EXHIBIT 10.11
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COLLABORATION AND LICENSE AGREEMENT
by and between
WYETH
acting through its Wyeth Pharmaceuticals Division
and
TRUBION PHARMACEUTICALS, INC.
December 19, 2005
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TABLE OF CONTENTS
Page
1. DEFINITIONS.............................................................................................. 1
2. LICENSES................................................................................................. 17
2.1 Licenses to Wyeth............................................................................ 17
2.1.1 Exclusive Licenses............................................................... 17
2.1.2 Retained Rights of Trubion....................................................... 17
2.2 License to Trubion........................................................................... 17
2.3 Exclusivity.................................................................................. 17
2.3.1 CD20 Product Exclusivity......................................................... 18
2.3.2 ***.............................................................................. 18
2.3.3 Limitations...................................................................... 18
2.4 Sublicensing................................................................................. 19
2.5 Direct Licenses to Affiliates................................................................ 19
2.6 Right of Reference........................................................................... 20
2.7 Section 365(n) of Bankruptcy Code............................................................ 20
2.8 No Implied Rights............................................................................ 21
3. RESEARCH PROGRAM......................................................................................... 21
3.1 Scope and Conduct of the Research Program.................................................... 21
3.2 Designation of Targets....................................................................... 22
3.2.1 Target Candidates................................................................ 22
3.2.2 Released Targets................................................................. 23
3.2.3 Wyeth Targets.................................................................... 24
3.2.4 Excluded Targets................................................................. 25
3.3 Term and Termination of the Research Program................................................. 27
3.3.1 Research Term.................................................................... 27
3.3.2 Termination of Research Program by Wyeth......................................... 27
3.4 Joint Research Committee..................................................................... 28
3.4.1 Composition...................................................................... 28
3.4.2 Responsibilities................................................................. 28
3.4.3 Meetings......................................................................... 28
3.4.4 Voting........................................................................... 28
3.4.5 Dispute Resolution............................................................... 28
3.4.6 Minutes.......................................................................... 29
3.5 Research Plan................................................................................ 29
3.6 Funding of the Research Program.............................................................. 29
3.6.1 Research Funding................................................................. 29
3.6.2 Reimbursement Payments........................................................... 30
3.6.3 Records and Audits............................................................... 30
3.7 Data and Deliverables........................................................................ 31
3.8 Alliance Managers............................................................................ 32
4. PRODUCT DEVELOPMENT, MANUFACTURING, COMMERCIALIZATION AND REGULATORY MATTERS............................. 32
4.1 Product Development.......................................................................... 32
4.2 Transfer of Product Data and Filings......................................................... 33
4.3 Regulatory Approvals......................................................................... 33
4.4 Regulatory Reporting......................................................................... 34
4.5 Progress Reports............................................................................. 34
4.6 CD20 Product Development..................................................................... 35
4.7 Joint Development Committee.................................................................. 36
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4.8 Joint Project Team; Development Plan......................................................... 36
4.9 Manufacturing................................................................................ 37
4.10 Commercialization............................................................................ 37
4.11 Co-Promotion Option.......................................................................... 38
4.12 Co-Promotion Committee....................................................................... 38
4.13 Co-Branding.................................................................................. 39
4.14 Marking...................................................................................... 39
5. CONSIDERATION............................................................................................ 39
5.1 Initial Research and Development Expense Payment............................................. 39
5.2 Equity....................................................................................... 39
5.3 Additional Research and Development Expense Payments......................................... 39
5.4 Royalties.................................................................................... 39
5.4.1 Product Royalties................................................................ 39
5.4.2 CD20 Product Royalties........................................................... 40
5.4.3 ***.............................................................................. 42
5.4.4 Other Product Royalties.......................................................... 44
5.4.5 Expiration of Royalty Period..................................................... 45
5.4.6 Royalty Adjustments.............................................................. 46
5.5 Reports and Payments......................................................................... 46
5.5.1 Cumulative Royalties............................................................. 46
5.5.2 Royalty Statements and Payments.................................................. 47
5.5.3 Taxes and Withholding............................................................ 47
5.5.4 Currency......................................................................... 48
5.5.5 Additional Provisions Relating to Royalties...................................... 48
5.5.6 Interest on Past Due Payments.................................................... 48
5.6 Maintenance of Records; Audits............................................................... 48
5.6.1 Record Keeping................................................................... 48
5.6.2 Audits........................................................................... 49
5.6.3 Underpayments/Overpayments....................................................... 49
5.6.4 Confidentiality.................................................................. 49
6. INTELLECTUAL PROPERTY.................................................................................... 50
6.1 Inventions; Joint Patent Committee........................................................... 50
6.1.1 Ownership and Inventorship............................................................. 50
6.1.2 SMIP Improvements................................................................ 50
6.1.3 Joint Patent Committee........................................................... 51
6.2 Patent Rights................................................................................ 52
6.2.1 Filing, Prosecution and Maintenance of Patent Rights............................. 52
6.2.2 Enforcement of Patent Rights..................................................... 59
6.2.3 Infringement and Third Party Licenses............................................ 62
6.2.4 Patent Certifications............................................................ 64
6.2.5 Patent Term Restoration.......................................................... 64
6.3 Trademarks................................................................................... 64
7. CONFIDENTIALITY.......................................................................................... 65
7.1 Confidentiality.............................................................................. 65
7.2 Authorized Disclosure and Use................................................................ 65
7.2.1 Disclosure....................................................................... 65
7.2.2 Use.............................................................................. 66
7.3 SEC Filings.................................................................................. 67
7.4 Public Announcements; Publications........................................................... 67
7.4.1 Coordination..................................................................... 67
7.4.2 Announcements.................................................................... 67
7.4.3 Publications..................................................................... 67
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8. REPRESENTATIONS AND WARRANTIES........................................................................... 68
8.1 Representations and Warranties of Each Party................................................. 68
8.2 Additional Representations and Warranties of Trubion......................................... 69
8.3 Mutual Covenant.............................................................................. 70
8.4 Additional Covenants of Trubion.............................................................. 70
8.5 Representation by Legal Counsel.............................................................. 70
8.6 No Inconsistent Agreements................................................................... 70
8.7 Disclaimer................................................................................... 70
9. GOVERNMENT APPROVALS; TERM AND TERMINATION............................................................... 71
9.1 HSR Filing................................................................................... 71
9.2 Other Government Approvals................................................................... 71
9.3 Term......................................................................................... 71
9.4 Termination Upon HSR Denial.................................................................. 71
9.5 Material Breach.............................................................................. 72
9.6 Termination by Wyeth......................................................................... 72
9.6.1 Termination Without Cause........................................................ 73
9.6.2 Termination for a Material Safety or Regulatory Issue............................ 73
9.7 Effects of Termination....................................................................... 73
9.7.1 Effect of Termination by Wyeth for Cause......................................... 73
9.7.2 Effect of Termination by Trubion for Cause....................................... 77
9.7.3 Effect of Termination by Wyeth Without Cause..................................... 80
9.7.4 Effect of Termination by Wyeth for a Material Safety or Regulatory Issue......... 82
9.7.5 Post-Termination Rights to Wyeth Technology and Trubion Technology............... 83
9.7.6 Post-Termination Licenses to Wyeth Technology.................................... 84
9.7.7 Post-Termination Transfer of Product Data and Filings and Existing Trademarks.... 84
9.7.8 Manufacturing of Licensed Products After Termination............................. 85
9.7.9 Post-Termination Disposition of Inventories of Licensed Products................. 86
9.7.10 Continuation of Rights and Licenses Under Sections 6.1.1 and 6.1.2............... 86
9.7.11 Continuation of Other Rights and Obligations..................................... 86
9.8 Modification of Agreement Terms by Wyeth..................................................... 86
9.9 Survival of Certain Obligations.............................................................. 87
9.10 Change of Control............................................................................ 88
9.10.1 Definition....................................................................... 88
9.10.2 Change of Control of Wyeth....................................................... 89
9.10.3 Change of Control of Trubion..................................................... 91
10. INDEMNIFICATION AND INSURANCE............................................................................ 91
10.1 Indemnification by Wyeth..................................................................... 91
10.2 Indemnification by Trubion................................................................... 91
10.3 Procedure.................................................................................... 92
10.4 Insurance.................................................................................... 93
11. DISPUTE RESOLUTION....................................................................................... 93
11.1 General...................................................................................... 93
11.2 Failure of Executive Officers to Resolve Dispute............................................. 93
11.3 Disclaimer of Consequential and Punitive Damages............................................. 93
12. MISCELLANEOUS............................................................................................ 93
12.1 Periodic Executive Meetings.................................................................. 93
12.2 Assignment................................................................................... 94
12.3 Further Actions.............................................................................. 94
12.4 Force Majeure................................................................................ 94
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12.5 Non-Solicitation............................................................................. 94
12.6 Correspondence and Notices................................................................... 95
12.6.1 Ordinary Notices................................................................. 95
12.6.2 Extraordinary Notices............................................................ 95
12.7 Amendment.................................................................................... 96
12.8 Waiver....................................................................................... 96
12.9 Severability................................................................................. 96
12.10 Descriptive Headings......................................................................... 96
12.11 Governing Law................................................................................ 97
12.12 Entire Agreement of the Parties.............................................................. 97
12.13 Independent Contractors...................................................................... 97
12.14 Counterparts................................................................................. 97
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EXHIBITS
Exhibit 1.122 - TRU-015
Exhibit 1.129 - Trubion Patent Rights
Exhibit 1.132 - Trubion Third Party Agreements
Exhibit 3.2.1 - Trubion's "Milestone One"
Exhibit 3.2.4 - Excluded Targets
Exhibit 4.4 - Adverse Event Reporting Procedures
Exhibit 5.2A - Stock Purchase Agreement
Exhibit 5.2B - Amendment to Investor Rights Agreement
Exhibit 5.3 - Additional Research and Development Expense Payments
Exhibit 8.2(d) - Third Party Rights
Exhibit 8.2(e) - Government Funding Agreements
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COLLABORATION AND LICENSE AGREEMENT
This Collaboration and License Agreement (the "Agreement") is entered into
as of December 19, 2005 (the "Signing Date"), by and between Wyeth, together
with its Affiliates (as defined below), acting through its Wyeth Pharmaceuticals
Division, a corporation organized and existing under the laws of the State of
Delaware and having a place of business at ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇,
▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ (collectively, "Wyeth") and Trubion Pharmaceuticals, Inc.,
together with its Affiliates (as defined below), a corporation organized and
existing under the laws of the State of Delaware and having a principal place of
business at ▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
(collectively, "Trubion"). Wyeth and Trubion may each be referred to herein
individually as a "Party" and collectively as the "Parties".
WHEREAS, Wyeth is engaged in the research, development and
commercialization of pharmaceutical and health care products;
WHEREAS, as of the Signing Date, Trubion has developed certain SMIPs (as
defined below) and CD20 Products (as defined below), as well as certain Patent
Rights (as defined below) and Know-How (as defined below) pertaining to
Trubion's SMIP technology platform;
WHEREAS, Wyeth and Trubion desire to collaborate to discover, research and
develop, and Wyeth desires to research, develop, manufacture and commercialize,
Licensed Products (as defined below) as provided herein; and
WHEREAS, Wyeth desires to obtain from Trubion, and Trubion desires to
grant to Wyeth, certain exclusive rights so that Wyeth may develop, manufacture
and commercialize such Licensed Products, as provided herein.
NOW THEREFORE, in consideration of the mutual promises and covenants set
forth below and other good and valuable consideration, the receipt and
sufficiency of which is hereby acknowledged, the Parties hereby agree as
follows:
1. DEFINITIONS.
1.1. "ADDITIONAL RESEARCH AND DEVELOPMENT EXPENSE PAYMENT" shall have the
meaning set forth in Section 5.3 hereof.
1.2. "ADDITIONAL THIRD PARTY LICENSES" shall have the meaning set forth
in Section 6.2.3(a) hereof.
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1.3. "AFFILIATE(S)" shall mean, with respect to any Person, any other
Person which controls, is controlled by or is under common control
with such Person. A Person shall be regarded as in control of
another entity if it owns or controls at least fifty percent (50%)
of the equity securities of the subject entity entitled to vote in
the election of directors (or, in the case of an entity that is not
a corporation, for the election of the corresponding managing
authority); provided, however, that the term "Affiliate" shall not
include subsidiaries or other entities in which a Party or its
Affiliates owns a majority of the ordinary voting power necessary to
elect a majority of the board of directors or other governing board,
but is restricted from electing such majority by contract or
otherwise, until such time as such restrictions are no longer in
effect.
1.4. "AGREEMENT" shall have the meaning set forth in the preamble hereof.
1.5. "BANKRUPTCY CODE" shall have the meaning set forth in Section 2.7
hereof.
1.6. "BLA" shall have the meaning set forth in Section 1.100 hereof.
1.7. "CALENDAR QUARTER" shall mean the respective periods of three (3)
consecutive calendar months ending on March 31, June 30, September
30 or December 31, for so long as this Agreement is in effect.
1.8. "CATEGORY 1 COVERED SMIP IMPROVEMENT" shall have the meaning set
forth in Section 6.1.3(b) hereof.
1.9. "CATEGORY 2 COVERED SMIP IMPROVEMENT" shall have the meaning set
forth in Section 6.1.3(b) hereof.
1.10. "CD20 ANTIGEN" shall mean the human protein antigen that is known as
CD20, and identified as a full length CD20 protein antigen in ***,
and any other protein that *** as the foregoing.
1.11. "CD20 EFFECTIVE ROYALTY RATE" shall have the meaning set forth in
Section 5.4.2(a) hereof.
1.12. "CD20 PRODUCT" shall mean any TRU-015 Product and/or Follow-On CD20
Product (as the context requires).
1.13. "CELL LINES" shall mean the cell lines and any other expression
systems that produce or express any SMIP.
1.14. "CHANGE OF CONTROL" shall have the meaning set forth in Section
9.10.1 hereof.
1.15. "CLINICAL STUDY SUPPLIES" shall have the meaning set forth in
Section 4.9 hereof.
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1.16. "COMBINATION PRODUCT" shall mean any product containing as active
ingredients both (a) a Product and (b) one or more other
pharmaceutically active compounds or substances.
1.17. "COMBINATION SALE" shall have the meaning set forth in Section 1.76
hereof.
1.18. "COMMERCIALIZATION" OR "COMMERCIALIZE" shall mean activities
directed to marketing, promoting, distributing, importing or selling
a product. Commercialization shall not include any activities
related to Manufacturing or Development.
1.19. "COMMERCIALLY REASONABLE EFFORTS" shall mean, with respect to the
efforts to be expended by any Party with respect to any objective,
those reasonable, diligent, good faith efforts to accomplish such
objective as such Party would normally use to accomplish a similar
objective under similar circumstances. With respect to any objective
relating to the Development and/or Commercialization of a Licensed
Product by any Party, "Commercially Reasonable Efforts" shall mean
those efforts and resources normally used by such Party with respect
to a product owned or controlled by such Party, or to which such
Party has similar rights, which product is of similar market
potential and is at a similar stage in its development or life as is
such Licensed Product, taking into account issues of safety,
efficacy, product profile, the competitiveness of the marketplace,
the proprietary position of the Licensed Product, the regulatory
structure involved, profitability of the Licensed Product and other
relevant commercial factors. A "COMMERCIALLY REASONABLE" action or
decision of a Party refers in this Agreement to an action or
decision taken or made by such Party using its Commercially
Reasonable Efforts.
1.20. "CONFIDENTIAL INFORMATION" of a Party shall mean all Know-How or
other information, including, without limitation, proprietary
information and materials (whether or not patentable) regarding such
Party's technology, products, business information or objectives,
that is communicated in any way or form by the Disclosing Party to
the Receiving Party, either prior to or after the Effective Date of
this Agreement, and whether or not such Know-How or other
information is identified as confidential at the time of disclosure;
provided that, information not identified as confidential by the
Disclosing Party shall be deemed to be Confidential Information of
the Disclosing Party if the Receiving Party knows, or should have
had a reasonable expectation, that the information communicated by
the Disclosing Party is Confidential Information of the Disclosing
Party. The terms and conditions of this Agreement shall be
considered Confidential Information of both Parties.
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1.21. "CONJUGATE(S)" shall mean SMIP(s) fused genetically or linked,
either directly or through a linker molecule, with any biological,
cytostatic, cytotoxic or radioactive agent.
1.22. "CONTROL" OR "CONTROLLED" shall mean with respect to any (a) item of
information, including, without limitation, Know-How, or (b)
intellectual property right, the possession (whether by ownership or
license, other than pursuant to this Agreement) by a Party of the
ability to grant to the other Party a license or to extend other
rights as provided herein, under such item or right without
violating the terms of any agreement or other arrangements with any
Third Party.
1.23. "CO-PROMOTION" shall mean the joint promotion of a CD20 Product in
the United States by both Parties and/or their respective Affiliates
under the same CD20 Product Trademark(s). "CO-PROMOTE," when used as
a verb, shall mean to engage in such Co-Promotion.
1.24. "CO-PROMOTION PERIOD" shall have the meaning set forth in Section
4.11 hereof.
1.25. "COVERED SMIP IMPROVEMENT" shall have the meaning set forth in
Section 6.1.2 hereof.
1.26. "DEPOSITED PROTEIN" shall have the meaning set forth in Section 1.45
hereof.
1.27. "DESIGNATED TARGET(S)" shall have the meaning set forth in Section
9.8 hereof.
1.28. "DEVELOPMENT" OR "DEVELOP" shall mean non-clinical and clinical drug
development activities pertaining to a product, including, without
limitation, toxicology, pharmacology, test method development and
stability testing, process development, formulation development,
delivery system development, quality assurance and quality control
development, statistical analysis, clinical studies (including pre-
and post-approval studies), regulatory affairs, pharmacovigilance
and Regulatory Approval and clinical study regulatory activities
(including regulatory activities directed to obtaining pricing and
reimbursement approvals).
1.29. "DEVELOPMENT PLAN" shall mean the written plan for the Development
of CD20 Products described in Section 4.8 hereof.
1.30. "DISCLOSING PARTY" shall have the meaning set forth in Section 7.1
hereof.
1.31. "EFFECTIVE DATE" shall mean the later to occur of (a) the Signing
Date and (b) the HSR Clearance Date.
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1.32. "EXCHANGE ACT" shall mean the Securities Exchange Act of 1934, as
amended.
1.33. "EXCLUDED TARGET(S)" shall mean the Target(s) described in Section
3.2.4 hereof as Excluded Target(s).
1.34. "EXCLUSIVITY COVENANTS" shall have the meaning set forth in Section
9.10.2(c) hereof.
1.35. "EXECUTIVE OFFICERS" shall mean the President of Wyeth
Pharmaceuticals (or an executive officer of Wyeth designated by such
President of Wyeth Pharmaceuticals) and the Chief Executive Officer
of Trubion (or an executive officer of Trubion designated by such
Chief Executive Officer).
1.36. "EXERCISE NOTICE" shall have the meaning set forth in Section
9.10.2(c) hereof.
1.37. "EXISTING ACTIVITIES" shall have the meaning set forth in Section
9.10.2(c) hereof.
1.38. "EXISTING TRADEMARKS" shall have the meaning set forth in Section
9.7.1(a).
1.39. "FDA" shall mean the United States Food and Drug Administration or
any successor agency thereto.
1.40. "FD&C ACT" shall mean the United States Federal Food, Drug, and
Cosmetic Act (21 U.S.C. Section 301 et seq.), as amended, and the
rules and regulations promulgated thereunder.
1.41. "FIRST COMMERCIAL SALE" shall mean, with respect to a given Licensed
Product and any country in the Territory, the first sale or transfer
for value of such Licensed Product under this Agreement by Wyeth or
its sublicensees to a Third Party in such country following receipt
of marketing authorization from the appropriate Regulatory Authority
permitting commercial sale of such Licensed Product in such country.
1.42. "FOLLOW-ON CD20 PRODUCT" shall mean any product containing a
Follow-On CD20 SMIP.
1.43. "FOLLOW-ON CD20 SMIP" shall mean any SMIP (other than TRU-015)
directed against the CD20 Antigen or a portion thereof.
1.44. "FTE" shall mean a full time equivalent scientific person (M.S. or
Ph.D. level) year, consisting of a minimum of a total of one
thousand eight hundred eighty (1,880) hours per year of scientific
work by an employee of Trubion on or directly related to and in
support of the Research Program. Work on or directly related to the
Research Program can include, but is not
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limited to, experimental preclinical laboratory and research work,
recording and writing up results, reviewing literature and
references, holding scientific discussions, managing and leading
scientific staff and carrying out management duties, in each case
where such activities are directly related to the Research Program.
1.45. "HAS THE SAME SEQUENCE" shall mean, with respect to a specific
protein (as described by an amino acid sequence identified by a
GenBank accession number; a "New Protein"), that another specific
protein (as described by an amino acid sequence identified by a
GenBank accession number; each, a "Deposited Protein") has at least
*** amino acid sequence identity over at least *** of the length of
the New Protein.
By way of example only, if the New Protein consists of *** amino
acids, and any contiguous sequence of *** amino acids contained in
the Deposited Protein has at least *** sequence identity to any
contiguous sequence of *** amino acids in the New Protein (that is,
at least *** of the *** contiguous amino acids in such Deposited
Protein sequence are identical to any *** of any *** contiguous
amino acids in such New Protein), then the New Protein Has The Same
Sequence as the Deposited Protein.
1.46. ***
1.47. ***
1.48. ***
1.49. ***
1.50. "HSR ACT" shall mean the ▇▇▇▇-▇▇▇▇▇-▇▇▇▇▇▇ Antitrust Improvements
Act of 1976, as amended, and the rules and regulations promulgated
thereunder.
1.51. "HSR FILING" shall mean filings by Wyeth and Trubion with the United
States Federal Trade Commission and the Antitrust Division of the
United States Department of Justice of a Notification and Report
Form for Certain Mergers and Acquisitions (as that term is defined
in the HSR Act) with respect to the matters set forth in this
Agreement, together with all required documentary attachments
thereto.
1.52. "HSR CLEARANCE DATE" shall mean the earliest date on which the
Parties have actual knowledge that all applicable waiting periods
under the HSR Act with respect to the transactions contemplated
hereunder have expired or have been terminated.
1.53. "IND" shall mean an Investigational New Drug Application, as defined
in the FD&C Act, that is required to be filed with the FDA before
beginning clinical testing of a Licensed Product in human subjects,
or an equivalent foreign filing.
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1.54. "INDEMNIFIED PARTY" shall have the meaning set forth in Section 10.3
hereof.
1.55. "INDEMNIFYING PARTY" shall have the meaning set forth in Section
10.3 hereof.
1.56. "INITIAL TERM" shall have the meaning set forth in Section 3.3.1
hereof.
1.57. "JDC" shall have the meaning set forth in Section 4.7 hereof.
1.58. "JOINT INVENTION(S)" shall have the meaning set forth in Section
6.1.1 hereof.
1.59. "JOINT KNOW-HOW" shall mean that Know-How related to the Licensed
Products that is jointly owned by the Parties in accordance with
Section 6.1.1 of this Agreement.
1.60. "JOINT PATENT COMMITTEE" shall mean the committee described in
Section 6.1.3 hereof.
1.61. "JOINT PATENT RIGHT(S)" shall mean those Patent Right(s) that claim
Joint Know-How or Joint Invention(s).
1.62. "JOINT TECHNOLOGY" shall mean the Joint Patent Rights, the Joint
Inventions and the Joint Know-How.
1.63. "JPT" shall have the meaning set forth in Section 4.8 hereof.
1.64. "JRC" shall have the meaning set forth in Section 3.4.1 hereof.
1.65. "JRC LIAISON" shall mean a JRC member designated by a Party as its
"JRC Liaison" in accordance with Section 3.4.3 hereof.
1.66. "KNOW-HOW" shall mean inventions, discoveries, data, information,
processes, methods, techniques, materials, technology, results or
other know-how, whether or not patentable.
1.67. "LIABILITIES" shall have the meaning set forth in Section 10.1
hereof.
1.68. "LICENSED PRODUCT(S)" shall mean any Product(s) or Combination
Product(s).
1.69. "LICENSED TARGET(S)" shall mean any Trubion Target(s) or Wyeth
Target(s), so long as they remain the subject of the licenses
granted to Wyeth under this Agreement.
1.70. "MAJOR INDICATION(S)" shall mean, with respect to any CD20 Product,
any indication with a prevalence-based patient population of at
least two hundred thousand (200,000) patients in the United States,
including,
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without limitation, non-Hodgkin's lymphoma, rheumatoid arthritis,
systemic lupus erythematosus, Crohn's disease and multiple
sclerosis.
1.71. "MAJOR MARKET COUNTRY" shall mean any of the United States, the
United Kingdom, France, Germany, Italy, Spain or Japan.
1.72. "MANUFACTURING" or "MANUFACTURE" shall mean activities directed to
producing, manufacturing, processing, filling, finishing, packaging,
labeling, quality assurance testing and release, shipping and
storage of a product.
1.73. "NCBI" shall have the meaning set forth in Section 3.2.1 hereof.
1.74. "NDA" shall have the meaning set forth in Section 1.100 hereof.
1.75. "NET COMBINATION SALE AMOUNT" shall have the meaning set forth in
Section 1.76 hereof.
1.76. "NET SALES" shall mean the gross amounts charged for sales of
Licensed Products (on which payments are due under this Agreement)
by Wyeth or its sublicensees to Third Parties, less the sum of (a)
and (b) where (a) is a provision, determined under Generally
Accepted Accounting Principles in the United States and in
accordance with Wyeth's customary and usual accrual procedures,
consistently applied, for the accrual of (i) trade, cash, quantity
and wholesaler discounts or rebates (other than price discounts
granted at the time of sale), if any, allowed or paid, (ii) credits
or allowances given or made for rejection or return of, previously
sold Licensed Products or for retroactive price reductions
(including Medicaid, managed care and similar types of rebates),
(iii) taxes, duties or other governmental charges levied on or
measured by the billing amount (excluding income and franchise
taxes), as adjusted for rebates and refunds, and (iv) charges for
packing, freight, and shipping to the extent included in the invoice
price and (b) is a periodic adjustment (positive or negative, as
applicable), determined under Generally Accepted Accounting
Principles in the United States and in accordance with Wyeth's
customary and usual adjustment procedures, consistently applied, of
the provision determined in (a) to reflect amounts actually incurred
for (i), (ii), (iii) and (iv) based on amounts actually invoiced or
as separately set forth in agreements with Third Parties or as
deducted or paid as required by applicable law or regulations. (The
deductions described in (i), (ii), (iii) and (iv) are referred to
herein as "Permitted Deductions.") In the case of any sale of
Licensed Products for consideration other than cash, Net Sales shall
be calculated on the fair market value of the consideration
received.
Notwithstanding the foregoing, if a Licensed Product is sold as a
Combination Product (a "Combination Sale"), the Net Sales for such
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Combination Product shall be the portion of such Combination Sale
allocable to the Licensed Product determined as follows:
Except as provided below, the Net Sales amount for a Combination
Sale shall equal the gross amount invoiced for the Combination Sale,
reduced by the Permitted Deductions (the "Net Combination Sale
Amount"), multiplied by the fraction A/(A+B), where:
A is the invoice price, in the country where such Combination
Sale occurs, of the Licensed Product contained in the
Combination Product, if sold as a separate product in such
country by Wyeth or its sublicensees, as the case may be, and
B is the aggregate of the invoice price or prices, in such
country, of products which collectively contain as their
respective sole active ingredient such other pharmaceutically
active compounds or substances, as the case may be, included
in the Combination Product, if sold separately in such country
by Wyeth or its sublicensees, as applicable.
In the event that Wyeth or its sublicensees sell the Licensed
Product included in a Combination Product as a separate product in a
country, but do not separately sell all of the other
pharmaceutically active compounds or substances, as the case may be,
included in such Combination Product in such country, the
calculation of the Net Sales amount for such Combination Sale shall
be determined by multiplying the Net Combination Sale Amount by the
fraction A/C where:
A is the average wholesale price, in such country, charged by
Wyeth or its sublicensees, as the case may be, for the
Licensed Product contained in such Combination Product, when
sold as a separate product by Wyeth or its sublicensees, as
applicable, and C is the average wholesale price, in such
country, charged by Wyeth or its sublicensees, as applicable,
for the entire Combination Product.
In the event that Wyeth or its sublicensees do not sell the Licensed
Product included in a Combination Product as a separate product in a
country where such Combination Sale occurs, but do separately sell
products which collectively contain as their respective sole active
ingredient all of the other pharmaceutically active compounds or
substances, as the case may be, included in the Combination Product
in such country, the calculation of Net Sales resulting from such
Combination Sale shall be determined by multiplying the Net
Combination Sale Amount by the fraction (C-D)/C, where:
C is the average wholesale price, in such country, charged by
Wyeth or its sublicensees, as the case may be, for the entire
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Combination Product, and D is the average wholesale price
charged by Wyeth or its sublicensees, as the case may be, for
the products which collectively contain as their sole active
ingredient such other pharmaceutically active compounds or
substances, as the case may be, included in the Combination
Product.
Where active ingredient portions of a Combination Product are sold
separately as other products but in different dosage strengths than
are in the Combination Product, the calculation of the Net Sales
amount for such Combination Product shall be based on appropriate
proration of the amounts of each active ingredient component
included therein when applying the formulas set forth above.
Where the calculation of Net Sales resulting from a Combination Sale
in a country cannot be determined by any of the foregoing methods,
the calculation of Net Sales for such Combination Sale shall be that
portion of the Net Combination Sale Amount reasonably determined in
good faith by the Parties as properly reflecting the value of the
Licensed Product included in the Combination Product.
Notwithstanding the foregoing, Net Sales shall not include any
reimbursement received by Wyeth or its sublicensees in respect of
the use of a Licensed Product in a country solely as part of a
clinical trial prior to the receipt of marketing authorization
required to commence commercial sales of such Licensed Product in
such country.
1.77. "NEW PROTEIN" shall have the meaning set forth in Section 1.45
hereof.
1.78. "NICHE INDICATION(S)" shall mean, with respect to any CD20 Product,
any indication, including, but not limited to, ***, for such CD20
Product other than a Major Indication.
1.79. "NOTICE OF BREACH" shall have the meaning set forth in Section 9.5
hereof.
1.80. "NOTICE OF MODIFICATION" shall have the meaning set forth in Section
9.5 hereof.
1.81. "NOTICE OF TERMINATION" shall have the meaning set forth in Section
9.5 hereof.
1.82. "OTHER PRODUCT" shall mean any product containing a SMIP directed
against a Wyeth Target or a portion thereof.
1.83. "PART(Y/IES)" shall have the meaning set forth in the preamble
hereof.
1.84. "PATENT RIGHTS" shall mean any and all (a) patents, (b) pending
patent applications, including, without limitation, all provisional
applications, substitutions, continuations, continuations-in-part,
divisions, renewals, and
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all patents granted thereon, (c) all patents-of-addition, reissues,
reexaminations and extensions or restorations by existing or future
extension or restoration mechanisms, including, without limitation,
supplementary protection certificates or the equivalent thereof, (d)
inventor's certificates, and (e) all United States and foreign
counterparts of any of the foregoing.
1.85. "PERSON" shall mean an individual, sole proprietorship, partnership,
limited partnership, limited liability partnership, corporation,
limited liability company, business trust, joint stock company,
trust, incorporated association, joint venture or similar entity or
organization, including a government or political subdivision,
department or agency of a government.
1.86. "PERMITTED DEDUCTION" shall have the meaning set forth in Section
1.76 hereof.
1.87. "PHASE I CLINICAL STUDY" shall mean a study of a Licensed Product in
human subjects with the endpoint of determining initial tolerance,
safety or pharmacokinetic information in single dose, single
ascending dose, multiple dose and/or multiple ascending dose
regimens.
1.88. "PHASE II CLINICAL STUDY" shall mean a study of a Licensed Product
in human patients to determine initial efficacy and dose range
finding before embarking on Phase III Clinical Studies.
1.89. "PHASE IIA CLINICAL STUDY" shall mean Trubion's TRU-015 Protocol
15001.
1.90. "PHASE IIB CLINICAL STUDY" shall mean Trubion's TRU-015 Protocol
15002.
1.91. "PHASE III CLINICAL STUDY" shall mean a pivotal study (whether or
not denominated a "Phase III" clinical study under applicable
regulations) in human patients with a defined dose or a set of
defined doses of a Licensed Product designed to ascertain efficacy
and safety of such Licensed Product for the purpose of enabling the
preparation and submission of Regulatory Approval Applications to
the competent Regulatory Authorities in a country of the Territory.
1.92. "PREVIOUSLY DEPOSITED PROTEIN" shall have the meaning set forth in
Section 3.2.4(b) hereof.
1.93. "PRODUCT" shall mean any CD20 Product, ***, or Other Product, or any
Conjugate of any CD20 Product, ***, or Other Product.
1.94. "PRODUCT DATA AND FILINGS" shall mean (a) all clinical protocols,
studies, clinical data and results used in or resulting from any
clinical trial of any
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Licensed Product and (b) all INDs, Regulatory Approval
Applications and Regulatory Approvals regarding any Licensed
Product.
1.95. "PRODUCT LICENSE" shall have the meaning set forth in Section
2.1.1 hereof.
1.96. "PRODUCT-RELATED PATENT RIGHTS" shall have the meaning set forth
in Section 6.2.1(a) hereof.
1.97. "PROVISIONAL EXCLUDED TARGET" shall mean a Target described in
Section 3.2.4 hereof as a Provisional Excluded
1.98. "RECEIVING PARTY" shall have the meaning set forth in Section 7.1
hereof.
1.99. "RECOMBINANT DNA" shall mean the DNA sequences encoding any SMIP
including, without limitation, any DNA plasmid expression
construct encoding any such SMIP.
1.100. "REGULATORY APPROVAL" shall mean the technical, medical and
scientific licenses, registrations, authorizations and approvals
(including, without limitation, approvals of New Drug Applications
("NDAs") or Biologic License Applications ("BLAs"), supplements
and amendments, pre- and post- approvals, pricing approvals, and
labeling approvals) of any national, supra-national, regional,
state or local regulatory agency, department, bureau, commission,
council or other governmental entity, necessary for the commercial
Manufacture, distribution, marketing, promotion, offer for sale,
use, import, export and sale of Licensed Product(s) in a
regulatory jurisdiction in the Territory. For the sake of clarity,
Regulatory Approval shall not be deemed to have been obtained in a
country other than the United States until any applicable
governmental pricing approvals have also been obtained in such
country. Regulatory Approval of a Licensed Product shall be deemed
to have been obtained in the United States immediately upon BLA
approval for such Licensed Product in the United States.
1.101. "REGULATORY APPROVAL APPLICATION" shall mean an application
submitted to the appropriate Regulatory Authority seeking
Regulatory Approval of a Licensed Product for use in one or more
therapeutic indications in a regulatory jurisdiction within the
Territory.
1.102. "REGULATORY AUTHORIT(Y/IES)" shall mean any national (e.g., the
FDA), supra-national (e.g., the European Commission, the Council
of the European Union, or the European Agency for the Evaluation
of Medicinal Products), regional, state or local regulatory
agency, department, bureau, commission, council or other
governmental entity in each country of the Territory involved in
the granting of Regulatory Approval for a Licensed Product.
1.103. "RELEASED TARGET" shall have the meaning set forth in Section
3.2.2 hereof.
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1.104. "REPLACEMENT TARGET" shall have the meaning set forth in Section
3.2.3 hereof.
1.105. "RESEARCH BUDGET" shall have the meaning set forth in Section 3.5
hereof.
1.106. "RESEARCH PLAN" shall mean the written plan for the conduct of the
Research Program described in Section 3.5 hereof as approved and
amended by the Parties in accordance with Section 3.5 hereof.
1.107. "RESEARCH PROGRAM" shall have the meaning set forth in Section 3.1
hereof.
1.108. "RESEARCH PROGRAM DATA" shall have the meaning set forth in
Section 3.7 hereof.
1.109. "RESEARCH TERM" shall have the meaning set forth in Section 3.3.1
hereof.
1.110. "ROYALTY PERIOD" shall mean the period of time beginning on the
date of the First Commercial Sale of a Licensed Product in any
country and, on a Licensed Product-by-Licensed Product and
country-by-country basis, extending until the earlier of (a) the
termination of this Agreement pursuant to Article 9 hereof with
respect to such Licensed Product in such country or (b) the later
of (i) the date on which the last Valid Claim included within the
Trubion Technology ceases to be a Valid Claim, which Valid Claim
would be infringed by the composition, Manufacture, use, sale,
offer for sale or importing of such Licensed Product in such
country, or (ii)(A) with respect to CD20 Products, the ten (10)
year anniversary of the First Commercial Sale for the first Major
Indication of such CD20 Product in such country (provided,
however, that if such CD20 Product has received Regulatory
Approval for a Niche Indication in such country but has not
received Regulatory Approval for a Major Indication in such
country, the Royalty Period as defined under and for purposes of
this clause (ii)(A) for such CD20 Product in such country shall be
suspended beginning on the ten (10) year anniversary of the First
Commercial Sale of such CD20 Product in such country until such
time, if at all, as Regulatory Approval has been obtained
permitting the marketing of such CD20 Product for a Major
Indication in such country, at which point such Royalty Period
shall commence with respect to such CD20 Product for a Major
Indication) and (B) with respect to each other Licensed Product,
the ten (10) year anniversary of the First Commercial Sale of such
Licensed Product in such country.
1.111. "SIGNING DATE" shall have the meaning set forth in the preamble
hereof.
1.112. "SMIP(S)" or small modular immuno-pharmaceutical(s) shall mean a
single chain polypeptide that (i) *** (ii) binds with specificity
to a target antigen, (iii) has a binding domain, and (iv) may have
an effector domain which may or may not have effector function,
***.
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1.113. "SMIP IMPROVEMENT" shall mean an invention consisting of any
modification to the polynucleotide sequence encoding or the amino
acid sequence of a SMIP, if the practice of such invention would
infringe Patent Rights Controlled by Trubion at the time such
invention is made.
1.114. "SPECIFICALLY BINDS" shall mean, in the case of a SMIP or other
protein, the binding of such SMIP or other protein to a Target (or
a portion thereof) above the level of background binding and
wherein such SMIP or other protein is designed or being developed
to exert its biological effect through binding to such Target (or
such portion thereof).
1.115. "SUCCESSOR PARTY" shall have the meaning set forth in Section
9.10.2(a) hereof.
1.116. "SUED PARTY" shall have the meaning set forth in Section 6.2.3(b)
hereof.
1.117. "TARGET" shall mean a specific named human protein that is
identified as a full length protein of that name and further
identified by up to *** GenBank accession numbers for its amino
acid sequence, as well as any additional protein(s) that Has The
Same Sequence as such specific named human protein.
1.118. "TARGET CANDIDATE" shall have the meaning set forth in Section
3.2.1 hereof.
1.119. "TERRITORY" shall mean the entire world.
1.120. "THIRD PART(Y/IES)" shall mean any Person(s) other than Wyeth or
Trubion.
1.121. "TRADEMARK" shall mean those trademarks used in connection with
the Commercialization of any Licensed Product by Wyeth or its
sublicensees hereunder.
1.122. "TRU-015" shall mean the chimeric SMIP directed against the CD20
Antigen that is currently designated by Trubion as "TRU-015," as
further described on Exhibit 1.122 attached hereto.
1.123. "TRU-015 PRODUCT" shall mean any product containing TRU-015.
1.124. "TRUBION" shall have the meaning set forth in the preamble hereof.
1.125. "TRUBION ADDITIONAL THIRD PARTY LICENSE" shall have the meaning
set forth in Section 6.2.3(a) hereof.
1.126. "TRUBION INDEMNIFIED PARTY" shall have the meaning set forth in
Section 10.1 hereof.
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1.127. "TRUBION KNOW-HOW" shall mean any Know-How, other than the Joint
Know-How, that (a) Trubion Controls as of the Effective Date or
that comes into the Control of Trubion during the term of this
Agreement (other than through the grant of a license by Wyeth) and
(b) relates to any Cell Lines, Conjugates, Licensed Products,
Recombinant DNA, SMIPs, Licensed Targets, Target Candidates or the
Development, Manufacture or use of any of the foregoing.
1.128. "TRUBION LAWYERS" shall have the meaning set forth in Section 3.2.1
hereof.
1.129. "TRUBION PATENT RIGHTS" shall mean Patent Rights, other than Joint
Patent Rights, that (a) Trubion Controls as of the Effective Date
or that come into the Control of Trubion during the term of this
Agreement and (b) claim any Trubion Know-How. Those Trubion Patent
Rights known to be existing as of the Signing Date are listed on
Exhibit 1.129 attached hereto.
1.130. "TRUBION TARGET" shall mean each of the human CD20 Antigen and/or
***, as the context may require.
1.131. "TRUBION TECHNOLOGY" shall mean Trubion's interest in the Trubion
Patent Rights, the Trubion Know-How, the Joint Technology and the
Research Program Data.
1.132. "TRUBION THIRD PARTY AGREEMENT(S)" shall mean the agreements
specified on Exhibit 1.132 between Trubion and the indicated Third
Parties that relate to the research, Development, Manufacture
and/or Commercialization of Licensed Products under this Agreement.
1.133. "U.S. WYETH PHARMACEUTICALS" shall have the meaning set forth in
Section 12.5 hereof.
1.134. "VALID CLAIM" shall mean a claim that (a) in the case of any
unexpired United States or foreign patent, shall not have been
dedicated to the public, disclaimed, nor held invalid or
unenforceable by a court or government agency of competent
jurisdiction in an unappealed or unappealable decision, or (b) in
the case of any United States or foreign patent application, (i)
shall not have been cancelled, withdrawn or abandoned, without
being refiled in another application in the applicable
jurisdiction, (ii) shall not have been finally rejected by an
administrative agency or other governmental action from which no
appeal can be taken and (iii) shall not have been pending for more
than ***, in either case which claim (if issued) would cover the
Manufacture, use or sale of any Licensed Product. For purposes of
this definition, the time period for which a claim is pending shall
begin on the priority date for such claim, and shall continue until
such claim is either issued or is no longer deemed to be a Valid
Claim in accordance with the preceding sentence regardless of
whether such claim is
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amended or refiled in another application in the applicable
jurisdiction. If a claim of a patent application which ceased to be
a Valid Claim under (b) due to the passage of time later issues as
part of a patent described within (a) then it shall again be
considered to be a Valid Claim effective as of the issuance of such
patent.
1.135. "WYETH" shall have the meaning set forth in the preamble hereof.
1.136. "WYETH APPLIED TECHNOLOGY" shall mean, with respect to any Licensed
Product, that Wyeth Technology which (a) Wyeth had applied to such
Licensed Product prior to any termination of any rights under this
Agreement with respect to such Licensed Product, provided that such
Wyeth Technology is necessary or useful for the continued research,
Development, Manufacture or Commercialization of such Licensed
Product as it exists at the time of such termination, or (b) Wyeth
had incorporated into such Licensed Product prior to any
termination of rights under this Agreement with respect to such
Licensed Product; provided that Wyeth shall use its Commercially
Reasonable Efforts to sublicense or otherwise transfer rights under
any Third-Party license to which the use or exploitation of such
Wyeth Applied Technology is subject; and further provided, however,
that with respect to each of clauses (a) and (b) of this Section
1.136, such Wyeth Technology shall not include any of Wyeth's
conjugation technology.
1.137. "WYETH INDEMNIFIED PARTY" shall have the meaning set forth in
Section 10.2 hereof.
1.138. "WYETH KNOW-HOW" shall mean any Know-How, other than the Joint
Know-How, that (a) Wyeth Controls as of the Effective Date or that
comes into the Control of Wyeth (other than as a result of the
licenses granted by Trubion to Wyeth under Section 2.1 hereof)
during the term of this Agreement and (b) relates to the Cell
Lines, Conjugates, Recombinant DNA, Licensed Products, SMIPs,
Target Candidates or Licensed Targets or the Development,
Manufacture, use or Commercialization of any of the foregoing.
1.139. "WYETH PATENT RIGHTS" shall mean Patent Rights, other than the
Joint Patent Rights, that (a) Wyeth Controls as of the Effective
Date or that come into the Control of Wyeth (other than as a result
of the licenses granted by Trubion to Wyeth under Section 2.1
hereof) during the term of this Agreement and (b) claim any Wyeth
Know-How.
1.140. "WYETH TARGETS" shall mean the Targets designated by Wyeth under
the Research Program, as described in Section 3.2 hereof.
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1.141. "WYETH TECHNOLOGY" shall mean Wyeth's interest in the Wyeth Patent
Rights, the Wyeth Know-How, the Joint Technology and the Research
Program Data.
2. LICENSES.
2.1. LICENSES TO WYETH.
2.1.1. EXCLUSIVE LICENSES. Subject to the terms and conditions of
this Agreement, Trubion, effective as of the Effective Date,
hereby grants to Wyeth an exclusive license (exclusive even
as to Trubion, except to the extent necessary for Trubion to
perform its obligations under this Agreement), with the
right to grant sublicenses in accordance with the provisions
of Section 2.4 hereof, under the Trubion Technology, to
research, Develop, have Developed, make, have made,
Manufacture, use, have used, import, have imported, export,
have exported, distribute, have distributed, market, have
marketed, offer and have offered for sale, sell, have sold
and Commercialize (subject to Section 4.11) Licensed
Products in the Territory (the license granted under this
Section 2.1.1 is sometimes referred to herein as the
"Product License").
2.1.2. RETAINED RIGHTS OF TRUBION. For the avoidance of doubt, but
subject to Sections 2.3 and 3.2 hereof, Trubion shall
retain: (a) all rights under the Trubion Technology with
respect to the research, Development, Manufacture, use and
Commercialization of SMIPs that (i) *** to Targets that are
not Licensed Targets and (ii) do not *** to any Licensed
Targets; and (b) the right to use SMIPs which *** to one or
more Licensed Targets in in vitro studies conducted solely
as part of Trubion's internal research efforts, provided,
however, that Trubion shall not provide any such SMIP (that
*** to a Licensed Target) to any Third Party or utilize any
such SMIP (that *** to a Licensed Target) in a collaboration
with any Third Party, except with Wyeth's prior written
consent.
2.2. LICENSE TO TRUBION. Wyeth hereby grants to Trubion a royalty-free
non-exclusive license, with no right to grant sublicenses, under
the Wyeth Technology, solely for the purpose of, and limited to,
Trubion's use of the Wyeth Technology in connection with the
Trubion Technology to research, Develop, have Developed, make, have
made, use and have used Licensed Products to fulfill its
obligations under this Agreement. In addition, Wyeth hereby grants
to Trubion the non-exclusive license under Wyeth's rights to
Covered SMIP Improvements as set forth in greater detail in Section
6.1.2.
2.3. EXCLUSIVITY.
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2.3.1. CD20 PRODUCT EXCLUSIVITY. Subject to Section 2.3.3, and
except for Development of the CD20 Products pursuant to the
terms of this Agreement, neither Party shall Develop any
human therapeutic product that contains a protein that ***
to the CD20 Antigen during the time period beginning on the
Effective Date and ending on the earlier of: (a) the First
Commercial Sale of any CD20 Product for a Major Indication
in a Major Market Country or (b) the termination of the
licenses granted by Trubion to Wyeth under this Agreement
with respect to all CD20 Products.
Subject to Section 2.3.3, and except for Commercialization
of the CD20 Products pursuant to the terms of this
Agreement, neither Party shall Commercialize any human
therapeutic product that contains a protein that *** to the
CD20 Antigen during the time period beginning on the
Effective Date and ending on the earlier of: (a) five (5)
years after the First Commercial Sale of any CD20 Product
for a Major Indication in a Major Market Country or (b) the
termination of the licenses granted by Trubion to Wyeth
under this Agreement with respect to all CD20 Products.
2.3.2. *** EXCLUSIVITY. Subject to Section 2.3.3, and except for
Development of the *** pursuant to the terms of this
Agreement, neither Party shall Develop any human therapeutic
product that contains a protein that *** to the *** during
the time period beginning on the Effective Date and ending
on the earlier of: (a) the First Commercial Sale of any ***
in any Major Market Country or (b) the termination of the
licenses granted by Trubion to Wyeth under this Agreement
with respect to all ***.
Subject to Section 2.3.3, and except for Commercialization
of the *** pursuant to the terms of this Agreement, neither
Party shall Commercialize any human therapeutic product that
contains a protein that *** to the *** during the time
period beginning on the Effective Date and ending on the
earlier of: (a) five (5) years after the First Commercial
Sale of any *** in any Major Market Country or (b) the
termination of the licenses granted by Trubion to Wyeth
under this Agreement with respect to all ***.
2.3.3. LIMITATIONS. The exclusivity provisions of Sections 2.3.1
and 2.3.2 above (a) shall not apply to Wyeth's Manufacture
of any product for a Third Party pursuant only to a contract
manufacturing or supply agreement between Wyeth and such
Third Party where Wyeth is acting only as a contract
manufacturer or supplier for such Third Party, (b) shall in
no
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way limit any of the licenses granted by Trubion to Wyeth
under Section 2.1 hereof, and (c) shall in no way limit any of
the retained rights of Trubion set forth in Section 2.1.2
hereof.
2.4. SUBLICENSING. Wyeth may grant to one or more Third Parties
sublicenses of the rights granted to it under Section 2.1 hereof at
any time; provided that Wyeth shall execute a written agreement with
each such sublicensee and shall comply with the following: Each such
sublicense (a) shall be subject and subordinate to, and consistent
with, the terms and conditions of this Agreement, (b) shall not in
any way diminish, reduce or eliminate any of Wyeth's obligations
under this Agreement, (c) shall require each such sublicensee to
comply with all applicable terms of this Agreement, including to
keep books and records, and permit Wyeth to audit (either directly
or through an independent auditor) such books and records, and (d)
shall provide that any such sublicensee shall not further sublicense
except on terms consistent with this Section 2.4. Wyeth shall
provide Trubion with a copy of each such sublicense agreement within
thirty (30) days after the execution thereof. Such copy may be
redacted to exclude confidential, non-Licensed Product-related
information and financial information (other than such financial
information that is necessary for assessing the obligations to
Trubion under this Agreement). Upon Trubion's request and at
Trubion's expense, Wyeth shall exercise its right to conduct an
audit of a sublicensee's books and records pertaining to the sale of
a Licensed Product under any such sublicense agreement at the next
time that conducting such an audit is permissible under such
sublicense agreement. Wyeth shall provide Trubion with a copy of the
report of the findings made in any such audit. If such audit reveals
that such sublicensee has understated its Net Sales by *** or more,
Wyeth shall be responsible for the costs of the audit. Wyeth shall
remain responsible for its obligations hereunder and for the
performance of its sublicensees (including, without limitation,
making all payments due Trubion by reason of any Net Sales of
Licensed Products), and shall ensure that any such sublicensees
comply with all relevant provisions of this Agreement. In the event
of any uncured material breach by any sublicensee under a sublicense
agreement that would constitute a breach of Wyeth's obligations
under this Agreement, Wyeth will promptly inform Trubion in writing
and shall take such action which in Wyeth's reasonable business
judgment will address such default; provided, however, any such
uncured material breach by such sublicensee of an obligation that
would constitute a breach of Wyeth's obligations under this
Agreement shall be deemed an uncured material breach of Wyeth
hereunder unless Wyeth cures such material breach within the time
provided under Section 9.5 hereof.
2.5. DIRECT LICENSES TO AFFILIATES. Wyeth may at any time request and
authorize Trubion to grant licenses within the scope of Section 2.1
directly to Affiliates of Wyeth by giving written notice designating
to which Affiliate a direct license is to be granted. Upon receipt
of any such notice,
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Trubion shall enter into and sign a separate direct license
agreement with such designated Affiliate of Wyeth. All such direct
license agreements shall be consistent with the terms and conditions
of this Agreement, except for such modifications as may be required
by the laws and regulations in the country in which the direct
license will be exercised; provided, however, that Trubion shall
have no obligation to enter into any such direct license agreement
if the effect of entering into such agreement (and continuing as a
Party to this Agreement) would be to increase the level of
obligations owed by Trubion, decrease the obligations owed to
Trubion or the enforceability thereof, or decrease the consideration
owed to Trubion relative to the obligations owed by or to, or the
consideration owed to, Trubion under this Agreement, had such direct
license(s) not been granted. In countries where the validity of such
direct license agreement requires prior government approval or
registration, such direct license agreement shall not become binding
between the parties thereto until such approval or registration is
granted, which approval or registration shall be obtained by Wyeth.
All costs of making such direct license agreement(s), including
Trubion's reasonable attorneys' fees, under this Section 2.5 shall
be borne solely by Wyeth.
2.6. RIGHT OF REFERENCE. Trubion hereby grants to Wyeth a "Right of
Reference," as that term is defined in 21 C.F.R. Section 314.3(b),
to any data Controlled by Trubion that relates to any CD20 Product
(and any other Licensed Product, to the extent applicable), and
Trubion shall provide a signed statement to this effect, if
requested by Wyeth, in accordance with 21 C.F.R. Section
314.50(g)(3).
2.7. SECTION 365(N) OF BANKRUPTCY CODE. All rights and licenses now or
hereafter granted under or pursuant to any Section of this
Agreement, including Sections 2.1 and 2.5 hereof, are rights to
"intellectual property" (as defined in Section 101(35A) of Title 11
of the United States Code, as amended (such Title 11, the
"Bankruptcy Code")). In the event this Agreement is rejected under
Section 365 of the Bankruptcy Code, Trubion hereby grants to Wyeth,
subject to Wyeth's obligations under Sections 365(n)(2)(A) and (B),
a right of access and to obtain possession of and to benefit from
each of the following embodiments to the extent related to Wyeth's
exercise of its license rights to any Licensed Products or otherwise
related to any rights or licenses granted under or pursuant to any
Section of this Agreement: (i) copies of pre-clinical and clinical
research data and results, (ii) aliquots of laboratory samples,
(iii) Licensed Product samples and inventory, (iv) Cell Lines
expressing Licensed Products, libraries encoding Licensed Products
or components thereof and sequences thereof, (v) copies of
laboratory notes and notebooks pertaining to Licensed Products, (vi)
copies of data and results related to clinical trials of Licensed
Products, (vii) regulatory filings and approvals of Licensed
Products, (viii) rights of reference in respect of regulatory
filings and approvals of Licensed Products, and (ix) plasmid and
vectors encoding Licensed Product SMIPs,
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all of which constitute "embodiments" of intellectual property
pursuant to Section 365(n) of the Bankruptcy Code, and (xi) all
other embodiments of such intellectual property in Trubion's
possession or control. Recognizing that the embodiments described
above may be useful or necessary to Trubion in connection with its
continued operation of its business, and that a Third Party may also
have a right of access to such embodiment under Section 365(n) of
the Bankruptcy Code or applicable non-bankruptcy law, where there is
a fixed or limited quantity of any biological material or other
tangible item of such embodiment described above, Wyeth shall be
entitled to a pro rata portion thereof. Trubion agrees not to
interfere with Wyeth's exercise under the Bankruptcy Code of rights
and licenses to intellectual property licensed hereunder and
embodiments thereof in accordance with this Agreement and agrees to
use Commercially Reasonable Efforts (short of any obligation of
Trubion to incur expenses in connection therewith) to assist Wyeth
to obtain such intellectual property and embodiments thereof in the
possession or control of Third Parties as reasonably necessary or
useful for Wyeth to exercise such rights and licenses in accordance
with this Agreement; provided, however, that Trubion's Commercially
Reasonable Efforts for purposes of this Section 2.7 shall not be
deemed to include an obligation to make payments to Third Parties to
obtain such intellectual property rights and embodiments thereof.
The Parties hereto acknowledge and agree that reimbursement payments
pursuant to Sections 3.6 and 4.6 and all other payments by Wyeth to
Trubion hereunder other than royalty payments pursuant to Section
5.4 and Additional Research and Development Expense Payments under
Section 5.3 do not constitute royalties within the meaning of
Bankruptcy Code Section 365(n) or relate to licenses of intellectual
property hereunder.
2.8. NO IMPLIED RIGHTS. Except as expressly provided in this Agreement,
neither Party shall be deemed by estoppel or implication to have
granted the other Party any license or other right with respect to
any intellectual property of such Party.
3. RESEARCH PROGRAM.
3.1. SCOPE AND CONDUCT OF THE RESEARCH PROGRAM. Under the terms and
conditions set forth herein, Trubion and Wyeth shall collaborate
through one or more joint project teams in the conduct of a
pre-clinical research program to identify and evaluate (a) SMIPs
directed against Licensed Targets and (b) Licensed Products,
including CD20 Products, *** and Other Products (collectively, the
"Research Program"). Such activities shall include, but not be
limited to, the following:
***
Subject to and in accordance with the Research Plan and the
Development Plan (to the extent applicable), the JRC shall determine
the appropriate
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activities to be undertaken by Trubion and Wyeth; provided, however,
that, as of the Signing Date, the Parties anticipate that Trubion
shall conduct activity (i) above (with input from Wyeth), Wyeth
shall conduct activities (v), (vi) and (vii) above, and Trubion and
Wyeth shall jointly conduct activities (ii), (iii) and (iv) above.
The Research Program shall be conducted in accordance with the
Research Plan, and each Party shall use its Commercially Reasonable
Efforts to perform all of its obligations under the Research Program
in accordance with the Research Plan and current good laboratory
practices.
3.2. DESIGNATION OF TARGETS.
3.2.1. TARGET CANDIDATES. Within thirty (30) days after the
Effective Date, Wyeth shall provide Trubion's Vice President,
Legal Affairs & Chief Patent Counsel with a list of up to ***
Targets (each a "Target Candidate") from which Wyeth shall
have the exclusive right, until ***, to designate up to ***
Wyeth Targets, in accordance with the following provisions
(subject to Wyeth's right under Section 3.2.3 to designate as
Wyeth Targets up to *** Targets (of the *** Targets that
Wyeth may designate as Wyeth Targets) that are not Target
Candidates at the time of selection). In the case of protein
Targets that are Target Candidates, Wyeth shall designate
each such Target Candidate on the list by its GenBank
accession number provided by the National Center for
Biotechnology Information ("NCBI") (including any
nomenclature describing such Target Candidate that is
provided therewith) or, if an NCBI GenBank accession number
is not available for such Target Candidate, by its nucleotide
and amino acid sequences. For the avoidance of doubt, Wyeth
may not designate as Target Candidates any Targets that are
Excluded Targets. Subject to the following procedures,
Trubion shall not undertake any research or Development
activities beyond Milestone One (as defined on Exhibit 3.2.1
attached hereto) of Trubion's internal product development
process, or propose to enter into or enter into any agreement
with any Third Party with respect to any SMIP directed
against any Target Candidate or with respect to any Licensed
Product containing such a SMIP, unless and until such Target
Candidate becomes a Released Target, Excluded Target or
Provisional Excluded Target. Trubion, through its Legal
Department, shall maintain a copy of the list of Target
Candidates in a secure location. Trubion shall take
reasonable measures and implement reasonable procedures to
ensure that only its inside attorneys who are employees of
its Legal Department and its outside patent counsel
(collectively, "Trubion Lawyers") have knowledge of and
access to Wyeth's Target Candidate list. The Target Candidate
list shall be
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considered Confidential Information of Wyeth, and except as
expressly permitted under this Section 3.2 or otherwise under
this Agreement, Trubion shall not use or disclose the Target
Candidate list or the information set forth therein to any of
its Affiliates, to any Third Party, or to any employees,
officers or agents of Trubion other than Trubion Lawyers. For
so long as a Target remains a Target Candidate, Trubion,
through its Legal Department, shall implement reasonable
procedures to maintain records of all Third Party inquiries
to Trubion and Trubion's responses to same, relating to the
Target Candidate list made pursuant to this Section 3.2. The
Trubion Legal Department shall also maintain the list of
Released Targets, Excluded Targets and Provisional Excluded
Targets in accordance with the provisions of Sections 3.2.2
and 3.2.4. In the event of a bona fide dispute arising under
this Agreement relating to the Target selection process
described in this Section 3.2, Trubion shall provide to an
independent Third Party selected by Wyeth and reasonably
acceptable to Trubion access to the lists of Target
Candidates, Released Targets, Excluded Targets and
Provisional Excluded Targets and records and processes
related thereto (to the extent relevant to the bona fide
dispute) maintained by Trubion in accordance with this
Section 3.2. Such independent Third Party may only
communicate to Wyeth whether or not the Target selection
process was properly performed by Trubion's Lawyers.
3.2.2. RELEASED TARGETS. On or before the ***, Wyeth, by written
notice to Trubion's Vice President, Legal Affairs & Chief
Patent Counsel, shall identify *** Target Candidates from the
list delivered pursuant to Section 3.2.1 (inclusive of any
Target Candidates that have become Released Targets during
such period pursuant to Section 3.2.4 hereof), which from the
date of such identification shall cease to be Target
Candidates (each, a "Released Target"). At the time that a
Target Candidate becomes a Released Target, Trubion, subject
to Section 2.8, shall be free to undertake research and
Development activities independent of obligations under this
Agreement, and to enter into discussions or an agreement with
a Third Party, with respect to SMIPs directed against any
such Released Target or any other activities in connection
with such Released Target. On or before the ***, Wyeth, by
written notice to Trubion, shall identify such additional
Target Candidates from the list delivered pursuant to Section
3.2.1, if any, as additional Released Targets, such that
there are no more than *** Target Candidates remaining on the
list delivered pursuant to Section 3.2.1 (less the number of
Wyeth Targets that were Target Candidates at the time of
selection as a Wyeth Target(s) pursuant to Section 3.2.3),
which
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from the date of such identification shall cease to be Target
Candidates and, thereafter each shall also become a Released
Target. At the end of the Research Term, all remaining Target
Candidates, if any, shall become Released Targets.
3.2.3. WYETH TARGETS. Wyeth Targets shall be designated only from
either (a) Target Candidates that have not become Released
Targets, or (b) any other Target (including a Released Target
that is or becomes available, as described below) that is not
then an Excluded Target or a Provisional Excluded Target;
provided, however, that no more than *** of the Targets
designated by Wyeth as Wyeth Targets may be Targets that are
not Target Candidates at the time of selection. Subject to
the foregoing sentence, Wyeth shall designate: (y) *** Target
Candidates or other Targets as Wyeth Targets on or before
***; and (z) up to *** Target Candidates or other Targets
(inclusive of those designated as Wyeth Targets during the
***) as Wyeth Targets on or before the second anniversary of
the Effective Date; provided, however, if Wyeth does not
designate a total of *** Wyeth Targets on or before such ***,
then the lesser number of Wyeth Targets so designated shall
be the total number of Wyeth Targets under this Agreement
unless Wyeth extends the Research Program, in which case
Wyeth may designate, before ***, one or more additional Wyeth
Targets (up to a cumulative *** in the aggregate). For the
avoidance of doubt and subject to the following sentence,
Wyeth may designate only up to a *** Wyeth Targets from the
Effective Date of this Agreement through the end of the
Research Program (even if extended). During the term of the
Research Program, Wyeth shall have the right to ***; provided
that *** (a "Replacement Target") must be ***. In the event
that Wyeth nominates as a Wyeth Target (whether as a proposed
initial designation of a Wyeth Target or as a replacement
designation as a Wyeth Target) a Target that is not then a
Target Candidate, Trubion's Legal Department, within ten (10)
business days after receiving written notice of such
nomination, shall determine and advise Wyeth in writing
whether such Target is an Excluded Target or a Provisional
Excluded Target, as described below (and shall indicate
whether such Target is an Excluded Target or is a Provisional
Excluded Target). If such Target is an Excluded Target or a
Provisional Excluded Target, it shall not be eligible to be
considered a Wyeth Target. If a proposed Replacement Target
is not an Excluded Target or a Provisional Excluded Target,
then the JRC shall either approve or disapprove designation
of such proposed Replacement Target as a Wyeth Target;
provided that the original Wyeth Target that Wyeth proposes
to replace shall be
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automatically deemed a Released Target upon the JRC's
approval of the designation of the Replacement Target.
3.2.4. EXCLUDED TARGETS. Excluded Targets are not eligible to be
Wyeth Targets for so long as they remain Excluded Targets.
The Targets deemed "Excluded Targets" as of the Effective
Date are set forth in Exhibit 3.2.4 attached hereto. Trubion
may add additional Targets as Excluded Targets or Provisional
Excluded Targets (which may be selected from Released Targets
and other Targets, but would not include any Wyeth Targets or
any Target Candidate that has not become a Released Target)
in accordance with the following procedures:
(a) During the period when ***, and upon the written
request of a potential Third Party collaborator and/or
licensee of Trubion pertaining to the identification,
generation and/or Development of SMIPs directed against
a Target or Targets, Trubion's Legal Department shall
promptly determine whether or not any of such Targets
is a Wyeth Target.
(b) With respect to any Target newly submitted by a Party
to Trubion's Legal Department hereunder, Trubion's
Lawyers will determine whether such submitted Target
*** Licensed Targets, Target Candidates, Released
Targets, Excluded Targets and Provisional Excluded
Targets available to Trubion's Lawyers (each a
"Previously Deposited Protein"). By way of example
only, *** Should Wyeth designate a Target that is not a
protein, the Parties agree to negotiate in good faith
the procedure for identifying and testing whether a
subsequent proposed non-protein Target is the "same as"
such designated non-protein Target for purposes of this
Section 3.2.
(c) If Trubion's Legal Department determines, in accordance
with Section 3.2.4(b) above, that any such Target is a
Wyeth Target, Trubion shall not proceed with such
potential Third Party collaboration or license with
respect to such Target. If any of such Targets is not a
Wyeth Target or a Target Candidate, such Target shall
automatically be deemed a "Provisional Excluded
Target". If such Target is a Target Candidate, Trubion
shall notify Wyeth in writing of Trubion's request that
a Target Candidate be recategorized as a Released
Target, in order for Trubion to be able to enter
substantive negotiations with such Third Party
regarding such Target that is a Target Candidate (i.e.,
Trubion shall "Put" such Target Candidate
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to Wyeth). Trubion shall have no obligation to notify
Wyeth of the identity of such Third Party or the purpose
of the proposed collaboration or license. From the date
that Trubion "Puts" such Target Candidate to Wyeth,
Wyeth shall have *** with respect to such Puts made to
Wyeth prior to ***, and shall have *** with respect to
such Puts made thereafter, to notify Trubion in writing
whether Wyeth designates such Target Candidate as a
Wyeth Target or recategorizes such Target Candidate as a
Released Target. If Wyeth fails to notify Trubion within
such *** period, respectively, then such Target
Candidate shall automatically be deemed a Released
Target. Any such Released Targets shall be deemed to be
Provisional Excluded Targets.
(d) If Trubion and such potential Third Party collaborator
and/or licensee do not enter into a definitive agreement
regarding such Provisional Excluded Target within ***
after the date that such Target is deemed a Provisional
Excluded Target (such *** being subject to a ***
extension by Trubion, if Trubion declares, in writing,
to Wyeth that at least one draft definitive agreement
has been exchanged between Trubion and such potential
Third Party collaborator and/or licensee), thereafter
such Provisional Excluded Target would revert to being a
Released Target. If Trubion and such potential
Third-Party collaborator and/or licensee enter into a
definitive agreement within the time period provided
above, such Provisional Excluded Target shall be deemed
an Excluded Target.
(e) During the period when ***, if Trubion itself identifies
internally a Target that has progressed to Milestone One
(as defined in Exhibit 3.2.1 attached hereto) of
Trubion's internal product development process,
Trubion's Legal Department shall promptly determine
whether or not such Target is a Target Candidate. If
such Target is not a Target Candidate, such Target shall
be deemed an Excluded Target. If Trubion thereafter
abandons work on such Excluded Target, Trubion shall
notify Wyeth in writing that Trubion has abandoned work
on such Excluded Target and such Excluded Target shall
thereafter be deemed a Released Target. If such Target
is a Target Candidate, Trubion may Put such Target
Candidate to Wyeth. From the date that Trubion Puts such
Target Candidate to Wyeth, Wyeth shall have *** with
respect to such Puts made to Wyeth prior to ***, and
shall have *** with respect to such Puts made
thereafter, to notify Trubion in writing whether
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Wyeth designates such Target Candidate as a Wyeth Target
or recategorizes such Target Candidate as a Released
Target. If Wyeth fails to notify Trubion within such
***, respectively, then such Target Candidate shall
automatically be deemed a Released Target. Any such
Released Target shall be deemed to be Excluded Target.
If Trubion thereafter abandons work on any such Excluded
Target, Trubion shall notify Wyeth in writing that
Trubion has abandoned work on such Excluded Target and
such Excluded Target shall thereafter be deemed a
Released Target.
(f) With respect to the Puts described in (c) and (e) above,
Trubion shall not be permitted to Put more than ***
Target Candidates to Wyeth during the first *** of the
Research Program.
3.3. TERM AND TERMINATION OF THE RESEARCH PROGRAM.
3.3.1. RESEARCH TERM. The term of the Research Program (the
"Research Term") shall begin on the Effective Date and shall
continue until *** (the "Initial Term"), subject to extension
as described below. At Wyeth's option (exercisable by
providing written notice to Trubion no later than *** prior
to the end of the Initial Term of the Research Program or any
extension year thereof), the Research Term may be extended
for up to *** additional *** periods and, thereafter, shall
be renewable annually only upon mutual written agreement of
the Parties.
3.3.2. TERMINATION OF RESEARCH PROGRAM BY WYETH. Commencing on the
first anniversary of the Effective Date, Wyeth shall have the
right to terminate the Research Program, at will, at any
time, in its entirety, upon one (1) year prior written notice
to Trubion; provided that Trubion shall have no obligation
after the effective termination date to complete any Research
Program activities in connection with any Trubion Target,
Wyeth Target, SMIP or Licensed Product. Such termination of
the Research Program shall not constitute termination of this
Agreement and shall not affect the Parties' rights and
obligations under this Agreement other than those relating to
the Research Program.
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3.4. JOINT RESEARCH COMMITTEE.
3.4.1. COMPOSITION. Within thirty (30) days after the Effective
Date, the Parties shall establish a Joint Research Committee
(the "JRC") to oversee the Research Program. The JRC will be
in effect only during the Research Term. The JRC shall be
composed of three (3) representatives from each Party. Each
Party may replace any of its representatives at any time upon
written notice to the other Party. From time to time, the JRC
may establish subcommittees to oversee particular projects or
activities, and such subcommittees shall be constituted as
the JRC decides.
3.4.2. RESPONSIBILITIES. The JRC shall be responsible for
establishing, reviewing and recommending modifications and
updates to the Research Plan, including the Research Budget,
in accordance with Section 3.5 hereof, monitoring and
reporting to the Parties on activities conducted pursuant to
the Research Plan, and for such other functions as agreed by
the Parties.
3.4.3. MEETINGS. The JRC shall meet as soon as practicable after it
is established by the Parties and, thereafter, at such
additional times as the Parties deem appropriate, not less
frequently than quarterly. Each Party shall designate one of
its JRC members as its "JRC Liaison" to co-chair meetings,
prepare and circulate JRC meeting agendas and JRC meeting
minutes. The meetings of the JRC shall be held in the United
States, and shall alternate between the Parties' business
locations or as otherwise decided by the JRC. JRC meetings
may be conducted in person, by telephone or by
videoconference. Each Party shall use reasonable efforts to
cause its representatives to attend the meetings of the JRC.
If a representative of a Party is unable to attend a meeting,
such Party may designate an alternate member to attend such
meeting in place of the absent member.
3.4.4. VOTING. Decisions of the JRC shall be made by unanimous
consent, with each Party having one vote. The JRC may act
without a meeting if an action by unanimous written consent
is signed by each Party's JRC Liaison.
3.4.5. DISPUTE RESOLUTION. If the JRC is unable to reach agreement
on a matter, the matter may be referred, at the request of
either Party, for resolution through good faith discussions
between Wyeth's Executive Vice President of Discovery
Research and Trubion's Senior Vice President of Research and
Development or their respective designees. Notwithstanding
the foregoing, in the event the JRC cannot promptly resolve a
disagreement or a
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voting deadlock regarding the Research Program, Wyeth's
Executive Vice President of Discovery Research shall have the
right to cast a tie-breaking vote to resolve any such
disagreement or voting deadlock, such right and tie-breaking
authority being subject to the terms and conditions of this
Agreement.
3.4.6. MINUTES. The JRC shall keep accurate and complete minutes of
its meetings that record all proposals and recommendations
made, and all actions and decisions taken. The JRC minutes
shall not be effective until approved in writing by each
Party's JRC Liaison. All records of the JRC shall be
available at all times to each Party.
3.5. RESEARCH PLAN. The Parties shall use their Commercially Reasonable
Efforts to develop and approve a complete Research Plan (including a
corresponding Research Budget) within sixty (60) days of the
Effective Date. The Parties shall ensure that the Research Plan is
consistent with the terms and conditions of this Agreement, and the
Research Plan shall not impose obligations on either Party that are
inconsistent with the terms of this Agreement. The Research Plan
shall set forth generally (a) the activities to be undertaken by the
Parties under the Research Program consistent with the terms of
Section 3.1, (b) the utilization of *** Trubion FTEs in conducting
such activities, (c) the anticipated schedule on which such
activities are to be conducted, (d) the desired deliverables to be
provided by each Party with respect to each Licensed Target that is
the subject of the Research Program, and (e) the annual budget for
non-ordinary expenses (as described in Section 3.6.1 below) to be
incurred by Trubion under the Research Program (the "Research
Budget"). The JRC shall review the Research Plan, including the
Research Budget, on at least an annual basis and submit any proposed
modifications or updates to the Parties for review and approval; any
such modifications or updates shall not become effective until
approved in writing by an authorized officer of each of the Parties.
The Parties shall review and consider any such proposed
modifications or updates on an expeditious basis. The Parties shall
promptly amend the Research Plan from time to time to address the
performance of the Research Program as it relates to any Licensed
Targets designated by Wyeth in accordance with Section 3.2 above.
3.6. FUNDING OF THE RESEARCH PROGRAM.
3.6.1. RESEARCH FUNDING. During each year of the Research Term (as
it may be extended), Wyeth shall pay Trubion *** per year for
services performed in accordance with the Research Plan.
Trubion shall commit to the Research Program ten (10) FTEs per
year to provide services in furtherance of the Research
Program in accordance with the Research Plan. For the
avoidance of doubt, Trubion may, at its sole expense and
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discretion, devote more than *** FTEs from time to time to
provide services in furtherance of the Research Program. The
*** in research funding described above shall be increased
automatically once per calendar year by the percentage change
in the U.S. Consumer Price Index, All Urban Consumers over
the previous year; provided, however, that no increase shall
be effective prior to January 1, 2007. ***. Trubion shall
provide to Wyeth, prior to the first day of each Calendar
Quarter, a forecast of such expenses (by major expense
category, on an accrual basis) reimbursable under this
Section 3.6.1 which Trubion expects to incur during such
Calendar Quarter and the subsequent three Calendar Quarters,
in each case shown by month. Other than the foregoing amounts
and except as otherwise expressly provided in this Agreement,
each Party shall be solely responsible for its costs and
expenses incurred in performing its obligations under the
Research Program.
3.6.2. REIMBURSEMENT PAYMENTS. Reimbursement to be made to Trubion
by Wyeth pursuant to Section 3.6.1 will be made pursuant to
invoices submitted by Trubion to Wyeth no more often than
once with respect to any Calendar Quarter, within thirty (30)
days of the end of such Calendar Quarter. Payment shall be
due within forty-five (45) days after Wyeth receives such an
invoice from Trubion. Each invoice must be accompanied by
supporting documentation sufficiently demonstrating the
expense so paid on a cash basis (such as receipts for
out-of-pocket expenses and other written documentation
reasonably acceptable to Wyeth) and by a certificate executed
by Trubion's VP, Finance & Administration, of the number of
FTEs used by Trubion in such Calendar Quarter in performing
Trubion's obligations under the Research Program. Except as
approved in writing in advance by Wyeth, Wyeth shall not be
obligated to reimburse Trubion for amounts in excess of the
applicable budgeted amounts in the Research Budget.
3.6.3. RECORDS AND AUDITS. During the Research Term, Trubion shall
keep books and accounts of record in connection with the
expenses reimbursable under Section 3.6.1 hereof in
accordance with GAAP and in sufficient detail to permit
accurate determination of all figures necessary for
verification of costs to be reimbursed hereunder. Trubion
shall maintain such cost records for a period of at least
three (3) years after the end of the calendar year in which
they were generated in order to enable audit of such records
as set forth below. Upon thirty (30) days prior written
notice from Wyeth, Trubion shall permit an independent
certified public accounting firm of nationally recognized
standing selected by Wyeth and reasonably acceptable to
Trubion, to examine, at Wyeth's sole expense, the relevant
books and records of Trubion
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as may be reasonably necessary to verify the amount of
reimbursable out-of-pocket expenses incurred. An examination
by Wyeth under this Section 3.6.3 shall occur not more than
once in any calendar year and shall be limited to the
pertinent books and records for any calendar year ending not
more than thirty six (36) months before the date of the
request. The accounting firm shall be provided access to such
books and records at Trubion's facility(ies) where such books
and records are normally kept and such examination shall be
conducted during Trubion's normal business hours. Trubion may
require the accounting firm to sign a standard non-disclosure
agreement before providing the accounting firm access to
Trubion's facilities or records. The accounting firm shall
provide both Trubion and Wyeth a written report disclosing
whether the certificates and invoices submitted by Trubion
under Section 3.6.2 are correct or incorrect and the specific
details concerning any discrepancies. No other information
shall be provided to Wyeth. If the accounting firm determines
that the aggregate amount of out-of-pocket expenses actually
incurred by Trubion was less than the amount reimbursed by
Wyeth during the period covered by the audit, Trubion shall
refund the excess payments to Wyeth within thirty (30) days of
its receipt of the auditor's report so concluding (or, if
later, within fifteen (15) days after resolution of a bona
fide objection by Trubion to the findings in such report). If
the amount to be refunded exceeds more than ten percent (10%)
of the amount that was properly payable, Trubion shall
reimburse Wyeth for the cost of the audit. All information of
Trubion which is subject to review under this Section 3.6.3
shall be deemed to be Confidential Information of Trubion
subject to the provisions of Article 7, and such Confidential
Information shall not be disclosed to any Third Party or used
for any purpose other than verifying the information provided
by Trubion to Wyeth; provided, however, that such Confidential
Information may be disclosed to Third Parties only to the
extent necessary to enforce Wyeth's rights under this
Agreement, as may be necessary for Wyeth to exercise its
rights under this Agreement, or as otherwise expressly
permitted under this Agreement.
3.7. DATA AND DELIVERABLES. During the Research Term, each Party will use
Commercially Reasonable Efforts to promptly provide to the other
Party the data or desired deliverables specified in the Research
Plan, including, without limitation, (a) SMIPs, Recombinant DNA, and
Cell Lines, to the extent related to Licensed Targets and/or
Licensed Products, (b) activity evaluation of the items listed in
(a) obtained from in vitro or in vivo assays, pharmacology studies,
process development data, drug product formulation data, toxicology
and safety studies, and evaluation of chemotherapy conjugates, but
only to the extent and in the manner that items listed in (a)
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and (b) are set forth in the Research Plan. Each Party shall also
disclose to the other Party in writing all data, information,
inventions, techniques and discoveries (whether patentable or not)
arising out of the conduct of the Research Program. Disclosure of
all such aforementioned inventions and discoveries shall be
delivered to the other Party in a manner mutually agreed upon by the
Joint Patent Committee. Subject to the terms and conditions of this
Agreement, each Party shall have the right to use any data or
information generated under the Research Program for its permitted
activities under the Research Program and this Agreement
(collectively, "Research Program Data"). TRUBION MAKES NO
REPRESENTATION OR WARRANTY, EITHER EXPRESS OR IMPLIED, THAT IT WILL
BE ABLE TO SUCCESSFULLY DISCOVER, DEVELOP OR DELIVER ANY SMIP
DIRECTED AGAINST A LICENSED TARGET OR ANY LICENSED PRODUCT.
3.8. ALLIANCE MANAGERS. Each Party shall designate a single alliance
manager, who shall perform such duties relating to the day-to-day
worldwide coordination of the collaboration contemplated by this
Agreement as are determined by the JRC and the JDC. Such alliance
managers shall have experience and knowledge appropriate for
managers with such project management responsibilities. Such
alliance managers may attend, as non-voting members, any meetings of
the committees contemplated by this Agreement as deemed fit by such
committees. Each Party may change its designated alliance manager
from time to time upon notice to the other Party.
4. PRODUCT DEVELOPMENT, MANUFACTURING, COMMERCIALIZATION AND REGULATORY
MATTERS.
4.1. PRODUCT DEVELOPMENT. Except as otherwise expressly provided in
Articles 2 and 3 hereof and in this Article 4, Wyeth shall have the
sole authority, at its expense, for the Development of Licensed
Products, including the initiation and conduct of clinical trials.
Wyeth shall be responsible for the Development of and shall use its
Commercially Reasonable Efforts to Develop Licensed Products
throughout the Territory where it is Commercially Reasonable to do
so (it being understood that Wyeth shall have the sole discretion to
select those countries in which it will conduct clinical studies of
Licensed Products and, when Commercially Reasonable to do so, to
delay or discontinue the Development of any Licensed Product
directed against a particular Licensed Target in favor of pursuing
Development of another Licensed Product directed against such
Licensed Target). When appropriate based on the data obtained during
Development, Wyeth shall use its Commercially Reasonable Efforts to
secure Regulatory Approval for Licensed Products in the Territory.
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4.2. TRANSFER OF PRODUCT DATA AND FILINGS. Upon Wyeth's reasonable
request and in consultation with the JDC from time to time during
the term of this Agreement and to the extent permitted by applicable
law, Trubion shall assign and transfer to Wyeth Trubion's entire
right, title and interest in and to any of the Product Data and
Filings pursuant to an instrument to such effect in form and
substance reasonably satisfactory to Wyeth and shall perform all
other actions reasonably requested by Wyeth to effect and confirm
such transfer. The Parties shall cooperate through the JDC to ensure
that assignment and transfer of Trubion's right, title and interest
in and to Product Data and Filings relating to CD20 Products is made
in a manner that does not impede Trubion's activities and
responsibilities under Section 4.6. After receipt of Wyeth's request
consistent with the foregoing, Trubion shall provide to Wyeth, at
Wyeth's expense, within sixty (60) days of receipt of such request,
complete copies of such Product Data and Filings, including, without
limitation, relevant clinical data, INDs, additional regulatory
filings with FDA or other Regulatory Authorities, supplements or
amendments thereto, all written correspondence with FDA or other
Regulatory Authorities regarding the regulatory filings, and all
existing written minutes of meetings and memoranda of conversations
between Trubion (including, to the extent practicable, Trubion's
investigators) and FDA or other Regulatory Authorities in Trubion's
possession (or in the possession of any of Trubion's agents and
subcontractors, such as contract research organizations used by
Trubion), to the extent Trubion has the right to access and provide
to Wyeth such Product Data and Filings, regarding such regulatory
filings, each to the extent they relate to Licensed Products. Within
thirty (30) days (or such later date as Wyeth may request) after the
date of receipt of Wyeth's reasonable request after consultation
with the JDC, Trubion shall execute and deliver a letter to the FDA
or other Regulatory Authorities, in a form approved by Wyeth,
transferring ownership to Wyeth of such regulatory filings, if any,
filed in the name of Trubion that are related to Licensed Products.
After such transfer of ownership of regulatory filings relating to a
Licensed Product, during the term of this Agreement all regulatory
filings with the FDA or other Regulatory Authorities pertaining to
such Licensed Product shall be made in the name of Wyeth, in
accordance with the terms of Section 4.3 below.
4.3. REGULATORY APPROVALS. Wyeth shall have the sole authority to file,
in its own name, at its sole expense, all Regulatory Approval
Applications for Licensed Products. Wyeth shall have the sole
authority and responsibility for communicating with any Regulatory
Authority regarding any Regulatory Approval Application, or any
Regulatory Approval once granted. To the extent necessary to satisfy
applicable regulatory requirements with respect to the INDs for the
clinical studies of CD20 Products described in Section 4.6, Wyeth
hereby grants to Trubion a "Right of Reference," as that term is
defined in 21 C.F.R. Section 314.3(b), to any data Controlled by
Wyeth that relates to any CD20 Products that are the subject
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of the clinical studies described in Section 4.6 hereof, and Wyeth
shall provide a signed statement to this effect, if requested by
Trubion, in accordance with 21 C.F.R. Section 314.50(g)(3). Copies
of Section all Wyeth regulatory filings that relate to Trubion's
Development activities under this Agreement will be provided by
Wyeth to Trubion upon request, subject to reasonable resource and
time constraints.
4.4. REGULATORY REPORTING. Wyeth shall be responsible for preparing and
filing all reports required to be filed in order to maintain any
Regulatory Approvals granted for Licensed Products in the Territory,
including, without limitation, adverse drug experience reports. To
the extent Trubion has or receives any information regarding any
adverse drug experience which may be related to the use of any
Licensed Product or to Licensed Product Development, Trubion shall
promptly provide Wyeth with all such information in accordance with
the Adverse Event Reporting and pharmacovigilance procedures set
forth in Exhibit 4.4 attached hereto (as may be amended from time to
time upon written mutual agreement of the Parties). From time to
time after the Effective Date, representatives from both Parties
shall meet to review and revise or replace such Adverse Event
Reporting and pharmacovigilance procedures.
4.5. PROGRESS REPORTS.
(a) Wyeth shall provide Trubion with confidential summary
reports of its and its sublicensees' Development
activities, on a Licensed Product-by-Licensed Product
basis, on a ***, with respect to CD20 Products and ***,
and on an ***, with respect to Other Products. The form
of the summary reports, and the type of information and
the appropriate and reasonable level of detail to be
included in such reports, shall be mutually and
reasonably agreed by the Parties; provided that the
Parties agree that such reports shall include
information regarding progress towards and achievement
of any event set forth in Exhibit 5.3 attached hereto.
(b) Wyeth shall provide Trubion with confidential summary
reports of its and its sublicensees' CD20 Product
Commercialization activities on a *** after the First
Commercial Sale of a CD20 Product. Beginning *** prior
to the anticipated First Commercial Sale of a CD20
Product, and thereafter on a ***, Wyeth shall meet with
Trubion and provide updates on CD20 Product
Commercialization activities.
(c) Wyeth shall provide Trubion with confidential summary
reports of its and its sublicensees' ***
Commercialization
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activities on a *** after the First Commercial Sale of a
***. Beginning *** prior to the anticipated First
Commercial Sale of a ***, and thereafter on a ***, Wyeth
shall meet with Trubion and provide updates on ***
Commercialization activities.
(d) Wyeth shall provide Trubion with confidential summary
reports of its and its sublicensees' Other Product
Commercialization activities on an *** after the First
Commercial Sale of an Other Product. Beginning *** prior
to the anticipated First Commercial Sale of an Other
Product, and thereafter on an ***, Wyeth shall meet with
Trubion and provide updates on Other Product
Commercialization activities.
(e) The meetings described in clauses (b) - (d) above shall
be coordinated to occur at the same time, to the extent
practicable.
4.6. CD20 PRODUCT DEVELOPMENT. Subject to Section 4.7 hereof, Trubion
shall use its Commercially Reasonable Efforts to conduct the
following Development activities for CD20 Products: (a) Trubion
shall continue the Phase I Clinical Studies and Phase IIa Clinical
Studies of TRU-015 ongoing at the Effective Date for treatment of
rheumatoid arthritis until completion or termination of such
studies, including the re-treatment periods of such studies; (b)
Trubion shall initiate and perform the planned Phase IIb Clinical
Study of TRU-015 for treatment of rheumatoid arthritis through the
completion or termination of such study; (c) Trubion shall continue
the Phase I Clinical Study ongoing at the Effective Date, and shall
initiate and perform the planned Phase III Clinical Studies (or the
appropriate subsequent clinical study) of TRU-015 for the treatment
of *** through the completion or termination of such studies; (d)
Trubion shall have responsibility for and shall perform the clinical
studies for at least two (2) additional Niche Indications selected
by the Parties and set forth in the Development Plan; and (e)
Trubion shall continue to perform the ongoing bioprocess development
activities, and in each case (a-e) such activities and
responsibilities of Trubion shall be performed in accordance with
the Development Plan. None of the clinical studies described in this
Section 4.6 shall be terminated prior to completion before
discussion of such matter by the JDC. Trubion shall keep accurate
records of its clinical study activities under this Section 4.6 in
accordance with applicable laws and, upon reasonable request, shall
provide Wyeth with access to such records. Trubion shall maintain
such records for a period of at least three (3) years after the end
of the calendar year in which they were generated. The Development
Plan shall provide that Trubion is responsible for conducting the
clinical trials for rheumatoid arthritis, *** and additional Niche
Indications through the completion or termination of such clinical
studies
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described above and shall contain a budget for such clinical trials.
Trubion shall be solely responsible for its internal FTE and other
internal costs for such Development activities, but Wyeth shall
reimburse Trubion for all out-of-pocket costs incurred by Trubion in
connection with the foregoing Development activities in accordance
with the budget contained in the Development Plan (which shall
include, without limitation, all expenses paid to one or more
contract research organizations for such Development activities).
Trubion shall provide to Wyeth, on or before the first day of each
Calendar Quarter, a forecast of such out-of-pocket costs (by major
expense category, on an accrual basis) reimbursable under this
Section 4.6 that Trubion expects to incur during such Calendar
Quarter and the subsequent three (3) Calendar Quarters, in each case
shown by month. Reimbursement to be made to Trubion by Wyeth
pursuant to this Section 4.6 will be made pursuant to invoices
submitted by Trubion to Wyeth no more often than once with respect
to any Calendar Quarter, within forty-five (45) days of the end of
such Calendar Quarter. Payment shall be due within forty-five (45)
days after Wyeth receives such an invoice from Trubion. Each invoice
must be accompanied by supporting documentation sufficiently
demonstrating the expense so incurred (such as receipts for
out-of-pocket expenses). The provisions of Section 3.6.3 shall apply
to the expenses reimbursable by Wyeth under this Section 4.6 in the
same manner as they apply to expenses reimbursable under Section
3.6.1.
4.7. JOINT DEVELOPMENT COMMITTEE. Within thirty (30) days of the
Effective Date, Wyeth and Trubion shall establish a CD20 Product
Joint Development Committee (the "JDC"), comprised of appropriate
representatives of both Parties, to review and provide input to
Wyeth regarding CD20 Product Development in the Territory, including
the strategic direction of the overall CD20 Product Development
program. Wyeth shall consider in good faith any of Trubion JDC
members' comments and recommendations regarding CD20 Product
Development, but Wyeth shall have final decision-making authority
with respect to how the Parties proceed with CD20 Product
Development, subject to Wyeth's obligations under Section 4.1 in
connection therewith. If Trubion disagrees with an action or
decision by the JDC, Trubion may express its concerns through good
faith discussions between the Executive Officers of Trubion and
Wyeth, with Wyeth Research's President having the final
decision-making authority with respect to such matter. For the
avoidance of doubt, the JDC may not impose different or greater CD20
Product Development obligations on Trubion than those specified in
Section 4.6.
4.8. JOINT PROJECT TEAM; DEVELOPMENT PLAN. Trubion and Wyeth shall form a
Joint Project Team ("JPT") comprised of appropriate representatives
of both Parties to plan and implement the CD20 Product Development
activities in accordance with the Development Plan. The JPT shall
report to the JDC. If the JPT cannot promptly resolve a disagreement
or a voting deadlock regarding the CD20 Product Development
activities, the matter
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shall be brought before the JDC for resolution. Wyeth shall prepare
the Development Plan with input and advice from Trubion through the
JPT. The Development Plan will define each Party's roles and
responsibilities, provide a mechanism to coordinate each Party's
and/or joint activities, and provide a process for monthly meetings
of the JPT to monitor and report on all activities of the Parties
conducted under the Development Plan. The Development Plan shall not
impose different or greater CD20 Product Development obligations on
Trubion than those specified in Section 4.6. The Development Plan
shall be updated annually by the JPT.
4.9. MANUFACTURING. Wyeth shall have the exclusive right to Manufacture
Licensed Products itself or through one or more Third Parties
selected by Wyeth; provided, however, that Trubion shall use its
Commercially Reasonable Efforts to Manufacture and supply Wyeth with
its requirements of the TRU-015 Product in accordance with the
Development Plan under Trubion's existing contract Manufacturing
arrangements for use in pre-clinical studies and clinical trials
("Clinical Study Supplies"); provided that Trubion cannot guarantee
as of the Effective Date that it will be able to Manufacture and
supply such requirements. Wyeth shall reimburse Trubion for its
direct out-of-pocket cost of Clinical Study Supplies, including,
without limitation, out-of-pocket expenses incurred by Trubion prior
to the Effective Date that are directly related to the Manufacture,
testing and release of Clinical Study Supplies to be used after the
Effective Date (such pre-Effective Date out-of-pocket expenses not
to exceed ***). Reimbursement of such pre-Effective Date expenses
shall be due within thirty (30) days after the first patient is
dosed in the first Phase IIb Clinical Study for rheumatoid arthritis
using such Clinical Study Supplies. Upon Wyeth's written request,
Trubion shall provide reasonable assistance to Wyeth, until the
first cGMP batch of TRU-015 Product is Manufactured in a Wyeth
facility (or the facility of a Third Party designated by Wyeth), in
support and facilitation of Wyeth's efforts to Manufacture TRU-015
Products and to secure appropriate TRU-015 Product Manufacturing
arrangements with Third Parties. Such assistance shall be at no cost
to Wyeth; provided that Wyeth shall reimburse Trubion for all of its
reasonable out-of-pocket expenses related thereto. If applicable,
upon Wyeth's written request, Trubion shall assign or otherwise
transfer to Wyeth (to the extent allowable under such agreements)
its TRU-015 Product Manufacturing agreements with Third Parties.
4.10. COMMERCIALIZATION. Subject to the terms and conditions of this
Agreement, Wyeth shall have the sole authority and the exclusive
right to Commercialize Licensed Products itself or through one or
more Third Parties selected by Wyeth and shall have sole authority
and responsibility in all matters relating to the Commercialization
of Licensed Products. Wyeth shall use Commercially Reasonable
Efforts to Commercialize Licensed Products in the Territory in each
country where Wyeth has obtained Regulatory Approval for such
Licensed Product(s) and for each indication
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of such Licensed Product(s) for which Regulatory Approval has been
obtained in such country.
4.11. CO-PROMOTION OPTION. Subject to the foregoing, in the event of a BLA
filing with the FDA for Regulatory Approval of a CD20 Product for a
Niche Indication in the United States, Trubion shall have the option
to Co-Promote the CD20 Product in the United States for such Niche
Indication in accordance with Wyeth's marketing plan for up to five
(5) years after the First Commercial Sale of the first CD20 Product
for any Niche Indication in the United States (the "Co-Promotion
Period"). The Trubion Co-Promotion option shall be exercisable by
Trubion giving written notice to Wyeth no later than *** after the
date of the first BLA filing with the FDA for the first Niche
Indication for the first CD20 Product (or such longer time as the
Parties may mutually agree). Promptly after Trubion's exercise of
such option, the Parties shall negotiate, in good faith, a
definitive Co-Promotion Agreement, which shall require Trubion and
Wyeth to use Commercially Reasonable Efforts to Co-Promote such CD20
Product. Such Co-Promotion Agreement shall contain 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 (including medical science liaisons) that will be devoted
to such Co-Promotion activities. The Parties hereby agree, inter
alia, that such Co-Promotion Agreement, and Wyeth's marketing plan
for such CD20 Product, shall provide (a) Trubion's sales force with
a meaningful role in the Commercialization of such CD20 Product; (b)
that Wyeth shall provide CD20 Product-related sales training to
Trubion's sales force, at no cost to Trubion; and (c) that Trubion's
sales force shall use CD20 Product promotional materials and
samples, to be provided by Wyeth at no cost, in connection with
their sales efforts. As compensation for sales force support
provided by Trubion in connection with such Co-Promotion, Wyeth
shall pay Trubion a fixed fee (to be set forth in the definitive
Co-Promotion Agreement) for each Product sales detail performed by
members of Trubion's sales force in accordance with Wyeth's
marketing plan for such CD20 Product. Trubion will not have the
right to contract out for or otherwise delegate to any Third Party
any responsibility for such sales force support. Trubion's sales
force activities shall be conducted in accordance with Wyeth's
policies and the marketing and promotion plan for the CD20 Product.
4.12. CO-PROMOTION COMMITTEE. If Trubion exercises its Co-Promotion option
with respect to a CD20 Product in accordance with Section 4.11
hereof, a Co-Promotion Committee shall be formed by the Parties
within thirty (30) days after such exercise. The Co-Promotion
Committee shall oversee all aspects of Co-Promotion-related
activities and reasonably relevant aspects of Commercialization of
such CD20 Product during the Co-Promotion Period, and shall include
Trubion's Chief Executive Officer and Wyeth's Executive Vice
President and General Manager, Wyeth BioPharma.
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4.13. CO-BRANDING. To the extent allowed by applicable law, all product
labeling for CD20 Products shall include both Parties' names, which
shall be of similar size and prominence to the extent practicable
(except (i) with respect to labeling of vials or other components of
a CD20 Product that do not include either Party's name or (ii) with
respect to labeling of diluent or other components packaged together
with the CD20 Product that do not customarily contain another
Person's name).
4.14. MARKING. All Licensed Products shall be marked with the patent
numbers of issued patents within Trubion Patent Rights and Wyeth
Patent Rights that cover such Licensed Products, to the extent
practicable and permitted by law in countries in which such markings
have notice value against infringers of patents.
5. CONSIDERATION.
5.1. INITIAL RESEARCH AND DEVELOPMENT EXPENSE PAYMENT. In consideration
of Trubion's agreement to conduct the Research Program and to
participate on the JRC and JDC, Wyeth shall pay to Trubion Forty
Million Dollars ($40,000,000.00) within ten (10) days after the
Effective Date, which payment shall be non-refundable and
non-creditable.
5.2. EQUITY. Wyeth shall purchase from Trubion common stock of Trubion at
such time, in such amounts and for such price as specified in the
Stock Purchase Agreement, attached hereto as Exhibit 5.2A.
Concurrent with the execution of the Stock Purchase Agreement, the
Parties shall enter into an amendment of Trubion's Amended and
Restated Investor Rights Agreement, attached hereto as Exhibit 5.2B.
5.3. ADDITIONAL RESEARCH AND DEVELOPMENT EXPENSE PAYMENTS. In further
consideration of Trubion's contributions under the Research Program
and the Development Program, as provided in Articles 3 and 4 above,
Wyeth shall pay to Trubion the payments specified in Exhibit 5.3
attached hereto (each an "Additional Research and Development
Expense Payment") in the amounts and at such times as specified in
Exhibit 5.3. Wyeth shall notify Trubion promptly upon the
achievement of each event specified in Exhibit 5.3.
5.4. ROYALTIES.
5.4.1. LICENSED PRODUCT ROYALTIES. In consideration for the
licenses granted to Wyeth under Section 2.1 hereof, and in
addition to those payments required to be made by Wyeth
pursuant to Section 5.1, Section 5.2 and Section 5.3,
Wyeth shall pay to Trubion royalties during the Royalty
Period as set forth in Sections 5.4.2, 5.4.3 and 5.4.4
below, subject to the adjustments provided in Section
5.4.6 below.
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5.4.2. CD20 PRODUCT ROYALTIES.
(a) Except as provided in Sections 5.4.2(b) and 5.4.2(c)
below, Wyeth shall pay to Trubion royalties in the
amount of the Marginal Royalty Rates (set forth below)
of the aggregate Net Sales collectively obtained by
Wyeth and its sublicensees from the sale of CD20
Products in the Territory during each calendar year in
the applicable Royalty Period:
Marginal Royalty Rate
(% of the Applicable Portion of
Annual Net Sales Level Annual Net Sales)
---------------------- --------------------------------
Less than *** ***
From *** ***
From *** ***
From *** ***
Greater than *** ***
Each Marginal Royalty Rate set forth in the table above
shall apply only to that portion of the annual Net Sales
that falls within the indicated range. By way of example
only, if the aggregate Net Sales of CD20 Products during
a calendar year equaled ***, the total royalty for CD20
Products during such year would equal the specified
Marginal Royalty Rate (***) of the first *** of Net
Sales, plus the specified Marginal Royalty Rate (***) of
the next *** of Net Sales, plus the specified Marginal
Royalty Rate (***) of the remaining *** of Net Sales
(that is, ***, which would equal ***).
For purposes of this Section 5.4.2, the "CD20 Effective
Royalty Rate" for a particular time period shall mean
the weighted average, expressed as a percentage, of the
Marginal Royalty Rates that would apply under the
provisions of this Section 5.4.2(a) to the aggregate
CD20 Product Net Sales in the Territory during such time
period (without regard, for these purposes, to any
adjustments made under Sections 5.4.2(b) or 5.4.2(c)).
By way of example only, if the aggregate Net Sales of
CD20 Products in the Territory during a calendar year
equaled ***, the CD20 Effective Royalty Rate for such
calendar year would be calculated as follows: ((*** of
***) plus (*** of ***) plus (*** of ***)) divided by
***, expressed as a percentage, which would equal ***.
By way of further example only, if the aggregate Net
Sales of CD20 Products in the Territory during each of
the four Calendar Quarters
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of such calendar year were ***, respectively (for a
total of ***), the CD20 Effective Royalty Rates for each
of the four Calendar Quarters would be ***,
respectively.
(b) Subject to the provisions of Section 5.4.2(c) below, in
the event that, at any time during the term of the
Product License, no issued Valid Claim is included
within the Trubion Patent Rights in a country where a
CD20 Product is sold (which claim, but for the licenses
granted hereunder to Wyeth, would be infringed by
Wyeth's or its sublicensees' Manufacture, use, sale,
offer for sale or import of such CD20 Product in such
country), Wyeth shall pay to Trubion royalties with
respect to such CD20 Product in such country during such
time period, in lieu of the royalties described in
Section 5.4.2(a), equal to the following amount: (i) the
CD20 Effective Royalty Rate of the aggregate Net Sales
obtained by Wyeth and its sublicensees from the sale of
such CD20 Product in such country during such time
period minus (ii) *** of the aggregate Net Sales
obtained by Wyeth and its sublicensees from the sale of
such CD20 Product in such country during such time
period. By way of example only, if the aggregate Net
Sales of such a CD20 Product in such country during the
relevant time period were *** and the CD20 Effective
Royalty Rate (based on Net Sales of CD20 Products
throughout the Territory) for such time period were ***,
the royalties payable under this Section 5.4.2(b) on Net
Sales in such country would equal (i) ***of ***, (or
***), minus (ii) *** of ***, (or ***), which would equal
***. By way of further example only, if the aggregate
Net Sales of such a CD20 Product in such country during
the relevant time period were *** and the CD20 Effective
Royalty Rate (based on Net Sales of CD20 Products
throughout the Territory) for such time period were ***,
the royalties payable under this Section 5.4.2(b) on Net
Sales in such country would equal (i) *** of ***, (or
***), minus (ii) *** of ***, (or ***), which would equal
***.
(c) In the event that at any time during the term of the
Product License: (i) no issued Valid Claim is included
within the Trubion Patent Rights in a country where a
CD20 Product is sold (which claim, but for the licenses
granted hereunder to Wyeth, would be infringed by
Wyeth's or its sublicensees' Manufacture, use, sale,
offer for sale or import of such CD20 Product in such
country), (ii) a product is sold by a Third Party in
such country, which product would, if sold by such Third
Party in the United
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States, infringe an issued Valid Claim included within
the Trubion Patent Rights in the United States, and
(iii) such product sold by the Third Party has a *** or
greater unit market share in such country (where the
market is defined as the sum of the unit sales of such
CD20 Product and of the product described in clause
(ii)), Wyeth shall pay to Trubion royalties with respect
to such CD20 Product in such country during such time
period, in lieu of the royalties described in Section
5.4.2(a) and Section 5.4.2(b), equal to the following
amount: (i) *** of (ii) the CD20 Effective Royalty Rate
of the aggregate Net Sales obtained by Wyeth and its
sublicensees from the sale of such CD20 Product in such
country during such time period. By way of example only,
if the aggregate Net Sales of such a CD20 Product in
such country during the relevant time period were ***
and the CD20 Effective Royalty Rate for such time period
were ***, the royalties payable under this Section
5.4.2(c) would equal (i) *** of (ii) *** of ***, (or
***), which would equal ***.
5.4.3. ***.
(a) Except as provided in Sections 5.4.3(b) and 5.4.3(c)
below, Wyeth shall pay to Trubion royalties in the
amount of the Marginal Royalty Rates (set forth below)
of the aggregate Net Sales collectively obtained by
Wyeth and its sublicensees from the sale of each *** in
the Territory during each calendar year in the
applicable Royalty Period:
Marginal Royalty Rate
(% of the Applicable Portion of
Annual Net Sales Level Annual Net Sales)
---------------------- -------------------------------
Less than *** ***
From *** ***
From *** ***
From *** ***
Greater than *** ***
Each Marginal Royalty Rate set forth in the table above
shall apply only to that portion of the annual Net Sales
for a particular *** that falls within the indicated
range. By way of example only, if the aggregate Net
Sales of a *** during a calendar year equaled ***, the
total royalty for such *** during such calendar year
would equal the specified Marginal Royalty Rate (***) of
the first *** of Net Sales, plus the specified Marginal
Royalty Rate *** of the next *** of Net Sales, plus the
specified Marginal Royalty Rate
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*** of the remaining *** of Net Sales (that is, ***,
which would equal ***).
For purposes of this Section 5.4.3, the "*** Royalty
Rate" for a particular time period for a particular ***
shall mean the weighted average, expressed as a
percentage, of the Marginal Royalty Rates that would
apply under the provisions of this Section 5.4.3(a) to
the Net Sales in the Territory of such *** during such
time period (without regard, for these purposes, to any
adjustments made under Sections 5.4.3(b) or 5.4.3(c)).
By way of example only, if the Net Sales of a *** in the
Territory during a calendar year equaled***, the ***
Royalty Rate for such calendar year for such *** would
be calculated as follows: ((***) plus (***) plus (***))
divided by ***, expressed as a percentage, which would
equal ***. By way of further example only, if the Net
Sales of such *** in the Territory during each of the
four Calendar Quarters of such calendar year were ***,
respectively (for a total of *** in such calendar year),
the *** Royalty Rates for each of the four Calendar
Quarters would be ***, respectively.
(b) Subject to the provisions of Section 5.4.3(c) below, in
the event that, at any time during the term of the
Product License, no issued Valid Claim is included
within the Trubion Patent Rights in a country where a
*** is sold (which claim, but for the licenses granted
hereunder to Wyeth, would be infringed by Wyeth's or its
sublicensees' Manufacture, use, sale, offer for sale or
import of such *** in such country), Wyeth shall pay to
Trubion royalties with respect to such *** in such
country during such time period, in lieu of the
royalties described in Section 5.4.3(a), equal to the
following amount: (i) the *** Royalty Rate for such ***
of the aggregate Net Sales obtained by Wyeth and its
sublicensees from the sale of such *** in such country
during such time period minus (ii) *** of the aggregate
Net Sales obtained by Wyeth and its sublicensees from
the sale of such *** in such country during such time
period. By way of example only, if the aggregate Net
Sales of such a *** in such country during the relevant
time period were *** and the *** Royalty Rate (based on
Net Sales of such *** throughout the Territory) for such
time period for such *** were ***, the royalties payable
under this Section 5.4.3(b) on Net Sales in such country
would equal (i) ***, (or ***), minus (ii) ***, (or ***),
which would equal ***. By way of further example only,
if the Net Sales of such *** in such country during the
relevant time period were
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*** and the *** Royalty Rate (based on Net Sales of such
*** throughout the Territory) for such time period were
***, the royalties payable under this Section 5.4.3(b)
on Net Sales in such country would equal (i) ***, (or
***), minus (ii) ***, (or ***), which would equal ***.
(c) In the event that at any time during the term of the
Product License: (i) no issued Valid Claim is included
within the Trubion Patent Rights in any country where a
*** is sold (which claim, but for the licenses granted
hereunder to Wyeth, would be infringed by Wyeth's or its
sublicensees' Manufacture, use, sale, offer for sale or
import of such *** in such country), (ii) a product is
sold by a Third Party in such country, which product
would, if sold by such Third Party in the United States,
infringe an issued Valid Claim included within the
Trubion Patent Rights in the United States, and (iii)
such product sold by a Third Party has a *** or greater
unit market share in such country (where the market is
defined as the sum of the unit sales of such *** and of
the product described in clause (ii)), Wyeth shall pay
to Trubion royalties with respect to such *** in such
country during such time period, in lieu of the
royalties described in Section 5.4.3(a) and Section
5.4.3(b), equal to the following amount: (i) *** of (ii)
the *** Royalty Rate for such *** of the aggregate Net
Sales obtained by Wyeth and its sublicensees from the
sale of such *** in such country during such time
period. By way of example only, if the aggregate Net
Sales of such a *** in such country during the relevant
time period were *** and the *** Royalty Rate for such
time period for such *** were ***, the royalties payable
under this Section 5.4.3(c) on Net Sales in such country
would equal (i) *** of (ii) *** of ***, (or ***), which
would equal ***. By way of further example only, if the
Net Sales of such *** in such country during the
relevant time period were *** and the *** Royalty Rate
(based on Net Sales of such *** throughout the
Territory) for such time period were ***, the royalties
payable under this Section 5.4.3(c) on Net Sales in such
country would equal (i) *** multiplied by (ii) *** of
***, (or ***), which would equal ***.
5.4.4. OTHER PRODUCT ROYALTIES.
(a) Except as provided in Sections 5.4.4(b) and 5.4.4(c)
below, Wyeth shall pay Trubion a royalty of *** of the
aggregate Net Sales obtained by Wyeth and its
sublicensees from the
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sale of each Other Product in the Territory during each
calendar year in the applicable Royalty Period.
(b) Subject to the provisions of Section 5.4.4(c) below, in
the event that, at any time during the term of the
Product License, no issued Valid Claim is included
within the Trubion Patent Rights in a country where an
Other Product is sold (which claim, but for the licenses
granted hereunder to Wyeth, would be infringed by
Wyeth's or its sublicensees' Manufacture, use, sale,
offer for sale or import of such Other Product in such
country), Wyeth shall pay to Trubion, with respect to
such Other Product in such country during such time
period, in lieu of the royalty described in Section
5.4.4(a), a royalty of *** of the aggregate Net Sales
obtained by Wyeth and its sublicensees from the sale of
such Other Product in such country during such time
period.
(c) In the event that at any time during the term of the
Product License: (i) no issued Valid Claim is included
within the Trubion Patent Rights in any country where an
Other Product is sold (which claim, but for the licenses
granted hereunder to Wyeth, would be infringed by
Wyeth's or its sublicensees' Manufacture, use, sale,
offer for sale or import of such Other Product in such
country), (ii) a product is sold by a Third Party in
such country, which product would, if sold by such Third
Party in the United States, infringe an issued Valid
Claim included within the Trubion Patent Rights in the
United States, and (iii) such product sold by a Third
Party has a *** or greater unit market share in such
country (where the market is defined as the sum of the
unit sales of such Other Product and of the product
described in clause (ii)), Wyeth shall pay to Trubion,
with respect to such Other Product in such country
during such time period, in lieu of the royalties
described in Section 5.4.4(a) and Section 5.4.4(b), a
royalty of *** of the aggregate Net Sales obtained by
Wyeth and its sublicensees from the sale of such Other
Product in such country during such time period.
5.4.5. EXPIRATION OF ROYALTY PERIOD. After the expiration of the
Royalty Period for any Licensed Product in any country in the
Territory, no further royalties shall be payable in respect
of sales of such Licensed Product in such country and
thereafter the licenses granted to Wyeth under Section 2.1
with respect to such Licensed Product in such country shall
be fully paid-up, perpetual, irrevocable, royalty-free,
exclusive licenses.
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5.4.6. ROYALTY ADJUSTMENTS.
(a) CERTAIN THIRD PARTY AGREEMENTS. On a country-by-country
basis in a given calendar year, Wyeth shall deduct from
CD20 Product royalties otherwise payable to Trubion
under Section 5.4.2 *** of the aggregate amount of
royalties actually paid to Third Parties under
Additional Third Party Licenses with respect to the
Development, Manufacture or Commercialization of CD20
Products in such country in such calendar year;
provided, however, that (i) the amount of such deduction
shall not exceed *** of the amount of the CD20 Product
royalties otherwise payable to Trubion under Section
5.4.2 in a given calendar year and (ii) such deduction
shall not have the effect, under any circumstances, of
reducing the CD20 Product royalties payable under
Section 5.4.2 below *** of the aggregate Net Sales
obtained by Wyeth and its sublicensees from the sale of
CD20 Products in such country in a given calendar year
(before taking into account the operation of Sections
5.4.2(b) and 5.4.2(c)). On a country-by-country basis in
a given calendar year, Wyeth shall deduct from ***
royalties otherwise payable to Trubion under Section
5.4.3 *** of the aggregate amount of royalties actually
paid to Third Parties under Additional Third Party
Licenses with respect to the Development, Manufacture or
Commercialization of such *** in such country in such
calendar year; provided, however, that (i) the amount of
such deduction shall not exceed *** of the amount of the
*** royalties otherwise payable to Trubion under Section
5.4.3 in a given calendar year and (ii) such deduction
shall not have the effect, under any circumstances, of
reducing the *** royalties payable under Section 5.4.3
below *** of the aggregate Net Sales obtained by Wyeth
and its sublicensees from the sale of such *** in such
country in a given calendar year (before taking into
account the operation of Sections 5.4.3(b) and
5.4.3(c)). ***
(b) OTHER THIRD PARTY AGREEMENTS. Wyeth shall be solely
responsible for all payment obligations related to ***.
Trubion shall be solely responsible for all payment
obligations related to ***.
5.5. REPORTS AND PAYMENTS.
5.5.1. CUMULATIVE ROYALTIES. The obligation to pay royalties under
Section 5.4 of this Agreement shall be imposed only once with
respect to a single unit of a Licensed Product, regardless of
how
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many Valid Claims included within the Trubion Technology
would, but for this Agreement, be infringed by the
Manufacture, use, import, offer for sale or sale of such
Licensed Product in the countr(y)ies of such Manufacture, use
or sale. For the avoidance of doubt, if a single Licensed
Product is both a CD20 Product and an Other Product, such
Licensed Product shall be deemed to be a CD20 Product for
purposes of the royalty obligations under Section 5.4. If a
single Licensed Product is both a *** and an Other Product,
such Licensed Product shall be deemed to be a *** for
purposes of the royalty obligations under Section 5.4.
5.5.2. ROYALTY STATEMENTS AND PAYMENTS. Within *** after the end of
each Calendar Quarter, Wyeth shall deliver to Trubion a
report setting forth for such Calendar Quarter the following
information, on a Licensed Product-by-Licensed Product and
country-by-country basis: (a) the gross sales amount (by
Wyeth and its sublicensees) for each category of Licensed
Product sold in the United States and the number of units of
Licensed Product sold in the United States and other
countries in the Territory, on a country-by-country basis;
(b) the Net Sales for each Licensed Product; (c) any
adjustments (including the basis therefor) made pursuant to
Sections 5.4.2(b), 5.4.2(c), 5.4.3(b), 5.4.3(c), 5.4.4(b),
5.4.4(c) or 5.4.6(a) to the royalty amount payable for the
sale of each Licensed Product, the applicable Marginal
Royalty Rates and the CD20 Effective Royalty Rate or ***
Royalty Rate (as the case may be) payable on the Net Sales,
and (d) the royalty amount due hereunder for the sale of each
Licensed Product. No such reports shall be due for any
Licensed Product before the First Commercial Sale of such
Licensed Product. The total royalty due for the sale of
Licensed Products during such Calendar Quarter shall be
remitted at the time such report is made.
5.5.3. TAXES AND WITHHOLDING. All payments due Trubion under this
Agreement will be made without any deduction or withholding
for or on account of any tax unless such deduction or
withholding is required by applicable laws or regulations to
be assessed against Trubion. If Wyeth is so required to
deduct or withhold, Wyeth will (a) promptly notify Trubion of
such requirement, (b) pay to the relevant authorities the
full amount required to be deducted or withheld promptly upon
the earlier of determining that such deduction or withholding
is required or receiving notice that such amount has been
assessed against Trubion, (c) promptly forward to Trubion an
official receipt (or certified copy) or other documentation
reasonably acceptable to Trubion evidencing such payment to
such authorities, and (d) otherwise reasonably cooperate with
Trubion in connection with
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Trubion's attempts to obtain favorable tax treatment and
credit therefor (where appropriate) in accordance with
applicable laws.
5.5.4. CURRENCY. All amounts payable and calculations hereunder
shall be in United States Dollars. As applicable, Net Sales
and any royalty deductions shall be translated into United
States dollars in accordance with Wyeth's customary and usual
translation procedures, consistently applied, which
procedures are in accordance with Generally Accepted
Accounting Principles in the United States.
5.5.5. ADDITIONAL PROVISIONS RELATING TO ROYALTIES. Trubion
acknowledges and agrees that nothing in this Agreement
(including, without limitation, any exhibits or attachments
hereto) shall be construed as representing an estimate or
projection of either (a) the number of Licensed Products that
will or may be successfully Developed or Commercialized or
(b) anticipated sales or the actual value of any Licensed
Product and that the figures set forth in Section 5.4 or
elsewhere in this Agreement or that have otherwise been
discussed by the Parties are merely intended to define
Wyeth's royalty obligations to Trubion in the event such
sales performance is achieved. WYETH MAKES NO REPRESENTATION
OR WARRANTY, EITHER EXPRESS OR IMPLIED, THAT IT WILL BE ABLE
TO SUCCESSFULLY DEVELOP OR COMMERCIALIZE ANY LICENSED PRODUCT
OR, IF COMMERCIALIZED, THAT IT WILL ACHIEVE ANY PARTICULAR
SALES LEVEL OF SUCH LICENSED PRODUCT(S).
5.5.6. INTEREST ON PAST DUE PAYMENTS. If either Party fails to pay
any payment due under this Agreement on or before the date
such payment is due, as provided in this Agreement, such late
payment shall bear interest, to the extent permitted by
applicable law, *** as reported from time to time in The Wall
Street Journal, effective for the first date on which payment
was delinquent and calculated on the number of days such
payment is overdue or, if such rate is not regularly
published, as published in such source as the Parties agree.
5.6. MAINTENANCE OF RECORDS; AUDITS.
5.6.1. RECORD KEEPING. Wyeth shall keep accurate books and accounts
of record in connection with the sale of Licensed Products,
in sufficient detail to permit accurate determination of all
figures necessary for verification of royalties and other
payments to be paid to Trubion hereunder. Wyeth shall keep
accurate records of its activities under this Agreement that
relate
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to the events with respect to which Additional Research and
Development Expense Payments may be made under Section 5.3
hereof. Wyeth shall maintain such records for a period of at
least three (3) years after the end of the calendar year in
which they were generated.
5.6.2. AUDITS. Upon thirty (30) days prior written notice from
Trubion, Wyeth shall permit an independent certified public
accounting firm of nationally recognized standing selected by
Trubion and reasonably acceptable to Wyeth, to examine, at
Trubion's sole expense, the relevant books and records of
Wyeth as may be reasonably necessary to verify the accuracy
of the reports submitted by Wyeth in accordance with Section
5.5 and the payment of royalties hereunder. An examination by
Trubion under this Section 5.6.2 shall occur not more than
once in any calendar year and shall be limited to the
pertinent books and records for any calendar year ending not
more than three (3) years before the date of the request. The
accounting firm shall be provided access to such books and
records at Wyeth's facility(ies) where such books and records
are normally kept and such examination shall be conducted
during Wyeth's normal business hours. Wyeth may require the
accounting firm to sign a standard non-disclosure agreement
before providing the accounting firm access to Wyeth's
facilities or records. Upon completion of the audit, the
accounting firm shall provide both Wyeth and Trubion a
written report disclosing whether the reports submitted by
Wyeth are correct or incorrect, whether the royalties paid
are correct or incorrect, and in each case, the specific
details concerning any discrepancies. No other information
shall be provided to Trubion.
5.6.3. UNDERPAYMENTS/OVERPAYMENTS. If such accounting firm concludes
that additional royalties were due to Trubion, Wyeth shall
pay to Trubion the additional royalties within thirty (30)
days of the date Wyeth receives such accountant's written
report so concluding. If such royalty underpayment exceeds
ten percent (10%) of the royalties that were to be paid to
Trubion, Wyeth also shall reimburse Trubion for the
out-of-pocket expenses incurred in conducting the audit. If
such accounting firm concludes that Wyeth overpaid royalties
to Trubion, Trubion, within thirty (30) days of the date
Trubion receives such account's report so concluding, will
refund such overpayments to Wyeth less the reasonable
out-of-pocket costs incurred by Trubion in conducting the
audit.
5.6.4. CONFIDENTIALITY. All financial information of Wyeth which is
subject to review under this Section 5.6 shall be deemed to
be
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Wyeth's Confidential Information subject to the provisions of
Article 7 hereof, and Trubion shall not disclose such
Confidential Information to any Third Party or use such
Confidential Information for any purpose other than verifying
payments to be made by Wyeth to Trubion hereunder; provided,
however, that such Confidential Information may be disclosed
by Trubion to Third Parties only to the extent necessary to
enforce Trubion's rights under this Agreement.
6. INTELLECTUAL PROPERTY.
6.1. INVENTIONS; JOINT PATENT COMMITTEE.
6.1.1. OWNERSHIP AND INVENTORSHIP. A Party shall own all inventions
and Know-How made solely by employees of such Party, and
shall jointly own with the other Party any invention, whether
or not patentable, made jointly by employees of both Parties
(a "Joint Invention"), all Joint Patent Rights directed
thereto, and any Know-How made jointly by employees of both
Parties ("Joint Know-How"). All determinations of
inventorship under this Agreement shall be made in accordance
with United States patent law. Each Party shall disclose
promptly in writing to the other any Joint Inventions and any
candidate Joint Inventions of which it becomes aware. Subject
to (a) the grant of licenses to Wyeth under Section 2.1 and
to Trubion under Section 2.2, (b) the exclusivity provisions
of Section 2.3, and (c) the Parties' other rights and
obligations under this Agreement, each Party shall be free to
exploit (including to research, Develop, Manufacture,
Commercialize and enforce), either itself or through the
grant of licenses to Third Parties (which Third Party
licenses are further sublicensable), Joint Patent Rights and
Joint Know-How throughout the world without restriction,
without the need to obtain further consent from the other
Party, and without payment of any compensation to the other
Party.
6.1.2. SMIP IMPROVEMENTS. All SMIP Improvements made by Wyeth,
whether independently or jointly with Trubion, in the course
of performing Wyeth's obligations under this Agreement during
the term of the Agreement (each, a "Covered SMIP
Improvement") shall be promptly disclosed by Wyeth to
Trubion. Wyeth, subject to the rights and licenses granted by
Trubion to Wyeth hereunder, hereby grants to Trubion a
worldwide, royalty-free (other than as expressly set forth in
this Section 6.1.2), irrevocable, non-exclusive license (with
the right to sublicense), under Wyeth's rights to such
Covered SMIP Improvements, to practice, exploit and use such
Covered SMIP Improvements in connection with the research,
Manufacture, Development, Commercialization or use of SMIPs
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(***); provided, however, for the avoidance of doubt, that the
license granted to Trubion pursuant to this sentence shall not
be deemed to constitute or include a license with respect to
any underlying Wyeth technology or any Wyeth Technology
(including without limitation Manufacturing, delivery,
formulation and conjugation technology) other than Wyeth's
rights to such Covered SMIP Improvements. In the event, and to
the extent, that Wyeth is obligated to pay a Third Party any
royalties or other payments as a result of the licensing of a
Covered SMIP Improvement to Trubion pursuant to this Section
6.1.2 or as a result of Trubion's or its sublicensees'
(excluding Wyeth's) practice of such Covered SMIP Improvement,
the license by Wyeth to Trubion pursuant to this Section 6.1.2
with respect to such Covered SMIP Improvement shall be
conditioned on Trubion's continuing obligation to pay Wyeth
the amount of such royalties and other payments according to
the terms of the applicable agreement between Wyeth and such
Third Party. In the event that Trubion grants a sublicense to
any Third Party with respect to a Covered SMIP Improvement
that is not a Joint Invention (but rather was invented solely
by Wyeth), Trubion shall pay Wyeth a royalty of *** of the net
sales by such sublicensee (or its affiliates or sublicensees)
of any product that incorporates such Covered SMIP
Improvement. For purposes of the preceding sentence, "net
sales" shall be defined in a manner substantially similar to
the definition of "Net Sales" under this Agreement.
6.1.3. JOINT PATENT COMMITTEE.
(a) ESTABLISHMENT; MEETINGS; DECISIONS. Within thirty (30)
days after the Effective Date, the Parties shall
establish a Joint Patent Committee composed of at least
one (1) representative from each Party with experience
in the prosecution of biotechnology patents. The Joint
Patent Committee will have such duties and
responsibilities as are expressly assigned to it under
this Article 6. The Joint Patent Committee shall meet as
soon as practicable after it is established by the
Parties and, thereafter, at such additional times as the
Parties deem appropriate, not less frequently than
quarterly. The meetings of the Joint Patent Committee
shall alternate between the Parties' business locations
or as otherwise decided by the Joint Patent Committee;
provided that Joint Patent Committee meetings may be
conducted in person, by telephone or by videoconference.
Each Party shall use reasonable efforts to cause its
representative(s) to attend each Joint Patent Committee
meeting. Decisions of the Joint Patent Committee shall
be made by unanimous consent, with each
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Party having one vote. The Joint Patent Committee may
act without a meeting if an action by unanimous written
consent is signed by each committee member. If the Joint
Patent Committee is unable to reach agreement on a
matter for which it has decision-making authority
pursuant to Section 6.1.3(b), 6.2.1(c) or 6.2.2(c), the
matter may be referred, at the request of either Party,
for resolution by outside patent counsel mutually
selected by the Parties (wherein such outside patent
counsel shall be knowledgeable and experienced in the
subject matter of the matter so referred), and such
resolution shall be deemed the decision of the Joint
Patent Committee. Unless otherwise agreed by the
Parties, the patent counsel selected will not have
served as primary outside IP counsel to either Party
prior to being selected to resolve the Joint Patent
Committee disagreement. ***
(b) CATEGORY 1 COVERED SMIP IMPROVEMENTS AND CATEGORY 2
COVERED SMIP IMPROVEMENTS. Without limiting Wyeth's
obligation under Section 6.1.1 and Section 6.1.2 to
disclose promptly to Trubion any inventions and
candidate inventions made hereunder (including, without
limitation, any Covered SMIP Improvements), each Party
shall report on a quarterly basis to the Joint Patent
Committee whether any of its activities hereunder during
the prior Calendar Quarter involved a new Covered SMIP
Improvement. The Joint Patent Committee shall decide
whether a given Covered SMIP Improvement (i) is solely
applicable to SMIP coding regions (a "Category 1 Covered
SMIP Improvement"), or (ii) is not solely applicable to
SMIP coding regions (a "Category 2 Covered SMIP
Improvement"). ***.
6.2. PATENT RIGHTS.
6.2.1. FILING, PROSECUTION AND MAINTENANCE OF PATENT RIGHTS.
(a) TRUBION PATENT RIGHTS.
(i) TRUBION PATENT RIGHTS. Trubion shall use its
Commercially Reasonable Efforts to prepare,
file, prosecute and maintain, throughout the
Territory, all of the Trubion Patent Rights,
using patent counsel of Trubion's choice;
provided, however, that Trubion shall give
Wyeth before filing a reasonable opportunity
to review and comment upon the text of any
applications for Trubion Patent Rights to
the
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extent related to any Licensed Product, any
SMIPs directed against any Licensed Target,
or the Development, Manufacture, use or
Commercialization thereof (collectively,
"Product-Related Patent Rights"); and
provided further, however, that patent
counsel for patent applications for
Product-Related Patent Rights that are
prepared or filed on or after the Signing
Date and that do not rely on the priority
date of a patent or patent application filed
before the Signing Date will be mutually
agreed upon by the Parties. Trubion shall
reasonably consider and address Wyeth's
comments on patent applications included in
Product-Related Patent Rights. Trubion shall
consult with Wyeth with respect to such
patent applications, and shall supply Wyeth
with a copy of such patent applications as
filed, together with notice of each filing
date and serial number. Trubion shall also
keep Wyeth advised of the status of
prosecution of all such patent applications
included in the Product-Related Patent
Rights, and shall consult with Wyeth and
provide Wyeth with a reasonable opportunity
to comment on all correspondence received
from and all submissions to be made to any
government patent office or authority with
respect to any such patent application or
patent. Trubion shall reasonably consider
and address Wyeth's comments on such
correspondence and submissions. Each Party
shall be responsible for *** of Trubion's
out-of-pocket expenses incurred in
connection with preparing, filing,
prosecuting and maintaining such
Product-Related Patent Rights throughout the
Territory, including, but not limited to,
out-of-pocket expenses for inventorship
determinations and inventorship disputes
(other than between the Parties); provided,
however, that in the event Trubion grants a
license(s) in a given country or countries
to one or more Third Parties under any
patent application or patent that is
included in the Product-Related Patent
Rights, Wyeth shall be responsible for a pro
rata portion, based on a total number of
parties that includes Trubion, Wyeth and all
Third Party licensees under such patent
application or patent (e.g., if there are
two (2) Third Party licensees in addition to
Wyeth and Trubion, then Wyeth shall be
responsible for twenty-five
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percent (25%)), of Trubion's out-of-pocket
expenses incurred in a given country in
connection with preparing, filing,
prosecuting and maintaining such patent
application or patent. (As used in this
Article 6, "out-of-pocket expenses" shall be
deemed to include, without limitation,
reasonable attorneys' fees.) Wyeth shall
reimburse Trubion on a quarterly basis
within *** of receiving an invoice
accompanied by supporting documentation
demonstrating the out-of-pocket expenses so
incurred. On an annual basis, during the
last Calendar Quarter of each year, Trubion
shall provide Wyeth with a good faith,
written estimate of the out-of-pocket
expenses reimbursable by Wyeth under this
Section 6.2.1(a) that Trubion expects to
incur in the following calendar year. In
addition, if Trubion elects not to file a
patent application on Trubion Know-How that,
if filed, would be a Product-Related Patent
Right, or to cease the prosecution and/or
maintenance of any Product-Related Patent
Rights, (except for abandonment of a patent
application in favor of a patent application
subsequently filed for purposes of
continuing the prosecution of Patent Rights
claiming the inventions included in the
abandoned patent application), Trubion shall
provide Wyeth with written notice
immediately upon the decision to not file or
continue the prosecution of such patent
application or maintenance of such patent.
In such event, Trubion shall permit Wyeth,
at Wyeth's sole discretion, to file and/or
continue prosecution and/or maintenance of
such Product-Related Patent Right on
Trubion's behalf and at Wyeth's own expense.
If Wyeth elects to file or to continue such
prosecution or maintenance, it shall notify
Trubion in writing of such decision within
*** of receipt of Trubion's written notice,
in which case Trubion shall assign to Wyeth
such Product-Related Patent Right abandoned
by Trubion and shall execute such documents
and perform such acts, at Wyeth's expense,
as may be reasonably necessary to permit
Wyeth to file, prosecute and/or maintain
such Product-Related Patent Right. In the
event that Wyeth files or continues the
prosecution or maintenance of any such
Product-Related Patent Right pursuant to
this Section 6.2.1(a), then Wyeth
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shall no longer be obligated to pay to Trubion any
royalty payments that would be due solely with
respect to such Product-Related Patent Right.
(b) WYETH PATENT RIGHTS. Subject to Section 6.2.1(d), and
except with respect to Covered SMIP Improvements, Wyeth,
at its own expense, shall have the sole right, but not
the obligation, to prepare, file, prosecute and
maintain, throughout the Territory, all Wyeth Patent
Rights, using patent counsel of Wyeth's choice.
(c) JOINT PATENT RIGHTS. Subject to Section 6.2.1(d), in the
event the Parties make any Joint Invention (excluding a
Covered SMIP Improvement), the Joint Patent Committee
shall promptly meet to discuss and determine whether to
seek patent protection thereon. If the Joint Patent
Committee decides to seek patent protection on such
Joint Invention, then Wyeth shall have the primary
obligation to prepare, file, prosecute and maintain any
corresponding Joint Patent Rights throughout the
Territory using patent counsel mutually agreeable to the
Parties, such agreement not to be unreasonably withheld.
Wyeth shall give Trubion a reasonable opportunity to
review and comment on the text of any patent application
with respect to such Joint Patent Right before filing,
shall consult with Trubion with respect thereto, shall
reasonably consider and address any of Trubion's
comments, and shall supply Trubion with a copy of each
such patent application as filed, together with notice
of its filing date and serial number. Wyeth shall keep
Trubion advised of the status of the actual and
prospective patent filings (including, without
limitation, the grant of any Joint Patent Rights), shall
provide Trubion with a reasonable opportunity to comment
on all correspondence received from and all proposed
submissions to be made to any government patent office
or authority related to the filing, prosecution and
maintenance of such patent filings, shall consult with
Trubion with respect thereto, and shall reasonably
consider and address any of Trubion's comments on such
correspondence and submissions. Trubion shall reimburse
Wyeth for *** of the out-of-pocket expenses incurred by
Wyeth in connection with preparing, filing, prosecuting
and maintaining such Joint Patent Rights (other than
out-of-pocket expenses for inventorship determinations
and inventorship disputes), which reimbursement will be
made within *** of receiving invoices, such invoices to
be submitted by Wyeth no more often than once per
Calendar Quarter and to be
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accompanied by supporting documentation demonstrating
and detailing the expenses so incurred. On an annual
basis, during the last Calendar Quarter of each year,
Wyeth shall provide Trubion with a good faith, written
estimate of the out-of-pocket expenses reimbursable by
Trubion under this Section 6.2.1(c) that Wyeth expects
to incur in the following calendar year. If Wyeth elects
not to file a patent application on any such Joint
Patent Rights, or to cease the prosecution and/or
maintenance of any such Joint Patent Rights (except for
abandonment of a patent application in favor of a patent
application subsequently filed for purposes of
continuing the prosecution of Patent Rights claiming the
inventions included in the abandoned patent
application), Wyeth shall provide Trubion with written
notice immediately upon the decision to not file or
continue the prosecution of such patent application or
maintenance of such patent. In such event, Wyeth shall
permit Trubion, at Trubion's sole discretion, to file
and/or continue prosecution and/or maintenance of such
Joint Patent Rights at Trubion's own expense. If Trubion
elects to continue such prosecution or maintenance, it
shall notify Wyeth in writing of such decision within
*** of receipt of Wyeth's written notice, in which case,
Wyeth shall assign to Trubion such Joint Patent Rights
abandoned by Wyeth and shall execute such documents and
perform such acts, at Trubion's expense, as may be
reasonably necessary to permit Trubion to file,
prosecute and/or maintain such Joint Patent Rights.
(d) CATEGORY 1 AND CATEGORY 2 COVERED SMIP IMPROVEMENTS.
(i) CATEGORY 1 COVERED SMIP IMPROVEMENTS. In the event
that Wyeth makes any Category 1 Covered SMIP
Improvement (whether it is an invention solely by
Wyeth or a Joint Invention), Trubion shall have
the first right and primary obligation to prepare,
file, prosecute and maintain any Patent Rights
covering such Category 1 Covered SMIP Improvement,
using patent counsel mutually agreeable to the
Parties, such agreement not to be unreasonably
withheld. Trubion shall give Wyeth a reasonable
opportunity to review and comment on the text of
any patent application with respect to such
Category 1 Covered SMIP Improvement before filing,
shall consult with Wyeth with respect thereto,
shall reasonably consider and address any of
Wyeth's comments, and shall supply
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Wyeth with a copy of the patent application as
filed, together with notice of its filing date and
serial number. Trubion shall keep Wyeth advised of
the status of the actual and prospective patent
filings (including, without limitation, the grant
of any Patent Rights covering such Category 1
Covered SMIP Improvements), shall provide Wyeth
with a reasonable opportunity to comment on all
correspondence received from and all proposed
submissions to be made to any government patent
office or authority related to the filing,
prosecution and maintenance of such patent
filings, shall consult with Wyeth with respect
thereto, and shall reasonably consider and address
any of Wyeth's comments on such correspondence and
submissions. Each Party shall be responsible for
*** of Trubion's out-of-pocket expenses incurred
in connection with preparing, filing, prosecuting
and maintaining such Category 1 Covered SMIP
Improvement-related Patent Rights throughout the
Territory, other than out-of-pocket expenses for
inventorship determinations and inventorship
disputes. Wyeth shall reimburse Trubion on a
quarterly basis within *** of receiving an invoice
accompanied by supporting documentation
demonstrating the out-of-pocket expenses so
incurred. On an annual basis, during the last
Calendar Quarter of each year, Trubion shall
provide Wyeth with a good faith, written estimate
of the out-of-pocket expenses reimbursable by
Wyeth under this Section 6.2.1(d)(i) that Trubion
expects to incur in the following calendar year.
In addition, if Trubion elects not to file a
patent application on a Category 1 Covered SMIP
Improvement, or to cease the prosecution and/or
maintenance of any Category 1 Covered SMIP
Improvement-related Patent Right (except for
abandonment of a patent application in favor of a
patent application subsequently filed for purposes
of continuing the prosecution of Patent Rights
claiming the inventions included in the abandoned
patent application), Trubion shall provide Wyeth
with written notice immediately upon the decision
to not file or continue the prosecution of such
patent application or maintenance of such patent.
If Wyeth elects to continue such prosecution or
maintenance, it shall notify Trubion in writing of
such decision within *** of receipt of Trubion's
written notice, in which case Trubion shall assign
to
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Wyeth the right to file, prosecute and maintain
such Category 1 Covered SMIP Improvement-related
Patent Right, and shall execute such documents and
perform such acts, at Wyeth's expense, as may be
reasonably necessary to permit Wyeth to file,
prosecute and/or maintain such Category 1 Covered
SMIP Improvement-related Patent Right. In the
event that Wyeth continues the prosecution or
maintenance of any Category 1 Covered SMIP
Improvement-related Patent Right pursuant to this
Section 6.2.1(d)(i), Wyeth shall do so at its own
expense, and Wyeth shall no longer be obligated to
pay to Trubion any royalty payments that would be
due solely with respect to any such Category 1
Covered SMIP Improvement-related Patent Right.
(ii) CATEGORY 2 COVERED SMIP IMPROVEMENTS. In the event
that Wyeth makes any Category 2 Covered SMIP
Improvement (whether it is an invention solely by
Wyeth or a Joint Invention), Wyeth shall have the
first right and primary obligation to prepare,
file, prosecute and maintain any Patent Rights
covering such Category 2 Covered SMIP Improvement,
at its own expense, using patent counsel mutually
agreeable to the Parties, such agreement not to be
unreasonably withheld. Wyeth shall give Trubion a
reasonable opportunity to review and comment on
the text of any patent application with respect to
such Category 2 Covered SMIP Improvement before
filing, shall consult with Trubion with respect
thereto, shall reasonably consider and address any
of Trubion's comments, and shall supply Trubion
with a copy of the patent application as filed,
together with notice of its filing date and serial
number. Wyeth shall keep Trubion advised of the
status of the actual and prospective patent
filings (including, without limitation, the grant
of any Patent Rights covering such Category 2
Covered SMIP Improvement), shall provide Trubion
with a reasonable opportunity to comment on all
correspondence received from and all proposed
submissions to be made to any government patent
office or authority related to the filing,
prosecution and maintenance of such patent
filings, shall consult with Trubion with respect
thereto, and shall reasonably consider and address
any of Trubion's comments on such correspondence
and submissions. If Wyeth elects not to file a
patent application on a
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Category 2 Covered SMIP Improvement, or to cease
the prosecution and/or maintenance of any Category
2 Covered SMIP Improvement-related Patent Right
(except for abandonment of a patent application in
favor of a patent application subsequently filed
for purposes of continuing the prosecution of
Patent Rights claiming the inventions included in
the abandoned patent application), Wyeth shall
provide Trubion with written notice immediately
upon the decision to not file or continue the
prosecution of such patent application or
maintenance of such patent. If Trubion elects to
continue such prosecution or maintenance, it shall
notify Wyeth in writing of such decision within
*** of receipt of Wyeth's written notice, in which
case Wyeth shall assign to Trubion such Category 2
Covered SMIP Improvement-related Patent Right
abandoned by Wyeth and shall execute such
documents and perform such acts, at Trubion's
expense, as may be reasonably necessary to permit
Trubion to file, prosecute and/or maintain such
Category 2 Covered SMIP Improvement-related Patent
Right.
6.2.2. ENFORCEMENT OF PATENT RIGHTS.
(a) NOTICE. If either Wyeth or Trubion becomes aware of any
infringement, anywhere in the Territory, of any issued
patent within the Trubion Patent Rights (including
Product-Related Patent Rights), Wyeth Patent Rights or
Joint Patent Rights, which infringing activity adversely
affects or is reasonably expected to adversely affect
any SMIP or Licensed Product hereunder, it will promptly
notify the other Party in writing to that effect and the
Parties will consult with each other through the Joint
Patent Committee regarding any actions to be taken with
respect to such infringing activity; provided, however,
that neither Party is obligated to disclose confidential
information of a Third Party (other than a sublicensee
under this Agreement, to the extent such Party is
permitted to do so under the terms of the sublicense).
(b) PRODUCT-RELATED PATENT RIGHTS. To the extent permitted
under the Trubion Third Party Agreements, if applicable,
Wyeth shall have the first right, but not the
obligation, to take action to obtain a discontinuance of
infringement or bring suit against a Third Party
infringer of Product-Related Patent Rights under which
Wyeth has an exclusive license
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to make, use and sell Licensed Products under this
Agreement, to the extent such infringement involves a
product directed against a Licensed Target. Wyeth shall
have such first right within three (3) months from the
date of notice and the right to join Trubion as a party
plaintiff. Wyeth shall be responsible for, and shall
bear, all the out-of-pocket expenses of any suit brought
by it claiming infringement of any such Product-Related
Patent Rights; provided that Trubion shall reimburse
Wyeth for *** of the out-of-pocket expenses incurred in
connection therewith. Trubion will cooperate with Wyeth
in any such suit and shall have the right to consult
with Wyeth and to participate in and be represented by
independent counsel in such litigation at its own
expense. Wyeth shall incur no liability to Trubion as a
consequence of such litigation or any unfavorable
decision resulting therefrom, including any decision
holding any of the Product-Related Patent Rights invalid
or unenforceable. Any recoveries obtained by Wyeth as a
result of any proceeding against such Third Party
infringer shall be allocated as follows:
(i) Such recovery shall first be used to reimburse
each Party for all out-of-pocket litigation
expenses in connection with such litigation paid
by that Party; and
(ii) With respect to any remaining recovery, *** shall
go to Wyeth and *** shall go to Trubion.
If, after the expiration of the three (3) month period
(or, if earlier, the date upon which Wyeth provides
written notice that it does not plan to bring suit),
Wyeth has not obtained a discontinuance of such
infringement of Product-Related Patent Rights or filed
suit against any such Third Party infringer hereunder,
then Trubion shall have the right, but not the
obligation, to bring suit against such Third Party
infringer of the Product-Related Patent Rights under
which Wyeth has an exclusive license under this
Agreement, provided that each Party shall bear *** of
the out-of-pocket expenses of such suit. Wyeth will
cooperate with Trubion in any such suit for infringement
of such Product-Related Patent Rights brought by Trubion
against a Third Party, and shall have the right to
consult with Trubion and to participate in and be
represented by independent counsel in such litigation at
its own expense. Trubion shall incur no liability to
Wyeth as a consequence of such litigation or any
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unfavorable decision resulting therefrom, including any
decision holding any of the Product-Related Patent
Rights invalid or unenforceable. Any recoveries obtained
by Trubion as a result of any such proceeding against a
Third Party infringer shall be allocated as follows:
(iii) Such recovery shall first be used to reimburse
each Party for all out-of-pocket litigation
expenses in connection with such litigation paid
by that Party; and
(iv) With respect to any remaining recovery, *** shall
go to Trubion.
(c) JOINT PATENT RIGHTS. With respect to any notice of a
Third Party infringer of the Joint Patent Rights, the
Joint Patent Committee shall meet as soon as reasonably
practicable to discuss such infringement and determine
an appropriate course of action. Wyeth shall have the
first right but not the obligation to bring an action
against such Third Party infringer or otherwise address
such alleged infringement within *** from the date of
notice and to control such litigation or other means of
addressing such infringement. Wyeth shall be responsible
for, and shall bear, all the out-of-pocket expenses of
any suit brought by it claiming infringement of any such
Joint Patent Rights; provided that Trubion shall
reimburse Wyeth for *** of the out-of-pocket expenses
incurred in connection therewith. Trubion shall
cooperate with Wyeth, at Wyeth's expense, in any such
suit brought by Wyeth and shall have the right to
consult with Wyeth and participate in and be represented
by independent counsel in such litigation at its own
expense. Wyeth shall incur no liability to Trubion as a
consequence of such litigation or any unfavorable
decision resulting therefrom, including any decision
holding any of the Joint Patent Rights invalid or
unenforceable. Any recoveries obtained by Wyeth as a
result of any proceeding against such Third Party
infringer shall be allocated as follows:
(i) Such recovery shall first be used to reimburse
each Party for all out-of-pocket litigation
expenses in connection with such litigation paid
by that Party; and
(ii) With respect to any remaining recovery, *** shall
go to Wyeth and *** shall go to Trubion.
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If, after the expiration of the three (3) month period
(or, if earlier, the date upon which Wyeth provides
written notice that it does not plan to bring suit)
Wyeth elects not to take action against a Third Party
infringer of the Joint Patent Rights and Trubion elects
to bring an action, then Wyeth shall cooperate, at
Trubion's expense, in such action. Trubion shall incur
no liability to Wyeth as a consequence of such
litigation or any unfavorable decision resulting
therefrom, including any decision holding any of the
Joint Patent Rights invalid or unenforceable. Any
recoveries obtained by Trubion shall go to Trubion.
6.2.3. INFRINGEMENT AND THIRD PARTY LICENSES.
(a) INFRINGEMENT OF THIRD PARTY PATENTS - COURSE OF ACTION.
If the research, Development, Manufacture or
Commercialization of any Licensed Product is alleged by
a Third Party to infringe a Third Party's patent, the
Party becoming aware of such allegation shall promptly
notify the other Party.
Additionally, if either Party determines (with
consultation by the Joint Patent Committee) that, based
upon the review of a Third Party's patent or patent
application or other intellectual property rights, it
may be desirable to obtain a license from such Third
Party with respect thereto, such Party shall promptly
notify the other Party of such determination. In the
event Wyeth determines, after good faith consultation
with Trubion through the Joint Patent Committee, that it
is necessary or useful to obtain licenses under
intellectual property rights from Third Parties
("Additional Third Party Licenses") in order to Develop,
Manufacture or Commercialize Licensed Products under
this Agreement, Wyeth shall be solely responsible for
negotiating and obtaining any such Additional Third
Party Licenses, but shall not be obligated to do so.
Trubion may elect, in its sole discretion, to obtain one
or more Third Party licenses that are applicable to
Trubion Technology in general but are not Licensed
Product-specific ("Trubion Additional Third Party
Licenses"); if Trubion so elects, then Trubion shall be
solely responsible for negotiating and obtaining any
such licenses, but shall not be obligated to do so.
(b) THIRD PARTY INFRINGEMENT SUIT. If a Third Party sues a
Party (the "Sued Party") alleging that the Sued Party or
its Affiliates' or sublicensees' research, Development,
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Manufacture or Commercialization of any Licensed Product
during the term of and pursuant to this Agreement
infringes or will infringe said Third Party's patent,
then, upon the Sued Party's request and in connection
with the Sued Party's defense of any such Third Party
infringement suit, the other Party shall provide
reasonable assistance to the Sued Party for such
defense. If both Wyeth and Trubion are sued by a Third
Party, then the Parties shall consult with one another
through the Joint Patent Committee. Unless otherwise
determined by the Joint Patent Committee, Wyeth will
control the defense of any suit relating to Licensed
Products (whether one or both Parties are Sued Parties)
and shall select counsel for such suit after
consultation through the Joint Patent Committee. Trubion
shall have the right to participate in and be
represented by independent counsel in such litigation at
its own expense. If the alleged infringement is of
claims related to the Trubion Technology utilized by
Wyeth hereunder, Wyeth shall be responsible for, and
shall bear, all the out-of-pocket expenses of such
actions; provided that Trubion shall reimburse Wyeth for
*** of the out-of-pocket expenses incurred in connection
therewith. In the event Trubion is the Party paying such
expenses, Trubion shall periodically, but no more than
once per Calendar Quarter, invoice Wyeth for its ***
share of expenses incurred. All invoices shall be
accompanied by supporting documentation reasonably
showing the expenses so incurred. Such invoices shall be
paid within *** of receipt. In the event Wyeth is the
Party paying such expenses, Wyeth shall receive a credit
in the amount of Trubion's share of such expenses, which
credit shall be applied to royalties due to Trubion
under Section 5.4, as adjusted under Section 5.4.6;
provided that, no such royalty payment to Trubion shall
be reduced by more than *** in any Calendar Quarter as a
result of such credit. Any portion of the credit not
utilized due to the limitations of the preceding
sentence shall be carried over and credited to future
royalty payments.
(c) INTERFERENCE, OPPOSITION, REVOCATION, AND DECLARATORY
JUDGMENT ACTIONS. If the Parties, through the Joint
Patent Committee, mutually determine that, based upon
the review of a Third Party's patent or patent
application or other intellectual property rights, it
may be desirable to provoke or institute an
interference, opposition, revocation or declaratory
judgment action with respect thereto, then the Parties
shall consult with one another and shall reasonably
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cooperate in connection with such an action. Unless
otherwise determined by the Joint Patent Committee,
Wyeth will control such action and shall select counsel
for such action. Wyeth shall be responsible for, and
shall bear, all the out-of-pocket expenses of such
action; provided that Trubion shall reimburse Wyeth for
*** of the out-of-pocket expenses incurred in connection
therewith. Wyeth shall submit invoices to Trubion for
such expenses, such invoices to be accompanied by
supporting documentation reasonably showing the expenses
so incurred. Trubion shall have the right to participate
in and be represented by independent counsel in such
action at its own expense.
6.2.4. PATENT CERTIFICATIONS. Each Party shall immediately give
written notice to the other of any certification of which it
becomes aware filed pursuant to 21 U.S.C. Section
355(b)(2)(A) or Section 355(j)(2)(A)(vii) (or any amendment
or successor statute thereto), any similar statutory or
regulatory requirement enacted in the future regarding
biologic products, or any similar statutory or regulatory
requirement in any non-U.S. country in the Territory claiming
that a Joint Patent Right, Wyeth Patent Right or a Trubion
Patent Right covering a Licensed Product is invalid or that
infringement will not arise from the Manufacture, use or sale
of a product by a Third Party. Upon the giving or receipt of
such notice, Wyeth shall have the first right, but not the
obligation, to bring an infringement action against such
Third Party. In such a case, Wyeth shall notify Trubion at
least ten (10) days prior to the date set forth by statute or
regulation of its intent to exercise, or not exercise, this
right. Any infringement action against a Third Party arising
under this Section 6.2.4 shall be governed by the provisions
of Section 6.2.2(b) hereof.
6.2.5. PATENT TERM RESTORATION. The Parties hereto shall cooperate
with each other in obtaining patent term restoration, or its
equivalent anywhere in the Territory, including under 35
U.S.C. Section 156 and its foreign counterparts, where
applicable to the Trubion Patent Rights, Wyeth Patent Rights
and Joint Patent Rights. If elections with respect to
obtaining such patent term restoration are to be made, Wyeth
shall make such election (after consultation with Trubion
through the Joint Patent Committee) and Trubion shall abide
by such election.
6.3. TRADEMARKS. Wyeth shall, in its sole discretion select and own all
Licensed Product-related Trademarks, trade dress, logos and
copyrights and names to be used in connection with the
Commercialization of any Licensed Product hereunder. Trubion shall
neither use nor seek to register, anywhere in the Territory, any
trademarks which are confusingly similar to
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any Trademark or any other trademarks, trade names, trade dress or
logos used by or on behalf of Wyeth or its sublicensees in
connection with any Licensed Product; provided, however, that
nothing in this Section 6.3 shall be construed to prevent Trubion
from enforcing its own trademark, trade name, trade dress or logo
rights or affect the Parties' obligations under Section 4.13.
7. CONFIDENTIALITY.
7.1. CONFIDENTIALITY. Except to the extent expressly authorized by this
Agreement or otherwise agreed in writing, the Parties agree that,
for the term of this Agreement and for *** thereafter, each Party
(the "Receiving Party"), receiving any Confidential Information of
the other Party (the "Disclosing Party") hereunder shall keep such
Confidential Information confidential and shall not publish or
otherwise disclose or use such Confidential Information for any
purpose other than as provided for in this Agreement except for
Confidential Information that the Receiving Party can establish:
(a) was already known by the Receiving Party (other than
under an obligation of confidentiality), at the time of
disclosure by the Disclosing Party and such Receiving
Party has documentary evidence to that effect;
(b) was generally available to the public or otherwise part
of the public domain at the time of its disclosure to
the Receiving Party;
(c) became generally available to the public or otherwise
part of the public domain after its disclosure or
development, as the case may be, and other than through
any act or omission of a Party in breach of this
confidentiality obligation;
(d) was disclosed to that Party, other than under an
obligation of confidentiality, by a Third Party who had
no obligation to the Disclosing Party not to disclose
such information to others; or
(e) was independently discovered or developed by or on
behalf of the Receiving Party without the use of the
Confidential Information belonging to the other Party
and the Receiving Party has documentary evidence to that
effect.
7.2. AUTHORIZED DISCLOSURE AND USE.
7.2.1. DISCLOSURE. Notwithstanding the foregoing Section 7.1, each
Party may disclose Confidential Information belonging to the
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other Party to the extent such disclosure is reasonably
necessary to:
(a) file or prosecute patent applications covering Trubion
Know-How, Wyeth Know-How or Joint Know-How as
contemplated by this Agreement, in a manner consistent
with decisions and recommendations of the Joint Patent
Committee under Article 6, if the affected Party
consents to such disclosure (such consent not to be
unreasonably withheld or delayed); provided that a
disclosure of a Party's Confidential Information under
this Section 7.2.1(a) shall be treated as a publication
under Section 7.4.3, and shall be subject to the
requirements of advance notice, review period and
opportunity to file patent application(s), as set forth
in Section 7.4.3,
(b) prosecute or defend litigation,
(c) exercise rights hereunder provided such disclosure is
covered by terms of confidentiality similar to those set
forth herein,
(d) facilitate discussions with prospective investors (other
than pharmaceutical or biotechnology companies) in
connection with financing arrangements (not involving
any license, collaboration or other arrangement relating
to such Party's technology or products) or a proposed
acquisition of such Party, subject to appropriate
confidentiality agreements and limiting such disclosure
to disclosure of the terms and conditions of this
Agreement and Know-How to the extent contained in such
Party's patent applications; and
(e) comply with applicable governmental laws and
regulations.
In the event that a Party shall reasonably deem it necessary
to disclose, pursuant to this Section 7.2.1, Confidential
Information belonging to the other Party, the Disclosing
Party shall to the extent possible give reasonable advance
notice of such disclosure to the other Party and take
reasonable measures to ensure confidential treatment of such
information.
7.2.2. USE. Notwithstanding the foregoing Section 7.1, each Party
shall have the right to use Confidential Information of the
other Party in carrying out its responsibilities under this
Agreement in the research, Development, Manufacture and
Commercialization of Licensed Products.
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7.3. SEC FILINGS. Either Party may disclose the terms of this
Agreement to the extent required, in the reasonable opinion of
such Party's legal counsel, to comply with applicable laws,
including, without limitation, the rules and regulations
promulgated by the United States Securities and Exchange
Commission. Notwithstanding the foregoing, before disclosing
this Agreement or any of the terms hereof pursuant to this
Section 7.3, the Parties will reasonably consult with one
another on the terms of this Agreement to be redacted in
making any such disclosure. If a Party discloses this
Agreement or any of the terms hereof in accordance with this
Section 7.3, such Party agrees, at its own expense, to seek
confidential treatment of portions of this Agreement or such
terms, as may be reasonably requested by the other Party.
7.4. PUBLIC ANNOUNCEMENTS; PUBLICATIONS.
7.4.1. COORDINATION. The Parties agree on the importance of
coordinating their public announcements respecting this
Agreement and the subject matter thereof (other than
academic, scientific or medical publications that are
subject to the publication provision set forth below).
Trubion and Wyeth shall, from time to time, and at the
request of the other Party, discuss and agree on the
general information content relating to this Agreement
(including relating to the Research Program and
Development Program, and/or to research, Development,
Manufacture and/or Commercialization of Licensed
Products) which may be publicly disclosed (including,
without limitation, by means of any printed publication
or oral presentation).
7.4.2. ANNOUNCEMENTS. Except as may be expressly permitted
under Section 7.3 or Section 7.4.3 or as may be
appropriate for Wyeth to make in connection with its
Commercialization activities as contemplated hereunder,
subject to Sections 7.1 and 7.2 hereof, neither Party
will make any public announcement regarding this
Agreement, the Research Program or the Development
Program, and/or the research, Development,
Manufacturing or Commercialization of Licensed Products
without the prior written approval of the other Party.
7.4.3. PUBLICATIONS. During the term of this Agreement, each
Party will submit to the other Party for review and
approval all proposed academic, scientific and medical
publications and public presentations relating to the
Research Program, the Development Program and/or to the
research, Development, Manufacture and/or
Commercialization of any Licensed Product, or any
proposed disclosure under Section 7.2.1(a), for review
in connection with preservation of Patent Rights and/or
to determine whether any of such other Party's
Confidential
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Information should be modified or deleted. Written
copies of such proposed publications and presentations
shall be submitted to the non-publishing Party no later
than thirty (30) days before submission for publication
or presentation and the non-publishing Party shall
provide its comments with respect to such publications
and presentations within fifteen (15) business days of
its receipt of such written copy. The review period may
be extended for an additional thirty (30) days in the
event the non-publishing Party can demonstrate
reasonable need for such extension, including, but not
limited to, the preparation and filing of patent
applications. By mutual agreement, this period may be
further extended. Wyeth and Trubion will each comply
with standard academic practice regarding authorship of
scientific publications and recognition of contribution
of other parties in any publications relating to the
Research Program, the Development Program and/or to the
research, Development, Manufacture and/or
Commercialization of any Licensed Product.
8. REPRESENTATIONS AND WARRANTIES.
8.1. REPRESENTATIONS AND WARRANTIES OF EACH PARTY. Each of Trubion and
Wyeth hereby represents and warrants to the other Party hereto as
follows:
(a) it is a corporation or entity duly organized and validly
existing under the laws of the state or other
jurisdiction of its incorporation or formation;
(b) the execution, delivery and performance of this
Agreement by such Party has been duly authorized by all
requisite corporate action and does not require any
shareholder action or approval;
(c) it has the power and authority to execute and deliver
this Agreement and to perform its obligations and to
grant the licenses granted by it to the other Party
pursuant to this Agreement;
(d) the execution, delivery and performance by such Party of
this Agreement and its compliance with the terms and
provisions hereof does not and will not conflict with or
result in a breach of any of the terms and provisions of
or constitute a default under (i) any agreement or
instrument binding or affecting it or the subject matter
of this Agreement; (ii) the provisions of its charter or
operative documents or bylaws; or (iii) any order, writ,
injunction or decree of any court or governmental
authority entered
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against it or by which any of its property is bound,
except where such conflict, breach or default would not
materially impact (A) the Party's ability to meet its
obligations hereunder or (B) the rights granted to the
other Party hereunder; and
(e) it has not granted to any Third Party any right or
license which would conflict in any material respect
with the rights granted by it to the other Party
hereunder.
8.2. ADDITIONAL REPRESENTATIONS AND WARRANTIES OF TRUBION. In addition to
the representations and warranties made by Trubion in Section 8.1,
Trubion, subject to Section 8.7, hereby represents and warrants to
Wyeth that as of the Signing Date:
(a) except as disclosed in Exhibit 8.2(d) attached hereto,
Trubion is the sole and exclusive owner of the Trubion
Patent Rights and Trubion has not placed, or suffered to
be placed, any liens, charges or encumbrances on or
against the Trubion Patent Rights;
(b) Exhibit 1.129 is a true and complete list of Trubion
Patent Rights that pertain to Licensed Products,
provided that an inadvertent omission from such list may
be cured by amending Exhibit 1.129;
(c) the Trubion Patent Rights are existing and, to Trubion's
knowledge, no issued or granted patents within the
Trubion Patent Rights are invalid or unenforceable;
(d) ***;
(e) except as set forth in Exhibit 8.2(e) attached hereto,
no Trubion Patent Right listed in Exhibit 1.129 attached
hereto is subject to any funding agreement with any
government or government agency;
(f) Trubion has received no written notice alleging
infringement of a Third Party Patent Right in connection
with its research and Development of SMIPs directed
against a Trubion Target, and Trubion has disclosed to
Wyeth all material information of which Trubion is aware
as to whether the research, Development, Manufacture,
use or sale of SMIPs directed against a Trubion Target,
in the form that is the subject of the clinical studies
ongoing as of the Signing Date, if such SMIPs were
researched, Developed, Manufactured, used or sold as of
the Signing
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Date, infringes or would infringe issued or granted
patents owned by a Third Party as of the Signing Date;
(g) the Trubion Patent Rights are not subject to any
litigation, judgments or settlements against or owed by
Trubion, nor has Trubion received written notice of any
threats of such litigation;
(h) Trubion is in compliance in all material respects with
all agreements with Third Parties relating to Licensed
Products that are sublicensed to Wyeth hereunder;
(i) ***
(j) the Trubion Patent Rights are not the subject of any
interference, opposition, reissue or reexamination
proceeding in the United States or, to the knowledge of
Trubion, any opposition proceeding outside of the United
States.
8.3. MUTUAL COVENANT. Each Party covenants to the other Party that it
shall at all times comply with all applicable material laws and
regulations relating to its activities under this Agreement.
8.4. ADDITIONAL COVENANTS OF TRUBION. During the term of this Agreement,
Trubion will use diligent efforts not to materially breach any
agreement between Trubion and a Third Party that provides Trubion
Patent Rights pertaining to the research, Development, Manufacture
or Commercialization of any Licensed Product, and it will provide
Wyeth promptly with notice of any such alleged breach. ***. During
the term of this Agreement, Trubion will not knowingly use any
Know-How misappropriated from a Third Party in connection with any
Licensed Product being provided for Commercialization under this
Agreement.
8.5. REPRESENTATION BY LEGAL COUNSEL. Each Party hereto represents that
it has been represented by legal counsel in connection with this
Agreement and acknowledges that it has participated in the drafting
hereof. In interpreting and applying the terms and provisions of
this Agreement, the Parties agree that no presumption shall exist or
be implied against the Party which drafted such terms and
provisions.
8.6. NO INCONSISTENT AGREEMENTS. Neither Party has in effect and after
the Signing Date neither Party shall enter into any oral or written
agreement or arrangement that would be inconsistent with its
obligations under this Agreement.
8.7. DISCLAIMER. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN SECTIONS 8.1,
8.2 AND 8.5, THE PARTIES MAKE NO
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REPRESENTATIONS AND EXTEND NO WARRANTIES OF ANY KIND, EITHER EXPRESS
OR IMPLIED, AND PARTICULARLY THAT LICENSED PRODUCTS WILL BE
SUCCESSFULLY DEVELOPED HEREUNDER, AND IF LICENSED PRODUCTS ARE
DEVELOPED, WITH RESPECT TO SUCH LICENSED PRODUCTS, THE PARTIES
DISCLAIM ALL IMPLIED WARRANTIES OF TITLE, NON-INFRINGEMENT,
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
9. GOVERNMENT APPROVALS; TERM AND TERMINATION.
9.1. HSR FILING. Each Party shall be responsible for its own costs,
expenses, and filing fees associated with any HSR Filing; provided,
however, that Wyeth shall be solely responsible for any fees (other
than penalties that may be incurred as a result of actions or
omissions on the part of Trubion) required to be paid to any
government agency in connection with making any such HSR Filing.
9.2. OTHER GOVERNMENT APPROVALS. Trubion and Wyeth will cooperate and use
respectively all reasonable efforts to make all registrations,
filings and applications, to give all notices and to obtain as soon
as practicable all governmental or other consents, transfers,
approvals, orders, qualifications authorizations, permits and
waivers, if any, and to do all other things necessary or desirable
for the consummation of the transactions as contemplated hereby.
9.3. TERM. The term of this Agreement will commence on the Signing Date
and shall extend, unless this Agreement is terminated earlier in
accordance with this Article 9, on a Licensed Product by Licensed
Product and country by country basis until such time as the Royalty
Period with respect to the sale of such Licensed Product in such
country expires.
9.4. TERMINATION UPON HSR DENIAL. This Agreement shall terminate (a) at
Wyeth's option, immediately upon written notice to Trubion, in the
event that the United States Federal Trade Commission and/or the
United States Department of Justice shall seek a preliminary
injunction under the HSR Act against Trubion and Wyeth to enjoin the
transactions contemplated by this Agreement, (b) at the election of
either Party, immediately upon written notice to the other Party, in
the event that the United States Federal Trade Commission and/or the
United States Department of Justice shall obtain a preliminary
injunction under the HSR Act against Trubion and Wyeth to enjoin the
transactions contemplated by this Agreement, or (c) at the election
of either Party, immediately upon written notice to the other Party,
in the event that the HSR Clearance Date shall not have occurred on
or prior to *** after the effective date of the HSR Filing.
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9.5. MATERIAL BREACH. In the event that either Party commits a material
breach of its representations, warranties or obligations under this
Agreement, the other Party may terminate this Agreement (a) on a
Licensed Target by Licensed Target and country by country basis, to
the extent that such material breach relates to Licensed Product(s)
directed against such Licensed Target(s) in such country(ies) or (b)
in its entirety only if such material breach fundamentally
frustrates the objectives or transactions contemplated by this
Agreement taken as a whole. If a Party elects to exercise such right
to terminate, it shall do so by providing written notice of the
alleged breach (the "Notice of Breach") to the breaching Party. If
such material breach pertains to the payment of undisputed amounts
payable under this Agreement and remains uncured for *** after the
breaching Party's receipt of such Notice of Breach or, if such
material breach pertains to another material breach (other than for
non-payment) and remains uncured for *** after the breaching Party's
receipt of such Notice of Breach, then the non-breaching Party may
terminate this Agreement, as and to the extent permitted in (a) or
(b) above, on *** notice by giving a written notice of termination
("Notice of Termination") to the breaching Party; provided, however,
that if such breach (other than for non-payment) is not susceptible
to cure within the initial *** period and the breaching Party uses
continuous, diligent, good faith efforts to cure such breach, it
shall document such efforts by written notice to the non-breaching
Party on or before the end of such *** period, and the stated cure
period will be extended by an additional ***. This Agreement shall
be deemed terminated (as and to the extent permitted in (a) or (b)
above) *** after the breaching Party's receipt of such Notice of
Termination, unless the breaching Party has fully cured the breach
prior to the expiration of such *** period.
In the event that Trubion is the breaching Party and fails to cure
any such material breach within the applicable time period(s) set
forth above, Wyeth, within *** after the expiration of the cure
period for such breach, may elect, in lieu of terminating this
Agreement, by written notice to Trubion (a "Notice of
Modification"), to modify the terms of this Agreement, as (and only
to the extent) provided in Section 9.8, on a Licensed
Target-by-Licensed Target and country-by-country basis (but only to
the extent such material breach relates to Licensed Product(s)
directed against such Licensed Target(s) in such country(ies)), in
which event, Wyeth shall be deemed to have waived its right to
terminate this Agreement under this Section 9.5 with respect to such
Licensed Target(s) in such country(ies) only with respect to the
material breach giving rise to such action under this Section 9.5.
Notwithstanding the foregoing, a Party shall not be in breach of its
obligations under this Agreement to the extent that such breach was
caused by the other Party's failure to perform its obligations
hereunder.
9.6. TERMINATION BY WYETH.
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9.6.1. TERMINATION WITHOUT CAUSE. Commencing on the second
anniversary of the Effective Date, Wyeth shall have the
right, exercisable upon ninety (90) days prior written notice
to Trubion, to terminate this Agreement either (a) in its
entirety, or (b) on a Licensed Target by Licensed Target and
country by country basis. Wyeth's rights under this Section
9.6.1 are separate from and in addition to its rights to
terminate the Research Program under Section 3.3.2 hereof.
9.6.2. TERMINATION FOR A MATERIAL SAFETY OR REGULATORY ISSUE. Wyeth
shall have the right to terminate this Agreement, at any
time, on a Licensed Target by Licensed Target basis, by
giving *** prior written notice to Trubion in the event of
any safety or regulatory issue that would have a material
adverse effect on Wyeth's ability to research, Develop,
Manufacture or Commercialize any Licensed Product directed
against such Licensed Target, as determined in Wyeth's
reasonable judgment and according to Wyeth's standard
internal procedures for evaluating such safety or regulatory
issues. Effects of such termination shall be as set forth in
Section ***.
9.7. EFFECTS OF TERMINATION.
9.7.1. EFFECT OF TERMINATION BY WYETH FOR CAUSE.
(a) Without limiting any other legal or equitable remedies
that Wyeth or Trubion may have, subject to Section
11.3, if this Agreement is terminated in its entirety
by Wyeth for cause under Section 9.5, the following
provisions shall apply:
(i) all licenses granted by each Party to the other
Party under this Agreement shall terminate
(except as provided in Section 9.7.10 below);
(ii) during the *** period after the effective date of
such termination, Trubion shall have the right to
negotiate with Wyeth an agreement which grants to
Trubion a non-exclusive license (with the right
to grant sublicenses) to practice, use and
exploit the Wyeth Applied Technology with respect
to the research, Development, Manufacture and
Commercialization of Licensed Products on
commercially reasonable terms. If Trubion
exercises such right, Wyeth shall negotiate the
terms of such license with Trubion diligently and
in good faith; provided that, if Trubion and
Wyeth negotiate, but do not enter into, such
non-exclusive license, Wyeth shall not enter into
any agreement
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granting a license to a Third Party under the
Wyeth Applied Technology within *** after the end
of such negotiations on terms more favorable to
such Third Party than those last offered by Wyeth
to Trubion, without first offering Trubion, for a
period of not less than ***, the opportunity to
review such terms after full disclosure thereof
and enter into a non-exclusive license on such
more favorable terms, and, if Trubion accepts such
more favorable terms, the Parties shall promptly
negotiate definitive agreements relating thereto;
(iii) during the *** period after the effective date of
such termination, Trubion shall have the right to
negotiate with Wyeth for the transfer of Product
Data and Filings to Trubion, and for the grant by
Wyeth to Trubion of the right and license to use
the Licensed Product-specific Trademarks and
Product-specific names pertaining to the Licensed
Product(s) as existing at the time of termination
(collectively, "Existing Trademarks"), on
commercially reasonable terms. If Trubion
exercises such right, Wyeth shall negotiate the
terms of such transfer and license with Trubion
diligently and in good faith; provided that, if
Trubion and Wyeth negotiate but do not enter into
such an agreement, Wyeth shall not enter into any
agreement granting such rights to a Third Party
within *** after the end of such negotiation on
terms more favorable to such Third Party than
those last offered by Wyeth to Trubion, without
first offering Trubion, for a period of not less
than ***, the opportunity to review such terms
after full disclosure thereof and enter into such
an agreement on such more favorable terms, and, if
Trubion accepts such more favorable terms, the
Parties shall promptly negotiate definitive
agreements relating thereto; and
(iv) subject to the provisions of Section 9.9, this
Agreement shall be of no further force or effect.
(b) Without limiting any other legal or equitable remedies
that Wyeth or Trubion may have, subject to Section 11.3,
if this Agreement is terminated by Wyeth for cause under
Section 9.5 with respect to a Licensed Target in all
countries, but not in its entirety, the following
provisions shall apply:
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(i) if such Licensed Target is a Trubion Target, all of the
Parties' rights and obligations under Article 3 in
connection with the Research Program shall cease in
their entirety; provided that all amounts due for
research performed and costs incurred prior to the date
of such termination shall remain payable in accordance
with the provisions of Article 3;
(ii) if such Licensed Target is a Wyeth Target, all of the
Parties' rights and obligations under Article 3 in
connection with the Research Program shall continue,
subject to Wyeth's option, exercisable in its sole
discretion, to terminate the Research Program as
follows: Wyeth shall exercise such option to terminate
the Research Program (if it so elects) by a written
statement to that effect included in Wyeth's Notice of
Termination (described in Section 9.5 above). If Wyeth
exercises such option to terminate the Research Program,
all of the Parties' rights and obligations under Article
3 in connection with the Research Program shall cease in
their entirety *** after Trubion's receipt of such
Notice of Termination; provided that all amounts due for
research performed and costs incurred prior to the date
of such termination shall remain payable in accordance
with the provisions of Article 3;
(iii) if such terminated Licensed Target is the CD20 Antigen,
Wyeth shall have no further obligation to reimburse
Trubion under Section 4.6 with respect to expenses
incurred after the effective date of termination;
(iv) all licenses granted by each Party to the other Party
under this Agreement with respect to Licensed Products
directed against such Licensed Target shall terminate
(except as provided in Section 9.7.10 below);
(v) the provisions of Section 9.7.1(a)(ii), with such
changes as are appropriate in the context of such
limited termination, shall apply with respect to the
Licensed Products directed against such Licensed Target;
and
(vi) the provisions of Section 9.7.1(a)(iii), with such
changes as are appropriate in the context of such
limited termination, shall apply with respect to Product
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limited termination, shall apply with respect to
Product Data and Filings, and Existing Trademarks,
relating to the Licensed Products directed against
such Licensed Target.
(c) Without limiting any other legal or equitable remedies
that Wyeth or Trubion may have, subject to Section 11.3,
if this Agreement is terminated by Wyeth for cause under
Section 9.5 with respect to all Licensed Targets in a
country, but not in its entirety, the following
provisions shall apply:
(i) if such country is a Major Market Country, all of
the Parties' rights and obligations under Article
3 in connection with the Research Program shall
cease in their entirety; provided that all amounts
due for research performed and costs incurred
prior to the date of such termination shall remain
payable in accordance with the provisions of
Article 3;
(ii) if such country is not a Major Market Country, all
of the Parties' rights and obligations under
Article 3 in connection with the Research Program
shall continue, subject to Wyeth's option,
exercisable in its sole discretion, to terminate
the Research Program as follows: Wyeth shall
exercise such option to terminate the Research
Program (if it so elects) by a written statement
to that effect included in Wyeth's Notice of
Termination (described in Section 9.5 above). If
Wyeth exercises such option to terminate the
Research Program, all of the Parties' rights and
obligations under Article 3 in connection with the
Research Program shall cease in their entirety ***
after Trubion's receipt of such Notice of
Termination; provided that all amounts due for
research performed and costs incurred prior to the
date of such termination shall remain payable in
accordance with the provisions of Article 3;
(iii) all licenses granted by each Party to the other
Party under this Agreement with respect to such
country shall terminate (except as provided in
Section 9.7.10 below); and
(iv) the term "Territory" as used in this Agreement
shall thereafter exclude such country;
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(v) except as provided in Section 9.9, neither Wyeth
nor Trubion shall have any further obligations
under this Agreement with respect to such country;
(vi) the provisions of Section 9.7.1(a)(ii), with such
changes as are appropriate in the context of such
limited termination, shall apply with respect to
Licensed Products in such country; and
(vii) the provisions of Section 9.7.1(a)(iii), with such
changes as are appropriate in the context of such
limited termination, shall apply with respect to
Product Data and Filings, and Existing Trademarks,
relating to Licensed Products in such country.
9.7.2. EFFECT OF TERMINATION BY TRUBION FOR CAUSE.
(a) Without limiting any other legal or equitable remedies
that Trubion or Wyeth may have, subject to Section 11.3,
if this Agreement is terminated in its entirety by
Trubion for cause under Section 9.5, the following
provisions shall apply:
(i) all licenses granted by each Party to the other
Party under this Agreement shall terminate (except
as provided in Section 9.7.10 below);
(ii) Wyeth and Trubion shall, upon Trubion's request,
such request made within ninety (90) days after
such termination, enter into negotiations of a
non-exclusive license from Wyeth to Trubion under
which Wyeth will grant to Trubion a non-exclusive
license (with the right to grant sublicenses) to
practice, use and exploit the Wyeth Applied
Technology with respect to the research,
Development, Manufacture and Commercialization of
Licensed Products as constituted at the time of
termination of this Agreement. The Parties hereby
agree that such license shall include, inter alia,
provisions whereby Trubion shall agree (A) to
comply with the applicable requirements of any
Third Party license to which the use or
exploitation of such Wyeth Applied Technology is
subject including, but not limited to the payment
of royalties; (B) with respect to any CD20
Products ***, to pay to Wyeth (I) if such
termination occurs prior to BLA filing in a Major
Market Country, royalties and Additional Research
and Development Expense Payments in
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amounts equal to *** of those amounts Wyeth would
have been obligated to pay Trubion had this
Agreement remained in full force and effect or
(II) if such termination occurs after BLA filing
in a Major Market Country, royalties and
Additional Research and Development Expense
Payments in amounts equal to *** of those amounts
Wyeth would have been obligated to pay Trubion had
this Agreement remained in full force and effect;
(C) with respect to any Licensed Products other
than CD20 Products ***; to pay to Wyeth royalties
and other non-royalty payments on commercially
reasonable terms; (D) that Trubion shall have no
other financial obligations to Wyeth;
(iii) the provisions of Section 9.7.7 (Post-Termination
Transfer of Product Data and Filings and Existing
Trademarks) shall apply;
(iv) the provisions of Section 9.7.8 (Manufacturing of
Licensed Products After Termination) shall apply;
and
(v) subject to the provisions of Section 9.9, this
Agreement shall be of no further force or effect.
(b) Without limiting any other legal or equitable remedies
that Trubion or Wyeth may have, subject to Section 11.3,
if this Agreement is terminated by Trubion for cause
under Section 9.5 with respect to a Licensed Target in
all countries, but not in its entirety, the following
provisions shall apply:
(i) all of the Parties' rights and obligations under
Article 3 in connection with the Research Program
shall cease in their entirety; provided that all
amounts due for research performed and costs
incurred prior to the date of such termination
shall remain payable in accordance with the
provisions of Article 3;
(ii) if such terminated Licensed Target is the CD20
Antigen, Wyeth shall have no further obligation to
reimburse Trubion under Section 4.6 with respect
to expenses incurred after the effective date of
termination;
(iii) all licenses granted by each Party to the other
Party under this Agreement with respect to
Licensed Products directed against such Licensed
Target shall
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terminate (except as provided in Section 9.7.10
below);
(iv) the provisions of Section 9.7.2(a)(ii) (Wyeth's
grant of a non-exclusive license to Trubion under
Wyeth Applied Technology), with such changes as
are appropriate in the context of such limited
termination, shall apply to Licensed Products
directed against such Licensed Target;
(v) the provisions of Section 9.7.7 (Post-Termination
Transfer of Product Data and Filings and Existing
Trademarks), with such changes as are appropriate
in the context of such limited termination, shall
apply with respect to Product Data and Filings,
and Existing Trademarks, related to Licensed
Products directed against such Licensed Target;
and
(vi) the provisions of Section 9.7.8 (Manufacturing of
Licensed Products After Termination), with such
changes as are appropriate in the context of such
limited termination, shall apply with respect to
Licensed Products directed against such Licensed
Target.
(c) Without limiting any other legal or equitable remedies
that Trubion or Wyeth may have, subject to Section 11.3,
if this Agreement is terminated by Trubion for cause
under Section 9.5 with respect to all Licensed Targets
in a country, but not in its entirety, the following
provisions shall apply:
(i) all of the Parties' rights and obligations under
Article 3 in connection with the Research Program
shall cease in their entirety; provided that all
amounts due for research performed and costs
incurred prior to the date of such termination
shall remain payable in accordance with the
provisions of Article 3;
(ii) all licenses granted by each Party to the other
Party under this Agreement with respect to such
country shall terminate (except as provided in
Section 9.7.10 below);
(iii) the provisions of Section 9.7.2(a)(ii) (Wyeth's
grant of a non-exclusive license to Trubion under
Wyeth Applied Technology), with such changes as
are
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appropriate in the context of such limited
termination, shall apply to a non-exclusive
license to research, Develop, Manufacture and
Commercialize Licensed Products in such country;
(iv) the provisions of Section 9.7.7 (Post-Termination
Transfer of Product Data and Filings and Existing
Trademarks), with such changes as are appropriate
in the context of such limited termination, shall
apply with respect to Product Data and Filings,
and Existing Trademarks, related to Licensed
Products in such country; and
(v) the term "Territory" as used in this Agreement
shall thereafter exclude such country.
9.7.3. EFFECT OF TERMINATION BY WYETH WITHOUT CAUSE.
(a) If this Agreement is terminated in its entirety by Wyeth
under Section 9.6.1, the following provisions shall
apply:
(i) all licenses granted by each Party to the other
Party under this Agreement shall terminate (except
as provided in Section 9.7.10 below);
(ii) the provisions of Section 9.7.2(a)(ii) (Wyeth's
grant of a non-exclusive license to Trubion under
Wyeth Applied Technology) shall apply;
(iii) the provisions of Section 9.7.7 (Post-Termination
Transfer of Product Data and Filings and Existing
Trademarks) shall apply;
(iv) the provisions of Section 9.7.8 (Manufacturing of
Licensed Products After Termination) shall apply;
and
(v) subject to the provisions of Section 9.9, this
Agreement shall be of no further force or effect.
(b) If this Agreement is terminated by Wyeth under Section
9.6.1 with respect to a Licensed Target in all
countries, but not in its entirety, the following
provisions shall apply:
(i) all of the Parties' rights and obligations under
Article 3 in connection with the Research Program
shall cease in their entirety; provided that all
amounts due for research performed and costs
incurred prior to the date
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of such termination shall remain payable in
accordance with the provisions of Article 3;
(ii) if such terminated Licensed Target is the CD20
Antigen, Wyeth shall have no further obligation to
reimburse Trubion under Section 4.6 with respect
to expenses incurred after the effective date of
termination;
(iii) all licenses granted by each Party to the other
Party under this Agreement with respect to
Licensed Products directed against such Licensed
Target shall terminate (except as provided in
Section 9.7.10 below);
(iv) the provisions of Section 9.7.2(a)(ii) (Wyeth's
grant of a non-exclusive license to Trubion under
Wyeth Applied Technology), with such changes as
are appropriate in the context of such limited
termination, shall apply to a non-exclusive
license to research, Develop, Manufacture and
Commercialize Licensed Products directed against
such Licensed Target;
(v) the provisions of Section 9.7.7 (Post-Termination
Transfer of Product Data and Filings and Existing
Trademarks), with such changes as are appropriate
in the context of such limited termination, shall
apply with respect to Product Data and Filings,
and Existing Trademarks, related to Licensed
Products directed against such Licensed Target;
and
(vi) the provisions of Section 9.7.8 (Manufacturing of
Licensed Products After Termination), with such
changes as are appropriate in the context of such
limited termination, shall apply with respect to
Licensed Products directed against such Licensed
Target.
(c) If this Agreement is terminated by Wyeth under Section
9.6.1 with respect to all Licensed Targets in a country,
but not in its entirety, the following provisions shall
apply:
(i) if such country is a Major Market Country, all of
the Parties' rights and obligations under Article
3 in connection with the Research Program shall
cease in their entirety; provided that all amounts
due for research performed and costs incurred
prior to the date
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of such termination shall remain payable in
accordance with the provisions of Article 3; and
if such country is not a Major Market Country, all
of the Parties' rights and obligations under
Article 3 in connection with the Research Program
shall continue;
(ii) all licenses granted by each Party to the other
Party under this Agreement with respect to such
country shall terminate (except as provided in
Section 9.7.10 below);
(iii) the provisions of Section 9.7.2(a)(ii) (Wyeth's
grant of a non-exclusive license to Trubion under
Wyeth Applied Technology), with such changes as
are appropriate in the context of such limited
termination, shall apply to a non-exclusive
license to research, Develop, Manufacture and
Commercialize Licensed Products in such country;
(iv) the provisions of Section 9.7.7 (Post-Termination
Transfer of Product Data and Filings and Existing
Trademarks), with such changes as are appropriate
in the context of such limited termination, shall
apply with respect to Product Data and Filings,
and Existing Trademarks, related to Licensed
Products in such country; and
(v) the term "Territory" as used in this Agreement
shall thereafter exclude such country.
9.7.4. EFFECT OF TERMINATION BY WYETH FOR A MATERIAL SAFETY OR
REGULATORY ISSUE. If this Agreement is terminated with respect
to a Licensed Target by Wyeth under Section 9.6.2, the
following provisions shall apply:
(a) all of the Parties' rights and obligations under Article
3 in connection with the Research Program shall
continue;
(b) if such terminated Licensed Target is the CD20 Antigen,
Wyeth shall have no further obligation to reimburse
Trubion under Section 4.6 with respect to with respect
to expenses incurred after the effective date of
termination;
(c) all licenses granted by each Party to the other Party
under this Agreement with respect to Licensed Products
directed against such Licensed Target shall terminate
(except as provided in Section 9.7.10 below);
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(d) unless the basis of termination under Section 9.6.2 is
the imposition of a clinical hold by a Regulatory
Authority, a determination by Wyeth to place a hold on
further clinical studies of a Licensed Product directed
against such Licensed Target (such determination to be
made by Wyeth in accordance with its standard procedures
of addressing such safety issues) or a withdrawal of a
Licensed Product from the market for patient safety
reasons, whether voluntary or otherwise, the provisions
of Section 9.7.2(a)(ii) (Wyeth's grant of a
non-exclusive license to Trubion under Wyeth Applied
Technology), with such changes as are appropriate in the
context of such limited termination, shall apply to a
non-exclusive license to research, Develop, Manufacture
and Commercialize Licensed Products directed against
such Licensed Target;
(e) the provisions of Section 9.7.7 (Post-Termination
Transfer of Product Data and Filings and Existing
Trademarks), with such changes as are appropriate in the
context of such limited termination, shall apply with
respect to Product Data and Filings, and Existing
Trademarks, related to Licensed Products directed
against such Licensed Target; and
(f) unless the basis of termination under Section 9.6.2 is
the imposition of a clinical hold by a Regulatory
Authority, a determination by Wyeth to place a hold on
further clinical studies of a Licensed Product directed
against such Licensed Target (such determination to be
made by Wyeth in accordance with its standard procedures
of addressing such safety issues) or a withdrawal of a
Licensed Product from the market for patient safety
reasons, whether voluntary or otherwise, the provisions
of Section 9.7.8 (Manufacturing of Licensed Products
After Termination), with such changes as are appropriate
in the context of such limited termination, shall apply
with respect to Licensed Products directed against such
Licensed Target.
9.7.5. POST-TERMINATION RIGHTS TO WYETH TECHNOLOGY AND TRUBION
TECHNOLOGY. Except as otherwise expressly set forth in this
Agreement, expiration or termination of this Agreement for any
reason shall have no effect on Wyeth's rights with respect to
the Wyeth Technology, and Trubion shall have no right, title
or interest in or to any of the Wyeth Technology, and such
expiration or termination shall have no effect on Trubion's
rights with respect to the Trubion Technology, and Wyeth shall
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have no right, title or interest in or to any of the Trubion
Technology.
9.7.6. POST-TERMINATION LICENSES TO WYETH TECHNOLOGY. In the event
that Wyeth grants to Trubion a license under any Wyeth
Technology pursuant to Section 9.7.1, 9.7.2, 9.7.3 or 9.7.4,
such license shall include, inter alia, provisions whereby
Trubion shall agree to comply with the applicable requirements
of any Third Party license to which the use or exploitation of
any such items may be subject including, but not limited to,
the payment of royalties.
9.7.7. POST-TERMINATION TRANSFER OF PRODUCT DATA AND FILINGS AND
EXISTING TRADEMARKS. The following provisions shall apply in
the event of termination by Trubion under Section 9.5 or
termination by Wyeth under Section 9.6. To the extent
permitted by applicable law, Wyeth shall assign and transfer
to Trubion Wyeth's entire right, title and interest in and to
Product Data and Filings, provide copies of all the Research
Program Data, and license or otherwise transfer rights to
Existing Trademarks that are necessary or useful for Trubion
to continue to research, Develop, Manufacture or Commercialize
Licensed Products as constituted at the time of termination.
To the extent such Research Program Data, Product Data and
Filings and other rights or items were previously transferred
from Trubion to Wyeth, Wyeth shall perform such transfer at no
cost to Trubion. To the extent such Research Program Data and
Product Data and Filings were not previously transferred from
Trubion to Wyeth, Trubion shall reimburse Wyeth for its
reasonable out-of-pocket expenses in connection with such
transfer, and such transfer shall be pursuant to an instrument
in form and substance reasonably satisfactory to Trubion.
Wyeth shall perform all other actions reasonably requested by
Trubion to effect and confirm such transfer. After receipt of
Trubion's request consistent with the foregoing, Wyeth shall
provide to Trubion, within *** of receipt of such request,
complete copies of such Product Data and Filings, including,
without limitation, relevant clinical data, INDs, additional
regulatory filings with FDA or other Regulatory Authorities,
supplements or amendments thereto, all written correspondence
with FDA or other Regulatory Authorities regarding the
regulatory filings, and all existing written minutes of
meetings and memoranda of conversations between Wyeth
(including, to the extent practicable, Wyeth's investigators)
and FDA or other Regulatory Authorities in Wyeth's possession
(or in the possession of any of Wyeth's agents and
subcontractors, such as contract research organizations used
by Wyeth), to the extent Wyeth has the right
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to access and provide to Trubion such Product Data and
Filings, regarding such regulatory filings, each to the extent
they relate to Licensed Products. Within thirty (30) days (or
such later date as Trubion may request) after the date of
receipt of Trubion's request, Wyeth shall execute and deliver
a letter to the FDA or other Regulatory Authorities, in a form
approved by Trubion, transferring ownership to Trubion of such
regulatory filings, if any, filed in the name of Wyeth that
are related to Licensed Products.
9.7.8. MANUFACTURING OF LICENSED PRODUCTS AFTER TERMINATION. If (a)
with respect to a particular Licensed Target, Trubion
terminates this Agreement pursuant to Section 9.5 hereof or
Wyeth terminates this Agreement pursuant to Section 9.6
hereof, and (b) Wyeth is engaged in the Manufacturing of a
Licensed Product directed against such Licensed Target on the
date the terminating Party gives notice of termination under
Section 9.5 or Section 9.6, as the case may be, then Wyeth
shall Manufacture such Licensed Product for Trubion and use
Commercially Reasonable Efforts to supply Trubion with its
entire requirements of such Licensed Product until (i) the ***
anniversary of the effective date of such termination if at
the time of such notice there shall have been filed a
Regulatory Approval Application for such Licensed Product or
(ii) the *** anniversary of the effective date of such
termination if at the time of such notice there shall not have
been filed a Regulatory Approval Application for such Licensed
Product; provided, however, that (w) Wyeth shall not be
required to conduct any activities to increase the scale on
which it is then Manufacturing such Licensed Product, (x)
Wyeth shall not be required to Manufacture or supply such
Licensed Product in an amount in excess of its available
capacity in the Manufacturing suite that was used by Wyeth for
the Manufacture of such Licensed Product (taking into account
the other uses Wyeth is making of the manufacturing suite as
of the date of the Notice of Termination) or to change the
location of the Manufacturing activities, (y) Wyeth shall have
no obligation to maintain idle capacity in such manufacturing
suite for purposes of meeting such Manufacturing obligations
and (z) Wyeth may at its option assign to Trubion one or more
of its Licensed Product manufacturing agreements with Third
Parties, to the extent assignable, in lieu of continuing to
contract directly with such Third Parties. The purchase price
for such Licensed Product units actually Manufactured by Wyeth
shall be at Wyeth's fully absorbed manufacturing cost plus
***, and Wyeth's obligations under this Section 9.7.8 shall be
subject to the execution of a supply agreement and a quality
agreement, each mutually
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acceptable to both Parties, which agreements shall
contain the terms set forth in this Section 9.7.8 and
such other reasonable terms as mutually agreed by the
Parties.
9.7.9. POST-TERMINATION DISPOSITION OF INVENTORIES OF
LICENSED PRODUCTS. Following termination of this
Agreement with respect to one or more Licensed
Targets, Wyeth and its sublicensees shall have the
right to continue to sell their existing inventories
of Licensed Products directed against such Licensed
Targets for a period not to exceed *** after the
effective date of such termination. Wyeth shall pay
royalties and report on such sales, and maintain
records thereon, in accordance with Sections 5.4, 5.5
and 5.6, which shall survive termination for such
purpose.
9.7.10. CONTINUATION OF RIGHTS AND LICENSES UNDER SECTIONS
6.1.1 AND 6.1.2. Notwithstanding anything in this
Section 9.7 to the contrary, the Parties' rights and
licenses set forth in Sections 6.1.1 and 6.1.2 shall
survive any expiration or termination of this
Agreement.
9.7.11. CONTINUATION OF OTHER RIGHTS AND OBLIGATIONS. Except
as expressly provided to the contrary in this Section
9.7, in the event that a Party exercises any right
that results in the termination of some, but not all,
of the Parties' rights and obligations under this
Agreement, all non-terminated rights and obligations
of the Parties shall continue in full force and
effect.
9.8. MODIFICATION OF AGREEMENT TERMS BY WYETH. Without limiting any other
legal or equitable remedies that Wyeth or Trubion may have, subject
to Section 11.3, in the event that Wyeth elects to modify the terms
of this Agreement as provided in Section 9.5, in lieu of terminating
this Agreement under Section 9.5, with respect to one or more
Licensed Targets identified by Wyeth in its Notice of Modification
(the "Designated Target(s)"), the following terms shall apply:
9.8.1. except as set forth in Section 9.8.4 below, all rights
and obligations of the Parties under this Agreement
shall continue in full force and effect, and shall not
be subject to any unilateral modification by Wyeth;
provided that, ***;
9.8.2. all licenses granted by Trubion to Wyeth under this
Agreement with respect to Licensed Products directed
against each Designated Target shall remain in effect;
9.8.3. all of the Parties' rights and obligations under
Article 3 in connection with the Research Program
shall cease in their
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entirety; provided that all amounts due for research
performed and costs incurred prior to the date of such
termination shall remain payable in accordance with
the provisions of Article 3; and
9.8.4. only in the event of (i) a material breach by Trubion
of Section 2.3.1 or 2.3.2; or (ii) a material breach
by Trubion of Section 8.1(e), 8.2(c) or 8.2(d); or
(iii) a material breach by Trubion of Section 8.2(a)
(and, in the case of a material breach by Trubion of
Section 8.2(a), only where Wyeth establishes that
Trubion had knowledge, as of the Signing Date, that
Trubion was not the sole and exclusive owner of the
Trubion Patent Rights or that Trubion had placed, or
suffered to be placed, any liens, charges or
encumbrances on or against the Trubion Patent Rights);
or (iv) if during the term of this Agreement, Trubion
grants to a Third Party a right or license that
conflicts in a material respect with Wyeth's
then-existing rights under this Agreement pertaining
to such Licensed Target(s), and thereby materially
breaches Trubion's obligations hereunder, then:
(a) Wyeth's diligence obligations to use Commercially
Reasonable Efforts under Sections 4.1 and 4.10
shall no longer apply to Licensed Products
directed against such Designated Target;
(b) the amount of any Additional Research and
Development Expense Payment that Wyeth thereafter
becomes obligated to pay under Section 5.3
relating to Licensed Products directed against
such Designated Target shall be reduced by fifty
percent (50%) of such amount; and
(c) the amounts of any royalties that Wyeth thereafter
becomes obligated to pay under Section 5.4
relating to Licensed Products directed against
such Designated Target shall be reduced by fifty
percent (50%) of such amounts.
9.9. SURVIVAL OF CERTAIN OBLIGATIONS. Expiration or termination of this
Agreement shall not relieve the Parties of any obligation accrued or
accruing before such expiration or termination (including situations
where it becomes clear only after the time of such expiration or
termination that such obligation had already accrued). The following
provisions shall survive the expiration or termination of this
Agreement: Article 1 (to the extent definitions are embodied in the
following listed Articles and Sections); Sections 3.6.3, 3.7, 5.6,
6.1.1, 6.1.2, 9.2, 9.5, 9.6, 9.7, 9.9, 9.10.2, 12.3, 12.6, 12.8,
12.9, 12.10, 12.11 and 12.12; and Articles 7, 10 and 11. Any
expiration or early termination of this Agreement shall be without
prejudice to the rights of either Party against the other accrued or
accruing
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under this Agreement before expiration or termination, including,
without limitation, the obligations (1) to provide research funding
and reimbursement of expenses for activities undertaken prior to
such expiration or termination under and in accordance with Sections
3.6.1, 3.6.2, 4.6, 4.9, 6.1.3, 6.2.1(a), (c) and (d), 6.2.2(b) and
(c), and 6.2.3(b) and (c); and (2) to pay royalties for Licensed
Products sold before such expiration or termination, and, to the
extent permitted under Section 9.7.9, after expiration or
termination in accordance with Section 5.4 (and subject to the
related obligations under Section 5.5); and (3) to pay any
Additional Research and Development Expense Payments in connection
with any events specified on Exhibit 5.3 that are achieved prior to
such expiration or termination, but with respect to which the
corresponding payments under Exhibit 5.3 were not paid prior to such
expiration or termination.
9.10. CHANGE OF CONTROL.
9.10.1. DEFINITION. With respect to any Party, a "Change of Control"
means an event in which: (a) any other person or group of
persons (as the term "person" is used for purposes of
Section 13(d) or 14(d) of the Exchange Act) not then
beneficially owning more than fifty percent (50%) of the
voting power of the outstanding securities of such Party
acquires or otherwise becomes the beneficial owner (within
the meaning of Rule 13d-3 promulgated under the Exchange
Act) of securities of such Party representing more than
fifty percent (50%) of the voting power of the then
outstanding securities of such Party with respect to the
election of directors of such Party; or (b) such Person (i)
consummates a merger, consolidation or similar transaction
with another Person where the voting securities of such
Party outstanding immediately preceding such transaction (or
the voting securities issued with respect to the voting
securities of such Party outstanding immediately preceding
such transaction) represent less than fifty percent (50%) of
the voting power of such Party or surviving entity, as the
case may be, immediately following such transaction, (ii)
sells or otherwise transfers to any Person(s) in one or more
related transactions more than fifty percent (50%) of its
consolidated total assets, or assets from which more than
fifty percent (50%) of its consolidated operating income for
its most recent financial year was derived, (iii) disposes
by sale, assignment, exclusive license or otherwise of all
or substantially all of its intellectual property rights,
except for licenses under such intellectual property rights
in the ordinary course of business and any isolated sale or
assignment of specific items of intellectual property, or
(iv) liquidates, dissolves or winds-up; or (c) with respect
to Wyeth and with respect to Trubion, (at any time following
any public offering of voting securities by Trubion), any
"person" (as the
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term "person" is used for the purposes of Sections 13(d) or
14(d) of the Exchange Act) other than Wyeth acquires
nineteen and nine-tenths percent (19.9%) or more of the
voting power of the then-outstanding voting securities of
such Party.
9.10.2. CHANGE OF CONTROL OF WYETH.
(a) In the event that any transaction results in a Change of
Control of Wyeth, Trubion shall be entitled to request
further written assurances from the successor in
interest to Wyeth (the "Successor Party") re-affirming
the commitment of the Successor Party to comply with the
terms and conditions of the Agreement. Such further
written assurances shall be delivered within *** of
written request by Trubion. Trubion may so request at
any time during the *** period following completion of
the subject transaction. Subject to the operation of
Section 9.10.2(b) below, the failure of such Successor
Party to provide the requested written assurance shall
be deemed to be a material breach of the Agreement.
(b) In the event that in connection with, or during the ***
period following, a Change of Control of Wyeth, Wyeth or
the Successor Party is required, or voluntarily decides,
to divest itself of one or more Licensed Products, Wyeth
or the Successor Party, subject to any restrictions or
limitations imposed by the Federal Trade Commission or
other governmental agency on such divestiture, shall
offer to Trubion an exclusive opportunity to negotiate
the acquisition or license of all rights of Wyeth or
such Successor Party, as the case may be, to such
Licensed Product(s) on commercially reasonable terms. In
the event that Trubion and the Successor Party, after
*** good faith negotiations, are unable to conclude a
definitive agreement regarding the acquisition or
license of such Licensed Product(s), the Successor Party
shall be entitled to divest itself of such Licensed
Product(s) to a party other than Trubion; provided,
however, no such divestiture to a Third Party shall take
place on terms more favorable to such Third Party than
those last offered by the Successor Party to Trubion,
without first offering such Licensed Product(s) to
Trubion on such more favorable terms. Such Third Party
shall be required to assume all of the Successor Party's
obligations owed to Trubion pursuant to this Agreement
with respect to the Licensed Product(s) so divested.
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(c) In the event of a Change of Control of Wyeth, the
restrictive covenants set forth in Sections 2.3.1 and
2.3.2 (the "Exclusivity Covenants") shall apply to the
Successor Party's then-existing Development and
Commercialization activities that otherwise would
violate the Exclusivity Covenants (the "Existing
Activities"). In such event, Trubion shall have the
right, exercisable upon written notice given by Trubion
(an "Exercise Notice") within *** after consummation of
the Change of Control, to require such Successor Party
to engage in good faith discussions regarding the terms
and conditions on which such Successor Party would pay
reasonable financial consideration to Trubion with
respect to such Existing Activities. If Trubion and such
Successor Party do not agree on such terms and
conditions within *** after Trubion gives the Exercise
Notice (or such longer period as may be agreed to by
such parties), or if such Successor Party notifies
Trubion in writing during such *** period that it does
not desire to engage in such discussions, Trubion shall
have the right, exercisable upon written notice given by
Trubion within ten (10) days (i) after the end of such
*** period (or such longer period as agreed to by such
parties) or (ii) after receipt of such notice from such
Successor Party, to require such Successor Party to
enter into an agreement to divest to a Third Party
either (a) the Existing Activities or (b) the relevant
CD20 Products or ***, as the case may be (such Third
Party, in the case of a divestiture of the relevant CD20
Products or ***, to be reasonably acceptable to Trubion)
within *** after the date of such notice by Trubion,
subject to applicable governmental and regulatory
approval. If such Successor Party does not enter into an
agreement with a Third Party (such Third Party, in the
case of a divestiture of the relevant CD20 Products or
***, to be reasonably acceptable to Trubion) to divest
such Existing Activities or such Products within such
*** period (or if such Successor Party does enter into
such an agreement but such agreement terminates after
such *** period and such divestiture is not consummated)
or if such Successor Party notifies Trubion in writing
that it does not intend to divest such Existing
Activities or such Products, Trubion shall have the
right, exercisable within *** after the end of such ***
period (or upon termination of such agreement, if later)
to terminate, in its sole discretion, all CD20-related
licenses (only where such Existing Activities relate to
products directed against the CD20 Antigen which would
otherwise violate Wyeth's
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exclusivity covenants in Section 2.3.1 hereof) and/or
all *** (only where such Existing Activities relate to
products directed against the *** which would otherwise
violate Wyeth's exclusivity covenants in Section 2.3.2
hereof) granted to Wyeth under the Agreement, on those
terms and subject to those conditions that would apply
to a termination by Wyeth without cause.
9.10.3. CHANGE OF CONTROL OF TRUBION. In the event of a Change of
Control of Trubion where the acquiring party is a top
fifteen (15) pharmaceutical company (measured by market
capitalization), Wyeth shall have the right to ***
10. INDEMNIFICATION AND INSURANCE.
10.1. INDEMNIFICATION BY WYETH. Wyeth will indemnify, defend and hold
harmless Trubion, and each of its respective employees, officers,
directors and agents (each, a "Trubion Indemnified Party") from and
against any and all liability, loss, damage, expense (including
reasonable attorneys' fees and expenses) and cost (collectively,
"Liabilities") that the Trubion Indemnified Party may be required to
pay to one or more Third Parties resulting from or arising out of:
(a) any claims of any nature pertaining to any act or
omission related to performance under this Agreement by,
on behalf of, or under the authority of Wyeth (other
than by any Trubion Indemnified Party) including, but
not limited to, research, Development, Manufacture or
Commercialization of Licensed Product(s) or any
violation of applicable law, rule or regulation by, on
behalf of, or under the authority of Wyeth (other than
by any Trubion Indemnified Party); and/or
(b) any Wyeth representation or warranty set forth herein
being untrue in any material respect when made;
except in each case, to the extent caused by the negligence or
willful misconduct of Trubion or any other Trubion Indemnified
Party.
10.2. INDEMNIFICATION BY TRUBION. Trubion will indemnify, defend and hold
harmless Wyeth and its sublicensees, distributors and each of its
and their respective employees, officers, directors and agents
(each, a "Wyeth Indemnified Party") from and against any and all
Liabilities that the Wyeth Indemnified Party may be required to pay
to one or more Third Parties resulting from or arising out of:
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(a) any claims of any nature pertaining to any act or
omission related to performance under this Agreement by,
on behalf of, or under the authority of Trubion (other
than by any Wyeth Indemnified Party) or any violation of
applicable law, rule or regulation by, on behalf of, or
under the authority of Trubion (other than by any Wyeth
Indemnified Party); and/or
(b) any Trubion representation or warranty set forth herein
being untrue in any material respect when made;
except in each case, to the extent caused by the negligence or
willful misconduct of Wyeth or any other Wyeth Indemnified Party.
10.3. PROCEDURE. Each Party will notify the other in the event it becomes
aware of a claim for which indemnification may be sought hereunder.
In case any proceeding (including any governmental investigation)
shall be instituted involving any Party in respect of which
indemnity may be sought pursuant to this Article 10, such Party (the
"Indemnified Party") shall promptly notify the other Party (the
"Indemnifying Party") in writing within fifteen (15) days and the
Indemnifying Party and Indemnified Party shall meet to discuss how
to respond to any claims that are the subject matter of such
proceeding. The Indemnifying Party, upon request of the Indemnified
Party, shall retain counsel reasonably satisfactory to the
Indemnified Party to represent the Indemnified Party and shall pay
the fees and expenses of such counsel related to such proceeding.
The Indemnified Party agrees to cooperate fully with the
Indemnifying Party in the defense of any such claim, action or
proceeding, or any litigation resulting from any such claim. In any
such proceeding, the Indemnified Party shall have the right to
retain its own counsel, but the fees and expenses of such counsel
shall be at the expense of the Indemnified Party unless (a) the
Indemnifying Party and the Indemnified Party shall have mutually
agreed to the retention of such counsel or (b) the named parties to
any such proceeding (including any impleaded parties) include both
the Indemnifying Party and the Indemnified Party and representation
of both Parties by the same counsel would be inappropriate due to
actual or potential differing interests between them. All such fees
and expenses shall be reimbursed as they are incurred. The
Indemnifying Party shall not be liable for any settlement of any
proceeding effected without its written consent, but if settled with
such consent or if there be a final judgment for the plaintiff, the
Indemnifying Party agrees to indemnify the Indemnified Party from
and against any loss or liability by reason of such settlement or
judgment. The Indemnifying Party shall not, without the written
consent of the Indemnified Party, effect any settlement of any
pending or threatened proceeding in respect of which the Indemnified
Party is, or arising out of the same set of facts could have been, a
party and indemnity could have been sought hereunder by the
Indemnified Party, unless such settlement includes an unconditional
release
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of the Indemnified Party from all liability on claims that are the
subject matter of such proceeding.
10.4. INSURANCE. Each Party shall use Commercially Reasonable Efforts to
obtain and maintain, during the term of this Agreement, commercial
general liability insurance, including products liability insurance,
with reputable and financially secure insurance carriers to cover
its indemnification obligations under Sections 10.1 or 10.2, as
applicable, or self-insurance, in each case with limits of not less
than *** per occurrence and in the aggregate. Insurance shall be
procured with carriers having an A.M. Best Rating of A-VII or
better.
11. DISPUTE RESOLUTION.
11.1. GENERAL. Any controversy, claim or dispute arising out of or
relating to this Agreement shall be settled, if possible, through
good faith negotiations between the Parties. If, however, the
Parties are unable to settle such dispute after good faith
negotiations, the matter shall be referred to the Executive Officers
to be resolved by negotiation in good faith as soon as is
practicable but in no event later than thirty (30) days after
referral. Such resolution, if any, of a referred issue shall be
final and binding on the Parties.
11.2. FAILURE OF EXECUTIVE OFFICERS TO RESOLVE DISPUTE. If the Executive
Officers are unable to settle the dispute after good faith
negotiation in the manner set forth above, either Party (including
its successors and permitted assigns but excluding its Affiliates
unless an Affiliate is a successor or permitted assign) may seek
resolution of the dispute through any remedies available at law or
in equity from any court of competent jurisdiction.
11.3. DISCLAIMER OF CONSEQUENTIAL AND PUNITIVE DAMAGES. Subject to and
without limiting the indemnification obligations of each Party under
Article 10, under no circumstances shall either Party be liable to
the other Party for consequential or punitive damages arising out of
or relating to this Agreement or any breach thereof. Both Parties
hereby disclaim such damages.
12. MISCELLANEOUS.
12.1. PERIODIC EXECUTIVE MEETINGS. The Chief Executive Officer of Trubion,
the Senior Vice President, Research and Development of Trubion, the
Executive Vice President and General Manager of the Wyeth
Pharmaceuticals Biopharma Business Unit and the Executive Vice
President and Operating Officer of Wyeth's Research Division (and
such other executive officers of the Parties as may be designated
from time to time by the Parties) shall meet from time to time
during the first *** of the term of this Agreement to review and
discuss the Parties' activities under
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this Agreement. Such meetings will be held on a quarterly basis or
such other periodic basis as such executive officers decide, and
will take place in locations selected by such executive officers.
Such meetings may take place by telephone or video conference.
12.2. ASSIGNMENT. Neither this Agreement nor any interest hereunder shall
be assignable by either Party, without the prior written consent of
the other Party, which consent shall not be unreasonably withheld or
delayed, except a Party may make such an assignment without the
other Party's consent to Affiliates or to a successor to
substantially all of the business of such Party to which this
Agreement relates, whether in merger, sale of stock, sale of assets
or other transaction. This Agreement shall be binding upon the
successors and permitted assigns of the Parties, and the name of a
Party appearing herein shall be deemed to include the names of such
Party's successors and permitted assigns to the extent necessary to
carry out the intent of this Agreement. In addition to the
foregoing, Trubion may assign its right, in whole or part, to
receive payments under this Agreement; provided, however, Trubion
shall notify Wyeth of its intention to do so and shall provide Wyeth
an opportunity for at least *** to negotiate in good faith the
purchase of any such right Trubion intends to so assign. Any
assignment not in accordance with this Section 12.2 shall be void.
12.3. FURTHER ACTIONS. Each Party agrees to execute, acknowledge and
deliver such further instruments, and to do all such other acts, as
may be necessary or appropriate in order to carry out the purposes
and intent of the Agreement.
12.4. FORCE MAJEURE. Neither Party shall be liable to the other for delay
or failure in the performance of the obligations on its part
contained in this Agreement if and to the extent that such failure
or delay is due to circumstances beyond its control which it could
not have avoided by the exercise of reasonable diligence. It shall
notify the other Party promptly should such circumstances arise,
giving an indication of the likely extent and duration thereof, and
shall use all Commercially Reasonable Efforts to resume performance
of its obligations as soon as practicable; provided, however, that
neither Party shall be required to settle any labor dispute or
disturbance.
12.5. NON-SOLICITATION. During the period between the Effective Date and
the later of (a) the end of *** or (b) the date ***, but in the case
of (a) and (b) not later than the *** of the Effective Date, neither
Trubion nor the Wyeth pharmaceuticals business operating in the
United States ("U.S. Wyeth Pharmaceuticals") shall solicit for
employment any key or technical employee(s) of the other Party who
become known to U.S. Wyeth Pharmaceuticals or Trubion, as the case
may be, through the transactions contemplated by this Agreement
without the other's prior written consent (which consent may be
granted or denied in the other's sole discretion);
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provided, however, that nothing in this Section 12.5 shall prohibit
U.S. Wyeth Pharmaceuticals or Trubion, as the case may be, from
hiring any employees of the other who respond to general employment
solicitations not targeted at the employees of the other, advertised
employment opportunities, or hiring by the other by personnel not
working on the transactions contemplated by this Agreement or who
are not otherwise directly or indirectly exposed to the personnel
working thereon.
12.6. CORRESPONDENCE AND NOTICES.
12.6.1. ORDINARY NOTICES. Correspondence, reports, documentation,
and any other communication in writing between the Parties
in the course of ordinary implementation of this Agreement
shall be delivered by hand, sent by facsimile transmission
(receipt verified), or by airmail to the employee or
representative of the other Party who is designated by such
other Party to receive such written communication.
12.6.2. EXTRAORDINARY NOTICES. Extraordinary notices and other
communications hereunder (including, without limitation, any
notice of force majeure, breach, termination, change of
address, etc.) shall be in writing and shall be deemed given
if delivered personally or by facsimile transmission
(receipt verified), mailed by registered or certified mail
(return receipt requested), postage prepaid, or sent by
nationally recognized express courier service, to the
Parties at the following addresses (or at such other address
for a Party as shall be specified by like notice; provided,
however, that notices of a change of address shall be
effective only upon receipt thereof):
All correspondence to Wyeth shall be addressed as follows:
Wyeth Pharmaceuticals
▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Attn: Senior Vice President, Corporate Business
Development
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
with a copy to:
Wyeth
▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
Attn: Executive Vice President and General Counsel
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
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All correspondence to Trubion shall be addressed as follows:
Trubion Pharmaceuticals, Inc.
▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Attn: President & CEO
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
with a copy to:
Trubion Pharmaceuticals, Inc.
Vice President, Legal Affairs
▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
12.7. AMENDMENT. No amendment, modification or supplement of any provision
of this Agreement shall be valid or effective unless made in writing
and signed by a duly authorized officer of each Party.
12.8. WAIVER. No provision of the Agreement shall be waived by any act,
omission or knowledge of a Party or its agents or employees except
by an instrument in writing expressly waiving such provision and
signed by a duly authorized officer of the waiving Party. The waiver
by either of the Parties of any breach of any provision hereof by
the other Party shall not be construed to be a waiver of any
succeeding breach of such provision or a waiver of the provision
itself.
12.9. SEVERABILITY. If any clause or portion thereof in this Agreement is
for any reason held to be invalid, illegal or unenforceable, the
same shall not affect any other portion of this Agreement, as it is
the intent of the Parties that this Agreement shall be construed in
such fashion as to maintain its existence, validity and
enforceability to the greatest extent possible. In any such event,
this Agreement shall be construed as if such clause of portion
thereof had never been contained in this Agreement, and there shall
be deemed substituted therefor such provision as will most nearly
carry out the intent of the Parties as expressed in this Agreement
to the fullest extent permitted by applicable law.
12.10. DESCRIPTIVE HEADINGS. The descriptive headings of this Agreement
are for convenience only, and shall be of no force or effect in
construing or interpreting any of the provisions of this Agreement.
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12.11. GOVERNING LAW. This Agreement shall be governed by and interpreted
in accordance with the substantive laws of the State of New York,
without regard to conflict of law principles thereof.
12.12. ENTIRE AGREEMENT OF THE PARTIES. This Agreement constitutes and
contains the complete, final and exclusive understanding and
agreement of the Parties and cancels and supersedes any and all
prior negotiations, correspondence, understandings and agreements,
whether oral or written, among the Parties respecting the subject
matter hereof and thereof, including, but not limited to, that
certain Non-Disclosure Agreement of the Parties effective May 27,
2004. For the avoidance of doubt, disclosures made under such
Confidentiality Agreement shall continue to be subject to the
terms of this Agreement as if first disclosed pursuant hereto.
Except as expressly set forth in this Agreement, neither Party
shall have any other obligations, whether by implication or
otherwise, with respect to the research, Development, Manufacture
or Commercialization of Licensed Products.
12.13. INDEPENDENT CONTRACTORS. Both Parties are independent contractors
under this Agreement. Nothing herein contained shall be deemed to
create an employment, agency, joint venture or partnership
relationship between the Parties hereto or any of their agents or
employees, or any other legal arrangement that would impose
liability upon one Party for the act or failure to act of the
other Party. Neither Party shall have any express or implied power
to enter into any contracts or commitments or to incur any
liabilities in the name of, or on behalf of, the other Party, or
to bind the other Party in any respect whatsoever.
12.14. COUNTERPARTS. This Agreement may be executed in any number of
counterparts, each of which need not contain the signature of more
than one Party but all such counterparts taken together shall
constitute one and the same agreement. Facsimile signatures shall
be binding upon the Parties and shall be treated as if originals.
IN WITNESS WHEREOF, duly authorized representatives of the Parties have
duly executed this Agreement to be effective as of the Signing Date.
WYETH, TRUBION PHARMACEUTICALS, INC.
ACTING THROUGH ITS
WYETH PHARMACEUTICALS DIVISION
By /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ By /s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
------------------------------ ------------------------------
Name: ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ Name: ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇, M.D.
Title: Vice President Title: President & CEO
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EXHIBIT 1.122
TRU-015
***
As of the Signing Date, TRU-015 is investigated in the Phase IIa Clinical Study.
EXECUTION COPY
EXHIBIT 1.129
TRUBION PATENT RIGHTS
***
EXECUTION COPY
EXHIBIT 1.132
TRUBION THIRD PARTY AGREEMENTS
***
EXECUTION COPY
EXHIBIT 3.2.1
TRUBION'S "MILESTONE ONE"
MILESTONE #1
Defined in Trubion's internal project management process, which may be modified
from time to time.
The following specifications are determined:
- Scientific Rationale that supports the therapeutic potential
- Mechanism of Action (MOA)
- Specific biochemical and therapeutic properties (targeted)
- Binding Domain
- Target
- In vivo activity
- Safety
- pk
- Market rationale (preliminary) for product profile
- Economics (COGs)
- Clinical rationale (preliminary) for product profile
- Alliance Opportunity assessment
- Intellectual property assessment
EXECUTION COPY
EXHIBIT 3.2.4
EXCLUDED TARGETS
GENBANK ACCESSION NUMBER (AMINO ACID SEQUENCE)
***
EXECUTION COPY
EXHIBIT 4.4
ADVERSE EVENT REPORTING PROCEDURES
The terms adverse event or experience (AE) and adverse drug reaction (ADR), used
in this Exhibit 4.4 shall have the meanings set forth in worldwide reporting
regulations. The Parties agree to comply with any and all governmental laws,
regulations and orders that are applicable now and in the future in connection
with product safety collection and reporting.
The Parties agree to meet after the Effective Date to establish a detailed
Safety Agreement outlining the pharmacovigilance responsibilities of each Party
including but not limited to: AE or ADR reporting including literature review
and associated reporting; AE or ADR follow-up reporting; preparation and
submission of all safety reports to the Regulatory Authorities as required by
local laws and/or regulations in the Territory; maintaining the global safety
database; all interactions with health authorities regarding safety; periodic
submissions; labeling modifications; safety monitoring and detection; and safety
measures (e.g., Dear Doctor Letter, restriction on distribution). Wyeth shall
maintain the global safety database for the Licensed Products.
Notwithstanding the foregoing and until such time as the Safety Agreement is
executed, to the extent Trubion has or receives any information regarding any
AE/ADR which may be related to the use of any Licensed Product or to Licensed
Product Development, Trubion shall promptly forward such information as follows:
- Fatal or life-threatening serious AE(s)/ADR(s) judged by either the
investigator and/or sponsor to be reasonably related to the Licensed
Product(s) Development/protocol shall be transmitted to Wyeth within
three (3) calendar days from the date received by Trubion.
- All other serious AE(s)/ADR(s) not fatal or life-threatening but
judged by either the investigator and/or sponsor to be reasonably
related to the Licensed Product(s) Development/protocol shall be
transmitted to Wyeth within five (5) calendar days from the date
received by Trubion.
AE/ADR information may be transmitted to Wyeth by:
a. Facsimile: ▇▇▇-▇▇▇-▇▇▇▇ OR
b. Overnight courier to:
Global Safety Surveillance & Epidemiology
Wyeth Research
GSSE Triage Unit
Dock E
▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
EXECUTION COPY
EXHIBIT 5.2A
STOCK PURCHASE AGREEMENT
TRUBION PHARMACEUTICALS, INC.
COMMON STOCK PURCHASE AGREEMENT
This Common Stock Purchase Agreement (this "Agreement") is made as
of December __, 2005 by and between Trubion Pharmaceuticals, Inc., a
Delaware corporation (the "Company"), and Wyeth, a Delaware corporation (the
"Purchaser").
RECITALS
A. The Purchaser and the Company are entering into a collaboration
agreement of even date herewith (the "Collaboration Agreement");
B. In connection with the Collaboration Agreement, Purchaser desires
to purchase from the Company shares of its Common Stock (the "Common Stock"),
concurrently with and conditioned upon the closing of the Company's initial
public offering, upon the terms and conditions set forth herein;
C. The Company and the Purchaser wish to set forth the terms and
conditions upon which the Company will sell the Common Stock to the Purchaser;
and
D. Concurrent with the execution of this Agreement, the Company and
Purchaser are entering into an amendment (the "Rights Agreement Amendment") to
the Company's Amended and Restated Investor Rights Agreement (the "Rights
Agreement") to provide Purchaser with certain rights and obligations thereunder
upon the issuance of the Common Stock hereunder.
NOW, THEREFORE, in consideration of the premises and mutual
covenants and conditions contained herein, the Company and the Purchaser hereby
agree as follows:
ARTICLE I
PURCHASE AND SALE OF SHARES
1.1 Purchase Price and Closing. Subject solely to the conditions set forth
in Sections 1.2 - 1.5 and Article IV hereof, the Company will issue and sell to
the Purchaser and, subject to the terms and conditions set forth in this
Agreement, the Purchaser will purchase from the Company (the "Sale"), that
number of shares of Common Stock (the "Shares") equal to the quotient obtained
by dividing Twenty-Five Million Dollars ($25,000,000) (the "Investment Amount")
by the per-share price to the public (the "IPO Price") of shares of Common Stock
in the Company's first underwritten, firm commitment public offering (the "IPO")
pursuant to an effective registration statement (the "Registration Statement")
under
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the Securities Act of 1933, as amended (the "Securities Act"). The per share
price to Purchaser shall be the IPO Price. The purchase and sale will take place
at a closing (the "Closing") to be held on the date, at the location and
simultaneously with the closing of the IPO, subject to the satisfaction of all
of the conditions to the Closing specified in Article IV herein. At the Closing
the Company will issue and deliver a certificate evidencing the Shares to the
Purchaser against payment of the full purchase price therefor by wire transfer
of immediately available funds to an account designated by the Company.
1.2 Maximum Share Number. Notwithstanding Section 1.1 above, in the event
the number of Shares would otherwise constitute more than (i) nineteen and
nine-tenths percent (19.9%) of the Actual Voting Power (as defined in Section
5.1(i)) or (ii) twenty percent (20%) of the number of shares issued in the IPO
(including any shares covered by a related registration statement filed pursuant
to Rule 462(b) of the Securities Act but excluding any shares issued or to be
issued in an overallotment option), then in either case (i) or (ii) above the
Investment Amount (and correspondingly the number of shares purchased by the
Purchaser) shall be reduced by the minimum dollar amount and share amount
necessary to avoid either such event.
1.3 Restrictions on Transfer. Pursuant to the Rights Agreement Amendment,
Purchaser agrees and acknowledges that the restrictions set forth in Sections
2.1 and 2.12 of the Rights Agreement shall apply to Purchaser and the Shares.
1.4 HSR Act. Prior to the execution of the Collaboration Agreement and
this Agreement, the parties made certain filings under the ▇▇▇▇-▇▇▇▇▇ ▇▇▇▇▇▇
Antitrust Improvements Act of 1976, as amended (the "HSR Act"). If either party
concludes in good faith that additional filings or proceedings are necessary or
desirable as a result of the transactions contemplated hereby either as a result
of the signing of this Agreement or in connection with the Closing or otherwise,
the parties agree to promptly file such additional notices, applications and
documents that may be required under the HSR Act, or any other required foreign
or domestic competition law (collectively, the "Competition Laws") and all
applicable additional filings fees associated therewith shall be paid by the
party required to so pay such additional filing fees under the applicable
Competition Law(s). In connection therewith, the Company and Purchaser each
shall use their commercially reasonable efforts to take such actions as may be
required to cause the expiration or early termination of the notice periods
under the Competition Laws as promptly as possible and to resolve such
objections, if any, as may be asserted with respect to the transactions
contemplated by this Agreement under the Competition Laws; provided, however,
that notwithstanding the foregoing, neither party shall agree to any change or
amendment to this Agreement unless such change or amendment is agreed by the
other party in advance. Nothing in this Agreement shall require either party or
any subsidiary or affiliate of either party to sell, hold separate, license or
otherwise dispose of any assets or conduct its business in a specified manner,
or agree or proffer to sell, hold separate, license or otherwise dispose of any
assets or conduct its business in a specified manner, or permit or agree to the
sale, holding separate, licensing or other disposition of any assets of either
party or any subsidiary or affiliate of either party, whether as a condition to
obtaining any approval from, or to avoid potential litigation or administrative
action by, a governmental entity or any other person or for any other reason.
1.5 Termination of Purchase Right and Obligation. Notwithstanding any
provision of this Agreement to the contrary, Purchaser's right and obligation to
purchase, and the Company's right and obligation to sell, the Shares shall
terminate if the closing of the IPO has not occurred prior to the earliest to
occur of the following:
(a) The termination of the Collaboration Agreement; or
(b) The Company (1) undergoes a Change of Control (as defined in
Section 5.1(iv));; provided, however, the following shall be deemed to not be a
Change of Control for purposes of this
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Section 1.5(b): (i) a transaction effected exclusively for the purpose of
changing the domicile of the Company, or (ii) an equity financing in which the
Company is the surviving corporation, or (2) engages in a merger, consolidation,
reorganization or similar transaction in which the surviving entity has a class
of equity securities registered under Section 12 of the Exchange Act (as defined
below).
ARTICLE II
REPRESENTATIONS AND WARRANTIES OF THE COMPANY
The Company hereby represents and warrants to the Purchaser as follows:
2.1 Corporate Action. The Company has all necessary corporate power and
has taken all corporate action required to enter into and perform this Agreement
and the Rights Agreement Amendment (collectively, the "Financing Documents").
The Financing Documents have been duly executed and delivered, and constitute
valid, legal, binding and enforceable obligations of the Company, enforceable in
accordance with their terms, except (i) as limited by applicable bankruptcy,
insolvency, reorganization, moratorium and other laws of general application
affecting enforcement of creditors' rights generally and (ii) as limited by laws
relating to the availability of specific performance, injunctive relief or other
equitable remedies. The issuance, sale and delivery of the Shares in accordance
with this Agreement have been duly authorized by all necessary corporate action
on the part of the Company. The issuance of the Shares is not subject to
preemptive rights or other preferential rights in any present stockholders of
the Company that have not been waived and will not conflict with any provision
of any agreement or instrument to which the Company is a party or by which it or
its property is bound and to which the Company has not obtained appropriate
waivers.
2.2 No Conflict. The execution and delivery of this Agreement by the
Company does not, and the consummation of the transactions contemplated hereby
will not, conflict with, or result in any violation of, or default under (with
or without notice or lapse of time, or both), or give rise to a right of
termination, cancellation, modification or acceleration of any obligation under
(i) any provision of the Certificate of Incorporation of the Company or Bylaws
of the Company, (ii) any material mortgage, indenture, lease, contract or other
agreement or instrument, permit, concession, or license to which the Company or
any of its properties or assets is subject or (iii) any judgment, order, decree,
applicable to the Company or its properties or assets. To the Company's
knowledge as of the date hereof, no provision of any applicable law, rule or
regulation and no judgment, order, decree or injunction applicable to the
Company or its properties or assets shall prohibit the consummation of the
Closing nor shall the Closing result in any violation of any such law, rule,
regulation, judgment, order, decree or injunction.
2.3 Status of Shares. The Shares, when issued and delivered in accordance
with the terms hereof and after payment of the purchase price therefor, will be
duly authorized, validly issued, fully-paid and non-assessable, issued in
compliance with applicable state and federal securities laws (subject, in part,
to the representations and warranties of Purchase in Article III hereof) and
free of restrictions on transfer other than restrictions on transfer under the
Financing Documents and applicable state and federal securities laws.
2.4 Organization, Good Standing and Qualification. The Company is a
corporation duly organized, validly existing and in good standing under the laws
of the State of Delaware and has all requisite corporate power and authority to
carry on its business.
2.5. Collaboration Agreement. The Collaboration Agreement has been duly
authorized, executed, and delivered by the Company and constitutes a valid and
binding obligation of the Company, enforceable in accordance with its terms,
except (i) as limited by applicable bankruptcy, insolvency,
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reorganization, moratorium and other laws of general application affecting
enforcement of creditors' rights generally and (ii) as limited by laws relating
to the availability of specific performance, injunctive relief or other
equitable remedies.
2.6 Final Prospectus and Registration Statement. The Company,
acknowledging that the Purchaser will be relying on the accuracy and
completeness of the Company's disclosure in connection with the IPO, warrants to
the Purchaser that the Prospectus (as defined below) used in connection with the
Company's IPO will comply, at the time of filing or use, with the requirements
of the Securities Act, and the Prospectus filed or used in connection with the
IPO will not, at such time, contain an untrue statement of a material fact or
omit to state a material fact required to be stated therein or necessary to make
the statements therein, in light of the circumstances under which they were
made, not misleading; the Registration Statement, when it becomes effective,
will comply, in all material respects, with the requirements of the Securities
Act; and the Registration Statement will not, when it becomes effective, contain
an untrue statement of a material fact or omit to state a material fact required
to be stated therein or necessary to make the statements therein; provided,
however, that the Company makes no warranty with respect to any statement
contained in the Registration Statement or a prospectus in reliance upon and in
conformity with information concerning the Purchaser that is furnished by the
Purchaser expressly for use therein. "Prospectus" means the final prospectus (as
such term is defined in Section 2(a)(10) of the Securities Act) as first filed
with the SEC pursuant to paragraph (1) or (4) of Rule 424(b) of the Securities
Act.
ARTICLE III
REPRESENTATIONS AND WARRANTIES AND COVENANTS BY PURCHASER
The Purchaser represents and warrants and covenants to the Company that:
3.1 Purchaser is an "accredited investor" as defined in Rule 501(a) under
the Securities Act of 1933, as amended.
3.2 Purchaser will acquire the Shares for its own account, for the purpose
of investment and not with a view to distribution or resale thereof.
3.3 Purchaser has all necessary corporate power and has taken all
corporate action required to enter into and perform the Financing Documents. The
Financing Documents have been duly executed and delivered, and constitute valid,
legal, binding and enforceable obligations of Purchaser, enforceable in
accordance with their terms, except (i) as limited by applicable bankruptcy,
insolvency, reorganization, moratorium and other laws of general application
affecting enforcement of creditors' rights generally and (ii) as limited by laws
relating to the availability of specific performance, injunctive relief or other
equitable remedies.
3.4 Purchaser has taken no action which would give rise to any claim
against the Company by any other person for any brokerage commissions, finders'
fees or the like relating to this Agreement or the transactions contemplated
hereby.
3.5 Purchaser has had the opportunity to ask questions of and receive
answers from representatives of the Company concerning the terms of the offering
of the Shares and to obtain additional information concerning the Company and
its business.
3.6 The acquisition by the Purchaser of the Shares shall constitute a
confirmation of these representations and warranties made by the Purchaser as of
the Closing. Purchaser understands that the
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Shares are "restricted securities" under the Securities Act and have not been
registered under the Securities Act in reliance upon an exemption for non-public
offerings. The Purchaser further represents that it understands and agrees that,
until registered under the Securities Act or transferred pursuant to the
provisions of Rule 144 as promulgated by the Commission, all certificates
evidencing any of the Shares, whether upon initial issuance or upon any transfer
thereof, shall be subject to the transfer restrictions and bear the legends set
forth in Section 2.1 of the Rights Agreement.
3.7 To the Purchaser's knowledge as of the date hereof, no provision of
any applicable law, rule or regulation and no judgment, order, decree or
injunction applicable to the Purchaser or its properties or assets shall
prohibit the consummation of the Closing nor shall the Closing result in any
violation of any such law, rule, regulation, judgment, order, decree or
injunction.
ARTICLE IV
CONDITIONS TO CLOSING
4.1 Conditions of the Purchaser's Obligation. The obligation of the
Purchaser to purchase and pay for the Shares at the Closing is subject to the
satisfaction of the following conditions:
(a) Documentation at Closing. The Purchaser shall have received
prior to or at the Closing all of the following documents or instruments, or
evidence of completion thereof, each in form and substance satisfactory to the
Purchaser:
(i) A copy of the Certificate of Incorporation of the Company,
certified by the Secretary of State of the State of Delaware, a copy of the
resolutions of the Board of Directors of the Company evidencing the approval of
this Agreement, the issuance of the Shares and the other matters contemplated
hereby, and a copy of the Bylaws of the Company, all of which shall have been
certified by the Secretary of the Company to be true, complete and correct in
every particular, and certified copies of all documents evidencing other
necessary corporate or other action and governmental approvals, if any, with
respect to this Agreement and the Shares.
(ii) A customary opinion of counsel to the Company covering
the matters set forth in Exhibit A hereto.
(iii) A certificate of the Secretary of the Company which
shall certify the names of the officers of the Company authorized to sign this
Agreement, the certificate for the Shares and the other documents, instruments
or certificates to be delivered pursuant to this Agreement by the Company or any
of its officers, together with the true signatures of such officers.
(iv) A certificate of the President of the Company stating (A)
that the representations and warranties made by the Company in this Agreement
are true and correct in all material respects at the date hereof and as of the
Closing with the same force and effect as though all such representations and
warranties had been made as of the Closing, and (B) that all covenants and
conditions required to be performed prior to or at the Closing have been
performed as of the Closing.
(v) A Certificate of Good Standing for the Company from the
Secretary of State of the State of Delaware, dated as of a recent date.
(b) Performance. The Company shall have performed and complied with
in all material respects all agreements, obligations and conditions contained in
this Agreement that are required to be performed or complied with by it on or
before the Closing.
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(c) Consents, Waivers, Etc. The Company shall have obtained all
consents or waivers, if any, necessary to execute and deliver this Agreement,
issue the Shares and to carry out the transactions contemplated hereby and
thereby and the waiting period applicable to this Agreement and the
Collaboration Agreement under the HSR Act (or any other applicable Competition
Laws) shall have expired or terminated early. All corporate and other action and
governmental filings necessary to effect the terms of this Agreement, the
issuance of the Shares and other agreements and instruments executed and
delivered by the Company in connection herewith shall have been made or taken,
except for any post-sale filing that may be required under federal or state
securities laws.
(d) Rights Agreement Amendment. The Rights Agreement Amendment shall
have been executed by the Company and by the holders of the requisite majority
of Registrable Securities (as such term is defined in the Rights Agreement);
provided, however, the parties acknowledge that subsequent to the date hereof
the Rights Agreement may be further amended in accordance with its terms;
provided, further, however, Purchaser shall be required to consent to such
amendment or be provided substantially equivalent rights in such amendment or
another written agreement with the Company.
(e) Collaboration Agreement. The Collaboration Agreement shall have
been duly authorized, executed, and delivered by the Company and constitute a
valid and binding obligation of the Company, enforceable in accordance with its
terms, except (i) as limited by applicable bankruptcy, insolvency,
reorganization, moratorium and other laws of general application affecting
enforcement of creditors' rights generally and (ii) as limited by laws relating
to the availability of specific performance, injunctive relief or other
equitable remedies. The Purchaser shall not have the right to terminate the
Collaboration Agreement for cause pursuant to Section 9.5 thereof (provided,
however, if Purchaser's right to so terminate the Collaboration Agreement for
cause is solely dependent on the lapsing on any applicable "cure" period
pursuant to Section 9.5 thereof, solely for purposes of this Section 4.1(e),
Purchaser shall be deemed to have the right to terminate the Collaboration
Agreement for cause notwithstanding the failure of any such cure period to have
lapsed); and the Company shall not have given notice to the Purchaser of its
intent to terminate the Collaboration Agreement.
(f) Representations and Warranties. The representations and
warranties made by the Company in this Agreement shall have been true and
correct in all material respects at the date hereof and as of the Closing with
the same force and effect as though all such representations and warranties had
been made as of the Closing.
(g) No Injunctions. No provision of any applicable law, rule or
regulation and no judgment, order, decree or injunction shall prohibit the
consummation of the Closing.
(h) Listing. The shares of Common Stock sold in the IPO shall be
listed on the New York Stock Exchange ("NYSE") or traded on the Nasdaq National
Market.
(i) Closing of IPO. The Closing hereunder shall be concurrent with
the closing of the IPO.
4.2 Conditions of the Company's Obligation. The obligation of the Company
to sell the Shares at the Closing is subject to the satisfaction of the
following conditions:
(a) Performance. The Purchaser shall have performed and complied
with in all material respects all agreements, obligations and conditions
contained in this Agreement that are required to be performed or complied with
by it on or before the Closing.
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(b) Consents, Waivers, Etc. Any waiting period applicable to this
Agreement and the Collaboration Agreement under the HSR Act (or any other
applicable Competition Laws) shall have expired or terminated early.
(c) Rights Agreement Amendment. The Rights Agreement Amendment shall
have been executed by the Purchaser.
(d) Collaboration Agreement. The Collaboration Agreement shall have
been duly authorized, executed and delivered by the Purchaser and constitute a
valid and binding obligation of the Purchaser, enforceable in accordance with
its terms, subject to laws of general application relating to bankruptcy,
insolvency and the relief of debtors and rules of law governing specific
performance, injunctive relief or other equitable remedies. The Company shall
not have the right to terminate the Collaboration Agreement for cause pursuant
to Section 9.5 thereof (provided, however, if the Company's right to so
terminate the Collaboration Agreement for cause is solely dependent on the
lapsing on any applicable "cure" period pursuant to Section 9.5 thereof, solely
for purposes of this Section 4.2(d), the Company shall be deemed to have the
right to terminate the Collaboration Agreement for cause notwithstanding the
failure of any such cure period to have lapsed; and the Purchaser shall not have
given notice to the Company of its intent to terminate the Collaboration
Agreement.
(e) Representations and Warranties. The representations and
warranties made by the Purchaser in this Agreement shall have been true and
correct in all material respects at the date hereof and as of the Closing with
the same force and effect as though all such representations and warranties had
been made as of the Closing.
(f) No Injunctions; Applicable Law. No provision of any applicable
law, rule or regulation and no judgment, order, decree or injunction shall
prohibit the consummation of the Closing nor shall the Closing result in any
violation of any such law, rule, regulation, judgment, order, decree or
injunction.
(g) Listing. The shares of Common Stock sold in the IPO shall be
listed on the NYSE or traded on the Nasdaq National Market.
(h) Closing of IPO. The Closing hereunder shall be concurrent with
the closing of the IPO.
(i) Securities Regulations. The sale of the Shares to Purchaser
shall not be prohibited under state and federal securities laws and regulations.
ARTICLE V
STANDSTILL AGREEMENT
5.1. Definitions. For the purposes of this Agreement, the following words
and phrases shall have the following meanings:
(i) "Actual Voting Power" means, as of the date of determination,
the total number of votes attaching to the outstanding securities entitled to
vote for the election of directors of the Company.
(ii) "Affiliate" shall have the meaning given it in Rule 12b-2 under
the Securities Exchange Act of 1934, as amended (the "Exchange Act").
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(iii) "Beneficial Ownership" "Beneficial Owner" and "Beneficially
Own" shall have the meanings described to those terms in Rule 13d-1 under the
Exchange Act.
(iv) "Change of Control" means (1) the acquisition by a Third Party
of more than 50% of the Company's then outstanding Voting Securities or (2) the
consummation of a merger, acquisition, consolidation or reorganization or series
of such related transactions involving the Company, unless immediately after
such transaction or transactions, the Beneficial Owners of the Company
immediately prior to the first such transaction shall Beneficially Own at least
50% of the outstanding Voting Securities of the Company (or, if the Company
would not be the surviving company in such merger, consolidation or
reorganization, the Voting Securities of the surviving corporation issued in
such transaction or transactions in respect of Voting Securities of the Company
shall represent at least 50% of the Voting Securities of such surviving
company).
(v) "Investor Group" means Purchaser and any member of a 13D Group
to which the Purchaser belongs.
(vi) "Person" means an individual, corporation, partnership,
association, trust, unincorporated organization or other entity
(vii) "13D Group" means any group of persons formed for the purpose
of acquiring, holding, voting or disposing of Voting Securities which would be
required under the Exchange Act and the rules and regulations promulgated
thereunder, to file a statement on Schedule 13D with the Securities and Exchange
Commission as a "person" within the meaning of Section 13(d)(3) of the Exchange
Act if such group beneficially owned sufficient securities to require such a
filing under the Exchange Act.
(viii) "Standstill Period" shall mean the period beginning on the
Closing of the IPO and ending on the date that is one year following the Closing
of the IPO.
(ix) "Threshold Percentage" means the percentage of Actual Voting
Power owned by the Purchaser immediately following the closing of the IPO and
the sale of Shares hereunder, which in no case shall exceed nineteen and
nine-tenths percent (19.9%) of Actual Voting Power.
(x) "Third Party" means any Person or two or more Persons acting in
concert, other than the Purchaser and its Affiliates or the Company and its
Affiliates.
(xii) "Voting Security" means, as of the date of determination, the
Common Stock of the Company, any other security generally entitled to vote for
the election of directors and any outstanding convertible securities, options,
warrants or other rights which are convertible into or exchangeable or
exercisable for securities entitled to vote for the election of directors.
5.2. Standstill Obligations.
(a) Limitation. At any time during the Standstill Period, except
with the prior written consent of the Company's Board of Directors, no member of
the Investor Group shall, directly or indirectly:
(i) acquire any Voting Securities (except by way of stock
splits, stock dividends or other distributions) if the effect of such
acquisition or exercise would be to increase the percentage interest of the
Investor Group in the Actual Voting Power to more than the Threshold Percentage;
or
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(ii) publicly propose (on behalf of itself or to or with a
Third Party) any merger, business combination, restructuring, recapitalization
or similar transaction involving the Company or its subsidiaries or the
purchase, sale or other disposition outside the ordinary course of business of
any material portion of the assets of the Company or any of its subsidiaries.
(b) Repurchases. Notwithstanding Section 5.2(a), no member of the
Investor Group shall be obligated to dispose of any Voting Securities if the
aggregate percentage ownership of the Investor Group is increased as a result of
a repurchase of Voting Securities by the Company.
(c) Participation. Except with the prior written consent of the
Company's Board of Directors, during the Standstill Period the Investor Group
will not:
(i) solicit proxies (or powers of attorney or similar
rights to vote) in respect of any Voting Securities;
(ii) become a "participant" or "participant in a
solicitation", as those terms are defined in Regulation 14A of the General Rules
and Regulations promulgated pursuant to the Exchange Act, in opposition to a
solicitation by the Company; provided, however, that the Investor Group shall
not be deemed to be a "participant" or to have become engaged in a solicitation
hereunder solely by reason of the Company's solicitation of proxies in
connection with any meeting of the stockholders of the Company;
(iii) seek to advise or intentionally influence any person or
entity with respect to the voting of Voting Securities in connection with any
such solicitation, in opposition to the recommendation of a majority of the
Board of Directors with respect to any matter relating to a Change of Control;
(iv) initiate, propose or otherwise solicit stockholders for
the approval of any stockholder proposal (as described in Rule 14a-8 under the
Exchange Act or otherwise) with respect to the Company that is opposed by the
Board of Directors;
(v) form or join any 13D Group for the purpose of voting,
purchasing or disposing of Voting Securities or the acquisition of all or
substantially all of assets of the Company;
(vi) deposit any Voting Securities in a voting trust or
subject them to a voting agreement or other arrangement of similar effect,
except in order to comply with Competition Laws or other legal requirements;
(vii) otherwise act, alone or in concert with others, in a
manner designed or having the deliberate effect of circumventing the
restrictions otherwise imposed hereunder, publicly announce any intention, plan
or arrangement inconsistent with the foregoing or finance or agree to finance
any other person in connection with any of the activities prohibited by this
Agreement; or
(viii) publicly request, propose or otherwise seek any
amendment or waiver of the provisions of this Article 5.
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5.3 Exceptions. The limitations provided in Section 5.2 shall immediately
terminate upon the occurrence of any of the following events:
(a) the commencement by any Person (other than a member of the
Investor Group or an Affiliate thereof) of a bona fide tender or exchange offer
seeking to acquire Beneficial Ownership of fifty percent (50%) or more of the
outstanding shares of Voting Securities of the Company;
(b) the execution of an agreement by the Company and any Person
which, if consummated, would result in either (i) a Change of Control of the
Company or (ii) the sale of all or substantially all of the Company's assets; or
(c) the adoption by the Company of a plan of liquidation or
dissolution with respect to the Company.
5.4 Exclusion. No action or actions taken by the Purchaser pursuant to the
terms of the Collaboration Agreement or in connection with exercising or
enforcing its rights thereunder shall be deemed to violate the restrictions in
Section 5.2.
ARTICLE VI
MISCELLANEOUS
6.1 No Waiver. No failure or delay on the part of any party to this
Agreement in exercising any right, power or remedy hereunder shall operate as a
waiver thereof; nor shall any single or partial exercise of any such right,
power or remedy preclude any other or further exercise thereof or the exercise
of any other right, power or remedy hereunder. None of the terms, covenants and
conditions of this Agreement can be waived except by the written consent of the
party waiving compliance.
6.2 Publicity. The parties may, subject to compliance with the Securities
Act, issue a joint press release announcing this Agreement and the transactions
contemplated hereby following execution of this Agreement. Any proposed
announcement, press release or other public disclosure concerning this Agreement
and/or any of the transactions or relationships contemplated hereby shall be
mutually approved by both parties (which approval shall not be unreasonably
withheld); provided, however, that the restrictions contained in this Section
6.2 do not apply to disclosures required by law, the rules of the NYSE, the NASD
or under U.S. generally accepted accounting principles. The Purchaser agrees and
acknowledges that this Agreement and the transactions contemplated hereby shall
be disclosed in, and filed as an exhibit to, the Registration Statement.
6.3 Amendments, Waivers and Consents. Any provision in this Agreement to
the contrary notwithstanding, and except as hereinafter provided, changes in or
additions to this Agreement may be made, and compliance with any covenant or
provision set forth herein may be omitted or waived, if the party requesting
such change, addition, omission or waiver shall obtain consent thereto in
writing from the other party. Any waiver or consent may be given subject to
satisfaction of conditions stated therein and any waiver or consent shall be
effective only in the specific instance and for the specific purpose for which
given. Any such amendment or waiver or consent effected in accordance with this
Section 6.3 shall be binding upon the parties and their respective successors
and assigns.
6.4 Addresses for Notices. Any notice required or permitted by this
Agreement shall be in writing and shall be deemed sufficient upon receipt, when
delivered personally or by courier, overnight delivery service or confirmed
facsimile, or seventy-two (72) hours after being deposited in the regular
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mail as certified or registered mail (airmail if sent internationally) with
postage prepaid, if such notice is addressed to the party to be notified at such
party's address or facsimile number as set forth below, or as subsequently
modified by written notice.
If to the Company:
Trubion Pharmaceuticals, Inc.
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attn: Chief Executive Officer and General Counsel
Facsimile Number: (▇▇▇) ▇▇▇-▇▇▇▇
If to the Purchaser:
Wyeth Pharmaceuticals
▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Attn: Senior Vice President, Corporate Business Development
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
with a copy to:
Wyeth
▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attn: Executive Vice President and General Counsel
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇
6.5 Binding Effect; Assignment. This Agreement may not be assigned by
either party without the prior written consent of the other; provided, however,
that the Purchaser may assign its rights and delegate its duties hereunder to an
Affiliate without the prior written consent of the Company; provided, however,
Purchaser shall remain subject to Section 5 hereof regardless of any such
assignment; and provided further that if the Company undergoes a Change of
Control in which (a) the Company is not the surviving entity and (b) this
Agreement does not terminate pursuant to Section 1.5(b) in connection with such
Change of Control, the surviving entity and the Purchaser shall enter into a
replacement agreement with substantially the same terms as this Agreement.
Subject to the foregoing, the terms and conditions of this Agreement shall inure
to the benefit of and be binding upon the respective successors and assigns of
the parties. Nothing in this Agreement, express or implied, is intended to
confer upon any party other than the parties hereto or their respective
successors and assigns any rights, remedies, obligations, or liabilities under
or by reason of this Agreement, except as expressly provided in this Agreement.
6.6 Entire Agreement. This Agreement and the documents referred to herein
constitute the entire agreement between the parties and supersede any prior
understandings or agreements concerning the subject matter hereof.
6.7 Specific Performance. The parties acknowledge and agree that
irreparable damage would occur in the event any of the provisions of Article V
of this Agreement were not performed in accordance with their specific terms or
were otherwise breached. Accordingly, it is agreed that the parties shall be
entitled to an injunction or injunctions to prevent or cure breaches of the
provisions of Article V of this
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Agreement and to enforce specifically the terms and provisions of such Article
in any court of the United States or any state thereof having jurisdiction, in
addition to any other remedy to which they may be entitled in law or in equity.
6.8 Severability. The provisions of this Agreement are severable and, in
the event that any court of competent jurisdiction shall determine that any one
or more of the provisions or part of a provision contained in this Agreement
shall, for any reason, be held to be invalid, illegal or unenforceable in any
respect, such invalidity, illegality or unenforceability shall not affect any
other provision or part of a provision of this Agreement; but this Agreement,
shall be reformed and construed as if such invalid or illegal or unenforceable
provision, or part of a provision, had never been contained herein, and such
provisions or part reformed so that it would be valid, legal and enforceable to
the maximum extent possible.
6.9 Governing Law. This Agreement shall be governed by, and construed and
enforced in accordance with, the laws of the State of Delaware without reference
to Delaware conflicts of law provisions.
6.10 Headings. Article, Section and subsection headings in this Agreement
are included herein for convenience of reference only and shall not constitute a
part of this Agreement for any other purpose.
6.11 Counterparts. This Agreement may be executed in any number of
counterparts, each of which shall be enforceable against the party actually
executing the counterpart, and all of which together shall constitute one
instrument.
[Signature page follows.]
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EXECUTION COPY
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed as of the date first above written.
TRUBION PHARMACEUTICALS, INC.
By:__________________________________
Name:________________________________
Title:_______________________________
WYETH
By:__________________________________
Name:________________________________
Title:_______________________________
EXECUTION COPY
EXHIBIT A
MATTERS TO BE COVERED BY COMPANY COUNSEL
1. The Company is a corporation validly existing under Delaware law and in
good standing with the Secretary of the State of Delaware and has the corporate
power to execute and deliver the Agreement and to perform its obligations
thereunder.
2. The Company has duly authorized, executed and delivered the Agreement,
and the Agreement constitutes the Company's valid and binding agreement
enforceable against the Company in accordance with its terms, except as
enforceability may be limited by bankruptcy, insolvency, reorganization,
moratorium or similar laws relating to or affecting creditors' rights generally
or by general equitable principles.
3. No consent, approval, authorization or order of, or any filing or
declaration with, any court or governmental agency or body is required in
connection with the execution, delivery and performance of the Agreement by the
Company or in connection with the taking by the Company of any action
contemplated thereby, other than as indicated in the Agreement or such as have
been obtained and made and such as may be required under federal and state
securities laws.
4. The execution, delivery and performance of the Agreement by the
Company, and the consummation by the Company of the transactions contemplated
therein do not and will not (a) violate the Certificate of Incorporation or
By-Laws of the Company, (b) materially violate any judgment, ruling, decree or
order known to such counsel, (c) materially violate any statute or regulation
applicable to the business or properties of the Company, or (d) result in a
material breach or violation of any of the terms or provisions of, or constitute
a default or result in the acceleration of any obligation under any material
contract to which the Company is a party or bound.
5. The Shares delivered on the date hereof have been duly authorized and
validly issued and are fully paid and non-assessable shares of the Company.
EXECUTION COPY
EXHIBIT 5.2B
TRUBION PHARMACEUTICALS, INC.
AMENDMENT NO. 1 TO
AMENDED AND RESTATED INVESTOR RIGHTS AGREEMENT
This Amendment No. 1 to the Amended and Restated Investor Rights Agreement
(the "RIGHTS AGREEMENT") dated as of July 13, 2004 is entered into as of
________, 2005, by and among Trubion Pharmaceuticals, Inc., a Delaware
corporation (the "COMPANY"), Wyeth, a Delaware corporation ("WYETH"), and the
investors set forth on EXHIBIT A hereto (collectively the "INVESTORS" and each
individually an "INVESTOR").
RECITALS
A. The Company and the Investors are parties to the Rights Agreement.
B. The Company and Wyeth have entered into a Common Stock Purchase
Agreement dated as of December __, 2005 (the "PURCHASE AGREEMENT") pursuant to
which the Company will sell to Purchaser and Purchaser will purchase from the
Company shares of the Company's Common Stock concurrent with and conditioned
upon the closing of the Company's initial public offering (the "CLOSING"). A
condition to the Purchaser's obligations under the Purchase Agreement is that
the Rights Agreement be amended in order to provide Purchaser with certain
rights to register shares of the Company's Common Stock.
C. Pursuant to Section 6.5 of the Rights Agreement, the written consent of
the Company and the Investors holding a majority of the Registrable Securities
(the "REQUISITE HOLDERS") is required to amend the Rights Agreement.
D. The Company and the Requisite Holders desire to induce Purchaser to
enter into the Purchase Agreement by agreeing to the terms and conditions set
forth herein.
NOW, THEREFORE, in consideration of the mutual promises, representations,
warranties, covenants and conditions set forth in this Agreement, the parties
hereto agree as follows:
1. Definitions. Capitalized terms used herein without definition shall
have the meaning ascribed to them in the Rights Agreement.
2. Addition of Purchaser as a Party to the Rights Agreement. Effective
upon the Closing pursuant to the Purchase Agreement, the parties hereby agree to
add Purchaser as a party to the Rights Agreement and Purchaser shall be deemed a
"Holder" of Registrable Securities for purposes of Sections 1, 2 and 6 of the
Rights Agreement and subject to all of the rights and obligations of such
Sections. For purposes of clarification, Purchaser shall not be entitled to the
rights or subject to the obligations set forth in Sections 3, 4 and 5 of the
Rights Agreement and Purchaser shall not be deemed an "INVESTOR" for purposes of
the Rights Agreement.
REDACTED COPY
3. Amendment to Section 1.1. The definition of "Registrable Securities"
set forth in Section 1.1 is hereby amended and restated to read in its entirety
as follows:
"REGISTRABLE SECURITIES" means (a) Common Stock of the Company issued
or issuable upon conversion of the Shares, (b) Common Stock of the Company
issued to ▇▇▇▇▇▇▇ Healthcare Fund ("▇▇▇▇▇▇▇"), ARCH Venture Fund ("ARCH") and
▇▇▇▇▇ ▇▇▇▇▇▇ ("▇▇▇▇▇▇") pursuant to those certain Common Stock Purchase
Agreements dated November 19, 2002 by and between the Company and each of
▇▇▇▇▇▇▇, Arch and ▇▇▇▇▇▇, (c) Common Stock of the Company issued to Wyeth
pursuant to the Purchase Agreement, and (d) any Common Stock of the Company
issued as (or issuable upon the conversion or exercise of any warrant, right or
other security which is issued as) a dividend or other distribution with respect
to, or in exchange for or in replacement of, the securities described in (a),
(b) and (c) above; provided, however, the shares referred to in clause (c) above
shall not qualify as Registrable Securities for the purposes of Sections 2.2
hereof until the 15 month anniversary of the Closing. For the avoidance of
doubt, in the event that the Company effects a registration under the Securities
Act pursuant to Section 2.2 hereof prior to the 15 month anniversary of the
Closing, in connection with such registration the Shares referred to in clause
(c) above shall qualify as Registrable Securities for the purposes of Section
2.3. Notwithstanding the foregoing, Registrable Securities shall not include any
securities sold by a person to the public pursuant to a registration statement
or Rule 144 or sold in a private transaction in which the transferor's rights
under SECTION 2 of this Agreement are not assigned.
4. Amendment to Section 2.1(a)(ii). Section 2.1(a)(ii) is amended
effective immediately following the expiration of the "Market Stand-Off" period
set forth in Section 2.12 hereof, by deleting the last sentence thereof and
substituting therefor the following:
"Subject to the other terms of this Agreement (including without
limitation the restrictions on assignment of registration rights set forth
in Section 2.10 and Sections 2.1(b) and (d)), it is agreed that the
restrictions contained in this Section 2.1(a)(ii) shall not apply to
dispositions of Shares or Registrable Securities made pursuant to Rule 144
promulgated under the Securities Act."
5. Amendment to Section 6.5. Section 6.5 is hereby amended by adding,
after the final sentence thereof, the following:
Notwithstanding the foregoing, neither this Agreement nor any term
hereof may be amended, waived, discharged or terminated in any way that
diminishes or eliminates the rights particular to Wyeth hereunder and in a
manner different than the other holders of Registrable Securities, such action
shall require the prior written consent of Wyeth.
6. Waiver of Right of Participation. Each Investor on behalf of itself and
all other Investors and holders of Registrable Securities hereby waives any
right of participation set forth in Section IV of the Rights Agreement with
respect to the sale and issuance of the shares of Company Common Stock to Wyeth
pursuant to the Purchase Agreement.
7. No Other Amendments. Except as expressly amended or waived as set forth
above, the Rights Agreement shall remain in full force and effect in accordance
with its terms.
8. Counterparts. This Amendment may be executed in any number of
counterparts, each of which shall be deemed an original and all of which
together shall constitute one document.
-2-
REDACTED COPY
[Signature pages follow.]
-3-
EXECUTION COPY
IN WITNESS WHEREOF, the parties hereto have executed this AMENDMENT NO. 1 TO THE
RIGHTS AGREEMENT as of the date set forth in the first paragraph hereof.
"COMPANY"
TRUBION PHARMACEUTICALS, INC.
a Delaware corporation
By: _________________________________
▇▇▇▇▇ ▇▇▇▇▇▇▇▇, M.D., FACP
President and Chief Executive
Officer
SIGNATURE PAGE TO AMENDMENT NO. 1 TO
AMENDED AND RESTATED INVESTOR RIGHTS AGREEMENT
EXECUTION COPY
IN WITNESS WHEREOF, the parties hereto have executed this AMENDMENT NO. 1 TO THE
RIGHTS AGREEMENT as of the date set forth in the first paragraph hereof.
"WYETH"
WYETH
By: _________________________________
Name: _______________________________
Its: ________________________________
SIGNATURE PAGE TO AMENDMENT NO. 1 TO
AMENDED AND RESTATED INVESTOR RIGHTS AGREEMENT
EXECUTION COPY
IN WITNESS WHEREOF, the parties hereto have executed this AMENDMENT NO. 1 TO THE
RIGHTS AGREEMENT as of the date set forth in the first paragraph hereof.
"INVESTOR"
PROSPECT VENTURE PARTNERS II, L.P.
By: Prospect Management Co. II, LLC
Its General Partner
By: _________________________________
Name: ▇▇▇▇▇ ▇▇▇▇▇▇▇
Title: Managing Member
PROSPECT ASSOCIATES II, L.P.
By: Prospect Management Co. II, LLC
Its General Partner
By: _________________________________
Name: ▇▇▇▇▇ ▇▇▇▇▇▇▇
Title: Managing Member
SIGNATURE PAGE TO AMENDMENT NO. 1 TO
AMENDED AND RESTATED INVESTOR RIGHTS AGREEMENT
EXECUTION COPY
IN WITNESS WHEREOF, the parties hereto have executed this AMENDMENT NO. 1 TO THE
RIGHTS AGREEMENT as of the date set forth in the first paragraph hereof.
"INVESTOR"
VENROCK PARTNERS, L.P.
by its General Partner, Venrock Partners
Management, LLC
VENROCK ASSOCIATES IV, L.P.
by its General Partner, Venrock Management IV,
LLC
VENROCK ENTREPRENEURS FUND IV, L.P.
by its General Partner, VEF Management IV, LLC
By:______________________________________________
Name: ▇▇▇▇▇▇ ▇. ▇▇▇▇
Title: Member
Address: ▇▇ ▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇ ▇▇▇▇
▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇
SIGNATURE PAGE TO AMENDMENT NO. 1 TO
AMENDED AND RESTATED INVESTOR RIGHTS AGREEMENT
EXECUTION COPY
IN WITNESS WHEREOF, the parties hereto have executed this AMENDMENT NO. 1 TO THE
RIGHTS AGREEMENT as of the date set forth in the first paragraph hereof.
"INVESTOR"
ARCH VENTURE FUND V, L.P.
By: ARCH Venture Partners V, L.P.
Its general partner
By: ARCH Venture Partners V, L.L.C.
Its general partner
By: _____________________________________________
Title: Managing Director
ARCH V ENTREPRENEURS FUND, L.P.
By: ARCH Venture Partners V, L.P.
Its general partner
By: ARCH Venture Partners V, L.L.C.
Its general partner
By: _____________________________________________
Title: Managing Director
HEALTHCARE FOCUS FUND, L.P.
By: ARCH Venture Partners V, L.P.
Its general partner
By: ARCH Venture Partners V, L.L.C.
Its general partner
By: _____________________________________________
Title: Managing Director
8
EXECUTION COPY
IN WITNESS WHEREOF, the parties hereto have executed this AMENDMENT NO. 1 TO THE
RIGHTS AGREEMENT as of the date set forth in the first paragraph hereof.
"INVESTOR"
OXFORD BIOSCIENCE PARTNERS IV L.P.
By: OBP Management IV L.P.
By: _____________________________________________
▇▇▇▇ ▇. ▇▇▇▇▇▇ - General Partner
mRNA FUND II L.P.
By: OBP Management IV L.P.
By: _____________________________________________
▇▇▇▇ ▇. ▇▇▇▇▇▇ - General Partner
SIGNATURE PAGE TO AMENDMENT NO. 1 TO
AMENDED AND RESTATED INVESTOR RIGHTS AGREEMENT
EXECUTION COPY
IN WITNESS WHEREOF, the parties hereto have executed this AMENDMENT NO. 1 TO THE
RIGHTS AGREEMENT as of the date set forth in the first paragraph hereof.
"INVESTOR"
▇▇▇▇▇▇▇ HEALTHCARE IV, L.P.
By FHM IV, LP, its general partner
By FHM IV, LLC, its general partner
By: _____________________________________________
Name: ___________________________________________
Its: ____________________________________________
▇▇▇▇▇▇▇ AFFILIATES IV, L.P.
By FHM IV, LP, its general partner
By FHM IV, LLC, its general partner
By: _____________________________________________
Name: ___________________________________________
Its: ____________________________________________
▇▇▇▇▇▇▇ HEALTHCARE III, L.P.
By FHM III, LLC
By: _____________________________________________
Name: ___________________________________________
Its: ____________________________________________
▇▇▇▇▇▇▇ AFFILIATES III, L.P.
By FHM III, LLC
By: _____________________________________________
Name: ___________________________________________
Its: ____________________________________________
SIGNATURE PAGE TO AMENDMENT NO. 1 TO
AMENDED AND RESTATED INVESTOR RIGHTS AGREEMENT
EXECUTION COPY
IN WITNESS WHEREOF, the parties hereto have executed this AMENDMENT NO. 1 TO THE
RIGHTS AGREEMENT as of the date set forth in the first paragraph hereof.
"INVESTOR"
ATP CAPITAL, L.P.
By: ATP General Partner LLC
Its General Partner
By: _____________________________________________
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, Manager
SIGNATURE PAGE TO AMENDMENT NO. 1 TO
AMENDED AND RESTATED INVESTOR RIGHTS AGREEMENT
REDACTED COPY
IN WITNESS WHEREOF, the parties hereto have executed this AMENDMENT NO. 1 TO THE
RIGHTS AGREEMENT as of the date set forth in the first paragraph hereof.
"INVESTOR"
CASCADE INVESTMENTS, L.L.C.
By: _____________________________________________
Name: ___________________________________________
Its:
______________________________
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EXECUTION COPY
IN WITNESS WHEREOF, the parties hereto have executed this AMENDMENT NO. 1 TO THE
RIGHTS AGREEMENT as of the date set forth in the first paragraph hereof.
"INVESTOR"
___________________________
By: _____________________________________________
Name: ___________________________________________
Its:
___________________________
SIGNATURE PAGE TO AMENDMENT NO. 1 TO
AMENDED AND RESTATED INVESTOR RIGHTS AGREEMENT
EXECUTION COPY
EXHIBIT 5.3
ADDITIONAL RESEARCH AND DEVELOPMENT
EXPENSE PAYMENTS
A. ADDITIONAL RESEARCH AND DEVELOPMENT EXPENSE PAYMENTS FOR CD20 PRODUCTS
Within *** after Trubion's or Wyeth's achievement of the following events with
respect to any *** (each payable one time only even if achieved with respect to
more than one ***), Wyeth shall make the following payments to Trubion:
***
B. ADDITIONAL RESEARCH AND DEVELOPMENT EXPENSE PAYMENTS FOR ***
Within *** after Wyeth's achievement of the following events with respect to any
*** (each payable one time only even if completed or achieved with respect to
more than one ***), Wyeth shall make the following payments to Trubion:
***
C. ADDITIONAL RESEARCH AND DEVELOPMENT EXPENSE PAYMENTS FOR OTHER PRODUCTS
Within *** after Wyeth's achievement of the following events with respect to
each Other Product (up to a maximum of *** Other Products), Wyeth shall make the
following payments to Trubion; provided, however, that: (i) in the event that
any of the following events is achieved with respect to two or more Other
Products that are directed against the same Wyeth Target, such payment shall be
payable only with respect to the first such Other Product for which the event
occurred; and (ii) in the event that an Other Product is directed against two or
more Wyeth Targets, such Licensed Product shall be a Multispecific SMIP Product,
the consequences of which are as described in Section D below:
***
D. NO ADDITIONAL PAYMENTS; OTHER APPLICABLE TERMS AND CONDITIONS
(i) Other than the payments listed in Sections A - C of this Exhibit 5.3, no
Additional Research and Development Expense Payments shall be due or payable by
Wyeth to Trubion for any Licensed Product, regardless of the number of Licensed
Products Developed against any Trubion Target or Wyeth Target.
(ii) Each of the Additional Research and Development Expense Payments set forth
above shall be payable one time only with respect to each Licensed Target
(regardless
2
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of the number of times the specified event is achieved with respect to any
Licensed Product(s)).
(iii) In the event that the Development of a Licensed Product directed against a
particular Licensed Target hereunder (an "Initial Licensed Product") is
discontinued prior to the Commercialization of such Initial Licensed Product,
and Development has been initiated with respect to another Licensed Product
directed against such Licensed Target (a "Replacement Licensed Product"),
payments with respect to such Replacement Licensed Product shall be due under
this Exhibit 5.3 only upon the achievement of those events that have not been
achieved by the Initial Licensed Product.
(iv) Without limiting the foregoing, if a specified event listed in Sections A -
C of this Exhibit 5.3 occurs with respect to a Licensed Product directed
against two or more Licensed Targets (a "Multispecific SMIP Product"), then (a)
no more than one Additional Research and Development Expense Payment shall
become payable with respect to the achievement of such event for such
Multispecific SMIP Product, (b) only the highest Additional Research and
Development Expense Payment based on the achievement of such event that has not
already become payable shall be payable, and (c) if all Additional Research and
Development Expense Payments based on the achievement of such event have already
become payable, then no payment shall be due with respect to such event for such
Multispecific SMIP Product. By way of example only, if a BLA filing and
acceptance for review in the U.S. occurs with respect to a Multispecific SMIP
Product directed against the *** and a Wyeth Target ("Wyeth Target Q"), then:
(x) if the *** Additional Research and Development Expense Payment under Section
B for such event has not already become payable, only such $15.0 million amount
shall become payable; (y) if such *** Additional Research and Development
Expense Payment had already become payable, then the *** Additional Research and
Development Expense Payment under Section C for such event shall become payable,
if it has not previously become payable; and, (z) if both such *** and such ***
Additional Research and Development Expense Payment had previously become
payable, then no payment shall be due upon BLA filing and acceptance for review
in the U.S. with respect to such Multispecific SMIP Product. To continue the
same example, if the same Multispecific SMIP Product meets the condition set
forth in (x) above, and thereafter a BLA filing and acceptance for review in the
U.S. occurs with respect to a separate Licensed Product directed only against
such Wyeth Target Q, then upon such subsequent occurrence by such separate
Licensed Product, the *** Additional Research and Development Expense Payment
shall be payable with respect to such Wyeth Target Q (if such *** payment had
not previously become payable in connection with Wyeth Target Q).
(v) Subject to the limitations set forth above in Sections A, B and C and in
this Section D, if an Additional Research and Development Expense Payment based
on a clinical study of, or Regulatory Approval filing for, a Licensed Product
for a particular indication (a "Later Development Event") becomes payable before
the achievement of an earlier phase clinical study event with respect to such
Licensed
3
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Product for the same indication for which Additional Research and Development
Expense Payments would have been payable (an "Earlier Development Event"), then
the Additional Research and Development Expense Payment for the Earlier
Development Event also shall become payable upon occurrence of the Later
Development Event. ***
4
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EXHIBIT 8.2(d)
THIRD PARTY RIGHTS
[INTENTIONALLY LEFT BLANK]
EXECUTION COPY
EXHIBIT 8.2(e)
GOVERNMENT FUNDING AGREEMENTS
NIH GRANT # 5 R01 CA90143
PROJECT TITLE: GENE THERAPY WITH MAB DERIVATIVES EXPRESSED ON TUMORS
CONFIDENTIAL
APPENDIX
WYETH TARGETS
GENBANK NUCLEOTIDE GENBANK PROTEIN ACCESSION
TARGET # TARGET NAME GENE SYMBOL ACCESSION NUMBER NUMBER
------------ ----------- ----------- ------------------ -------------------------
*** *** *** *** ***