Exhibit 99.46
EXECUTION COPY
COLLABORATION AGREEMENT
BETWEEN
WARATAH PHARMACEUTICALS INC.
AND
ELAN PHARMA INTERNATIONAL LIMITED
SEPTEMBER 25, 2006
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TABLE OF CONTENTS
Page
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1. DEFINITIONS.......................................................... 1
2. ADMINISTRATION OF THE COLLABORATION.................................. 15
2.1 JOINT EXECUTIVE COMMITTEE...................................... 15
2.2 JOINT LEADERSHIP TEAM.......................................... 18
3. DEVELOPMENT PROGRAM; COMMERCIALIZATION OF PRODUCTS................... 21
3.1 OBJECTIVES OF THE DEVELOPMENT PROGRAM.......................... 21
3.2 RESPONSIBILITY FOR DEVELOPMENT OF AND COMMERCIALIZATION OF THE
PRODUCT..................................................... 22
3.3 ANNUAL BUDGET AND DEVELOPMENT PLAN............................. 22
3.4 PRODUCT COMMERCIALIZATION PLANS................................ 23
3.5 DEVELOPMENT AND COMMERCIALIZATION DILIGENCE.................... 23
3.6 COMPLIANCE AND COOPERATION..................................... 23
3.7 EXCHANGE OF REPORTS............................................ 23
3.8 FUNDING........................................................ 24
3.9 PRODUCT RECALLS................................................ 29
4. LICENSE AND MILESTONE PAYMENTS....................................... 29
4.1 LICENSE FEES................................................... 29
4.2 MILESTONE PAYMENTS............................................. 29
4.3 OVERDUE PAYMENTS............................................... 30
4.4 PAYMENTS....................................................... 30
4.5 TAXES.......................................................... 30
5. TREATMENT OF CONFIDENTIAL INFORMATION; PUBLICITY; NON-SOLICITATION... 30
5.1 CONFIDENTIALITY................................................ 30
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5.2 PUBLICITY...................................................... 32
5.3 PUBLICATIONS AND PRESENTATIONS................................. 32
6. LICENSE GRANTS....................................................... 33
6.1 WARATAH LICENSE GRANTS......................................... 33
6.2 ELAN LICENSE GRANTS............................................ 34
6.3 ACADEMIC AGREEMENTS............................................ 34
7. INTELLECTUAL PROPERTY RIGHTS......................................... 34
7.1 WARATAH INTELLECTUAL PROPERTY RIGHTS........................... 34
7.2 ELAN INTELLECTUAL PROPERTY RIGHTS.............................. 34
7.3 JOINT TECHNOLOGY RIGHTS........................................ 34
7.4 PATENT COORDINATORS............................................ 35
7.5 INVENTORSHIP................................................... 35
7.6 COOPERATION.................................................... 35
8. INTELLECTUAL PROPERTY................................................ 35
8.1 PATENT FILING, PROSECUTION AND MAINTENANCE..................... 35
8.2 LEGAL ACTIONS.................................................. 37
8.3 TRADEMARK AND COPYRIGHT OWNERSHIP.............................. 39
8.4 THIRD PARTY LICENSES........................................... 39
9. TERM AND TERMINATION................................................. 40
9.1 TERM........................................................... 40
9.2 TERMINATION.................................................... 40
9.3 CONSEQUENCES OF TERMINATION OF AGREEMENT....................... 41
10. REPRESENTATIONS AND WARRANTIES....................................... 44
10.1 MUTUAL REPRESENTATIONS AND WARRANTIES.......................... 44
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10.2 ADDITIONAL REPRESENTATIONS OF WARATAH.......................... 44
11. DISCLAIMERS.......................................................... 45
11.1 WARRANTY DISCLAIMER............................................ 45
11.2 NO WARRANTY OF SUCCESS......................................... 45
12. MISCELLANEOUS........................................................ 45
12.1 MEDIATION...................................................... 45
12.2 ARBITRATION.................................................... 45
12.3 INDEMNIFICATION AND INSURANCE.................................. 46
12.4 CHANGE OF CONTROL.............................................. 47
12.5 NOTICES........................................................ 47
12.6 GOVERNING LAW.................................................. 48
12.7 BINDING EFFECT................................................. 48
12.8 HEADINGS....................................................... 48
12.9 COUNTERPARTS................................................... 49
12.10 AMENDMENT; WAIVER.............................................. 49
12.11 NO THIRD PARTY BENEFICIARIES................................... 49
12.12 PURPOSES AND SCOPE............................................. 49
12.13 ASSIGNMENT AND SUCCESSORS...................................... 49
12.14 FORCE MAJEURE.................................................. 50
12.15 INTERPRETATION................................................. 50
12.16 INTEGRATION; SEVERABILITY...................................... 50
12.17 EQUITABLE RELIEF............................................... 51
12.18 HSR FILING..................................................... 51
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List of Exhibits and Schedules
Exhibit A Annual Budget
Exhibit B Development Plan
Exhibit C Interim Costs
Schedule 1 Licensed Patent Rights
Schedule 2 Form of Press Release
Schedule 3 Academic Agreements
Schedule 4 Technological Competitors
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COLLABORATION AGREEMENT
This COLLABORATION AGREEMENT (this "Agreement") is entered into as of
September 25, 2006, by and between Waratah Pharmaceuticals Inc. a company with
offices at Xxxxx 000, 000 Xxxxxxx Xxxxxx, Xxxxxxx, Xxxxxxx, X0X 0X0 ("WARATAH"),
and Elan Pharma International Limited, a private company limited by shares
organized under the laws of Ireland with offices at Xxxxxxxxx, Xxxxxxx, Xxxxxx
Xxxxxxxxx, Xxxxxxx ("ELAN"). Each of ELAN and WARATAH is sometimes referred to
individually herein as a "Party" and are sometimes referred to collectively as
the "Parties."
WHEREAS, WARATAH has developed and controls certain technology, patent
rights and proprietary materials related to (a) the compound ("deleted text")
("AZD-103") and (b) the use of such compound for treating, preventing or
delaying onset or progression of diseases or conditions; and
WHEREAS, ELAN is engaged in the research, development and commercialization
of human therapeutics; and
WHEREAS, the Parties desire to enter into a collaboration for the purposes
of further developing and commercializing AZD-103 and derivatives or
formulations of AZD-103.
NOW, THEREFORE, in consideration of the mutual covenants contained herein,
and for other good and valuable consideration, the Parties hereto, intending to
be legally bound, hereby agree as follows:
1. DEFINITIONS
Whenever used in this Agreement with an initial capital letter, the terms
defined in this Article 1 and elsewhere throughout this Agreement shall have the
meanings specified.
1.1 "AFFILIATE" means, with respect to any Person, any other Person that,
directly or indirectly, controls, or is controlled by, or is under common
control with, such Person. For purposes of this definition, "control" means (a)
ownership of fifty percent (50%) or more of the shares of stock entitled to vote
for the election of directors in the case of a corporation, fifty percent (50%)
or more of the equity interests in the case of any other type of legal entity,
(b) status
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as a general partner in any partnership, or (c) any other arrangement whereby a
Person controls or has the right to control the board of directors of a
corporation or equivalent governing body of an entity.
1.2 "ANNUAL BUDGET" means the budget for the Development and/or
Commercialization of the Product for a Calendar Year, as such budget may be
amended, modified or updated, as further described in this Agreement.
1.3 "APPLICABLE LAWS" means federal, state, local, national and
supra-national laws, statutes, rules and regulations, including any rules,
regulations or requirements of Regulatory Authorities, national securities
exchanges or securities listing organizations, that are in effect from time to
time during the Term and apply to a particular activity hereunder.
1.4 "AZD-103" or ("deleted text") means the compound ("deleted text")
1.5 "CALENDAR YEAR" means each successive period of twelve (12) months
commencing on January 1 and ending on December 31.
1.6 "CHANGE OF CONTROL" means (a) a merger, consolidation, share exchange
or other similar transaction involving WARATAH or its ultimate parent entity and
any Third Party which results in the holders of the outstanding voting
securities of WARATAH or its ultimate parent entity immediately prior to such
merger, consolidation, share exchange or other similar transaction ceasing to
hold more than fifty percent (50%) of the combined voting power of the
surviving, purchasing or continuing entity immediately after such merger,
consolidation, share exchange or other similar transaction, (b) any transaction
or series of related transactions in which a Third Party, together with its
Affiliates, becomes the beneficial owner of fifty percent (50%) or more of the
combined voting power of the outstanding securities of WARATAH or its ultimate
parent entity, or (c) the sale or other transfer to a Third Party of all or
substantially all of WARATAH's or its ultimate parent entity's assets which
relate to this Agreement. For purposes of clarity an internal amalgamation or
consolidation is not deemed a Change of Control.
1.7 "COLLABORATION" means the alliance of WARATAH and ELAN established
pursuant to this Agreement for the purposes of Developing and Commercializing
the Product in the Territory.
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1.8 "COMMERCIALIZATION" means any and all activities related to the
offering for sale and/or sale of the Product, including but not limited to
activities related to marketing, manufacturing for commercial distribution,
educating providers and consumers, contracting, pharmacoeconomics studies, payer
reimbursement, promoting, detailing, distributing, importing, conducting
post-marketing human clinical studies and interacting with Regulatory
Authorities regarding the foregoing. When used as a verb, to "Commercialize" or
"Commercializing" means to engage in Commercialization and "Commercialized" has
a corresponding meaning.
1.9 "COMMERCIALIZATION COSTS" means the sum of the following direct and
internal costs incurred by a Party or its Affiliates in carrying out its (or
their) obligations under the Product Commercialization Plan: ("deleted text")
1.10 "COMMERCIALIZATION REGULATORY APPROVAL" means, with respect to the
Product, the Regulatory Approval required by Applicable Laws to sell the Product
in a country or region. "Commercialization Regulatory Approval" shall include,
without limitation, the approval of any Drug Approval Application.
1.11 "COMMERCIALLY REASONABLE EFFORTS" means with respect to the conduct of
Development activities, or the Commercialization of the Product by a Party, the
use of efforts and resources comparable to those undertaken by ELAN or WARATAH,
as the case may be, in pursuing the development and commercialization of
products that are not subject to the Collaboration and that are at an equivalent
stage of development or commercialization and have similar market potential and
are at a similar stage in their lifecycle. All relevant factors as measured by
the facts and circumstances at the time such efforts are due shall be taken into
account, including, as applicable and without limitation, mechanism of action;
efficacy and safety; product profile; actual or anticipated Regulatory Authority
approved labeling; the nature and extent of market exclusivity (including patent
coverage, proprietary position and regulatory exclusivity; cost, time required
for and likelihood of obtaining Commercialization Regulatory Approval;
competitiveness of alternative products and market conditions; and actual or
projected profitability and availability of capacity to manufacture and supply
for commercial sale).
1.12 "CONFIDENTIAL INFORMATION" means (a) with respect to WARATAH, all
embodiments of WARATAH Technology and WARATAH shall be deemed the "Disclosing
Party" and ELAN the "Receiving Party" with respect thereto; (b) with respect to
ELAN, all
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embodiments of ELAN Technology and ELAN shall be deemed the "Disclosing Party"
and WARATAH the "Receiving Party" with respect thereto; and (c) with respect to
each Party, each of which shall be deemed both the "Disclosing Party" and
"Receiving Party" with respect thereto, (i) all embodiments of Joint Technology,
(ii) all information, including, without limitation, information concerning the
business or operations, patents and patent positioning, strategic plans or
business opportunities of a Party or its Affiliates, Technology and Proprietary
Materials, to the extent not described in (a) or (b), disclosed or provided by
or on behalf of a Disclosing Party to a Receiving Party or to any of the
Receiving Party's employees, consultants, Affiliates or Sublicensees, (iii) the
terms of this Agreement, (iv) confidential information disclosed pursuant to the
Confidentiality Agreements and (v) all Technology generated hereunder in
connection with the Development and the Commercialization of the Product;
provided that none of the foregoing shall be Confidential Information if: (A) as
of the date of disclosure, it is known to the Receiving Party or its Affiliates,
as demonstrated by credible written documentation, other than by virtue of a
prior confidential disclosure by or on behalf of the Disclosing Party; (B) as of
the date of disclosure it is in the public domain, or it subsequently enters the
public domain through no unauthorized disclosure and no fault of the Receiving
Party; (C) it is obtained by the Receiving Party from a Third Party having a
lawful right to make such disclosure free from any obligation of confidentiality
to the Disclosing Party; or (D) it is independently developed by or for the
Receiving Party without benefit from, reference to or use of any Confidential
Information of the Disclosing Party as demonstrated by credible written
documentation.
1.13 "CONFIDENTIALITY AGREEMENTS" means the Confidentiality Agreement
between Elan Pharmaceuticals, Inc. and Ellipsis Neurotherapeutics, Inc.
effective as of ("deleted text") and the Prior Confidentiality Agreement defined
therein.
1.14 "CONTROL" or "CONTROLLED" means (a) with respect to Technology or
Patent Rights, the possession by a Party of the right to grant a license or
sublicense to such Technology or Patent Rights as provided herein, and without
violating the terms of any agreement or arrangement with, any Third Party and
without violating any Applicable Laws and (b) with respect to Proprietary
Materials, the possession by a Party of the right to supply such Proprietary
Materials to the other Party as provided herein, and without violating the terms
of any agreement or arrangement with, any Third Party and without violating any
Applicable Laws.
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1.15 "CO-PROMOTER" means a Third Party ELAN contracts with to co-promote
the Product.
1.16 "COST OF GOODS" means the ("deleted text").
1.17 "CMC SECTION" means the chemistry, manufacturing and controls section
of the Regulatory Filings in the United States of America as defined in 21 CFR
Section 314.50(d)(1), as may be amended from time to time, and/or its equivalent
in other Regulatory Filings in the Territory.
1.18 "DERIVATIVE" means any compounds identified, obtained, developed,
created, synthesized, generated, designed or resulting from, based upon,
containing or incorporating the chemical structure of ("deleted text") as those
compounds are generically and/or specifically disclosed and claimed in the
Licensed Patent Rights.
1.19 "DEVELOPMENT" or "DEVELOP" means all pre-clinical, CMC and clinical
activities performed to obtain Regulatory Approval of the Product up to and
including the obtaining of Commercialization Regulatory Approval of the Product.
When used as a verb, "Developing" means to engage in Development and "Developed"
has a corresponding meaning.
1.20 "DEVELOPMENT COSTS" means ("deleted text").
1.21 "DEVELOPMENT PLAN" means the written plan and timelines for the
Development of the Product in a Calendar Year, as such written plan may be
amended, modified or updated, as further described in this Agreement.
1.22 "DEVELOPMENT PROGRAM" means the Development activities to be conducted
during the Term with respect to the Product pursuant to an Annual Budget and
Development Plan.
1.23 "DISTRIBUTION EXPENSES" means ("deleted text").
1.24 "DRUG APPROVAL APPLICATION" means, in a particular country or region,
an application for Commercialization Regulatory Approval for the Product in such
country or region, including without limitation: (a) an NDA; (b) a counterpart
of an NDA in any country or region in the Territory; and (c) all supplements and
amendments to any of the foregoing.
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1.25 "DRUG MASTER FILE" OR "DMF" means the Drug Master File in the United
States of America, as defined in 21 CFR Section 314.420 and/or its equivalent in
the other countries in the Territory.
1.26 "EARLY STAGE DEVELOPMENT COSTS" means ("deleted text").
1.27 "EFFECTIVE DATE" means September 25, 2006.
1.28 "ELAN DEVELOPMENT ACTIVITIES" means all Development activities
specified to be conducted by ELAN in any Annual Budget and Development Plan (or
amendment thereto).
1.29 "ELAN PATENT RIGHTS" means any Patent Rights Controlled by ELAN that
contain one or more claims that cover ELAN Technology which would, but for this
Agreement, be infringed by WARATAH Development Activities or Commercialization
activities performed under this Agreement.
1.30 "ELAN TECHNOLOGY" means any Technology that is used by ELAN, or
provided by ELAN for use, in the performance of the Development and
Commercialization of the Product that is (a) Controlled by ELAN as of the
Effective Date or (b) Made by employees of, or consultants to, ELAN after the
Effective Date. ELAN Technology includes formulations comprising AZD-103 or
Derivatives developed in the performance of the Development Program.
1.31 "FDA" means the United States Food and Drug Administration or any
successor agency or authority thereto.
1.32 "FDCA" means the United States Federal Food, Drug, and Cosmetic Act,
as amended.
1.33 "FIELD" means all human and veterinarian therapeutic, prophylactic,
prognostic, or diagnostic uses of the Product.
1.34 "FIRST COMMERCIAL SALE" means, with respect to the Product in a
country in the Territory, the first sale, transfer or disposition for value to
an end-user of the Product in such country after receipt of Commercialization
Regulatory Approval for such country. A sale of the Product shall be deemed to
occur on the earlier of (a) the date the Product is shipped to an end-user or
(b) the date of the invoice to the end-user of the Product.
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1.35 "FORCE MAJEURE" means any occurrence beyond the reasonable control of
a Party that (a) prevents or substantially interferes with the performance by
such Party of any of its obligations hereunder and (b) occurs by reason of any
act of God, flood, fire, explosion, earthquake, strike, lockout, labor dispute,
casualty or accident, or war, revolution, civil commotion, act of terrorism,
blockage or embargo, or any injunction, law, order, proclamation, regulation,
ordinance, demand or requirement of any government or of any subdivision,
authority or representative of any such government, to the extent and for the
duration of such occurrence.
1.36 "FTE" shall mean ("deleted text") hours of work devoted to or in
support of the Development and Commercialization of the Product that is carried
out by one or more employees, contract personnel or consultants of ELAN or
WARATAH, as the case may be, measured in accordance with ELAN's or WARATAH's
respective time allocation practices from time to time.
1.37 "FTE COST" means, for any period, the FTE Rate multiplied by the
applicable number of FTEs in such period.
1.38 "FTE RATE" means ("deleted text"); provided that the FTE Rate will be
increased ("deleted text") on January 1 of each Calendar Year in the Term,
commencing with January 1, 2008. Any such increase shall be rounded to the
nearest one hundred US Dollars ($100).
1.39 "GAAP" means United States generally accepted accounting principles,
consistently applied.
1.40 "HSR ACT" means the Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of
1976, as amended.
1.41 "IND" means: (a) an Investigational New Drug Application as defined in
the FDCA and regulations promulgated thereunder or any successor application or
procedure required to initiate clinical testing of the Product in humans in the
United States; (b) a counterpart of an Investigational New Drug Application that
is required in any other country or region in the Territory before beginning
clinical testing of the Product in humans in such country or region; and (c) all
supplements and amendments to any of the foregoing.
1.42 "INITIATION" means, with respect to a human clinical trial, the first
date that a subject or patient is dosed in such clinical trial.
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1.43 "JOINT EXECUTIVE COMMITTEE" or "JEC" means the committee composed of
WARATAH and ELAN representatives established pursuant to Section 2.1.
1.44 "JOINT LEADERSHIP TEAM" or "JLT" means the committee composed of
WARATAH and ELAN representatives established pursuant to Section 2.2.
1.45 "JOINT PATENT RIGHTS" means Patent Rights that contain one or more
claims that cover Joint Technology.
1.46 "JOINT TECHNOLOGY" means any Technology that is jointly Made by
employees of, or consultants to, ELAN and employees of, or consultants to,
WARATAH in the performance of the Development Program.
1.47 "LICENSED PATENT RIGHTS" means any WARATAH Patent Rights and WARATAH's
interest in Joint Patent Rights that contain one or more claims that cover
AZD-103 or Derivatives of AZD-103 or Products, including their manufacture or
their formulation or a method of their delivery or of their use. The Licensed
Patent Rights as of the Effective Date include without limitation the Patent
Rights listed on Schedule 1 attached hereto; and the Parties shall update
Schedule 1 not less than annually during the Term to add any additional Patent
Rights that become Licensed Patent Rights.
1.48 "LICENSED TECHNOLOGY" means any WARATAH Technology and WARATAH's
interest in Joint Technology that is necessary or useful for the Development or
Commercialization of AZD-103, Derivatives or Products including their
manufacture or their formulation or a method of their delivery or of their use
or that is necessary for ELAN to exercise the licenses granted to it pursuant to
Section 6.1.
1.49 "MADE" means (a) with respect to patentable Technology, discovered,
conceived or first reduced to practice, whether actively or constructively under
this Agreement, and (b) with respect to all other Technology, first generated,
identified, synthesized or developed under this Agreement.
1.50 "MAJOR MARKET COUNTRY" means each of the United Kingdom, Germany,
France, Spain and Italy.
1.51 "MANUFACTURING COST" means, ("deleted text").
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1.52 "NDA" means a New Drug Application, as defined in the FDCA and
regulations promulgated thereunder or any successor application or procedure
required to sell the Product in the United States.
1.53 "NET INCOME (LOSS)" means, ("deleted text").
For purposes of this Agreement, the following principles shall apply:
1. There shall be no double counting of any costs or expenses or of any
revenues, and to the extent a cost or expense has been included in one category
or sub-category, it shall not be included in another; similarly, to the extent
any revenue has been taken into account in one category or sub-category it shall
not be taken into account in another.
2. When allocating costs and expenses under this Agreement, each Party
shall utilize the same policies and principles as it utilizes consistently
within its group and business units when making internal cost allocations and
such policies and principles shall be reasonable and in accordance with industry
standards.
3. To the extent an item of income or revenue is received by a Party or a
cost or expense is incurred by a Party, and is necessary and specifically and
directly identifiable, attributable and allocable to the Commercialization of
the Product and is not otherwise accounted for in the calculation of Net Income
(Loss), such Party shall credit such income or revenue and shall be permitted to
charge such cost or expense to the Net Income (Loss).
4. All costs and expenses shall be determined, and all calculations shall
be made, in accordance with GAAP.
5. Commercialization Costs, Development Costs, and Cost of Goods shall not
include any costs attributable to general corporate activities including by way
of example, executive management, investor relations, business development,
legal affairs (but legal costs which are attributable to intellectual property
matters with respect to the Collaboration contemplated in, and in accordance
with Article 8 of this Agreement shall be included in Commercialization Costs,
Development Costs and Cost of Goods, as applicable) and finance.
1.54 "NET SALES" means, where WARATAH has not exercised its opt out rights
in accordance with Section 3.8.6 (b), the gross amount billed or invoiced by
ELAN or any of its Affiliates, or Co-Promoters to Third Parties throughout the
Territory for sales or other
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dispositions or transfers for value of the Product less (i) reasonable
allowances for normal and customary trade (including those granted in core
distribution agreements and inventory management agreements), quantity and cash
discounts on Product actually allowed and taken (but excluding price discounts
granted at the time of invoice which are already reflected in the determination
of the amount charged), (ii) transportation, insurance and postage charges, if
paid by ELAN or any Affiliate, or Co-Promoter of ELAN (excluding amounts
reimbursed by Third Party customers), (iii) credits, chargebacks, rebates or
returns on Product sold pursuant to agreements (including, without limitation,
managed care agreements) or government regulations, accounted for in accordance
with GAAP, (iv) any tax, tariff, customs duty, excise or other duty or other
governmental charge (other than a tax on income) levied on the sale,
transportation or delivery of Product and actually paid by ELAN, or any of its
Affiliates or Co-Promoters and (v) amounts retained by Co-promoters; provided
none of (i) through (v) shall be included in Commercialization Costs. In
addition, Net Sales are subject to the following:
(a) If ELAN or any of its Affiliates or Co-promoters effects a sale,
disposition or transfer of a Product to a customer in a particular country other
than on customary commercial terms or as part of a package of products and
services, the Net Sales of such Product to such customer shall be deemed to be
"the fair market value" of such Product. For purposes of this subsection (a),
"fair market value" shall mean the value that would have been derived had such
Product been sold as a separate product to another customer in the country
concerned on customary commercial terms.
(b) In the case of pharmacy incentive programs, hospital performance
incentive program chargebacks, disease management programs, similar programs or
discounts on "bundles" of products, all discounts and the like shall be
allocated among products on the basis on which such discounts and the like were
actually granted or, if such basis cannot be determined, in proportion to the
respective list prices of such products.
(c) For purposes of clarity, use of any Product in clinical trials,
pre-clinical studies or other research or Development activities, or disposal or
transfer of Products for a bona fide charitable purpose or purposes of a
commercially reasonable sampling program shall not give rise to any Net Sales.
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1.55 "OPERATING INCOME (LOSS)" means the Net Income (Loss) derived in any
Calendar Year.
1.56 "OPT OUT NET SALES" means Net Sales as defined in Section 1.54 further
including the gross amount billed or invoiced by Sublicensees to Third Parties
throughout the Territory for sales or other dispositions or transfers for value
of Product less deductions (i) to (iv) in Section 1.54, and excluding in respect
to all Net Sales the deduction of amounts retained by Co-promoters in Section
1.54.
1.57 "PATENT RIGHTS" means all (i) patents and patent applications, whether
foreign or domestic, all patents arising from such applications, and all patents
and patent applications based on, or claiming or corresponding to the
priorities, of any of the foregoing and (ii) any renewals, reissues, term
extensions (or other governmental actions that provide exclusive rights to the
owner thereof in the patented subject matter beyond the original expiration
date, including, without limitation, supplementary protection certificates),
substitutions, confirmations, registrations, revalidations, reexaminations,
additions, continuations, continued prosecutions, continuations-in-part or
divisions of or to any of the foregoing.
1.58 "PERSON" means an individual, sole proprietorship, partnership,
limited partnership, limited liability partnership, corporation, limited
liability company, business trust, joint stock company, trust, incorporated
association, joint venture or similar entity or organization, including a
government or political subdivision, department or agency of a government.
1.59 "PERSONNEL COSTS" means the FTE Cost of Persons employed by a Party
and the costs of Persons under contract to a Party.
1.60 "PHASE I CLINICAL TRIAL" means a clinical trial conducted in healthy
humans or patients, which clinical trial is designed to establish the safety,
drug-drug interactions and/or pharmacokinetics of the Product given its intended
use, and to support continued testing of such drug in Phase II Clinical Trials.
1.61 "PHASE II CLINICAL TRIAL" means a controlled clinical trial conducted
in patients with a particular disease or condition, which clinical trial is
designed to establish the safety, appropriate dosage and pharmacological
activity of the Product given its intended use, and to initially explore its
efficacy for such disease or condition.
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1.62 "PHASE III CLINICAL TRIAL" means a controlled pivotal clinical trial
conducted in patients with a particular disease or condition, which clinical
trial is designed to ascertain efficacy and safety of an investigational drug
for its intended use and to define warnings, precautions and adverse events that
are associated with the Product in the dosage range intended to be prescribed,
with the purpose of preparing and submitting applications for Regulatory
Approval.
1.63 "POST-APPROVAL RESEARCH AND REGULATORY EXPENSES" means ("deleted
text").
1.64 "PRE-MARKETING EXPENSES" means("deleted text").
1.65 "PRODUCT" means any pharmaceutical preparation or dosage form
containing ("deleted text") or a Derivative thereof.
1.66 "PRODUCT COMMERCIALIZATION PLAN" means, with respect to the Product,
the written plan for the Commercialization of the Product in the Territory
(including, without limitation, expected formulation, manufacturing scale-up,
manufacture, testing, validation, packaging and stability requirements for the
Product and a detailed strategy, budget and proposed timelines), as such plan
may be amended or updated, including forecasted Commercialization Costs and Cost
of Goods and proposed timelines, as amended or updated in writing.
1.67 "PRODUCT TRADEMARKS" means any trademark or trade name, whether or not
registered, or any trademark application or renewal, extension or modification
thereof, in the Territory, or any trade dress and packaging, in each case that
are applied to or used with the Product by ELAN.
1.68 "PROMOTION EXPENSE" means ("deleted text").
1.69 "PROPRIETARY MATERIALS" means proprietary tangible chemical,
biological or physical materials (a) that are furnished by or on behalf of one
Party to the other Party in connection with this Agreement, whether or not
specifically designated as proprietary by the transferring Party or (b) that are
otherwise first Made by a Party in the conduct of the Development Program.
1.70 "QUARTER" means the stub period beginning on the Effective Date and
ending on the ("deleted text") in which the ("deleted text") falls, and
thereafter each successive period of ("deleted text").
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1.71 "REGULATORY APPROVAL" means, with respect to any country or region in
the Territory, any approval or license of any Regulatory Authority required for
the manufacture, use, storage, importation, exportation, transport, sale or
other distribution of the Product for use in such country or region.
1.72 "REGULATORY AUTHORITY" means the FDA, or any counterpart of the FDA
outside the United States, or any other national, supra-national, regional,
state or local regulatory agency, department, bureau, commission, council or
other governmental entity with authority over the distribution, importation,
exportation, manufacture, production, use, storage, transport, clinical testing
or sale of the Product.
1.73 "REGULATORY FILINGS" means, collectively: (a) all INDs, license
applications, drug master files for "Fast Track" status under Section 506 of the
FDCA (21 U.S.C. Section 356) or for a Special Protocol Assessment under Section
505(b)(4)(B) and (C) of the FDCA (21 U.S.C. Section 355(b)(4)(B)), NDAs, and all
other similar filings (including, without limitation, counterparts of any of the
foregoing in any country or region in the Territory); (b) all supplements and
amendments to any of the foregoing; and (c) all data and other information
contained in, and correspondence relating to, any of the foregoing.
1.74 "SALES AND MARKETING EXPENSES" means ("deleted text").
1.75 "SUBLICENSE AGREEMENT" means any agreement entered into by ELAN with a
Sublicensee.
1.76 "SUBLICENSE INCOME" means any income payable to ELAN under any
Sublicense Agreement, including, without limitation, upfront payments,
maintenance fees, license fees, milestone payments and royalties.
1.77 "SUBLICENSEE" means any Third Party to which ELAN grants a sublicense.
1.78 "TECHNOLOGY" means, collectively, conceptions, inventions,
discoveries, improvements, trade secrets and proprietary methods, whether or not
patentable, including without limitation: (a) methods of production or use of,
and structural and physical properties pertaining to, chemical compounds and (b)
biological know-how, including without limitation, performance of assays,
histological techniques and interpretation, data, automation, formulations,
processes, techniques, imaging, and results (including without limitation any
negative results).
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1.79 "TECHNOLOGICAL COMPETITOR" means a Third Party listed on Schedule 4
and divisions, subsidiaries and successors thereof.
1.80 "TERRITORY" means all countries and territories of the world.
1.81 "THIRD PARTY" means a Person other than ELAN and WARATAH and their
respective Affiliates.
1.82 "THIRD PARTY LICENSE" means any agreement with a Third Party approved
by the JEC for a license under intellectual property Controlled by such Third
Party, if the absence of such license may cause the Development or
Commercialization of the Product to infringe such intellectual property.
1.83 "THIRD PARTY LICENSE FEES" means all upfront payments, milestone
payments, license fees, royalties or other payments, payable to any Third Party
by either Party under any Third Party License to the extent such payments are
attributable to the Product. If the rights under any Third Party License are
also attributable to products other than the Product, then only an equitable
portion of any amounts payable under it shall be allocated to the Product as
License Fees.
1.84 "WARATAH DEVELOPMENT ACTIVITIES" means all Development activities
specified to be conducted by WARATAH in any Development Plan (or amendment
thereto).
1.85 "WARATAH DEVELOPMENT PERCENTAGE" means ("deleted text"), or if WARATAH
elects to increase its WARATAH Development Percentage pursuant to Section 3.8.3,
a whole number percentage less than or equal to ("deleted text") and greater
than or equal to ("deleted text") as specified by WARATAH pursuant to Section
3.8.3.
1.86 "WARATAH PATENT RIGHTS" means any Patent Rights Controlled by WARATAH
that contain one or more claims that cover WARATAH Technology which would, but
for this Agreement, be infringed by the ELAN Development Activities or the
Commercialization activities performed under this Agreement.
1.87 "WARATAH TECHNOLOGY" means any Technology that is used by WARATAH, or
provided by WARATAH, for use in the course of the Development and
Commercialization of the Product that is (a) Controlled by WARATAH as of the
Effective Date or (b) Made by employees of, or consultants to, WARATAH after the
Effective Date.
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1.88 "WORKING CAPITAL CHARGES" means ("deleted text").
1.89 ADDITIONAL DEFINITIONS. In addition, each of the following definitions
shall have the respective meanings set forth in the section of this Agreement
indicated below:
AAA 12.1
Academic Agreements 6.3
ANDA patent certification 8.2.1(a)
Collaboration Manager 2.2.5
Data Review Period 3.8.3
Infringement 8.2.1(a)
Infringement Notice 8.2.1(a)
Losses 12.3
Manufacturing License 9.3.1(f)
Opt Out Notice 3.8.6(b)
Patent Coordinator 7.4
Publications 5.3
Quarterly Report 3.8.13(b)
Term 9.1
Third Party Formulation License 2.1.4(j)
2. ADMINISTRATION OF THE COLLABORATION
2.1 JOINT EXECUTIVE COMMITTEE
2.1.1 ESTABLISHMENT. WARATAH and ELAN hereby establish the Joint
Executive Committee. The JEC shall have and perform the responsibilities set
forth in Section 2.1.4.
2.1.2 MEMBERSHIP. Each Party shall designate, in its sole discretion,
three (3) members to the JEC, which shall be members of its, or its Affiliates',
management. Unless otherwise agreed by the Parties, one of ELAN's designees
shall be designated by ELAN as the Chair. Each Party shall have the right at any
time to substitute individuals, on a permanent or temporary basis, for any of
its previously designated representatives to the JEC, by giving written notice
to the other Party. Initial designees of the Parties to the JEC shall be as
follows:
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For WARATAH:
("deleted text")
For ELAN:
("deleted text")
2.1.3 MEETINGS
(a) Schedule of Meetings; Agenda. The JEC shall establish a
schedule of times for regular meetings, taking into account the planning needs
of the Collaboration and its responsibilities. Special meetings of the JEC may
be convened by any member upon ("deleted text") (or, if such meeting is proposed
to be conducted by teleconference, upon ("deleted text") written notice to the
other members; provided that (i) notice of any such special meeting may be
waived at any time, either before or after such meeting, and such waiver shall
be the equivalent to the giving of a valid notice hereunder, and (ii) attendance
of any member at a special meeting shall constitute a valid waiver of notice
from such member. In no event shall the JEC meet less frequently than twice in
each Calendar Year. Regular and special meetings of the JEC may be held in
person or by teleconference or videoconference; provided that meetings held in
person shall alternate between the respective offices of the Parties. The Chair
shall prepare and circulate to each JEC member an agenda for each JEC meeting
not later than one (1) week prior to such meeting.
(b) Quorum; Voting; Decisions. At each JEC meeting (i) the
presence in person of at least two (2) members designated by each Party shall
constitute a quorum. The JEC shall use reasonable efforts in good faith to
resolve by unanimous consent any issue within its jurisdiction. Alternatively,
the JEC may act by written consent signed by at least one (1) member designated
by each Party, subject to Section 2.1.5. Whenever any action by the JEC is
called for hereunder during a time period in which the JEC is not scheduled to
meet, the chair of the JEC shall cause the JEC to take the action in the
requested time period by calling a special meeting or by circulating a draft
written consent. ("deleted text") Representatives of each Party or of its
Affiliates who are not members of the JEC, and consultants who are subject to
confidentiality obligations no less stringent than those contained herein, may
attend JEC meetings as non-voting observers with the consent of the other Party,
which shall not be unreasonably withheld, conditioned or delayed.
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(c) Minutes. The JEC shall keep minutes of its meetings that
record all decisions and all actions recommended or taken in reasonable detail.
Drafts of the minutes shall be prepared and circulated to the members of the JEC
within a reasonable time after the meeting, not to exceed ("deleted text"). The
chair of the JEC shall have responsibility for the preparation and circulation
of draft minutes. Each member of the JEC shall have the opportunity to provide
comments on the draft minutes. The minutes shall be approved, disapproved and
revised as necessary at the next JEC meeting or within ("deleted text") of the
meeting, whichever occurs first. Upon approval, final minutes of each meeting
shall be circulated to the members of the JEC by the chair of the JEC.
(d) Expenses. WARATAH and ELAN shall each bear all expenses of
their respective JEC members related to their participation on the JEC and
attendance at JEC meetings.
2.1.4 RESPONSIBILITIES. The JEC shall be responsible for (a)
overseeing the conduct and progress of the Development and Commercialization of
the Product, and (b) providing a forum for the exchange of information between
the Parties with respect to the Development and Commercialization of the
Product; ("deleted text"). Without limiting the generality of the foregoing, the
JEC shall have the following responsibilities:
(a) overseeing the JLT's performance of its responsibilities;
(b) reviewing the Annual Budget, the Development Plan and Product
Commercialization Plan; ("deleted text");
(c) reviewing any amendment, modification or update to the Annual
Budget or the Development Plan;
(d) reviewing data, reports or other information submitted to it
by the JLT from time to time;
(e) discussing the progress of the Commercialization of the
Product in accordance with the applicable Product Commercialization Plan,
("deleted text");
(f) resolving all JLT matters that are in dispute;
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(g) making such other decisions as may be delegated to the JEC
pursuant to this Agreement or by mutual written agreement of the Parties after
the Effective Date; and
(h) reviewing and approving any amendment, modification or update
to the Annual Budget and the Development Plan, ("deleted text")
(i) determining whether or not a milestone listed in Section 4.2 has been
met.
(j) discussing the necessity for a Third Party License for
intellectual property covering a formulation incorporating the Product that the
Parties mutually agree will enhance the patent protection for the Product
("Third Party Formulation License"), ("deleted text").
2.1.5 DISPUTE RESOLUTION. The JEC members shall use reasonable efforts
to reach agreement on any and all matters. In the event that, despite such
reasonable efforts, agreement on a particular matter cannot be reached by the
JEC within("deleted text") after the JEC first meets to consider such matter,
then, ("deleted text").
2.2 JOINT LEADERSHIP TEAM
2.2.1 ESTABLISHMENT. WARATAH and ELAN hereby establish the Joint
Leadership Team. The JLT shall have and perform the responsibilities set forth
in Section 2.2.4.
2.2.2 MEMBERSHIP. Each Party shall designate, in its sole discretion,
up to three (3) members to the JLT (which members shall be employees or
consultants of such Party or an Affiliate of such Party). Unless otherwise
agreed by the Parties, one of ELAN's designees shall be designated by ELAN as
the chair of the JLT. Each Party shall have the right at any time to substitute
individuals, on a permanent or temporary basis, for any of its previously
designated representatives to the JLT. Initial designees of the Parties to the
JLT shall be as follows:
For WARATAH:
("deleted text")
For ELAN:
("deleted text")
2.2.3 MEETINGS
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(a) Schedule of Meetings; Agenda. Meetings of the JLT may be held
in person or by teleconference or videoconference. The Chair shall prepare and
circulate to each JLT member an agenda for each JLT meeting prior to such
meeting. The JLT shall meet at least twice each Calendar Year.
(b) Quorum; Voting; Decisions. At each JLT meeting, (i) the
presence in person of at least two (2) members designated by each Party shall
constitute a quorum and (ii) all members designated by each Party who are
present shall have one collective vote on all matters before the JLT at such
meeting. All decisions of the JLT shall be made by unanimous vote.
Alternatively, the JLT may act by written consent signed by at least two (2)
members designated by each Party. Whenever any action by the JLT is called for
hereunder during a time period in which the JLT is not scheduled to meet, the
Chair shall cause the JLT to take the action in the requested time period by
calling a special meeting or by circulating a written consent. Representatives
of each Party or of its Affiliates who are not members of the JLT may attend JLT
meetings as non-voting observers. In the event that the JLT is unable to resolve
any matter before it, such matter shall be referred to the JEC to be resolved in
accordance with Section 2.1.5.
(c) Minutes. The JLT shall keep minutes of its meetings that
record all decisions and all actions recommended or taken in reasonable detail.
Drafts of the minutes shall be prepared and circulated to the members of the JLT
within a reasonable time after the meeting. The chair shall have responsibility
for the preparation and circulation of draft minutes. Each member of the JLT
shall have the opportunity to provide comments on the draft minutes. The minutes
shall be approved, disapproved and revised as necessary at the next JLT meeting.
Upon approval, the chair of the JLT shall circulate final minutes of each
meeting to the members of the JLT.
(d) Expenses. WARATAH and ELAN shall each bear all expenses of
their respective JLT members related to their participation on the JLT and
attendance at JLT meetings.
2.2.4 RESPONSIBILITIES. The JLT shall be responsible for overseeing
the conduct and progress of the Development Program. Without limiting the
generality of the foregoing, the JLT shall have the following responsibilities:
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(a) preparing or directing the preparation of, and recommending
to the JEC for its approval, the Annual Budget and the Development Plan;
(b) preparing or directing the preparation of all amendments to
the JEC-approved Annual Budget and/or Development Plan as it deems appropriate
in furtherance of the objectives of the Development Program and submitting such
amendments to the JEC for its consideration;
(c) monitoring the progress of, and expenditures under, the
Annual Budget and the Development Plan and of each Party's activities thereunder
and determining if any changes may be necessary in view of the progress and the
results of the Development Program;
(d) providing a forum for consensual decision making with respect
to the Development Program;
(e) reviewing data, reports or other information submitted by
either Party with respect to work conducted in the Development Program;
(f) preparing for the JEC on at least a semi-annual basis a
progress report for the Development Program in reasonable detail and providing
to the JEC such additional information as it may request;
(g) preparing for the JEC on at least an annual basis a
reasonably detailed progress report regarding the Development of the Product and
providing to the JEC such additional information as it may reasonably request on
this subject;
(h) discussing strategies for the promotion and marketing of the
Product("deleted text");
(i) making any other decisions and performing such activities as
may reasonably be delegated to the JLT pursuant to this Agreement or by mutual
written agreement of the Parties after the Effective Date;
(j) establishing a subcommittee within ("deleted text") of the
Effective Date to oversee and develop the patent strategy, including patent
prosecution and filing strategies, with respect to WARATAH Patent Rights and
Joint Patent Rights. The subcommittee shall
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comprise the Patent Coordinators appointed in accordance with Section 7.4, and a
member of the JLT from each Party with management experience in the development
of pharmaceutical products. In the event, despite the reasonable efforts of the
subcommittee, agreement on a particular matter cannot be reached by the
subcommittee, the matter shall be referred to the JEC. In the event the JEC is
unable to reach a decision with respect to any such matter, then such matter
shall be resolved in accordance with Section 2.1.5.
2.2.5 ALLIANCE MANAGEMENT. Each Party shall appoint a person who shall
oversee contact between the Parties for all matters related to the Collaboration
between meetings of the JEC and JLT and shall have such other responsibilities
as the Parties may mutually agree in writing after the Effective Date (each, a
"Collaboration Manager"). Each Party may replace its Collaboration Manager at
any time. The initial Collaboration Managers shall be:
For WARATAH: ("deleted text")
For ELAN: ("deleted text")
3. DEVELOPMENT PROGRAM; COMMERCIALIZATION OF PRODUCTS
3.1 OBJECTIVES OF THE DEVELOPMENT PROGRAM
In accordance with the terms of this Agreement, within the Field and
Territory, the Parties agree to: (a) engage in a Development Program to Develop
a Product to enable the Commercialization of the Product; and (b) engage in
Commercialization of the Product with the goal of realizing the economic
potential of the Product and allowing both Parties to benefit from realization
of such potential and share in the profitability of the Product. The guiding
principles to be followed by the Parties include the following: achieve synergy
and avoid duplication of resources; maximize the profitability of the Product
over its life; utilize to the extent practicable the then-prevailing
infrastructure and expertise of each Party with respect to specific activities
in the Development Program and Product Commercialization Plan; and, except as
otherwise permitted in this Agreement (e.g., through Sublicense Agreements or
co-promotion arrangements), the Parties shall collaborate exclusively and
diligently with each other and neither Party shall alone or in collaboration
with or through the grant of any rights to any Third Party, research, Develop,
make, import, export, distribute, offer for sale, or otherwise Commercialize
Product for use in the Field.
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3.2 RESPONSIBILITY FOR DEVELOPMENT OF AND COMMERCIALIZATION OF THE PRODUCT
ELAN and WARATAH shall conduct all aspects of the Development of the
Product in accordance with the Annual Budget and the Development Plan, and all
aspects of the Commercialization of Products in accordance with the Product
Commercialization Plan, subject to the oversight of the JLT and JEC and
("deleted text"), through its representatives on the JEC and the JLT. ELAN or an
Affiliate shall own and shall be responsible for, obtaining and maintaining all
Regulatory Approvals, any DMF with respect to the Product and all necessary
manufacturing license approvals for the manufacture of the Product at an ELAN
facility. WARATAH will transfer to ELAN the U.S. and Canadian INDs for AZD-103
within ("deleted text") of the Effective Date subject to any delays occasioned
by the FDA or Health Canada. Obligations specific to safety data transfer or
data exchange between the Parties are to be described in a safety data exchange
agreement to be entered into between the Parties within ("deleted text") of the
("deleted text").
3.3 ANNUAL BUDGET AND DEVELOPMENT PLAN
The initial Annual Budget and the initial Development Plan for the time
period commencing on ("deleted text") and ending the earlier of ("deleted text")
are attached to this Agreement as Exhibits A and B, respectively. Thereafter,
for each Calendar Year during the Term, the JLT shall prepare and submit to the
JEC for its review, an Annual Budget and a Development Plan for the Product.
Each Annual Budget shall set forth the budget for the Calendar Year covered by
the Annual Budget. Each Development Plan shall: (a) set forth (i) the
Development objectives, activities, priorities and timelines for the Calendar
Year covered by the Development Plan with reasonable specificity, (ii) the
expected Regulatory Filings and Drug Approval Applications to be prepared and
filed and the expected timetable of completing such Development activities; and
(b) be consistent with the other terms of this Agreement. Each amendment,
modification and update to any such Annual Budget and Development Plan shall
include the resulting changes to the budget and shall be set forth in a written
document prepared by the JLT and submitted to the JEC.
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3.4 PRODUCT COMMERCIALIZATION PLANS
Within ("deleted text") after the Initiation of the first Phase III
Clinical Trial for the Product, ("deleted text"), ELAN shall prepare and provide
to the JLT for its review and discussion a Product Commercialization Plan for
the Product in the applicable countries in the Territory, and shall update and
submit such Product Commercialization Plan to the JLT for review and discussion
not less than annually; ("deleted text").
3.5 DEVELOPMENT AND COMMERCIALIZATION DILIGENCE
ELAN and its Affiliates shall exercise Commercially Reasonable Efforts
during the Term to Develop and Commercialize the Product in the United States,
Canada and the Major Countries. WARATAH and its Affiliates shall exercise
Commercially Reasonable Efforts during the Term to Develop the Product.
3.6 COMPLIANCE AND COOPERATION
Each Party shall perform its obligations under each Annual Budget and
Development Plan, the Product Commercialization Plan and this Agreement using
Commercially Reasonable Efforts in good faith and in compliance in all material
respects with all Applicable Laws. Scientists at WARATAH and ELAN shall
cooperate in the performance of the Development Program and Product
Commercialization Plan, subject to the terms of this Agreement and any
confidentiality obligations to Third Parties, and shall exchange such data,
information and materials as are reasonably necessary for the other Party to
perform its obligations under any Annual Budget and Development Plan.
3.7 EXCHANGE OF REPORTS
3.7.1 DEVELOPMENT PROGRAM REPORTS. Each Party shall keep the JLT
generally informed of the progress of its efforts to Develop the Product.
Before, during or after any JLT meeting, ELAN and WARATAH will provide the JLT
with copies of any presentations or summaries that they have each created
relating to their activities performed in connection with the Development
Program. ("deleted text").
3.7.2 COMMERCIALIZATION REPORTS. ELAN shall keep the JLT generally
informed of the progress of ELAN's efforts to Commercialize the Product in the
Territory
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through periodic updates. ELAN will provide to the JEC a written report
summarizing in reasonable detail its activities performed in connection with the
Product Commercialization Plan during the preceding year, ("deleted text").
3.8 FUNDING
3.8.1 ELAN FUNDING OBLIGATION. Subject to WARATAH's funding
obligations in accordance with this Section 3.8, ELAN shall fund or arrange for
funding of all Development Costs and Commercialization Costs including the Cost
of Goods.
3.8.2 WARATAH FUNDING OBLIGATION. Prior to the Commercialization of
the Product, WARATAH shall fund that amount of Development Costs and
Commercialization Costs incurred ("deleted text") equal to the WARATAH
Development Percentage multiplied by the amount of such Development Costs and
Commercialization Costs. ("deleted text").
3.8.3 INCREASE IN WARATAH DEVELOPMENT PERCENTAGE. WARATAH may,
within("deleted text") elect to increase the WARATAH Development Percentage from
("deleted text") up to ("deleted text") (in whole number increments).
3.8.4 WARATAH SHARE OF SUBLICENSE INCOME PRIOR TO COMMERCIALIZATION.
Prior to Commercialization of the Product and provided WARATAH has not opted out
in accordance with Section 3.8.6, WARATAH shall share in the fraction of
Sublicense Income in the Territory equal to the WARATAH Development Percentage
multiplied by the applicable Sublicense Income.
3.8.5 WARATAH SHARE OF OPERATING INCOME (LOSS). Subsequent to the
Commercialization of the Product and provided WARATAH has not opted out in
accordance with Section 3.8.6, WARATAH shall share in the fraction of Operating
Income (Loss) derived from the Product in the Territory equal to the WARATAH
Development Percentage multiplied by the applicable Operating Income (Loss) for
the Product in the Territory.
3.8.6 WARATAH FAILURE TO PAY AND OPT-OUT.
(a) Failure to Pay. If WARATAH does not timely pay ELAN the
amounts WARATAH owes under Section 3.8.2 or Section 3.8.5 as the case may be,
and if ELAN notifies WARATAH of such failure to pay, and the under payment, plus
interest, is not
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paid within ("deleted text") of when it was originally due or WARATAH has not
opted out of its funding obligations in accordance with Section 3.8.6(b),
("deleted text").
(b) Opt Out. WARATAH may opt out of funding the Development Costs
and Commercialization Costs hereunder by giving notice of such opting out to
ELAN ("Opt Out Notice") not earlier than("deleted text") If WARATAH does so opt
out, WARATAH will no longer be entitled to receive a percentage of Operating
Income (Loss) under Section 3.8.5, or except as provided below, milestone
payments payable under Section 4.2 subsequent to the date of the Opt Out Notice
and instead ELAN shall pay WARATAH the following amounts:
(i) Running royalties on worldwide aggregate Net Sales calculated on an
annual basis according to the following royalty rates:
(1) For Opt Out Net Sales less than ("deleted text");
(2) For Opt Out Net Sales equal to or greater than ("deleted
text"); and
(3) For Opt Out Net Sales equal to or greater than ("deleted
text").
(ii) ("deleted text") of all Sublicense Income (excluding royalties payable
to ELAN by a Sublicensee) received by ELAN and its Affiliates within ("deleted
text")of receipt of such Sublicense Income.
(iii) ("deleted text") of milestones payments payable under Article 4 after
the date WARATAH opts out.
("deleted text").
3.8.7 THIRD PARTY LICENSE ROYALTY ADJUSTMENT. With the exception of
Third Party License Fees paid by ELAN pursuant to a Third Party Formulation
License subject to Section 3.8.8, if WARATAH has opted out in accordance with
3.8.6 (b) and ELAN pays any Third Party License Fees, then the amounts to be
paid to WARATAH in accordance with Subsections 3.8.6 (b) (i)(2) or (3) shall be
reduced by ("deleted text").
3.8.8 THIRD PARTY FORMULATION LICENSE ROYALTY ADJUSTMENT. If WARATAH
has opted out in accordance with 3.8.6 (b) and ELAN pays Third Party License
Fees in respect to a Third Party Formulation License approved by the JEC in
accordance with Section 2.1.4(j), the
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amounts to be paid to WARATAH in accordance with Subsections 3.8.6 (b)(i) (1)
(2) or (3) shall be reduced by("deleted text").
3.8.9 CO-PROMOTION OR SUBLICENSE ROYALTY ADJUSTMENT. If WARATAH has
opted out in accordance with 3.8.6(b) and the Opt Out Net Sales by Sublicensees
and Co-promoters in a Calendar Year are greater than ("deleted text") of the
total Opt Out Net Sales for such period, ELAN, solely for purposes of
calculating royalty payments in such period under Section 3.8.6(b)(i)(3), may
reduce the Opt Out Net Sales in excess of ("deleted text").
3.8.10 CHANGES IN ESTIMATED DEVELOPMENT OR COMMERCIALIZATION COSTS. If
ELAN amends or adjusts its estimate, or exceeds the budget, for Development
Costs and Commercialization Costs with respect to the Product, WARATAH shall
("deleted text").
3.8.11 WARATAH DEVELOPMENT PERCENTAGE INCREASE FEE. If WARATAH elects
to increase the WARATAH Development Percentage it will, upon such election,
("deleted text").
3.8.12 ESTIMATED DEVELOPMENT COSTS. In ("deleted text") of each
Calendar Year ELAN and WARATAH shall provide each other with their respective
non-binding, good faith estimates of all Development Costs and Commercialization
Costs that each expects to incur with respect to the Product in the second half
of the Calendar Year.
3.8.13 RECONCILIATION AND AUDITING OF DEVELOPMENT COSTS AND
COMMERCIALIZATION COSTS AND OPERATING INCOME (LOSS).
(a) Reconciliation of Development Costs and Commercialization Costs.
Within ("deleted text") following the end of each Quarter each of WARATAH and
ELAN shall submit to the other Party a written report setting forth in
reasonable detail, and subsequently, if requested, reasonable supporting
documentation, all Development Costs and Commercialization Costs incurred by
each such Party over such Quarter. By the later of ("deleted text") or within
("deleted text")following the receipt by ELAN of WARATAH's written report, ELAN
shall prepare and submit to WARATAH a written report setting forth in reasonable
detail (a) the calculation of all such Development Costs and Commercialization
Costs incurred and charged and how the costs are allocated by both Parties over
such Quarter and (b) the calculation of the net amount owed by WARATAH to ELAN
or by ELAN to WARATAH in order to ensure the
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appropriate sharing of such Development Costs and Commercialization Costs in
accordance with the terms of this Agreement. The net amount payable shall be
paid by WARATAH or ELAN to the other, as applicable, within ("deleted text")
after the receipt of such written report by WARATAH or ELAN, as the case may be.
(b) Reports following Regulatory Approval. Following receipt of
Commercialization Regulatory Approval for the Product ELAN shall be responsible
for issuing a written report (each, a "Quarterly Report") to WARATAH by the
later of within ("deleted text") after the end of the ("deleted text") or
("deleted text") following receipt by ELAN of WARATAH's written report described
in paragraph (a) above, which Quarterly Report shall include the following
calculations for such preceding Quarter: (i) the quantity of Product sold by
ELAN or its Affiliates, Sublicensees or Co-promoters; (ii) the calculation of
Net Sales or Opt Out Net Sales with respect to the Product; (iii) the amount of
Sublicense Income and Operating Income (Loss) or royalties due to WARATAH; and
(iv) the amount of Operating Income (Loss) that each Party is entitled or
obligated to, or amount of royalties if WARATAH has opted out in accordance with
Section 3.8.6(b) based on the terms of this Agreement.
(c) Records; Audit Rights. Each Party shall keep and maintain for
three (3) years records of Development Costs and Commercialization Costs
incurred with respect to the Product, and, in ELAN's case, Operating Income
(Loss), Sublicense Income, and Net Sales or Opt Out Net Sales of the Product in
sufficient detail to enable tracking of such Development Costs,
Commercialization Costs, Operating Income (Loss), Net Sales or Opt Out Net Sales
and Sublicense Income and to allow confirmation of same by the other Party. Each
Party shall have the right for a period of ("deleted text") after such
Development Costs and Commercialization Costs, Sublicense Income, Net Sales, Opt
Out Net Sales or Operating Income (Loss) are incurred to appoint at its expense
an independent certified public accountant reasonably acceptable to the other
Party to audit the relevant records of the other Party and its Affiliates to
verify that the amounts of such Development Costs and Commercialization Costs,
Operating Income (Loss), Sublicense Income, Opt Out Net Sales or Net Sales were
correctly determined. The audited Party and its Affiliates shall each make its
records available for audit by such independent certified public accountant
during regular business hours at such place or places where such records are
customarily kept, upon ("deleted text") written notice from the auditing Party,
solely
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to verify that such Development Costs and Commercialization Costs, Operating
Income (Loss), Sublicense Income, Net Sales, or Opt Out Net Sales were correctly
determined. Such audit right shall not be exercised by the auditing Party more
than once in any Calendar Year and no period may be audited more than once. All
records made available for audit shall be deemed to be Confidential Information
of the audited Party. The results of each audit, if any, shall be reported in
writing to both Parties promptly (but in no event later than ("deleted text")
after the audit and shall be binding on both Parties. In the event there was an
error in the amount of Development Costs, Commercialization Costs, or Operating
Income (Loss) reported by the audited Party hereunder, (a) if the amount of such
costs or payments was over reported, the audited Party shall promptly (but in
any event no later than ("deleted text") after the audited Party's receipt of
the report so concluding) make payment to the auditing Party of the amount
required to achieve the appropriate sharing of such costs and (b) if the amount
of such costs, or income or loss was under reported, the auditing Party shall
promptly (but in any event no later than ("deleted text") after the auditing
Party's receipt of the report so concluding) make payment to the audited Party
of the amount required to achieve the appropriate sharing of such costs or
income or loss. The auditing Party shall bear the full cost of such audit unless
such audit discloses an under-payment by the audited Party of more than("deleted
text") of the relevant amount of Development Costs and Commercialization Costs,
Operating Income (Loss), or royalties in any Calendar Year, in which case the
audited Party shall reimburse the auditing Party for all costs incurred by the
auditing Party in connection with such audit. If the discrepancy is an
under-payment of royalties to WARATAH, the amount of such underpayment shall be
paid to WARATAH within ("deleted text") of receiving a copy of the audit report.
If the discrepancy is an over-payment of royalties to WARATAH, the amount of
such over-payment of royalties shall be paid to ELAN within ("deleted text") of
receiving a copy of the audit report.
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3.9 PRODUCT RECALLS
In the event that any Regulatory Authority issues or requests a recall or
takes similar action in connection with the Product, or in the event a Party
reasonably believes that an event, incident or circumstance has occurred that
may result in the need for a recall, market withdrawal or other corrective
action regarding the Product, such Party shall promptly advise the other Party
thereof by telephone or facsimile. Following such notification, ("deleted
text").
4. LICENSE AND MILESTONE PAYMENTS
4.1 LICENSE FEES
ELAN shall pay WARATAH a license fee in the amount of seven million five
hundred thousand dollars (US $7,500,000) by wire transfer within ("deleted
text") according to instructions that WARATAH shall provide. Unless this
Agreement has been earlier terminated, ELAN will pay WARATAH a second license
fee of seven million five hundred thousand dollars (US $7,500,000) by wire
transfer within ("deleted text").
4.2 MILESTONE PAYMENTS
ELAN shall make each of the following payments to WARATAH within ("deleted
text") after the occurrence of the following milestone events.
MILESTONE EVENT PAYMENTS
--------------- --------
1. ("deleted text") ("deleted text")
2. ("deleted text") ("deleted text")
3. ("deleted text") ("deleted text")
4. ("deleted text") ("deleted text")
5. ("deleted text") ("deleted text")
6. ("deleted text") ("deleted text")
7. ("deleted text") ("deleted text")
8. ("deleted text") ("deleted text")
9. ("deleted text") ("deleted text")
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4.3 OVERDUE PAYMENTS
All payments not made within the time period specified in this Agreement
shall bear interest at a rate of ("deleted text") per month from the due date
until paid in full or, if less, the maximum interest rate permitted by
Applicable Laws.
4.4 PAYMENTS
All amounts set out in this Agreement are denoted in US Dollars and all
payments made by a Party hereunder shall be made by wire transfer in US Dollars
in accordance with instructions given in writing from time to time by the other
Party.
4.5 TAXES
("deleted text").
5. TREATMENT OF CONFIDENTIAL INFORMATION; PUBLICITY; NON-SOLICITATION
5.1 CONFIDENTIALITY
5.1.1 CONFIDENTIALITY OBLIGATIONS. WARATAH and ELAN each recognizes
that a Disclosing Party's Confidential Information and Proprietary Materials
constitute highly valuable assets of such Disclosing Party. A Receiving Party
agrees that, subject to Section 5.1.2, it will not disclose, and will cause its
Affiliates, Sublicensees and Co-promoters not to disclose, any Confidential
Information or Proprietary Materials of the Disclosing Party and it will not
use, and will cause its Affiliates, Sublicensees and Co-Promoters not to use,
any Confidential Information or Proprietary Materials of a Disclosing Party
except as expressly permitted hereunder; provided that such obligations shall
apply during the Term and ("deleted text").
5.1.2 LIMITED DISCLOSURE. WARATAH and ELAN each agrees that disclosure
of its Confidential Information or any transfer of Proprietary Materials may be
made by a Receiving Party to any employee, consultant or Affiliate of such
Receiving Party to enable such Receiving Party to exercise its rights or to
carry out its responsibilities under this Agreement; provided that any such
disclosure or transfer shall only be made to Persons who are bound by written
obligations as described in Section 5.1.3. In addition, WARATAH and ELAN each
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agrees that the Receiving Party may disclose its Confidential Information (a) on
a need-to-know basis to the Receiving Party's legal and financial advisors, (b)
as reasonably necessary in connection with an actual or potential (i) permitted
sublicense of such Receiving Party's rights hereunder, (ii) debt or equity
financing of such Receiving Party or (iii) Change of Control involving such
Receiving Party, (c) to any Third Party that is or may be engaged by such
Receiving Party to perform services in connection with the Development Program,
and (d) for any other purpose with the Disclosing Party's written consent, not
to be unreasonably withheld, conditioned or delayed; provided, that, (A) in the
case of subsections (b)(i) and (iii) and (c) above, the Receiving Party and the
applicable Third Party first enter into a Confidentiality Agreement with terms
no less stringent than those contained in the Confidentiality Agreement between
the Parties, and (B) in the case of subsections (a) and (b)(ii) above, the
Receiving Party uses good faith efforts to enter into a Confidentiality
Agreement with the applicable Third Party with terms no less stringent than
those contained in the Confidentiality Agreement between the Parties. Further
each Party agrees that the Receiving Party may disclose the Disclosing Party's
Confidential Information or Proprietary Materials (A) as reasonably necessary to
file, prosecute or maintain Patent Rights, or to file, prosecute or defend
litigation related to Patent Rights in accordance with this Agreement; (B) as
necessary to Develop and Commercialize the Product under this Agreement; and (C)
as required by Applicable Laws; provided, that, in the case of any disclosure
under this clause (C), the Receiving Party shall (1) if practicable, provide the
Disclosing Party with reasonable advance notice of and an opportunity to comment
on any such required disclosure and (2) if requested by the Disclosing Party,
cooperate in all reasonable respects with the Disclosing Party's efforts to
obtain confidential treatment or a protective order with respect to any such
disclosure, at the Disclosing Party's expense.
5.1.3 EMPLOYEES AND CONSULTANTS. WARATAH and ELAN each hereby
represents that all of its employees and consultants, and all of the employees
and consultants of its Affiliates, who participate in the activities of the
Collaboration or have access to Confidential Information or Proprietary
Materials of the other Party are or will, prior to their participation or
access, be bound by obligations to maintain such Confidential Information or
Proprietary Materials in confidence and not to use such information except as
expressly permitted hereunder. Each Party agrees to use, and to cause its
Affiliates to use, reasonable efforts to enforce such obligations.
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5.2 PUBLICITY
The Parties acknowledge that the terms of this Agreement constitute
Confidential Information of each Party and may not be disclosed except as
permitted by Section 5.1.2. However, notwithstanding anything to the contrary in
Section 5.1, WARATAH, upon the execution of this Agreement, may issue a press
release with respect to this Agreement, in the form attached as Schedule 2, and
either Party may make subsequent public disclosure of the contents of such press
release without further approval of the other Party. After issuance of such
press release, except as required by Applicable Laws, neither Party shall issue
a press or news release or make any similar public announcement (it being
understood that publication in scientific journals, presentation at scientific
conferences and meetings and the like are intended to be covered by Section 5.3
and not subject to this Section 5.2) related to the Development Program without
the prior written consent of an authorized representative of the other Party.
5.3 PUBLICATIONS AND PRESENTATIONS
Each Party agrees that, except as required by Applicable Laws, it shall not
publish or present, or permit to be published or presented, the results of or
information pertaining to the Annual Budget or the Development Plan, without the
prior review by and approval of an authorized representative of the other Party.
Further, WARATAH shall not publish or present, or allow to be published or
presented any information pertaining to (a) Development of the Product or (b)
any Commercialization activities, without the prior review by and approval of an
authorized representative of ELAN. ELAN shall be free to publish and present
results of Development, including details regarding the Product, in accordance
with the remainder of this Section 5.3.
The Parties acknowledge that scientific publications and public
presentations must be strictly monitored to prevent any adverse effect from
premature publication or dissemination of results of the activities hereunder,
including adverse effects on patentability. Accordingly, each Party shall
provide to the other Party the opportunity to review each of the submitting
Party's proposed abstracts, manuscripts or public presentations (including,
without limitation, information to be presented verbally to the public)
(collectively "Publications") that relate to the Product or to the Development
Program at least ("deleted text") prior to its intended public presentation or
submission for publication, and such submitting Party agrees, upon written
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32
request from the other Party given within such ("deleted text"), not to submit
or present such Publication until the other Party is given up to ("deleted
text") from the date of such written request to seek appropriate patent
protection for any material in such intended publication or public presentation
that it reasonably believes may be patentable. If ELAN makes a reasonable
showing why such Publication may adversely affect patent prosecution or patent
procurement strategies which can not be cured by filing a patent application to
cover the disclosure, WARATAH agrees to remove the interfering portion from its
Publication, or if redaction is not possible, not to publish or present the
Publication. Further, WARATAH agrees to provide AZD-103 and Derivatives and
WARATAH Technology to academic researchers or collaborators under material
transfer agreements or confidentiality agreements that provide WARATAH with the
right to review potential Publications concerning AZD-103 and Derivatives and to
exercise the protections provided for in this Section 5.3 or such other
protections agreed to by the Parties. Once such abstracts, manuscripts or
presentations have been reviewed and approved by each Party, the same abstracts,
manuscripts or presentations, respectively, do not have to be provided again to
the other Party for review for a later submission for publication. Each Party
also shall have the right to require that any of its Confidential Information
that is disclosed in any such proposed publication or public presentation be
deleted prior to such publication or presentation. In any permitted publication
or public presentation by a Party, the other Party's contribution shall be duly
recognized, and co-authorship shall be determined in accordance with customary
scientific standards.
6. LICENSE GRANTS
6.1 WARATAH LICENSE GRANTS
Subject to the terms and conditions of this Agreement, WARATAH hereby
grants to ELAN and its Affiliates an exclusive (except to the extent necessary
for WARATAH to conduct WARATAH Development Activities), license in the Territory
in the Field during the Term, under the Licensed Technology and Licensed Patent
Rights, including WARATAH's interest in the Joint Technology and Joint Patent
Rights, to make and use the Product for the sole purpose of researching,
Developing and Commercializing the Product (including, but not limited to, the
right to make, use, sell, have sold, offer to sell, distribute for sale, import,
have imported, make or have made the Product) in the Territory in the Field.
("deleted text"). The foregoing licenses
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include the right to grant sublicenses and co-promotion rights to Third Parties
provided that the terms of any Sublicense Agreements and co-promotion agreements
shall, in general, be subject in applicable respects to the provisions contained
in this Agreement, provided, ("deleted text") Such agreements shall include a
requirement that the Sublicensee or Co-Promoter use commercially reasonable
efforts to fulfill such Sublicensee's or Co-promoter's obligations under such
Sublicense Agreement or co-promotion agreement. ("deleted text").
6.2 ELAN LICENSE GRANTS
Subject to the terms and conditions of this Agreement, ELAN hereby grants
to WARATAH and its Affiliates a non-exclusive, royalty-free license in the
Territory during the Term, without the right to grant sublicenses, under ELAN
Technology and ELAN Patent Rights for the sole purpose of conducting WARATAH
Development Activities.
6.3 ACADEMIC AGREEMENTS
ELAN acknowledges that WARATAH has certain agreements, material transfer
agreements and research agreements with academic institutions/investigators
involving AZD-103 Derivatives and Products ("Academic Agreements") that are all
identified in Schedule 3. ("deleted text").
7. INTELLECTUAL PROPERTY RIGHTS
7.1 WARATAH INTELLECTUAL PROPERTY RIGHTS
WARATAH shall Control WARATAH Technology and WARATAH Patent Rights, except
to the extent of the license granted to ELAN under Section 6.1.
7.2 ELAN INTELLECTUAL PROPERTY RIGHTS
ELAN shall have sole and exclusive ownership of all right, title and
interest on a worldwide basis in and to any and all ELAN Technology and ELAN
Patent Rights, except to the extent of the license granted to WARATAH under
Section 6.2.
7.3 JOINT TECHNOLOGY RIGHTS
ELAN and WARATAH shall jointly own all Joint Technology and Joint Patent
Rights, but shall only be permitted to use such rights to further the
Collaboration.
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7.4 PATENT COORDINATORS
WARATAH and ELAN shall each appoint a patent coordinator reasonably
acceptable to the other Party (each, a "Patent Coordinator") to serve as such
Party's primary liaison with the other Party on matters relating to patent
filing, prosecution, maintenance and enforcement. Each Party may replace its
Patent Coordinator at any time by notice in writing to the other Party. The
initial Patent Coordinators shall be:
For WARATAH: ("deleted text")
For ELAN: ("deleted text")
7.5 INVENTORSHIP
In case of a dispute between WARATAH and ELAN over inventorship and, as a
result, whether any particular Technology is WARATAH Technology, ELAN Technology
or Joint Technology, such dispute shall be resolved by patent counsel who (and
whose firm) is not at the time of the dispute, and was not at any time during
the ("deleted text") prior to such dispute, performing services for either of
the Parties, such patent counsel to be selected by mutual written agreement of
the Patent Coordinators. The fees for, and expenses of, such patent counsel
shall be shared equally by the Parties.
7.6 COOPERATION
Each Party shall cooperate with the other Party to effect the intent of
this Article 7, including without limitation by executing documents and making
its employees and independent contractors available to execute documents as
necessary to achieve the foregoing allocation of ownership rights.
8. INTELLECTUAL PROPERTY
8.1 PATENT FILING, PROSECUTION AND MAINTENANCE
8.1.1 ELAN'S PROSECUTION RIGHTS. ELAN, acting through the subcommittee
under Section 2.2.4(j), and outside patent counsel or agents reasonably
acceptable to WARATAH, shall be responsible for the planning, preparation,
filing, prosecution and maintenance of Licensed Patent Rights and Joint Patent
Rights. At ELAN's request, WARATAH shall cooperate with ELAN in all reasonable
respects in connection with such preparation, filing, prosecution and
maintenance of such Licensed Patent Rights, including but
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35
not limited to: providing inventor or expert affidavits and technical data and
interpretation in support of prosecution; obtaining assignments to reflect chain
of title consistent with the terms of this Agreement; listing eligible patents
in the FDA's Orange Book pursuant to the provisions of 21 USC 355(b)(1) and
(c)(2); gaining United States patent term extensions, supplementary protection
certificates and any other extensions that are now or become available in the
future wherever applicable to Licensed Patent Rights.
8.1.2 INFORMATION AND COOPERATION. ELAN shall (a) regularly and
promptly provide WARATAH with copies of all prospective patent applications and
patent applications filed hereunder for Joint Patent Rights and Licensed Patent
Rights and other material submissions and correspondence with the patent
offices, in sufficient time to allow for review and comment by WARATAH; and (b)
provide WARATAH and its patent counsel with an opportunity to consult with ELAN
and its patent counsel regarding the filing and contents of any such
application, amendment, submission or response, and the advice and suggestions
of WARATAH and its patent counsel shall be taken into consideration in good
faith by ELAN and its patent counsel in connection with such filing.
8.1.3 ABANDONMENT. If ELAN decides to abandon or to allow to lapse any
of the Licensed Patent Rights or Joint Patent Rights, it shall notify WARATAH of
such decision promptly so as to provide WARATAH a reasonable amount of time to
meet any applicable deadline to establish or preserve such License Patent Rights
or Joint Patent Rights in such country or region. WARATAH shall have the right
to assume responsibility for continuing the prosecution of such Licensed Patent
Rights and Joint Patent Rights in such country or region and paying any required
fees to maintain such Licensed Patent Rights or Joint Patent Rights in such
country or region or defending such Licensed Patent Rights or Joint Patent
Rights, through patent counsel or agents of its choice, which shall be at
WARATAH's sole expense. WARATAH shall become an assignee of any such Joint
Patent Rights as a result of its assumption of any such responsibility. As of
the date of ELAN's notice, such Licensed Patent Rights and Joint Patent Rights
shall not be included in the Licensed Patent Rights licensed to ELAN under
Section 6.1. Upon transfer of such responsibility under this Section 8.1.3, ELAN
shall promptly deliver to WARATAH copies of all necessary files related to the
Licensed Patent Rights or Joint Patent Rights with respect to which
responsibility has been transferred and shall
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take all actions and execute all documents reasonably necessary for WARATAH to
assume such responsibility and to assign such Joint Patent Rights to WARATAH.
8.2 LEGAL ACTIONS
8.2.1 THIRD PARTY INFRINGEMENT.
(a) Notice. In the event either Party becomes aware of (i) any
possible infringement of any Licensed Patent Rights, ELAN Patent Rights, or
Joint Patent Rights through the Development or Commercialization of the Product,
or (ii) receives notice by an ANDA applicant of a certification under 21 USC
355(b)(2)(a) or 355(j)(2)(A)(vii) ("an ANDA patent certification") with respect
to any Licensed Patent Right (each, an "Infringement"), that Party shall
promptly notify the other Party and provide it with all details of such
Infringement of which it is aware (each, an "Infringement Notice").
(b) ELAN Right to Enforce.
(i) Enforcement of ELAN Background Technology Patent Rights.
In the event that any Infringement relates to any Patent Rights covering ELAN
Technology, ELAN shall have the sole right but not the obligation to enforce
such claim.
(ii) Enforcement of Other Patent Rights. In the event that
any Infringement relates to any Patent Rights that ELAN is responsible for
prosecuting pursuant to Sections 8.1.1 (other than a claim related to ELAN
Technology), ELAN shall have the first right (but not the obligation) to enforce
such claim, which may include the institution of legal proceedings or other
action; provided that, notwithstanding the foregoing, ELAN shall not admit the
invalidity or unenforceability of any Licensed or Joint Patent Rights or settle
any action without WARATAH's prior written consent.
ELAN shall keep WARATAH reasonably informed on a quarterly basis, in person
or by telephone, prior to and during any such enforcement. WARATAH shall assist
ELAN, upon request in taking any action to enforce any such Patent Rights and
shall join in any such action if deemed to be a necessary party. Except as
provided in this Agreement, ELAN shall incur no liability to WARATAH as a
consequence of such litigation or any unfavorable decision resulting therefrom,
including any decision holding any such claim invalid, not infringed or
unenforceable, provided that in the event that as a result of any action taken
by ELAN under this
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Section 8.2.1 any claim or counter claim is made against WARATAH, then ELAN
shall defend and indemnify WARATAH against any such claim or counterclaim
according to the indemnification procedures set forth in Section 12.3. All
costs, including without limitation attorneys' fees, relating to such legal
proceedings or other action shall be borne by ELAN. If ELAN does not take
commercially reasonable steps to xxxxx the Infringement of such Patent Rights
within ("deleted text") from any Infringement Notice (or("deleted text") in the
case of an Infringement resulting from an ANDA patent certification), then
WARATAH shall have the right and option to do so at its expense.
(c) Cooperation by the Parties. In any action, suit or proceeding
instituted under this Section 8.2.1, the Parties shall cooperate with and assist
each other in all reasonable respects. Upon the reasonable request of the Party
instituting such action, suit or proceeding, the other Party shall join such
action, suit or proceeding and shall be represented using counsel of its own
choice, at the requesting Party's expense. If ELAN lacks standing to initiate
legal proceedings under Section 8.2.1 and WARATAH has standing to initiate such
legal proceedings, then WARATAH shall initiate such legal proceedings at the
request and expense of ELAN.
(d) Allocation of Recoveries. Any amounts recovered by ELAN
pursuant to actions under Section 8.2.1, whether by settlement or judgment,
shall be allocated in the following order: ("deleted text").
8.2.2 DEFENSE OF CLAIMS.
(a) Notice. In the event that a Third Party alleges that the
conduct of the Development or Commercialization of the Product infringes a Third
Party's patent, the Party becoming aware of such allegation shall promptly
notify the other Party hereof, in writing, reasonably detailing the claim.
(b) Third Party Suit.
In the event that any action, suit or proceeding is brought against either Party
or any Affiliate or Sublicensee of either Party alleging the infringement of the
Patent Rights of a Third Party by reason of activities conducted pursuant to
this Agreement, (A) ELAN shall have the right and obligation to defend such
action, suit or proceeding at its sole expense; (B) WARATAH or any
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of its Affiliates or Sublicensees shall have the right to separate counsel at
its own expense in any such action, suit or proceeding and, if such action, suit
or proceeding has been brought against WARATAH or any of its Affiliates or
Sublicensees, WARATAH may elect to defend itself at its sole expense; and (C)
the Parties shall cooperate with each other in all reasonable respects in any
such action, suit or proceeding. Settlement costs, royalties paid in settlement
of any such suit, and the payment of any damages to the Third Party shall be
subject to sharing ("deleted text")
(c) Cooperation in Defense. The Parties shall cooperate with each
other in all reasonable respects in any action, suit or proceeding under this
Section 8.2.2. Each Party shall provide the other Party with prompt written
notice of the commencement of any such suit, action or proceeding, or of any
evidence or allegation of infringement of which such Party becomes aware, and
shall promptly furnish the other Party with a copy of each communication
relating to the alleged infringement that is received by such Party. The Party
that is a party to the action, suit or proceeding shall not admit the invalidity
of any patent within the Licensed Patent Rights, Joint Patent Rights or ELAN
Patent Rights, nor settle such action, suit or proceeding in a manner that
adversely affects the other Party's rights under this Agreement, without the
written consent of the other Party, which consent shall not be unreasonably
withheld, delayed or conditioned.
8.3 TRADEMARK AND COPYRIGHT OWNERSHIP
ELAN shall own and be responsible for the filing, prosecution, maintenance,
defense and enforcement of all Product Trademarks and copyrights created during
the Development and Commercialization at ELAN's expense; provided that any such
expenses incurred with respect to Product Trademarks and copyrights for the
Product shall be treated as Commercialization Costs subject to the cost-sharing
mechanism set forth in Section 3.8.5.
8.4 THIRD PARTY LICENSES
If either Party believes that there exists an issued Third Party patent in
the absence of a license to which the conduct of the Development or
Commercialization of the Product may infringe a valid claim under such Third
Party patent, it shall notify the JEC and the other Party. Subject to Sections
2.1.4 and 2.1.5, the JEC shall discuss in good faith whether, and on what terms,
such Third Party Patent should be licensed for the purposes of this Agreement.
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9. TERM AND TERMINATION
9.1 TERM
This Agreement shall commence on ("deleted text") and shall continue in
full force and effect until such time as ELAN is no longer Developing or
Commercializing the Product (the "Term").
9.2 TERMINATION
This Agreement may be terminated at any time by either Party as follows:
9.2.1 UNILATERAL RIGHT TO TERMINATE. So long as ELAN is not in
material breach of this Agreement, ELAN may terminate this Agreement at any time
upon not less than ("deleted text") written notice to WARATAH.
9.2.2 TERMINATION FOR BREACH. Except as set forth herein (in
particular excluding Section 3.8.6), either Party may terminate this Agreement,
effective immediately upon written notice to the other Party, for a material
breach by the other Party of this Agreement that remains uncured ("deleted
text") in the event that the breach is a failure of a Party to make any payment
required hereunder) after the non-breaching Party first gives written notice to
the other Party of such breach and its intent to terminate this Agreement if
such breach is not cured.
9.2.3 TERMINATION FOR INSOLVENCY. In the event that either Party files
for protection under bankruptcy laws, makes a general assignment for the benefit
of creditors, appoints or suffers appointment of a receiver or trustee over its
business, files a petition under any bankruptcy or insolvency act or has any
such petition filed against it which is not dismissed or stayed within ("deleted
text") of the filing thereof, then the other Party may terminate this Agreement
effective immediately upon written notice to such Party. In connection
therewith, all rights and licenses granted under this Agreement are, and shall
be deemed to be, for purposes of Section 365(n) of the United States Bankruptcy
Code, licenses of rights to "intellectual property" as defined under Xxxxxxx 000
(00X) xx xxx Xxxxxx Xxxxxx Bankruptcy Code. Upon the bankruptcy of any Party the
non-bankrupt Party shall further be entitled to a complete duplicate of (or
complete access to, if duplication is impossible) any such intellectual property
and all embodiments thereof, which shall promptly be delivered to the
non-bankrupt Party upon written
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request. The Parties shall retain and may fully exercise all of their respective
rights, remedies and elections afforded by and under the Bankruptcy Code.
9.3 CONSEQUENCES OF TERMINATION OF AGREEMENT
In the event of the termination of this Agreement pursuant to Section 9.2,
the following provisions shall apply, as applicable; provided that, after
termination of this Agreement, all disputed matters shall immediately be
referred to the Chief Executive Officer of WARATAH and the Chief Executive
Officer of ELAN, or their designees, who shall promptly initiate discussions in
good faith to resolve such disputed matters. If any disputed matter is not
resolved by these individuals within ("deleted text") after the date of such
referral, then either Party may seek any remedy, at law or in equity, that may
be available. ("deleted text").
9.3.1 TERMINATION PURSUANT TO SECTION 9.2.1. If this Agreement is
terminated by ELAN pursuant to Section 9.2.1:
(a) WARATAH Licenses. All licenses granted to ELAN under Article
6 shall be terminated upon the effective date of termination; provided, that, if
ELAN is then Commercializing the Product, ELAN shall have the right to dispose
of all partially or previously made Product within a period of ("deleted text")
following the effective date of the notice of termination, subject to the terms
of this Agreement, including making any required payments and the rendering of
reports related thereto. Subject to these disposal rights, upon the effective
date of termination, ELAN, alone or in collaboration with or through any Third
Party, shall not Develop, make, import, export, distribute, offer for sale, sell
or otherwise Commercialize Product in the Territory in the Field.
(b) Joint Patent Rights License. Effective on the date of
termination, ELAN hereby grants and transfers to WARATAH and its Affiliates an
exclusive license in the Territory in the Field to ELAN's interest in the Joint
Technology and Joint Patent Rights for the sole purpose of researching,
Developing and Commercializing Product (including, but not limited to, the right
to make, use, sell, have sold, offer to sell, distribute for sale, import, have
imported, make or have made Product) in the Territory in the Field. The
foregoing license includes the right to grant sublicenses and co-promotion
rights, subject to the same restriction imposed on ELAN in granting sublicenses
and co-promotion rights.
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(c) ELAN Licenses. The licenses granted by ELAN to WARATAH
pursuant to Section 6.2 shall survive and extend to an exclusive right and
license solely for Development and Commercialization of the Product, including
the right to sublicense; provided, however, that in consideration for such
license WARATAH shall pay to ELAN ("deleted text");
(d) Confidential Information. Each Party shall promptly return
all Confidential Information and Proprietary Materials of the other Party that
are not subject to a continuing license hereunder; provided that each Party may
retain one copy of the Confidential Information of the other Party in its
archives solely for the purpose of establishing the contents thereof and
ensuring compliance with its obligations hereunder;
(e) Regulatory Filings. Upon written notice from WARATAH, ELAN
shall, as soon as reasonably practicable after WARATAH's request: (i) use
Commercially Reasonable Efforts to grant to WARATAH an exclusive, worldwide,
non-royalty-bearing license under all Product Trademarks, if any; (ii) transfer
to WARATAH all of its right, title and interest in all Regulatory Filings, Drug
Approval Applications and Regulatory Approvals Controlled by ELAN that are
applicable to the Product; ("deleted text").
(f) Manufacturing. Notwithstanding any provision to the contrary
in this Agreement, in the event ELAN terminates this Agreement pursuant to
Section 9.2.1, ("deleted text").
(g) Assumption of Third Party Expenses on Termination. If a Third
Party agreement between ELAN and a Third Party, including a Sublicense Agreement
or a co-promotion agreement, is necessary for the Development and
Commercialization of the Product, ELAN, if requested by WARATAH, and to the
extent it is permitted to do so under such agreement, shall use Commercially
Reasonable Efforts ("deleted text") to assign such agreement to WARATAH,
provided that WARATAH shall assume insofar as they relate to the period
following the date of such assignment, any and all ELAN financial and other
obligations under such agreement post the termination of this Agreement.
Following the termination of this Agreement ELAN shall not be obligated to make
any payment to Third Parties as the result of actions taken or omitted by
WARATAH or WARATAH's sublicensees or co-promoters pursuant to an agreement
between the Third Parties and WARATAH or WARATAH's sublicensees or co-promoters.
CONFIDENTIAL
42
(h) Patent Rights. WARATAH shall assume responsibility for the
planning, preparation, filing, prosecution and maintenance of Licensed Patent
Rights and Joint Patent Rights. ELAN shall promptly deliver to WARATAH copies of
all files related to the Licensed Patent Rights and Joint Patent Rights and
shall take all actions and execute all documents reasonably necessary for
WARATAH to assume such responsibility.
9.3.2 TERMINATION BY ELAN PURSUANT TO SECTION 9.2.2 OR 9.2.3. If this
Agreement is terminated by ELAN pursuant to Section 9.2.2 or 9.2.3:
(a) WARATAH Licenses. All licenses granted by WARATAH to ELAN
pursuant to Article 6 shall survive;
(b) Confidential Information. Each Party shall promptly return
all Confidential Information and Proprietary Materials of the other Party that
are not subject to a continuing license hereunder; provided that each Party may
retain one copy of the Confidential Information of the other Party in its
archives solely for the purpose of establishing the contents thereof and
ensuring compliance with its obligations hereunder; and
(c) Obligations to Pay. ELAN's obligations to pay WARATAH under
Section 3.8.6 shall survive.
9.3.3 TERMINATION BY WARATAH PURSUANT TO SECTION 9.2.2. If this
Agreement is terminated by WARATAH pursuant to Section 9.2.2, then the
provisions of Section 9.3.1 shall apply.
9.3.4 TERMINATION BY WARATAH PURSUANT TO SECTION 9.2.3. If this
Agreement is terminated by WARATAH pursuant to Section 9.2.3, the provisions of
Section 9.3.1 shall apply, provided, however, that ELAN shall have no obligation
to continue to conduct any clinical trials as provided in Section 9.3.1.
9.3.5 SURVIVING PROVISIONS. Termination or expiration of this
Agreement for any reason shall be without prejudice to the rights and
obligations of the Parties provided in Sections 12.3, 12.6, and 12.15 and
Articles 5, 9, and 10 (including all other Sections or Articles referenced in
any such Section or Article and including Article 1), all of which shall survive
such termination or expiration; and any other rights or remedies provided at law
or equity which either Party may otherwise have.
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43
10. REPRESENTATIONS AND WARRANTIES
10.1 MUTUAL REPRESENTATIONS AND WARRANTIES
WARATAH and ELAN each represents and warrants to the other, as of the
Effective Date, as follows:
10.1.1 ORGANIZATION. It is a corporation duly organized, validly
existing and in good standing under the laws of the jurisdiction of its
organization, and has all requisite power and authority, corporate or otherwise,
to execute, deliver and perform this Agreement.
10.1.2 AUTHORIZATION. The execution and delivery of this Agreement and
the performance by it of the transactions contemplated hereby have been duly
authorized by all necessary corporate action and will not violate (a) such
Party's charter documents, (b) any agreement, instrument or contractual
obligation to which such Party is bound in any material respect, (c) any
requirement of any Applicable Law, or (d) any order, writ, judgment, injunction,
decree, determination or award of any court or governmental agency presently in
effect applicable to such Party.
10.1.3 BINDING AGREEMENT. This Agreement is a legal, valid and binding
obligation of such Party enforceable against it in accordance with its terms and
conditions and it has all rights necessary to grant to the other Party the
rights it purports to grant under this Agreement.
10.1.4 NO INCONSISTENT OBLIGATION. It is not under any obligation,
contractual or otherwise, to any Person that conflicts with or is inconsistent
in any respect with the terms of this Agreement or that would impede the
diligent and complete fulfillment of its obligations hereunder.
10.2 ADDITIONAL REPRESENTATIONS OF WARATAH
WARATAH further represents and warrants to ELAN, as of the Effective Date,
as follows:
10.2.1 LICENSED PATENT RIGHTS. All Licensed Patent Rights listed on
Schedule 1 are existing and, to WARATAH's knowledge at the Effective Date, no
Licensed Patent Rights listed on Schedule 1 are invalid or unenforceable.
WARATAH has the right to enforce directly
CONFIDENTIAL
44
or through Third Parties under the Academic Agreements the Licensed Patent
Rights listed on Schedule 1.
10.2.2 CLAIMS OR JUDGMENTS. There are no claims, judgments or
settlements against WARATAH pending, or to WARATAH's knowledge, threatened, that
invalidate or seek to invalidate the Licensed Patent Rights listed on Schedule
1. ("deleted text").
11. DISCLAIMERS
11.1 WARRANTY DISCLAIMER
EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY
MAKES ANY WARRANTY WITH RESPECT TO ANY TECHNOLOGY, GOODS, SERVICES, RIGHTS OR
OTHER SUBJECT MATTER OF THIS AGREEMENT, INCLUDING WITHOUT LIMITATION ANY
WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE.
11.2 NO WARRANTY OF SUCCESS
Nothing contained in this Agreement shall be construed as a warranty on the
part of either Party that the Product will be successfully Developed and
Commercialized.
12. MISCELLANEOUS
12.1 MEDIATION
If any dispute, controversy or claim arises between the Parties that cannot
be resolved the Parties agree to attempt to resolve such dispute, controversy or
claim (except as to any issue relating to intellectual property) by non-binding
mediation administered by the American Arbitration Association ("AAA") in
accordance with its commercial mediation rules.
12.2 ARBITRATION
If the Parties are unable to resolve a dispute through mediation under
Section 12.1, they shall enter into arbitration under the terms of this Section
12.2. Within ("deleted text") of delivery of notice from one Party to the other
requesting arbitration under this Section, each Party shall select one expert in
the field of drug development and commercialization to serve on an arbitration
panel to decide the issue. The expert selected by a Party shall not be a past or
present employee of or consultant to such Party or of any Affiliate, Sublicensee
or Co-promoter of such Party. The members of the panel selected by the Parties
shall, within ("deleted text") of
CONFIDENTIAL
45
their selection, select a third member to serve on the panel who shall not be a
past or present employee of or consultant to either Party. If the members of the
panel selected by the Parties cannot, within ("deleted text") of their
selection, agree on a third member, the Parties shall request that AAA select
the third member who shall not be a past or present employee of or consultant of
either Party or of any Affiliate of either Party. Each Party shall then have
("deleted text") to submit to the panel and to the other Party a written
response presenting such Party's position on the issue. The Arbitrators may
request information from either Party as the Arbitrators deem necessary. The
panel shall, within ("deleted text") after receipt of both Parties responses,
hold a joint meeting on the issue at which each Party will have an opportunity
to make a presentation and to respond to the other Party's presentation. Within
("deleted text") of the conclusion of the meeting, the panel shall render its
decision in writing. The decision of the panel shall be binding on both Parties.
Each Party shall bear its own costs in connection with the arbitration
proceedings, including the costs of the panel member selected by it. The costs
of the third panel member will be shared equally. The arbitration shall be held
in New York, New York and conducted under the rules of the AAA, except as
otherwise expressly provided in this Section 12.2. Sections 12.1 and 12.2 shall
not prevent a Party from seeking and obtaining injunctive relief.
12.3 INDEMNIFICATION AND INSURANCE
(a) Indemnity. Each Party hereby agrees to save, defend and hold the
other Party and its directors, officers, shareholders, agents, employees, and
consultants harmless from and against any and all losses, damages, liabilities,
settlements, penalties, fines, costs and expenses (including, without
limitation, reasonable attorneys' fees and expenses) (collectively, the
"Losses") that may be instituted against any of them arising from the use,
handling, storage, sale or other disposition of Product sold or used in the
Territory by the indemnifying Party, its Affiliates, agents, employees,
consultants, sublicensees, or co-promoters but only to the extent such Losses
are not attributable to the Party seeking indemnification.
(b) Claim. In the event that either Party receives notice of a claim
with respect to the Product in the Territory, such Party shall inform the other
Party as soon as reasonably practicable. The Parties shall confer on how to
respond to the claim and how to handle the claim in an efficient manner.
CONFIDENTIAL
46
(c) Notice and Control. In the event that a Party is seeking
indemnification under this Section 12.3, it shall inform the indemnifying Party
of a claim as soon as reasonably practicable after it receives notice of the
claim, shall permit the indemnifying Party to assume direction and control of
the defense of the claim (including the right to settle the claim solely for
monetary consideration), shall cooperate as requested (at the expense of the
indemnifying Party) in the defense of the claim, and shall not settle or
compromise the claim without the express written consent of the indemnifying
Party.
(d) Insurance. A Party shall maintain insurance in commercially
reasonable amounts to insure against any claims arising out of the Party's
activities under this Agreement. Upon request a Party shall provide evidence of
such coverage to the other Party.
(e) Co-Development. ("deleted text").
12.4 CHANGE OF CONTROL
If WARATAH enters into an agreement that results or that, if the
transaction contemplated in such agreement is completed, would result in a
Change of Control, WARATAH shall provide ELAN with prompt notice describing such
Change of Control in reasonable detail. Upon the consummation of the Change of
Control, ("deleted text")
12.5 NOTICES
All notices and communications shall be in writing and delivered personally
or by courier, by electronic or facsimile transmission or mailed via certified
mail, return receipt requested, addressed as follows, or to such other address
as may be designated from time to time:
If to ELAN: If to WARATAH:
Elan Pharma International Limited Waratah Pharmaceuticals Inc.
c/o ELAN International Services Ltd. Xxxxx 000, 000 Xxxxxxx Xxxxxx
Clarendon House, 0 Xxxxxx Xxxxxx Xxxxxxx, Xxxxxxx X0X 0X0
Xxxxxxxx XX 11, Bermuda Tel: (000) 000-0000
Tel: (000) 000-0000 Fax: (000) 000-0000
Fax: (000) 000-0000 Attention: Chief Executive Officer
Attention: President
CONFIDENTIAL
47
With a copy to:
Elan Pharmaceuticals, Inc.
000 Xxxxxxx Xxxxxxxxx
Xxxxx Xxx Xxxxxxxxx, XX 00000
Tel: 000 000 0000
Fax: 000 000 0000
Attention: Sr. V.P. Legal
In addition, all notices to the JLT or JEC shall be sent to each Party's
designees at such Party's address stated above or to such other address as such
Party may designate by written notice given in accordance with this Section
12.5.
Except as otherwise expressly provided in this Agreement or mutually agreed
in writing, any notice, communication or document (excluding payment) required
to be given or made shall be deemed given or made and effective upon actual
receipt or, if earlier, (a) ("deleted text") after deposit with an
internationally-recognized overnight express courier with changes prepaid, or
(b) ("deleted text") after mailed by certified, registered or regular mail,
postage prepaid, in each case addressed to a Party at its address stated above
or to such other address as such Party may designate by written notice given in
accordance with this Section 12.5.
12.6 GOVERNING LAW
This Agreement shall be governed by and construed in accordance with the
laws of the State of New York (USA), without regard to the application of
principles of conflicts of law. ELAN and WARATAH consent to the jurisdiction of
the courts of New York for any suit, action or proceeding brought under this
Agreement.
12.7 BINDING EFFECT
This Agreement shall be binding upon and inure to the benefit of the
Parties and their respective legal representatives, successors and permitted
assigns.
12.8 HEADINGS
Section and subsection headings are inserted for convenience of reference
only and do not form a part of this Agreement.
CONFIDENTIAL
48
12.9 COUNTERPARTS
This Agreement may be executed simultaneously in two or more counterparts,
each of which shall be deemed an original and both of which, together, shall
constitute a single agreement.
12.10 AMENDMENT; WAIVER
This Agreement may be amended, modified, superseded or canceled, and any of
the terms of this Agreement may be waived, only by a written instrument executed
by each Party or, in the case of waiver, by the Party or Parties waiving
compliance. The delay or failure of either Party at any time or times to require
performance of any provisions shall in no manner affect the rights at a later
time to enforce the same. No waiver by either Party of any condition or of the
breach of any term contained in this Agreement, whether by conduct, or
otherwise, in any one or more instances, shall be deemed to be, or considered
as, a further or continuing waiver of any such condition or of the breach of
such term or any other term of this Agreement.
12.11 NO THIRD PARTY BENEFICIARIES
No Third Party shall have or acquire any rights by reason of this
Agreement.
12.12 PURPOSES AND SCOPE
The Parties hereto understand and agree that this Collaboration is limited
to the activities, rights and obligations as set forth in this Agreement.
Nothing in this Agreement shall be construed (a) to create or imply a general
partnership between the Parties, (b) to make either Party the agent of the other
for any purpose, (c) to alter, amend, supersede or vitiate any other
arrangements between the Parties with respect to any subject matters not covered
hereunder, (d) to give either Party the right to bind the other, (e) to create
any duties or obligations between the Parties except as expressly set forth
herein, or (f) to grant any direct or implied licenses or any other right other
than as expressly set forth herein.
12.13 ASSIGNMENT AND SUCCESSORS
Neither this Agreement nor any obligation of a Party hereunder may be
assigned by either Party without the consent of the other, which shall not be
unreasonably withheld, conditioned or
CONFIDENTIAL
49
delayed, except that each Party may assign this Agreement and the rights,
obligations and interests of such Party, in whole or in part, to any of its
Affiliates, to any purchaser of all of its assets or all of its assets to which
this Agreement relates or to any successor corporation resulting from any
merger, consolidation, share exchange or other similar transaction. Any
attempted assignment in violation of this Section 12.13 shall be void and of no
effect.
12.14 FORCE MAJEURE
Neither ELAN nor WARATAH shall be liable for failure of or delay in
performing obligations set forth in this Agreement, and neither shall be deemed
in breach of its obligations, if such failure or delay is due to a Force
Majeure. In event of such Force Majeure, the Party affected shall use reasonable
efforts to cure or overcome the same and resume performance of its obligations
hereunder.
12.15 INTERPRETATION
The Parties hereto acknowledge and agree that: (a) each Party and its
counsel reviewed and negotiated the terms and provisions of this Agreement and
have contributed to its revision; (b) the rule of construction to the effect
that any ambiguities are resolved against the drafting Party shall not be
employed in the interpretation of this Agreement; and (c) the terms and
provisions of this Agreement shall be construed fairly as to each Party,
regardless of which Party was generally responsible for the preparation of this
Agreement. In addition, unless a context otherwise requires, wherever used, the
singular shall include the plural and the plural the singular and the use of any
gender shall be applicable to all genders.
12.16 INTEGRATION; SEVERABILITY
This Agreement and the Confidentiality Agreements are the entire agreement
with respect to the subject matter hereof and supersedes all other agreements
and understandings between the Parties with respect to such subject matter. If
any provision of this Agreement is or becomes invalid or is ruled invalid by any
court of competent jurisdiction or is deemed unenforceable, it is the intention
of the Parties that the remainder of the Agreement shall not be affected.
Exhibits A, B and C and Schedules 1, 2, 3 and 4 attached hereto are incorporated
by reference herein.
CONFIDENTIAL
50
12.17 EQUITABLE RELIEF
The Parties acknowledge that under this Agreement each Party holds a
complex series of technology rights and licenses, as well as various
Development, Commercialization and related financial rights and obligations, the
breach of which would not be adequately compensated in money damages alone. The
Parties therefore agree that in the event of such breach, each shall be entitled
to seek remedies in the nature of specific grants of licenses or assignments
from the other Party and other forms of specific performance. Further,
notwithstanding anything to the contrary in this Agreement, if approved by a
court of competent jurisdiction, the Parties shall have the right to obtain
injunctive relief for breaches of this Agreement by one Party which have the
potential to cause irreparable injury to the other Party.
12.18 HSR FILING
If ELAN determines in good faith that an HSR Act filing is required with
respect to this Agreement, each Party shall, within ("deleted text") after the
execution date of this Agreement (or such later time as the Parties mutually
agree in writing), file with the Federal Trade Commission and the Antitrust
Division of the Department of Justice in the U.S. and any appropriate
governmental authorities outside the U.S. any filing required of a licensor and
licensee under the HSR Act, in connection with the transactions contemplated
hereby. In such event, this Agreement shall not take effect unless and until it
has been approved by all appropriate governmental authorities, or the period for
review by such authorities has lapsed without comment. The Parties shall
cooperate with each other to the extent necessary in the preparation of any such
filing. WARATAH shall be responsible for paying any fees required to be paid to
governmental authorities in connection with its filings as a licensor, ELAN
shall be responsible for paying any fees associated with its filings as a
licensee and each Party shall bear its own expenses, including but not limited
to legal fees associated with preparing any such filing. Neither Party shall be
required in connection with any filing under the HSR Act to resort to or respond
to litigation, agree to hold separate or divest any business or assets or
otherwise materially change its business if doing so is a condition of approvals
of the transaction contemplated hereby.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK.]
CONFIDENTIAL
51
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed
by their duly authorized representatives.
WARATAH PHARMACEUTICALS INC.
By: /s/ Xxxx Xxxx
------------------------------------
Name: Xxxx Xxxx
Title: CEO
ELAN PHARMA INTERNATIONAL LIMITED
By: /s/ Xxxxx Xxxxxx
------------------------------------
Name: Xxxxx Xxxxxx
Title: Authorizing Signatory
CONFIDENTIAL
EXHIBIT A
ANNUAL BUDGET
("deleted text")
EXHIBIT B
DEVELOPMENT PLAN
("deleted text")
EXHIBIT C - INTERIM COSTS
("deleted text")
SCHEDULE 1
LICENSED PATENT RIGHTS
SCHEDULE A
("deleted text")
SCHEDULE 2
FORM OF PRESS RELEASE
(ELAN LOGO) (TRANSITION THERAPEUTICS INC. LOGO)
FOR IMMEDIATE RELEASE
ELAN CONTACTS: TRANSITION THERAPEUTICS CONTACTS:
Investor Relations: Dr. Xxxx Xxxx
Xxxx Xxxxxxxx/Xxxxx Xxxxx Chief Executive Officer
Ph: 353-1-709-4000/000-000-0000 Ph: 416-260-7770, x.223
Media Relations:
Xxxxx Xxxxx Xx. Xxxx Xxxxx
Ph: 000-000-0000 CFO and VP, Corporate Development
Xxxxxxxxx Xxxxxx Ph: 416-260-7770, x.203
Ph: 353-1-498-0300
ELAN AND TRANSITION THERAPEUTICS INC. ANNOUNCE GLOBAL COLLABORATION
TO DEVELOP AND COMMERCIALIZE ALZHEIMER'S DISEASE DRUG AZD-103
DUBLIN, IRELAND AND TORONTO, CANADA, SEPTEMBER 27TH, 2006 - ELAN CORPORATION,
PLC ("Elan") (NYSE:ELN) and TRANSITION THERAPEUTICS INC. ("Transition") (TSX:
TTH), today announced an exclusive, worldwide collaboration agreement for the
joint development and commercialization of a novel therapeutic agent, AZD-103,
for the treatment of Alzheimer's disease. AZD-103 is a small molecule compound
in Phase I clinical development that acts by breaking down and preventing the
assembly of beta amlyoid fibrils, a hallmark pathology of Alzheimer's disease.
Under the terms of the agreement, Transition will receive upfront payments of
US$15 million: US$7.5 million in 2006 and the remaining US$7.5 million in 2007.
In addition, dependant upon the successful development, regulatory approval and
commercialization of AZD-103, Transition will be eligible to receive milestone
payments of up to US$185 million. Elan and Transition will share the costs and
operating profits of AZD-103 if successfully developed and commercialized. Each
party's cost share and ownership interest may vary throughout the term of the
Agreement dependant on certain elections that may be made during the development
of AZD-103.
"We are delighted to have this opportunity to work closely with Xx. Xxxx and his
team at Transition. The opportunity to advance this program to provide much
needed therapeutic choice in the treatment of Alzheimer's will be a strategic
priority and focus for all of us here at Elan. By joining forces, we increase
our probability of success. The AZD-103 program represents a significant
addition to our scientific portfolio and continues to reinforce our commitment
and leadership in bringing more therapeutic choice to patients and their
caregivers suffering from Alzheimer's around the world," said Xxxxx Xxxxxx,
Chief Executive Officer and President of Elan.
"We are extremely pleased to have Elan as our collaborator in developing
AZD-103. Elan shares our vision and commitment to develop an effective
Alzheimer's disease therapy. We are confident this collaboration will allow us
to fully achieve the potential of the disease-modifying compound AZD-103 and
help make a difference in the lives of millions of Alzheimer's disease patients
and their loved ones," said Dr. Xxxx Xxxx, Chairman and Chief Executive Officer
of Transition.
CONFERENCE CALL
Transition will hold a conference call at 11:00am Eastern time on Wednesday,
September 27th, 2006 to discuss today's news in more detail. This call is open
to the public and can be accessed live either over the Internet from the
company's website xxx.xxxxxxxxxxxxxxxxxxxxxx.xxx or by dialling 0(000) 000-0000
or (000) 000-0000.
ABOUT THE AZD-103 DRUG
AZD-103 is a novel therapeutic agent in Phase 1 clinical development for the
treatment of Alzheimer's disease that has the potential to both reduce disease
progression and improve symptoms such as cognitive function. As reported
recently in a Nature Medicine publication, oral treatment with AZD-103 reduced
accumulation of amyloid beta and amyloid beta plaques in the brain, and reduced
or eliminated learning deficits in a leading transgenic mouse model of
Alzheimer's disease. In addition, AZD-103 is well positioned as a potential
Alzheimer's therapy as it is a small molecule, crosses the blood brain barrier
and has exhibited a favorable safety profile.
ABOUT ALZHEIMER'S DISEASE
Alzheimer's disease is a progressive brain disorder that gradually destroys a
person's memory and ability to learn, reason, make judgments, communicate and
carry out daily activities. The disease affects more than 4 million Americans
and approximately 20 million people worldwide, and with an aging population
incidence of Alzheimer's disease is expected to double over the next 20 years.
Currently approved Alzheimer's therapies treat some disease symptoms but do not
reverse or slow down disease progression. These products have worldwide annual
sales of US$3.1 billion; however, the Alzheimer's pharmaceutical market is
expected to grow significantly with the arrival of products that have the
potential to alter disease progression.
ABOUT ELAN
Elan Corporation, plc is a neuroscience-based biotechnology company committed to
making a difference in the lives of patients and their families by dedicating
itself to bringing innovations in science to fill significant unmet medical
needs that continue to exist around the world. Elan shares trade on the New
York, London and Dublin Stock Exchanges. For additional information about the
company, please visit xxx.xxxx.xxx.
ABOUT TRANSITION
Transition is a biopharmaceutical company, developing novel therapeutics for
disease indications with large markets. Transition's lead products include
regenerative therapies E1-I.N.T.(TM) and GLP1-I.N.T.(TM) for the treatment of
diabetes, AZD-103 for the treatment of Alzheimer's disease, and HCV-I.E.T. for
the treatment of hepatitis C. Transition has a strong pipeline of preclinical
drug candidates developed using its proprietary drug discovery engine.
Transition's shares are listed on the Toronto Stock Exchange under the symbol
"TTH". For additional information about the company, please visit
xxx.xxxxxxxxxxxxxxxxxxxxxx.xxx.
FORWARD LOOKING STATEMENT
This press release contains forward-looking statements regarding the
collaboration agreement between Elan and Transition. These statements are based
on Elan's and Transition's current beliefs and expectations. AZD-103 may not be
successfully developed or commercialized under the collaboration agreement.
Factors which could cause actual results to differ materially from Elan's and
Transition's current expectations include the risks that clinical development of
AZD-103 fails due to safety or efficacy issues, the results from preclinical
testing of AZD-103 are not predictive of results obtained in clinical trials,
that any patents will issue with respect to AZD-103 or that, even if issued,
whether such patents would provide substantial protection or commercial benefit,
the development and commercialization of competitive therapies, the
collaboration agreement is terminated early or Elan and Transition encounter
other unexpected delays or hurdles. Drug development and commercialization
involves a high degree of risk. For more detailed information on the risks and
uncertainties associated with Elan's drug development and other activities, see
the periodic and current reports that Elan has filed with the Securities and
Exchange Commission. For more detailed information on the risks and
uncertainties associated with Transition's drug development and other
activities, see the risk factors and other cautionary statements discussed in
Transition's quarterly and annual filings with the Canadian commissions. Elan
and Transition assume no obligation to update any forward-looking statements,
whether as a result of new information, future events or otherwise.
SCHEDULE 3
ACADEMIC AGREEMENTS
SCHEDULE C
("deleted text")
SCHEDULE 4
TECHNOLOGICAL COMPETITORS
("deleted text")
