EXHIBIT 10.11
REDACTED COPY
COLLABORATION AND LICENSE AGREEMENT
by and between
WYETH
acting through its Wyeth Pharmaceuticals Division
and
TRUBION PHARMACEUTICALS, INC.
December 19, 2005
REDACTED COPY
TABLE OF CONTENTS
Page
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1. DEFINITIONS.......................................................... 1
2. LICENSES............................................................. 16
2.1 Licenses to Wyeth.............................................. 16
2.1.1 Exclusive Licenses...................................... 16
2.1.2 Retained Rights of Trubion.............................. 17
2.2 License to Trubion............................................. 17
2.3 Exclusivity.................................................... 17
2.3.1 CD20 Product Exclusivity................................ 17
2.3.2 ***..................................................... 18
2.3.3 Limitations............................................. 18
2.4 Sublicensing................................................... 18
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......................................... 21
3.2.1 Target Candidates....................................... 22
3.2.2 Released Targets........................................ 23
3.2.3 Wyeth Targets........................................... 23
3.2.4 Excluded Targets........................................ 24
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....................................... 27
3.4.1 Composition............................................. 27
3.4.2 Responsibilities........................................ 27
3.4.3 Meetings................................................ 28
3.4.4 Voting.................................................. 28
3.4.5 Dispute Resolution...................................... 28
3.4.6 Minutes................................................. 28
3.5 Research Plan.................................................. 28
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.............................................. 31
4. PRODUCT DEVELOPMENT, MANUFACTURING, COMMERCIALIZATION AND
REGULATORY MATTERS................................................... 32
4.1 Product Development............................................ 32
4.2 Transfer of Product Data and Filings........................... 32
4.3 Regulatory Approvals........................................... 33
4.4 Regulatory Reporting........................................... 33
4.5 Progress Reports............................................... 34
4.6 CD20 Product Development....................................... 35
4.7 Joint Development Committee.................................... 36
4.8 Joint Project Team; Development Plan........................... 36
4.9 Manufacturing.................................................. 36
4.10 Commercialization.............................................. 37
4.11 Co-Promotion Option............................................ 38
4.12 Co-Promotion Committee......................................... 38
4.13 Co-Branding.................................................... 38
4.14 Marking........................................................ 38
5. CONSIDERATION........................................................ 38
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.................................. 39
5.4.3 ***..................................................... 42
5.4.4 Other Product Royalties................................. 44
5.4.5 Expiration of Royalty Period............................ 45
5.4.6 Royalty Adjustments..................................... 45
5.5 Reports and Payments........................................... 46
5.5.1 Cumulative Royalties.................................... 46
5.5.2 Royalty Statements and Payments......................... 46
5.5.3 Taxes and Withholding................................... 47
5.5.4 Currency................................................ 47
5.5.5 Additional Provisions Relating to Royalties............. 47
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................................................ 49
6.1 Inventions; Joint Patent Committee............................. 49
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................... 61
6.2.4 Patent Certifications................................... 64
6.2.5 Patent Term Restoration................................. 64
6.3 Trademarks..................................................... 64
7. CONFIDENTIALITY...................................................... 64
7.1 Confidentiality................................................ 64
7.2 Authorized Disclosure and Use.................................. 65
7.2.1 Disclosure.............................................. 65
7.2.2 Use..................................................... 66
7.3 SEC Filings.................................................... 66
7.4 Public Announcements; Publications............................. 66
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........... 68
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........................... 70
9.1 HSR Filing..................................................... 70
9.2 Other Government Approvals..................................... 71
9.3 Term........................................................... 71
9.4 Termination Upon HSR Denial.................................... 71
9.5 Material Breach................................................ 71
9.6 Termination by Wyeth........................................... 72
9.6.1 Termination Without Cause............................... 72
9.6.2 Termination for a Material Safety or Regulatory Issue... 72
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.............. 76
9.7.3 Effect of Termination by Wyeth Without Cause............ 79
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........... 83
9.7.7 Post-Termination Transfer of Product Data and Filings
and Existing Trademarks................................. 83
9.7.8 Manufacturing of Licensed Products After Termination.... 84
9.7.9 Post-Termination Disposition of Inventories of
Licensed Products....................................... 85
9.7.10 Continuation of Rights and Licenses Under Sections
6.1.1 and 6.1.2......................................... 85
9.7.11 Continuation of Other Rights and Obligations............ 85
9.8 Modification of Agreement Terms by Wyeth....................... 85
9.9 Survival of Certain Obligations................................ 86
9.10 Change of Control.............................................. 86
9.10.1 Definition.............................................. 86
9.10.2 Change of Control of Wyeth.............................. 87
9.10.3 Change of Control of Trubion............................ 89
10. INDEMNIFICATION AND INSURANCE........................................ 89
10.1 Indemnification by Wyeth....................................... 89
10.2 Indemnification by Trubion..................................... 90
10.3 Procedure...................................................... 90
10.4 Insurance...................................................... 91
11. DISPUTE RESOLUTION................................................... 91
11.1 General........................................................ 91
11.2 Failure of Executive Officers to Resolve Dispute............... 92
11.3 Disclaimer of Consequential and Punitive Damages............... 92
12. MISCELLANEOUS........................................................ 92
12.1 Periodic Executive Meetings.................................... 92
12.2 Assignment..................................................... 92
12.3 Further Actions................................................ 93
12.4 Force Majeure.................................................. 93
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12.5 Non-Solicitation............................................... 93
12.6 Correspondence and Notices..................................... 93
12.6.1 Ordinary Notices........................................ 93
12.6.2 Extraordinary Notices................................... 94
12.7 Amendment...................................................... 95
12.8 Waiver......................................................... 95
12.9 Severability................................................... 95
12.10 Descriptive Headings........................................... 95
12.11 Governing Law.................................................. 95
12.12 Entire Agreement of the Parties................................ 95
12.13 Independent Contractors........................................ 96
12.14 Counterparts................................................... 96
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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
EXECUTION COPY
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 000 Xxxxxx Xxxx, Xxxxxxxxxxxx,
Xxxxxxxxxxxx 00000 (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 0000 0xx Xxxxxx, Xxxxx 0000, Xxxxxxx, Xxxxxxxxxx 00000
(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.
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
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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 GenBank
and identified by ***, 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.
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.
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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.
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
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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.
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.
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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 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
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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 Xxxx-Xxxxx-Xxxxxx 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.
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.
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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, 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.
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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
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:
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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
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
9
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 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.
10
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 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.
11
1.97. "PROVISIONAL EXCLUDED TARGET" shall mean a Target described in
Section 3.2.4 hereof as a Provisional Excluded Target.
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.
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.
12
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
*** 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 *** 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 *** 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, ***.
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
13
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.
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.
14
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 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.
15
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.
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,
16
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.
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.
17
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 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
18
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, 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,
19
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, 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
20
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 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.
21
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 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
22
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
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
23
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
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:
24
(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 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
25
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 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.
26
(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.
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
27
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 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
28
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 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.
29
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
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
30
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) 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
31
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.
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
32
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 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 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
33
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
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.
34
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 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
35
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 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
36
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 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
37
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.
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.
38
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.
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 *** ***
39
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 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
40
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 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
41
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 ***
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
42
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 *** 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
43
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
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
44
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.
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
45
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
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
46
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 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
47
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 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
48
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
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.
49
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 (***); 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
50
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 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
51
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 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
52
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 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
53
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 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
54
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 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
55
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 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
56
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 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
57
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
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
58
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 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
59
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 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.
60
(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.
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.
61
(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,
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.
62
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
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.
63
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 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
64
"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
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
65
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.
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.
66
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 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
67
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
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:
68
(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 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
69
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 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)
70
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.
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
71
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.
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
72
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
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
73
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:
(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
74
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 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
75
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;
(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.
76
(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 *** 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 ***; (C) with respect to any Licensed
Products other than CD20 Products ***; and (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
77
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 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
78
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
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;
79
(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 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
80
(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
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.
81
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);
(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
82
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
have no right, title or interest in or to any of the Trubion
Technology.
9.7.6. POST-TERMINATION LICENSES TO WYETH TECHNOLOGY. ***
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,
83
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 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
84
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 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:
85
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
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 ***
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 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
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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
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
87
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.
(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,
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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 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
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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:
(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
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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 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
91
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 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
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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); 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.
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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
000 Xxxxxx Xxxx
Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000
Attn: Senior Vice President, Corporate Business Development
Fax: (000) 000-0000
with a copy to:
Wyeth
0 Xxxxxxx Xxxxx
Xxxxxxx, Xxx Xxxxxx 00000
Attn: Executive Vice President and General Counsel
Fax: (000) 000-0000
All correspondence to Trubion shall be addressed as follows:
Trubion Pharmaceuticals, Inc.
0000 0xx Xxxxxx
Xxxxx 0000
Xxxxxxx, Xxxxxxxxxx 00000
Attn: President & CEO
Fax: (000) 000-0000
with a copy to:
Trubion Pharmaceuticals, Inc.
Vice President, Legal Affairs
0000 0xx Xxxxxx
Xxxxx 0000
Xxxxxxx, Xxxxxxxxxx 00000
Fax: (000) 000-0000
94
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.
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.
95
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/ Xxxxxxx X. Xxxxxx By /s/ Xxxxx X. Xxxxxxxx
---------------------------------- -------------------------------------
Name: Xxxxxxx X. Xxxxxx Name: Xxxxx X. Xxxxxxxx, M.D.
Title: Vice President Title: President & CEO
96
EXECUTION COPY
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: 000-000-0000 OR
b. Overnight courier to:
Global Safety Surveillance & Epidemiology
Wyeth Research
GSSE Triage Unit
Dock E
000 Xxxxxx Xxxx
Xxxxxxxxxxxx, XX 00000
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 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 Xxxx-Xxxxx Xxxxxx
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 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).
2
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, 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
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 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,
4
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.
(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
5
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.
(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.
6
(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").
(iii) "Beneficial Ownership" "Beneficial Owner" and "Beneficially Own"
shall have the meanings described to those terms in Rule 13d-1 under the
Exchange Act.
7
(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
(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.
8
(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.
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
9
(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 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.
0000 Xxxxxx Xxxxxx, Xxxxx 0000
Xxxxxxx, XX 00000
Attn: Chief Executive Officer and General Counsel
Facsimile Number: (000) 000-0000
10
If to the Purchaser:
Wyeth Pharmaceuticals
000 Xxxxxx Xxxx
Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000
Attn: Senior Vice President, Corporate Business Development
Fax: (000) 000-0000
with a copy to:
Wyeth
0 Xxxxxxx Xxxxx
Xxxxxxx, XX 00000
Attn: Executive Vice President and General Counsel
Facsimile: (000) 000-0000
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 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.
11
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.]
12
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:
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Title:
---------------------------------
WYETH
By:
------------------------------------
Name:
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Title:
---------------------------------
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.
REDUCTED 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 Xxxxxxx Healthcare Fund ("XXXXXXX"), ARCH Venture Fund ("ARCH") and
Xxxxx Xxxxxx ("XXXXXX") pursuant to those certain Common Stock Purchase
Agreements dated November 19, 2002 by and between the Company and each of
Xxxxxxx, Arch and Xxxxxx, (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-
[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:
------------------------------------
Xxxxx Xxxxxxxx, M.D., FACP
President and Chief Executive
Officer
SIGNATURE PAGE TO AMENDMENT NO. 1 TO
AMENDED AND RESTATED INVESTOR RIGHTS AGREEMENT
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
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: Xxxxx Xxxxxxx
Title: Managing Member
PROSPECT ASSOCIATES II, L.P.
By: Prospect Management Co. II, LLC
Its General Partner
By:
------------------------------------
Name: Xxxxx Xxxxxxx
Title: Managing Member
SIGNATURE PAGE TO AMENDMENT NO. 1 TO
AMENDED AND RESTATED INVESTOR RIGHTS AGREEMENT
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: Xxxxxx X. Xxxx
Title: Member
Address: 00 Xxxxxxxxxxx Xxxxx
Xxxx 0000
Xxx Xxxx, XX 00000
SIGNATURE PAGE TO AMENDMENT NO. 1 TO
AMENDED AND RESTATED INVESTOR RIGHTS AGREEMENT
REDUCTED 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:
------------------------------------
Xxxx X. Xxxxxx - General Partner
MRNA FUND II L.P.
By: OBP Management IV L.P.
By:
------------------------------------
Xxxx X. Xxxxxx - General Partner
SIGNATURE PAGE TO AMENDMENT NO. 1 TO
AMENDED AND RESTATED INVESTOR RIGHTS AGREEMENT
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"
XXXXXXX HEALTHCARE IV, L.P.
By FHM IV, LP, its general partner
By FHM IV, LLC, its general partner
By:
------------------------------------
Name:
----------------------------------
Its:
-----------------------------------
XXXXXXX AFFILIATES IV, L.P.
By FHM IV, LP, its general partner
By FHM IV, LLC, its general partner
By:
------------------------------------
Name:
----------------------------------
Its:
-----------------------------------
XXXXXXX HEALTHCARE III, L.P.
By FHM III, LLC
By:
------------------------------------
Name:
----------------------------------
Its:
-----------------------------------
XXXXXXX AFFILIATES III, L.P.
By FHM III, LLC
By:
------------------------------------
Name:
----------------------------------
Its:
-----------------------------------
SIGNATURE PAGE TO AMENDMENT NO. 1 TO
AMENDED AND RESTATED INVESTOR RIGHTS AGREEMENT
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:
------------------------------------
Xxxxxxxx Xxxxxx, Manager
SIGNATURE PAGE TO AMENDMENT NO. 1 TO
AMENDED AND RESTATED INVESTOR RIGHTS AGREEMENT
REDUCTED 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:
-----------------------------------
2
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
REDUCTED COPY
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.
***
(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 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. ***
3
EXECUTION COPY
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
