
(d) Ruling..................................................... -36-
22.3 Arbitration Costs.......................................... -36-
22.4 Attorneys' Fees/Costs...................................... -37-
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Appendix 1 - Supply Agreement
Appendix 2 - CENTAUR Licenses
Appendix 3 - Oklahoma/Kentucky License
Appendix 4 - ASTRA Strategic Research Areas
Appendix 5 - First Amendment to CENTAUR Licenses
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DEVELOPMENT, LICENSE AND MARKETING AGREEMENT
This Development, License and Marketing Agreement (the "LICENSE AGREEMENT"),
entered into as of June 26, 1995 (the "EFFECTIVE DATE"), is made by and between
ASTRA AB, a corporation organized and existing under the laws of Sweden, ▇-▇▇▇
▇▇ ▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇ ("ASTRA")
and
CENTAUR PHARMACEUTICALS, INC., a corporation organized and existing under the
laws of the State of Delaware, ▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇, ▇▇▇
("CENTAUR").
WITNESSETH
WHEREAS, ASTRA, through its fully owned Affiliate, Astra Arcus AB, inter
alia is conducting research and development of agents for diseases of the
central nervous system; and
WHEREAS, CENTAUR has certain proprietary information comprising expertise,
know-how and patents in the Field; and
WHEREAS, the parties desire to enter into a collaborative research and
development program in the Field; and
WHEREAS, CENTAUR is willing to grant ASTRA an exclusive, worldwide right and
license to commercialize Licensed Product under the CENTAUR Technology and
Product Know-How, with a retained co-promotion right for CENTAUR in the United
States; and
WHEREAS, CENTAUR and ASTRA as of the Effective Date, have entered into the
Supply Agreement, a copy of which is attached hereto as Appendix 1, regarding
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supply of Substance to be included in Licensed Product.
NOW THEREFORE, in consideration of the promises and mutual covenants herein
contained, the parties agree as follows:
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1. DEFINITIONS
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As used herein, the following terms have the following meaning:
1.1 "AFFILIATE" means any company or entity which controls, is controlled by or
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is under common control with a party to this License Agreement. "CONTROL"
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shall mean direct or indirect ownership of at least fifty percent (50%) of
the stock or shares entitled to vote for the election of directors or direct
or indirect ownership of at least fifty percent (50%) of the equity interest
with the power to direct the management and policies of such non-corporate
entities. The terms "ASTRA" and "CENTAUR" as used herein shall be deemed to
include Affiliates of ASTRA and CENTAUR respectively.
1.2 The "ALZHEIMERS' PROJECT" or "AP" means the development of spin trapping
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agents and derivatives and compositions thereof used as free radical
scavengers and/or therapeutics for the treatment of Alzheimer's disease, as
specified in the R&D Plan.
1.3 "ANNUAL FUNDING" has the meaning provided in Section 5.4.
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1.4 "ARCUS" means Astra Arcus AB, ▇-▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇, which company is
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authorized by ASTRA to represent ASTRA in all aspects under this License
Agreement.
1.5 "ASTRA LICENSE" has the meaning provided in Section 2.1.
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1.6 "BANKRUPTCY" has the meaning provided in Section 20.3.
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1.7 "CANDIDATE DRUG" or "CD" means any compound selected hereunder for GLP
-------------- --
safety and/or other studies necessary for IND filing in the Field.
1.8 "CENTAUR GRANT" has the meaning provided in Section 2.3.
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1.9 "CENTAUR LICENSES" mean collectively and as attached hereto as Appendix 2:
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(a) License Agreement dated as of July 15, 1992 by and among Oklahoma
Medical Research Foundation, The University of Kentucky Research
Foundation and CENTAUR,
(b) Research Study Agreement dated as of February 1, 1993 by and between
CENTAUR and [*],
(c) Research Study Agreement dated as of June 6, 1994 by and between
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CENTAUR and [*],
(d) Research Study Renewal Agreement dated as of January 1, 1995 by and
between CENTAUR and [*], and
(e) Research Study Agreement dated as of February 1, 1995 by and between
CENTAUR and [*],
as the same may be amended, extended or modified from time to time during the
Term of this License Agreement.
1.10 "CENTAUR PATENTS" means collectively:
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(a) the patents and patent applications, if any, listed in the CENTAUR
Patents index dated as of June 26, 1995 and initialed by the
parties,
(b) all additional chemical entity patents with respect to Substance for
Licensed Product that are purchased by or licensed to CENTAUR from
Third Persons and under which CENTAUR has the right to grant
licenses to ASTRA during the Term hereof (collectively the "NEW
CHEMICAL ENTITY PATENTS"), and
(c) all "New Inventions Patents", as defined in Section 14.2,
including with respect to all such patents, all additions, divisions,
continuations, continuations-in-part, substitutions, extensions, patent term
extensions and renewals thereof and all patents issuing from such patent
applications and their foreign counterparts, provided, however, that all New
Chemical Entity Patents and New Inventions Patents referenced in this Section
1.10(b) and (c) shall only be deemed to be "CENTAUR Patents" pursuant to the
provisions of Section 14.6. Joint Patents shall not be deemed to be "CENTAUR
Patents".
1.11 "CENTAUR TECHNOLOGY" means collectively (i) CENTAUR Patents, (ii) CENTAUR
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Know-How now or hereafter owned by or licensed to CENTAUR or under which
CENTAUR has, or may in the future have, the right to grant licenses to
ASTRA during the Term of this License Agreement that are used or useful in
the research, development, manufacture, use or sale of Substance and
Licensed Product, and (iii) CENTAUR's interest in the Joint Patents and
Joint Project Technology.
1.12 "CO-PROMOTE" shall mean the right of CENTAUR to Co-Promote Licensed
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Product in the United States pursuant to Section 8.
1.13 "CONFIDENTIAL INFORMATION" shall mean any and all information of or about
------------------------
a party
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including all information relating to any technology, product, process or
intellectual property of such party (including, but not limited to, owned
or licensed intellectual property rights, data, know-how, samples,
technical and non-technical materials, and specifications) as well as any
business plan, financial information, or other confidential commercial
information of or about such other party. Notwithstanding the foregoing,
specific information shall not be considered "Confidential Information"
with respect to such party to the extent that the other party possessing
such information can demonstrate by written record or other suitable
physical evidence that:
(a) such specific information was lawfully in such other party's
possession or control prior to the time such information was
disclosed to such other party by the party to whom the information
relates,
(b) such specific information was developed by such other party
independently of the Confidential Information of the other party,
(c) such specific information was lawfully obtained by such other party
from a third party under no obligation of confidentiality to the
party to whom such information relates, or
(d) such specific information was at the time it was disclosed or
obtained by such other party, or thereafter became, publicly known
otherwise than through a breach by such other party of such other
party's obligations to the party to whom such information relates,
provided, however, that disclosure of such information to a
regulatory authority or governmental body, unless it becomes widely
disseminated, will not be considered publicly known.
1.14 "DEFAULT" has the meaning provided in Section 20.2.
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1.15 "DEVELOPMENT WORK" means all work reasonably necessary to develop a CD
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into a Licensed Product approved for marketing and sale by the relevant
regulatory authorities in the Major Markets.
1.16 "DOLLAR" and "$" shall mean United States dollars.
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1.17 "EC" shall mean the member countries of the European Union, as presently
--
exist and as may be in the future.
1.18 "FDA" shall mean the United States Food and Drug Administration.
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1.19 "FTES" means the equivalent of one person devoted full time for one year
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(consisting of
-4-
a single person devoted full time or a number of persons devoted part
time) to carrying out CENTAUR's obligations to perform Project Work as
measured by CENTAUR's time allocation practices.
1.20 "FIELD" means the fields of treatment specified in the SP and the AP
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through the use of spin trapping agents and derivatives and compositions
thereof used as free radical scavengers.
1.21 "FIRST COMMERCIAL SALE" shall mean, with respect to each Licensed Product
---------------------
in each country, the first bona fide, arm's length sale of such Licensed
Product in such country following receipt of all regulatory approvals
necessary to commence regular, commercial scale sales of such Licensed
Product in such country. Sales prior to receipt of all approvals necessary
to commence commercial sales, such as so-called "treatment IND sales,"
"named patient sales," and "compassionate use sales," shall not be First
Commercial Sales.
1.22 "IND" means an "Investigational New Drug" application as such term is
---
defined under the rules and regulations of the FDA, or its equivalent in
any country.
1.23 "JOINT PATENTS" has the meaning provided in Section 14.3.
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1.24 "JOINT PROJECT TECHNOLOGY" has the meaning provided in Section 13.1.
------------------------
1.25 "KNOW-HOW" means with respect to either party, collectively, all
--------
proprietary information, Confidential Information, methods, products,
ideas, processes, technologies, inventions, data, information and all
intellectual property rights connected therewith, whether or not
patentable and whether oral, written or stored in any computer format,
owned, controlled or licensed to either party, now or during the Term of
this License Agreement, to the extent related to the research,
development, manufacture, use or sale of any Licensed Product in the Field
worldwide, and in the case where licensed to a party, where such party
has, or may in the future have, the right to transfer, disclose and/or
grant licenses to the other party without violating contractual agreements
with such third party existing prior or subsequent to the Effective Date.
1.26 "LICENSED PRODUCT" means any compound, product or process utilizing
----------------
CENTAUR Technology.
1.27 "MAJOR MARKETS" means France, Germany, Japan, Sweden, United Kingdom and
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the United States.
1.28 "NDA" means a New Drug Approval application, as defined under the rules
---
and
-5-
regulations of the FDA, or its equivalent in any country.
1.29 "NET SALES" means the aggregate gross revenues derived by ASTRA and its
---------
sublicensees on account of the sale of Licensed Product(s) in an arm's
length transaction, less:
(a) trade and quantity discounts or rebates actually taken or allowed,
(b) credits or allowances given or made for rejection, damaged Licensed
Product, return of previously sold Licensed Product or retroactive
price reductions actually taken or allowed,
(c) any tax or government charge (including any tax such as a value
added or similar tax or government charge other than an income tax)
levied on the sale, transportation or delivery of a Licensed Product
and borne by the seller thereof, and
(d) any charges for freight or insurance billed to the final customer.
Where (i) a Licensed Product is sold as one of a number of items without a
separate price; or (ii) the consideration for the Licensed Product shall
include any non-cash element; or (iii) the Licensed Product shall be
transferred in any manner other than an invoiced sale, the Net Sales
applicable to any such transaction shall be deemed to be ASTRA's average
Net Sales for the applicable quantity of Licensed Product at that time in
the country in which the transaction occurred. If there are no independent
Net Sales of Licensed Product in the country at that time, then ASTRA and
CENTAUR shall mutually agree on a surrogate measurement.
1.30 "NEW CHEMICAL ENTITY PATENTS" has the meaning provided in the definition
---------------------------
of CENTAUR Patents.
1.31 "NEW INVENTIONS PATENTS" has the meaning provided in Section 14.2.
----------------------
1.32 "OKLAHOMA/KENTUCKY LICENSE" means the license granted as of the Effective
-------------------------
Date to ASTRA by the Oklahoma Medical Research Foundation and the
University of Kentucky Research Foundation, attached hereto as Appendix 3.
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1.33 "OUT-OF-POCKET RESEARCH COSTS" means all amounts paid by CENTAUR to third
----------------------------
parties as provided in Budget(s) set forth in the R&D Plans in connection
with CENTAUR's performance of Project Work, except for such categories of
such expenses which CENTAUR and ASTRA agree in the R&D Plans are to be
paid by CENTAUR through the payments received by CENTAUR in respect of
CENTAUR's FTEs. Out-of-Pocket
-6-
Research Costs will not include employee salaries or other related
expenses, lab supplies used in CENTAUR's business generally, rent,
overhead or depreciation or legal expenses.
1.34 "PRODUCT KNOW-HOW" means all enabling information with respect to
----------------
production and quality control of Substance (including patented
processes), now owned by or licensed to CENTAUR or hereinafter acquired or
developed by CENTAUR or ASTRA during the Term of this License Agreement or
the Supply Agreement.
1.35 "PROJECT" means either of SP or AP, and "PROJECTS" means collectively SP
------- --------
and AP.
1.36 "PROJECT WORK" means collectively the Research Work and the Development
------------
Work.
1.37 "R&D PERIOD" has the meaning given in Section 4.3.
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1.38 "R&D PLAN(S)" means the research and development plans and budgets for SP
-----------
and AP respectively dated as of June 26, 1995 and initialed by the
parties, outlining the parties' best estimate as of the Effective Date of
the entire scope of Research Work and Development Work to be performed
within the respective Project and the Annual Funding to be provided by
ASTRA to CENTAUR for the Research Work intended to be performed by CENTAUR
under such R&D Plans.
1.39 "RESEARCH WORK" means the pre-clinical work outlined for each Project in
-------------
the respective R&D Plan up to selection of adequate number of CDs.
1.40 "SPECIFICATIONS" has the meaning provided in the Supply Agreement.
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1.41 "STEERING COMMITTEE" has the meaning provided in Section 3.1.
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1.42 "STROKE PROJECT" or "SP" means development of spin trapping agents and
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derivatives and compositions thereof used as free radical scavengers
and/or therapeutics for (i) acute treatment of stroke, (ii) prophylactic
treatment of stroke, (iii) head trauma, and (iv) multi-infarct dementia,
all as specified in the R&D Plans.
1.43 "SUBSTANCE" means the active ingredient(s) included in Licensed Product.
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1.44 "SUPPLY AGREEMENT" means the agreement entered into by the parties as of
----------------
the Effective Date regarding manufacture and supply of active ingredients
included in Licensed Product, a copy of which is attached hereto as
Appendix 1.
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1.45 "TERM" has the meaning provided in Section 20.1.
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1.46 "THIRD PARTY ROYALTIES" has the meaning provided in Section 7.6.
---------------------
1.47 "THIRD PERSONS" has the meaning provided in Section 3.6.
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2. GRANT
-----
2.1 LICENSE GRANT TO ASTRA - ASTRA LICENSE. Subject to the terms and
--------------------------------------
conditions of this License Agreement and the Supply Agreement, CENTAUR
hereby grants to ASTRA:
(a) EXCLUSIVE LICENSE. An exclusive, royalty-bearing, worldwide license
-----------------
(the "EXCLUSIVE LICENSE"), including ASTRA's right to grant
sublicenses, under the CENTAUR Technology to research, develop, use,
sell and have sold Licensed Product in the Field in accordance with
this License Agreement. The Exclusive License shall be subject to
CENTAUR's right to Co-Promote Licensed Product pursuant to Section
9, and
(b) CO-EXCLUSIVE LICENSE. Collectively, co-exclusive (with CENTAUR)
--------------------
worldwide license(s) (the "CO-EXCLUSIVE LICENSE") (i) a royalty-
bearing license under the CENTAUR Technology and Product Know-How to
manufacture Substance for Licensed Product for use and sale in the
Field to the extent such manufacture is undertaken by ASTRA pursuant
to the Supply Agreement, and (ii) a non-royalty bearing license of
CENTAUR's rights in the Field, including ASTRA's right to grant
sublicenses, under the CENTAUR Licenses, provided, further, that in
the event of termination of this License Agreement by ASTRA pursuant
to (x) Default by CENTAUR pursuant to Section 20.2, or (y)
Bankruptcy of CENTAUR pursuant to Section 20.3, said Co-Exclusive
License shall be deemed to be an exclusive license to ASTRA for such
purposes in the Field.
The Exclusive License and Co-Exclusive License may be herein collectively
referred to as the "ASTRA LICENSE".
2.2 ASTRA AFFILIATES. ASTRA may designate Affiliates in countries where such
----------------
exist and third parties in countries where no Affiliates exist, to carry
out ASTRA's rights and obligations hereunder in whole or in part, provided
that ASTRA remains primarily liable and such Affiliates or third parties
consent to be bound by this License Agreement to the same extent as ASTRA.
ASTRA shall inform CENTAUR from time to time of the names of the
Affiliates and third parties appointed by ASTRA hereunder.
-8-
2.3 LICENSE GRANT TO CENTAUR - CENTAUR GRANT. Subject to the terms and
----------------------------------------
conditions of this License Agreement and the Supply Agreement, ASTRA
hereby grants to CENTAUR a co-exclusive (with ASTRA), royalty-free,
worldwide license (the "CENTAUR GRANT") under ASTRA's interests in the
Joint Patents and Joint Project Technology for use by CENTAUR solely to
fulfill its obligations under this License Agreement and the Supply
Agreement.
2.4 CENTAUR CO-PROMOTE RIGHTS. CENTAUR retains the right in the United States
-------------------------
to Co-Promote, directly and solely through its own wholly-owned sales
force and not that of a third party, any Licensed Product launched by
ASTRA in the United States. The general terms for such Co-Promote are set
forth in Section 8, but the detailed conditions thereof shall be
separately agreed upon by the parties.
2.5 OKLAHOMA/KENTUCKY LICENSE. CENTAUR agrees and acknowledges that this
-------------------------
License Agreement and ASTRA's obligations hereunder (including, without
limitation, the obligation to make payments to CENTAUR pursuant to Section
7.2) are specifically contingent upon (i) the execution and delivery of
the Oklahoma/Kentucky License to ASTRA in substantially the form attached
hereto as Appendix 3, and (ii) the First Amendment to the CENTAUR
----------
Licenses, in substantially the form attached hereto as Appendix 5. CENTAUR
----------
agrees and acknowledges that the Oklahoma/Kentucky License to ASTRA is co-
exclusive with CENTAUR, notwithstanding the prior exclusive right and
license granted to CENTAUR pursuant to the CENTAUR Licenses.
2.6 ACCESS TO CENTAUR TECHNOLOGY. In order to permit ASTRA the full use and
----------------------------
enjoyment of the ASTRA License, CENTAUR shall, on the Effective Date and
from time to time thereafter during the Term, make available to ASTRA all
CENTAUR Technology and Product Know-How.
3. STEERING COMMITTEE AND DAY TO DAY MANAGEMENT OF THE PROJECT WORK
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3.1 FORMATION OF STEERING COMMITTEE. Following the Effective Date, the
-------------------------------
parties will form a Steering Committee comprised of senior managers (two
(2) each from ASTRA and CENTAUR), responsible for the Projects. The
Steering Committee shall be initially chaired by a manager selected by
CENTAUR up to the date when Development Work under a Project is first
commenced, and thereafter, by a manager selected by ASTRA. The Steering
Committee may, from time to time, when deemed necessary or appropriate,
call upon other representatives of the parties to participate in the work
of the Steering Committee.
-9-
3.2 MEETINGS OF THE STEERING COMMITTEE. The Steering Committee will meet at
----------------------------------
least quarterly, either in person or by telephone conference. At least two
meetings each year will be held in person, alternating between ASTRA and
CENTAUR locations. Extraordinary meetings shall be held when necessary.
3.3 STEERING COMMITTEE REVIEW OF PROJECT WORK. Within the framework of this
-----------------------------------------
License Agreement and the R&D Plans, the Steering Committee will review
the progress of the Project Work, scrutinize the non-financial reporting
and direct the work performed hereunder, including, without limitation,
decision-making with regard to inter alia the following matters:
- procedures for exchange of Know-How between the parties; and
- directing the Research Work in pursuit of CDs; and
- selection of CDs for further development - it being understood that
more than one CD may be selected within each Project and that such CDs
may later be excluded from further development without affecting
ASTRA's rights under this License Agreement; and
- deciding on whether or not to search for additional CDs within a
Project; and
- regulatory matters.
3.4 STEERING COMMITTEE - DISPUTE RESOLUTION. Disagreements, if any, which may
---------------------------------------
arise between the respective parties' representatives in the Steering
Committee shall be amicably resolved whenever possible. In the event the
Steering Committee is deadlocked, the matter shall be referred to the
President of each of CENTAUR and ARCUS for resolution. In the event the
Presidents are unable to resolve such deadlock, ASTRA will have the sole
right to finally decide on all matters regarding (i) the Development Work,
(ii) approach of the Research Work in pursuit of CDs, (iii) selection of
CDs, (iv) the development of a CD for more than one (1) indication for
use, and (v) whether or not to search for additional CDs in a respective
Project; and CENTAUR shall have the sole right to finally decide all other
matters regarding the Research Work to be performed by CENTAUR.
3.5 PROJECT GROUPS. Each party will appoint managers for the respective
--------------
Projects to form Project Groups. The Project Groups shall meet at regular
intervals to plan, share ideas and review progress on the Project Work.
The Project Groups shall be responsible to the Steering Committee for
accomplishing Project goals and objectives and will coordinate
-10-
joint research and development efforts between the parties. During the
course of the Project Work, each party shall permit individuals designated
by the other to be present, when reasonable, while various tasks,
inspections and other activities under the Project Work are being
conducted.
3.6 THIRD PERSONS. Subject to the prior approval of the Steering Committee,
-------------
the parties may from time to time appoint third persons ("THIRD PERSONS")
to provide services with respect to the Projects.
4. RESEARCH WORK
-------------
4.1 COMMENCEMENT AND COMPLETION OF RESEARCH WORK. The parties shall commence
--------------------------------------------
the Research Work without undue delay following the Effective Date, and
shall use their best reasonable efforts to complete the Research Work
substantially in accordance with the R&D Plans and the other terms and
conditions of this License Agreement.
4.2 R&D PLANS. The parties acknowledge that the R&D Plans as of the Effective
---------
Date are estimates of the scope of Research Work and Development Work to
be performed under the respective Project during the indicated five year
timeframe, which R&D Plans will be specified in further detail by the
Steering Committee from time to time.
4.3 R&D PERIOD. The parties have agreed upon five R&D Periods (i.e., July 1,
----------
1995 - June 30, 2000). The first R&D Period shall commence as of July 1,
1995 and shall continue thereafter through and including June 30, 1996.
Subsequent R&D Periods shall be for the same twelve (12) calendar months
(i.e., July 1 - June 30) (the "R&D PERIOD"). During the third R&D Period
(i.e., July 1, 1997 - June 30, 1998), the Steering Committee will propose
R&D Plan(s) covering Research and Development Work, if any, which will
remain to be completed after the fifth and final R&D Period (i.e., on and
after June 30, 2000) with respect to each Project. If the parties are
unable to agree on extensions of the R&D Plan(s) and R&D Periods after the
fifth R&D Period, ASTRA will have the sole right to determine the scope
and budget of such R&D Plan(s), if any, extending after the fifth R&D
Period.
5. FUNDING OF RESEARCH WORK
------------------------
5.1 BUDGETS. The budget set forth in the R&D Plans (the "BUDGET") as of the
-------
Effective Date is intended to provide for Research Work to be undertaken
during the five R&D Periods.
5.2 CENTAUR FTE. ASTRA shall provide Annual Funding to CENTAUR at an annual
-----------
rate of [*] (the "FTE
-11-
RATE") times the number of CENTAUR FTEs employed by CENTAUR to perform
Research Work during the relevant R&D Period. The FTE Rate shall be
increased annually on the anniversary of the Effective Date by [*].
5.3 ASTRA PAYMENTS OF ANNUAL FUNDING/OUT-OF-POCKET RESEARCH COSTS. ASTRA
-------------------------------------------------------------
shall pay CENTAUR quarterly in advance the amount of Annual Funding
contemplated to be provided to CENTAUR with respect to each calendar
quarter as specified in the Budget pursuant to the respective R&D Plan
(the "ADVANCE AMOUNT"), based on (i) the number of CENTAUR FTEs specified
with respect to such calendar quarter, and (ii) Out-of-Pocket Research
Costs. Within thirty (30) days following the end of each calendar quarter,
CENTAUR shall submit to ASTRA an accounting of the actual amount of
research funding incurred with respect to such calendar quarter (the
"ACTUAL AMOUNT"), indicating the number of CENTAUR FTEs utilized and the
actual Out-of-Pocket Research Costs incurred by CENTAUR in such calendar
quarter. If the Actual Amount exceeds the Advance Amount and provided that
ASTRA has agreed in advance to the expenditure of such excess amount,
ASTRA shall pay such excess amount to CENTAUR at the time of payment of
Annual Funding for the following calendar quarter. If the Advance Amount
exceeds the Actual Amount, ASTRA shall deduct such excess amount from
payments of Annual Funding for the next calendar quarter. Annual Funding
Payments shall be made by wire transfer to a bank designated by CENTAUR
from time to time.
5.4 FUNDING OF R&D PERIODS - ANNUAL MAXIMUM. The Steering Committee may
---------------------------------------
modify the R&D Plans from time to time, it being understood, however, that
unless otherwise agreed by ASTRA, and notwithstanding the provisions of
Sections 5.2 and 5.3, ASTRA's undertaking to fund Research Work and
Development Work to be performed by CENTAUR hereunder shall not be more
than Six Million Dollars ($6,000,000.00) annually for each of R&D Periods
one through five, unless such sum is increased by ASTRA in its sole
discretion or decreased pursuant to Section 20.4 (the "ANNUAL FUNDING").
5.5 CENTAUR'S RECORDS. CENTAUR shall keep accurate records of the number of
-----------------
CENTAUR FTEs that perform Project Work and Out-of-Pocket Research Costs
expended by CENTAUR for the latest three (3) R&D Periods. ASTRA shall have
the right annually, at ASTRA's expense, to have an independent, certified
public accountant reasonably acceptable to CENTAUR, review and audit such
records, upon reasonable notice and during regular business hours, for the
purpose of verifying the number of CENTAUR FTEs that performed Project
Work and the expenditure of Out-of-Pocket Research Costs. If such review
and audit reflects an overpayment to CENTAUR, CENTAUR shall promptly remit
such overpayment to ASTRA, together with reasonable interest. If the
overpayment is equal to or greater than five percent (5%) of the Annual
-12-
Funding made by ASTRA to CENTAUR for such R&D Period(s), for which the
review and audit has been undertaken, CENTAUR shall reimburse ASTRA for
all costs of such review and audit.
6. DEVELOPMENT WORK
----------------
6.1 DEVELOPMENT WORK - ASTRA. Under the supervision of the Steering
------------------------
Committee, ASTRA shall be primarily responsible for undertaking
Development Work. The Steering Committee will decide on detailed plans for
Development Work and may from time to time amend such plans as the
Steering Committee deems mutually appropriate.
6.2 DEVELOPMENT WORK - CENTAUR. CENTAUR will perform such portions of the
--------------------------
Development Work as agreed upon by the Steering Committee. The Annual
Funding will include the Development Work to be performed by CENTAUR in
accordance with the provisions of Section 5.4.
6.3 REGULATORY APPROVALS. All registrations, approvals and other regulatory
--------------------
requirements relating to Licensed Product will be applied for by ASTRA and
held in ASTRA's name, provided, however, that with respect to the
manufacture of Substance for Licensed Product, such obligations of the
parties will be governed by the Supply Agreement.
6.4 DEVELOPMENT OF LICENSED PRODUCT - MAJOR MARKETS. Following successful
-----------------------------------------------
completion of the Research Work for a respective Project, ASTRA agrees,
for each Project, to use best reasonable efforts, including providing
adequate resources and qualified personnel, to undertake Development Work
for at least one Licensed Product to secure marketing approval for such
Licensed Product for at least the Major Markets. In such regard, ASTRA
shall:
(a) NDA APPROVAL. File for NDA approval in each of the Major Market
------------
countries within twelve (12) months following completion of all
required clinical trials and other studies in each relevant country,
(b) FIRST COMMERCIAL SALE. Make the First Commercial Sale and commence
---------------------
regular commercial sales of each Licensed Product in each country of
the Major Markets as promptly as practicable, but within nine (9)
months after receipt of NDA and such other approvals and permits as
ASTRA deems reasonably necessary to successfully commercialize the
Licensed Product in the relevant Major Markets (i.a. government
----
reimbursement or price approval).
-13-
Notwithstanding the time limits set forth in Section 6.4(a) or 6.4(b), such
limits shall be extended (i) to account for any period during which ASTRA
encounters technical or regulatory delays which prevent ASTRA's compliance
with such time limits, provided that ASTRA informs CENTAUR on an ongoing
basis of such delays, which delays have not resulted from ASTRA's gross
negligence or willful misconduct, and (ii) for other commercial reasons
which ASTRA and CENTAUR reasonably believe will benefit long-term commercial
sales of such Licensed Product.
6.5 DEVELOPMENT OF LICENSED PRODUCT - OTHER THAN MAJOR MARKETS. Following
----------------------------------------------------------
successful commercial sale of Licensed Product in any of the Major Markets,
ASTRA agrees to use best reasonable efforts to make the First Commercial
Sale and commence regular commercial sales of each Licensed Product in each
country of the world, other than the Major Markets. ASTRA and CENTAUR will
confer with respect to such countries where sales and marketing of Licensed
Product is not warranted as a result of economies of scale.
6.6 ASTRA NON-COMPLIANCE. In the event ASTRA fails to comply with Section 6.4
--------------------
(a), 6.4(b) or 6.5, and CENTAUR provides a written notice to ASTRA of such
failure, ASTRA shall, within sixty (60) days of ASTRA's receipt of such
notice from CENTAUR, provide CENTAUR with a plan reasonably acceptable to
CENTAUR of ASTRA's proposal to remedy such failure within a time period not
to exceed one hundred eighty (180) days from the date of CENTAUR's receipt
of such plan. In the event ASTRA shall fail to (i) provide CENTAUR with such
a plan within such 60-day period, or (ii) cure such failure with respect to
ASTRA's obligations pursuant to Section 6.4(a), 6.4(b) or 6.5 within one
hundred eighty (180) days, in accordance with such plan, such failure shall
not be deemed a breach or Default by ASTRA of this License Agreement and
CENTAUR's sole and exclusive remedy thereupon shall be the right to notify
ASTRA within one hundred twenty (120) days thereafter of CENTAUR's intent to
terminate the ASTRA License with regard to the relevant country and Licensed
Product for which ASTRA has failed to comply with respect to Section 6.4(a),
6.4(b) or 6.5. In such event, ASTRA shall allow CENTAUR or its nominee to
make cross reference to ASTRA's relevant NDA file(s) and take such other
actions as may be reasonably necessary for CENTAUR to efficiently
commercialize the relevant Licensed Product in such country.
6.7 NOTIFICATION OF DEVELOPMENT WORK. Each party will inform the other from
--------------------------------
time to time as to the progress of the Development Work performed by such
party in accordance with the routines agreed upon by the Steering Committee.
7. REMUNERATION TO CENTAUR
-----------------------
-14-
7.1 TOTAL COMPENSATION TO CENTAUR. As total compensation to CENTAUR for (i)
-----------------------------
CENTAUR's obligations undertaken pursuant to this License Agreement, and
(ii) the grant of the ASTRA License, CENTAUR shall be paid only such
compensation and for such periods as set forth in Sections 7 and 8 of this
License Agreement.
7.2 PAYMENTS. As payment for prior and future research and development
--------
performed by CENTAUR, ASTRA will make the following non-refundable payments
to CENTAUR upon the occurrence of the following events:
(a) EFFECTIVE DATE. On the Effective Date (subject to ASTRA's receipt of
--------------
the Oklahoma/Kentucky License and First Amendment to CENTAUR
Licenses provided in Section 2.5), Four Million Dollars
($4,000,000.00) as reimbursement for prior research and development
expenses incurred by CENTAUR,
(b) SELECTION OF FIRST CD OF SP. [*] within thirty (30) days from the
---------------------------
date of selection of the first CD for the first indication within
SP, and [*] within thirty (30) days from the date of selection of
the first CD for each subsequent indication within the SP, it being
understood, however, that payment (i) will only be made once in
respect of each CD, even if a CD is selected for more than one
indication, and (ii) payment under this Section 7.2(b) is limited to
a maximum of [*],
(c) SELECTION OF FIRST CD OF AP. [*] within thirty (30) days from the
---------------------------
date of selection of the first CD within the AP,
(d) FIRST SP IND IN U.S.. [*] within thirty (30) days from the date of
--------------------
filing of the first IND on a Licensed Product in the United States
within the SP,
(e) FIRST SP IND IN EC MAJOR MARKET OR JAPAN. [*] within thirty (30)
----------------------------------------
days from the date of filing of the first IND on a Licensed Product
in any of the Major Markets within EC, or Japan within the SP,
(f) FIRST AP IND IN U.S.. [*] within thirty (30) days from the date of
--------------------
filing of the first IND on a Licensed Product in the United States
within the AP,
(g) FIRST AP IND IN EC MAJOR MARKET OR JAPAN. [*]
----------------------------------------
-15-
[*] within thirty (30) days from the date of filing of the first IND
on a Licensed Product in any of the Major Markets within EC, or
Japan within the AP,
(h) FIRST SP PHASE III TRIAL IN U.S.. [*] within thirty (30) days from
--------------------------------
the date ASTRA receives the first approval to start phase III
clinical trials in the United States on a Licensed Product within
the SP,
(i) FIRST SP PHASE III TRIAL IN EC MAJOR MARKETS OR JAPAN. [*] within
-----------------------------------------------------
thirty (30) days from the date ASTRA receives the first approval to
start phase III clinical trials in any of the Major Markets within
EC, or Japan, on a Licensed Product within the SP,
(j) FIRST AP PHASE III TRIAL IN U.S.. [*] within thirty (30) days from
--------------------------------
the date ASTRA receives the first approval to start phase III
clinical trials in the United States on a Licensed Product within
the AP,
(k) FIRST AP PHASE III TRIAL IN EC MAJOR MARKETS OR JAPAN. [*] within
-----------------------------------------------------
thirty (30) days from the date ASTRA receives the first approval to
start phase III clinical trials in any of the Major Markets within
EC, or Japan, on a Licensed Product within the AP,
(l) FIRST SP NDA FILING IN U.S.. [*] within thirty (30) days from the
---------------------------
date of filing by ASTRA of the first NDA in the United States on a
Licensed Product within the SP,
(m) FIRST SP NDA FILING IN EC MAJOR MARKET OR JAPAN. [*] within thirty
-----------------------------------------------
(30) days from the date of filing by ASTRA of the first NDA in any
of the Major Markets within EC, or Japan, on a Licensed Product
within the SP,
(n) FIRST AP NDA FILING IN U.S.. [*] within thirty (30) days from the
---------------------------
date of filing by ASTRA of the first NDA in the United States on a
Licensed Product within the AP,
-16-
(o) FIRST AP NDA FILING IN EC MAJOR MARKET OR JAPAN. [*] within thirty
-----------------------------------------------
(30) days from the date of filing by ASTRA of the first NDA in any
of the Major Markets within EC, or Japan, on a Licensed Product
within the AP,
(p) FIRST SP NDA APPROVAL IN U.S.. [*] within thirty (30) days from
-----------------------------
the date of the first NDA approval obtained by ASTRA in the United
States on a Licensed Product within the SP,
(q) FIRST SP NDA APPROVAL IN EC MAJOR MARKET OR JAPAN. [*] within
-------------------------------------------------
thirty (30) days from the date of the first NDA approval obtained by
ASTRA in any of the Major Markets within EC, or Japan, on a Licensed
Product within the SP,
(r) FIRST AP NDA APPROVAL IN U.S.. [*] within thirty (30) days from
-----------------------------
the date of the first NDA approval obtained by ASTRA in the United
States on a Licensed Product within the AP, and
(s) FIRST AP NDA APPROVAL IN EC MAJOR MARKET OR JAPAN. [*] within
-------------------------------------------------
thirty (30) days from the date of the first NDA approval obtained by
ASTRA in any of the Major Markets within EC, or Japan, on a Licensed
Product within the AP.
7.3 NET SALES ROYALTY. ASTRA will pay to CENTAUR royalty based on the Net Sales
-----------------
of Licensed Product as follows:
(a) COUNTRIES WHERE CENTAUR PATENTS ARE EFFECTIVE. [*] of Net Sales
---------------------------------------------
of Licensed Product in countries where, without the ASTRA License
granted hereunder, the manufacture, use or sale of such Licensed
Product would infringe the CENTAUR Patents,
(b) COUNTRIES WHERE CENTAUR PATENTS INAPPLICABLE. [*] of Net Sales
--------------------------------------------
of Licensed Product in countries other than those set forth in
Section 7.3(a).
7.4 CENTAUR DEFAULT/BANKRUPTCY. In the event of termination of this License
--------------------------
Agreement by ASTRA pursuant to (i) Default by CENTAUR pursuant to Section
20.2, or (ii) Bankruptcy of CENTAUR pursuant to Section 20.3, ASTRA may
assume development and manufacture of Substance for ASTRA's and ASTRA's
sublicensee's use worldwide, and in such event, ASTRA shall, in lieu of all
other payments otherwise to be made by
-17-
ASTRA to CENTAUR under this License Agreement or the Supply Agreement,
including, without limitation, such amounts set forth in Sections 7.2 and
7.3, make payments to CENTAUR for such period of time as limited by the
provisions of Section 7.5, in an amount equal to [*] of Net Sales of
Licensed Product, less all Third Party Royalties pursuant to Section 7.6. In
the event of such termination of this License Agreement, the ASTRA License
shall be deemed to be an exclusive, worldwide, perpetual, royalty-free, with
the right to grant sublicenses, except for such payments to be made pursuant
to this Section 7.4 as limited by the provisions of Section 7.5.
7.5 TERMINATION OF CENTAUR ROYALTY - ASTRA PAID UP LICENSE. ASTRA's obligation
------------------------------------------------------
to pay CENTAUR royalty on Net Sales of Licensed Product will expire, on a
country-by-country basis, on the later of (i) the last to expire of the
CENTAUR Patents, and (ii) the fifteenth (15th) anniversary of the First
Commercial Sale of a Licensed Product in a relevant country. Upon
termination of the CENTAUR royalty, the ASTRA License will be deemed co-
exclusive with CENTAUR, perpetual, worldwide and non-royalty bearing.
7.6 THIRD PARTY ROYALTIES ON SALES OF LICENSED PRODUCT. ASTRA and CENTAUR will
--------------------------------------------------
share, on an equal (50/50) basis the cost of all royalties, fees and license
fees payable to third parties due on Net Sales of Substance or Licensed
Product pursuant to license agreements existing (i) on the Effective Date,
including, without limitation, payments, if any, due pursuant to the CENTAUR
Licenses, and (ii) after the Effective Date to the extent approved by the
Steering Committee (collectively, the "THIRD PARTY ROYALTIES"), but not
including research funding or grant payments payable by CENTAUR to third
parties.
7.7 COMPUTATION AND PAYMENT OF ROYALTY TO CENTAUR. ASTRA shall deliver to
---------------------------------------------
CENTAUR within sixty (60) days after the end of each calendar quarter a
written report showing its computation of remuneration to CENTAUR due under
this License Agreement during such calendar quarter and at the same time
make the payment of all Net Sales royalties due CENTAUR. All Net Sales shall
be segmented in each such report according to sales on a country-by-country
basis, including the rates of exchange used for conversion to Dollars from
the currency in which such sales were made. For the purposes hereof, the
rates of exchange to be used for conversion hereunder, Dollars shall be the
average purchase rates of the respective currencies as quoted by
Skandinaviska Enskilda Banken, Sweden for the quarter in question.
7.8 ASTRA RECORDS. ASTRA shall keep for a period of three (3) years following
-------------
the year to which such records relate, full, true and accurate books of
accounts and other records containing all information and data which may be
necessary to ascertain and verify the Net Sales royalties payable to CENTAUR
hereunder.
7.9 CENTAUR AUDIT. CENTAUR shall have the right to have such pertinent books
-------------
and
-18-
records of ASTRA inspected and examined at all reasonable times for the
purpose of determining the accuracy of payments made hereunder. Such
inspection and examination shall be conducted by an independent, certified
public accountant selected by CENTAUR and to whom ASTRA shall have no
reasonable objection. Such accountant shall not disclose to CENTAUR any
information except for information necessary to verify the accuracy of the
reports and payments made pursuant to this License Agreement. Results of
such review shall be made available to both parties. If the review reflects
an underpayment, ASTRA shall promptly remit to CENTAUR any amounts due with
reasonable interest. If the underpayment is equal to or greater than five
percent (5%) of the payments made by ASTRA to CENTAUR for such period under
review, ASTRA shall pay all costs of such review and audit.
8. OPTION TO CO-PROMOTE IN THE U.S.
--------------------------------
8.1 NOTIFICATION TO CO-PROMOTE. Within sixty (60) days after filing of an NDA
--------------------------
with respect to any Licensed Product in the United States, CENTAUR shall
notify ASTRA of its willingness to Co-Promote such Licensed Product with
ASTRA in the United States. Should CENTAUR fail to do so, CENTAUR's option
to Co-Promote such Licensed Product shall automatically expire.
8.2 ELECTION OF CO-PROMOTION RIGHTS. Upon CENTAUR's exercise of its Co-Promote
-------------------------------
rights set forth in Section 8.1, ASTRA and CENTAUR shall discuss how to
implement the Co-Promote activities and agree in good faith upon conditions
therefor according to the following principles:
(a) CO-PROMOTE MARKET PLAN. CENTAUR and ASTRA shall promote the
----------------------
Licensed Product under ASTRA's trademark and the NDA held by ASTRA.
ASTRA or its nominee shall be the sole distributor of the Licensed
Product. CENTAUR and ASTRA shall in good faith discuss strategies
for marketing the Licensed Product including the pricing, and seek
to produce a mutually agreeable marketing plan for the Licensed
Product. The marketing plan shall include role, activities and
obligations of ASTRA and CENTAUR. In the event the parties fail to
agree as above said, ASTRA is entitled to make the final decision.
The parties shall review progress against the marketing plan from
time to time.
(b) CENTAUR MEDICAL REPRESENTATIVES. In no event shall the number of
-------------------------------
CENTAUR's medical representatives be less than ten percent (10%) of
ASTRA's medical representatives used for detailing the Licensed
Product or exceed the number of ASTRA's medical representatives to
be used for
-19-
detailing the Licensed Product. The total number of medical
representatives shall not be higher than the respective market
reasonably requires for the Licensed Product in question.
(c) CO-PROMOTE PROFITS. CENTAUR and ASTRA shall share the profit
------------------
obtained from the Co-Promote activities on a [*]
The term "profit" as used herein shall mean, with respect to the
given period, the Net Sales of the Licensed Product in the United
States less
(i) the cost of the Licensed Product including, without limitation
(1) all Third Party Royalties, (2) Net Sales royalty payable
to CENTAUR hereunder, (3) the supply price for Substance
payable to CENTAUR pursuant to the Supply Agreement, if
CENTAUR is manufacturing Substance, and (4) other direct and
indirect costs actually incurred in connection with the
manufacture of the Licensed Product in finished form in
accordance with generally acceptable accounting principles;
and
(ii) distribution cost of ASTRA not exceeding [*] of the Net Sales;
and
(iii) advertisement and promotional expenses actually used by the
parties comprising media publicity, sample package,
promotional materials and other selling materials and
seminars, conventions and symposia and any other activities
generally recognized in the United States to be advertisement
and promotion, but excluding cost for detailing the Licensed
Product by the medical representatives of the parties; and
(iv) the cost of phase IV studies on the Licensed Product amortized
over five years; and
(v) [*] of the Net Sales for the cost of Development Work related
to the Licensed Product undertaken at ASTRA's expense, such
cost to be deducted from the Net Sales at the said rate for
the initial [*] of co-promotion hereunder.
-20-
8.3 CO-PROMOTE TERM. The co-promotion by CENTAUR subject to this Article 8
---------------
shall continue for a period of not less than [*], as separately agreed by
the parties.
9. EXCHANGE OF INFORMATION
-----------------------
9.1 COMMUNICATION OF INFORMATION. Commencing on the Effective Date and
----------------------------
continuing thereafter during the Term, each party shall, on a timely and
regular basis, furnish each other with any Know-How obtained by such party
pursuant to the procedures agreed upon by the Steering Committee. Each
party shall promptly and thoroughly disclose to the other party all
information and data in the Field resulting from activities undertaken as
part of the Project Work. In addition, each party shall promptly disclose
to the other party all safety and toxicity data relating to Licensed
Product. The parties shall agree on a plan for adverse event reporting and
shall keep one another appropriately informed.
10. REPRESENTATIONS AND WARRANTIES
------------------------------
10.1 GENERAL REPRESENTATIONS. Each party hereby represents and warrants to the
-----------------------
other as follows:
(a) DULY ORGANIZED. It is a corporation duly organized, validly
--------------
existing and is in good standing under the laws of the jurisdiction
of its incorporation, is qualified to do business and is in good
standing as a foreign corporation in each jurisdiction in which the
conduct of its business or the ownership of its properties requires
such qualification and has all requisite power and authority,
corporate or otherwise, to conduct its business as now being
conducted, to own, lease and operate its properties and to execute,
deliver and perform this License Agreement.
(b) DUE EXECUTION. The execution, delivery and performance by it of
-------------
this License Agreement (including the grant of the ASTRA License by
CENTAUR and of the CENTAUR Grant by ASTRA) have been duly authorized
by all necessary corporate action and do not and will not (i)
require any consent or approval of its stockholders, (ii) violate
any provision of any law, rule, regulation, order, writ, judgment,
injunction, decree, determination or award presently in effect
having applicability to it or any provision of its charter or by-
laws, or (iii) result in a breach of or constitute a default under
any material agreement (including, without limitation, the CENTAUR
Licenses), mortgage, lease, license, permit, patent or other
instrument or obligation to which it is a party or by which it or
its assets may
-21-
be bound or affected.
(c) NO THIRD PARTY APPROVAL. No authorization, consent, approval,
-----------------------
license, exemption of, or filing or registration with, any court or
governmental authority or regulatory body is required for the due
execution, delivery or performance by it of this License Agreement
(including the grant of the ASTRA License by CENTAUR and of the
CENTAUR Grant by ASTRA).
(d) BINDING AGREEMENT. This License Agreement is a legal, valid and
-----------------
binding obligation of such party, enforceable against it in
accordance with its terms and conditions, except as may be limited
by bankruptcy laws or other laws affecting the rights of creditors
generally, and rules of law governing equitable remedies. Each is
not under any obligation to any person, contractual or otherwise,
that is conflicting or inconsistent in any respect with the terms of
this License Agreement (including the grant of the ASTRA License by
CENTAUR and of the CENTAUR Grant by ASTRA) or that would impede the
diligent and complete fulfillment of its obligations hereunder.
(e) GOVERNMENTAL STATUS. It is not debarred or suspended from receiving
-------------------
contracts from the United States or Swedish government or other
governmental authority or agency.
(f) FULL DISCLOSURE. Each party has disclosed to the other in good
---------------
faith any and all material information relevant to the subject
matter of this License Agreement and the Supply Agreement to such
party's ability to observe and perform its obligations hereunder,
and each party covenants on and after the Effective Date to provide
to the other such additional material information which may, or with
the passage of time, effect the subject matter of this License
Agreement or the Supply Agreement or the ability of such party to
observe and perform its obligations hereunder or thereunder.
10.2 CENTAUR REPRESENTATIONS. CENTAUR covenants, represents and warrants to
-----------------------
ASTRA that
(a) CENTAUR is the owner or licensee, as the case may be, of the CENTAUR
Technology and Product Know-How and the same are free of any liens,
encumbrances, restrictions and other legal or equitable claims of
any kind or nature, excepting the rights of grantors of the CENTAUR
Licenses,
(b) CENTAUR has the right to grant the ASTRA License,
-22-
(c) CENTAUR has not granted and will not grant during the Term of this
License Agreement any license or sublicense of the CENTAUR Licenses,
CENTAUR Technology and Product Know-How in the Field,
(d) With respect to each of the CENTAUR License(s) that (i) CENTAUR will
fully comply with all of CENTAUR's covenants and obligations
thereunder, (ii) to the best of its knowledge, each is in full force
and effect, not having been amended, other than as set forth in
▇▇▇▇▇▇▇▇ ▇, (▇▇▇) CENTAUR has received no oral or written
----------
notification of any alleged breach or default by CENTAUR, (iv)
CENTAUR is not aware of any breach or default by any party, and (v)
CENTAUR will not terminate or otherwise amend the CENTAUR Licenses
(x) on less than sixty (60) days' prior written notice to ASTRA, and
(y) in any manner which would materially adversely affect the ASTRA
License, and
(e) As of the Effective Date, to the best of CENTAUR's knowledge and
belief, there are no third party rights, licenses or patents, other
than the CENTAUR Licenses, which are necessary for ASTRA's use and
enjoyment of the ASTRA License and the research, development,
production, manufacture, sale or use of Licensed Products.
11. PUBLICATIONS
------------
11.1 DISCLOSURE OF KNOW-HOW. Unless as necessary for ASTRA to utilize the
----------------------
ASTRA License granted to ASTRA hereunder, neither party will make any
publications of Know-How of the other party or other results developed
hereunder without the other party's prior written approval, which approval
shall not be unreasonably withheld.
11.2 USE OF OTHER PARTY'S NAME. Unless as required by law and/or applicable
-------------------------
government regulation, neither party will use the name of the other party,
nor of any member of such party's staff, in any publicity, advertising, or
news release without the prior written approval of an authorized
representative of such party.
12. MARKETING OF LICENSED PRODUCT
-----------------------------
12.1 ASTRA'S COMMERCIALIZATION OF LICENSED PRODUCT. ASTRA agrees to use its
---------------------------------------------
best reasonable efforts to commercialize any Licensed Product successfully
developed hereunder, and will keep CENTAUR continuously informed with
respect to such
-23-
commercialization period.
12.2 LABELING. Unless otherwise prohibited by regulatory authority, Licensed
--------
Product(s) or the packaging in which they are contained shall bear the
label "Manufactured under license from Centaur Pharmaceuticals, Inc., ▇▇▇
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇, USA", or any similar wording as may
be mutually agreed upon by the parties.
13. INVENTION, IMPROVEMENTS AND DISCOVERIES
---------------------------------------
13.1 OWNERSHIP OF TECHNOLOGY. The parties shall keep each other apprised on
-----------------------
the development of patentable and other inventions in the Field. Each party
shall retain sole title to any technology, know-how, inventions, concepts,
processes and the like (whether or not patentable) which it develops
solely. Except as provided in this License Agreement, neither party shall
have any right to use or license technology to which the other party has
sole title. Each party shall own a fifty percent (50%) undivided interest
in all technology, know-how, inventions, concepts, processes and the like
(whether or not patentable) made, conceived, reduced to practice or
generated jointly in connection with the Project Work by (i) one party
and/or Third Persons obligated to assign their rights therein to such
party, and (ii) the other party and/or Third Persons obligated to assign
their rights therein to such other party (collectively the "JOINT PROJECT
TECHNOLOGY"). Such Joint Project Technology, to the extent in the Field,
shall be used by each party exclusively within the context of this License
Agreement and the Supply Agreement, provided, however, either party may use
such Joint Project Technology outside the Field, as such party deems
appropriate.
14. PATENTS AND PATENT APPLICATIONS
-------------------------------
14.1 MAINTENANCE OF CENTAUR PATENTS. CENTAUR shall diligently prosecute and
------------------------------
maintain, at CENTAUR's sole cost and expense, the CENTAUR Patents unless,
with regard to one or more patents comprising the CENTAUR Patents, the
parties agree that such is not necessary or commercially advisable. If
CENTAUR fails to diligently prosecute, maintain and defend the CENTAUR
Patents, ASTRA may (but shall not be obligated to), upon notice to CENTAUR,
undertake such prosecution, maintenance and defense of the CENTAUR Patents,
and all costs incurred by ASTRA in such regard may be deducted from Net
Sales royalty payable to CENTAUR hereunder from countries where such
Centaur patents are being prosecuted and maintained over a three (3) year
period.
14.2 CENTAUR NEW INVENTIONS PATENTS. If ASTRA, in its sole discretion, and
------------------------------
following
-24-
consultation with CENTAUR, determines that any invention of CENTAUR in the
Field, developed solely by CENTAUR (as opposed to Joint Patents) not
already covered by the CENTAUR Patents in one or more countries, is
patentable (the "NEW INVENTIONS PATENTS"), CENTAUR shall, upon notice from
ASTRA, promptly prepare, file, and prosecute in CENTAUR's name patent
application(s) and/or any related continuation, continuation-in-part,
divisional, and/or reissue application(s) thereof, with respect to such
invention in such countries as selected by ASTRA. ASTRA shall reimburse
CENTAUR for all out-of-pocket expenses incurred in connection with the
above preparation, filing, and prosecution of application(s) and
maintenance of New Inventions Patents directed to such inventions in the
countries chosen by ASTRA. ASTRA shall cooperate with CENTAUR to assure
that such application(s) and any related continuation, continuation-in-
part, divisional, and/or reissue applications(s) thereof, will cover, to
the best of ASTRA's knowledge, all items of commercial interest and
importance and ASTRA shall have the right, through ASTRA's patent attorneys
and/or agents, to advise and cooperate with CENTAUR's patent attorneys in
the prosecution of such patent applications. In the event CENTAUR shall
fail to prepare, file and prosecute any New Inventions Patents, ASTRA may
(but shall not be obligated to) undertake such preparation, filing and
prosecution of the New Inventions Patents in CENTAUR's name, at ASTRA's
sole cost and expense.
14.3 JOINT PATENTS. If ASTRA, in its sole discretion and following
-------------
consultation with CENTAUR, determines that any invention made jointly by
the parties (a "JOINT PATENT") is patentable, ASTRA shall, at its expense
and discretion, promptly prepare, file and prosecute in both parties' names
patent application(s) and/or any related continuation, continuation-in-
part, divisional, and/or reissue application(s) thereof, in the United
States and in such foreign countries selected by ASTRA, with respect to
such joint invention. CENTAUR shall have the right, through CENTAUR's
patent attorneys and/or agents, to advise and cooperate with ASTRA's patent
attorneys in the prosecution of such patent applications. ASTRA and CENTAUR
agree to use all Joint Patents exclusively within the context of this
License Agreement. Should the inventions, improvements and/or discoveries
referred to in Section 14.3 fall within the definition of Know-How or if
same are patentable, then they shall be used exclusively within the context
of this License Agreement and the Supply Agreement if within the Field.
Either party may use such inventions, improvements and/or discoveries which
are outside the Field, whether or not patentable, as such party may deem
appropriate.
(a) JOINT PATENT - ASTRA DEFAULT OR BANKRUPTCY. In the event this
------------------------------------------
License Agreement is terminated as a result of a Default or
Bankruptcy by ASTRA, then such joint inventions, improvements and/or
discoveries whether existing as Know-How or as a patent application
or patent, and ASTRA's interests in the Joint Patents will be
automatically exclusively licensed, royalty-free, to
-25-
CENTAUR to develop, use, market, distribute and sell Licensed
Product(s) worldwide in the Field. In addition, should this License
Agreement be terminated with respect to only one of the Projects in
accordance with Section 20.4, then such inventions, improvements
and/or discoveries related to the terminated Project as well as
ASTRA's interests in the Joint Patents related to the terminated
Project will be automatically exclusively licensed in the Field to
CENTAUR, royalty-free.
(b) JOINT PATENT - CENTAUR DEFAULT OR BANKRUPTCY. In the event this
--------------------------------------------
License Agreement is terminated as a result of a Default or
Bankruptcy by CENTAUR, then such joint inventions, improvements
and/or discoveries whether existing as Know-How or as a patent
application or patent, and CENTAUR's interests in the Joint Patents
will be automatically exclusively licensed to ASTRA to develop, use,
market, distribute and sell Licensed Product(s) worldwide in the
Field, subject to the royalty obligations provided herein.
14.4 NOTIFICATION WITH RESPECT TO PATENTS. Each party shall keep the other
------------------------------------
advised as to all developments with respect to any patent application(s)
referred to in this Section 14, and shall promptly supply to the other
copies of relevant papers received and filed by it in connection with the
prosecution thereof in sufficient time for such party to comment thereon.
The parties shall reasonably cooperate and assist each other in the patent
prosecution provided for in this Section 14.
14.5 CENTAUR'S ELECTION. If ASTRA elects, with regard to CENTAUR Patents, New
------------------
Inventions Patents, or Joint Patents not to have CENTAUR seek or maintain
patent protection in one or more countries, CENTAUR will have the right, at
CENTAUR's sole expense and discretion, to file, procure, maintain and
enforce such patents in such countries and ASTRA will cooperate fully. The
parties agree that should CENTAUR exercise said right it will not in any
way affect the ASTRA License granted hereunder other than should ASTRA or
its sublicensees later sell a Licensed Product, the sale of which would
infringe such patent procured by CENTAUR at its own expense, ASTRA will
reimburse CENTAUR for its patent out-of-pocket expenses, plus twenty
percent (20%) thereof related to the relevant country or countries. ASTRA
agrees to advise CENTAUR in a timely manner of any decision not to continue
to seek or maintain, or have CENTAUR continue to seek, or to maintain
patent protection with respect to CENTAUR Patents, New Inventions Patents
or Joint Patents in one or more countries in order to allow CENTAUR the
timely exercise of its rights under this Section 14.5.
14.6 ASTRA'S ELECTION. Notwithstanding the provisions of Section 14.2, New
----------------
Inventions Patents and New Chemical Entity Patents shall not be deemed to
be "CENTAUR
-26-
Patents" for purposes of determining the period during which ASTRA shall
pay royalty to CENTAUR on Net Sales of Licensed Product pursuant to Section
7.5, unless (i) ASTRA's manufacture, use or sale of Licensed Product in a
particular country would infringe such New Inventions Patents or New
Chemical Entity Patents, or (ii) ASTRA shall, in ASTRA's sole discretion,
agree that such New Inventions Patents and/or New Chemical Entity Patents
shall be deemed to be "CENTAUR Patents" for purposes of Section 7.5.
14.7 MINIMUM PATENT PROTECTION. Unless extraordinary circumstances require
-------------------------
otherwise, patent protection is to be sought and upheld on inventions
falling under the license herein granted in at least the countries in which
ASTRA Affiliates are established.
15. PATENT INFRINGEMENTS
--------------------
15.1 NOTIFICATION OF ALLEGED PATENT INFRINGEMENT. If a third party notifies
-------------------------------------------
CENTAUR, ASTRA or its sublicensees that any act by either party allegedly
infringes any patent owned by the third party or any patent rights owned by
or licensed to the third party, CENTAUR or ASTRA, as the case may be, shall
promptly notify the other in writing.
15.2 THIRD PARTY CLAIMS. In the event of a third party claim that the exercise
------------------
of the ASTRA License with respect to the manufacture, sale or other use of
Licensed Product infringes any patent of such third party (a "THIRD PARTY
CLAIM"), CENTAUR shall consult with ASTRA and with respect to such Third
Party Claim, CENTAUR shall (i) undertake, at CENTAUR's sole cost and
expense, defense of such Third Party Claim, or (ii) request ASTRA to
undertake such defense, at ASTRA's sole cost and expense. Neither ASTRA nor
CENTAUR shall settle any Third Party Claim, including an agreement to pay
Third Party Royalties, without the reasonable approval of the other party.
If ASTRA shall, at ASTRA's sole cost and expense, undertake to defend such
Third Party Claim, fifty percent (50%) of all costs and expenses incurred
by ASTRA, including, without limitation, expert witness and attorneys'
fees, and such damages payable to any third party (other than Third Party
Royalties) shall be deducted from Net Sales royalties payable to CENTAUR
hereunder from countries where such Third Party Claim claims infringement,
over a three (3) year period.
15.3 PAYMENT OF ADDITIONAL THIRD PARTY ROYALTIES. Should ASTRA or its
-------------------------------------------
sublicensees obtain one or more licenses under any patent not licensed
hereunder and agree to pay Third Party Royalties in order to make, use or
sell a Licensed Product (whether as a condition of settlement of an
infringement action or by court order), the Net Sales royalties payable to
CENTAUR hereunder shall be reduced by fifty percent (50%) of such Third
Party Royalties as set forth in Section 7.6.
-27-
15.4 INFRINGEMENT OF CENTAUR PATENTS/JOINT PATENTS/NEW INVENTIONS PATENTS. If
--------------------------------------------------------------------
a third party shall, in the reasonable opinion of either party, infringe
any CENTAUR Patent, Joint Patent or New Inventions Patents, then such party
shall promptly notify the other party. ASTRA or its sublicensees shall have
the initial sole right to commence an action for infringement against the
third party, in its own name and/or in the name of CENTAUR, together with
the right to enforce and collect any judgment thereon. If ASTRA or its
sublicensee elects to exercise the right to commence an action, then
CENTAUR shall, at ASTRA's request and at ASTRA's expense, assist in the
prosecution of such action, including, but not limited to, consenting to
being joined in such action as a voluntary plaintiff. ASTRA shall bear its
own internal and external legal and other costs and expenses associated
with the prosecution of the action. CENTAUR shall have the right to
independently retain legal counsel and consultants, at CENTAUR's sole cost
and expense, but such counsel or consultants shall not have the right to
affect ASTRA's or its sublicensee(s) sole management of the prosecution of
the action.
15.5 MONETARY RECOVERY - ASTRA PROSECUTION. Any monetary recovery (whether by
-------------------------------------
settlement or judgment) in connection with an infringement action commenced
by ASTRA or ASTRA's sublicensees shall be applied first to reimburse ASTRA
and its sublicensees, if applicable, for their out-of-pocket expenses
(including reasonable attorneys' fees) incurred in prosecuting such action
and the expenses of CENTAUR borne by ASTRA hereunder. Any balance remaining
shall be shared in the ratio of 80:20 (ASTRA:CENTAUR, respectively).
15.6 MONETARY RECOVERY - CENTAUR PROSECUTION. Should neither ASTRA, its
---------------------------------------
Affiliates nor its sublicensees take appropriate and diligent action with
respect to any such infringement within three (3) months after receiving
notice of any infringement or possible infringement of a CENTAUR Patent,
Joint Patent or New Inventions Patents, CENTAUR shall have the right, but
not the obligation, to take such action, at its own expense, in its own
name, and the right to enforce and collect any judgment thereon. If the
recovery exceeds CENTAUR's out-of-pocket expenses (including reasonable
attorneys' fees) for prosecuting the claim, then such excess recovery shall
be shared by the parties in the ratio of 80:20 (CENTAUR:ASTRA,
respectively).
16. CONFIDENTIALITY
---------------
16.1 TREATMENT OF CONFIDENTIALITY. A party receiving Confidential Information
----------------------------
of the other party shall maintain such Confidential Information in strict
confidence and shall not disclose the Confidential Information to any third
party. Furthermore, neither party shall use the Confidential Information
for any purpose other than those purposes specified in
-28-
this License Agreement. The parties may disclose Confidential Information
to the minimum number of its employees reasonably requiring access thereto
for the purposes of this License Agreement, provided, however, that prior
to making such disclosures, each such employee shall be apprised of the
duty and obligation to maintain Confidential Information in confidence and
not to use such Confidential Information for any purpose other than in
accordance with the terms and conditions of this License Agreement.
16.2 RELEASE FROM RESTRICTIONS. The provisions of Section 16.1 shall not apply
-------------------------
to any Confidential Information disclosed hereunder which is required to be
disclosed by the receiving party to comply with applicable laws, or to
comply with laws or regulations (including, without limitation, testing and
marketing regulations), in each case only to the extent required to carry
out the work contemplated by this License Agreement or other legal
obligations provided that the receiving party provides prior written notice
of such disclosure to the other party and takes reasonable and lawful
actions to avoid and/or minimize the degree of such disclosure.
17. TRADEMARK
---------
ASTRA shall market, distribute and sell Licensed Product under trademarks
selected and owned by ASTRA and to which CENTAUR shall have no reasonable
objections.
18. EXCLUSIVITY AND OPTION TO EXTEND THE LICENSE
--------------------------------------------
18.1 RESTRICTIONS. During the Term of this License Agreement and the Supply
------------
Agreement (i) neither party shall sell any products or provide any service
in the Field other than Licensed Product, or conduct any research alone
(excepting as provided in this Section 18.1), or with third parties or fund
research by third parties in the Field, except research conducted pursuant
to the Research Program, and (ii) CENTAUR shall not grant any license or
sublicense in the Field of (w) CENTAUR Technology, (x) Product Know-How,
(y) the CENTAUR Licenses in the Field, or (z) any right which would
materially adversely affect ASTRA's use and enjoyment of the ASTRA License,
and (iii) ASTRA will not grant any license or sublicense of any right which
would materially, adversely affect CENTAUR's use and enjoyment of the
CENTAUR Grant in the Field. The foregoing restrictions shall not prohibit
either party from conducting research, either alone or with third parties,
that has applicability outside the Field, notwithstanding that such
research may also have utility in the Field. CENTAUR further acknowledges
that ASTRA has, and may continue to undertake research, development and
marketing of products outside the Field which may have indications for use
comparable to Licensed Product.
-29-
18.2 ASTRA RIGHT OF FIRST NEGOTIATION. ASTRA acknowledges that CENTAUR may
--------------------------------
undertake research, development and marketing of products outside the Field
which may have indications for use comparable to Licensed Product.
Notwithstanding the foregoing, CENTAUR will not enter into any agreement or
collaboration with any third party with respect to the development,
manufacture or sale of any substance or product outside the Field, but
falling within ASTRA's strategic research areas and/or such other research
areas of interest to ASTRA as set forth on Appendix 4 hereof, and as the
----------
same may be modified from time to time by ASTRA in writing, without, in the
first instance, CENTAUR providing ASTRA by written notice with a right of
first negotiation with CENTAUR. ASTRA shall, within sixty (60) days of
written notification from CENTAUR, either (i) waive such right of first
negotiation, or (ii) enter into discussions with CENTAUR in which the
parties shall diligently and in good faith seek to agree upon the terms and
conditions of such agreement and/or collaboration. Should the parties not
reach agreement within one hundred twenty (120) days (which period may be
extended by mutual agreement of the parties), CENTAUR shall be free to
enter into negotiations and/or agreements or collaborations with third
parties.
19. WARRANTY DISCLAIMER
-------------------
19.1 DISCLAIMER BY PARTIES. Other than with respect to the provisions of this
---------------------
License Agreement and the Supply Agreement, nothing in this License
Agreement shall be construed as:
(a) CENTAUR TECHNOLOGY/PRODUCT KNOW-HOW. A warranty or representation
-----------------------------------
by CENTAUR as to the validity or scope of the CENTAUR Technology or
Product Know-How, other than as specifically provided to the
contrary herein,
(b) THIRD PARTY INFRINGEMENT. A warranty or representation that
------------------------
anything made, used, sold or otherwise disposed of under this
License Agreement is or will be free from infringement of patents,
copyrights and trademarks of third parties,
(c) PROSECUTION. An obligation to bring or prosecute actions or suits
-----------
against third parties for infringement,
(d) USE OF NAME/TRADEMARK. Conferring rights to use in advertising,
---------------------
publicity or otherwise any trademark or the name of CENTAUR or
ASTRA,
-30-
(e) CENTAUR LIMITATION. Granting by implication, estoppel or otherwise
------------------
any licenses under (i) patents of CENTAUR other than the CENTAUR
Patents, and (ii) the CENTAUR Patents and Know- How outside the
Field. Except as expressly set forth in this License Agreement
and/or the Supply Agreement, CENTAUR makes no representations and
extends no warranties of any kind, either express or implied. There
are no express or implied warranties of merchantability or fitness
for a particular purpose, or that the use of the Licensed Product
will not infringe any third party patent, copyright, trademark or
other rights,
(f) ASTRA LIMITATION. Except as expressly set forth in this License
----------------
Agreement, ASTRA makes no representations and extends no warranties
of any kind, either express or implied. There are no express or
implied warranties of merchantability or fitness for a particular
purpose, or that the use of the Licensed Product will not infringe
any patent, copyright or trademark or other rights.
20. TERM AND TERMINATION
--------------------
20.1 TERM. The Term of this License Agreement (the "TERM") shall commence as of
----
the Effective Date. Unless sooner terminated pursuant to Section 20.2, 20.3
or 20.4, the Term shall expire at such time as ASTRA shall have no further
obligation to make payments to CENTAUR on Net Sales of Licensed Product
pursuant to Section 7.5.
20.2 DEFAULT. Other than as provided in Section 6.6, failure by either party to
-------
comply with any of its material obligations contained in this License
Agreement following notice and opportunity to cure, as hereinafter provided
(a "DEFAULT") shall entitle the other party to terminate this License
Agreement. The non-defaulting party shall give the other party notice
specifying the nature of the breach of this License Agreement and requiring
it to cure. If such breach is not cured within ninety (90) days after the
receipt of such notice (or one hundred twenty (120) days in event such
breach cannot be reasonably expected to be cured within ninety (90) days,
and the defaulting party gives notice to the other party of its inability
to cure such breach within a 90-day period and the defaulting party
thereafter uses reasonable efforts to cure such breach as soon as
practicable, but in no event longer than one hundred twenty (120) days),
the notifying party shall be entitled, without prejudice to any of its
other rights under this License Agreement, and in addition to any other
remedies available to it by law or in equity, to terminate this License
Agreement by giving notice to that effect to the defaulting party. The
right of either party to terminate this License Agreement, as hereinabove
provided, shall not be affected in any way by its waiver or failure to take
action with respect to any previous Default.
-31-
Notwithstanding the foregoing, and other than as provided in Section 20.3
and 20.4, a party shall not have a right to terminate this License
Agreement in the event the other party pursuant to Section 22 has sought to
resolve the dispute for which termination is being sought.
20.3 INSOLVENCY OR BANKRUPTCY. Either party may, in addition to any other
------------------------
remedies available to it by law or in equity, terminate this License
Agreement by written notice to the other party in the event (i) the other
party shall have become insolvent or bankrupt, or shall have made an
assignment for the benefit of its creditors, or (ii) there shall have been
appointed a trustee or receiver of the other party or for all or a
substantial part of its property, or (iii) any case or proceeding shall
have been commenced or some other action taken by or against the other
party in bankruptcy or seeking reorganization, liquidation, dissolution,
winding-up, arrangement, composition or readjustment of its debts or any
other relief under any bankruptcy, insolvency, reorganization or other
similar act or law of any jurisdiction now or hereafter in effect or there
shall have been issued a warrant of attachment, execution, distraint or
similar process against any substantial part of the property of the other
party, and any such event or action (except where a party voluntarily takes
such actions (e.g., where a party makes a bankruptcy filing)) shall have
----
continued for ninety (90) days undismissed, unbounded and undischarged
(alternatively a "BANKRUPTCY"); provided, however, that no such right to
terminate shall pertain solely by virtue of a voluntary reorganization for
the purpose of solvent amalgamation or reconstruction.
20.4 SPECIAL TERMINATION PROVISIONS. ASTRA shall have the right to terminate
------------------------------
this License Agreement partially or entirely with respect to a specific
Project, at any time, for any reason, upon twelve (12) months' prior notice
to CENTAUR following the second R&D Period, provided, however, that ASTRA
may terminate this License Agreement with respect to a specific indication
for use of SP at any time, for any reason upon twelve (12) months' prior
notice to CENTAUR, although the Annual Funding shall remain the same.
Should a specific Project (i.e., either SP or AP) be terminated, while the
other Project remains, research funds will be reallocated to the remaining
Project (or to a substitute project if such is mutually agreed upon by the
parties) but at a reduced minimum Annual Funding of [*], as adjusted in
accordance with Section 5. If this License Agreement is terminated with
respect to only one of the Projects, the scope of the Field and other terms
of this License Agreement shall be modified accordingly, including that all
rights with regard to such Project or such indication or use with respect
to SP as terminated, will revert to CENTAUR.
20.5 EFFECT OF TERMINATION OF LICENSE AGREEMENT.
------------------------------------------
(a) EXISTING OBLIGATIONS. Upon termination of this License Agreement
--------------------
for any
-32-
reason, nothing herein shall be construed to release either party
from any obligation that matured prior to the effective date of such
termination.
(b) EXPIRATION OF TERM OR CENTAUR DEFAULT OR BANKRUPTCY. Upon
---------------------------------------------------
termination of this License Agreement (i) at the expiration of the
Term, or (ii) by ASTRA as a result of (x) a Default by CENTAUR
hereunder, or (y) the Bankruptcy of CENTAUR, the following
provisions of this License Agreement shall survive such termination:
Section 2.1 - License Grant to ASTRA - ASTRA License
Section 2.4 - Oklahoma/Kentucky License
Section 14.1 - Ownership of Technology
Section 15.3 - Joint Patents
Section 16 - Confidentiality
Section 21.12- CENTAUR Indemnification
Section 21.14- Governing Law
Section 22 - Resolution of Disputes
(c) EXPIRATION OF TERM OR ASTRA DEFAULT OR BREACH. Upon termination of
---------------------------------------------
this License Agreement (i) at the expiration of the Term, or (ii) by
CENTAUR as a result of (x) a Default by ASTRA hereunder, or (y) the
Bankruptcy of ASTRA, the following provisions of this License
Agreement shall survive such termination:
Section 2.3 - License Grant to CENTAUR - CENTAUR Grant
Section 14.1 - Ownership of Technology
Section 15.3 - Joint Patents
Section 16 - Confidentiality
Section 21.11- ASTRA Indemnification
Section 21.14- Governing Law
Section 22 - Resolution of Disputes
21. MISCELLANEOUS PROVISIONS
------------------------
21.1 NO PARTNERSHIP. Nothing in this License Agreement is intended or shall be
--------------
deemed to constitute a partnership, agency, employer, employee or joint
venture relationship between the parties. Neither party shall incur any
debts or make any commitments for the other.
21.2 ASSIGNMENTS. Except as otherwise provided herein, neither this License
-----------
Agreement nor
-33-
any interest hereunder shall be assignable by either party by operation of
law or otherwise without the prior written consent of the other; provided,
however, that either party may assign this License Agreement to any
wholly-owned subsidiary or to any successor by merger or sale of
substantially all of its assets to which this License Agreement relates in
a manner such that the assignor shall remain liable and responsible for
the performance and observance of all its duties and obligations
hereunder, or if the assignor disappears because of such transaction, the
assignee must agree to abide by the terms and conditions of this License
Agreement, provided, however, that if a third party engaged in the
manufacture and/or sale of pharmaceutical products acquires in one (1) or
a series of transactions more than thirty percent (30%) of the capital
stock of CENTAUR entitled to vote for directors (a "TAKEOVER EVENT"),
ASTRA may, at its option, within one hundred eighty (180) days following
notice to ASTRA of such Takeover Event, upon twelve (12) months' prior
notice to CENTAUR, cease Annual Funding, in which event ASTRA shall
undertake (i) to reasonably complete the Project Work on its own, and (ii)
manufacture (or have manufactured) Substance for Licensed Product for
ASTRA's (and ASTRA's sublicensees) use worldwide as provided in the Supply
Agreement. ASTRA will make payments pursuant to Section 7.2 and Net Sales
royalty payments to CENTAUR pursuant to Section 7.3, until such time as
ASTRA's obligation to pay Net Sales royalties terminates pursuant to
Section 7.5.
21.3 FORCE MAJEURE. Neither party shall be liable to the other for loss or
-------------
damages or shall have any right to terminate this License Agreement for
any default or delay (including, without limitation, an inability to
supply Licensed Product) attributable to any act of God, earthquake,
flood, fire, explosion, strike, lockout, labor dispute, casualty or
accident, war, revolution, civil commotion, act of public enemies,
blockage or embargo, injunction, law, order, proclamation, regulation,
ordinance, demand or requirement of any government or subdivision,
authority (including, without limitation, drug regulatory authorities) or
representative of any such government, or any other cause beyond the
reasonable control of such party, if the party affected shall give prompt
notice of any such cause to the other party. The party providing such
notice shall thereupon be excused from such of its obligations hereunder
as it is so disabled and for thirty (30) days thereafter. Notwithstanding
the foregoing, nothing in this Section 21.3 shall excuse or suspend the
obligation to make any payment due hereunder in the manner and at the time
provided.
21.4 NO TRADEMARK RIGHTS. No right, express or implied, is granted by this
-------------------
License Agreement to use in any manner any trade name or trademark of
CENTAUR or ASTRA in connection with the performance of this License
Agreement or the exploitation of any license granted hereunder; each party
may make any legally required reference to the other in connection with
such manufacture or sale of Licensed Product.
-34-
21.5 PUBLIC ANNOUNCEMENTS. Copies of press releases or similar written
--------------------
communications containing a party's name shall be provided to that party
prior to release.
21.6 ENTIRE AGREEMENT OF THE PARTIES AND AMENDMENT. This License Agreement and
---------------------------------------------
the Supply Agreement together with the Project Work to be entered into as
provided herein constitutes and contains the entire understanding and
agreement of the parties, and cancel and supersede any and all prior
negotiations, correspondence and understandings and agreements, whether
verbal or written, between the parties respecting the subject matter
hereof. No waiver, modification or amendment of any provision of this
License Agreement shall be valid or effective unless made in writing and
signed by a duly authorized officer of each of the parties.
21.7 SEVERABILITY. In the event any one or more of the provisions of this
------------
License Agreement should for any reason be held by any court or authority
having jurisdiction over this License Agreement or either of the parties to
be invalid, illegal or unenforceable, such provision or provisions shall be
validly reformed by addition or deletion of wording as appropriate to avoid
such result and as nearly as possible approximate the intent of the parties
and, if unreformable, shall be divisible and deleted in such jurisdiction
to the extent necessary to comply with such holding, and in all other
jurisdictions this License Agreement shall not be affected; provided,
however, that no such reformation shall be made if the effect of such
reformation would be such as to fundamentally alter the terms of this
License Agreement beyond the intent of the parties.
21.8 CAPTIONS. The captions to this License Agreement are for convenience
--------
only, and are to be of no force or effect in construing or interpreting any
of the provisions of this License Agreement.
21.9 NOTICE AND DELIVERY. Any notice, requests, delivery, approval or consent
-------------------
required or permitted to be given under this License Agreement shall be in
writing and shall be deemed to have been sufficiently given if delivered in
person, delivered by internationally recognized courier, telegraph or sent
by registered air mail letter to the party (which notice shall be
considered effective when received) to whom it is directed at its address
shown below, or such other address as such party shall have last given by
notice to the other party.
If to CENTAUR, addressed to:
President and Chief Executive Officer
Centaur Pharmaceuticals, Inc.
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇, ▇▇▇
-35-
If to ASTRA, addressed to:
President and Chief Executive Officer
ASTRA AB
▇-▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇
21.10 LIMITATION OF LIABILITY. Neither party shall be liable to the other for
-----------------------
indirect, incidental or consequential damages arising out of any of the
terms or conditions of this License Agreement or with respect to its
performance or lack thereof, except in the case of a Default resulting
from any reckless and intentional breach of its material obligations
hereunder.
21.11 ASTRA INDEMNIFICATION. ASTRA shall indemnify, defend and hold CENTAUR
---------------------
and each of its officers, directors, employees, agents and consultants
and their respective heirs and assigns (each a "CENTAUR INDEMNITEE")
harmless from and against all third party costs, claims, suits, expenses
(including reasonable attorneys' fees) and damages arising out of or
resulting from (i) the development, testing, manufacture, sale, use or
promotion by ASTRA, or ASTRA's sublicensees, of any Licensed Product,
(ii) a claim of product liability with respect to a Licensed Product
(including, without limitation, a cause of action in the form of tort,
warranty or strict liability), (iii) arising out of any other activity
carried out by ASTRA or ASTRA's sublicensees pursuant to this License
Agreement, provided, however, that the CENTAUR Indemnitee gives
reasonable notice to ASTRA of any such claim or action, tenders the
defense of such claim or action to ASTRA and assists ASTRA, at ASTRA's
expense, in defending such claim or action and does not compromise or
settle such claim or action without ASTRA's prior written consent,
provided, further, however, that ASTRA's indemnification of CENTAUR
hereunder shall not extend to any cost, claim, suit, expense or damage
which arises or results from any gross negligence or intentional
misconduct of CENTAUR, or any third party for whom CENTAUR is
responsible, in the manufacture of Substance for Licensed Product by
CENTAUR, which results in the failure of CENTAUR to manufacture Substance
for Licensed Product in accordance with the Specifications.
21.12 CENTAUR INDEMNIFICATION. CENTAUR shall indemnify, defend and hold ASTRA
-----------------------
and each of its officers, directors, employees, agents and consultants
(and their respective heirs and assigns) (each an "ASTRA INDEMNITEE")
harmless from any gross negligence or intentional misconduct of CENTAUR,
or any third party for whom CENTAUR is responsible (i) in the manufacture
of Substance for Licensed Product by CENTAUR, which results in the
failure of CENTAUR to manufacture Substance for Licensed Product in
accordance with the Specifications, and (ii) arising out of
-36-
CENTAUR's Co-Promote pursuant to Section 8, and provided, further, that
the ASTRA Indemnitee gives reasonable notice to CENTAUR of any such
claims or action, tenders the defense of such claim or action to CENTAUR
and assists CENTAUR at CENTAUR's expense in defending such claim or
action and does not compromise or settle such claim or action without
CENTAUR's prior written consent.
21.13 REMEDIES CUMULATIVE. Except as provided in Section 6.6, the remedies
-------------------
provided hereunder are cumulative and not exclusive.
21.14 GOVERNING LAW. This License Agreement shall be governed by and construed
-------------
in accordance with the laws of the State of New York without regard to
the conflict of laws provisions thereof.
22. RESOLUTION OF DISPUTES
----------------------
22.1 GENERAL. In acknowledgment of the benefit to both parties to resolve
-------
differences quickly and efficiently with as little disruption of each
parties' business as possible, the parties agree to abide by the
following provisions in connection with any dispute that should arise
between the parties with respect to any matter relating to this License
Agreement or the Supply Agreement, including any questions regarding the
existence, validity or termination thereof.
22.2 DISPUTE RESOLUTION PROCESS.
--------------------------
(a) SELECTION OF ARBITRATORS. In the event that the parties are unable to
------------------------
resolve a dispute within thirty (30) days after commencement of
mediation efforts by members of senior management (as described in
Section 3.4), either party may submit the matter to binding
arbitration in accordance with the procedures set forth in this
Section 22.2. If a party intends to commence arbitration to resolve a
dispute, such party shall provide written notice to the other party of
such intention, and shall designate one arbitrator. Within ten (10)
days of receipt of such notice, the other party shall designate in
writing a second arbitrator. The two arbitrators so designated shall,
within ten (10) days thereafter, designate a third arbitrator. The
arbitrators so designated shall not be employees, consultants,
officers, directors or shareholders of or otherwise associated with
either party or an Affiliate of either party. Except as modified by
the provisions of this Section 22, the arbitration shall be conducted
in accordance with the then rules of commercial arbitration of and
before the American Arbitration Association in New York, New York. The
language of such arbitration shall be English and all notices and
written submissions provided in such proceeding shall be in English.
-37-
(b) WRITTEN PROPOSALS. Within thirty (30) days after the designation of
-----------------
the third arbitrator, the arbitrators and the parties shall meet, at
which time each party shall be required to set forth in writing the
issues which need to be resolved and a proposed ruling on each such
issue. Written submissions shall be limited to 30 pages of text (not
including exhibits which may include copies of agreements, or extracts
from books and records, but including testimony affidavits).
(c) HEARING. The arbitrators shall set a date for a hearing, which shall
-------
be no later than thirty (30) days after the submission of written
proposals, to discuss each of the issues identified by the parties.
Each party shall have the right to be represented by counsel. The
arbitrators shall have sole discretion with regard to the
admissibility of any evidence. Unless otherwise determined by
unanimous agreement of the arbitrators the hearing shall be concluded
in one (1) day unless the arbitrators conclude by majority vote that
the hearing should be extended to avoid working an injustice to one of
the parties.
(d) RULING. The arbitrators shall use their best efforts to rule on each
------
disputed issue within thirty (30) days after the completion of the
hearings described in subsection (c) above. The arbitrators shall, by
majority decision, select the ruling proposed by one of the parties as
the arbitrators' ruling. The arbitrators' ruling shall be, in the
absence of fraud or manifest error, binding and conclusive upon both
parties and may be enforced in a court of competent jurisdiction. The
arbitrators may not award punitive or exemplary damages.
22.3 ARBITRATION COSTS. The arbitrators shall be paid a reasonable fee plus
-----------------
expenses, which fees and expenses shall be paid as designated by the
arbitrators or if the arbitrators do not so designate, such costs shall be
shared equally by the parties.
22.4 ATTORNEYS' FEES/COSTS. If any arbitration, litigation, or other legal
---------------------
proceeding occurs between the parties relating to this License Agreement,
the prevailing party shall be entitled to recover (in addition to any
other relief awarded or granted) its reasonable costs and expenses,
including attorneys' fees, incurred in the proceeding.
IN WITNESS WHEREOF, this License Agreement has been duly executed as of June 26,
1995.
ASTRA AB CENTAUR PHARMACEUTICALS, INC.
(PUBL)
-▇▇-
/▇/ ▇▇▇▇▇ ▇▇▇▇▇▇ /s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇
------------------ ----------------------
Name: ▇▇▇▇▇ ▇▇▇▇▇▇ Name: ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇
Title: President and Title: President and
Chief Executive Officer Chief Executive Officer
-39-
APPENDIX 1
----------
TO
DEVELOPMENT, LICENSE AND MARKETING AGREEMENT
DATED JUNE 26, 1995
BETWEEN
CENTAUR PHARMACEUTICALS, INC.
AND
ASTRA AB
SUPPLY AGREEMENT
----------------
[SEE EXHIBIT 10.14 TO THE REGISTRATION STATEMENT]
APPENDIX 2
----------
TO
DEVELOPMENT, LICENSE AND MARKETING AGREEMENT
DATED JUNE 26, 1995
BETWEEN
CENTAUR PHARMACEUTICALS, INC.
AND
ASTRA AB
CENTAUR LICENSES PREVIOUSLY FURNISHED TO ASTRA
----------------------------------------------
1. License Agreement dated as of July 15, 1992 by and among Oklahoma
Medical Research Foundation, The University of Kentucky Research
Foundation and CENTAUR
2. Research Study Agreement dated as of February 1, 1993 by and between
CENTAUR and [*]
3. Research Study Agreement dated as of June 6, 1994 by and between
CENTAUR and [*]
4. Research Study Renewal Agreement dated as of January 1, 1995 by and
between CENTAUR and [*]
5. Research Study Agreement dated as of February 1, 1995 by and between
CENTAUR and [*]
APPENDIX 3
----------
TO
DEVELOPMENT, LICENSE AND MARKETING AGREEMENT
DATED JUNE 26, 1995
BETWEEN
CENTAUR PHARMACEUTICALS, INC.
AND
ASTRA AB
OKLAHOMA/KENTUCKY LICENSE
-------------------------
LICENSE AGREEMENT
-----------------
This License Agreement (the "LICENSE AGREEMENT") is made and entered into
as of this _____ day of June, 1995, by and among the OKLAHOMA MEDICAL RESEARCH
FOUNDATION, an Oklahoma nonprofit corporation ("OMRF"), ▇▇▇ ▇.▇. ▇▇▇▇ ▇▇▇▇▇▇,
▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇; THE UNIVERSITY OF KENTUCKY RESEARCH FOUNDATION, a
Kentucky nonprofit corporation ("UKRF"), ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇ 40506-
0051 (OMRF and UKRF may be hereinafter collectively referred to as "LICENSORS");
and ASTRA AB, a corporation organized and existing under the laws of Sweden
("ASTRA"), having an office at ▇-▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇. OMRF, URKF,
Licensors and Astra may be individually referred to as a "PARTY" and
collectively as the "PARTIES".
RECITALS
A. Licensors own rights in and to technology relating to compositions of
and methods for using spin-trapping compounds developed or investigated by ▇▇.
▇▇▇▇ ▇. ▇▇▇▇▇▇ of UKRF and/or ▇▇. ▇▇▇▇▇▇ ▇. ▇▇▇▇▇ of OMRF, including the
Licensed Technology.
B. Licensors, desiring and intending to have such Licensed Technology used
in the public interest, entered into a License Agreement dated as of July 15,
1992 with Centaur Pharmaceuticals, Inc. ("CENTAUR"), a copy of which, together
with all amendments thereto as of the date hereof, is attached as Exhibit A
---------
(collectively and as subsequently hereafter amended from time to time, the
"CENTAUR LICENSE AGREEMENT"), providing in part for a grant of license to
Centaur with respect to the Licensed Technology, with Centaur's right of
sublicense.
C. Astra and Centaur entered into a Development, License and Marketing
Agreement dated as of June 26, 1995 (the "ASTRA-CENTAUR AGREEMENT") wherein
Centaur granted to Astra (the "ASTRA SUBLICENSE"), pursuant to the Centaur
License Agreement, certain
-1-
sublicense rights in and to the Licensed Technology.
D. UKRF and OMRF entered into Research Study Agreement(s) with Centaur
dated as of December 1, 1992 and February 1, 1993, respectively, with respect to
the conduct of an integrated, multi-part research program relating to the
synthesis and evaluation of certain anti-oxidant compounds (collectively and as
subsequently hereafter amended from time to time, the "RESEARCH AGREEMENTS"),
copies of which, together with all amendments thereto as of the date hereof, are
attached collectively as Exhibit B.
---------
E. Pursuant to the Astra-Centaur Agreement, Astra has agreed to provide
Centaur with certain funding (the "ASTRA FUNDING") for research and development
of certain aspects of the Licensed Technology.
F. Licensors agree and acknowledge that Astra requires continued and
uninterrupted right of access to and use of the Licensed Technology in order to
exercise Astra's rights pursuant to the Astra Sublicense and Licensor Grant, in
order to research, develop, make, have made, use and sell Licensed Products.
G. Licensors desire that the Licensed Technology be used in the public
interest and is willing to grant a license to Astra on the terms and conditions
set forth herein.
NOW, THEREFORE, for and in consideration of the foregoing and the mutual
covenants and agreements contained herein, the Parties agree as follows:
1. DEFINITIONS
-----------
As used herein:
1.1 "AFFILIATE" means any person, corporation or business entity that owns
---------
or controls Astra, is under common control with Astra or which is owned or
controlled by Astra through ownership of a majority interest, directly or
indirectly, of the outstanding stock eligible to vote for the Board of Directors
or other similar governing body of the entity.
1.2 "ASTRA-CENTAUR AGREEMENT" is defined in Recital C of this License
-----------------------
Agreement.
1.3 "ASTRA SUBLICENSE" is defined in Recital C of this License Agreement.
----------------
1.4 "ASTRA'S AUDITORS" means the independent certified or chartered
----------------
accountants regularly employed by Astra to audit its accounts and certify its
financial statements.
-2-
1.5 "EFFECTIVE DATE" is defined in paragraph 3.3 of this License
--------------
Agreement.
1.6 "FDA" means the U.S. Food and Drug Administration.
---
1.7 "FIRST COMMERCIAL SALE" shall mean the initial transfer by Astra, its
---------------------
Affiliate or Sublicensee, to an unrelated third party of Licensed Products
subject to royalties hereunder for commercial use, and not for research,
development or testing purposes.
1.8 "LICENSE AGREEMENT" means this License Agreement including all
-----------------
Exhibits and any amendments thereof.
1.9 "LICENSED PATENTS" shall mean the United States and foreign patents,
----------------
and patent applications set forth below and any other United States or foreign
patent applications subsequently filed by or on behalf of Licensors (or patents
licensed to the Licensors with right of sublicense) which arise out of, or which
are based on, the Licensed Technology:
(a) United States Patent No. 5,025,032, titled "Phenyl Butyl Nitrone
Compositions and Methods for Treatment of Oxidative Tissue
Damage," issued June 18, 1991;
(b) United States Patent No. 5,036,097, titled "Phenylbutyl Nitrone
Compositions and Methods for Prevention of Gastric Ulceration,"
issued July 30, 1991;
(c) United States Patent Application No. [*];
(d) United States Patent Application No. [*];
(e) United States Patent Application No. 08/173,579, titled "2,4
Disulfonyl PBN, Its Salts, and Their Use as Pharmaceuticals"
issued _______________;
(f) All patent applications and continuations-in-part contemplated by
OMRF or UKRF as of the date of the Centaur License Agreement
relating to compositions of and methods for using spin-trapping
compounds as evidenced by documented communications between ▇▇.
▇▇▇▇▇▇ and/or ▇▇. ▇▇▇▇▇ and ▇▇▇▇▇▇▇▇▇▇ and ▇▇▇▇, patent counsel
for UKRF and
-3-
OMRF;
any and all divisions, continuations, continuations-in-part, reexaminations,
reissues, extensions and foreign counterparts of these applications and patents
and all patents and comparable rights that issue thereon."
1.10 "LICENSED PROCESS" means any existing or future process which is
----------------
covered in whole or in part by an issued, unexpired claim or a pending claim
contained in the Licensed Patents in the country in which the process is
practiced.
1.11 "LICENSED PRODUCT(S)" means any product or part of a product which:
-------------------
(a) is covered in whole or in part by an issued, unexpired claim or a
pending claim contained in the Licensed Patents in the country in
which the product or part of a product is made, used or sold,
(b) is manufactured using a Licensed Process, or
(c) is used in a Licensed Process and has no substantial use except
in a Licensed Process.
1.12 "LICENSED TECHNOLOGY" means collectively the
-------------------
(a) Licensed Patents, and
(b) Licensed Process, and
(c) all ideas, designs, inventions, discoveries, technical
information, know-how, knowledge, data, specifications, test
results and other information (including but not limited to
designs, technical information, know-how, knowledge, data,
specifications, test results and other information previously
disclosed to Centaur) relating to the subject matter of the
Licensed Patents or Licensed Process (i) known to Licensors on
the date of the Centaur License Agreement, or (ii) arising out of
collaboration between Licensors and Centaur, whether or not
pursuant to the Research Agreements.
1.13 "LICENSED TERRITORY" means the entire world.
------------------
1.14 "LICENSOR GRANT" is defined paragraph 2.1 of this License Agreement.
--------------
1.15 "NDA" means a New Drug Application or its equivalent under then
---
applicable
-4-
FDA regulations for the marketing of a human pharmaceutical Licensed Product.
1.16 "NET SELLING PRICE" of Licensed Products means the actual cash
-----------------
receipts of Astra or its Sublicensees and, if applicable, the value of all
properties and services received in consideration of a Sale of Licensed
Products, less only:
(a) customary trade, quantity, cash discounts, or rebates actually
allowed and taken,
(b) any freight or other transportation costs, insurance charges,
import/export duties, tariffs or other excise taxes separately
invoiced to and paid or reimbursed by the purchaser,
(c) returns which are accepted by Astra or its Sublicensees from
unrelated purchasers in accordance with their normal practice and
for which Astra or its Sublicensees give credit to such
purchasers, and
(d) sales, excise, turnover and similar use taxes and any duties and
governmental charges imposed upon the production, importation,
use or Sale of such Licensed Products which Astra or its
Sublicensees are under a legal obligation to pay.
provided, however, that where a Sale is deemed consummated by the transfer or
-------- -------
other disposition of Licensed Products for other than a selling price stated in
cash, the term "Net Selling Price" shall mean the average Net Selling Price
billed by Astra or its Sublicensee, as the case may be, in consideration of the
Sale of comparable Licensed Products during the three (3) month period
immediately preceding such Sale, without reduction of any kind.
1.17 "PROPRIETARY INFORMATION" is defined in paragraph 9.1 of this License
-----------------------
Agreement.
1.18 "RESEARCH AGREEMENTS" means collectively (i) the "Research Study
--------------------
Agreement" dated as of December 1, 1992, between UKRF and Centaur, and (ii) the
"Research Study Agreement" dated as of February 1, 1993, between OMRF and
Centaur, as the same are amended to date and may be hereafter amended, extended
or modified from time to time, copies of which, together with all amendments
thereto as of the date hereof, are collectively attached as Exhibit B.
---------
1.19 "REQUIRED CONSENTS" is defined in paragraph 13.3 of this License
-----------------
Agreement.
1.20 "SALE"/"SOLD" means the sale, transfer, exchange or other disposition
-----------
of
-5-
Licensed Products, excluding:
---------
(a) transfers of Licensed Products by Astra to its Sublicensees,
(b) transfers of Licensed Products for which Astra or its
Sublicensees receives no more than nominal payment in connection
with clinical testing in support of efforts to obtain regulatory
approvals to sell Licensed Products in the Licensed Territory,
and
(c) all distribution of Licensed Products for promotional purposes
for which Astra or its Sublicensees receives no more than nominal
payment.
Sales of Licensed Products shall be deemed consummated upon the later of
recognition of revenue or receipt of payment, by Astra or its Sublicensees, as
the case may be, for such Sales of Licensed Products from the purchaser.
1.21 "SUBLICENSE INITIATION FEE" means any Sublicense Fee or non-
-------------------------
refundable advance against royalties paid or to be paid by a Sublicensee, but
does not include any payment for research or other services or reimbursement of
Astra's expenses.
1.22 "SUBLICENSEES" is defined in paragraph 2.3 of this License Agreement.
------------
2. GRANT OF LICENSE
----------------
2.1 LICENSE. Subject to the license retained by Licensors in paragraph
-------
2.2 and the other terms of this License Agreement, and effective as of the date
hereof, Licensors hereby grant to Astra (the "LICENSOR GRANT") an exclusive
right and license (co-exclusive with Centaur), with Astra's right to sublicense,
of such rights and licenses under and pursuant to the Licensed Technology, but
only to the extent set forth in the Astra Sublicense granted by Centaur, to use
the Licensed Technology to research, develop, make, have made, use, lease and
sell and have sold Licensed Products and to practice the Licensed Processes in
the Licensed Territory during the term of this License Agreement unless sooner
terminated as provided in this License Agreement.
2.2 RETAINED LICENSE. Licensors retain the perpetual, royalty-free right
----------------
and license to practice the Licensed Technology solely for research and
educational purposes.
2.3 SUBLICENSES. Astra shall have the right to sublicense the rights
-----------
granted hereunder to third parties and Affiliates of Astra (collectively the
"SUBLICENSEES") provided that Astra promptly notifies Licensors of each such
Sublicense. Any such Sublicense will survive termination of this License
Agreement only if Licensors approve the identity of the
-6-
Sublicensee in writing, either before or after Astra's grant of the Sublicense.
Astra may request Licensors' approval of a Sublicensee at any time, and
Licensors will not unreasonably withhold or delay such approval.
2.4 SUBLICENSEE OBLIGATIONS. All Sublicenses granted by Astra shall
-----------------------
provide that the obligations of Astra to Licensors under Sections 5, 9, 11 and
12 of this License Agreement shall be binding upon Sublicensee as if it were a
party to this License Agreement.
2.5 SUBLICENSE COPIES AND REPORTS. Astra shall provide to Licensors (i) a
-----------------------------
copy of all Sublicense agreements promptly after execution, and (ii) annually,
following the Effective Date, copies of all reports relating to Sales of
Licensed Product received by Astra from its Sublicensees during the preceding
twelve (12) month period.
2.6 NONCASH CONSIDERATION. If Astra receives from Sublicensees anything
---------------------
of value in lieu of cash payments in satisfaction of payment of obligations
under the Sublicense and this License Agreement, then Astra shall determine the
cash value of such consideration in good faith and shall pay Licensors based on
such cash value as set forth in Section 4.
2.7 NO IMPLIED LICENSE. The license and rights granted in this License
------------------
Agreement shall not be construed to confer any rights upon Astra by implication,
estoppel or otherwise as to any technology not specifically identified in this
License Agreement as "Licensed Technology", nor shall it be construed to confer
any rights outside the Licensed Territory.
2.8 FIRST RIGHT OF NEGOTIATION. [*]
--------------------------
3. DUE DILIGENCE - EFFECTIVE DATE
------------------------------
3.1 DILIGENCE. Astra shall use its reasonable efforts throughout the term
---------
of this License Agreement to bring one or more Licensed Products to market
through a program for
-7-
exploiting the Astra Sublicense and Licensor Grant and for creating, supplying
and servicing a market for Licensed Products in the Licensed Territory.
3.2 DELIVERY. Promptly after the date hereof and thereafter from time to
--------
time upon reasonable notice, Licensors shall deliver to Astra (to the extent not
provided to Astra by Centaur pursuant to the Astra Sublicense) all data,
documentation, and other physical embodiments of the Licensed Technology
together with all cooperation, assistance and access to data reasonably
requested by Astra to effect transfer of the Licensed Technology and permit
Astra to fully utilize the Astra Sublicense and Licensor Grant.
3.3 EFFECTIVE DATE. Notwithstanding the current effectiveness of the
--------------
Licensor Grant, Astra, and its Sublicensees, covenant and agree not to use the
Licensor Grant, or any right granted herein, until on and after the date (the
"EFFECTIVE DATE") which is the earlier to occur of:
(a) notification by Licensors (the "LICENSORS NOTIFICATION") that the
Centaur License Agreement has been terminated, or
(b) notification by Astra (the "ASTRA NOTIFICATION") that the Astra-
Centaur Agreement has been terminated by Astra as a result of a
"Default" or "Bankruptcy" of Centaur (as such terms are defined
in the Astra-Centaur Agreement).
Upon the Effective Date, Astra and its Sublicensees may use and exercise the
Licensor Grant in full, without further agreement or documentation being entered
into by Astra or Licensors. Licensors covenant and agree that the effect,
accuracy or underlying basis of the Astra Notification shall be uncontestable by
Licensors. Upon termination of the Centaur License Agreement, the Licensor
Grant to Astra shall be deemed exclusive.
3.4 TERMINATION OF ASTRA FUNDING. Any termination, cessation or
----------------------------
interruption of the Astra Funding shall have no affect upon Licensor Grant or
Astra's rights herein.
4. ROYALTY
-------
4.1 PAYMENT OF ROYALTY. Commencing with the First Commercial Sale
------------------
following the Effective Date and continuing during the term of this License
Agreement as set forth in paragraph 10.1 hereof, Astra agrees to pay to
Licensors, in full consideration for the Licensor Grant:
(a) A royalty equal to [*] of the Net Selling Price of
Licensed Products Sold by or for Astra and its Sublicensees;
-8-
(b) With respect to each Sublicense granted by Astra under this
License Agreement, [*] of all Sublicensee
Initiation Fees paid to Astra pursuant to such Sublicense;
(c) in the event that Astra's total annual royalty and Sublicense
payments to Licensors pursuant to the preceding paragraph 4.1(a)
and (b) during the calendar year following the Effective Date and
each calendar year thereafter is less than the annual minimum set
forth opposite such year below (the "ANNUAL MINIMUM"), a payment
to Licensors together with the annual report required in
paragraph 6.3 of this License Agreement (or, if no such annual
report is required, together with the quarterly report required
in paragraph 6.1 of this License Agreement for the three (3)
month period ending on December 31 of such calendar year) equal
to the difference between such Annual Minimum and the total
royalty and Sublicense payments paid to Licensors for the
preceding calendar year pursuant to paragraphs 4.1(a) and (b)
above:
Calendar Year Annual Minimum
------------- --------------
. First year [*]
. Second and each subsequent
year through the year
the FDA first approves
an NDA [*]
. Each year after the year the
FDA first approves an NDA [*]
4.2 NON-CUMULATIVE ROYALTIES. Royalties shall be payable by Astra with
------------------------
respect to all of its or its Sublicensees' Sales except for Astra's resale of
any products purchased from Licensors. Royalties shall not become payable at
the time of Sublicense or transfer from Astra to its Sublicensees, but shall
become payable only when Astra receives payment of royalties (after recovery of
any prepaid royalties included in any Sublicense Initiation Fee) from its
Sublicensee with respect to such Sublicensee's Sales.
4.3 NO MULTIPLE ROYALTIES. No multiple royalties shall be payable because
---------------------
any Licensed Product is covered by more than one patent within the Licensed
Patents.
4.4 DEDUCTION OF TAXES. Any income or other tax which Astra is required
------------------
to withhold and pay on behalf of Licensors with respect to the royalties payable
to Licensors under this License Agreement shall be deducted from such royalties
prior to remittance to
-9-
Licensors; provided, however, that in regard to any tax so deducted, Astra shall
-------- -------
give Licensors such assistance as may reasonably be necessary to enable
Licensors to claim exemption therefrom. In each case, Astra shall furnish
Licensors with proper evidence of the taxes so paid on its behalf.
4.5 INTEREST. Royalty and other payments required in this License
--------
Agreement shall, if overdue, bear interest until payment at a per annum rate of
two percent (2%) above the prime rate in effect at the Chase Manhattan Bank,
N.A., New York, New York, U.S.A., on the due date, but not more than the highest
rate permitted by law. The payment of such interest shall not foreclose
Licensors from exercising any other rights they may have because any payment is
late.
4.6 CURRENCY CONVERSION AND DELIVERY. All payments required in this
--------------------------------
License Agreement shall be paid in United States dollars, delivered in
accordance with paragraph 6.2 and 13.9 of this License Agreement or to such
other place as Licensors may reasonably designate consistent with the applicable
laws and regulations in any foreign country. If any currency conversion shall
be required in connection with the payment of royalties hereunder, such
conversion shall be at the rate in effect at the Chase Manhattan Bank, New York,
New York, U.S.A., on the last business day of the calendar quarterly reporting
period to which such payment(s) relate.
5. RECORDS
-------
5.1 RECORDS OF SALES. Commencing on and after the Effective Date, Astra
----------------
shall at all times during the term of this License Agreement and for a period of
three (3) years after termination of this License Agreement keep at its
principal place of business true and accurate records of all Sales subject to
Section 4 of this License Agreement in such form and manner that all royalties
owed hereunder to Licensors may be readily and accurately determined. Such
records shall be kept for a period of at least three (3) years after the end of
the royalty period to which they pertain and shall include, but not by way of
limitation, all information necessary for Astra's Auditors to prepare the
reports required by Section 6 of this License Agreement.
5.2 INSPECTION. Commencing on and after the Effective Date, Licensors
----------
shall have the right, from time to time, at reasonable times during normal
business hours no later than three (3) years after expiration or termination of
this License Agreement and at Licensors' expense, to examine the records of
Astra, at Astra's place of business, through an independent certified public
accountant for the purpose of verifying the amounts owed to Licensors hereunder
and the accuracy of the reports furnished by Astra under Section 6 of this
License Agreement. Licensors and their accountant shall maintain the
confidentiality of all confidential information obtained from examination of
Astra's records and shall use such information only for the purposes of this
License Agreement.
-10-
6. REPORTS
-------
6.1 QUARTERLY REPORTS. Astra shall, on and after the Effective Date,
-----------------
prepare and deliver to Licensors within sixty (60) days after March 31, June 30,
September 30 and December 31 of each year during the term of this License
Agreement, a true and accurate report, giving such particulars of the business
conducted by Astra and its Sublicensees during the preceding three (3) month
period as is required to calculate the royalties due Licensors hereunder. Such
report shall include at least the following:
(a) the total Net Selling Price of all Licensed Products Sold by
Astra and its Sublicensees during the preceding three (3) month
period and for the calendar year to date,
(b) all Sublicense Initiation Fees received from Sublicensees during
the preceding three (3) month period and for the calendar year to
date, and
(c) the names and address of all new Sublicensees of Astra since the
previous report.
6.2 PAYMENTS. With each such report delivered, Astra shall pay to
--------
Licensors (by delivery to OMRF) all amounts due under this License Agreement.
If no payments are due, Astra shall so report.
6.3 AUDIT REPORT. Commencing on and after the Effective Date, and within
------------
one hundred fifty (150) days after the end of each whole or partial fiscal year
of Astra in which Licensed Products are Sold during the term of this License
Agreement, Astra shall have its books and records audited by Astra's Auditors
and shall direct them to prepare and submit to Licensors, certified financial
statements for the preceding fiscal year including, at a minimum, a balance
sheet together with an operating statement together with an audit report
thereon. Appropriate disclosure will be made in the footnotes to Astra's
audited financial statements of (i) the total Sales of Licensed Products by
Astra and its Sublicensees during the past year, and (ii) the amounts owed to
Licensors in total at the year end balance sheet date. If such disclosure is
not made in the footnotes to Astra's audited financial statements, then Astra's
Auditors shall prepare a special report covering items (i) and (ii) above and
submit it to Licensors.
7. PATENT PROSECUTION
------------------
7.1 LICENSED PATENTS. Licensors shall apply for, seek prompt issuance of,
----------------
and maintain during the term of this License Agreement the patents, patent
applications and foreign
-11-
counterparts, as the case may be, included within the Licensed Patents that are
(i) specifically identified by patent number or application serial number in
paragraph 1.9 of this License Agreement, or (ii) timely identified or specified
by Astra by notice to Licensors. Except as provided in paragraph 7.4, the
prosecution and maintenance of all patent applications, foreign counterparts and
patents within the Licensed Patents shall be the primary responsibility of
Licensors; provided, however, that Astra shall be afforded reasonable
-------- -------
opportunities to advise Licensors and shall cooperate with Licensors in such
prosecution and maintenance.
7.2 LICENSORS' REIMBURSEMENT. Except as provided in paragraph 7.4, Astra
------------------------
shall on and after the Effective Date reimburse Licensors for all reasonable
out-of-pocket fees, costs and expenses reasonably paid or incurred by Licensors
in filing, prosecuting and maintaining the Licensed Patents on a pro-rata basis
with other Foundation licensees under the Licensed Technology, taking into
consideration the relative value obtained by each such licensee from such patent
or patent application as determined by Licensors in good faith consultation with
such licensees. Astra shall, on and after the Effective Date, deliver such
reimbursement to Licensors (or, if Licensors request, directly to Licensors'
patent counsel) within thirty (30) days after Licensors (or Licensors' patent
counsel) notify Astra from time to time of the amount of such fees, costs and
expenses which have been paid or incurred by Licensors.
7.3 PATENT ABANDONMENT. Licensors shall, on and after the date hereof,
------------------
promptly advise Astra of the grant, lapse, revocation, surrender, any threatened
invalidation of, or of their intention to abandon any such patent, application
or foreign counterpart. If Licensors advise Astra of their intention not to
pursue a patent on any Licensed Technology or to abandon any such patent,
application or foreign counterpart, Astra shall have the right, at its own
expense, to pursue such patent, application or foreign counterpart, in Astra's
name or in Licensors' name, as Astra may determine, and all rights resulting
therefrom shall vest in Astra alone.
7.4 FOREIGN APPLICATION. Astra shall on and after the Effective Date
-------------------
designate each country, if any, in which Astra desires that patent
application(s) corresponding to the Licensed Patents be filed. Astra shall, on
and after the Effective Date, pay all costs and legal fees associated with the
preparation and filing of such designated foreign patent applications, and such
applications shall be in Licensors' name. Licensors may elect to file
corresponding patent applications in countries other than those designated by
Astra, but in that event Licensors shall be responsible for all costs associated
with such non-designated filings. Licensors will notify Astra that it intends
to make such filings. Astra will, on and after the Effective Date, have thirty
(30) days to decide to pay for such filings and prosecutions. If it does not
decide to pay for such applications within the 30-day period, on and after the
Effective Date, neither of such applications nor any patents that issue thereon
shall be considered to be Licensed Patents, and Astra shall forfeit its rights
under this License Agreement with respect to such applications and patents.
-12-
8. PATENT INFRINGEMENT
-------------------
8.1 NOTICE OF INFRINGEMENT. Astra shall promptly notify Licensors of any
----------------------
alleged infringement of the Licensed Patents and of any available evidence of
such infringement.
8.2 SUIT BY ASTRA. Astra shall have the right, but not the obligation, to
-------------
commence suit for any infringement of the Licensed Patents, and Licensors agree
that Astra may cause Licensors to join Astra as a party to any such suit at no
expense to Licensors. The total cost of any such infringement action commenced
or defended solely by Astra shall be borne by Astra, and Astra shall retain any
recovery or damages awarded in such action, but such recovery or damages (less
the cost of such recovery, including reasonable attorneys' and experts' fees)
shall be treated as Sales of Licensed Products, and Astra shall pay royalties
thereon to Licensors in accordance with paragraph 4.1(a) of this License
Agreement. No settlement, consent judgment or other voluntary final disposition
of the suit may be entered into without the written consent of Licensors, which
consent shall not be unreasonably withheld. Astra shall indemnify Licensors
against any order for costs or award of sanctions that may be made or entered
against Licensors in such proceedings commenced or defended solely by Astra.
8.3 SUIT BY LICENSORS. If within six (6) months after notice by Astra to
-----------------
Licensors, or by one of Licensors to Astra, of any alleged infringement, Astra
has been unsuccessful in persuading the alleged infringer to desist and has not
brought an infringement action, or if Astra notifies Licensors at any time of
Astra's intention not to bring suit against an alleged infringer, then and only
then, Licensors shall have the right, but not the obligation, to commence suit
for such infringement at Licensors' sole expense, and Licensors may, in such
suit, use the name of Astra as a nominal party. No settlement, consent judgment
or other voluntary final disposition of the suit may be entered into without the
written consent of Astra, which consent shall not be unreasonably withheld.
Astra shall not be responsible for any order for costs or awards of sanctions
that may be made or entered against Astra in such proceedings.
8.4 DEFENSE. In the event that a declaratory judgment action alleging
-------
invalidity, unenforceability or noninfringement of any of the Licensed Patents
shall be brought against Astra, Licensors or either of them, Astra shall have
the first right to defend such action; provided, however, that if Astra
-----------------
determines at any time that it does not desire to defend such action, it shall
promptly so advise Licensors, and Licensors shall then have the right to defend
such action at Licensors' sole expense. Astra shall not be responsible for any
order for costs or award of sanctions that may be made or entered against Astra
in such proceedings.
8.5 COOPERATION. In any suit either Party may commence or defend pursuant
-----------
to its rights under this License Agreement in order to enforce or defend the
validity or enforceability
-13-
of the Licensed Patents, the other Party shall, at the reasonable request and
expense of the Party initiating or defending such suit, reasonably cooperate in
all respects and, to the extent possible, have its employees testify when
requested and make available relevant records, papers, information, samples,
specimens and the like.
9. CONFIDENTIALITY
---------------
9.1 MAINTENANCE OF CONFIDENTIALITY. No Party shall, without the express
------------------------------
written consent of the other Parties to this License Agreement in advance, for
any reason or at any time either during or for a period of three (3) years
subsequent to the term of this License Agreement, except as otherwise provided
in this paragraph 9.1, (i) use (except in the course of practicing the licenses
granted in this License Agreement), or (ii) disclose (except as is necessary in
the course of sublicensing, marketing or selling Licensed Products or obtaining
governmental approval to do so, or as is required to be disclosed pursuant to
law (provided that the receiving Party uses reasonable efforts to give the
disclosing Party reasonable notice of such required disclosure) as contemplated
in this License Agreement) to any person (including without limitation any
director, officer or employee of a Party who is not under an obligation of
confidentiality substantially similar to the obligation contained herein) the
Licensed Technology or any other information relating to the Licensed Products
(collectively the "PROPRIETARY INFORMATION"). This obligation of non-use and
non-disclosure shall not extend to Proprietary Information:
(a) which can be demonstrated by the receiving Party to have been
within its legitimate possession prior to the time of disclosure
by the disclosing Party,
(b) which was in the public domain prior to disclosure by the
disclosing Party, as evidenced by documents which were generally
published prior to such disclosure,
(c) which, after disclosure by the disclosing Party, comes into the
public domain through no fault of the receiving Party, or
(d) which is disclosed to the receiving Party by a third party having
legitimate possession thereof and the unrestricted right to make
such disclosure.
9.2 PRIOR AGREEMENTS. The provisions of this License Agreement supersede
----------------
and shall be substituted for any terms of any prior confidentiality agreement(s)
relating to the Proprietary Information between Astra and either of the
Licensors which are not consistent with this License Agreement.
-14-
10. TERM AND TERMINATION
--------------------
10.1 DURATION. Unless sooner terminated as otherwise provided in this
--------
License Agreement, the term of this License Agreement shall commence upon the
date hereof and shall continue until the later of (i) fifteen (15) years from
the date hereof, or (ii) the date of expiration of the last to expire of the
Licensed Patents, except that upon expiration of this License Agreement at the
-----------
end of such term, Astra shall automatically have a perpetual, paid-up, royalty-
free license to use and sublicense Licensed Technology without restriction.
10.2 TERMINATION. Licensors shall have the right to terminate this
-----------
License Agreement on the occurrence of any one or more of the following events
and notice to Astra pursuant to paragraph 10.3:
(a) failure of Astra to make any payment when due required pursuant
to this License Agreement;
(b) failure of Astra to render reports to Licensors as required by
this License Agreement;
(c) the insolvency of Astra;
(d) the institution of any proceeding by Astra under any bankruptcy,
insolvency or moratorium law;
(e) any assignment by Astra of substantially all of its assets for
the benefit of creditors;
(f) placement of Astra's assets in the hands of a trustee or a
receiver unless the receivership or trust is dissolved within
thirty (30) days thereafter; or
(g) the material or intentional breach by Astra of any other term of
this License Agreement.
10.3 EXERCISE. Licensors may exercise their right of termination as
--------
provided in paragraph 10.2, by giving Astra, its trustees, receivers or assigns,
sixty (60) days prior written notice of Licensors' election to terminate this
License Agreement. Upon the expiration of such period, this License Agreement
shall automatically terminate unless (i) Astra has previously cured the breach
or condition permitting termination under the preceding paragraph 10.2, or (ii)
such breach or condition cannot reasonably be cured within sixty (60) days due
to causes beyond Astra's reasonable control, Astra commences good faith efforts
to cure such breach
-15-
within such 60-day period and Astra does cure the breach within one hundred
twenty (120) days after the expiration of such 60-day period, in which case this
License Agreement shall not terminate. Such notice and termination shall not
prejudice Licensors' rights to any royalties and other sums due hereunder and
shall not prejudice any cause of action or claim of Licensors accrued or to
accrue on account of any breach or default by Astra.
10.4 FAILURE TO ENFORCE. The failure of Licensors at any time, or for any
------------------
period of time, to enforce any of the provisions of this License Agreement shall
not be construed as a waiver of such provisions or the right of Licensors
thereafter to enforce each and every such provision.
10.5 TERMINATION BY ASTRA. Astra may terminate this License Agreement at
--------------------
any time giving Licensors six (6) months prior written notice of Astra's
election to terminate.
10.6 EFFECT. In the event this License Agreement is terminated prior to
------
its expiration for any reason whatsoever, Astra (i) shall not have any right to
return of any payments of any kind theretofore made by Astra to Licensors
pursuant to this License Agreement, (ii) shall return, or at Licensor's
direction, destroy, all plans, drawings, papers, notes, writings and other
documents, samples, organisms, biological materials and models constituting the
Licensed Technology, retaining no copies, (iii) shall refrain from using or
publishing any portion of the Licensed Technology as provided in Section 9 of
this License Agreement, and (iv) shall cease manufacturing, processing,
producing, using, selling or distributing Licensed Products; provided, however
-----------------
that Astra may continue to sell in the ordinary course of business for a period
of one hundred eighty (180) days reasonable quantities of Licensed Products
which are fully manufactured and in Astra's normal inventory at the date of
termination if:
(a) all monetary obligations of Astra to Licensors have been
satisfied, and
(b) royalties on such sales are paid to Licensors in the amounts and
in the manner provided in this License Agreement.
Upon termination of this License Agreement, any Sublicenses granted by Astra to
Sublicensees that have been approved by Licensor as contemplated by Section 2.3
and in which the Sublicensees are in full compliance, including without
limitation compliance with the obligations under Section 5, 9, 11 and 12 of this
License Agreement, shall continue in full force and effect with Licensors
substituted in Astra's place. The provisions of Sections 9, 11 and 12 of this
License Agreement shall remain in full force and effect notwithstanding any
termination of this License Agreement.
11. INDEMNIFICATION AND INSURANCE
-----------------------------
-16-
11.1 INDEMNIFICATION. Other than as specifically provided elsewhere in
---------------
this License Agreement, Astra shall defend, indemnify, and hold harmless
Licensors, The University of Kentucky, the University of Oklahoma and their
officers, directors, trustees and employees and all of their heirs, executors,
administrators and legal representatives ("INDEMNITEES") from and against any
and all claims, demands, loss, liability, expense or damage (including
investigative costs, court costs and attorneys' fees) Indemnitees may suffer,
pay or incur as a result of claims, demands or actions against any of the
Indemnitees arising or alleged to arise by reason of or in connection with any
and all personal injury, economic loss and property damage caused or alleged to
be caused or contributed to in whole or in part by the manufacture, use, lease,
sale or sublicense of Licensed Products by Astra, whether asserted under a tort
or contractual theory or any other legal theory, including but not limited to
any and all claims, demands, and actions in which it is alleged that (i) an
Indemnitee's negligence or representations about the Licensed Products caused
any defect in their manufacture, design, labeling or performance, or (ii) any
alleged infringement of any patent, trademark or copyright, caused or
contributed in whole or in part to the personal injury, economic loss or
property damage. Astra's obligations under this paragraph 11.1 shall survive
the expiration or termination of this License Agreement for any reason. The
foregoing indemnification shall not apply in the event a court of competent
jurisdiction determines that such liability, demands, damages, expenses and
losses, arose in whole or in part as a result of Licensors' intentional
misconduct or gross negligence.
11.2 INSURANCE. Without limiting Astra's indemnity obligations under the
---------
preceding paragraph 11.1, prior to testing any compounds in humans, Astra shall
obtain a liability insurance policy which:
(a) insures Indemnitees for all claims, demands and actions mentioned
in the preceding paragraph 11.1 of this License Agreement;
(b) includes a contractual endorsement providing coverage for all
such liability which may be incurred by Indemnitees in connection
with this License Agreement;
(c) requires the insurance carrier to provide Licensors with no less
than thirty (30) days written notice of any change in the terms
of coverage of the policy or its cancellation; and
(d) provides Indemnitees with product liability coverage in the
following amounts for the periods indicated below:
(i) [*] in product liability coverage during the period in which
one (1) or more Licensed Products are being used in United
-17-
States FDS clinical trials in human beings but no Licensed
Products are approved by FDA for use in human beings;
(ii) [*] in product liability coverage for each Licensed Product
approved by FDA for use in human beings;
provided that the aggregate maximum amount of product liability coverage for all
-------------
Licensed Products at any time shall not exceed [*] combined single limit for
bodily injury and property damage liability, subject to a deductible of not more
than [*] per occurrence, and provided further that Astra, at its option, may
provide Licensors with a certificate of Astra's insurer substantially in the
form of Exhibit C attached hereto, in lieu of naming
---------
Licensors as insureds.
Astra shall maintain such liability insurance policy throughout the term of this
License Agreement and for three (3) years thereafter.
11.3 NOTICE OF CLAIMS. Astra will promptly notify Licensors of all claims
----------------
involving Licensed Products.
11.4 EVIDENCE OF INSURANCE. Astra shall provide Licensors with copies of
---------------------
liability policies which comply fully with this License Agreement during the
entire period Astra is required to maintain such insurance. If Astra fails at
any time to maintain insurance as required in this License Agreement, Licensors
may (but shall be under no obligation to) purchase their own policy providing
all or any of the coverage and recover from Astra the cost thereof, which shall
be payable on demand.
11.5 INDEMNIFICATION BY ASTRA. Astra shall indemnify and hold harmless
------------------------
Indemnitees against and with respect to all losses, damages, claims, liabilities
or expenses (including reasonable attorneys' fees and expenses) incurred or
sustained by any of them as a result of, or arising out of, any violation,
breach or nonfulfillment on the part of Astra of any representation, warranty,
covenant or agreement made by Astra pursuant to this License Agreement.
Licensors or Indemnities shall notify Astra in writing promptly after it or they
acquire actual knowledge of any action or claim against it or them hereunder
which may give rise to liability of Astra pursuant to this paragraph 11.5.
Astra may, at its own expense, through legal counsel reasonably approved by
Licensors, defend or settle any such claim or action, provided that Astra posts
security that is adequate in the reasonable discretion of Licensors to protect
Licensors or Indemnities and provided Licensors are notified in writing of
Astra's intent to so defend within ten (10) days after Astra has been notified
by Licensors or such other Indemnities of such claim or action.
11.6 CONTRIBUTION BY ASTRA. If the indemnification provided for in the
---------------------
preceding
-18-
paragraph 11.5 is unavailable or insufficient to hold harmless Indemnities in
respect of any of the losses, claims, damages or liabilities (or actions in
respect thereof) referred to above, then Astra shall contribute to the amount
paid or payable by each such Indemnities as a result of such losses, claims,
damages or liabilities (or actions in respect thereof) in such proportion as is
appropriate to reflect the relative benefits received by Astra on the one hand
and Licensors and any other Indemnities on the other from the activities from
which such losses, claims, damages or liabilities arose, as well as the relative
fault of Astra on the one hand and Licensors on the other in connection with the
actions or inactions which resulted in such losses, claims, damages or
liabilities (or actions in respect thereof), as well as any other relevant
equitable considerations.
12. MERCHANTABILITY, EXCLUSION OF WARRANTIES, LIMITATION OF DAMAGES AND
-------------------------------------------------------------------
WARRANTIES.
----------
12.1 NO WARRANTY. Astra has made its own evaluation of the potential
-----------
capabilities, safety, utility and commercial application of the Licensed
Technology, Licensed Products and Licensed Processes.
ACCORDINGLY, LICENSORS MAKE NO REPRESENTATION OR WARRANTY OF ANY KIND
WITH RESPECT TO THE LICENSED TECHNOLOGY, LICENSED PRODUCTS OR LICENSED
PROCESSES AND EXPRESSLY DISCLAIM ANY WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE AND ANY OTHER IMPLIED WARRANTIES WITH
RESPECT TO THE CAPABILITIES, SAFETY, UTILITY OR COMMERCIAL APPLICATION
OF LICENSED TECHNOLOGY, LICENSED PRODUCTS AND LICENSED PROCESSES.
12.2 LIMITATION OF LIABILITY. LICENSORS SHALL NOT BE LIABLE FOR ANY
-----------------------
DIRECT, CONSEQUENTIAL OR OTHER DAMAGES SUFFERED BY ASTRA OR ANY OTHER RESULTING
FROM THE USE OF THE LICENSED TECHNOLOGY, LICENSED PRODUCTS OR LICENSED
PROCESSES.
12.3 REPRESENTATIONS AND WARRANTIES OF ASTRA. Astra hereby makes the
---------------------------------------
following representations and warranties to Licensors, which representations and
warranties, together with all other representations and warranties of Astra in
this License Agreement, are true and correct on the date hereof:
(a) Astra is a corporation duly organized, validly existing and in
good standing under the laws of Sweden and has all requisite
corporate power and authority to enter into this License
Agreement and perform its obligations hereunder.
-19-
(b) Neither the execution or delivery of this License Agreement, nor
the consummation of the transactions contemplated herein, will
(i) violate or conflict with any provision of the incorporation
documents or By-laws of Astra, as each may have been amended,
(ii) with or without the giving of notice of the lapse of time or
both (x) result in a breach of, or violate, or be in conflict
with or constitute a default under, or result in the termination
or cancellation of, or accelerate the performance required under,
any security instrument, mortgage, note, debenture, indenture,
loan, lease, contract, agreement or other instrument, to which
Astra is a party or by which Astra or any of Astra's properties
or assets may be bound or affected, or (y) result in the loss or
adverse modification of any lease, franchise, license or other
contractual right or other authorization granted to or otherwise
held by Astra, (iii) require the consent of any party to any such
agreement or commitment to which Astra is a party or by which any
of Astra's properties or assets are bound, (iv) result in the
creation or imposition of any lien, claim or encumbrance upon any
property or assets of Astra, or (v) require any consent,
approval, authorization, order, filing, registration or
qualification of or with any court or governmental authority or
arbitrator to which Astra is subject or by which any of its
properties or assets may be bound or affected.
(c) All actions to authorize the execution and delivery of this
License Agreement and the consummation of the transactions
contemplated herein have been duly taken, and this License
Agreement constitutes the valid and binding obligation of Astra
enforceable in accordance with its terms.
(d) There are no claims (relating to patent infringement or any other
matters), actions, suits, proceedings, arbitrations or
investigations pending or, to the best of Astra's knowledge,
threatened, against Astra which is adversely determined would
adversely affect the Licensed Technology (or the patentability
thereof) or other technology practiced by Astra, or Astra's
ability to enter into or carry out this License Agreement or use
or license Licensed Technology.
12.4 REPRESENTATIONS AND WARRANTIES OF OMRF. OMRF hereby makes the
--------------------------------------
following representations and warranties to Astra, which representations and
warranties, together with all other representations and warranties of OMRF in
this License Agreement, are true and correct on the date hereof:
-20-
(a) OMRF is a nonprofit corporation duly organized, validly existing
and in good standing under the laws of the State of Oklahoma and
has all requisite corporate power and authority to enter into
this License Agreement and perform its obligations hereunder.
(b) Neither the execution or delivery of this License Agreement, nor
the consummation of the transactions contemplated herein, will
(i) violate or conflict with any provision of the Articles of
Incorporation or By-laws of OMRF, as each may have been amended,
(ii) require the consent of any party to any agreement or
commitment to which OMRF is a party or which affects the Licensed
Technology, (iii) result in the creation or imposition of any
lien, claim or encumbrance upon the Licensed Technology; or (iv)
require any consent, approval, authorization, order, filing,
registration or qualification of or with any court or
governmental authority or arbitrator to which OMRF is subject or
by which the Licensed Technology may be affected.
(c) All actions to authorize the execution and delivery of this
License Agreement and the consummation of the transactions
contemplated herein have been duly taken, and this License
Agreement constitutes the valid and binding obligation of OMRF
enforceable in accordance with its terms.
(d) There are no claims (relating to patent infringement or any other
matters relating to the Licensed Technology), actions, suits,
proceedings, arbitrations or investigations pending or, to the
best of OMRF's knowledge, threatened, against OMRF which if
adversely determined would adversely affect the Licensed
Technology (or the patentability thereof) or OMRF's ability to
enter into or carry out this License Agreement.
(e) OMRF represents and warrants to the best of its knowledge and
belief that OMRF (together with UKRF) is the sole owner of the
Licensed Technology and such is free of any lien, encumbrance,
restriction, and other legal or equitable claim, apart from the
possible non-exclusive rights held by the United States
Government as a result of research sponsorship.
(f) OMRF further represents and warrants that OMRF has not granted
(and will not grant during the term of this License Agreement)
such rights or licenses to the Licensed Technology as set forth
in the Licensor Grant
-21-
(other than to Centaur pursuant to Centaur License Agreement).
12.5 REPRESENTATIONS AND WARRANTIES OF UKRF. UKRF hereby makes the
--------------------------------------
following representations and warranties to Astra, which representations and
warranties, together with all other representations and warranties of UKRF in
this License Agreement, are true and correct on the date hereof:
(a) UKRF is a nonprofit corporation duly organized, validly existing
and in good standing under the laws of the State of Kentucky and
has all requisite corporate power and authority to enter into
this License Agreement and perform its obligations hereunder.
(b) Neither the execution or delivery of this License Agreement, nor
the consummation of the transactions contemplated herein, will
(i) violate or conflict with any provision of the Articles of
Incorporation or By-laws of UKRF, as each may have been amended,
(ii) require the consent of any party to any agreement or
commitment to which UKRF is a party or which affects the Licensed
Technology, (iii) result in the creation or imposition of any
lien, claim or encumbrance upon the Licensed Technology, or (iv)
require any consent, approval, authorization, order, filing,
registration or qualification of or with any court or
governmental authority or arbitrator to which UKRF is subject or
by which the Licensed Technology may be affected.
(c) All actions to authorize the execution and delivery of this
License Agreement and the consummation of the transactions
contemplated herein have been duly taken, and this License
Agreement constitutes the valid and binding obligation of UKRF
enforceable in accordance with its terms.
(d) There are no claims (relating to patent infringement or any other
matters relating to the Licensed Technology), actions, suits,
proceedings, arbitrations or investigations pending or, to the
best of UKRF's knowledge, threatened, against OMRF which if
adversely determined would adversely affect the Licensed
Technology (or the patentability thereof) or UKRF's ability to
enter into or carry out this License Agreement.
(e) UKRF represents and warrants to the best of its knowledge and
belief that UKRF (together with OMRF) is the sole owner of the
Licensed Technology and such is free of any lien, encumbrance,
restriction, and other legal or equitable claim, apart from the
possible non-exclusive
-22-
rights held by the United States Government as a result of
research sponsorship.
(f) UKRF further represents and warrants that UKRF has not granted
(and will not grant during the term of this License Agreement)
such rights or licenses to the Licensed Technology as set forth
in the Licensor Grant (other than to Centaur pursuant to Centaur
License Agreement).
13. MISCELLANEOUS AND GENERAL
-------------------------
13.1 EXPORT CONTROLS. Astra acknowledges that Licensors are subject to
---------------
United States laws and regulations controlling the export of technical data,
computer software, laboratory prototypes and other commodities and that
Foundation's obligations hereunder are contingent on compliance with all
applicable United State export and other laws and regulations. The transfer of
certain technical data and commodities may require a license from the cognizant
agency of the United States Government and/or written assurances by Astra that
Astra shall not export data or commodities to certain foreign countries without
prior approval of such agency. Licensors neither represent that a license shall
not be required nor that, if required, it shall be issued.
13.2 LEGAL COMPLIANCE. Astra agrees that it will comply with all
----------------
applicable laws and regulations in relation to its manufacture, processing,
producing, use, selling or distributing of Licensed Products and that it will
not at any time take any action which would cause Licensors or Astra to be in
violation of any of such applicable laws and regulations.
13.3 REQUIRED CONSENTS. Astra shall obtain any and all licensees,
-----------------
permits, approvals or authorizations (the "REQUIRED CONSENTS") required by any
governmental entity or agency having jurisdiction over the transactions
contemplated by this License Agreement. Licensors shall cooperate with, and
provide reasonable assistance to, Astra in obtaining the Required Consents;
provided, however, that Astra shall reimburse Licensors for all of Licensor's
-------- -------
out-of-pocket expenses incurred in providing such assistance.
13.4 INDEPENDENT CONTRACTOR. Astra's relationship to Licensors hereunder
----------------------
shall be that of a license only. Astra shall not be the agent of Licensors and
shall have no authority to act for or on behalf of Licensors in any matter.
Persons retained by Astra as employees or agents shall not by reason thereof be
deemed to be employees or agents of Licensors.
13.5 PATENT MARKING. Astra agrees to ▇▇▇▇, to the extent practical, the
--------------
Licensed Products sold in the United States with all applicable United States
patent numbers. All Licensed Products shipped to or sold in other countries
shall be marked, to the extent practical, in such a manner as to conform with
the patent laws and practice of the country of manufacture or sale.
-23-
13.6 USE OF NAMES. No name of any Party to this License Agreement, or of
------------
any officer, trustee, director or employee of any Party, may be used by any
Party in any manner for announcing, advertising, promoting or marketing Licensed
Products or Licensed Processes unless the written permission of such Party, or
the individual, as the case may be, is obtained in advance.
13.7 INTERPRETATION. The Parties are equally responsible for the
--------------
preparation of this License Agreement, and in any judicial proceeding the terms
hereof shall not be more strictly construed against one Party than the other.
13.8 NOTICES. All notices, statements and reports required or
-------
contemplated herein by one Party to the other shall be in writing and shall be
deemed to have been given upon delivery in person or upon the expiration of five
(5) days after the deposit in a lawful mail depository in the country of
residence of the Party giving the notice, registered or certified airmail
postage prepaid, and addressed as follows:
If to Licensors:
---------------
OMRF:
Attention: President
Oklahoma Medical Research Foundation
▇▇▇ ▇. ▇. ▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇
With a copy to:
▇▇▇▇ ▇. ▇▇▇▇▇, Esquire
▇▇▇▇▇▇▇▇▇▇ & ▇▇▇▇
▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇
UKRF:
Director
Office of Intellectual Property
University of Kentucky Research Foundation
▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇
-▇▇-
▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
Facsimile:
With a copy to:
Office of Legal Counsel
University of Kentucky
▇ ▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
Facsimile:
If to Astra:
-----------
Astra AB
▇-▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇
Attention: President and Chief Executive
Officer
Facsimile: 011 46 85 53 29 000
Any Party hereto may change the address to which notices to such Party are
to be sent by giving notice to the other Parties at the addresses and in the
manner provided above. Any notice herein required or permitted to be given may
be given, in addition to the manner set forth above, by telex, facsimile or
cable, provided that the Party giving such notice obtains acknowledgement by
telex, facsimile or cable to be notified. Notice made in this manner shall be
deemed to have been given when such acknowledgement has been transmitted.
13.9 ASSIGNMENTS AND INUREMENT. Except as otherwise provided in this
-------------------------
License Agreement, Astra shall not grant, transfer, convey or otherwise assign
any of its rights or delegate any of its obligations under this License
Agreement (except in the course of a merger, consolidation or acquisition of all
or substantially all of Astra's business) without the prior written consent of
Licensors, which consent shall not be unreasonably withheld or delayed, and any
attempt by Astra to do so shall be of no effect; however, this License Agreement
shall be assignable by each of Licensors, provided that any such assignee has
agreed in writing with Astra to be bound by the terms and provisions of this
License Agreement. This License Agreement shall be binding upon and inure to
the benefit of the successors and permitted assigns of the Parties hereto.
13.10 GOVERNING LAW. This License Agreement shall be construed, governed,
-------------
interpreted and applied in accordance with the laws of the State of New York,
except that questions affecting the construction and effect of any patent shall
be determined by the law of
-25-
the country in which the patent was granted.
13.11 ENTIRE AGREEMENT. This License Agreement constitutes the entire
----------------
agreement between Licensors and Astra with respect to the subject matter hereof
and shall not be modified, amended or terminated except as herein provided or
except by another agreement in writing executed by the Parties hereto.
13.12 HEADINGS. The section and paragraph headings are for convenience
--------
only and are not part of this License Agreement.
13.13 SEVERABILITY. All rights and restrictions contained herein may be
------------
exercised and shall be applicable and binding only to the extent that they do
not violate any applicable laws and are intended to be limited to the extent
necessary so that they will not render this License Agreement illegal, invalid
or unenforceable. If any provision or portion of any provision of this License
Agreement not essential to the commercial purpose of this License Agreement
shall be held to be illegal, invalid or unenforceable by a court of competent
jurisdiction, it is the intention of the Parties that the remaining provisions
or portions thereof shall constitute their agreement with respect to the subject
matter hereof, and all such remaining provisions or portions thereof shall
remain in full force and effect. To the extent legally permissible, any
illegal, invalid or unenforceable provision of this License Agreement shall be
replaced by a valid provision which will implement the commercial purpose of the
illegal, invalid or unenforceable provision. In the event that any provision
essential to the commercial purpose of this License Agreement is held to be
illegal, invalid or unenforceable and cannot be replaced by a valid provision
which will implement the commercial purpose of this License Agreement, this
License Agreement and the rights granted herein shall terminate.
13.14 COUNTERPARTS. This License Agreement may be executed in two or more
------------
counterparts, each of which shall be deemed an original, but all of which shall
constitute one and the same instrument.
IN WITNESS WHEREOF, the Parties have caused this License Agreement to be
executed by their duly authorized representatives as of the day and year first
above written.
-26-
Licensors:
---------
OKLAHOMA MEDICAL RESEARCH FOUNDATION
By:_________________________________
▇▇. ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇, President
hereunto duly authorized
UNIVERSITY OF KENTUCKY RESEARCH
FOUNDATION
By:__________________________________
hereunto duly authorized
ASTRA:
-----
ASTRA AB
(publ)
By:__________________________________
▇▇▇▇▇ ▇▇▇▇▇▇, President and
Chief Executive Officer
hereunto duly authorized
-27-
EXHIBIT A
---------
TO
LICENSE AGREEMENT
MADE AND ENTERED INTO AS OF JUNE ___, 1995
BY AND AMONG
OKLAHOMA MEDICAL RESEARCH FOUNDATION,
AND
THE UNIVERSITY OF KENTUCKY RESEARCH FOUNDATION
AND
ASTRA AB
CENTAUR LICENSE AGREEMENT
-------------------------
EXHIBIT B
---------
TO
LICENSE AGREEMENT
MADE AND ENTERED INTO AS OF JUNE ___, 1995
BY AND AMONG
OKLAHOMA MEDICAL RESEARCH FOUNDATION,
AND
THE UNIVERSITY OF KENTUCKY RESEARCH FOUNDATION
AND
ASTRA AB
RESEARCH AGREEMENTS
-------------------
EXHIBIT C
---------
TO
LICENSE AGREEMENT
MADE AND ENTERED INTO AS OF JUNE ___, 1995
BY AND AMONG
OKLAHOMA MEDICAL RESEARCH FOUNDATION,
AND
THE UNIVERSITY OF KENTUCKY RESEARCH FOUNDATION
AND
ASTRA AB
ASTRA INSURANCE CERTIFICATE
---------------------------
APPENDIX 4
----------
TO
DEVELOPMENT, LICENSE AND MARKETING AGREEMENT
DATED JUNE 26, 1995
BETWEEN
CENTAUR PHARMACEUTICALS, INC.
AND
ASTRA AB
ASTRA STRATEGIC RESEARCH AREAS
------------------------------
[REFERENCE TO APPENDIX 4 REPLACED IN ITS ENTIRETY BY AMENDMENT DATED OCTOBER 7,
1997 -- SEE EXHIBIT 10.15 TO THE REGISTRATION STATEMENT]
APPENDIX 5
----------
TO
DEVELOPMENT, LICENSE AND MARKETING AGREEMENT
DATED JUNE 26, 1995
BETWEEN
CENTAUR PHARMACEUTICALS, INC.
AND
ASTRA AB
FIRST AMENDMENT TO CENTAUR LICENSES
-----------------------------------
[SEE EXHIBIT 10.12 TO THE REGISTRATION STATEMENT]