EXECUTION COPY
EXHIBIT 10.3
CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
BY AND BETWEEN
MILLENNIUM PHARMACEUTICALS, INC.
AND
GLAXOSMITHKLINE
JUNE 22, 2004
TABLE OF CONTENTS
PAGE
ARTICLE I DEFINITIONS..................................................1
Section 1.1. "Action"...................................................1
Section 1.2. "Affiliate"................................................2
Section 1.3. "Allocable Overhead".......................................2
Section 1.4. "Annual Plan(s)"...........................................2
Section 1.5. "Assignment and Transfer of Regulatory Approval(s)"........2
Section 1.6. "Business Day".............................................2
Section 1.7. "Central Marketing Authorization"..........................2
Section 1.8. "CMA Transfer Period"......................................2
Section 1.9. "Commercially Reasonable Efforts"..........................2
Section 1.10. "Commercialization" or "Commercialize".....................2
Section 1.11. "Competing Product"........................................2
Section 1.12. "Compound".................................................3
Section 1.13. "Confidential Information".................................3
Section 1.14. "Control" or "Controlled"..................................3
Section 1.15. "Copyright(s)".............................................3
Section 1.16. "Cost of Compound".........................................3
Section 1.17. "Cost of Fill/Finish"......................................4
Section 1.18. "Cost of Goods Shipped" or "COGS"..........................4
Section 1.19. "Cost of Secondary Packaging"..............................4
Section 1.20. "Cover", "Covering" or "Covered"...........................4
Section 1.21. "Development" or "Develop".................................5
Section 1.22. "EMEA".....................................................5
Section 1.23. "European Commission"......................................5
Section 1.24. "Executive Officers".......................................5
Section 1.25. "Existing Third Party Agreements"..........................5
Section 1.26. "FDA"......................................................5
Section 1.27. "Fill/Finish"..............................................5
Section 1.28. "Finished Product".........................................5
Section 1.29. "First Commercial Sale"....................................5
Section 1.30. "Good Clinical Practice"...................................6
Section 1.31. "Good Laboratory Practice".................................6
Section 1.32. "Governmental Authority"...................................6
Section 1.33. "Government Order".........................................6
Section 1.34. "GSK Intellectual Property"................................6
Section 1.35. "GSK Other Intellectual Property"..........................6
Section 1.36. "GSK Know-How".............................................6
Section 1.37. "GSK Other Know-How".......................................6
Section 1.38. "GSK Other Patent Rights"..................................6
Section 1.39. "GSK Patent Rights"........................................6
Section 1.40. "Intellectual Property Costs"..............................7
Section 1.41. "Investigator Sponsored Clinical Study"....................7
Section 1.42. "Joint Intellectual Property"..............................7
Section 1.43. "Joint Know-How"...........................................7
Section 1.44. "Joint Patent Rights"......................................7
Section 1.45. "Know-How".................................................7
Section 1.46. "Law"......................................................7
Section 1.47. "Licensed Product".........................................7
Section 1.48. "Losses"...................................................7
Section 1.49. "Major Market Countries"...................................7
Section 1.50. "Manufacturing" or "Manufacture"...........................8
Section 1.51. "Millennium Intellectual Property".........................8
Section 1.52. "Millennium Know-How"......................................8
Section 1.53. "Millennium Patent Rights".................................8
Section 1.54. "Net Sales"................................................8
Section 1.55. "Party"....................................................9
Section 1.56. "Patent Rights"............................................9
Section 1.57. "Phase IV Clinical Study".................................10
Section 1.58. "Primary Detail"..........................................10
Section 1.59. "Product Trademark(s)"....................................10
Section 1.60. "Regulatory Approval".....................................10
Section 1.61. "Regulatory Authority"....................................10
Section 1.62. "Sales Call"..............................................10
Section 1.63. "Sales Representative"....................................10
Section 1.64. "Schering"................................................10
Section 1.65. "Schering Collaboration Agreement"........................10
Section 1.66. "Schering Corporation"....................................11
Section 1.67. "Schering Indemnified Parties"............................11
Section 1.68. "Schering/Millennium European Agreement"..................11
Section 1.69. "Schering Know-How".......................................11
Section 1.70. "Schering Patent Rights"..................................11
Section 1.71. "Schering-Plough, Ltd."...................................11
Section 1.72. "Secondary Detail"........................................11
Section 1.73. "Secondary Packaging".....................................12
Section 1.74. "Secondary Packaging Regulatory Approval".................12
Section 1.75. "Territory"...............................................12
Section 1.76. "Third Party".............................................12
Section 1.77. "Transition Period".......................................12
Section 1.78. "UK GAAP".................................................12
Section 1.79. "United States" or "U.S.".................................12
Section 1.80. "US GAAP".................................................12
Section 1.81. "Valid Claim".............................................12
Section 1.82. Additional Definitions....................................12
ARTICLE II MANAGEMENT OF ACTIVITIES....................................14
Section 2.1. General Development and Commercialization Scope...........14
Section 2.2. Steering Committee........................................14
Section 2.3. Membership................................................14
Section 2.4. Meetings..................................................14
ARTICLE III TRANSFER OF REGULATORY APPROVALS AND DOCUMENTS..............15
Section 3.1. General; Notification of Effective Date...................15
Section 3.2. Transition Activities and Processes.......................15
Section 3.3. Transfer Fees.............................................15
Section 3.4. Effects of the Assignment and Transfer of Regulatory
Approvals.................................................15
ARTICLE IV DEVELOPMENT.................................................16
Section 4.1. Current Status; General...................................16
Section 4.2. Development Responsibilities; Annual Plans; Amendments....17
Section 4.3. Development Efforts; Manner of Performance................17
Section 4.4. Regulatory Approvals......................................18
Section 4.5. Access to Regulatory Submissions, Approvals and Drug
Master Files..............................................19
Section 4.6. Development Costs.........................................19
Section 4.7. Patient Safety Matters....................................21
ARTICLE V COMMERCIALIZATION...........................................21
Section 5.1. Transfer of Rights to Distribute..........................21
Section 5.2. Launch Plan; Pre-Launch Activities........................21
Section 5.3. Diligence.................................................22
Section 5.4. Diligence Inquiry.........................................22
Section 5.5. Special Meeting of Steering Committee.....................22
Section 5.6. Supplemental Plan.........................................22
Section 5.7. Availability of Other Remedies............................23
Section 5.8. Responsibility for Pricing and Reimbursement Approvals....23
Section 5.9. Advertising and Promotional Materials.....................23
Section 5.10. Sales.....................................................24
Section 5.11. Sharing of Commercial Information.........................24
Section 5.12. Adverse Event and Licensed Product Complaint Reporting
Procedures................................................24
Section 5.13. Medical Inquiries; Recall Decision Making.................25
Section 5.14. Sales and Marketing Costs.................................26
Section 5.15. Other Responsibilities....................................26
ARTICLE VI MANUFACTURE AND SUPPLY......................................27
Section 6.1. General...................................................27
Section 6.2. Secondary Packaging.......................................27
Section 6.3. Supply Agreement..........................................27
Section 6.4. Supply to Sublicensees of GSK.............................28
ARTICLE VII LICENSE GRANTS..............................................28
Section 7.1. Grants Under Millennium Intellectual Property.............28
Section 7.2. GSK Intellectual Property.................................29
Section 7.3. GSK Intellectual Property Developed by GSK Affiliates
and Third Party Contractors...............................30
Section 7.4. Millennium Retained Rights................................30
Section 7.5. GSK Know-How..............................................31
Section 7.6. Millennium's Product Trademarks...........................31
Section 7.7. Copyright.................................................31
Section 7.8. Rights Retained by Both Parties...........................31
ARTICLE VIII FINANCIAL PROVISIONS........................................31
Section 8.1. License Fees; Milestones..................................31
Section 8.2. Payment for Manufacture of Fill/Finished Product..........32
Section 8.3. Supply Price Percentages..................................33
Section 8.4. Royalty Payment Term......................................34
Section 8.5. Generic Competition.......................................34
Section 8.6. Generic Erosion...........................................34
Section 8.7. Third Party Royalties.....................................34
Section 8.8. Compulsory Licenses and Compulsory Competition............35
Section 8.9. Aggregate Reduction.......................................35
Section 8.10. Reports; Payments.........................................35
Section 8.11. Other Payments............................................35
Section 8.12. Audits....................................................35
Section 8.13. Tax Matters...............................................36
Section 8.14. Payment Procedures........................................36
Section 8.15. Currency Exchange.........................................37
Section 8.16. Late Payments.............................................37
ARTICLE IX INTELLECTUAL PROPERTY OWNERSHIP, PROTECTION AND
RELATED MATTERS.............................................37
Section 9.1. Ownership of Inventions...................................37
Section 9.2. Prosecution and Maintenance of Patent Rights..............38
Section 9.3. Third Party Infringement..................................38
Section 9.4. Claimed Infringement......................................39
Section 9.5. Patent Term Extensions....................................40
Section 9.6. Patent Marking............................................40
Section 9.7. Trademarks................................................40
ARTICLE X CONFIDENTIALITY AND PUBLICITY...............................42
Section 10.1. Confidential Information..................................42
Section 10.2. Employee, Consultant and Advisor Obligations..............43
Section 10.3. Publicity.................................................43
Section 10.4. Publications..............................................44
ARTICLE XI REPRESENTATIONS AND WARRANTIES; CERTAIN COVENANTS;
INDEMNIFICATION.............................................44
Section 11.1. Representations and Warranties of Millennium..............44
Section 11.2. Representations of GSK....................................47
Section 11.3. Covenant Regarding Third Party Agreements.................47
Section 11.4. Exclusivity Covenant......................................47
Section 11.5. Compliance with Laws......................................48
Section 11.6. No Warranties.............................................48
Section 11.7. No Debarment..............................................48
Section 11.8. Indemnification...........................................48
Section 11.9. Insurance.................................................51
ARTICLE XII TERM AND TERMINATION........................................52
Section 12.1. Term......................................................52
Section 12.2. Termination For Material Breach...........................52
Section 12.3. Termination by GSK........................................52
Section 12.4. Certain Rights and Obligations Upon Termination...........53
Section 12.5. Survival..................................................55
ARTICLE XIII FINAL DECISION-MAKING; DISPUTE RESOLUTION...................55
Section 13.1. Referral to Executive Officers............................55
Section 13.2. Final Decision-Making Authority...........................55
Section 13.3. Arbitration...............................................56
Section 13.4. Intended Third Party Beneficiary..........................56
ARTICLE XIV MISCELLANEOUS...............................................57
Section 14.1. Choice of Law.............................................57
Section 14.2. English Translations......................................58
Section 14.3. Notices...................................................58
Section 14.4. Severability..............................................59
Section 14.5. Captions..................................................59
Section 14.6. Integration...............................................59
Section 14.7. Independent Contractors; No Agency........................59
Section 14.8. Assignment; Successors....................................59
Section 14.9. Execution in Counterparts; Facsimile Signatures...........59
Section 14.10. No Consequential or Punitive Damages......................60
Section 14.11. Performance by Affiliates.................................60
Section 14.12. Performance by Subcontractors.............................60
Section 14.13. No Third Party Beneficiaries..............................60
Section 14.14. Interpretative Rules......................................60
Section 14.15. Force Majeure.............................................60
EXHIBITS
Exhibit A Compound Description
Exhibit B-1 Schering Collaboration Agreement
Exhibit B-2 Schering/Millennium European Agreement
Exhibit C Ongoing Development Activities in the Territory
Exhibit D Product Trademarks
Exhibit E Certain Exceptions to Representations
Exhibit F Existing Third Party Agreements
Exhibit G Pricing Reference Information
Exhibit H Transition Activities and Processes
Exhibit I Millennium Patent Rights
Exhibit J INTEGRILIN Sales Information
LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
This License, Development and Commercialization Agreement (the
"Agreement") is made and effective as of the 22nd day of June, 2004 (the
"Effective Date") by and between Millennium Pharmaceuticals, Inc., a Delaware
corporation, with offices at 00 Xxxxxxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx
00000-0000, X.X.X. ("Millennium"), and Glaxo Group Limited, d/b/a/
GlaxoSmithKline, a corporation organized under the laws of England, with offices
at Glaxo Xxxxxxxx Xxxxx, Xxxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxx, XX0 0XX, Xxxxxx
Xxxxxxx ("GSK").
INTRODUCTION
1. Schering Corporation, Schering-Plough, Ltd. and Millennium are
parties to a collaboration agreement which agreement provides Schering (as
defined herein) with the opportunity to participate in the development and
commercialization of Millennium's product known in the United States as
INTEGRILIN(R) (eptifibatide) Injection and known outside the United States under
that name or similar names ("INTEGRILIN").
2. Millennium and Schering have agreed that Schering's role in the
commercialization of INTEGRILIN in the Territory (as defined herein) is
terminated in accordance with the terms and conditions of the
Schering/Millennium European Agreement (as defined herein).
3. Millennium desires to grant GSK the right to develop, promote and
market INTEGRILIN in the Territory, and GSK desires to acquire such rights.
4. On and subject to the terms and conditions set forth herein,
Millennium and GSK therefore desire to provide for the development, manufacture
and commercialization of the Licensed Product in the Territory, as described
herein.
NOW, THEREFORE, for and in consideration of the mutual covenants
contained herein, Millennium and GSK, intending to be legally bound, hereby
agree as follows:
ARTICLE I
DEFINITIONS
As used in this Agreement, the following terms, whether used in the
singular or plural, will have the meanings set forth below:
Section 1.1. "ACTION". Action means any claim, action, cause of
action or suit (whether in contract or tort or strict liability or otherwise),
litigation (whether at law or in equity, whether civil or criminal),
controversy, assessment, arbitration, investigation, hearing, charge, complaint,
demand, notice or proceeding of, to, from, by or before any Governmental
Authority.
Section 1.2. "AFFILIATE". Affiliate of a Party means any
corporation, firm, partnership or other entity, which directly or indirectly
through one or more intermediaries controls, is controlled by or is under common
control with a Party to this Agreement. An entity will be deemed to control
another entity if it (a) owns, directly or indirectly, at least fifty percent of
the outstanding voting securities or capital stock (or such lesser percentage
which is the maximum allowed to be owned by a foreign corporation in a
particular jurisdiction) of such other entity, or has other comparable ownership
interest with respect to any entity other than a corporation; or (b) has the
power, whether pursuant to contract or ownership of securities, to direct the
management and policies of the entity.
Section 1.3. "ALLOCABLE OVERHEAD". Allocable Overhead means costs
incurred by a Party or for its account that are attributable to such Party's
[**] related to the supply of Licensed Product, [**] and which are allocated to
company [**]. Allocable Overhead [**].
Section 1.4. "ANNUAL PLAN(S)". Annual Plan means the annual plan
describing GSK's Development and Commercialization efforts including marketing
strategy, proposed clinical development activities, [**] to be applied with
respect to the Licensed Product in the Territory, as prepared by GSK in
accordance with this Agreement.
Section 1.5. "ASSIGNMENT AND TRANSFER OF REGULATORY APPROVAL(S)".
Assignment and Transfer of Regulatory Approval(s) (or variations of that phrase)
means, in a given country, the date on which all necessary approvals of
Regulatory Authorities for the assignment and transfer to GSK or its Affiliate
of all Regulatory Approvals for Commercialization of the Licensed Product in
such country have been obtained, and such assignments and transfers are valid
and effective.
Section 1.6. "BUSINESS DAY". Business Day means a day on which
banking institutions in both London, England, United Kingdom and Boston,
Massachusetts are open for business.
Section 1.7. "CENTRAL MARKETING AUTHORIZATION". Central Marketing
Authorization means the Marketing Authorization for the Licensed Product that is
filed through the centralized procedure for the European Union and approved by
the European Commission.
Section 1.8. "CMA TRANSFER PERIOD". CMA Transfer Period means the
period commencing on the Effective Date and ending upon the European Commission
approval of the transfer of the Central Marketing Authorization for the Licensed
Product to GSK.
Section 1.9. "COMMERCIALLY REASONABLE EFFORTS". Commercially
Reasonable Efforts means efforts [**] commonly used by GSK for [**] in the
Territory [**] and other relevant commercial factors.
Section 1.10. "COMMERCIALIZATION" or "COMMERCIALIZE". Commercialization
or Commercialize means activities directed to obtaining pricing and
reimbursement approvals, marketing, promoting, distributing, importing or
selling a pharmaceutical product. Commercialization will not include any
activities related to Development or Manufacturing.
Section 1.11. "COMPETING PRODUCT". Competing Product means any
parenteral prescription pharmaceutical product [**]. Examples of Competing
Products include [**].
Section 1.12. "COMPOUND". Compound means the compound known as
eptifibatide manufactured in bulk form for use as the active pharmaceutical
ingredient in the Manufacture of the Licensed Product, as further described in
EXHIBIT A.
Section 1.13. "CONFIDENTIAL INFORMATION". Confidential Information
means any scientific, technical, trade or business information possessed or
obtained by, developed for or given to the disclosing Party which is treated by
the disclosing Party as confidential or proprietary, including formulations,
techniques, methodology, formulae, procedures, tests, equipment, data, computer
software (including object code and source code), documentation, reports,
know-how, sources of supply, patent position, relationships with consultants and
employees, business plans and business developments, information concerning the
existence, scope or activities of any research, Development, Manufacturing,
marketing or other projects of the disclosing Party, Development strategies,
patient/subject accrual strategies, sales force deployment, marketing and
Commercialization plans and strategies, and any other confidential information
about or belonging to the disclosing Party's suppliers, contractors, licensors,
licensees, partners, affiliates, customers, potential customers or others, and
any other information which due to its nature would cause a reasonable person to
know that it is confidential and proprietary to a Party.
Section 1.14. "CONTROL" or "CONTROLLED". Control or Controlled means,
with respect to any intellectual property right or other intangible property,
the possession (whether by license or ownership, or by control over an Affiliate
having possession by license or ownership) by a party of the ability to grant to
another party a license or sublicense in the Territory as provided herein
without violating the terms of any agreement with any Third Party or applicable
Law.
Section 1.15. "COPYRIGHT(S)". Copyright(s) means rights associated with
works of authorship, including, but not limited to, exploitation rights,
copyrights, moral rights and database rights in connection with marketing
materials produced in connection with the Licensed Product.
Section 1.16. "COST OF COMPOUND". Cost of Compound means certain costs
for the provision of Compound for the Licensed Product. As used herein, such
Compound costs for the Licensed Product means the actual unit costs calculated
as follows:
Actual unit costs will consist of: (a) [**] costs and [**] costs plus
(b) [**] attributable to the Compound for the Licensed Product at standard
rates, all calculated in accordance with US GAAP, consistently applied by
Millennium.
Direct material costs will include the costs [**], including [**], and
all costs of [**] and costs of [**] Direct material costs [**] costs.
Direct labor costs will include the cost of [**]in direct [**] and
direct [**] in Licensed Product Compound Manufacturing.
Manufacturing [**] attributable to the Manufacture of Compound for the
Licensed Product [**].
Section 1.17. "COST OF FILL/FINISH". Cost of Fill/Finish means
certain costs for the performance of Fill/Finish for the Licensed Product. As
used herein, such Fill/Finish costs for the Licensed Product means the actual
unit costs calculated as follows:
Actual unit costs will consist of: (a) [**] costs and [**] costs plus
(b) [**] attributable to the performance of Fill/Finish of Licensed Product at
standard rates, all calculated in accordance with US GAAP, consistently applied
by Millennium. If, pursuant to Section 6.3, GSK performs Fill/Finish of the
Licensed Product, standard rates referenced in the preceding sentence will be
calculated in accordance with UK GAAP, consistently applied by GSK.
Direct material costs will include the costs incurred in [**],
including [**], and all costs of [**] and costs of [**] Direct material costs
[**] costs.
Direct labor costs will include the cost of [**] and direct [**]
Licensed Product Fill/Finish.
Manufacturing [**] attributable to the Fill/Finish of the Licensed
Product [**].
Section 1.18. "COST OF GOODS SHIPPED" or "COGS". Cost of Goods
Shipped or COGS means the cost of Licensed Product shipped by or on behalf of
GSK. As used herein, such costs of Licensed Product means:
(a) Cost of Compound;
(b) Cost of Fill/Finish; and
(c) Cost of Secondary Packaging.
Section 1.19. "COST OF SECONDARY PACKAGING". Cost of Secondary
Packaging means certain Secondary Packaging costs incurred by or on behalf of
GSK pertaining to such Licensed Product, in any form. As used herein, such
Secondary Packaging costs for the Licensed Product means the actual unit costs
calculated as follows:
Actual unit costs will consist of: (a) [**] costs and [**] costs plus
(b) [**] attributable to the Secondary Packaging of Licensed Product at standard
rates, all calculated in accordance with UK GAAP, consistently applied by GSK.
Direct material costs will include the costs [**], including [**] costs
of Secondary Packaging [**] and costs of [**] the Secondary Packaging [**]
Direct material costs [**] costs.
Direct labor costs will include the cost of [**]in direct Secondary
Packaging [**] and direct [**] Licensed Product Secondary Packaging.
Manufacturing overhead directly attributable to the Secondary Packaging
of the Licensed Product [**].
Section 1.20. "COVER", "COVERING" or "COVERED". Cover, Covering or
Covered means, with respect to the Licensed Product or with respect to
technology, that, in the absence of a license granted under a Valid Claim, the
making, use, offering for sale, sale, or importation of the Licensed Product or
the practice of such technology would infringe such Valid Claim.
Section 1.21. "DEVELOPMENT" or "DEVELOP". Development or Develop means
non-clinical and clinical research and drug development activities related to
obtaining and maintaining Regulatory Approval (excluding pricing and
reimbursement approvals) for the Licensed Product, including test method
development and stability testing, process development, formulation development,
delivery system development, quality assurance and quality control development
for clinical supplies, statistical analysis, clinical studies (including pre-
and post-approval studies, Phase IV Clinical Studies and Investigator Sponsored
Clinical Studies), regulatory affairs, and Regulatory Approval (excluding
pricing and reimbursement approvals) and clinical study regulatory activities
(excluding regulatory activities directed to obtaining pricing and reimbursement
approvals).
Section 1.22. "EMEA". EMEA means the European Medicines Evaluation
Agency (European Medicines Agency) and the Committee for Proprietary Medicinal
Products (Committee for Medicinal Products for Human Use) or any successor
agency thereof.
Section 1.23. "EUROPEAN COMMISSION". European Commission means the
European Union authority that has legal authority to grant licenses and
approvals on an European Union-wide basis following input from CPMP, EMEA or
other applicable Regulatory Authorities.
Section 1.24. "EXECUTIVE OFFICERS". Executive Officers means the
Chief Executive Officer of Millennium (or a senior executive officer of
Millennium designated by Millennium's Chief Executive Officer) and the President
of Pharma Europe of GSK (or a senior executive officer of GSK designated by the
President of Pharma Europe of GSK).
Section 1.25. "EXISTING THIRD PARTY AGREEMENTS". Existing Third
Party Agreements means the agreements identified in EXHIBIT F hereto.
Section 1.26. "FDA". FDA means the United States Food and Drug
Administration or any successor agency thereto.
Section 1.27. "FILL/FINISH". Fill/Finish means the formulating of the
Compound, and filling, finishing and storage of such formulated Compound in
unlabeled vials, so that such vials are ready to be shipped to the quality
control/qualified person and the Secondary Packaging site.
Section 1.28. "FINISHED PRODUCT". Finished Product means the Licensed
Product that: (a) has undergone Fill/Finish; (b) has undergone quality control
review and qualified person release and Secondary Packaging; and (c) is ready
for sale.
Section 1.29. "FIRST COMMERCIAL SALE". First Commercial Sale means,
with respect to the Licensed Product in a country of the Territory, the date of
the first commercial sale of the Licensed Product in such country on or after
the Effective Date. Sales for clinical study purposes or compassionate, named
patient or similar use will not constitute a First Commercial Sale.
Section 1.30. "GOOD CLINICAL PRACTICE". Good Clinical Practice means
the current good clinical practice applicable to the clinical Development of the
Licensed Product under applicable Law, to the extent such standards are not less
stringent than the U.S. current good clinical practice, including the guidelines
of the International Conference on Harmonization of Technical Requirements for
Registration of Pharmaceuticals for Human Use.
Section 1.31. "GOOD LABORATORY PRACTICE". Good Laboratory Practice
means the current good laboratory practice applicable to the Development of the
Licensed Product under applicable Law, to the extent such standards are not less
stringent than the U.S. current good laboratory practice, including 21 C.F.R.
Part 58.
Section 1.32. "GOVERNMENTAL AUTHORITY". Governmental Authority means
any federal, state or local government in any country, or political subdivision
thereof, or any multinational organization or authority or any authority, agency
or commission entitled to exercise any administrative, executive, judicial,
legislative, police, regulatory or taxing authority or power, any court or
tribunal (or any department, bureau or division thereof), or any governmental
arbitrator or arbitral body.
Section 1.33. "GOVERNMENT ORDER". Government Order means any order,
writ, judgment, injunction, decree, stipulation, ruling, determination or award
entered by or with any Governmental Authority.
Section 1.34. "GSK INTELLECTUAL PROPERTY". GSK Intellectual
Property means GSK Know-How and GSK Patent Rights, collectively.
Section 1.35. "GSK OTHER INTELLECTUAL PROPERTY". GSK Other Intellectual
Property means GSK Other Know-How and GSK Other Patent Rights, collectively.
Section 1.36. "GSK KNOW-HOW". GSK Know-How means any Know-How relating
to the use of or treatment with the Licensed Product that is either (a)
Controlled by GSK and/or its Affiliates on the Effective Date or (b) comes
within the Control of GSK or its Affiliates during the Term, including the
interest of GSK or its Affiliates in GSK Sole Inventions and in Joint Know-How.
Section 1.37. "GSK OTHER KNOW-HOW". GSK Other Know-How means any
Know-How relating to the Licensed Product that is either (a) Controlled by GSK
and/or its Affiliates on the Effective Date or (b) comes within the Control of
GSK or its Affiliates during the Term, including the interest of GSK or its
Affiliates in GSK Sole Inventions and in Joint Know-How, but excluding GSK
Know-How.
Section 1.38. "GSK OTHER PATENT RIGHTS". GSK Other Patent Rights means
Patent Rights relating to the Licensed Product, including the interest of GSK
and/or its Affiliates in Joint Patent Rights, that (a) Cover GSK Other Know-How
and (b) are Controlled by GSK and/or its Affiliates.
Section 1.39. "GSK PATENT RIGHTS". GSK Patent Rights means Patent
Rights, including the interest of GSK and/or its Affiliates in Joint Patent
Rights, that (a) Cover GSK Know-How and claim the use of or treatment of
patients with the Licensed Product and (b) are Controlled by GSK and/or its
Affiliates.
Section 1.40. "INTELLECTUAL PROPERTY COSTS". Intellectual Property
Costs means all reasonable out-of-pocket costs and expenses actually incurred by
a Party in preparing, filing, prosecuting and/or maintaining Patent Rights in
the Territory (including applications and proceedings relating to patent term
extensions) or trademarks.
Section 1.41. "INVESTIGATOR SPONSORED CLINICAL STUDY". Investigator
Sponsored Clinical Study means a human clinical study of the Licensed Product
that is sponsored and conducted by a Third Party under an agreement with a Party
pursuant to which such Party provides clinical supplies of the Licensed Product
and/or funding for such clinical study.
Section 1.42. "JOINT INTELLECTUAL PROPERTY". Joint Intellectual
Property means Joint Know-How and Joint Patent Rights, collectively.
Section 1.43. "JOINT KNOW-HOW". Joint Know-How means any Know-How that
is developed jointly by the Parties in connection with their activities pursuant
to this Agreement, including Joint Inventions.
Section 1.44. "JOINT PATENT RIGHTS". Joint Patent Rights means Patent
Rights that Cover Joint Know-How.
Section 1.45. "KNOW-HOW". Know-How means all non-public ideas,
concepts, formulas, compounds, works of authorship, data, information, methods,
procedures, processes and materials, but only to the extent that such ideas,
concepts, formulas, compounds, works of authorship, data, information, methods,
procedures, processes and materials are related to the Manufacture, Development,
or Commercialization of a Compound or a Licensed Product, including but not
limited to, biological, chemical, biochemical, toxicological, pharmacological,
metabolic, formulation, clinical, analytical and stability information and data.
Section 1.46. "LAW". Law means any federal, state or local, foreign,
national or multinational law, statute, standard, ordinance, code, rule,
regulation, resolution or promulgation, or any government order, or any license,
franchise, permit or similar right granted under any of the foregoing, or any
similar provision having the force or effect of law.
Section 1.47. "LICENSED PRODUCT". Licensed Product means the product
containing the Compound in any dosage form or formulation, for all approved and
future indications and currently referred to as INTEGRILIN.
Section 1.48. "LOSSES". Losses means any Actions, demands, liabilities,
expenses (including costs of investigation, defense and enforcement of this
Agreement), damages, fines, penalties, Government Orders, taxes, expenses or
amounts paid in settlement or other losses, including reasonable legal expenses
and attorneys' and experts' fees and expenses actually incurred.
Section 1.49. "MAJOR MARKET COUNTRIES". Major Market Countries means
the following countries as may be amended by the Parties upon mutual agreement
from time to time: [**].
Section 1.50. "MANUFACTURING" or "MANUFACTURE". Manufacturing or
Manufacture means all the activities relating to production of each Licensed
Product, including without limitation, purchasing raw materials, production of
the Compound, the Finished Product or the Licensed Product, quality control and
assurance, filling, finishing, labeling, packaging, release, holding, shipping
and storage and the tests and analyses conducted in connection therewith.
Manufacturing includes Secondary Packaging.
Section 1.51. "MILLENNIUM INTELLECTUAL PROPERTY". Millennium
Intellectual Property means Millennium Know-How and Millennium Patent Rights,
collectively. Millennium Intellectual Property excludes the Product
Trademark(s).
Section 1.52. "MILLENNIUM KNOW-HOW". Millennium Know-How means any
Know-How that either (a) is Controlled by Millennium or its Affiliates on the
Effective Date or (b) comes within Millennium's or its Affiliates' Control
during the Term, including Millennium's interest in Millennium Sole Inventions,
Joint Know-How and Schering Know-How.
Section 1.53. "MILLENNIUM PATENT RIGHTS". Millennium Patent Rights
means Patent Rights, including the interest of Millennium and/or its Affiliates
in Joint Patent Rights, that (a) Cover Millennium Know-How and (b) are
Controlled by Millennium and/or its Affiliates on the Effective Date or at any
time during the Term. Millennium Patent Rights includes, but is not limited to,
those Patent Rights listed on EXHIBIT I hereto.
Section 1.54. "NET SALES". Net Sales means, with respect to the
Licensed Product, the gross invoiced sales of the Licensed Product by GSK, its
Affiliates, sublicensees or Excluded Distributors (as defined below) from or on
account of the first sale or distribution of the Licensed Product to Third
Parties which are not Affiliates, sublicensees or Excluded Distributors, less
the following deductions to the extent specifically relating to such sales of
the Licensed Product and, in all cases, calculated in accordance with UK GAAP:
(a) discounts, credits, retroactive price reductions, rebates,
refunds, rejections, returns, chargebacks, allowances and adjustments granted to
non-sublicensee Third Parties, including managed care and similar types of
rebates, determined in accordance with and to the extent consistent with GSK's
usual course of dealing for its products other than the Licensed Product;
(b) trade, quantity and cash discounts and rebates allowed or
given, each to the extent consistent with GSK's usual course of dealing for its
products other than the Licensed Product;
(c) sales, excise, inventory, value-added, and similar taxes
assessed on the sale of the Licensed Product (other than income taxes of GSK,
its Affiliates, or sublicensees), and import and customs duties;
(d) transportation, shipping insurance, freight and other
handling expenses as are customary and reasonable for the industry;
(e) government imposed rebates or discounts;
(f) any bona fide payments made by GSK to government agencies
permitted under the U.S. Foreign Corrupt Practices Act of 1977, as amended, with
respect to sales of Licensed Products in order to be allowed to tender the sale
of the Licensed Products in a given country in the Territory; and
(g) actual specifically identifiable, documented uncollectible
receivables, up to [**]% of such gross invoiced sales amount.
For purposes of clarity, no permitted deduction to Net Sales will be counted
more than once or, with the exception of uncollectible receivables, adjusted
more than six (6) months following the calculation of Net Sales for a given
month.
For the purpose of the definition of Net Sales, "Excluded Distributor(s)" means
a distributor acting in the capacity of a sublicensee such that such distributor
holds (A) sales and distribution rights in a country or countries in the
Territory responsible for sales and distribution of the Licensed Product in such
country or countries, coupled with (B) pricing authority or government pricing
negotiation authority with respect to wholesalers or sub-distributors in such
country or countries.
Sales of Licensed Product by and between GSK and its Affiliates or sublicensees
or Excluded Distributors are not sales to non-sublicensee Third Parties and will
be excluded from Net Sales calculations for all purposes. If GSK or any of its
Affiliates, Excluded Distributors or sublicensees makes any transfer of Licensed
Products to Third Parties for consideration other than monetary value or as part
of a multiproduct transaction, such transfer will be considered a sale hereunder
for Net Sales, accounting and royalty purposes. Net Sales for any such transfers
will be determined on a country by country basis and will be the average price
of "arms length" sales by GSK or its Affiliates or sublicensees or Excluded
Distributors in such country during the royalty reporting period in which such
transfer occurs or, if no such "arms length" sales occurred in such country
during such period, during the last period in which such "arms length" sales
occurred. If no "arms length" sales have occurred in a particular country, Net
Sales for any such transfer in such country will be the average price of "arms
length" sales in all countries in the Territory by GSK, its Affiliates, Excluded
Distributors or sublicensees.
The Parties agree that to the extent permitted under Article VII, should GSK or
its Affiliates or sublicensees desire to Develop or Commercialize a product
which includes other active ingredients in addition to the Compound, prior to
undertaking any such activities, the Parties will negotiate in good faith
appropriate modifications, if any, to be made to the calculation of Net Sales,
which such modifications will be mutually agreeable to each Party, and which
royalty rates applicable to such Net Sales will not exceed those stated in
Section 8.3 hereof.
Section 1.55. "PARTY". Party means either Millennium or GSK. "PARTIES"
mean both Millennium and GSK.
Section 1.56. "PATENT RIGHTS". Patent Rights means patents and patent
applications and all substitutions, divisions, continuations,
continuations-in-part, reissues, reexaminations and extensions thereof including
the Supplemental Certificate of Protection of Member States of the European
Union, and all counterparts thereof in any country.
Section 1.57. "PHASE IV CLINICAL STUDY". Phase IV Clinical Study means
a human clinical study initiated in a country in an approved indication after
receipt of Regulatory Approval for such indication in such country.
Section 1.58. "PRIMARY DETAIL". Primary Detail means a Sales Call for
the Licensed Product in which the Licensed Product [**] during the Sales Call
[**] during the Sales Call[**] in accordance with GSK's standard operating
procedures for its own products to the target physician group for the Licensed
Product.
Section 1.59. "PRODUCT TRADEMARK(S)". Product Trademark(s) means all
registrations, applications for registration and other rights in and to the
INTEGRILIN(R) xxxx and the tradename, commercial symbols and logos associated
therewith or any variations thereof.
Section 1.60. "REGULATORY APPROVAL". Regulatory Approval means the
approval of the applicable Regulatory Authority necessary for the use, import,
storage, Manufacturing, marketing and sale of the Licensed Product for a
particular indication in a country, including separate pricing and/or
reimbursement approvals that may be required, and including the expansion or
modification of the label for such indication.
Section 1.61. "REGULATORY AUTHORITY". Regulatory Authority means any
federal, national, multinational, state, provincial or local regulatory agency,
department, bureau or other governmental entity with authority over the
manufacture, pricing, reimbursement, marketing and sale of a pharmaceutical
product in a country.
Section 1.62. "SALES CALL". Sales Call means a face-to-face contact of
a Sales Representative with a medical professional with prescribing authority
during which scientific and/or medical information about the use of the Licensed
Product for the prevention and/or treatment of indications for which the
Licensed Product has received Regulatory Approval is discussed. Sales Call
includes attendance of a Sales Representative at scientific and medical
conferences where information regarding the Licensed Product is presented by the
Sales Representative to medical professionals with prescribing authority, as
well as Primary Details and Secondary Details.
Section 1.63. "SALES REPRESENTATIVE". Sales Representative means an
individual who engages in or manages Sales Calls and who is employed by GSK. In
no event will a medical science liaison be considered to be a Sales
Representative.
Section 1.64. "SCHERING". Schering means, collectively, Schering
Corporation and Schering-Plough Ltd., or where the context requires, the
applicable Affiliate of Schering Corporation or Schering-Plough Ltd. acting on
behalf of Schering Corporation or Schering-Plough Ltd., as the case may be.
Section 1.65. "SCHERING COLLABORATION AGREEMENT". Schering
Collaboration Agreement means the Collaboration Agreement dated April 10, 1995
(as amended) among Schering Corporation, Schering Ltd. and COR Therapeutics,
Inc. (the predecessor in interest to Millennium). A copy of the redacted
Schering Collaboration Agreement is attached to this Agreement as EXHIBIT B-1.
For clarity, the Schering Collaboration Agreement (as amended) excludes the
Schering/Millennium European Agreement.
Section 1.66. "SCHERING CORPORATION". Schering Corporation means the
New Jersey corporation known as Schering Corporation having its principal place
of business at 0000 Xxxxxxxxx Xxxx Xxxx, Xxxxxxxxxx, Xxx Xxxxxx 00000, X.X.X.
and its successors and assigns.
Section 1.67. "SCHERING INDEMNIFIED PARTIES". Schering Indemnified
Parties means Schering, its Affiliates and their respective directors, officers,
employees and agents.
Section 1.68. "SCHERING/MILLENNIUM EUROPEAN AGREEMENT".
Schering/Millennium European Agreement means the Agreement about European
Commercialization of INTEGRILIN among Millennium, Schering Corporation and
Schering-Plough, Ltd. dated June 21, 2004. A copy of the redacted
Schering/Millennium European Agreement is attached to this Agreement as EXHIBIT
B-2, such redactions to be limited to financial matters and other matters and
terms not pertinent to this Agreement that are confidential as between Schering
and Millennium.
Section 1.69. "SCHERING KNOW-HOW". Schering Know-How means Information
(as defined below) relating to the Development, Manufacture or Commercialization
of the Licensed Product which (a) Schering discloses to Millennium under the
Schering Collaboration Agreement and (b) is within the Control of Schering.
Schering Know-How excludes Schering Patent Rights. For purposes of this Section
1.69, "Information" means (i) techniques and data specifically relating to
development, manufacture, use or sale of the Licensed Product, including
inventions, practices, methods, knowledge, know-how, skill, experience, test
data including pharmacological, toxicological and clinical test data, analytical
and quality control data, regulatory submissions, correspondence and
communications, marketing, pricing, distribution, cost, sales, manufacturing,
patent and legal data or descriptions and (ii) compositions of matter, assays
and biological materials specifically relating to development, manufacture, use
or sale of the Licensed Product.
Section 1.70. "SCHERING PATENT RIGHTS". Schering Patent Rights means
the right granted by any Governmental Authority under a Patent (as defined
below) which Covers the Licensed Product or a method, apparatus, material or
manufacture useful in the development, manufacture, use or sale of the Licensed
Product, which Patent is Controlled by Schering. For purposes of this Section
1.70, "Patent" means (a) unexpired letters patent (including inventor's
certificates) which have not been held invalid or unenforceable by a court of
competent jurisdiction from which no appeal can be taken or has been taken
within the required time period, including without limitation any substitution,
extension, registration, confirmation, reissue, re-examination, renewal or any
like filing thereof and (b) pending applications for letters patent, including
without limitation any continuation, division or continuation-in-part thereof
and any provisional applications.
Section 1.71. "SCHERING-PLOUGH, LTD.". Schering-Plough, Ltd. means the
corporation known as Schering-Plough, Ltd. organized under the Laws of
Switzerland having its principal place of business at Xxxxxxxxxx 00, X.X. Xxx,
XX-0000, Xxxxxxx 0, Xxxxxxxxxxx, and its successors and assigns, or where the
context requires, the applicable Affiliate of Schering-Plough, Ltd. acting on
its behalf.
Section 1.72. "SECONDARY DETAIL". Secondary Detail means a Sales Call
for the Licensed Product in which the Licensed Product [**] during the Sales
Call [**] for the Licensed Product [**] during the Sales Call[**] in accordance
with GSK's standard operating procedures for its own products to the target
physician group for the Licensed Product.
Section 1.73. "SECONDARY PACKAGING". Secondary Packaging means the
importation, testing, labeling, packaging, and qualified person release, storage
and shipping functions.
Section 1.74. "SECONDARY PACKAGING REGULATORY APPROVAL". Secondary
Packaging Regulatory Approval means the approval of the applicable Regulatory
Authorities necessary for the Secondary Packaging of the Licensed Product.
Section 1.75. "TERRITORY". Territory means [**], and any other
countries that may arise by succession, subdivision, consolidation or
reconstitution of these countries.
Section 1.76. "THIRD PARTY". Third Party means any person other than a
Party or any of its Affiliates.
Section 1.77. "TRANSITION PERIOD". Transition Period means the time
period commencing on the Effective Date and ending upon GSK's receipt of all
required Regulatory Approvals for Commercialization of the Licensed Product in a
given country of the Territory.
Section 1.78. "UK GAAP". UK GAAP means International Financial
Reporting Standards or United Kingdom generally accepted accounting principles
applied on a consistent basis.
Section 1.79. "UNITED STATES" OR "U.S.". United States or U.S. means
the United States of America and its territories and possessions.
Section 1.80. "US GAAP". US GAAP means United States generally accepted
accounting principles applied on a consistent basis.
Section 1.81. "VALID CLAIM". Valid Claim means a claim (a) of any
issued, unexpired patent that has not been revoked or held unenforceable or
invalid by a decision of a court or governmental agency of competent
jurisdiction from which no appeal can be taken, or with respect to which an
appeal is not taken within the time allowed for appeal, and that has not been
disclaimed or admitted to be invalid or unenforceable through reissue,
disclaimer or otherwise or (b) of any patent application that has not been
pending for more than five (5) years.
Section 1.82. ADDITIONAL DEFINITIONS. Each of the following definitions
is set forth in the Section of this Agreement indicated below:
DEFINITION SECTION
---------- -------
1974 Convention 14.1
AAA 13.3
Baseline Cost of Fill/Finish 6.3(d)
Breaching Party 12.2
CMC 4.5
Cost of Goods Rate 8.3(a)
Cost of Fill/Finish Savings 6.3(d)
Country Approval Notice 5.12(a)
[**] 8.3(a)(iii)
EARLY ACS Study 4.1(e)
Effective Date Preamble
Excluded Distributor 1.54
Force Majeure Event 14.15
Future Supply Agreement 6.3(b)
Generic Equivalent 8.5(b)
Generic Erosion 8.5(b)
Global AE Database 5.12(a)
GSK Preamble
GSK Indemnified Parties 11.8(a)
GSK Product Trademark 9.7(b)
GSK Sole Inventions 9.1(a)
IND 4.5
Indemnified Party 11.8(f)(i)
Indemnifying Party 11.8(f)(i)
Joint Inventions 9.1(b)
Launch Plan 5.2(a)
Local Third Parties 7.1(d)
Millennium Preamble
Millennium Indemnified Parties 11.8(b)
Millennium Sole Inventions 9.1(a)
Millennium Trademarks 9.7(d)
Non-Breaching Party 12.2
Ongoing Development Activities 4.1(c)
Operational Notice 5.1
Promotional Materials 5.9(a)
Receiving Party 8.12
Reporting Agreement 5.12(a)
Requesting Party 8.12
Severed Clause 14.4
Special Meeting 5.5
Steering Committee 2.2
Supplemental Plan 5.6
Supply Agreement 6.3(a)
Supply Price Percentage 8.3(a)(ii)
Taxes 8.13(d)
Term 12.1
Transition Activities and Processes 3.2
TTBE Regulation 7.2(a)
Unresolved Matter 13.2
ARTICLE II
MANAGEMENT OF ACTIVITIES
Section 2.1. GENERAL DEVELOPMENT AND COMMERCIALIZATION SCOPE. GSK will
be responsible for the Development and Commercialization of the Licensed Product
in the Territory during the Term, and Millennium and its Third Party licensees
will retain all other rights to the Licensed Product to Develop and
Commercialize the Licensed Product outside the Territory. In addition, to the
extent expressly provided in this Agreement, Millennium and its Third Party
licensees will retain the right to Develop the Licensed Product in the Territory
for the purpose of supporting the Development and Commercialization of the
Licensed Product outside the Territory.
Section 2.2. STEERING COMMITTEE. As soon as reasonably practicable
after the Effective Date, Millennium and GSK will establish a steering committee
(the "Steering Committee"), to oversee the activities to be undertaken pursuant
to this Agreement. The Steering Committee will facilitate communication between
the two Parties and provide a forum to review any Development, regulatory,
Manufacturing and Commercialization matters pertaining to the Licensed Product.
The Steering Committee will, among other things (a) review the Annual Plans,
including the key Commercialization product strategies proposed by GSK for the
Territory and potential benefits from synergies of such activities in the
Territory with efforts outside the Territory; (b) provide a forum for
communication of GSK's activities in the Territory, and Millennium's and Third
Party licensees' activities outside the Territory, with respect to the Licensed
Product; (c) review the Parties' proposed Development activities in the
Territory; (d) review the Manufacture and supply of Licensed Product for the
Territory and [**] as set forth in Sections 6.3(b) and 6.3(c) hereof; and (e)
resolve any open matters that may exist between the two Parties in accordance
with the remaining provisions of this Section.
Section 2.3. MEMBERSHIP. The Steering Committee will be composed of
three (3) representatives appointed by each of Millennium and GSK for a total of
six (6) representatives. Each Party may replace its Steering Committee
representatives at any time upon written notice to the other Party. Subject to
Article XIII, the Steering Committee will operate by consensus, and each Party
will consider the other Party's input in good faith. The Steering Committee may
establish certain ad hoc sub-committees which consider certain matters (e.g.,
Development and Manufacturing activities) related to the Licensed Product in the
Territory and which will advise the Steering Committee accordingly.
Section 2.4. MEETINGS. The Steering Committee will hold meetings at
such times as the Parties will reasonably determine, but in no event will such
meetings be held less frequently than twice per year (once face to face). Unless
otherwise agreed, the Steering Committee will meet alternately at location(s)
designated by GSK and Millennium. Each Party will be responsible for all of its
own expenses of participating in the Steering Committee and may include
non-voting representatives in such meetings as necessary to address matters
under consideration by the Steering Committee.
ARTICLE III
TRANSFER OF REGULATORY APPROVALS AND DOCUMENTS
Section 3.1. GENERAL; NOTIFICATION OF EFFECTIVE DATE. During the
Transition Period for the countries in the Territory, the Parties will cooperate
in order to facilitate the transfer activities identified in this Article III.
Promptly after the Effective Date, Millennium will notify Schering that GSK is
Millennium's licensee for Development and Commercialization of the Licensed
Product in the Territory. Promptly after the Effective Date, GSK will provide to
Millennium, and Millennium will provide to Schering, all necessary contact
information to enable Schering to communicate with GSK with respect to the
activities set forth in this Article III. Millennium will use commercially
reasonable efforts and GSK will use Commercially Reasonable Efforts to complete
the Assignment and Transfer of Regulatory Approvals as soon as practicable after
the Effective Date.
Section 3.2. TRANSITION ACTIVITIES AND PROCESSES. Millennium agrees as
of the Effective Date to perform its obligations under the Schering/Millennium
European Agreement. In addition, as of the Effective Date, Millennium will
undertake commercially reasonable efforts to cause Schering to, and acknowledges
that it has received written assurances from Schering, pursuant to the
Schering/Millennium European Agreement that Schering will, undertake the
transition activities and obligations set forth in EXHIBIT H attached hereto
("Transition Activities and Processes"), to implement the Assignment and
Transfer of Regulatory Approvals and to transfer other rights and
responsibilities to GSK to Develop and Commercialize the Licensed Product in the
Territory.
Section 3.3. TRANSFER FEES. GSK will reimburse Millennium for all fees
imposed by Regulatory Authorities after the Effective Date in the Territory on
Schering or Millennium for processing and approving filings, including fees
imposed for the Assignment and Transfer of Regulatory Approvals. For purposes of
clarity, GSK will not be responsible for any fees imposed by Regulatory
Authorities in connection with the Licensed Product on a country-by-country
basis and incurred after the Effective Date until GSK has received all
Regulatory Approvals necessary to Commercialize the Licensed Product in such
country of the Territory. On a country-by-country basis, upon receipt of all
necessary Regulatory Approvals to Commercialize the Licensed Product, Millennium
will invoice GSK, and GSK will pay to Millennium, expenses incurred for all fees
imposed by Regulatory Authorities to obtain such Regulatory Approvals. Except as
expressly provided in the preceding sentence, each of Millennium, GSK and
Schering will bear its own cost of fulfilling its obligations related to the
Transition Activities and Processes.
Section 3.4. EFFECTS OF THE ASSIGNMENT AND TRANSFER OF REGULATORY
APPROVALS. Upon the Assignment and Transfer of all Regulatory Approvals for each
country within the Territory, and on a country-by-country basis, GSK will own
all Regulatory Approvals and submissions, including all applications, for
Regulatory Approvals in the Territory and will be solely responsible for seeking
and obtaining, and will have the exclusive right to seek and obtain, all
Regulatory Approvals in the Territory. During the Term upon the Assignment and
Transfer of all Regulatory Approvals on a country-by-country basis, GSK will be
responsible for maintaining Regulatory Approval(s) for the Licensed Products in
each country in the Territory for which such approvals exist as of the Effective
Date.
ARTICLE IV
DEVELOPMENT
Section 4.1. CURRENT STATUS; GENERAL.
(a) Prior to the Effective Date, Millennium (alone or with Third
Parties) has conducted and continues to conduct pre-clinical and/or clinical
studies (registration and/or non-registration) of the Licensed Product in and
outside the Territory.
(b) From and after the Effective Date, as more particularly
described and solely to the extent expressly provided in this Agreement below,
(i) GSK will be responsible for all Development of the Licensed Product that GSK
may in its sole discretion propose to initiate and execute that pertain solely
to the Territory, including registration and non-registration trials (including
Phase IV Clinical Studies, post-approval studies and Investigator Sponsored
Clinical Studies) and, (ii) Millennium (alone, with Third Parties or by a Third
Party itself) will continue to be responsible for Development of the Licensed
Product (A) outside the Territory, and (B) inside the Territory to the extent
permitted by this Agreement, including registration and non-registration trials
inside and outside the Territory (including Phase IV Clinical Studies,
post-approval studies and Investigator Sponsored Clinical Studies).
(c) As of the Effective Date, Schering has identified its
ongoing Development activities in the Territory as set forth in EXHIBIT C hereto
(the "Ongoing Development Activities"). Promptly after the Effective Date, GSK
shall notify Millennium of [**] such Ongoing Development Activities. [**] the
Ongoing Development Activities, [**] with respect to such Ongoing Development
Activities, [**] the Ongoing Development Activities in [**] Ongoing Development
Activities [**] in the Territory [**].
(d) The foregoing provisions of Section 4.1(b) notwithstanding,
GSK acknowledges that Millennium (alone, with Third Parties or by a Third Party
itself) will retain the right to conduct Development activities in the Territory
where such Development activity is conducted in support of Millennium's
Development or Commercialization efforts for the Licensed Product outside the
Territory, provided, that Millennium will (i) notify GSK prior to initiating any
such Development activities in the Territory (whether such activities are to be
conducted by Millennium, its Third Party licensee or both) and provide GSK with
[**] provided by GSK, and (iii) discuss with GSK in good faith the
implementation of such activity with due consideration to [**] in the Territory.
However, final decision-making authority regarding any such Development
activities for the Licensed Product in the Territory will reside with Millennium
except for matters related to patient safety which will be determined in
accordance with Section 4.7 hereof.
(e) GSK acknowledges that Development activities pertaining to
the registration study [**] are underway as of the Effective Date, that the [**]
will be conducted by Millennium or a Third Party in part in the Territory, and
that the terms of this Article IV do not apply to the [**]. GSK will have
non-exclusive access under the licenses granted in Section 7.1 of this Agreement
to use data generated in the course of the [**].
(f) Millennium will provide GSK with an annual clinical
Development plan describing all clinical Development activities that Millennium
proposes to conduct inside the Territory (whether such activities are to be
conducted by Millennium, a Third Party or both), such plan to include site
locations and principal investigators of the proposed clinical Development
activities. Millennium will consider comments regarding such plan from GSK in
good faith; provided, however, that final decisions related to such plan will
reside with Millennium; provided further that all decisions with regard to
patient safety will be decided in accordance with the provisions of Section 4.7
below. Millennium may amend the annual clinical Development Plan, subject to
provisions for review by GSK and decision-making as set forth in this subsection
4.1(f). Neither Millennium nor its Affiliates or sublicensees will, directly or
through any Third Party, initiate, sponsor, fund or supply Licensed Product or
otherwise conduct any clinical study or Development of the Licensed Product
except as contemplated by the annual plan.
Section 4.2. DEVELOPMENT RESPONSIBILITIES; ANNUAL PLANS; AMENDMENTS.
(a) In the event GSK conducts Development activities hereunder,
GSK agrees to conduct all of its Development activities substantially in
accordance with the Annual Plan. The Annual Plan will include reasonably
detailed information regarding all non-registration and registration trials GSK
proposes to conduct in the Territory, and will take into account and be
consistent with the global branding for the Licensed Product. A copy of the
Annual Plan will be provided to Millennium each year and more frequently, if
amended, during the Term promptly upon completion by GSK. The Steering Committee
will review the Annual Plan not less frequently than annually and as necessary
for review of amendments to the then current Annual Plan.
(b) Except as provided in Section 4.1(e) above, with respect to
matters regarding the conduct of Development in the Territory by GSK pursuant to
this Article IV, to the extent permitted by applicable Law, GSK will provide
copies to Millennium of both draft and final forms of protocols and informed
consents with respect to such Development (and, upon Millennium's request, forms
of agreements with Third Parties with respect to such Development) prior to
initiation of such activities. For purposes of clarity, GSK will not provide any
confidential patient identifying information under this Section 4.2(b).
(c) Neither GSK nor its Affiliates, sublicensees or distributors
will, directly or through any Third Party, initiate, sponsor, fund or supply
Licensed Product or otherwise conduct any clinical study or Development of the
Licensed Product except as contemplated by the Annual Plan without the prior
approval of the Steering Committee.
Section 4.3. DEVELOPMENT EFFORTS; MANNER OF PERFORMANCE.
(a) GSK will use Commercially Reasonable Efforts to execute and
to perform, or cause to be performed, the Development activities set forth in
the Annual Plan, in each case in good scientific manner and in compliance with
applicable Law, Good Clinical Practice and Good Laboratory Practice. For the
avoidance of doubt, and notwithstanding anything in this Agreement to the
contrary, GSK, in its sole discretion, will determine its level of Development
activities in the Territory, if any, subject to Millennium's right to review and
approve protocols as provided in Section 4.2(b).
(b) Millennium will provide copies to GSK of registration
clinical study protocols pertaining to Development of the Licensed Product by
Millennium or its Third Party licensees or contractors. Millennium will use
commercially reasonable efforts to execute and to perform, or cause to be
performed, any Development activities it or its Third Party licensee or
contractor conducts with the Licensed Product, in each case in good scientific
manner and in compliance with applicable Law, Good Clinical Practice and Good
Laboratory Practice. For the avoidance of doubt and notwithstanding anything in
this Agreement to the contrary, Millennium, in its sole discretion, will
determine its level of Development activities outside the Territory.
Section 4.4. REGULATORY APPROVALS.
(a) On a country-by-country basis, after completion of the
Transition Period, and subject to Section 4.4.(d) hereof, GSK will be solely
responsible for seeking Regulatory Approvals for the Licensed Product in such
country in the Territory, including, preparing and filing Regulatory Authority
applications and meeting with Regulatory Authorities. All such applications will
be filed in the name of GSK which will be the holder of all resulting Regulatory
Approvals. GSK will provide to the Steering Committee periodic reports
describing the regulatory filing status of the Licensed Product throughout the
Territory.
(b) After approval of (i) the transfer of the Central Marketing
Authorization to GSK for the countries in the European Union, or (ii) in the
case of patient safety related matters, proposed modifications to the labeling
or Manufacturing matters for the Licensed Product in countries in the Territory
outside the European Union, by any Regulatory Authority (so long as the
Transition Period for the relevant country has been completed), GSK will provide
Millennium with reasonable advance notice of meetings with the applicable
Regulatory Authority and provide advance copies of all material documents and
other relevant information relating to such meetings to permit for a discussion
between the Parties pursuant to Section 4.4(c) hereof. For each such meeting,
GSK will inform Millennium in writing within [**] Business Days as to topics
discussed and decisions reached at such meetings.
(c) GSK and Millennium will discuss any material documents
relating to all safety matters, proposed modifications to the labeling or
Manufacturing matters for the Licensed Product (other than correspondence
relating to pricing and reimbursement approvals) relating to the Licensed
Product that GSK receives from, or intends to submit to, the Regulatory
Authorities in the Territory. GSK will provide Millennium with drafts of such
documents and correspondence sufficiently in advance of submission by GSK (but
no later than [**] Business Days prior to such submission), copies of final
submissions, and material correspondence received by GSK in response to such
submissions, so that Millennium may review and comment thereon and have a
reasonable opportunity to influence the substance of such submissions or
responses. The Parties will discuss such submissions and proposed modifications
in good faith, and will attempt to resolve any disagreements arising from such
discussions. Any material disagreement pertaining to correspondence, discussions
with, or submissions to the Regulatory Authorities in the Territory for the
Licensed Product will be brought to the Steering Committee for resolution, other
than matters related to pricing and reimbursement approvals which will be
resolved by GSK. If the Parties are not able to reach agreement at the Steering
Committee level, the disagreement will be handled in accordance with the
procedures set forth in Article XIII hereof.
(d) Upon reasonable request from Millennium, GSK will
communicate and coordinate with Millennium, and/or make submissions to the
Regulatory Authorities on behalf of Millennium, as may be required by applicable
Law with respect to the Licensed Product in the Territory during the Term,
including, but not limited to, Manufacturing matters.
Section 4.5. ACCESS TO REGULATORY SUBMISSIONS, APPROVALS AND DRUG
MASTER FILES. From and after the Effective Date, Millennium and Schering will
have the right to access all data contained or referenced in GSK submissions or
applications for Regulatory Approvals (other than pricing and reimbursement
approvals) for use outside the Territory. Millennium will receive copies of all
relevant reports, associated correspondence and key interactions in a timely
manner, and summaries in English of meetings with the Regulatory Authorities in
connection with the Licensed Product. Millennium and GSK will have the right to
cross-reference the relevant drug master file, including Third Party drug master
files, associated with the Licensed Product in the Territory in the format
required by the applicable Regulatory Authority (except with respect to pricing
and reimbursement approvals), to the extent necessary (a) in the case of GSK, to
exercise its rights hereunder and perform its obligations with respect to the
Licensed Product in the Territory, and (b) in the case of Millennium and its
Third Party licensees or contractors, to Develop, Manufacture and Commercialize
the Licensed Product outside the Territory, to Develop the Licensed Product in
the Territory, to the extent permitted by this Agreement, and to Manufacture the
Licensed Product. Millennium will promptly provide to GSK copies of all material
regulatory submissions related to the safety, labeling, clinical Development,
chemistry manufacturing and controls ("CMC") and Manufacturing of Licensed
Product made to the FDA. For purposes of clarity, clinical Development shall not
include routine submissions related to an investigational new drug ("IND")
application such as investigator and sub-investigator submissions and
notifications, Form 1572s, and site enrollment notifications.
Section 4.6. DEVELOPMENT COSTS.
(a) From and after the Effective Date, GSK will be responsible
for all Development costs associated with any registration and non-registration
clinical trials (including Phase IV Clinical Trials and Investigator Sponsored
Clinical Studies) of Licensed Product that GSK initiates in the Territory. After
the Regulatory Approvals necessary for GSK to Commercialize the Licensed Product
have been transferred to GSK, GSK will be responsible for [**]% of the
Development costs incurred in obtaining and maintaining Regulatory Approvals in
the Territory, including without limitation, all (i) filing fees for Regulatory
Approvals payable to Regulatory Authorities in the Territory and (ii)
maintenance fees relating to Regulatory Approvals payable to Regulatory
Authorities in the Territory.
(b) From and after the Effective Date, Millennium or its
licensee will be responsible for all Development costs associated with any
registration and non-registration clinical trials (including Phase IV Clinical
Trials and Investigator Sponsored Clinical Studies) of Licensed Product that
Millennium initiates inside and outside the Territory. In addition, Millennium
will be responsible for [**]% of the Development costs incurred in obtaining and
maintaining Regulatory Approvals outside the Territory, including without
limitation, all (i) filing fees for Regulatory Approvals payable to Regulatory
Authorities outside the Territory and (ii) maintenance fees relating to
Regulatory Approvals payable to Regulatory Authorities outside the Territory.
(c) If GSK wishes to access or use data Controlled by Millennium
and generated in a registration study (excluding the [**] as set forth in
Section 4.1(e)) conducted in (as permitted by this Agreement) or outside the
Territory for the Licensed Product in the Territory, GSK will have the right to
access and use such data for the Development and Commercialization of the
Licensed Product in the Territory, as further provided in this Section 4.6.
(i) Millennium will provide GSK with the protocol,
anticipated budget and other pertinent information about each proposed
registration study to be conducted by Millennium with respect to the Licensed
Product, in or outside the Territory.
(ii) Upon review of the information provided to it pursuant
to Section 4.6(c)(i), GSK may inform Millennium that it is interested in
accessing and using the data to be generated pursuant to the proposed
registration study, and will agree to pay the portion of the budgeted
Development costs associated with such registration study equal to (A) [**]
multiplied by (B) a fraction X, where X is [**] the Licensed Product in the
Territory [**] of such study, divided by, the [**] the Licensed Product [**].
(iii) If GSK elects not to share Development costs for a
particular registration study as described in Section 4.6(c)(ii), then upon
conclusion of a registration study conducted by Millennium or a Third Party
pursuant to this Article IV Millennium will present a summary of the data
generated pursuant to the study. Based on the information provided to GSK
pursuant to this Section 4.6(c)(iii), if GSK desires to access and use the data
generated pursuant to such registration study and Controlled by Millennium, then
GSK will have the right to obtain access to and the right to use such data upon
written notification to Millennium and payment to Millennium of an amount equal
to [**] percent ([**]%) of the amount that it would have been required to pay
under Section 4.6(c)(ii), it being understood that such [**] will be based on
[**].
(iv) If GSK declines the opportunity to access and use data
generated in the conduct of a registration study, as described in this Section
4.6, GSK will not have the right to access or use any data generated in such
study for any purposes.
(v) GSK will not conduct site visits or engage in
discussions with study investigators regarding any registration study conducted
by Millennium or a Third Party in connection with the Licensed Product. For
purposes of clarity, the terms of this Agreement do not preclude GSK from
engaging in Development activities with the same investigators used by
Millennium or a Third Party for different Development activities.
(vi) Millennium will calculate and maintain records of
Development costs for such registration studies that are incurred by Millennium
or Third Parties. Any payments under Section 4.6(c)(ii) or 4.6(c)(iii) by GSK of
its share of Development costs will be made by GSK within [**] days after
receipt of an invoice for such amounts from Millennium which will be sent at the
end of the relevant calendar quarter in which GSK has elected to gain access to
the study results. If GSK elects to purchase access to such data, GSK will have
the right to request, and Millennium will provide, auditable documentation
related to such costs for purposes of confirming such costs.
Section 4.7. PATIENT SAFETY MATTERS. With regard to matters of patient
safety, Millennium and GSK will discuss any concerns regarding clinical
Development activities in the Territory and reach consensus regarding whether
such Development activities should be undertaken either by Millennium, GSK or
their Third Party licensees. In the event the Parties cannot agree as such
matters, any unresolved dispute will be resolved in accordance with the dispute
resolution provisions of Sections 13.1 and 13.3 below.
ARTICLE V
COMMERCIALIZATION
Section 5.1. TRANSFER OF RIGHTS TO DISTRIBUTE. During the Term once
the Transition Period has been completed in a particular country, Millennium
will appoint GSK as Millennium's exclusive distributor of the Licensed Product
in such country, including the right to appoint sub-distributors, following (a)
Regulatory Approval (where required) with respect to GSK's role as exclusive
distributor for the Licensed Product in the country and (b) GSK's notice to
Millennium that it has established the necessary operational capability to
perform as Millennium's exclusive distributor for the Licensed Product in such
country ("Operational Notice"). GSK will undertake efforts to establish such
operational capabilities as soon as practicable after the Effective Date in
those countries of the Territory in which the Licensed Product is currently
Commercialized.
Section 5.2. LAUNCH PLAN; PRE-LAUNCH ACTIVITIES.
(a) LAUNCH PLAN. GSK will formulate a launch plan for the
Licensed Product in the Territory outlining key Commercialization steps to be
undertaken by GSK during pre-launch and launch of the Licensed Product in the
Territory ("Launch Plan") and provide the Launch Plan as soon as practicable
after the Effective Date to Millennium for review and comment, but no later than
[**] following the Effective Date. To the extent practicable given labeling and
market forces in the Territory, the Launch Plan will be consistent with the
global branding message for the Licensed Product as discussed between the
Parties. Final decisions regarding all Commercialization activities contemplated
by elements of the Launch Plan will reside with GSK. The Launch Plan will be a
component of the initial Annual Plan.
(b) CO-PROMOTION ACTIVITIES. Subject to the terms of this
Section 5.2(b), GSK will be appointed by Schering as agreed in the
Schering/Millennium European Agreement as the exclusive co-promoter for the
marketing and promotion (but not the sale) of Licensed Product in the Territory.
GSK will consult with Schering and Millennium and [**] with respect to [**]
relating to the Licensed Product [**] in the Territory that are approved by
Millennium and Schering in advance.
(c) NOTICE OF TRANSFER TO GSK. Schering has agreed that it will
promptly notify all customers in writing that GSK will be assuming the marketing
rights to the Licensed Product in the Territory. [**] prior to Schering sending
such notice to customers. GSK will reimburse Millennium for all reasonable,
documented charges incurred by Millennium in connection with such notice.
(d) INVENTORY [**]. GSK may, [**] Licensed Product [**] in the
Territory and [**] such Licensed Product [**] in accordance with applicable Law.
Section 5.3. DILIGENCE. GSK will use Commercially Reasonable Efforts
to Commercialize the Licensed Product in the Territory, including by providing
appropriate incentives consistent with its normal business practices to Sales
Representatives involved in the Commercialization of the Licensed Product [**].
[**], the GSK Sales Representatives will promote the Licensed Product [**], GSK
will promote the Licensed Product through [**]. In addition to such
Commercialization effort, GSK will use Commercially Reasonable Efforts to
provide appropriate medical affairs personnel to support the Licensed Product in
the Territory during the Term. GSK's Commercialization activities will be
consistent with the Annual Plan.
Section 5.4. DILIGENCE INQUIRY. If Millennium believes that GSK has
failed to apply Commercially Reasonable Efforts to Commercialize the Licensed
Product as provided in Section 5.3 above, it will notify GSK in writing, and
within [**] days [**]GSK will submit a report to Millennium containing
sufficient detail to allow Millennium to verify GSK's compliance. If, after
receiving the report, Millennium is not satisfied that GSK has complied with its
diligence requirements as described above, Millennium may convene a Special
Meeting of the Steering Committee as provided in Section 5.5 below to address
the matter.
Section 5.5. SPECIAL MEETING OF STEERING COMMITTEE. If Millennium
believes that GSK has failed to comply with its diligence obligations under this
Article V, then Millennium may, by written notice to GSK, convene a special
meeting of the Steering Committee to discuss the matter (a "Special Meeting").
Such notice may include a general statement of the areas of concern to
Millennium. The Parties will convene the Special Meeting no later than [**]
Business Days after such notice is given. At the Special Meeting, the Steering
Committee will discuss the areas of concern to Millennium and the additional
actions (if any) GSK could take to address such concerns.
Section 5.6. SUPPLEMENTAL PLAN. If, after a Special Meeting,
Millennium continues to believe that GSK is not meeting its diligence
obligations hereunder or if Millennium wishes to formalize GSK's commitment to
take such additional actions (if any) discussed in the Special Meeting, then
Millennium may so notify GSK in writing. Within [**] Business Days after the
date of any such notice, GSK will indicate in writing to Millennium whether it
agrees with the concerns of Millennium. If the Parties disagree, then either
Party may invoke the dispute resolution mechanism described in Article XIII. If
GSK agrees that additional actions need to be taken, GSK will provide Millennium
with a plan within [**] days describing the actions that GSK proposes to take to
meet such obligation. If Millennium then notifies GSK in writing that Millennium
agrees that such plan describes actions sufficient to meet such obligation, then
such plan will be a "Supplemental Plan" and GSK will carry out the actions
described in such plan. If Millennium disagrees with GSK as to the sufficiency
of the actions described in such plan to meet such obligation, and the Parties
are unable to resolve such disagreement within [**] Business Days, either Party
may invoke the dispute resolution mechanisms described in Article XIII. Any
Supplemental Plan will be deemed to constitute an amendment to the relevant
Annual Plan.
Section 5.7. AVAILABILITY OF OTHER REMEDIES. If the Parties agree
[**], Millennium will [**] under Article V [**], as applicable. If Millennium is
of the opinion that GSK [**], then Millennium will [**], and either Party may
invoke the dispute resolution mechanisms described in Article XIII.
Section 5.8. RESPONSIBILITY FOR PRICING AND REIMBURSEMENT APPROVALS.
GSK and its Affiliates will be solely responsible for all pricing and
reimbursement approval proceedings relating to the Licensed Product in the
Territory. GSK will have complete discretion in setting pricing for the Licensed
Product in the Territory. GSK will be responsible for filing and maintenance
fees relating to pricing and reimbursement approvals. To the extent permitted by
applicable Law, GSK will provide Millennium with copies of any material
documents or other material correspondence pertaining to pricing and
reimbursement approvals in the Territory; provided, however, (a) GSK will not be
obligated to provide any information that is related to any GSK products other
than the Licensed Product and (b) the timing of the disclosure and content of
such information will be tailored such that the disclosure is for information
purposes only and that Millennium will not have any opportunity to influence GSK
as to the price for the Licensed Product in the Territory.
Section 5.9. ADVERTISING AND PROMOTIONAL MATERIALS.
(a) From and after the Effective Date, GSK will develop relevant
written or electronic sales, promotion, educational and advertising materials
relating to the Licensed Product ("Promotional Materials") consistent with its
standard operating procedures, for the Territory, that will be compliant with
all applicable Law and applicable Regulatory Approvals. Copies of all
Promotional Materials used in the Territory will be archived by GSK in
accordance with applicable Law. The Parties will discuss on an annual basis the
primary Promotional Materials to be used by GSK in the Major Market Countries.
GSK will provide copies in English of all Promotional Materials for use in the
Major Market Countries to Millennium prior to their use. GSK agrees to consider
in good faith any comments Millennium may have with respect to the Promotional
Materials, provided; however, that GSK will retain final decision making
authority over the Promotional Materials. Millennium will provide to GSK copies
of Promotional Materials in Millennium's possession which are used in the United
States and which Millennium believes may be useful to GSK in its design and
implementation of Promotional Materials for use in the Territory.
(b) Subject to any limitations imposed by applicable Law and
Article IX, all such Promotional Materials created in connection with the
Development or Commercialization of the Licensed Product in the countries of the
Territory, including all Licensed Product package inserts, trade packages,
packaging and labeling, will display the GSK housemark (trademark, company name
and logo) and, to the extent permitted by applicable Law, the Millennium
housemark (trademark, company name and logo). This requirement pertains to
materials in any form, including both written and electronic materials. GSK will
not include any other trademarks or trade names on materials related to the
Licensed Product, except (i) the Product Trademark, (ii) those required by
applicable Law, or (iii) other trademarks subject to Millennium's prior written
consent.
(c) SALES TRAINING. From the Effective Date through [**],
Millennium will provide to GSK access to certain Millennium personnel
responsible for training Sales Representatives on the Licensed Product, as well
as educational materials and training information that Millennium reasonably
believes will assist GSK in its future training efforts related to the Licensed
Product in the Territory. Such Licensed Product sales training will take place
at GSK's facilities in the European Union on mutually agreeable dates. GSK will
bear all costs associated with the sales training of its sales force for the
Licensed Product in the Territory as well as the [**] Millennium.
Section 5.10. SALES. Following the Transition Period, on a
country-by-country basis, GSK will be responsible for booking sales of the
Licensed Product in such country during the Term. If, following the Transition
Period, Millennium receives any orders for the Licensed Product in or for such
country, it will refer such orders to GSK. If GSK receives any orders for the
Licensed Product in or for countries in the Territory that have not yet
completed the applicable Transition Period, or for the United States or any
other country outside the Territory, it will refer such orders to Millennium.
Section 5.11. SHARING OF COMMERCIAL INFORMATION. In addition to the
royalty reports required by Section 8.10, GSK will provide Millennium, on a
semi-annual basis, information relating to [**] on a country-by-country basis in
the Territory and, to the extent available, [**] on a country-by-country basis
for the Major Market Countries and the Territory.
Section 5.12. ADVERSE EVENT AND LICENSED PRODUCT COMPLAINT REPORTING
PROCEDURES.
(a) GSK acknowledges that the global adverse event database for
the Licensed Product is currently maintained by Schering (the "Global AE
Database"). As set forth in the Schering/Millennium European Agreement, as soon
as reasonably practicable after the Effective Date to permit for an orderly
transition, but prior to receipt of the first Country Approval Notice (as
defined in the Schering/Millennium European Agreement), and as agreed by
Millennium and Schering in the Schering/Millennium European Agreement,
Millennium and GSK will enter into a definitive agreement with Schering for the
maintenance by Millennium or Schering of a unified global adverse event database
for the Licensed Product and for the timely exchange and reporting of product
quality complaints, adverse events and product safety data related to the
Licensed Product among Millennium, Schering and GSK (the "Reporting Agreement").
The Reporting Agreement will cover in detail, among other topics, the mechanism
and time table for exchanging safety data, the procedural documents (e.g.,
coding conventions, seriousness) that will be used when processing safety
reports to ensure consistency, how the reporting of individual cases to the
regulatory health authorities will be performed, how Millennium, Schering and
GSK will create PSUR and US PR, how the parties to the Reporting Agreement will,
among themselves, respond effectively and in a timely manner to all requests of
Regulatory Authorities in the Territory to ensure that each of them can satisfy
their respective regulatory reporting obligations with respect to the Licensed
Product, including recalls, market withdrawals or corrective actions. Following
the Effective Date, each Party shall promptly notify the other Party if it
becomes aware of any safety-related information or circumstance that is likely
to have a material adverse effect on the Development, Commercialization or
Manufacture of the Licensed Product.
(b) Until the effectiveness of the Reporting Agreement, Schering
has agreed to, and Millennium will continue to, fulfill its respective
obligations with respect to the maintenance of the Global AE Database, and with
respect to the exchange and reporting of product quality complaints, adverse
events and product safety data related to the Licensed Product in the same
manner as followed by Schering and Millennium prior to the Effective Date.
Millennium or Schering will inform GSK of its pharmacovigilance obligations
during the Transition Period prior to receipt of the applicable Country Approval
Notice pursuant to Schering/Millennium European Agreement, and GSK agrees to
reasonably comply.
(c) For as long as Schering is responsible for maintaining the
Global AE Database, Schering has agreed to generate adverse event reports as
necessary for Millennium's and GSK's use in the Territory, and to grant
Millennium and, following the effective date of the Reporting Agreement, GSK
access to the adverse event and safety data related to the Licensed Product
contained in the Global AE Database. The Parties will each bear its own expenses
in connection with establishing and maintaining the Global AE Database.
Section 5.13. MEDICAL INQUIRIES; RECALL DECISION MAKING.
(a) TERRITORY. On a country-by-country basis, following the end
of the Transition Period, GSK will handle all medical questions or inquiries
from members of the medical profession regarding the Licensed Product in the
Territory at GSK's expense. Millennium will refer to GSK all such questions and
inquiries [**] of receipt. In no event will Millennium respond to any such
medical question or inquiry. Notwithstanding anything contained in this Section
5.13 to the contrary, medical questions and inquiries with respect to clinical
trials sponsored by Millennium in the Territory will be referred to, and will be
handled by, Millennium or its designees, but Millennium will promptly inform GSK
of any adverse events reported or any safety-related inquiries and Millennium's
proposed resolution thereof.
(b) OUTSIDE THE TERRITORY. Millennium or its designee will
handle all medical questions or inquiries from members of the medical profession
regarding the Licensed Product outside the Territory at Millennium's expense.
GSK will refer to Millennium all such questions and inquiries [**] of receipt.
In no event will GSK respond to any such medical question or inquiry.
(c) RECALL DECISION MAKING.
(i) If any Regulatory Authority issues or requests a recall
or takes a similar action in connection with the Licensed Product in the
Territory, or if either Party determines that an event, incident or circumstance
has occurred that may result in the need for a recall or market withdrawal of
the Licensed Product in the Territory, the Party notified of such recall or
similar action, or the Party that desires such recall or similar action, will
advise the other Party thereof by telephone or facsimile [**]. Prior to the
transfer of the Central Marketing Authorization to GSK, Millennium shall be
responsible for making decisions regarding recalls of Licensed Product in such
countries in the Territory covered by the Central Marketing Authorization and,
following the transfer of the Central Marketing Authorization to GSK, GSK shall
be responsible for making such recall decisions. Prior to the transfer of
Regulatory Approvals necessary for Commercialization in the countries in the
Territory not covered by the Central Marketing Authorization, on a
country-by-country basis, Millennium shall be responsible for making decisions
regarding recalls of Licensed Product in the applicable country, and following
such transfer of Regulatory Approval to GSK in such country, GSK shall be
responsible for making such recall decisions. The Parties shall cooperate with
each other to allow such recalls to occur under the direction of the
decision-making Party and in implementing such recalls, including without
limitation the reshipment, storage and disposal of recalled Licensed Product,
the preparation and maintenance of relevant reports and records, and the
notification to any Third Party recipients or users of the Licensed Product.
Notwithstanding the foregoing, GSK will [**] on the basis of [**] such Licensed
Product.
(ii) As set forth in the Supply Agreement, after expiration
of the Transition Period, on a country-by-country basis, GSK will be responsible
for the expenses of recall, unless Millennium breaches its representations and
warranties under Section 10.1 of the Supply Agreement, in which event Millennium
has agreed to be responsible for such expenses. For purposes of this Agreement,
the expenses of recall will be limited to the expenses of notification and
destruction or return of the recalled Licensed Product, the costs of Licensed
Product recalled and any costs directly associated with the Manufacture or
distribution of replacement Licensed Product.
Section 5.14. SALES AND MARKETING COSTS. GSK will be responsible for
all costs associated with the Commercialization of the Licensed Product in the
Territory.
Section 5.15. OTHER RESPONSIBILITIES. GSK will be solely responsible
for the following functions in the Territory:
(a) processing all returns of the Licensed Product for sales or
Development by GSK. If Licensed Product sold by GSK in the Territory is returned
to Millennium, it will promptly be shipped to a facility designated by GSK at
GSK's expense; and
(b) distribution services, including order processing,
invoicing, receivables, collections and inventory management of the Licensed
Product in the Territory.
In addition, GSK will ensure by contract with wholesalers and other purchasers
for the Licensed Product that such wholesalers and other purchasers will not
permit diversion of Licensed Product outside the Territory.
ARTICLE VI
MANUFACTURE AND SUPPLY
Section 6.1. GENERAL. Millennium will supply GSK with Licensed Product
that has completed the Fill/Finish process for the Territory pursuant to the
Supply Agreement, as referenced in Section 6.3. It is anticipated that certain
existing relationships relating to the Manufacture and supply of Licensed
Product for the Territory will be maintained or executed by Millennium and/or
Third Parties.
Section 6.2. SECONDARY PACKAGING. As soon as practicable after the
Effective Date, the Parties will [**] with respect to the Licensed Product for
the Territory. During the CMA Transfer Period, Schering has agreed, [**] of the
Licensed Product for the Territory. In no event than the later of (a) [**]
following the [**], (b)[**] following the [**], GSK will implement the Secondary
Packaging function with respect to Licensed Product for those countries in the
Territory in which Regulatory Approval is achieved through the approval of the
Central Marketing Authorization. GSK will implement the Secondary Packaging
function for those countries in the Territory in which [**] receipt of
Regulatory Approval in such country. [**] Secondary Packaging [**] as provided
in EXHIBIT G hereto. Millennium will use commercially reasonable efforts to
facilitate the establishment of GSK as a supplier of Secondary Packaging for the
Licensed Product for the Territory. Costs incurred by GSK that are associated
with any efforts GSK undertakes or that Millennium must undertake to facilitate
the transfer of responsibility to GSK to establish Secondary Packaging will be
borne by GSK, [**] in accordance with [**] agreed upon by the Parties.
Section 0.0.XXXXXX AGREEMENT.
(a) INITIAL SUPPLY. Millennium shall supply GSK's and its
Affiliate's reasonable initial requirements of Licensed Product for the
Territory, and GSK shall purchase such requirements of Licensed Product from
Millennium, pursuant to the terms of a supply agreement between the Parties of
even date ("Supply Agreement").
(b) FUTURE SUPPLY. Promptly after the Effective Date, Millennium
and GSK will meet to discuss in good faith options for [**] the Licensed Product
for the Territory, including the [**] for the Territory [**] of the Supply
Agreement. The Parties will [**] pursuant to this Section 6.3(b) [**] pursuant
to which GSK will purchase [**] (either supply agreement, the "Future Supply
Agreement").
(c) The Parties [**] with respect to the [**] the Licensed
Product for the Territory as follows:
(i) [**] GSK, and [**] Millennium or its designated Third
Parties. [**] subcommittee of the Steering Committee with equal representation
from both Parties, [**] with respect to [**] the Licensed Product in the
Territory:
(A) [**];
(B) [**];
(C) [**]; and
(D) [**].
Notwithstanding the foregoing, [**], subject to subsection 6.3(f) below.
(ii) The [**] subcommittee will review [**] in good faith
and provide [**] the Steering Committee [**] of the Licensed Product for the
Territory during the remainder of the Term.
(d) Any [**] by the Parties as follows. [**] would receive [**]
percent ([**]%) of the [**], the amount of [**] would be calculated [**] and
would be equal to [**]: (A) [**] the Licensed Product [**] of Licensed Product
Manufactured [**] and (B) the [**] the Licensed Product [**] of Licensed Product
Manufactured [**]. The Parties would be entitled to [**] by an amount equal to
[**] percent ([**]%) of the [**]. By way of example only, [**] the average [**]
Licensed Product [**] the Parties would [**].
(e) In the event that [**], the Parties will [**] the Licensed
Product.
(f) [**], Millennium agrees to [**] the Licensed Product. Costs
incurred [**] and will [**] Millennium hereunder, including [**] Millennium [**]
in accordance with [**] agreed upon by the Parties.
(g) In the event that the [**]subcommittee is [**] subcommittee
will request that the Steering Committee [**]. If following the Steering
Committee [**], the Steering Committee will refer the matter to the Executive
Officers pursuant to Section 13.1. In the event that the Executive Officers [**]
the Licensed Product pursuant to Section 13.1, [**] will be referred to
arbitration in accordance with Section 13.3 (and will not be treated as an
Unresolved Matter subject to Section 13.2), and the appropriate agreement in
accordance with this Section 6.3 will be executed between the Parties based on
the results of such arbitration proceedings.
Section 6.4. [**] GSK. Should GSK [**] under [**], GSK may [**] supply
of Licensed Product [**] GSK [**], Millennium will [**] Licensed Product
pursuant to [**] Millennium [**]. Should Millennium [**], Millennium will,
pursuant to a license agreement to be executed between Millennium [**] the
Licensed Product [**] the Licensed Product in a country of the Territory in
accordance with Section 7.1(d).
ARTICLE VII
LICENSE GRANTS
Section 7.1. GRANTS UNDER MILLENNIUM INTELLECTUAL PROPERTY.
(a) DEVELOPMENT LICENSE. Millennium hereby grants to GSK a
non-exclusive right and license under Millennium Intellectual Property to use
and import the Licensed Product to the extent necessary to Develop the Licensed
Product in the Territory under this Agreement. For the avoidance of doubt,
Millennium has retained a non-exclusive right under the Millennium Intellectual
Property with the right to sublicense, to continue to Develop the Licensed
Product in the Territory to the extent permitted by this Agreement.
(b) COMMERCIALIZATION LICENSE. Millennium hereby grants to GSK
an exclusive right and license under Millennium Intellectual Property to use,
sell, offer to sell and import the Licensed Product to the extent necessary to
Commercialize the Licensed Product in the Territory, except that Schering has
retained a limited right under the Millennium Intellectual Property to continue
to distribute and sell the Licensed Product in each country of the Territory
during the Transition Period of such country until the appointment of GSK as
exclusive distributor pursuant to Section 5.1 of this Agreement.
(c) MANUFACTURING LICENSE. Millennium hereby grants to GSK a
non-exclusive right and license, under Millennium Intellectual Property, to use
and import the Licensed Product in order to perform [**] with respect to the
Licensed Product [**] the Licensed Product[**] pursuant to Section 6.3 hereof.
(d) SUBLICENSES. Under the licenses granted in Sections 7.1(a)
and 7.1(b), GSK will have the right to grant Development and Commercialization
sublicenses to its Affiliates. [**] GSK will [**]Commercialization sublicenses
[**] for Commercialization [**] in the Territory [**]. GSK will [**] under
Section 7.1(b) [**], provided that (i) GSK will [**], and (ii) that [**]. For
purposes of this Section 7.1(d), [**] within the Territory.
(e) EXPANSION OF TERRITORY. If at any time during the Term,
Millennium has the exclusive right to Commercialize the Licensed Product in a
country outside the Territory and elects not to promote and sell the Licensed
Product in such country, and Millennium elects to appoint a co-promotion or
co-marketing collaborator for such country outside the Territory (other than
wholesalers, distributors or contract sales organizations), Millennium will
promptly notify GSK. [**], and Millennium will have no further obligation to GSK
with respect to the right to Commercialize the Licensed Product outside the
Territory.
(f) LIMITATIONS ON GSK ACCESS TO DATA AND EXERCISE OF LICENSES.
Notwithstanding anything to the contrary in Section 7.1(a) or 7.1(b), GSK's
license under Millennium Intellectual Property will not include Millennium
Know-How generated by or on behalf of Millennium in connection with [**]
pursuant to the conduct of registration clinical studies in or outside the
Territory where GSK has not exercised its right to access and use such data, and
paid its share of the associated Development costs pursuant to Section 4.6
hereof except to the extent provided under the Reporting Agreement or applicable
Law.
(g) EXISTING THIRD PARTY AGREEMENTS. The licenses and
sublicenses granted by Millennium to GSK in Sections 7.1(a), 7.1(b) and 7.1(c)
are subject to the terms of the Existing Third Party Agreements, as amended by
the Schering/Millennium European Agreement.
Section 7.2. GSK INTELLECTUAL PROPERTY.
(a) GSK hereby irrevocably assigns to Millennium all rights,
title and interest worldwide to GSK Patent Rights. To the extent the GSK Patent
Rights includes "severable improvements" within the meaning of Article 5 of the
European Union Technology Transfer Block Exemption Regulation 2004 (the "TTBE
Regulation"), the GSK Patent Rights will not be assigned to Millennium. Instead
GSK hereby grants Millennium an irrevocable, paid-up, non-exclusive, worldwide,
non-royalty-bearing right and license, with the right to grant sublicenses,
under such GSK Patent Rights to Develop, Manufacture, and Commercialize the
Licensed Product.
(b) Subject to the terms and conditions of this Agreement, GSK
hereby grants to Millennium a co-exclusive (with GSK), non-royalty bearing right
and license under GSK Other Intellectual Property to Develop or Manufacture the
Licensed Product for the Territory during the Term. Millennium will have the
right to grant sublicenses under this Section 7.2(b) to Third Parties solely for
the purposes of Developing or Manufacturing the Licensed Product for the
Territory. To the extent the GSK Other Intellectual Property includes "severable
improvements" within the meaning of Article 5 of the TTBE Regulation, the
license described above will not be co-exclusive. Instead GSK hereby grants
Millennium an irrevocable, paid-up, non-exclusive, non-royalty-bearing,
worldwide right and license, with the right to grant sublicenses, under GSK
Other Intellectual Property to Develop or Manufacture the Licensed Product for
the Territory during the Term.
(c) GSK hereby grants to Millennium the exclusive option to
obtain a co-exclusive (with GSK), royalty-bearing right and license under GSK
Other Intellectual Property to Develop or Commercialize Licensed Product in, or
Manufacture Licensed Product for, outside the Territory. Millennium may exercise
this option any time during the Term by providing written notice to GSK,
declaring its intent to enter into a license agreement with GSK. [**], the
Parties will negotiate any such license in good faith and on commercially
reasonable terms within [**] following notification by Millennium of exercise of
said option, or for such additional time as may be mutually agreed by the
Parties. To the extent the GSK Other Intellectual Property includes "severable
improvements" within the meaning of Article 5 of the TTBE Regulation, the
license described above will not be exclusive. Instead GSK would grant
Millennium a non-exclusive, royalty-bearing right and license under GSK Other
Intellectual Property to Develop or Commercialize Licensed Product in, or
Manufacture Licensed Product for, outside the Territory.
Section 7.3. GSK INTELLECTUAL PROPERTY DEVELOPED BY GSK AFFILIATES AND
THIRD PARTY CONTRACTORS. To the extent that GSK contracts with its Affiliates or
Third Parties for the performance of GSK obligations hereunder, GSK shall obtain
the right under the intellectual property rights of such Affiliate or Third
Party related to the Licensed Product, with the right to grant sublicenses to
Millennium (and such license shall be further sublicensable by Millennium), to
use any intellectual property pertaining to the Licensed Product that is
discovered or developed by such Affiliate or Third Party under such contract for
the Development or Manufacture of Licensed Product throughout the world or the
Commercialization of the Licensed Product outside the Territory. In addition to
the foregoing, GSK shall use commercially reasonable efforts [**]with respect to
the Development, Manufacture or Commercialization of the Licensed Product in the
Territory, [**].
Section 7.4. MILLENNIUM RETAINED RIGHTS. Any rights of Millennium not
expressly granted to GSK under the provisions of this Agreement will be retained
by Millennium, including the right (a) to exploit Millennium Intellectual
Property to Develop Licensed Product in the Territory as permitted by this
Agreement and outside the Territory, (b) to Commercialize the Licensed Product
outside the Territory, and (c) to Manufacture the Licensed Product.
Section 7.5. GSK KNOW-HOW. Subject to the terms and conditions of this
Agreement, GSK hereby grants to Millennium a perpetual, irrevocable,
non-exclusive, worldwide, non-royalty-bearing right and license, with the right
to grant sublicenses, under GSK Know-How to Develop, Manufacture, and
Commercialize the Licensed Product.
Section 7.6. MILLENNIUM'S PRODUCT TRADEMARKS. GSK, its Affiliates and
designees will, subject to this Section 7.6, use Millennium's Product Trademarks
on a royalty-free, fully paid up, (a) non-exclusive basis with respect to
Development, (b) exclusive basis with respect to Commercialization, and/or (c)
non-exclusive basis with respect to Secondary Packaging, in each case during the
Term in the Territory, and solely for display, advertising or informational
purposes in connection with such Development, Commercialization, and the conduct
of Secondary Packaging of the Licensed Product for the Territory, in accordance
with this Agreement. GSK will not at any time do or permit any act to be done
which may in any way impair the rights of Millennium in the Product Trademarks.
Section 7.7. COPYRIGHT.
(a) GSK, its Affiliates and designees will have the right to
use, display, modify, have modified, distribute, have distributed and make or
have made derivative works of Millennium's Copyrights on a royalty-free, fully
paid up, exclusive basis during the Term and in the Territory solely for display
or advertising purposes in connection with Development and Commercialization of
the Licensed Product in the Territory, and the conduct of Secondary Packaging of
the Licensed Product for the Territory, in accordance with this Agreement. GSK
will not at any time do or permit any act to be done which may in any way impair
the rights of Millennium in Millennium's Copyrights.
(b) Schering has agreed to grant to GSK the right to use
Schering's Copyrights on a royalty-free, fully paid up, exclusive basis solely
to the extent necessary to permit GSK, its Affiliates or designees to use,
display, distribute, and have distributed all Licensed Product Promotional
Materials, educational materials, product labeling, product inserts and product
packaging used by Schering in Commercializing the Licensed Product in the
Territory, solely to the extent that such materials may display Schering's
Copyrights. GSK will not at any time do or permit any act to be done which may
in any way impair the rights of Schering in Schering's Copyrights.
Section 7.8. RIGHTS RETAINED BY BOTH PARTIES. Each Party will retain
the right to exploit Joint Intellectual Property after the Term, without any
duty to account to the other Party or obtain the other Party's consent for such
exploitation.
ARTICLE VIII
FINANCIAL PROVISIONS
Section 8.1. LICENSE FEES; MILESTONES. In consideration for the
license of the rights granted to Develop and Commercialize the Licensed Product
pursuant to the Millennium Intellectual Property under this Agreement, GSK will
pay the following amounts to Millennium as further provided herein.
(a) LICENSE FEES
(i) GSK will pay to Millennium a license fee payment of [**]
Dollars (USD $[**]) on the Effective Date.
(ii) The amounts set forth in clause (i) above will be due
and payable by GSK not later than [**] days after the last day of the calendar
month in which the license fee is due.
(b) MILESTONE PAYMENTS. GSK shall make [**] non-refundable,
non-creditable, one-time, irrevocable milestone payments to Millennium totaling
[**] Dollars (USD $[**]) as follows:
(i) GSK will pay to Millennium a one-time, non-refundable,
non-creditable, irrevocable milestone payment of [**] Dollars (USD $[**]) upon
the satisfaction of all of the following conditions:
[**].
(ii) GSK will pay to Millennium a second one-time,
non-refundable, non-creditable, irrevocable milestone payment in the amount of
[**] Dollars (USD $[**]) upon the satisfaction of all of the following
conditions:
[**].
(c) Millennium will be entitled to send GSK an invoice for
milestone payments described in subsection 8.1(b) above upon the satisfaction of
the milestone event conditions. GSK will pay such amount within [**] days of
receipt of such an invoice from Millennium. The Parties understand and agree
that each milestone payment described in Section 8.1 is a one-time payment and
will not be made more than once. For the avoidance of doubt, the Parties
understand and agree that no additional milestone payments will be made for any
reason, including but not limited to, development of additional Compounds,
Licensed Products, formulations, or indications, or the making of additional
regulatory filings or registrations.
(d) Failure to satisfy the conditions in Section 8.1(b)(i)
above, [**] shall not be deemed to be a failure of Millennium to achieve the
conditions described in Section 8.1(b)(i) above and in such case Millennium will
be deemed to have satisfied such milestone conditions and GSK will pay the
applicable milestone payment to Millennium.
Section 8.2. PAYMENT FOR MANUFACTURE OF FILL/FINISHED PRODUCT. GSK
will pay Millennium for Fill/Finished Product provided under the Supply
Agreement at the amount equal to the Cost of Compound and the Cost of
Fill/Finish per unit of Licensed Product.
Section 8.3. SUPPLY PRICE PERCENTAGES. GSK shall pay to Millennium
royalties on the Net Sales of the Licensed Product sold in the Territory by GSK,
its Affiliates, sublicensees and Excluded Distributors as follows:
(a) For purposes of calculating royalties, the following Cost of
Goods Rate, as applicable, will be used:
ANNUAL NET SALES OF LICENSED PRODUCTS "COST OF GOODS RATE"
Up to and including USD $[**] [**]%
Over USD $[**] [**]%
(i) GSK will calculate the Cost of Goods Shipped for the
Licensed Product in the Territory on a quarterly basis;
(ii) If, in any particular quarter during the Term, the [**]
Licensed Product sold in a calendar quarter is [**] such Licensed Product, [**]
for such calendar quarter. Such [**] Net Sales, and a royalty payment made to
Millennium.
(iii) If, in any particular quarter during the Term, the
[**] Net Sales applicable to Licensed Product sold in a calendar quarter [**]
for such Licensed Product, then the royalty payment owed to Millennium by GSK
for such quarter [**]. The [**] Net Sales for such calendar quarter applicable
to Licensed Product sold in a calendar quarter and the [**] Net Sales of the
Licensed Product for such quarter [**] Net Sales for such calendar quarter, [**]
as described above [**] throughout the Term, beginning on the Effective Date. As
of the Effective Date, [**].
(iv) For the quarter beginning [**], and all subsequent
quarters during the Term, [**], including but not limited to [**] and [**] under
Section 8.3(a)(ii) hereof. In no event will the royalty payment to Millennium
for any given quarter be less than [**] Millennium by GSK in a particular
quarter, [**]. No other deductions are permitted against royalty payments
hereunder.
(v) If, in any particular quarter during the period between
the Effective Date and [**], the Cost of Goods Shipped [**] for such calendar
quarter applicable to Licensed Product sold in such quarter [**], then to the
extent that [**] during such period under the Supply Agreement, [**] and handled
in accordance with Section 8.3(a)(iv).
(b) [**]. Notwithstanding the provisions of Sections 8.3(a), in
the event that: (i) the approved label for the Licensed Product in each of
[**]includes the use of the Licensed Product [**], and (ii) annual Net Sales of
Licensed Product in the Territory exceed [**] Dollars (USD $[**]), the Cost of
Goods Rate for calculation of royalties on all Net Sales of Licensed Products in
the Territory will modified to be [**]% on a going forward basis (starting from
the date that both the conditions specified in clauses (b)(i) and (b)(ii) have
been fulfilled) and will apply to all future total amounts (and not incremental)
of annual Net Sales of the Licensed Product in the Territory. For purposes of
clarity, the event noted in subsection 8.3(b)(i) will be deemed to have been met
should such approval label for [**], including but not limited to, [**].
Section 8.4. ROYALTY PAYMENT TERM. The obligations of GSK to calculate
and make royalty payments as set forth in Section 8.3 above will commence upon
the First Commercial Sale of the Licensed Product in the Territory by GSK, its
Affiliates, sublicensees or Excluded Distributors and will continue for the
Term.
Section 8.5. GENERIC COMPETITION.
(a) Generic Erosion (as defined below) for any Licensed Product
then-currently Commercialized by GSK will be calculated on a calendar quarterly
basis for each country in the Territory using reference data published by [**]
or another industry-accepted data source used by GSK in the Territory at the
time that such determination is made. If Generic Erosion for any such Licensed
Product is documented for a particular calendar quarter, the applicable Supply
Price Percentage for such country described in Section 8.3 above will be reduced
for that quarter in such country as follows:
(i) GSK would be entitled to reduce the applicable Supply
Price Percentage by [**] percent ([**]%) of that which would otherwise be due to
Millennium on sales of the Licensed Product in the Territory without such
reduction.
(b) "Generic Erosion" means achievement by all Generic
Equivalents of a prescription market share equal to [**] percent ([**]%) or
greater in the aggregate of the total prescriptions for the particular Licensed
Product plus its Generic Equivalent(s), assessed on a moving basis for the last
[**], as calculated in this Section 8.5. "Generic Equivalent" means [**], in
each case Commercialized in the Territory as approved for marketing and sale by
the European Commission, which generic version [**] Licensed Product marketed by
GSK in the Territory.
Section 8.6. GENERIC EROSION. Once Generic Erosion (as defined above
in Section 8.5) has occurred in a country in the Territory, [**]; provided,
however, if [**] a Major Market Country, [**] Major Market Countries and [**]
Licensed Product by GSK in the Territory as set forth in Section 8.3 or 8.5, as
applicable for such country.
Section 8.7. THIRD PARTY ROYALTIES. Subject to Section 8.8, in the
case of an issued Third Party patent claiming the composition of matter or use
of the Licensed Product in the Territory, without a license to which GSK's
practice of the licenses granted to it by Millennium under Section 7.1 in the
Territory would infringe such Third Party patent, [**] hereunder as follows: GSK
will provide Millennium with notice of such obligation or commercial necessity
of such Third Party patent and sufficient documentation to show the existence of
such Third Party patent and its relation to the Millennium Intellectual Property
prior to entering into any license agreement with a Third Party which would
trigger such deduction. The Parties will discuss in good faith whether such a
license is required, [**] such a license. If [**] the Third Party patent in the
Territory, then the Supply Price Percentage applicable on Net Sales of such
Licensed Product may be reduced by [**] percent ([**]%) of [**] paid to such
Third Party under any such license agreement pertaining to the Territory. To the
extent practicable [**] GSK in respect of the Licensed Product, [**], will
include the right [**] of promoting, marketing, selling, using and manufacturing
the Licensed Product [**]. If Millennium executes a license or sublicense for
such intellectual property rights, [**] such license [**] of the Licensed
Product outside the Territory [**].
Section 8.8. COMPULSORY LICENSES AND COMPULSORY COMPETITION. If any
Regulatory Authority in any country within the Territory grants or compels
either Party to grant a compulsory license under the Millennium Patent Rights to
a Third Party to sell a Licensed Product containing the same Compound as in a
Licensed Product sold by GSK for the same approved indication in any country in
the Territory [**], then the applicable [**] sales of Licensed Products in such
country by GSK will be adjusted [**] in such country, for so long as such Third
Party is selling such Licensed Product in such country. GSK will use
Commercially Reasonable Efforts and Millennium will use commercially reasonable
efforts to [**]. Such efforts may include [**] in such country, [**].
Section 8.9. AGGREGATE REDUCTION. In no event may the aggregate
deductions under Sections [**] exceed [**] percent ([**]%) of the Supply Price
Percentage otherwise due to Millennium in any calendar quarter, or cause
Millennium to make payments to GSK or Third Parties.
Section 8.10. REPORTS; PAYMENTS.
(a) Within [**] Business Days after (a) the end of the calendar
quarter during which the First Commercial Sale occurred and (b) all subsequent
quarters, GSK will submit to Millennium a report, on a country-by-country and
Territory basis, providing in reasonable detail an accounting of all Net Sales
(including an accounting of all unit sales and all sales (converted to U.S.
dollars) of the Licensed Product on a country-by-country and Territory basis)
made during such calendar quarter, any payments made by GSK to Millennium under
Section 6.3(a), the calculation of the applicable royalties under Sections 8.3,
8.5 and/or 8.7 and all supporting data for calculation of any adjustments (e.g.,
Net Sales price, Cost of Compound, Cost of Fill/Finish, Cost of Secondary
Packaging, Cost of Goods, etc.).
(b) GSK will pay to Millennium all royalties payable by GSK
under Sections 8.3, 8.5 and/or 8.7 as indicated in the quarterly report within
[**] days of the end of the calendar quarter for which such royalties are due to
Millennium.
Section 8.11. OTHER PAYMENTS. Costs contemplated under this Agreement
to be incurred by a Party and reimbursed by the other Party will be paid by the
paying Party within [**] days of receipt of invoice accompanied by reasonable
substantiation thereof.
Section 8.12. AUDITS. The Parties will keep complete and accurate
records of the items underlying COGS, Net Sales, Supply Price Percentage, [**],
royalties and other amounts relating to the reports and payments required by
Article VIII. Either Party will have the right annually at its own expense to
have an independent, certified public accountant selected by the requesting
Party (the "Requesting Party") review any such records of the Party receiving
the audit request (the "Receiving Party") in the location(s) where such records
are maintained upon reasonable notice and during regular business hours and
under obligations of confidence, for the sole purpose of verifying the basis and
accuracy of payments made under this Agreement.
(a) If such examination results in a determination that Net
Sales have been understated or COGS have been overstated, then any resulting
underpayment or overpayment will be paid to the Requesting Party with interest
from the date originally due (calculated at a per annum rate equal to the prime
rate as published in the THE WALL STREET JOURNAL, Eastern Edition, on the first
day of each calendar quarter for as long as such payments are overdue), within
[**] after the date on which Requesting Party receives the accounting report. If
the audit results in a determination that Net Sales have been understated or
COGS overstated by more than [**]% for the period examined, the Receiving Party
will pay all fees, costs and expenses incurred by the Requesting Party in the
course of making such determination.
(b) In the event that any understatement of Net Sales [**] of
the Licensed Products pursuant to Section 1.54(a), with such adjustments not to
occur any later than [**] after the gross sales that are the subject of such
calculation took place, then the Parties agree that the [**]% threshold
described above [**] will apply to the amount of such underpayment.
Section 8.13. TAX MATTERS.
(a) GSK will make all payments to Millennium under this
Agreement without deduction or withholding except to the extent that any such
deduction or withholding is required by Law to be made on account of Taxes.
(b) Any Tax required to be withheld under Law on amounts payable
under this Agreement will promptly be paid by GSK on behalf of Millennium to the
appropriate Governmental Authority, and GSK will furnish Millennium with proof
of payment of such Tax. Any such Tax required to be withheld will be an deemed
to be an expense of and will be borne by Millennium. GSK will give notice of its
intention to begin withholding any such Tax in advance and cooperate to reduce
such Tax on payments made to Millennium hereunder.
(c) GSK and Millennium will cooperate with respect to all
documentation required by any taxing authority or reasonably requested by GSK or
Millennium to secure a reduction in the rate of applicable withholding Taxes.
(d) Solely for purposes of this Section 8.13, "Tax" or "Taxes"
means any present or future taxes, levies, imposts, duties, charges, assessments
or fees of any nature (including interest, penalties and additions thereto) that
are imposed by Law.
Section 8.14. PAYMENT PROCEDURES. All dollar ($) amounts specified in
this Agreement are United States dollar amounts. All payments to be made by GSK
to Millennium will be made in U.S. Dollars, to a Millennium bank account able to
receive U.S. Dollars. All payments hereunder will be made by wire transfer to
such bank and account as Millennium may from time to time designate in writing.
Whenever any payment hereunder will be stated to be due on a day which is not a
Business Day, such payment will be made on the immediately succeeding Business
Day. Payments hereunder will be considered to be made as of the day on which
they are credited to Millennium's designated bank and account.
Section 8.15. CURRENCY EXCHANGE. If any Net Sales or COGS are stated in
a currency other than United States Dollars, then, for the purpose of
calculating the amount due to any Party hereunder, such Net Sales or COGS will
be converted into United States Dollars at the exchange rate between those two
currencies most recently quoted in the Wall Street Journal in New York as of the
last Business Day of the calendar quarter for which such amounts are being paid.
If no such exchange rate has been quoted in the Wall Street Journal in New York
at any time during the twelve (12) month period preceding the date on which such
amount becomes due to a Party, such Net Sales or COGS will be deemed to be equal
to the average Net Sales or COGS for such Licensed Product in the Territory for
the most recently completed calendar quarter, as stated in Euros.
Section 8.16. LATE PAYMENTS. Any amounts that are not paid on or before
the date such payments are due under this Agreement will bear interest at an
annual rate of interest equal to the prime rate of interest, plus two (2)
percentage points, as published in the WALL STREET JOURNAL, Eastern Edition, on
the first day of each calendar quarter for as long as such payments are overdue
calculated on the number of days such payment is delinquent.
ARTICLE IX
INTELLECTUAL PROPERTY OWNERSHIP,
PROTECTION AND RELATED MATTERS
Section 9.1. OWNERSHIP OF INVENTIONS.
(a) SOLE INVENTIONS. Inventions made solely by GSK, its
Affiliates, and its or its Affiliate's employees, agents and consultants in
connection with GSK performance of this Agreement and related to the Licensed
Product are referred to herein as "GSK Sole Inventions" and are owned by GSK
subject to Section 7.2 above. GSK will give Millennium prompt written notice of
each GSK Sole Invention. Inventions made solely by Millennium, its Affiliates,
and its or its Affiliate's employees, agents and consultants in connection with
Millennium's performance of this Agreement are referred to herein as "Millennium
Sole Inventions" and are owned by Millennium. Millennium will give GSK prompt
written notice of each Millennium Sole Invention.
(b) JOINT INVENTIONS. Inventions made jointly by employees,
agents and consultants of GSK and its Affiliates and employees, agents and
consultants of Millennium in connection with the Parties' performance of this
Agreement are jointly owned on the basis of each Party having an undivided
interest in the whole ("Joint Inventions"). Subject to the rights granted under
this Agreement, each Party can use a Joint Invention without the other Party's
consent and has no duty to account to the other Party for such use.
(c) INVENTORSHIP. For purposes of determining whether an
invention is a GSK Sole Invention, a Millennium Sole Invention or a Joint
Invention, questions of inventorship will be resolved in accordance with the
applicable Law of the country in which the patent applications directed to such
inventions are filed. GSK and Millennium will ensure that their employees will
cooperate and comply with all reasonable requests necessary to effect the intent
of this Section 9.1.
Section 9.2. PROSECUTION AND MAINTENANCE OF PATENT RIGHTS.
(a) Millennium will have the first right and option to file and
prosecute (including applications and proceedings for patent term extension) the
Millennium Patent Rights, GSK Patent Rights, Millennium Sole Inventions, and
Joint Inventions anywhere in the world. If Millennium elects not to undertake
the filing, prosecution and/or maintenance of any such Patent Rights in the
Territory (or, after commencement of such filing, prosecution and/or
maintenance, desires to cease the prosecution or the maintenance of any such
Patent Rights in the Territory), then Millennium will notify GSK of such
election with at least thirty (30) days' prior written notice, identifying the
specific Patent Rights to which such election pertains and GSK will be, at its
own expense, entitled to file, prosecute and/or maintain such Patent Rights in
the Territory in the name of Millennium, GSK, or both GSK and Millennium, as the
case may be.
(b) GSK will have the first right and option to file and
prosecute (including applications and proceedings for patent term extension) the
GSK Other Patent Rights anywhere in the world at its own expense. If GSK elects
not to undertake the filing, prosecution and/or maintenance of any such Patent
Rights in or outside the Territory (or, after commencement of such filing,
prosecution and/or maintenance, desires to cease the prosecution or the
maintenance of any such Patent Rights in or outside the Territory), then GSK
will notify Millennium of such election with at least [**] days' prior written
notice, identifying the specific Patent Rights to which such election pertains
and Millennium will be entitled to file, prosecute and/or maintain such Patent
Rights in or outside the Territory in the name of Millennium, GSK, or both GSK
and Millennium, as the case may be.
(c) GSK shall reimburse Millennium for all Intellectual Property
Costs incurred by Millennium with respect to the activities related to Patent
Rights in the Territory described in Section 9.2(a) and 9.5 hereof. GSK shall
reimburse Millennium for all such Intellectual Property Costs within [**] days
after receiving an invoice from Millennium for such Intellectual Property Costs
accompanied by reasonable substantiation thereof.
(d) Each Party agrees to, and will ensure that its employees
will cooperate with, and comply with all reasonable requests of the other with
respect to the preparation, filing, prosecution and maintenance of patents and
patent applications pursuant to this Section 9.2. The Party responsible for
preparing, filing, prosecuting and/or maintaining such Patent Rights will
provide the other Party with advance copies (which may be in draft form)
whenever possible of all material filings as well as copies of all material
correspondence from the relevant patent office, in each case relating to such
Patent Rights, and will consider in good faith all comments from such other
Party relating to such filings and correspondence.
Section 9.3. THIRD PARTY INFRINGEMENT.
(a) NOTICE. Each Party will promptly report in writing to the
other Party during the Term any known or suspected (i) infringement of any of
the Patent Rights which Cover the Licensed Product or (ii) unauthorized use of
any of the Millennium Know-How, GSK Know-How, GSK Other Know-How or Joint
Know-How of which such Party becomes aware, and will provide the other Party
with all available evidence supporting such known or suspected infringement or
unauthorized use.
(b) INITIAL RIGHT TO PROTECT OR ENFORCE. Subject to Section
9.3(c) below and the provisions of any Third Party license agreement under which
Millennium's rights in Millennium Patent Rights are granted, Millennium will
have the first right to initiate a suit or take other appropriate action that it
believes is reasonably required to protect or otherwise enforce the Millennium
Intellectual Property and GSK Intellectual Property.
(c) STEP-IN RIGHT. Subject to the provisions of any Third Party
license agreement under which Millennium's rights in Millennium Patent Rights
are granted, if Millennium fails to initiate a suit or take other appropriate
action within [**] days after becoming aware of the basis for such suit or
action in the Territory, then GSK may, in its discretion, provide Millennium
with written notice of GSK's intent to initiate a suit or take other appropriate
action in the Territory. If GSK provides such notice and Millennium fails to
initiate a suit or take such other appropriate action within [**] days after
receipt of such notice from GSK, then GSK will have the right to initiate a suit
or take other appropriate action in the Territory that it believes is reasonably
required to protect the Millennium Intellectual Property, the GSK Intellectual
Property or the GSK Other Intellectual Property in the Territory.
(d) CONDUCT OF CERTAIN ACTIONS; COSTS. The Party initiating suit
will have the sole and exclusive right to select counsel for any suit initiated
by it pursuant to Section 9.3(b) or 9.3(c). If required under applicable Law in
order for the initiating Party to initiate and/or maintain such suit, the other
Party will join as a party to the suit. Such other Party will offer reasonable
assistance to the initiating Party in connection therewith at no charge to the
initiating Party except for reimbursement of reasonable out-of-pocket expenses
incurred in rendering such assistance. The initiating Party will assume and pay
all of its own out-of-pocket costs incurred in connection with any litigation or
proceedings initiated by it pursuant to Sections 9.3(b) and 9.3(c), including
the fees and expenses of the counsel selected by it. The other Party will have
the right to participate and be represented in any such suit by its own counsel
at its own expense. Neither Party will settle or compromise any suit or action
without the consent of the other Party, which consent will not be unreasonably
withheld.
(e) RECOVERIES. With respect to any suit or action referred to
in Sections 9.3(b) and 9.3(c), any recovery obtained as a result of any such
proceeding, by settlement or otherwise, will be applied in the following order
of priority:
(i) first, the Parties will be reimbursed for all costs
incurred in connection with such proceeding paid by the Parties and not
otherwise recovered [**] in the Territory; and
(ii) second, any remainder will be paid [**]% to the Party
initiating suit and [**]% to the other Party.
Section 9.4. CLAIMED INFRINGEMENT. If a Party becomes aware of, or as
of the Effective Date is aware of, (a) any claim alleging infringement of the
intellectual property rights of a Third Party by the practice by either Party of
Millennium Intellectual Property, GSK Intellectual Property or GSK Other
Intellectual Property in the Development, Manufacture or Commercialization of
the Licensed Product, (b) any patent nullity actions brought against or
threatened to be brought against Millennium Intellectual Property, GSK
Intellectual Property and GSK Other Intellectual Property, (c) any declaratory
judgment actions brought against or threatened to be brought against Millennium
Intellectual Property, GSK Intellectual Property or GSK Other Intellectual
Property, or (d) any alleged misappropriation of Third Party intellectual
property by the practice by either Party of Millennium Intellectual Property in
the Development, Manufacture or Commercialization of the Licensed Product, such
Party will promptly notify the other Party.
Section 9.5. PATENT TERM EXTENSIONS. The Parties will cooperate with
each other in gaining patent term extensions (including those extensions
available under the Supplementary Certificate of Protection of Member States of
the European Union and other similar measures in any other country) wherever
applicable to Patent Rights in the Territory Controlled by either Party that
Cover the Licensed Product. The Parties will, if necessary and appropriate, use
commercially reasonable efforts to agree upon a joint strategy relating to
patent term extensions, but, in the absence of mutual agreement with respect to
any extension issue in the Territory, the patent and/or the claims of the patent
will be selected on the basis of the scope, enforceability and remaining term of
the patent in the relevant country or region. All filings for such extensions
will be made by the Party Controlling such patent or, in the case of Joint
Patent Rights Covering the Licensed Product, by Millennium.
Section 9.6. PATENT MARKING. GSK agrees to comply with the patent
marking statutes in each country in which the Licensed Product is sold by GSK,
its Affiliates, sublicensees and/or distributors.
Section 9.7. TRADEMARKS.
(a) Each Party and its Affiliates will retain all right, title
and interest in and to its and their respective corporate names and logos.
(b) The Licensed Product will be promoted and sold, in
accordance with the provisions of this Agreement, in the Territory under the
INTEGRILIN(R) xxxx unless the INTEGRILIN(R) xxxx cannot be legally used to
promote and sell the Licensed Product in a country in the Territory, in which
case an alternative product trademark proposed by GSK and approved by the
Steering Committee will be used in such country. Such alternative product
trademark will thereafter be deemed to be a "GSK Product Trademark" for the
purposes of this Agreement. Subject to Article XII, GSK (or its local Affiliate,
as appropriate) will own and retain all rights to the GSK Product Trademarks,
and all goodwill associated therewith in the Territory. Millennium (or its local
Affiliate, as appropriate) will own and retain all rights to the GSK Product
Trademarks, and all goodwill associated therewith outside the Territory.
(c) GSK will comply, and will cause its Affiliates and designees
to comply, strictly with Millennium's trademark style and commercially
reasonable usage standards that Millennium communicates to GSK from time to time
in connection with GSK's use of the Product Trademarks. GSK will at its own
expense, at the request of Millennium from time to time, submit to Millennium
for approval a reasonable number of production samples of the Licensed Product,
related packaging materials and Promotional Materials, in both written and
electronic forms. If Millennium reasonably objects to the usage of the Product
Trademark(s) or GSK Product Trademark(s) in connection with any sample, it will
give written notice of such objection to GSK within [**] days of receipt by
Millennium of such sample, specifying the way in which such usage of its Product
Trademark(s) or GSK Product Trademark(s) fails to meet the style, usage or
quality standards for the Licensed Product or Promotional Materials set forth in
the first sentence of this Section 9.7(c), and GSK will cease sale and
distribution of any units of the Licensed Product or Promotional Materials that
fail to meet the style, usage or quality standards in the same manner as the
sample objected to by Millennium as soon as commercially practicable so long as
supply of the Licensed Product is not disrupted. GSK will remedy the failure and
submit further samples to Millennium for approval. Millennium will cooperate
with GSK to insure that issues related to Product Trademark(s) and GSK Product
Trademark(s) do not compromise the supply or distribution chain of the Licensed
Product. In addition, GSK will: (i) use the GSK Product Trademark(s) and the
Product Trademark(s) in compliance with all relevant Laws and regulations; and
(ii) not modify any of the GSK Product Trademark(s) and the Product Trademark(s)
in any way and not use any GSK Product Trademark or Product Trademark on or in
connection with any goods or services other than the Licensed Product in the
Territory.
(d) In no event will GSK: (i) establish, operate, sponsor or
contribute content to any site on the Internet which incorporates the word
"INTEGRILIN," any of Millennium's trademarks, service marks or trade names (the
"Millennium Trademarks") or any variation or part of such word or Millennium
Trademark as its URL address or any part of such address; (ii) register any
domain name which incorporates the word "INTEGRILIN" or Millennium Trademarks;
(iii) register any Millennium Trademarks or any trademarks, service marks or
trade names that are confusingly similar to any of the word "INTEGRILIN" or
Millennium Trademarks; (iv) form (or change the name of) any corporation or
other entity under or to a name which incorporates any of the word "INTEGRILIN"
or Millennium Trademarks; or (v) at any time during or after the Term, in order
to attract visitors to any site on the Internet, (A) use "INTEGRILIN," any
Millennium Trademark or any variation or part thereof as a meta-tag or invisible
text or on any unused frame or bridge page, (B) purchase "INTEGRILIN," any
Millennium Trademark or any variation or part thereof as a search term from any
search engine; or (C) engage in any other practice designed to direct web
browsers using search engines to different web pages or versions of web pages
than the pages corresponding to search terms entered by the user (including
"bridge pages," "cloaking" or "pagejacking").
(e) Should GSK have an interest in the inclusion of a specific
reference to the Product Trademarks on the content of a site on the internet
Controlled by GSK, it will notify Millennium. GSK will provide detailed
information on the proposed location and use of the Product Trademark. The
Parties agree to discuss the details of such proposed use and review its
compliance with all applicable Laws. If the Parties mutually agree on such
specific use of the Product Trademark, then GSK will implement such use, subject
to this Section 9.7. If the Parties do not mutually agree on the proposed use of
the Product Trademark by GSK, then GSK will not implement the proposed reference
to the Product Trademark. Any modification or alteration to the agreed upon
reference to the Product Trademark will be considered a new specific reference
to the Product Trademark and the proposed modification or alteration thus not
allowed without review and mutual approval by the Parties in accordance with the
terms of this Section 9.7(e).
(f) Millennium will use commercially reasonable efforts to
establish, maintain and enforce the Product Trademark(s) and the GSK Product
Trademark(s) during the Term in all countries in the Territory where such
Product Trademark(s) and GSK Product Trademark(s) are registered as of the
Effective Date, a listing of which is attached hereto as EXHIBIT D. If
Millennium elects not to undertake to establish, maintain and enforce the
Product Trademark(s) and the GSK Product Trademark(s) during the Term in any
country in the Territory (or, after commencement of such establishment,
maintenance and/or enforcement, desires to cease such prosecution, maintenance
or enforcement in such country of the Territory), then Millennium will notify
GSK of such election and GSK will be entitled to establish, maintain and enforce
the Product Trademark(s) and the GSK Product Trademark(s) in such country of the
Territory. Irrespective of which Party has the right to establish, maintain, or
enforce the Product Trademark(s) and the GSK Product Trademark(s) during the
Term in the Territory, GSK will be responsible for [**]% of the costs of
establishment, maintenance and enforcement efforts for the Licensed Product in
the Territory and GSK will reimburse Millennium for all such costs incurred by
Millennium within [**] days after receiving an invoice from Millennium for such
costs, accompanied by reasonable substantiation thereof.
(g) If either Party becomes aware of any infringement of any
Product Trademark or GSK Product Trademark by a Third Party, such Party will
promptly notify the other Party and the Parties will consult with each other and
jointly determine the best way to prevent such infringement, including by the
institution of legal proceedings against such Third Party.
ARTICLE X
CONFIDENTIALITY AND PUBLICITY
Section 10.1. CONFIDENTIAL INFORMATION. During the Term and for a
period of [**] years after any termination or expiration hereof, each Party
agrees to keep in confidence and not to disclose to any Third Party, or use for
any purpose, except pursuant to, and in order to carry out, the terms and
objectives of this Agreement, any Confidential Information of the other Party.
The Parties will use commercially reasonable efforts, consistent with reasonable
business practices, to (x) label or identify as "CONFIDENTIAL", at the time of
disclosure, or by written notice to the other Party, within thirty (30) days
following such disclosures, Confidential Information which is disclosed in
writing or other tangible form, and (y) reduce to writing or other tangible form
and similarly label, within thirty (30) days of disclosure, Confidential
Information which is disclosed verbally. The terms of this Agreement will be
considered Confidential Information hereunder. The restrictions on the
disclosure and use of Confidential Information set forth in the first sentence
of this Section 10.1 will not apply to any Confidential Information that:
(a) was known by the receiving Party prior to disclosure by the
disclosing Party hereunder (as evidenced by the receiving Party's written
records or other competent evidence);
(b) is or becomes part of the public domain under circumstances
involving no breach of this Agreement;
(c) is disclosed to the receiving Party by a Third Party who had
a legal right to make such disclosure without restrictions for the benefit of
the disclosing Party; or
(d) is independently developed by personnel of the receiving
Party who did not have access to the Confidential Information (as evidenced by
the receiving Party's written records or other competent evidence).
The foregoing notwithstanding, if either Party is required (as reasonably
determined by its legal counsel) by regulation, Law or legal process, including
without limitation by the rules or regulations of the United States Securities
and Exchange Commission or similar regulatory agency in a country other than the
United States or of any stock exchange or Nasdaq, to disclose the existence of
this Agreement and/or any information related to the terms and conditions of
this Agreement, such Party will provide prior written notice of such intended
disclosure to the other Party, which notice will include a copy of the proposed
disclosure. Upon receipt of such notice, the other Party will have a reasonable
period to review and comment on the proposed disclosure (not to exceed five (5)
Business Days), and the Party required to disclose will in good faith consider
any changes or modifications to the proposed disclosure requested by the other
Party. In the event that the legal requirements compelling such disclosure will
not reasonably allow for a review period of five (5) Business Days, the notice
provided by the Party required to disclose will specify a shorter period for
review (of not less than one (1) Business Day) necessary under such
circumstances. The Party legally required to disclose will use commercially
reasonable efforts to obtain confidential treatment (to the extent available) of
the Confidential Information proposed to be disclosed, and will disclose only
such Confidential Information of the other Party as is required to be disclosed
in order to comply. In addition, either Party may disclose to bona fide
potential investors, lenders and acquirors/acquirees, and to such Party's
consultants and advisors, the existence and terms of this Agreement only if and
to the extent necessary in connection with a proposed equity or debt financing
of such Party, or a proposed acquisition, merger or other similar business
combination, so long as such recipients are bound in writing to maintain the
confidentiality of such information in accordance with the terms of this
Agreement.
Section 10.2. EMPLOYEE, CONSULTANT AND ADVISOR OBLIGATIONS. Each Party
agrees that it and its Affiliates will provide or permit access to Confidential
Information received from the other Party and such Party's Affiliates and
representatives only to the employees, consultants, advisors and permitted
subcontractors, sublicensees, distributors and sub-distributors of the receiving
Party and its Affiliates, who in such Party's reasonable judgment have a need to
know such Confidential Information to assist the receiving Party with the
activities contemplated by this Agreement and who are subject to contractual
obligations of confidentiality and non-use with respect to such Confidential
Information similar to the obligations of confidentiality and non-use of the
receiving Party pursuant to Section 10.1; provided, that Millennium and GSK will
each remain responsible for any failure by its Affiliates, and its and its
Affiliates' employees, consultants, advisors and permitted subcontractors,
sublicensees, distributors and sub-distributors, to treat such Confidential
Information as required under Section 10.1 (as if such Affiliates, employees,
consultants, advisors and permitted subcontractors, sublicensees, distributors
and sub-distributors were Parties directly bound by the requirements of Section
10.1).
Section 10.3. PUBLICITY. Upon the execution of this Agreement,
Millennium and GSK will issue a mutually agreed press release regarding the
subject matter of this Agreement. After such initial press release, neither
Party will issue a press release or public announcement relating to the Licensed
Product in the Territory or this Agreement without the prior written approval of
the other Party, which approval will not be unreasonably withheld, except that a
Party may (a) issue such press release or public announcement if the contents of
such press release or public announcement have previously been made public other
than through a breach of this Agreement by the issuing Party and (b) issue such
a press release or public announcement if required by applicable Law, in each
case under clause (a) and (b) after first notifying the other Party of such
planned press release or public announcement at least three (3) Business Days in
advance of issuing such press release or making such public announcement (or,
with respect to press releases and public announcements made pursuant to the
foregoing clause (b), with as much advance notice as possible under the
circumstances if it is not possible to provide notice at least three (3)
Business Days in advance) for the sole purpose of allowing the other Party to
review the proposed press release or public announcement for the inclusion of
Confidential Information, provided, that, the Party subject to the requirement
will include in such press release or public announcement made pursuant to the
foregoing clause (b) only such information relating to the Licensed Product or
this Agreement as is required by such applicable Law.
Section 10.4. PUBLICATIONS. Subject to the restrictions provided below,
GSK may publish or present the results of Development carried out on the
Licensed Product in the Territory, subject to prior review by Millennium for
patentability and protection of Millennium's Confidential Information. GSK will
provide Millennium any proposed abstracts, manuscripts or summaries of
presentations that cover the results of Development of the Licensed Product at
least thirty (30) days' prior to its proposed submission for publication or
presentation. Millennium will designate a person or persons who will be
responsible for reviewing such publications. Such designated person will respond
in writing promptly and in no event later than thirty (30) days after receipt of
the proposed material with either approval of the proposed material or a
specific statement of concern, based upon either the need to seek patent
protection or concern regarding competitive disadvantage arising from the
proposal. If Millennium expresses such a concern, GSK agrees not to submit such
publication or to make the presentation that contains such information until
Millennium is given a reasonable period of time (not to exceed ninety (90) days)
to seek patent protection for any material in such publication or presentation
that it believes is patentable or to resolve any other issues, and GSK will
remove any Confidential Information of Millennium from the publication if
requested by Millennium. With respect to proposed abstracts, manuscripts or
summaries of presentations by investigators (including results of Investigator
Sponsored Clinical Studies) or other Third Parties (other than Schering), such
materials will be subject to review under this Section 10.4 to the extent that
GSK has the right and ability (after using Commercially Reasonable Efforts) to
do so.
ARTICLE XI
REPRESENTATIONS AND WARRANTIES; CERTAIN COVENANTS; INDEMNIFICATION
Section 11.1. REPRESENTATIONS AND WARRANTIES OF MILLENNIUM. Millennium
hereby represents and warrants to GSK that, as of the Effective Date:
(a) Millennium is a corporation duly incorporated, validly
existing and in good standing under the laws of the State of Delaware, with the
corporate power and authority to enter into this Agreement and to perform its
obligations hereunder. The execution and delivery of this Agreement and the
consummation of the transactions contemplated hereby have been duly authorized
by all requisite corporate action on the part of Millennium. This Agreement has
been duly executed and delivered by Millennium and constitutes the valid,
binding and enforceable obligation of Millennium, subject to applicable
bankruptcy, reorganization, insolvency, moratorium and other Laws affecting
creditors' rights generally from time to time in effect and to general
principles of equity.
(b) Millennium is not subject to, or bound by, any provision of:
(i) any articles or certificates of incorporation or
by-laws;
(ii) any mortgage, deed of trust, lease, note, shareholders'
agreement, bond, indenture, license, permit, trust, custodianship, or other
instrument, contract, agreement or restriction; or
(iii) any judgment, order, writ, injunction or decree of any
court, governmental body, administrative agency or arbitrator;
that would prevent, or be violated by, or under which there would be a default
as a result of, nor is the consent of any person required for, the execution,
delivery and performance by Millennium of this Agreement and the obligations
contained herein, including without limitation, the grant to GSK of the licenses
described in Article VII hereof.
(c) Millennium is the exclusive owner of all right, title and
interest in, or is a licensee of the Millennium Patent Rights listed on EXHIBIT
I pertaining to the composition of matter and use of the Compound. To the best
of Millennium's knowledge, the issued claims in the patents listed on EXHIBIT I
are valid and enforceable, and the patent applications have been duly filed.
(d) To the best of Millennium's knowledge, neither the
Manufacture, Development nor Commercialization of the Compound or Licensed
Product in the Territory as currently being manufactured or commercialized
infringes upon any Third Party's valid patents or constitutes a misappropriation
of a Third Party's trade secrets or other intellectual property rights. For
purposes of this Section 11.1(d) and Section 11.1(e) below, the phrase "to the
best of Millennium's knowledge" means the actual knowledge of the attorneys in
Millennium's legal department and the members of Millennium's corporate
management team.
(e) To the best of Millennium's knowledge, in the Territory,
there is no Third Party infringing any of the Millennium Patent Rights or
misappropriating Millennium Know-How in derogation of the rights granted to GSK
in this Agreement with respect to the Compound and Licensed Product.
(f) Except as set forth in EXHIBIT E attached hereto, to the
best of Millennium's knowledge, there is no interference action or litigation
pending or any communication which threatens interference action, or other
litigation before any patent and trademark office, court, or any other
governmental entity in any jurisdiction in regard to the Patent Rights.
(g) To the best of Millennium's knowledge, after inquiry of, and
representation from, Schering, there are no material contracts for the
Commercialization of the Licensed Product to be assigned to GSK in connection
with the transfer of Regulatory Approvals hereunder.
(h) With regard to the Schering/Millennium European Agreement,
it has been fully executed and delivered by each of Schering and Millennium,
such agreement has not been amended and a correct redacted copy of such
agreement is attached hereto as EXHIBIT B-2.
(i) To the best knowledge of Millennium, Millennium is not in
material breach or default of the Schering/Millennium European Agreement and no
event has occurred which with notice or lapse of time would constitute a
material breach or default thereof by Millennium. To the best knowledge of
Millennium, Schering is not in breach of the Schering/Millennium European
Agreement, provided that this representation does not apply to Schering's
performance under the Schering Collaboration Agreement.
(j) Millennium has not, and to the best knowledge of Millennium,
no other party has received notice of default under the Schering/Millennium
European Agreement.
(k) Millennium is the sole and exclusive owner of all right,
title and interest in and to the Product Trademarks listed on EXHIBIT D existing
as of the Effective Date. To the best of Millennium's knowledge, such Product
Trademarks are free and clear of any liens, charges and encumbrances in those
countries in the Territory for which they are registered.
(l) EXISTING THIRD PARTY AGREEMENTS. To the best of its
knowledge, prior to the Effective Date, Millennium has provided GSK with
redacted copies of the Existing Third Party Agreements in effect as of the
Effective Date. To the best of Millennium's knowledge, such agreements remain in
full force and effect as of the Effective Date. To the best of its knowledge, as
of the Effective Date, Millennium is in compliance in all material respects with
the terms of the Existing Third Party Agreements to which Millennium is a party
and shall use commercially reasonable efforts not to take or omit to take any
actions that would constitute a breach of the Existing Third Party Agreements or
enter into any amendment to any Existing Third Party Agreement to which
Millennium is a party, which breach or amendment would be reasonably likely to
have a material adverse effect on GSK's rights to Develop, Manufacture or
Commercialize the Licensed Product in the Territory.
(m) As of the Effective Date, Millennium has not granted, and
will not grant during the term of this Agreement, any right, license or interest
in or to the Millennium Intellectual Property that is in material conflict with
the rights or licenses granted to GSK under this Agreement.
(n) The information contained on EXHIBIT J hereto (INTEGRILIN
Sales Information) has been furnished by Schering and, based on a representation
from Schering, it is accurate, truthful and complete, and, to the best of
Millennium's knowledge, Millennium has no reason to believe that such
information is not accurate, truthful or complete.
(o) Millennium has [**].
Section 11.2. REPRESENTATIONS OF GSK. GSK represents and warrants to
Millennium that, as of the Effective Date:
(a) GSK is a corporation duly incorporated, validly existing and
in good standing under the laws of England with the corporate power and
authority to enter into this Agreement and to perform its obligations hereunder.
The execution and delivery of this Agreement and the consummation of the
transactions contemplated hereby have been duly authorized by all requisite
corporate action on the part of GSK. This Agreement has been duly executed and
delivered by GSK and constitutes the valid, binding and enforceable obligation
of GSK, subject to applicable bankruptcy, reorganization, insolvency, moratorium
and other laws affecting creditors' rights generally from time to time in effect
and to general principles of equity.
(b) GSK is not subject to, or bound by, any provision of:
(i) any articles or certificates of incorporation or
by-laws;
(ii) any mortgage, deed of trust, lease, note, shareholders'
agreement, bond, indenture, license, permit, trust, custodianship, or other
instrument, contract, agreement or restriction, or
(iii) any judgment, order, writ, injunction or decree of any
court, governmental body, administrative agency or arbitrator;
that would prevent, or be violated by, or under which there would be a default
as a result of, nor is the consent of any person required for, the execution,
delivery and performance by GSK of this Agreement and the obligations contained
herein, including without limitation, the grant to Millennium of the licenses
described in Article VII hereof.
(c) GSK represents and warrants to Millennium that, as of the
Effective Date, there is no GSK Other Intellectual Property.
Section 11.3. COVENANT REGARDING THIRD PARTY AGREEMENTS. Millennium
covenants and agrees that: (a) it will perform its material obligations and
responsibilities under the Existing Third Party Agreements, including but not
limited to the Schering/Millennium European Agreement; (b) it will use
commercially reasonable efforts to avoid taking any action or omitting to take
any action that could constitute a material breach of its obligations under the
Existing Third Party Agreements; and (c) it will promptly notify GSK if it
receives a notice of default under any Existing Third Party Agreement that could
trigger termination of such Existing Third Party Agreement.
Section 11.4. EXCLUSIVITY COVENANT. Neither Party will, alone or in
collaboration with others, Commercialize any Competing Product, directly or
indirectly, in the Territory for a period of [**] years from the Effective Date,
unless during such [**] period [**] the Licensed Product pursuant to Section
6.3, in which case the period shall be [**]. If a Party would violate the
provisions of this Section 11.4 as a result of a merger, acquisition or
combination with a Third Party, then such Party will, within [**] after the
completion of such merger, acquisition or combination, either (a) [**] if such
Party is either Millennium or GSK, or (b) [**] if the Party is GSK.
Section 11.5. COMPLIANCE WITH LAWS. Each Party covenants and agrees to
comply with all Laws applicable to such Party with respect to the Development,
Manufacture and Commercialization of the Licensed Product in their respective
territory.
Section 11.6. NO WARRANTIES. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH
HEREIN, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTIES OF ANY
KIND, EITHER EXPRESS OR IMPLIED, TO THE OTHER PARTY, AND EACH PARTY HEREBY
DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE AND NONINFRINGEMENT WITH RESPECT TO THE COMPOUND AND THE LICENSED
PRODUCT. NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY THAT THE
DEVELOPMENT, MANUFACTURE AND COMMERCIALIZATION OF THE LICENSED PRODUCT PURSUANT
TO THIS AGREEMENT WILL BE SUCCESSFUL OR THAT ANY PARTICULAR SALES LEVEL WITH
RESPECT TO THE LICENSED PRODUCT WILL BE ACHIEVED.
Section 11.7. NO DEBARMENT. As of the Effective Date, neither Party nor
any of its Affiliates or employees responsible for (or in the case of GSK to be
responsible for) the Development, Manufacture or Commercialization of the
Licensed Product in or for the Territory has been debarred or is subject to
debarment. During the Term neither Party nor any of its Affiliates will use in
any capacity, in connection with the Development, Manufacture or
Commercialization of the Licensed Product in the Territory, any person who has
been debarred pursuant to Section 306 of the United States Federal Food, Drug,
and Cosmetic Act, or who is the subject of a conviction described in such
section. Each Party agrees to inform the other Party in writing immediately if
it or any person who is performing services hereunder is debarred or is the
subject of a conviction described in Section 306, or if any action, suit, claim,
investigation or legal or administrative proceeding is pending or, to the best
of such Party's knowledge, is threatened, relating to the debarment or
conviction of such Party or any person used in any capacity by such Party or any
of its Affiliates in connection with the Development, Manufacture or
Commercialization of the Licensed Product in or for the Territory.
Section 11.8. INDEMNIFICATION.
(a) INDEMNIFICATION BY MILLENNIUM. Millennium will defend,
indemnify and hold harmless GSK, its Affiliates and their respective directors,
officers, employees and agents (collectively, the "GSK Indemnified Parties"),
from, against and in respect of any and all Losses involving a claim or Action
brought by a Third Party, incurred or suffered by, or asserted against, the GSK
Indemnified Parties or any of them resulting directly or indirectly from (i) any
material breach of, or material inaccuracy in, any representation or warranty
made by Millennium in this Agreement, or (ii) any material breach or material
violation of any covenant or agreement of Millennium (including, but not limited
to, under this Section 11.8) in or pursuant to this Agreement.
(b) INDEMNIFICATION BY GSK. GSK will defend, indemnify and hold
harmless Millennium, its Affiliates and their respective directors, officers,
employees and agents (collectively, the "Millennium Indemnified Parties"), from,
against and in respect of any and all Losses involving a claim or Action brought
by a Third Party, incurred or suffered by, or asserted against, the Millennium
Indemnified Parties or any of them, resulting directly or indirectly from (i)
any material breach of, or material inaccuracy in, any representation or
warranty made by GSK in this Agreement, or (ii) any material breach or material
violation of any covenant or agreement of GSK (including, but not limited to,
under this Section 11.8) in or pursuant to this Agreement.
(c) OTHER ACTIONS.
(i) Millennium will defend, indemnify and hold harmless the
GSK Indemnified Parties from, against and in respect of any and all Losses
involving a claim or Action (including product liability claims in tort,
contract, strict liability or any other theory of liability) brought by a Third
Party incurred or suffered by, or asserted against, the GSK Indemnified Parties
or any of them directly or indirectly relating to the Licensed Product
resulting, directly or indirectly, from: (A) the Development or
Commercialization of the Licensed Product outside the Territory by Millennium,
Schering, their Affiliates, sublicensees or distributors, except and to the
extent caused by the gross negligence or willful misconduct of, or violation of
Law by, GSK or any of the other GSK Indemnified Parties in connection with
pharmacovigilance activities pursuant to the Reporting Agreement among the
Parties and Schering as set forth in Section 5.12, (B) the Development or
Commercialization of the Licensed Product in a given country of the Territory
prior to the completion of the Transition Period for such country, (C) the
Manufacture of the Licensed Product (to the extent performed by Millennium) in
or for a given country of the Territory prior to the completion of the
Transition Period for such country, or (D) activities after the Effective Date
with respect to the Development of the Licensed Product in the Territory by
Millennium or Schering, including but not limited to clinical trials conducted
by Millennium, Schering, their Affiliates, sublicensees, contractors, agents or
distributors or any other Third Party licensee thereof, except and to the extent
caused by the negligence or willful misconduct of, or violation of Law by, GSK
or any of the other GSK Indemnified Parties in connection with the use by
Millennium or its sublicensee of Licensed Product Manufactured by GSK in such
Development activities.
(ii) GSK will defend, indemnify and hold harmless the
Millennium Indemnified Parties from, against and in respect of any and all
Losses involving a claim or Action (including product liability claims in tort,
contract, strict liability or any other theory of liability) brought by a Third
Party incurred or suffered by, or asserted against, the Millennium Indemnified
Parties or any of them resulting, directly or indirectly, from the Development,
Commercialization or Manufacture (to the extent actually performed by GSK) of
the Licensed Product in a given country of the Territory by GSK after the
completion of the Transition Period for such country, except to the extent
caused by the gross negligence or willful misconduct of, or violation of Law by,
Millennium, Schering, its Affiliates, agents or sublicensees or any of the other
Millennium Indemnified Parties. GSK will not, however, defend, indemnify or hold
harmless the Millennium Indemnified Parties from, against and in respect of any
and all Losses involving a claim or Action (including product liability claims
in tort, contract, strict liability or any other theory of liability) brought by
a Third Party incurred or suffered by, or asserted against, the Millennium
Indemnified Parties or any of them to the extent such Losses result, directly or
indirectly, from (A) the Development or Commercialization of the Licensed
Product outside the Territory, (B) the Commercialization of the Licensed Product
in a given country of the Territory prior to the completion of the Transition
Period for such country, (C) Millennium's, Schering's or any Third Party
Licensee's (of either Millennium or Schering) activities with respect to the
Development of the Licensed Product in a given country in the Territory prior
to[**]and after the completion of the Transition Period for such country, or (D)
the Manufacture of the Licensed Product, except to the extent Manufacturing is
performed by GSK.
(iii) GSK will defend, indemnify and hold harmless the
Schering Indemnified Parties from, against and in respect of any and all Losses
involving a claim or Action (including product liability claims in tort,
contract, strict liability or any other theory of liability) brought by a Third
Party incurred or suffered by, or asserted against, the Schering Indemnified
Parties or any of them resulting, directly or indirectly, from (1) the
Development, Commercialization or Manufacture (performed by GSK) of the Licensed
Product in the Territory after the completion of the Transition Period, on a
country-by-country basis, or (2) any co-promotion activities conducted by GSK
pursuant to Section 5.2(b) during the period of time commencing on the Effective
Date and ending upon completion of the Transition Period, except in each case to
the extent caused by the gross negligence or willful misconduct of, or violation
of Law by, Schering or any of the other Schering Indemnified Parties. GSK will
not, however, defend, indemnify or hold harmless the Schering Indemnified
Parties from, against and in respect of any and all Losses involving a Third
Party products liability claim or Action incurred or suffered by, or asserted
against, the Schering Indemnified Parties or any of them to the extent such
Losses result, directly or indirectly, from (A) the Development or
Commercialization by non-GSK parties of the Licensed Product in the Territory
prior to the completion of the Transition Period, on a country-by-country basis,
(B) the Development or Commercialization of the Licensed Product outside the
Territory, (C) Schering's activities with respect to the Development of the
Licensed Product in the Territory prior to the Effective Date, and after the
Effective Date (as permitted by this Agreement), or (D) the Manufacture of the
Licensed Product, except to the extent Manufacturing is performed by GSK.
(d) INDEMNIFICATION UNDER THE SUPPLY AGREEMENT. The Parties
agree that claims or Actions involving Third Party products liability claims
(whether in tort, contract, strict liability or any other theory of liability)
related to the Manufacture of the Licensed Product pursuant to the Supply
Agreement will be addressed in the Supply Agreement.
(e) CLAIMS FOR INDEMNIFICATION.
(i) A person entitled to indemnification under this Section
11.8 (an "Indemnified Party") will give prompt written notification to the
person from whom indemnification is sought (the "Indemnifying Party") of the
commencement of any action, suit or proceeding relating to a Third Party or
Governmental Authority claim for which indemnification may be sought or, if
earlier, upon the assertion of any such claim by a Third Party or Governmental
Authority (it being understood and agreed, however, that the failure by an
Indemnified Party to give notice of a Third Party or Governmental Authority
claim as provided in this Section 11.8 will not relieve the Indemnifying Party
of its indemnification obligation under this Agreement except and only to the
extent that such Indemnifying Party is actually prejudiced as a result of such
failure to give notice).
(ii) Within [**] days after delivery of such notification,
the Indemnifying Party may, upon written notice thereof to the Indemnified
Party, assume control of the defense of such action, suit, proceeding or claim
with counsel reasonably satisfactory to the Indemnified Party. If the
Indemnifying Party does not assume control of such defense, the Indemnified
Party will control such defense.
(iii) The Party not controlling such defense may participate
therein at its own expense; provided, that if the Indemnifying Party assumes
control of such defense and the Indemnified Party reasonably concludes, based on
advice from counsel, that the Indemnifying Party and the Indemnified Party have
conflicting interests with respect to such action, suit, proceeding or claim,
the Indemnifying Party will be responsible for the reasonable fees and expenses
of counsel to the Indemnified Party solely in connection therewith; provided
further, however, that in no event will the Indemnifying Party be responsible
for the fees and expenses of more than one counsel in any one jurisdiction for
all Indemnified Parties.
(iv) The Party controlling such defense will keep the other
Party advised of the status of such action, suit, proceeding or claim and the
defense thereof and will consider recommendations made by the other Party with
respect thereto.
(v) The Indemnified Party will cooperate fully with the
Indemnifying Party and its legal counsel (including the provision of testimony
or documents) with respect to the defense or settlement of any such action,
suit, proceeding or claim.
(vi) The Indemnified Party will not agree to any settlement
of such action, suit, proceeding or claim without the prior written consent of
the Indemnifying Party, which will not be unreasonably withheld. The
Indemnifying Party will not agree to any settlement of such action, suit,
proceeding or claim or consent to any judgment in respect thereof that does not
include a complete and unconditional release of the Indemnified Party from all
liability with respect thereto or that imposes any liability or obligation on
the Indemnified Party without the prior written consent of the Indemnified
Party, which consent will not be unreasonably withheld.
Section 11.9. INSURANCE. Each Party will maintain insurance, including
product liability insurance, with respect to its activities or obligations
hereunder. Such insurance will be in such amounts and subject to such
deductibles as the Parties may agree based upon standards prevailing in the
industry at the time, provided, that, as of the Effective Date, each Party will
maintain a minimum of Twenty Million Dollars ($20,000,000) in product liability
insurance. Notwithstanding the preceding two sentences, either Party may satisfy
its obligations hereunder through reasonable self-insurance to the same extent.
A Party will name the other Party as an additional insured on any policies it
maintains pertaining to the Development, Manufacturing or Commercialization of
the Licensed Product.
ARTICLE XII
TERM AND TERMINATION
Section 12.1. TERM. Unless terminated earlier in accordance with this
Article XII, this Agreement will commence on the Effective Date and will remain
in force and effect until the later of (a) December 31, 2014, or (b) for as long
as GSK continues to Commercialize the Licensed Product in any country in the
Territory (the "Term"). Upon expiration or earlier termination of this
Agreement, the licenses granted to GSK under Article VII will terminate.
Section 12.2. TERMINATION FOR MATERIAL BREACH. Upon any material breach
of this Agreement by a Party (the "Breaching Party"), the other Party (the
"Non-Breaching Party") may terminate this Agreement by providing thirty (30)
days' written notice to the Breaching Party if such material breach is a breach
of a payment obligation, or sixty (60) days' written notice to the Breaching
Party in the case of any other material breach. The termination will become
effective at the end of the notice period unless the Breaching Party cures such
breach during such notice period; provided, that the Non-Breaching Party may, by
notice to the Breaching Party, designate a later date for such termination in
order to facilitate an orderly transition of activities relating to the Licensed
Product. Notwithstanding the foregoing,
(a) if such breach, by its nature, is incurable, the
Non-Breaching Party may terminate this Agreement immediately upon written notice
to the Breaching Party;
(b) if such breach (other than a payment breach), by its nature,
is curable, but not within the applicable cure period, then such cure period
will be extended if the Breaching Party provides an appropriate written plan for
curing such breach to the Non-Breaching Party and uses commercially reasonable
efforts to cure such breach in accordance with such written plan; provided that
no such extension will exceed sixty (60) days without the consent of the
Non-Breaching Party; and
(c) if there is a good faith dispute as to whether performance
has been made by either Party pursuant to this Agreement, the relevant cure
period with respect thereto will be tolled pending resolution of such dispute in
accordance with the applicable provisions of this Agreement.
Section 12.3. TERMINATION BY GSK. GSK has the right to terminate this
Agreement as set forth in this Section 12.3.
(a) TERMINATION ARISING FROM GSK ELECTIVE DECISION TO
DISCONTINUE COMMERCIALIZATION OF LICENSED PRODUCT PRIOR TO GENERIC Erosion. If
based on a reasonable determination, the Commercially Reasonable Efforts to be
undertaken by GSK for Development and Commercialization do not justify, in GSK's
sole discretion, the continued Commercialization of the Licensed Product, then
GSK may, upon written notice to Millennium, terminate this Agreement in the
Territory as a whole; provided, however, that GSK [**]. In the event that
GSK chooses to exercise its right of termination under this provision, [**];
provided, however, that in the event that GSK's decision not to continue the
Commercialization of the Licensed Product is due to: (i) actions by a Government
or Regulatory Agency that results in the [**] of the Licensed Product in the
Major Market Countries by greater than [**] percent ([**]%), or (ii) actions by
a Government or Regulatory Agency to [**] for the Licensed Product in the Major
Market Countries, or (iii) [**] in connection with Commercialization [**] of the
Licensed Product in the Territory [**] per cent ([**]%) [**], in each case, not
directly or indirectly caused by the actions or inactions of GSK, then in such
event GSK may terminate this Agreement [**].
(b) TERMINATION BY GSK DUE TO GENERIC COMPETITION. In the event
GSK elects to stop Commercializing the Licensed Product in the Major Market
Countries after Generic Erosion has occurred pursuant to Section 8.5, which
countries accounted for [**]percent ([**]%) or more of the total sales in the
Territory [**], GSK will promptly send written notice to Millennium of such
election and either Party will have the opportunity to terminate this Agreement.
(c) TERMINATION BY GSK DUE TO COMPETING PRODUCT. If GSK elects
to retain a Competing Product pursuant to Section 11.4 hereof, GSK will notify
Millennium and [**] and this Agreement will terminate.
(d) TERMINATION BY GSK FOR SAFETY ISSUES. GSK may unilaterally
terminate this Agreement for the Territory as a whole if (i) the withdrawal of
the Licensed Product from the market in the United States, or one or more of
France, Germany, Italy, Spain or the United Kingdom for all indications and uses
(other than compassionate uses requested or required by any Regulatory
Authority) for health or safety reasons is ordered or required by the FDA, EMEA
or other Regulatory Authority, or (ii) the Parties reasonably agree that there
is a significant patient health or safety issue with respect to the Licensed
Product which may lead to any of the events enumerated in the immediately
preceding clause 12.3(d)(i).
(e) TERMINATION UPON TERMINATION OF THE SUPPLY AGREEMENT. GSK
may elect to terminate this Agreement for the Territory as a whole upon any
termination of the Supply Agreement or the Future Supply Agreement.
(f) TERMINATION BY GSK FOR DELAYED TRANSITION. In the event the
Transition Activities and Processes listed on Exhibit H have not been completed
by [**] and such lack of completion is not due to the gross negligence or
willful misconduct of GSK, GSK may terminate this Agreement for the Territory as
a whole [**] prior written notice to Millennium. During such notice period, upon
Millennium's request, the Executive Officers for each Party will discuss the
situation; provided, however, if the Transition Activities and Processes listed
on Exhibit H have not been completed by [**], GSK may proceed with termination
in its sole discretion. If GSK terminates this Agreement pursuant to this
Section 12.3(f) Millennium will [**] days of the date of termination.
Section 12.4. CERTAIN RIGHTS AND OBLIGATIONS UPON TERMINATION. Without
limiting any other legal or equitable remedies that either Party may have, if
this Agreement is terminated by either Party pursuant to Article XII hereof, the
following provisions will take effect as of the effective date of such
termination:
(a) GSK will, as soon as practicable, transfer to Millennium or
Millennium's designee (i) possession and ownership of all governmental and
regulatory correspondence, conversation logs, filings and approvals (including
all Regulatory Approvals) relating to the Development, Manufacture or
Commercialization of the Licensed Product in the Territory, (ii) copies of all
data, reports, records and materials in GSK's possession or control relating to
the Development, Manufacture or Commercialization of the Licensed Product in the
Territory, including all non-clinical and clinical data relating to the Licensed
Product, and (iii) all records and materials in GSK's possession or Control
containing Confidential Information of Millennium;
(b) GSK will appoint Millennium as GSK's and/or its Affiliates'
agent for all Licensed Product-related matters involving Regulatory Authorities
in the Territory;
(c) in the event that this Agreement is terminated by GSK
pursuant to Section 12.3(a), 12.3(b) or 12.3(d) above, if Millennium so
requests, GSK will assign to Millennium any agreements with Third Parties
relating solely to the Development, Manufacture or Commercialization of the
Licensed Product to which GSK is a party to the extent permitted by the terms of
such agreements;
(d) GSK will, upon notice from Millennium, appoint Millennium or
its designee as its exclusive distributor of the Licensed Product in the
Territory, and grant Millennium or its designee the right to appoint
sub-distributors;
(e) at Millennium's option, GSK will, [**] with respect to the
Licensed Product, [**] with respect to the Licensed Product for a period of up
to [**] with respect to the Licensed Product, and (ii) [**] in the Territory for
such[**] and, during such [**] period, GSK will diligently perform all
transition activity necessary [**] at the end of such [**] period;
(f) the licenses granted to GSK in Section 7.1 will terminate
(except to the extent necessary to enable GSK to perform its obligations under
this Section 12.4) and the licenses and rights granted to Millennium under
Section 7.2 and 7.3 will survive;
(g) GSK will assign to Millennium all right, title and interest
in the GSK Product Trademark(s) and all goodwill associated therewith;
(h) if Millennium so requests, GSK will transfer to Millennium
any agreements with Third Parties relating to the Development, Manufacture or
Commercialization of the Licensed Product to which GSK is a party to the extent
permitted under the terms of such agreements;
(i) GSK will continue to fund all clinical Development
activities initiated by GSK prior to the date of termination through completion;
(j) GSK will at its cost, return to Millennium all inventory of
Licensed Product in its possession as of the date of termination and make
payment to Millennium for any Fill/Finished Product ordered by GSK pursuant to
the Supply Agreement but not yet paid for at Millennium's election; provided,
however, if Millennium elects for GSK to pay for Licensed Product, GSK will be
permitted to take delivery and sell such Licensed Product subject to the payment
terms of Article VIII hereof;
(k) GSK will execute all documents and take all such further
actions as may be reasonably requested by Millennium in order to give effect to
the foregoing clauses (a) through (j); and
(l) Until the earlier of (i) [**] or (ii) [**] this Agreement,
GSK will Commercialize the Licensed Product in the Territory; provided, however,
such Commercialization efforts by GSK will be consistent with (i) a level of
activity appropriate for the commercial potential of the Licensed Product during
the [**] period immediately preceding such notice of termination and (ii) the
Parties efforts to transfer Commercialization of the Licensed Product to
Millennium while preserving the commercial potential of the Licensed Product.
Section 12.5. SURVIVAL. In the event of any expiration or termination
of this Agreement, (a) all financial obligations hereunder owed as of the
effective date of such expiration or termination will remain in effect and (b)
the provisions set forth in Articles X, XI, XIII and XIV and in Sections 7.2(a),
7.3, 7.4, 7.8, 8.10 through 8.16, 9.1, 12.1, 12.3(a), 12.3(c), 12.3(d), 12.3(f),
12.4, and this 12.5 will survive any such expiration or termination.
ARTICLE XIII
FINAL DECISION-MAKING; DISPUTE RESOLUTION
Section 13.1. REFERRAL TO EXECUTIVE OFFICERS. In general the Parties
will use good faith efforts to resolve matters at the Steering Committee by
consensus. If for any reason the Steering Committee cannot resolve any matter
properly referred to it pertaining to the Licensed Product in the Territory
either Party may refer the matter to the Executive Officers for resolution. If
after discussing the matter in good faith and attempting to find a mutually
satisfactory resolution to the issue, the Executive Officers fail to come to
consensus within [**] Business Days after the date on which the matter is
referred to the Executive Officers (unless a longer period is agreed to in
writing by the Executive Officers), the provisions of Sections 13.2 and 13.3
will apply and resolutions reached through such provisions will be binding on
the Parties.
Section 13.2. FINAL DECISION-MAKING AUTHORITY. If the Executive
Officers fail to come to consensus on any matter referred to them within the
period for resolution set forth in Section 13.1 (an "Unresolved Matter"), then
the following provisions will apply:
(a) GSK will have final decision-making authority with respect
to Unresolved Matters with respect to the pricing or reimbursement of the
Licensed Product in the Territory, [**] in the Territory in connection with the
Development and Commercialization of the Licensed Product, the contents of the
label for the Licensed Product in the Territory other than those contents
related to patient safety, Promotional Materials and the Commercialization
strategy, including those set forth in the Launch Plan and Annual Plan, for the
Licensed Product in the Territory.
(b) Millennium will have final decision-making authority with
respect to Development activities where Millennium reasonably believes that
conduct of the proposed Development activity [**] of the Licensed Product
outside the Territory.
(c) All other Unresolved Matters arising in connection with
disputes under this Agreement, including but not limited to patient health or
safety matters, financial provisions, diligence and any disputes regarding the
Supplemental Plan will be handled pursuant to Section 13.3 hereof.
(d) For purposes of clarity, Millennium will have final
decision-making authority with respect to all matters arising in connection with
the Development, Manufacture and Commercialization of the Licensed Product
outside the Territory.
Section 13.3. ARBITRATION. Any dispute, controversy or claim arising
out of or relating to this Agreement, or the breach, termination or invalidity
thereof, in each case which is not subject to Section 13.1 or 13.2, shall be
finally settled by binding arbitration conducted in the English language in
Cambridge, Massachusetts under the commercial arbitration rules of the American
Arbitration Association ("AAA"). The arbitration shall be conducted by a single
arbitrator jointly appointed by the Parties; provided, HOWEVER, that if they
cannot agree within thirty (30) days after the initiation of the arbitration,
then the arbitrator shall be appointed by the President of the AAA. Disputes
about arbitration procedure shall be resolved by the arbitrator. The arbitrator
may proceed to an award notwithstanding the failure of either Party to
participate in the proceedings. Discovery shall be limited to mutual exchange of
documents relevant to the dispute, controversy or claim; depositions shall not
be permitted unless agreed to by both Parties. The arbitrator shall be
authorized to grant interim relief, including to prevent the destruction of
goods or documents involved in the dispute, protect trade secrets and provide
for security for a prospective monetary award. The limitations on liability set
out in Section 14.10 hereof shall apply to an award of the arbitrator.
Specifically, but without limitation, under no circumstances shall the
arbitrator be authorized to award punitive or multiple damages. Any purported
award of punitive or multiple damages or of other damages not permitted under
Section 14.10 hereof shall be beyond the arbitrator's authority, void, and
unenforceable. The prevailing Party shall be entitled to an award of reasonable
attorney fees incurred in connection with the arbitration in such amount as may
be determined by the arbitrator. The award of the arbitrator shall be the sole
and exclusive remedy of the Parties and shall be enforceable in any court of
competent jurisdiction, subject only to revocation on grounds of fraud or clear
bias on the part of the arbitrator. Notwithstanding this, application may be
made to any court for a judicial acceptance of the award or order of
enforcement. Notwithstanding anything contained in this Section 13.3 to the
contrary, each Party shall have the right to institute judicial proceedings
against the other Party or anyone acting by, through or under such other Party,
in order to enforce the instituting Party's rights hereunder through reformation
of contract, specific performance, injunction or similar equitable relief.
Section 13.4. INTENDED THIRD PARTY BENEFICIARY.
(a) The Parties intend that, effective on the Effective Date,
GSK shall be deemed an intended third party beneficiary of the
Schering/Millennium European Agreement, including, without limitation, with the
right to enforce the terms of such agreement listed below in subsections (i),
(ii) and (iii), including but not limited to the representations, warranties and
covenants of Schering stated in Article X of such agreement with respect to:
(i) Millennium's rights to Develop, Commercialize and
Manufacture Licensed Products in the Territory under this Agreement;
(ii) Schering's obligations under Sections 3.2(c), 3.2(d),
3.3, 3.4, 4.3, 4.4, 5.1, 5.2, 5.3, 7.2 and 8.1 of the Schering/Millennium
European Agreement; and
(iii) Schering's indemnification obligations under Sections
11.2, 11.4 (last sentence only), and 11.5 of the Schering/Millennium European
Agreement.
GSK's right to enforce such rights is permitted only in the manner provided in
the dispute resolution provision of such agreement and are subject to compliance
by Millennium and GSK with the terms and conditions, as applicable, of Sections
3.3, 5.1(b), 5.5, 7.3, 11.2(b), 11.3, 11.6(b), 11.7, 11.8, 11.9 and 11.10 of the
Schering/Millennium European Agreement. In addition, GSK agrees to be bound by
Section 12.3 of the Schering/Millennium European Agreement with regard to its
enforcement of the terms of such agreement as an intended third party
beneficiary, and to join or be joined by Schering or Millennium in any
proceeding described in Section 12.3 of such agreement relevant to GSK. GSK
agrees to be bound by the dispute resolution provisions of such agreement with
regard to its enforcement of the terms of such agreements as an intended third
party beneficiary, and to agree to join or be joined by Schering or Millennium
in any proceeding described in the dispute resolution provisions of such
agreements; PROVIDED HOWEVER, that GSK may enforce its rights as a third party
beneficiary hereunder by going directly to dispute resolution under Section
12.3(b) of the Schering/Millennium European Agreement; provided, further that
GSK will be permitted, in such instance in which GSK initiates such proceeding,
to select, in lieu of Millennium, at least of one (1) of the three (3)
arbitrators to decide such dispute if the AAA rules governing the dispute so
provide and the parties each select one (1) arbitrator who then will select the
third arbitrator. Millennium agrees that Millennium and Schering will not modify
or amend the terms of the Schering/Millennium European Agreement with respect to
the provisions set forth above in this Section 13.4(a) without the prior written
consent of GSK, which consent shall not be unreasonably withheld. Millennium
agrees that GSK may exercise its rights under this Agreement and its rights
under the Schering/Millennium European Agreement independently.
(b) The Parties intend that, effective on the Effective Date,
the Schering Indemnified Parties, individually or collectively, shall be deemed
intended third party beneficiaries of this Agreement with respect to GSK's
indemnification obligations under Section 11.8(d)(iii) of this Agreement.
Millennium agrees that GSK may exercise its rights under this Agreement and its
rights under the Schering/Millennium European Agreement independently.
ARTICLE XIV
MISCELLANEOUS
Section 14.1. CHOICE OF LAW. This Agreement shall be governed by and
interpreted under, and any arbitration or court action in accordance with
Section 13.3 shall apply, the Law of the State of New York excluding: (a) its
conflicts of laws principles; (b) the United Nations Conventions on Contracts
for the International Sale of Goods; (c) the 1974 Convention on the Limitation
Period in the International Sale of Goods (the "1974 Convention"); and (d) the
Protocol amending the 1974 Convention, done at Vienna April 11, 1980.
Section 14.2. ENGLISH TRANSLATIONS. GSK will provide Millennium with
English translations of the documents and correspondence required to be
submitted to Millennium under this Agreement by GSK that GSK produces for its
own use.
Section 14.3. NOTICES. Any notice or report required or permitted to be
given or made under this Agreement by one of the Parties to the other will be in
writing and will be deemed to have been delivered upon personal delivery on the
same day, if sent via facsimile with confirming receipt on the same day (except
if such notice is not sent on a Business Day, then on the next Business Day), or
the next Business Day following deposit with a reputable overnight courier with
confirming receipt as follows (or at such other addresses or facsimile numbers
as may have been furnished in writing by one of the Parties to the other as
provided in this Section 14.3):
If to Millennium: Millennium Pharmaceuticals, Inc.
00 Xxxxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000-0000
X.X.X.
Attention: Chief Executive Officer
Facsimile No.: (000) 000-0000
With a copy to: Millennium Pharmaceuticals, Inc.
00 Xxxxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000-0000
X.X.X.
Attention: General Counsel
Facsimile No.: (000) 000-0000
If to GSK: Glaxo Group Limited
Glaxo Xxxxxxxx Xxxxx
Xxxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxxx
Xxxxxxx XX0 0XX
Attention: The Company Secretary Facsimile
Facsimile No.: 44 208 047 6905
With a copy to: GlaxoSmithKline
0000 Xxxxxxxxxxx Xxxxxxxxx
Xxxx xx Xxxxxxx, Xxxxxxxxxxxx 00000-0000
Attention: Vice President and Associate
General Counsel, Business
Development Transactions Team
Facsimile No.: (000) 000-0000
Section 14.4. SEVERABILITY. If, under applicable Law or regulation, any
provision of this Agreement is invalid or unenforceable, or otherwise directly
or indirectly affects the validity of any other material provision(s) of this
Agreement (such invalid or unenforceable provision, a "Severed Clause"), the
Parties will substitute, by mutual consent, a valid provision for Such Clause.
In case such substitute valid provision cannot be agreed upon, the Severed
Clause will not affect the validity of this Agreement as a whole.
Section 14.5. CAPTIONS. All captions herein are for convenience only
and will not be interpreted as having any substantive meaning.
Section 14.6. INTEGRATION. This Agreement (including all Exhibits),
together with the Supply Agreement, constitutes the entire agreement between the
Parties hereto with respect to the subject matter of this Agreement and
supersedes all previous agreements, whether written or oral. Notwithstanding the
authority granted to the Steering Committee under this Agreement, this Agreement
(not including the Exhibits hereto) may only be amended by a written agreement
that refers to this Agreement that is signed by properly authorized
representatives of each of Millennium and GSK. If there is a conflict between
the Launch Plan, Annual Plan or Supplemental Plan and this Agreement, the terms
of this Agreement will control.
Section 14.7. INDEPENDENT CONTRACTORS; NO AGENCY. No employee or
representative of a Party will have any authority to bind or obligate the other
Party to this Agreement for any sum or in any manner whatsoever, or to create or
impose any contractual or other liability on the other Party without said
Party's written approval. For all purposes, and notwithstanding any other
provision of this Agreement to the contrary, GSK's legal relationship under this
Agreement to Millennium will be that of independent contractor.
Section 14.8. ASSIGNMENT; SUCCESSORS. Neither Millennium nor GSK may
assign this Agreement in whole or in part, nor any rights hereunder, without the
prior written consent of the other Party; provided that either Party may assign
this Agreement to one of its Affiliates on the condition that the assigning
Party will remain liable hereunder for the prompt payment and performance of all
obligations of the assignee. Any assignment made other than in accordance with
the immediately preceding sentence will be wholly void and invalid. This
Agreement will be binding upon, and will inure to the benefit of, all permitted
successors and assigns.
Section 14.9. EXECUTION IN COUNTERPARTS; FACSIMILE SIGNATURES. This
Agreement may be executed in counterparts, each of which counterparts, when so
executed and delivered, will be deemed to be an original, and all of which
counterparts, taken together, will constitute one and the same instrument even
if both Parties have not executed the same counterpart. A signature on a copy of
this Agreement by either Party by facsimile is binding upon the other Party as
an original. Both Parties agree that a photocopy of such facsimile may also be
treated by the Parties as an original.
Section 14.10. NO CONSEQUENTIAL OR PUNITIVE DAMAGES. NEITHER PARTY
HERETO WILL BE LIABLE FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL,
EXEMPLARY, PUNITIVE OR MULTIPLE DAMAGES ARISING OUT OF THIS AGREEMENT OR THE
EXERCISE OF ITS RIGHTS HEREUNDER, OR FOR ANY LOSS OR INJURY TO A PARTY'S PROFITS
OR GOODWILL ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS
OF ANY NOTICE OF SUCH DAMAGES. NOTHING IN THIS SECTION 14.10 IS INTENDED TO
LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY WITH
RESPECT TO THIRD PARTY CLAIMS UNDER SECTION 11.8(a), 11.8(b) OR 11.8(c).
Section 14.11. PERFORMANCE BY AFFILIATES. To the extent that this
Agreement imposes obligations on Affiliates of a Party, such Party agrees to
cause its Affiliates to perform such obligations. Either Party may use one or
more of its Affiliates to perform its obligations and duties hereunder, provided
that the Parties will remain liable hereunder for the prompt payment and
performance of all their respective obligations hereunder.
Section 14.12. PERFORMANCE BY SUBCONTRACTORS. Either Party may perform
any of its rights and obligations under this Agreement through subcontractors.
Such Party shall ensure that all of its subcontractors comply with, and perform
its obligations in accordance with, the terms of this Agreement; provided,
however, that the use of such subcontractors by such Party shall not relieve
such Party of its respective obligations under this Agreement.
Section 14.13. NO THIRD PARTY BENEFICIARIES. Except as expressly
provided in Section 13.4(b) herein, nothing in this Agreement is intended to
confer upon any other person other than the Parties hereto and their respective
successors and permitted assigns, any benefit, right, or remedy under or by
reason of this Agreement.
Section 14.14. INTERPRETATIVE RULES. By executing this Agreement, both
Parties acknowledge and accept that the final draft of this Agreement was
reached by negotiation and mutual consent and this Agreement will be deemed
drafted by both Parties and will not be interpreted against any one Party. All
references in this Agreement to "including" or "include" will mean including
without limitation. All references in this Agreement to a "day" which are not
explicitly referred to as a Business Day, will mean a calendar day. In those
instances herein where the words "will" or "shall" follow a reference to a Party
hereto as part of a description of a Party's obligation, such obligations will
be understood to be obligations that such Party is expected to fulfill in
accordance with the terms of this Agreement.
Section 14.15. FORCE MAJEURE. Except as otherwise expressly set forth
in this Agreement, no Party shall be deemed to have defaulted under or breached
this Agreement for failure or delay in fulfilling or performing any term of this
Agreement when such failure or delay is caused by or results from causes beyond
the reasonable control of the affected Party, including, without limitation,
fire, floods, embargoes, shortages, epidemics, quarantines, war, acts of war,
acts of terrorism, insurrections, riots, civil commotion, strikes, lockouts or
other labor disturbances, acts of God or acts, omissions or delays in acting by
any Regulatory Authority ("Force Majeure Event"). The Party affected by any
Force Majeure Event shall promptly notify the other affected Parties, explaining
the nature, details and expected duration thereof. Such Party shall also notify
the other Parties from time to time as to when the affected Party reasonably
expects to resume performance in whole or in part of its obligations hereunder,
and notify the other Parties of the cessation of any such event. A Party
affected by a Force Majeure Event shall use commercially reasonable efforts to
remedy, remove or mitigate such event and the effects thereof with all
reasonable dispatch. If a Party anticipates that a Force Majeure Event may
occur, such Party shall notify the other Parties of the nature, details and
expected duration thereof. Upon termination of the Force Majeure Event, the
performance of any suspended obligation or duty shall promptly recommence.
[Remainder of page intentionally left blank.]
IN WITNESS WHEREOF, Millennium and GSK have caused this Agreement to be
duly executed by their authorized representatives as of the date indicated
above.
MILLENNIUM PHARMACEUTICALS, INC.
By: /S/XXXX XXXXX
--------------------------------------
Name: XXXX XXXXX
Title: CHIEF EXECUTIVE OFFICER
GLAXO GROUP LIMITED, d/b/a
GLAXOSMITHKLINE
By: /S/XXXXXXX XXXXXXXX
Name: XXXXXXX XXXXXXXX
Title: ASSISTANT SECRETARY
EXHIBIT A
COMPOUND DESCRIPTION
[**]
EXHIBIT B-1
SCHERING COLLABORATION AGREEMENT
[Filed separately as Exhibit 10.41 to Form10-Q as filed on 8/8/1995 and
amended by Exhibit 10.33 to Form 10-K filed on 3/25/1999; Exhibit 10.35 to
Form 10-K as filed 3/3/2000; Exhibit 10.1 to Form 10-Q filed 8/10/2000;
Exhibits 10.1 and 10.2 to Form 10-Q filed 11/08/2000 and Exhibits 10.8, 10.9
and 10.10 to the Form 10-K filed 3/10/2004.]
EXHIBIT B-2
SCHERING/MILLENNIUM EUROPEAN AGREEMENT
[Filed separately as Exhibit 10.2]
EXHIBIT C
ONGOING DEVELOPMENT ACTIVITIES IN THE TERRITORY
Protocol # Study Title Country
[**] [**] [**]
EXHIBIT D
PRODUCT TRADEMARKS
COUNTRY TRADEMARK 0.REG.DT EXPIRES AP OR REG #
------- --------- -------- ------- -----------
[**] [**] 21OC1998 [**] 3696
[**] [**] 11JL1996 [**] 165097
[**] [**] 21SE1999 [**] 990957
[**] [**] 12MY1998 [**] 8704
[**] [**] 22AU1995 [**] 583053
[**] [**] 24JA1997 [**] 29711
[**] [**] 09OC1997 [**] Z960308
[**] [**] 29JL1997 [**] 202278
[**] [**] 29SE1995 [**] 6470/95
[**] [**] 09MY1997 [**] 23575
[**] [**] 05MR1996 [**] 143327
[**] [**] 09AU1995 [**] 95584237
[**] [**] 09AU1995 [**] 2029753
[**] [**] 03SE1997 [**] 6620
[**] [**] 03SE1997 [**] 6621
[**] [**] 26AP1996 [**] 39533178
[**] [**] 19MR2001 [**] 125803
[**] [**] 26AU1998 [**] 153433
[**] [**] 28OC1997 [**] 1463/1997
[**] [**] 28AP1995 [**] 170852
[**] [**] 04DE1997 [**] 101797
[**] [**] 23JL1997 [**] 719702
[**] [**] 28FE2001 [**] 11272
[**] [**] 28AP1997 [**] 3903
[**] [**] 20FE1998 [**] M39710
[**] [**] 20FE1998 [**] M39709
[**] [**] 15DE1998 [**] 30491
[**] [**] 39486
[**] [**] 18AU1997 [**] 4938
[**] [**] 31OC1996 [**] 177708
[**] [**] 06OC1999 [**] 109031
[**] [**] 06MY1996 [**] 309676
[**] [**] 21MR1996 [**] 29239
[**] [**] 31OC1997 [**] 157963
[**] [**] 31OC1997 [**] 157964
[**] [**] 25AP1997 [**] 9670467
[**] [**] 21JA1999 [**] 184010
[**] [**] 03MR2000 [**] 1981878
[**] [**] 22MR1996 [**] 310560
[**] [**] 24FE1997 [**] 435605
[**] [**] 28OC1998 [**] 3330
[**] [**] 25DE2000 [**] 5754
[**] [**] 08FE1996 [**] 167597
[**] [**] 15AU2000 [**] 15588
[**] [**] 22JA1997 [**] 5876
EXHIBIT E
CERTAIN EXCEPTIONS TO REPRESENTATIONS
Exceptions [**]:
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EXHIBIT F
EXISTING THIRD PARTY AGREEMENTS
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EXHIBIT G
PRICING REFERENCE INFORMATION
[**] [**]
[**] [**] [**]
EXHIBIT H
TRANSITION ACTIVITIES AND PROCESSES
Under the Schering/Millennium European Agreement, Millennium has received the
following assurances set forth in writing from Schering, of activities which
Schering will perform to enable GSK to exercise the rights granted to GSK under
the Agreement. Capitalized terms used herein but not defined herein will have
the meaning set forth in the License Agreement.
1. CONTACT INFORMATION
1.1. Schering shall provide all necessary contact information to
enable GSK and Millennium to communicate with Schering to
facilitate the transfers described in this Agreement,
including, without limitation, a designated representative for
manufacturing and regulatory, and a designated representative
for each country in the Territory and for the Territory as a
whole; all such representatives shall have appropriate
knowledge and experience with the Licensed Product. Schering
will ensure that these representatives provide GSK with all
reasonable assistance they may need to accomplish the
transfers to GSK described in the License Agreement including
the performance of all obligations below.
2. TRANSFER OF REGULATORY APPROVALS
2.1. Schering, in coordination with, and with the cooperation of
GSK, will use commercially reasonable efforts to complete the
Transfer of the Central Marketing Authorization in the
Territory for the Licensed Product to GSK, including, without
limitation, [**].
2.2. During the CMA Transfer Period, Schering and GSK will jointly
participate in discussions and meetings with EMEA (and any
other relevant regulatory authorities in the Territory) to
gain any agreements necessary for the Transfer to GSK of the
Central Marketing Authorization for the Licensed Product. GSK
will [**], provided that [**].
2.3. GSK will have the right to cross-reference any applicable drug
master file for the active pharmaceutical ingredient in the
Licensed Product in each country in the Territory, as
necessary, in the format required by the applicable Regulatory
Authority.
2.4. During the CMA Transfer Period, Schering (while this
responsibility has not been transferred to Millennium) shall
continue to fulfill its obligations with respect to the
maintenance of the Global AE Database and the exchange and
reporting of product quality complaints, adverse events and
product safety data related to the Licensed Product in the
Territory.
2.5. Upon the Effective Date, Schering or Millennium shall grant
to GSK the right to use Copyrights controlled by Schering on
a royalty-free, fully paid up, non-exclusive basis to permit
GSK to carry out pre-transfer activities including the right
to use, display, distribute, and have distributed promotional
materials, educational materials, product labelling, product
inserts and product packaging (the "Marketing Materials")
used by Schering in Commercializing the Licensed Product in
the Territory, in accordance with the terms of the Agreement.
For purposes of clarity, GSK acknowledges that the copyright
license granted under this Section 2.5 includes all necessary
rights to use any of Schering's or its Affiliate's corporate
logos or trademarks only to the extent the Marketing
Materials may display such logos or trademarks, and no other
license to use such logos or trademarks is granted.
2.6. Upon the Effective Date, Millennium shall grant GSK and its
Affiliates Millennium's Product Trademarks on a royalty-free,
fully paid-up, license under Millennium's Product Trademarks
on a (a) non-exclusive basis with respect to Development, (b)
exclusive basis with respect to Commercialization, and/or (c)
non-exclusive basis with respect to Secondary Packaging, in
each case during the Term in the Territory, and solely for
display, advertising or information purposes in connection
with such Development, Commercialization, and the conduct of
Secondary Packaging of the Licensed Product for the Territory,
in accordance with the Agreement.
3. SCHERING'S ACTIVITIES [**]:
3.1. Schering shall appoint GSK as exclusive co-promoter of the
Licensed Product in the Territory. As set forth in Section
5.2(b) of the Agreement, GSK will consult with Schering and
Millennium [**] with respect to [**] related to the Licensed
Product [**]. All such GSK co-promotion activities shall
effectively be carried out by GSK and not by Schering.
3.2. Upon the Effective Date, Schering will provide GSK, on Exhibit
J of the Agreement, with accurate and complete information on
[**] the Licensed Product in any country in the Territory in
which the Licensed Product is Commercialized.
3.3. During the CMA Transfer Period, Schering shall use
commercially reasonable efforts in the relevant country in the
Territory to [**] the Licensed Product for such country [**].
3.4. During the CMA Transfer Period, Schering will maintain all
[**] for the Licensed Product in the Territory [**] During the
CMA Transfer Period, Schering will undertake to [**] of the
Licensed Product, [**] for the Licensed Product for such
country in the Territory.
3.5. Schering or Millennium shall transfer to GSK copies of all
documents and records that are in Schering's control that [**]
transfer [**] to GSK.
3.6. Schering shall in good faith provide GSK with the following
information in Schering's control that is [**] the Licensed
Product in those countries in the Territory where the Licensed
Product has as of the Effective Date, been developed, is
approved for sale and is Commercialized by Schering [**]:
(i) all governmental or regulatory correspondence (with all
attachments) in Schering's control, including all labelling
and CMC variations and assessment reports, conversation logs,
filings and approvals (including all Regulatory Approvals, all
withdrawals or rejections of applications for Regulatory
Approvals and all pricing and reimbursement approvals)
concerning the Development, Manufacture and/or
Commercialization of the Licensed Product in the Territory;
(ii) reports (including all pre-clinical and clinical data
concerning the Licensed Product) in Schering's control which
are contained in the health registration dossiers for, or
otherwise used in support of, the Regulatory Approvals for the
Licensed Product in the Territory;
(iii) with regard to each country within the Territory where the
Licensed Product is currently Commercialized by Schering,
electronic and paper copies in all official languages of such
country of product labeling, product packaging and product
inserts currently used by Schering in Commercialising the
Licensed Product in such country;
(iv) [**] pharmaceutical products, including [**] to the extent
permitted by contract or applicable Law; and
(v) information related to the marketing of the Licensed Product
in the Key Countries (as defined below) in Schering's
possession, including, the most recent marketing plan for the
Licensed Product, sales force training materials, sales force
alignment and sizing information, sales data related to the
launch of the Licensed Product, sales operations plans for
such countries, and copies of all current marketing and
promotional materials, as well as educational materials used
by Schering in connection with the Licensed Product in such
year preceding the Effective Date.
For purposes of clarity, upon GSK's achievement of [**] Dollars (USD
$[**]) [**] of the Licensed Product in the Territory, [**] of the Agreement,
[**].
3.7. Schering shall in good faith provide GSK with the following
information in Schering's control that is reasonably necessary to
enable GSK to Develop and Commercialize the Licensed Product in those
countries in the Territory where the Licensed Product has as of the
Effective Date, been developed, is approved for sale and is
Commercialized by Schering [**]: including
(i) the Marketing Authorization Application, International Regulatory
file, if any, and the health registration dossier for, or otherwise
used in support of, the Central Marketing Authorization, if any;
(ii) [**] the Licensed Product in the Territory, [**]; and
(iii) [**] the Licensed Product [**] the Licensed Product [**].
4. SCHERING'S ACTIVITIES [**]:
4.1. Prior to the date on which Central Marketing Authorization is
transferred to GSK and subject to Section 5.2 of the Agreement,
Schering shall provide notification to all customers in the Territory
that GSK is assuming Commercialisation of the Licensed Product. The
notification [**].
4.2. On a country-by-country basis, following the Transition Period,
Schering will terminate Commercialization of the Licensed Product in
such country.
4.3. In accordance with the Agreement, following the Effective Date,
Schering and Millennium shall arrange for the timely and orderly
transfer to GSK of all responsibility for the continued performance of
the Ongoing Development Activities in Europe, provided that GSK shall
[**] and in the event that GSK [**] for purposes [**] of the
Agreement.
EXHIBIT I
BIT C
MILLENNIUM PATENT RIGHTS
INTEGRILIN PATENT PORTFOLIO-FIRST FAMILY [**]
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Millennium Title Application No. Patent No. Filing Expiration Date
Docket Number Date/Issue
Date
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PATENT TERM EXTENSION INFORMATION FOR FIRST FAMILY [**]
------------------------------------------- -------------------------- ---------
Millennium Docket Title SPC Application SPC No. Filing Expiration
Number/Country No. Date/Grant Date
Date
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PATENT TERM EXTENSION INFORMATION FOR FIRST FAMILY [**] (CONT'D)
-------------------------------------------------------------------------------
Millennium Docket Title SPC Application SPC No. Filing Expiration
Number/Country No. Date/Grant Date
Date
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INTEGRILIN PATENT PORTFOLIO-SECOND FAMILY [**]
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Millennium Docket Title Application Patent No. Filing Date/ Expiration
Number/Country No. Issue Date Date
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PATENT TERM EXTENSION INFORMATION FOR SECOND FAMILY [**]
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Millennium Docket Title SPC SPC No. Filing Expiration
Number/Country Application Date/Grant Date
No. Date
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EXHIBIT J
INTEGRILIN SALES INFORMATION
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TERRITORY SCHERING
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