Exhibit 99.2
EXECUTION VERSION
DEVELOPMENT, COMMERCIALIZATION AND LICENSE AGREEMENT
BETWEEN
AETERNA ZENTARIS GMBH
AND
SANOFI-AVENTIS U.S. LLC,
DATED
MARCH 5, 2009
TABLE OF CONTENTS
ARTICLE 1 DEFINITIONS.................................................................1
ARTICLE 2............................................................................13
2.1 Grants to Licensee.........................................................14
2.2 Grants to Licensor.........................................................14
2.3 Trademark License Agreement................................................14
2.4 Distributors...............................................................14
2.5 Sublicenses................................................................14
2.6 Use of Corporate Names.....................................................16
2.7 No Implied Rights; Reservation of Rights...................................16
2.8 Non-Compete................................................................16
2.9 Transfer of Licensed Know-How..............................................17
ARTICLE 3 GOVERNANCE.................................................................17
3.1 General....................................................................17
3.2 Joint Development Committee................................................17
3.3 Joint Commercial Committee.................................................18
3.4 General Provisions.........................................................18
ARTICLE 4 DEVELOPMENT................................................................20
4.1 Development Plan...........................................................20
4.2 Amendments to the Development Plan.........................................21
4.3 Diligence, Compliance and Assistance.......................................21
4.4 Budget.....................................................................21
4.5 Development Outside the Territory/Outside the Field........................22
4.6 Reporting..................................................................22
ARTICLE 5 REGULATORY MATTERS.........................................................22
5.1 Responsibility for Regulatory Matters......................................23
5.2 Data.......................................................................23
5.3 DDMAC......................................................................23
5.4 Submissions................................................................23
5.5 Communications and Meetings................................................24
5.6 Records....................................................................25
ARTICLE 6 COMMERCIALIZATION..........................................................26
6.1 General....................................................................26
6.2 Studies....................................................................26
6.3 Commercialization Plan.....................................................26
6.4 Statements and Compliance with Applicable Law..............................27
6.5 Sales and Distribution.....................................................27
6.6 Product Trademarks and Markings............................................27
6.7 Records and Reporting......................................................27
6.8 Co-Promotion Option........................................................28
6.9 Delegation of Certain Commercialization Obligations........................29
ARTICLE 7 MANUFACTURE AND SUPPLY.....................................................29
7.1 Manufacture of Licensed Products...........................................29
7.2 Secondary Packaging and Labeling...........................................30
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7.3 Manufacturing Technology Transfer..........................................30
7.4 Waiver of Domestic Manufacture Obligation..................................30
ARTICLE 8 CONSIDERATION..............................................................30
8.1 Payments to Licensor.......................................................31
8.2 Royalties..................................................................31
8.3 Combination Products.......................................................34
8.4 Other Income from Sublicensees.............................................35
8.5 Payment of Development Expenses............................................35
8.6 Recovery of Amounts Paid to Tulane.........................................36
8.7 Mode of Payment............................................................36
8.8 Currency...................................................................36
8.9 Taxes......................................................................36
8.10 Interest on Late Payments..................................................37
8.11 Financial Records..........................................................37
8.12 Audit......................................................................37
8.13 Reconciliation.............................................................37
8.14 Confidentiality............................................................38
ARTICLE 9 INTELLECTUAL PROPERTY......................................................38
9.1 Ownership of Intellectual Property.........................................38
9.2 Maintenance and Prosecution of Patents.....................................40
9.3 Enforcement of Patents.....................................................43
9.4 Infringement Claims by Third Parties.......................................45
9.5 Invalidity or Unenforceability Defenses or Actions.........................46
ARTICLE 10 ADVERSE EVENT REPORTING; RECALL...........................................48
10.1 Adverse Event Reporting....................................................48
10.2 Pharmacovigilance..........................................................49
10.3 Recall.....................................................................49
ARTICLE 11 CONFIDENTIALITY AND NON-DISCLOSURE........................................49
11.1 Licensed Know-How..........................................................49
11.2 General Confidentiality Obligations........................................50
11.3 Permitted Disclosures......................................................51
11.4 Use of Name................................................................52
11.5 Press Releases and Public Filings..........................................52
11.6 Patient Information........................................................52
11.7 Publications...............................................................53
ARTICLE 12 REPRESENTATIONS, WARRANTIES AND COVENANTS.................................53
12.1 Representations, Warranties and Covenants..................................53
12.2 Additional Representations, Warranties and Covenants of Licensee...........54
12.3 Additional Representations, Warranties and Covenants of Licensor...........55
12.4 DISCLAIMER OF WARRANTY.....................................................57
ARTICLE 13 INDEMNITY.................................................................57
13.1 Indemnification of Licensor................................................57
13.2 Indemnification of Licensee................................................58
13.3 Notice of Claim............................................................58
13.4 Control of Defense.........................................................58
13.5 Limitation on Damages and Liability........................................60
13.6 Insurance..................................................................60
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ARTICLE 14 TERM AND TERMINATION......................................................60
14.1 Term.......................................................................61
14.2 Termination of this Agreement in its Entirety for Material Breach..........61
14.3 Certain Licensee Termination Rights........................................61
14.4 Termination for Failure to Supply..........................................62
14.5 Termination Upon Insolvency................................................62
14.6 Rights in Bankruptcy.......................................................62
14.7 Consequences of Termination................................................63
14.8 Accrued Rights; Surviving Obligations......................................65
ARTICLE 15 MISCELLANEOUS.............................................................67
15.1 Force Majeure..............................................................67
15.2 Export Control.............................................................67
15.3 Assignment.................................................................67
15.4 Severability...............................................................68
15.5 Governing Law, Jurisdiction, Venue and Service.............................69
15.6 Dispute Resolution.........................................................69
15.7 Notices....................................................................70
15.8 Entire Agreement...........................................................71
15.9 English Language...........................................................71
15.10 Equitable Relief...........................................................71
15.11 Waiver and Non-Exclusion of Remedies.......................................72
15.12 No Benefit to Third Parties................................................72
15.13 Further Assurance..........................................................72
15.14 Relationship of the Parties................................................72
15.15 Counterparts...............................................................72
15.16 References.................................................................72
15.17 Construction...............................................................73
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LIST OF SCHEDULES
Schedule 1.5 Cetrorelix Pamoate
Schedule 1.77 Licensed Know-How
Schedule 1.78 Licensed Patents
Schedule 1.125 Cetrorelix Acetate
Schedule 1.128 Target Product Profile
Schedule 3.4.1(a) Initial Joint Development Committee Members
Schedule 3.4.1(b) Initial Joint Commercial Committee Members
Schedule 4.1 Initial Development Plan
Schedule 4.4 Development Budget for Open Label Extension Study
Schedule 6.3 Initial Commercialization Plan and Form of Commercialization Plan
Schedule 6.7 Form of Commercialization Report
Schedule 7.1.2 Commercial Supply Agreement Terms
Schedule 7.3 Manufacturing Licensed Know-How
Schedule 8.2.2 Example of Step-Down Provisions
Schedule 8.3 Example of Combination Product Calculation
Schedule 9.2.1 Shared Cost Patents
Schedule 12.3 Exception to Representations and Warranties
Schedule 15.3.3 Licensor's Designees
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DEVELOPMENT, COMMERCIALIZATION AND LICENSE AGREEMENT
This
Development, Commercialization and License Agreement (the "AGREEMENT") is
made and entered into as of March 5, 2009 (the "EXECUTION DATE") by and between
AEterna Zentaris GmbH, a limited liability company, having its place of business
at ▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇ ("LICENSOR"); and
sanofi-aventis U.S. LLC, a Delaware limited liability company, having a place of
business at ▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇ ("LICENSEE").
Licensor and Licensee are sometimes referred to herein individually as a "PARTY"
and collectively as the "PARTIES."
RECITALS
WHEREAS, Licensor has rights with respect to Licensed Products (as
defined below) and has commenced Phase IIIA Clinical Studies (as defined below)
for the use of the same for the treatment of benign prostatic hyperplasia;
WHEREAS, Licensee and its Affiliates have specialized experience in,
among other things, the development and commercialization of pharmaceutical
compounds in the urology field; and
WHEREAS, Licensor desires to grant a license to Licensee, and
Licensee desires to obtain a license, to commercialize Licensed Products (as
defined below) in the Field (as defined below) in the Territory (as defined
below) in accordance with the terms and conditions set forth below.
NOW, THEREFORE, in consideration of the foregoing premises, the
mutual promises and covenants of the Parties contained therein and other good
and valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, the Parties, intending to be legally bound, do hereby agree as
follows:
ARTICLE 1
DEFINITIONS
Unless otherwise specifically provided herein, the following terms
shall have the following meanings:
1.1. "ADVERSE EVENT" or "AE" shall have the meaning set forth in
Section 10.1.
1.2. "AFFILIATE" shall mean, with respect to a Party, any Person that,
directly or indirectly, through one or more intermediaries, controls, is
controlled by or is under common control with such Party. For purposes of this
definition, "control" and, with correlative meanings, the terms "controlled by"
and "under common control with" shall mean (a) the possession, directly or
indirectly, of the power to direct the management or policies of a business
entity, whether through the ownership of voting securities, by contract relating
to voting rights or corporate governance, or otherwise, or (b) the ownership,
directly or indirectly, of more than fifty percent (50%) of the voting
securities or other ownership interest of a business entity (or, with respect to
a limited partnership or other similar entity, its general partner or
controlling entity).
1.3. "AGREEMENT" shall have the meaning set forth in the preamble hereto.
1.4. "ANDA ACT" shall have the meaning set forth in Section 9.3.3.
1.5. "API" shall mean the compound cetrorelix pamoate described in
SCHEDULE 1.5 hereto.
1.6. "APPLICABLE LAW" shall mean applicable laws, rules and regulations,
including any rules, regulations, guidelines, guidance or other requirements of
Regulatory Authorities in the Territory, that may be in effect from time to
time.
1.7. "A RATED" shall mean, "therapeutically equivalent" as evaluated by
the FDA, applying the definition of "therapeutically equivalent" set forth in
the preface to the then-current edition of the FDA publication "Approved Drug
Products With Therapeutic Equivalence Evaluations."
1.8. "AUDITOR" shall have the meaning set forth in Section 8.12.
1.9. "BENCHMARK CALENDAR QUARTER" shall mean the Calendar Quarter of the
Calendar Year immediately prior to the Calendar Year in which Generic Launch
occurs that corresponds to the Calendar Quarter in which Generic Launch occurs
(e.g., if Generic Launch occurs in Q1 of a given Calendar Year, the Benchmark
Calendar Quarter shall be Q1 of the immediately preceding Calendar Year).
1.10. "BPH" shall mean the treatment of the signs and symptoms of benign
prostatic hyperplasia in humans.
1.11. "BREACHING PARTY" shall have the meaning set forth in Section 14.2.
1.12. "BUSINESS DAY" shall mean a day other than a Saturday or Sunday on
which banking institutions in ▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ are open
for business.
1.13. "CALENDAR QUARTER" shall mean each successive period of three (3)
calendar months commencing on each of January 1, April 1, July 1 and October 1.
1.14. "CALENDAR YEAR" shall mean each successive period of twelve (12)
calendar months commencing on January 1 and ending on December 31.
1.15. "CHANGE OF CONTROL" shall mean:
(a) the bona fide acquisition by any Person or group
(within the meaning of Sections 13(d)(3) or 14(d)(2) of the Securities Exchange
Act of 1934) of beneficial ownership of any capital stock of the Parent or
Licensor, if after such acquisition, such Person or group would be the
"beneficial owner" (as defined in Rule 13d-3 under the Securities Exchange Act
of 1934), directly or indirectly, of securities of the Parent or Licensor
representing more than fifty percent (50%) of the combined voting power of the
Parent's or Licensor's then outstanding securities entitled to vote generally in
the election of directors;
(b) the consummation after approval by the Parent's or
Licensor's stockholders of a bona fide merger or consolidation of the Parent or
Licensor, with any other Person, other than a merger or consolidation which
would result in the Parent's or Licensor's voting securities outstanding
immediately prior thereto continuing to represent (either by remaining
outstanding or by being converted into voting securities of the surviving
entity)
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more than fifty percent (50%) of the combined voting power of the Parent's or
Licensor's voting securities or such surviving entity's voting securities
outstanding immediately after such merger or consolidation; or
(c) the bona fide sale, lease, transfer, exclusive license
or other disposition, in a single transaction or series of related transactions,
by the Parent or any of its subsidiaries of all or substantially all the assets
of (i) the Parent and its subsidiaries taken as a whole or (ii) Licensor, except
in the case of both (i) and (ii) if such sale, lease, transfer, exclusive
license or other disposition is to a majority owned (direct or indirect)
subsidiary of the Parent.
1.16. "CHANGE OF CONTROL NOTICE" shall have the meaning set forth in
Section 14.3.3.
1.17. "CHANGE OF CONTROL TERMINATION NOTICE" shall have the meaning set
forth in Section 14.3.3.
1.18. "CLINICAL DATA" shall mean all Information with respect to a
Licensed Product made, collected or otherwise generated under or in connection
with the Clinical Studies, Phase IIIB Clinical Studies, Phase IV Clinical
Studies or Post-Approval Commitments that are clinical studies, each for a
Licensed Product, including any data, reports and results with respect thereto.
1.19. "CLINICAL STUDIES" shall mean (a) Phase I Clinical Studies, Phase II
Clinical Studies, Phase IIIA Clinical Studies and such other tests and studies
in human subjects that are required by Applicable Law, or otherwise required by
the FDA to obtain or maintain NDA Approvals in the Field in the Territory and
(b) the Open Label Extension Study, but, in each case, excluding any Phase IIIB
Clinical Studies, Phase IV Clinical Studies or Post-Approval Commitments.
1.20. "CLINICAL SUPPLY AGREEMENT" shall have the meaning set forth in
Section 7.1.1.
1.21. "COMBINATION PRODUCTS" means products in forms suitable for human
applications that contain API as an active ingredient together with one or more
other active ingredients that are sold either as a fixed dose or as separate
doses in a single package.
1.22. "COMMERCIALIZATION" shall mean, with respect to a Licensed Product,
any and all activities (whether before or after NDA Approval) directed to the
marketing, detailing, promotion and sale of such Licensed Product after NDA
Approval for commercial sale has been obtained, and shall include (a) Phase IIIB
Clinical Studies, Phase IV Clinical Studies and any Post-Approval Commitments,
(b) marketing, promoting, detailing, and marketing research, (c) finishing,
packaging, labeling, shipping and holding (in each case, other than by
Licensor), (d) distributing, offering to commercially sell and commercially
selling such Licensed Product, (e) importing, exporting or transporting such
Licensed Product for commercial sale (in each case, other than by Licensor) and
(f) regulatory affairs with respect to any of the foregoing. When used as a
verb, "Commercializing" means to engage in Commercialization and "Commercialize"
and "Commercialized" shall have a corresponding meanings.
1.23. "COMMERCIALIZATION PLAN" shall have the meaning set forth in
Section 6.3.
1.24. "COMMERCIALLY REASONABLE EFFORTS" shall mean, with respect to the
efforts to
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be expended by a Party with respect to the objective that is the subject of such
efforts, reasonable, good faith efforts and resources to accomplish such
objective that such Party would normally use to accomplish a similar objective
under similar circumstances, it being understood and agreed that, with respect
to Exploitation of a Licensed Product by Licensee, such efforts shall be similar
to those efforts and resources consistent with the usual practice of Licensee in
pursuing the development or commercialization of pharmaceutical products owned
by it or to which it otherwise has rights that are of similar market potential
as such Licensed Product, taking in to account its safety and efficacy, its cost
to develop, the competitiveness of alternative products and the nature and
extent of market exclusivity (including Patent coverage and regulatory
exclusivity), the likelihood of obtaining Regulatory Approval, including the
expected or actual Product Labeling, its expected or actual pricing,
reimbursement and formulary status, its expected or actual profitability,
including the amounts of marketing and promotional expenditures with respect to
such Licensed Product, the likelihood, timing or existence of Generic Versions
and all other relevant factors with respect to such market.
1.25. "COMMERCIAL SUPPLY AGREEMENT" shall have the meaning set forth in
Section 7.1.2(a).
1.26. "COMMITTEE" shall have the meaning set forth in Section 3.4.
1.27. "COMPLAINING PARTY" shall have the meaning set forth in
Section 14.2.
1.28. "CONFIDENTIAL INFORMATION" shall have the meaning set forth in
Section 11.2.
1.29. "CONTROL" shall mean, with respect to any item of Information,
Regulatory Documentation, Patent, Trademark or other intellectual property
right, possession of the right, whether directly or indirectly, and whether by
ownership, license or otherwise (other than by operation of the license and
other grants in Sections 2.1 and 2.2) to assign or grant a license, sublicense
or other right to or under such Information, Regulatory Documentation, Patent,
Trademark or other intellectual property right as provided for herein without
violating the terms of any agreement or other arrangement with any Third Party.
1.30. "CO-PROMOTION" shall mean the joint Promotion of a Licensed Product
in the Field in the Territory by both Parties or their respective Affiliates
under the same Licensed Trademark(s). When used as a verb, "Co-Promote" shall
mean to engage in such Co-Promotion.
1.31. "CO-PROMOTION AGREEMENT" shall have the meaning set forth in
Section 6.8.1(b).
1.32. "CO-PROMOTION OPTION" shall have the meaning set forth in
Section 6.8.1.
1.33. "CORPORATE NAMES" shall mean the Trademark AEterna Zentaris,
Licensor's and its Affiliates' corporate logos, and such other company names and
logos as Licensor or its Affiliates may designate in writing from time to time.
1.34. "CREATE ACT" shall have the meaning set forth in Section 9.2.4.
1.35. "CSO" shall have the meaning set forth in Section 6.8.
1.36. "DDMAC" shall mean the FDA Division of Drug Marketing, Advertising,
and Communications.
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1.37. "DEVELOPMENT" shall mean, with respect to a Licensed Product, all
activities that are reasonably required to obtain NDA Approval, including
without limitation research, preclinical and other non-clinical testing, test
method development and stability testing, toxicology, formulation, process
development, manufacturing scale-up, qualification and validation, quality
assurance/quality control, Clinical Studies (but not, for clarity, Phase IIIB
Clinical Studies, Phase IV Clinical Studies or any Post-Approval Commitments),
including Manufacturing in support thereof, statistical analysis and report
writing, the preparation and submission of the NDA, regulatory affairs with
respect to the foregoing and all other activities necessary or reasonably useful
or otherwise requested or required by the FDA as a condition or in support of
obtaining NDA Approval. When used as a verb, "Develop" shall mean to engage in
Development.
1.38. "DEVELOPMENT BUDGET" shall have the meaning set forth in
Section 4.4.
1.39. "DEVELOPMENT COSTS" shall have the meaning set forth in Section 4.4.
1.40. "DEVELOPMENT PLAN" shall have the meaning set forth in Section 4.1.
1.41. "DISCRETIONARY DEVELOPMENT AMENDMENT" shall have the meaning set
forth in Section 4.2.
1.42. "DISCRETIONARY DEVELOPMENT BUDGET" shall have the meaning set forth
in Section 4.4.
1.43. "DISPUTE" shall have the meaning set forth in Section 15.6.1.
1.44. "DISTRIBUTOR" shall have the meaning set forth in Section 2.4.
1.45. "DOLLARS" or "$" shall mean United States Dollars.
1.46. "DRUG MASTER FILE" shall mean any drug master files submitted to the
FDA with respect to a Licensed Product for use in the Field.
1.47. "EFFECTIVE ROYALTY RATE" shall mean, with respect to a given
Calendar Quarter, the rate equal to (a) the total royalties due in such Calendar
Quarter under Section 8.2.1 (without regard to any reductions to which Licensee
may be entitled under Section 8.2.2 or otherwise under this Agreement) for all
Licensed Products in such Calendar Quarter divided by (b) the total Net Sales
attributable to all Licensed Products in such Calendar Quarter.
1.48. "EXECUTION DATE" shall have the meaning set forth in the preamble
hereto.
1.49. "EXECUTIVES" shall mean, with respect to Licensor, any of its
Managing Directors, and with respect to Licensee, its Vice President, General
Therapeutics or an equivalent executive.
1.50. "EX-FIELD/TERRITORY STUDY" shall have the meaning set forth in
Section 4.5.
1.51. "EXISTING LICENSED PRODUCT" shall mean the Licensed Product(s)
contemplated by IND # [REDACTED], as amended, which Licensed Product(s) are
formulated, composed and administered under a dosing regimen consistent with
such IND and which are undergoing Phase IIIA Clinical Studies as of the
Execution Date.
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1.52. "EXPLOIT" shall mean to make, have made, import, use, sell or offer
for sale, including to Develop, Commercialize, Manufacture and have Manufactured
Licensed Product. "Exploitation" shall mean the act of Exploiting Licensed
Products.
1.53. "FDA" shall mean the United States Food and Drug Administration and
any successor agency thereto.
1.54. "FFDCA" shall mean the United States Food, Drug, and Cosmetic Act,
as amended from time to time.
1.55. "FIELD" shall mean the treatment, prevention, diagnosis, control, or
prevention of progression in humans of (a) BPH, (b) prostatitis and (c) lower
urinary tract symptoms in males.
1.56. "FIRST COMMERCIAL SALE" shall mean the first sale by Licensee or its
Affiliates of a Licensed Product in the Territory for use in the Field after NDA
Approval of such Licensed Product has been obtained in the Territory.
1.57. "GENERIC LAUNCH" shall have the meaning set forth in
Section 8.2.2(b).
1.58. "GENERIC VERSION" shall mean a product that (a) contains API as the
active ingredient, (b) has been approved for sale in the Territory for use in
the Field pursuant to Section 505(b)(2) or Section 505(j) of the FFDCA (21
U.S.C. 355(b)(2) and 21 U.S.C 355(j), respectively), as amended, and (c) is A
Rated with respect to a Licensed Product.
1.59. "GOOD CLINICAL PRACTICE" or "GCP" shall mean the current good
clinical practices relating to the conduct of clinical investigations, the use
of investigational drugs in humans, including supranational, national and local
legislation, regulations and official guidance (including the International
Conference on Harmonization Guideline for Good Clinical Practice (E6))
applicable from time to time to the Development of Licensed Products pursuant to
Applicable Law.
1.60. "IFRS" shall mean International Financial Reporting Standards,
consistently applied.
1.61. "IND" shall mean an investigational new drug application, as such
term is defined in the FFDCA and the regulations promulgated thereunder.
1.62. "INDEMNIFICATION CLAIM NOTICE" shall have the meaning set forth in
Section 13.3.
1.63. "INDEMNIFIED PARTY" shall have the meaning set forth in
Section 13.3.
1.64. "INFORMATION" shall mean all technical, scientific and other
know-how and information, inventions, discoveries, trade secrets, knowledge,
technology, means, methods, processes, practices, formulae, instructions,
skills, techniques, procedures, experiences, expressed ideas, technical
assistance, designs, drawings, assembly procedures, computer programs,
apparatuses, specifications, data, results, materials (including biological,
chemical, pharmacological, toxicological, pharmaceutical, physical and
analytical), pre-clinical, clinical, safety, manufacturing and quality control
data and information (including study designs and protocols) and assays and
biological methodology, in each case, whether or not confidential, proprietary
or patentable and in written, electronic or any other form now known or
hereafter developed.
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1.65. "INITIAL APPROVAL" shall have the meaning set forth in Section 4.1.
1.66. "IN-LICENSE AGREEMENTS" shall have the meaning set forth in
Section 12.3.5.
1.67. "INVOICED SALES" shall have the meaning set forth in the definition
of "Net Sales."
1.68. "JOINT COMMERCIAL COMMITTEE" or "JCC" shall have the meaning set
forth in Section 3.1.
1.69. "JOINT DEVELOPMENT COMMITTEE" or "JDC" shall have the meaning set
forth in Section 3.1.
1.70. "JOINT INTELLECTUAL PROPERTY RIGHTS" shall have the meaning set
forth in Section 9.1.3.
1.71. "JOINT KNOW-HOW" shall have the meaning set forth in Section 9.1.3.
1.72. "JOINT PATENTS" shall have the meaning set forth in Section 9.1.3.
1.73. "KNOWLEDGE" shall mean, with respect to Licensor, the actual
knowledge of [REDACTED] [Exclusion of confidential information relating to
identity of certain of Licensor's employees].
1.74. "LEGAL MATTER" shall mean any dispute regarding the rights or
obligations of a Party that arise out of or relate to the existence,
negotiation, validity, formation, interpretation, breach, performance or
application of this Agreement.
1.75. "LETTER AGREEMENT" shall mean that certain letter agreement, dated
February 26, 2009, by and between Licensor and Tulane.
1.76. "▇▇-▇▇" shall mean luteinizing hormone-releasing hormone.
1.77. "LICENSED KNOW-HOW" shall mean all Information (including Clinical
Data) that Licensor and its Affiliates own or Control as of the Execution Date
or during the Term that is not generally known and is necessary or reasonably
useful for the Exploitation of Licensed Products in the Field, but excluding any
Information to the extent covered or claimed by any Licensed Patent or Joint
Patent or constituting any Joint Know-How; PROVIDED, HOWEVER, that in the event
that a Third Party becomes an Affiliate of the Licensor after the Execution Date
due to a merger or acquisition transaction (a "SUBSEQUENT AFFILIATE"),
Information owned or Controlled by such Third Party prior to the date on which
such Person became an Affiliate of Licensor shall not be deemed "Licensed
Know-How." The Licensed Know-How existing in written form as of the Execution
Date is attached hereto as SCHEDULE 1.77.
1.78. "LICENSED PATENTS" shall mean all of the Patents that Licensor and
its Affiliates own or Control as of the Execution Date that relate to Licensed
Products, including those Patents listed on SCHEDULE 1.78, or during the Term
that (a) are necessary or reasonably useful for the Exploitation of Licensed
Products in the Field or (b) claim or cover a Licensed Product, Licensed
Know-How, or Exploitation in the Field of any of the foregoing, but excluding
any Joint Patents; PROVIDED, HOWEVER, that Patents owned or Controlled by any
Subsequent Affiliate prior to the date on which such Person became an Affiliate
of Licensor
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shall not be deemed "Licensed Patents."
1.79. "LICENSED PRODUCTS" shall mean the Products and the Combination
Products.
1.80. "LICENSED TRADEMARK(S)" shall mean the Trademark(s) for Licensed
Products that are licensed by Licensor to Licensee pursuant to the Trademark
License Agreement.
1.81. "LICENSEE" shall have the meaning set forth in the preamble hereto.
1.82. "LICENSEE KNOW-HOW" shall mean all Information that is
(a) Controlled by Licensee or any of its Affiliates only after the Execution
Date, (b) not generally known, (c) developed or acquired by or licensed to
Licensee or any of its Affiliates under or in connection with this Agreement and
(d) necessary or reasonably useful for the Exploitation of Licensed Products,
but excluding any Information solely to the extent covered or claimed by any
Licensee Patent or Joint Patent or constituting any Joint Know-How.
1.83. "LICENSEE PATENTS" shall mean all Patents (a) arising under the
Clinical Studies, Phase IIIB Clinical Studies, Phase IV Clinical Studies or
Post-Approval Commitments performed solely by or on behalf of Licensee pursuant
to this Agreement, (b) that are Controlled by Licensee and any of its Affiliates
only after the Execution Date, and (c) that are necessary or reasonably useful
for the Exploitation of Licensed Products, but solely to the extent that such
Patents claim or cover a Licensed Product, Licensee Know-How, or Exploitation of
any of the foregoing, but excluding any Joint Patents.
1.84. "LICENSOR" shall have the meaning set forth in the preamble hereto.
1.85. "LOSSES" shall have the meaning set forth in Section 13.1.
1.86. "MANDATORY DEVELOPMENT AMENDMENT" shall have the meaning set forth
in Section 4.2.
1.87. "MANDATORY DEVELOPMENT BUDGET" shall have the meaning set forth in
Section 4.4.
1.88. "MANUFACTURE" and "MANUFACTURING" shall mean all activities related
to the production, manufacture, processing, filling, finishing, packaging,
labeling, shipping and holding of a Licensed Product or any intermediate
thereof, including process development, process qualification and validation,
scale-up, pre-clinical, clinical and commercial manufacture and analytic
development, product characterization, stability testing, quality assurance and
quality control.
1.89. "MANUFACTURING CLAIM" shall have the meaning set forth in
Section 1.142.
1.90. "MARKINGS" shall have the meaning set forth in Section 6.6.
1.91. "NDA" shall mean a new drug application, as such term is defined in
the FFDCA and the regulations promulgated thereunder.
1.92. "NDA APPROVAL" shall mean, with respect to a Licensed Product for a
given indication in the Field in the Territory, approval of the NDA.
1.93. "NECESSARY IP" shall have the meaning set forth in Section 9.5.4(a).
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1.94. "NET SALES" shall mean, for any period, the gross amount invoiced by
Licensee or any of its respective Affiliates, or any of its Sublicensees, for
the sale of Licensed Products in the Field in the Territory (the "INVOICED
SALES") to Third Parties (other than Sublicensees), less deductions for: (a)
normal and customary trade, quantity and cash discounts and sales returns and
allowances, including those granted on account of price adjustments, billing
errors, rejected goods, damaged goods and returns, and chargebacks; (b) freight,
postage, shipping and insurance expenses to the extent that such items are
included in the gross amount invoiced; (c) customs and excise duties and other
duties related to the sales, to the extent that such items are included in the
gross amount invoiced; and (d) rebates and similar payments made with respect to
sales paid for by any governmental or regulatory authority such as, by way of
illustration and not in limitation of the Parties' rights hereunder, federal or
state Medicaid, Medicare or similar state program or equivalent foreign
governmental program. Any of the deductions listed above that involves a payment
by Licensee or any of its Affiliates or Sublicensees shall be taken as a
deduction in the Calendar Quarter in which the payment is accrued by such
entity. For purposes of determining Net Sales, a Licensed Product shall be
deemed to be sold when invoiced and a "sale" shall not include transfers or
dispositions of such Licensed Product for pre-clinical or clinical purposes or
as samples, in each case, without charge.
For clarity, the transfer by Licensee or any of its Affiliates or Sublicensees
of Licensed Product to Licensee or any of its Affiliates or Sublicensees shall
not result in any Net Sales.
1.95. "NOTICE OF INTEREST IN CO-PROMOTION" shall have the meaning set
forth in Section 6.8.1(a).
1.96. "NOTICE PERIOD" shall have the meaning set forth in Section 14.2.
1.97. "OPEN LABEL BUDGET" shall have the meaning set forth in Section 4.4.
1.98. "OPEN LABEL EXTENSION STUDY" shall mean the open label extension
portion (to the extent relating to North America) of that certain Phase IIIA
Clinical Study titled "Cetrorelix pamoate intermittent IM dosage regimens in
patients with symptomatic BPH: a 1 year placebo-controlled efficacy study and
long-term safety assessment," identified by Protocol No. Z033.
1.99. "PARENT" shall mean
Aeterna Zentaris Inc., a Canadian corporation
and parent of Licensor with principal offices at ▇▇▇▇-▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇.,
▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇, ▇▇▇ ▇▇▇ ▇▇▇▇▇▇.
1.100. "PARTY" and "PARTIES" shall have the meaning set forth in the
preamble hereto.
1.101. "PATENTS" shall mean (a) all national, regional and international
patents and patent applications, including provisional patent applications,
(b) all patent applications filed either from such patents, patent applications
or provisional applications or from an application claiming priority from either
of these, including divisionals, continuations, continuations-in-part,
provisionals, converted provisionals and requests for continued examinations,
(c) any and all patents that have issued or in the future issue from the
foregoing patent applications ((a) and (b)), including utility models, ▇▇▇▇▇
patents and design patents and certificates of invention, (d) any and all
extensions or restorations by existing or future extension or restoration
mechanisms, including revalidations, reissues, re-examinations and extensions
(including any supplementary protection certificates and the like) of the
foregoing patents or patent applications ((a), (b) and (c)) and (e) any similar
rights, including so-called pipeline protection or any importation,
revalidation, confirmation or introduction patent or registration
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patent or patent of additions to any of such foregoing patent applications and
patents.
1.102. "PAYMENTS" shall have the meaning set forth in Section 8.9.
1.103. "PERSON" shall mean an individual, sole proprietorship, partnership,
limited partnership, limited liability partnership, corporation, limited
liability company, business trust, joint stock company, trust, unincorporated
association, joint venture or other similar entity or organization, including a
government or political subdivision, department or agency of a government.
1.104. "PHARMACOVIGILANCE AGREEMENT" shall have the meaning set forth in
Section 10.2.
1.105. "PHASE I CLINICAL STUDY" shall mean a human clinical trial of a
Licensed Product, the principal purpose of which is a preliminary determination
of safety in healthy individuals or patients, or similar clinical study
prescribed by the FDA, including the trials referred to in 21 C.F.R. Section
312.21(a), as amended.
1.106. "PHASE II CLINICAL STUDY" shall mean a human clinical trial of a
Licensed Product, the principal purpose of which is a determination of safety
and efficacy in the target patient population, or a similar clinical study
prescribed by the FDA, from time to time, pursuant to Applicable Law or
otherwise, including the trials referred to in 21 C.F.R. Section 312.21(b), as
amended.
1.107. "PHASE IIIA CLINICAL STUDY" shall mean a human clinical trial of a
Licensed Product on a sufficient number of subjects that is designed to
establish that a pharmaceutical product is safe and efficacious for its intended
use and to determine warnings, precautions and adverse reactions that are
associated with such pharmaceutical product in the dosage range to be
prescribed, which trial is intended to support marketing approval of such
Licensed Product for use in the Field.
1.108. "PHASE IIIB CLINICAL STUDY" shall mean a human clinical trial of a
Licensed Product that is initiated after the NDA is filed, but before the NDA
Approval is obtained, the goal of which trial is to provide additional data for
marketing support and the launch of a Licensed Product for use in the Field in
the Territory.
1.109. "PHASE IV CLINICAL STUDY" shall mean a human clinical trial
conducted after NDA Approval to obtain additional data on the safety or efficacy
of a Licensed Product or for another appropriate purpose as articulated in the
Commercialization Plan.
1.110. "POST-APPROVAL BUDGET" shall have the meaning set forth in
Section 6.2.1.
1.111. "POST-APPROVAL COMMITMENTS" shall mean any human clinical study or
other test or study or other obligation with respect to a Licensed Product that
is required by the FDA as a condition of obtaining NDA Approval for such
Licensed Product for an indication, to be performed following NDA Approval of
such Licensed Product for such indication.
1.112. "POST-APPROVAL COSTS" shall have the meaning set forth in
Section 6.2.1.
1.113. "PRODUCT" shall mean any form or dosage of pharmaceutical
composition or preparation that contains the API as the active ingredient.
1.114. "PRODUCT LABELING" shall mean, with respect to a Licensed Product in
the Field
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in the Territory, the FDA approved (a) full prescribing information for such
Licensed Product, including any required patient information and any package
insert and (b) labels and other written, printed or graphic matter upon a
container, wrapper or otherwise, including any package insert, included in or
with the Licensed Product when sold in the Field in the Territory.
1.115. "PROMOTION" shall mean those activities normally undertaken by a
pharmaceutical company's sales force to implement marketing plans and strategies
aimed at encouraging the appropriate use of a product. When used as a verb,
"Promote" shall mean to engage in such activities.
1.116. "PROSECUTING PARTY" shall have the meaning set forth in
Section 9.2.2.
1.117. "REGULATORY APPROVAL" shall mean, with respect to a Licensed Product
and a country, any and all approvals (including NDAs), licenses, registration or
authorizations of any Regulatory Authority necessary to commercially distribute,
sell or market or otherwise Commercialize such Licensed Product in such country.
1.118. "REGULATORY APPROVAL TRANSFER" shall have the meaning set forth in
Section 5.1.
1.119. "REGULATORY AUTHORITY" shall mean any applicable supra-national,
federal, national, regional, state, provincial or local regulatory agencies,
departments, bureaus, commissions, councils or other government entities
regulating or otherwise exercising authority with respect to the Exploitation of
a Licensed Product.
1.120. "REGULATORY DOCUMENTATION" shall mean all applications,
registrations, licenses, authorizations and approvals, all correspondence
submitted to or received from the FDA (including minutes and official contact
reports relating to any communications with the FDA), and all supporting
documents and all clinical studies and tests, in each case, relating to Licensed
Products, and all data contained in any of the foregoing, including all INDs,
the NDA, regulatory drug lists, marketing and promotion documents, Clinical
Data, adverse event files and complaint files and Manufacturing records
(including any chemistry, manufacturing or control data).
1.121. "RELATED AGREEMENTS" shall have the meaning set forth in
Section 11.2.
1.122. "ROYALTY FLOOR" shall have the meaning set forth in
Section 8.2.2(c).
1.123. "ROYALTY TERM" shall mean, on a Licensed Product-by-Licensed Product
basis, the period commencing upon the First Commercial Sale of the first
Licensed Product in the Field in the Territory and ending on the later of
(a) the Valid Claim Expiration with respect to the applicable Licensed Product
and (b) fifteen (15) years after such First Commercial Sale.
1.124. "SHARED COST PATENTS" shall have the meaning set forth in
Section 9.2.1.
1.125. "STARTING MATERIAL" shall mean the compound cetrorelix acetate
described in SCHEDULE 1.125 hereto.
1.126. "SUBLICENSEE" shall have the meaning set forth in Section 2.5.1.
1.127. "SUBSEQUENT AFFILIATE" shall have the meaning set forth in
Section 1.77.
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1.128. "TARGET PRODUCT PROFILE" shall mean the target product profile for
the Existing Licensed Product attached hereto as SCHEDULE 1.128 as such profile
may be amended from time to time by mutual written agreement of the Parties.
1.129. "TAXES" shall mean any present or future sales or use, value added,
ad valorem or similar amounts, gross receipts, income, stamp or other taxes,
customs, duties, levies, imposts, deductions, charges, fees, withholdings,
liabilities, restrictions or conditions of any nature whatsoever now or
hereafter imposed, levied, collected, assessed or withheld by any jurisdiction,
by any political subdivision thereof or therein or by any other government or
taxing authority of any kind, and all interest, penalties, additions to tax or
similar liabilities levied or imposed on a Party as a result of the transactions
contemplated by this Agreement.
1.130. "TERM" shall have the meaning set forth in Section 14.1.
1.131. "TERMINATED LICENSED PRODUCT" shall have the meaning set forth in
Section 9.5.4(c).
1.132. "TERRITORY" shall mean the United States.
1.133. "THIRD PARTY" shall mean any Person other than Licensor, Licensee
and their respective Affiliates.
1.134. "THIRD PARTY CLAIMS" shall have the meaning set forth in
Section 13.1.
1.135. "TRADEMARK" shall include any word, name, symbol, color, designation
or device or any combination thereof, including any trademark, trade dress,
brand ▇▇▇▇, service ▇▇▇▇, trade name, brand name, logo or business symbol,
whether or not registered.
1.136. "TRADEMARK LICENSE AGREEMENT" shall have the meaning set forth in
Section 2.3.
1.137. "TULANE" shall mean the Administrators of the Tulane Educational
Fund, a Louisiana nonprofit corporation.
1.138. "TULANE LICENSE" shall mean the License Agreement, dated as of
September 17, 2002, among Licensor, ASTA Medica GmbH (as predecessor in interest
to Licensor) and Tulane, as in effect on the Execution Date and as amended
thereafter, from time to time.
1.139. "TULANE PATENT" shall mean the Licensed Patent owned by Tulane and
identified by the U.S. Patent and Trademark Office as No. 5,198,533.
1.140. "UNITED STATES" or "U.S." shall mean the United States of America
and its territories and possessions, including the District of Columbia and the
Commonwealth of Puerto Rico.
1.141. "VALID CLAIM" shall mean a claim (a) of any issued, unexpired
Licensed Patent or Joint Patent in the Territory which has not been revoked or
held unenforceable or invalid by a decision of a court or governmental agency of
competent jurisdiction from which no appeal can be taken, or with respect to
which an appeal is not taken within the time allowed for appeal, and which has
not been disclaimed, denied or admitted to be invalid or unenforceable through
reissue, disclaimer or otherwise, or (b) of any Licensed Patent application
pending in the Territory, which was filed prior to [REDACTED] and shall not have
been pending on or
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after the fifth (5th) anniversary of the date of issuance of a first patent
office communication regarding the first application related thereto, and shall
not have been earlier cancelled, withdrawn or abandoned, and which is
enforceable on the operative date of inquiry by virtue of applicable law in the
Territory.
1.142. "VALID CLAIM EXPIRATION" shall mean, on a Licensed
Product-by-Licensed Product basis, the later of (a) the date on which the sale
or use of the applicable Licensed Product in the Field in the Territory would no
longer infringe a Valid Claim (without regard to the licenses granted herein)
and (b) the date on which the Manufacture of the applicable Licensed Product by
or on behalf of Licensee (including by Licensor pursuant to any Commercial
Supply Agreement) using the then-current manufacturing process would no longer
literally infringe a Valid Claim (without regard to the licenses granted
herein); PROVIDED, HOWEVER, that notwithstanding anything to the contrary in
clause (b) above, in the event that (i) the only Valid Claim remaining is a
method of manufacturing claim (a "MANUFACTURING CLAIM") and (ii) a Generic
Version being sold is manufactured using a manufacturing process that does not
literally infringe such Manufacturing Claim, then, for purposes of clause (b)
above, such Manufacturing Claim shall not be deemed to be a Valid Claim.
ARTICLE 2
GRANT OF RIGHTS
2.1 GRANTS TO LICENSEE. Subject to the terms and conditions of this
Agreement, Licensor hereby grants to Licensee:
2.1.1 an exclusive (including with regard to Licensor and its
Affiliates, but subject to Section 2.7.1), royalty-bearing license, with the
right to grant sublicenses in accordance with Section 2.5, under the Licensed
Patents, the Licensed Know-How, the Joint Patents (to the extent Controlled by
Licensor) and the Joint Know-How (to the extent Controlled by Licensor) to
Develop and Commercialize Licensed Products in the Field in the Territory;
2.1.2 a non-exclusive, royalty-bearing license, with the right to
grant sublicenses in accordance with Section 2.5, under the Licensed Patents,
the Licensed Know-How, the Joint Patents (to the extent Controlled by Licensor)
and the Joint Know-How (to the extent Controlled by Licensor) to Manufacture and
have Manufactured Licensed Products anywhere in the world for distribution in
the Field in the Territory pursuant to this Agreement; PROVIDED, HOWEVER, that
the license granted by Licensor to Licensee in this Section 2.1.2 shall
automatically become an exclusive (including with regard to Licensor and its
Affiliates), perpetual, irrevocable, royalty-bearing license thereunder at such
time as Licensee has the right to Manufacture Licensed Product pursuant to
Section 7.1.2(b);
2.1.3 a co-exclusive right and license and right of reference in
the Territory, with the right to grant sublicenses in accordance with Section
2.5, under Licensor's and its Affiliates' rights, titles and interests in and to
the Regulatory Approvals and any IND for Licensed Products in the Field owned or
Controlled by Licensor, to Exploit Licensed Products in the Field in the
Territory as permitted under Sections 2.1.1, 2.1.2 and 7.1.2(b), which
co-exclusive right and license with respect the Regulatory Approvals (but not,
for clarity, with respect to any IND for Licensed Products in the Field owned or
Controlled by Licensor) shall automatically become an exclusive (including with
regard to Licensor and its Affiliates), perpetual, irrevocable right and license
thereunder, to the extent such Regulatory Approvals are
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not assigned pursuant to Section 9.1.2, upon the grant by the FDA of the Initial
Approval; and
2.1.4 a non-exclusive, royalty-free license, with the right to
grant sublicenses in accordance with Section 2.5, and subject to Sections 2.6
and 9.1.6, to use certain of the Corporate Names as necessary to exercise its
rights under the grants set forth in Section 2.1.1, including as necessary to
identify Licensor or its applicable Affiliate as having Developed or
Manufactured Licensed Products sold in the Territory.
2.2 GRANTS TO LICENSOR. Subject to the terms and conditions of this
Agreement, Licensee hereby grants to Licensor:
2.2.1 a non-exclusive, royalty-free license, without the right to
sublicense, under the Licensee Patent Rights, Licensee Know-How, Joint Patents
(to the extent Controlled by Licensee) and Joint Know-How (to the extent
Controlled by Licensee) to Develop Licensed Products in the Field in the
Territory as provided for expressly herein, including in the Development Plan;
and
2.2.2 an exclusive (including with regard to Licensee and its
Affiliates), royalty-free license, with the right to grant sublicenses in
accordance with Section 2.5, under the Licensee Patents, the Licensee Know-How,
the Joint Patents (to the extent Controlled by Licensee) and the Joint Know-How
(to the extent Controlled by Licensee) to Exploit Licensed Products (a) in the
Territory outside the Field and (b) outside the Territory for any purpose.
2.2.3 a non-exclusive right and license and right of reference in
the Territory, with the right to grant sublicenses pursuant to Section 2.5,
under Licensee's and its Affiliates' rights, titles and interests in and to the
Regulatory Approvals to Exploit Licensed Products (a) in the Territory outside
the Field and (b) outside the Territory for any purpose.
2.3 TRADEMARK LICENSE AGREEMENT. The Parties acknowledge that they have
entered into that certain Trademark License Agreement of even date herewith
(such agreement, as amended from time to time, the "TRADEMARK LICENSE
AGREEMENT"), pursuant to which agreement Licensor has granted Licensee rights to
use certain Trademarks in connection with the Commercialization of Licensed
Products in the Field in the Territory.
2.4 DISTRIBUTORS. Licensee shall have the right, in its sole discretion,
to appoint its Affiliates, and Licensee and its Affiliates shall have the right,
in their sole discretion, to appoint any other Persons in the Territory, to
distribute, market (solely at the direction and on behalf of Licensee or its
Affiliates) and sell Licensed Products in circumstances where the Person
purchases its requirements of Licensed Products from Licensee or its Affiliates
but does not otherwise make any royalty or other payment to Licensee with
respect to its intellectual property rights. If Licensee or one of its
Affiliates appoints such a Person, such Person shall be a "DISTRIBUTOR" for
purposes of this Agreement. Licensor acknowledges that Licensee anticipates
using a specialty Distributor with respect to Licensed Product. For clarity,
nothing in this Section 2.4 is intended as an exception to the restrictions on
the use of a CSO set forth in Section 6.9.
2.5 SUBLICENSES.
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2.5.1 BY LICENSEE. Subject to Section 2.5.3, the rights and
licenses granted to Licensee under Section 2.1 shall include the right to grant
sublicenses (or further rights of reference to Sublicensees) through multiple
tiers of sublicensees as may be reasonably necessary for: (a) at such time as
Licensee has the right to Manufacture Licensed Product pursuant to Section
7.1.2(b), the Manufacture of Licensed Products on behalf of Licensee or any of
its permitted Sublicensees for resale to Licensee or any of its permitted
Sublicensees, (b) beginning on the third (3rd) anniversary of the First
Commercial Sale of a Licensed Product, the Commercialization of such Licensed
Product in the Field in the Territory, or (c) at any time during the Term,
Licensee's permitted subcontractors to perform activities on behalf of the
Licensee hereunder, subject to provisions safeguarding non-disclosure and
non-use at least as strict as those provided in this Agreement; PROVIDED,
HOWEVER, that Licensee shall ensure that any such sublicensee grants rights to
Licensee sufficient to allow Licensee to (sub)license to Licensor without any
additional compensation, Patents and Information analogous to the Patents and
Information included in the Licensee Patents and the Licensee Know-How,
respectively, to Exploit Licensed Products (i) outside the Field in the
Territory and (ii) outside the Territory for any purpose, each as permitted
under Section 2.2. If Licensee grants a sublicense under the licenses granted in
Section 2.1 to a Person that is not an Affiliate of Licensee, and such Person is
not a Distributor, that Person shall be a "SUBLICENSEE" for purposes of this
Agreement.
2.5.2 BY LICENSOR. Subject to Section 2.5.3, the rights and
licenses granted to Licensor under Section 2.2 shall include the right to grant
sublicenses (or further rights of reference to sublicensees) through multiple
tiers of sublicensees (a) outside the Field in the Territory and (b) outside the
Territory for any purpose; PROVIDED, HOWEVER, that Licensor shall ensure that
any such sublicensee grants rights to Licensor sufficient to allow Licensor to
(sub)license to Licensee without any additional compensation, Patents and
Information analogous to the Patents and Information included in the Licensed
Patents and the Licensed Know-How, respectively, to Exploit Licensed Products in
the Field in the Territory as permitted under Section 2.1.
2.5.3 IN GENERAL. Upon or before granting any sublicense pursuant
to this Section 2.5, the sublicensing Party shall ensure that the intended
sublicensee agrees in writing to (a) terms and conditions that do not deviate
materially from the terms and conditions of this Agreement with respect to the
licensing and ownership of intellectual property rights, including Patents,
confidentiality, use of Corporate Names, maintenance of records, rights of
publication, insurance and audit, for the benefit of non-sublicensing Party and,
(b) in the case of Licensee, terms and conditions as required pursuant to
paragraph 2(a)(v) of the Letter Agreement. Notwithstanding the foregoing,
(i) subject to the provisions of Section 6.5, Section 8.2 and Section 8.4, the
financial terms between the sublicensing Party and any such sublicensee shall be
established at the sublicensing Party's discretion, (ii) the sublicensing Party
shall be responsible to the non-sublicensing Party for any breach by one or more
of the sublicensing Party's sublicensees of the terms or conditions of this
Agreement as if the sublicensing Party had committed such breach and (iii) the
sublicensing Party shall remain responsible for the performance of all of its
obligations under this Agreement, including all payments due to the
non-sublicensing Party under this Agreement, regardless of whether such payments
become due as a result of the activities, including without limitation sales of
Licensed Product made by the sublicensing Party or its sublicensees. The
sublicensing Party shall provide the other Party with a true and complete copy
of each executed sublicense and any amendments thereto, including all
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exhibits and attachments, no later than thirty (30) days after the execution
thereof, which copy may be redacted to eliminate confidential terms and
conditions that do not relate to the rights of the receiving Party under this
Agreement.
2.6 USE OF CORPORATE NAMES. With respect to any Corporate Names licensed
to Licensee under Section 2.1.4, Licensee agrees to conform to the customary
guidelines of Licensor with respect to manner of use and to maintain the quality
standards of Licensor with respect to the goods sold and services provided in
connection with the Corporate Names. Licensee shall, and shall cause its
Sublicensees to, use Commercially Reasonable Efforts not to diminish the value
of the goodwill pertaining to the Corporate Names. Licensee shall, and shall
cause its Sublicensees to, execute any documents required in the reasonable
opinion of Licensor to be entered as a recorded licensee of Licensor's Corporate
Names or to be removed as recorded licensee thereof.
2.7 NO IMPLIED RIGHTS; RESERVATION OF RIGHTS. For the avoidance of
doubt:
2.7.1 Licensee and its Affiliates shall have no right, express or
implied, with respect to the Licensed Patents, the Licensed Know-How or the
Corporate Names, except as expressly provided in Section 2.1. Subject to Section
9.1.3 with respect to the Joint Patents, Licensor reserves the right under the
Licensed Patents, the Licensed Know-How, the Joint Patents (to the extent
Controlled by Licensor) and the Joint Know-How (to the extent Controlled by
Licensor) to perform its obligations hereunder and to Exploit (a) Licensed
Products (i) in the Territory outside the Field and (ii) outside the Territory
for any purpose and (b) other products for any purpose.
2.7.2 Licensor and its Affiliates shall have no right, express or
implied, with respect to the Licensee Patents or the Licensee Know-How except as
expressly provided in Section 2.2. Subject to Section 9.1.3 with respect to the
Joint Patents, Licensee reserves the right under the Licensee Patents, the
Licensee Know-How, the Joint Patents (to the extent Controlled by Licensee) and
the Joint Know-How (to the extent Controlled by Licensee) to perform its
obligations hereunder and to Exploit (a) Licensed Products in the Field in the
Territory as permitted under Section 2.1 and (b) other products for any purpose.
2.8 NON-COMPETE.
2.8.1 LICENSEE NON-COMPETITION OBLIGATIONS. As a condition of this
Agreement, and as a material inducement to Licensor's entry into this Agreement,
Licensee covenants to Licensor that, during the Term, Licensee (or any successor
or assign of Licensee) shall not, and shall cause its Affiliates or Sublicensees
(or any successor or assign of any such Affiliate or Sublicensee) not to
[REDACTED] [Exclusion of confidential competitive information] in the Field in
the Territory, other than (a) any Licensed Product or (b) to a (sub)licensee for
which Licensee is serving as a manufacturer of such [REDACTED].
2.8.2 LICENSOR NON-COMPETITION OBLIGATIONS. As a condition of this
Agreement, and as a material inducement to Licensee's entry into this Agreement,
Licensor covenants to Licensee that, during the Term, Licensor (or any successor
or assign of Licensor) shall not, and shall cause its Affiliates (or any
successor or assign of any such Affiliate) not to
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[REDACTED] [Exclusion of confidential competitive information] in the Field in
the Territory, other than to a (sub)licensee for which Licensor is serving as a
manufacturer of such [REDACTED]. In the event that Licensor has granted or
grants rights to a Third Party to commercialize an [REDACTED] in the Field in
the Territory, then Licensor's alliance manager for such relationship shall not
be the same person as Licensor's alliance manager for this Agreement.
2.8.3 IN GENERAL. If a court of competent jurisdiction determines
that the restrictions set forth in this Section 2.8 are too broad or otherwise
unreasonable under Applicable Law, including with respect to duration,
geographic scope or space, the court is hereby requested and authorized by the
Parties hereto to revise the foregoing restriction to include the maximum
restrictions allowable under Applicable Law. Each of the Parties hereto
acknowledges, however, that (a) this Section 2.8 has been negotiated by the
Parties, (b) the geographical and time limitations on activities, are
reasonable, valid and necessary in light of the circumstances pertaining to the
Parties and necessary for the adequate protection of Licensed Products and
(c) the Parties would not have entered in this Agreement without the protection
afforded it by this Section 2.8.
2.9 TRANSFER OF LICENSED KNOW-HOW. Promptly after the Execution Date,
the Parties shall coordinate a transfer to Licensee of any Licensed Know-How
existing on the Execution Date, including any Licensed Know-How listed on but
not attached to SCHEDULE 1.77 and shall use Commercially Reasonable Efforts to
do so within ninety (90) days or such longer period as the Parties may agree
after the Execution Date.
ARTICLE 3
GOVERNANCE
3.1 GENERAL. The Parties shall establish two governing committees: the
joint development committee (the "JOINT DEVELOPMENT COMMITTEE" or the "JDC") and
the joint commercial committee (the "JOINT COMMERCIAL COMMITTEE" or the "JCC").
The Joint Development Committee shall monitor the Development of the Existing
Licensed Product up to the Initial Approval of such Existing Licensed Product.
The Joint Development Committee shall have members as set forth in
Section 3.4.1, shall have the duties set forth in Section 3.2 and shall have
authority as set forth in Section 3.4. The Joint Commercial Committee shall
monitor (a) the Development of any Licensed Products other than the Existing
Licensed Product (by way of the subcommittee described in Section 3.3) and
(b) the status of Post-Approval Commitments and Commercialization, including
Phase IIIB Clinical Studies and Phase IV Clinical Studies, of each Licensed
Product following the Initial Approval of the Existing Licensed Product. The
Joint Commercial Committee shall have members as set forth in Section 3.4.1,
shall have the duties set forth in Section 3.3 and shall have authority as set
forth in Section 3.4.
3.2 JOINT DEVELOPMENT COMMITTEE. Subject to the terms of this Agreement,
including Section 3.4.5, the JDC shall: (a) review and approve a strategy
throughout the Territory for the Development of and Regulatory Approvals for the
Existing Licensed Product up to the Initial Approval; (b) review and approve any
Development Amendments as provided in Section 4.2; (c) review and approve the
Development Budget for any cost-sharing agreed by the Parties with respect to
any Development Amendment as provided in Section 4.4; (d) review the
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periodic reports provided by Licensor pursuant to Section 4.6 and otherwise
monitor Licensor's activities under, and compliance with, the Development Plan;
(e) approve all Product Labeling, the NDA and other filings with the FDA (other
than submissions to DDMAC) with respect to the Development of the Existing
Licensed Product in the Field in the Territory prior to the Regulatory Approval
Transfer, as provided in Section 5.4.1; (f) create such other subcommittees with
such responsibilities as the Parties may mutually agree to from time to time;
and (g) perform such other functions as are set forth herein or as the Parties
may mutually agree in writing, except where in conflict with any provision of
this Agreement. The chairperson of the JDC shall be appointed by Licensor.
3.3 JOINT COMMERCIAL COMMITTEE. Subject to the terms of this Agreement,
including Section 3.4.5, the JCC shall: (a) review and approve a strategy
throughout the Territory for the Commercialization of each Licensed Product;
(b) review and approve the Commercialization Plan and any amendments thereto as
provided in Section 6.3; (c) review the periodic reports provided by Licensee
pursuant to Section 6.7 and otherwise monitor Licensee's activities under and
compliance with the Commercialization Plan; (d) review the Manufacture of
Licensed Products as provided in Section 7.1.2(a); (e) monitor the conduct of,
and establish the Post-Approval Budget for, any Post-Approval Commitments
conducted by the Licensor as provided in Section 6.2; (f) be apprised of the
conduct of Phase IIIB Clinical Studies, Phase IV Clinical Studies or
Post-Approval Commitments conducted by the Licensee as provided in Section 6.2;
(g) be apprised of any filings with the FDA relating to Product Labeling or the
NDA and other filings with the FDA (other than submissions to DDMAC) in the
Field in the Territory on or after the date of Regulatory Approval Transfer;
(h) review and comment on submissions to the FDA relating to significant changes
to the Product Labeling for safety or efficacy, (i) create such other committees
with such responsibilities as the Parties may mutually agree to from time to
time; and (j) perform such other functions as are set forth herein or as the
Parties may mutually agree in writing, except where in conflict with any
provision of this Agreement. In the event that Licensee elects to Develop any
Licensed Product other than the Existing Licensed Product in the Field in the
Territory or the Existing Licensed Product for an indication in the Field other
than BPH in connection with life cycle management, the JCC shall form a
subcommittee to review and approve a strategy throughout the Territory for such
Development of and Regulatory Approvals for such Licensed Product in the Field
in the Territory. The chairperson of the JCC shall be appointed by Licensee.
3.4 GENERAL PROVISIONS. The following general provisions shall govern
the conduct of the JDC and the JCC and such other subcommittees as either of
them may establish from time to time under this Agreement (the JDC, the JCC and
such subcommittees each, a "COMMITTEE"), except as otherwise expressly provided
elsewhere in this Agreement or as agreed to by the Parties in writing:
3.4.1 MEMBERSHIP. Each Committee shall include an equal number of
representatives from each of the Parties, each with the requisite experience and
seniority to enable them to make decisions on behalf of the Parties with respect
to the issues falling within the jurisdiction of such Committee. From time to
time, each Party may substitute one or more of its representatives to a
Committee on written notice to the other Party. The initial members of the JCC
are set forth in SCHEDULE 3.4.1(b). The initial members of the JDC are set forth
in SCHEDULE 3.4.1(a).
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3.4.2 MEETINGS AND MINUTES. The initial meeting of the JDC shall be
held within thirty (30) days of the Execution Date. The JDC and any
subcommittees of the JDC shall meet quarterly through the date of the Initial
Approval and thereafter as determined by the Parties (but not more than
quarterly), provided that following the Initial Approval, the JDC may determine
to disband. The initial meeting of the JCC shall be held within sixty (60) days
after the Execution Date. Following its initial meeting, with respect to each
Licensed Product, the JCC and any subcommittees thereof shall meet quarterly
through end of the first Calendar Year in which the First Commercial Sale of
such Licensed Product occurs. Thereafter the JCC and any subcommittee thereof
shall meet twice per Calendar Year. The location of the meetings of each
Committee shall alternate between locations designated by Licensor and locations
designated by Licensee. The chairperson of each Committee or his or her designee
shall be responsible for calling meetings on no less than thirty (30) days'
notice. Each Party shall disclose to the other proposed agenda items along with
appropriate information at least ten (10) Business Days in advance of each
meeting of the applicable Committee; provided that under exigent circumstances
requiring Committee input, a Party may provide its agenda items to the other
Party within a shorter period of time in advance of the meeting, or may propose
that there not be a specific agenda for a particular meeting, so long as such
other Party consents in writing to such later addition of such agenda items or
the absence of a specific agenda for such Committee meeting, such consent not to
be unreasonably withheld or delayed. The chairperson or his or her designee
shall prepare and circulate, for review and approval of the Parties, minutes of
such meeting within ten (10) days after such meeting. The Parties shall agree on
the minutes of each meeting promptly, but in no event later than the next
meeting of the applicable Committee.
3.4.3 RULES. A Committee shall have the right to adopt such
standing rules as shall be necessary for its work to the extent that such rules
are not inconsistent with this Agreement. A quorum of a Committee shall exist
whenever there is present at a meeting at least one (1) representative appointed
by each Party. Members of a Committee may attend a meeting either in person or
by telephone, video conference or similar means in which each participant can
hear what is said by, and be heard by, the other participants. A Committee shall
take action by consensus of the members present at a meeting at which a quorum
exists, with each Party having a single vote irrespective of the number of
representatives of such Party in attendance or by a written resolution signed by
the members of the Committee. Employees or consultants of either Party that are
not members of a Committee may attend any meeting of such Committee; PROVIDED,
HOWEVER, that such attendees (a) shall not vote or otherwise participate in the
decision-making process of such Committee and (b) are bound by obligations of
confidentiality and non-disclosure equivalent to those set forth in ARTICLE 11.
3.4.4 DECISION-MAKING.
(a) If a subcommittee cannot, or does not, reach consensus
on an issue, then the dispute shall be referred to the applicable Committee for
resolution and a special meeting of the applicable Committee may be called for
such purpose.
(b) If the Committee cannot, or does not, reach consensus
on an issue, including any dispute arising in a subcommittee and referenced to
it for resolution, within a period of ten (10) Business Days or such other
period as the Parties may agree, then, unless
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(i) this Agreement expressly provides for mutual agreement of the Parties or the
Committee members, (ii) this Agreement expressly requires a Party's or its
Committee members' consent or (iii) the issue is a Legal Matter, then (A) with
respect to the JDC, subject to the limitations on authority in Section 3.4.5,
Licensor's JDC members shall have the deciding vote and (B) with respect to the
JCC, subject to the limitations on authority in Section 3.4.5, Licensee's JCC
members shall have the deciding vote.
(c) Each Party shall, or shall cause its Committee members
to, make any decision in good faith, taking into consideration the other Party's
(or its Committee members') comments on the matter, in a manner consistent with
this Agreement, the Development Plan, any Development Amendment, the Development
Budget and the Commercialization Plan. In exercising such decision-making
authority, the deciding Party (or its Committee members) shall not have the
right to breach or violate any term or condition of this Agreement.
3.4.5 LIMITATIONS ON AUTHORITY. Notwithstanding a Party's Committee
members' having final decision-making authority with respect to a matter
pursuant to Section 3.4.4, neither Party's members shall have the power to
impose performance or payment obligations on the other Party without such other
Party's written consent. Each Party shall retain the rights, powers and
discretion granted to it under this Agreement and no such rights, powers or
discretion shall be delegated to or vested in a Committee unless such delegation
or vesting of rights is expressly provided for in this Agreement or the Parties
expressly so agree in writing. No Committee shall have the power to amend,
modify or waive compliance with this Agreement, which may only be amended or
modified as provided in Section 15.8 and compliance with which may only be
waived as provided in Section 15.11.
ARTICLE 4
DEVELOPMENT
4.1 DEVELOPMENT PLAN. The initial development plan governing the conduct
of Development of the Existing Licensed Product in BPH in the Territory is
attached as SCHEDULE 4.1 (the "DEVELOPMENT PLAN"). The Parties contemplate that
the activities set forth in the Development Plan are the primary Development
activities required to obtain NDA Approval of the Existing Licensed Product for
BPH in the Territory (such NDA Approval, whether it covers BPH only or BPH and
other indications, the "INITIAL APPROVAL"). As of the Execution Date, Licensor
is conducting certain Phase IIIA Clinical Studies described in the Development
Plan for the Existing Licensed Product for BPH in the Territory. On or before
the Execution Date, Licensor has made available to Licensee (a) all Clinical
Data with respect to the Licensed Products for use in the Field generated by or
on behalf of Licensor, its Affiliates or any of its licensees existing as of the
Execution Date, including all Clinical Study results and resultant data
analyses, (b) all regulatory submissions made to the FDA by or on behalf of
Licensor or its Affiliates with respect to Licensed Products in the Field and
(c) protocols for any ongoing Clinical Studies and proposed designs for any
anticipated Clinical Studies with respect to any Licensed Product in the Field.
Subject to the terms and conditions of this Agreement and in accordance with the
Development Plan, Licensor shall have the responsibility, at its sole expense,
for performing all activities set forth in the Development Plan; PROVIDED,
HOWEVER, that the Open Label Extension Study set forth in the Development Plan
shall be conducted by
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Licensor at Licensee's expense for Development Costs, pursuant to the provisions
of Section 4.4 below. For the avoidance of doubt, Licensor shall have no right
to conduct any Development in the Field in the Territory except pursuant to this
Section 4.1.
4.2 AMENDMENTS TO THE DEVELOPMENT PLAN. From time to time, but at least
twice per Calendar Year, the JDC shall review any proposed amendments to the
Development Plan, including the addition of new Clinical Studies or other
Development activities (a) that are required by the FDA to obtain the Initial
Approval ("MANDATORY DEVELOPMENT AMENDMENTS") or (b) desirable to obtain the
Initial Approval, as may be suggested by the members of the JDC ("DISCRETIONARY
DEVELOPMENT AMENDMENTS") (collectively, "DEVELOPMENT AMENDMENTS"). The JDC shall
approve any Mandatory Development Amendments. The JDC may approve Discretionary
Development Amendments only if the Parties mutually agree in writing. The
performance of all activities set forth in any Development Amendment shall be
the responsibility of Licensor, and the costs of performing such activities
shall be budgeted and allocated pursuant to Section 4.4 below. Subject to
Licensee's compliance with Section 4.4 below, Licensor's members of the JDC
shall not withhold their consent for any Discretionary Development Amendment
reasonably proposed by Licensee.
4.3 DILIGENCE, COMPLIANCE AND ASSISTANCE. All Development activities set
forth in the Development Plan or any Development Amendments shall be conducted
by Licensor in accordance with the Development Plan and the applicable
Development Amendment, in accordance with current GCP and in compliance with all
Applicable Law. Licensor shall perform or cause to be performed, any and all of
its Development obligations hereunder in good scientific manner, and shall
endeavor to achieve the objectives of the Development Plan diligently and
efficiently by allocating sufficient time, effort, equipment and skilled
personnel to complete such Development activities successfully and promptly.
Without limiting the generality of the foregoing, Licensor shall, and shall
cause its Affiliates to, use Commercially Reasonable Efforts to perform its
activities under the Development Plan and any Development Amendments. Licensor
shall keep the JDC reasonably informed regarding Licensor's progress with
respect to the goals and timelines set forth in the Development Plan and any
Development Amendments. Upon Licensor's written request, Licensee shall consider
in good faith whether to provide, at Licensee's expense, reasonable technical
assistance to Licensor in conducting the activities described in the Development
Plan.
4.4 BUDGET. The JDC (a) shall monitor the budget for the Open Label
Extension Study, which budget is attached hereto as SCHEDULE 4.4 (the "OPEN
LABEL BUDGET"), and (b) shall establish and monitor a budget for the activities
set forth in any Discretionary Development Amendment approved by the JDC in
accordance with Section 4.2 for which the Parties agree in writing that Licensee
shall reimburse Licensor in whole or in part (a "DISCRETIONARY DEVELOPMENT
BUDGET") and any Mandatory Development Amendment (a "MANDATORY DEVELOPMENT
BUDGET") (each such budget, including the Open Label Budget, a "DEVELOPMENT
BUDGET"). Each Discretionary Development Budget and each Mandatory Development
Budget shall include line item estimates of expenses with respect thereto broken
down on a Calendar Year basis, which expenses shall include only external,
out-of-pocket costs and expenses of Licensor. "DEVELOPMENT COSTS" shall mean
with respect to the applicable activity, the external, out-of-pocket costs and
expenses of Licensor incurred in connection therewith. With respect to the Open
Label Extension Study and any Discretionary Development Amendments, Licensee
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shall reimburse [REDACTED] [Exclusion of confidential information relating to
cost-sharing] of the actual Development Costs incurred by Licensor, to the
extent that such expenses do not exceed, in the aggregate, [REDACTED] [Exclusion
of confidential information relating to cost-sharing] of the applicable
Development Budget. With respect to any Mandatory Development Amendments,
Licensee shall reimburse [REDACTED] [Exclusion of confidential information
relating to cost-sharing] of the actual Development Costs incurred by Licensor,
to the extent that such expenses do not exceed in the aggregate [REDACTED]
[Exclusion of confidential information relating to cost-sharing] of the
applicable Development Budget. In addition, following the conclusion of the Open
Label Extension Study and receipt of an invoice and appropriate supporting
documentation, Licensee shall reimburse Licensor for fifty percent (50%) of the
internal costs of Licensor incurred in connection with the Open Label Extension
Study, up to a maximum of [REDACTED], within thirty (30) days after receipt of
such invoice. Licensor's internal costs incurred in connection with the Open
Label Extension Study shall be charged at the full time equivalent rates as
follows: one full time equivalent equal to [REDACTED] hours worked per year at
an hourly rate of [REDACTED] for 2009, [REDACTED] for 2010 and [REDACTED] for
2011.
4.5 DEVELOPMENT OUTSIDE THE TERRITORY/OUTSIDE THE FIELD. In the event
that Licensor, its Affiliates or its (sub)licensees other than Licensee intend
to conduct, sponsor or support, independently or together with one or more Third
Parties, any Clinical Study with respect to any Licensed Products outside the
Territory or in the Territory outside the Field, which Clinical Study may effect
the Commercialization or regulatory status of a Licensed Product in the Field in
the Territory (an "EX-FIELD/TERRITORY STUDY"), then prior to the commencement of
any such Clinical Study, Licensor shall provide a high-level summary of the
protocol(s) for such Clinical Study to Licensee's members on the JCC (it being
understood that neither such representatives nor the JCC shall have any approval
rights with respect to such Clinical Study or protocol(s)); PROVIDED, HOWEVER,
that (a) each such summary shall constitute Confidential Information of Licensor
to the extent that the information provided in such summary satisfies the
criteria set forth in Section 11.2, and (b) Licensee shall not use such summary
for any purpose other than providing comments thereon to Licensor (which
comments shall be considered in good faith, but may be accepted or rejected by
Licensor in its sole discretion).
4.6 REPORTING. Licensor shall provide to Licensee and the JDC a detailed
report regarding its Development of Licensed Products in the Territory in the
Field during each Calendar Quarter during the Term within thirty (30) days after
the end of such Calendar Quarter. Such report shall contain sufficient detail to
enable Licensee to assess Licensor's compliance with the Development Plan, any
Development Amendment, and, if applicable, the Development Budget, including:
(a) its activities with respect to achieving the Initial Approval; (b) Clinical
Study results and results of other Development activities in the Field in the
Territory, including copies of all Clinical Data and all non-clinical data,
results and analyses with respect to Licensed Products in the Field in the
Territory; and (c) for any Clinical Study for which Licensee has an obligation
of reimbursement to Licensor, actual expenditures with respect thereto compared
to the amounts set forth in the Development Budget with respect thereto.
Licensor shall promptly provide Licensee with such additional information
regarding the Development of the Licensed Products as Licensee may reasonably
request from time to time.
ARTICLE 5
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REGULATORY MATTERS
5.1 RESPONSIBILITY FOR REGULATORY MATTERS. In accordance with the
Development Plan and any Development Amendment, at its sole expense, under the
oversight of the JDC, Licensor shall retain control and responsibility for all
regulatory submissions for the Existing Licensed Product in the Field in the
Territory with respect to obtaining the Initial Approval. As promptly as
practicable after the grant of the Initial Approval, Licensor shall transfer the
NDA for the Existing Licensed Product in the Field in the Territory as set forth
Section 9.1.2 (such transfer, the "REGULATORY APPROVAL TRANSFER"), and such NDA
and related submissions in the Territory related to such Existing Licensed
Product in the Field shall be, subject to the terms of this Agreement, the
property of Licensee and held in the name of Licensee. Thereafter, at Licensee's
sole expense, Licensee shall, subject to Section 5.3, 5.4, 5.5, 5.6 and ARTICLE
14, assume control of and responsibility for all regulatory submissions with
respect to all Regulatory Approvals for Licensed Products in the Field in the
Territory; PROVIDED, HOWEVER, that, notwithstanding anything in this ARTICLE 5,
as between Licensee and Licensor, Licensor shall retain responsibility for any
IND owned or Controlled by Licensor or any of its Affiliates and any Drug Master
Files of Licensor, its Affiliates or any of their respective contract
manufacturers.
5.2 DATA. Without limitation of Section 4.6, Licensor shall promptly
provide Licensee with copies of all non-clinical and Clinical Data, results and
analyses with respect to (a) all activities conducted by it pursuant to the
Development Plan or any Development Amendment or (b) any Ex-Field/Territory
Study, in each case ((a) and (b)) when and as such data, results and analyses
become available. Without limitation of Section 6.7, (i) Licensor shall promptly
provide Licensee with copies of all non-clinical and Clinical Data, results and
analyses with respect to all activities conducted by it pursuant to Section 6.2,
and (ii) Licensee shall promptly provide Licensor with copies of all
non-clinical and Clinical Data, results and analyses with respect to all
activities conducted by it pursuant to Section 6.2, solely to the extent useful
to Licensor for obtaining Regulatory Approvals (A) in the Territory outside the
Field and (B) outside the Territory for any purpose, in each case ((i) and (ii))
when and as such data, results and analyses become available. Each Party shall
support the other Party, as may be reasonably necessary, in obtaining Regulatory
Approvals for Licensed Products in the Field in the Territory, including by
providing necessary documents or other materials required by Applicable Law to
obtain Regulatory Approvals in the Field in the Territory, in each case in
accordance with the terms and conditions of this Agreement, including the
Development Plan and any Development Amendments.
5.3 DDMAC. At all times during the Term, Licensee shall have the sole
right and responsibility for making submissions to and interfacing,
corresponding and meeting with DDMAC with respect to the marketing and promotion
of Licensed Products in the Field in the Territory. In the event that Licensor
or its Affiliates receives any written or electronic communications from DDMAC
with respect to a Licensed Product in the Field in the Territory, it shall
promptly provide Licensee with copies of such communications within five (5)
Business Days of receiving any of the foregoing.
5.4 SUBMISSIONS. This Section 5.4 shall apply to regulatory submissions
and related correspondence with respect to Licensed Products for use in the
Field in the Territory other than
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submissions to DDMAC, which are addressed in Section 5.3.
5.4.1 PRE-APPROVAL SUBMISSIONS. Prior to the Regulatory Approval
Transfer, (a) Licensor, in consultation with Licensee, shall prepare and submit
all submissions, including the pre-NDA briefing documents, the NDA and the
pre-approval NDA updates (and any supplements or modifications thereto) to the
FDA to the JDC for its review and approval and (b) the JDC shall have the right
to review and approve the content and subject matter of, and strategy for, the
NDA submission, all correspondence submitted to the FDA related to the design of
Clinical Studies and all proposed Product Labeling for the Existing Licensed
Product and related communications and decisions with the FDA (including the
final approved Product Labeling for the Existing Licensed Product).
5.4.2 POST-APPROVAL SUBMISSIONS. Following the Regulatory Approval
Transfer, Licensee, shall prepare and submit all submissions (and any
supplements or modifications thereto) to the FDA; PROVIDED, HOWEVER, that any
submissions relating to significant changes to the Product Labeling for safety
or efficacy of any Licensed Product shall be presented to the JCC for review and
comment in advance of submission to the FDA. On a Calendar Quarter basis, at the
regularly scheduled JCC meetings, Licensee shall inform the JCC of its
communications with the FDA related to (a) the design of any Phase IIIB Clinical
Studies, Phase IV Clinical Studies or Post-Approval Commitments or (b) the final
approved Product Labeling for Licensed Products and any changes thereto.
5.4.3 ASSISTANCE. Upon Licensor's written request, Licensee shall
provide, at its expense, reasonable technical assistance to Licensor in
preparing any regulatory submissions to be made to the FDA with respect to
obtaining the Initial Approval, which assistance may include making its
employees, consultants and other scientific staff available upon reasonable
notice during normal business hours at their respective places of employment to
consult with Licensor on issues arising with respect to the Initial Approval.
5.5 COMMUNICATIONS AND MEETINGS. This Section 5.5 shall apply to
communications and meetings with respect to Licensed Products for use in the
Field in the Territory other than communications and meetings with DDMAC, which
are addressed in Section 5.3.
5.5.1 SHARING COMMUNICATIONS. Without limiting the foregoing, prior
to the Regulatory Approval Transfer, each Party shall, and following the
Regulatory Approval Transfer, Licensor shall, promptly provide the other Party
with copies of all written or electronic communications received by such Party
or its Affiliates from, or forwarded by such Party or its Affiliates to, the FDA
relating to (a) obtaining or maintaining any Regulatory Approvals or (b) any
Development or Commercialization of a Licensed Product and copies of all contact
reports produced by such Party or its Affiliates, in either case within five (5)
Business Days of receiving, forwarding or producing any of the foregoing.
5.5.2 NOTICE OF MEETINGS. Prior to the Regulatory Approval
Transfer, each Party shall, and following the Regulatory Approval Transfer,
Licensor shall, provide the other Party with written notice within five (5)
Business Days (or within such shorter period as may be necessary under the
circumstances) of receiving notice of any meetings, conferences and
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discussions to be scheduled with the FDA concerning a Licensed Product for use
in the Field (including advisory committee meetings and any other meeting of
experts convened by the FDA concerning any topic relevant to any Licensed
Product). Following the Regulatory Approval Transfer, Licensor shall not
communicate with the FDA regarding any Licensed Product in the Field without the
prior written consent of Licensee, unless Licensor is required to do so by
Applicable Law, in which case Licensor shall notify Licensee, as promptly as
possible and if possible in advance, of any such communication or anticipated
communication (to the extent Licensor is permitted by Applicable Law to provide
such notification).
5.5.3 PARTICIPATION IN MEETINGS. Licensee shall be entitled to have
reasonable representation present at, and to participate in, all such meetings,
conferences or discussions described in Section 5.5.2. Following the Regulatory
Approval Transfer, Licensor may, at Licensee's election, have one or more of its
representatives present at, and participate in, such meetings, conferences or
discussions.
5.5.4 MINUTES. Prior to the Regulatory Approval Transfer, Licensor
shall promptly forward to Licensee copies of all meeting minutes and summaries
of all such meetings, conferences and discussions with the FDA relating to any
Licensed Products for use in the Field. After the Regulatory Approval Transfer,
Licensee shall promptly forward to Licensor copies of meeting minutes and
summaries of such meeting, conferences and discussion with the FDA to the extent
that such meetings relate to significant safety or efficacy issues, including
with respect to Product Labeling or recall or similar action with respect to a
Licensed Product.
5.6 RECORDS. With respect to the Existing Licensed Product in the Field
in the Territory, Licensee and Licensor each shall maintain, or cause to be
maintained, records of, in the case of Licensor, its performance of the
Development Plan, any Development Amendments or any Post-Approval Commitment,
and in the case of Licensee, its performance of any Phase IIIB or Phase IV
Clinical Studies or any Post-Approval Commitment, in each case, in sufficient
detail and in good scientific manner appropriate for patent and regulatory
purposes, which shall be complete and accurate and shall fully and properly
reflect all work done and results achieved, and which shall be retained by such
Party for at least three (3) years after the expiration or termination of this
Agreement, or for such longer period as may be required by Applicable Law. With
respect to each Licensed Product in the Field in the Territory other than the
Existing Licensed Product, each Party shall maintain, or cause to be maintained,
records of any Clinical Studies, Phase IIIB Clinical Studies, Phase IV Clinical
Studies or Post-Approval Commitments performed by such Party, in sufficient
detail and in good scientific manner appropriate for patent and regulatory
purposes, which shall be complete and accurate and shall fully and properly
reflect all work done and results achieved, and which shall be retained by such
Party for at least three (3) years after the expiration or termination of this
Agreement, or for such longer period as may be required by Applicable Law. To
the extent reasonably required in connection with Licensee's Exploitation of the
Licensed Products in the Field in the Territory, Licensee shall have the right,
during normal business hours and upon reasonable notice, to inspect and copy any
such records, except to the extent that Licensor reasonably determines that such
records contain Confidential Information that is not licensed to Licensee, or to
which Licensee does not otherwise have a right hereunder. To the extent
reasonably required (a) to exercise its rights of reference under Section 2.2.3
or (b) in the case of a reversion of rights to the Licensed Products in the
Field in the Territory to Licensor pursuant to Section 14.7.1(a), in connection
with
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Licensor's Exploitation of the Licensed Products in the Field in the Territory,
Licensor shall have the right, during normal business hours and upon reasonable
notice, to inspect and copy any such records, except to the extent that Licensee
reasonably determines that such records contain Confidential Information that is
not licensed to Licensor, or to which Licensor does not otherwise have a right
hereunder.
ARTICLE 6
COMMERCIALIZATION
6.1 GENERAL. Subject to Section 6.8, Licensee shall have the sole right
to Commercialize, and the sole obligation for the Commercialization of, Licensed
Products in the Field in the Territory at its own cost and expense; PROVIDED,
HOWEVER, that such Commercialization shall be conducted under the supervision of
the JCC and in accordance with this Agreement. Without limitation of the
foregoing, Licensee shall use Commercially Reasonable Efforts to Commercialize
Licensed Products for indications in the Field in the Territory in accordance
with (a) the terms and conditions of this Agreement and (b) Applicable Law. For
the avoidance of doubt, Licensee shall have no obligation to market or sell any
Licensed Product in any indication for which NDA Approval has not been obtained.
6.2 STUDIES.
6.2.1 POST-APPROVAL COMMITMENTS. In the event that the FDA shall
require any Post-Approval Commitment in connection with the Initial Approval of
the Existing Licensed Product, the Parties shall mutually agree which Party
shall conduct such Post-Approval Commitment. In the event that Licensor is
conducting any Post-Approval Commitment, the JCC shall establish a budget with
respect to such Post-Approval Commitment (each such budget, a "POST-APPROVAL
BUDGET"). Each Post-Approval Budget shall include line item estimates of
expenses with respect to such Post-Approval Commitments broken down on a
Calendar Year basis, which costs and expenses shall include only external,
out-of-pocket costs and expenses (such costs and expenses collectively, the
"POST-APPROVAL COSTS"). Licensee shall bear [REDACTED] [Exclusion of
confidential information relating to cost-sharing] of the actual Post-Approval
Costs incurred by Licensor, to the extent that such expenses do not exceed in
the aggregate [REDACTED] [Exclusion of confidential information relating to
cost-sharing] of the applicable Post-Approval Budget. All Post-Approval
Commitments shall be conducted under the oversight of the JCC.
6.2.2 PHASE IIIB AND PHASE IV CLINICAL STUDIES. Without limiting
the provisions of Section 6.1 or Section 6.2.1, the Parties contemplate that
Licensee shall perform, at its own cost and expense, such Phase IIIB Clinical
Studies and Phase IV Clinical Studies as Licensee may deem appropriate in the
Field in the Territory. All such Phase IIIB Clinical Studies and Phase IV
Clinical Studies shall be conducted in accordance with the Commercialization
Plan. Licensee shall keep the JCC reasonably informed of the conduct of such
Phase IIIB Clinical Studies and Phase IV Clinical Studies.
6.3 COMMERCIALIZATION PLAN. The Commercialization of each Licensed
Product in the Territory shall be conducted pursuant to a multi-year plan (the
"COMMERCIALIZATION PLAN"), which plan shall be consistent with Licensee's
obligations set forth in Section 6.1. A description
- 26 -
of the topics that the Parties anticipate will be addressed in the
Commercialization Plan is attached as SCHEDULE 6.3. The Joint Commercial
Committee shall create and approve the Commercialization Plan on or before
July 1, 2009 and, thereafter, shall review such plan no later than January 1 and
July 1 of each Calendar Year, and shall make amendments thereto with respect to
the Commercialization of Licensed Products in the Field in the Territory. Each
Commercialization Plan shall cover substantially those topics addressed in the
outline attached hereto as SCHEDULE 6.3.
6.4 STATEMENTS AND COMPLIANCE WITH APPLICABLE LAW. Licensee shall, and
shall cause its Sublicensees, its and their respective Affiliates and, if
applicable, Distributors to, comply with all Applicable Laws with respect to the
Commercialization of Licensed Products in the Territory. Licensee shall be
responsible for disseminating accurate information regarding any Licensed
Products, including accurate labeling and marketing and promotional materials
(which materials shall be consistent with any applicable Regulatory Approval
with respect to such Licensed Products), and for causing its Sublicensees and
its and their respective Affiliates to so disseminate such accurate information.
Licensee shall use Commercially Reasonable Efforts to, and shall use
Commercially Reasonable Efforts to cause its Sublicensees and its and their
respective Affiliates to, avoid taking, or failing to take, any actions that
Licensee knows or reasonably should know would jeopardize the goodwill or
reputation of Licensor or any Licensed Products.
6.5 SALES AND DISTRIBUTION. Licensee shall be solely responsible for
invoicing and booking sales, establishing all terms of sale (including pricing
and discounts) and warehousing and distributing Licensed Products in the Field
in the Territory and shall perform all related activities, in each case, in a
manner consistent with the terms and conditions of this Agreement. Licensee
shall also be solely responsible for handling all technical complaints, medical
information inquiries, customer service issues, returns, recalls or withdrawals
(which shall be conducted in accordance with Section 10.3), order processing,
invoicing and collection, distribution and inventory and receivables, in each
case with respect to the Licensed Products in the Field in the Territory.
6.6 PRODUCT TRADEMARKS AND MARKINGS. All packaging and Product Labeling
for Licensed Products used by Licensee, its Sublicensees or any of its or their
respective Affiliates in connection with Licensed Products in the Field in the
Territory shall contain (a) unless prohibited by Applicable Law, the name of
Licensor, and (b) if required by Applicable Law, the logo and corporate name of
the manufacturer (including the Corporate Names, if applicable) of the
applicable Licensed Product (collectively, the "MARKINGS"). For clarity,
Licensee shall not be required to include the name of Licensor on any marketing
or promotional materials used in connection with Licensed Products in the Field
in the Territory. Except with respect to the Markings as provided in this
Section 6.6, Licensee, its Sublicensees and its and their respective Affiliates
shall Commercialize the Licensed Products solely (i) under the applicable
Licensed Trademarks or such other Trademarks as Licensee shall select from time
to time and (ii) to the extent required by Applicable Law and as Licensee (or
its applicable Affiliate or Sublicensee) otherwise elects, using the Trademarks
constituting the corporate names and logos of any of Licensee, its Affiliates
and Sublicensees.
6.7 RECORDS AND REPORTING. Licensee shall prepare and maintain complete
and
- 27 -
accurate records regarding Commercialization of the Licensed Products in the
Field in the Territory during each Calendar Quarter during the Term and shall
provide to Licensor and the JCC a detailed report regarding such
Commercialization within forty-five (45) days after the end of such Calendar
Quarter. Each such report shall be in substantially the form attached hereto as
SCHEDULE 6.7. Licensee shall promptly provide Licensor with such additional
information regarding the Commercialization of the Licensed Products in the
Field in the Territory as Licensor may reasonably request from time to time. In
the event that either Party is conducting any Phase IIIB Clinical Studies, Phase
IV Clinical Studies or Post-Approval Commitments, then, in addition to the
information contained in the form attached hereto as SCHEDULE 6.7, such Party
shall report to the JCC and the other Party the results of such Phase IIIB
Clinical Studies, Phase IV Clinical Studies or Post Approval Commitments.
6.8 CO-PROMOTION OPTION.
6.8.1 Licensee hereby grants to Licensor an exclusive (subject to
the rights of Licensee in Section 2.5.1 and Section 6.9) option (the
"CO-PROMOTION OPTION") to Co-Promote the Existing Licensed Product in the Field
in the Territory, subject to the following terms and conditions.
(a) Commencing on the [REDACTED] [Exclusion of confidential
competitive information] anniversary of the Initial Approval, Licensor may
exercise the Co-Promotion Option by providing Licensee with written notice
thereof (each, a "NOTICE OF INTEREST IN CO-PROMOTION").
(b) Within thirty (30) days after Licensee receives such
Notice of Interest in Co-Promotion, the Parties shall negotiate, for a period
not to exceed ninety (90) days, a definitive Co-Promotion agreement
("CO-PROMOTION AGREEMENT") on commercially reasonable terms, including customary
provisions relating to relative sales force efforts, responsibility for sales
calls, sales force training, promotional materials and samples, detailing and
the number and qualifications of sales force personnel that will be devoted to
such Co-Promotion activities.
(c) If, after good faith negotiation, the Parties do not
agree on the terms of a Co-Promotion Agreement before such negotiation period
expires in accordance with Section 6.8.1(b), Licensor shall not commence
Co-Promotion of the Existing Licensed Product. Commencing twelve (12) months
thereafter, Licensor may provide a Notice of Interest in Co-Promotion, and the
Parties shall follow again the procedures set forth in this Section 6.8.
6.8.2 If Licensor has the right to Co-Promote pursuant to a
Co-Promotion Agreement, Licensor shall have the right to Co-Promote using a
contract sales organization ("CSO") reasonably acceptable to Licensee in a
manner consistent with the Co-Promotion Agreement and subject to the following
terms and conditions: (a) Licensor shall have a marketing and sales management
team that includes only full-time employees of Licensor and (b) any agreement
between Licensor and its CSO shall permit Licensor the option to hire the CSO's
sales representatives engaged in Co-Promotion of the Existing Licensed Product.
6.8.3 In the event that Licensee sells a Licensed Product other
than the Existing
- 28 -
Licensed Product, the JCC shall consider in good faith the desirability of
Co-Promotion of such Licensed Product by Licensor. If the JCC determines that
such Co-Promotion would be desirable, the Parties shall negotiate in good faith
the terms of a Co-Promotion Agreement with respect to such Licensed Product on
commercially reasonable terms, including customary provisions relating to
relative sales force efforts, responsibility for sales calls, sales force
training, promotional materials and samples, detailing and the number and
qualifications of sales force personnel that will be devoted to such
Co-Promotion activities.
6.9 DELEGATION OF CERTAIN COMMERCIALIZATION OBLIGATIONS. Licensee shall
have the right to Promote Licensed Products using a CSO; PROVIDED, HOWEVER, that
prior to the [REDACTED], Licensee may use CSOs to conduct [REDACTED] of its
overall Promotional efforts with respect to the Licensed Products.
ARTICLE 7
MANUFACTURE AND SUPPLY
7.1 MANUFACTURE OF LICENSED PRODUCTS.
7.1.1 CLINICAL SUPPLIES. Promptly upon request of Licensee, the
Parties shall negotiate in good faith to enter into one or more clinical supply
agreement(s), pursuant to which Licensor shall use Commercially Reasonable
Efforts to Manufacture and supply, or have Manufactured and supplied, in
accordance with Applicable Law, clinical supplies of Licensed Products and
placebos, in such form and in such quantities as may be required for any
Clinical Studies, Phase IIIB Clinical Studies, Phase IV Clinical Studies or
Post-Approval Commitments that are clinical studies to be conducted by Licensee
hereunder (any such agreement, a "CLINICAL SUPPLY AGREEMENT"). The price to be
paid by Licensee to Licensor for clinical supplies pursuant to any Clinical
Supply Agreement shall equal [REDACTED] [Exclusion of confidential information
relating to pricing] of Licensor's directly allocable costs with respect thereto
plus the cost of shipping such clinical supplies from Licensor to Licensee,
including the cost of insuring such clinical supplies.
7.1.2 POST-APPROVAL MANUFACTURE.
(a) SUPPLY BY LICENSOR. At the election of Licensor, at
least twenty-four (24) months prior to the anticipated date of the Initial
Approval, the Parties shall commence negotiations and thereafter enter into a
commercial supply agreement on terms substantially as set forth in
SCHEDULE 7.1.2, pursuant to which Licensor shall be responsible for the
Manufacture of, and Licensee shall purchase exclusively from Licensor,
commercial quantities of Licensed Products for sale and distribution in the
Field in the Territory (such agreement or any other agreement for the
Manufacture of Licensed Product or Starting Material by Licensor for supply to
Licensee for sale as Licensed Product hereunder (or in the case of Starting
Material, for use in the Manufacture thereof), a "COMMERCIAL SUPPLY AGREEMENT").
Licensor shall conduct its activities under any Commercial Supply Agreement
under the oversight of the JCC and shall keep the JCC apprised of the status of
its Manufacturing activities, whether conducted internally, by its Affiliates or
by Third Parties. Without limitation of Licensor's obligations pursuant to any
Commercial Supply Agreement, Licensor shall use Commercially Reasonable Efforts
to develop, under the review of the JCC, commercially reasonable arrangements
and strategies for back-up
- 29 -
sources of supply of the Licensed Products that appropriately and reasonably
minimize the risk of supply shortfalls and that take into account expected
inventory levels and demand.
(b) ASSUMPTION OF MANUFACTURING RESPONSIBILITY BY LICENSEE.
Licensee shall have the right to Manufacture or have Manufactured the Licensed
Products (or the Starting Material for use in such Manufacture) for sale and
distribution of the Licensed Products in the Field in the Territory only in the
event that (i) Licensor elects not to enter into a Commercial Supply Agreement
pursuant to Section 7.1.2(a) or to terminate any Commercial Supply Agreement
entered into pursuant to Section 7.1.2(a) or (ii) Licensee has such right under
any Commercial Supply Agreement (including the surviving terms thereof). If
Licensee exercises its right to Manufacture or have Manufactured the Licensed
Products (or the Starting Material for use in the Manufacture thereof) for sale
and distribution of the Licensed Products in the Field in the Territory,
Licensor shall use Commercially Reasonable Efforts to transfer certain Licensed
Know-How as provided in Section 7.3 and to assist Licensee in negotiating and
entering into agreements for such Manufacture with Licensor's contract
manufacturers, which assistance shall be further defined in the applicable
Commercial Supply Agreement. Notwithstanding anything to the contrary in Section
2.1.2, except as provided in Section 7.2, Licensee shall have no right to
Manufacture Licensed Products except as set forth in this Section 7.1.2(b).
7.2 SECONDARY PACKAGING AND LABELING. The Parties agree that, regardless
of the Party Manufacturing or having Manufactured Licensed Products hereunder,
Licensee shall be responsible for all secondary packaging and labeling with
respect to the Licensed Products in the Field in the Territory. For clarity,
subject to Section 15.3.4, Licensee shall have the right to perform its
secondary packaging and labeling responsibilities using a subcontractor.
7.3 MANUFACTURING TECHNOLOGY TRANSFER. Promptly after Licensee notifies
Licensor that it elects to exercise its rights under Section 7.1.2(b) to
Manufacture the Licensed Products (or the Starting Material for use in such
Manufacture), which notice may be provided in advance of the date on which such
right arises, the Parties shall use Commercially Reasonable Efforts to
coordinate a plan for a full technology transfer of the Licensed Know-How
relating to the Manufacture of the Licensed Products (or the Starting Material
for use in such Manufacture) for use in the Field to Licensee or its designee
within ninety (90) days thereafter or such longer period as the Parties may
agree. The Licensed Know-How relating to the Manufacture of Licensed Product
(including the Starting Material for use in such Manufacture) existing in
written form on the Execution Date is set forth on SCHEDULE 7.3 hereto.
7.4 WAIVER OF DOMESTIC MANUFACTURE OBLIGATION. Promptly following a
reasonable request of Licensee, Licensor shall seek, and thereafter shall use
reasonable efforts to obtain, from the United States federal government a waiver
with respect to the Existing Licensed Product excusing compliance with that
certain requirement set forth in 37 C.F.R. Ch. IV requiring that certain
products be Manufactured in the United States unless under the circumstances
domestic manufacture is not commercially feasible.
ARTICLE 8
CONSIDERATION
- 30 -
8.1 PAYMENTS TO LICENSOR. In partial consideration of the licenses and
other rights granted herein, Licensee shall make the following payments to
Licensor:
8.1.1 LICENSE FEE. Licensee shall pay a non-refundable (but without
limitation to Licensee's right to recover any amounts as damages),
non-creditable license fee of thirty million U.S. Dollars ($30,000,000.00)
within ten (10) days of the Execution Date.
8.1.2 MILESTONE PAYMENTS. The following non-refundable (but without
limitation to Licensee's right to recover any amounts as damages) milestone
payments shall be due (a) with respect to each clinical milestone described in
(i) and (ii) below, within fourteen (14) days following Licensee's receipt of
written notice of Licensor's achievement of such milestone, and (b) with respect
to each commercial milestone described in (iii) - (v) below, within thirty (30)
days following the last day of the month in which such milestone is achieved.
Licensee shall notify Licensor promptly of the occurrence of any such commercial
milestone. Licensee shall make the milestone payments in the amounts provided
below as set forth in the first sentence of this Section 8.1.2:
Clinical Milestones & Payments
(i) [REDACTED] [Exclusion of confidential [REDACTED] [Exclusion of confidential
information relating to milestone] information relating to milestone
payment]
(ii) [REDACTED] [Exclusion of [REDACTED] [Exclusion of confidential
confidential information relating to information relating to milestone
milestone] payment]
Commercial Milestones & Payments
(iii) [REDACTED] [Exclusion of [REDACTED] [Exclusion of confidential
confidential information relating to information relating to milestone
milestone] payment]
(iv) [REDACTED] [Exclusion of [REDACTED] [Exclusion of confidential
confidential information relating to information relating to milestone
milestone] payment]
(v) [REDACTED] [Exclusion of confidential [REDACTED] [Exclusion of confidential
information relating to milestone] information relating to milestone
payment]
For clarification, each milestone payment shall be payable only once
irrespective of the number of times the milestone events set forth in this
Section 8.1.2 have been achieved such that the maximum amount payable pursuant
to this Section 8.1.2 is One Hundred Thirty-Five Million U.S. Dollars
($135,000,000).
8.2 ROYALTIES.
8.2.1 IN GENERAL. During each Royalty Term Licensee shall pay to
Licensor royalties in U.S. Dollars based on aggregate Net Sales during each full
or partial Calendar Year at the rates set forth below:
- 31 -
(a) for that portion of aggregate Net Sales in such
Calendar Year that is less than [REDACTED], the royalty rate shall be [REDACTED]
[Exclusion of confidential information relating to royalties];
(b) for that portion of aggregate Net Sales in such
Calendar Year that equals or exceeds [REDACTED] but is less than [REDACTED], the
royalty rate shall be [REDACTED] [Exclusion of confidential information relating
to royalties];
(c) for that portion of aggregate Net Sales in such
Calendar Year that equals or exceeds [REDACTED] but is less than [REDACTED], the
royalty rate shall be [REDACTED] [Exclusion of confidential information relating
to royalties]; and
(d) for that portion of aggregate Net Sales in such
Calendar Year that equals or exceeds [REDACTED], the royalty rate shall be
[REDACTED] [Exclusion of confidential information relating to royalties];
PROVIDED, HOWEVER, that, for any period during the term of the Trademark License
Agreement for which royalties are paid by Licensee to Licensor for use of any
Licensed Trademark, the royalty rates set forth in (a) - (d) above shall each be
decreased by [REDACTED] [Exclusion of confidential information relating to
royalties] for the corresponding period; and
PROVIDED, further, that, without limiting the foregoing, in the event that
Licensor does not Manufacture or have Manufactured some or all quantities of
Licensed Product for supply to Licensee for commercial sale in the Field in the
Territory, the royalty rates set forth in (a) - (d) above shall each be
increased by [REDACTED] [Exclusion of confidential information relating to
royalties] with respect to any quantity of Licensed Product that the Licensor
does not so Manufacture or have Manufactured.
8.2.2 ROYALTY STEP-DOWNS. On a Licensed Product-by-Licensed Product
basis, the following royalty rate reductions shall apply during the Royalty Term
applicable to such Licensed Product. For illustrative purposes only, sample
calculations of each of the following royalty rate reductions are set forth in
SCHEDULE 8.2.2.
(a) On and after the Valid Claim Expiration with respect to
a given Licensed Product in the Field in the Territory, during the remainder of
the applicable Royalty Term, the royalty rate applicable to the calculation of
royalties payable by Licensee to Licensor with respect to such Licensed Product
pursuant to Section 8.2.1 shall equal the Effective Royalty Rate less [REDACTED]
[Exclusion of confidential information relating to royalties] of the Effective
Royalty Rate.
(b) In addition to any reduction that may be permitted
pursuant to Section 8.2.2(a), in the event that one or more Generic Versions of
a Licensed Product becomes commercially available in the Territory during the
applicable Royalty Term, then for each Calendar Quarter after the Generic
Version first becomes commercially available ("GENERIC LAUNCH"), including the
portion of the Calendar Quarter in which the Generic Launch occurs, the royalty
rate applicable to the calculation of royalties payable by Licensee to Licensor
with respect to such Licensed Product pursuant to Section 8.2.1 shall equal the
Effective Royalty Rate (as adjusted pursuant to the foregoing clause (a), if
applicable) less a percentage of the Effective
- 32 -
Royalty Rate equal to the following, subject to Section 8.2.2(c):
[REDACTED] [Exclusion of confidential information relating to royalties]
For the Calendar Quarter in which Generic Launch occurs, such calculation shall
be made solely with respect to the portion of the Calendar Quarter following
Generic Launch and, for purposes of such calculation, [REDACTED] [Exclusion of
confidential information relating to royalties] shall be prorated accordingly.
(c) Notwithstanding anything to the contrary contained
herein, in no event shall any reductions made under Section 8.2.2(a), 8.2.2(b)
or 9.5.4(b), in the aggregate, reduce the royalties payable by Licensee to
Licensor to an amount less than the amounts calculated in accordance with the
following (each, the applicable "ROYALTY FLOOR").
(i) Subject to clause (ii) below, the royalty rate
reductions applicable to a Licensed Product in a Calendar Quarter under
Sections 8.2.2(a) and 8.2.2(b), in the aggregate, shall not reduce the royalty
rate applied to Net Sales of such Licensed Product in such Calendar Quarter to
less than [REDACTED] [Exclusion of confidential information relating to
royalties] of the Effective Royalty Rate.
(ii) If Licensee has exercised its right to obtain a
license from a Third Party as described in Section 9.5.4(a) and such license is
required to Exploit the Existing Licensed Product for BPH, the reductions
applicable to such Existing Licensed Product in such Calendar Quarter under
Sections 8.2.2(a) (if any), 8.2.2(b) (if any) and 9.5.4(b), in the aggregate,
shall not reduce the royalty rate applied to Net Sales of such Existing Licensed
Product in such Calendar Quarter to [REDACTED] [Exclusion of confidential
information relating to royalties] of the Effective Royalty Rate. If Licensee
has exercised its right to obtain a license from a Third Party as described in
Section 9.5.4(a) and such license is required to Exploit (A) any Licensed
Product other than the Existing Licensed Product or (B) the Existing Licensed
Product for any indication other than BPH, the reductions applicable to such
Licensed Product under Sections 8.2.2(a) (if any), 8.2.2(b) (if any) and
9.5.4(b), in the aggregate, shall not reduce the royalty rate applied to Net
Sales of the applicable Licensed Product in such Calendar Quarter to [REDACTED]
[Exclusion of confidential information relating to royalties] of the Effective
Royalty Rate.
8.2.3 ROYALTY TERM. Upon expiration of the Royalty Term with
respect to a given Licensed Product in the Field in the Territory, the licenses
granted to Licensee in Section 2.1 with respect to such Licensed Product in the
Field in the Territory shall become non-exclusive, perpetual, irrevocable and
fully paid-up.
8.2.4 BLENDED ROYALTY RATES. The Parties acknowledge and agree that
the Licensed Patents and Licensed Know-How licensed from Licensor to Licensee
pursuant to this Agreement justify royalty rates of differing amounts with
respect to the sales of Licensed Products, which rates could each be applied
separately to the Licensed Products, and that, if such royalties were calculated
separately, royalties relating to Licensed Patents and royalties relating to
Licensed Know-How would each last for different terms. Notwithstanding the
foregoing, the Parties have determined, for reasons of convenience, that blended
royalty rates for the Licensed
- 33 -
Patents and Licensed Know-How licensed hereunder, as set forth above, shall
apply during a single payment term (i.e., the Royalty Term). The Parties
acknowledge and agree that nothing in this Agreement shall be construed as
representing an estimate or projection of the anticipated sales or the actual
value of the Licensed Products, and that the figures set forth in this Section
8.2 or elsewhere in this Agreement or that have otherwise been discussed by the
Parties are merely intended to define the Licensee's royalty payment obligations
if such sales performance is achieved.
8.2.5 ROYALTY PAYMENTS. Running royalties shall be payable on a
quarterly basis, within thirty (30) days after the end of each Calendar Quarter,
based upon the aggregate Net Sales during such Calendar Quarter. Royalties shall
be calculated in accordance with IFRS and with the terms of this ARTICLE 8. Only
one royalty payment shall be due on Net Sales even though the sale or use of a
Licensed Product may be covered by more than one Licensed Patent or item of
Licensed Know-How in the Territory.
8.2.6 ROYALTY STATEMENTS. Each royalty payment hereunder shall be
accompanied by a statement in sufficient detail to allow for the calculation of
royalties due hereunder, including by showing, at a minimum, for the applicable
Calendar Quarter (a) the number of units of Licensed Product sold in the Field
in the Territory, (b) Net Sales, (c) the amount of royalties due on such Net
Sales and (d) any other information reasonably requested by Licensor. For any
Calendar Quarter for which a royalty is due under the Tulane License for sales
of Licensed Products in the Field in the Territory, such statement shall be
certified by an officer of Licensee.
8.3 COMBINATION PRODUCTS. With respect to Combination Products, the Net
Sales used for the calculation of the royalties under Section 8.2 shall be
determined as follows:
A x Net Sales of the Combination Product, where:
-----
A+B
----------
A = standard sales price of the Product, containing the same amount of API as
the sole active ingredient as the Combination Product in question.
B = standard sales price of the ready-for-sale form of a product containing the
same amount of the other therapeutically active ingredient(s) that are contained
in the Combination Product in question.
An example of such calculation, provided for illustrative purposes only, is set
forth in SCHEDULE 8.3.
In the event, however, that if, (a) the other therapeutically active
ingredient(s) in such Combination Product are not sold separately, Net Sales
shall be adjusted by multiplying actual Net Sales of such Combination Product by
the fraction A/C, where C is the standard sales price of such Combination
Product, and (b) if a Product containing such API is not sold separately, Net
Sales shall be calculated by multiplying actual Net Sales of such Combination
Product by the fraction (C-B)/C, where B is the standard sales price of the
other therapeutically active ingredient(s) in the Combination Product and C is
the standard sales price of the Combination
- 34 -
Product. The standard sales price for the Product containing API and for each
other active ingredient shall be for a quantity comparable to that used in such
Combination Product and of the same class, purity and potency. If both a Product
containing the API and a product containing the other active ingredients in such
Combination Product are not sold separately, a market price for such Product and
such other active ingredients shall be negotiated by the Parties in good faith
based upon the costs, overhead and profit as are then incurred for such
Combination Product and all products then being made and marketed by Licensee
and having an ascertainable market price that is comparable to such Product or
such other active ingredients, as applicable. If the foregoing calculations do
not fairly represent the value of the various active ingredients included in a
Combination Product, the allocation of Net Sales for such Combination Product
shall be negotiated by the Parties in good faith.
8.4 OTHER INCOME FROM SUBLICENSEES. Licensee shall pay or transfer, as
applicable, to Licensor [REDACTED] [Exclusion of confidential information
relating to consideration payable hereunder] of any and all payments or other
consideration (other than (a) payments received by Licensee based on Invoiced
Sales by a Sublicensee, to the extent such payments are less than or equal to
the amount that Licensee is obligated to pay to Licensor as royalties based on
such Invoiced Sales pursuant to Section 8.2 and (b) upfront and milestone
payments, to the extent such payments constitute a pass through of any upfront
or milestone payment obligation set forth in Section 8.1) received directly or
indirectly by Licensee, whether in cash, equity securities or other form, from
any Sublicensee as consideration for the grant by Licensee of any right or
sublicense to such Sublicensee pursuant to the terms of Section 2.5. Licensee
shall make all payments and transfers due to Licensor pursuant to this Section
8.4 no later than sixty (60) days following Licensee's receipt of the applicable
payment or other consideration from the applicable Sublicensee. With respect to
any consideration provided by any Sublicensee to Licensee in a form other than
cash, which consideration triggers a payment obligation under this Section 8.4,
Licensee may elect to either (i) transfer to Licensor [REDACTED] [Exclusion of
confidential information relating to consideration payable hereunder] of such
consideration in the form received by Licensee (e.g., transfer of equity shares)
or (b) pay an amount equal to [REDACTED] [Exclusion of confidential information
relating to consideration payable hereunder] of the fair market value of such
consideration. Notwithstanding anything in this Section 8.4, no payment to
Licensor shall be due pursuant to this Section 8.4 with respect to any payments
or other consideration received by Licensee, directly or indirectly, from any
Sublicensee, which payments or other consideration constitute reasonable payment
or consideration by a Sublicensee for any bona fide services, including
development and manufacturing services, actually provided by Licensee after the
Execution Date or which Licensee is obligated to provide in the future pursuant
to an agreement entered into with a Sublicensee after the Execution Date.
8.5 PAYMENT OF DEVELOPMENT EXPENSES. Licensor shall invoice Licensee
within thirty (30) days after the end of each Calendar Quarter for any
Development Costs incurred by Licensor during such Calendar Quarter to the
extent reimbursable by Licensee pursuant to Section 4.4. Such invoice shall
specify in reasonable detail all amounts included in such Development Costs
during such Calendar Quarter (broken down by activity) and shall be accompanied
by appropriate supporting documentation, including any Third Party invoices for
such Development Costs. Within thirty (30) days after the date on which such
invoice is received by Licensee, Licensee shall pay the amount due thereunder in
Euros to Licensor.
- 35 -
8.6 RECOVERY OF AMOUNTS PAID TO TULANE. In the event that the Tulane
License is terminated and Licensee is obligated to pay any amounts to Tulane
pursuant to (a) paragraph 9 of the Letter Agreement in order to enter into a New
License Agreement (as defined in the Letter Agreement) or (b) a New License
Agreement, which amounts constitute royalties or other payments due thereunder,
then Licensor shall reimburse Licensee for such amounts within thirty (30) days
after receipt by Licensor of an invoice for such amounts and appropriate
supporting documentation with respect to such invoice. If Licensor fails to
reimburse Licensee for any such amounts when due, Licensee may deduct such
amounts from the amounts due to Licensor hereunder, which deduction may be made
without regard to any Royalty Floor (although, for clarity, such royalties as
calculated pursuant to Section 8.2 prior to taking such deduction shall remain
subject to the applicable Royalty Floor), until such amount has been fully
offset, at which point it shall be considered paid in full.
8.7 MODE OF PAYMENT. Except with respect to upfront and milestone
payments payable to Licensor under Section 8.1, royalties payable to Licensor
under Section 8.2 and as otherwise specified herein, all payments to a Party
under this Agreement shall be made in Euros. All payments under this Agreement
shall be made by deposit of the applicable currency by wire transfer to:
in the case of Licensor, the following account or such other account designated
by Licensor by written notice to Licensee:
▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇ ▇▇ ▇▇▇▇
▇▇▇▇▇▇▇-▇▇▇▇▇-▇▇▇▇▇ ▇▇
▇▇▇▇▇ Frankfurt
Account No.: [REDACTED]
Bankcode: [REDACTED]
IBAN: [REDACTED]
Swift- BIC: [REDACTED]
or, in the case of Licensee, the account designated by Licensee by written
notice to Licensor.
8.8 CURRENCY. For the purpose of converting any Development Costs
incurred in a currency other than Euros to Euros, such Development Costs shall
be converted from the applicable currency to Euros on a calendar monthly basis
at the rate of exchange between the currency in which such Development Costs
were incurred and the Euro at the European Central Bank spot rate at 2:15 pm
European Central Time on the last day of the calendar month in which such
Development Costs were incurred.
8.9 TAXES. The royalties, milestones and other amounts payable by
Licensee to Licensor pursuant to this Agreement ("PAYMENTS") shall not be
reduced on account of any Taxes unless required by Applicable Law. Licensor
alone shall be responsible for paying any and all Taxes (other than withholding
taxes required by Applicable Law to be deducted from Payments and remitted by
Licensee) levied on account of, or measured in whole or in part by reference to,
any Payments it receives. Licensee shall deduct or withhold from the Payments
any Taxes that it is required by Applicable Law to deduct or withhold.
Notwithstanding the foregoing, if Licensor is entitled under any applicable tax
treaty to a reduction of rate of, or the elimination of,
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applicable withholding Tax, it may deliver to Licensee or the appropriate
governmental authority (with the assistance of Licensee to the extent that this
is reasonably required and is expressly requested in writing) the prescribed
forms necessary to reduce the applicable rate of withholding or to relieve
Licensee of its obligation to withhold Tax, and Licensee shall apply the reduced
rate of withholding, or dispense with withholding, as the case may be; provided
that Licensee has received evidence, in a form reasonably satisfactory to
Licensee, of Licensor's delivery of all applicable forms (and, if necessary, its
receipt of appropriate governmental authorization) at least fifteen (15) days
prior to the time that the Payments are due. If, in accordance with the
foregoing, Licensee withholds any amount, it shall pay to Licensor the balance
when due, make timely payment to the proper taxing authority of the withheld
amount and send to Licensor proof of such payment within ten (10) days following
such payment.
8.10 INTEREST ON LATE PAYMENTS. If any payment due to Licensor under this
Agreement is not paid when due then Licensee shall pay interest thereon (before
and after any judgment) at an annual rate (but with interest accruing on a daily
basis) of two (2) percentage points above LIBOR as reported on the first
Business Day of each month such payment is overdue in THE WALL STREET JOURNAL,
Eastern Edition, such interest to run from the date upon which payment of such
sum became due until payment thereof in full together with such interest.
8.11 FINANCIAL RECORDS. Licensee shall, and shall cause its Sublicensees
and its and their respective Affiliates to, keep complete and accurate financial
books and records pertaining to all Invoiced Sales (including any deductions
therefrom) and Net Sales of Licensed Products in sufficient detail to calculate
the royalties and other amounts payable under this Agreement. Licensor shall,
and shall cause its Affiliates to, keep complete and accurate books and records
pertaining to any Development Costs for which Licensor seeks reimbursement
hereunder. Such books and records shall be retained by such Party or its
applicable Affiliate, or, with respect to Licensee, its Sublicenses, until the
later of (a) three (3) years after the end of the period to which such books and
records pertain and (b) the expiration of the applicable tax statute of
limitations (or any extensions thereof), or for such longer period as may be
required by Applicable Law.
8.12 AUDIT. At the request of either Party, the other Party shall, and
shall cause its Affiliates and, with respect to Licensee, its Sublicensees to,
permit an independent certified public accounting firm of internationally
recognized standing (the "AUDITOR") selected by the requesting Party, and
reasonably acceptable to the other Party, at reasonable times and upon
reasonable notice, to examine the books and records maintained pursuant to
Section 8.11. Such examinations may not (a) be conducted for any Calendar
Quarter more than three (3) years after the end of such Calendar Quarter, (b) be
conducted more than once in any twelve (12) month period or (c) be repeated for
any Calendar Quarter. The Auditor shall disclose to the Parties only whether the
reported amounts and any related invoices are correct or incorrect and the
specific details concerning any discrepancies. The decision of the Auditor shall
be final and the cost of this examination shall be borne by the Party that
requested the examination, unless the audit reveals a variance (to the detriment
of the auditing Party) of more than five percent (5%) from the reported amounts,
in which case the audited Party shall bear the cost of the audit.
8.13 RECONCILIATION. If an audit pursuant to Section 8.12 demonstrates
that additional payments were owed or that excess payments were made during any
period, the applicable Party shall make a reconciling payment to the other Party
within thirty (30) days after the date on
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which the accounting firm's written report is delivered to the Parties pursuant
to Section 8.12.
8.14 CONFIDENTIALITY. The receiving Party shall treat all information
subject to review under this ARTICLE 8 in accordance with the confidentiality
provisions of ARTICLE 11, and the Parties shall cause any Auditor to enter into
a reasonably acceptable confidentiality agreement with the audited Party
obligating such firm to retain all such financial information in confidence
pursuant to such confidentiality agreement.
ARTICLE 9
INTELLECTUAL PROPERTY
9.1 OWNERSHIP OF INTELLECTUAL PROPERTY.
9.1.1 OWNERSHIP OF TECHNOLOGY. Subject to Section 9.1.3, ARTICLE 14
and the license grants under Section 2.1 and 2.2, as between the Parties, each
Party shall own and retain all right, title and interest in and to any and all:
(a) Information that is conceived, discovered, developed or otherwise made by or
on behalf of such Party (or its Affiliates or its licensees (other than, in the
case of Licensor, Licensee)) under or in connection with this Agreement, whether
or not patented or patentable, and any and all Patent and other intellectual
property rights with respect thereto, except to the extent that any such
Information or any Patent or intellectual property rights with respect thereto,
is Joint Know-How or Joint Patents, and (b) other Information, Patents and other
intellectual property rights that are owned or otherwise Controlled (other than
pursuant to the license grants set forth in ARTICLE 2) by such Party, its
Affiliates or its licensees (other than, in the case of Licensor, Licensee),
including in the case of Licensor, the Licensed Patents and the Licensed
Know-How, and in the case of Licensee, the Licensee Patents and the Licensee
Know-How.
9.1.2 OWNERSHIP OF REGULATORY DOCUMENTATION. From the Execution
Date until the date that Licensor obtains the Initial Approval, subject to the
right of references granted to the other Party under Section 2.1.3 and
Section 2.2.3, as between the Parties, Licensor shall own and retain all right,
title and interest in and to all Regulatory Approvals, all Regulatory
Documentation and all Drug Master Files with respect to Licensed Products in the
Field in the Territory, as well as all Clinical Data, in each case that are
Controlled by Licensor as of the Execution Date and from time to time until the
grant of the Initial Approval. Following the grant of the Initial Approval,
subject to the licenses and rights of reference granted to Licensor under
Section 2.2, as between the Parties, Licensee shall own all right, title and
interest in and to all Regulatory Approvals (other than any IND owned or
Controlled by Licensor and the Drug Master Files of Licensor or its contract
manufacturers) with respect to Licensed Products in the Field in the Territory
and the Regulatory Documentation with respect thereto. Upon receipt of the
Initial Approval (or such later date as is elected by Licensee) and from time to
time during the Term, Licensor shall promptly disclose to Licensee in writing,
and shall cause its Affiliates to so disclose, the development, making,
conception or reduction to practice of any such Regulatory Approvals, Regulatory
Documentation and Clinical Data, and Licensor shall and does hereby, assign, and
shall cause its Affiliates to so assign, to Licensee, without additional
compensation, such right, title and interest in and to any such Regulatory
Approvals (other than any IND owned or Controlled by Licensor and the Drug
Master Files of Licensor or its contract manufacturers), Regulatory
Documentation and Clinical Data as well as any intellectual property rights with
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respect thereto, as is necessary to fully vest sole ownership in Licensee.
9.1.3 OWNERSHIP OF JOINT PATENTS AND JOINT KNOW-HOW. Subject to the
license grants under Sections 2.1 and 2.2, the Parties shall each own an equal,
undivided interest in any and all (a) Information and inventions that are
conceived, discovered, developed or otherwise made, as necessary to establish
authorship, inventorship or ownership under applicable United States law,
jointly by or on behalf of Licensor (or its Affiliates), on the one hand, and
Licensee (or its Affiliates or its Sublicensees), on the other hand, in
connection with the work conducted under or in connection with this Agreement,
whether or not patented or patentable (the "JOINT KNOW-HOW"), and (b) Patents
(the "JOINT PATENTS") and other intellectual property rights with respect
thereto (together with Joint Know-How and Joint Patents, the "JOINT INTELLECTUAL
PROPERTY RIGHTS"). Subject to this Section 9.1.3, the licenses granted under
Sections 2.1 and 2.2 and the restrictions set forth in Section 2.8, in no event
shall either Party or any of its respective Affiliates or Sublicensees assign,
license or transfer any of their right, title and ownership in and to any Joint
Intellectual Property Rights to any Third Party without the prior written
consent of the other Party, such consent not to be unreasonably withheld;
PROVIDED, HOWEVER, that each Party shall have the right to (sub)license its
rights with respect to the Joint Intellectual Property Rights to the extent that
it has a right to (sub)license pursuant to Section 2.5. Subject to this
Section 9.1.3, the licenses granted under Sections 2.1 and 2.2 and the
restrictions set forth in Section 2.8, each Party shall have the right to
Exploit any Joint Intellectual Property Rights without the consent of, or a duty
of accounting to, the other Party.
9.1.4 DISCLOSURE OF INTELLECTUAL PROPERTY. Each Party shall
promptly disclose to the other Party in writing, and shall cause its Affiliates
and (sub)licensees to so disclose, the development, making, conception or
reduction to practice of any Patents or Information to which the other Party has
a license under ARTICLE 2, including, with respect to Licensee, any Licensee
Patents, Licensee Know-How, Joint Patents and Joint Know-How, and, with respect
to Licensor, any Licensed Patents, Licensed Know-How, Joint Patents and Joint
Know-How.
9.1.5 UNITED STATES LAW. The determination of whether Information
is conceived, discovered, developed or otherwise made by a Party for the purpose
of allocating proprietary rights (including Patent, copyright or other
intellectual property rights) therein, shall, for purposes of this Agreement, be
made in accordance with applicable law in the United States. In the event that
United States law does not apply to the conception, discovery, development or
making of any Information hereunder, each Party shall, and does hereby, assign,
and shall cause its Affiliates and Sublicensees to so assign, to the other
Party, without additional compensation, such right, title and interest in and to
any Information as well as any intellectual property rights with respect
thereto, as is necessary to fully effect, as applicable, (a) the sole ownership
provided for in Section 9.1.1 and (b) the joint ownership provided for in
Section 9.1.3.
9.1.6 OWNERSHIP OF CORPORATE NAMES. As between the Parties,
Licensor shall retain all right, title and interest in and to the Corporate
Names and Licensee agrees that it shall not attack, dispute or contest the
validity of or ownership of the Corporate Names or any registrations issued or
issuing with respect thereto. Licensee expressly acknowledges and agrees that no
ownership rights are vested or created by the limited rights of use granted
pursuant to Section 2.1.4 and that all use of the Corporate Names in accordance
therewith, including any goodwill generated in connection therewith, inures to
the benefit of Licensor and Licensor may
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call for a confirmatory assignment thereof.
9.2 MAINTENANCE AND PROSECUTION OF PATENTS.
9.2.1 LICENSED PATENTS AND LICENSEE PATENTS.
(a) LICENSED PATENTS. Subject to Sections 9.2.1(c) and
9.2.5, Licensor shall, using outside legal counsel reasonably acceptable to
Licensee, diligently file, prosecute (including any interferences, reissue
proceedings and re-examinations) and maintain the Licensed Patents in the Field
in the Territory. Licensee and Licensor shall bear equally all reasonable costs
and expenses of obtaining and maintaining the Licensed Patents listed on
SCHEDULE 9.2.1 (the "SHARED COST PATENTS") during the Term, including reasonable
fees and expenses paid to outside legal counsel and experts; PROVIDED, HOWEVER,
that Licensee's share of such costs and expenses shall not exceed [REDACTED] in
any Calendar Year (prorated for partial Calendar Years during the Term) and
Licensor shall bear any such costs and expenses in excess thereof. Licensor
shall bear all costs and expenses of obtaining and maintaining the Licensed
Patents other than the Shared Cost Patents, including fees and expenses paid to
outside legal counsel and experts. In this regard, Licensor shall (i) file,
prosecute and maintain Patent applications to secure Patent rights for the
Licensed Patents in the Territory and for the use of Licensed Products in the
Field in the Territory (except to the extent that a Third Party licensor has
retained the right to do so, in which case Licensor shall use commercially
reasonable efforts to cause such Third Party licensor to do so), and such other
patentable Licensed Know-How as Licensee may from time to time designate in
writing, in each case in the Territory; and (ii) upon issuance, maintain such
Patents in full force in the Territory. Licensor shall take such action in
support of filing or prosecuting such Patent applications and maintaining such
Patents (including pursuing or defending any interferences, reissue proceedings
or re-examinations) as Licensee may from time to time request in writing.
(b) LICENSEE PATENTS. Licensee, through legal counsel of
its choosing, shall have the right, but not the obligation, to obtain, prosecute
(including carrying out any interferences, reissue proceedings and
re-examinations), and maintain throughout the world the Licensee Patents, at its
cost and expense.
(c) DECISIONS TO PROSECUTE.
(i) Without limitation of Section 9.2.1(a), if
Licensor elects not (A) to pursue or continue the filing, prosecution (including
any interferences, reissue proceedings and re-examinations) or maintenance of a
Licensed Patent in the Field in the Territory, or (B) to take any other action
with respect to a Licensed Patent in the Field in the Territory that is
necessary or useful to establish, preserve or extend rights thereto, then in
each such case Licensor shall so notify Licensee in writing not less than two
(2) months before any deadlines by which an action must be taken to establish or
preserve any such rights in a Licensed Patent in the Field in the Territory.
Upon receipt of each such notice by Licensee or if, at any time, Licensor fails
to initiate any such action within thirty (30) days after a request by Licensee
that it do so (or, if after initiating any requested action, Licensor at any
time thereafter fails to diligently pursue such action), Licensee shall have the
right, but not the obligation, through counsel of its choosing, to pursue the
filing or registration, or support the continued prosecution
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(including any interferences, reissue proceedings and re-examinations) or
maintenance, of such Licensed Patent at its expense. If Licensee elects to
pursue such filing or registration, as the case may be, or continue such
support, then Licensee shall notify Licensor of such election and Licensor
shall, and shall cause its Affiliates to, (1) reasonably cooperate with Licensee
in this regard, and (2) promptly release or assign to Licensee, without
consideration, all right, title and interest in and to such Licensed Patent in
the Field in the Territory, whereupon such Patent shall cease to be a Licensed
Patent.
(ii) If Licensee elects not (A) to pursue or
continue the filing, prosecution (including any interferences, reissue
proceedings and re-examinations) or maintenance of a Licensee Patent, or (B) to
take any other action with respect to a Licensee Patent that is necessary or
useful to establish, preserve or extend rights thereto, then in each such case
Licensee shall so notify Licensor in writing not less than two (2) months before
any deadlines by which an action must be taken to establish or preserve any such
rights in such Licensee Patent. Upon receipt of each such notice by Licensor or
if, at any time, Licensee fails to initiate any such action within thirty (30)
days after a request by Licensor that it do so (or, if after initiating any
requested action, Licensee at any time thereafter fails to diligently pursue
such action), Licensor shall have the right, but not the obligation, through
counsel of its choosing, to pursue the filing or registration, or support the
continued prosecution (including any interferences, reissue proceedings and
re-examinations) or maintenance, of such Licensee Patent at its expense. If
Licensor elects to pursue such filing or registration, as the case may be, or
continue such support, then Licensor shall notify Licensee of such election and
Licensee shall, and shall cause its Affiliates to, (1) reasonably cooperate with
Licensor in this regard, and (2) promptly release or assign to Licensor, without
consideration, all right, title and interest in and to such Licensee Patent.
9.2.2 JOINT PATENTS. The Parties shall determine, on a
case-by-case basis, which Party shall have the responsibility, through counsel
of its choosing, for obtaining, prosecuting (including any interferences,
reissue proceedings and re-examinations) and maintaining a Joint Patent
throughout the world (such Party, the "PROSECUTING PARTY"). In selecting the
Prosecuting Party, the Parties shall consider the relative contributions of each
Party to the Joint Intellectual Property Rights and the expected efficiencies of
the patent prosecution procedures of the respective Parties. The Prosecuting
Party shall have the sole right to determine in which countries to obtain,
prosecute and maintain the Joint Patents. The other Party shall have the right
to request that the Prosecuting Party obtain, prosecute and maintain a Joint
Patent in a particular country. If the Prosecuting Party declines, or otherwise
fails, to initiate any such requested action with respect to a Joint Patent
within sixty (60) days (or, if after initiating any requested action, the
Prosecuting Party at any time thereafter fails to diligently pursue such
action), in each case the other Party shall have the right to take such action
with respect to such Joint Patent. The Parties shall, and shall cause their
respective Affiliates, as applicable, to assist and cooperate with one another
in, and share equally the cost and expense of, filing, prosecuting and
maintaining the Joint Patents. Notwithstanding the above, either Party may
decline to pay its share of the costs and expenses for filing, prosecuting and
maintaining any Joint Patent in a particular country or particular countries, in
which case the declining Party shall assign, and shall cause its Affiliates to
assign, to the other Party all of their rights, titles and interests in and to
any such Joint Patent in the relevant country or countries whereupon such Joint
Patent shall become a Licensee Patent owned solely by Licensee or a Licensed
Patent in such country or countries, as
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the case may be.
9.2.3 COOPERATION. In connection with the activities set forth
in Sections 9.2.1 or 9.2.2: (a) each Party shall consult with the other as to
the strategy and prosecution of applications for Patents and the maintenance or
extension of the Licensed Patents, Licensee Patents and Joint Patents; (b) each
filing Party shall regularly provide the other Party with copies of all Patent
applications filed hereunder and other material submissions and correspondence
with the patent offices in sufficient time to allow for review and comment by
the other Party, and in any event at least thirty (30) days in advance of the
due date of any payment or other administrative action that is required to
obtain or maintain a Patent; (c) such filing Party shall provide the other Party
and its patent counsel with an opportunity to consult with the filing Party and
its patent counsel regarding the filing and contents of any such application,
amendment, submission or response; and (d) such filing Party shall notify the
other Party as early as reasonably practicable, and in any event at least thirty
(30) days in advance of all meetings and material communications with any patent
authorities concerning the Licensed Patents, Licensee Patents or Joint Patents
and shall permit the other Party to participate in such meetings, and the advice
and suggestions of the other Party and its patent counsel shall be taken into
consideration in good faith by such Party and its patent counsel in connection
with such filing.
9.2.4 CREATE ACT. Notwithstanding anything to the contrary in
this ARTICLE 9, each Party shall have the right to invoke the Cooperative
Research and Technology Enhancement Act of 2004, 35 U.S.C. 103(c)(2)-(c)(3) (the
"CREATE ACT") when exercising its rights under this ARTICLE 9, without the prior
written consent of the other Party. Where a Party intends to invoke the CREATE
Act, as permitted by the preceding sentence, it shall notify the other Party and
the other Party shall cooperate and coordinate its activities with Licensee with
respect to any submissions, filings or other activities in support thereof. The
Parties acknowledge and agree that this Agreement is a "joint research
agreement" as defined in the CREATE Act.
9.2.5 PATENT TERM EXTENSION. Regardless of which Party is filing,
prosecuting and maintaining any Patents pursuant to this ARTICLE 9, the Parties
shall agree in writing on all decisions regarding all patent term extensions
with respect to the Licensed Patents and the Joint Patents in the Territory, and
Licensee shall have the right to make all decisions regarding all patent term
extensions with respect to the Licensee Patents in the Territory, including with
respect to extensions pursuant to 35 U.S.C. Section 156 et. seq. Upon request by
a Party, the other Party shall reasonably cooperate in the implementation of
such decisions.
9.2.6 ORANGE BOOK LISTINGS. Notwithstanding anything to the
contrary in Section 9.1.2, Licensee shall have the sole right to make all
filings with the FDA with respect to the Licensed Patents in the Field in the
Territory (or to direct Licensor to make such filings before the Regulatory
Approval Transfer), including as required or allowed in connection with the
FDA's Orange Book. Licensor shall (a) provide to Licensee all Information,
including a correct and complete list of Licensed Patents covering any Licensed
Product, that is necessary or reasonably useful to enable Licensee to make such
filings with the FDA with respect to the Licensed Patents, and (b) cooperate
with Licensee's reasonable requests in connection therewith, including meeting
any submission deadlines, in each case, to the extent required or permitted by
Applicable Law. Licensee shall promptly notify Licensor of any such filings with
the FDA with
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respect to the Licensed Patents.
9.3 ENFORCEMENT OF PATENTS.
9.3.1 RIGHTS AND PROCEDURES. In the event that either Party has
cause to believe that a Third Party may be infringing any of the Licensed
Patents, Licensee Patents or Joint Patents in the Field in the Territory, it
shall promptly notify the other Party in writing, identifying the alleged
infringer and the alleged infringement complained of and furnishing the
information upon which such determination is based. Subject to any rights of
Tulane under the Tulane License, Licensee shall have the first right, but not
the obligation, through counsel of its choosing, to take measures to stop such
infringement of the Licensed Patents or Joint Patents by such Third Party in the
Field in the Territory or to grant to the infringing Third Party adequate rights
and licenses necessary for continuing the otherwise infringing activities in the
Field in the Territory. Licensee shall control such action and, upon reasonable
request by Licensee, Licensor shall give Licensee all reasonable information and
assistance, including allowing Licensee access to Licensor's files and documents
and to Licensor's personnel who may have possession of relevant information and,
if necessary for Licensee to prosecute any legal action, joining in the legal
action as a party, and the Parties shall share Licensor's reasonable costs and
expenses incurred with respect to such joinder in accordance with Section 9.3.4.
Licensor shall use its Commercially Reasonable Efforts to obtain any consents
required by Tulane under the Tulane License to remove such infringement. If
Licensee fails within ninety (90) days following notice of such infringement, or
earlier notifies Licensor in writing of its intent not to take commercially
appropriate steps to remove any infringement of any Licensed Patent or Joint
Patent, and Licensee has not granted the infringing Third Party rights and
licenses to continue its otherwise infringing activities, then Licensor shall
have the right to remove such infringement at Licensor's expense; PROVIDED,
HOWEVER, that if Licensee has commenced negotiations with an alleged infringer
for discontinuance of such infringement within such ninety (90) day period,
Licensee shall have an additional ninety (90) days to conclude its negotiations
before Licensor may bring suit for such infringement. Upon reasonable request by
Licensor and at Licensor's cost and expense, Licensee shall give Licensor all
reasonable information and assistance in connection with such suit for
infringement.
9.3.2 SETTLEMENT OF AN ENFORCEMENT CLAIM. The Party seeking to
remove any infringement of the Licensed Patents or Joint Patents in the Field in
the Territory shall have the right to control settlement of any claims that a
Third Party may be infringing such Patents, subject, in the case of the Tulane
Patent, to any consent rights of Tulane under the Tulane License; PROVIDED,
HOWEVER, that if Licensor is controlling such settlement, no settlement shall be
entered into without the prior written consent of Licensee. Licensor shall use
its Commercially Reasonable Efforts to obtain any consents to such settlement
required by Tulane under the Tulane License.
9.3.3 ANDA ACT. Notwithstanding the foregoing, either Party shall,
within three (3) Business Days, advise the other party of receipt of any notice
of (a) any certification filed under the U.S. "Drug Price Competition and Patent
Term Restoration Act" of 1984 (21 United States Code Section 355(b)(2)(A)(iv) or
(j)(2)(A)(vii)(IV)) ("ANDA ACT") claiming that any Licensed Patents or Joint
Patents are invalid or unenforceable or claiming that any Licensed Patent or
Joint Patent will not be infringed by the manufacture, use, marketing, sale or
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importation of a product for which an application under the ANDA ACT is filed,
or (b) any equivalent or similar certification or notice in any other
jurisdiction. The Parties' rights and obligations with respect to any legal
action as a result of such certification shall be as set forth in
Sections 9.3.1, 9.3.2 and 9.3.4, PROVIDED, HOWEVER, that within thirty (30) days
of such notice the enforcing Party shall notify the other Party as to whether or
not it elects to prosecute such infringement.
9.3.4 EXPENSES AND RECOVERY. With respect to all reasonable costs
and expenses of either Party incurred in connection with Licensee's pursuing any
action under Section 9.3.1 (including any costs or expenses incurred that exceed
the amounts recovered by such Party pursuant to this Section 9.3.4 and all
judgment amounts against or agreed to be paid by Licensee pursuant to such
action), as between the Parties, Licensee shall bear [REDACTED] [Exclusion of
confidential information relating to cost-sharing] of such costs and expenses
and Licensor shall bear [REDACTED] [Exclusion of confidential information
relating to cost-sharing] of such costs and expenses. Any such amount due to
Licensee may, at the election of Licensee, be deducted from the royalties due to
Licensor hereunder, which deduction may be made without regard to any Royalty
Floor (although, for clarity, such royalties as calculated pursuant to
Section 8.2 prior to taking such deduction shall remain subject to the
applicable Royalty Floor), until such amount has been fully offset, at which
point it shall be considered paid in full. As between the Parties, any amounts
recovered by either Party pursuant to Section 9.3.1 or Section 9.3.2, whether by
settlement or judgment, shall be in accordance with the following:
(a) Such amounts first shall be used to reimburse the
Parties for their reasonable costs and expenses in making such recovery,
including any unreimbursed legal expenses of Tulane for which Licensor is
obligated to reimburse Tulane pursuant to Section 14.6 of the Tulane License,
which amounts shall be allocated in a manner consistent with the expense
allocation set forth in this Section 9.3 if insufficient to cover the totality
of such expenses.
(b) Any remaining recovery (after application of the
foregoing clause (a) in the case of Licensee as the enforcing Party) shall be
retained by or paid to Licensee; PROVIDED, HOWEVER, that, such amounts shall be
deemed Net Sales for which Licensor shall be paid royalties in accordance with
Section 8.2. Such amounts shall be deemed Net Sales in the Calendar Year(s) in
which the sales of the infringing product occurred (and the applicable royalty
tiers provided in Section 8.2.1 and royalty rate reductions under Section 8.2.2,
if any, shall apply). For purposes of this Section 9.3.4, except as set forth in
clause (a), recoveries that Licensor is required to share with Tulane pursuant
to the Tulane License shall not constitute expenses of Licensor for purposes of
this Section 9.3.4, and this Section 9.3.4 shall apply prior to taking into
account Licensor's sharing obligation to Tulane under the Tulane License.
For the avoidance of doubt, this Section 9.3.4 shall not apply in the event
Licensor exercises its second right to enforce any Licensed Patent or Joint
Patent pursuant to Section 9.3.1, in which case any recoveries shall be retained
solely by Licensor.
9.3.5 LICENSEE PATENTS. With respect to any Licensee Patents, as
between the Parties, Licensee shall have and retain the sole right, but shall
not be obligated, through counsel of its own choosing, to take any measure it
deems as appropriate to stop infringing activities by Third Parties in the
Territory or to grant the infringing Third Party rights and licenses for
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continuing activities in the Territory. Any such measures or grants shall, as
between the Parties, be made at Licensee's sole cost and expense, and Licensee
shall be entitled to retain any and all recoveries in connection therewith.
Licensor shall provide all reasonable assistance to Licensee in connection
therewith at Licensee's expense.
9.4 INFRINGEMENT CLAIMS BY THIRD PARTIES.
9.4.1 DEFENSE OF THIRD PARTY CLAIMS. Except as otherwise provided
in the Trademark Agreement, if a Third Party asserts that a Patent or other
intellectual property right owned or controlled by it is infringed by the
Exploitation of the Licensed Products in the Field in the Territory, the Party
first obtaining knowledge of such a claim shall immediately provide the other
Party notice of such claim along with the related facts in reasonable detail.
Licensee (or its Sublicensees or any of their respective Affiliates) shall
control such defense with respect to Licensed Products in the Field in the
Territory. Licensor shall cooperate with Licensee in any such defense.
9.4.2 SETTLEMENT OF THIRD PARTY CLAIMS. Licensee shall have the
right, without the consent of Licensor, to settle any claims relating solely to
the payment of money damages if Licensee (or its Affiliates or Sublicensees)
bears all such money damages. Licensee also shall have the right to control
other settlement of claims pursuant to Section 9.4.1; PROVIDED, HOWEVER, that
(a) no settlement shall be entered into without the prior written consent of
Licensor if such settlement would adversely affect or diminish the rights and
benefits of Licensor under this Agreement, or impose any new obligations or
adversely affect any obligations of Licensor under this Agreement, and (b)
Licensee shall not be entitled to settle any such Third Party claim by granting
a license or covenant not to ▇▇▇ under or with respect to Licensor's Patents or
other intellectual property rights without the prior written consent of
Licensor, not to be unreasonably withheld or delayed; provided Licensee may
grant any sublicenses pursuant to Section 2.5 in accordance therewith.
9.4.3 ALLOCATION OF COSTS AND RECOVERY. With respect to all
reasonable costs and expenses relating to any defense, settlement and judgments
in actions commenced pursuant to this Section 9.4 (x) with respect to the
Existing Licensed Product for BPH (or the Exploitation thereof), Licensor shall
bear [REDACTED] [Exclusion of confidential information relating to cost-sharing]
of such costs and expenses and Licensee shall bear [REDACTED] [Exclusion of
confidential information relating to cost-sharing] of such costs and expenses
and (y) with respect to any Licensed Product other than the Existing Licensed
Product or the Existing Licensed Product for any indication other than BPH (or
the Exploitation of either of the foregoing), the Parties shall bear such costs
and expenses equally. As between the Parties, any damages or other amounts
collected shall be allocated as follows:
(a) Such amounts first shall be used to reimburse the
Parties for their reasonable costs and expenses in making such recovery and, if
insufficient to cover the totality of such costs and expenses, shall be
allocated in a manner consistent with the foregoing expense sharing principle.
(b) Any remainder shall be retained by or paid to Licensee;
PROVIDED, HOWEVER, that such amounts shall be deemed Net Sales for which
Licensor shall retain or be paid
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royalties in accordance with Section 8.2.
9.5 INVALIDITY OR UNENFORCEABILITY DEFENSES OR ACTIONS.
9.5.1 THIRD PARTY DEFENSE OR COUNTERCLAIM. If a Third Party
asserts, as a defense or as a counterclaim in any infringement action under
Section 9.3, that any Licensed Patent or Joint Patent is invalid or
unenforceable, then the Party pursuing such infringement action shall promptly
give written notice to the other Party. Subject to any rights of Tulane under
the Tulane License, with respect to the Licensed Patents and Joint Patents,
Licensee shall have the first right, but not the obligation, through counsel of
its choosing, to respond to such defense or defend against such counterclaim (as
applicable) and, if Licensor is pursuing the applicable infringement action
under Section 9.3, Licensor shall allow Licensee to control such response or
defense (as applicable). Any costs and expenses with respect to such response or
defense against such counterclaim shall be borne by the Parties in accordance
with the principles set forth in Section 9.3, as though Licensee were the
enforcing Party thereunder. If Licensee determines not to assume such defense,
Licensor shall, at its sole cost and expense, have the right to defend against
such action or claim. The Party conducting such response or defense shall obtain
the written consent of Licensor, with respect to the Tulane Patent and Joint
Patents, or Licensee, with respect to the Licensed Patents or Joint Patents,
prior to ceasing to defend, settling or otherwise compromising any such action
or claim, such consent not to be unreasonably withheld or delayed. Any amounts
recovered by either Party in connection with a response or defense pursuant to
this Section 9.5.1 shall be allocated between the Parties in accordance with
Section 9.3, as though the defending Party were the enforcing Party thereunder.
9.5.2 THIRD PARTY DECLARATORY JUDGMENT OR SIMILAR ACTION. If a
Third Party asserts, in a declaratory judgment action or similar action or claim
filed by such Third Party, that any Licensed Patent or Joint Patent is invalid
or unenforceable, then the Party first becoming aware of such action or claim
shall promptly give written notice to the other Party. Subject to any rights of
Tulane under the Tulane License, with respect to the Licensed Patents and Joint
Patents, Licensee (or its Sublicensees or any of its or their respective
Affiliates) shall have the first right, but not the obligation, through counsel
of its choosing, to defend against such action or claim. Any costs and expenses
with respect to such defense shall be borne by the Parties in accordance with
the principles set forth in Section 9.4, as though Licensee were the defending
Party thereunder. If Licensee determines not to assume such defense, Licensor
shall, at its sole cost and expense, have the right to defend against such
action or claim. The Party defending such action or claim shall obtain the
written consent of Licensor, with respect to the Tulane Patent and Joint
Patents, or Licensee, with respect to the Licensed Patents and Joint Patents,
prior to ceasing to defend, settling or otherwise compromising any such action
or claim, such consent not to be unreasonably withheld or delayed. Any amounts
recovered by either Party in connection with a defense pursuant to this
Section 9.5.2 shall be allocated between the Parties in accordance with
Section 9.4, as though the defending Party in this Section 9.5.2 were the
defending Party thereunder.
9.5.3 ASSISTANCE. Each Party shall provide to the other Party all
reasonable assistance requested by the other Party in connection with any
action, claim or suit under this Section 9.5, at the requesting Party's expense
(for reasonable costs and expenses), including allowing such other Party access
to the assisting Party's files and documents and to the assisting
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Party's personnel who may have possession of relevant information. In
particular, the assisting Party shall promptly make available to the other
Party, free of charge, all information in its possession or control that it is
aware shall assist the other Party in responding to any such action, claim or
suit.
9.5.4 THIRD PARTY LICENSES.
(a) GENERALLY. If the Exploitation of the Licensed Products
by Licensee, its Sublicensees or any of its or their respective Affiliates
infringes or misappropriates any Patent or other intellectual property right of
a Third Party, such that Licensee, its Sublicensees or any of its or their
respective Affiliates determines in good faith that they cannot Exploit the
Licensed Products in the Field in the Territory without infringing the Patent or
intellectual property right of such Third Party ("NECESSARY IP"), then Licensee
(or its Sublicensees or any of its or their respective Affiliates) shall have
the first right, but not the obligation, to obtain a license in the Field in the
Territory from such Third Party. In the event that Licensee or its Affiliates
elects not to obtain such a license, then Licensor may do so, in which case such
Patent or other intellectual property right of such Third Party shall be
included in the licenses granted to Licensee in Section 2.1.
(b) ALLOCATION OF COSTS.
(i) In the event that Licensee exercises its first
right to obtain a license from a Third Party as described in Section 9.5.4(a)
and such license is required to Exploit the Existing Licensed Product for BPH,
then, without limiting Licensee's right to make applicable reductions pursuant
to Section 8.2.2(a) or 8.2.2(b) (and after application of such reductions), the
amount of Licensee's royalty payment to Licensor under Section 8.2.1 of this
Agreement shall be reduced, subject to Section 8.2.2(c), by an amount equal to
[REDACTED] [Exclusion of confidential information relating to cost-sharing] of
the license fees, milestones, royalties or other such payments due to such Third
Party in each Calendar Quarter that such payments are due to such Third Party.
In the event that Licensee exercises its first right to obtain a license from a
Third Party as described in Section 9.5.4(a) and such license is required to
Exploit (A) any Licensed Product other than the Existing Licensed Product or (B)
the Existing Licensed Product for any indication other than BPH, but not, in
each case ((A) and (B)), the Exploitation of the Existing Licensed Product for
BPH, then, without limiting Licensee's right to make applicable reductions
pursuant to Section 8.2.2(a) or 8.2.2(b) (and after application of such
reductions), the amount of Licensee's royalty payment to Licensor under
Section 8.2.1 of this Agreement shall be reduced, subject to Section 8.2.2(c),
by an amount equal to [REDACTED] [Exclusion of confidential information relating
to cost-sharing] of the license fees, milestones, royalties or other such
payments due to such Third Party in each Calendar Quarter that such payments are
due to such Third Party. Deductions to which Licensee is entitled under this
Section 9.5.4(b), to the extent not exhausted in any Calendar Quarter, may be
carried into future Calendar Quarters until the full deduction is taken.
(ii) In the event that Licensor exercises its second
right to obtain a license from a Third Party as described in Section 9.5.4(a)
and such license is required to Exploit the Existing Licensed Product for BPH,
Licensee shall reimburse Licensor for [REDACTED] [Exclusion of confidential
information relating to cost-sharing] of the license
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fees, milestones, royalties or other such payments attributable to the
Exploitation of Licensed Products in the Field in the Territory due to such
Third Party. In the event that Licensor exercises its second right to obtain a
license from a Third Party as described in Section 9.5.4(a) and such license is
required to Exploit (i) any Licensed Product other than the Existing Licensed
Product or (ii) the Existing Licensed Product for any indication other than BPH,
but not, in each case ((i) and (ii)), the Exploitation of the Existing Licensed
Product for BPH, Licensee shall reimburse Licensor for [REDACTED] [Exclusion of
confidential information relating to cost-sharing] of the license fees,
milestones, royalties or other such payments attributable to the Exploitation of
Licensed Products in the Field in the Territory due to such Third Party.
Licensee shall pay any such reimbursements within thirty (30) days after receipt
by Licensee of an invoice for such amounts and appropriate supporting
documentation with respect to such invoice.
(c) FAILURE TO OBTAIN NECESSARY THIRD PARTY LICENSE. In the
event that neither Party obtains a license to Necessary IP for Exploitation of
the applicable Licensed Product in the Field in the Territory from the
applicable Third Party as described in Section 9.5.4(a), then upon thirty (30)
days' prior written notice to Licensor, Licensee shall have the right to
terminate this Agreement with respect to such Licensed Product (the "TERMINATED
LICENSED PRODUCT"), and the consequences in Section 14.7.1 shall apply, provided
that such consequences shall apply solely with respect to the Terminated
Licensed Product and Licensee may retain ownership of any NDA that covers any
other Licensed Product and may retain possession of any data, files and other
materials Controlled by Licensee, its Sublicensees or its or their respective
Affiliates relating to any other Licensed Product. In the event that Licensee
terminates this Agreement with respect to a Terminated Licensed Product pursuant
to this Section 9.5.4(c), then for a period of two (2) years from the effective
date of such termination, Licensor shall not, and shall cause its Affiliates not
to, enter into a license agreement with the applicable Third Party for the
Necessary IP in the Field in the Territory that was the cause of such
termination that contains terms and conditions that, taking into account the
termination of this Agreement with respect to such Terminated Licensed Product
and all other relevant factors, costs and expenses, are materially less
favorable to Licensor than the terms of the license from such Third Party that
Licensor could have entered into prior to the termination of this Agreement with
respect to such Terminated Licensed Product.
ARTICLE 10
ADVERSE EVENT REPORTING; RECALL
10.1 ADVERSE EVENT REPORTING. Licensee shall be responsible for reporting
Adverse Events in the Field in the Territory to the FDA pursuant to Applicable
Law and shall provide a copy of any such expedited reports to Licensor within
five (5) days of Licensee's becoming aware of any Adverse Event requiring filing
of any such report. Licensor shall be responsible for reporting Adverse Events
outside the Field in the Territory and outside the Territory to the applicable
Regulatory Authorities pursuant to Applicable Law and shall provide a copy of
any such expedited reports to Licensee within five (5) days of Licensor's
becoming aware of any Adverse Event requiring filing of any such report. Without
limitation of Section 5.6, each Party shall provide each other with copies of
any aggregate periodic reports or safety related submissions, in each case, with
respect to Licensed Products, to Regulatory Authorities at the time of
submission thereof to such Regulatory Authorities. Licensor shall provide
Licensee with all information in its possession from preclinical and animal
toxicology studies necessary for
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Licensee to comply with its pharmacovigilance responsibilities in the Territory.
Each Party shall bear its own costs incurred in connection with receiving,
recording, reviewing, communicating, reporting and responding to Adverse Events.
An "ADVERSE EVENT" or "AE" shall mean any untoward medical occurrence in a
patient who has been administered a Licensed Product, where the untoward medical
occurrence is temporally associated with the use of such Licensed Product,
whether or not considered related to such Licensed Product. An AE includes any
unfavorable and unintended sign (including an abnormal laboratory finding),
symptom or disease (new or exacerbated) temporally associated with the use of a
Licensed Product. For a marketed Licensed Product, an Adverse Event also
includes (a) any failure to produce expected benefits (i.e. lack of efficacy),
and (b) any Adverse Event associated with circumstances of abuse or misuse.
10.2 PHARMACOVIGILANCE. Within three (3) months of the Execution Date,
Licensor and Licensee shall discuss and develop mutually acceptable guidelines
and procedures for the investigation, exchange, receipt, recordation,
communication (as between the Parties) and exchange of Adverse Event information
and all other information regarding matters covered in this ARTICLE 10. Until
such guidelines and procedures are set forth in a written agreement between the
Parties (the "PHARMACOVIGILANCE AGREEMENT"), the terms of Section 10.1 shall
apply. Following the execution of the Pharmacovigilance Agreement, such Section
shall cease to apply unless expressly agreed otherwise by the Parties in such
agreement or otherwise in writing.
10.3 RECALL. In the event that any Regulatory Authority anywhere in the
world issues or requests a recall or takes similar action in connection with a
Licensed Product or in the event either Party determines that an event, incident
or circumstance has occurred that may result in the need for a recall or market
withdrawal, the Party notified of or desiring such recall or similar action
shall, within twenty-four (24) hours, advise the other Party thereof by
telephone (and confirmed by email or facsimile), email or facsimile to (a)
Contact: ▇▇. ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇ ▇▇▇▇,
Telephone: ▇▇▇ ▇▇ ▇▇▇▇▇ ▇▇▇▇, Fax ▇▇▇ ▇▇ ▇▇▇▇▇ ▇▇▇▇, e-mail:
▇▇▇▇▇▇▇▇@▇▇▇▇▇▇▇.▇▇▇, in the case of Licensor and (b) ▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇-▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇, Telephone: (908)
▇▇▇-▇▇▇▇, Fax: (▇▇▇) ▇▇▇-▇▇▇▇, e-mail: ▇▇▇▇.▇▇▇▇▇▇▇▇▇@▇▇▇▇▇▇-▇▇▇▇▇▇▇.▇▇▇, in the
case of Licensee; PROVIDED, HOWEVER, that neither Party shall be required to
report to the other Party any voluntary recalls initiated by such Party relating
to product defects that arose during shipment. Following such notification, the
JCC shall meet to discuss such notification and, except as set forth in any
Commercial Supply Agreement, Licensee shall decide whether to conduct a recall
(except in the case of a government-mandated recall in the Field in the
Territory) and the manner in which any such recall shall be conducted. Licensee
shall bear the expenses of any recall of any Licensed Product in the Field in
the Territory, except that Licensor shall bear such expenses if such recall is
due to the supply by Licensor of non-conforming Licensed Product.
ARTICLE 11
CONFIDENTIALITY AND NON-DISCLOSURE
11.1 LICENSED KNOW-HOW. Licensor recognizes that by reason of Licensee's
status as a licensee pursuant to certain grants under ARTICLE 2, Licensee has an
interest in Licensor's retention in confidence of the Licensed Know-How.
Accordingly, Licensor shall, and shall cause its Affiliates and their respective
officers, directors, employees and agents to, keep
- 49 -
completely confidential, and not publish or otherwise disclose, and not use
directly or indirectly for any purpose the Licensed Know-How; except to the
extent (a) the Licensed Know-How is in the public domain through no wrongful
act, fault or negligence on the part of Licensor, its Affiliates or any of their
respective officers, directors, employees and agents, or (b) such disclosure or
use is expressly permitted under Section 11.3 or the other terms of this
Agreement.
11.2 GENERAL CONFIDENTIALITY OBLIGATIONS. At all times during the Term
and for a period of ten (10) years following termination or expiration hereof,
subject to the other terms and conditions of this Agreement, each Party shall,
and shall cause its Affiliates and its and their respective officers, directors,
employees and agents to, keep completely confidential and not publish or
otherwise disclose and not use, directly or indirectly, for any purpose, any
Confidential Information furnished or otherwise made known to it, directly or
indirectly, by the other Party, except to the extent such disclosure or use is
expressly permitted by the terms of this Agreement, the Trademark License
Agreement, any Clinical Supply Agreement, any Commercial Supply Agreement or the
Pharmacovigilance Agreement (such agreements, other than this Agreement, the
"RELATED AGREEMENTS") or is reasonably necessary for the performance of this
Agreement or any of the Related Agreements. "CONFIDENTIAL INFORMATION" means any
information provided by one Party or any of its Affiliates to the other Party or
any of its Affiliates relating to or constituting the terms of this Agreement or
any Related Agreement, the Licensed Products (including the Regulatory
Documentation and Regulatory Approvals and any information or data contained
therein), any Development or Commercialization of the Licensed Products or the
scientific, regulatory or business affairs or other activities of either Party
or its Affiliates. Notwithstanding the foregoing, Confidential Information shall
not include any information that:
11.2.1 is or hereafter becomes part of the public domain by public
use, publication, general knowledge or the like through no wrongful act, fault
or negligence on the part of or breach of this Agreement or any Related
Agreement by the receiving Party or its Affiliates or any of their respective
officers, directors, employees and agents;
11.2.2 can be demonstrated by documentation or other competent proof
to have been in the receiving Party's (or its Affiliates') possession prior to
disclosure by the disclosing Party without any obligation of confidentiality
with respect to said information;
11.2.3 is subsequently received by the receiving Party (or any of
its Affiliates) from a Third Party who is not bound by any obligation of
confidentiality with respect to said information; or
11.2.4 can be demonstrated by documentation or other competent
evidence to have been independently developed by or for the receiving Party or
its Affiliates without reference to the disclosing Party's Confidential
Information.
Specific aspects or details of Confidential Information or Licensed Know-How
shall not be deemed to be within the public domain or in the possession of the
receiving Party (or in the case of Licensed Know-How, Licensor) or its
Affiliates merely because the Confidential Information or Licensed Know-How is
embraced by more general information in the public domain or in the possession
of the receiving Party (or in the case of Licensed Know-How, Licensor) or its
- 50 -
Affiliates. Further, any combination of Confidential Information or Licensed
Know-How shall not be considered in the public domain or in the possession of
the receiving Party (or in the case of Licensed Know-How, Licensor) or its
Affiliates merely because individual elements of such Confidential Information
or Licensed Know-How are in the public domain or in the possession of the
receiving Party (or in the case of Licensed Know-How, Licensor) or its
Affiliates unless the combination and its principles are in the public domain or
in the possession of the receiving Party (or in the case of Licensed Know-How,
Licensor) or its Affiliates.
11.3 PERMITTED DISCLOSURES. Each Party (and its Affiliates) may disclose
Confidential Information of the other Party, and Licensor may disclose the
Licensed Know-How (each such Party, the "OBLIGATED PARTY"), to the extent that
such disclosure is:
11.3.1 Made in response to a valid order of a court of competent
jurisdiction or other supra-national, federal, national, regional, state,
provincial and local governmental or regulatory body of competent jurisdiction
or, if in the reasonable opinion of the Obligated Party's legal counsel, such
disclosure is otherwise required by law; PROVIDED, HOWEVER, that the Obligated
Party shall first have given notice to the other Party and given the other Party
a reasonable opportunity to quash such order and to obtain a protective order
requiring that the Confidential Information (or Licensed Know-How) and documents
that are the subject of such order be held in confidence by such court or agency
or, if disclosed, be used only for the purposes for which the order was issued;
and provided further that if a disclosure order is not quashed or a protective
order is not obtained, the Confidential Information (or Licensed Know-How)
disclosed in response to such court or governmental order shall be limited to
that information which is legally required to be disclosed in response to such
court or governmental order;
11.3.2 Made by the Obligated Party or its Affiliates to the
Regulatory Authorities as required in connection with any filing, application or
request for Regulatory Approvals; PROVIDED, HOWEVER, that reasonable measures
shall be taken to assure confidential treatment of such information;
11.3.3 Made by the Obligated Party or its Affiliates to its or their
attorneys, auditors, advisors, consultants, contractors, existing or prospective
collaboration partners or licensees or other Third Parties as may be necessary
or useful in connection with the Exploitation of the Licensed Products or
otherwise in connection with the performance of its obligations or exercise of
its rights as contemplated by this Agreement; PROVIDED, HOWEVER, that such
Persons shall be subject to obligations of confidentiality and non-use with
respect to such Confidential Information (or Licensed Know-How) substantially
similar to the obligations of confidentiality and non-use of the receiving Party
pursuant to this ARTICLE 11; or
11.3.4 Made by Licensor to Tulane in order to satisfy its
obligations under the Tulane License; PROVIDED, HOWEVER, that (a) Tulane shall
be subject to obligations of confidentiality and non-use with respect to such
Confidential Information (or Licensed Know-How) as set forth in the Tulane
License, (b) Licensor designates such Confidential Information (or Licensed
Know-How) as confidential, and (c) Licensor shall not consent to disclosure of
such Confidential Information (or Licensed Know-How) by Tulane unless Licensee
provides its prior written consent to do so.
- 51 -
11.4 USE OF NAME. Except as expressly set forth in Section 2.1.4 or
elsewhere in this Agreement or a separate written agreement between the Parties,
neither Party nor any of its Affiliates shall mention or otherwise use the name,
insignia, symbol, Trademark, trade name or logotype of the other Party (or any
abbreviation or adaptation thereof) in any publication, press release, marketing
and promotional material or other form of publicity without the prior written
approval of such other Party in each instance. The restrictions imposed by this
Section 11.4 shall not prohibit either Party or its Affiliates from making any
disclosure identifying the other Party or its Affiliates (a) as a counterparty
to this Agreement to its investors (b) that is required by Applicable Law or the
requirements of a national securities exchange or another similar regulatory
body (provided that any such disclosure shall be governed by this ARTICLE 11) or
(c) with respect to which consent has previously been obtained. Further, the
restrictions imposed on each Party under this Section 11.4 are not intended, and
shall not be construed, to prohibit a Party from identifying the other Party in
its internal business communications, provided that any Confidential Information
in such communications remains subject to this ARTICLE 11.
11.5 PRESS RELEASES AND PUBLIC FILINGS.
11.5.1 PRESS RELEASES. Press releases or other similar public
communication by either Party relating to the terms of this Agreement or any
Related Agreement or by Licensor with respect to the activities hereunder or
thereunder shall be approved in advance by the other Party, which approval shall
not be unreasonably withheld or delayed, except for those communications
required by Applicable Law, disclosures of information for which consent has
previously been obtained, information that has been previously disclosed
publicly or as otherwise set forth in this Agreement; provided that the other
Party is given a reasonable opportunity to review and comment on any such press
release or public communication in advance thereof.
11.5.2 PUBLIC FILING OF THIS AGREEMENT. If either Party is required
to file or disclose this Agreement or any portion thereof with the Toronto Stock
Exchange, the United States Securities and Exchange Commission or any other
securities exchange or governmental entity, such Party shall notify the other
Party in writing and shall provide the other Party with at least seven (7)
Business Days to request redactions thereof prior to making such filing or
disclosure. The disclosing Party shall seek confidential treatment of any such
proposed redactions timely made, to the extent consistent with law, and use
reasonable efforts to procure confidential treatment of such proposed redactions
pursuant to the Securities Act of 1933 or the Securities Exchange Act of 1934,
in each case as amended, and the rules, regulations and guidelines promulgated
thereunder, or any other applicable law or the rules, regulations or guidelines
promulgated thereunder.
11.6 PATIENT INFORMATION. The Parties agree to abide (and to cause their
respective Affiliates to abide) and to take (and to cause their respective
Affiliates to take) all reasonable and appropriate actions to ensure that all
Third Parties conducting or assisting with any clinical development activities
hereunder in accordance with, and subject to the terms of, this Agreement, shall
abide, to the extent applicable, by all Applicable Law concerning the
confidentiality or protection of patient identifiable information or patient's
protected health information, including the regulations at 45 C.F.R. Parts 160
and 164 and, where relevant, the applicable national laws implementing the
European Union Directive 95/46/EC on the protection
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of individuals with regard to the processing of personal data and on the free
movement of such data of 24 October 1995 and any other Applicable Law, in the
course of their performance under this Agreement.
11.7 PUBLICATIONS. Each Party recognizes that the publication of papers
regarding results of and other information regarding activities under this
Agreement, including oral presentations and abstracts, may be beneficial to both
Parties; provided such publications are subject to reasonable controls to
protect Confidential Information. In particular, it is the intent of the Parties
to maintain the confidentiality of any Confidential Information included in any
patent application until such Patent application has been filed. Accordingly,
(a) Licensee shall have the right to review and approve, and (b) Licensor shall
have the right to review and comment on, any paper proposed for publication by
the other Party or any of its Affiliates, including any oral presentation or
abstract, that contains Clinical Data or pertains to results of Clinical
Studies, Phase IIIB Clinical Studies, Phase IV Clinical Studies, Post-Approval
Commitments or other studies with respect to the Licensed Products for use in
the Field or includes other data generated under this Agreement or which
includes Confidential Information of such first Party. Before any such paper is
submitted for publication or an oral presentation is made, the publishing or
presenting Party (or its applicable Affiliate) shall deliver a complete copy of
the paper or materials for oral presentation to the other Party at least thirty
(30) days prior to submitting the paper to a publisher or making the
presentation. The other Party shall review any such paper and give its comments,
if any, (and, in the case of Licensee as the reviewing Party, notify Licensor
whether or not it is granting its approval) to the publishing Party within
fifteen (15) days of the delivery of such paper to the other Party. With respect
to oral presentation materials and abstracts, the other Party shall make
reasonable efforts to expedite review of such materials and abstracts, and shall
return such items as soon as practicable to the publishing or presenting Party
with appropriate comments, if any, but in no event later than fifteen (15) days
from the date of delivery to the other Party. In the case of Licensee as the
reviewing Party, failure to respond within such fifteen (15) days shall be
deemed approval to publish or present. The publishing or presenting Party (or
its applicable Affiliate) shall consider the comments of the other Party in good
faith and shall comply with the other Party's request to delete references to
such other Party's Confidential Information in any such paper and shall withhold
publication of any such paper or any presentation of same for an additional
sixty (60) days in order to permit the Parties to obtain patent protection if
either Party deems it necessary. Any publication shall include recognition of
the contributions of the other Party according to standard practice for
assigning scientific credit, either through authorship or acknowledgement, as
may be appropriate. Each Party shall use Commercially Reasonable Efforts to
cause investigators and institutions participating in Clinical Studies, Phase
IIIB Clinical Studies, Phase IV Clinical Studies or Post-Approval Commitments
for the Licensed Products with which it contracts to agree to terms
substantially similar to those set forth in this Section 11.7, which efforts
shall satisfy such Party's obligations under this Section 11.7 with respect to
such investigators and institutions.
ARTICLE 12
REPRESENTATIONS, WARRANTIES AND COVENANTS
12.1 REPRESENTATIONS, WARRANTIES AND COVENANTS. Each Party hereby
represents and warrants to the other Party as of the Execution Date as follows:
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12.1.1 Such Party (a) has the power and authority and the legal
right to enter into this Agreement and perform its obligations hereunder and (b)
has taken all necessary action on its part required to authorize the execution
and delivery of this Agreement and the performance of its obligations hereunder.
This Agreement has been duly executed and delivered by such Party and
constitutes a legal, valid and binding obligation of such Party and is
enforceable against it in accordance with its terms subject to the effects of
bankruptcy, insolvency or other laws of general application affecting the
enforcement of creditor rights and judicial principles affecting the
availability of specific performance and general principles of equity, whether
enforceability is considered in a proceeding at law or equity.
12.1.2 There is no pending or, to such Party's knowledge, threatened
litigation (and such Party has not received any communication) that alleges that
such Party's activities related to this Agreement have violated or that by
conducting the activities as contemplated herein such Party would violate, any
of the Patent, Trademark or other intellectual property rights of any other
Person.
12.1.3 All necessary consents, approvals and authorizations of all
regulatory and governmental authorities and other Persons required to be
obtained by such Party in connection with the execution and delivery of this
Agreement and the performance of its obligations hereunder have been obtained.
12.1.4 The execution and delivery of this Agreement and the
performance of such Party's obligations hereunder (a) do not conflict with or
violate any requirement of Applicable Law or any provision of the articles of
incorporation, bylaws or other similar organizational documents of such Party in
any material way and (b) do not conflict with, violate or breach or constitute a
default or require any consent under, any contractual obligation or court or
administrative order by which such Party or any of its Affiliates is bound or
any agreement, instrument or similar document by or under which such Party's or
any of its Affiliates' assets or properties may be bound or affected.
12.2 ADDITIONAL REPRESENTATIONS, WARRANTIES AND COVENANTS OF LICENSEE.
Licensee represents, warrants and covenants as of the Execution Date to Licensor
that:
12.2.1 Licensee (a) is a limited liability company duly organized
and in good standing under the laws of Delaware and (b) has full power and
authority and the legal right to own and operate its property and assets and to
carry on its business as it is now being conducted and as it is contemplated to
be conducted by this Agreement.
12.2.2 Neither Licensee nor any of its Affiliates has been debarred
or is subject to debarment, and neither Licensee nor any of its Affiliates will
use in any capacity, in connection with the services to be performed under this
Agreement, any Person who has been debarred pursuant to Section 306 of the FFDCA
or who is the subject of a conviction described in such section. Licensee shall
inform Licensor in writing immediately if it or any Person who is performing
services hereunder is debarred or is the subject of a conviction described in
Section 306 of the FFDCA or if any action, suit, claim, investigation or legal
or administrative proceeding is pending or, to the best of Licensee's knowledge,
is threatened, relating to the debarment or conviction of Licensee or any Person
performing services hereunder.
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12.3 ADDITIONAL REPRESENTATIONS, WARRANTIES AND COVENANTS OF LICENSOR.
Licensor represents, warrants and covenants as of the Execution Date to Licensee
that:
12.3.1 Licensor is a limited liability company (GESELLSCHAFT MIT
BESCHRANKTER HAFTUNG) duly organized under the laws of Germany and has full
power and authority and the legal right to own and operate its property and
assets and to carry on its business as it is now being conducted and as is
contemplated to be conducted by this Agreement.
12.3.2 Licensor has made available to Licensee all the information,
documents and materials reasonably available to Licensor that (a) Licensee has
requested for deciding whether to enter into this Agreement or (b) that, to the
Knowledge of Licensor, are material, individually or in the aggregate, to the
rights granted to Licensee under this Agreement.
12.3.3 Neither Licensor nor any of its Affiliates has been debarred
or is subject to debarment, and neither Licensor nor any of its Affiliates will
use in any capacity, in connection with the services to be performed under this
Agreement, any Person who has been debarred pursuant to Section 306 of the FFDCA
or who is the subject of a conviction described in such section. Licensor shall
inform Licensee in writing immediately if it or any Person who is performing
services hereunder is debarred or is the subject of a conviction described in
Section 306 of the FFDCA or if any action, suit, claim, investigation or legal
or administrative proceeding is pending or, to the best of Licensor's knowledge,
is threatened, relating to the debarment or conviction of Licensee or any Person
performing services hereunder.
12.3.4 Except with respect to the Tulane Patent and the Licensed
Know-How licensed from Tulane, Licensor is the sole and exclusive owner of the
entire right, title and interest in the Licensed Patents listed on SCHEDULE 1.78
and the Licensed Know-How, and is entitled to grant the rights and licenses
specified herein. Except as set forth in the Tulane License and as provided in
SCHEDULE 12.3, such rights in the Field in the Territory (and such rights with
respect to the Manufacture of Licensed Products for sale or distribution in the
Field in the Territory) are not subject to any liens, claims of ownership,
mortgages, encumbrances, pledges, security interests or charges of any nature
whatsoever by any Third Party. Licensor is the sole and exclusive licensee of
and Controls all right title and interest in and to the Tulane Patent and is
entitled to grant the rights and licenses specified herein. Except as set forth
in the Tulane License and as provided in SCHEDULE 12.3, such rights in the Field
in the Territory (and such rights with respect to the Manufacture of Licensed
Products for sale or distribution in the Field in the Territory) are not subject
to any encumbrance, lien or claim of ownership by any Third Party. True,
complete and correct copies of the complete file wrapper and other documents and
materials relating to the prosecution, defense, maintenance, validity and
enforceability of the Licensed Patents and all license and other agreements
regarding the Tulane Patent, including, for clarity, the Letter Agreement (such
licenses and other agreements, collectively, the "IN-LICENSE AGREEMENTS"), as
amended to the date hereof, have been provided to Licensee prior to the date
first above written. The Patents listed on SCHEDULE 1.78 constitute all of the
Licensed Patents as of the Execution Date. During the Term, Licensor shall not
encumber or diminish the rights granted to Licensee hereunder with respect to
the Licensed Patents, including by not (a) committing any acts or permitting the
occurrence of any omissions that would cause a breach that would be grounds for
termination if not cured or termination of any In-License Agreement (including
by declining to defend or settle any third party claims or
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actions outside the Field or outside the Territory as described in Section 15.5
of the Tulane License) or (b) amending or otherwise modifying or permitting to
be amended or modified, any In-License Agreement in a manner that would
adversely effect Licensee's rights hereunder. Licensor shall promptly provide
Licensee with notice of any alleged, threatened or actual breach of any
In-License Agreement that would be grounds for termination if not cured. As of
the Execution Date, none of the Licensor, its Affiliates and, to the Knowledge
of Licensor, any Third Party, is in breach of any In-License Agreement, which
breach would be grounds for termination if not cured. Licensor shall maintain
each Licensed Patent until the earlier of (i) the end of the Term and (ii) the
date on which such Licensed Patent expires.
12.3.5 The Licensed Patents are being diligently procured in the
Territory in accordance with all Applicable Laws and regulations. The Licensed
Patents have been and will continue to be filed and maintained properly and
correctly and all applicable fees have been paid on or before the due date for
payment.
12.3.6 To the Knowledge of Licensor, no Third Party is infringing
any Licensed Patents or has misappropriated any Licensed Know-How or has
threatened to do either of the foregoing.
12.3.7 To the Knowledge of Licensor, the Licensed Patents existing
as of the Execution Date are subsisting and are not invalid or unenforceable, in
whole or in part. To the Knowledge of Licensor, the Exploiting of Licensed
Products by Licensor or Licensee does not and will not infringe any issued
Patent of any Third Party that has not been invalidated by a court of competent
jurisdiction and does not and will not misappropriate any Information of any
Third Party. There are no claims, judgments or settlements against or amounts
with respect thereto owed by Licensor or any of its Affiliates relating to the
Licensed Patents or the Licensed Know-How. No claim or litigation has been
brought or threatened by any Person alleging, and, to the Knowledge of Licensor,
no Third Party intends to assert any claim that (a) the Licensed Patents are
invalid or unenforceable or (b) the practice of the Licensed Patents or use of
the Licensed Know-How or the Exploiting of a Licensed Product violates,
infringes or otherwise conflicts or interferes with any intellectual property or
proprietary rights of a Third Party.
12.3.8 Except as set forth in SCHEDULE 12.3, Licensor has not
previously entered into any agreement presently in effect, whether written or
oral, with respect to, or otherwise assigned, transferred, licensed, conveyed or
otherwise encumbered its right, title or interest in or to, the Licensed
Patents, Licensed Know-How, Regulatory Documentation or Licensed Product
(including by granting any covenant not to ▇▇▇ with respect thereto) in the
Field in the Territory (and such rights with respect to the Manufacture of
Licensed Products for sale or distribution in the Field in the Territory), and
it will not enter into any such agreements or grant any such right, title or
interest to any Person that is inconsistent with the rights and licenses granted
to Licensee under this Agreement.
12.3.9 With respect to any pending United States Patent applications
included in the Licensed Patents, Licensor has presented all relevant prior art
of which it and the inventors are aware to the relevant patent examiner at the
United States Patent and Trademark Office.
12.3.10 The Licensed Know-How has been kept confidential or has
been
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disclosed to Third Parties only under terms of confidentiality.
12.3.11 Licensor has made (and will make) available to Licensee
all Regulatory Documentation, Licensed Know-How and other Information in its
possession or Control regarding or related to any Licensed Product and all such
Regulatory Documentation, Licensed Know-How and other Information are (and, if
made available after the Execution Date, will be) true, complete and correct. As
of the Execution Date, Licensor has prepared, maintained and retained all
Regulatory Documentation that is required to be maintained or reported pursuant
to and in accordance with good laboratory and clinical practice and Applicable
Law and all such information is true, complete and correct and what it purports
to be.
12.3.12 Licensor has conducted, and has caused its contractors
and consultants to conduct, all Development with respect to the Licensed
Products that it has conducted prior to the Execution Date, and will conduct,
and will caused its contractors and consultants to conduct, all its Development
activities hereunder, in accordance with good laboratory practice, current GCP
and Applicable Law. Licensor has employed (and, with respect to such tests and
studies that Licensor will perform, will employ) Persons with appropriate
education, knowledge and experience to conduct and to oversee the conduct of all
of the aforesaid Development. To the Knowledge of Licensor, there is nothing
that could adversely affect the acceptance, or the subsequent approval, by the
FDA of any filing, application or request for NDA Approval.
12.3.13 Licensor has obtained and will obtain from each of its
Affiliates, employees and agents, and from the employees and agents of its
Affiliates, who have performed or are performing tests or studies with respect
to the Licensed Products, or have otherwise participated or are otherwise
participating in the Exploitation of the Licensed Products or who have had or
will have access to any Information in which Licensee has an interest in
confidentiality pursuant to ARTICLE 11 or any Confidential Information of
Licensee, rights to any and all Information that relate to the Licensed
Products, such that Licensee shall, by virtue of this Agreement, receive from
Licensor, without payments beyond those required by ARTICLE 8, the licenses and
other rights granted to Licensee hereunder.
12.4 DISCLAIMER OF WARRANTY. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH
IN SECTIONS 12.1, 12.2 AND 12.3, NEITHER PARTY MAKES ANY REPRESENTATIONS OR
GRANTS ANY WARRANTY, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW,
BY STATUTE OR OTHERWISE, AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER
WARRANTIES, WHETHER WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING ANY
WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE
OR ANY WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR THE NON-INFRINGEMENT OF ANY
INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.
ARTICLE 13
INDEMNITY
13.1 INDEMNIFICATION OF LICENSOR. Licensee shall indemnify Licensor, its
Affiliates
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and their respective directors, officers, employees and agents, and defend and
save each of them harmless, from and against any and all losses, damages,
liabilities, costs and expenses (including reasonable attorneys' fees and
expenses) (collectively, "LOSSES") in connection with any and all suits,
investigations, claims or demands of Third Parties (collectively, "THIRD PARTY
CLAIMS") arising from or occurring as a result of: (a) the breach by Licensee of
any term of this Agreement or the Trademark License Agreement; (b) the gross
negligence or willful misconduct on the part of Licensee in performing its
obligations under this Agreement or the Trademark License Agreement and (c) any
claim for death, bodily injury or property damage arising from the Exploitation
of any Licensed Product in the Field in the Territory by or on behalf of
Licensee (and, for clarity, not by or on behalf of Licensor, including by its
contract manufacturers), except in each case for those Losses which Licensor has
an obligation to indemnify Licensee pursuant to Section 13.2 or any Co-Promotion
Agreement, as to which Losses each Party shall indemnify the other to the extent
of their respective liability; PROVIDED, HOWEVER, that Licensee shall not be
obligated to indemnify Licensor for any Losses to the extent that such Losses
arise as a result of gross negligence or willful misconduct on the part of
Licensor or any of its Affiliates.
13.2 INDEMNIFICATION OF LICENSEE. Licensor shall indemnify Licensee, its
Affiliates and their respective directors, officers, employees and agents, and
defend and save each of them harmless, from and against any and all Losses in
connection with any and all Third Party Claims arising from or occurring as a
result of: (a) the breach by Licensor of this Agreement or the Trademark License
Agreement, (b) any claim for death, bodily injury or property damage arising
from the Exploitation of the Licensed Products in the Field in the Territory by
or on behalf of Licensor, including by its contract manufacturers, (c) the
Exploitation by or on behalf of Licensor, including by its contract
manufacturers, its (sub)licensees or any of its or their respective Affiliates
of the Licensed Products outside the Field in the Territory or outside the
Territory (whether occurring before or after the Execution Date), or (d) the
gross negligence or willful misconduct on the part of Licensor in performing its
obligations under this Agreement or the Trademark License Agreement, except for
those Losses for which Licensee has an obligation to indemnify Licensor pursuant
to Section 13.1 or any Co-Promotion Agreement, as to which Losses each Party
shall indemnify the other to the extent of their respective liability for the
Losses; PROVIDED, HOWEVER, that Licensor shall not be obligated to indemnify
Licensee for any Losses to the extent that such Losses arise as a result of
gross negligence or willful misconduct on the part of Licensee, any Sublicensee,
its or their respective Affiliates, or any Distributor.
13.3 NOTICE OF CLAIM. All indemnification claims in respect of a Party,
its Affiliates or their respective directors, officers, employees and agents
shall be made solely by such Party to this Agreement (the "INDEMNIFIED PARTY").
The Indemnified Party shall give the indemnifying Party prompt written notice
(an "INDEMNIFICATION CLAIM NOTICE") of any Losses or discovery of fact upon
which such indemnified Party intends to base a request for indemnification under
Section 13.1 or 13.2, but in no event shall the indemnifying Party be liable for
any Losses that result from any delay in providing such notice. Each
Indemnification Claim Notice must contain a description of the claim and the
nature and amount of such Loss (to the extent that the nature and amount of such
Loss is known at such time). The Indemnified Party shall furnish promptly to the
indemnifying Party copies of all papers and official documents received in
respect of any Losses and Third Party Claims.
13.4 CONTROL OF DEFENSE. At its option, the indemnifying Party may assume
the
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defense of any Third Party Claim by giving written notice to the Indemnified
Party within thirty (30) days after the indemnifying Party's receipt of an
Indemnification Claim Notice. The assumption of the defense of a Third Party
Claim by the indemnifying Party shall not be construed as an acknowledgment that
the indemnifying Party is liable to indemnify the Indemnified Party in respect
of the Third Party Claim, nor shall it constitute a waiver by the indemnifying
Party of any defenses it may assert against the Indemnified Party's claim for
indemnification. Upon assuming the defense of a Third Party Claim, the
indemnifying Party may appoint as lead counsel in the defense of the Third Party
Claim any legal counsel selected by the indemnifying Party. In the event the
indemnifying Party assumes the defense of a Third Party Claim, the Indemnified
Party shall immediately deliver to the indemnifying Party all original notices
and documents (including court papers) received by the Indemnified Party in
connection with the Third Party Claim. Should the indemnifying Party assume the
defense of a Third Party Claim, except as provided in Section 13.4.1, the
indemnifying Party shall not be liable to the Indemnified Party for any legal
expenses subsequently incurred by such Indemnified Party in connection with the
analysis, defense or settlement of the Third Party Claim. In the event that it
is ultimately determined that the indemnifying Party is not obligated to
indemnify, defend or hold harmless the Indemnified Party from and against the
Third Party Claim, the Indemnified Party shall reimburse the indemnifying Party
for any and all costs and expenses (including attorneys' fees and costs of suit)
and any Third Party Claims incurred by the indemnifying Party in its defense of
the Third Party Claim.
13.4.1 RIGHT TO PARTICIPATE IN DEFENSE. Without limiting
Section 13.4 above, any Indemnified Party shall be entitled to participate in,
but not control, the defense of such Third Party Claim and to employ counsel of
its choice for such purpose; PROVIDED, HOWEVER, that such employment shall be at
the Indemnified Party's own expense unless (a) the employment thereof has been
specifically authorized by the indemnifying Party in writing, (b) the
indemnifying Party has failed to assume the defense and employ counsel in
accordance with Section 13.4 (in which case the Indemnified Party shall control
the defense) or (c) the interests of the indemnitee and the indemnifying Party
with respect to such Third Party Claim are sufficiently adverse to prohibit the
representation by the same counsel of both Parties under Applicable Law, ethical
rules or equitable principles.
13.4.2 SETTLEMENT. With respect to any Third Party Claims relating
solely to the payment of money damages in connection with a Third Party Claim
that shall not result in the Indemnified Party's becoming subject to injunctive
or other relief or otherwise adversely affecting the business of the Indemnified
Party in any manner and as to which the indemnifying Party shall have
acknowledged in writing the obligation to indemnify the Indemnified Party
hereunder, the indemnifying Party shall have the sole right to consent to the
entry of any judgment, enter into any settlement or otherwise dispose of such
Loss, on such terms as the indemnifying Party, in its sole discretion, shall
deem appropriate. With respect to all other Losses in connection with Third
Party Claims, where the indemnifying Party has assumed the defense of the Third
Party Claim in accordance with Section 13.4.1, the indemnifying Party shall have
authority to consent to the entry of any judgment, enter into any settlement or
otherwise dispose of such Loss; provided it obtains the prior written consent of
the Indemnified Party (which consent shall not be unreasonably withheld or
delayed). The indemnifying Party shall not be liable for any settlement or other
disposition of a Loss by an Indemnified Party that is reached without the
written consent of the indemnifying Party. Regardless of whether the
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indemnifying Party chooses to defend or prosecute any Third Party Claim, no
Indemnified Party shall, and the Indemnified Party shall ensure that no
indemnitee shall, admit any liability with respect to or settle, compromise or
discharge, any Third Party Claim without the prior written consent of the
indemnifying Party, such consent not to be unreasonably withheld or delayed.
13.4.3 COOPERATION. Regardless of whether the indemnifying Party
chooses to defend or prosecute any Third Party Claim, the Indemnified Party
shall cooperate in the defense or prosecution thereof and shall furnish such
records, information and testimony, provide such witnesses and attend such
conferences, discovery proceedings, hearings, trials and appeals as may be
reasonably requested in connection therewith.
13.4.4 EXPENSES. Except as provided above, the costs and expenses,
including fees and disbursements of counsel, incurred by the Indemnified Party
in connection with any claim shall be reimbursed on a Calendar Quarter basis by
the indemnifying Party, without prejudice to the indemnifying Party's right to
contest the Indemnified Party's right to indemnification and subject to refund
in the event the indemnifying Party is ultimately held not to be obligated to
indemnify the Indemnified Party.
13.5 LIMITATION ON DAMAGES AND LIABILITY. EXCEPT IN CIRCUMSTANCES OF (a)
FRAUD, (b) BREACH OF ARTICLE 11 OR (c) WITH RESPECT TO THIRD PARTY CLAIMS UNDER
SECTION 13.1, 13.2 OR OTHERWISE, NEITHER PARTY NOR ANY OF THEIR RESPECTIVE
AFFILIATES SHALL BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL
DAMAGES, WHETHER IN CONTRACT, WARRANTY, NEGLIGENCE, TORT, STRICT LIABILITY OR
OTHERWISE, ARISING OUT OF THE PERFORMANCE OR FAILURE TO PERFORM ANY OF THE
PROVISIONS OF THIS AGREEMENT.
13.6 INSURANCE. Each Party shall, and shall cause its (sub)licensees and
its and their respective Affiliates to, have and maintain such type and amounts
of liability insurance, which, in Licensee's case may be in the form of
self-insurance, covering the Manufacture, use and sale of the Licensed Products
as is normal and customary in the pharmaceutical industry generally for parties
similarly situated, but in any event including product liability insurance with
respect to the Licensed Products with not less than Twenty Million U.S. Dollars
($20,000,000), or the equivalent amount in Canadian dollars, in coverage in the
aggregate; PROVIDED, HOWEVER, that Licensor shall not be obligated to have such
insurance until First Commercial Sale of the first Licensed Product. Licensor
shall upon request provide Licensee with a copy of such policies of insurance,
along with any amendments and revisions thereto. Licensor shall list Licensee as
an additional insured and loss payee on such policies of Licensor and ensure
that such policies provide that Licensor shall be given thirty (30) days'
advance written notice of the termination thereof. Such policies or programs of
self-insurance shall remain in effect throughout the Term and for a period of
three (3) years thereafter and shall not be cancelled or subject to a reduction
of coverage without the prior written authorization of the other Party.
Maintenance of such insurance coverage shall not relieve a Party of any
responsibility under this Agreement for damages in excess of insurance limits or
otherwise.
ARTICLE 14
TERM AND TERMINATION
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14.1 TERM. This Agreement shall commence on the Execution Date and shall
continue in effect until expiration of the last to expire Royalty Term, unless
terminated earlier in accordance with this ARTICLE 14 (such period, the "TERM").
14.2 TERMINATION OF THIS AGREEMENT IN ITS ENTIRETY FOR MATERIAL BREACH.
In the event that either Party (the "BREACHING PARTY") shall be in material
breach of any of its obligations under this Agreement, in addition to any other
right and remedy the other Party (the "COMPLAINING PARTY") may have, the
Complaining Party may terminate this Agreement, in its entirety by sixty (60)
days' prior written notice (the "NOTICE PERIOD") to the Breaching Party,
specifying the breach and its claim of right to terminate; provided always that
the termination shall not become effective at the end of the Notice Period if
the Breaching Party cures the breach complained of during the Notice Period (or,
if such default cannot be cured within such sixty (60)-day period, if the
Breaching Party commences actions to cure such default within the Notice Period
and thereafter diligently continues such actions, provided that such default is
cured within ninety (90) days after the receipt of such notice) and except in
the case of a payment default, as to which the Breaching Party shall have only a
ten (10)-day cure period.
14.3 CERTAIN LICENSEE TERMINATION RIGHTS.
14.3.1 WITHOUT CAUSE. Beginning on the third (3rd) anniversary of
the First Commercial Sale, Licensee may terminate this Agreement in its
entirety, in its sole discretion, by providing to Licensor one hundred eighty
(180) days' prior written notice.
14.3.2 FAILURE TO OBTAIN THE INITIAL APPROVAL. Licensee may
terminate this Agreement in its entirety by providing to Licensor thirty (30)
days' prior written notice in the event that the Licensor has not obtained the
Initial Approval prior to the second anniversary of the first Prescription Drug
User Fee Act date with respect to the NDA for the Initial Approval (regardless
of whether such date is later amended or modified by the FDA).
14.3.3 UPON A CHANGE OF CONTROL OF LICENSOR. If Licensor proposes to
enter into an agreement or set of agreements that, if the transaction(s)
contemplated thereby is completed, would result in a Change of Control, then
Licensor may provide Licensee with written notice describing the proposed Change
of Control in reasonable detail (the "CHANGE OF CONTROL NOTICE"). If Licensor
enters into any such agreement(s) and has not previously provided a Change of
Control Notice to Licensee in connection with such Change of Control pursuant to
the preceding sentence, Licensor shall provide Licensee with a Change of Control
Notice promptly following the date on which such agreement(s) are executed and
in no event later than five (5) days thereafter. Upon receipt of a Change of
Control Notice, Licensee shall have the right to terminate this Agreement,
provided that within thirty (30) days of its receipt of such Change of Control
Notice, Licensee provides written notice to Licensor of its intention to so
terminate the Agreement (the "CHANGE OF CONTROL TERMINATION NOTICE"). If
Licensee delivers a Change of Control Termination Notice within such time
period, the termination of this Agreement shall be effective upon the later of
(a) one hundred fifty (150) days from the date on which the Change of Control
Termination Notice is received by Licensor or (b) the effective date of such
Change of Control. For the avoidance of doubt, if Licensee does not provide
Licensor with a Change of Control Termination Notice within the thirty (30) days
of its receipt of a Change of Control Notice, Licensee shall have no right to
terminate this Agreement in
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connection with the Change of Control specified in the Change of Control Notice.
Licensee shall have no further payment obligation pursuant to Section 8.1.2 for
any milestones that may be achieved after the date of the Change of Control
Termination Notice.
14.3.4 TERMINATION BY LICENSEE FOR SAFETY CONCERNS OR FOR FAILURE TO
ACHIEVE THE TARGET PRODUCT PROFILE. Licensee may terminate this Agreement in its
entirety, upon thirty (30) days' prior written notice in the event that (a) the
Initial Approval does not permit Product Labeling that is at least as favorable
as the Target Product Profile or (b) Licensee reasonably determined that it is
not feasible for Licensee to pursue the Development or Commercialization of any
Licensed Products in the Field in the Territory for safety or efficacy reasons,
including due to severe adverse events with respect to any Licensed Product or
(c) following completion of the Phase IIIA Clinical Studies of the Existing
Licensed Product ongoing as of the Execution Date and any other Clinical
Studies, preclinical and non-clinical testing, or other Development activities
contemplated in the Development Plan as of the Execution Date, and that are
ongoing as of, or that take place after, the Execution Date, if it is reasonably
anticipated by Licensee, based upon Licensee's good faith analysis of the final
results of such studies or tests, that the Target Product Profile would not be
met. With respect to clause (a) above, such written notice shall be provided to
Licensor no later than sixty (60) days after the date of the Initial Approval,
and, with respect to clause (c) above, such written notice shall be provided to
Licensor no later than filing of the NDA for the Existing Product. Licensee
shall have no further payment obligation pursuant to Section 8.1.2 for any
milestones that may be achieved after the date on which Licensee provides a
notice of termination pursuant to this Section 14.3.4, and, in the event that
Licensee terminates this Agreement pursuant to clause (b) above, Licensee shall
be permitted to cease all Commercialization and Development efforts immediately
upon determination that such reasonable safety concern exists.
14.4 TERMINATION FOR FAILURE TO SUPPLY. If, pursuant to any Commercial
Supply Agreement, Licensee terminates such Commercial Supply Agreement due to a
material breach by Licensor of its obligation to supply Licensed Products to
Licensee, Licensee shall have the right to terminate this Agreement in its
entirety. For the avoidance of doubt, Licensor shall not have any liability
under this Agreement for any breaches of its obligations under any Commercial
Supply Agreement other than under ARTICLE 13.
14.5 TERMINATION UPON INSOLVENCY. Either Party may terminate this
Agreement if, at any time, the other Party shall file in any court or agency
pursuant to any statute or regulation of any state, country or jurisdiction, a
petition in bankruptcy or insolvency or for reorganization or for an arrangement
or for the appointment of a receiver or trustee of such other Party or of its
assets, or if the other Party proposes a written agreement of composition or
extension of its debts, or if the other Party shall be served with an
involuntary petition against it, filed in any insolvency proceeding, and such
petition shall not be dismissed within sixty (60) days after the filing thereof,
or if the other Party shall propose or be a party to any dissolution or
liquidation, or if the other Party shall make an assignment for the benefit of
its creditors.
14.6 RIGHTS IN BANKRUPTCY. All rights and licenses granted under or
pursuant to this Agreement by Licensee or Licensor are, and shall otherwise be
deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code,
licenses of right to "intellectual property" as defined under Section 101 of the
U.S. Bankruptcy Code. The Parties agree that the Parties, as
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licensees of such rights under this Agreement, shall retain and may fully
exercise all of their rights and elections under the U.S. Bankruptcy Code. The
Parties further agree that, in the event of the commencement of a bankruptcy
proceeding by or against either Party under the U.S. Bankruptcy Code, the Party
hereto that is not a Party to such proceeding shall be entitled to a complete
duplicate of (or complete access to, as appropriate) any such intellectual
property and all embodiments of such intellectual property, which, if not
already in the non-subject Party's possession, shall be promptly delivered to it
(a) upon any such commencement of a bankruptcy proceeding upon the non-subject
Party's written request therefor, unless the Party subject to such proceeding
elects to continue to perform all of its obligations under this Agreement or (b)
if not delivered under (a) above, following the rejection of this Agreement by
or on behalf of the Party subject to such proceeding upon written request
therefor by the non-subject Party.
14.7 CONSEQUENCES OF TERMINATION.
14.7.1 UPON TERMINATION BY LICENSOR UNDER SECTION 14.2 OR 14.5 OR
TERMINATION BY LICENSEE UNDER SECTION 9.5.4(c), 14.3 OR 14.4. Upon termination
by Licensor under Section 14.2 or 14.5 or termination by Licensee under
Section 9.5.4(c), 14.3 or 14.4, the following shall apply:
(a) LICENSES GRANTED TO LICENSEE. The licenses granted by
Licensor to Licensee in ARTICLE 2 shall terminate in their entirety and if
Licensor assigned to Licensee pursuant to this Agreement any NDA for a Licensed
Product in the Field in the Territory, then, reasonably promptly and in
coordination with Licensor, Licensee shall, without any further consideration,
assign to Licensor such NDA.
(b) LICENSES GRANTED TO LICENSOR. Upon the effective date
of termination, (i) the licenses granted by Licensee to Licensor pursuant to
ARTICLE 2 shall become non-exclusive, perpetual, irrevocable, fully paid-up,
royalty-free licenses and (ii) Licensor shall have a perpetual, irrevocable,
fully paid-up, royalty-free license, with the right to sublicense, under the
Licensee Patent Rights, Licensee Know-How, Joint Patents (to the extent
Controlled by Licensee) and Joint Know-How (to the extent Controlled by
Licensee) to Exploit the Licensed Products in the Field in the Territory.
(c) TRANSFER OF REGULATORY DOCUMENTATION. Licensee shall,
and shall cause its Sublicensees and its and their respective Affiliates to,
cooperate with Licensor or its designee (at Licensee's own expense) to effect
the assignment set forth in Section 14.7.1(a), if applicable, and shall provide
to Licensor or its designee any copies of relevant documents Controlled by
Licensee, its Sublicensees and its and their respective Affiliates and rights of
reference or access necessary to allow Licensor or its designee to exercise its
rights under this ARTICLE 14.
(d) THIRD PARTY AGREEMENTS, CLINICAL STUDIES, PHASE IIIB
CLINICAL STUDIES, PHASE IV CLINICAL STUDIES AND POST-APPROVAL COMMITMENTS. To
the extent requested by Licensor in writing and permitted under the applicable
agreement, Licensee shall, and does hereby automatically, and shall cause its
Sublicensees and its and their respective Affiliates to, transfer and assign to
Licensor or its designee, and Licensor or its designee hereby accepts, all
right, title and interest in and to any agreements with any Third Parties to the
extent
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such agreements relate to the Licensed Products in the Field in the Territory
(including agreements with contract research organizations, clinical sites and
investigators). In addition, with respect to any Clinical Studies, Phase IIIB
Clinical Studies, Phase IV Clinical Studies and Post-Approval Commitments for
the Licensed Products being conducted by or on behalf of Licensee or any of its
Affiliates or Sublicensees as of the effective date of termination, at
Licensor's option, Licensee shall, and shall cause such Affiliates and
Sublicensees to, either (i) end each of such Clinical Studies, Phase IIIB
Clinical Studies, Phase IV Clinical Studies and Post-Approval Commitment with
respect to enrolled subjects in an orderly and prompt manner in accordance with
Applicable Law and consistent with ethical norms, including by providing any
required follow up treatment with previously enrolled subjects, or (ii) transfer
control to Licensor or its designee of each of such Clinical Studies, Phase IIIB
Clinical Studies, Phase IV Clinical Studies and Post-Approval Commitments and
cooperate with Licensor or its designee to ensure a smooth and orderly
transition thereof that will not involve any disruption of each of such Clinical
Studies, Phase IIIB Clinical Studies, Phase IV Clinical Studies and
Post-Approval Commitments.
(e) ASSIGNMENT OF TRADEMARKS. To the extent requested by
Licensor in writing, Licensee shall, without any further consideration, assign
to Licensor any product Trademarks Controlled by Licensee (other than the
Licensed Trademarks), if used exclusively in the Commercialization of Licensed
Products at the time of such termination.
(f) CEASING EXPLOITATION OF LICENSED PRODUCTS. Subject to
Section 14.7.1(h), Licensee shall, and shall cause its Affiliates and
Sublicensees to, promptly cease all Exploitation of the Licensed Products in the
Field in the Territory and, within thirty (30) days of the effective date of
such termination and, at Licensor's election, either destroy or transfer to
Licensor or its designee, at Licensee's expense, any and all unsold quantities
of Licensed Products.
(g) TRANSFER OF MATERIALS. Without limiting Licensor's
rights under other provisions of this ARTICLE 14 and except as provided in
Section 14.7.1(h), Licensee shall, and shall cause its Sublicensees and its and
their respective Affiliates to, cooperate with Licensor or its designee in
transferring to Licensor or a designee, as Licensor or its designee may direct,
within sixty (60) days of the termination hereof, all data, files and other
materials in the Control of Licensee, any Sublicensee or its or their respective
Affiliates relating to the NDA for the Licensed Products (to the extent
Controlled by Licensee, any Sublicensee or its or their respective Affiliates as
of the date of termination) and all Confidential Information of Licensor in the
Territory, except that Licensee may retain one (1) copy of such data, files or
materials, to the extent that Licensee requires such data, files and materials
for the purpose of performing any obligations under this Agreement that may
survive such termination. Upon termination by Licensor under Section 9.5.4(c),
14.2 or 14.5 or termination by Licensee under Section 14.3 or 14.4, the
foregoing Regulatory Documentation with respect to the Territory, shall be
deemed to be the Confidential Information of Licensor (subject to Section 11.2).
(h) SALE OF INVENTORY. Provided that Licensee is not in
material breach of any obligation under this Agreement at the time of such
termination, Licensee (and its Affiliates and Sublicensees) shall have the right
for six (6) months after the effective date of such termination to dispose of
all Licensed Products then in its (or their) inventory, as though this Agreement
had not terminated. For the avoidance of doubt, Licensee shall continue to make
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payments with respect to such Licensed Products as provided in ARTICLE 8
(subject to Section 8.2.3 and any other applicable terms of this Agreement).
(i) ASSIGNMENTS. In connection with any and all assignments
contemplated by this Section 14.7.1, Licensee shall, and shall cause its
Sublicensees and its and their respective Affiliates to, execute and deliver,
such instruments and take such actions as may be necessary or desirable to
effect such assignment.
(j) ASSISTANCE. Without limiting Licensor's rights under
other provisions of this Section 14.7.1, Licensee shall, and shall cause its
Sublicensees and its and their respective Affiliates to, at the request Licensor
or its designee, provide Licensor or its designee, at Licensee's expense, with
such assistance as is reasonably necessary to effectuate a smooth and orderly
transition of any such Development, Manufacture and Commercialization activities
to Licensor or its designee so as to minimize any disruption of such activities.
14.7.2 UPON TERMINATION BY LICENSEE FOR LICENSOR BREACH OR
INSOLVENCY. Upon termination by Licensee under Section 14.2 or 14.5, (a) the
licenses granted by Licensor to Licensee in Section 2.1 shall continue in full
force and effect (provided that the royalty rate in Section 8.2 shall be reduced
by fifty percent (50%)), and (b) the license by Licensee to Licensor in
Section 2.2 shall terminate in its entirety.
14.7.3 INTELLECTUAL PROPERTY LITIGATION. Following expiration or
termination of this Agreement for any reason, the provisions of this
Section 14.7.3 shall apply: Licensee shall control (a) subject to any rights of
Tulane under the Tulane License, any litigation relating to enforcement of the
Licensed Patents and the Joint Patents, including ANDA-related litigation, which
litigation commenced prior to expiration or termination of the Agreement and (b)
any litigation brought by a Third Party alleging that the Licensed Products in
the Field in the Territory infringe such Third Party's intellectual property
rights, which litigation arises due to activities occurring prior to expiration
or termination. For all such actions, Licensee shall bear all court costs and
attorneys' fees that accrue after expiration or termination of this Agreement
except that Licensor shall have the right to join and participate in any such
litigation at its own expense. Each Party's cooperation and assistance
obligations under Sections 9.3, 9.4 and 9.5 shall survive with respect to any
such actions. Any recoveries resulting from all such actions shall be shared as
provided in ARTICLE 9. Any damage awards resulting for all such actions shall be
borne as provided in ARTICLE 9, provided that, in the case of termination due to
breach of Licensee, Licensee shall bear one hundred percent (100%) of damage
awards to the extent that such damages are directly attributable to such breach
by Licensee. In any such action, Licensee shall not admit or agree that any
claims of the Licensed Patents or Joint Patents (in the case of the Joint
Patents, solely to the extent relating directly to Licensed Products) are
invalid or otherwise unenforceable without the written consent of Licensor, not
to be unreasonably withheld.
14.7.4 REMEDIES. Except as otherwise expressly provided herein,
termination of this Agreement in accordance with the provisions hereof shall not
limit remedies which may otherwise be available in law or equity.
14.8 ACCRUED RIGHTS; SURVIVING OBLIGATIONS.
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14.8.1 ACCRUED RIGHTS. Termination or expiration of this Agreement
for any reason shall be without prejudice to any rights that shall have accrued
to the benefit of a Party prior to such termination or expiration, including
Licensor's right to receive any payment payable by Licensee that accrues prior
to such termination or expiration. Such termination or expiration shall not
relieve a Party from obligations that are expressly indicated to survive the
termination or expiration of this Agreement pursuant to this Section 14.8.
14.8.2 SURVIVAL.
(a) UPON EXPIRATION. Without limiting the foregoing,
Sections 2.1 (Grants to Licensee) (subject to Section 8.2.3), 2.2 (Grants to
Licensor), 2.4 (Distributors), 2.5 (Sublicenses), 2.6 (Use of Corporate Names),
2.7 (No Implied Rights; Reservation of Rights), 5.6 (Records), 7.1.2(b)
(Assumption of Manufacturing Responsibility by Licensee), 7.2 (Secondary
Packaging and Labeling), 7.3 (Manufacturing Technology Transfer), 8.2.3 (Royalty
Term), 8.2.6 (Royalty Statements) (with respect to the last Calendar Quarter of
the Term), 8.7 (Mode of Payment), 8.8 (Currency), 8.9 (Taxes), 8.10 (Interest on
Late Payments), 8.11 (Financial Records), 8.12 (Audit), 8.13 (Reconciliation),
8.14 (Confidentiality), 12.4 (Disclaimer of Warranty), 14.6 (Rights in
Bankruptcy), 14.7 (Consequences of Termination), and this Section 14.8 (Accrued
Rights; Surviving Obligations) and ARTICLE 1 (Definitions) (to the extent the
definitions set forth therein are used in provisions surviving under this
Section 14.8.2), ARTICLE 10 (Adverse Event Reporting; Recall), ARTICLE 11
(Confidentiality and Non-Disclosure), ARTICLE 13 (Indemnity) and ARTICLE 15
(Miscellaneous) (other than Section 15.3.2) of this Agreement shall survive the
expiration of this Agreement. Following any such expiration, any matter assigned
to the JCC for decision under any of the foregoing surviving provisions shall be
decided by Licensee.
(b) UPON TERMINATION BY LICENSOR UNDER SECTION 14.2 OR 14.5
OR TERMINATION BY LICENSEE UNDER SECTION 9.5.4(c), 14.3 OR 14.4. Without
limiting the foregoing, Sections 2.2 (Grants to Licensor), 2.7 (No Implied
Rights; Reservation of Rights), 5.6 (Records), 8.2.6 (Royalty Statements) (with
respect to the last Calendar Quarter of the Term), 8.7 (Mode of Payment), 8.8
(Currency), 8.9 (Taxes), 8.10 (Interest on Late Payments), 8.11 (Financial
Records), 8.12 (Audit), 8.13 (Reconciliation), 8.14 (Confidentiality), 12.4
(Disclaimer of Warranty), 14.6 (Rights in Bankruptcy), 14.7 (Consequences of
Termination) and this Section 14.8 (Accrued Rights; Surviving Obligations) and
ARTICLE 1 (Definitions) (to the extent the definitions set forth therein are
used in provisions surviving under this Section 14.8.2), ARTICLE 10 (Adverse
Event Reporting; Recall) (provided that Licensee's obligations under such
Article shall be limited to Licensed Product sold or distributed by or on behalf
of Licensee), ARTICLE 11 (Confidentiality and Non-Disclosure) (other than
Sections 11.1 and 11.7), ARTICLE 13 (Indemnity) and ARTICLE 15 (Miscellaneous)
(other than Section 15.3.2) of this Agreement shall survive the termination of
this Agreement by Licensor pursuant to Section 14.2 or 14.5 or by Licensee
pursuant to Section 9.5.4(c), 14.3 or 14.4.
(c) UPON TERMINATION BY LICENSEE UNDER SECTION 14.2 OR
14.5. Without limiting the foregoing, Sections 2.1 (Grants to Licensee), 2.4
(Distributors), 2.5 (Sublicenses), 2.6 (Use of Corporate Names), 2.7 (No Implied
Rights; Reservation of Rights), 5.6 (Records), 6.7 (Records and Reporting),
7.1.2(b) (Assumption of Manufacturing Responsibility by Licensee), 7.2
(Secondary Packaging and Labeling), 7.3 (Manufacturing
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Technology Transfer), 8.2 (Royalties), 8.3 (Combination Products), 8.6 (Recovery
of Amounts Paid to Tulane), 8.7 (Mode of Payment), 8.8 (Currency), 8.9 (Taxes),
8.10 (Interest on Late Payments), 8.11 (Financial Records), 8.12 (Audit), 8.13
(Reconciliation), 8.14 (Confidentiality), 12.4 (Disclaimer of Warranty), 14.6
(Rights in Bankruptcy), 14.7 (Consequences of Termination) and this Section 14.8
(Accrued Rights; Surviving Obligations), ARTICLE 1 (Definitions) (to the extent
the definitions set forth therein are used in provisions surviving under this
Section 14.8.2), ARTICLE 10 (Adverse Event Reporting; Recall), ARTICLE 11
(Confidentiality and Non-Disclosure), ARTICLE 13 (Indemnity) and ARTICLE 15
(Miscellaneous) (other than Section 15.3.2) of this Agreement shall survive the
termination of this Agreement by Licensee pursuant to Section 14.2 or 14.5.
Following any such termination, any matter assigned to the JCC for decision
under any of the foregoing surviving provisions shall be decided by Licensee.
ARTICLE 15
MISCELLANEOUS
15.1 FORCE MAJEURE. Neither Party shall be held liable or responsible to
the other Party or be deemed to have defaulted under or breached this Agreement
for failure or delay in fulfilling or performing any term of this Agreement
(other than an obligation to make payments) when such failure or delay is caused
by or results from events beyond the reasonable control of the non-performing
Party, including fires, floods, earthquakes, embargoes, shortages, epidemics,
quarantines, war, acts of war (whether war be declared or not), terrorist acts,
insurrections, riots, civil commotion, strikes, lockouts or other labor
disturbances (whether involving the workforce of the non-performing Party or of
any other Person), acts of God or acts, omissions or delays in acting by any
governmental authority. The non-performing Party shall notify the other Party of
such force majeure within thirty (30) days after such occurrence by giving
written notice to the other Party stating the nature of the event, its
anticipated duration, and any action being taken to avoid or minimize its
effect. The suspension of performance shall be of no greater scope and no longer
duration than is necessary and the non-performing Party shall use Commercially
Reasonable Efforts to remedy its inability to perform.
15.2 EXPORT CONTROL. This Agreement is made subject to any restrictions
concerning the export of products or technical information from the United
States or other countries that may be imposed on related to the Parties from
time to time. Each Party agrees that it will not export, directly or indirectly,
any technical information acquired from the other Party under this Agreement or
any products using such technical information to a location or in a manner that
at the time of export requires an export license or other governmental approval,
without first obtaining the written consent to do so from the appropriate agency
or other governmental entity in accordance with Applicable Law.
15.3 ASSIGNMENT.
15.3.1 IN GENERAL. Without the prior written consent of the other
Party hereto, neither Party shall sell, transfer, assign, delegate, pledge or
otherwise dispose of, whether voluntarily, involuntarily, by operation of law or
otherwise, this Agreement or any of its rights or duties hereunder; PROVIDED,
HOWEVER, that (a) Licensor may, without such consent, assign this Agreement and
its rights and obligations hereunder to an Affiliate or to its successor entity
or
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acquirer in the event of a Change of Control of Licensor, or, in the event that
Licensee does not purchase the Licensed Patents and Licensed Know-How pursuant
to Section 15.3.2, to the purchaser of substantially all of its assets related
to the Licensed Products and (b) Licensee may, without such consent, assign this
Agreement and its rights and obligations hereunder to an Affiliate, to the
purchaser of substantially all of its assets related to the Licensed Products or
to its successor entity or acquirer in the event of a merger, consolidation or
change in control of Licensee; provided, further, that in either case ((a) or
(b)), with respect to any assignment hereunder, such assigning Party shall
remain responsible for the performance by such assignee of the rights and
obligations hereunder. Any attempted assignment or delegation in violation of
the preceding sentence shall be void and of no effect. All validly assigned and
delegated rights and obligations of the Parties hereunder shall be binding upon
and inure to the benefit of and be enforceable by and against the successors and
permitted assigns of Licensor or Licensee, as the case may be. In the event
either Party seeks and obtains the other Party's consent to assign or delegate
its rights or obligations to another Party, the assignee or transferee shall
assume all obligations of its assignor or transferor under this Agreement.
15.3.2 FIRST RIGHT TO PURCHASE LICENSED PATENTS AND LICENSED
KNOW-HOW. In the event that Licensor desires to sell the Licensed Patents or
Licensed Know-How to a Third Party other than a successor entity or acquirer of
Licensor in the event of a Change of Control of Licensor, then Licensor shall
notify Licensee in writing and Licensee shall have thirty (30) days from receipt
of such notice in which to respond and, if applicable, begin negotiations to
purchase such assets. If (a) Licensee does not respond to Licensor's notice
within the thirty (30)-day period or (b) the Parties are unable to execute a
definitive agreement within three (3) months after opening such negotiations,
then Licensor shall be free to offer such Licensed Patents or Licensed Know-How
to such Third Party; PROVIDED, HOWEVER, that if the Parties attempted to
negotiate a definitive agreement, then for a period of ninety (90) days
following the termination of such negotiations, Licensor shall not sell the
Licensed Patents or Licensed Know-How to any Third Party on terms which, taken
as a whole, are more favorable to the Third Party than those offered by Licensee
in writing.
15.3.3 LICENSOR DESIGNEES. Notwithstanding anything to the contrary
in this Section 15.3, Licensee hereby consents to the delegation by Licensor of
the activities set forth in SCHEDULE 15.3.3 to the applicable Third Parties
named in SCHEDULE 15.3.3.
15.3.4 LICENSEE DESIGNEES. Notwithstanding anything to the contrary
in this Section 15.3 and except with respect to the engagement of CSOs, which
are addressed in Section 6.9, Licensee shall have the right to subcontract its
obligations hereunder to any of its Affiliates or any Third Party provided that
Licensee shall remain liable for any such subcontractor's performance of such
obligations.
15.4 SEVERABILITY. If any provision of this Agreement is held to be
illegal, invalid or unenforceable under any present or future law, and if the
rights or obligations of either Party under this Agreement will not be
materially and adversely affected thereby, (a) such provision shall be fully
severable, (b) this Agreement shall be construed and enforced as if such
illegal, invalid or unenforceable provision had never comprised a part hereof,
(c) the remaining provisions of this Agreement shall remain in full force and
effect and shall not be affected by the illegal, invalid or unenforceable
provision or by its severance herefrom and (d) in lieu of such
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illegal, invalid or unenforceable provision, there shall be added automatically
as a part of this Agreement a legal, valid and enforceable provision as similar
in terms to such illegal, invalid or unenforceable provision as may be possible
and reasonably acceptable to the Parties. To the fullest extent permitted by
applicable law, each Party hereby waives any provision of law that would render
any provision hereof illegal, invalid or unenforceable in any respect.
15.5 GOVERNING LAW, JURISDICTION, VENUE AND SERVICE.
15.5.1 GOVERNING LAW. This Agreement shall be governed by and
construed in accordance with the laws of the State of
New York, excluding any
conflicts or choice of law rule or principle that might otherwise refer
construction or interpretation of this Agreement to the substantive law of
another jurisdiction. The Parties agree to exclude the application to this
Agreement of the United Nations Convention on Contracts for the International
Sale of Goods.
15.5.2 JURISDICTION. Subject to Sections 15.6 and 15.10, the Parties
hereby irrevocably and unconditionally consent to the exclusive jurisdiction of
the courts of the State of
New York and the United States District Court for the
Southern District of
New York for any action, suit or proceeding (other than
appeals therefrom) arising out of or relating to this Agreement, and agree not
to commence any action, suit or proceeding (other than appeals therefrom)
related thereto except in such courts.
15.5.3 VENUE. The Parties further hereby irrevocably and
unconditionally waive any objection to the laying of venue of any action, suit
or proceeding (other than appeals therefrom) arising out of or relating to this
Agreement in the courts of the State of
New York or in the United States
District Court for the Southern District of
New York, and hereby further
irrevocably and unconditionally waive and agree not to plead or claim in any
such court that any such action, suit or proceeding brought in any such court
has been brought in an inconvenient forum.
15.6 DISPUTE RESOLUTION.
15.6.1 GENERAL. If a dispute, other than a dispute that is subject
to ARTICLE 3, arises between the Parties in connection with or relating to this
Agreement or any document or instrument delivered in connection herewith (a
"DISPUTE"), then either Party shall have the right to refer such dispute to the
Executives who shall confer for attempted on the resolution of the Dispute by
good faith negotiations during a period of ten (10) Business Days. Any final
decision mutually agreed to by such representatives shall be conclusive and
binding on the Parties. Except for matters for which this Agreement assigns
decision-making to the Parties or requires the consent of one or both of the
Parties, if such Executives are not able to agree on the resolution of an issue
within thirty (30) Business Days after such issue was first referred to them,
either Party may, by written notice to the other Party, initiate litigation for
resolution of such Dispute, provided that such matter is a Legal Matter.
15.6.2 INTELLECTUAL PROPERTY DISPUTES. For clarity, in the event
that a Dispute arises with respect the validity, scope, enforceability,
inventorship or ownership of any Patent, Trademark or other intellectual
property rights, and such Dispute cannot be resolved in accordance with
Section 15.6.1, unless otherwise agreed by the Parties in writing, either Party
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may initiate litigation pursuant to Section 15.5.
15.6.3 INTERIM RELIEF. Notwithstanding anything herein to the
contrary, nothing in this Section 15.6 shall preclude either Party from seeking
interim or provisional relief, including a temporary restraining order,
preliminary injunction or other interim equitable relief concerning a dispute,
if necessary to protect the interests of such Party. This Section 15.6 shall be
specifically enforceable.
15.7 NOTICES.
15.7.1 NOTICE REQUIREMENTS. Any notice, request, demand, waiver,
consent, approval or other communication permitted or required under this
Agreement shall be in writing, shall refer specifically to this Agreement and
shall be deemed given only if delivered by hand or sent by facsimile
transmission (with transmission confirmed) or by internationally recognized
overnight delivery service that maintains records of delivery, addressed to the
Parties at their respective addresses specified in Section 15.7.2 or to such
other address as the Party to whom notice is to be given may have provided to
the other Party in accordance with this Section 15.7. Such Notice shall be
deemed to have been given as of the date delivered by hand or transmitted by
facsimile (with transmission confirmed) or on the second Business Day (at the
place of delivery) after deposit with an internationally recognized overnight
delivery service. Any notice delivered by facsimile shall be confirmed by a hard
copy delivered as soon as practicable thereafter. This Section 15.7 is not
intended to govern the day-to-day business communications necessary between the
Parties in performing their obligations under the terms of this Agreement.
15.7.2 Address for Notice.
If to Licensee, to:
sanofi-aventis U.S.
▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇-▇▇▇▇
▇▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attention: General Counsel
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇
with a copy to (which shall not constitute notice):
▇▇▇▇▇▇▇▇▇ & ▇▇▇▇▇▇▇ LLP
▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attention: ▇▇▇ ▇▇▇▇
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇
If to Licensor, to:
Aeterna Zentaris GmbH
▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇, ▇▇▇▇▇
- ▇▇ -
▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇
Attention: ▇▇. ▇▇▇▇▇▇▇ ▇▇▇▇▇
Facsimile: ▇▇-(▇)-▇▇-▇▇▇▇▇-▇▇▇▇
with a copy to (which shall not constitute notice):
Aeterna Zentaris, Inc.
▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
Attention: ▇▇▇-▇▇▇-▇▇▇▇
Facsimile: 908-626-5426
with another copy to (which shall not constitute notice):
Ropes & ▇▇▇▇ LLP
▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attention: ▇▇▇▇▇▇▇ ▇'▇▇▇▇▇
Facsimile: ▇▇▇-▇▇▇-▇▇▇▇
15.8 ENTIRE AGREEMENT. This Agreement, together with the Schedules and
Exhibits attached hereto, along with the Trademark License Agreement, sets forth
and constitutes the entire agreement and understanding between the Parties with
respect to the subject matter hereof and all prior agreements, understandings,
promises and representations, whether written or oral, with respect thereto are
superseded hereby. Each Party confirms that it is not relying on any
representations or warranties of the other Party except as specifically set
forth herein. No amendment, modification, release or discharge shall be binding
upon the Parties unless in writing and duly executed by authorized
representatives of both Parties.
15.9 ENGLISH LANGUAGE. This Agreement shall be written and executed in,
and all other communications under or in connection with this Agreement shall be
in, the English language. Any translation into any other language shall not be
an official version thereof, and in the event of any conflict in interpretation
between the English version and such translation, the English version shall
control.
15.10 EQUITABLE RELIEF. The Parties acknowledge and agree that the
restrictions set forth in Section 2.8 and ARTICLE 9 and ARTICLE 11 are
reasonable and necessary to protect the legitimate interests of the other Party
and that such other Party would not have entered into this Agreement in the
absence of such restrictions, and that any breach or threatened breach of any
provision of Section 2.8 and ARTICLE 9 and ARTICLE 11 may result in irreparable
injury to such other Party for which there will be no adequate remedy at law. In
the event of a breach or threatened breach of any provision of Section 2.8 and
ARTICLE 9 and ARTICLE 11, the non-breaching Party shall be authorized and
entitled to obtain from any court of competent jurisdiction injunctive relief,
whether preliminary or permanent, specific performance and an equitable
accounting of all earnings, profits and other benefits arising from such breach,
which rights shall be cumulative and in addition to any other rights or remedies
to which such non-breaching Party may be entitled in law or equity. Both Parties
agree to waive any requirement
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that the other (a) post a bond or other security as a condition for obtaining
any such relief and (b) show irreparable harm, balancing of ▇▇▇▇▇, consideration
of the public interest or inadequacy of monetary damages as a remedy.
15.11 WAIVER AND NON-EXCLUSION OF REMEDIES. Any term or condition of this
Agreement may be waived at any time by the Party that is entitled to the benefit
thereof, but no such waiver shall be effective unless set forth in a written
instrument duly executed by or on behalf of the Party waiving such term or
condition. The waiver by either Party hereto of any right hereunder or of the
failure to perform or of a breach by the other Party shall not be deemed a
waiver of any other right hereunder or of any other breach or failure by said
other Party whether of a similar nature or otherwise.
15.12 NO BENEFIT TO THIRD PARTIES. The representations, warranties,
covenants and agreements set forth in this Agreement are for the sole benefit of
the Parties hereto and their successors and permitted assigns, and they shall
not be construed as conferring any rights on any other Persons.
15.13 FURTHER ASSURANCE. Each Party shall duly execute and deliver, or
cause to be duly executed and delivered, such further instruments and do and
cause to be done such further acts and things, including the filing of such
assignments, agreements, documents and instruments, as may be necessary or as
the other Party may reasonably request in connection with this Agreement or to
carry out more effectively the provisions and purposes hereof, or to better
assure and confirm unto such other Party its rights and remedies under this
Agreement.
15.14 RELATIONSHIP OF THE PARTIES. It is expressly agreed that Licensor,
on the one hand, and Licensee, on the other hand, shall be independent
contractors and that the relationship between the two Parties shall not
constitute a partnership, joint venture or agency. Neither Licensor, on the one
hand, nor Licensee, on the other hand, shall have the authority to make any
statements, representations or commitments of any kind, or to take any action,
which shall be binding on the other, without the prior written consent of the
other Party to do so, such consent not to be unreasonably withheld or delayed.
All persons employed by a Party shall be employees of such Party and not of the
other Party and all costs and obligations incurred by reason of any such
employment shall be for the account and expense of such Party.
15.15 COUNTERPARTS. This Agreement may be executed in any number of
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument. This Agreement may be
executed by facsimile signatures and such signatures shall be deemed to bind the
parties hereto as if they were original signatures.
15.16 REFERENCES. Unless otherwise specified, (a) references in this
Agreement to any Article, Section, Schedule or Exhibit shall mean references to
such Article, Section, Schedule or Exhibit of this Agreement, (b) references in
any section to any clause are references to such clause of such section and (c)
references to any agreement, instrument or other document in this Agreement
refer to such agreement, instrument or other document as originally executed or,
if subsequently varied, replaced or supplemented from time to time, as so
varied, replaced or supplemented and in effect at the relevant time of reference
thereto.
- 72 -
15.17 CONSTRUCTION. Except where the context otherwise requires, wherever
used, the singular shall include the plural, the plural the singular, the use of
any gender shall be applicable to all genders and the word "or" is used in the
inclusive sense (and/or). The captions of this Agreement are for convenience of
reference only and in no way define, describe, extend or limit the scope or
intent of this Agreement or the intent of any provision contained in this
Agreement. The term "including" as used herein shall mean including, without
limiting the generality of any description preceding such term. The language of
this Agreement shall be deemed to be the language mutually chosen by the Parties
and no rule of strict construction shall be applied against either Party hereto.
[SIGNATURE PAGE FOLLOWS.]
- 73 -
THIS AGREEMENT IS EXECUTED by the authorized representatives of the Parties as
of the date first written above.
AETERNA ZENTARIS GMBH SANOFI-AVENTIS U.S. LLC
By: /s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇ By: /s/ ▇▇▇▇ ▇. ▇'▇▇▇▇▇
Name: ▇▇▇▇▇▇▇ ▇▇▇▇▇ Name: ▇▇▇▇ ▇. ▇'▇▇▇▇▇
Title: Managing Director Title: Vice President, Market Access and
Business Development
By: /s/ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ By: /s/ Laurent Gilhodes
Name: ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ Name: Laurent Gilhodes
Title: Managing Director Title: Vice President & Chief Financial
Officer
SCHEDULE 1.5
CETRORELIX PAMOATE
(attached)
- i -
SCHEDULE 1.5
CETRORELIX PAMOATE
Description of Compound
INN: Cetrorelix
[REDACTED]
[Exclusion of confidential information relating to Licensed Product]
- ii -
SCHEDULE 1.77
LICENSED KNOW-HOW
(attached)
- iii -
SCHEDULE 1.77 LICENSED KNOW HOW
[REDACTED]
[Exclusion of proprietary information related to Licensed Know-How]
Table of Contents: Quality Documentation......................................2
Table of Contents: Non Clinical Documentation................................14
Table of Contents: Clinical Documentation....................................29
Table of Contents: Pharmacovigilance Documentation...........................33
Table of Contents: Regulatory Documentation..................................34
Table of Contents: Quality Assurance Documentation...........................35
Table of Contents: Other Documents...........................................36
- iv -
SCHEDULE 1.78
LICENSED PATENTS
TITLE: "LHRH ANTAGONISTS"
OWNER: ADMINISTRATORS OF THE TULANE EDUCATIONAL FUND
INTERNAL NO.: 87 229 PH
INTERNAL_NO COUNTRY APPLICATION_NO APPLICATION_DATE PATENT_NO GRANTED_DATE EXPIRY_DATE
-----------------------------------------------------------------------------------------------
▇▇ ▇▇ ▇▇▇ ▇▇ ▇▇▇ 07/074,126 7/17/1987 4,800,191 1/24/1989 7/17/2007
▇▇ ▇▇ ▇▇▇ ▇▇/▇ ▇▇▇ 07/197,153 5/23/1988 5,198,533 3/30/1993 10/24/2010
[REDACTED] [Exclusion of proprietary information related to Licensed Patents]
- v -
SCHEDULE 1.125
CETRORELIX ACETATE
INN: Cetrorelix
[REDACTED]
[Exclusion of confidential information relating to Licensed Product]
- vi -
SCHEDULE 1.128
TARGET PRODUCT PROFILE
(attached)
- vii -
Schedule 1.128
TARGET PRODUCT PROFILE
INDICATIONS AND USAGE
- Cetrorelix pamoate is indicated for the treatment of symptoms and
signs of benign prostatic hyperplasia
DOSAGE AND ADMINISTRATION
[REDACTED] [Exclusion of confidential information relating to proposed labeling
of Initial Licensed Product]
CONTRAINDICATIONS
[REDACTED] [Exclusion of confidential information relating to proposed labeling
of Initial Licensed Product]
WARNINGS AND PRECAUTIONS & ADVERSE REACTIONS
[REDACTED] [Exclusion of confidential information relating to proposed labeling
of Initial Licensed Product]
DRUG INTERACTIONS
[REDACTED] [Exclusion of confidential information relating to proposed labeling
of Initial Licensed Product]
- viii -
SCHEDULE 3.4.1(a)
INITIAL JOINT DEVELOPMENT COMMITTEE MEMBERS
LICENSOR MEMBERS:
- [REDACTED], Senior Vice President/Chief Medical Officer
- [REDACTED], Vice President Alliance Management & IP
- [REDACTED], Senior Vice President Regulatory Affairs and Quality
- [REDACTED], Managing Director, Vice President Pharmaceutical
Development
LICENSEE MEMBERS:
- [REDACTED], Alliance Manager
- [REDACTED], Vice Predident U.S. Regulatory Development
- [REDACTED], Medical Affairs
- [REDACTED], Injectable Marketing
- ix -
SCHEDULE 3.4.1(b)
INITIAL JOINT COMMERCIAL COMMITTEE MEMBERS
LICENSOR MEMBERS:
- [REDACTED], Senior Vice President/Chief Medical Officer
- [REDACTED], Managing Director, Vice President Pharmaceutical
Development
- [REDACTED], Head Global Marketing & Business Development
LICENSEE MEMBERS:
- [REDACTED] UID head
- [REDACTED], Alliance Manager
- [REDACTED], Medical Affairs
- [REDACTED], Injectable Marketing
- x -
SCHEDULE 4.1
INITIAL DEVELOPMENT PLAN
(attached)
- xi -
SCHEDULE 4.1 INITIAL DEVELOPMENT PLAN
INITIAL DEVELOPMENT PLAN - CETRORELIX SP BPH
[REDACTED]
[Exclusion of confidential information relating to development of Initial
Licensed Product]
- xii -
SCHEDULE 4.4
DEVELOPMENT BUDGET FOR OPEN LABEL EXTENSION STUDY
COST ESTIMATION OF THE CLINICAL EXTENSION PHASE OF CETRORELIX BPH STUDY 033 AND
MANUFACTURE OF CLINICAL SUPPLIES
[Redacted]
[Exclusion of confidential information relating to Development Costs]
- xiii -
SCHEDULE 6.3
INITIAL COMMERCIALIZATION PLAN AND FORM OF COMMERCIALIZATION PLAN
[REDACTED]
[Exclusion of confidential competitive information]
- xiv -
SCHEDULE 6.7
FORM OF COMMERCIALIZATION REPORT
[REDACTED]
[Exclusion of confidential competitive information]
- xv -
SCHEDULE 7.1.2
COMMERCIAL SUPPLY AGREEMENT TERMS
Parties Supplier - Aeterna Zentaris GmbH
Purchaser - sanofi-aventis U.S. LLC or its affiliate
Product form or dosage of pharmaceutical composition or preparation that contains the API for use in the
Field
API Cetrorelix pamoate
Starting Material Cetrorelix acetate
Manufacturer [REDACTED]
Alternate manufacturer [REDACTED] [Exclusion of confidential information relating to establishment of an alternate
manufacturer]
Form; Units The Product will be delivered in bulk units. [REDACTED] [Exclusion of proprietary information
relating to packaging]. The details of the design and the packaging of the bulk unit will be agreed
in the Supply Agreement. However, for the avoidance of doubt, the bulk unit will not contain more
components than listed above.
Secondary Packaging Purchaser shall perform secondary packaging at a site to be determined; Purchaser shall have
responsibility to release Product following secondary packaging.
Territory US
Option Purchaser shall have the right, at its option, to manufacture Product (a) for quantities above
[REDACTED] during the Term of the Supply Agreement and (b) for all quantities, following the
termination or expiration of the Supply Agreement.
Purchaser shall have the right, at its option, to manufacture Starting Material. In case Purchaser
elects to manufacture Starting Material, Supplier shall have the option to obtain Starting Material
from Purchaser.
Upon decision to manufacture the Product itself, Purchaser shall have the right, at its option,
exercisable at any time, to obtain Starting Material for the manufacture of the Product directly
from the current Starting Material supplier or another Starting Material supplier. If Purchaser
obtains Starting Material from the current Starting Material supplier at a time when Supplier is
also purchasing Starting Material from the current Starting Material supplier, it will coordinate
such purchases with Supplier.
Supplier's Obligations
a. Exclusive supply of quantities of Product as Purchaser may order from time to time up to [REDACTED]
vials per year
b. Product shall be manufactured in accordance with the specifications set forth in the NDA, cGMP and
applicable law; Product must be manufactured at a cGMP approved facility
- xvi -
c. Product shall be released by [REDACTED] in accordance with specifications set forth in the NDA, cGMP
and applicable law and provide certificate of analysis to Purchaser for each batch supplied
d. At the time of delivery to Purchaser, the remaining shelf life of the Product shall be at least the
greater of three years from the date components are compounded with the API or 75-80% of the total
shelf life, to be specified in the Supply Agreement.
e. Product shall be CPT (Incoterms 2000) airport in the U.S specified by Purchaser, providedSupplier
shall clear the goods for export, pay the carriage cost of the Product to such airport in the U.S.
specified by Purchaser and title and risk of losses shall pass at such airport in the U.S. specified
by Purchaser. If Purchaser elects delivery in a country outside the U.S, the Supply Agreement shall
include appropriate provisions to reflect cost/risk sharing analogous to the foregoing.
f. Supplier shall provide all raw materials, API, components and other materials (including Starting
Material) and shall ensure sufficient quantities of same throughout the Term.
In the event Purchaser exercises its option to manufacture Product, Supplier agrees to supply
Purchaser with Purchaser's requirements of Starting Material, for such period of time as Purchaser
may elect, on a pass-through basis, additional delivery costs to be paid by Purchaser, and otherwise
on terms analogous to those set forth in the Supply Agreement, which shall be set forth in a
separate written agreement.
g. Supplier shall maintain a safety stock of Product equal to [REDACTED] [Exclusion of confidential
information relating to quantity of safety stock] supply based on the then applicable forecast.
Purchaser's Obligations In the event that Purchaser has not purchased at least [REDACTED] vials of Product during the Term
of the Supply Agreement, upon expiration of the Term, Purchaser shall pay Supplier the equivalent of
Manufacturer's per unit tolling cost, excluding the cost of API, excipients, packaging and all other
raw materials and components, per vial for the shortfall (i.e., such amount multiplied by the
difference between [REDACTED] vials and the vials purchased). The outcome in the event of early
termination will be addressed in the Supply Agreement.
Annual Capacity [REDACTED] units in the Field in the Territory; Supplier shall not increase the annual capacity
without the prior written consent of Purchaser. Purchaser shall have the right to require Supplier
to expand annual capacity due to anticipated demand in excess of [REDACTED] vials per year. Any
expansion of capacity shall be subject of negotiations between Purchaser and Supplier. Such
negotiations shall take into account demand for Product outside the Territory
Forecasting Commencing [REDACTED], Purchaser shall provide Supplier with a monthly [REDACTED] rolling,
non-binding forecast. [to be confirmed in Supply Agreement]
- xvii -
Binding Orders The first [REDACTED] months of each forecast shall be binding at times when the supply of units per
year is in excess of [REDACTED] units. For annual quantities of less than [REDACTED] units the first
[REDACTED] months shall be binding; Purchaser shall place binding orders for Product with purchase
orders.
Minimum Orders The minimum order is one batch. Each batch shall not exceed [REDACTED] vials.
Term Subject to earlier termination, five years commencing from first commercial sale.
Termination At all times during the Term for breach and insolvency together with the right to terminate (i) by
Purchaser following a failure to supply [REDACTED] of Purchaser's orders for a period of 6 months,
or (ii) immediately upon termination of the License Agreement.
Price See Annex 1.
Price Adjustment The Price shall be decreased to account for (i) increases in volume purchased, and (ii) increases in
productivity, including cost savings on API and other components, in each case as more fully
described on Annex 1.
The Price shall not be increased for a period of two years from the effective date of the Supply
Agreement, subject to inclusion of an analogous provision in Supplier's agreement with Manufacturer,
which provision Supplier shall use commercially reasonable efforts to obtain. Thereafter, the
component of the Price representing labor expenses with respect to the manufacture of the Product from
Starting Material (and excluding the manufacture of Starting Material) may be increased in accordance
with increases in the [REDACTED] index, provided such increases shall not exceed 3% of such component
of the Price per annum.
Payment terms [45 days] from receipt of invoice, which may be provided on delivery; payments in EURO
Implementation Costs and See Annex 2. Purchaser agrees to pay 50% of the amounts described on Annex 2, but shall not be
Timelines obligated to pay more than 50% of the amount described in the Annex. Supplier shall provide
Purchaser with invoices for the expenses described on Annex 2 as such expenses arise, together with
supporting documentation. Supplier's and Manufacturer's records relating to such expenses shall be
subject to audit by Purchaser. Supply of the syringe shall be determined when the Supply Agreement
is negotiated.
Ownership of Equipment Supplier shall retain ownership of all equipment provided or purchased by Supplier (whether or not
reimbursed by Purchaser) for use by Manufacturer in manufacturing Product
Technical Transfer In the event Purchaser elects to manufacture Product, Supplier shall transfer all know-how and other
information and technology related to the manufacture of the Product to Purchaser free of charge.
Supplier and Manufacturer shall cooperate and assist fully in such transfer.
Audit Right Purchaser shall have the right to visit Supplier's and Manufacturer's sites
- xviii -
to audit the financial records of Supplier and the manufacturing and quality records of
Manufacturer, in either case, on reasonable notice in advance, during regular business hours.
Details for auditing shall be described in the corresponding quality agreement.
Representations, Warranties Customary
and Covenants
Indemnification License Agreement shall govern
Quality Agreement Purchaser, Supplier and Manufacturer shall enter into one or more quality agreement(s) within 30
days after the execution of the Supply Agreement
Governing Law NY
Other Terms This term sheet does not contain all of the terms that will be contained in the definitive
agreement.
Assignment Supplier and Purchaser shall be free to assign the Supply Agreement to an affiliate without prior
written consent of the other party or in connection with a permitted assignment of the License
Agreement.
- xix -
SCHEDULE 7.1.2
ANNEX 1
PRICING
[REDACTED]
[Exclusion of confidential information relating to pricing]
- xx -
SCHEDULE 7.1.2
ANNEX 2
IMPLEMENTATION COSTS AND TIMELINES
[REDACTED]
[Exclusion of confidential information relating to manufacturing costs and
timeline for such implementation]
- xxi -
SCHEDULE 7.3
MANUFACTURING LICENSED KNOW-HOW
(attached)
- xxii -
SCHEDULE 7.3 MANUFACTURING LICENSED KNOW-HOW
MANUFACTURING TECHNOLOGY AND ANALYTICAL TRANSFER
The following documents apply to the transfer in its latest valid version
1. Executive Master Batch Record
2. Protocol for the validation batches
3. Report for the validation batches
4. Protocol for the Media Fill Trials
5. Report for the Media Fill Trials
6. Development report(s) for the manufacturing process
7. Validation Reports for the analytical methods including IPC
8. Analytical testing procedures
9. Specifications (release, shelf-life) for the Product
- xxiii -
SCHEDULE 8.2.2
EXAMPLE OF STEP-DOWN PROVISIONS
[REDACTED]
[Exclusion of confidential information relating to royalties]
- xxiv -
SCHEDULE 8.3
EXAMPLE OF COMBINATION PRODUCT CALCULATION
[REDACTED]
[Exclusion of confidential information relating to calculation of Net Sales]
- xxv -
SCHEDULE 9.2.1
SHARED COST PATENTS
[REDACTED]
[Exclusion of confidential information relating to Licensed Patents]
- xxvi -
SCHEDULE 12.3
EXCEPTION TO REPRESENTATIONS AND WARRANTIES
Licensor has licensed to a Third Party certain rights under the Licensed
Know-How for use in connection with the exploitation of certain products
containing the ozarelix compound (but not the cetrorelix compound) pursuant to
that certain License and Collaboration Agreement for D-63153, dated August 12,
2004, by and between Licensor and Spectrum Pharmaceuticals, Inc.
- xxvii -
SCHEDULE 15.3.3
LICENSOR'S DESIGNEES
(attached)
- xxviii -
EXHIBIT 15.3.3
LICENSOR'S DESIGNEES
1. Clinical Supply
STUDY 033, 036, 041 AND 043
ACTIVITY NAME OF CRO ADDRESS
------------------------------------------------------------------------------------
Manufacturer of API [REDACTED] [REDACTED]
Testing of the API (sterility) [REDACTED] [REDACTED]
Testing of the API (residual solvent) and drug product [REDACTED] [REDACTED]
(residual ethanol)
Testing of API (purity amino acid content) [REDACTED] [REDACTED]
Manufacturer of production equipments [REDACTED] [REDACTED]
Manufacturer of Drug Product and testing of drug product [REDACTED] [REDACTED]
(sterility)
STUDY ▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇ AND EUROPE
ACTIVITY NAME OF CRO ADDRESS
------------------------------------------------------------------------------------
Labeling, Packaging [REDACTED] [REDACTED]
(North America - open label phase, Europe blinded and
open label phases)
Distribution [REDACTED] [REDACTED]
(North America - open label phase)
STUDY 036 EUROPE
ACTIVITY NAME OF CRO ADDRESS
------------------------------------------------------------------------------------
Labeling, Packaging and Distribution [REDACTED] [REDACTED]
Distribution (Belarus) [REDACTED] [REDACTED]
- xxix -
Distribution (France) [REDACTED] [REDACTED]
Distribution (Macedonia) [REDACTED] [REDACTED]
STUDY ▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇
ACTIVITY NAME OF CRO ADDRESS
------------------------------------------------------------------------------------
Labeling, Packaging [REDACTED] [REDACTED]
Distribution [REDACTED] [REDACTED]
STUDY ▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇
ACTIVITY NAME OF CRO ADDRESS
------------------------------------------------------------------------------------
Labeling, Packaging and Distribution [REDACTED] [REDACTED]
- xxx -
2. Clinical Trial Investigations
STUDY ▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇ AND EUROPE
ACTIVITY NAME OF CRO ADDRESS
------------------------------------------------------------------------------------
Monitoring (North America) [REDACTED] [REDACTED]
Monitoring (Europe) [REDACTED] [REDACTED]
Monitoring (Bulgaria) [REDACTED] [REDACTED]
Data Management and Biostatistics [REDACTED] [REDACTED]
(North America and Europe)
Central Laboratory [REDACTED] [REDACTED]
(North America)
Central Laboratory [REDACTED] [REDACTED]
(Europe)
Pharmacokinetic/Analytic [REDACTED] [REDACTED]
(North America and Europe)
Evaluation of Bone mineral density: [REDACTED] [REDACTED]
Central Readings of DEXA Scans
(North America and Europe)
Clinical Trial Management [REDACTED] [REDACTED]
(Europe - Germany)
Clinical Trial Management [REDACTED] [REDACTED]
(Europe - Bulgaria)
STUDY 036 EUROPE
ACTIVITY NAME OF CRO ADDRESS
------------------------------------------------------------------------------------
Monitoring - Europe [REDACTED] [REDACTED]
Monitoring - Bulgaria [REDACTED] [REDACTED]
Monitoring - Macedonia [REDACTED] [REDACTED]
- xxxi -
Monitoring - Romania [REDACTED] [REDACTED]
Monitoring - Czech Republic and Belarus [REDACTED] [REDACTED]
Data Management and Biostatistics [REDACTED] [REDACTED]
Central Laboratory [REDACTED] [REDACTED]
Pharmacokinetic/Analytic [REDACTED] [REDACTED]
Evaluation of Bone mineral density: [REDACTED] [REDACTED]
Central Readings of DEXA Scans
Clinical Trial Management [REDACTED] [REDACTED]
(Europe - Bulgaria)
Clinical Trial Management and Monitoring [REDACTED] [REDACTED]
(Europe - The Netherlands)
Regulatory Services [REDACTED] [REDACTED]
(Europe - Italy)
STUDY ▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇
ACTIVITY NAME OF CRO ADDRESS
------------------------------------------------------------------------------------
Monitoring, Data Management and Biostatistics [REDACTED] [REDACTED]
STUDY ▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇
ACTIVITY NAME OF CRO ADDRESS
------------------------------------------------------------------------------------
Monitoring [REDACTED] [REDACTED]
Data Management and Biostatistics, Quality Assurance, [REDACTED] [REDACTED]
Laboratory, PD Analysis
ECG Analysis [REDACTED] [REDACTED]
Pharmacokinetic/Analytic [REDACTED] [REDACTED]
- xxxii -
3. Preclinical Activities
ACTIVITY NAME OF CRO ADDRESS
------------------------------------------------------------------------------------
Carcinogenicity Study [REDACTED] [REDACTED]
Toxicokinetics/Bioanalytics [REDACTED] [REDACTED]
Mechanism of Action/Pharmacology Studies [REDACTED] [REDACTED]
Mechanism of Action/Pharmacology Studies [REDACTED] [REDACTED]
- xxxiii -