EXHIBIT 10.4
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CONFIDENTIAL MATERIALS OMITTED AND FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
COLLABORATION AND LICENSE AGREEMENT
BY AND AMONG
MOMENTA PHARMACEUTICALS, INC.
AND
BIOCHEMIE WEST INDIES, N.V.
AND
GENEVA PHARMACEUTICALS, INC.
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NOVEMBER 1, 2003
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TABLE OF CONTENTS
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1. DEFINITIONS.................................................................1
1.1. "Additional Costs Amount"...........................................1
1.2. "Affiliate".........................................................1
1.3. "ANDA"..............................................................2
1.4. "ANDA Final Approval"...............................................2
1.5. "Annual Collaboration Plan".........................................2
1.6. "Aventis"...........................................................2
1.7. "Aventis [**]"......................................................2
1.8. "Business Day"......................................................2
1.9. "Capped Costs"......................................................2
1.10. "cGMP"..............................................................3
1.11. "Characterize"......................................................3
1.12. "Collaboration Know-How"............................................3
1.13. "Collaborative Program".............................................3
1.14. "Commercial Third Party"............................................3
1.15. "Commercialization," "Commercialize" or "Commercializing"...........3
1.16. "Commercialization Costs"...........................................3
1.17. "Commercially Reasonable Efforts"...................................3
1.18. "Confidential Information"..........................................4
1.19. "Contract Year".....................................................4
1.20. "Control" or "Controlled"...........................................4
1.21. "Develop" or "Development"..........................................4
1.22. "Development Costs".................................................5
1.23. "District Court Legal Clearance"....................................5
1.24. "Excess Costs"......................................................5
1.25. "Executive Officers"................................................5
1.26. "FDA"...............................................................6
1.27. "Field".............................................................6
1.28. "Final Legal Clearance".............................................6
1.29. "First Commercial Sale".............................................6
1.30. "Fragmin Opportunity"...............................................6
1.31. "FTE"...............................................................6
1.32. "FTE Rate"..........................................................6
1.33. "Improved Enoxaparin"...............................................6
1.34. "Improvement".......................................................6
1.35. "Joint Collaboration IP"............................................7
1.36. "Joint Collaboration Know-How"......................................7
1.37. "Joint Collaboration Patent Rights".................................7
1.38. "Joint Product-Specific Know-How"...................................7
1.39. "Joint Product-Specific Patent Rights"..............................7
1.40. "Know-How"..........................................................7
1.41. "Label".............................................................7
1.42. "Legal Activities"..................................................7
1.43. "Legal Clearance"...................................................7
1.44. "Legal Clearance Costs".............................................8
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1.45. "Legal Expenses"....................................................8
1.46. "Locked Manufacturing Process"......................................8
1.47. "Lovenox(R)-Equivalent Product".....................................8
1.48. "Manufacturing Costs"...............................................8
1.49. "Marketing Approval"................................................9
1.50. "M118 Opportunity"..................................................9
1.51. "MIT"...............................................................9
1.52. "MIT Agreement".....................................................9
1.53. "Momenta Collaboration Know-How"....................................9
1.54. "Momenta Collaboration Patent Rights"...............................9
1.55. "Momenta Indemnified Parties".......................................9
1.56. "Momenta IP"........................................................9
1.57. "Momenta Know-How"..................................................9
1.58. "Momenta Patent Rights"............................................10
1.59. "Momenta Product-Specific Know-How"................................10
1.60. "Momenta Product-Specific Patent Rights"...........................10
1.61. "Net Sales"........................................................10
1.62. "Non-Injectable or Improved Enoxaparin Opportunity"................11
1.63. "Non-Owning Party".................................................11
1.64. "Non-U.S. Territory"...............................................11
1.65. "Owning Party".....................................................11
1.66. "Owning Party's IP"................................................11
1.67. "Party"............................................................11
1.68. "Patent Litigation"................................................11
1.69. "Patent Right".....................................................12
1.70. "Person"...........................................................12
1.71. "Post-Launch Quarter"..............................................12
1.72. "Post-Launch Year".................................................12
1.73. "Pre Final Legal Clearance Launch".................................12
1.74. "Product"..........................................................12
1.75. "Product Liability Costs"..........................................12
1.76. "Product-Specific Patent Activities"...............................12
1.77. "Product-Specific Patent Costs"....................................12
1.78. "Product-Specific Patent Rights"...................................13
1.79. "Profits"..........................................................13
1.80. "Project Leader"...................................................13
1.81. "Quarter"..........................................................13
1.82. "Regulatory Authority".............................................13
1.83. "Sandoz Collaboration Know-How"....................................13
1.84. "Sandoz Collaboration Patent Rights"...............................13
1.85. "Sandoz Indemnified Parties".......................................13
1.86. "Sandoz IP"........................................................13
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1.87. "Sandoz Know-How"..................................................14
1.88. "Sandoz Patent Rights".............................................14
1.89. "Sandoz Product-Specific Know-How".................................14
1.90. "Sandoz Product-Specific Patent Rights"............................14
1.91. "Selling Expenses".................................................14
1.92. "Settlement".......................................................14
1.93. "Settlement Costs".................................................14
1.94. "Stability Studies"................................................14
1.95. "Supply Chain".....................................................14
1.96. "Third Party"......................................................15
1.97. "Third-Party Competitor"...........................................15
1.98. "Third Party Royalties"............................................15
1.99. "U.S. Launch"......................................................15
1.100. "U.S. Territory"...................................................15
1.101. Other Defined Terms................................................15
2. GRANT OF RIGHTS............................................................18
2.1. Momenta License Grants.............................................18
2.2. Sandoz Parties License Grants......................................18
2.3. Exclusivity........................................................18
2.4. Retained Rights....................................................19
2.5. Third Party Licensor Rights........................................19
3. ADDITIONAL RIGHTS..........................................................19
3.1. Fragmin Opportunity; Right of First Negotiation....................19
3.2. M118 Opportunity; Right of First Negotiation.......................20
3.3. Non-Injectable or Improved Enoxaparin Opportunities................21
3.4. Non-U.S. Territory Option..........................................23
3.5. Equity Investment..................................................26
3.6. Sandoz Affiliates..................................................26
4. FINANCIAL PAYMENTS.........................................................27
4.1. Capped Costs.......................................................27
4.2. FTE Funding........................................................27
4.3. Excess Costs.......................................................27
4.4. Commercialization Costs............................................28
4.5. U.S. Profit Interest...............................................28
4.6. U.S. Post-[**] Royalty.............................................28
4.7. U.S. [**] Royalty..................................................28
4.8. Aventis [**].......................................................29
4.9. Allocation Between Periods.........................................29
4.10. Milestone Payments.................................................29
4.11. Payment/Accounting.................................................31
4.12. True-Up............................................................32
5. JOINT DEVELOPMENT AND COMMERCIALIZATION....................................33
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5.1. Joint Collaboration................................................33
5.2. Joint Project Team.................................................33
5.3. JPT Responsibilities...............................................33
5.4. Joint Steering Committee...........................................33
5.5. JSC Administration.................................................34
5.6. JSC Meetings.......................................................34
5.7. JSC Responsibilities...............................................34
5.8. Annual Collaboration Plan..........................................35
5.9. Compliance with Laws...............................................35
5.10. Legal Clearance....................................................36
6. COMMERCIALIZATION BY SANDOZ................................................36
6.1. Review and Oversight...............................................36
6.2. Pre Final Legal Clearance Launch...................................36
7. REGULATORY MATTERS.........................................................36
7.1. Review and Oversight...............................................36
7.2. ANDA Filing........................................................36
7.3. Ownership Of The ANDAs.............................................37
7.4. ANDA Responsibility................................................37
7.5. Regulatory Interaction.............................................37
8. INTELLECTUAL PROPERTY......................................................37
8.1. Ownership..........................................................37
8.2. Patent Prosecution.................................................38
8.3. Participation of other Persons.....................................39
8.4. Enforcement of Non-Product-Specific Patent Rights..................40
8.5. Claimed Infringement...............................................42
8.6. Patent Invalidity Claim............................................42
8.7. Joint Collaboration IP and Product-Specific Patent Rights..........42
8.8. Obligations to Licensors...........................................43
8.9. Patent Marking.....................................................43
9. WARRANTIES.................................................................43
9.1. Representations and Warranties of the Parties......................43
9.2. Momenta Representations............................................45
9.3. Sandoz Parties Representations.....................................45
9.4. Covenant...........................................................45
9.5. No Reliance by Third Parties.......................................45
9.6. No Other Warranties................................................45
10. CONFIDENTIALITY............................................................45
10.1. Prior Confidentiality Agreement....................................45
10.2. Confidential Information...........................................46
10.3. Nondisclosure of Confidential Information..........................46
10.4. Exceptions.........................................................46
10.5. Identification.....................................................47
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10.6. Equitable Relief...................................................48
10.7. Survival...........................................................48
11. TERM & TERMINATION.........................................................48
11.1. Term...............................................................48
11.2. Termination For Cause..............................................48
11.3. Termination Due to Lack of Commercial Viability....................49
11.4. Sandoz Milestone Termination.......................................49
11.5. Excessive Cost Termination.........................................50
11.6. Effects of Termination.............................................51
11.7. Bankruptcy.........................................................54
11.8. Survival...........................................................55
11.9. Non-Exclusive Remedy...............................................55
12. INDEMNIFICATION............................................................55
12.1. Sandoz Indemnification of Momenta..................................55
12.2. Momenta Indemnification of Sandoz..................................56
12.3. Procedure..........................................................56
12.4. Insurance..........................................................57
13. DISPUTE RESOLUTION.........................................................57
13.1. First Level Resolution.............................................57
13.2. Negotiation Between Executives.....................................58
13.3. Legal Remedies.....................................................58
14. ADDITIONAL PROVISIONS......................................................58
14.1. Entire Agreement...................................................58
14.2. Amendments and Waiver..............................................58
14.3. Assignment.........................................................59
14.4. Nature of Relationship.............................................59
14.5. Notices............................................................59
14.6. Governing Law......................................................60
14.7. Jury Waiver........................................................60
14.8. Counterparts; Facsimile Signature..................................60
14.9. Severability.......................................................60
14.10. Expenses...........................................................61
14.11. Further Actions and Documents......................................61
14.12. Use of Trade Names and Trademarks..................................61
14.13. Affiliates.........................................................61
14.14. Exports............................................................61
14.15. Force Majeure......................................................61
14.16. Non-Use of MIT Name................................................62
14.17. Headings...........................................................62
14.18. Key Person Life Insurance..........................................62
14.19. No Consequential Damages...........................................62
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Schedule 1.22 - Pre-Existing Costs 65
Schedule 1.48 - Calculation of Manufacturing Costs 66
Schedule 1.58 - Current Momenta Patent Rights 67
Schedule 4.3 - Adjustment Schedule 74
Schedule 5.8 - Annual Collaboration Plan: Preliminary List of Activities
and Assignment of lead responsibility to Party(ies) 83
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PRIVILEGED AND CONFIDENTIAL
COLLABORATION AND LICENSE AGREEMENT
This
Collaboration and License Agreement ("AGREEMENT") is entered into
as of this 1st day of November, 2003 ("EFFECTIVE DATE"), by and between Momenta
Pharmaceuticals, Inc., a Delaware corporation ("MOMENTA") with a principal place
of business at 00 Xxxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx, XXX 00000, Biochemie
West Indies, N.V., a Netherlands Antilles corporation ("BCWI") with a principal
place of business at Xxxxxxxxxx 0X, Xxxxxxxxxx, Xxxxxxx, Xxxxxxxxxxx Antilles,
and Geneva Pharmaceuticals, Inc., a Colorado corporation ("SANDOZ") with a
principal place of business at 000 Xxxxxxxx Xxxxxx, Xxxxx 000, Xxxxxxxxx, Xxx
Xxxxxx XXX 00000 (Sandoz, collectively with BCWI, are the "SANDOZ PARTIES", and
individually, each is a "SANDOZ PARTY").
RECITALS
WHEREAS, Momenta is a biotechnology company with specific expertise in
enoxaparin and the science of complex sugars, polysaccharides, their structures,
their sequencing, and their characterization;
WHEREAS, Momenta is the owner and/or licensee of the Momenta Patent
Rights and Momenta Know-How, each as defined hereinafter;
WHEREAS, Sandoz has substantial knowledge and expertise in the research,
development, manufacture and sale of pharmaceuticals;
WHEREAS, the Sandoz Parties are the owners and/or licensees of the
Sandoz Patent Rights and Sandoz Know-How, each as defined hereinafter;
WHEREAS, the Sandoz Parties wish to collaborate with Momenta to develop
and commercialize the Product, as defined hereinafter, using the Momenta Patent
Rights and Momenta Know-How under the terms and conditions specified herein.
NOW, THEREFORE, in consideration of the mutual promises and covenants
set forth, the Parties agree as follows:
1. DEFINITIONS
When used in this Agreement, each of the following terms shall have the
meanings set forth in this Article 1:
1.1. "ADDITIONAL COSTS AMOUNT". Additional Costs Amount means,
initially, Three Million Dollars (U.S.$3,000,000), as may be increased
pursuant to Section 11.5.2.
1.2. "AFFILIATE". Affiliate means any corporation, company,
partnership, joint venture and/or firm that controls, is controlled by, or is
under common control with a Person. For purposes of this Section 1.2, "CONTROL"
shall mean (a) in the case of corporate entities, direct or
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indirect ownership of at least fifty percent (50%) of the stock or shares having
the right to vote for the election of directors, and (b) in the case of
non-corporate entities, direct or indirect ownership of at least fifty percent
(50%) of the equity interest with the power to direct the management and
policies of such non-corporate entities. The Parties acknowledge that in the
case of certain entities organized under the laws of certain countries outside
the United States, the maximum percentage ownership permitted by law for a
foreign investor may be less than fifty percent (50%), and that in such case
such lower percentage shall be substituted in the preceding sentence, PROVIDED
THAT such foreign investor has the power to direct the management and policies
of such entity.
1.3. "ANDA". ANDA means any of the following: (a) an Abbreviated New
Drug Application filed with the FDA or any successor applications or procedures
seeking authorization and approval to manufacture, package, ship, and sell a
product in the U.S. Territory; (b) any other regulatory filing in the U.S.
Territory as mutually agreed by the Parties in the Collaborative Program,
including without limitation filings that are similar to filings under clause
(a), such as an NDA, supplemental NDA or an application pursuant to Section
505(b)(2) of the Federal Food, Drug, and Cosmetic Act (the "FD&C ACT"); and (c)
all supplements and amendments that may be filed with respect to the foregoing.
1.4. "ANDA FINAL APPROVAL". ANDA Final Approval means the granting by
the FDA of final Marketing Approval to Sandoz or any of its Affiliates for an
ANDA for a Lovenox(R)-Equivalent Product.
1.5. "ANNUAL COLLABORATION PLAN". Annual Collaboration Plan means the
Development, Commercialization and Legal Activities plan for the Collaborative
Program to be developed by the Joint Project Team and approved by the Joint
Steering Committee for each Contract Year.
1.6. "AVENTIS". Aventis means (a) Aventis Pharmaceuticals Inc., (b)
its Affiliates, (c) the licensees and distributors of Aventis Pharmaceuticals
Inc. or its Affiliates for a Lovenox(R)-Equivalent Product (the Persons
described in Sections 1.6(a), (b) and (c), collectively, the "AVENTIS PERSONS"),
and (d) the successors and assigns of any Aventis Persons with respect to any
rights to any Lovenox(R)-Equivalent Product.
1.7. "AVENTIS [**]". Aventis [**] means [**] Dollars (U.S.$[**]);
PROVIDED, HOWEVER, THAT, if the Aventis [**] begins on a day after the first day
of a Post-Launch Year, the Aventis [**] for the remainder of such Post-Launch
Year shall equal the product of (a) the number of days between (and including)
the date of such termination of the [**] until the end of such Post-Launch Year,
multiplied by (b) the quotient of (i) U.S.$[**] divided by (ii) 365.
1.8. "BUSINESS DAY". Business Day means any day that is not a
Saturday, Sunday or other day on which commercial banks located in the State of
New York are authorized or required to be closed.
1.9. "CAPPED COSTS". Capped Costs means collectively Development
Costs and Legal Expenses.
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1.10. "cGMP". cGMP means current good manufacturing practices as set
forth in Title 21, Parts 210 and 211 of the CFR, as established by FDA.
1.11. "CHARACTERIZE". Characterize and Characterization, with respect
to the Product, means chemical and physical characterization of the Product and
Lovenox(R) with sufficient specificity, and documentation thereof as is
necessary to establish to the satisfaction of the FDA that the active ingredient
of the Product is the same as that of Lovenox(R), as required by 21 U.S.C.
Section 355(j)(2)(A)(ii)(I).
1.12. "COLLABORATION KNOW-HOW". Collaboration Know-How means Sandoz
Collaboration Know-How, Joint Collaboration Know-How and Momenta Collaboration
Know-How.
1.13. "COLLABORATIVE PROGRAM". Collaborative Program means the joint
initiative to be undertaken by the Parties to Develop and Commercialize, and
conduct Legal Activities with respect to, the Product in the U.S. Territory
within the Field as described in Articles 5, 6 and 7 and in the Annual
Collaboration Plans.
1.14. "COMMERCIAL THIRD PARTY". Commercial Third Party means a Third
Party that is not (a) an academic or non-profit research institution or (b) a
hospital; PROVIDED THAT, should any such entity market or manufacture
pharmaceutical products, such entity shall be considered a Commercial Third
Party.
1.15. "COMMERCIALIZATION," "COMMERCIALIZE" or "COMMERCIALIZING".
Commercialization, Commercialize or Commercializing means any and all activities
directed to commercial manufacturing (including, without limitation, the
manufacture of commercial supply for distribution in the U.S. Territory and the
manufacture of commercial inventory), marketing, promoting, distributing,
importing and/or selling the Product. "COMMERCIALIZATION," "COMMERCIALIZE" or
"COMMERCIALIZING" does not include Development or Legal Activities.
1.16. "COMMERCIALIZATION COSTS". Commercialization Costs means all
costs incurred by the Sandoz Parties, Momenta or their Affiliates in connection
with Commercializing the Product for sale in the U.S. Territory pursuant to this
Agreement, including any capital investment with respect thereto.
Commercialization Costs do not include (a) [**] pursuant to the [**] (which
shall be the sole responsibility of Momenta), (b) [**], (c) [**], (d) [**] or
(e) [**].
1.17. "COMMERCIALLY REASONABLE EFFORTS". Commercially Reasonable
Efforts shall mean, with respect to the efforts to be expended by a Party with
respect to any objective, reasonable, diligent, good faith efforts to accomplish
such objective as such Party would normally use to accomplish a similar
objective under similar circumstances exercising reasonable business judgment,
it being understood and agreed that, with respect to the Development or
Commercialization of the Product or Legal Activities, such efforts shall be
substantially equivalent to those efforts and resources commonly used by such
Party for a product owned by it or to which it has rights, which product is at a
similar stage in its development or product life and is of similar market
potential, taking into account efficacy, safety, approved labeling, the
competitiveness of alternative products in the marketplace, the
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patent and other proprietary position of the Product, the likelihood of
regulatory approval given the regulatory structure involved, the profitability
of the Product, alternative products and other relevant factors commonly
considered in similar circumstances. It is anticipated that the level of effort
will change over time, reflecting changes in the status of the Product.
1.18. "CONFIDENTIAL INFORMATION". Confidential Information means all
Know-How or other confidential or proprietary information and materials (whether
or not patentable) regarding a Party's technology, products or business, which
is designated as confidential in writing by the disclosing Party, whether by
letter or by the use of an appropriate stamp or legend, prior to or at the time
any such Know-How or other information or material is disclosed by the
disclosing Party to the other Party. Notwithstanding the foregoing to the
contrary, Know-How or other information or material that is orally or visually
disclosed by a Party, or is disclosed in writing without an appropriate letter,
stamp or legend, shall constitute Confidential Information of a Party (a) for
thirty (30) days after its disclosure and thereafter shall remain Confidential
Information if within such 30-day period after such disclosure the disclosing
Party delivers to the other Party a written document or documents describing the
Know-How or other information or material and referencing the place and date of
such oral, visual or written disclosure and the names of the persons to whom
such disclosure was made or (b) such information is of the type that is
customarily considered to be confidential information by persons engaged in
activities that are substantially similar to the activities being engaged in by
the Parties pursuant to this Agreement. "CONFIDENTIAL INFORMATION" shall not
include information: (i) which is or becomes generally available to the public
other than as a result of disclosure thereof by the Receiving Party; (ii) which
is lawfully received by the Receiving Party on a non-confidential basis from a
Third Party that is not itself under any obligation of confidentiality or
nondisclosure to the Disclosing Party or any other Person with respect to such
information; (iii) which is already known to the Receiving Party at the time of
disclosure by the Disclosing Party, or (iv) which can be shown by the Receiving
Party to have been independently developed by the Receiving Party without
reference to the Disclosing Party's Confidential Information.
1.19. "CONTRACT YEAR". Contract Year means the period beginning on the
Effective Date and ending on December 31, 2003 (the "FIRST CONTRACT YEAR"), or
each succeeding twelve (12) month calendar year period thereafter during the
term of the Agreement (referred to as the "SECOND CONTRACT YEAR", "THIRD
CONTRACT YEAR", etc.).
1.20. "CONTROL" or "CONTROLLED". Control or Controlled means with
respect to any item of Know-How or any intellectual property right, the
possession, whether by ownership or license (other than pursuant to this
Agreement), by a Party (and, in the case of Momenta, any of its Affiliates) of
the ability to grant to the other Party access and/or a license as provided
herein under such item or right without violating the terms of any agreement or
arrangement with any Third Party existing before or after the Effective Date.
1.21. "DEVELOP" or "DEVELOPMENT". Develop or Development means, with
respect to the Product: (a) Characterization of the Product; (b) all activities
associated with the filing of an ANDA for the Product as provided for in this
Agreement, including, without limitation, preclinical and clinical
drug-development activities, such as, but not limited to, toxicology,
preclinical and clinical studies; (c) formulation, process development and
commercial scale-up
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(to the commercial batch size agreed upon in the Annual Collaboration Plans
which shall be a batch size that is commercially reasonable given expected
production) activities (including test-method development); (d) development of
quality assurance/quality control procedures; (e) with respect to the drug
substance for the Product, commercial scale validation and commercial scale
stability studies; (f) with respect to the drug product form of the Product,
commercial scale process validation, commercial scale stability studies,
packaging, tooling, package design, packaging validation and labeling
preparation; (g) statistical analysis; (h) regulatory affairs (including legal
activities with respect thereto); and (i) Product approval and registration
activities. "DEVELOP" or "DEVELOPMENT" does not include Commercialization or
Legal Activities.
1.22. "DEVELOPMENT COSTS". Development Costs means (a) all costs paid
by Sandoz, BCWI or Momenta to Third Parties after the Effective Date in
connection with the Development of the Product with respect to the U.S.
Territory which are incurred in accordance with the Annual Collaboration Plan,
including, without limitation, contractors and licensors in connection with the
Development of the Product; (b) those costs incurred by Momenta prior to the
Effective Date which are listed on SCHEDULE 1.22 (the "PRE-EXISTING COSTS"); and
(c) the costs, calculated pursuant to the definition of Manufacturing Costs, to
manufacture any commercial batch(es) of the Product prior to the first batch
which is usable as commercial inventory, and (d) any payments for Additional
FTEs. Development Costs do not include: (i) [**] for the [**]; (ii) [**] Costs;
(iii) [**] the Product; (iv) [**] the Product other than as indicated in clause
(c) above; (v) [**] pursuant to the [**]; (vi) [**] Costs; (vii) [**] Expenses;
or (viii) [**] Costs.
1.23. "DISTRICT COURT LEGAL CLEARANCE". District Court Legal Clearance
means, with respect to the U.S. Territory, in the event that Orange Book
Litigation occurs prior to the granting of ANDA Final Approval for an ANDA filed
by Sandoz or any of its Affiliates for the Product, the earlier of (a) a
determination, including a summary judgment, from a federal district court (a
"DISTRICT COURT") in the Orange Book Litigation (a "DISTRICT COURT DECISION")
that marketing the Product by or on behalf of Sandoz does not infringe Aventis'
Patent Rights, or (b) a determination, from a federal district court, in a
patent infringement suit between Aventis and a Third Party, which would permit
the marketing of the Product by or on behalf of Sandoz without infringing
Aventis' Patent Rights (i) because such Patent Rights have been declared invalid
or unenforceable or (ii) if such Patent Rights have not been declared invalid or
unenforceable, in Sandoz's reasonable judgment.
1.24. "EXCESS COSTS". Excess Costs means the sum of (a) the amount by
which [**], (b) any [**] Costs, and (c) any [**] Costs (notwithstanding any [**]
with respect to [**]).
1.25. "EXECUTIVE OFFICERS". Executive Officers mean (a) the Chief
Executive Officer, Chief Financial Officer or Vice President of Business
Development of Sandoz (or an officer of Sandoz designated by any of the
foregoing officers) (the relevant officer, the "SANDOZ EXECUTIVE OFFICER"), (b)
the Head Caribic of BCWI (or an officer of BCWI designated by such person) (the
relevant officer, the "BCWI EXECUTIVE OFFICER"), and (c) the Chief Executive
Officer of Momenta (or an executive officer of Momenta designated by such
officer) (the relevant officer, the "MOMENTA EXECUTIVE OFFICER").
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1.26. "FDA". FDA means the United States Food and Drug Administration,
or any successor agency thereto.
1.27. "FIELD". Field means the injectable administration of the
Product for any and all medical indications.
1.28. "FINAL LEGAL CLEARANCE". Final Legal Clearance means, with
respect to the U.S. Territory, (a) the absence of Patent Litigation pursuant to
21 U.S.C. 355(c)(3)(C) or 355(j)(5)(B) with respect to the patents listed in the
Orange Book for Lovenox(R) ("ORANGE BOOK LITIGATION") prior to the granting of
ANDA Final Approval for an ANDA filed by Sandoz or any of its Affiliates for the
Product, or (b) in the event that Orange Book Litigation occurs prior to the
granting of ANDA Final Approval for an ANDA filed by Sandoz or any of its
Affiliates for the Product, the earliest of: (i) receipt by Sandoz or any of its
Affiliates of a final, unappealable judgment that determines that marketing of
the Product by or on behalf of Sandoz does not infringe Aventis' Patent Rights;
or (ii) receipt by a Third Party of a final, unappealable judgment in a patent
infringement suit between Aventis and such Third Party, which would permit the
marketing of the Product by or on behalf of Sandoz without infringing Aventis'
Patent Rights either (x) because such Patent Rights have been declared invalid
or unenforceable, or (y) if such Patent Rights have not been declared invalid or
unenforceable (in Sandoz's reasonable judgment); or (iii) a Settlement.
1.29. "FIRST COMMERCIAL SALE". First Commercial Sale means the first
commercial sale of the Product in the U.S. Territory as part of a nationwide
introduction by Sandoz, its Affiliates and/or distributors. Sales for test
marketing, clinical trial purposes or compassionate or similar use shall not
give rise to a First Commercial Sale.
1.30. "FRAGMIN OPPORTUNITY". Fragmin Opportunity means the research,
development, manufacturing or commercialization of dalteparin as a generic
version of Fragmin.
1.31. "FTE". FTE means a full time equivalent person year (consisting
of a total of [**] hours per year) of scientific, technical or managerial work
on or directly related to the Collaborative Program.
1.32. "FTE RATE". FTE Rate means U.S.$[**] per FTE.
1.33. "IMPROVED ENOXAPARIN". Improved Enoxaparin means any improved
form of enoxaparin which meets the specifications for [**] as of the Effective
Date and for which approval by the FDA would require the filing of a New Drug
Application under Section [**] of the FD&C Act ([**]).
1.34. "IMPROVEMENT". Improvement means any enhancement to Sandoz
Know-How, Momenta Know-How, Sandoz Collaboration Know-How or Momenta
Collaboration Know-How, as the case may be, based on and arising from exposure
to such Know-How and made during the conduct of the Collaborative Program,
including enhancements made to such Improvements made during the conduct of the
Collaborative Program.
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1.35. "JOINT COLLABORATION IP". Joint Collaboration IP means Joint
Collaboration Know-How and Joint Collaboration Patent Rights.
1.36. "JOINT COLLABORATION KNOW-HOW". Joint Collaboration Know-How
means all Know-How constituting, based upon or derived from inventions or
developments which are conceived and reduced to practice or developed jointly by
Sandoz or its Affiliates, on the one hand, and Momenta or its Affiliates, on the
other hand, during and in the conduct of the Collaborative Program, excluding
those Improvements to Sandoz Know-How, Improvements to Sandoz Collaboration
Know-How, Improvements to Momenta Know-How or Improvements to Momenta
Collaboration Know-How which are made jointly by Sandoz or its Affiliates, on
the one hand, and Momenta or its Affiliates, on the other hand.
1.37. "JOINT COLLABORATION PATENT RIGHTS". Joint Collaboration Patent
Rights means all Patent Rights throughout the world covering the Joint
Collaboration Know-How.
1.38. "JOINT PRODUCT-SPECIFIC KNOW-HOW". Joint Product-Specific
Know-How means all Joint Collaboration Know-How which solely relates to the
Product and does not relate, or cannot be used with, any other product or for
any other general purpose.
1.39. "JOINT PRODUCT-SPECIFIC PATENT RIGHTS". Joint Product-Specific
Patent Rights means all Patent Rights throughout the world covering Joint
Product-Specific Know-How.
1.40. "KNOW-HOW". Know-How means any information and material that is
confidential and proprietary, including, without limitation, ideas, concepts,
discoveries, inventions, developments, improvements, know-how, trade secrets,
designs, devices, equipment, process conditions, algorithms, notation systems,
works of authorship, computer programs, technologies, formulas, techniques,
methods, procedures, assay systems, applications, data, documentation, reports,
sugars, polysaccharides, heparinases, enzymes, reagents, glycoproteins,
proteins, peptides, glycoconjugates, primers, plasmids, vectors, expression
systems, cells, cell lines, antibodies, organisms, chemical compounds, products
and formulations, whether patentable or otherwise. Know-How shall also include
non-confidential information and material to the extent such information and
material first lost its confidentiality by virtue of its disclosure in an issued
patent or published patent application, a filing with a Regulatory Authority or
as part of a legal proceeding.
1.41. "LABEL". Label shall mean any package labeling designed for use
with the Product, pursuant to the terms of this Agreement, in accordance with
cGMP, including the package insert for such Product, that is approved by the FDA
pursuant to the terms of this Agreement; and any variation of such term, such as
"LABELED" or "LABELING", shall mean the act of doing the foregoing, and
"LABELER" shall mean a Party or Third Party who performs the act of Labeling.
1.42. "LEGAL ACTIVITIES". Legal Activities means (a) all
Product-Specific Patent Activities, and (b) all activities with respect to Legal
Clearance.
1.43. "LEGAL CLEARANCE". Legal Clearance means collectively District
Court Legal Clearance and Final Legal Clearance.
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1.44. "LEGAL CLEARANCE COSTS". Legal Clearance Costs means all legal
and related costs incurred to achieve Legal Clearance; provided, however, that
Legal Clearance Costs specifically exclude (a) Settlement Costs, and (b) the
cost of any attorneys which Momenta independently involves in the activities to
achieve Legal Clearance (which shall be the sole responsibility of Momenta),
unless the JSC agrees that such costs should be included in Legal Clearance
Costs.
1.45. "LEGAL EXPENSES". Legal Expenses means, with respect to the U.S.
Territory: (a) Product-Specific Patent Costs; (b) Legal Clearance Costs; (c) all
Liabilities related to Patent Litigation; (d) all Liabilities incurred by the
Parties or the Indemnified Parties with respect to any claims described in
Section 12.1(e); and (e) all Liabilities incurred by the Sandoz Parties with
respect to any claims or demands related to the Product that are commenced by
Aventis or any Third Party against any Sandoz Indemnified Party based on the
activities of Momenta or the Sandoz Parties (including those undertaken by
Affiliates or Third Parties on behalf of Momenta or the Sandoz Parties) [**]
pursuant to this Agreement. Notwithstanding any provision to the contrary
herein, Legal Expenses do not include: (i) damages (including [**]) due to
Aventis as a result of a Pre Final Legal Clearance Launch; (ii) Product
Liability Costs; and (iii) Settlement Costs.
1.46. "LOCKED MANUFACTURING PROCESS". Locked Manufacturing Process
means, with respect to the Product, an economically practical, highly controlled
and highly reproducible manufacturing process that enables the manufacture of
Characterized Product to FDA standards (including compatibility with cGMP) and
in accordance with any ANDA requirements for the Product, including without
limitation the Product's FDA specifications.
1.47. "LOVENOX(R)-EQUIVALENT PRODUCT". Lovenox(R)-Equivalent Product
means (a) Lovenox(R) in injectable form sold as a brand, including Lovenox(R)
sold by Aventis using another tradename, such as Clexane(R) (collectively,
"BRANDED LOVENOX"), or (b) any product sold in the U.S. Territory (other than
Branded Lovenox) that is a generic AB-rated or AP-rated equivalent to Lovenox(R)
in injectable form.
1.48. "MANUFACTURING COSTS". Manufacturing Costs means, with respect
to the Product, the aggregate of each Party's cost to commercially manufacture
(including the buildup of commercial inventory) and/or Label the Product,
calculated as follows: (a) if the Product is manufactured and/or Labeled by a
Party or its Affiliate, then Manufacturing Costs shall be determined as set
forth on SCHEDULE 1.48; or (b) if the Product is manufactured and/or Labeled by
a Third Party manufacturer, Manufacturing Costs shall equal the costs as
invoiced by such Third Party manufacturer for the manufacture and/or Labeling of
a specified quantity of the Product, plus any of the costs set forth on SCHEDULE
1.48 that are incurred by the Parties or their Affiliates in completing the
manufacture, Labeling and delivery to a warehouse(s) designated by the Sandoz
Parties of such quantity of the Product.
If there are any Third Party Royalties payable hereunder, such amounts shall be
considered a Manufacturing Cost for purposes of calculating any Profit Interest
payable to Momenta hereunder.
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1.49. "MARKETING APPROVAL". Marketing Approval means the approval of
the FDA necessary and sufficient for the marketing and First Commercial Sale of
the Product in the U.S. Territory.
1.50. "M118 XXXXXXXXXXX". X000 Opportunity means the research,
development, manufacturing or commercialization of Momenta's low molecular
weight heparin candidate known as M118.
1.51. "MIT". MIT means Massachusetts Institute of Technology.
1.52. "MIT AGREEMENT". MIT Agreement means the Amended and Restated
Exclusive Patent License Agreement by and between MIT and Momenta, dated as of
November 1, 2002 and as amended by a First Amendment dated November 15, 2002 and
letter agreements dated September 12, 2003 and October 22, 2003, as the same may
be amended from time to time.
1.53. "MOMENTA COLLABORATION KNOW-HOW". Momenta Collaboration Know-How
means (a) all Know-How constituting, based upon or derived from inventions or
developments which are conceived and reduced to practice or developed solely by
the employees, contractors (subject to Section 8.3), consultants or agents of
Momenta or its Affiliates during, and in the conduct of, the Collaborative
Program, excluding Improvements to Sandoz Know-How or Improvements to Sandoz
Collaboration Know-How, and (b) (i) Improvements to Momenta Know-How or (ii)
Improvements to Momenta Collaboration Know-How, which, with respect to each of
(b)(i) and (b)(ii), are made solely by the employees, contractors, consultants
or agents of Sandoz or its Affiliates, or jointly by the employees, contractors,
consultants or agents of Sandoz or its Affiliates, on the one hand, and by the
employees, contractors, consultants or agents of Momenta or its Affiliates, on
the other hand, during, and in the conduct of, the Collaborative Program.
1.54. "MOMENTA COLLABORATION PATENT RIGHTS". Momenta Collaboration
Patent Rights means all Patent Rights throughout the world covering Momenta
Collaboration Know-How that are Controlled by Momenta.
1.55. "MOMENTA INDEMNIFIED PARTIES". Momenta Indemnified Parties means
Momenta, Momenta's Affiliates, any of their successors or assigns, and any of
their respective then-current or then-former directors, officers, employees,
consultants, agents, suppliers, contract manufacturers, contract service
providers, Third Parties engaged to perform activities under the Collaborative
Program, and MIT (including MIT's trustees, officers, faculty, students,
employees, and agents).
1.56. "MOMENTA IP". Momenta IP means Momenta Know-How, Momenta
Collaboration Know-How, Momenta Patent Rights and Momenta Collaboration Patent
Rights, including, without limitation, those license rights granted to Momenta
under the MIT Agreement to the extent such would be included in Momenta
Know-How, Momenta Collaboration Know-How, Momenta Patent Rights and Momenta
Collaboration Patent Rights.
1.57. "MOMENTA KNOW-HOW". Momenta Know-How means all Know-How which
(a) is Controlled by Momenta (i) as of the Effective Date or (ii) during the
term of the Collaborative
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Program, but which is not developed or acquired by Momenta or any of its
Affiliates in the conduct of the Collaborative Program, and (b) could reasonably
be used in the conduct of the Collaborative Program.
1.58. "MOMENTA PATENT RIGHTS". Momenta Patent Rights means all Patent
Rights throughout the world covering Momenta Know-How that are Controlled by
Momenta, including, without limitation, the Patent Rights listed on SCHEDULE
1.58.
1.59. "MOMENTA PRODUCT-SPECIFIC KNOW-HOW". Momenta Product-Specific
Know-How means all Momenta Know-How or Momenta Collaboration Know-How which
solely relates to the Product and does not relate, or cannot be used with, any
other product or for any other general purpose.
1.60. "MOMENTA PRODUCT-SPECIFIC PATENT RIGHTS". Momenta
Product-Specific Patent Rights means all Patent Rights throughout the world
covering Momenta Product-Specific Know-How that are Controlled by Momenta.
1.61. "NET SALES". Net Sales means the gross amount invoiced by Sandoz
or its Affiliates (or, with respect to Section 11.6.3, Momenta, its Affiliates
and/or sublicensees) to Third Parties (whether an end-user, a distributor or
otherwise) for sales of the Product, less: (a) the total value (to the extent
actually allowed and taken directly with respect to such sales, as reflected in
the amount invoiced) of trade, cash and quantity discounts and/or rebates,
allowances, credits and charge backs, discounts in kind and/or other forms of
consideration offered as inducements for the purchase of such Product, and/or
required payments, including, without limitation, from (i) managed health care
organizations, (ii) federal, state or local governmental agency programs
(including Medicare and Medicaid or other similar programs in countries outside
the U.S. Territory), their agencies and purchasers and reimbursers, and (iii)
wholesalers and chain pharmacy buying groups and any other trade customers; and
(b) any credits or allowances booked on account of shelfstock and other price
adjustments, rejections or returns of Products previously sold; and (c) taxes,
customs charges, duties and any other governmental charges, levied on, absorbed,
or otherwise imposed on the production, importation, transportation, use or sale
of the Product (excluding national, state or local taxes based on income); and
(d) any Product recall costs, including Manufacturing Costs, costs of Product
destruction and out-of-pocket administrative costs, that are not identifiable as
being (x) the fault of the Sandoz Parties (in which case Sandoz shall be
responsible for such costs) or (y) the fault of Momenta (in which case Momenta
shall be responsible for such costs).
If there are any Third Party Royalties payable hereunder, such amounts shall be
subtracted in order to arrive at Net Sales for purposes of all royalty payments
to Momenta hereunder.
Such amounts shall be determined from the books and records of Sandoz or its
Affiliates (or, with respect to Section 11.6.3, Momenta, its Affiliates and/or
sublicensees), maintained in accordance with generally accepted accounting
principles, consistently applied.
In the case of any sale of the Product for consideration other than cash, such
as barter or countertrade, Net Sales shall be calculated on the fair market
value of consideration received.
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Each of the Sandoz Parties agrees not to use the Product as a loss leader. Each
of the Sandoz Parties also agrees that if either of them price the Product in
order to gain or maintain sales of other products, then for purposes of
calculating the payments due hereunder, the Net Sales shall be adjusted to
reverse any discount which was given to a customer that was in excess of
customary discounts for this Product (or, in the absence of relevant data for
this Product, other similar products under similar market conditions), if such
discount was given in order to gain or maintain sales of other products.
In the case of any sale of the Product between or among Sandoz or its Affiliates
(or, with respect to Section 11.6.3, Momenta, its Affiliates and sublicensees)
for resale, Net Sales shall be calculated as above only on the value charged or
invoiced on the first arm's length sale thereafter to a Third Party.
1.62. "NON-INJECTABLE OR IMPROVED ENOXAPARIN OPPORTUNITY".
Non-Injectable or Improved Enoxaparin Opportunity means the research,
development, manufacturing or commercialization of (a) enoxaparin to be
administered [**] or (b) Improved Enoxaparin.
1.63. "NON-OWNING PARTY". Non-Owning Party means, with respect to
Sandoz IP, Momenta, and, with respect to Momenta IP, BCWI (or Sandoz, if so
designated in writing by the Sandoz Parties).
1.64. "NON-U.S. TERRITORY". Non-U.S. Territory means all countries
outside the U.S. Territory.
1.65. "OWNING PARTY". Owning Party means, with respect to Momenta IP,
Momenta, and, with respect to Sandoz IP, BCWI (or Sandoz, if so designated in
writing by the Sandoz Parties).
1.66. "OWNING PARTY'S IP". Owning Party's IP means, with respect to
Momenta, the Momenta IP, and, with respect to a Sandoz Party, the Sandoz IP.
1.67. "PARTY". Party means Sandoz, BCWI or Momenta; "PARTIES" means
Sandoz, BCWI and Momenta.
1.68. "PATENT LITIGATION". Patent Litigation means (a) a claim or
demand by Aventis that alleges patent infringement against any Momenta
Indemnified Party or any Sandoz Indemnified Party based on (i) the activities of
the Sandoz Parties or Momenta (including those undertaken by Affiliates or Third
Parties on behalf of them) pursuant to this Agreement related to the Product
(including the manufacture of the Product), or (ii) the activities of the Sandoz
Parties or Momenta (including those undertaken by Affiliates or Third Parties on
behalf of them) [**] related to the Product (including the manufacture of the
Product), or (b) a declaratory judgment or other legal or equitable proceeding
approved by the JSC (or if the JSC cannot reach agreement, through the
provisions of Article 13) and commenced or joined by Momenta, Sandoz or one of
their Affiliates that seeks a judgment against Aventis that Sandoz, Momenta,
their Affiliates and/or Momenta's licensees have not infringed, or will not
infringe, any patent related to the Product (including the manufacture of the
Product), in each case, irrespective of the nature
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of the relief sought (which may include, without limitation, actual,
consequential or enhanced damages) and irrespective of the jurisdiction in which
such claim, demand or action is brought.
1.69. "PATENT RIGHT". Patent Right means a United States and/or
foreign patent or patent application and all substitutions, divisions,
continuations, continuations-in-part, reissues, reexaminations and extensions
thereof.
1.70. "PERSON". Person means any natural person, corporation, firm,
business trust, joint venture, association, organization, company, partnership
or other business entity, or any government, or any agency or political
subdivisions thereof.
1.71. "POST-LAUNCH QUARTER". Post-Launch Quarter means the Quarter in
which U.S. Launch Occurs (the "FIRST POST-LAUNCH QUARTER") or each subsequent
Quarter (referred to as the "SECOND POST-LAUNCH QUARTER", "THIRD POST-LAUNCH
QUARTER", etc.).
1.72. "POST-LAUNCH YEAR". Post-Launch Year means each four Post-Launch
Quarter period, with the First Post-Launch Year encompassing the period of the
First Post-Launch Quarter through the Fourth Post-Launch Quarter, the Second
Post-Launch Year encompassing the period of the Fifth Post-Launch Quarter
through the Eighth Post-Launch Quarter, etc.
1.73. "PRE FINAL LEGAL CLEARANCE LAUNCH". Pre Final Legal Clearance
Launch means the occurrence of the U.S. Launch prior to Final Legal Clearance.
For the avoidance of doubt, any such launch shall be in the sole discretion of
Sandoz.
1.74. "PRODUCT". Product means injectable enoxaparin and any improved
injectable form of enoxaparin for which Lovenox(R), as defined in the relevant
New Drug Application approved as of the Effective Date or any past or future
Supplemental New Drug Applications, is the reference listed drug and for which
an ANDA could be approved by the FDA, but specifically excluding any Improved
Enoxaparin. "PRODUCT" includes, without limitation, a Lovenox(R)-Equivalent
Product developed by the Parties pursuant to this Agreement.
1.75. "PRODUCT LIABILITY COSTS". Product Liability Costs means all
Liabilities incurred by any Momenta Indemnified Party or Sandoz Indemnified
Party arising from actual or alleged product liability with respect to the
Product, including, without limitation, any such Liabilities incurred or paid by
the Parties or the Indemnified Parties with respect to any claims described in
Sections 12.1(d) or 12.1(e) (as applicable).
1.76. "PRODUCT-SPECIFIC PATENT ACTIVITIES". Product-Specific Patent
Activities means all activities of the Parties with respect to the preparation,
filing, prosecution, maintenance, enforcement and invalidity defense of
Product-Specific Patent Rights to the extent such Product-Specific Patent Rights
are relevant to the exercise by the Sandoz Parties of the licenses granted in
Section 2.1.
1.77. "PRODUCT-SPECIFIC PATENT COSTS". Product-Specific Patent Costs
means all costs paid by a Party to Third Parties with respect to the
Product-Specific Patent Activities.
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1.78. "PRODUCT-SPECIFIC PATENT RIGHTS". Product-Specific Patent Rights
means Sandoz Product-Specific Patent Rights, Momenta Product-Specific Patent
Rights and Joint Product-Specific Patent Rights.
1.79. "PROFITS". Profits means Net Sales less (a) Selling Expenses and
(b) Manufacturing Costs for the Product sold (regardless of whether the Product
is rejected, returned or recalled).
1.80. "PROJECT LEADER". Project Leader means an executive appointed by
Momenta, on the one hand, or the Sandoz Parties, on the other hand, to serve as
such Party's principal coordinator and liaison for the Collaborative Program.
The Project Leader appointed by the Sandoz Parties is referred to as the "SANDOZ
PROJECT LEADER" and the Project Leader appointed by Momenta is referred to as
the "MOMENTA PROJECT LEADER."
1.81. "QUARTER". Quarter means each three month period ending March
31, June 30, September 30 and December 31 in each calendar year.
1.82. "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 testing,
manufacture, use, storage, import, promotion, marketing and sale of a
therapeutic product in a country, including the FDA.
1.83. "SANDOZ COLLABORATION KNOW-HOW". Sandoz Collaboration Know-How
means (a) all Know-How constituting, based upon or derived from inventions or
developments which are conceived and reduced to practice or developed solely by
the employees, contractors (subject to Section 8.3), consultants or agents of
Sandoz or its Affiliates during, and in the conduct of, the Collaborative
Program, excluding Improvements to Momenta Know-How or Improvements to Momenta
Collaboration Know-How, and (b) (i) Improvements to Sandoz Know-How or (ii)
Improvements to Sandoz Collaboration Know-How, which, with respect to each of
(b)(i) and (b)(ii), are made solely by the employees, contractors, consultants
or agents of Momenta or its Affiliates, or jointly by the employees,
contractors, consultants or agents of Sandoz or its Affiliates, on the one hand,
and by the employees, contractors, consultants or agents of Momenta or its
Affiliates, on the other hand, during, and in the conduct of, the Collaborative
Program.
1.84. "SANDOZ COLLABORATION PATENT RIGHTS". Sandoz Collaboration
Patent Rights means all Patent Rights throughout the world covering Sandoz
Collaboration Know-How that are Controlled by a Sandoz Party.
1.85. "SANDOZ INDEMNIFIED PARTIES". Sandoz Indemnified Parties means
Sandoz, BCWI, their Affiliates, any of their successors or assigns, and any of
their respective then-current or then-former directors, officers, employees,
consultants, suppliers, contract manufacturers, contract service providers, and
Third Parties engaged to perform activities under the Collaborative Program.
1.86. "SANDOZ IP". Sandoz IP means Sandoz Know-How, Sandoz
Collaboration Know-How, Sandoz Patent Rights and Sandoz Collaboration Patent
Rights. Sandoz IP expressly excludes the intellectual property rights of any
Affiliate of the Sandoz Parties, unless such
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intellectual property rights are Controlled by a Sandoz Party, it being
understood that the Sandoz Parties shall have the obligation to obtain Control
set forth in Section 8.3.
1.87. "SANDOZ KNOW-HOW". Sandoz Know-How means all Know-How which (a)
is Controlled by a Sandoz Party (i) as of the Effective Date or (ii) during the
term of the Collaborative Program, but which is not developed by Sandoz or its
Affiliates or acquired by Sandoz or its Affiliates in the conduct of the
Collaborative Program, and (b) is contributed and approved for use by a Sandoz
Party in the conduct of the Collaborative Program, it being understood that any
such contribution shall be in the sole discretion of such Sandoz Party and that,
unless the Parties otherwise agree in writing, such Sandoz Party shall not
charge Momenta for any such contribution.
1.88. "SANDOZ PATENT RIGHTS". Sandoz Patent Rights means all Patent
Rights throughout the world covering Sandoz Know-How that are Controlled by a
Sandoz Party.
1.89. "SANDOZ PRODUCT-SPECIFIC KNOW-HOW". Sandoz Product-Specific
Know-How means all Sandoz Know-How or Sandoz Collaboration Know-How which solely
relates to the Product and does not relate, or cannot be used with, any other
product or for any other general purpose.
1.90. "SANDOZ PRODUCT-SPECIFIC PATENT RIGHTS". Sandoz Product-Specific
Patent Rights means all Patent Rights throughout the world covering Sandoz
Product-Specific Know-How that are Controlled by a Sandoz Party.
1.91. "SELLING EXPENSES". Selling Expenses means Sandoz's or its
Affiliates' expenditures to market, distribute and sell the Product, which shall
be deemed for purposes of this Agreement to be equal to [**] percent ([**]%) of
Net Sales of such Product for each applicable period.
1.92. "SETTLEMENT". Settlement means an agreement or settlement, made
at any time, between a Sandoz Party or its Affiliate(s), on the one hand, and
Aventis, on the other hand, that finally resolves any existing Patent Litigation
and precludes any future Patent Litigation by Aventis against the Sandoz
Parties, their Affiliates and the Momenta Indemnified Parties related to the
Product, such that the Product may be marketed by or continue to be marketed by
or on behalf of Sandoz or its Affiliates subject to ANDA Final Approval of an
ANDA filed by Sandoz or any of its Affiliates for the Product.
1.93. "SETTLEMENT COSTS". Settlement Costs means all amounts paid to
Aventis (whether [**] or similar arrangement, including without limitation [**]
in accordance with Section 6.2.2) in order to achieve a Settlement.
1.94. "STABILITY STUDIES". Stability Studies means, with respect to
the Product, the performance of stability testing at one-tenth commercial scale
in accordance with the stability protocol set forth in the ANDA for the Product.
1.95. "SUPPLY CHAIN". Supply Chain, with respect to Product, means
stable, reliable, and commercially practical sources to obtain all starting
materials, biological products,
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biological molecules, chemicals, precursors, intermediates, and reagents of
sufficient quantity, quality, and purity necessary to manufacture the required
commercial quantities of the Product according to the Locked Manufacturing
Process. "SUPPLY CHAIN" includes commercial sources of all packaging components
and packaging materials, including primary and printed packaging materials
according to the standards set forth in the ANDA for the Product.
1.96. "THIRD PARTY". Third Party means any Person other than a Party
or any of its Affiliates.
1.97. "THIRD-PARTY COMPETITOR". Third-Party Competitor means each
Third Party (including, [**], collectively with all of such Third Party's
Affiliates, licensees and/or distributors, which Third Party owns, itself or
through its Affiliates, [**] in the U.S. Territory for [**] Products and which
Third Party is marketing, itself or through its Affiliates, licensees and/or
distributors, [**] in the U.S. Territory; PROVIDED, HOWEVER, THAT Third-Party
Competitor shall exclude Sandoz's and BCWI's Affiliates and distributors. If
[**], it shall be termed the "[**]".
1.98. "THIRD PARTY ROYALTIES". Third Party Royalties means any
royalties, license fees or other monetary payments made by the Sandoz Parties
(either directly or via reimbursement to Momenta) to any Third Party in
consideration of a license(s) under such Third Party patent(s), know-how or
other intellectual property rights, when such license is reasonably determined
by the JPT to be necessary to commercially manufacture and/or sell the Product
without infringing such Third Party intellectual property rights; PROVIDED,
HOWEVER, that Third Party Royalties shall not include any payments to Third
Party contractors hired by Momenta or any Sandoz Parties, with prior approval of
the JPT, in order to provide services in connection with Development activities
under this Agreement, under which royalty-free licenses are granted to
intellectual property created during the course of providing such services.
1.99. "U.S. LAUNCH". U.S. Launch means the time when Sandoz, its
Affiliates or distributors achieve the First Commercial Sale of the Product in
the U.S. Territory.
1.100. "U.S. TERRITORY". U.S. Territory shall mean the fifty states of
the United States of America, the District of Columbia and all territories and
possessions of the United States of America and any other location where the FDA
has jurisdiction over medicinal products intended for human use.
1.101. OTHER DEFINED TERMS. Each of the following definitions is set
forth in the section of this Agreement indicated below:
Definition Section
---------- -------
Actual Momenta Economic Interest Schedule 4.3
Additional Excessive Cost Termination 11.5.2
Additional Excessive Cost Termination Option Period 11.5.2
Additional Excessive Cost Trigger 11.5.2
Additional FTE's 4.2
Agreement Preamble
Aventis Persons 1.6
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Aventis [**] 1.97
Aventis [**] 4.8.1
BCWI Preamble
BCWI Executive Officer 1.25
Branded Lovenox 1.47
Carryforward Schedule 4.3
Commercial Milestone Payments 4.10.2
Commercial Viability Termination 11.3
Commercial Viability Trigger 11.3
Controlled Contractors 3.1
Cost Cap 4.1
Disclosing Party 00.0
Xxxxxxxx Xxxxx 0.00
Xxxxxxxx Court Decision 1.23
Economic Interest Variance Schedule 4.3
Entire Capacity Schedule 1.48
Effective Date Preamble
FD&C Act 1.3
Final Misappropriation Determination 12.2
Force Majeure Event 14.15
Fragmin Notice 3.1
Fragmin Response 3.1
Fragmin Response Period 3.1
FTE Records 4.2
Full Capacity Schedule 1.48
Full Milestone Payment(s) 4.10.2
Indemnified Party 12.3
Indemnifying Party 12.3
Initial Excessive Cost Termination 11.5.1
Initial Excessive Cost Termination Option Period 11.5.1
Initial Excessive Cost Trigger 11.5.1
Initial Non-U.S. Territory Negotiation Period 3.4.2
Invalidity Claim 8.6
Joint Project Team / JPT 5.2
Labeler 1.41
Joint Steering Committee / JSC 5.3
Legal Strategy Diminishment 11.4
Liabilities 12.1
Milestone Payment Quarter 4.10.2
M118 Notice 3.2
M118 Response 3.2
M118 Response Period 3.2
MIT Associates 14.16
Momenta Preamble
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Momenta Assigned Improvements 8.1.1
Momenta Economic Interest Schedule 4.3
Momenta Executive Officer 1.25
Momenta Project Leader 1.80
Momenta Share of Excess Costs Schedule 4.3
New Excess Costs Schedule 4.3
[**] Period 4.7.1
[**] Royalty 4.7.1
Non-Injectable or Improved Enoxaparin Response 3.3.1
Non-Injectable or Improved Enoxaparin Notice 3.3.1
Non-Injectable or Improved Enoxaparin Response Period 3.3.1
Non-U.S. Option 3.4.1
Non-U.S. Option Period 3.4.1
Non-U.S. Territory Agreement 3.4.2
[**] Period 4.5
Orange Book Litigation 1.28
Pleadings 12.3.3
Post-[**] Period 4.6.1
Post-[**] Royalty 4.6.1
Pre-Existing Costs 1.21
Prior Confidentiality Agreement 10.1
Product Records 4.11.4
Profit Interest 4.5
Program Output 3.4.6
Receiving Party 10.2
Regulatory Milestone Payment 4.10.1
Representing Party 9.1
Sandoz Preamble
Sandoz Assigned Improvements 8.1.1
Sandoz Executive Officer 1.25
Sandoz Party Preamble
Sandoz Parties Preamble
Sandoz Milestone Termination 11.4
Sandoz Milestone Trigger 11.4
Sandoz Parties Royalty 11.6.3
Sandoz Project Leader 1.80
Supply Continuation Plan 11.2.2
Supply Interruption 11.2.2
Supply Interruption Notice 11.2.2
Term 11.1
Third Party Term Sheet 3.4.5
Third Party Term Sheet Notice 3.4.5
True-Up Amount Schedule 4.3
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2. GRANT OF RIGHTS
2.1. MOMENTA LICENSE GRANTS. Subject to the terms and conditions of
this Agreement, Momenta hereby grants to BCWI during the Term, (a) an exclusive
license, without the right to grant sublicenses, under Momenta IP and under
Momenta's rights in the Joint Collaboration IP, to Develop, make, have made,
use, sell, offer to sell, lease, import and export the Product in the U.S.
Territory in the Field, and (b) a non-exclusive license, with no right to grant
sublicenses, under the Momenta IP to make, have made, and use the Product in the
Non-U.S. Territory, but only for the purposes of sale of the Product in or into
the U.S. Territory; PROVIDED, HOWEVER, THAT Momenta retains the right to
practice, and to grant sublicenses, under Momenta IP and under Momenta's rights
in the Joint Collaboration IP in the U.S. Territory in the Field to (i) perform
its obligations to the Sandoz Parties under this Agreement, including, without
limitation, to conduct the Momenta activities under this Agreement and in the
Annual Collaboration Plans and (ii) make and have made the Product in the U.S.
Territory solely for the purposes of sales of the Product in the Field (A) in
those countries in the Non-U.S. Territory for which Sandoz does not, during the
Non-U.S. Option Period, exercise the Non-U.S. Option, or (B) if Sandoz exercises
the Non-U.S. Option within the Non-U.S. Option Period, in those countries in the
Non-U.S. Territory for which Sandoz and Momenta do not execute a Non-U.S.
Territory Agreement either during the Initial Non-U.S. Territory Negotiation
Period or pursuant to Section 3.4.5. Notwithstanding the foregoing prohibition
on sublicensing, (a) BCWI may sublicense its rights under this Section 2.1 to
Sandoz to the extent it deems necessary for Sandoz to perform its obligations
under this Agreement, and (b) subject to the provisions of Section 8.3.3, BCWI
may sublicense its rights under this Section 2.1 to an Affiliate of BCWI other
than Sandoz to the extent as may be permitted under the Annual Collaboration
Plans or as otherwise approved in writing by Momenta.
2.2. SANDOZ PARTIES LICENSE GRANTS. Subject to the terms and
conditions of this Agreement, the Sandoz Parties hereby grant to Momenta, during
the term of this Agreement, a worldwide, non-exclusive, royalty-free license,
without the right to grant sublicenses (except to the extent as may be permitted
under the relevant Annual Collaboration Plan or as otherwise approved in writing
by the relevant Sandoz Party) under Sandoz IP and under the Sandoz Parties'
rights in the Joint Collaboration IP, solely to the extent necessary or
appropriate to perform Momenta's obligations to the Sandoz Parties under this
Agreement, including, without limitation, to conduct the Momenta activities
under this Agreement and in the Annual Collaboration Plans.
2.3. EXCLUSIVITY. Subject to Momenta's retained right in Section 2.1,
except as otherwise agreed in writing by the Parties, Momenta agrees that it
shall not, and shall ensure that its Affiliates do not, during the Term, grant
any license in Momenta IP or Joint Collaboration IP to any Third Party to
Develop, make, have made, use, sell, offer to sell, lease, import, export or
otherwise Commercialize the Product in the Field in the U.S. Territory. Except
as otherwise agreed in writing by the Parties, each Sandoz Party agrees that it
shall not, and shall use reasonable efforts to cause its Affiliates not to,
during the Term, grant any license to any Third Party to Develop, make, have
made, use, sell, offer to sell, lease, import, export or otherwise Commercialize
the Product in the Field in the U.S. Territory, except to the extent necessary
or appropriate to perform the Sandoz Parties' obligations to Momenta under this
Agreement;
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PROVIDED, HOWEVER, THAT if an Affiliate of any Sandoz Party grants any such
license to any Third Party, it shall be considered a breach of this Agreement by
the Sandoz Parties. Momenta shall, and shall ensure that its Affiliates,
exclusively develop and Commercialize the Product with the Sandoz Parties during
the Term in the U.S. Territory. Each Sandoz Party shall, and shall use
reasonable efforts to ensure that its Affiliates, exclusively develop and
Commercialize the Product with Momenta during the Term in the U.S. Territory;
PROVIDED, HOWEVER, THAT if an Affiliate of any Sandoz Party develops or
commercializes the Product without Momenta during the Term in the U.S.
Territory, it shall be considered a breach of this Agreement by the Sandoz
Parties.
2.4. RETAINED RIGHTS. Any rights of Momenta not expressly granted to
Sandoz or BCWI under the provisions of this Agreement shall be retained by
Momenta and any rights of Sandoz or BCWI not expressly granted to Momenta under
the provisions of this Agreement shall be retained by Sandoz or BCWI,
respectively.
2.5. THIRD PARTY LICENSOR RIGHTS. The rights granted in Sections 2.1
and 2.2 are granted to the extent permitted or qualified by the nature of the
licenses granted by the relevant Third Party licensors, if any, of Momenta IP or
Sandoz IP, as the case may be. The Party receiving such license shall comply
with all restrictions and obligations imposed by such Third Party licensors;
PROVIDED, HOWEVER, THAT, if Momenta or a Sandoz Party, as the case may be,
enters into a license with a Third Party licensor for any intellectual property
that may be considered Momenta IP or Sandoz IP, respectively, Momenta or such
Sandoz Party shall notify the Sandoz Parties or Momenta, respectively, of the
restrictions and obligations imposed by such Third Party licensor, and, if the
Sandoz Parties or Momenta, respectively, do not wish to comply with such
restrictions and obligations, such licensed intellectual property shall not be
considered Momenta IP or Sandoz IP, respectively, hereunder. Sandoz acknowledges
receipt of a copy of the MIT Agreement from Momenta. Momenta represents that the
copy of the MIT Agreement delivered to Sandoz in accordance with the foregoing
represents the MIT Agreement as in effect as of the Effective Date.
3. ADDITIONAL RIGHTS
3.1. FRAGMIN OPPORTUNITY; RIGHT OF FIRST NEGOTIATION. During the
Term, prior to entering into any detailed negotiations regarding key terms
and/or entering into any contract, agreement, term sheet, understanding or
arrangement (verbal or written) with a Commercial Third Party (other than Third
Party contractors such as contract research organizations, contract
manufacturers, contract employees, consultants and the like which merely conduct
activities on behalf of Momenta and subject to Momenta's supervision and control
("CONTROLLED CONTRACTORS")) with respect to a Fragmin Opportunity in the U.S.
Territory or the Non-U.S. Territory, Momenta shall provide written notice to the
Sandoz Parties of its bona fide present intent to engage in such activities at
such time (the "FRAGMIN NOTICE"), which Fragmin Notice shall include information
in reasonable detail sufficient to enable the Sandoz Parties to make an informed
decision with respect to such Fragmin Opportunity; PROVIDED, HOWEVER, THAT this
Section 3.1 shall not prevent Momenta from participating in general discussions
or negotiations with Third Parties with respect to a Fragmin Opportunity in the
U.S. Territory or the Non-U.S. Territory. If either (but not both) of the Sandoz
Parties notifies Momenta in writing within thirty
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(30) days of receipt of the Fragmin Notice (the "FRAGMIN RESPONSE PERIOD", such
notice, the "FRAGMIN RESPONSE") that it has a bona fide interest in discussing a
collaboration with Momenta with respect to such Fragmin Opportunity, Momenta and
such Sandoz Party shall enter into good faith negotiations on an exclusive
basis, on such terms as may be mutually agreeable. If (a) neither Sandoz Party
indicates during the Fragmin Response Period that it is interested in discussing
such Fragmin Opportunity, (b) the Sandoz Parties indicate in writing during the
Fragmin Response Period that they have no interest in such Fragmin Opportunity,
or (c) one of the Sandoz Parties indicates such an interest during the Fragmin
Response Period but Momenta and such Sandoz Party are unable, after good faith
negotiations, to reach mutual agreement and execute a definitive agreement with
respect to a collaboration with respect to such Fragmin Opportunity within [**]
from the date of the Fragmin Response (or such extended period as may be
approved in writing by Momenta and such Sandoz Party), Momenta shall be free for
a period of [**] thereafter to undertake detailed negotiations regarding key
terms and enter into a transaction (including execution of a definitive
agreement) relating to such Fragmin Opportunity with a Commercial Third
Party(ies), which, with respect only to clause (c) above, shall be on terms not
less favorable, taken as a whole, to Momenta than those last offered to the
applicable Sandoz Party. Momenta and the Sandoz Parties recognize that, in
evaluating the favorability to Momenta of the terms of such Third Party
transaction relating to such Fragmin Opportunity, numerous factors may be taken
into account and given appropriate weight, including, without limitation, the
amount of up-front payments, the amount and timing of subsequent license or
research payments, the royalty rate(s) or profit sharing terms, the definition
of territory, marketing and promotion rights, the purchase and pricing of
equity, if applicable, and the identity, experience and market position of such
Third Party(ies) in the relevant markets. If, after the expiration of such [**]
period, Momenta has not entered into a transaction with any Third Party with
respect to such Fragmin Opportunity, then Momenta and the Sandoz Parties shall
again follow the procedures described in this Section 3.1 with respect to such
Fragmin Opportunity. Momenta shall not be obligated to reveal to the Sandoz
Parties the identity of any Third Party involved in any such transaction.
3.2. M118 OPPORTUNITY; RIGHT OF FIRST NEGOTIATION. During the Term,
prior to entering into any detailed negotiations regarding key terms and/or
entering into any contract, agreement, term sheet, understanding or arrangement
(verbal or written) with a Commercial Third Party (other than Controlled
Contractors) with respect to an M118 Opportunity in the U.S. Territory or the
Non-U.S. Territory, Momenta shall provide written notice to the Sandoz Parties
of its bona fide present intent to engage in such activities at such time (the
"M118 NOTICE"), which M118 Notice shall include information in reasonable detail
sufficient to enable the Sandoz Parties to make an informed decision with
respect to such M118 Opportunity; PROVIDED, HOWEVER, THAT this Section 3.2 shall
not prevent Momenta from participating in general discussions or negotiations
with Third Parties with respect to an M118 Opportunity in the U.S. Territory or
the Non-U.S. Territory. If either (but not both) of the Sandoz Parties notifies
Momenta in writing within thirty (30) days of receipt of the M118 Notice (the
"M118 RESPONSE PERIOD", such notice, the "M118 RESPONSE") that it has a bona
fide interest in discussing a collaboration with Momenta with respect to such
M118 Opportunity, Momenta and such Sandoz Party shall enter into good faith
negotiations on an exclusive basis, on such terms as may be mutually agreeable.
If (a) neither Sandoz Party indicates during the M118 Response Period that it is
interested in discussing such M118 Opportunity, (b) the Sandoz Parties indicate
in writing during the M118 Response Period
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that they have no interest in such M118 Opportunity, or (c) one of the Sandoz
Parties indicates such an interest during the M118 Response Period but Momenta
and such Sandoz Party are unable, after good faith negotiations, to reach mutual
agreement and execute a definitive agreement with respect to a collaboration
with respect to such M118 Opportunity within [**] from the date of the M118
Response (or such extended period as may be approved in writing by Momenta and
such Sandoz Party), Momenta shall be free for a period of [**] thereafter to
undertake detailed negotiations regarding key terms and enter into a transaction
(including execution of a definitive agreement) relating to such M118
Opportunity with a Commercial Third Party(ies), which, with respect only to
clause (c) above, shall be on terms not less favorable, taken as a whole, to
Momenta than those last offered to the applicable Sandoz Party. Momenta and the
Sandoz Parties recognize that, in evaluating the favorability to Momenta of the
terms of such Third Party transaction relating to such M118 Opportunity,
numerous factors may be taken into account and given appropriate weight,
including, without limitation, the amount of up-front payments, the amount and
timing of subsequent license or research payments, the royalty rate(s) or profit
sharing terms, the definition of territory, marketing and promotion rights, the
purchase and pricing of equity, if applicable, and the identity, experience and
market position of such Third Party(ies) in the relevant markets. If, after the
expiration of such [**] period, Momenta has not entered into a transaction with
any Third Party with respect to such M118 Opportunity, then Momenta and the
Sandoz Parties shall again follow the procedures described in this Section 3.2
with respect to such M118 Opportunity. Momenta shall not be obligated to reveal
to the Sandoz Parties the identity of any Third Party involved in any such
transaction.
3.3. NON-INJECTABLE OR IMPROVED ENOXAPARIN OPPORTUNITIES.
3.3.1 U.S. TERRITORY. If, during the Term, Momenta intends to
begin detailed negotiations regarding key terms and/or enter
into any contract, agreement, term sheet, understanding or
arrangement (verbal or written) with a Commercial Third Party
(other than Controlled Contractors) with respect to a
Non-Injectable or Improved Enoxaparin Opportunity in the U.S.
Territory, Momenta shall provide written notice of such bona
fide present intent to the Sandoz Parties (the "NON-INJECTABLE
OR IMPROVED ENOXAPARIN NOTICE"), which Non-Injectable or
Improved Enoxaparin Notice shall include information in
reasonable detail sufficient to enable the Sandoz Parties to
make an informed decision with respect to such Non-Injectable or
Improved Enoxaparin Opportunity; PROVIDED, HOWEVER, THAT this
Section 3.3 shall not prevent Momenta from participating in
general discussions or negotiations with Third Parties with
respect to a Non-Injectable or Improved Enoxaparin Opportunity
in the U.S. Territory. If either (but not both) of the Sandoz
Parties notifies Momenta in writing within [**] of receipt of
the Non-Injectable or Improved Enoxaparin Notice (the
"NON-INJECTABLE OR IMPROVED ENOXAPARIN RESPONSE PERIOD", such
notice, the "NON-INJECTABLE OR IMPROVED ENOXAPARIN RESPONSE")
that it has a bona fide interest in discussing a collaboration
with Momenta with respect to such Non-Injectable or Improved
Enoxaparin Opportunity, Momenta and such Sandoz Party shall
enter into good faith negotiations on an exclusive basis, on
such terms as may be mutually agreeable. If (a) neither Sandoz
Party indicates during the Non-Injectable or Improved Enoxaparin
Response Period that it is interested in discussing such
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Non-Injectable or Improved Enoxaparin Opportunity, (b) the
Sandoz Parties indicate in writing during the Non-Injectable or
Improved Enoxaparin Response Period that they have no interest
in such Non-Injectable or Improved Enoxaparin Opportunity, or
(c) one of the Sandoz Parties indicates such an interest during
the Non-Injectable or Improved Enoxaparin Response Period but
Momenta and such Sandoz Party are unable to, after good faith
negotiations, reach mutual agreement and execute a definitive
agreement with respect to a collaboration with respect to such
Non-Injectable or Improved Enoxaparin Opportunity within [**]
from the date of the Non-Injectable or Improved Enoxaparin
Response (or such extended period as may be approved in writing
by Momenta and such Sandoz Party), Momenta shall be free for a
period of [**] thereafter, to undertake detailed negotiations
regarding key terms and/or enter into a transaction (including
execution of a definitive agreement) relating to such
Non-Injectable or Improved Enoxaparin Opportunity with a
Commercial Third Party(ies), which, with respect only to clause
(c) above, shall be on terms not less favorable, taken as a
whole, to Momenta than those last offered to the applicable
Sandoz Party. Momenta and the Sandoz Parties recognize that, in
evaluating the favorability to Momenta of the terms of such
Third Party transaction relating to such Non-Injectable or
Improved Enoxaparin Opportunity, numerous factors may be taken
into account and given appropriate weight, including, without
limitation, the amount of up-front payments, the amount and
timing of subsequent license or research payments, the royalty
rate(s) or profit sharing terms, the definition of territory,
marketing and promotion rights, the purchase and pricing of
equity, if applicable, and the identity, experience and market
position of such Third Party(ies) in the relevant markets. If,
after the expiration of such [**] period, Momenta has not
entered into a transaction with any Third Party with respect to
such Non-Injectable or Improved Enoxaparin Opportunity, then
Momenta and the Sandoz Parties shall again follow the procedures
described in this Section 3.3.1 with respect to such
Non-Injectable or Improved Enoxaparin Opportunity. Momenta shall
not be obligated to reveal to the Sandoz Parties the identity of
any Third Party involved in any such transaction.
3.3.2 NON-U.S. TERRITORY.
a. During the Non-U.S. Option Period, Momenta shall provide
a Non-Injectable or Improved Enoxaparin Notice under
Section 3.3.1 to the Sandoz Parties if Momenta has a
bona fide present intent to begin detailed negotiations
regarding key terms or enter into any contract,
agreement, term sheet, understanding or arrangement
(verbal or written) with a Commercial Third Party at
such time with respect to a Non-Injectable or Improved
Enoxaparin Opportunity in the Non-U.S. Territory, and
the provisions of Section 3.3.1 shall apply MUTATIS
MUTANDIS with respect to the Non-U.S. Territory.
b. During the Initial Non-U.S. Territory Negotiation
Period, if any, and during the term of the Non-U.S.
Territory Agreement, Momenta shall
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provide a Non-Injectable or Improved Enoxaparin Notice
under Section 3.3.1 to the Sandoz Parties if Momenta has
a bona fide present intent to begin detailed
negotiations regarding key terms or enter into any
contract, agreement, term sheet, understanding or
arrangement (verbal or written) with a Commercial Third
Party at such time with respect to a Non-Injectable or
Improved Enoxaparin Opportunity in the portion of the
Non-U.S. Territory for which a Sandoz Party has
exercised the Non-U.S. Option or executed the Non-U.S.
Territory Agreement, as applicable, and the provisions
of Section 3.3.1 shall apply with respect to such
countries.
c. Notwithstanding the provisions of Sections 3.3.2(a) and
3.3.2(b), (i) if neither Sandoz Party indicates during
the Non-U.S. Option Period that it is interested in
exercising the Non-U.S. Option or the Sandoz Parties
indicate in writing during the Non-U.S. Option Period
that they have no interest in exercising the Non-U.S.
Option, Momenta shall have no further obligations to the
Sandoz Parties or their Affiliates with respect to the
Non-Injectable or Improved Enoxaparin Opportunity in the
Non-U.S. Territory; (ii) Momenta shall not be obligated
to enter into definitive agreements with a Sandoz Party
with respect to a Non-Injectable or Improved Enoxaparin
Opportunity in the Non-U.S. Territory unless and until
Momenta and a Sandoz Party have entered into the
Non-U.S. Territory Agreement; PROVIDED, HOWEVER, that
the negotiation period for any such Non-Injectable or
Improved Enoxaparin Opportunity in the Non-U.S.
Territory shall be tolled without penalty during the
Non-U.S. Option Period and the Initial Non-U.S.
Territory Negotiation Period; (iii) if a Sandoz Party
exercises the Non-U.S. Option but Momenta and such
Sandoz Party do not enter into the Non-U.S. Territory
Agreement either prior to the expiration of the Initial
Non-U.S. Territory Negotiation Period or pursuant to
Section 3.4.5, Momenta shall have no further obligations
to the Sandoz Parties or their Affiliates with respect
to the Non-Injectable or Improved Enoxaparin Opportunity
in the Non-U.S. Territory; (iv) if a Sandoz Party
exercises the Non-U.S. Option with respect to only a
portion of the Non-U.S. Territory, Momenta shall have no
further obligations to the Sandoz Parties or their
Affiliates with respect to a Non-Injectable or Improved
Enoxaparin Opportunity with respect to those countries
in the Non-U.S. Territory for which a Sandoz Party did
not exercise the Non-U.S. Option; and (v) this Section
3.3 shall not prevent Momenta from participating in
general discussions or negotiations with Third Parties
with respect to a Non-Injectable or Improved Enoxaparin
Opportunity in the Non-U.S. Territory.
3.4. NON-U.S. TERRITORY OPTION.
3.4.1 OPTION. Momenta hereby grants to either (but not both)
of the Sandoz Parties the exclusive option to commence
negotiations to obtain an exclusive license to Develop and
Commercialize the Product in all or part of the Non-U.S.
Territory on terms to be determined in accordance with the
provisions of this
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Section 3.4 (the "NON-U.S. OPTION"). A Sandoz Party shall notify
Momenta in writing as to its exercise of the Non-U.S. Option
within four (4) months after the Effective Date (the "NON-U.S.
OPTION PERIOD"). During the Non-U.S. Option Period, no Party
shall, and each Party shall ensure that its Affiliates do not,
develop or commercialize the Product with a Third Party in the
Non-U.S. Territory. During the Initial Non-U.S. Negotiation
Period, if any, no Party shall, and each Party shall ensure that
its Affiliates do not, develop or commercialize the Product with
a Third Party in the portion of the Non-U.S. Territory for which
a Sandoz Party has exercised the Non-U.S. Option.
3.4.2 INITIAL NON-U.S. TERRITORY NEGOTIATION PERIOD. Upon
exercise by a Sandoz Party of the Non-U.S. Option, Momenta and
such Sandoz Party shall negotiate in good faith a definitive
agreement containing terms and conditions for the exclusive
license in the portion of the Non-U.S. Territory for which such
Sandoz Party has exercised the Non-U.S. Option in Section 3.4.1
(the "NON-U.S. TERRITORY AGREEMENT"). Unless extended by mutual
agreement of Momenta and such Sandoz Party, the negotiations
shall cease after the first anniversary of the Effective Date
(the "INITIAL NON-U.S. TERRITORY NEGOTIATION PERIOD") if the
Parties have not entered into the Non-U.S. Territory Agreement
by such time.
3.4.3 AGREED TERMS. Momenta and the Sandoz Parties agree that
the Non-U.S. Territory Agreement will (a) be generally
consistent with the terms of this Agreement (PROVIDED, HOWEVER,
THAT the Non-U.S. Territory Agreement will, unless otherwise
agreed by Momenta and the applicable Sandoz Party, permit
sublicensing of marketing rights, and, if sublicensing of
marketing rights by a Sandoz Party is permitted, the Non-U.S.
Territory Agreement shall include such Sandoz Party's payment to
Momenta of a mutually agreed percentage of any payment received
by the Sandoz Party from a sublicense of the Product; and
PROVIDED FURTHER THAT the Non-U.S. Territory Agreement shall
include provisions specific to the relevant countries and/or to
inter-jurisdictional agreements, which may include, without
limitation, provisions with respect to tax withholding and
addressing legal restrictions on inter-jurisdictional payments,
as applicable), (b) take into consideration the economics of the
international markets for enoxaparin, and (c) not include
upfront payments or Development-related milestone payments.
3.4.4 NON-EXERCISE OF OPTION. If the Sandoz Parties elect not
to exercise the Non-U.S. Option pursuant to Section 3.4.1 within
the Non-U.S. Option Period, or elect to exercise the Non-U.S.
Option with respect to only a portion of the Non-U.S. Territory,
on a country-by-country basis, Momenta shall be free to begin
discussions or negotiations and/or enter into any contract,
agreement, understanding or arrangement with Third Parties
relating to the Development and/or Commercialization of the
Product in the Non-U.S. Territory or, if applicable, the portion
of the Non-U.S. Territory as to which the Sandoz Parties did not
exercise the Non-U.S. Option.
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3.4.5 FAILURE TO REACH AGREEMENT; RIGHT OF FIRST REFUSAL. If a
Sandoz Party exercises the Non-U.S. Option but Momenta and such
Sandoz Party do not enter into the Non-U.S. Territory Agreement
prior to the expiration of the Initial Non-U.S. Territory
Negotiation Period, Momenta shall be free to begin discussions
or negotiations with Third Parties relating to the Development
and/or Commercialization of the Product in the portion of the
Non-U.S. Territory for which a Sandoz Party has exercised the
Non-U.S. Option; PROVIDED THAT Momenta will not enter into any
contract, agreement, term sheet, understanding or arrangement
with a Commercial Third Party relating to the Development and/or
Commercialization of the Product in the portion of the Non-U.S.
Territory for which such Sandoz Party has exercised the Non-U.S.
Option without first complying with the following procedures: At
such time as Momenta has reached agreement on key terms with a
Third Party relating to the Development and/or Commercialization
of the Product in the portion of the Non-U.S. Territory for
which a Sandoz Party has exercised the Non-U.S. Option (a "THIRD
PARTY TERM SHEET"), Momenta shall provide a copy of such Third
Party Term Sheet (which may be redacted to delete the name of
the Third Party) to the applicable Sandoz Party (a "THIRD PARTY
TERM SHEET NOTICE"). Within [**] after receipt of a Third Party
Term Sheet Notice, such Sandoz Party shall indicate in writing
to Momenta whether it wishes to negotiate and enter into
definitive agreements reflecting the terms set forth in the
Third Party Term Sheet. If the Sandoz Party indicates within
such [**] period that it wishes to negotiate and enter into
definitive agreements, Momenta and such Sandoz Party shall in
good faith negotiate definitive agreements reflecting the terms
set forth in the Third Party Term Sheet. If, despite such good
faith negotiations, Momenta and the Sandoz Party have not
entered into such definitive agreements within [**] after such
Sandoz Party's receipt of the Third Party Term Sheet Notice (as
such period may be extended by mutual agreement of the Parties),
then Momenta shall be free to negotiate and enter into
definitive agreements reflecting the terms set forth in the
Third Party Term Sheet with the applicable Third Party. Momenta
shall not be obligated to reveal to the Sandoz Parties the
identity of any Third Party involved in any such transaction.
3.4.6 LICENSE TO MOMENTA. Momenta shall have the right to use
any and all preclinical, clinical, technical and other relevant
data, records, reports, information, materials and technology in
its possession or in the possession of the Sandoz Parties (to
the extent the Sandoz Parties have the right to transfer the
foregoing to Momenta) (including, without limitation,
manufacturing technology) that arises from and is used in the
Collaborative Program (collectively, "PROGRAM OUTPUT") in its
Development and Commercialization of the Product for any country
in the Non-U.S. Territory with respect to which a Sandoz Party
has not exercised the Non-U.S. Option prior to the expiration of
the Non-U.S. Option Period and for any country in the Non-U.S.
Territory with respect to which Momenta and a Sandoz Party have
not executed the Non-U.S. Territory Agreement either prior to
the expiration of the Initial Non-U.S. Territory Negotiation
Period or pursuant to Section 3.4.5. In the event that any item
of
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Program Output constitutes Sandoz IP, the Sandoz Parties
automatically grant to Momenta, upon the expiration of the
Non-U.S. Option Period and/or the expiration of the Initial
Non-U.S. Territory Negotiation Period, as applicable, a
non-exclusive, sublicenseable, royalty-free license under such
Sandoz IP to (a) Develop, make, have made, use, sell, offer to
sell, lease, import and export the Product in the Field in any
country in the Non-U.S. Territory with respect to which a Sandoz
Party has not exercised the Non-U.S. Option prior to the
expiration of the Non-U.S. Option Period and in any country in
the Non-U.S. Territory with respect to which Momenta and a
Sandoz Party have not executed the Non-U.S. Territory Agreement
either prior to the expiration of the Initial Non-U.S. Territory
Negotiation Period or pursuant to Section 3.4.5, and (b) make
and have made the Product anywhere in the world for the purpose
of sale of the Product in the Field into any country in the
Non-U.S. Territory with respect to which a Sandoz Party has not
exercised the Non-U.S. Option prior to the expiration of the
Non-U.S. Option Period and into any country in the Non-U.S.
Territory with respect to which Momenta and a Sandoz Party have
not executed the Non-U.S. Territory Agreement either prior to
the expiration of the Initial Non-U.S. Territory Negotiation
Period or pursuant to Section 3.4.5. Program Output shall
expressly exclude, and Momenta shall have no right to use or
share with any Third Party, any financial information (other
than total per-unit costs of the Product with no breakdown of
the components thereof), that was created, generated or compiled
pursuant to the Collaborative Program and otherwise pursuant to
this Agreement. Nothing in this Section 3.4.6 shall be
interpreted or construed to in any way license, authorize or
otherwise permit Momenta or any Third Party to use any Program
Output or practice any Sandoz IP in any manner that is
inconsistent with the Sandoz Parties' rights under this
Agreement.
3.5. EQUITY INVESTMENT. Momenta hereby grants to Sandoz a
non-exclusive option to invest between U.S.$5,000,000 and U.S.$10,000,000 in a
class of preferred stock of Momenta to be substantially equivalent to Momenta's
Series B Convertible Preferred Stock, U.S.$0.01 par value per share, at a
mutually agreed share price and subject to such obligations and restrictions,
and entitled to such rights and preferences, as those currently imposed and
bestowed on the holders of Momenta's Series B Convertible Preferred Stock. The
exercise of such option shall be subject to the execution of definitive
agreements containing the terms and conditions customary in such agreements and
the approval thereof by the respective boards of directors of Momenta and
Sandoz, and, to the extent applicable, by certain stockholders of Momenta. The
option granted by Momenta pursuant to this Section 3.5 shall expire unless such
definitive agreements are executed within ninety (90) days after the Effective
Date, as such date may be extended by mutual consent of Momenta and Sandoz. In
the event of the exercise by Sandoz of its option pursuant to this Section 3.5,
Momenta and Sandoz agree to negotiate such definitive agreements in good faith
and to use Commercially Reasonable Efforts to obtain all necessary approvals and
execute such definitive agreements prior to the expiration of such ninety-day
period.
3.6. SANDOZ AFFILIATES. The Sandoz Parties may permit any of their
Affiliates to exercise all or any portion of the rights of the Sandoz Parties
pursuant to this Article 3 and in
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such event, all applicable references to 'Sandoz,' a 'Sandoz Party' or the
'Sandoz Parties' shall be considered references to such Affiliate(s); PROVIDED
THAT any such Affiliate(s) agree to be bound by the restrictions and obligations
applicable to the Sandoz Parties pursuant to the applicable provisions of this
Article 3.
4. FINANCIAL PAYMENTS
4.1. CAPPED COSTS. Subject to the provisions of this Agreement, BCWI
shall be responsible for all Development Costs and Sandoz shall be responsible
for all Legal Expenses incurred by the Parties in performing their obligations
under this Agreement, up to a maximum of an aggregate of such Development Costs
and Legal Expenses of U.S.$[**] (the "COST CAP"). Within thirty (30) days after
the end of each Quarter during this Agreement, the Sandoz Parties shall provide
to Momenta a written report documenting any Capped Costs incurred by the Sandoz
Parties during such just-ended Quarter. Within thirty (30) days after the end of
each Quarter during this Agreement, Momenta shall provide to the Sandoz Parties
an invoice (together with supporting documentation) for any Capped Costs
incurred by Momenta during such just-ended Quarter (which, with respect to the
first Quarter under this Agreement, shall include the Pre-Existing Costs), and
payments will be due to be made to Momenta by the applicable Sandoz Party(ies)
for any Capped Costs incurred by Momenta within forty-five (45) days of receipt
of such invoice. Capped Costs shall be incurred by the Parties according to the
Annual Collaboration Plan. Any material deviation from the Annual Collaboration
Plan shall immediately be reported to the Joint Steering Committee.
4.2. FTE FUNDING. Momenta will provide [**] FTEs during the [**]
period commencing October 1, 2003 under this Agreement and [**] FTEs during the
following [**] period under this Agreement, devoted exclusively to efforts on
behalf and in furtherance of the Collaborative Program. As compensation for the
provision of such FTEs, BCWI shall pay Momenta, effective as of October 1, 2003,
at the FTE Rate. Additional FTEs, as mutually agreed to in the applicable Annual
Collaboration Plan, will be provided by Momenta, and paid for by BCWI (subject
to the provisions of Section 4.11.8) at the FTE Rate ("ADDITIONAL FTE'S").
Within thirty (30) days after the end of each Quarter during such time periods,
Momenta shall provide to BCWI a report of the number of FTEs actually devoted by
Momenta to the Collaborative Program during such just-ended Quarter and payments
will be due by BCWI within forty-five (45) days after receipt of such report,
based on the number of FTEs actually committed by Momenta to the Collaborative
Program during such Quarter at the FTE Rate, PRO RATA for such actual number of
FTEs. Momenta shall track the number of FTEs devoted to the Collaborative
Program on a monthly basis in accordance with Momenta's standard record-keeping
practices (including without limitation the use of at a minimum monthly
timesheets) (the "FTE RECORDS").
4.3. EXCESS COSTS. Subject to the provisions of Sections 4.11.8 and
11.5 and SCHEDULE 4.3, Sandoz shall bear responsibility for all Excess Costs.
Within fifteen (15) days after the end of each Quarter during this Agreement,
Momenta shall provide to Sandoz an invoice (together with supporting
documentation) for any Excess Costs paid by Momenta during such just-ended
Quarter, and payments will be due to be made to Momenta by Sandoz for any Excess
Costs paid by Momenta within forty-five (45) days of receipt of such invoice.
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4.4. COMMERCIALIZATION COSTS. Sandoz shall be responsible for all
Commercialization Costs. Momenta shall bear no responsibility for the
Commercialization Costs.
4.5. U.S. PROFIT INTEREST. In the event that, at the time of U.S.
Launch, there [**] (the "[**]Period"), then, subject to the provisions of
Section 4.9, for each Post-Launch Quarter during such [**] Period during which
Sandoz, its Affiliates or distributors is selling the Product in the U.S.
Territory, Sandoz shall pay Momenta an amount computed by multiplying [**]
percent ([**]%) times the Profits in the U.S. Territory during such Post-Launch
Quarter (the "PROFIT INTEREST"), which shall be adjusted pursuant to SCHEDULE
4.3. The [**] Period shall automatically terminate upon the existence of [**]
the U.S. Territory and the provisions of this Section 4.5 shall not apply
thereafter.
4.6. U.S. POST-[**] ROYALTY.
4.6.1 Upon termination of the [**] Period, Section 4.5 shall
no longer apply. Subject to the provisions of Section 4.8, if
such termination occurs after the [**] anniversary of the U.S.
Launch, then, following such termination (subject to the
provisions of Section 4.9), for each Post-Launch Quarter during
which Sandoz, its Affiliates or distributors is selling the
Product in the U.S. Territory (the "[**] PERIOD"), Sandoz shall
pay Momenta a royalty (the "[**][**] ROYALTY") as a percentage
of Net Sales of the Product in the U.S. Territory to be computed
according to the following table, by multiplying Net Sales in
the U.S. Territory for such Post-Launch Quarter times the
applicable percentage listed in the following table:
Net Sales in U.S. Territory
During a Post-Launch Year Royalty Rate
--------------------------- ------------
First U.S.$[**] Million in Net Sales in
the U.S. Territory [**]%
Over U.S.$[**] Million in Net Sales in
the U.S. Territory [**]%
4.6.2 The amounts payable under Section 4.6.1 shall be
adjusted pursuant to SCHEDULE 4.3.
4.7. U.S. [**] ROYALTY.
4.7.1 In the event that (a) at the time of U.S. Launch there
are [**] or (b) termination of the [**] Period occurs on or
before the [**] anniversary of the U.S. Launch (in which case,
upon such termination the provisions of Section 4.5 shall no
longer apply), then, subject to the provisions of Sections 4.8
and 4.9, for each Post-Launch Quarter during which Sandoz, its
Affiliates or distributors is selling the Product in the U.S.
Territory (the "[**] PERIOD"), Sandoz shall pay Momenta a
royalty (the "[**] ROYALTY") as a percentage of Net Sales of the
Product in the
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U.S. Territory to be computed according to the following table,
by multiplying Net Sales in the U.S. Territory for such
Post-Launch Quarter times the applicable percentage listed in
the table:
Net Sales in U.S. Territory During a
Post-Launch Year Royalty Rate
------------------------------------ ------------
First U.S.$[**] Million in Net Sales in the
U.S. Territory [**]%
Over U.S.$[**] Million in Net Sales in the
U.S. Territory [**]%
4.7.2 The amounts payable under Section 4.7.1 shall be
adjusted pursuant to SCHEDULE 4.3.
4.8. AVENTIS [**].
4.8.1 If the [**] Period (i) terminates because there is [**],
or (ii) never existed as a result of [**]; then (subject to the
provisions of Section 4.9) thereafter until such time as there
is [**] (the "Aventis [**]"), at which time the provisions of
Section 4.6 or Section 4.7, as applicable, shall govern, Sandoz
shall pay the Post-[**] Royalty during each Post-Launch Year (or
portion thereof) until such time as the total Profits for the
Product in the U.S. Territory for such Post-Launch Year (or
portion thereof) equal the Aventis [**], and thereafter, solely
with respect to any Profits exceeding the Aventis [**], during
the remainder of such Post-Launch Year, Sandoz shall pay Momenta
the Profit Interest with respect to such excess. The Aventis
[**] shall automatically terminate upon the existence of [**] in
the U.S. Territory and the provisions of this Section 4.8 shall
not apply thereafter.
4.8.2 The amounts payable under Section 4.8.1 shall be
adjusted pursuant to SCHEDULE 4.3.
4.9. ALLOCATION BETWEEN PERIODS. In the event that a termination of
the [**] and/or the Aventis [**] falls on a day other than the first day of a
Post-Launch Quarter, the Profit Interest and Post-[**] Royalty or [**] Royalty,
as the case may be, for such Post-Launch Quarter shall be paid for such
Post-Launch Quarter based upon the actual Net Sales made during such Post-Launch
Quarter under the [**] Period, the Aventis [**] and/or the Post-[**] Royalty
Period or [**] Royalty Period, as the case may be.
4.10. MILESTONE PAYMENTS.
4.10.1 REGULATORY MILESTONE PAYMENT. The Sandoz Parties shall
pay Momenta a one-time non-creditable, non-refundable milestone
payment equal to [**] Dollars (U.S.$[**]) ("REGULATORY MILESTONE
PAYMENT") on the earlier of (a) Final Legal Clearance or (b)
U.S. Launch; PROVIDED, HOWEVER, THAT the Regulatory Milestone
Payment is payable only if (i) Sandoz receives ANDA Final
Approval for an
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ANDA filed by Sandoz or any of its Affiliates for the Product
before any Third Party (other than [**]) receives ANDA Final
Approval for an ANDA filed by such Third Party for a
Lovenox(R)-Equivalent Product, and (ii) (A) if U.S. Launch
occurs prior to Final Legal Clearance, there is [**] in the U.S.
Territory at the time of U.S. Launch, or (B) if Final Legal
Clearance occurs prior to U.S. Launch, no Third Party (other
than [**]) has received ANDA Final Approval for an ANDA filed by
such Third Party for a Lovenox(R)-Equivalent Product at the time
of Final Legal Clearance.
4.10.2 COMMERCIAL MILESTONE PAYMENTS.
a. The Sandoz Parties shall pay Momenta the following
milestone payments (the "FULL MILESTONE PAYMENTS") (as
shall be adjusted pursuant to SCHEDULE 4.3, the
"COMMERCIAL MILESTONE PAYMENTS"); PROVIDED THAT each
such milestone payment shall be payable only if (i)
Sandoz has sold the Product during the twelve (12)
months immediately preceding the events described below,
or Sandoz's failure to sell the Product during such
period is a breach of this Agreement, and (ii) as of
each anniversary described below, there is [**] in the
U.S. Territory:
Milestone Event Amount of Milestone
-------------- -------------------
[**] anniversary of U.S. Launch U.S.$[**]
[**] anniversary of U.S. Launch U.S.$[**]
[**] anniversary of U.S. Launch U.S.$[**]
[**] anniversary of U.S. Launch U.S.$[**]
[**] anniversary of U.S. Launch U.S.$[**]
b. Each Commercial Milestone Payment shall be made within
forty-five (45) days after the end of the applicable
Post-Launch Quarter in which the Milestone Event
referenced in the above table occurs; PROVIDED, HOWEVER,
that if any Milestone Event occurs prior to Final Legal
Clearance, the applicable Commercial Milestone Payment
for such Milestone Event shall be made within forty-five
(45) days after the end of the Post-Launch Quarter in
which Final Legal Clearance occurs. For purposes of this
Agreement, each such Post-Launch Quarter when a
Commercial Milestone Payment is actually made shall be a
"MILESTONE PAYMENT QUARTER". For example, if Final Legal
Clearance occurs midway between the [**] and [**]
anniversary of U.S. Launch, the first two (2) Commercial
Milestone Payments shall be due 45 days after the end of
the Post-Launch Quarter in which Final Legal Clearance
occurs. For the avoidance of doubt, if Final Legal
Clearance does not occur during the Term, no Commercial
Milestone Payment(s) shall be due to Momenta.
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4.11. PAYMENT/ACCOUNTING.
4.11.1 TIME AND MANNER OF PAYMENT OF ROYALTIES. The Sandoz
Parties (and/or Momenta in the event Section 11.6.3 applies)
shall report the amount of Product sold in each Post-Launch
Quarter, the gross amount invoiced, the deductions used in the
calculation of Net Sales, the applicable Manufacturing Costs and
the resulting calculation of Profit Interest or royalties due to
Momenta (or the Sandoz Parties, as applicable), within
forty-five (45) days after the end of such Post-Launch Quarter.
With each such report, the Sandoz Parties (or Momenta, as
applicable) shall pay the amount of Profit Interest or royalties
due. If no Profit Interest or royalties are due, the report
shall so state. Reports shall provide a reconciliation showing
the amount due.
4.11.2 COMPUTATION. All payments due shall be payable in United
States dollars. Such payments shall be without deduction of
exchange, collection, or other charges, and, specifically,
without deduction of withholding or similar taxes or other
government imposed fees or taxes, except as otherwise permitted
in the definition of "Net Sales" or by this Section 4.11.
4.11.3 INTEREST. Interest shall be payable on the aggregate
amount of any payments that are not paid on or before the date
such payments are due under this Agreement at a rate per annum
equal to the lesser of (a) two percentage points above the prime
rate of interest, as reported by THE WALL STREET JOURNAL for the
applicable period, or (b) the highest rate permitted by
applicable law, in each case calculated on the number of days
such payments are paid after the date they are due.
4.11.4 RECORD KEEPING. The Sandoz Parties and Momenta shall
keep, and shall require their Affiliates, distributors,
licensees and sublicensees to keep, accurate and complete
accounting records of the Products sold under this Agreement
("PRODUCT RECORDS") appropriate to determine the amount of
Profit Interest or royalties due hereunder and to support the
reports made pursuant to Section 4.11.1. Such records shall be
retained for at least five (5) years following a given reporting
period.
4.11.5 SANDOZ AUDIT. Upon sixty (60) days' prior written
notice, the Sandoz Parties shall permit their books and records
of Capped Costs, Excess Costs and Product Records to be examined
for a particular calendar year, no more than once annually,
during normal business hours, by an independent auditor
appointed by Momenta and reasonably acceptable to the Sandoz
Parties, and at Momenta's expense, to the extent necessary to
verify the accuracy of the Profit Interest and royalty reports
delivered by the Sandoz Parties under this Agreement. Any
information received as a result of such inspection shall be
maintained as the Sandoz Parties' Confidential Information.
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4.11.6 MOMENTA AUDIT. Upon sixty (60) days' prior written
notice, Momenta will permit its books and records of Capped
Costs, Excess Costs, the FTE Records and Product Records to be
examined for a particular calendar year, no more than once
annually, during normal business hours, by an independent
auditor appointed by Sandoz (on behalf of itself and BCWI) and
reasonably acceptable to Momenta, and at Sandoz's expense, to
the extent necessary to verify the accuracy of the invoices and
royalty reports delivered by Momenta under this Agreement. Any
information received as a result of such inspection shall be
maintained as Momenta's Confidential Information.
4.11.7 UNDERPAYMENT/OVERPAYMENT AND PAYMENT DISPUTES. In the
event an examining auditor specified in Sections 4.11.5 or
4.11.6 concludes that an underpayment or overpayment was made,
the auditor will specify such in a written report along with the
information on which such conclusion is based. This report will
be shared promptly with the audited Party. The amount of any
such underpayment or the reimbursement of any such overpayment
shall be due and payable by the audited Party within forty-five
(45) days of the date of such report, PROVIDED THAT if a Party
disputes the conclusion of the auditor, the Parties will resolve
the dispute according to Article 13. If the underpayment by the
audited Party or the overpayment by the auditing Party differs
by greater than five percent (5%) from the amount that was
otherwise due, the audited Party shall pay all of the costs of
such review, together with interest calculated on the amount of
such underpayment or overpayment in the manner provided in
Section 4.11.3.
4.11.8 RELATIONSHIP BETWEEN THE SANDOZ PARTIES. As between
Sandoz and BCWI, (a) BCWI shall bear responsibility for all
Development Costs to the extent such Development Costs are part
of Capped Costs and for FTE costs for the first fifteen (15)
FTEs in accordance with Section 4.2; (b) Sandoz shall bear
responsibility for all payments under Sections 4.3, 4.4, 4.5,
4.6, 4.7 and 4.8, unless Sandoz otherwise makes arrangements
with BCWI for any such payments; and (c) the Sandoz Parties
shall bear responsibility for all payments under Section 4.10.
Sandoz and BCWI are permitted to enter into an agreement between
themselves pursuant to which each Sandoz Party shall bear its
portion of the Profit Interest and royalties due to Momenta
pursuant to this Agreement and for payment of Development Costs
that are part of Excess Costs and for Additional FTEs. Sandoz
shall guarantee all obligations of BCWI under this Agreement,
other than those obligations guaranteed by Sandoz GmbH, as set
forth on the signature page of this Agreement.
4.12. TRUE-UP. Notwithstanding any other provision of this Agreement,
the Parties agree that for a two-year period after the end of the Term, the
Sandoz Parties shall submit to Momenta, on a quarterly basis within forty-five
(45) days following the close of each Quarter, a schedule showing any adjustment
to the calculations of the Profits from the Product and Net Sales, and the
resulting adjustment to payments made to Momenta hereunder, which occurred in
such Quarter, and the Party owing any amounts pursuant to such reconciliation
shall, within forty-five (45) days of the receipt of such reconciliation, submit
payment to the other Party.
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5. JOINT DEVELOPMENT AND COMMERCIALIZATION
5.1. JOINT COLLABORATION. Sandoz and Momenta, and, to the extent
appropriate, BCWI, shall jointly collaborate in the Development and
Commercialization of the Product and the Legal Activities, using Commercially
Reasonable Efforts to Develop the Product, to achieve Legal Clearance, to bring
the Product to the market in the U.S. Territory within a commercially reasonable
time period (subject to the provisions of Section 6.2.1) and to Commercialize
the Product in the U.S. Territory. Sandoz shall be responsible for ensuring that
representatives of BCWI participate in the Development and Commercialization
activities and the Legal Activities as appropriate.
5.2. JOINT PROJECT TEAM. The Development and Commercialization
activities and Legal Activities shall be conducted and managed on a day-to-day
basis through a Joint Project Team ("JOINT PROJECT TEAM" or "JPT"). Momenta and
Sandoz shall each appoint one (1) Project Leader promptly following the
Effective Date and may change its Project Leader at any time by giving written
notice to the other. The JPT shall consist of three (3) (or such other mutually
agreed number) representatives from each of Sandoz and Momenta (including each
Party's then-current Project Leader), which representatives shall be directly
involved with and responsible for Development and Commercialization activities
and Legal Activities. Promptly after the Effective Date, Momenta and Sandoz
shall each appoint its representatives to the JPT. Momenta and Sandoz may each
change its JPT representatives at any time by giving written notice to the
other. The JPT shall meet within thirty (30) days after the Effective Date and,
thereafter, at least quarterly during the course of the Collaborative Program.
Additional representatives of a Party may attend meetings of the JPT on an AD
HOC invited basis as appropriate.
5.3. JPT RESPONSIBILITIES. Except as provided in Sections 5.10, 6.1
and 6.2.1, the JPT shall be responsible for: (a) directing all day-to-day
aspects of the Development and Commercialization of, and the Legal Activities
with respect to, the Product; (b) preparing and submitting to the Joint Steering
Committee ("JOINT STEERING COMMITTEE" or "JSC") an Annual Collaboration Plan for
each Contract Year; (c) discussing and resolving ongoing issues; and (d)
periodically reporting to the JSC and referring any disputes not resolved by the
JPT to the JSC for resolution. The JPT shall only act unanimously and each
Party, acting through its representatives, shall have one vote on the JPT.
Within thirty (30) days after each meeting, the Project Leaders will jointly
provide the JSC with a written report describing, in reasonable detail, the
status of the Collaborative Program and the Development and Commercialization
of, and Legal Activities with respect to, the Product, including, without
limitation, a summary of the results and progress to date, the status of the
then-current budget in the Annual Collaboration Plan (actuals vs. estimates),
project timelines, critical path issues and any other issues requiring
resolution, proposed solutions to such issues, and the agreed resolution of
previously reported issues.
5.4. JOINT STEERING COMMITTEE. The JSC shall consist of six (6)
members, three (3) representatives from each of Sandoz and Momenta, each of whom
shall have experience and seniority sufficient to enable him or her to make
decisions on behalf of the Party he or she represents. Promptly after the
Effective Date, Momenta and Sandoz shall each appoint its
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representatives to the JSC. Momenta and Sandoz may each change its JSC
representatives at any time by giving written notice to the other.
5.5. JSC ADMINISTRATION. The JSC shall appoint a chairperson from
among its members, which shall rotate annually between the representatives from
Sandoz and the representatives from Momenta. The chairperson shall be
responsible for calling meetings of the JSC and for leading the meetings. A JSC
member of the Party hosting a meeting of the JSC (or someone designated by the
JSC) shall serve as secretary of that meeting. The secretary of the meeting
shall prepare and distribute to all members of the JSC draft minutes of the
meeting within thirty (30) days following the meeting to allow adequate review
and comment. Such minutes shall provide a description in reasonable detail of
the discussions held at the meeting and a list of any actions, decisions or
determinations approved by the JSC. Minutes of each JSC meeting shall be
approved or disapproved, and revised as necessary, at the next meeting. Final
minutes of each meeting shall be distributed to the members of the JSC by the
chairperson.
5.6. JSC MEETINGS. The location of meetings of the JSC shall
alternate between Sandoz's principal place of business and Momenta's principal
place of business, or as otherwise agreed by the Parties. The JSC may also meet
by means of a telephone conference call or videoconference. Each Party shall use
reasonable efforts to cause its representatives to attend the meetings of the
JSC. If a representative of a Party is unable to attend a meeting, such Party
may designate an alternate to attend such meeting in place of the absent
representative. In addition, each of Momenta and Sandoz may, at its discretion,
invite non-voting employees, and, with the consent of Sandoz and Momenta,
respectively, consultants or scientific advisors, to attend the meetings of the
JSC to, among other things, review and discuss the Collaborative Program and its
results. Either Momenta or Sandoz may convene a special meeting of the JSC for
the purpose of resolving disputes.
5.7. JSC RESPONSIBILITIES. Except as provided in Sections 5.10, 6.1
and 6.2.1, the JSC shall be responsible for: (a) overseeing the Development and
Commercialization activities and Legal Activities under the Collaborative
Program (including, without limitation, (i) determining the strategy to achieve
Legal Clearance, such as the decision regarding which Locked Manufacturing
Process to employ, (ii) determining the enforcement strategy with respect to the
Joint Collaboration IP, and (iii) determining the patent prosecution and
enforcement strategy with respect to those Product-Specific Patent Rights
relevant to the exercise by Sandoz of the licenses granted in Section 2.1); (b)
providing overall guidance to the JPT; (c) approving the Annual Collaboration
Plan or any changes thereto, including without limitation, the budget contained
therein pursuant to Section 5.8 and any changes thereto; (d) reviewing progress
toward milestones in the Annual Collaboration Plan; (e) attempting to resolve
disputes; and (f) performing such other tasks and undertaking such other
responsibilities as are set forth in this Agreement. The JSC shall only act
unanimously and each of Momenta and Sandoz, acting through its representatives,
shall have one vote on the JSC. The JSC shall meet within thirty (30) days after
the Effective Date and, thereafter, at least quarterly during the course of the
Collaborative Program. Within thirty (30) days after each meeting, the persons
appointed by the JSC will provide Sandoz (on behalf of Sandoz and BCWI) and
Momenta with a written report describing, in reasonable detail, the status of
the Collaborative Program and the Development and Commercialization of, and
Legal Activities with respect to, the Product, a summary of the
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results and progress to date, any issues requiring resolution, and the agreed
resolution of previously reported issues. Disputes shall be resolved pursuant to
Article 13.
5.8. ANNUAL COLLABORATION PLAN. The Parties shall undertake the
Collaborative Program in accordance with the Annual Collaboration Plans. The JPT
shall prepare the Annual Collaboration Plan (a) for the First Contract Year
within thirty (30) days after the Effective Date, (b) for the Second Contract
Year at least sixty (60) days prior to the commencement of such Contract Year,
and (c) for the Third Contract Year and subsequent Contract Years at least
ninety (90) days prior to the commencement of such Contract Year. The JSC shall
review and approve the Annual Collaboration Plan (i) for the First Contract Year
within forty-five (45) days after the Effective Date, (ii) for the Second
Contract Year at least thirty (30) days prior to the commencement of such
Contract Year, and (iii) for the Third Contract Year and subsequent Contract
Years at least sixty (60) days prior to the commencement of such Contract Year.
The JPT shall prepare, and the JSC shall review and approve, updates and
amendments, as appropriate, to the then-current Annual Collaboration Plan during
the course of the applicable Contract Year. Each Annual Collaboration Plan shall
be consistent with the other terms and conditions of this Agreement. Each Annual
Collaboration Plan shall specify, among other things, (A) specific objectives of
the Collaborative Program during the applicable Contract Year, (B) specific
activities to be performed by each Party, or by Third Parties, in support of the
Collaborative Program during the applicable Contract Year, and (C) a budget
reflecting the resources (including FTEs) to be assigned and amounts expended by
each Party in support of the Collaborative Program. In particular, to support
the Development and Commercialization of, and Legal Activities with respect to,
the Product, the Annual Collaboration Plan shall specify the activities to be
performed by each Party, or by Third Parties, and the related resources
(including FTEs) to be assigned and the strategic marketing plan for the Product
in the U.S. Territory. In preparing the initial Annual Collaboration Plan, the
JPT shall assign specific activities to the relevant Party(ies). While all
activities will be considered joint activities within the collaboration, the JPT
shall assign specific activities to the relevant Party(ies) to execute. SCHEDULE
5.8 provides a preliminary list of activities to be included in the Annual
Collaboration Plan, along with a preliminary assignment of the Party(ies)
responsible for each activity. The Annual Collaboration Plan, to be approved by
the JSC, will include a complete list of activities and the assignment of the
relevant Party(ies) for each such activity. While a given Party may be assigned
the lead responsibility for an activity, it will be the responsibility of such
Party to achieve cross-company alignment on the strategy and the plans to
complete the activity consistent with the integrated strategy as defined in the
Annual Collaboration Plan.
5.9. COMPLIANCE WITH LAWS. Each Party agrees to use Commercially
Reasonable Efforts to carry out all work assigned to such Party in the Annual
Collaboration Plan and its other obligations under this Agreement in material
compliance with all applicable federal, state or local laws, regulations and
guidelines governing the conduct of such work, including, without limitation,
(a) the FD&C Act and any applicable implementing regulations; (b) cGMPs; (c) all
other applicable FDA guidelines; (d) all other applicable laws, including all
applicable U.S., federal, state, foreign and local environmental, health and
safety laws in effect at the time and place of manufacture of a Product; and (e)
all applicable export and import control laws.
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5.10. LEGAL CLEARANCE. Sandoz shall have sole responsibility to make
decisions with respect to Legal Clearance (except with respect to the
determination of whether Legal Clearance has occurred, which shall be determined
in accordance with the definitions herein of District Court Legal Clearance and
Final Legal Clearance); PROVIDED THAT such decisions are generally consistent
with the strategy set therefor by the JSC, and subject to the provisions of
Section 13.2.
6. COMMERCIALIZATION BY SANDOZ
6.1. REVIEW AND OVERSIGHT. Other than with respect to Section 6.2.1,
which shall be in the sole discretion of Sandoz, all responsibilities of the
Parties with respect to Commercialization of the Product shall be subject to the
oversight and review of the Joint Project Team and the Joint Steering Committee
as set forth in Article 5. Notwithstanding Section 5.8 or any other provision of
this Agreement, Sandoz and its Affiliates (or, with respect to Section 11.6.1,
Momenta, its Affiliates and sublicensees) shall have the sole discretion and
exclusive authority to set the prices for the Product sold to Third Parties. The
Parties shall agree upon the trademark to be used for the Product, which shall
not include any trademark or tradename or a part thereof that uses the name
"Novartis" or "Sandoz" or a derivative thereof or any other trademark or part or
derivative thereof that is the name or derivative of a name of any other Sandoz
Affiliate.
6.2. PRE FINAL LEGAL CLEARANCE LAUNCH.
6.2.1 Notwithstanding any other provision in this Agreement,
the Parties agree that, if ANDA Final Approval for an ANDA filed
by Sandoz or any of its Affiliates for the Product has been
obtained and a District Court Decision has been obtained but
Final Legal Clearance has not yet been obtained, Sandoz may, in
its sole discretion, decide whether to proceed with U.S. Launch,
or to defer U.S. Launch until Final Legal Clearance. Upon
deciding to proceed with Pre Final Legal Clearance Launch,
Sandoz shall promptly notify Momenta of such decision and shall
use Commercially Reasonable Efforts to Commercialize the
Product.
6.2.2 Notwithstanding anything else herein to the contrary,
the Parties agree that, consistent with the provisions of
Section 12.1(c), Sandoz shall bear, and Momenta shall not be
responsible for, any damages of Aventis in the event that Sandoz
or its Affiliates are held liable for [**] under Patent
Litigation, other than with respect to Momenta's responsibility
for a portion of Settlement Costs pursuant to the provisions of
Section 4.3.
7. REGULATORY MATTERS
7.1. REVIEW AND OVERSIGHT. All responsibilities under this Article 7
shall be subject to the review and oversight of the Joint Project Team and the
Joint Steering Committee as set forth in Article 5.
7.2. ANDA FILING. Sandoz shall file an ANDA for the Product in
accordance with the Annual Collaboration Plans. The ANDA for the Product shall
be filed with the FDA by Sandoz under Sandoz's name. If the ANDA for the Product
includes a certification pursuant to 21
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U.S.C. 355(b)(2)(iv) or 355(j)(2)(A)(vii), Sandoz shall also provide to the
applicable Aventis Person notice, as required by 21 USC Section 355(b)(3) or 21
U.S.C. Section 355(j)(2)(B), respectively.
7.3. OWNERSHIP OF THE ANDAs. Sandoz shall own all ANDAs for the
Product and all rights in all data supporting the ANDAs for the Product.
7.4. ANDA RESPONSIBILITY. The JSC shall determine the
responsibilities of each Party with respect to the preparation of the ANDAs for
the Product and related activities.
7.5. REGULATORY INTERACTION. The JSC shall determine the
responsibilities of each Party with respect to interactions with the FDA with
respect to the Product; PROVIDED, HOWEVER, THAT Sandoz shall interact with the
FDA with respect to adverse event reporting obligations.
8. INTELLECTUAL PROPERTY
8.1. OWNERSHIP.
8.1.1 SINGLE OWNERSHIP. As between Momenta and the Sandoz
Parties, the Sandoz Parties shall own all Sandoz IP and Momenta
shall own all Momenta IP. Momenta hereby assigns to the Sandoz
Parties all right, title and interest in and to any Improvements
to Sandoz Know-How or Improvements to Sandoz Collaboration
Know-How that are conceived and reduced to practice or developed
solely by Momenta or its Affiliates, or jointly by a Sandoz
Party or its Affiliates, on the one hand, and by Momenta or its
Affiliates, on the other hand, during, and in the conduct of,
the Collaborative Program ("MOMENTA ASSIGNED IMPROVEMENTS").
Each of Sandoz and BCWI hereby assigns to Momenta all right,
title and interest in and to any Improvements to Momenta
Know-How or Improvements to Momenta Collaboration Know-How that
are conceived and reduced to practice or developed solely by
Sandoz or BCWI, or jointly by Sandoz or BCWI, on the one hand,
and by Momenta or its Affiliates, on the other hand, during, and
in the conduct of, the Collaborative Program ("SANDOZ ASSIGNED
IMPROVEMENTS"). The assigning Party shall execute all documents
necessary to effectuate this Section 8.1.1. Notwithstanding
anything to the contrary herein, BCWI, with respect to the
Sandoz IP, and Momenta, with respect to the Momenta IP, shall
have the right to assign the Sandoz IP, in the case of BCWI, or
the Momenta IP, in the case of Momenta, to its respective
Affiliates, without the consent of the other Party, or to Third
Parties, with the consent of the other Party, such consent not
to be unreasonably withheld, so long as any such assignment
pursuant to this sentence is subject to the licenses granted
pursuant to this Agreement and is otherwise consistent with this
Agreement.
8.1.2 Momenta hereby grants to Sandoz and BCWI an irrevocable,
perpetual, non-exclusive, royalty-free, sublicensable license to
practice the Sandoz Assigned Improvements outside of the Field.
Each Sandoz Party hereby grants to Momenta an irrevocable,
perpetual, non-exclusive, royalty-free, sublicensable license to
practice the Momenta Assigned Improvements outside of the Field.
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8.1.3 JOINT OWNERSHIP. All Joint Collaboration IP shall be
owned jointly on the basis of an undivided one-half interest by
BCWI and Momenta. Notwithstanding anything to the contrary
herein, BCWI and Momenta shall each have the right to sell,
license or otherwise transfer such Joint Collaboration IP to its
Affiliates or any Third Party without the consent of the other
Party so long as such sale, license or transfer is subject to
the licenses granted pursuant to this Agreement and is otherwise
consistent with this Agreement.
8.1.4 INVENTORSHIP. Inventorship shall be determined by the
Parties in good faith in accordance with relevant patent laws.
In the event of a dispute regarding inventorship or the
ownership of Collaboration Know-How that the Parties are unable
to resolve, mutually acceptable outside patent counsel not
regularly employed by any Party or their Affiliates shall be
retained to resolve such dispute.
8.1.5 POLICIES. In order to protect the Parties' Patent Rights
under United States laws in any inventions conceived or reduced
to practice during or as a result of the Collaborative Program,
each Party agrees to maintain a policy that requires its
employees, individual contractors, consultants and agents to
record and maintain all data and information developed in the
course of the Collaborative Program in such a manner as to
enable the Parties to use such records to establish the earliest
date of conception, invention and/or to document diligent
reduction to practice. At a minimum, the policy shall require
such individuals to record all inventions generated by them in
standard laboratory notebooks that are dated and corroborated by
non-inventors on a regular, contemporaneous basis.
8.2. PATENT PROSECUTION.
8.2.1 MOMENTA PATENT RIGHTS. Subject to any contractual
obligations to, or restrictions imposed by, Momenta's Third
Party licensors, Momenta shall use Commercially Reasonable
Efforts to timely prepare, file, prosecute and maintain, at its
expense, Momenta Patent Rights and Momenta Collaboration Patent
Rights (in each case, other than any Product-Specific Patent
Rights relevant to the exercise by the Sandoz Parties of the
licenses granted in Section 2.1) in the United States and
throughout the world.
8.2.2 SANDOZ PATENT RIGHTS. Subject to any contractual
obligations to, or restrictions imposed by, the Sandoz Parties'
Third Party licensors, the Sandoz Parties shall use Commercially
Reasonable Efforts to timely prepare, file, prosecute and
maintain, at its expense, Sandoz Patent Rights and Sandoz
Collaboration Patent Rights (in each case, other than any
Product-Specific Patent Rights relevant to the exercise by the
Sandoz Parties of the licenses granted in Section 2.1) in the
United States and throughout the world.
8.2.3 JOINT PATENT RIGHTS. Subject to any contractual
obligations to, or restrictions imposed by, the Parties' Third
Party licensors, the JSC shall make all decisions regarding
whether and how to file, prosecute and maintain any Joint
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Collaboration Patent Rights (other than any Product-Specific
Patent Rights), including without limitation, the ability of
Momenta or a Sandoz Party, as the case may be, to assume control
of the filing, prosecution or maintenance of such Joint
Collaboration Patent Rights in the name of the Sandoz Parties or
Momenta, respectively, if the Sandoz Parties or Momenta,
respectively, decline to file, prosecute or maintain such Joint
Collaboration Patent Rights, elect to allow any such Joint
Collaboration Patent Rights to lapse or elect to abandon any
such Joint Collaboration Patent Rights before all appeals within
the respective patent office have been exhausted; PROVIDED,
HOWEVER, THAT, in the event of a dispute with respect to such
decisions that the Parties are unable to resolve, mutually
acceptable outside patent counsel not regularly employed by any
Party or their Affiliates shall be retained to resolve such
dispute.
8.2.4 PRODUCT-SPECIFIC PATENT RIGHTS. Subject to any
contractual obligations to, or restrictions imposed by, the
Parties' Third Party licensors, the JSC shall make all decisions
regarding whether and how to file, prosecute and maintain any
Product-Specific Patent Rights relevant to the exercise by the
Sandoz Parties of the licenses granted in Section 2.1, including
without limitation, the ability of Momenta or a Sandoz Party, as
the case may be, to assume control of the filing, prosecution or
maintenance of such Product-Specific Patent Rights of the Sandoz
Parties or Momenta, respectively, in the name of the Sandoz
Parties or Momenta, respectively, if the Sandoz Parties or
Momenta, respectively, decline to file, prosecute or maintain
such Product-Specific Patent Rights, elect to allow any such
Product-Specific Patent Right to lapse or elect to abandon any
such Product-Specific Patent Right before all appeals within the
respective patent office have been exhausted; PROVIDED, HOWEVER,
THAT, in the event of a dispute with respect to such decisions
that the Parties are unable to resolve, mutually acceptable
outside patent counsel not regularly employed by any Party or
their Affiliates shall be retained to resolve such dispute.
8.2.5 COOPERATION AND ASSISTANCE. The Parties agree to
cooperate with each other and render all reasonable assistance
as may be necessary to support any patent application filed by
another Party under this Section 8.2, including, but not limited
to, consulting and coordinating with each other on any such
patent filing activities to ensure that any Patent Rights or
Confidential Information are not unduly compromised.
8.3. PARTICIPATION OF OTHER PERSONS.
8.3.1 Each of the Sandoz Parties and Momenta shall be
responsible for executing an appropriate agreement with each
employee, individual contractor, consultant or agent (including,
for purposes of clarity, individuals who regularly work for
Affiliates of the Sandoz Parties or Momenta) working on their
respective behalves on the Collaborative Program, including a
provision requiring such employee, individual contractor,
consultant or agent to assign to a Sandoz Party or Momenta,
respectively, all Know-How and Patent Rights which he or she
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develops or conceives and/or reduces to practice during his or
her work on the Collaborative Program so that such Know-How and
Patent Rights are Controlled by such Sandoz Party or Momenta,
respectively.
8.3.2 In the event that a Sandoz Party elects to contribute
any Know-How of an Affiliate of such Sandoz Party and any
associated Patent Rights to the Collaborative Program, such
Sandoz Party shall be responsible for executing an appropriate
agreement with such Affiliate requiring such Affiliate to assign
to such Sandoz Party, or to exclusively license to such Sandoz
Party in the Field, all such Know-How and/or Patent Rights so
that such Know-How and/or Patent Rights are Controlled by such
Sandoz Party. For purposes of clarity, the decision whether or
not to contribute any such Know-How and associated Patent Rights
for use in the Collaborative Program shall be in the sole
discretion of such Sandoz Party.
8.3.3 Except as the Parties may otherwise agree in writing,
each of the Sandoz Parties and Momenta shall be responsible for
executing an appropriate agreement with each Affiliate or Third
Party contracting entity working on their respective behalves on
the Collaborative Program, including a provision requiring such
entity to assign to such Sandoz Party or Momenta, respectively,
or exclusively license to such Sandoz Party or Momenta,
respectively, in the Field, all Know-How and Patent Rights with
respect to the Field which such entity develops or conceives
and/or reduces to practice during its work on the Collaborative
Program so that such Know-How and Patent Rights are Controlled
by such Sandoz Party or Momenta, respectively.
8.3.4 Each Party shall use Commercially Reasonable Efforts to
enforce the terms of their respective agreements described in
Sections 8.3.1, 8.3.2 and 8.3.3.
8.4. ENFORCEMENT OF NON-PRODUCT-SPECIFIC PATENT RIGHTS.
8.4.1 INITIAL RIGHTS. Subject to any contractual obligations
to, or restrictions imposed by, its Third Party licensors, the
Owning Party shall have the initial right, but not the
obligation, to institute an infringement action or take other
appropriate action that it believes is reasonably required to
protect the Owning Party's IP (other than any Product-Specific
Patent Rights relevant to the exercise by the Sandoz Parties of
the licenses granted in Section 2.1) from infringement in the
Field, when, from its own knowledge or upon notice from another
Party, the Owning Party becomes aware of the reasonable
probability that such infringement exists in the Field. With
respect to infringement in the Field in the U.S. Territory, the
Non-Owning Party may at any time join in any infringement action
brought by the Owning Party and may be represented by counsel of
its choice, but control of such action shall remain with the
Owning Party. Each other Party shall join in any infringement
action as a party at the Owning Party's request in the event
that an adverse party asserts, or the Owning Party determines in
good faith, that a court lacks jurisdiction based on such other
Party's absence as a party in such suit.
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8.4.2 STEP-IN RIGHTS. Subject to any contractual obligations
to, or restrictions imposed by, the Owning Party's Third Party
licensors, in the event that the Owning Party shall not, within
six (6) months of written notice from another Party of a
suspected infringement of the Owning Party's IP (other than any
Product-Specific Patent Rights relevant to the exercise by the
Sandoz Parties of the licenses granted in Section 2.1) by a
Third Party making, using, selling, offering to sell or
importing a product in the Field in the U.S. Territory, commence
and vigorously pursue an action to enjoin such infringement, the
Non-Owning Party shall be entitled, at its expense, to commence
the action in its name; PROVIDED, HOWEVER, THAT the Non-Owning
Party shall consult with the Owning Party with respect to such
action and shall give due consideration to the Owning Party's
advice and the Owning Party's intellectual property protection
strategy. The Owning Party shall join in any infringement action
as a party, at the request of the Non-Owning Party, in the event
that the court rules or other laws then applicable shall require
the joinder of the Owning Party as the owner of the Owning
Party's IP (other than any Product-Specific Patent Rights
relevant to the exercise by the Sandoz Parties of the licenses
granted in Section 2.1) for purposes of prosecuting such
infringement action, but shall have no obligation to actively
participate or incur expenses beyond the minimum level necessary
to appear for the purpose of sustaining jurisdiction.
8.4.3 COSTS. Each Party shall assume and pay all of its own
out-of-pocket costs incurred in connection with any litigation
or proceedings described in this Section 8.4, including, without
limitation, the fees and expenses of such Party's counsel.
8.4.4 RECOVERIES. Subject to any contractual obligations to,
or restrictions imposed by, the Owning Party's Third Party
licensors, any recovery obtained by a Party(ies) as a result of
any proceeding described in this Section 8.4 or from any
counterclaim or similar claim asserted in a proceeding described
in Section 8.5, by settlement or otherwise, shall be applied as
follows:
a. First, to reimburse each Party for all
litigation costs in connection with such
proceeding paid by that Party (on a pro rata
basis based on each Party's respective
litigation costs, to the extent the recovery was
less than all such litigation costs); and
b. Second, the remainder of the recovery shall be
paid [**] percent ([**]%) to the Sandoz Parties
and [**] ([**]%) to Momenta.
8.4.5 COOPERATION; SETTLEMENTS. In the event that any Party
takes action pursuant to this Section 8.4, each other Party
shall cooperate with the Party so acting to the extent
reasonably possible, including the joining of suit as required
by this Agreement or as otherwise desirable. No Party
participating in such suit shall settle or compromise any claim
or proceeding relating to another Party's Patent Rights or
Know-How without obtaining the prior written consent of such
other Party, such consent not to be unreasonably withheld, it
being understood that the consent of a Third Party licensor of
such other Party may also be required
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in order to settle or compromise any claim or proceeding
relating to such Party's Patent Rights or Know-How.
8.5. CLAIMED INFRINGEMENT. In the event that a Party becomes aware
that the manufacture, use, sale, offer to sell or importation of the Product
infringes, or is likely to or is alleged to infringe, the Patent Rights or
Know-How of any Third Party, such Party shall promptly notify the other Parties
in writing, and, with respect to activities undertaken pursuant to this
Agreement, the Parties shall cooperate and shall mutually agree, through the
JSC, upon an appropriate course of action and shall act in accordance with such
JSC-approved course of action; PROVIDED, HOWEVER, that, to the extent that any
action would involve the enforcement of a Party's Patent Rights or the defense
of an Invalidity Claim with respect to a Party's Patent Rights, the general
concepts of Section 8.4 shall apply to the enforcement of such Party's Patent
Rights or the defense of such Invalidity Claim (i.e., the Owning Party shall
have the initial right, and the Non-Owning Party shall have a step-in right in
the case of claims in the Field in the U.S. Territory, to enforce or defend).
Each Party shall provide to each other Party copies of any notices it receives
from Third Parties regarding any patent nullity actions, any declaratory
judgment actions, or any alleged infringement or misappropriation of Momenta IP,
Sandoz IP or the Patent Rights or Know-How of any Third Party. Such notices
shall be provided promptly, but in no event after more than fifteen (15) days
following receipt thereof.
8.6. PATENT INVALIDITY CLAIM. Subject to any contractual obligations
to, or restrictions imposed by, a Party's Third Party licensors, if a Third
Party at any time asserts a claim that any Momenta IP or Sandoz IP (in each
case, other than any Product-Specific Patent Rights relevant to the exercise by
Sandoz of the licenses granted in Section 2.1) is invalid or otherwise
unenforceable (an "INVALIDITY CLAIM"), whether as a defense in an infringement
action brought by a Party pursuant to Section 8.4 or in an action brought
against a Party under Section 8.5, the general concepts of Section 8.4 shall
apply to such Invalidity Claim (i.e., the Owning Party shall have the initial
right, and the Non-Owning Party shall have a step-in right in the case of claims
in the Field in the U.S. Territory, to defend such Invalidity Claim). No Party
shall settle or compromise any Invalidity Claim without obtaining the prior
written consent of Momenta or BCWI (or Sandoz, if so designated in writing by
the Sandoz Parties), such consent not to be unreasonably withheld, it being
understood that the consent of a Third Party licensor of Momenta or BCWI (or
Sandoz, if so designated in writing by the Sandoz Parties), respectively, may
also be required in order to settle or compromise such Invalidity Claim.
8.7. JOINT COLLABORATION IP AND PRODUCT-SPECIFIC PATENT RIGHTS.
Subject to any contractual obligations to, or restrictions imposed by, the
Parties' Third Party licensors, the JSC shall make all decisions regarding
enforcement of the Joint Collaboration IP and of those Product-Specific Patent
Rights relevant to the exercise by the Sandoz Parties of the licenses granted in
Section 2.1, in the Field, and responses to any assertions by a Third Party that
the Joint Collaboration IP or those Product-Specific Patent Rights relevant to
the exercise by the Sandoz Parties of the licenses granted in Section 2.1 are
invalid or otherwise unenforceable; PROVIDED, HOWEVER, THAT, in the event of a
dispute within the JSC with respect to such decisions, mutually acceptable
outside patent counsel not regularly employed by any Party or their Affiliates
shall be retained to resolve such dispute. Each Party shall provide to the other
Parties copies of any notices it receives from Third Parties regarding any
patent nullity actions, any
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declaratory judgment actions, any alleged infringement or any alleged
misappropriation of the Joint Collaboration IP or those Product-Specific Patent
Rights relevant to the exercise by the Sandoz Parties of the licenses granted in
Section 2.1. Such notices shall be provided promptly, but in no event after more
than fifteen (15) days following receipt thereof.
8.8. OBLIGATIONS TO LICENSORS. Notwithstanding anything to the
contrary in this Article 8, the terms of this Article 8 are subject to and
limited by the provisions of any applicable agreement with Third Party
licensors, including, as applicable, the MIT Agreement. Neither Momenta nor the
Sandoz Parties shall amend any agreement existing as of the Effective Date
(including, without limitation, the MIT Agreement) in a manner that would be
inconsistent with this Agreement, nor enter into any agreement after the
Effective Date that would be inconsistent with this Agreement.
8.9. PATENT MARKING. Sandoz shall, and shall cause its Affiliates and
distributors, to (a) xxxx the Product that is manufactured, offered for sale,
sold or imported under this Agreement with the number of each issued patent
under the Momenta IP, Sandoz IP or Joint Collaboration IP that applies to the
Product and (b) comply with the patent marking statutes in each country in which
the Product is manufactured by or on behalf of Sandoz or its Affiliates.
9. WARRANTIES
9.1. REPRESENTATIONS AND WARRANTIES OF THE PARTIES. Each of Momenta,
on the one hand, and each Sandoz Party, on the other hand, (the "REPRESENTING
PARTY") represents and warrants, or covenants, to the Sandoz Parties and
Momenta, respectively, that:
9.1.1 The Representing Party is a corporation duly organized,
validly existing and in good standing under the laws of its
state of incorporation or foreign jurisdiction;
9.1.2 The Representing Party has the requisite corporate power
and authority to execute and deliver this Agreement and to
perform all of its obligations hereunder. The execution and
delivery of this Agreement and the performance by the
Representing Party of its obligations hereunder have been
authorized by all requisite corporate action on its part. This
Agreement has been validly executed and delivered by the
Representing Party, and, assuming that such document has been
duly authorized, executed and delivered by the other Party,
constitutes a valid and binding obligation of the Representing
Party, enforceable against such Party in accordance with its
terms;
9.1.3 Except as otherwise set forth in this Agreement, no
material filing with, and no material permit, authorization,
consent or approval of any governmental authority is necessary
for the consummation by the Representing Party of the
transactions contemplated by this Agreement, except for those
filings, permits, authorizations, consents or approvals, the
failure of which to be made or obtained would not materially
impair such Party's ability to consummate the transactions
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contemplated hereby or materially delay the consummation of the
transactions contemplated hereby;
9.1.4 The execution and delivery of this Agreement by the
Representing Party and the performance by such Party of its
obligations hereunder, will not (a) violate the certificate of
incorporation, by-laws or other organizational document of such
Party; (b) conflict in any material respect with or result in a
material violation or breach of, or constitute a material
default under, any material contract, agreement or instrument to
which such Party is bound, or result in the creation of
imposition of any material lien upon the Product; or (c) violate
or conflict in any material respect with any material law, rule,
regulation, judgment, order or decree of any court or
governmental authority applicable to such Party or the Product;
9.1.5 The Representing Party has the full power and right to
grant to the relevant Party the license rights set forth in
Article 2 and Sections 3.4.6, 11.6.1 and 11.6.2, free of any
liens or encumbrances (other than the rights of any Third Party
licensors therein);
9.1.6 The Representing Party has not, as of the Effective
Date, received any notice from any Third Party that the practice
of the Momenta IP, if the Representing Party is Momenta, or the
Sandoz IP, if the Representing Party is Sandoz or BCWI,
infringes any patent or other proprietary rights of any Third
Party, and the Representing Party has, as of the Effective Date,
no knowledge that any Third Party patent or proprietary rights
are infringed as of the Effective Date by the practice by
Momenta of the Momenta IP, if the Representing Party is Momenta,
or by the practice by the Sandoz Parties of the Sandoz IP, if
the Representing Party is Sandoz or BCWI;
9.1.7 As of the Effective Date, there are no interferences or
oppositions pending before any court or administrative office or
agency relating to the Momenta IP, if the Representing Party is
Momenta, or the Sandoz IP, if the Representing Party is Sandoz
or BCWI;
9.1.8 To the Representing Party's best knowledge, as of the
Effective Date, all Momenta IP, if the Representing Party is
Momenta, or Sandoz IP, if the Representing Party is Sandoz or
BCWI, is valid and enforceable and has not been challenged in
any judicial or administrative proceeding; and
9.1.9 There is no action or proceeding pending or, insofar as
the Representing Party knows as of the Effective Date,
threatened against the Representing Party before any court,
administrative agency or other tribunal that might have a
material adverse effect on the Representing Party's performance
of this Agreement.
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9.2. MOMENTA REPRESENTATIONS. Momenta represents and warrants to
Sandoz that Momenta has delivered to Sandoz, on or before the Effective Date, a
copy of each invention assignment agreement between Momenta and each employee of
Momenta employed as of or prior to the Effective Date, in which such employee
has assigned to Momenta all of such employee's rights in any invention which is
encompassed by the Momenta IP and which is or was conceived, reduced to practice
or developed by such employee during the term of his or her employment with
Momenta.
9.3. SANDOZ PARTIES REPRESENTATIONS. Each Sandoz Party represents and
warrants to Momenta that Sandoz and BCWI are Affiliates of each other.
9.4. COVENANT. In performing its obligations hereunder, Momenta shall
not, during the Term, use any research tool, patent or know how for the [**]
where the use of such tool, in and of itself, would constitute the willful
infringement or misappropriation of the Patent Rights or trade secret rights of
any Third Party, it being understood that if a Party becomes aware of such an
infringement, or likelihood of or allegation of such an infringement or
misappropriation, of the Patent Rights or trade secret rights of a Third Party,
the provisions of Section 8.5 shall apply to such circumstance.
9.5. NO RELIANCE BY THIRD PARTIES. The representations, warranties
and covenants of a Party set forth in this Agreement are intended for the sole
and exclusive benefit of the other Party hereto and the Indemnified Parties, and
may not be relied upon by any Third Party other than the Indemnified Parties,
and may only be relied on by the Indemnified Parties for purposes of their
indemnity hereunder.
9.6. NO OTHER WARRANTIES. Nothing in this Agreement shall be
construed as a representation made or warranty given by any Party that (a) any
patents will issue based on pending patent applications, (b) any pending patent
applications or patents issued thereon will be valid, or (c) no Third Party will
bring a claim against Sandoz, BCWI, Momenta or any of their Affiliates or
licensees claiming infringement or misappropriation of such Third Party's Patent
Rights, Know-How or confidential information. EXCEPT AS OTHERWISE EXPRESSLY SET
FORTH IN THIS AGREEMENT, EACH PARTY EXPRESSLY DISCLAIMS, WAIVES, RELEASES AND
RENOUNCES ANY WARRANTY, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY
WARRANTY OF TITLE, NON-INFRINGEMENT, MERCHANTABILITY AND FITNESS FOR A
PARTICULAR PURPOSE.
10. CONFIDENTIALITY
10.1. PRIOR CONFIDENTIALITY AGREEMENT. Momenta and Sandoz are parties
to a certain Confidentiality Agreement dated as of June 17, 2003 (the "PRIOR
CONFIDENTIALITY AGREEMENT"). The provisions of this Article 10 shall apply to
all Confidential Information, and to all Proprietary Information (as that term
is defined in the Prior Confidentiality Agreement) disclosed pursuant to the
Prior Confidentiality Agreement (which shall be deemed to be Confidential
Information, subject to the exceptions in Section 1.18, for purposes of this
Agreement). The nature or terms of this Agreement shall be deemed to be
Confidential Information of each Party, subject to the exceptions in Section
1.18, for purposes of this Agreement.
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10.2. CONFIDENTIAL INFORMATION. Each of Sandoz, BCWI and Momenta (the
"RECEIVING PARTY") shall keep strictly confidential any Confidential Information
disclosed by any other Party (the "DISCLOSING PARTY"), using at least the same
degree of care that it uses to protect its own confidential or proprietary
information but in no event less than reasonable care.
10.3. NONDISCLOSURE OF CONFIDENTIAL INFORMATION. The Receiving Party
shall use Confidential Information solely for the purposes of this Agreement and
the transactions contemplated hereby and shall not disclose or disseminate any
Confidential Information to any Person at any time, except for disclosure to
those of its Affiliates, directors, officers, employees, consultants,
accountants, attorneys, advisers and agents that have a need to know such
information to permit the Receiving Party to exercise its rights or fulfill its
obligations pursuant to this Agreement, PROVIDED THAT such Persons are bound to
maintain the confidentiality of such Confidential Information to the same extent
as if they were parties hereto.
10.4. EXCEPTIONS. The foregoing confidentiality and nondisclosure
obligations are subject to the following exceptions:
10.4.1 The Receiving Party may disclose the Disclosing Party's
Confidential Information that is required to be publicly
disclosed by law or by regulation; PROVIDED, HOWEVER, THAT
a. the Receiving Party shall (i) use its best efforts to
ensure that it discloses the minimum amount of the
Disclosing Party's Confidential Information necessary to
comply with law, (ii) where possible, seeks confidential
treatment for any such information which is disclosed to
a governmental agency or group, and (iii) provides the
Disclosing Party with prompt advance notice of such
disclosure (which notice shall be given at least two (2)
Business Days in advance of such disclosure if possible)
and reasonable opportunity to review any such disclosure
so that the Disclosing Party has the opportunity if it
so desires to seek a protective order or other
appropriate remedy;
b. Momenta shall give Sandoz, on behalf of the Sandoz
Parties, a reasonable opportunity to review all filings
by Momenta with the United States Securities and
Exchange Commission describing the terms of this
Agreement prior to submission of such filings, and shall
give due consideration to any reasonable comments by
Sandoz, on behalf of the Sandoz Parties, relating to
such filing, including without limitation the provisions
of this Agreement for which confidential treatment
should be sought; and
c. the Sandoz Parties or their Affiliates may disclose the
terms of this Agreement in any filings with the United
States Securities and Exchange Commission (provided that
the Sandoz Parties or such Affiliates, as applicable,
use Commercially Reasonable Efforts to seek confidential
treatment for any financial terms).
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10.4.2 Notwithstanding anything to the contrary in this
Agreement, each Party, and its employees, representatives or
other agents, may disclose to any and all Persons, including,
without limitation, the U.S. Internal Revenue Service, the
federal tax treatment and tax structure of the transaction and
all materials of any kind (including opinions or other tax
analyses) that are provided to such Party relating to such tax
treatment and tax structure.
10.4.3 Pursuant to an agreement to maintain confidentiality,
any Party may discuss the terms of this Agreement with, or
provide a copy of this Agreement to, its accountants, its
attorneys and its current, future or potential investors or
shareholders.
10.4.4 Any Party may discuss the general terms of this
Agreement with, but not provide a copy of this Agreement or a
redacted copy of this Agreement to, a current, future or
potential investor or shareholder who does not execute an
agreement to maintain confidentiality, PROVIDED THAT (i) after a
preliminary conversation, such Party has used Commercially
Reasonable Efforts to have such investor or shareholder execute
an agreement to maintain confidentiality and (ii) any disclosure
pursuant to this Section 10.4.4 may not include the names of the
other Parties, the specific financial terms of this Agreement
(including without limitation the specific percentages of Profit
Interest and royalties and the details of the payment of the
Development Costs, Legal Expenses and FTE's), the specific terms
of the rights granted to the Sandoz Parties under Article III,
or the specifics of the indemnification provided hereunder (in
each case, unless and until such information is otherwise
publicly disclosed).
10.4.5 Pursuant to an agreement to maintain confidentiality,
Momenta may provide a copy of this Agreement or relevant
portions thereof, to MIT and any other Third Party licensor, if
required pursuant to the relevant license agreement with respect
to Momenta IP.
10.4.6 Any other disclosure of the nature or terms of this
Agreement (including, without limitation, any public
announcements, press releases or similar publicity with respect
to this Agreement) by Momenta, on the one hand, or either Sandoz
Party, on the other hand, must be approved in advance in writing
by Sandoz or Momenta, respectively, as to form and content of
such disclosure; PROVIDED, HOWEVER, that the contents of any
public announcement, press release or similar publicity which
has been reviewed and approved by the reviewing Party can be
re-released by either Party in any form without a requirement
for re-approval. The Parties agree that Momenta and the Sandoz
Parties (or an Affiliate thereof) shall issue a joint press
release in a mutually agreeable form on an agreed upon date
within fourteen (14) days after the mutual execution and
delivery of this Agreement to all Parties.
10.5. IDENTIFICATION. In any disclosure by Sandoz or BCWI permitted
hereunder which refers to Momenta IP or the Joint Collaboration IP, Sandoz or
BCWI, as the case may be, shall
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identify Momenta as the inventor, co-inventor, originator, owner, co-owner
and/or licensee, as appropriate, of such Momenta IP or Joint Collaboration IP.
In any disclosure by Momenta permitted hereunder which refers to Sandoz IP or
Joint Collaboration IP, Momenta shall identify Sandoz or BCWI as the inventor,
co-inventor, originator, owner, co-owner and/or licensee, as appropriate, of
such Sandoz IP or Joint Collaboration IP.
10.6. EQUITABLE RELIEF. The Receiving Party agrees that any breach of
this Article 10 may cause the Disclosing Party substantial and irreparable
injury and, therefore, in the event of any such breach, in addition to other
remedies that may be available, the Disclosing Party shall have the right to
specific performance and other injunctive and equitable relief.
10.7. SURVIVAL. The confidentiality and nondisclosure obligations of
this Article 10 shall survive the expiration or termination of this Agreement
and remain in effect for a period of ten (10) years following the expiration or
termination of this Agreement.
11. TERM & TERMINATION
11.1. TERM. The term of this Agreement (the "TERM") shall begin on the
Effective Date and continue until the last sale of the Product by Sandoz, its
Affiliates or distributors anywhere in the U.S. Territory, unless earlier
terminated by either Party pursuant to the provisions of this Agreement.
11.2. TERMINATION FOR CAUSE.
11.2.1 Momenta, on the one hand, and Sandoz (on behalf of the
Sandoz Parties), on the other hand, may terminate this Agreement
for any breach of a material provision by a Sandoz Party or
Momenta, respectively, thirty (30) days after written notice
containing details of the breach if the breach remains uncured
at the end of the notice period.
11.2.2 Notwithstanding Section 11.2.1, in the event that the
Sandoz Parties are unable to perform any of their respective
obligations under this Agreement as a result of any interruption
of the Supply Chain or manufacturing capability for the Product,
including as a result of any action taken or threatened by the
FDA or other Regulatory Authority (each such event a "SUPPLY
INTERRUPTION"), and such inability to perform hereunder would
otherwise constitute a breach of a material provision of this
Agreement, and such breach is not cured within thirty (30)
days following receipt by Sandoz (on behalf of the Sandoz
Parties) of written notice from Momenta of such breach, such
Supply Interruption shall not be considered a breach of this
Agreement provided that Sandoz (on behalf of the Sandoz
Parties) provides the JSC with written notice and evidence, in
form and substance reasonably satisfactory to the JSC, that the
alleged breach is as a result of a Supply Interruption within
fifteen (15) days following receipt by Sandoz (on behalf of the
Sandoz Parties) from Momenta of notice of such alleged breach
(a "SUPPLY INTERRUPTION NOTICE"). Such Supply Interruption
Notice shall extend the thirty (30) day cure period set forth
in Section 11.2.1 in accordance with the following procedure:
(a)
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Sandoz (on behalf of the Sandoz Parties) shall furnish to the
JSC a written plan (the "SUPPLY CONTINUATION PLAN") within
thirty (30) days following the JSC's receipt of the Supply
Interruption Notice setting forth the actions that the Sandoz
Parties shall take to cure the Supply Interruption as soon as
commercially possible following the occurrence of the Supply
Interruption; (b) the Supply Continuation Plan shall be subject
to the review and approval of the JSC, which shall not be
unreasonably withheld, conditioned or delayed; (c) following
the JSC's review and approval of the Supply Continuation Plan,
such plan may be amended or modified with the prior consent and
approval of the JSC, which shall approve any reasonable request
by the Sandoz Parties for such an amendment or modification; and
(d) the Sandoz Parties shall not be considered in breach of this
Agreement under Section 11.2.1 as a result of the Supply
Interruption if the Supply Continuation Plan is approved by the
JSC and the Sandoz Parties use Commercially Reasonable Efforts
to execute the Supply Continuation Plan.
11.2.3 To the extent permitted under applicable law, Momenta,
on the one hand, and Sandoz (on behalf of the Sandoz Parties),
on the other hand, may terminate this Agreement effective
immediately with written notice if a Sandoz Party or Momenta,
respectively, shall file for bankruptcy, shall be adjudicated
bankrupt, shall file a petition under insolvency laws, shall be
dissolved or shall have a receiver appointed for substantially
all of its property.
11.2.4 With respect to a default or breach of this Agreement,
failure of a Party to provide notice to the defaulting or
breaching Party provided in this Article 11 shall not constitute
a waiver of the right to give such notice with respect to any
subsequent default or breach.
11.3. TERMINATION DUE TO LACK OF COMMERCIAL VIABILITY. If (a) there
is a withdrawal from the market of all Lovenox [Registered Trademark]
Equivalent Products due to material safety concerns, which withdrawal could
significantly impact the commercial viability of the Product, (b) a new
product [**] enters the market and the number of units of [**] sold during the
immediately following [**] period is less than [**]percent ([**]%) of the
number of units sold in the twelve-month period immediately prior to such
entry, (c) at least [**] Products (other than [**]) have been on the market in
the U.S. Territory for at least [**] each prior to the U.S. Launch, (d) at
least [**] Third-Party Competitors have received tentative approval of [**]
Products prior to Sandoz's receipt of tentative approval of the [**] for the
Product or (e) the Product fails to generate Profits equal to or greater than
[**] percent ([**]%) of corresponding Net Sales for any Post-Launch Year
during the Post-[**] Period, the [**] Period or the Aventis [**] Period (each,
a "COMMERCIAL VIABILITY TRIGGER"), then, for a period of thirty (30) days
after the occurrence of such Commercial Viability Trigger, Sandoz (on behalf
of the Sandoz Parties) shall have the right to terminate this Agreement upon
thirty (30) days' prior written notice to Momenta. The termination rights
specified in this Section 11.3 shall be termed a "COMMERCIAL VIABILITY
TERMINATION".
11.4. SANDOZ MILESTONE TERMINATION. If, for any reason other than as a
result of a breach by Sandoz or BCWI under this Agreement, (a) the drug product
form of the Product is not ready for initiation of Stability Studies on or
before December 31, 2004 or (b) during the course of the Parties'
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attempt to achieve District Court Legal Clearance, a decision by a District
Court, a United States Court of Appeals, or the United States Supreme Court is
issued, or an applicable law or regulation is enacted or amended, which
materially and substantially diminishes achievement of Final Legal Clearance
based on the legal theories and strategies then being pursued by the Parties to
achieve District Court Legal Clearance (including, without limitation, a
District Court Decision that the marketing of the Product by Sandoz or its
Affiliates [**] Patent Rights) (a "LEGAL STRATEGY DIMINISHMENT") (each of
subsections 11.4(a) and 11.4(b) a "SANDOZ MILESTONE TRIGGER"), then for a period
of [**] after the later of the occurrence of such Sandoz Milestone Trigger or
Sandoz's actual knowledge of such Sandoz Milestone Trigger, Sandoz (on behalf of
the Sandoz Parties) shall have the right to terminate this Agreement upon [**]
prior written notice to Momenta (PROVIDED, HOWEVER, THAT, (i) if there is a
dispute between the Parties as to whether a Legal Strategy Diminishment has
occurred, outside patent counsel not regularly employed by any Party or their
Affiliates who is mutually acceptable to the Parties shall be retained to
resolve such dispute, and (ii) if there is a dispute between the Sandoz Parties,
on the one hand, and Momenta, on the other hand, as to whether a Sandoz
Milestone Trigger has occurred, the Agreement shall not be terminated pursuant
to this Section 11.4 unless and until such dispute is resolved, in accordance
with the terms of this Agreement, in Sandoz's favor). The termination rights
specified in this Section 11.4 shall be termed a "SANDOZ MILESTONE TERMINATION".
11.5. EXCESSIVE COST TERMINATION. Sandoz (on behalf of the Sandoz
Parties) shall have the right to terminate this Agreement in the event of
excessive Capped Costs, as follows:
11.5.1 In the event that, prior to the U.S. Launch, the Capped
Costs exceed the Cost Cap (the "INITIAL EXCESSIVE COST
TRIGGER"), Sandoz shall have the option, in its sole discretion,
to terminate this Agreement (the "INITIAL EXCESSIVE COST
TERMINATION") effective immediately upon written notice thereof
to Momenta, which option may be exercised by Sandoz within
sixty (60) days after the Parties have, pursuant to Section 4.1,
exchanged the written reports and invoices which reflect that
the Initial Excessive Cost Trigger was achieved in the prior
Quarter (the "INITIAL EXCESSIVE COST TERMINATION OPTION
PERIOD"). Notwithstanding Section 4.1, in the event of an
Initial Excessive Cost Termination, the Sandoz Parties shall
not be responsible for any Capped Costs in excess of the Cost
Cap, except as provided in Section 11.6.1. If Sandoz does not
exercise its right to an Initial Excessive Cost Termination, the
Sandoz Parties shall continue to be responsible for Capped Costs
in excess of the Cost Cap, subject to the provisions of Section
11.5.2 and SCHEDULE 4.3.
11.5.2 If, prior to the U.S. Launch, (a) the Capped Costs
exceed the Cost Cap by more than the then-current Additional
Costs Amount and (b) more than twelve (12) months have elapsed
since the expiration of the immediately preceding Excessive Cost
Termination Option Period (each, an "ADDITIONAL EXCESSIVE COST
TRIGGER"), Sandoz shall have the option, in its sole discretion,
to terminate this Agreement (each, an "ADDITIONAL EXCESSIVE COST
TERMINATION") effective immediately upon written notice thereof
to Momenta, which option may be exercised by Sandoz within
sixty (60) days after the later of (i) the exchange by the
Parties,
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pursuant to Section 4.1, of the written reports and invoices
which reflect that such Additional Excessive Cost Trigger was
achieved in the prior Quarter (each, an "ADDITIONAL EXCESSIVE
COST TERMINATION OPTION PERIOD") or (ii) the end of such
twelve-month period. Notwithstanding Section 4.1, in the event
of an Additional Excessive Cost Termination, the Sandoz Parties
shall not be responsible for any Capped Costs in excess of the
amount that triggered the applicable Additional Excessive Cost
Trigger, except as provided in Section 11.6.1. If Sandoz does
not exercise its right to an Additional Excessive Cost
Termination, (A) the Sandoz Parties shall continue to be
responsible for Capped Costs in excess of the sum of the Cost
Cap and the then-current Additional Costs Amount, subject to the
provisions of this Section 11.5.2 and SCHEDULE 4.3, and (B) the
Additional Costs Amount shall be increased by Three Million
Dollars (U.S.$3,000,000).
11.6. EFFECTS OF TERMINATION.
11.6.1 In the event of termination of this Agreement by Sandoz
(on behalf of the Sandoz Parties) pursuant to Sections 11.3,
11.4 or 11.5, or by Momenta pursuant to Section 11.2, (a) all
licenses granted by Momenta to the Sandoz Parties or their
Affiliates shall terminate; (b) all licenses granted by the
Sandoz Parties to Momenta under Article 2 shall remain in effect
on an irrevocable, perpetual, sublicenseable (provided that such
sublicensees comply with the relevant provisions of this
Agreement) and exclusive basis and shall be converted to
licenses to (i) Develop, make, have made, use, sell, offer to
sell, lease, import and export the Product in the Field anywhere
in the world (subject to the terms of the Non-U.S. Territory
Agreement, if such has been executed prior to the date of
termination of this Agreement) and (ii) make, have made and use
the Product in the Non-U.S. Territory (subject to the terms of
the Non-U.S. Territory Agreement, if such has been executed
prior to the date of termination of this Agreement) but only for
the purposes of sale of the Product in or into the U.S.
Territory and any country which is not subject to the terms of
the Non-U.S. Territory Agreement; (c) the license granted by the
Sandoz Parties to Momenta pursuant to Section 3.4.6 shall remain
in effect on an irrevocable and perpetual basis; (d) each of
Sandoz and BCWI shall cease to use and shall assign to Momenta
all of its right, title and interest in and to all clinical,
technical and other relevant reports, records, data, information
and materials relating to the Product and all regulatory filings
and Marketing Approvals in the U.S. Territory relating to the
Product (and the Sandoz Parties shall deliver to Momenta, at
Momenta's expense (or at Sandoz's expense in the case of
termination by Momenta under Section 11.2), one (1) copy of each
physical embodiment of the aforementioned items within thirty
(30) days after termination); (e) Sandoz and BCWI shall cease to
use in the Field any technology arising out of the Collaborative
Program, including, without limitation, any manufacturing
processes; (f) Sandoz and BCWI shall promptly return to Momenta
all materials and records in their possession or control
containing Confidential Information of Momenta; (g) Sandoz and
BCWI shall transfer and assign to Momenta all trademarks and
tradenames of the Product that have received Marketing Approval
in the U.S. Territory, except for any such
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trademarks or tradenames or a part thereof that use the name
"Novartis" or "Sandoz" or a derivative thereof or any other
trademark or tradename or part or derivative thereof that is the
name or derivative of a name of any other Sandoz Affiliate; (h)
if so requested by Momenta, the Sandoz Parties shall, at
Momenta's expense (or at Sandoz's expense in the case of
termination by Momenta under Section 11.2), take reasonable
steps to assist Momenta in establishing a contract manufacturing
relationship with their suppliers (if any) of the Product, it
being understood that Sandoz and BCWI in no way guarantees the
ability to transfer any such relationship to Momenta; (i) at
Momenta's request, Sandoz and BCWI shall sell to Momenta at
Manufacturing Cost all units of the Product, whether in finished
product or work-in-process form, in their inventory for sale in
or into the U.S. Territory; (j) subject to any contractual
obligations to, or restrictions imposed by, the Sandoz Parties'
Third Party licensors, the Sandoz Parties shall continue to use
Commercially Reasonable Efforts to timely prepare, file,
prosecute and maintain, at their expense, Sandoz Patent Rights
and Sandoz Collaboration Patent Rights in the Field in the U.S.
Territory; PROVIDED, HOWEVER, THAT if the Sandoz Parties decline
to file, prosecute or maintain any such Patent Right or if the
Sandoz Parties elect to allow any such Patent Right to lapse or
elects to abandon any such Patent Right before all appeals
within the respective patent office have been exhausted, then,
subject to any contractual obligations to, or restrictions
imposed by, the Sandoz Parties' Third Party licensors, (1)
Momenta shall have the right, at its own expense and upon
written notice to the relevant Sandoz Party(ies), to assume
control of the filing, prosecution and maintenance of such
Patent Right in the relevant Sandoz Party's name or the name of
its Third Party licensor, as applicable, in which event, the
relevant Sandoz Party shall provide assistance to and cooperate
with Momenta in prosecuting the subject Patent Right, should
Momenta elect to prosecute and maintain the subject Patent
Right, and (2) the relevant Sandoz Party shall provide Momenta
with reasonable notice of its decision to decline to file,
prosecute or maintain any such Patent Right or its election to
allow any such Patent Right to lapse or its election to abandon
any such Patent Right so as to permit Momenta (A) to review the
patent or application, (B) to decide whether to prosecute or
maintain the same, and (C) to take appropriate action to
prosecute or maintain the patent application or patent; (k) the
provisions of Sections 8.4 and 8.8 shall continue to apply with
respect to Sandoz Patent Rights (and, notwithstanding anything
therein, any Product-Specific Patent Rights therein) in the
Field in the U.S. Territory; and (l) the Sandoz Parties shall be
responsible for all amounts incurred and owing to Momenta
pursuant to Article 4 hereof (as modified by SCHEDULE 4.3, as
applicable) prior to the date of termination but not previously
paid, which payments shall be made in the time and manner
provided under Article 4. The post-termination license rights
granted to Momenta in (b) and (c) of this subsection shall apply
only as to any Sandoz IP that has actually been used in the
Collaborative Program prior to the date of termination of this
Agreement, and shall expressly exclude any other Sandoz IP.
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11.6.2 In the event of termination of this Agreement by Sandoz
(on behalf of the Sandoz Parties) pursuant to Section 11.2, (a)
all licenses granted by the Sandoz Parties to Momenta shall
terminate; (b) all licenses granted by Momenta to the Sandoz
Parties under this Agreement shall remain in effect on an
irrevocable, perpetual, sublicenseable (provided that such
sublicensees comply with the relevant provisions of this
Agreement) and exclusive basis; (c) Momenta shall cease to use
and shall assign to Sandoz all of its right, title and interest
in and to all clinical, technical and other relevant reports,
records, data, information and materials relating to the Product
and all regulatory filings and Marketing Approvals in the U.S.
Territory relating to the Product (and Momenta shall deliver to
Sandoz, at Momenta's expense, one (1) copy of each physical
embodiment of the aforementioned items within thirty (30) days
after termination); (d) Momenta shall promptly return to Sandoz
or BCWI, as the case may be, all materials and records in
Momenta's possession or control containing Confidential
Information of Sandoz or BCWI, respectively; (e) subject to any
contractual obligations to, or restrictions imposed by,
Momenta's Third Party licensors, Momenta shall continue to use
Commercially Reasonable Efforts to timely prepare, file,
prosecute and maintain, at its expense, Momenta Patent Rights
and Momenta Collaboration Patent Rights in the Field in the U.S.
Territory; PROVIDED, HOWEVER, THAT if Momenta declines to file,
prosecute or maintain any such Patent Right or if Momenta elects
to allow any such Patent Right to lapse or elects to abandon any
such Patent Right before all appeals within the respective
patent office have been exhausted, then, subject to any
contractual obligations to, or restrictions imposed by,
Momenta's Third Party licensors, (1) BCWI (or Sandoz, if so
designated in writing by the Sandoz Parties) shall have the
right, at its own expense and upon written notice to Momenta, to
assume control of the filing, prosecution and maintenance of
such Patent Right in Momenta's name or the name of its Third
Party licensor, as applicable, in which event, Momenta shall
provide assistance to and cooperate with BCWI (or Sandoz, if so
designated in writing by the Sandoz Parties) in prosecuting the
subject Patent Right, should BCWI (or Sandoz, if so designated
in writing by the Sandoz Parties) elect to prosecute and
maintain the subject Patent Right, and (2) Momenta shall provide
BCWI (or Sandoz, if so designated in writing by the Sandoz
Parties) with reasonable notice of its decision to decline to
file, prosecute or maintain any such Patent Right or its
election to allow any such Patent Right to lapse or its election
to abandon any such Patent Right so as to permit BCWI (or
Sandoz, if so designated in writing by the Sandoz Parties) (A)
to review the patent or application, (B) to decide whether to
prosecute or maintain the same, and (C) to take appropriate
action to prosecute or maintain the patent application or
patent; (f) the financial obligations set forth in Article 4
(other than Sections 4.1 and 4.2), including the provisions of
SCHEDULE 4.3, each as applicable, the patent marking obligations
set forth in Section 8.9, and the insurance obligations of
Section 12.4 shall remain in effect; (g) in the event the Sandoz
Parties' rights under Section 3.4 have not yet lapsed at the
time of termination, the rights of the Sandoz Parties under
Section 3.4 shall survive in accordance with the terms thereof;
(h) subject to the provisions of Article 3, for as
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long as Sandoz is marketing the Product and abiding by its
financial obligations to Momenta pursuant to subsection (f) of
this Section 11.6.2, Momenta shall not provide any Patent
Rights, Know-How or any other assistance to any third party to
Characterize, develop, produce, manufacture or Commercialize
Lovenox(R)-Equivalent Products in the Field in the U.S.
Territory, or, in the event that the Sandoz Parties' rights
under Section 3.4 have not yet lapsed at the time of such
termination, worldwide; and (i) the provisions of Sections 8.4
and 8.8 shall continue to apply with respect to Momenta Patent
Rights (and, notwithstanding anything therein, any
Product-Specific Patent Rights therein) in the Field in the U.S.
Territory. The post-termination license rights granted to the
Sandoz Parties in (b) and (c) of this subsection shall apply
only as to any Momenta IP that has actually been used in the
Collaborative Program prior to the date of termination of this
Agreement, and shall expressly exclude any other Momenta IP.
11.6.3 In the event that, subsequent to any Initial Excessive
Cost Termination or Additional Excessive Cost Termination,
Momenta, its Affiliates, licensees or distributors is selling
the Product in the U.S. Territory, then, in addition to the
provisions of Section 11.6.1, for each Quarter during which
Momenta, its Affiliates or licensees is selling the Product in
the U.S. Territory, Momenta shall pay the Sandoz Parties (in the
proportion designated by Sandoz) a royalty (the "SANDOZ PARTIES
ROYALTY") as a percentage of Net Sales by Momenta, its
Affiliates, licensees or distributors of the Product in the U.S.
Territory, to be computed according to the following table, by
multiplying Net Sales by Momenta, its Affiliates or licensees in
the U.S. Territory for such Quarter times the applicable
percentage listed in the table:
Royalty Rate
------------
NET SALES IN THE U.S.
TERRITORY DURING SUCH QUARTER [**] [**]
For all such Net Sales [**]% [**]%
If, during a particular Quarter, the number of Third-Party
Competitors changes, the Sandoz Parties Royalty shall be paid
based on actual Net Sales made during such Quarter under the
respective royalty rates.
11.7. BANKRUPTCY. All rights and licenses granted under or pursuant to
any Section of this Agreement are, and shall otherwise be deemed to be, for
purposes of Section 365(n) of the Bankruptcy Code, licenses of rights to
"intellectual property" as defined under Section 101(35A) of the Bankruptcy
Code. The Parties shall retain and may fully exercise all of their respective
rights and elections under the Bankruptcy Code. Upon the bankruptcy of any
Party, the non-bankrupt Party shall further be entitled to a complete duplicate
of (or complete access to, as appropriate) any such intellectual property, and
such, if not already in its possession, shall be promptly delivered to the
non-bankrupt Party, unless the bankrupt Party elects to continue, and continues,
to perform all of its obligations under this Agreement.
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11.8. SURVIVAL. Upon expiration or termination of this Agreement for
any reason, (a) nothing in this Agreement shall be construed to release either
Party from any obligations that were incurred prior to the effective date of
expiration or termination; (b) the following provisions shall expressly survive
any such expiration or termination: Articles 1, 10 and 14, Sections 2.5, Article
3 (to the extent that the Agreement has terminated as a result of a breach by
Momenta under Section 11.2), Sections 4.11, 4.12, 8.1, 8.2.3, 9.6, 11.6 (as
applicable), 11.7, 11.8, 11.9, 13.2, 13.3, and SCHEDULE 4.3 (to the extent
applicable); and (c) (i) the obligations to indemnify under Sections 12.1 and
12.2 (subject to Section 12.3) shall survive the expiration or termination of
this Agreement with respect to any Liabilities, whether asserted during or after
the Term, that result from activities that occurred before or during the Term,
(ii) the obligations of Momenta to indemnify the Sandoz Indemnified Parties
under Section 12.2 (subject to Section 12.3) shall survive the expiration or
termination of this Agreement with respect to any Liabilities that result from
activities that occur after the Term pursuant to Section 11.6.1, (iii) the
obligations of the Sandoz Parties to indemnify the Momenta Indemnified Parties
under Section 12.1 (subject to Section 12.3) shall survive the expiration or
termination of this Agreement with respect to any Liabilities that result from
activities that occur after the Term pursuant to Section 11.6.2, and (iv)
otherwise there shall be no continuing obligation of the Indemnifying Party to
indemnify, defend or hold harmless the Indemnified Party after the date of
expiration or termination of this Agreement.
11.9. NON-EXCLUSIVE REMEDY. Termination of this Agreement shall be in
addition to, and shall not prejudice, the Parties' remedies at law or in equity,
including, without limitation, the Parties' ability to receive legal damages
and/or equitable relief with respect to any breach of this Agreement, regardless
of whether or not such breach was the reason for the termination.
12. INDEMNIFICATION
12.1. SANDOZ INDEMNIFICATION OF MOMENTA. The Sandoz Parties shall
indemnify, defend and hold harmless the Momenta Indemnified Parties from and
against all losses, costs, damages, judgments, settlements, interest, fees or
expenses (including all reasonable attorneys' fees, experts' or consultants'
fees, expenses and costs) ("LIABILITIES") awarded to a Third Party against any
Momenta Indemnified Party, or that may be incurred or paid by any Momenta
Indemnified Party in the defense or compromise of legal or equitable claims
asserted by a Third Party, arising out of or resulting from (a) any breach of
any obligation by Sandoz or BCWI hereunder, (b) any misrepresentation by Sandoz
or BCWI hereunder (including but not limited to any such breach by Sandoz or
BCWI of Article 9 - Warranties), (c) any Patent Litigation, (d) any property
damage or personal injury (including, without limitation, death) resulting from
the development, use, manufacture, sale, offering for sale or importation of the
Product by Sandoz, its Affiliates or their Third Party contractors or
distributors, or (e) any claims or demands related to the Product that are
commenced by [**] any Third Party against any Momenta Indemnified Party based on
the activities of Momenta or the Sandoz Parties (including those undertaken by
Affiliates or Third Parties on behalf of Momenta or the Sandoz Parties) [**]
pursuant to this Agreement; PROVIDED, HOWEVER, that the Sandoz Parties shall
have no obligation to indemnify the Momenta Indemnified Parties against
Liabilities under (a) through (e) to the extent that such Liabilities arise from
any Third Party legal or equitable claim that is subject to Momenta's obligation
to indemnify, defend, and hold the Sandoz Indemnified Parties harmless under
Section 12.2.
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12.2. MOMENTA INDEMNIFICATION OF SANDOZ. Momenta shall indemnify,
defend and hold harmless the Sandoz Indemnified Parties from and against all
Liabilities awarded to a Third Party against the Sandoz Indemnified Parties or
that may be incurred or paid by any of the Sandoz Indemnified Parties in the
defense or compromise of legal or equitable claims asserted by a Third Party,
arising out of or resulting from (a) any breach of any obligation by Momenta
hereunder, including, without limitation, the covenant in Section 9.4, (b) any
misrepresentation by Momenta hereunder (including but not limited to any such
breach by Momenta of Article 9 - Warranties) of this Agreement, or (c) any
actual misappropriation by any Momenta Indemnified Party of any Third Party
trade secret or know-how, provided that, (i) with respect to actual
misappropriation, there has been a final adjudication of liability for
misappropriation by a court of competent jurisdiction, or, (ii) with respect to
misappropriation that has been alleged but not finally adjudicated, there is a
settlement with a Third Party which the Parties determine by mutual agreement
constitutes an acknowledgement by Momenta of actual misappropriation. (either
case under (i) or (ii) being a "FINAL MISAPPROPRIATION DETERMINATION"). If there
is a dispute between the Parties as to whether a settlement constitutes such an
acknowledgement, nationally-recognized outside counsel not regularly employed by
any Party or their Affiliates who is mutually acceptable to the Parties shall be
retained to resolve such dispute. In the event that Sandoz has, pursuant to the
provisions of Section 12.1, incurred Liabilities with respect to an actual or
alleged misappropriation by any Momenta Indemnified Party of any Third Party
trade secret or know-how and a Final Misappropriation Determination occurs,
Momenta shall, in addition to indemnifying the Sandoz Indemnified Parties for
such Liabilities incurred by them pursuant to subsection (c) of this Section
12.2, reimburse Sandoz for any Liabilities which Sandoz previously paid to or
incurred on behalf of any of the Momenta Indemnified Parties that are allocable
to the misappropriation claim that gave rise to the Final Misappropriation
Determination.
12.3. PROCEDURE. If any Momenta Indemnified Party or any Sandoz
Indemnified Party (in each case, an "INDEMNIFIED PARTY") receives any written
claim or demand which such Indemnified Party believes is the subject of
indemnity hereunder by Sandoz or Momenta as the case may be (in each case, an
"INDEMNIFYING PARTY"), the Indemnified Party shall, as soon as reasonably
practicable after forming such belief, give notice thereof to the Indemnifying
Party; PROVIDED THAT the failure to give timely notice to the Indemnifying Party
as contemplated hereby shall not release the Indemnifying Party from any
liability to the Indemnified Party unless the Indemnifying Party demonstrates
that the defense of such claim is materially prejudiced by such failure. The
Indemnifying Party shall assume and diligently pursue the defense of such claim,
at its cost, with counsel reasonably satisfactory to the Indemnified Party. The
Indemnifying Party shall have absolute control of the conduct of the litigation;
PROVIDED, HOWEVER, THAT
12.3.1 the Indemnified Party may, nevertheless, participate
therein through counsel of its choice and at its cost, and shall
be permitted to effectively associate with the Indemnifying
Party in the defense, the prosecution and the negotiation of any
settlement of the claim or demand;
12.3.2 the Indemnifying Party shall keep the Indemnified Party
informed, through the JSC, of the status of the litigation;
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12.3.3 the Indemnifying Party shall provide the Indemnified
Party with a reasonable opportunity to review and comment on all
pleadings, motions and other papers exchanged with the opposing
party or filed with any court by the Indemnifying Party with
respect to such claim or demand (collectively, the "PLEADINGS")
and the Indemnifying Party shall consider in good faith any
input provided by the Indemnified Party with respect to the
Pleadings; and
12.3.4 if the suit includes a defense of Momenta IP or an
Invalidity Claim with respect to Momenta IP or the Joint
Collaboration IP (in the event Momenta is the Indemnified
Party), then the Indemnifying Party's conduct of the litigation
with respect to such claim(s) shall be subject to:
a. the approval of Momenta and/or
b. any contractual obligations to, or restrictions imposed
by, the relevant Third Party licensor.
The Party not assuming the defense of any such claim or demand shall
render all reasonable assistance to the Party assuming such defense as requested
by such defending Party, and all reasonable out-of-pocket costs of such
assistance shall be for the account of the Indemnifying Party. No such claim or
demand shall be settled other than by the Party defending the same, and then
only with the consent of the other Party, which shall not be unreasonably
withheld; PROVIDED THAT the Indemnified Party shall have no obligation to
consent to any settlement of any such claim which imposes on the Indemnified
Party any liability or obligation which cannot be assumed and performed in full
by the Indemnifying Party (subject, in the case of a Settlement, to the terms of
Section 4.3) or which agrees that any element of any of Momenta IP or Joint
Collaboration IP (in the event Momenta is the Indemnified Party) is invalid, not
infringed or unenforceable.
12.4. INSURANCE. The Sandoz Parties shall be self-insured. To the
extent Momenta is required to obtain the consent or waiver of MIT under the MIT
Agreement to permit such self-insurance by the Sandoz Parties, Momenta shall use
its best efforts to obtain such waiver or consent. Momenta shall comply with the
insurance obligations imposed on Momenta pursuant to the MIT Agreement.
13. DISPUTE RESOLUTION
13.1. FIRST LEVEL RESOLUTION. Unless otherwise expressly provided for
herein, any claim or controversy between Momenta, on the one hand, and the
Sandoz Parties, on the other hand, arising out of or relating to the execution,
interpretation and performance of this Agreement (including the validity, scope
and enforceability of this provision) which has not been resolved by the JPT
will be identified in writing and presented by the JPT to the JSC. The JSC shall
meet within fourteen (14) days after delivery of the notice of dispute pursuant
to this Section 13.1 and attempt in good faith to resolve the dispute. If the
JSC is unable to decide or resolve an issue unanimously or in the event of any
dispute or claim arising out of or relating to this Agreement, or to the breach,
termination, or validity of this Agreement a notice of dispute shall be
submitted
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to the relevant Executive Officers of the Parties for resolution by good-faith
negotiations pursuant to Section 13.2.
13.2. NEGOTIATION BETWEEN EXECUTIVES. Within fourteen (14) days after
delivery of the notice of dispute pursuant to Section 13.1, the Sandoz Executive
Officer (unless the Sandoz Parties designate, within one (1) Business Day after
delivery of the notice of dispute pursuant to Section 13.1, that the BCWI
Executive Officer shall participate instead) and the Momenta Executive Officer
shall meet at a mutually acceptable time and place, and thereafter as often as
they reasonably deem necessary, to attempt to resolve the dispute in good faith.
All reasonable requests for information made by one Party to another will be
honored. All negotiations pursuant to this clause are confidential and shall be
treated as compromise and settlement negotiations for purposes of applicable
rules of evidence. If such Executive Officers cannot resolve such dispute within
fourteen (14) days after such meeting, then each Party reserves its right to any
and all remedies available under law or equity with respect to any other
dispute. Notwithstanding the foregoing, such Executive Officers shall meet and
attempt to resolve any dispute regarding the strategy to achieve Legal Clearance
within seven (7) days (or such other mutually agreed period) after delivery of
the notice of dispute pursuant to Section 13.1, and, if such Executive Officers
cannot resolve such dispute within such time period, then (except as provided in
Section 11.4) such dispute shall be considered resolved in Sandoz's favor.
13.3. LEGAL REMEDIES. Notwithstanding anything to the contrary in this
Article 13, any Party may seek immediate injunctive or other interim relief from
any court of competent jurisdiction as necessary to enforce and prevent
infringement or misappropriation of the patent rights, copyright rights,
trademarks, confidential information, trade secrets, or other intellectual
property rights owned or controlled by a Party or its Affiliates or to prevent
breach of Article 10.
14. ADDITIONAL PROVISIONS
14.1. ENTIRE AGREEMENT. This Agreement, including the Schedules
hereto, contains the entire agreement and understanding between the Parties
relating to the subject matter hereof and all prior agreements and
understandings between the Parties and relating to the subject matter hereof,
including, without limitation, the Prior Confidentiality Agreement, are
superseded by this Agreement. Neither Party shall be liable or bound to any
other Party in any manner by any representations, warranties or covenants
relating to such subject matter except as specifically set forth herein.
14.2. AMENDMENTS AND WAIVER. This Agreement may not be amended except
by an instrument in writing signed on behalf of each of the Parties. By an
instrument in writing either Party may waive compliance by the other Party with
any term or provision of this Agreement that such other Party was or is
obligated to comply with or perform. Any failure of a Party to enforce at any
time, or for any period of time, any of the provisions of this Agreement shall
not be deemed or construed to be a waiver of such provisions or a waiver of any
right of such Party thereafter to enforce each and every such provision on any
succeeding occasion or breach thereof.
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14.3. ASSIGNMENT. This Agreement shall be assignable only: (a) by a
Party to an Affiliate of that Party, without the consent of the other Parties,
PROVIDED THAT in such case, the assigning Party remains liable with the assignee
for all of its obligations hereunder; (b) by a Party with the written consent of
the other Parties; or (c) automatically by a Party without the consent of the
other Parties to (i) the purchaser of (A) all or substantially all of the
assets, or (B) a majority of the voting equity securities, of the assigning
Party's business to which this Agreement relates, or (ii) the surviving Person,
in the event of a merger of the assigning Party and another Person, and any such
purchaser or successor shall be bound by the terms hereof. Any attempted
assignment that does not comply with the terms of this Section 14.3 shall be
void. This Agreement shall be binding upon and inure to the benefit of the
Parties, their successors and permitted assigns.
14.4. NATURE OF RELATIONSHIP. In making and performing this Agreement,
the Parties are acting, and intend to be treated, as independent entities and
nothing contained herein shall be deemed or implied to create an agency,
distributorship, joint venture or partnership relationship among the Parties
hereto. Except as otherwise expressly provided herein, no Party may make any
representation, warranty or commitment, whether express or implied, on behalf of
or incur any charges or expenses for, or in the name of, any other Party. Except
as provided in Article 12 or Section 4.11.8, no Party shall be liable for the
act of any other Party unless such act is expressly authorized in writing by the
Parties hereto.
14.5. NOTICES. All notices and other communications required or
permitted to be given or made pursuant to this Agreement shall be in writing
signed by the sender and shall be deemed duly given (a) on the date delivered,
if personally delivered, (b) on the date sent by telecopier with automatic
confirmation by the transmitting machine showing the proper number of pages were
transmitted without error, (c) on the Business Day after being sent by Federal
Express or another recognized overnight mail service which utilizes a written
form of receipt for next day or next business day delivery, or (d) two (2)
Business Days after mailing, if mailed by United States postage-prepaid
certified or registered mail, return receipt requested, in each case addressed
to the applicable party at the address set forth below; PROVIDED THAT a Party
may change its address for receiving notice by the proper giving of notice
hereunder:
IF TO SANDOZ: IF TO MOMENTA:
Geneva Pharmaceuticals, Inc. Momenta Pharmaceuticals, Inc.
000 Xxxxxxxx Xxxxxx, Xxxxx 000 00 Xxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000 Xxxxxxxxx, XX 00000
Attn: Chief Executive Officer Attn: Chief Executive Officer
Tele: (000) 000-0000 Tele: 000-000-0000
Fax: (000) 000-0000 Fax: 000-000-0000
WITH A COPY TO: WITH A COPY TO:
Geneva Pharmaceuticals, Inc. Xxxx and Xxxx LLP
000 Xxxxxxxx Xxxxxx, Xxxxx 000 60 State Street
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Xxxxxxxxx, XX 00000 Xxxxxx, XX 00000
Attn: Chief Executive Officer Attn: Xxxxxx X. Xxxxxx, Esq.
Tele: (000) 000-0000 Tele: (000) 000-0000
Fax: (000) 000-0000 Fax: (000) 000-0000
IF TO BCWI: IF TO SANDOZ GMBH:
Biochemie West Indies N.V. Sandoz GmbH
Pietermaai 6A Xxxxxxxxxxxxxxxx 00
Xxxxxxxxxx, Xxxxxxx Xxxxx, Xxxxxxx
Xxxxxxxxxxx Antilles Attn: Legal Counsel
Attn: Xxxxx Xxxxxxxxx, Head Caribic Tele: 01143 5338 200 2207
Tele: 599-9-461-4084 Fax: 01143 0000 0000
Fax: 000-0-000-0000
WITH A COPY TO:
Sandoz GmbH
Xxxxxxxxxxxxxxxx 00
Xxxxx, Xxxxxxx
Attn: Legal Counsel
Tele: 00000 0000 000 0000
Fax: 01143 0000 0000
14.6. GOVERNING LAW. This Agreement and any and all matters arising
directly or indirectly herefrom shall be governed by and construed and enforced
in accordance with the internal laws of the State of
New York applicable to
agreements made and to be performed entirely in such state, without giving
effect to the conflict of law principles thereof.
14.7. JURY WAIVER. EACH PARTY HERETO HEREBY WAIVES, TO THE FULLEST
EXTENT PERMITTED BY APPLICABLE LAW, ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN
RESPECT OF ANY CLAIM BASED UPON, DIRECTLY OR INDIRECTLY ARISING OUT OF, UNDER OR
IN CONNECTION WITH THIS AGREEMENT AND THE TRANSACTIONS CONTEMPLATED HEREBY. EACH
PARTY HERETO ACKNOWLEDGES THAT IT AND THE OTHER PARTY HERETO HAVE BEEN INDUCED
TO ENTER INTO THIS AGREEMENT BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND
CERTIFICATIONS IN THIS SECTION 14.7.
14.8. COUNTERPARTS; FACSIMILE SIGNATURE. This Agreement may be
executed in any number of counterparts, each of which shall be an original, but
all of which together shall constitute one instrument. This Agreement may also
be executed via facsimile, which shall be deemed an original.
14.9. SEVERABILITY. In the event that any one or more of the
provisions contained herein, or the application thereof in any circumstances, is
held invalid, illegal or unenforceable in any respect for any reason, the
Parties shall negotiate in good faith with a view to the substitution therefor
of a suitable and equitable solution in order to carry out, so far as may be
valid and
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enforceable, the intent and purpose of such invalid provision; PROVIDED,
HOWEVER, THAT the validity, legality and enforceability of any such provision in
every other respect and of the remaining provisions contained herein shall not
be in any way impaired thereby, it being intended that all of the rights and
privileges of the Parties hereto shall be enforceable to the fullest extent
permitted by law.
14.10. EXPENSES. Each Party hereto shall bear its own direct and
indirect expenses incurred in connection with the negotiation and preparation of
this Agreement and, except as set forth in this Agreement, the performance of
the obligations contemplated hereby and thereby.
14.11. FURTHER ACTIONS AND DOCUMENTS. Each Party agrees to execute,
acknowledge and deliver all such further instruments, and to do all such further
acts, as may be reasonably necessary or appropriate to carry out the intent and
purposes of this Agreement.
14.12. USE OF TRADE NAMES AND TRADEMARKS. Each Party recognizes that
the name of the other Party represents valuable assets of such other Party and
that substantial recognition and goodwill are associated with such assets. Each
Party hereby agrees that neither it nor any of its Affiliates shall use such
assets of the other Party without prior written authorization from such other
Party. Nothing in this Agreement constitutes a license entitling any Party to
use any other Party's name, logos or trademarks; provided, however, that any
Party may use any other Party's name, logos or trademarks to the extent
permitted in Section 10.4.
14.13. AFFILIATES. To the extent that the rights granted to a Party
hereunder may be and are exercised by an Affiliate of such Party, such Affiliate
shall be bound by the corresponding obligations of such Party.
14.14. EXPORTS. The Parties acknowledge that the export of technical
data, materials or products is subject to the exporting Party receiving any
necessary export licenses and that the Parties cannot be responsible for any
delays attributable to export controls that are beyond the reasonable control of
either Party. The Parties agree not to export or re-export, directly or
indirectly, any information, technical data, the direct product of such data,
samples or equipment received or generated under this Agreement in violation of
any governmental regulations that may be applicable. The Parties agree to obtain
similar covenants from their licensees with respect to the subject matter of
this Section 14.14.
14.15. FORCE MAJEURE. No failure or omission by a Party hereto in the
performance of any obligation of this Agreement (excluding payment obligations)
shall be deemed a breach of this Agreement or create any liability if the same
shall arise from any cause or causes beyond the reasonable control of such
Party, including, but not limited to, the following: acts of God; acts or
omissions of any government; any rules, regulations or orders issued by any
governmental authority or by any officer, department, agency or instrumentality
thereof; fire; storm; flood; earthquake; accident; war; rebellion; terrorism;
insurrection; riot; and invasion (a "FORCE MAJEURE EVENT"); and PROVIDED THAT
such failure or omission resulting from a Force Majeure Event is cured as soon
as is practicable after the occurrence of such Force Majeure Event. The Party
claiming force majeure shall notify the other Party with notice of the Force
Majeure Event as soon as practicable, but in no event later than fourteen (14)
days after its occurrence, which
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notice shall reasonably identify such obligations under this Agreement and the
extent to which performance thereof will be affected. In such event, the Parties
shall meet promptly to determine an equitable solution to the effects of any
such Force Majeure Event.
14.16. NON-USE OF MIT NAME. Neither Sandoz nor its Affiliates shall use
the name of "MIT," "Lincoln Laboratory" or any variation, adaptation, or
abbreviation thereof, or of any of its trustees, officers, faculty, students,
employees, or agents (collectively, "MIT ASSOCIATES"), or any trademark owned by
MIT, or any terms of the MIT Agreement, in any promotional material or other
public announcement or disclosure without the prior written consent of MIT, or
in the case of the name of any MIT Associate, the written consent of such MIT
Associate. The immediately preceding sentence notwithstanding, without the
consent of MIT (but subject to the provisions of Article 10), Sandoz and its
Affiliates may state that they are sublicensed by MIT under one or more of the
applicable Momenta Patent Rights, may make statements of facts, and may make
disclosures or statements required by law.
14.17. HEADINGS. The captions or headings of the Sections or other
subdivisions hereof are inserted only as a matter of convenience or for
reference and are not part of the agreement of the parties and shall have no
effect on the meaning of the provisions hereof. All references in this Agreement
to Sections and Schedules are to sections and schedules to this Agreement,
unless otherwise indicated.
14.18. KEY PERSON LIFE INSURANCE. Sandoz may, at its option and sole
expense, secure life insurance policies, naming Sandoz as the beneficiary, with
respect to any principal scientist of Momenta. Momenta shall, at Sandoz's
expense, reasonably cooperate with Sandoz's attempts to secure such life
insurance policies.
14.19. NO CONSEQUENTIAL DAMAGES. UNLESS RESULTING FROM A PARTY'S
WILLFUL MISCONDUCT OR FROM A PARTY'S BREACH OF ARTICLE 10, NO PARTY HERETO WILL
BE LIABLE TO ANY OTHER PARTY OR ITS AFFILIATES FOR SPECIAL, INCIDENTAL,
CONSEQUENTIAL, EXEMPLARY, PUNITIVE, MULTIPLE OR OTHER INDIRECT DAMAGES ARISING
OUT OF THIS AGREEMENT OR THE EXERCISE OF ITS RIGHTS HEREUNDER, OR FOR LOSS OF
PROFITS, LOSS OF DATA OR LOSS OF USE DAMAGES ARISING FROM OR RELATING TO ANY
BREACH OF THIS AGREEMENT WHETHER BASED XXXX XXXXXXXX, XXXXXXXX, XXXX, XXXXXX
LIABILITY OR OTHERWISE, REGARDLESS OF ANY NOTICE OF SUCH DAMAGES. NOTHING IN
THIS SECTION 14.19 IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS
OR OBLIGATIONS OF ANY PARTY UNDER THIS AGREEMENT.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
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IN WITNESS WHEREOF, the Parties have executed this
Collaboration and License
Agreement in counterparts, effective as of the 1st day of November, 2003.
MOMENTA PHARMACEUTICALS, INC. GENEVA PHARMACEUTICALS, INC.
By: /s/ Xxxx Xxxxx By: [illegible]
-------------------------- ------------------------------
Name Xxxx Xxxxx Name:
-------------------------- ------------------------------
Title: Chief Executive Officer Title: Vice President, Bus. Dev.
-------------------------- ------------------------------
BIOCHEMIE WEST INDIES, N.V.
By: NOVARTIS INTERNATIONAL A.G., its Managing Director
By: [illegible]
--------------------------
Name:
--------------------------
Title:
--------------------------
By: SANDOZ GMBH, its Managaing Director
By: [illegible] [illegible]
-------------------------- ------------------------------
Name:
-------------------------- ------------------------------
Title: CFO General Counsel
-------------------------- ------------------------------
Sandoz GmbH, a corporation organized under the laws of Austria, hereby
guarantees the performance of the obligations of its subsidiary, Biochemie West
Indies, N.V., under Sections 4.1, 4.2 and 4.3 of the Agreement.
SANDOZ GMBH
By: [illegible] [illegible]
-------------------------- ------------------------------
Name:
-------------------------- ------------------------------
Title: CFO General Counsel
-------------------------- ------------------------------
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SCHEDULE 1.22
PRE-EXISTING COSTS
Entity to Be Paid Payment Amount
----------------- --------------
[**] U.S.$[**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] Up to [**]
[**] [**]
APPROXIMATE TOTAL: U.S.$[**]
NOTE: The above payments exclude the following costs: $[**] to [**] (incurred
through August 2003) and $[**] to [**] (incurred through August 2003), which are
being or were paid solely by Momenta.
*Costs paid as of September 22, 2003. All other costs have been invoiced or
committed. After the Effective Date, further payments will be due under the
agreements with [**]and [**] and the anticipated agreement with [**]. With
respect to [**], a portion of the up to $[**] will be for services conducted
prior to the Effective Date and a portion of the up to $[**] will be for
services conducted on or after the Effective Date. Invoices from [**] for a
total of $[**] have been received to date for the month of September 2003.
**This is only the amount due on 11/01/03.
***Exact amount will be determined from invoices.
****This is only the amount due for initial equipment purchase.
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SCHEDULE 1.48
CALCULATION OF MANUFACTURING COSTS
Manufacturing Cost with respect to a Party's or its Affiliates' cost to
manufacture and/or Label the Product in finished form shall be calculated as the
sum of [Actual Cost of Raw Materials] + [Actual Direct Labor Costs] +
[Manufacturing Overhead Costs], where:
ACTUAL COST OF RAW MATERIALS. The Actual Cost of Raw Materials means: (a) the
actual purchase unit cost of raw materials, including, without limitation, all
starting materials, biological products, biological molecules, chemicals,
precursors, intermediates, reagents, and active pharmaceutical ingredients; and
(b) the actual purchase unit cost of packaging components necessary to
manufacture or Label the Product, as the case may be; in each case of (a) and
(b), multiplied by the actual quantity consumed in the production and
manufacturing and/or Labeling process, as the case may be, including any usage
or yield variances and any write-offs caused by expiration, obsolescence,
accident and/or book-to-physical differences, and (c) all direct shipping costs
to the manufacturer associated with (a) and (b) above.
ACTUAL DIRECT LABOR COSTS. Actual Direct Labor Costs means the actual cost of
direct labor (salary and benefits) to manufacture and/or Label the Product,
including, without limitation, (a) any efficiency, activity and spending
variances from standards; (b) material adjustments for off-grade or defective
material, handling losses, physical adjustments, and salvage; and (c) shipment
charges, including all direct costs of shipping from the Party's manufacturing
and/or distribution facility to a Third Party Labeler and from such Third Party
Labeler to such Party's destination facility.
MANUFACTURING OVERHEAD COSTS. Manufacturing Overhead Costs means the reasonable
manufacturing overhead resources consumed in the manufacturing and production
and/or Labeling process, as the case may be, of a specified quantity of the
Product, which, with respect to any plant, except a plant, or a part of a plant,
built exclusively for the manufacture of the Product, shall be based on the
then-current Full Capacity of the relevant plant, rather than the actual level
of demand throughput, and which shall include, without limitation: (a) normal
depreciation of building, machinery, and equipment; and (b) plant management.
"FULL CAPACITY" means, (x) with respect to a plant operating at or below [**]%
of its Entire Capacity, [**]% of the Entire Capacity, and (y) with respect to a
plant operating above [**]% of its Entire Capacity, the actual demand throughput
at which the plant is operating. "ENTIRE CAPACITY" means production at [**]
percent ([**]%), which shall not exclude any loss of capacity resulting from
planned maintenance.
For the sake of clarity, and by way of examples, (1) if a plant is operating at
[**]% of its Entire Capacity, and [**]% percent of the plant's Entire Capacity
is devoted to the manufacture of the Product, [**]% ([**]) of the plant's
overhead shall be allocated to the Product, and (2) if a plant is operating at
[**]% of its Entire Capacity and [**]% of the plant's Entire Capacity is devoted
to the manufacture of the Product, [**]% ([**]) of the plant's overhead shall be
allocated to the Product.
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SCHEDULE 1.58
CURRENT MOMENTA PATENT RIGHTS
PATENT RIGHTS [**] (LICENSED TO MOMENTA BY MIT IN ACCORDANCE WITH THE MIT
AGREEMENT):
I. UNITED STATES PATENTS AND APPLICATIONS
M.I.T. CASE NO. [**]
Entitled: [**]
USA Serial No. [**]
Entitled: [**]
M.I.T. CASE NO. [**]
Entitled: [**]
USA Serial No. [**]
Entitled: [**]
M.I.T. CASE NO. 8448
Entitled: "Method for Identifying or Characterizing
Properties of Polymeric Units" By Xxxxxx Xxxxxx, Xxxxx
Xxxxx, Xxx Xxxxxxxxxxxx, Xxxxxxx Xxxxxxx, and Xxxxxx
Xxxxxxxxxxxx
USA Patent No. 6,597,996, Issued July 22, 2003
Entitled: "Method for Identifying or
Characterizing Properties of Polymeric Units"
Divisional Filed (see directly below)
USA Serial No. [**]
Entitled: [**]
M.I.T. CASE NO. [**]
Entitled: [**]
USA Serial No. [**]
Entitled: [**]
M.I.T. CASE NO. [**](IN PART AS NOTED BELOW)
Entitled: [**]
USA Serial No. [**]
Entitled: [**]
II. INTERNATIONAL (NON-U.S.) PATENTS AND APPLICATIONS
M.I.T. CASE NO. [**]
Entitled: [**]
EPC Application No. [**]
Entitled: [**]
Canada Application No. [**]
Entitled: [**]
Japanese Application No. [**]
Entitled: [**]
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M.I.T. CASE NO. [**]
Entitled: [**]
EPC Application No. [**]
Entitled: [**]
Canada Application No. [**]
Entitled: [**]
Japanese Application No. [**]
Entitled: [**]
M.I.T. CASE NO. [**]
Entitled: [**]
PCT Application No. [**]
Entitled: [**]
M.I.T. CASE NO. [**] (IN PART AS NOTED BELOW)
Entitled: [**]
WO Application Serial No. [**]
Entitled: [**]
PATENT RIGHTS [**](LICENSED TO MOMENTA BY MIT IN ACCORDANCE WITH THE MIT
AGREEMENT):
I. UNITED STATES PATENTS AND APPLICATIONS
M.I.T. CASE NO. 5546
Entitled: M.I.T. Case No. 5546, "The Heparinase Gene from
Flavobacterium Heparinum", By Xxxxxxx X. Xxxxxx, Xxxxxx X.
Xxxxxx, Xx., Xxxxxx X. Xxxxxxx, and Xxx Xxxxxxxxxxxx
USA Patent No. 5,714,376, Issued February 3, 1998
Entitled: "The Heparinase Gene from Flavobacterium
Heparinum"
USA Patent No. 5,830,726, Issued November 3, 1998
Entitled: "Method for Obtaining a Modified
Heparinase Gene"
M.I.T. CASE NO. 5981
Entitled: "Purification, Composition and Characterization
of Heparinase II from Flavobacterium Heparinum"
By Xxxxxxx X. Xxxxxx, Xxxxxx X. Xxxxxx, Xx., Xxxxxx
Xxxxxxxxx, Xxxxxx Xxxxx, and Xxx Xxxxxxxxxxxx
USA Patent No. 5,389,539, Issued February 14, 1995
Entitled: "Purification, Composition and Specificity
of Heparinase I, II, and III from Flavobacterium
Heparinum"
USA Patent No. 5,569,600, Issued October 29, 1996
Entitled: "Purification, Composition and
Specificity of Heparinase I, II, and III from
Flavobacterium Heparinum"
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II. INTERNATIONAL (NON-U.S.) PATENTS AND APPLICATIONS
M.I.T. CASE NO. [**]
Entitled: [**]
AT Patent No. [**]
BE Patent No. [**]
CH Patent No. [**]
DE Patent No. [**]
DK Patent No. [**]
ES Patent No. [**]
FR Patent No. [**]
GB Patent No. [**]
GR Patent No. [**]
IE Patent No. [**]
IT Patent No. [**]
LI Patent No. [**]
LU Patent No. [**]
MC Patent No. [**]
NL Patent No. [**]
SE Patent No. [**]
EP Patent No. [**]
All Entitled: [**]
CA Patent Application Serial No. [**]
Entitled: [**]
JP Patent Application Serial No. [**]
Entitled: [**]
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M.I.T. CASE NO. 5981
Entitled [**]
EP Patent No. [**]
Entitled: [**]
CA Patent No. [**]
Entitled: [**]
JP Patent Application Serial No. [**]
Entitled: [**]
PATENT RIGHTS [**] (LICENSED TO MOMENTA BY MIT IN ACCORDANCE WITH THE MIT
AGREEMENT):
I. UNITED STATES PATENTS AND APPLICATIONS
M.I.T. CASE NO. 6582
Entitled: "A Method for the Mass Spectrometric
Determination of the Molecular Weight of Highly Acidic (and
Basic) Organic and Biological Molecules"
by Xxxxx Xxxxxxx and Xxxxx Xxxxxx
USA Patent No. 5,607,859, Issued March 4, 1997
Entitled: "Methods and Products for Mass
Spectrometric Molecular Weight Determination of
Polyionic Analytes Employing Polyionic Reagents"
PATENT RIGHTS [**] (LICENSED TO MOMENTA BY MIT IN ACCORDANCE WITH THE MIT
AGREEMENT):
I. UNITED STATES PATENTS AND APPLICATIONS
M.I.T. CASE NO. [**]
Entitled: [**]
USA Serial No. [**]
Entitled: [**]
M.I.T. CASE NO. [**]
Entitled: "[**]
USA Serial No. [**]
Entitled: [**]
M.I.T. CASE NO. [**]
Entitled: [**]
II. INTERNATIONAL (NON-U.S.) PATENTS AND APPLICATIONS
M.I.T. CASE NO. [**]
Entitled: [**]
PCT Application No. [**]
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Entitled: [**]
M.I.T. CASE NO. [**]
Entitled: [**]
JP Patent Application Serial No. [**]
Entitled: [**]
MOMENTA-OWNED PATENT RIGHTS:
Entitled: [**]
US Application No. [**]
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SCHEDULE 4.3
ADJUSTMENT SCHEDULE
A. OVERVIEW
The Parties agree that the Sandoz Parties shall have the right to offset
Excess Costs against Commercial Milestone Payments, Profit Interest and
royalties (whether paid pursuant to Sections 4.6.1, 4.7.1 or 4.8.1), to the
extent, and subject to the limitations, set forth in this Schedule.
DEFINITIONS:
"ACTUAL MOMENTA ECONOMIC INTEREST". Actual Momenta Economic Interest
means, with respect to a Post-Launch Quarter, the percentage calculated in
accordance with the following table:
Quarter Actual Momenta Economic Interest
------- --------------------------------
Each of the First Post-Launch The percentage calculated by dividing:
Quarter through the [**] Post-Launch
Quarter (i) the sum of the [**] pursuant to this
SCHEDULE 4.3) during such
Post-Launch Quarter and all
preceding Post-Launch Quarters; by
(ii) the [**] for such Post-Launch
Quarter and all preceding
Post-Launch Quarters
The [**] Post-Launch Quarter or any The percentage calculated by dividing:
subsequent Post-Launch Quarter
(i) the sum of the [**] pursuant to this
SCHEDULE 4.3) for the [**]
Post-Launch Quarter and any
subsequent Post-Launch Quarters
through the relevant Post-Launch
Quarter; by
(ii) the [**] for the [**] Post-Launch
Quarter and any subsequent
Post-Launch Quarters through the
relevant Post-Launch Quarter
"CARRYFORWARD". Carryforward means that portion of Momenta Share of
Excess Costs and True-Up Amounts that are not deductible from the Profit
Interest or royalties (whether paid pursuant to Sections 4.6.1, 4.7.1 or 4.8.1),
due to the provisions of subsection D of this SCHEDULE 4.3, as shall be adjusted
from time to time pursuant to subsections B.2 and C.3 of this SCHEDULE 4.3.
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"ECONOMIC INTEREST VARIANCE". Economic Interest Variance means (a) with
respect to the [**] Post-Launch Year, the difference between the Momenta
Economic Interest for the Fourth Post-Launch Quarter and the Momenta Economic
Interest for the First Post-Launch Quarter, and (b) with respect to the [**]
through [**] Post-Launch Years, the difference between the Momenta Economic
Interest for the last Post-Launch Quarter of such Post-Launch Year and the
Momenta Economic Interest for the last Post-Launch Quarter of the previous
Post-Launch Year.
"MOMENTA ECONOMIC INTEREST". Momenta Economic Interest means, with
respect to a Post-Launch Quarter, the percentage calculated in accordance with
the following table:
Quarter Momenta Economic Interest
------- --------------------------
The [**] Post-Launch Quarter through the [**] Post-Launch The lesser of (a) the then-current Estimated Momenta
Quarter, inclusve Economic Interest of [**]% or (b) the Actual Momenta
Economic Interest for the [**] Post-Launch Quarter
The [**] Post-Launch Quarter through the [**] Post-Launch The lesser of (a) the then-current Estimated Momenta
Quarter, inclusive Economic Interest of [**]% or (b) the Actual Momenta
Economic Interest for the [**] Post-Launch Quarter
The [**] Post-Launch Quarter through the [**] Post-Launch The lesser of (a) the then-current Estimated Momenta
Quarter, inclusive Economic Interest of [**]% or (b) the Actual Momenta
Economic Interest for the [**] Post-Launch Quarter
The [**] Post-Launch Quarter through the [**] Post-Launch The lesser of (a) the then-current Estimated Momenta
Quarter, inclusive Economic Interest of [**]% or (b) the Actual Momenta
Economic Interest for the [**] Post-Launch Quarter
The [**] Post-Launch Quarter through the [**] Post-Launch The lesser of (a) the then-current Estimated Momenta
Quarter, inclusive Economic Interest of [**]% or (b) the Actual Momenta
Economic Interest for the [**] Post-Launch Quarter
The [**] Post-Launch Quarter The lesser of (a) the then-current Estimated Momenta
Economic Interest of [**]% or (b) the Actual Momenta
Economic Interest for the [**]Post-Launch Quarter
The [**] through the [**] Post-Launch Quarter, inclusive The Actual Momenta Economic Interest for the [**]
Post-Launch Quarter
The [**] Post-Launch Quarter in the [**]and every The Actual Momenta Economic Interest for the [**]
subsequent Post-Launch Years Post-Launch Quarter in such Post-Launch Year
Each of the [**] Post-Launch Quarters in the [**] and The Actual Momenta Economic Interest for the [**]
every subsequent Post-Launch Years Post-Launch Quarter in the prior Post-Launch Year
"MOMENTA SHARE OF EXCESS COSTS". Momenta Share of Excess Costs means,
with respect to a Post-Launch Quarter, the product of the New Excess Costs for
such Post-Launch Quarter
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multiplied by the Momenta Economic Interest for such Post-Launch Quarter, as
shall be adjusted from time to time pursuant to subsections B.2 and C.2 of this
SCHEDULE 4.3.
"NEW EXCESS COSTS". New Excess Costs means (a) with respect to the [**]
Post-Launch Quarter, the sum of any Excess Costs which were incurred during the
[**] Post-Launch Quarter and all Excess Costs which were incurred prior to the
[**] Post-Launch Quarter, and (b) with respect to any subsequent Post-Launch
Quarter, any Excess Costs which were incurred during such Post-Launch Quarter.
"TRUE-UP AMOUNT". True-Up Amount means with respect to each of the
[**]through the [**] Post-Launch Years, an amount equal to the product of the
Economic Interest Variance for such Post-Launch Year multiplied by the sum of
the New Excess Costs for the [**] Post-Launch Quarter and each additional
Post-Launch Quarter thereafter, through the [**] Post-Launch Quarter in such
Post-Launch Year.
OPERATIVE PROVISIONS:
B. OFFSETS AGAINST COMMERCIAL MILESTONE PAYMENTS
1. SANDOZ'S [**]% PROFIT MINIMUM. The Commercial Milestone
Payment(s) shall be the lesser of (a) the Full Milestone Payment(s) which is to
be made (in accordance with the timing in Section 4.10.2(b) for an applicable
Milestone Payment Quarter, or (b) the remainder after (i) the aggregate portions
of Profits paid to Momenta (excluding the effects of subsections C and E of this
SCHEDULE 4.3) for all Post-Launch Quarters (including the then-current Milestone
Payment Quarter) after the most recent prior Milestone Payment Quarter (or, if
no prior Milestone Payment Quarter has occurred, all Post-Launch Quarters), are
deducted from (ii) [**]percent ([**]%) of the aggregate Profits for all
Post-Launch Quarters (including the then-current Milestone Payment Quarter)
after the most recent prior Milestone Payment Quarter (or, if no prior Milestone
Payment Quarter has occurred, all Post-Launch Quarters). FOR EXAMPLE, IF FINAL
LEGAL CLEARANCE IS ACHIEVED PRIOR TO THE [**] ANNIVERSARY OF THE U.S. LAUNCH AND
[**], AND IF PROFITS FOR THE [**] POST-LAUNCH QUARTERS ARE U.S.$[**], THEN
MOMENTA'S PORTION OF THE PROFITS WOULD BE U.S.$[**]. THE COMMERCIAL MILESTONE
PAYMENT WOULD BE REDUCED TO U.S. $[**] (I.E., THE LESSER OF (a) U.S.$[**] OR (b)
U.S.$[**] (I.E., U.S.$[**] - U.S.$[**] ([**]% OF THE U.S.$[**] PROFITS MINUS THE
PORTION OF PROFITS DUE TO MOMENTA))).
2. CARRYFORWARD AND MOMENTA SHARE OF EXCESS COSTS DEDUCTION. After
the provisions of subsection B.1 of this SCHEDULE 4.3 have been applied, if
there are New Excess Costs with respect to the Milestone Payment Quarter or a
Carryforward exists at the start of such Milestone Payment Quarter, then the
amounts of the Carryforward and the Momenta Share of Excess Costs with respect
to such Post-Launch Quarter shall first be applied to reduce the amount of the
Commercial Milestone Payment to be paid by Sandoz, and any Carryforward or
Momenta Share of Excess Costs remaining with respect to such Post-Launch Quarter
after the applicable Milestone Payment(s) has been reduced to zero in accordance
with this subsection B.2 shall then be applied in accordance with the provisions
of subsection C of this SCHEDULE 4.3.
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C. OFFSETS AGAINST PAYMENTS OF PROFIT INTEREST AND ROYALTIES
1. FULL MILESTONE PAYMENT DEDUCTION. If, pursuant to subsection B.1
of this SCHEDULE 4.3, the Commercial Milestone Payment(s) to be paid in a
Milestone Payment Quarter is equal to the applicable Full Milestone Payment(s),
the Profit Interest for such Post-Launch Quarter shall be adjusted to equal the
product of (a) [**] percent ([**]%) times (b) the remaining Profits after such
Full Milestone Payment(s) are deducted from Profits in the U.S. Territory for
the applicable Post-Launch Quarter.
2. NEW EXCESS COSTS DEDUCTION. If New Excess Costs exist with
respect to a Post-Launch Quarter, and Sandoz does not exercise its right to
terminate the Agreement pursuant to Section 11.5 (if applicable), then, to the
extent any Momenta Share of Excess Costs were not applied in full to reduce the
amount of the Commercial Milestone Payment(s) pursuant to subsection B.2 of this
SCHEDULE 4.3, the amount of any Profit Interest or royalties, as the case may
be, otherwise payable to Momenta for such Post-Launch Quarter shall be reduced
by the applicable Momenta Share of Excess Costs for such Post-Launch Quarter,
subject to the provisions of subsection D of this SCHEDULE 4.3.
3. CARRYFORWARD DEDUCTION. If a Carryforward exists with respect to
a Post-Launch Quarter, then, to the extent such Carryforward was not applied in
full to reduce the amount of the Commercial Milestone Payment pursuant to
subsection B.2 of this SCHEDULE 4.3, the amount of any Profit Interest or
royalties, as the case may be, otherwise payable to Momenta for such Post-Launch
Quarter shall be reduced by the applicable remaining Carryforward, subject to
the provisions of subsection D of this SCHEDULE 4.3.
D. [**]% REDUCTION FLOOR
1. DEDUCTION LIMIT. With respect to any Post-Launch Quarter, the
deduction of the Momenta Share of Excess Costs for such Post-Launch Quarter, the
Carryforward and the True-Up Amount for such Post-Launch Quarter, collectively,
shall not reduce by more than [**]percent ([**]%) the portion of Profits
otherwise payable to Momenta for such Post-Launch Quarter under Sections 4.5 or
4.8 or the royalties otherwise payable to Momenta for such Post-Launch Quarter
under Sections 4.6, 4.7 or 4.8, as applicable, and any portion of the Momenta
Share of Excess Costs for such Post-Launch Quarter or the True-Up Amount for
such Post-Launch Quarter not deducted from Profits or royalties payable to
Momenta as a result of such limitation shall be added to the Carryforward for
subsequent Post-Launch Quarters.
E. MOMENTA ECONOMIC INTEREST TRUE-UP.
1. OVERPAYMENT BY MOMENTA. If the Economic Interest Variance for a
Post-Launch Year is negative, then the Sandoz Parties shall pay to Momenta,
within forty-five (45) days after the end of such Post-Launch Year, an amount
equal to the absolute value of the True-Up Amount for such Post-Launch Year.
2. UNDERPAYMENT BY MOMENTA. If the Economic Interest Variance for a
Post-Launch Year is positive, then, prior to the payment of any portion of
Profits or the royalties to Momenta
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with respect to the last Post-Launch Quarter in such Post-Launch Year, the
True-Up Amount for such Post-Launch Year shall first be deducted from the
portion of Profits or the royalties otherwise payable to Momenta for such last
Post-Launch Quarter in such Post-Launch Year, subject to the provisions of
subsection D of this SCHEDULE 4.3.
F. EXAMPLES
THE FOLLOWING EXAMPLES ARE FOR ILLUSTRATIVE PURPOSES ONLY. Any errors or
omissions in this section should not be construed to change the meaning of the
rest of this SCHEDULE 4.3 or this Agreement. Figures 4.3(a) and 4.3(b) provide
spreadsheets with calculations through the [**] Post-launch Year.
ASSUMPTIONS. Net Sales, Manufacturing Costs, Selling Expenses, and New Excess
Costs are as reported in Figures 4.3(a) and 4.3(b). It is assumed for this
example that [**] until the beginning of the [**] Post-Launch Year (it is
assumed that [**] as of the first day of the [**] Launch Year and is not [**]).
It is also assumed that First Commercial Sale of the Product occurs part-way
through the [**] Post-Launch Quarter. Finally, it is assumed that First
Commercial Sale does not occur until after Final Legal Clearance in Figure
4.3(a), and that Final Legal Clearance occurs during the [**] Quarter of the
[**] Post-Launch Year in Figure 4.3(b). All numbers are reported to two decimal
points for ease of illustration and except as otherwise specified represent
millions of US dollars.
CALCULATIONS FOR FIGURE 4.3(a) (WORKING COLUMN BY COLUMN FROM LEFT TO RIGHT).
PROFIT. The total Profit is calculated by subtracting Manufacturing Costs and
Selling Expenses from Net Sales.
PRELIMINARY PROFIT/ROYALTY CALCULATION 1. The column entitled Preliminary
Profit/Royalty Calculation 1 (taking into account only Net Sales, Manufacturing
Costs, Selling Expenses and Third Party Competitor status), is calculated, based
on the assumptions listed above, as [**]% of Profits until a Third Party
Competitor exists at the beginning of the [**] Post-Launch Year, and then as
tiered Post-[**] Royalty rates on Net Sales of [**]% and [**]%, as applicable.
MOMENTA ECONOMIC INTEREST. In the first [**] Post-Launch Years, the Momenta
Economic Interest is calculated as the lesser of the Actual Momenta Economic
Interest or the Estimated Momenta Economic Interest (as described in subsection
A of this SCHEDULE 4.3). As an example, Actual Momenta Economic Interest in the
[**] Quarter of the [**] Post-Launch Year is calculated as follows. The sum of
the Profit/Royalty payable to Momenta (as calculated in the previous column) for
all Quarters from U.S. Launch through the [**] Quarter of the [**] Post-Launch
Year ($[**]) is divided by the sum of the Profits for the Product over the same
period ($[**]) to yield [**]%. Since this is less than the Estimated Momenta
Economic Interest of [**]% for that same Quarter, the Momenta Economic Interest
is [**]%. In the Sixth and subsequent Post-Launch Years, the Momenta Economic
Interest is calculated as described in subsection A of this SCHEDULE 4.3.
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COMMERCIAL MILESTONE PAYMENT. The first Commercial Milestone Payment in the
illustration is reduced for two reasons. First, the Sandoz Parties' portion of
Profits would be less than [**]% if the full $[**] Commercial Milestone Payment
was made. Therefore, the Commercial Milestone is reduced as follows. [**]% of
the Profits since the last Milestone Payment Quarter (or since U.S. Launch in
this case, since it is the first Commercial Milestone Payment) is calculated.
Here, the total Profits are $[**], and [**]% of the sum of such Profits for the
[**] through the [**] Post-Launch Quarters is $[**]. From this [**]% of the
$[**] in Profits is subtracted any Profit/royalty payments made to Momenta
(excluding the effects of subsections C and E of this SCHEDULE 4.3) during the
same [**] Quarters (in this case, Profit payments, which total $[**]), resulting
in $[**]. This $[**] is the Commercial Milestone Payment adjusted for the
provision that ensures the Sandoz Parties' minimum [**]% Profit share
(subsection B.1 of this SCHEDULE 4.3). The first Commercial Milestone Payment is
then further adjusted (as described in subsection B.2 of this SCHEDULE 4.3) by
subtracting $[**] for the Momenta Share of Excess Costs in that Quarter,
resulting in a final adjusted Commercial Milestone Payment of $[**]. The second
and third Commercial Milestone Payments do not require similar adjustments and
are both $[**].
PRELIMINARY PROFIT/ROYALTY CALCULATION 2. The Preliminary Profit/Royalty
Calculation 2 in the next column now includes the impact of any deductions made
as a result of the Commercial Milestone Payments. Note that the first Commercial
Milestone Payment which is reduced due to the provision related to the Sandoz
Parties' [**]% Profit minimum, as described above, is not subtracted in the
Profit calculation (as described in subsection C of this SCHEDULE 4.3). The
second and third Commercial Milestone Payments, which are full $[**] payments,
are subtracted.
MOMENTA SHARE OF EXCESS COSTS. Momenta Share of Excess Costs are calculated by
multiplying New Excess Costs in the applicable Quarter by the applicable Momenta
Economic Interest for that same Quarter.
TRUE UP AMOUNT. The True-Up Amount is calculated by multiplying the Economic
Interest Variance by the sum of all previous Quarters' (but not including the
current Quarter's) New Excess Costs. For example, in Q4 of the [**] Post-Launch
Year, the Economic Interest Variance of [**]% ([**]%-[**]%) is multiplied by the
sum of $[**], $[**], and $[**] (but not $[**]) to yield $[**].
PRELIMINARY PROFIT/ROYALTY CALCULATION 3. The Preliminary Profit/Royalty
Calculation 3 in the next column now takes into account both the Momenta Share
of Excess Costs and the True-Up Amount. Note that in the [**] Post-launch
Quarter, the Momenta Share of Excess Costs would reduce the payment by more than
[**]%. Hence (as described in subsection D of this SCHEDULE 4.3), the payment
amount is only reduced here from $[**] to [**]% of this amount, or $[**] Thus
only $[**] of the $[**] of the Momenta Share of Excess Costs is paid in this
Quarter. The remaining $[**] becomes part of the Carryforward.
CARRYFORWARD AND FINAL PROFIT/ROYALTY CALCULATION. Carryforwards are subtracted
from the Preliminary Profit/Royalty Calculations 3 in the previous column to
complete the Final Profit/Royalty Calculation.
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DIFFERENCES IN CALCULATIONS FOR FIGURE 4.3(b). Except as provided in this
paragraph, the assumptions and calculations of Figure 4.3(a) apply to Figure
4.3(b). In Figure 4.3(b), Final Legal Clearance occurs during the first Quarter
of the [**] Post-Launch Year. As a result, no Commercial Milestone Payments are
made in the first Quarter of the [**] Post-Launch Year or in the first Quarter
of the [**] Post-Launch Year. In the first Quarter of the [**] Post-Launch Year,
the Momenta Share of Excess Costs is deducted from the Preliminary
Profit/Royalty Calculation 2 rather than from the Commercial Milestone Payment.
Finally, the Commercial Milestone Payment in Figure 4.3(b) is made in the
Quarter that Final Legal Clearance occurs. The payment is calculated according
to subsection B.1 of this SCHEDULE 4.3. This payment is also subtracted from
Profits to calculate the Preliminary Profit/Royalty 2 for the first Quarter of
the [**] Post-Launch Year in accordance with subsection C.1 of this SCHEDULE
4.3.
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Figure 4.3(a) (page 1)
Preliminary
Profit Profit/Royalty Momenta
Net Third Party Manufacturing Selling (total for Calculation Economic COMMERCIAL
Sales Competitor Costs Expenses product) 1 Interest MILESTONE
-------------------------------------------------------------------------------------------------------------------
Q1 Yr 1 [**] [**] [**] [**] [**] [**] [**]%
Q2 Yr 1 [**] [**] [**] [**] [**] [**] [**]%
Q3 Yr 1 [**] [**] [**] [**] [**] [**] [**]%
Q4 Yr 1 [**] [**] [**] [**] [**] [**] [**]%
Q1 Yr 2 [**] [**] [**] [**] [**] [**] [**]% [**]
Q2 Yr 2 [**] [**] [**] [**] [**] [**] [**]%
Q3 Yr 2 [**] [**] [**] [**] [**] [**] [**]%
Q4 Yr 2 [**] [**] [**] [**] [**] [**] [**]%
Q1 Yr 3 [**] [**] [**] [**] [**] [**] [**]% [**]
Q2 Yr 3 [**] [**] [**] [**] [**] [**] [**]%
Q3 Yr 3 [**] [**] [**] [**] [**] [**] [**]%
Q4 Yr 3 [**] [**] [**] [**] [**] [**] [**]%
Q1 Yr 4 [**] [**] [**] [**] [**] [**] [**]% [**]
Q2 Yr 4 [**] [**] [**] [**] [**] [**] [**]%
Q3 Yr 4 [**] [**] [**] [**] [**] [**] [**]%
Q4 Yr 4 [**] [**] [**] [**] [**] [**] [**]%
Q1 Yr 5 [**] [**] [**] [**] [**] [**] [**]%
Q2 Yr 5 [**] [**] [**] [**] [**] [**] [**]%
Q3 Yr 5 [**] [**] [**] [**] [**] [**] [**]%
Q4 Yr 5 [**] [**] [**] [**] [**] [**] [**]%
Q1 Yr 6 [**] [**] [**] [**] [**] [**] [**]%
Q2 Yr 6 [**] [**] [**] [**] [**] [**] [**]%
Q3 Yr 6 [**] [**] [**] [**] [**] [**] [**]%
Q4 Yr 6 [**] [**] [**] [**] [**] [**] [**]%
Q1 Yr 7 [**] [**] [**] [**] [**] [**] [**]%
Q2 Yr 7 [**] [**] [**] [**] [**] [**] [**]%
Q3 Yr 7 [**] [**] [**] [**] [**] [**] [**]%
Q4 Yr 7 [**] [**] [**] [**] [**] [**] [**]%
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Figure 4.3(a) (page 2)
Preliminary Preliminary
Profit/Royalty Momenta Profit/Royalty FINAL
Calculation New Share of Calculation New Cummulative PROFIT/ROYALTY
2 Excess Costs Excess Costs True Up 3 Carryforward Carryforward CALCULATION
---------------------------------------------------------------------------------------------------------------------------
Q1 Yr 1 [**] [**] [**] [**] [**] [**] [**]
Q2 Yr 1 [**] [**] [**] [**]
Q3 Yr 1 [**] [**] [**]
Q4 Yr 1 [**] [**] [**] [**]
Q1 Yr 2 [**] [**] [**] [**] [**]
Q2 Yr 2 [**] [**] [**]
Q3 Yr 2 [**] [**] [**]
Q4 Yr 2 [**] [**] [**] [**] [**] [**]
Q1 Yr 3 [**] [**] [**]
Q2 Yr 3 [**] [**] [**]
Q3 Yr 3 [**] [**] [**]
Q4 Yr 3 [**] [**] [**] [**] [**] [**]
Q1 Yr 4 [**] [**] [**]
Q2 Yr 4 [**] [**] [**]
Q3 Yr 4 [**] [**] [**]
Q4 Yr 4 [**] [**] [**] [**]
Q1 Yr 5 [**] [**] [**]
Q2 Yr 5 [**] [**] [**]
Q3 Yr 5 [**] [**] [**]
Q4 Yr 5 [**] [**] [**] [**]
Q1 Yr 6 [**] [**] [**]
Q2 Yr 6 [**] [**] [**] [**] [**]
Q3 Yr 6 [**] [**] [**]
Q4 Yr 6 [**] [**] [**]
Q1 Yr 7 [**] [**] [**]
Q2 Yr 7 [**] [**] [**]
Q3 Yr 7 [**] [**] [**]
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Q4 Yr 7 [**] [**] [**]
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Figure 4.3(b) (page 1)
Preliminary
Profit Profit/Royalty Momenta
Net Third Party Manufacturing Selling (total for Calculation Economic COMMERCIAL
Sales Competitor Costs Expenses product) 1 Interest MILESTONE
-------------------------------------------------------------------------------------------------------------------
Q1 Yr 1 [**] [**] [**] [**] [**] [**] [**]%
Q2 Yr 1 [**] [**] [**] [**] [**] [**] [**]%
Q3 Yr 1 [**] [**] [**] [**] [**] [**] [**]%
Q4 Yr 1 [**] [**] [**] [**] [**] [**] [**]%
Q1 Yr 2 [**] [**] [**] [**] [**] [**] [**]%
Q2 Yr 2 [**] [**] [**] [**] [**] [**] [**]%
Q3 Yr 2 [**] [**] [**] [**] [**] [**] [**]%
Q4 Yr 2 [**] [**] [**] [**] [**] [**] [**]%
Q1 Yr 3 [**] [**] [**] [**] [**] [**] [**]%
Q2 Yr 3 [**] [**] [**] [**] [**] [**] [**]%
Q3 Yr 3 [**] [**] [**] [**] [**] [**] [**]%
Q4 Yr 3 [**] [**] [**] [**] [**] [**] [**]%
Q1 Yr 4 [**] [**] [**] [**] [**] [**] [**]% [**]
Q2 Yr 4 [**] [**] [**] [**] [**] [**] [**]%
Q3 Yr 4 [**] [**] [**] [**] [**] [**] [**]%
Q4 Yr 4 [**] [**] [**] [**] [**] [**] [**]%
Q1 Yr 5 [**] [**] [**] [**] [**] [**] [**]%
Q2 Yr 5 [**] [**] [**] [**] [**] [**] [**]%
Q3 Yr 5 [**] [**] [**] [**] [**] [**] [**]%
Q4 Yr 5 [**] [**] [**] [**] [**] [**] [**]%
Q1 Yr 6 [**] [**] [**] [**] [**] [**] [**]%
Q2 Yr 6 [**] [**] [**] [**] [**] [**] [**]%
Q3 Yr 6 [**] [**] [**] [**] [**] [**] [**]%
Q4 Yr 6 [**] [**] [**] [**] [**] [**] [**]%
Q1 Yr 7 [**] [**] [**] [**] [**] [**] [**]%
Q2 Yr 7 [**] [**] [**] [**] [**] [**] [**]%
Q3 Yr 7 [**] [**] [**] [**] [**] [**] [**]%
Q4 Yr 7 [**] [**] [**] [**] [**] [**] [**]%
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Figure 4.3(b) (page 2)
Preliminary Preliminary
Profit/Royalty Momenta Profit/Royalty FINAL
Calculation New Share of Calculation New Cummulative PROFIT/ROYALTY
2 Excess Costs Excess Costs True Up 3 Carryforward Carryforward CALCULATION
---------------------------------------------------------------------------------------------------------------------------
Q1 Yr 1 [**] [**] [**] [**] [**] [**] [**]
Q2 Yr 1 [**] [**] [**] [**]
Q3 Yr 1 [**] [**] [**]
Q4 Yr 1 [**] [**] [**] [**]
Q1 Yr 2 [**] [**] [**] [**] [**]
Q2 Yr 2 [**] [**] [**]
Q3 Yr 2 [**] [**] [**]
Q4 Yr 2 [**] [**] [**] [**] [**] [**]
Q1 Yr 3 [**] [**] [**]
Q2 Yr 3 [**] [**] [**]
Q3 Yr 3 [**] [**] [**]
Q4 Yr 3 [**] [**] [**] [**] [**] [**]
Q1 Yr 4 [**] [**] [**]
Q2 Yr 4 [**] [**] [**]
Q3 Yr 4 [**] [**] [**]
Q4 Yr 4 [**] [**] [**] [**]
Q1 Yr 5 [**] [**] [**]
Q2 Yr 5 [**] [**] [**]
Q3 Yr 5 [**] [**] [**]
Q4 Yr 5 [**] [**] [**] [**]
Q1 Yr 6 [**] [**] [**]
Q2 Yr 6 [**] [**] [**] [**] [**]
Q3 Yr 6 [**] [**] [**]
Q4 Yr 6 [**] [**] [**]
Q1 Yr 7 [**] [**] [**]
Q2 Yr 7 [**] [**] [**]
Q3 Yr 7 [**] [**] [**]
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Q4 Yr 7 [**] [**] [**]
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EXECUTION COPY
SCHEDULE 5.8
ANNUAL COLLABORATION PLAN:
PRELIMINARY LIST OF ACTIVITIES AND ASSIGNMENT OF LEAD RESPONSIBILITY
TO PARTY(IES)
FUNCTIONAL AREA ACTIVITY LEAD
--------------- -------- ----
TECHNOLOGY / Support [**] [**]
CHARACTERIZATION Complete [**] the Product
Continue to [**] the Product approval
REGULATORY Prior to [**] the Product [**]
-- Manage [**]
[**]-- [**] the Product
-- manage [**],
[**]-- submit [**]
-- [**]
PRE-CLINICAL / Design [**] the Product and Product commercialization [**]
CLINICAL
MANUFACTURING [**]-- research [**] [**]
-- secure [**]
[**]-- [**] process [**]
-- [**] and stability
-- [**] and stability
-- [**] support [**]
-- [**] stability
-- successful [**]
-- commercial [**]
-- commercial [**]
[**]-- [**]-- [**] and stability
-- [**] and stability
-- [**] methods [**]
-- manage [**]
LEGAL [**]-- to support [**] [**]
[**] Litigation
COMMERCIAL Pre-Launch Marketing Strategy and Plan [**]
Product Launch and Commercialization
S = Sandoz
M = Momenta
S/M = Lead to be defined between Sandoz or Momenta by JPT
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