EXHIBIT 3
PORTIONS OF THIS DOCUMENT HAVE BEEN OMITTED (DESIGNATED BY AN ASTERISK (*))
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
A REQUEST FOR CONFIDENTIAL TREATMENT DATED NOVEMBER 20, 1998.
LICENSE AGREEMENT
BETWEEN
XXXXXX LABORATORIES
AND
ARONEX PHARMACEUTICALS, INC.
TABLE OF CONTENTS
1. DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.1 "Affiliate" . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2 "Annual Net Sales". . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.3 "API Intellectual Property Rights". . . . . . . . . . . . . . . . . . . 2
1.4 "API Know-How". . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.5 "API Patents" . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.6 "API Patent Applications" . . . . . . . . . . . . . . . . . . . . . . . 2
1.7 "API Patent Rights" . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.8 "API Trademarks". . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.9 "Calendar Quarter". . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.10 "Calendar Year" . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.11 "EMEA". . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.12 "Empiric Claim" . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.13 "Factory Cost". . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.14 "First Commercial Sale" . . . . . . . . . . . . . . . . . . . . . . . . 3
1.15 "Generic Competition" . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.16 "LBU Countries" . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.17 "Major Subterritories". . . . . . . . . . . . . . . . . . . . . . . . . 4
1.18 "Net Sales" . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.19 "Party" (and "Parties") . . . . . . . . . . . . . . . . . . . . . . . . 5
1.20 "Product" . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.21 "Regulatory Approval" . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.22 "Term". . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.23 "Territory" . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.24 "Unaffiliated Sublicensee". . . . . . . . . . . . . . . . . . . . . . . 5
1.25 "U.S. FDA". . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.26 "U.S. FD&C Act" . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.27 "U.S. NDA". . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.28 "U.S. Product Development Plan" . . . . . . . . . . . . . . . . . . . . 6
1.29 "Valid Claim" . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2. GRANT AND SCOPE OF RIGHTS GRANTED . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.1 Exclusive License . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.2 Sublicensing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.3 No Implied Licenses . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.4 Extension of the Territory to Spain and Portugal. . . . . . . . . . . . 7
3. MILESTONE AND RESEARCH & DEVELOPMENT FUNDING PAYMENTS . . . . . . . . . . . . . . 7
3.1 Milestone Payments. . . . . . . . . . . . . . . . . . . . . . . . . . . 7
(a) Effective Date. . . . . . . . . . . . . . . . . . . . . . . . 7
(b) United States Regulatory Approval . . . . . . . . . . . . . . 7
3.2 Research & Development Funding Payments . . . . . . . . . . . . . . . . 7
3.3 Non-Refundability . . . . . . . . . . . . . . . . . . . . . . . . . . .10
3.4 Reimbursement of Payment Reductions . . . . . . . . . . . . . . . . . .10
3.6 Equity Investment . . . . . . . . . . . . . . . . . . . . . . . . . . .11
4. ROYALTY RATES AND PAYMENTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
4.1 Royalty Rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
(a) * . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
(b) * . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
(c) * . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
(d) * . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
(e) * . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
4.2 Lump Sum Royalty Payments . . . . . . . . . . . . . . . . . . . . . . .13
4.3 Royalty Reports and Payments. . . . . . . . . . . . . . . . . . . . . .14
4.4 Currency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
4.5 No Royalties Payable Between Affiliates . . . . . . . . . . . . . . . .15
4.6 No Multiple Royalties . . . . . . . . . . . . . . . . . . . . . . . . .15
5. PAYMENT, RECORD KEEPING AND AUDIT RIGHTS. . . . . . . . . . . . . . . . . . . . . .15
5.1 Method of Payment . . . . . . . . . . . . . . . . . . . . . . . . . . .15
5.2 Record Keeping and Audit Rights . . . . . . . . . . . . . . . . . . . .15
6. PRODUCT DEVELOPMENT AND REGISTRATIONS . . . . . . . . . . . . . . . . . . . . . . .16
6.1 Development and Registration Activities . . . . . . . . . . . . . . . .16
(a) United States . . . . . . . . . . . . . . . . . . . . . . . .16
(b) European Union. . . . . . . . . . . . . . . . . . . . . . . .16
(c) Japan . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
(d) Other Countries . . . . . . . . . . . . . . . . . . . . . . .17
(e) Mutual Assistance . . . . . . . . . . . . . . . . . . . . . .18
6.2 Development Costs . . . . . . . . . . . . . . . . . . . . . . . . . . .18
6.3 Modifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
(a) Material Changes. . . . . . . . . . . . . . . . . . . . . . .18
(b) Other Changes . . . . . . . . . . . . . . . . . . . . . . . .18
6.4 Reciprocal Access to Documentation and Data . . . . . . . . . . . . . .18
7. ABBOTT PRODUCT MARKETING AND SALES ACTIVITIES . . . . . . . . . . . . . . . . . . .19
7.1 Commercially Reasonable Efforts . . . . . . . . . . . . . . . . . . . .19
7.2 Marketing Costs and Expenses. . . . . . . . . . . . . . . . . . . . . .19
8. API CO-PROMOTION ACTIVITIES . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
8.1 Co-Promotion Territory. . . . . . . . . . . . . . . . . . . . . . . . .19
8.2 Allocation of Sales Representatives . . . . . . . . . . . . . . . . . .19
8.3 Co-Promotion Period . . . . . . . . . . . . . . . . . . . . . . . . . .19
8.4 Compensation to API . . . . . . . . . . . . . . . . . . . . . . . . . .20
8.5 Scope of Co-Promotion Collaboration . . . . . . . . . . . . . . . . . .20
9. CONFIDENTIALITY AND PUBLICITY . . . . . . . . . . . . . . . . . . . . . . . . . . .20
9.1 Confidentiality Obligation. . . . . . . . . . . . . . . . . . . . . . .20
9.2 Permitted Disclosures . . . . . . . . . . . . . . . . . . . . . . . . .20
9.3 Confidential Information. . . . . . . . . . . . . . . . . . . . . . . .21
(a) Publicly Available Information. . . . . . . . . . . . . . . .21
(b) Previously Known Information. . . . . . . . . . . . . . . . .21
(c) Subsequently Received Information . . . . . . . . . . . . . .21
(d) Independently Developed Information . . . . . . . . . . . . .21
(e) Legally Required Disclosures of Information . . . . . . . . .21
9.4 Duration of Confidentiality Obligation. . . . . . . . . . . . . . . . .22
9.5 Publicity and Announcements . . . . . . . . . . . . . . . . . . . . . .22
10. TRADEMARKS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
10.1 Assignment of API Trademarks. . . . . . . . . . . . . . . . . . . . . .22
10.2 Alternate Trademarks. . . . . . . . . . . . . . . . . . . . . . . . . .23
11. PATENT OWNERSHIP AND WARRANTIES . . . . . . . . . . . . . . . . . . . . . . . . . .23
11.1 Patent Ownership. . . . . . . . . . . . . . . . . . . . . . . . . . . .23
11.2 Joint Inventions. . . . . . . . . . . . . . . . . . . . . . . . . . . .23
11.3 API Patent Warranties . . . . . . . . . . . . . . . . . . . . . . . . .23
12. PATENT PROSECUTION AND INTELLECTUAL PROPERTY INFRINGEMENT . . . . . . . . . . . . .24
12.1 Patent Filing and Prosecution . . . . . . . . . . . . . . . . . . . . .24
12.2 Notification of Infringement. . . . . . . . . . . . . . . . . . . . . .24
12.3 Infringement of Third Party Rights. . . . . . . . . . . . . . . . . . .24
12.4 Infringement Indemnification. . . . . . . . . . . . . . . . . . . . . .25
12.5 Termination for Infringement. . . . . . . . . . . . . . . . . . . . . .26
12.6 Third Party Infringement of API Intellectual Property Rights. . . . . .26
(a) API Enforcement . . . . . . . . . . . . . . . . . . . . . . .26
(b) Abbott Enforcement. . . . . . . . . . . . . . . . . . . . . .26
12.7 Allocation of Recoveries. . . . . . . . . . . . . . . . . . . . . . . .27
12.8 Mutual Cooperation. . . . . . . . . . . . . . . . . . . . . . . . . . .27
12.9 Labeling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
12.10 Notification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
13. INDEMNIFICATION AND INSURANCE . . . . . . . . . . . . . . . . . . . . . . . . . . .28
13.1 Reciprocal Indemnification Provisions . . . . . . . . . . . . . . . . .28
(a) API Indemnification . . . . . . . . . . . . . . . . . . . . .28
(b) Abbott Indemnification. . . . . . . . . . . . . . . . . . . .28
13.2 Conditions of Indemnification . . . . . . . . . . . . . . . . . . . . .28
13.3 Insurance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29
14. ADVERSE DRUG EXPERIENCES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29
15. REPRESENTATIONS AND WARRANTIES. . . . . . . . . . . . . . . . . . . . . . . . . . .30
(a) Corporate Status. . . . . . . . . . . . . . . . . . . . . . .30
(b) Authority . . . . . . . . . . . . . . . . . . . . . . . . . .31
(c) No Conflicts. . . . . . . . . . . . . . . . . . . . . . . . .31
(d) No Approvals. . . . . . . . . . . . . . . . . . . . . . . . .31
(e) Enforceability. . . . . . . . . . . . . . . . . . . . . . . .31
(f) Compliance With Laws. . . . . . . . . . . . . . . . . . . . .31
(g) Year 2000 Compliance. . . . . . . . . . . . . . . . . . . . .31
16. TERM AND EARLY TERMINATION RIGHTS . . . . . . . . . . . . . . . . . . . . . . . . .32
16.1 Term. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
16.2 Termination for Cause . . . . . . . . . . . . . . . . . . . . . . . . .32
(a) Bankruptcy. . . . . . . . . . . . . . . . . . . . . . . . . .32
(b) Material Breach . . . . . . . . . . . . . . . . . . . . . . .32
16.3 Termination by Mutual Agreement . . . . . . . . . . . . . . . . . . . .32
16.4 Termination by Abbott . . . . . . . . . . . . . . . . . . . . . . . . .32
(a) Safety or Efficacy. . . . . . . . . . . . . . . . . . . . . .32
(b) Limited Commercial Viability. . . . . . . . . . . . . . . . .33
17. CONSEQUENCES OF TERMINATION . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
17.1 Effect of Termination . . . . . . . . . . . . . . . . . . . . . . . . .33
17.2 License Rights. . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
17.3 Fully Paid-Up License . . . . . . . . . . . . . . . . . . . . . . . . .34
17.4 Mutual Agreement. . . . . . . . . . . . . . . . . . . . . . . . . . . .34
17.5 Regulatory Approvals. . . . . . . . . . . . . . . . . . . . . . . . . .34
18. GOVERNING LAW AND DISPUTE RESOLUTION. . . . . . . . . . . . . . . . . . . . . . . .34
18.1 Governing Law . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
18.2 Dispute Resolution. . . . . . . . . . . . . . . . . . . . . . . . . . .34
(a) Attempted Amicable Resolution . . . . . . . . . . . . . . . .35
(b) ADR Procedure . . . . . . . . . . . . . . . . . . . . . . . .35
(c) ADR Ruling. . . . . . . . . . . . . . . . . . . . . . . . . .35
(d) Remedies. . . . . . . . . . . . . . . . . . . . . . . . . . .36
(e) Dispute Resolution for Section 7.1. . . . . . . . . . . . . .36
18.3 Effect of Commencing Dispute Resolution . . . . . . . . . . . . . . . .37
19. NOTICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
19.1 Manner of Giving Notices. . . . . . . . . . . . . . . . . . . . . . . .37
19.2 Addresses for Notices . . . . . . . . . . . . . . . . . . . . . . . . .38
20. INTEGRATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
21. ASSIGNMENT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
22. LIMITATION OF DAMAGES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
23. FORCE MAJEURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40
24. RELATIONSHIP OF PARTIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40
25. SEVERABILITY OF CLAUSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
26. NON-WAIVER. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
27. HEADINGS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
28. EXECUTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
LICENSE AGREEMENT
This License Agreement ("Agreement") is made and entered into as of the
___ day of November, 1998 ("Effective Date"), by and between ARONEX
PHARMACEUTICALS, INC., a Delaware corporation having its principal office at
8707 Technology Forest Place, the Xxxxxxxxx, Xxxxx 00000-0000 ("API"), and
XXXXXX LABORATORIES, an Illinois corporation having its principal office at 000
Xxxxxx Xxxx Xxxx, Xxxxxx Xxxx, Xxxxxxxx, 00000-0000 ("Abbott").
WHEREAS, API has developed a new, proprietary injectable formulation
of the compound nystatin presently being developed under the name Nyotran
-Registered Trademark- for treatment of systemic fungal infections; and
WHEREAS, Abbott and API desire to enter into this Agreement under which
Abbott shall acquire the exclusive world-wide rights to manufacture, distribute,
market and sell the above-referenced product.
NOW, THEREFORE, for and in consideration of the mutual covenants
contained herein and intending to be legally bound, the parties hereto agree as
follows:
1. DEFINITIONS
For purposes of this Agreement, the following terms shall be defined as
set forth below. Additional terms used in specific Sections of this Agreement
shall be defined in such Sections.
1.1 "AFFILIATE" shall mean any business entity controlled by a Party
(as defined below), or which controls a Party, or which is under common control
with a Party. "Control" herein means the direct or indirect ownership of at
least fifty percent (50%) of the authorized issued voting shares in such entity,
or such other relationship as in fact legally results in effective control over
the management, business and affairs of such entity or Party, as the case may
be. For purposes of this Agreement, Abbott Affiliates shall also include Xxxxxx
Laboratories Nigeria Limited.
1.2 "ANNUAL NET SALES" shall mean Net Sales (as defined below) in any
Calendar Year.
1.3 "API INTELLECTUAL PROPERTY RIGHTS" shall mean API Patents (as
defined below) and API Know-How (as defined below).
1.4 "API KNOW-HOW" shall mean all non-patented and unpublished
non-clinical, pre-clinical and clinical documentation, information, and data
relating to the Product owned or controlled by API and its Affiliates as of the
Effective Date or at any time during the Term (as defined below), including but
not limited to all registration materials for the Product (as defined below)
developed, acquired or compiled by API and its Affiliates as of the Effective
Date or at any time during the Term, and all documentation, information and data
relating to the formulation, manufacture and/or quality control of the Product
as API and its Affiliates have available as of the Effective Date or at any time
during the Term.
1.5 "API PATENTS" shall mean all issued patents owned by or licensed
to API and its Affiliates in the Territory as of the Effective Date and other
patents owned by or licensed to API and its Affiliates in the Territory issued
at any time during the Term which have claims covering the manufacture, sale or
use of the Product or its active ingredient (including any divisions,
continuations, continuations-in-part, reexaminations, reissues, additions,
renewals and extensions thereof). API Patents in existence as of the Effective
Date are set forth in Part I of Exhibit A and such Exhibit shall be amended by
API from time to time during the Term to include API Patents issued after the
Effective Date.
1.6 "API PATENT APPLICATIONS" shall mean patent applications owned by
or licensed to API and its Affiliates in the Territory pending as of the
Effective Date and patent applications owned by or licensed to API and its
Affiliates in the Territory filed at any time during the Term which have claims
covering the manufacture, sale or use of the Product or its active ingredient
(including any divisions, continuations, continuations-in-part, reexaminations,
reissues, additions, renewals and extensions thereof). API Patent Applications
in existence as of the Effective Date are set forth in Part II of Exhibit A and
such Exhibit shall be amended by API from time to time during the Term to
include API Patent Applications filed after the Effective Date.
1.7 "API PATENT RIGHTS" shall mean API Patents and API Patent
Applications.
1.8 "API TRADEMARKS" shall mean Nyotran -Registered Trademark-,
NystatinLF-Registered Trademark- and any other mutually agreed upon
trademark owned by API used with the Product.
1.9 "CALENDAR QUARTER" shall mean each of the three (3) month periods
beginning on January 1, April 1, July 1 and October 1 of each Calendar Year (as
defined below) during the Term.
1.10 "CALENDAR YEAR" shall mean any consecutive twelve (12) month
period from January 1 to December 31 during the Term.
1.11 "EMEA" shall mean the European Medicines Evaluation Agency or any
successor agency thereto.
1.12 "EMPIRIC CLAIM" shall mean Regulatory Approval (as defined below)
for the Product with an approved claim for empirical therapy for presumed fungal
infection in febrile, neutropenic patients.
1.13 "FACTORY COST" shall mean Xxxxxx'x cost of manufacturing the
Product calculated in accordance with the attached Exhibit B.
1.14 "FIRST COMMERCIAL SALE" shall mean the first sale of the Product
by Abbott, any Abbott Affiliate or Unaffiliated Sublicensee (as defined below)
to any end-user customer, excluding any sales or transfers of the Product to any
party in connection with clinical trials or regulatory or safety testing.
1.15 "GENERIC COMPETITION" shall mean competition from another
supplier of nystatin liposome for injection in a country in the Territory in
which no Valid Claim exists such that Abbott or an Abbott Affiliate or
Unaffiliated Sublicensee is forced to lower the price of the Product by * (*)
or more in such country, where such discount is in addition to the reasonable
and customary discounts offered to customers in such country.
1.16 "LBU COUNTRIES" shall mean the following countries in Europe,
individually or collectively, as applicable: France, Germany, the United
Kingdom, Italy
and Spain.
1.17 "MAJOR SUBTERRITORIES" shall mean the following countries or
areas of the Territory, individually or collectively, as applicable: the United
States, the LBU Countries and Japan.
1.18 "NET SALES" shall mean the gross sales of the Product in the
Territory actually billed and collected by Abbott, its Affiliates, or
Unaffiliated Sublicensees from any national or local governments, hospitals,
drug wholesalers or brokers, and other third party customers which are not
Abbott Affiliates or Unaffiliated Sublicensees (such as surgicenters and other
institutions, the primary business of which is providing medical care), less
reasonable and customary: (a) credits and allowances or adjustments actually
granted to such customers on account of retroactive price reductions,
governmental or other rebates, and rejections, recalls or returns of the Product
previously sold; (b) any trade and cash discounts, rebates, charge-backs granted
to customers in the case of sales to drug wholesalers or brokers where there are
no direct shipments by Abbott, its Affiliates or Unaffiliated Sublicensees to
such customers, and management fees paid during the relevant time period to
group purchasing organizations and relating specifically to the Product (which
discounts, rebates, charge-backs and fees shall be in the same proportion of the
invoice price as that borne by other products sold by Abbott or an Abbott
Affiliate or Unaffiliated Sublicensee to customers such that the portion of such
discounts, rebates, chargebacks and fees allocated to the Product does not
exceed the portion allocated to any other such product as a percentage of the
invoice price of the Product and such other product), and (c) any sales or other
taxes imposed upon the sale of the Product to the extent included in the gross
sales price, as adjusted (as applicable) for any credits, allowances, rebates
and chargebacks.
1.19 "PARTY" (and "PARTIES") shall mean either API or Abbott (or
both), as the context requires.
1.20 "PRODUCT" shall mean API's proprietary formulation of the
compound nystatin, presently being developed under the name
Nyotran -Registered Trademark-.
1.21 "REGULATORY APPROVAL" shall mean all governmental approvals
required to market and sell the Product in any given country in the Territory
(as defined below), including but not limited to, product registrations, medical
approvals, price, reimbursement and marketing approvals.
1.22 "TERM" shall mean the period commencing on the Effective Date and
continuing until the later of (a) ten (10) years after the date of Regulatory
Approval in the United States and (b) the date of expiration or invalidation of
the last to expire or be invalidated of the API Patents containing a Valid Claim
(as defined below), subject to earlier termination as provided herein.
1.23 "TERRITORY" shall mean all countries and territories of the
world; provided that the Territory shall include Spain and Portugal only if, and
to the extent that, in accordance with Section 2.4, Abbott and/or API enter into
one or more agreements with Grupo Xxxxxx Internacional, S.A. ("Xxxxxx")
modifying, replacing or terminating that certain Supply and Distribution
Agreement dated May 2, 1997 between API and Xxxxxx (the "Xxxxxx Agreement") to
permit the inclusion of such countries within the Territory without any breach
or violation of the rights of Xxxxxx.
1.24 "UNAFFILIATED SUBLICENSEE" shall mean any sublicensee of Abbott
under
this Agreement other than an Abbott Affiliate.
1.25 "U.S. FDA" shall mean the United States Food and Drug
Administration and any successor regulatory agency.
1.26 "U.S. FD&C ACT" shall mean the United States Food, Drug and
Cosmetic Act, including any amendments thereto and all regulations promulgated
thereunder.
1.27 "U.S. NDA" shall mean a New Drug Application filed with the U.S.
FDA.
1.28 "U.S. PRODUCT DEVELOPMENT PLAN" shall mean the Plan attached
hereto as Exhibit C setting forth API's Product development and registration
activities in the United States, as the same may be amended from time to time
during the Term in accordance with Section 6.3.
1.29 "VALID CLAIM" shall mean one (1) or more claim of an issued and
unexpired API Patent which neither has been held unenforceable, unpatentable or
invalid by a decision of a court or governmental agency of competent
jurisdiction, unappealable or unappealed within the time allowed for appeal, nor
has been admitted by the holder of the API Patent to be invalid or unenforceable
through reissue, disclaimer, abandonment or otherwise.
2. GRANT AND SCOPE OF RIGHTS GRANTED
2.1 EXCLUSIVE LICENSE. API hereby grants to Abbott an exclusive
license (or sublicense, as applicable) under API Intellectual Property Rights to
make, have made, use, import, offer for sale and sell the Product in the
Territory, which license shall be exclusive even as to API and its Affiliates,
except as provided in Section 6 and 8. The Parties acknowledge and agree that
the foregoing license shall apply to API Intellectual Property Rights developed
or acquired (whether by license, assignment or otherwise) by API after the
Effective Date only to the extent API has the right to grant such license to
Abbott. Notwithstanding the foregoing sentence, API, in developing or acquiring
such API Intellectual Property Rights, shall use its reasonable best efforts to
ensure that Xxxxxx'x rights under this Agreement extend thereto.
2.2 SUBLICENSING. Abbott shall have the right to sublicense its
rights under this Agreement in the Territory to any Abbott Affiliates, provided
that Abbott guarantees the performance of any Abbott Affiliates to which such
rights are sublicensed. Abbott shall also have the right to sublicense its
rights under this Agreement to Unaffiliated Sublicensees, provided that such
sublicensing of Xxxxxx'x rights shall not relieve Abbott of any obligations
hereunder, and provided further that Abbott has obtained API's prior written
consent for any sublicense of its rights in Japan, which consent shall not be
unreasonably withheld or delayed.
2.3 NO IMPLIED LICENSES. Any rights not expressly granted by either
Party to the other Party in this Agreement are expressly reserved by the Party
owning or controlling such rights and, accordingly, no licenses other than those
specified herein shall be deemed granted by this Agreement by implication,
estoppel or otherwise.
2.4 EXTENSION OF THE TERRITORY TO SPAIN AND PORTUGAL. Abbott and API
shall use their respective reasonable best efforts to enter into one or more
agreements with Xxxxxx as soon as practical after the Effective Date (with
discussions with Xxxxxx to be initiated within ninety (90) days after the
Effective Date) modifying, replacing or terminating the Xxxxxx Agreement to
permit the inclusion of Spain and Portugal within the Territory without any
breach or violation of the rights of Xxxxxx.
3. MILESTONE AND RESEARCH & DEVELOPMENT FUNDING PAYMENTS
3.1 MILESTONE PAYMENTS. In consideration of API's entering into this
Agreement and the rights and licenses granted to Abbott hereunder, during the
Term Abbott shall pay API milestone payments according to the following payment
schedule:
(a) EFFECTIVE DATE - Within ten (10) business days after the
Effective Date, Abbott shall pay API * (*);
(b) * - Within twenty (20) business days after * Abbott
shall pay API * (*).
3.2 RESEARCH & DEVELOPMENT FUNDING PAYMENTS. In further
consideration of API's entering into this Agreement and performing continued
research and development activities for the Product, during the Term Abbott
shall make research and development funding payments to API in accordance with
the following schedule, contingent on completion of the research and development
tasks referenced below:
R&D Funding Payment Payment Date
------------------- ------------
(a) * *
(b) * *
(c) * *
(d) * *
(e) * *
(f) * *
(g) * *
(h) * *
(i) * *
3.3 NON-REFUNDABILITY. All milestone payments and research and
development funding payments Abbott makes to API pursuant to Section 3.1 or
3.2 shall be non-refundable once paid. However, if this Agreement is
terminated for any reason prior to a given milestone or research and
development funding payment becoming due or if the events specified for a
given milestone or research and
development funding payment do not occur, then Abbott shall have no
obligation to make such milestone or research and development funding
payment; provided, however, that if API terminates this Agreement due to
Xxxxxx'x Material Breach pursuant to Section 16.2(b), the foregoing shall not
relieve Abbott of liability for damages, if any, that API may recover from
Abbott in an ADR proceeding pursuant to Section 18.2(b).
3.4 REIMBURSEMENT OF PAYMENT REDUCTIONS. The Parties acknowledge
their mutual goal to * on or before *. If Abbott * on or before *. *.
3.5 NOTICE OF ACHIEVEMENT OF MILESTONES; PAYMENT. API shall deliver
written notice to Abbott of API's achievement of the milestone referenced in
Section 3.1(b) and of API's satisfaction of the condition(s) to the research and
development funding payments referenced in Section 3.2. Abbott shall pay such
milestone payment and research and development payments within thirty (30)
calendar days of the delivery of the notice relating thereto.
3.6 EQUITY INVESTMENT. The Parties further acknowledge that
Abbott is making an equity investment in API in the aggregate amount of up to
* (*) under a Stock Purchase Agreement bearing even date herewith.
4. ROYALTY RATES AND PAYMENTS
4.1 ROYALTY RATES. In further consideration of the rights and
licenses granted to Abbott hereunder in API Intellectual Property Rights during
the Term Abbott shall pay API royalties on Xxxxxx'x, its Affiliates' and
Unaffiliated Sublicensees' Annual Net Sales at the following aggregate total
royalty rates:
(a) UP TO * IN ANNUAL NET SALES - If Annual Net Sales are
less than or equal to * (*), the aggregate total royalty payable to API shall
be * (*) of all Annual Net Sales.
(b) OVER * UP TO * IN ANNUAL NET SALES - If Annual Net Sales
exceed * (*) but are less than or equal to * (*), the aggregate total royalty
payable to API shall be * (*) of all Annual Net Sales.
(c) OVER * UP TO * IN ANNUAL NET SALES - If Annual Net Sales
exceed * (*) but are less than or equal to * (*), the aggregate total royalty
payable to API shall be
* (*) of all Annual Net Sales.
(d) OVER * UP TO * IN ANNUAL NET SALES - If Annual Net Sales
exceed * (*) but are less than or equal to * (*), the aggregate total royalty
payable to API shall be * (*) of all Annual Net Sales.
(e) OVER * IN ANNUAL NET SALES - If Annual Net Sales exceed
* (*), the aggregate total royalty payable to API shall be * (*) of all
Annual Net Sales.
If Generic Competition exists in any country of the Territory in which
no Valid Claim exists, royalties payable by Xxxxxx for Net Sales in such
country shall be reduced by * (*) during the period in which Generic
Competition exists.
The aggregate total royalty payable to API shall be determined by
total Annual Net Sales during each applicable Calendar Year. On or before
December 1 of each Calendar Year during the Term, the Parties shall mutually
agree on an Annual Net Sales forecast ("Net Sales Forecast") for the
following Calendar Year and Xxxxxx shall pay estimated royalties based on the
Net Sales Forecasts. If the Factory Cost for a Calendar Year exceeds * (*)
of the Net Average Selling Price (as defined below) of the Product for such
Calendar Year, the portion of the Factory Cost above * (*) shall be prorated
to the Parties in an amount equal to the proration of royalty payments to Net
Sales. On or before December 1 of each Calendar Year during the Term, the
Parties shall mutually agree on a Net Average Selling Price forecast ("ASP
Forecast") and Factory Cost estimate ("Factory Cost Estimate") for the
following Calendar Year and, if applicable, adjust royalties based on the ASP
Forecast and Factory Cost Estimate. The Parties shall reconcile actual
royalties payable for each Calendar Year on or before April 1 of the
following Calendar Year. As used in this Section, "Net Average Selling
Price" shall mean Net Sales divided by Net Units and "Net Units" shall mean
units of the Product actually sold, less returns in accordance with Section
1.17.
The Annual Net Sales thresholds set forth in subsections (a)
through (e) of this Section 4.1 shall be proportionately reduced: (i) in the
Calendar Year in which the First Commercial Sale occurs, by multiplying such
Annual Net Sales thresholds by a fraction, (A) the numerator of which shall be
the number of days remaining in such Calendar Year as of the First Commercial
Sale and (B) the denominator of which shall be 365; and (ii) in the Calendar
Year in which the Term expires, by multiplying such Annual Net Sales thresholds
by a fraction, (X) the numerator of which shall be the number of days in such
Calendar Year prior to the expiration of the Term and (Y) the denominator of
which shall be 365.
4.2 LUMP SUM ROYALTY PAYMENTS. In addition to the royalty payments
pursuant to Section 4.1 and research and development funding payments pursuant
to Sections 3.1 and 3.2, Xxxxxx shall make lump sum royalty payments to API if
any or all of the following Net Sales thresholds are attained during the time
periods referenced below:
Net Sales Applicable Time Period
Payment Amount Level ----------------------
-------------- -----
(a) * * *
(b) * * *
(c) * * *
(d) * * *
Each lump sum royalty payment referenced above shall be payable only
once during the Term within ten (10) business days after the end of the
applicable time period and shall be payable only if the applicable Net Sales
level is attained during the applicable time period.
4.3 ROYALTY REPORTS AND PAYMENTS. Commencing with the first Calendar
Quarter in which Xxxxxx, its Affiliates or Unaffiliated Sublicensees make the
First Commercial Sale of the Product in the Territory, Xxxxxx shall provide API
with a written report of Net Sales on a country-by-country basis within
forty-five (45) days after the last day of March, June, September and December
for royalties accruing on Net Sales in the United States during the three (3)
preceding calendar months and within seventy-five (75) days after the last day
of February, May, August and November for royalties accruing on Net Sales in the
Territory outside of the United States during the three (3) preceding calendar
months. Concurrently with the submission of each such written report, Xxxxxx
shall pay or cause to be paid to API the total amount of royalties shown to be
due thereon.
4.4 CURRENCY. Xxxxxx shall make all royalty payments to API pursuant
to Section 4.2 in U.S. Dollars. Royalty payments earned shall be first
determined by Xxxxxx in the currency of the country where the Net Sales were
made and then converted by Xxxxxx directly to its equivalent in U.S. Dollars.
The rates of exchange for converting the currencies involved to U.S. Dollars as
quoted by the WALL STREET JOURNAL, Midwest Edition, as Foreign Exchange Rates
quoted in New York as market rate (bid) on the last business day of the
quarterly period in which the royalty payments were earned shall be used by
Xxxxxx to determine such conversion rates.
4.5 NO ROYALTIES PAYABLE BETWEEN AFFILIATES. No royalties shall be
payable to API on sales between Xxxxxx, its Affiliates or Unaffiliated
Sublicensees, or between Xxxxxx Affiliates and Unaffiliated Sublicensees.
4.6 NO MULTIPLE ROYALTIES. No multiple royalties shall be payable
because the Product, its manufacture, use or sale is or shall be covered by
multiple API Patents.
5. PAYMENT, RECORD KEEPING AND AUDIT RIGHTS
5.1 METHOD OF PAYMENT. All payments by either Party to the other
Party hereunder (including, but not limited to, Xxxxxx'x milestone and
research and development payments under Sections 3.1 and 3.2 and royalty
payments under Sections 4.1 and 4.2) shall be made without deduction of any
withholdings for any purposes other than taxes, if applicable, to the extent
required by law. In the event of any tax withholding, the paying Party will
provide the receiving Party with the best available evidence of the taxes
withheld as well as any relevant certificates or documents required for
national, state or local tax credit and reporting purposes. Payments
hereunder shall not be creditable against any other amounts payable by the
other Party under this Agreement, except as otherwise expressly stated
herein. Payments may be made by check or wire transfer to an account
designated by the receiving Party.
5.2 RECORD KEEPING AND AUDIT RIGHTS. Each Party shall keep or cause
to
be kept accurate records relating to Net Sales, royalties, and any other costs
and expenses subject to payment or reimbursement by either Party to the other
Party in sufficient detail to enable the amounts payable hereunder to be
determined. Upon the written request of either Party (but not more frequently
than once in any calendar year), the requesting Party may retain an independent
certified public accountant, subject to approval by the other Party (which
approval shall not be unreasonably withheld), to review such records to verify
the accuracy of the payments made or payable hereunder. Such accountant shall
be required to execute a confidentiality agreement in a form reasonably
acceptable to the audited Party and shall report to the auditing Party only the
amount of any underpayment or overcharge. Within ten (10) business days after
completion of such review, the Parties shall reconcile any underpayment or
overcharge. The auditing Party shall pay the cost of any review of records
conducted at its request under this Section. However, if the review establishes
underpayment or overcharge by the audited Party of over five percent (5%) during
the period of the review, the audited Party shall promptly reimburse the
auditing Party for the fees and expenses of the accountant. Such audit rights
may be exercised by the Parties only with respect to records for the current
calendar year and the preceding two (2) calendar years.
6. PRODUCT DEVELOPMENT AND REGISTRATIONS
6.1 DEVELOPMENT AND REGISTRATION ACTIVITIES.
(a) UNITED STATES. In accordance with the U.S. Product
Development Plan attached hereto as Exhibit C, API shall undertake
development and registration activities for the Product in the United States,
including but not limited to conducting or sponsoring, and completing or
having completed, all clinical studies and other activities required for
Regulatory Approval in the United States. API shall use its commercially
reasonable efforts to pursue such development and registration activities
under the U.S. Product Development Plan with the objective of filing a U.S.
NDA for the Product with an Empiric Claim with the U.S. FDA on or before *.
Unless otherwise agreed by the Parties, API shall file the U.S. NDA for the
Product and any other applications for Regulatory Approval in the United
States in its own name, and, promptly after receipt of Regulatory Approval in
the United States, API shall assign the U.S. NDA for the Product and any
other Regulatory Approvals in the United States to Xxxxxx.
(b) EUROPEAN UNION. Xxxxxx shall undertake development
and registration activities for the Product in European Union member
countries, provided that API shall provide Xxxxxx with all such
documentation, data, clinical trial data and other scientific information
developed by API in connection with the U.S. NDA for the Product as may be
necessary for completing the registration package for submission to the EMEA
or a reference European Union member state for a mutual recognition
procedure. Xxxxxx shall use its commercially reasonable efforts to file the
registration package with the EMEA or a reference European Union member state
for a mutual recognition procedure or other appropriate regulatory
authorities within the European Union *. If additional clinical trials are
required for registration by the appropriate European Union regulatory
authorities, then API and Xxxxxx will jointly agree to a revised registration
filing schedule, taking into account the time required for such clinical
trials. API shall have the right to consult with
Xxxxxx concerning Xxxxxx'x regulatory dossier prior to submission to the EMEA or
a reference EMEA member state. Upon API's request, Xxxxxx shall give API a
reasonable opportunity to review and comment on the documentation included
within such regulatory dossier.
(c) JAPAN. *, Xxxxxx will provide API with a plan for the
development and registration of the Product in Japan. Following submission
of such a plan, Xxxxxx shall use its commercially reasonable efforts to
undertake development and registration activities for the Product in Japan in
accordance with such plan. If Xxxxxx elects not to develop the Product in
Japan, Xxxxxx shall notify API in writing within *, following which time the
Territory shall exclude Japan and rights to the Product in Japan will revert
to API. If Xxxxxx makes such election and notifies API in accordance with
the preceding sentence, Xxxxxx shall have no obligations or liabilities to
API with respect to development and registration activities in Japan.
(d) OTHER COUNTRIES. *, Xxxxxx will provide API with a
plan for the development and registration of the Product in countries and
territories outside of the United States, Japan and European Union member
countries. Following submission of such a plan, Xxxxxx shall use its
commercially reasonable efforts to undertake development and registration
activities for the Product in such countries and territories in accordance
with the plan.
(e) MUTUAL ASSISTANCE. The Parties shall use their
commercially reasonable efforts to assist each other with their respective
development and registration activities under Sections 6.1(a), (b), (c) and (d).
6.2 DEVELOPMENT COSTS. Xxxxxx shall fund API's research and
development activities for the Product during the Term in accordance with the
payment amounts and schedule set forth in Section 3.2, provided that the Parties
shall renegotiate the payment amounts and schedule of payments in good faith in
the event of any material changes to the U.S. Product Development Plan, as
described below. Xxxxxx shall be responsible for its own research and
development costs for the Product during the Term.
6.3 MODIFICATIONS.
(a) MATERIAL CHANGES - API may not make any material changes
to the U.S. Product Development Plan unless Xxxxxx has given its written consent
thereto, which consent shall not be unreasonably withheld or delayed. As used
in this Section, "material changes" shall mean any changes having a material
effect on the U.S. Product Development Plan timetable for United States
regulatory filings or on the Product claims referenced in the U.S. Product
Development Plan.
(b) OTHER CHANGES - API may make any changes to the U.S.
Product Development Plan other than material changes as API deems necessary or
appropriate, provided Xxxxxx has been given a reasonable opportunity to review
and consult with API as to any such changes.
6.4 RECIPROCAL ACCESS TO DOCUMENTATION AND DATA. During the Term
each Party shall provide the other Party, within a reasonable time, with
reasonable access to all clinical documentation, information and data resulting
from the Party's Product research and development activities which either Party
may reasonably request,
including but not limited to, case report forms, monitoring documents, patient
informed consents, institutional review board approvals, medical and statistical
study reports for individual studies, clinical data summaries, and expert
reports. Upon either Party's request, the other Party shall provide the
requesting Party with copies of such documentation and data, provided that, upon
the providing Party's request, the requesting Party shall reimburse the
providing Party for the cost of making such copies.
7. XXXXXX PRODUCT MARKETING AND SALES ACTIVITIES
7.1 COMMERCIALLY REASONABLE EFFORTS. Xxxxxx shall use commercially
reasonable efforts to promote and sell the Product throughout the Territory in
all countries in which (a) Regulatory Approval has been obtained and (b) a Valid
Claim exists.
7.2 MARKETING COSTS AND EXPENSES. Except as otherwise provided
herein or as otherwise mutually agreed by the Parties, Xxxxxx shall bear all
costs and expenses connected with its marketing and sales activities for the
Product and its performance under this Agreement.
8. API CO-PROMOTION ACTIVITIES
8.1 CO-PROMOTION TERRITORY. API shall have the right to co-promote
the Product with Xxxxxx and its Affiliates in the United States and Canada in
accordance with the terms of this Section 8.
8.2 ALLOCATION OF SALES REPRESENTATIVES. API shall have the right
to allocate up to * (*) API professional sales representatives to assist
Xxxxxx and its Affiliates in detailing the Product to physicians, hospitals
and others in the United States and Canada as directed by Xxxxxx in
accordance with Xxxxxx'x United States and Canada marketing plan(s) for the
Product.
8.3 CO-PROMOTION PERIOD. The initial period of API's co-promotion
shall be two (2) years commencing with the date of launch of the Product in the
United States and shall be renewed for consecutive one (1) year periods, unless
terminated by either Party upon no less than twelve (12) months prior written
notice to the other Party effective at the earliest upon the end of the initial
two (2) year period.
8.4 COMPENSATION TO API. During the period of co-promotion,
Xxxxxx will pay to API, on a quarterly basis, an amount up to * (*) of API's
fully-burdened cost of each API professional sales representative, which
costs shall be determined in accordance with the scope of co-promotion
collaboration and API normal accounting policies, both of which shall be
consistent in all material respects with industry custom and practice for
retaining contract sales resources. The aggregate amount payable by Xxxxxx
to API under this Section 8.4 shall not exceed * (*) per Calendar Year.
8.5 SCOPE OF CO-PROMOTION COLLABORATION. The Parties shall agree
upon coordinated performance benchmarks for the API professional sales
representatives which shall be consistent/complimentary with those of the Xxxxxx
sales force and the Xxxxxx United States and Canada marketing plan(s) for the
Product. Xxxxxx shall provide reasonable Product sales training for up to
twenty (20) API professional sales representatives and shall design and provide
all Product sales literature and materials. API shall have the right to provide
supplemental training and Product sales literature and materials to the API
professional sales representatives with Xxxxxx'x prior written
consent, which consent shall not be unreasonably withheld.
9. CONFIDENTIALITY AND PUBLICITY
9.1 CONFIDENTIALITY OBLIGATION. Each Party shall hold the other
Party's Confidential Information (as defined below) of which it becomes informed
in connection with this Agreement in strictest confidence and shall not disclose
such Confidential Information to third parties or otherwise use it, except to
the extent such use or
disclosure is expressly permitted by the terms of this Agreement or is
reasonably necessary for the performance of this Agreement.
9.2 PERMITTED DISCLOSURES. Permitted disclosures of Confidential
Information hereunder include, but are not limited to: (a) disclosures to
regulatory agencies to the extent required for Regulatory Approval, including
but not limited to, Product registrations and applications in the Territory, and
(b) disclosures to the Parties' Affiliates, employees, agents and independent
contractors (including clinical investigators, consultants and contract research
organizations) who have a bona fide "need to know", and Unaffiliated
Sublicensees (in the case of Xxxxxx), provided that for disclosures to parties
other than Affiliates under Section 9.2(b) the disclosing Party shall obligate
the recipients to maintain the confidentiality of Confidential Information under
terms substantially similar to those contained in this Section 9.
9.3 CONFIDENTIAL INFORMATION. "Confidential Information" includes,
but is not limited to, any information relating to the terms of this Agreement,
the Product, API Know-How, the U.S. Product Development Plan, clinical and
non-clinical studies involving the Product, and all sales and marketing plans
for the Product, as well as information concerning all other products and the
business affairs, manufacturing processes and other activities of the disclosing
Party. However, Confidential Information shall not include any information:
(a) PUBLICLY AVAILABLE INFORMATION - Which at the time of
disclosure is or later comes into public domain by publication or otherwise
through no fault of the receiving Party;
(b) PREVIOUSLY KNOWN INFORMATION - Which can be demonstrated
by documentation or other competent proof to have been in the receiving Party's
possession prior to disclosure hereunder;
(c) SUBSEQUENTLY RECEIVED INFORMATION - Which is subsequently
received by the receiving Party from a third party who is not bound by any
confidentiality undertaking to the disclosing Party or to any of its Affiliates
with respect to said information;
(d) INDEPENDENTLY DEVELOPED INFORMATION - Which is
independently developed by or for the receiving Party without reference to the
disclosing Party's Confidential Information; or
(e) LEGALLY REQUIRED DISCLOSURES OF INFORMATION - Which is
legally required to be disclosed pursuant to any statute or regulation or any
judicial or administrative order, provided that the receiving Party promptly
notifies the disclosing Party of such required disclosure in order to provide an
opportunity to seek a protective order or
other similar order with respect to such Confidential Information and thereafter
the receiving Party discloses to the requesting entity only the minimum
Confidential Information required to be disclosed in order to comply with the
request, whether or not a protective order or other similar order is obtained by
the disclosing Party.
9.4 DURATION OF CONFIDENTIALITY OBLIGATION. The confidentiality
obligations of the Parties hereunder shall remain in effect during the Term and
for seven (7) years thereafter.
9.5 PUBLICITY AND ANNOUNCEMENTS. Unless agreed upon in writing by
the Parties, neither Party shall originate any publicity, news release or other
public announcement, written or oral, whether to the public press, stockholders
or otherwise, relating to this Agreement, any amendment hereto, performance by
the Parties hereunder, or the Product, except for such announcement as in the
opinion of legal counsel to the Party making such announcement is legally
required, in which event such Party shall give the other Party a reasonable
opportunity to review the form and content of the announcement before such
legally required disclosure is made.
10. TRADEMARKS
10.1 ASSIGNMENT OF API TRADEMARKS. API hereby assigns to Xxxxxx all
of API's right, title and interest in and to the API Trademarks Nyotran7 and
NystatinLF7, including the trademark applications and registrations set forth in
the attached Exhibit E. API shall execute such documents and take such further
actions as Xxxxxx may reasonably request to effectuate such assignment,
including the execution of a Trademark Assignment document in the form of the
attached Exhibit F. Following such assignment, Xxxxxx shall be responsible for
filing and maintaining the API Trademarks at Xxxxxx'x sole expense, provided
that API shall be responsible for any costs of filing and maintaining such API
Trademarks incurred prior to the effective date of the assignment.
10.2 ALTERNATE TRADEMARKS. If Xxxxxx does not wish to use an API
Trademark for the Product in any country of the Territory or if Xxxxxx is
legally prevented from using any API Trademark originally registered in any
country in the Territory due to trademark infringement litigation or otherwise,
Xxxxxx may use one or more alternate trademarks selected by Xxxxxx for use in
such country ("Alternate Trademarks"). Xxxxxx shall own the Alternate
Trademarks and shall be responsible for filing and maintaining the Alternate
Trademarks at Xxxxxx'x sole expense.
11. PATENT OWNERSHIP AND WARRANTIES
11.1 PATENT OWNERSHIP. Subject to the license rights granted to
Xxxxxx hereunder, API retains its ownership rights and/or licenses in all of all
API Patent Rights and shall be responsible for filing, prosecuting, maintaining
and defending API Patent Rights pursuant to Section 12.1.
11.2 JOINT INVENTIONS. For all inventions (if any), made jointly by
the Parties according to the named inventors therefor, the Parties shall apply
for patent protection therefor upon the written request of either Party. Patent
protection for such invention(s) shall be applied for jointly in the name of the
Parties as co-assignees and co-owners of such invention(s) and all patent
application preparation, filing, maintenance and prosecution responsibilities
and costs thereof in the Territory shall be shared equally by the Parties. If
one of the Parties does not wish to share equally in the patent application and
related costs and expenses in any country of the Territory, then the other Party
may seek, obtain and maintain such patent(s) solely in its own name and at
its sole expense and shall have sole and exclusive rights to use the inventions
covered by such patent(s) without payment of any royalties or compensation to
the non-paying Party.
11.3 API PATENT WARRANTIES. API warrants and represents that: (a)
Exhibit A sets forth all of the API Patent Rights as of the Effective Date; (b)
API has not granted any licenses or other rights to any third party inconsistent
with the licenses and other rights granted to Xxxxxx hereunder; (c) with respect
to any API Patent Rights in existence as of the Effective Date that are being
sublicensed to Xxxxxx hereunder, the terms of this Agreement are not in conflict
with or in violation of any agreements to which API is a party; and (d) to the
best of its knowledge as of the Effective Date based upon API's reasonably
diligent investigation, the API Patent Rights are valid and enforceable and
there are no existing valid third party patents or other proprietary rights in
the Territory that might be infringed by the manufacture, marketing, sale or use
of the Product in the Territory by Xxxxxx, its Affiliates and Unaffiliated
Sublicensees.
12. PATENT PROSECUTION AND INTELLECTUAL PROPERTY INFRINGEMENT
12.1 PATENT FILING AND PROSECUTION. During the Term, except as
otherwise provided in Section 12.6(b), API shall, at its sole expense, file,
prosecute, maintain, and defend API Patent Rights in the Territory and API shall
control all API Patent Rights filings and actions. API shall use commercially
reasonable efforts to obtain API Patent extensions in any countries in the
Territory in which such extensions are available.
12.2 NOTIFICATION OF INFRINGEMENT. The Parties shall promptly inform
each other of any information that comes to their attention involving actual or
apparent infringements or misappropriations of API Intellectual Property Rights,
by any third party, or claims of alleged infringement made by any third party in
the Territory against API, API Affiliates, Xxxxxx, Xxxxxx Affiliates, or any
Unaffiliated Sublicensees resulting from the manufacture, sale, or use of the
Product.
12.3 INFRINGEMENT OF THIRD PARTY RIGHTS. Xxxxxx shall have the
right to direct or defend, in its own name and at its own expense, any legal
or other action or proceeding, including any settlement or negotiation, with
respect to any alleged infringement of a third party patent or other
proprietary right as a result of Xxxxxx, its Affiliates or Unaffiliated
Sublicensees making, having made, using, importing, offering for sale or
selling the Product in the Territory. During the pendency of any such
proceeding or any appeal thereof, Xxxxxx shall have a right to reduce
royalties otherwise payable to API in an amount equal to * (*) of Xxxxxx'x
out-of-pocket litigation expenses in the quarter in which such royalties are
payable; provided, however, that in no event shall Xxxxxx have a right to
reduce royalty payments by more than * (*) in any quarter. In the event that
* (*) of Xxxxxx'x out-of-pocket litigation expenses exceeds * (*) of the
royalties otherwise payable to API in such quarter, Xxxxxx shall have the
right to offset such unpaid amounts against future royalties payable to API,
but in no event shall Xxxxxx have a right to reduce royalty payments by more
than * (*) in any quarter. In the event that a final judgment is entered
against Xxxxxx pursuant to which Xxxxxx is required to pay to a third party
any monetary damages and/or attorneys' fees, Xxxxxx shall have a right to
reduce royalties otherwise payable to API in an amount equal to * (*) of such
judgment in the quarter in which such royalties are payable;
provided, however, that in no event shall Xxxxxx have a right to reduce
royalty payments by more than * (*) in any quarter. In the event that * (*)
of such judgment exceeds * (*) of the royalties otherwise payable to API in
such quarter, Xxxxxx shall have the right to offset such unpaid amounts
against future royalties payable to API, but in no event shall Xxxxxx have a
right to reduce royalty payments by more than * (*) in any quarter. In the
event that such final judgment entered against Xxxxxx includes an order that
precludes Xxxxxx from manufacturing, marketing, and/or selling the Product in
any country or countries in the Territory, API shall pay to Xxxxxx * (*) of
such final judgment within ninety (90) days after entry of such judgment or
upon completion of such appeal, whichever is later.
12.4 INFRINGEMENT INDEMNIFICATION. In the event that it is
necessary to obtain a license under any third party proprietary right in
order to continue commercialization of the Product in any country in the
Territory, Xxxxxx and API shall use commercially reasonable efforts to obtain
such a license naming Xxxxxx as the licensee. Xxxxxx shall have the right to
reduce royalty payments to API by * (*) of all licensing fees and royalties
payable by Xxxxxx to the third party licensor, such reductions to be taken in
the quarter in which such licensing fees and royalties are paid by Xxxxxx to
the third party; provided, however, that in no event shall Xxxxxx have a
right to reduce royalty payments by more than * (*) in any quarter.
12.5 TERMINATION FOR INFRINGEMENT. Should Xxxxxx be prevented by
reason of an adverse, non-appealable court or administrative proceeding, order
or judgment or arbitral award against it from making, using, or selling the
Product in any Major Subterritory, then, as to that part of the Territory so
affected, Xxxxxx may terminate this Agreement upon written notice to API, and
the Parties shall make a final transition accounting and settlement in such
Major Subterritory for outstanding bona fide costs, payments, and expenses to
which each Party is entitled hereunder.
12.6 THIRD PARTY INFRINGEMENT OF API INTELLECTUAL PROPERTY RIGHTS.
(a) API ENFORCEMENT - API shall have the right, but not the
obligation, at its own expense, to commence appropriate measures to enforce the
API Intellectual Property Rights against third party infringements within thirty
(30) days after the date API becomes aware of such infringement (including, but
not limited to, notifying the infringing third party of such infringement and
demanding that such third party cease and desist from such infringement) and, if
such infringement does not cease, commence a legal proceeding to enforce the API
Intellectual Property Rights against third party infringements within sixty (60)
days of the date API becomes aware of such infringement.
(b) XXXXXX ENFORCEMENT - If within sixty (60) days after the
date API becomes aware of any alleged third party infringement, either directly
or by notice from Xxxxxx, API fails to commence a legal proceeding pursuant to
Section 12.6(a), or if at any time API discontinues such proceeding, Xxxxxx may,
at its sole option, commence, continue, or intervene, as the case may be, in
such proceeding. During the pendency of any such proceeding or any appeal
thereof, Xxxxxx shall have the right to reduce royalties payable to API by the
lesser of (i) * (*) of Xxxxxx'x out-of-pocket litigation expenses in such legal
proceeding or (ii) * (*) of royalties payable in such country.
12.7 ALLOCATION OF RECOVERIES. In any action brought by or against a
third party infringer by either Party, any monetary damages or judgments
obtained by either Party in connection with such action shall be allocated as
follows: (a) the Party prosecuting such action shall recover its unreimbursed,
out-of-pocket litigation expenses in such action; (b) to the extent that any
monies remain, API and Abbott shall divide such monies to compensate API for its
lost royalties and Abbott for its lost profits; and (c) to the extent that any
monies remain, API and Abbott shall share equally such remaining monies.
12.8 MUTUAL COOPERATION. In the event of any patent infringement
litigation in the Territory involving the Product and any API Intellectual
Property Rights, the non-prosecuting or non-defending Party shall render such
reasonable assistance as may be requested by the prosecuting or defending Party
in connection with such infringement actions. If API requests Xxxxxx'x
assistance in connection with such infringement claims or actions, API shall
reimburse Abbott for such direct, documented out-of-pocket expenses as are
reasonably incurred by Abbott during the course of its providing such requested
assistance. Before incurring such expenses, the Parties shall in good faith
agree in writing on the nature and extent of assistance to be rendered, and an
estimate of the total expenses, which expenses shall be monitored periodically.
12.9 LABELING. Abbott shall be responsible for all labeling, inserts,
promotional materials and any other materials which accompany, are distributed,
used or referred to in any way by Abbott, its Affiliates or Unaffiliated
Sublicensees in connection with the Product. Such materials shall conform to
all legal requirements in each country of the Territory in which the Product is
sold. Subject to applicable legal requirements and space limitations, all
Product labeling, inserts and promotional materials shall indicate that the
Product is sold by Abbott under license from API. Upon API's request, Abbott
shall provide API with copies of representative samples of materials which
Abbott, its Affiliates and Unaffiliated Sublicensees intend to use in connection
with the marketing, promotion and sale of the Product prior to their first use
thereof. Abbott shall manufacture, register, promote, market and sell the
Product in the Territory only for the indications for which relevant Regulatory
Approvals have been obtained.
12.10 NOTIFICATION. Abbott shall also be responsible for notifying,
reporting or registering this Agreement or the business relationship created
hereby with any government authorities in the Territory to the extent legally
required. API shall provide Abbott with such assistance as Abbott may
reasonably request in connection therewith.
13. INDEMNIFICATION AND INSURANCE
13.1 RECIPROCAL INDEMNIFICATION PROVISIONS.
(a) API INDEMNIFICATION - API shall defend, indemnify and
hold Abbott, its Affiliates, Unaffiliated Sublicensees, and the officers,
directors, employees and agents of each, harmless from and against any and all
liabilities, damages, claims, demands, costs, or expenses (including reasonable
attorneys' fees) claimed by any third party for any property or other economic
loss or damage or injury or death suffered by it to the extent the same is
determined to have been caused by API's negligence or wilful misconduct or any
material breach of this Agreement by API, subject to the conditions of
indemnification set forth in Section 13.2.
(b) ABBOTT INDEMNIFICATION - Abbott shall defend, indemnify
and hold API, and
its Affiliates, and the officers, directors and employees and agents of each
harmless from and against any and all liabilities, damages, claims, demands
or costs, or expenses (including reasonable attorneys' fees) claimed by any
third party for any property or other economic loss or damage, injury or
death suffered by it to the extent the same is determined to have been caused
by Xxxxxx'x negligence or wilful misconduct or any material breach of this
Agreement by Abbott, subject to the conditions of indemnification set forth
in Section 13.2.
13.2 CONDITIONS OF INDEMNIFICATION. With respect to any
indemnification obligations of either Party to the other Party under this
Agreement, including but not limited to the indemnification obligations of
the Parties under Sections 13.1(a) and 13.1(b), the following conditions must
be met for such indemnification obligations to become applicable: (a) the
indemnified Party shall notify the indemnifying Party promptly in writing of
any claim which may give rise to an obligation on the part of the
indemnifying Party hereunder; (b) the indemnifying Party shall be allowed to
timely undertake the sole control of the defense of any such action and
claim, including all negotiations for the settlement, or compromise of such
claim or action at its sole expense; and (c) the indemnified Party shall
render reasonable assistance, information, co-operation and authority to
permit the indemnifying Party to defend such action, it being agreed that any
out-of-pocket expenses or other expenses incurred by the indemnified Party in
rendering the same shall be borne or reimbursed promptly by the indemnifying
Party.
13.3 INSURANCE. API shall at all times during the Term and for a
period of five (5) years thereafter maintain product liability insurance
covering the Product with minimum annual limits of $1,000,000 per occurrence and
$1,000,000 in the aggregate. Upon Xxxxxx'x request at any time during the Term
or in the five (5) year period thereafter, API shall deliver to Abbott a
certificate of insurance evidencing such insurance and stating that the policy
will not be canceled or modified without at least thirty (30) days prior written
notice to Abbott.
14. ADVERSE DRUG EXPERIENCES
During the relevant Reporting Period (as defined below), each Party
shall promptly inform the other Party of any information it obtains or develops
regarding the safety of the Product anywhere in the world and shall promptly
report to the other Party any information regarding serious adverse reactions or
side effects related to the use of the Product. To allow the Parties to comply
with the adverse drug experience reporting requirements for the Product to the
U.S. FDA and its counterpart regulatory agencies around the world, each Party
shall notify the other Party in writing of any "adverse drug experience" that is
considered "serious" as defined in U.S. FDA regulations (21 CFR 314.80) or the
comparable regulations of other regulatory agencies, regardless of source, so
that the other Party will receive such notice within three (3) business days of
a Party's first having "obtained or otherwise received" such "adverse drug
experience" from "any source", as those terms are defined in U.S. FDA
regulations (21 CFR 314.80). Such information shall be communicated by the
Parties to each other at the following addresses:
To Xxxxxx: Xxxxxx Laboratories
Hospital Products Division
Attn: Vice President, Medical and Regulatory Affairs
Dept. 970, Bldg. AP30
000 Xxxxxx Xxxx Xxxx
Xxxxxx Xxxx, Xxxxxxxx, X.X.X. 00000-0000
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
To API: API Pharmaceuticals, Inc.
Attn: Senior Vice President, Medical and
Regulatory Affairs
0000 Xxxxxxxxxx Xxxxxx Xxxxx
Xxx Xxxxxxxxx, Xxxxx 00000-0000
Phone: (000) 000-0000
Facsimile: (000) 000-0000
Each Party shall provide the other with copies of all adverse drug experience
reports on the Product filed with the U.S. FDA or other regulatory agencies in
the Territory. As used in this Section 14, the "Reporting Period" shall mean
(a) the Term with respect to API's reporting obligation to Abbott and (b) the
period from the Effective Date until the effective date of API's assignment of
the U.S. NDA for the Product to Abbott with respect to Xxxxxx'x reporting
obligation to API.
15. REPRESENTATIONS AND WARRANTIES
Each Party hereby represents and warrants to the other Party as follows:
(a) CORPORATE STATUS - It is a corporation duly organized and
validly existing under the laws of its state or other jurisdiction of
incorporation or formation;
(b) AUTHORITY - It has the power and authority to execute and
deliver this Agreement, and to perform its obligations hereunder;
(c) NO CONFLICTS - The execution, delivery and performance by
it of this Agreement and its compliance with the terms and provisions hereof
does not and will not conflict with or result in a breach of any of the terms
and provisions of or constitute a default under (i) any loan agreement,
guaranty, financing agreement, agreement affecting a product or other agreement
or instrument binding or affecting it or its property; (ii) the provisions of
its charter documents or by-laws; or (iii) any order, writ, injunction or decree
of any court or governmental authority entered against it or by which any of its
property is bound;
(d) NO APPROVALS - Except for the regulatory filings and
approvals for the Product referenced herein, no authorization, consent or
approval of any governmental authority or third party is required for the
execution, delivery or performance by it of this Agreement, and the execution,
delivery or performance of this Agreement will not violate any law, rule or
regulation applicable to such Party;
(e) ENFORCEABILITY - This Agreement has been duly authorized,
executed and delivered and constitutes its legal, valid and binding obligation
enforceable against it in accordance with its terms subject, as to enforcement,
to bankruptcy, insolvency, reorganization and other laws of general
applicability relating to or affecting creditors' rights and to the availability
of particular remedies under general equity principles;
(f) COMPLIANCE WITH LAWS - It shall comply with all
applicable laws and regulations relating to its activities under this Agreement;
and
(g) YEAR 2000 COMPLIANCE - All computer hardware and software
used
by either Party in its business relationship with the other Party will have no
lesser functionality with respect to records containing dates before or after
January 1, 2000 than previously with respect to dates prior to January 1, 2000.
16. TERM AND EARLY TERMINATION RIGHTS
16.1 TERM. The Term shall be as stated in Section 1.21.
16.2 TERMINATION FOR CAUSE. Either Party shall have the right,
without prejudice to any other rights or remedies available to it, to terminate
this Agreement for cause by written notice to the other Party in any of the
following events:
(a) BANKRUPTCY - If the other Party becomes insolvent, is
adjudged bankrupt, applies for judicial or extra-judicial settlement with its
creditors, makes an assignment for the benefit of its creditors, voluntarily
files for bankruptcy or has a receiver or trustee (or the like) in bankruptcy
appointed by reason of its insolvency, or in the event an involuntary
bankruptcy action is filed against the other Party and not dismissed within
ninety (90) days, or if the other Party becomes the subject of liquidation or
dissolution proceedings or otherwise discontinues business.
(b) MATERIAL BREACH - If the other Party commits a Material
Breach of this Agreement (as defined in Section 18.2(c)) and the Party alleged
to be in breach fails to (i) cure such breach or (ii) commence dispute
resolution proceedings under Section 18.2 contesting whether a breach has
occurred and/or whether such breach is a Material Breach within sixty (60) days
after receipt of written notice from the Party asserting the breach.
16.3 TERMINATION BY MUTUAL AGREEMENT. This Agreement may be
terminated at any time by written agreement of the Parties.
16.4 TERMINATION BY ABBOTT.
(a) SAFETY OR EFFICACY - If at any time during the Term: (i)
the Party with responsibility for filing an application for Regulatory Approval
hereunder ("Filing Party") decides not to file an application for Regulatory
Approval in any Major Subterritory or decides to withdraw such application due
to documented adverse reactions or other safety issues with the Product or the
Product's lack of efficacy or limited efficacy (collectively, "Safety or
Efficacy Issues"); (ii) the Filing Party's application(s) for Regulatory
Approval in any Major Subterritory is rejected due to Safety or Efficacy Issues;
(iii) the Filing Party's application(s) for Regulatory Approval in any Major
Subterritory is subsequently withdrawn because of Safety or Efficacy Issues;
(iv) the Product is withdrawn or recalled from the market in any Major
Subterritory because of Safety or Efficacy Issues; or (v) at any time during the
period from the Effective Date to the effective date of API's assignment of the
U.S. NDA for the Product to Xxxxxx, Xxxxxx reasonably believes documented Safety
or Efficacy Issues exist and Abbott has so notified API in writing, then Abbott
may, at its option, terminate this Agreement upon thirty (30) days prior written
notice to API. Abbott may, at its option, exercise its right of termination
under this Section 16.4(a) on a country-by-country basis, and, if Abbott does
so, Xxxxxx'x termination notice shall specify the country or countries of the
Territory affected.
(b) LIMITED COMMERCIAL VIABILITY - At any time during the
Term after the Filing Party has obtained Regulatory Approval in any country of
the Territory, Abbott shall have the right to terminate this Agreement upon one
hundred eighty (180) days
prior written notice to API for reasons of the Product's limited commercial
viability and/or due to competition, limited customer acceptance, regulatory
limitations and/or market dynamics, as determined by Abbott.
17. CONSEQUENCES OF TERMINATION
17.1 EFFECT OF TERMINATION. Termination or expiration of this
Agreement through any means and for any reason shall not relieve the Parties of
any obligations accruing prior thereto and shall be without prejudice to the
rights and remedies of either Party with respect to any prior breach of any of
the provisions of this Agreement.
17.2 LICENSE RIGHTS. If Abbott terminates this Agreement pursuant to
Section 16.2(a) or Section 16.4 or if API terminates this Agreement pursuant to
Section 16.2, then: (a) Xxxxxx'x license rights in API Intellectual Property
Rights hereunder shall terminate, (b) Abbott shall assign to API all of its
right, title and interest in and to the API Trademarks, with API assuming
responsibility for filing and maintaining the API Trademarks as of the effective
date of the assignment, including all recordal and future costs associated
therewith; and (c) upon API's request, the Parties shall negotiate in good faith
for the assignment of any Alternate Trademarks from Abbott to API.
17.3 FULLY PAID-UP LICENSE. Upon expiration of the Term or earlier
termination of this Agreement for any reason other than by API pursuant to
Section 16.2 or by Abbott pursuant to Section 16.2(a) or Section 16.4 or by the
Parties jointly pursuant to Section 16.3, Xxxxxx'x license rights in API
Intellectual Property Rights hereunder shall become fully paid-up and
irrevocable.
17.4 MUTUAL AGREEMENT. If the Parties terminate this Agreement by
mutual written agreement pursuant to Section 16.3, the Parties shall specify the
consequences of such termination in such written agreement.
17.5 REGULATORY APPROVALS. Upon expiration of the Term, or upon
earlier termination of this Agreement other than by API pursuant to Section 16.2
or by Abbott pursuant to Section 16.2(a) or Section 16.4, Xxxxxx'x right to
manufacture, market, and sell the Product in the United States pursuant to the
U.S. NDA for the Product shall become fully paid-up and irrevocable, and, if API
has not previously done so, API shall promptly assign such U.S. NDA to Abbott.
Upon termination of this Agreement by API pursuant to Section 16.2 or by Abbott
pursuant to Section 16.2(a) or Section 16.4, Abbott shall xxxxx to API a fully
paid-up, irrevocable right to manufacture, market, and sell the Product outside
the United States pursuant to Xxxxxx'x Regulatory Approvals for the Product, and
Abbott shall promptly assign such Regulatory Approvals to API.
18. GOVERNING LAW AND DISPUTE RESOLUTION
18.1 GOVERNING LAW. This Agreement, including the validity,
construction, interpretation and performance thereof, shall be governed entirely
by the laws of the State of Illinois, without regard to its conflict of laws
provisions. It is the specific intent and agreement of the Parties that the
United Nations Convention on the International Sale of Goods shall not apply to
this Agreement.
18.2 DISPUTE RESOLUTION. All disputes arising out of or in connection
with this Agreement (except those involving actions commenced by or involving
third parties and affecting or involving only one of the Parties) shall be
resolved with the following
mechanism:
(a) ATTEMPTED AMICABLE RESOLUTION - The Parties shall
promptly give each other written notice of any disputes requiring resolution
hereunder, which written notice shall specify the Section(s) of this
Agreement the other Party is alleged to have breached and shall briefly state
the initiating Party's claims, and the Parties shall use reasonable efforts
to resolve any such disputes in an amicable manner.
Any disputes arising in connection with this Agreement
which cannot be resolved in an amicable manner by representatives of the Parties
shall be referred, not later than thirty (30) days after initiation of dispute
resolution proceedings under this Section 18.2, to the following corporate
officers of the Parties for resolution:
For Abbott:
President, Hospital Products Division (or his or her designee)
For Aronex:
Chairman and CEO (or his or her designee)
Such officers (or their designees) shall attempt to
resolve the dispute and shall communicate with each other by facsimile or
telephone or in personal meetings in an effort to resolve the dispute.
(b) ADR PROCEDURE - Any disputes arising in connection with
this Agreement which cannot be resolved by the Parties within forty-five (45)
days after initiation of dispute resolution proceedings under Section 18.2(a)
shall be finally settled by binding Alternate Dispute Resolution ("ADR") in
accordance with the procedures set forth in the attached Exhibit D.
(c) ADR RULING - The neutral in any ADR proceeding under
Section 24.2(b) shall determine and advise the Parties in writing:
(i) Whether either Party has committed a breach of any
of its obligations under this Agreement; and
(ii) If either Party has committed a breach,
(A) Whether such breach is a Material Breach
or a breach other than a Material Breach, and
(B) The appropriate remedy for any such breach
pursuant to Section 18.2(d).
As used herein "Material Breach" shall mean either a failure by
Abbott to pay any milestone payments pursuant to Section 3.1, any research and
development funding payments pursuant to Section 3.2, or any royalty payments
pursuant to Sections 4.1 or 4.2 within sixty (60) days after written notice from
API ("Material Payment Breach"), provided that Abbott may in good faith contest
whether a given payment is due or the amount due and pay the amount the neutral
determines to be due without being deemed to have committed a Material Payment
Breach, or any other breach which involves willful disregard of the other
Party's rights under this Agreement or which materially and adversely affects
the rights of the other Party in at least one (1) Major Subterritory ("Other
Material Breach").
(d) REMEDIES - The neutral in any proceeding under Section
18.2(b) shall have the authority to award the non-breaching Party the following
relief (except as otherwise provided in Section 18.2(e) and (f)):
(i) For a Material Payment Breach, an order to pay the
amount
due and termination of this Agreement;
(ii) For any Other Material Breach, an award of damages
and/or equitable relief and/or termination of this Agreement in whole or in part
(including the termination of any licenses granted to the breaching Party,
whether in whole or in part, on a worldwide or country-by-country basis); and
(iii) For a breach other than a Material Breach, an
award of damages and/or equitable relief.
(e) DISPUTE RESOLUTION FOR SECTION 7.1 - API shall be
entitled to commence dispute resolution proceedings pursuant to Section 18.2 to
challenge Xxxxxx'x compliance with its commercially reasonable efforts
obligations in the Territory pursuant to Section 7.1 not more than once every
twelve (12) months for each respective country. The determination of whether
Abbott has used its commercially reasonable efforts in each respective country
shall be based on the totality of circumstances. If API successfully
establishes that Abbott has failed to use its commercially reasonable efforts,
(i) for the first such violation, the neutral shall have the authority to award
damages or equitable relief to API (but not termination of Xxxxxx'x license
rights) and (ii) for any subsequent violations in the same country, the neutral
shall have the authority to award damages, equitable relief or termination of
Xxxxxx'x license rights in the country where such breach occurs.
18.3 EFFECT OF COMMENCING DISPUTE RESOLUTION. If either Party in good
faith commences dispute resolution proceedings under Section 18.2, (a) any
applicable notice periods or cure periods hereunder (including but not limited
to the period referenced in Section 16.2(b)) shall be temporarily suspended
pending the outcome of such dispute resolution proceedings and (b) the
non-breaching Party may, at its option, pay any amounts payable to the other
Party that are in dispute into an interest-bearing escrow account pending the
outcome of such dispute resolution proceedings.
19. NOTICES
19.1 MANNER OF GIVING NOTICES. All notices required or permitted in
connection with this Agreement shall be writing and may be given by personal
delivery, prepaid registered or certified mail, or telecopier, addressed to the
Party to receive the same at its address set forth below, or to such other
address as it shall later designate by like notice to the other Party. Notice of
termination of this Agreement if given by telecopier shall be confirmed by
prepaid registered or certified mail dated and posted within twenty-four (24)
hours. The effective date of receipt of any notice if served by telecopier shall
be deemed the first business day in the city of destination following the
dispatch thereof and if given by letter only, it shall, unless earlier received,
be deemed effective not later than seven (7) days after the date of posting.
Notice by personal delivery shall be effective as of the date of such delivery.
19.2 ADDRESSES FOR NOTICES.
Notices to API shall be sent to:
Aronex Pharmaceuticals, Inc.
Attn: Chief Executive Officer
0000 Xxxxxxxxxx Xxxxxx Xxxxx
Xxx Xxxxxxxxx, Xxxxx 00000-0000
Facsimile: (000) 000-0000
With a copy to:
Xxxxxxx & Xxxxx, L.L.P.
Attn: Xxxxxxx X. Xxxx
0000 Xxxxxxxxxx Xxxxx, Xxxxx 000
Xxx Xxxxxxxxx, Xxxxx 00000
Facsimile: (000) 000-0000
Notices to Abbott shall be sent to:
Xxxxxx Laboratories
Hospital Products Division
Attn: Xxxxxxxxx
Xxxx. 0000, Xxxx. XX00
000 Xxxxxx Xxxx Xxxx
Xxxxxx Xxxx, Xxxxxxxx X.X.X. 00000-0000
Facsimile: (000) 000-0000
and
Xxxxxx Laboratories
Xxxxxx International
Attn: President
Dept. 06WP, Bldg. AP30
000 Xxxxxx Xxxx Xxxx
Xxxxxx Xxxx, Xxxxxxxx X.X.X. 00000-0000
Facsimile: (000) 000-0000
With a copy to:
Xxxxxx Laboratories
Attn: Div. V.P. - Domestic Legal Operations
Xxxxx Xxxxxxxx, Xxxx. 000, Xxxx. XX0X
000 Xxxxxx Xxxx Xxxx
Xxxxxx Xxxx, Xxxxxxxx X.X.X. 00000-0000
Facsimile: (000) 000-0000
20. INTEGRATION
This Agreement represents the entire Agreement between the Parties
relating to the subject matter hereof and supersedes all prior arrangements,
understandings, correspondence, notes, minutes and agreements between the
Parties (or their predecessors in interest) whether written or oral. No
supplement, modification or amendment of this Agreement shall be binding unless
executed by the Parties in writing and signed by the duly authorized
representatives of both Parties.
21. ASSIGNMENT
Neither Party may assign this Agreement or any of its rights hereunder,
nor delegate any of its duties or obligations hereunder, to any third party
without the prior written consent of the other Party; subject to Xxxxxx'x right
to grant sublicenses of its rights under this Agreement to an Abbott Affiliate
or Unaffiliated Sublicensee in accordance with Section 2.2. Neither Party shall
unreasonably withhold its consent to such contemplated assignment if such
contemplated assignment is in connection with the sale by either Party of all or
substantially all of its assets to a third party which is not a direct
competitor of the other Party in the hospital or pharmaceutical products area.
22. LIMITATION OF DAMAGES
In no event shall either Party be liable to the other Party for any
indirect, incidental or consequential damages in connection with the performance
of this Agreement or any breach of this Agreement.
23. FORCE MAJEURE
Neither Party shall be held in breach of this Agreement for failure to
perform any of its obligations hereunder to the extent and for the time period
such performance is prevented in whole or in part by reason of any Force Majeure
event, including but not limited to industrial disputes, strikes, lockouts,
riots, mobs, fires, floods, and other natural disasters and Acts of God, wars
declared or undeclared, civil strife, embargo, delays in delivery or defects or
shortages of raw materials from suppliers, loss or breakdown of any production
equipment, losses or shortage of power, damage to or loss of goods in transit,
currency restrictions, or events caused by reason of laws, regulations or orders
by any government, governmental agency or instrumentality or by any other
supervening unforeseeable circumstances whatsoever beyond the control of the
Party so affected. The Party so affected shall (a) give prompt written notice
to the other Party of the nature and date of commencement of the Force Majeure
event and its expected duration and (b) use its commercially reasonable efforts
to avoid or remove the Force Majeure event as soon as possible to the extent it
is so able to do.
24. RELATIONSHIP OF PARTIES
The relationship of the Parties under this Agreement is that of
independent contractors. Nothing contained in this Agreement shall be construed
so as to constitute the Parties as partners, joint venturers or agents of the
other. Neither Party has any express or implied right or authority under this
Agreement to assume or create any obligations or make any warranties and
representations on behalf of or in the name of the other Party, or to bind the
other Party to any contract, agreement or undertaking with any third party, and
no conduct of the Parties pursuant to the terms of this Agreement shall be
deemed to establish such right or authority. Neither Party shall make any
representation to third parties that the relationship created hereby constitutes
a partnership, joint venture or agency relationship.
25. SEVERABILITY OF CLAUSES
In case one or more of the provisions contained in this Agreement shall,
for any reason, be held invalid, illegal or unenforceable in any respect, such
invalidity, illegality or unenforceability shall not affect any other provisions
of this Agreement, but this Agreement shall be construed by limiting such
invalid, illegal or unenforceable provision, if such is not possible, by
deleting such provision from this Agreement.
26. NON-WAIVER
The failure by either Party at any time to enforce any of the terms or
provisions or conditions of this Agreement or exercise any right hereunder shall
not constitute a waiver of the same or affect that Party's rights thereafter to
enforce or exercise the same. No waiver of any of the provisions of this
Agreement shall be deemed binding
unless executed in writing by the Party to be bound by it.
27. HEADINGS
The headings in this Agreement are for convenience of reference only and
shall not be used in the interpretation of any provisions hereof.
28. EXECUTION
This Agreement shall be executed by the Parties in two (2) original
counterparts, one (1) original counterpart being retained by each Party and
either of which shall be deemed sufficient to prove the existence and terms and
conditions hereof. This Agreement may be executed by the Parties by the
exchange of facsimile signature pages, with signed original counterparts of the
Agreement to be exchanged by the Parties promptly thereafter.
IN WITNESS WHEREOF, the Parties' duly authorized representatives hereto
have executed this Agreement as of the Effective Date.
ARONEX PHARMACEUTICALS, INC. XXXXXX LABORATORIES
By: By:
-------------------------- --------------------------
Title: Title:
----------------------- -----------------------
Date: Date:
------------------------ ------------------------
LIST OF EXHIBITS
EXHIBIT A API PATENTS
EXHIBIT B FACTORY COST
EXHIBIT C U.S. PRODUCT DEVELOPMENT PLAN
EXHIBIT D ALTERNATIVE DISPUTE RESOLUTION
EXHIBIT E API TRADEMARK APPLICATIONS AND REGISTRATIONS
EXHIBIT F FORM OF TRADEMARK ASSIGNMENT
EXHIBIT A
API PATENT RIGHTS
Part I API Patents
1. US 4,812,312
Xxxxx-Berestein et al. "Liposome-Incorporated Nystatin"
Japan: 0000000 granted 10/3/97
EPO: 0348431 granted 8/5/92
Austria: E79028 "
Belgium: 0348431 "
Switzerland: 0348431 "
Germany: p3873528.8 "
France: 0348431 "
UK: 0348431 "
Italy: 0348431 "
Netherlands: 0348431 "
Sweden: 0348431 "
2. US 4,950,432
Xxxxx Xxxxx et al. "Polyene Microlide Pre-Liposomal Powders"
3. US 5,178,875
Xxxx at al. "Liposomal-Polyene Preliposomal Powder and Method of Its
Preparation"
Australia: 663074 granted 2/6/96
EPO: 0567582 granted 5/17/95
Xxxxxxx: X0 22559 "
Belgium: 0567582 "
Switzerland 0567582 "
Germany: 69202569 "
Denmark: 0567582 "
Spain: 0567582 "
France: 0567582 "
UK: 0567582 "
Greece: 0567582 "
Italy: 0567582 "
Luxembourg: 0567582 "
Monaco 0567582 "
Netherlands: 0567582 "
Sweden: 0348431 "
4. USSN: 08/535,885 (allowed, Issue Fee paid 7/31/98)
Xxxx el al. "Liposomal-Polyene Preliposomal Powder and Method of Its
Preparation"
* *
1. *
*
2. *
*
EXHIBIT B
FACTORY COST
DIRECT MATERIAL COST:
Direct material cost includes all raw material used in the manufacturing
process as contained in the xxxx of material to manufacture Product. Direct
material is identified by specific lot numbers. Items normally included are;
Raw drug.
Diluting material such as the alcohol.
Vial.
Vial stopper.
Vial seal
Inline solution filters and compounding filters.
Vial label
Single unit carton.
Shipper
Any other specialized packaging material.
DIRECT LABOR COST.
Includes the cost of employees directly involved in the manufacture of
the Product. Our direct labor employees are classified as Assistants, Operators,
Attendants, Technicians, Senior Production Operators, Productions Equipment
Specialists, and Group Leaders. The rate per hour includes the average base rate
for all direct employees plus a fringe rate that includes vacations, holidays,
insurance costs, pension, 401K, bonuses and legally mandated employer taxes.
Standard product cost uses an Industrial Engineering estimate of the hours to
perform each step of the production process. Additional procedures or employees
required to handle explosive material would be added as a direct labor
operation. Direct labor operations are normally considered to be:
Drug dispensing.
Drug mixing.
Preparation of the filling equipment.
Preparation of components such as washing vial stoppers.
Preparation of printed materials, primarily labels.
Filling of the vial.
Post filling light inspection.
Lyophilization
Labeling.
Packing.
VARIABLE OVERHEAD COST.
Includes the costs of operating the plant which change as the volume of
production in the plant changes. The major components of variable overhead are
related to the production operator and include their overtime, time spent for
training and plant meetings, and their uniforms and gowns. Any specialized
employee safety equipment such as used in an explosion proof environment would
be included in this category. Cost included in this category are assigned to
standard product cost as a rate per hour applied to direct labor hours
identified above.
FIXED OVERHEAD COSTS.
Includes the other costs associated with operating a manufacturing
plant. The key components are the cost of the quality assurance organization,
material planning, purchasing, receiving, and warehousing, plant maintenance,
utilities and engineering, the health and safety group, production
supervision, and fixed costs such as depreciation taxes, and insurance.
Investment in explosive proof equipment and changes to the facility required
to handle explosive material would be included in this category. These costs
are assigned to standard product cost based on fully utilized plant capacity.
The standard product cost development process occurs once per year in
the mid-summer time period. At that time, assumptions are made regarding
inflation rates for raw material and wages, productivity improvements, and plant
utilization levels.
EXHIBIT C
U.S. PRODUCT DEVELOPMENT PLAN
API shall conduct all clinical studies required to obtain Regulatory
Approval in the United States, including but not limited to the studies
referenced below, with the objective of obtaining U.S. NDA approval for the
Product in injectable dosage form with an Empiric Claim on or before *.
STUDY NO. STUDY TITLE BRIEF DESCRIPTION
AR-90-01-002 Pharmacokinetics of Nystatin(LF),"*, I.V. in Patients Phase 1, Single dose,
with Acquired Immunodeficiency Syndrome (AIDS)-Related dose-escalating up to 1
Complex ARC mg/kg
AR-91-35,606-004 A Phase I-ii Clinical Study of Nystatin-Trademark-, Phase I-II, Multiple
I.V. in Patients with HIV Infection dose, dose-escalating up
to 7 mg/kg
AR-41,000-00-000 Phase I Study to Determine the Maximum Tolerated Dose Phase I, Multiple dose,
of Liposomal Nystatin(LF)-trademark- in Patients with dose-escalating up to 8
Presumed or Proven Fungal infection Due to ASPERGILLUS mg/kg
or CANDIDA Species and Other Opportunistic Fungi
AR-92-41,356-005 A Multicenter Study to Evaluate the Safety and Phase II, Multiple dose
Efficacy of Various Doses of Nyotran-Registered at 2 or 4 mg/kg, in
Trademark- in Non-Neutropenic Patients with Candidemia patients with systemic
CANDIDA infections
AR-94-41,356-006 A Prospectively Randomized, Double-Blind, Comparative Phase III, Multiple dose
Multicenter Study to Evaluate Efficacy and Safety of blinded comparative
Nyotran-Registered Trademark- and Amphotericin B or study in patients with
Empiric Antifungal Treatment in Neutropenic Patients presumed fungal
infections, conducted in
US
AR-95-41,356-009 A Prospectively Randomized, Double-Blind, Comparative Phase III, Multiple dose
Multicenter Study to Evaluate Efficacy and Safety of blinded comparative
Nyotran-Registered Trademark- and Amphotericin B for study in patients with
Empiric Antifungal Treatment in Neutropenic Patients presumed fungal
infections, conducted in
Europe
AR-94-41,356-007 An Open-Label, Non-Comparative, Multicenter Study to Phase II, Multiple dose
Evaluate the Clinical Efficacy and Safety of Nyotran- salvage therapy trial in
Registered Trademark- (Liposomal Nystatin) in the aspergillosis conducted
Treatment of Patients with Proven or Probable primarily in Europe,
ASPERGILLUS Infection Who Are Failing Standard South Africa, and
Parenteral Antifungal Therapy Due to Lack of Response Australia
or Intolerance to Amphotericin B or Liposomal
Amphotericin
AR-96-41,356-008 An Open-Label, Non-Comparative, Multicenter Study to Phase II, Multiple dose
Evaluate the Clinical Efficacy and Safety of Nyotran- salvage therapy trial in
Registered Trademark- (Liposomal Nystatin) in the aspergillosis conducted
Treatment of Patients with Proven or Probable primarily in the US
ASPERGILLUS Infection Who Are Failing Standard
Parenteral Antifungal Therapy Due to Lack of Response
or Intolerance to Amphotericin B or Liposomal
Amphotericin
AR-97-41,356-013 A PhaseII/III Randomized, Multicenter Study to *
Determine the Optimal Dose of Nyotran-Registered
Trademark- (Liposomal Nystatin) for the Treatment of
Patients with Cryptococcal Meningitis by Comparing the
Safety and Efficacy of the 2 mg/kg/day, 3 mg/kg/day
and 4 mg/kg/day Doses of Nyotran-Registered Trademark-
and To Compare the Safety and Efficacy of the
Resulting Optimal Dose of Nyotran-Registered
Trademark- versus Fungizone-Registered Trademark-
(Amphotericin B) in Patients with Cryptococcal
Meningitis
* *
EXHIBIT D
ALTERNATIVE DISPUTE RESOLUTION
The parties recognize that a bona fide dispute as to certain matters may
arise from time to time during the term of this Agreement which relates to
either party's rights and/or obligations. To have such a dispute resolved by
this Alternative Dispute Resolution ("ADR") provision, a party first must send
written notice of the dispute to the other party for attempted resolution by
good faith negotiations between their respective representatives of the affected
subsidiaries, divisions, or business units within twenty-eight (28) days after
such notice is received (all references to "days" in this ADR provision are to
calendar days).
If the matter has not been resolved within twenty-eight (28) days of he
notice of dispute, or if the parties fail to meet within such twenty-eight (28)
days, either party may initiate an ADR proceeding as provided herein. The
parties shall have the right to be represented by counsel in such a proceeding.
1. To begin an ADR proceeding, a party shall provide written notice
to the other party of the issues to be resolved by ADR. Within fourteen (14)
days after its receipt of such notice, the other party may, by written notice to
the party initiating the ADR, add additional issues to be resolved within the
same ADR.
2. Within twenty-one (21) days following receipt of the original ADR
notice, the parties shall select a mutually acceptable neutral to preside in the
resolution of any disputes in this ADR proceeding. If the parties are unable to
agree on a mutually acceptable neutral within such period, the parties shall
request the President of the Center for Public Resources ("CPR"), 000 Xxxxxxx
Xxxxxx, Xxx Xxxx, Xxx Xxxx 00000 to select a neutral pursuant to the following
procedures:
(a) The CPR shall submit to the parties a list of not less
than five (5) candidates within fourteen (14) days after receipt of the request
from the parties, along with a CURRICULUM VITAE for each candidate. No
candidate shall be an employee, director, or shareholder of either party or any
of their subsidiaries or affiliates.
(b) Such list shall include a statement of disclosure by each
candidate of any circumstances likely to affect his or her impartiality.
(c) Each party shall number the candidates in order of
preference (with the number one (1) signifying the greatest preference) and
shall deliver the list to the CPR within seven (7) days following receipt of the
list of candidates. If a party believes a conflict of interest exists regarding
any of the candidates that party shall provide a written explanation of the
conflict to the CPR along with its list showing its order of preference for the
candidates. Any party failing to return a list of preferences on time shall be
deemed to have no order of preference.
(d) If the parties collectively have identified fewer than
three (3) candidates deemed to have conflicts, the CPR immediately shall
designate as the neutral the candidate for whom the parties collectively have
indicated the greatest preference. If a tie should result between two
candidates, the CPR may designate either candidate. If the parties collectively
have identified three (3) or more candidates deemed to have conflicts, the CPR
shall review the explanations regarding conflicts and, in its sole discretion,
may either (i) immediately designate as the neutral the candidate for whom the
parties collectively have indicated the greatest preference, or (ii) issue a new
list of not less than five (5) candidates, in which case the procedures set for
in subparagraphs 2(a) - 2(d) above shall be repeated.
3. No earlier than twenty-eight (28) days or later than fifty-six
(56) days after selection, the neutral shall hold a hearing to resolve each of
the issues identified by the parties. The ADR proceeding shall take place at a
location agreed upon by the parties. If the parties cannot agree, the neutral
shall designate a location other than the principal place of business of either
party or any of their subsidiaries or affiliates.
4. At least seven (7) days prior to the hearing, each party shall
submit the following to the other party and the neutral:
(a) a copy of all exhibits on which such party intends to
rely in any oral or written presentation to the neutral;
(b) a list of any witnesses such party intends to call at the
hearing, and a short summary of the anticipated testimony of each witness;
(c) a proposed ruling on each issue to be resolved, together
with a request for a specific damage award or other remedy for each issue. The
proposed rulings and remedies shall not contain any recitation of the facts or
any legal arguments and shall not exceed one (1) page per issue.
(d) a brief in support of such party's proposed rulings and
remedies, provided that the brief shall not exceed twenty (20) pages. This page
limitation shall apply regardless of the number of issues raised in the ADR
proceeding.
Except as expressly set forth in subparagraphs 4(a) - 4(d) above, no
discovery shall be required or permitted by any means, including depositions,
interrogatories, requests for admissions, or production of documents.
5. The hearing shall be conducted on two (2) consecutive days and
shall be governed by the following rules:
(a) Each party shall be entitled to five (5) hours of hearing
time to present its case. The neutral shall determine whether each party has
had the five (5) hours to which it is entitled.
(b) Each party shall be entitled, but not required, to make
an opening statement, to present regular and rebuttal testimony, documents or
other evidence, to cross-examine witnesses, and to make a closing argument.
Cross-examination of witnesses shall occur immediately after their direct
testimony, and cross-examination time shall be charged against the party
conducting the cross-examination.
(c) The party initiating the ADR shall begin the hearing and,
if it chooses to make an opening statement, shall address not only issues it has
raised but also any issues raised by the responding party. The responding
party, if it chooses to make an opening statement, also shall address all issues
raised in the ADR. Thereafter, the presentation of regular and rebuttal
testimony and documents, other evidence, and closing arguments shall proceed in
the same sequence.
(d) Witnesses shall be excluded from the hearing until
closing arguments.
(e) Neither affidavits nor settlement negotiations shall be
admissible under any circumstances. As to all other matters, the neutral shall
have sole discretion regarding the admissibility of any evidence.
6. Within seven (7) days following completion of the hearing, each
party may submit to the other party and the neutral a post-hearing brief in
support of its proposed rulings and remedies, provided that such brief shall not
contain or discuss any new evidence and shall not exceed ten (10) pages. This
page limitation shall apply regardless of the number of issues raised in the ADR
proceeding.
7. The neutral shall rule on each disputed issue within fourteen
(14) days following completion of the hearing. Such ruling shall adopt in its
entirety the proposed ruling and remedy of one of the parties on each disputed
issue but may adopt one party's proposed rulings and remedies on some issues and
the other party's proposed rulings and remedies on other issues. The neutral
shall not issue any written opinion or otherwise explain the basis of the
ruling.
8. The neutral shall be paid a reasonable fee plus expenses. These
fees and expenses, along with the reasonable legal fees and expenses of the
prevailing party (including all expert witness fees and expenses), the fees and
expenses of a court reporter, and any expenses for a hearing room, shall be paid
as follows:
(a) If the neutral rules in favor of one party on all
disputed issues in the ADR, the losing party shall pay 100% of such fees and
expenses.
(b) If the neutral rules in favor of one party on some issues
and the other party on other issues, the neutral shall issue with the rulings a
written determination as to how such fees and expenses shall be allocated
between the parties. The neutral shall allocate fees and expenses in a way that
bears a reasonable relationship to the outcome of the ADR, with the party
prevailing on more issues, or on issues of greater value or gravity, recovering
a relatively larger share of its legal fees and expenses.
9. The rulings of the neutral and the allocation of fees and
expenses shall be binding, non-reviewable, and non-appealable, and may be
entered as a final judgment in any court having jurisdiction.
10. Except as provided in paragraph 9 of this Exhibit D or as
required by law, the existence of the dispute, any settlement negotiations, the
ADR hearing, any submissions (including exhibits, testimony, proposed rulings,
and briefs), and the rulings shall be deemed Confidential Information. The
neutral shall have the authority to impose sanctions for unauthorized disclosure
of Confidential Information.
EXHIBIT E
API TRADEMARK APPLICATIONS AND REGISTRATIONS
API TRADEMARKS REGISTERED
Case Number Xxxx Registration No. Next Renewal Date
----------- ---- ---------------- -----------------
XXX-000
Xxxxxx Xxxxxx XX 0,000,000 00/00/00
XXX-000
Xxxxxx Xxxxxx Nyotran 2,173,459 07/04/08
EXHIBIT F
FORM OF TRADEMARK ASSIGNMENT
ASSIGNMENT
WHEREAS, Aronex Pharmaceuticals, Inc., a corporation existing under the
laws of the State of Delaware, having its principal place of business at 0000
Xxxxxxxxxx Xxxxxx Xxxxx, Xxx Xxxxxxxxx, Xxxxx 00000-0000 is the owner of the
United States Trademark Registrations as depicted on Schedule 1 attached hereto;
and
WHEREAS, Xxxxxx Laboratories, a corporation existing under the laws of
the State of Illinois, having its principal place of business at Xxxxxx Xxxx,
Xxxxxxxx 00000 is desirous of acquiring all right, title and interest in and to
said Trademark Registrations, and
WHEREAS, Aronex Pharmaceuticals, Inc. is willing to assign any and all
of its right to the said Trademark Registrations,
NOW, THEREFORE, for good and valuable consideration, receipt of which is
hereby acknowledged, Aronex Pharmaceuticals, Inc. does hereby sell, transfer,
convey and assign to Xxxxxx Laboratories any and all of its right, title and
interest in and to the trademarks and the Trademark Registrations associated
therewith, including the goodwill of the business symbolized by the trademark.
Dated this ______ day of ____________________, 1998.
Aronex Pharmaceuticals, Inc. Xxxxxx Laboratories
By: By:
Title: Title:
Schedule I
Trademark Country Registration Number
LF United States 1,785,153
NYOTRAN United States 2,173,459
