EXHIBIT NO. 10.45
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
EXECUTION VERSION
CONFIDENTIAL
MEDNOSTICS(TM) COLLABORATION AND LICENSE AGREEMENT
between
GENAISSANCE PHARMACEUTICALS, INC.
and
BIOGEN, INC.
dated as of January 31, 2002
CONFIDENTIAL
TABLE OF CONTENTS
PAGE
INTRODUCTION......................................................................................................1
ARTICLE I DEFINITIONS............................................................................................1
1.1. "Affiliate"........................................................................................1
1.2. "[**]".............................................................................................2
1.3. "[**] Diagnostic Product"..........................................................................2
1.4. "BLA"..............................................................................................2
1.5. "Biogen Know-How"..................................................................................2
1.6. "Biogen Patent Rights".............................................................................2
1.7. "Calendar Quarter".................................................................................2
1.8. "Clinical Phenotype"...............................................................................2
1.9. "Collaboration"....................................................................................2
1.10. "Collaboration Period".............................................................................2
1.11. "Collaboration Plan"...............................................................................2
1.12. "Confidential Information".........................................................................2
1.13. "Control" or "Controlled"..........................................................................3
1.14. "FDA"..............................................................................................3
1.15. "FDA-Approved Device"..............................................................................3
1.16. "First Commercial Use".............................................................................3
1.17. "Genaissance Know-How".............................................................................3
1.18. "Genaissance Patent Rights"........................................................................3
1.19. "Gene".............................................................................................3
1.20. "HAP(TM) Marker"...................................................................................4
1.21. "HAP(TM) Marker Association".......................................................................4
1.22. "HAP(TM) Marker Association Patent Rights".........................................................4
1.23. "HAP(TM) Marker Patent Rights".....................................................................4
1.24. "Home-Brew Test"...................................................................................4
1.25. "Improvement(s)"...................................................................................4
1.26. "Indication".......................................................................................4
1.27. "Isogene"..........................................................................................4
1.28. "Know-How".........................................................................................4
1.29. "Locus"............................................................................................4
1.30. "[**] Biogen Product"..............................................................................4
1.31. "Party"............................................................................................4
1.32. "Patent Rights"....................................................................................5
1.33. "Phase I Plan".....................................................................................5
1.34. "Phase I Research Trial"...........................................................................5
1.35. "Phase I Research Trial Term"......................................................................5
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1.36. "Phase II Plan"....................................................................................5
1.37. "Phase II Validation Trial"........................................................................5
1.38. "Phase II Validation Trial Term"...................................................................5
1.39. "Polymorphism".....................................................................................5
1.40. "Program Manager"..................................................................................5
1.41. "[**] Clinical Phenotypes".........................................................................5
1.42. "Surrogate Marker".................................................................................5
1.43. "Territory"........................................................................................6
1.44. "Third Party"......................................................................................6
1.45. "Third Party Diagnostics Partner"..................................................................6
1.46. "Valid Claim"......................................................................................6
1.47. Additional Definitions.............................................................................6
ARTICLE II COLLABORATION.........................................................................................7
2.1. Phase I Research Trial Management and Responsibilities.............................................7
2.2. Phase II Validation Trial Management and Responsibilities..........................................9
2.3. Steering Committee................................................................................10
2.4. Program Managers..................................................................................12
2.5. Informed Consent..................................................................................12
2.6. Regulatory Cooperation............................................................................12
ARTICLE III COMMERCIALIZATION...................................................................................12
3.1. Commercialization of [**] Diagnostic Products.....................................................12
3.2. Product Labeling..................................................................................13
ARTICLE IV GRANTS OF RIGHTS.....................................................................................13
4.1. Grant of Rights...................................................................................13
4.2. Section 365(n) of the Bankruptcy Code.............................................................14
ARTICLE V PAYMENTS..............................................................................................14
5.1. Phase I Research Trial Fees.......................................................................14
5.2. Phase II Validation Trial Fees....................................................................15
5.3. Milestone Payments................................................................................15
5.4. Test Fees for [**] Diagnostic Products............................................................16
5.5. Payment Provisions................................................................................18
5.6. Withholding Taxes.................................................................................19
5.7. Currency Exchange.................................................................................19
5.8. Interest on Late Payments.........................................................................19
5.9. Manner of Payment.................................................................................19
ARTICLE VI INTELLECTUAL PROPERTY................................................................................19
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6.1. Ownership of Inventions...........................................................................19
6.2. Prosecution and Maintenance of Patent Rights......................................................20
6.3. Third Party Infringement..........................................................................22
6.4. Claimed Infringement..............................................................................25
6.5. Patent Marking....................................................................................25
ARTICLE VII CONFIDENTIALITY.....................................................................................25
7.1. Nondisclosure and Non-Use Obligations.............................................................25
7.2. Injunctive Relief.................................................................................26
7.3. Publication.......................................................................................26
ARTICLE VIII REPRESENTATIONS AND WARRANTIES; LIMITATION OF LIABILITY............................................27
8.1. Representations and Warranties of Genaissance.....................................................27
8.2. Representations and Warranties of Biogen..........................................................28
8.3. Transamerica Loan.................................................................................29
8.4. Warranty Disclaimer...............................................................................29
8.5. Disclaimer of Consequential Damages...............................................................29
ARTICLE IX INDEMNITY............................................................................................30
9.1. Biogen Indemnity Obligations......................................................................30
9.2. Genaissance Indemnity Obligations.................................................................30
9.3. Limitation on Indemnity Obligations...............................................................30
9.4. Procedure.........................................................................................30
ARTICLE X TERM AND TERMINATION..................................................................................31
10.1. Term of Agreement.................................................................................31
10.2. Termination.......................................................................................31
10.3. Effect of Termination.............................................................................31
10.4. Surviving Provisions..............................................................................32
ARTICLE XI MISCELLANEOUS........................................................................................32
11.1. Force Majeure.....................................................................................32
11.2. Assignment........................................................................................33
11.3. Severability......................................................................................33
11.4. Notices...........................................................................................33
11.5. Applicable Law....................................................................................34
11.6. Dispute Resolution................................................................................34
11.7. Entire Agreement..................................................................................34
11.8. Publicity.........................................................................................34
11.9. Headings..........................................................................................35
11.10. No Partnership; Independent Contractors...........................................................35
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11.11. Exports...........................................................................................35
11.12. Waiver............................................................................................35
11.13. Counterparts......................................................................................36
11.14. No Strict Construction............................................................................37
Exhibits
Exhibit A [**]
Exhibit B Gene Criteria
Exhibit C Phase I Plan
Exhibit D [**] Clinical Phenotypes
Exhibit E Phase I Research Trial Correlation Definition
Exhibit F Molecular Pathway
Exhibit G [**]
Exhibit H Press Release
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MEDNOSTICS(TM)
COLLABORATION AND LICENSE AGREEMENT
THIS MEDNOSTICS(TM)
COLLABORATION AND LICENSE AGREEMENT (this
"Agreement") is dated as of January 31, 2002 (the "Effective Date") and is made
by and between BIOGEN, INC., a Massachusetts corporation having its principal
place of business at 00 Xxxxxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx 00000
("Biogen") and GENAISSANCE PHARMACEUTICALS, INC., a
Delaware corporation having
its principal place of business at Xxxx Xxxxxxx Xxxx, Xxx Xxxxx, Xxxxxxxxxxx
00000 ("Genaissance").
INTRODUCTION
1. Genaissance has expertise in discovering markers of genetic
variation and correlating such markers with drug response and in conducting
clinical genetics studies.
2. Biogen is currently developing [**] for a biologic called [**] for
the treatment of [**].
3. Biogen wishes to collaborate with Genaissance on a study of the
pharmacogenetic basis of variability in response to [**], and to obtain access
to certain pharmacogenetic findings of such research for potential use in
connection with marketing [**].
4. Genaissance is willing to grant Biogen such access and to
collaborate with Biogen in analyzing the results of such research, upon the
terms and conditions set forth in this Agreement.
5. Biogen is interested in obtaining, and Genaissance is willing to
grant to Biogen, certain licenses to use certain markers to develop diagnostic
tests for use in connection with marketing [**] in accordance with the terms of
this Agreement.
6. Biogen and Genaissance are also interested in whether the research
undertaken pursuant to this Agreement could lead to further pharmacogenetic
research with respect to use of [**] for new therapeutic indications.
NOW THEREFORE, Biogen and Genaissance agree as follows:
ARTICLE I
DEFINITIONS
For purposes of this Agreement, the terms defined in this Article I
shall have the meanings specified below:
1.1. "AFFILIATE". Affiliate means any corporation or other entity which
directly or indirectly controls, is controlled by or is under common control
with a Party. A corporation or other entity shall be regarded as in control of
another corporation or entity if it owns or directly or indirectly controls more
than fifty percent (50%) of the outstanding voting stock or other ownership
interest of the other corporation or entity, or if it possesses, directly or
indirectly, the
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power to manage, direct or cause the direction of the management
and policies of the corporation or other entity or the power to elect or appoint
fifty percent (50%) or more of the members of the governing body of the
corporation or other entity. Any such other relationship as in fact results in
actual control over the management, business and affairs of a corporation or
other entity shall also be deemed to constitute control.
1.2. [**] means [**] as more fully described in EXHIBIT A to this
Agreement.
1.3. "[**] DIAGNOSTIC PRODUCT". [**] Diagnostic Product means any
product or service that (a) is intended for use in the prognosis of an
individual's response to [**] as the basis for prescribing [**] and (b) detects
directly or indirectly (i) one or more HAP(TM) Markers referenced in a HAP(TM)
Marker Association licensed by Genaissance to Biogen or (ii) one or more
Surrogate Markers of such HAP(TM) Marker(s) referenced in subsection 1.3 (b)(i).
1.4. "BLA". BLA means (a) (i) a Biologics License Application or New
Drug Application submitted to the FDA or any successor application or procedure
and (ii) any foreign equivalent of a Biologics License Application or New Drug
Application, and (b) all supplements and amendments, including supplemental
Biologics License Applications or New Drug Applications (and any foreign
equivalents), that may be filed with respect to the foregoing.
1.5. "BIOGEN KNOW-HOW". Biogen Know-How means Know-How Controlled by
Biogen that relates to [**].
1.6. "BIOGEN PATENT RIGHTS". Biogen Patent Rights means Patent Rights
Controlled by Biogen that claim the making, using or selling of [**].
1.7. "CALENDAR QUARTER". Calendar Quarter means each successive period
of three (3) months beginning on the first day of January, April, July and
October.
1.8. "CLINICAL PHENOTYPE". Clinical Phenotype means [**] in the
treatment of any disease or condition.
1.9. "COLLABORATION". Collaboration means those activities to be
undertaken by the Parties under the Phase I Research Trial and Phase II
Validation Trial.
1.10. "COLLABORATION PERIOD". Collaboration Period means the period of
time beginning with the Effective Date until the later of (a) the end of the
Phase I Research Trial Term, or (b) the end of the Phase II Validation Trial
Term, if any, in each case unless earlier terminated as provided in Article X.
1.11. "COLLABORATION PLAN". Collaboration Plan means the Phase I Plan
and the Phase II Plan, if any.
1.12. "CONFIDENTIAL INFORMATION". Confidential Information means (a)
any information, inventions, copyrights, trade secrets, data or materials,
whether patentable or not, received by a Party from the other Party in
connection with the performance of this Agreement (and which, in
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the case of Biogen as recipient, shall include, without limitation, Genaissance
Know-How, and the results of the Phase I Research Trial and the Phase II
Validation Trial (excluding any information described in clause (c) below), and
which, in the case of Genaissance as recipient, shall include, without
limitation, Biogen Know-How and any information and data relating to Biogen's
research and development efforts and any research, testing, clinical,
regulatory, marketing or other scientific or business information, plans or data
pertaining to any product of Biogen), (b) all information and data not described
in clause (a) but supplied by either Party in connection with this Agreement,
and (c) notwithstanding the foregoing, all HAP(TM) Marker Associations shall be
considered Biogen Confidential Information.
1.13. "CONTROL" OR "CONTROLLED". Control or Controlled means with
respect to any compound, biomaterial, information or intellectual property
right, that the applicable Party, in whole or in part, owns or has a license to
such compound, biomaterial, information or intellectual property right and, if
applicable, has the ability to grant access, covenant against suit, or a license
(or a sublicense) without violating the terms of any agreement or other
arrangements with any Third Party existing at the time such Party would be first
required to grant such access, covenant, license or sublicense.
1.14. "FDA". FDA means the United States Food and Drug Administration
or any successor agency with responsibilities comparable to those of the United
States Food and Drug Administration.
1.15. "FDA-APPROVED DEVICE". FDA-Approved Device means an [**]
Diagnostic Product that has (a) received market clearance under the 510(k)
premarket notification process of the FDA, (b) received premarket approval from
the FDA, or (c) been approved for marketing by a regulatory authority or agency
of a country other than the United States with responsibilities comparable to
those of the FDA.
1.16. "FIRST COMMERCIAL USE". First Commercial Use shall mean, on a
country-by-country basis, the first use or consumption for the benefit of the
general public of an [**] Diagnostic Product in a country. Use related [**] or
similar use shall not be considered or constitute a First Commercial Use.
1.17. "GENAISSANCE KNOW-HOW". Genaissance Know-How means Know-How
Controlled by Genaissance that is either developed in the course of the
Collaboration or is necessary for the performance of the Collaboration as
reasonably determined by Genaissance.
1.18. "GENAISSANCE PATENT RIGHTS". Genaissance Patent Rights means
Patent Rights Controlled by Genaissance that claim Genaissance Know-How,
including without limitation, the HAP(TM) Marker Patent Rights and HAP(TM)
Marker Association Patent Rights.
1.19. "GENE". Gene means a nucleic acid sequence (including allelic
variations thereof) that (a) encodes a designated protein, and (b) satisfies the
criteria set forth in EXHIBIT B attached hereto.
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1.20. "HAP(TM) MARKER". HAP(TM) Marker means any Polymorphism or any
ordered combination of two or more Polymorphisms present at a Locus on a single
chromosome in a Gene selected for the Phase I Research Trial.
1.21. "HAP(TM) Marker Association". HAP(TM) Marker Association means a
statistically significant (i.e. p = or < 0.05) correlation between a Clinical
Phenotype and a specific HAP(TM) Marker or a specific combination of HAP(TM)
Markers.
1.22. "HAP(TM) MARKER ASSOCIATION PATENT RIGHTS". HAP(TM) Marker
Association Patent Rights means Patent Rights that claim a HAP(TM) Marker
Association discovered during the Collaboration Period or the use thereof.
1.23. "HAP(TM) MARKER PATENT RIGHTS". HAP(TM) Marker Patent Rights
means Patent Rights that claim a HAP(TM) Marker or the use thereof.
1.24. "HOME-BREW TEST". Home-Brew Test means an [**] Diagnostic Product
that (a) is sold or licensed solely to laboratories that are certified under the
Clinical Laboratory Improvement Amendments of 1988, as subsequently amended, and
implementing regulations, and (b) has not been approved by applicable regulatory
authorities.
1.25. "IMPROVEMENT(S)". Improvement(s) means any modifications
(including mutants, derivatives and mimetics) of [**] that are Controlled by
Biogen.
1.26. "INDICATION". Indication means a disease or condition for which
[**] is approved for use by the FDA or a regulatory authority or agency of a
country other than the United States with responsibilities comparable to those
of the FDA. For purposes hereof, [**] shall be [**] the FDA or other regulatory
authority or agency.
1.27. "ISOGENE". Isogene means an allelic variant of a Gene that is
defined by a HAP(TM) Marker.
1.28. "KNOW-HOW". Know-How means any information, inventions,
copyrights, trade secrets, regulatory submissions, data or materials, whether
patentable or not, including, without limitation, biological materials (such as
cell lines, DNA, DNA fragments, RNA, RNA fragments, organisms, proteins,
polypeptides, plasmids, vectors, fragments of such proteins, polypeptides,
plasmids and vectors, and derivatives, progeny and variants of all of the
foregoing) and intellectual property of any kind, other than Patent Rights.
1.29. "LOCUS". Locus means a location on a chromosome corresponding to
a Gene or a physical or phenotypic feature.
1.30. "[**] BIOGEN PRODUCT". [**] Biogen Product means any biologic or
drug product other than [**] that is Controlled by Biogen.
1.31. "PARTY". Party means Biogen or Genaissance; "PARTIES" means
Biogen and Genaissance.
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1.32. "PATENT RIGHTS". Patent Rights means (a) any United States or
foreign patent application, (b) any United States patent or foreign patent
issuing from such patent application and (c) any continuation,
continuation-in-part (to the extent the claims in such
continuation-in-part-application are directed to subject matter specifically
described in such prior patent application), divisional, reissue,
re-examination, renewal, substitution, addition, extension, supplementary
protection certificate or foreign counterpart thereof of any of the foregoing.
1.33. "PHASE I PLAN". Phase I Plan means the plan for the Phase I
Research Trial set forth on EXHIBIT C to this Agreement, as such plan may be
modified from time to time pursuant to Section 2.1.2, which sets forth the
genetic, clinical and statistical parameters for the Phase I Research Trial.
1.34. "PHASE I RESEARCH TRIAL". Phase I Research Trial means the study
to be undertaken by Genaissance pursuant to Section 2.1 to discover HAP(TM)
Marker Association(s) for [**] Clinical Phenotypes.
1.35. "PHASE I RESEARCH TRIAL TERM". Phase I Research Trial Term
means the period commencing on the Effective Date and ending on the earlier
of (a) [**]following the delivery of the Phase I Research Trial Report in
accordance with Section 2.1.3(e) or (b) the termination of this Agreement
pursuant to Article X.
1.36. "PHASE II PLAN". Phase II Plan means the plan for the Phase II
Validation Trial to be developed by the Parties pursuant to Section 2.2.3.
1.37. "PHASE II VALIDATION TRIAL". Phase II Validation Trial means the
study to be undertaken by Genaissance pursuant to Section 2.2.
1.38. "PHASE II VALIDATION TRIAL TERM". Phase II Validation Trial Term
means the period commencing upon the delivery by Biogen of the notice of its
intent to proceed with the Phase II Validation Trial pursuant to Section 2.2.1
and ending on the earlier of (a) the delivery of the Phase II Validation Trial
Report in accordance with Section 2.2.4(d) or (b) the termination of this
Agreement pursuant to Article X.
1.39. "POLYMORPHISM". Polymorphism means any alternative sequence found
at a given position in a chromosome within a population including, but not
limited to: (a) single nucleotide polymorphisms; (b) insertions and deletions of
one or more nucleotides; (c) repeats of one or more nucleotides; and (d)
restriction fragment length polymorphisms.
1.40. "PROGRAM MANAGER". Program Manager means the research scientist
appointed by a Party to serve as such Party's principal coordinator and liaison
for the Collaboration.
1.41. "[**] CLINICAL PHENOTYPES" . [**] Clinical Phenotypes means
Clinical Phenotypes of [**] to [**] in the treatment of [**] that are defined in
EXHIBIT D.
1.42. "SURROGATE MARKER". Surrogate Marker means any biomolecule
(including but not limited to Polymorphisms, proteins, sugars, and lipids) or
chemical compound (including but not
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limited to drugs and metabolites thereof), where the absence, presence, or
quantity of such biomolecule or chemical compound in an individual is measurable
and correlated to a statistically robust degree with the presence of one or more
HAP(TM) Markers referenced in a HAP(TM) Marker Association.
1.43. "TERRITORY". Territory means all countries of the world.
1.44. "THIRD PARTY". Third Party means any entity other than the
Parties or their respective Affiliates.
1.45. "THIRD PARTY DIAGNOSTICS PARTNER". Third Party Diagnostics
Partner means any Third Party that enters into an agreement with Biogen for the
grant to such Third Party of rights for the development and/or commercialization
of an [**] Diagnostics Product, including sublicensees of Biogen under HAP(TM)
Marker Patent Rights or HAP(TM) Marker Association Patent Rights.
1.46. "VALID CLAIM". Valid Claim means either (a) a claim of a pending
patent application which claim was filed in good faith and has not been
abandoned or finally disallowed without the possibility of appeal or refiling of
said patent application or (b) a claim of an issued and unexpired patent which
has not been held permanently revoked, unenforceable or invalid by a decision of
a court or other governmental agency of competent jurisdiction, unappealable or
unappealed within the time allowed for appeal. Notwithstanding the foregoing, if
a claim of a patent application has not issued as a claim of an issued patent
within the Patent Rights within seven (7) years after the filing date from which
such claim takes priority, such pending claim shall cease to be a Valid Claim
for purposes of this Agreement unless and until such claim becomes an issued
claim of an issued patent within the Patent Rights.
1.47. ADDITIONAL DEFINITIONS. Each of the following definitions is set
forth in the Section of this Agreement indicated below:
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DEFINED TERM SECTION
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Agreement Preamble
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[**] Net Sales 5.4.2
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Average Selling Price 5.4.3
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Biogen Preamble
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Biogen Inventions 6.1.2
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Breaching Party 10.2.2
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Commercially reasonable efforts 2.6
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Deemed Test Fee Sales Base 5.4.3
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Effective Date Preamble
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Exons Exhibit B
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Exon/Intron Junction Exhibit B
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Genaissance Inventions 6.1.1
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Genaissance Preamble
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Indemnitee 9.4
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Indemnitor 9.4
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Index Repository Exhibit B
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Initial Installment 5.2.2(a)(ii)
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Introns Exhibit B
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Invalidity Claim 6.3.6
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Joint Inventions 6.1.3
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Loan and Security Agreement 8.3
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Messenger RNA Exhibit B
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Off Label Uses 5.4.4
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Non-Breaching Party 10.2.2
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Non-Required Diagnostic 5.4.1
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Party Representatives 11.6
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Patent Prosecution 6.2
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Phase I Research Trial Report 2.1.3(e)
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Phase II Patient 5.2.2(a)
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Phase II Validation Trial Report 2.2.4(d)
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Promoter Exhibit B
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Related Third Party Payments 5.4.8
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Required Diagnostic 5.4.2
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SEC 11.8.1
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SNPs Exhibit B
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Steering Committee 2.3.1
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Test Ratio 5.4.4
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Third Party Claim 6.4
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Three-Prime Untranslated Region Exhibit B
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Transamerica 8.3
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Transamerica Note 8.3
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ARTICLE II
COLLABORATION
2.1. Phase I Research Trial Management and Responsibilities.
2.1.1 PHASE I OBJECTIVES. The objective of the Phase I Research
Trial is for Genaissance to [**] Genes selected by Biogen in accordance with
Section 2.1.3(c) and [**] patient samples to establish HAP(TM) Marker
Associations for [**] Clinical Phenotypes as defined in EXHIBIT D. The
statistically robust criteria required for such HAP(TM) Marker Associations for
purposes of the Phase I Plan is set forth in EXHIBIT E.
2.1.2 PHASE I PLAN. The Parties shall undertake the Phase I
Research Trial in accordance with the Phase I Plan. The Program Managers shall
review the Phase I Plan on at
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least a monthly basis and submit any proposed updates or amendments to the
Steering Committee (as hereinafter defined) for its approval, as well as
proposed revised research goals. Any such updates or amendments or revised
research goals shall not become effective until approved by the Steering
Committee. The Steering Committee shall review and consider any such proposed
updates or amendments or revised research goals on a reasonably expeditious
basis.
2.1.3 RESPONSIBILITIES.
(a) GENERAL. Each Party agrees to use commercially
reasonable efforts to (i) undertake the responsibilities assigned to such Party
in the Phase I Plan, including, but not limited to, the dedication of laboratory
facilities, equipment and personnel appropriate to such efforts; (ii) perform
its obligations hereunder in good faith in a scientific and commercially
reasonable and workmanlike manner; (iii) as appropriate, make available to the
other Party those resources set forth in the Phase I Plan; and (iv) carry out
all work done in the course of the Phase I Research Trial in material compliance
with all applicable federal, state or local laws, regulations and guidelines
governing the conduct of such work.
(b) GENAISSANCE RESPONSIBILITIES. Genaissance shall use
commercially reasonable efforts to perform those activities set forth in the
Phase I Plan which are to be undertaken by Genaissance in connection with the
Phase I Research Trial, including, but not limited to: (i) discovering HAP(TM)
Markers and HAP(TM) Marker Associations for [**] Genes selected by Biogen in
accordance with subsection (c) below; (ii) preparing, filing, prosecuting and
maintaining HAP(TM) Marker Patent Rights and HAP(TM) Marker Association Patent
Rights, as further provided in Article VI; (iii) providing such support as is
reasonably required by Biogen in order for Biogen to perform its
responsibilities under this Section 2.1.3; and (iv) preparing documentation
necessary to the Collaboration.
(c) BIOGEN RESPONSIBILITIES. Biogen shall use commercially
reasonable efforts to perform those activities set forth in the Phase I Plan
which are to be undertaken by Biogen in connection with the Phase I Research
Trial, including, but not limited to; (i) selecting [**] Genes for which
Genaissance shall discover HAP(TM) Markers in accordance with the Phase I Plan;
(ii) supplying to Genaissance by the date set forth in the Phase I Plan (EXHIBIT
C) blood (or DNA) samples and related clinical data for [**] in accordance with
the protocols established in the Phase I Plan and the informed consents required
under Section 2.5; (iii) preparing, filing, prosecuting and maintaining HAP(TM)
Marker Patent Rights and HAP(TM) Marker Association Patent Rights, as further
provided in Article VI; (iv) providing such support as is reasonably required by
Genaissance in order for Genaissance to perform its responsibilities under this
Section 2.1.3; and (v) preparing documentation necessary to the Collaboration.
(d) ADDITIONAL GENES. In the event that either (i)
Genaissance deems it necessary to generate a more robust correlation, or (ii)
Genaissance and Biogen mutually deem it necessary to generate a correlation
sufficient to meet generally accepted scientific standards, Genaissance will
[**] discover HAP(TM) Markers for [**] Genes [**] and measure such additional
HAP(TM) Markers in patient samples.
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(e) PHASE I RESEARCH TRIAL REPORT. Genaissance shall prepare
and deliver to Biogen a written summary report in a mutually-agreed format
setting forth in reasonable detail Genaissance's findings with respect to its
research regarding HAP(TM) Marker Associations in the Phase I Research Trial
(the "Phase I Research Trial Report"), which shall include all HAP(TM) Marker
Associations for [**] Clinical Phenotypes that meet the statistical significance
set forth in EXHIBIT E. At Biogen's request and at mutually-agreed times,
Genaissance shall (i) meet with Biogen to discuss the Phase I Research Trial
Report and its findings, and (ii) provide to Biogen access to statistical data
and analyses generated by Genaissance in the Phase I Research Trial.
(f) PHASE I RESEARCH TRIAL EVALUATION. If Genaissance
reasonably determines after complying with Sections 2.1.3(b) and 2.1.3(d) that
it is unable to identify any HAP(TM) Marker Association for a [**] Clinical
Phenotype, Genaissance shall provide written notice to Biogen of such
determination and the Parties shall mutually determine in good faith a proper
course of action.
2.2. PHASE II VALIDATION TRIAL MANAGEMENT AND RESPONSIBILITIES.
2.2.1 NOTICE. Within [**] days after the receipt by Biogen of the
Phase I Research Trial Report, Biogen shall provide written notice to
Genaissance if it intends to proceed with the Phase II Validation Trial. In the
event that Biogen provides such notice to Genaissance within such [**] day
period, the Parties agree to undertake the Phase II Validation Trial, subject to
definition by the Steering Committee within [**] days after delivery of such
notice of the detailed objectives for the Phase II Validation Trial.
2.2.2 PHASE II OBJECTIVES. The objectives of the Phase II
Validation Trial shall be to (a) validate the HAP(TM) Marker Associations
discovered in the Phase I Research Trial, and (b) develop a Home-Brew Test. The
Parties agree that the Phase II Validation Trial shall use an appropriate
clinical trial planned and controlled by Biogen and that further details for
each of these objectives, including but not limited to the statistically robust
criteria for validation of the HAP(TM) Marker Associations discovered in the
Phase I Research Trial, will be defined by the Steering Committee within the
time period set forth in Section 2.2.1. Genaissance acknowledges that Biogen has
the right to add adverse event data collected in the Phase II Validation Trial
to the Biogen clinical safety database for [**].
2.2.3 PHASE II PLAN. The Parties shall undertake the Phase II
Validation Trial in accordance with the Phase II Plan. The Program Managers
shall review the Phase II Plan on at least a monthly basis and submit any
proposed updates or amendments to the Steering Committee for its review. Any
such updates or amendments shall not become effective until approved by the
Steering Committee. The Steering Committee shall review and consider any such
proposed updates or amendments or revised research goals on a reasonably
expeditious basis.
2.2.4 RESPONSIBILITIES.
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(a) GENERAL. Each Party agrees to use commercially
reasonable efforts to (i) undertake the responsibilities assigned to such Party
in the Phase II Plan, including, but not limited to, the dedication of
laboratory facilities, equipment and personnel appropriate to such efforts; (ii)
perform its obligations hereunder in good faith in a scientific and commercially
reasonable and workmanlike manner; (iii) as appropriate, make available to the
other Party those resources set forth in the Phase II Plan; and (iv) carry out
all work done in the course of the Phase II Validation Trial in material
compliance with all applicable federal, state or local laws, regulations and
guidelines governing the conduct of such work.
(b) GENAISSANCE RESPONSIBILITIES. Genaissance shall use
commercially reasonable efforts to perform those activities set forth in the
Phase II Plan which are to be undertaken by Genaissance in connection with the
Phase II Validation Trial, including, but not limited to: (i) validating the
HAP(TM) Marker Associations; (ii) developing a Home-Brew Test; (iii) preparing,
filing, prosecuting and maintaining HAP(TM) Marker Patent Rights and HAP(TM)
Marker Association Patent Rights covering such Home-Brew Test, as further
provided in Article VI; (iv) providing such support as is reasonably required by
Biogen in order for Biogen to perform its responsibilities under this Section
2.2.4, and (v) providing documentation necessary to the Collaboration.
(c) BIOGEN RESPONSIBILITIES. Biogen shall use commercially
reasonable efforts to perform those activities set forth in the Phase II Plan
which are to be undertaken by Biogen in connection with the Phase II Validation
Trial, including, but not limited to: (i) supplying to Genaissance blood (or
DNA) samples and related clinical data for a mutually determined number of
patients (not to exceed [**] patients) in accordance with the protocols
established in the Phase II Plan and the informed consents required under
Section 2.5; (ii) preparing, filing, prosecuting and maintaining HAP(TM) Marker
Patent Rights and HAP(TM) Marker Association Patent Rights covering such
Home-Brew Test, as further provided in Article VI; (iii) providing such support
as is reasonably required by Genaissance in order for Genaissance to perform its
responsibilities under this Section 2.2.4; and (iv) preparing documentation
necessary to the Collaboration.
(d) PHASE II VALIDATION TRIAL REPORT. Genaissance shall
prepare and deliver to Biogen a written summary report in a mutually-agreed
format setting forth Genaissance's findings with respect to validation of
HAP(TM) Marker Associations and the development of a Home-Brew Test (the "Phase
II Validation Trial Report"), which will include (i) all HAP(TM) Marker
Associations for [**] Clinical Phenotypes, and (ii) all significant steps taken
and results achieved by Genaissance in its development of the Home-Brew Test. At
Biogen's request and at mutually-agreed times, Genaissance shall (i) meet with
Biogen to discuss the Phase II Validation Trial Report and its findings; and
(ii) provide to Biogen access to statistical data and analyses generated by
Genaissance in the Phase II Validation Trial.
2.3. STEERING COMMITTEE.
2.3.1 FORMATION AND COMPOSITION. A joint committee comprised of
three representatives of each of Biogen and Genaissance, one to be the Program
Manager and at least
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one to be director level or above (the "Steering Committee") shall be appointed
by the Parties within thirty (30) days after the Effective Date. The Steering
Committee shall meet as needed, but not fewer than once each Calendar Quarter
during the Collaboration Period. The Steering Committee shall, if requested by a
Party, meet within thirty (30) days after the request of such Party to act upon
any matter requiring action by the Steering Committee for approval. Meetings
shall be at such times agreed to by Biogen and Genaissance and shall alternate
between Genaissance's office in New Haven, Connecticut and Biogen's office in
Cambridge, Massachusetts unless the Parties otherwise agree or shall be in such
other form (e.g., telephone or video conference) as the members of the Steering
Committee shall agree. Each Party shall bear any expenses of its representatives
in connection with Steering Committee participation. The Steering Committee
shall remain in operation during the Collaboration Period unless otherwise
agreed by the Parties. A Party may change one or more of its representatives to
the Steering Committee at any time upon written notice to the other Party. The
Parties may mutually agree to change the number of representatives which
comprises the Steering Committee. Either Party may permit additional employees
and consultants to attend and participate (on a non-voting basis) in the
Steering Committee meetings, subject to the confidentiality provisions of
Article VII.
2.3.2 STEERING COMMITTEE FUNCTIONS AND POWERS. The Steering
Committee shall be responsible for the overall supervision and management of the
Collaboration. In particular, the Steering Committee shall:
(a) monitor and evaluate the status and progress of the
Collaboration;
(b) approve any material modifications to the Collaboration
Plan;
(c) define joint processes to manage the Collaboration and
exchange data;
(d) define the Home-Brew Test specifications pursuant to
Section 2.2.2;
(e) define the statistically robust criteria for HAP(TM)
Marker Associations pursuant to Section 2.2.2; and
(f) resolve operational disputes between the Parties.
2.3.3 DECISIONS OF THE STEERING COMMITTEE. All decisions of
the Steering Committee shall be made by unanimous vote of the representatives of
the Parties, with each Party's representatives collectively having one vote. If
the Steering Committee is unable to reach agreement on any matter referred to it
for resolution within thirty (30) days after the matter is referred to it, such
matter shall be referred to the Party Representatives and shall thereafter be
subject to Section 11.6.
2.3.4 MINUTES AND REPORTS. The Steering Committee shall be
responsible for keeping accurate minutes of its deliberations which record all
proposed decisions and all actions recommended or taken. Within ten (10)
business days after each meeting, the Party which hosted the meeting shall
provide the other Party with draft minutes of such meeting, including a
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summary of all actions taken at such meeting. Within thirty (30) days after each
meeting, the co-chairs will sign final versions of the meeting minutes and such
minutes shall thereafter be recognized as duly accepted by the Parties. All
records of the Steering Committee shall be distributed to and available to both
Parties.
2.4. PROGRAM MANAGERS. Genaissance and Biogen shall each appoint a
Program Manager prior to the Effective Date. Each Party shall have the right to
designate a different Program Manager at any time. The Program Managers shall
jointly oversee the conduct of the Phase I Research Trial and Phase II
Validation Trial and shall be responsible for, among other things, recommending
to the Steering Committee any updates and amendments to the Phase I Plan and
Phase II Plan. The Program Managers shall confer with each other on a regular
basis, and each shall keep the other reasonably and candidly informed of all
developments in the course of the Collaboration.
2.5. INFORMED CONSENT. Biogen will be responsible for obtaining all
necessary consents with respect to blood (or DNA) samples and related clinical
data to be supplied to Genaissance by Biogen for use in the Phase I Research
Trial and Phase II Validation Trial.
2.6. REGULATORY COOPERATION. Biogen and Genaissance may agree to
disclose Confidential Information, including HAP(TM) Marker Associations, in
filings for regulatory approval. Genaissance shall make commercially reasonable
efforts to assist Biogen in the filing of Biogen's application for FDA and
European Union approval of, or submission of premarket notification for, an [**]
Diagnostic Product. For purposes of this Section 2.6, the term "commercially
reasonable efforts" means providing Biogen with all documents and other
materials necessary for such application or submission, and such other
reasonable assistance as Biogen may request.
ARTICLE III
COMMERCIALIZATION
3.1. COMMERCIALIZATION OF [**] DIAGNOSTIC PRODUCTS.
3.1.1 OVERVIEW. During the term of this Agreement and after the
termination of this Agreement, [**] (a) whether or not any [**] Diagnostic
Product shall be commercialized, (b) the manner in which any [**] Diagnostic
Product shall be manufactured, marketed, promoted, sold and distributed, and (c)
whether or not the commercialization of any [**] Diagnostic Product shall be
terminated.
3.1.2 HOME-BREW TEST. If Biogen elects to commercialize a
Home-Brew Test, such test may be provided, at Biogen's election, either through
Genaissance, a Third Party Diagnostics Partner, or both. If Biogen elects to
commercialize the Home-Brew Test with Genaissance, the Parties shall enter into
a separate commercialization agreement, the terms of which shall be reasonable
and customary. If Biogen elects to commercialize the Home-Brew Test through
Genaissance and [**] the Parties agree to cooperate reasonably in connection
with
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the commercialization of any Home-Brew Test, and jointly support such
commercialization efforts upon terms to be negotiated in good faith.
3.1.3 FDA-APPROVED DEVICE. Biogen shall determine in its sole
discretion whether to develop and commercialize an FDA-Approved Device. If
Biogen decides to develop and commercialize an FDA-Approved Device, Biogen
agrees to consult with Genaissance regarding potential Third Party Diagnostic
Partners for any such commercialization. Notwithstanding the foregoing, Biogen
shall select such Third Party Diagnostic Partner in its sole discretion, and
shall enter into a commercialization agreement with such Third Party Diagnostic
Partner that contains reasonable and customary terms.
3.2. PRODUCT LABELING. In so far as is permitted by the relevant
regulatory authorities, the Genaissance name and logo shall each be prominently
and conspicuously displayed on the primary panel of any [**] Diagnostic Product
packaging, in reasonable relation to the size of the Biogen name and logo. In so
far as is permitted by the relevant regulatory authorities, all labeling,
written and electronic materials associated with the [**] Diagnostic Product
shall indicate that the [**] Diagnostic Product was developed with the use of
Genaissance technology. Genaissance shall grant Biogen an appropriate trademark
license for such purpose and either Genaissance or an Affiliate designated by
Genaissance shall have the right to monitor the quality of such [**] Diagnostic
Product in accordance with reasonable procedures to be agreed upon by the
Parties.
ARTICLE IV
GRANTS OF RIGHTS
4.1. GRANT OF RIGHTS.
4.1.1 COMMERCIALIZATION LICENSES. Subject to the terms and
conditions of this Agreement, Genaissance hereby grants to Biogen an
exclusive, fee-bearing license in the Territory, with the right to grant
sublicenses only to the extent provided in Section 4.1.4, under Genaissance
Know-How and Genaissance Patent Rights, to (a) use the HAP(TM) Marker
Associations and the HAP(TM) Markers referenced in such HAP(TM) Marker
Associations and (b) develop, make, have made, use, sell, have sold, offer to
sell, import and have imported [**] Diagnostic Products, Isogenes defined by
the HAP(TM) Markers referenced in such HAP(TM) Marker Associations, and any
fragment or other nucleic acid composition sufficient to specifically
identify any of these Isogenes, in each of case (a) and (b), solely for the
purposes of (i) identifying HAP(TM) Marker Associations for Clinical
Phenotypes including the [**] Clinical Phenotypes; and (ii) developing and
commercializing [**] for the treatment of any disease.
4.1.2 RESEARCH LICENSE. Subject to the terms and conditions of
this Agreement, Genaissance hereby grants to Biogen a [**] license in the
Territory, without the right to grant sublicenses, under Genaissance Know-How
and Genaissance Patent Rights, to (a) use the HAP(TM) Marker Associations and
the HAP(TM) Markers referenced in such HAPtm Marker Associations and (b) make
and use [**] Diagnostic Products, Isogenes defined by the HAP(TM) Markers
referenced in such HAP(TM) Marker Associations, and any fragment or other
nucleic acid composition
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sufficient to specifically identify any of these Isogenes, in each case (a) and
(b), solely for internal research with respect to, and the development of, any
biologic and/or drug other than [**]. The term of such license shall commence
upon the end of the Phase I Research Trial Term [**].
4.1.3 EXCLUSIVE COMMERCIALIZATION OPTION. Subject to the terms and
conditions of this Agreement, Genaissance hereby grants to Biogen an [**] option
to acquire an [**] license in the Territory, under Genaissance Know-How and
Genaissance Patent Rights, to (a) use the HAP(TM) Marker Associations and/or the
HAP(TM) Markers referenced in such HAP(TM) Marker Associations that (i) are
referenced in HAP(TM) Marker Associations for [**] Clinical Phenotypes, and (ii)
are in any [**], and (b) make and use Isogenes defined by the HAP(TM) Markers
referenced in subpart (a) of this Section 4.1.3 and any fragment or other
nucleic acid composition sufficient to specifically identify any of these
Isogenes, in each case (a) and (b) solely for developing and commercializing
[**] Biogen Products. Such option shall become operative upon the end of the
Phase I Research Trial Term and shall remain in effect [**]. The terms of any
such license shall be commercially reasonable and negotiated in good faith by
the Parties.
4.1.4 SUBLICENSES. Biogen shall have the right to grant
sublicenses of the rights granted to Biogen pursuant to Section 4.1.1 solely for
use in connection with the development and/or marketing of the applicable
HAP(TM) Marker Association, HAP(TM) Marker, Isogene and/or [**] Diagnostic
Product, PROVIDED, THAT each sublicensee shall execute a written agreement
pursuant to which it assumes the applicable obligations of Biogen hereunder.
Biogen shall provide a copy of any such sublicense agreement to Genaissance
within [**] days after execution.
4.2. SECTION 365(n) OF THE BANKRUPTCY CODE. All rights and licenses
granted under or pursuant to any section of this Agreement are, and shall
otherwise be deemed to be, for purposes of Section 365(n) of the Bankruptcy
Code, licenses of rights to "intellectual property" as defined under Section
101(35A) of the Bankruptcy Code. The Parties shall retain and may fully exercise
all of their respective rights and elections under the Bankruptcy Code. Upon the
bankruptcy of any Party, the non-bankrupt Party shall further be entitled to a
complete duplicate of (or complete access to, as appropriate) any such
intellectual property, and such, if not already in its possession, shall be
promptly delivered to the non-bankrupt Party, unless the bankrupt Party elects
to continue, and continues, to perform all of its obligations under this
Agreement.
ARTICLE V
PAYMENTS
5.1. PHASE I RESEARCH TRIAL FEES.
5.1.1 INITIAL FEE. Biogen shall pay to Genaissance within thirty
[**] of the Effective Date a non-refundable fee of [**] Dollars (U.S.$[**]).
5.1.2 PHASE I RESEARCH TRIAL REPORT FEE. Within [**] days after a
delivery of the Phase I Research Trial Report that includes establishment of any
HAP(TM) Marker Association
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for [**] Clinical Phenotypes using the statistically robust criteria defined in
Exhibit E, Biogen shall pay to Genaissance a non-refundable milestone payment of
[**] Dollars (U.S.$[**]).
5.2. PHASE II VALIDATION TRIAL FEES.
5.2.1 SET-UP FEE. Within [**] days after Biogen delivers to
Genaissance notice of its intent to proceed with the Phase II Validation Trial
pursuant to Section 2.2.1, Biogen shall pay to Genaissance a non-refundable
set-up fee of [**] Dollars (U.S.$[**]) and, in the event the fee set forth in
5.1.2 was not paid, Biogen shall pay to Genaissance a non-refundable milestone
payment of [**] Dollars (U.S.$[**]).
5.2.2 [**] SERVICE FEE.
(a) INITIAL INSTALLMENT. Biogen and Genaissance shall [**].
Upon delivery [**] to be provided [**]:
(i) [**] Dollars (U.S.$[**]) multiplied by
(b) [**] percent ([**]%) [**] FINAL INSTALLMENT. Upon [**].
Upon delivery [**]:
(i) [**] Dollars (U.S.$[**]) [**] percent [**]% [**], as
determined in Section 5.2.2(a);
PROVIDED THAT [**], as [**], then [**], and PROVIDED FURTHER THAT [**] pursuant
to this Section 5.2.2 [**] Dollars (U.S.$[**]).
5.2.3 PHASE II VALIDATION TRIAL REPORT FEE. Within [**] days after
delivery by Genaissance of a Phase II Validation Trial Report that includes
validation of HAP(TM) Marker Associations for [**] Clinical Phenotypes using the
statistically robust criteria determined pursuant to Section 2.2.2, Biogen shall
pay to Genaissance a non-refundable milestone payment of [**] Dollars
(U.S.$[**]).
5.3. MILESTONE PAYMENTS.
5.3.1 PAYMENT SCHEDULE. To the extent that Biogen elects to
proceed with commercialization in accordance with Article III, Biogen shall make
the following non-refundable milestone payments to Genaissance upon achievement
of the following milestones:
PAYMENT DUE UPON
MILESTONE ACHIEVEMENT OF MILESTONE
--------- ------------------------
(a) [**] (whichever occurs first) of a BLA for [**] other than the [**] Dollars
Indication set forth in EXHIBIT G, with a label [**] (U.S.$[**])
(b) [**] (whichever occurs first) of [**] other than the Indication set [**] Dollars
forth in EXHIBIT G, with a label [**] (U.S.$[**])
(c) [**] (whichever occurs first) of [**] for each different Indication [**] Dollars
(U.S.$[**])
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5.3.2 TIMING OF PAYMENTS. Each milestone payment shall be made by
Biogen to Genaissance within [**] days after the achievement of the applicable
milestone.
5.4. TEST FEES FOR [**] DIAGNOSTIC PRODUCTS. Biogen shall pay to
Genaissance, in the manner specified in Section 5.5, test fees determined as
follows:
5.4.1 NON-REQUIRED DIAGNOSTICS. If Biogen, its Affiliates and/or
sublicensees commercialize [**] in connection with an [**] Diagnostic Product
where [**] (a) [**] HAP(TM) Marker or Surrogate Marker [**], or (b) is [**] (a
"Non-Required Diagnostic"), Biogen shall pay to Genaissance a test fee equal to
[**] percent ([**]%) of the Deemed Test Fee Sales Base, as defined in Section
5.4.3.
5.4.2 REQUIRED DIAGNOSTIC. If Biogen, its Affiliates and/or
sublicensees commercialize [**] for [**] with [**] a HAP(TM) Marker referenced
in a HAP(TM) Marker Association, or a Surrogate Marker thereof, (a "Required
Diagnostic"), Biogen shall pay to Genaissance a test fee equal to [**] percent
([**]%) of the Deemed Test Fee Sales Base; PROVIDED THAT at no time shall the
test fee exceed [**] percent ([**]%) of [**] Net Sales, as defined below, in the
applicable Calendar Quarter. For purposes of this Section 5.4.2, the term" [**]
Net Sales" means the gross revenue for Calendar Quarter invoiced by Biogen, its
Affiliates and/or sublicensees from the sale of [**] in the applicable
Indication, as the case may be, after deducting in each case the following
actually-incurred amounts within such Calendar Quarter: (a) ordinary and
customary credits or allowances granted upon returns, rejections or recalls; (b)
shipping and insurance costs; (c) ordinary and customary quantity and other
trade discounts, rebates, credits or allowances, including allowances for
uncollectible amounts; (d) customs, duties, taxes and surcharges and other
governmental charges incurred in connection with exportation or importation; and
(e) government mandated rebates and retroactive price reductions.
5.4.3 DEEMED TEST FEE SALES BASE. For purposes of this Section
5.4, the term "Deemed Test Fee Sales Base" means the product of (a) the number
of tests based upon [**] Diagnostic Products used in any Calendar Quarter in a
country, and (b) the Average Selling Price. The term "Average Selling Price"
means the invoice price charged by Biogen in such country for a standard course
of [**], as the case may be. For example, if a Required Diagnostic is sold in
the United States, where, during a Calendar Quarter, one thousand (1,000) tests
are performed and the cost of [**], as the case may be, [**] Dollars
(U.S.$[**]), the test fee would be equal to [**] Dollars (U.S.$[**]) [[**]% of
(1,000 x ([**] x [**]))].
5.4.4 DETERMINATION OF NUMBER OF TESTS. For purposes of
determining the number of tests based upon [**] Diagnostic Products used in any
Calendar Quarter in a country, with respect to Non-Required Diagnostics, such
number shall be equal to the number of tests
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sold or distributed in such Calendar Quarter in such country to a Third Party,
or, if such number is otherwise unavailable, then the Parties shall discuss in
good faith a reasonable alternative method of determining the number of tests
used. In the case of Required Diagnostics, the same methodology shall be
followed, except that such number of tests shall be reduced by [**] on the [**],
PROVIDED THAT the [**]. In the event that tests based on[**] Diagnostic Products
are also used in connection with [**] as determined below [**], then the number
of tests used to calculate [**] shall be appropriately and proportionately
reduced, as described below, to take into consideration [**]. For purposes
hereof, in the event that a peer reviewed journal is published in which the use
of an [**] Diagnostic Product is recommended or favorably discussed as
predicting the outcome of a drug, other than [**] or other drug Controlled by
Biogen), and in the year or years following such publication the Test Ratio (as
defined below) drops by [**] percent ([**]%) or more, then the Parties agree
that [**] Diagnostic Products shall be deemed [**] and the number of tests
determined [**] shall not be included in the Deemed Test Fee Sales Base. Each
[**] Diagnostic Product, [**], in each case [**]. For purposes of illustration:
If in a [**] in a [**] during such [**]. If in the [**], but the [**] in the
[**], then one hundred (100) of such tests would be [**] and they would [**].
5.4.5 TEST FEE METHODOLOGY. To determine the number of Required
Diagnostics sold for a particular indication, the Parties shall establish an
allocation methodology based on available Third Party data, market research,
surveys and reasonable statistical assumptions.
5.4.6 LENGTH OF PAYMENTS. The test fees payable under this Section
5.4 shall be paid on a country-by-country basis on each [**] Diagnostic Product
until the later of (a) the expiration of the last-to-expire Valid Claim within
the Genaissance Patent Rights which cover such [**] Diagnostic Product or a
component thereof, or (b) [**] years after the First Commercial Use of such [**]
Diagnostic Product in such country. Provided that if the time period in
subclause (b) above extends beyond the time period in subclause (a) above, then
the test fees payable by Biogen to Genaissance shall be reduced in such country
by [**] percent ([**]%).
5.4.7 EVALUATION. The Parties may from time to time evaluate the
method for calculating test fees under this Section 5.4, and may agree on
modifications and refinements to such methodology as indicated by such
evaluation.
5.4.8 RELATED THIRD PARTY PAYMENTS. Biogen shall be entitled to
deduct, from the test fee payments made by it pursuant to this Section 5.4 in a
country, [**] percent ([**]%) of Related Third Party Payments, as defined below,
paid by Biogen with respect to such [**] Diagnostic Product in such country;
PROVIDED THAT in no event shall a deduction under this Section 5.4.8 reduce any
test fee payment otherwise due to Genaissance in respect of [**] Diagnostic
Products in a country by more than [**] percent ([**]%). Any deduction that is
not usable pursuant to the final clause of the immediately preceding sentence
may be carried forward for use in a future period. For purposes of this Section
5.4.8, the term "Related Third Party Payments" means payments to a Third Party
to license patents covering [**] to make, use or sell the [**] Diagnostic
Products if, in the absence of such license, the licensed use by Biogen of the
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specific technology licensed from Genaissance under Article IV would or is
likely to, in the reasonable judgment of Biogen, infringe such patents.
5.5. PAYMENT PROVISIONS.
5.5.1 TEST FEE REPORTS. During the term of this Agreement
following the First Commercial Use of any [**] Diagnostic Product, Biogen shall
within sixty (60) days after each Calendar Quarter furnish to Genaissance a
written quarterly report showing on a country-by-country basis: (a) the Deemed
Test Fee Sales Base, including the methodology used in calculating the number of
tests and the Average Selling Price; (b) the test fees which shall have accrued
hereunder; (c) withholding taxes, if any, required by law to be deducted in
respect of such test fees; (d) the dates of the First Commercial Use of [**]
Diagnostic Products in any country during the reporting period; and (e) the
exchange rates used in determining amounts payable hereunder. If no test fee is
due for any quarterly period hereunder, Biogen shall so report. Biogen shall
keep complete and accurate records in sufficient detail to enable the test fees
payable hereunder to be determined. Test fees shown to have accrued in each test
fee report shall be paid at the same time the report is provided.
5.5.2 EXAMINATIONS.
(a) PROCEDURES. Upon the written request of Genaissance,
Biogen shall permit an independent certified public accountant selected by
Genaissance and acceptable to Biogen, which acceptance shall not be unreasonably
withheld, to have access during normal business hours to such records of Biogen
as may be reasonably necessary to verify the accuracy of the test fee reports
described herein. Any such certified public accountant shall first be required
to enter into a confidentiality agreement in form acceptable to Biogen. Both
Parties shall use commercially reasonable efforts to schedule all such
verifications within forty-five (45) days after Genaissance makes its written
request. All such verifications shall be conducted not more than once in each
calendar year. Subject to Biogen's rights under Section 11.6, in the event
Genaissance's independent certified public accountant concludes that additional
test fees were owed to Genaissance during such period, the additional test fees
shall be paid by Biogen within thirty (30) days after the date Genaissance
delivers to Biogen such independent certified public accountant's written report
so concluding. In the event Genaissance's independent certified public
accountant concludes that there was an overpayment of test fees to Genaissance
during such period, the overpayment shall be repaid by Genaissance within thirty
(30) days of the date Genaissance received such independent certified public
accountant's written report so concluding. The fees charged by such independent
certified public accountant shall be paid by Genaissance unless the audit
discloses an underpayment of the test fees payable by Biogen for the audited
period of more than five percent (5%), in which case Biogen shall pay the
reasonable fees and expenses charged by such accountant. The foregoing
obligation by Biogen to maintain records shall be limited to three (3) years.
(b) THIRD PARTY DIAGNOSTIC PARTNERS. Biogen shall include in
each agreement with each applicable Third Party Diagnostic Partner a provision
requiring the Third Party Diagnostic Partner to make reports to Biogen, to keep
and maintain records of sales made
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pursuant to such agreement and to grant access to such records by Genaissance's
independent certified public accountant to the same extent required of Biogen
under this Agreement.
(c) CONFIDENTIALITY. Genaissance agrees that all information
subject to review under this Section 5.5.2 or under any agreement with a Third
Party Diagnostic Partner of Biogen is confidential and that Genaissance shall
cause its independent certified public accountant to retain all such information
in confidence.
5.6. WITHHOLDING TAXES. Biogen shall deduct withholding taxes from
payments under this Agreement and pay them to the proper tax authorities only to
the extent required by applicable laws. Biogen shall not deduct any other
withholding or any other governmental charges from the payments under this
Agreement, including but not limited to any such taxes or charges incurred as a
result of an assignment or sublicense by Biogen to any Affiliate or any Third
Party, except as noted above. Biogen shall maintain official receipts of payment
of any withholding taxes and forward these receipts to Genaissance within sixty
(60) days. The Parties will exercise diligent efforts to ensure that any
withholding taxes imposed are reduced as far as possible under the provisions of
any treaties applicable to any payment made hereunder.
5.7. CURRENCY EXCHANGE. The Average Selling Price shall be expressed in
its United States dollar equivalent, calculated using the applicable conversion
rate for buying United States dollars published by THE WALL STREET JOURNAL on
the last business day of the Calendar Quarter to which the test fee report
relates.
5.8. INTEREST ON LATE PAYMENTS. Any payments by Biogen to Genaissance
that are not paid on or before thirty (30) days after the date such payments are
due under this Agreement shall bear interest, to the extent permitted by
applicable law, at one percent (1%) per month calculated on the total number of
days payment is delinquent.
5.9. MANNER OF PAYMENT. Payments to be made by Biogen to Genaissance
under this Agreement shall be payable in United States dollars and shall be paid
by bank wire transfer in immediately available funds to such bank account as is
designated in writing by Genaissance from time to time.
ARTICLE VI
INTELLECTUAL PROPERTY
6.1. OWNERSHIP OF INVENTIONS.
6.1.1 GENAISSANCE INVENTIONS. Subject to Section 6.1.4,
Genaissance shall exclusively own all inventions made solely by its employees,
agents and consultants in the course of the Collaboration ("Genaissance
Inventions").
6.1.2 BIOGEN INVENTIONS. Subject to Section 6.1.4, Biogen shall
exclusively own all inventions made solely by its employees, agents and
consultants in the course of the Collaboration ("Biogen Inventions").
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6.1.3 JOINT INVENTIONS. Subject to Section 6.1.4, all inventions
made jointly by employees, agents and consultants of Biogen and employees,
agents and consultants of Genaissance in the course of the Collaboration ("Joint
Inventions") initially shall be owned jointly on the basis of each Party having
an undivided interest in the whole.
6.1.4 ASSIGNMENT. Notwithstanding the foregoing, (a) Biogen hereby
assigns to Genaissance all of its right, title and interest in and to Biogen
Inventions and Joint Inventions each relating exclusively to HAP(TM) Markers and
HAP(TM) Marker Associations, and (b) Genaissance hereby assigns to Biogen all of
its right, title and interest in and to Genaissance Inventions and Joint
Inventions each relating exclusively to [**], other than inventions relating
exclusively to HAP(TM) Markers and HAP(TM) Marker Associations. Each Biogen
Invention, Genaissance Invention or Joint Invention, as applicable, assigned
pursuant to the immediately preceding sentence shall thereby cease to be a
Biogen Invention, Genaissance Invention or Joint Invention as originally owned
and become a Biogen Invention or Genaissance Invention, in accordance with the
assignment thereof, as set forth above.
6.1.5 INVENTORSHIP. The determination of inventorship shall be
made in accordance with relevant United States patent laws.
6.2. PROSECUTION AND MAINTENANCE OF PATENT RIGHTS. The Parties
recognize that a single patent application may disclose and claim more than one
invention, e.g., a Genaissance Invention and a Joint Invention. In so far as
practicable, the Parties shall draft their respective patent applications such
that assignments made in accordance with Section 6.1.4 shall result in
assignment of the entire right, title and interest in and to a given patent
application; furthermore, the Parties agree to file any continuing or divisional
patent applications needed to effect the separate prosecution of Genaissance
Inventions, Biogen Inventions, and Joint Inventions (if any). If under the
circumstances of a given patent application, such separate prosecution is not
practicable or materially adversely affects patentability, or if the application
discloses a Joint Invention not subject to assignment in accordance with Section
6.1.4, then the Parties shall agree as to which of them shall be responsible for
filing, prosecution, and maintenance of such patent application, and such patent
application shall be filed, prosecuted, and maintained in accordance with
Sections 6.2.3 and 6.2.4. For purposes of this Article VI, "Patent Prosecution"
shall mean any or all of the activities related to filing, prosecution and
maintenance of Patent Rights in one or more countries.
6.2.1 GENAISSANCE INVENTIONS. Genaissance shall have the exclusive
right and option to file and prosecute any patent applications and maintain any
patents covering Genaissance Inventions; PROVIDED THAT: (i) Biogen shall have
the exclusive right and option to file, prosecute and maintain all HAP(TM)
Marker Association Patent Rights, under Biogen's sole control and at Biogen's
sole expense; (ii) in the event Genaissance declines to pursue Patent
Prosecution for any HAP(TM) Marker Patent Rights covering HAP(TM) Markers
referenced in any HAP(TM) Marker Association Patent Rights, Genaissance shall
give Biogen no less than sixty (60) days written notice to this effect and
thereafter Biogen may, upon written notice to Genaissance, elect to assume sole
control over filing and prosecution of such HAP(TM) Marker Patent Rights and
maintain such HAP(TM) Marker Patent Rights in Genaissance's name, under Biogen's
sole control,
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and all such Genaissance Inventions shall remain owned exclusively by
Genaissance; and (iii) in the event that Biogen declines to pursue Patent
Prosecution for any HAP(TM) Marker Association Patent Rights, or any HAP(TM)
Marker Patent Rights for which Biogen assumed control of Patent Prosecution
pursuant to subsection 6.2.1(ii), Biogen shall give Genaissance no less than
sixty (60) days written notice to this effect and thereafter Genaissance may,
upon written notice to Biogen, elect to assume sole control over Patent
Prosecution of such HAP(TM) Marker Association Patent Rights and HAP(TM) Marker
Patent Rights.
6.2.2 BIOGEN INVENTIONS. Biogen shall have the exclusive right and
option to file and prosecute any patent applications and to maintain any patents
covering Biogen Inventions, at its sole discretion and under its sole control.
6.2.3 COSTS AND EXPENSES. Each Party shall bear its own costs and
expenses in preparing, filing, prosecuting, maintaining and extending Patent
Rights hereunder, PROVIDED, HOWEVER, THAT Biogen shall bear all costs and
expenses in connection with the Patent Rights for which Patent Prosecution is
controlled solely by Biogen in accordance with Section 6.2.1.
6.2.4 COOPERATION. Each Party agrees to cooperate with the other
with respect to the preparation, filing, prosecution, maintenance and extension
of patents and patent applications pursuant to this Section 6.2, including,
without limitation, the execution of all such documents and instruments and the
performance of such acts as may be reasonably necessary in order to permit the
other Party to continue any preparation, filing, prosecution, maintenance or
extension of patents and patent applications that such Party has elected not to
pursue, as provided for in Section 6.2.1. Biogen shall have the right to
receive, within ten (10) business days of receipt by Genaissance, copies of all
correspondence to and from patent offices that are related to patent
applications within the HAP(TM) Marker Patent Rights which disclose HAP(TM)
Markers referenced in the HAP(TM) Marker Association Patent Rights, and/or any
HAP(TM) Marker Association Patent Rights for which Genaissance has assumed
control of Patent Prosecution in accordance with Section 6.2.1(iii), and shall
further have the right to review and comment upon such patent applications and
the prosecution thereof by Genaissance, including the right to receive and
review drafts no less than [**] business days prior to filing with any patent
office. Genaissance shall consider Biogen's comments in good faith and shall
adapt its Patent Prosecution strategy to accommodate Biogen's interest in
maximizing patent protection for [**] Diagnostic Products and technology used
therein. Genaissance shall have the right to receive, within [**] business days
of receipt by Biogen, copies of all correspondence to and from patent offices
that are related to patent applications within the HAP(TM) Marker Association
Patent Rights and/or any HAP(TM) Marker Patent Rights for which Biogen has
assumed control of Patent Prosecution in accordance with Section 6.2.1(ii), and
shall further have the right to review and comment upon such patent applications
and the prosecution thereof by Biogen, including the right to receive and review
drafts no less than [**] business days prior to filing with any patent office.
Biogen shall give good faith consideration to Genaissance's comments on all such
patent applications and shall adapt its Patent Prosecution strategy to
accommodate Genaissance's interest in maximizing patent protection for HAP(TM)
Markers Patent Rights, unless Biogen reasonably believes that any such requested
accommodation would negatively impact patent protection for [**] Diagnostic
Products. Each Party shall, on an annual basis, provide to the other Party a
list of all patents and
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patent applications filed, prosecuted and/or maintained by it pursuant to this
Section 6.2, including the status thereof.
6.2.5 PATENT DISCLOSURE. Biogen and Genaissance may agree to
disclose Confidential Information, including HAP(TM) Marker Associations, in
patent applications. Notwithstanding any prior agreement to the contrary, Biogen
shall have the sole right and option to decide whether to continue prosecution
and/or maintenance of any HAP(TM) Marker Association Patent Rights and of any
other application within the Patent Rights which discloses Biogen Confidential
Information. At Biogen's request, Genaissance shall take all necessary steps to
abandon, allow to lapse or withdraw any patent application within the Patent
Rights for which Genaissance has primary responsibility for Patent Prosecution,
and shall cooperate with Biogen in taking such steps with respect to any patent
application for which Biogen has such primary responsibility, prior to the
publication of such patent application if such application contains Confidential
Information of Biogen, specifically including HAP(TM) Marker Associations.
6.2.6 PATENT INTERFERENCE AND OPPOSITION. No more than thirty (30)
days following the discovery by either Party of a request for, or the filing or
declaration of any interference, opposition, or reexamination proceeding with
respect to those Genaissance Patent Rights for which Patent Prosecution is
controlled by Biogen in accordance with Section 6.2.1, or the discovery by
either party that any of such Genaissance Patent Rights should be reissued to
avert invalidity or unenforceability or to permissibly broaden such patent
rights, the discovering Party shall notify the other Party of such event. The
Parties shall consult with each other in good faith to determine a course of
action with respect to such event. Biogen shall have primary responsibility at
its own expense and under its sole control to take appropriate action to defend
or prosecute any such interference, opposition, reexamination or reissue. The
Parties shall cooperate with each other and each shall provide the other any
information or assistance that the other may reasonably request with any action
so taken. Biogen shall keep Genaissance informed of all developments in such
interference, opposition, reexamination or reissue, including to the extent
permissible the status of any settlement negotiations and the terms of any
settlement offer. Biogen shall provide Genaissance copies of all submissions or
agreements arising in connection with such proceeding sufficiently in advance of
their filing or due date so as to give Genaissance sufficient time to comment
thereon. Biogen shall give good faith consideration to Genaissance's comments.
Biogen shall not enter into any settlement or consent decree regarding any
Genaissance Patent Rights for which Patent Prosecution is controlled by Biogen
in accordance with Section 6.2.1 and involved in legal proceedings in accordance
with this Section 6.2.6 or assent to the grant of any reissued or reexamined
patent with the Genaissance Patent Rights without the prior written consent of
Genaisance, which shall not be withheld or delayed unreasonably.
6.3. THIRD PARTY INFRINGEMENT.
6.3.1 NOTICE. Each Party shall promptly report in writing to the
other Party during the term of this Agreement any (i) known or suspected
infringement of any of the Genaissance Patent Rights, or (ii) unauthorized use
of any of the Genaissance Know-How of which such Party becomes aware, and shall
provide the other Party with all available evidence
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supporting such infringement, suspected infringement, unauthorized use or
suspected unauthorized use.
6.3.2 INFRINGEMENT ACTION. Biogen shall have the initial right to
initiate a suit or take other appropriate action that it believes is reasonably
required to protect the Patent Rights for which Patent Prosecution is controlled
by it in accordance with Section 6.2.1, and Genaissance shall have the initial
right to initiate a suit or take other appropriate action that it believes is
reasonably required to protect all other Genaissance Patent Rights and
Genaissance Know-How. To the extent that any alleged infringement or
unauthorized use pertains to [**] Diagnostic Products, Biogen shall give
Genaissance sufficient advance notice of its intent to file any such suit or
take any such action and the reasons therefor, and shall provide Genaissance
with an opportunity to join in such suit or action. Thereafter, Genaissance and
Biogen shall keep each other informed, and shall agree upon the strategy for
such suit or action and shall provide each other with copies of all material
documents (i.e., complaints, answers, counterclaims, material motions, orders of
the court, memoranda of law and legal briefs, interrogatory responses,
depositions, material pre-trial filings, expert reports, affidavits filed in
court, transcripts of hearings and trial testimony, trial exhibits and notices
of appeal) filed in, or otherwise relating to, such suit or action. If
Genaissance elects not to join in such suit or action, Biogen shall keep
Genaissance informed (including providing copies of all relevant documents) and
provide Genaissance with a reasonable opportunity to review and comment on all
documents filed in connection with such suit or action.
6.3.3 CONDUCT OF ACTION; COSTS. Biogen shall have the sole and
exclusive right to select counsel for any suit initiated by it referred to in
Section 6.3.2 in which Genaissance elects not to join. If required under
applicable law in order for Biogen to initiate and/or maintain such suit,
Genaissance shall join as a party to the suit. Genaissance shall offer
reasonable assistance to Biogen in connection therewith at no charge to Biogen
except for reimbursement of reasonable out-of-pocket expenses incurred in
rendering such assistance. Biogen shall assume and pay all of its own
out-of-pocket costs incurred in connection with any litigation or proceedings
described in this Section 6.3, including, without limitation, the fees and
expenses of the counsel selected by it. Genaissance shall have the right to
participate and be represented in any such suit by its own counsel at its own
expense. Biogen shall not settle any such suit with respect to rights related to
the Genaisance Patent Rights controlled by Biogen in accordance with Section
6.2.1 without obtaining the prior written consent of Genaissance, which consent
shall not be unreasonably withheld or delayed.
6.3.4 GENAISSANCE RIGHT. If Biogen fails to initiate a suit or
take such other appropriate action within [**] days after becoming aware of the
alleged infringements or unauthorized use of Patent Rights for which Patent
Prosecution is controlled by Biogen in accordance with Section 6.2.1, then
Genaisssance may, in its discretion, provide Biogen with written notice of its
intent to initiate a suit or take other appropriate action, such notice to be
provided within [**] days after the expiration of such [**] day period. If
Genaissance provides such notice and Biogen fails to initiate a suit or take
such other appropriate action within [**] days after receipt of such notice from
Genaissance, then Genaissance shall have the right to initiate a suit or take
other appropriate action that it believes is reasonably required to protect the
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relevant Genaissance Patent Rights and Genaissance Know-How. Genaissance shall
give Biogen sufficient advance notice of its intent to file any such suit or
take any such action and the reasons therefor, and shall provide Biogen with an
opportunity to make suggestions and comments regarding such suit or action.
Thereafter, Genaissance shall keep Biogen promptly informed, and shall from time
to time consult with Biogen the status of any such suit or action and shall
provide Biogen with copies of all material documents (i.e., complaints, answers,
counterclaims, material motions, orders of the court, memoranda of law and legal
briefs, interrogatory responses, depositions, material pre-trial filings, expert
reports, affidavits filed in court, transcripts of hearings and trial testimony,
trial exhibits and notices of appeal) filed in, or otherwise relating to, such
suit or action. Genaissance shall have the sole and exclusive right to select
counsel for any suit initiated by it pursuant to this subsection, which counsel
shall be reasonably acceptable to Biogen. If necessary or desirable, Biogen
shall join as a party to the suit. Biogen shall offer reasonable assistance to
Genaissance in connection therewith at no charge to Genaissance except for
reimbursement of reasonable out-of-pocket expenses incurred in rendering such
assistance. Genaissance shall assume and pay all of its own out-of-pocket costs
incurred in connection with any litigation or proceedings described in this
subsection, including, without limitation, the fees and expenses of the counsel
selected by it. Biogen shall have the right to participate in and be represented
in any such suit by its own counsel at its own expense. Genaissance shall not
settle any such suit involving rights of Genaissance that are related to any
[**] Diagnostic Product commercialized by Biogen without obtaining the prior
written consent of Biogen, which consent shall not be unreasonably withheld or
delayed.
6.3.5 RECOVERIES. To the extent that any such suit or action
pertains to [**] Diagnostic Products, any recovery obtained as a result of any
proceeding described in this Section 6.3 shall be applied in the following order
of priority:
(a) first, the Party initiating the suit or action shall be
reimbursed for all costs in connection with such proceeding paid by such Party
and not otherwise recovered;
(b) second, the other Party shall be reimbursed for all
costs in connection with such proceeding paid by the other Party and not
otherwise recovered;
(c) third, any portion of the recovery fairly allocable to
activities that do not pertain to [**] Diagnostic Products shall be paid to
Genaissance;
(d) fourth, any portion of the recovery fairly allocable to
lost Deemed Test Fee Sales Base shall be paid to Genaissance; and
(e) fifth, any remainder shall be paid fifty percent (50%)
to Genaissance and fifty percent (50%) to Biogen.
6.3.6 PATENT INVALIDITY CLAIM. If a Third Party at any time
asserts a claim that any Genaissance Patent Right is invalid or otherwise
unenforceable (an "Invalidity Claim"), whether as a defense in an infringement
action brought by a Party pursuant to this Section 6.3 or
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in a Third Party Claim brought against Genaissance or Biogen, the Parties shall
cooperate and shall endeavor to agree upon an appropriate course of action.
6.4. CLAIMED INFRINGEMENT. In the event that a Third Party at any time
provides written notice of a claim to, or brings an action, suit or proceeding
against a Party, or any of its Affiliates, claiming infringement of such Third
Party's Patent Rights or unauthorized use of such Third Party's Know-How, based
upon an assertion or claim arising out of the research, development,
manufacture, use or sale of [**] Diagnostic Products or the activities to be
performed under this Agreement by such Party (a "Third Party Claim"), such Party
shall promptly notify the other Party of the claim or the commencement of such
action, suit or proceeding, enclosing a copy of the claim and/or all papers
served. The Parties shall cooperate and shall endeavor to agree upon an
appropriate course of action. Each Party agrees to make available to the other
Party its reasonable advice and counsel regarding the technical merits of any
such claim and to offer reasonable assistance to the other Party. Such advice,
counsel and assistance shall be provided without charge to the other Party,
unless such advice, counsel and assistance would require such assisting Party to
incur material external costs, in which case the assisting Party shall not be
required to provide such advice, counsel and assistance unless the other Party
agrees to reimburse them.
6.5. PATENT MARKING. Biogen agrees to comply with any applicable patent
marking statutes in any country in which [**] Diagnostic Products are sold by
Biogen, its Affiliates and/or its Third Party Diagnostic Partners.
ARTICLE VII
CONFIDENTIALITY
7.1. NONDISCLOSURE AND NON-USE OBLIGATIONS.
7.1.1 GENERAL. Except as otherwise provided in this Article VII,
during the term of this Agreement and for a period of ten (10) years thereafter,
each Party shall maintain the Confidential Information of the other Party in
confidence and use it only for purposes specifically authorized under this
Agreement.
7.1.2 LIMITATIONS. The Parties agree that the receiving Party
shall not have any obligation of confidentiality with respect to such
Confidential Information that:
(a) is or becomes part of the public domain other than by
unauthorized acts of the Party obligated not to disclose such Confidential
Information;
(b) can be shown by written documents to have been disclosed
to the receiving Party by a Third Party, provided such Confidential Information
was not obtained by such Third Party from the other Party to this Agreement
pursuant to a confidentiality agreement;
(c) prior to disclosure under this Agreement, was already in
the possession of the receiving Party, provided such Confidential Information
was not obtained from the other Party to this Agreement pursuant to a
confidentiality agreement;
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(d) can be shown by written documents to have been
independently developed by the receiving Party without breach of any of the
provisions of this Agreement;
(e) is disclosed by the receiving Party pursuant to an order
or demand issued by a court or governmental agency or as otherwise required by
law; PROVIDED, THAT the receiving Party notifies the other Party prior to
disclosure, giving such other Party sufficient advance notice, if possible, to
permit it to seek a protective order or other similar order with respect to such
Confidential Information and provided further that the receiving Party furnishes
only that portion of the Confidential Information which it is advised by counsel
is legally required whether or not a protective order or other similar order is
obtained by the other Party; or
(f) where the receiving Party reasonably believes such
disclosure is necessary or appropriate to fulfill its obligations or exercise
its rights under this Agreement, with such disclosure being limited to:
(i) actual or potential Third Party Diagnostic Partners,
sublicensees, consultants, outside contractors and clinical
investigators, on a need-to-know basis and on condition that
such entities or persons agree to keep the Confidential
Information confidential for the same time periods and to
the same extent as such Party is required to keep the
Confidential Information confidential; and
(ii) government or other regulatory authorities to the
extent that such disclosure is reasonably necessary to
obtain or maintain patents or authorizations to conduct
clinical trials of, and to commercially market, products
pursuant to this Agreement.
7.2. INJUNCTIVE RELIEF. The Parties understand and agree that remedies
at law may be inadequate to protect against any breach of any of the provisions
of this Article VII by either Party or their employees, agents, officers or
directors or any other person acting in concert with it or on its behalf.
Accordingly, each Party shall be entitled to the granting of injunctive relief
by a court of competent jurisdiction against any action that constitutes any
such breach of this Article VII.
7.3. PUBLICATION. The Parties agree to use commercially reasonable
efforts to monitor public scientific and other disclosures of the results of
the Collaboration to prevent any premature public disclosure of such results.
The Parties shall establish a procedure for publication review, and each
Party shall first submit to the other Party an early draft of all such
publications, whether they are to be presented orally or in written form, at
least [**] prior to submission (if in written form, including abstracts) or
presentation (if an oral disclosure) to determine (a) whether the proposed
disclosure contains any Confidential Information of the other Party or (b)
whether the information contained in the proposed disclosure should be the
subject of a patent application prior to such disclosure. The other Party
shall have [**] from its receipt of any such abstract, manuscript or
presentation in which to notify the Party
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in writing of any specific objections to the disclosure, based on either the
need to seek patent protection or concern regarding the specific disclosure
of the Confidential Information of such Party. In the event a Party objects
to the disclosure, the other Party agrees not to submit the publication or
make the presentation containing the objected-to information until the Party
is given a reasonable additional period of time (not to exceed an additional
[**]) to seek patent protection for any material in the disclosure which it
believes is patentable or, in the case of Confidential Information, to allow
the Party to delete any Confidential Information of the other Party from the
proposed disclosure. Each Party agrees to delete from the proposed disclosure
any Confidential Information of the other Party upon request. The Parties
agree that all publications of results of the Collaboration shall acknowledge
the contribution of the other Party to such results.
ARTICLE VIII
REPRESENTATIONS AND WARRANTIES; LIMITATION OF LIABILITY
8.1. REPRESENTATIONS AND WARRANTIES OF GENAISSANCE. Genaissance
represents and warrants to Biogen as of the Effective Date that:
(a) Genaissance is a corporation duly organized, validly
existing and in corporate good standing under the laws of
Delaware;
(b) Genaissance has the legal right, authority and power to
enter into this Agreement, perform its obligations under this Agreement, and
grant to Biogen the licenses granted pursuant to this Agreement;
(c) upon the execution and delivery of this Agreement, this
Agreement shall constitute a valid and binding obligation of Genaissance
enforceable in accordance with its terms, except as enforceability may be
limited by applicable bankruptcy, insolvency, reorganization, moratorium or
similar laws affecting creditors' and contracting Parties' rights generally and
except as enforceability may be subject to general principles of equity
(regardless of whether such enforceability is considered in a proceeding in
equity or at law);
(d) all necessary consents, approvals and authorizations of
all government authorities and other persons required to be obtained by it in
connection with the execution, delivery and performance of this Agreement have
been obtained;
(e) notwithstanding anything to the contrary in this
Agreement, the execution and delivery of this Agreement, the performance of
Genaissance's obligations in the conduct of the Collaboration and the licenses
and sublicenses to be granted pursuant to this Agreement (i) do not conflict
with or violate any requirement of applicable laws or regulations, and (ii) do
not conflict with, violate, breach or constitute a default under any contractual
obligations of Genaissance;
(f) all of its employees, officers, consultants and advisors
who are or will be involved in the Collaboration have executed or will have
executed agreements or have existing obligations under law requiring assignment
to Genaissance of all intellectual property
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made during the course of and as the result of its association with Genaissance,
and obligating the individual to maintain as confidential Genaissance's
Confidential Information, to the extent required to support Genaissance's
obligations under this Agreement;
(g) to the knowledge of Genaissance, the Genaissance
Know-How that will be used by the Parties in the Collaboration has not been
developed or obtained by Genaissance in violation of any contractual obligation
to any Third Party nor has it been misappropriated from any Third Party or
obtained without the proper consent of any Third Party;
(h) except as otherwise disclosed to Biogen by Genaissance
as of the Effective Date, there is no action, suit or proceeding which is
pending or, to the knowledge of the officers of Genaissance, no written claim or
demand of any Third Party that has been received, that challenges or would
materially adversely affect (i) the right of Genaissance to use in the conduct
of the Collaboration the Genaissance Know-How or Genaissance Patent Rights that
are reasonably expected to be utilized by the Parties to fulfill their duties
under the Collaboration Plan, or (ii) the right of Genaissance to grant to
Biogen the rights and licenses to use such Genaissance Know-How or Genaissance
Patent Rights; and
(i) Genaissance is not aware of any data or information
given to Biogen which is untrue or inaccurate or any data or information which
is necessary to make the data or information provided to Biogen complete and not
misleading. To the best of Genaissance's knowledge, all filings for Patent
Rights have been and will be made in compliance with applicable requirements of
37 C.F.R. section 1.56.
8.2. REPRESENTATIONS AND WARRANTIES OF BIOGEN. Biogen represents and
warrants to Genaissance as of the Effective Date that:
(a) Biogen is a corporation duly organized, validly existing
and in corporate good standing under the laws of Massachusetts;
(b) Biogen has the legal right, authority and power to enter
into this Agreement, and perform its obligations under this Agreement;
(c) upon the execution and delivery of this Agreement, this
Agreement shall constitute a valid and binding obligation of Biogen enforceable
in accordance with its terms, except as enforceability may be limited by
applicable bankruptcy, insolvency, reorganization, moratorium or similar laws
affecting creditors' and contracting Parties' rights generally and except as
enforceability may be subject to general principles of equity (regardless of
whether such enforceability is considered in a proceeding in equity or at law);
(d) all necessary consents, approvals and authorizations of
all government authorities and other persons required to be obtained by it in
connection with the execution, delivery and performance of this Agreement have
been obtained;
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(e) notwithstanding anything to the contrary in this
Agreement, the execution and delivery of this Agreement, the performance of
Biogen's obligations in the conduct of the Collaboration (i) do not conflict
with or violate any requirement of applicable laws or regulations existing as of
the Effective Date and (ii) do not conflict with, violate, breach or constitute
a default under any contractual obligations of Biogen existing as of the
Effective Date;
(f) all of its employees, officers, consultants and advisors
who are or will be involved in the Collaboration have executed or will have
executed agreements or have existing obligations under law obligating the
individual to maintain as confidential Biogen's Confidential Information, to the
extent required to support Biogen's obligations under this Agreement;
(g) it has obtained or will obtain all required and proper
patient consents with respect to the blood and/or DNA samples and related
clinical data to be supplied to Genaissance for use in the Phase I Research
Trial and Phase II Validation Trial; and
(h) there is no action, suit or proceeding which is pending
or, to the knowledge of officers of Biogen, no written claim or demand of any
Third Party that has been received, which would materially adversely affect the
Collaboration.
8.3. TRANSAMERICA LOAN. Genaissance agrees to make all interest and
principal payments due under the Promissory Note (the "Transamerica Note") and
the Loan and Security Agreement (the "Loan and Security Agreement"), both dated
April 30, 1999, with Transamerica Business Credit Corporation ("Transamerica"),
[**]. Genaissance further agrees that [**] the Transamerica Note or the Loan and
Security Agreement [**] WARRANTY DISCLAIMER. EXCEPT AS OTHERWISE EXPRESSLY
PROVIDED IN ARTICLE VIII OF THIS AGREEMENT, THE PARTIES MAKE NO REPRESENTATIONS
AND EXTEND NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, STATUTORY OR
OTHERWISE. THE PARTIES HEREBY DISCLAIM WARRANTIES OF TITLE, MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT WITH RESPECT TO [**]
DIAGNOSTIC PRODUCTS [**].
8.4. DISCLAIMER OF CONSEQUENTIAL DAMAGES. NEITHER PARTY WILL BE LIABLE
FOR SPECIAL, INCIDENTIAL, PUNITIVE, EXEMPLARY, MULTIPLE, CONSEQUENTIAL OR OTHER
INDIRECT DAMAGES ARISING OUT OF THIS AGREEMENT OR THE EXERCISE OF ITS RIGHTS
HEREUNDER, OR ANY LOST PROFITS, LOST SAVINGS, LOST REVENUES OR LOST DATA,
REGARDLESS OF ANY NOTICE OF SUCH DAMAGES. NOTHING IN THIS SECTION 8.5 IS
INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF
EITHER PARTY.
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ARTICLE IX
INDEMNITY
9.1. BIOGEN INDEMNITY OBLIGATIONS. Biogen agrees to defend, indemnify
and hold Genaissance and its directors, officers, employees and agents harmless
from all losses, damages or expenses (including attorneys' fees) arising as a
result of any Third Party claims relating to: (a) claims for bodily injury,
death or property damage attributable to the development, manufacture, or
improper use of [**] or any [**] Diagnostic Products by Biogen, its Affiliates,
or its sublicensees (excluding those claims for which Genaissance indemnifies
Biogen pursuant to Section 9.2); (b) a recall of [**] or any [**] Diagnostic
Product (excluding those claims for which Genaissance indemnifies Biogen
pursuant to Section 9.2); ordered by a governmental agency or required by a
confirmed product failure; (c) a breach of any of the representations,
warranties or obligations of Biogen; or (d) performance by Biogen of its
obligations under this Agreement or as a result of Biogen's use of its
proprietary technology and/or any Third Party technology including, but not
limited to, any claim that, in performing its obligations under this Agreement,
Biogen has infringed any Patent Rights of any Third Party.
9.2. GENAISSANCE INDEMNITY OBLIGATIONS. Genaissance agrees to defend,
indemnify and hold Biogen and its directors, officers, employees and agents
harmless from all losses, damages or expenses (including attorneys' fees)
arising as a result of any Third Party claims relating to (a) claims for bodily
injury, death or property damage attributable to the development, manufacture
(if applicable pursuant to Section 3.1.2), or improper use of any [**]
Diagnostic Products by Genaissance, its Affiliates, or its sublicensees
(excluding those claims for which Biogen indemnifies Genaissance pursuant to
Section 9.1); (b) a recall of any [**]Diagnostic Product manufactured by
Genaissance (if applicable pursuant to Section 3.1.2) which is ordered by a
governmental agency or required by a confirmed product failure; (c) a breach of
any of the representations, warranties or obligations of Genaissance; or (d)
performance by Genaissance of its obligations under this Agreement or as a
result of Genaissance' use of its proprietary technology and/or any Third Party
technology including, but not limited to, any claim that, in performing its
obligations under this Agreement, Genaissance has infringed any Patent Rights of
any Third Party.
9.3. LIMITATION ON INDEMNITY OBLIGATIONS. Neither Party nor its
respective directors, officers, employees and agents shall be entitled to the
indemnities set forth in Section 9.1 and Section 9.2 where the claim, loss,
damage or expense for which indemnification is sought was caused by a negligent
or intentional act or omission by such Party, its directors, officers, employees
or authorized agents.
9.4. PROCEDURE. If the Party being indemnified hereunder or its
respective directors, officers, employees or agents (the "Indemnitee") intends
to claim indemnification under this Article IX, the Indemnitee shall promptly
notify the other Party (the "Indemnitor") of any loss, claim, damage, liability
or action in respect of which the Indemnitee intends to claim such
indemnification, and the Indemnitor shall manage and control, at its sole
expense, the defense of the claim and its settlement. The Indemnitee shall
cooperate with the Indemnitor and may, at its option and its own expense, be
represented in any such action or proceeding. The Indemnitor
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shall not be liable for any litigation costs or expenses incurred by the
Indemnitee. The indemnity agreement in this Article IX shall not apply to
amounts paid in settlement of any loss, claim, damage, liability or action if
such settlement is effected without the consent of the Indemnitor. The
Indemnitor may enter into a settlement without the consent of the Indemnitee
unless such settlement (a) does not include a complete release of the Indemnitee
from all liability with respect thereto, or (b) imposes any restrictions on the
Indemnitee. The Indemnitee under this Article IX, and its directors, officers,
employees and agents, shall cooperate fully with the Indemnitor and its legal
representatives in the investigation of any action, claim or liability covered
by this indemnification. The Indemnitor shall additionally be liable to pay the
reasonable legal costs and attorneys' fees incurred by the Indemnitee in
establishing its claim for indemnity.
ARTICLE X
TERM AND TERMINATION
10.1. TERM OF AGREEMENT. This Agreement shall become effective as of
the Effective Date, may be terminated as set forth in this Article X, and shall
otherwise remain in effect until the later of: (i) the expiration of all
obligations to make payments set forth in Article V, or (ii) the expiration of
all licenses and other rights granted in Article IV.
10.2. TERMINATION.
10.2.1 EARLY TERMINATION. Biogen shall have the right to
terminate this Agreement at its sole discretion (a) within [**] days after
Genaissance submits to Biogen the Phase I Research Trial Report; (b) at any time
during the Phase II Validation Trial; or (c) at any time after Genaissance
submits to Biogen the Phase II Validation Trial Report; PROVIDED, THAT if Biogen
terminates this Agreement during the Phase II Validation Trial, Biogen shall pay
to Genaissance, as a termination fee, an amount equal to the sum of (a) [**]
percent ([**]%) of the set-up fee required to be paid pursuant to Section 5.2.1
and (b) the total amount paid or payable to Genaissance by Biogen for all work
performed by Genaissance pursuant to Section 5.2.2 during the Phase II
Validation Trial prior to such termination.
10.2.2 TERMINATION FOR MATERIAL BREACH. Upon any breach of a
material provision of this Agreement by a Party (the "Breaching Party"), the
other Party (the "Non-Breaching Party") may terminate this Agreement by
providing [**] days written notice to the Breaching Party, specifying the
material breach. The termination shall become effective at the end of the [**]
days period, or if such breach is not susceptible to cure within [**] days after
the receipt of written notice of the breach, and if the Breaching Party is
diligently pursuing a cure, then termination shall become effective within [**]
days of the receipt of written notice of the breach. Notwithstanding the
foregoing, if such breach, by its nature, is incurable, this Agreement may be
terminated immediately. The Parties shall use reasonable efforts to work
together to cure any breach.
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10.3. Effect of Termination.
10.3.1 EFFECT OF TERMINATION BY GENAISSANCE. If this Agreement is
terminated by Genaissance under Section 10.2.2 in connection with a material
breach by Biogen, then (a) the licenses and option granted to Biogen pursuant to
Article IV shall terminate and (b) any and all Confidential Information of, and
materials provided by, a Party pursuant to this Agreement, and any copies
thereof (including electronic copies) shall be promptly returned by such Party
to the other Party.
10.3.2 EFFECT OF TERMINATION BY BIOGEN. If this Agreement is
terminated by Biogen under Section 10.2.1, then (a) subject to Biogen's
compliance with all obligations set forth in Section 10.4, the license grant
under Section 4.1.1 shall survive such termination; (b) the license grant under
Section 4.1.2 and the option grant under Section 4.1.3 shall terminate, and (c)
any and all Confidential Information of, and materials provided by, a Party
pursuant to this Agreement, and any copies thereof (including electronic copies)
shall be promptly returned by such Party to the other Party, except to the
extent necessary to exercise rights retained pursuant to this Section. If this
Agreement is terminated by Biogen under Section 10.2.2, then (a) subject to
Biogen's compliance with all obligations set forth in Section 10.4, the license
grants under Sections 4.1.1 and 4.1.2 and the option grant under Section 4.1.3
shall survive such termination; and (b) any and all Confidential Information of,
and materials provided by Biogen pursuant to this Agreement, and any copies
thereof (including electronic copies) shall be promptly returned by Genaissance
to Biogen, except to the extent necessary to exercise rights retained pursuant
to this Section.
10.4. SURVIVING PROVISIONS. The expiration or termination of this
Agreement shall not relieve the Parties of any obligation accruing prior to such
expiration or termination. The provisions of Articles V (to the extent owed as
of the effective date of the expiration or termination), VII, IX, X and XI and
Sections 8.4 and 8.5 hereof shall survive the expiration or termination of this
Agreement. Notwithstanding anything in this Section 10.4 to the contrary, all
financial obligations under Article V remain in effect during the term of the
license grants that survive pursuant to Section 10.3.2.
ARTICLE XI
MISCELLANEOUS
11.1. FORCE MAJEURE. Neither Party shall be held liable or responsible
to the other Party nor be deemed to have defaulted under or breached this
Agreement for failure or delay in fulfilling or performing any term of this
Agreement when such failure or delay is caused by or results from causes beyond
the reasonable control of the affected Party, including but not limited to fire,
floods, embargoes, war, acts of war (whether war is declared or not), terrorism,
insurrections, riots, civil commotion, strikes, lockouts or other labor
disturbances, acts of God or acts, omissions or delays in acting by any
governmental authority or the other Party; PROVIDED THAT the Party so affected
shall use reasonable commercial efforts to avoid or remove such causes of
nonperformance, and shall continue performance hereunder with reasonable
dispatch whenever such causes are removed. Either Party shall provide the other
Party with prompt written notice of any delay or failure to perform that occurs
by reason of FORCE MAJEURE. The Parties shall mutually seek a resolution of the
delay or the failure to perform as noted above.
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11.2. ASSIGNMENT. This Agreement may not be assigned or otherwise
transferred by either Party without the consent of the other Party; PROVIDED
THAT either Genaissance or Biogen may, without such consent, assign its rights
and obligations under this Agreement (a) to any Affiliate, or (b) in connection
with a merger, consolidation or sale of substantially all of such Party's assets
to a Third Party; provided further that such Party's rights and obligations
under this Agreement shall be assumed by its successor in interest in any such
transaction and shall not be transferred separate from all or substantially all
of its other business assets relating to this Agreement, including those
business assets that are the subject of this Agreement. Any purported assignment
in violation of the preceding sentence shall be void. Any permitted assignee
shall assume all obligations of its assignor under this Agreement.
11.3. SEVERABILITY. If any provision hereof should be held invalid,
illegal or unenforceable in any respect in any jurisdiction, then, to the
fullest extent permitted by law, (a) all other provisions hereof shall remain in
full force and effect in such jurisdiction and shall be liberally construed in
order to carry out the intentions of the Parties as nearly as may be possible
and (b) such invalidity, illegality or unenforceability shall not affect the
validity, legality or enforceability of such provision in any other
jurisdiction.
11.4. NOTICES. Any consent, notice or report required or permitted to
be given or made under this Agreement by one of the Parties to the other Party
shall be in writing, delivered personally or by facsimile (and promptly
confirmed by telephone, personal delivery or courier) or courier, postage
prepaid (where applicable), addressed to such other Party at its address
indicated below, or to such other address as the addressee shall have last
furnished in writing to the addressor and shall be effective upon receipt by the
addressee.
If to Genaissance: Genaissance Pharmaceuticals, Inc.
Xxxx Xxxxxxx Xxxx
Xxx Xxxxx, Xxxxxxxxxxx 00000
Attention: Chief Executive Officer
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
With a copy to: Xxxx and Xxxx LLP
00 Xxxxx Xxxxxx
Xxxxxx, Xxxxxxxxxxxxx 00000
Attention: Xxxxxx X. Xxxxxx
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
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If to Biogen: Biogen, Inc.
00 Xxxxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000
Attention: Executive Vice President,
Legal and Public Affairs
Telephone: 617) 000-0000
Facsimile: (000) 000-0000
11.5. APPLICABLE LAW. This Agreement shall be governed by and construed
in accordance with the laws of the State of
Delaware, without giving effect to
the choice of laws provisions thereof.
11.6. DISPUTE RESOLUTION.The Parties hereby agree that they will
attempt in good faith to resolve any controversy or claim arising out of or
relating to this Agreement promptly by negotiations. If a controversy or claim
should arise hereunder, the matter shall be referred to an individual designated
by the Chief Executive Officer (or the equivalent position) of Genaissance and
an individual designated by the Chief Executive Officer or Executive Vice
President, Commercial Operations (or the equivalent position) of Biogen (the
"Party Representatives"). If the matter has not been resolved within thirty (30)
days after the first meeting of the Party Representatives (which period may be
extended by mutual agreement) concerning such matter, subject to rights to
injunctive relief and specific performance, and unless otherwise specifically
provided for herein, any controversy or claim arising out of or relating to this
Agreement, or the breach thereof, may at the election of either party be pursued
by whatever other remedies are legally available to resolve the dispute.
11.7. ENTIRE AGREEMENT. This Agreement, together with the exhibits
hereto, contains the entire understanding of the Parties with respect to the
subject matter hereof. All express or implied agreements and understandings,
either oral or written, heretofore made are expressly merged in and made a part
of this Agreement. This Agreement may be amended, or any term hereof modified,
only by a written instrument duly executed by both Parties.
11.8. PUBLICITY.
11.8.1 AGREEMENT. Except as required by law, and subject to
Section 11.8.2, Genaissance and Biogen each agree not to disclose the existence
or any terms or conditions of this Agreement to any Third Party without the
prior written permission of the other Party; PROVIDED THAT either Party may make
such disclosures to its financial and legal advisers on a need to know basis and
subject to confidentiality agreement. In the event that this Agreement shall be
included in any report, statement or other document filed by either Party or an
Affiliate of either Party with the United States Securities and Exchange
Commission (the "SEC"), such Party shall provide the other Party reasonable
notice and shall use, or shall cause its Affiliate, as the case may be, to use,
reasonable efforts to obtain confidential treatment from the SEC of any
financial information or other information of a competitive or confidential
nature, and shall include in
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such confidentiality request such provisions of this Agreement as may be
reasonably requested by the other Party.
11.8.2 PRESS RELEASE. Notwithstanding the foregoing, Genaissance
and Biogen agree that a press release may be issued promptly after execution of
this Agreement by either Party in the form(s) agreed by the Parties and as set
forth in EXHIBIT H attached hereto. The Parties agree that any such announcement
will not contain confidential business or technical information and, if
disclosure of confidential business or technical information is required by law
or regulation, will make commercially reasonable efforts to minimize such
disclosure and obtain confidential treatment for any such information which is
disclosed to a governmental agency or group. Each Party agrees to provide to the
other Party a copy of any public announcement with respect to this Agreement or
the subject matter of this Agreement as soon as reasonably practicable under the
circumstances prior to its scheduled release. Except under extraordinary
circumstances, each Party shall provide the other Party with an advance copy of
any such press release at least two (2) business days prior to the scheduled
disclosure. Each Party shall have the right to review and recommend changes to
any announcement regarding this Agreement or the subject matter of this
Agreement. Except as otherwise required by law, the Party whose press release
has been reviewed shall remove any information the reviewing Party reasonably
deems to be inappropriate for disclosure. The contents of any such announcement
or similar publicity which has been reviewed and approved by the reviewing Party
can be re-released by either Party without a requirement for re-approval.
11.9. HEADINGS. The captions to the several Articles and Sections
hereof are not a part of this Agreement, but are merely guides or labels to
assist in locating and reading the several Articles and Sections hereof.
11.10. NO PARTNERSHIP; INDEPENDENT CONTRACTORS. It is expressly agreed
that the relationship between Genaissance and Biogen shall not constitute a
partnership, joint venture or agency. Neither Genaissance nor Biogen shall have
the authority to make any statements, representations or commitments of any
kind, or to take any action, which shall be binding on the other, without the
prior consent of the other Party to do so.
11.11. EXPORTS. The Parties acknowledge that the export of technical
data, materials or products is subject to the exporting Party receiving any
necessary export licenses and that the Parties cannot be responsible for any
delays attributable to export controls which are beyond the reasonable control
of either Party. Genaissance and Biogen agree not to export or re-export,
directly or indirectly, any information, technical data, the direct product of
such data, samples or equipment received or generated under this Agreement in
violation of any applicable export control laws or governmental regulations.
Genaissance and Biogen agree to obtain similar covenants from their licensees,
sublicensees and contractors with respect to the subject matter of this Section.
11.12. WAIVER. The waiver by either Party of any right hereunder or the
failure to perform or of a breach by the other Party shall not be deemed a
waiver of any other right
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hereunder or of any other breach or failure by said other Party whether of a
similar nature or otherwise.
11.13. COUNTERPARTS. This Agreement may be executed in two or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
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11.14. NO STRICT CONSTRUCTION. This Agreement has been prepared jointly
and shall not be strictly construed against any Party.
IN WITNESS WHEREOF, the Parties have caused their duly authorized
officer to execute and deliver this Agreement as of the date first set forth
above.
BIOGEN, INC.
By: /s/ Xxxx Xxxxxxx, M.D.
------------------------------------------
Name: Xxxx Xxxxxxx, M.D.
----------------------------------------
Title: Executive Vice President,
Research and Development
---------------------------------------
GENAISSANCE PHARMACEUTICALS, INC.
By: /s/ Xxxxxxxx Xxxxxxxxxx, Ph.D.
------------------------------------------
Name: Xxxxxxxx Xxxxxxxxxx, Ph.D.
----------------------------------------
Title: Vice President, Alliances
---------------------------------------
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EXHIBIT A
[**]
[**].
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EXHIBIT B
GENE CRITERIA
Genaissance will discover HAP(TM) Markers for Genes using its standard
operating procedures for sequencing, detecting single nucleotide polymorphisms
(hereinafter "SNPs") and building Gene haplotypes. The sequencing procedure
consists of sequencing, from Genaissance's collection of individuals of diverse
ancestry (the "Index Repository"), ninety-three (93) individual samples of human
genomic DNA. The genomic regions of each Gene, which are targeted for
sequencing, are as follows:
(i) "Exons" shall mean the genomic DNA segments of a Gene whose
sequence information is translated into the protein product of that Gene. The
goal is to obtain sequence information for all Exons of a Gene.
(ii) "Exon/Intron Junction" shall mean the junctions between the Exons
and the Introns in genomic DNA. Beginning with the initiation codon at one end
of a Gene and ending with the termination codon at the other end of a Gene, the
goal is to obtain sequence information for each Exon/Intron Junction within this
genomic region.
(iii) "Introns" shall mean the genomic DNA segments of a Gene, which
are located between Exons. Beginning with the initiation codon at one end of a
Gene and ending with the termination codon at the other end of a Gene, the goal
is to obtain a minimum of ten (10) to twenty (20) bases and a maximum of one
hundred (100) bases of sequence information from the Exon/Intron Junction into
the Intron for every Intron within this genomic region.
(iv) "Promoter" shall mean the region that is immediately upstream of
the genomic segment that is found at the five-prime end of a Messenger RNA
molecule. ("Messenger RNA" shall mean a ribonucleic acid sequence from which the
protein product of a Gene is translated.) The goal is to obtain sequence
information for up to one thousand (1,000) bases of the Promoter.
(v) "Three-Prime Untranslated Region" shall mean the genomic region
immediately downstream from the termination codon of a Gene. The goal is to
obtain sequence information for at lease one hundred (100) bases of the
Three-Prime Untranslated Region downstream of the termination codon.
Specific genomic sequence information is required to meet the goals
outlined in (i) through (v) above. If genomic sequence information is not
available for all of these regions in a Gene selected by Biogen pursuant to
Section 2.1.1, [**] such Gene [**] should be [**] such information [**].
A Gene shall be considered completely sequenced if sequence information
is obtained for: (i) at least [**] of the [**]; (ii) the [**] containing the
[**]; and (iii) [**]. A specific region
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targeted for sequencing within a Gene shall be considered completely sequenced
if sequence information is obtained [**].
However, the presence of runs of guanine and cytosine, secondary
structure, highly homologous regions elsewhere in the human genome or errors in
publicly available sequence information may prevent the generation of sufficient
sequence information for a Gene to be considered completely sequenced as defined
above. In such a case, [**] for that Gene.
The sequences obtained for each Gene that is completely sequenced as
set forth above will be interrogated using Genaissance's standard operating
procedures for identification of SNPs and inference of Gene haplotypes.
2
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EXHIBIT C
PHASE I PLAN
PATIENT SAMPLES. Biogen will provide Genaissance with [**] samples from at least
[**] patients for [**] Clinical Phenotype (EXHIBIT D) to be analyzed for the
discovery of HAP(TM) Markers that correlate with [**]. Biogen will endeavor to
supply this minimum number of DNA samples within [**] days from the Effective
Date. To examine the maximum number of [**] genes outlined in Section 2.1.3(c),
Biogen will supply Genaissance with at [**] from each patient. Biogen will
provide Genaissance with the [**] for each such [**] sample. Biogen will ship
the [**] samples [**] by overnight courier service. Additional [**] will be
required to do the additional work outlined in Section 2.1.3(d).
HAP(TM) MARKER DETECTION. Genaissance will conduct a quality control analysis of
the [**] samples provided by Biogen. This quality control analysis will consist
of: [**] that will [**]. Genaissance will submit to the Steering Committee the
results of the quality control analysis. If some of the patient [**] samples do
not pass the quality control analysis, the Steering Committee will decide
whether [**] or whether [**] should be used. Once the minimum number of patient
[**] samples has been obtained for [**], Genaissance will [**] determine the
pair of HAP(TM) Markers that are present for a Gene in each patient sample.
The Genes to be examined for genetic variation will be determined as per
Sections 2.1.1 and 2.1.3 (d). Genaissance will use its standard operating
procedures for sequencing, detecting SNPs and building Gene haplotypes to detect
the pair of HAP(TM) Markers that are present in patient samples for each Gene
chosen for analysis. The genomic regions of each Gene, which are targeted for
sequencing, are described in EXHIBIT B.
HAP(TM) MARKER ASSOCIATIONS. Genaissance will use its standard analyses
procedures to discover the HAP(TM) Markers Associations. Genaissance will adjust
its analyses for the effects of population substructure and for multiple
comparisons, including the use of Bonferroni, Xxxx-Xxxxx or permutation test
methods. The results of these analyses shall be delivered to Biogen in the Phase
I Research Trial Report pursuant to Section 2.1.3(e).
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EXHIBIT D
[**] CLINICAL PHENOTYPES
[**]
[**] Clinical Phenotypes:
[**]
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EXHIBIT E
PHASE I RESEARCH TRIAL CORRELATION DEFINITION
Genaissance will identify HAP(TM) Marker Associations for [**] (as
defined in EXHIBIT D) at a statistical significance of[**], while at the same
time such HAP(TM) Marker Associations [**] (as defined in EXHIBIT D).
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EXHIBIT F
[**]
Genes [**]:
COMMON NAME HUGO SYMBOL
[**]
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EXHIBIT G
[**]
[**]
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EXHIBIT H
PRESS RELEASE
Contact: Xxxx Xxxxxxxxxxx, Ph.D. (media) Xxxxxx Xxxxxx (investors)
203.786.3490 917.322.2569
x.xxxxxxxxxxx@xxxxxxxxxxx.xxx xxxxxxx@XxXX.xxx
or
Xxxxxxxxx Faith (media)
203.786.3660
x.xxxxx@xxxxxxxxxxx.xxx
Genaissance Pharmaceuticals and Biogen Sign Pharmacogenomics Collaboration
for Research, Development and Marketing
New Haven, CT, month day, 2002 - Genaissance Pharmaceuticals, Inc. (Nasdaq:
GNSC) today announced that it has entered into an agreement with Biogen, Inc.
(Nasdaq: BGEN) in which the companies will apply Genaissance HAP(TM) Technology
to drugs currently in development and to drug targets under investigation at
Biogen, one of the world's premier biopharmaceutical companies. The goal of the
collaboration is to utilize pharmacogenomics for research applications as well
as to create prognostic tests for use in drug marketing. The pairing of a
pharmacogenomics test and a drug represents a new marketing paradigm that uses
gene variation information to help ensure successful treatment, and increase
physician and patient satisfaction.
Under the terms of the agreement, Genaissance will receive an upfront cash
payment, research funding and milestone payments based upon predetermined goals.
Genaissance will also reserve capacity in its HAP(TM) Typing facility to process
Biogen's clinical trial samples. In addition, Genaissance will be eligible to
receive downstream success-based payments.
"Biogen is very pleased to be working with Genaissance, a company at the
forefront of applying gene variation information to drug development," said
Xxxxxxx Xxxxxx, Ph.D., Senior Vice President, Research at Biogen. "We view the
collaboration as an opportunity to build on our leadership in using new
technologies to understand the heterogeneity of human disease and ensure that
our drugs deliver maximum benefit to patients."
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Genaissance discovers HAP(TM) Markers - akin to genomic bar codes that represent
the pattern and organization of DNA variability that each individual inherits -
to enable the development of safer and more effective medicines by identifying
associations between a patient's genetic make up and a drug response. The
Company is also developing its own internal drug pipeline that will complement
existing business strategies focused on establishing technology and
drug-specific partnerships with pharmaceutical and biotechnology companies.
"We are pleased to enter into an agreement with Biogen that spans research,
development and marketing applications," said Xxxxxxxxx Xxxxx, M.D., Ph.D., CEO
of Genaissance. "We are proud to be associated with Biogen as they have always
been at the forefront of using new technologies such as genetic engineering and,
now, pharmacogenomics. We look forward to working together and setting the stage
for the introduction of personalized medicines."
Genaissance Pharmaceuticals, Inc. is the world leader in the discovery and
use of human gene variation for the development of personalized medicines.
The Company has identified candidates for development in its own pipeline of
products - HAP(TM)-Clozapine and HAP(TM)-Statin - utilizing its proprietary
genetic markers. The Company also markets its technology and clinical
development skills to the pharmaceutical industry as a complete solution for
improving the development, marketing and prescribing of drugs. Genaissance
has agreements with three of the top five pharmaceutical companies as well as
one of the premier biopharmaceutical companies: AstraZeneca, Biogen, Xxxxxxx
& Xxxxxxx and Pfizer. Genaissance is located in Science Park in New Haven,
Connecticut.
THIS PRESS RELEASE CONTAINS FORWARD-LOOKING STATEMENTS, INCLUDING STATEMENTS
ABOUT THE ABILITY OF GENAISSANCE TO APPLY ITS TECHNOLOGIES TO THE DEVELOPMENT,
MARKETING AND PRESCRIBING OF DRUGS, AND THE EXPECTED RELEASE OF CLINICAL TRIALS
DATA. SUCH STATEMENTS ARE SUBJECT TO CERTAIN FACTORS, RISKS AND UNCERTAINTIES
THAT MAY CAUSE ACTUAL RESULTS, EVENTS AND PERFORMANCE TO DIFFER MATERIALLY FROM
THOSE REFERRED TO IN SUCH STATEMENTS, INCLUDING, BUT NOT LIMITED TO, THE
DEVELOPMENT OF NEW PRODUCTS, THE EXTENT TO WHICH GENETIC MARKERS (HAPLOTYPES)
ARE PREDICTIVE OF DRUG EFFICACY AND SAFETY, THE ADOPTION OF OUR TECHNOLOGIES BY
THE PHARMACEUTICAL INDUSTRY, THE TIMING AND SUCCESS OF CLINICAL TRIALS,
COMPETITION FROM PHARMACEUTICAL, BIOTECHNOLOGY AND DIAGNOSTICS COMPANIES, THE
STRENGTH OF OUR INTELLECTUAL PROPERTY RIGHTS AND THOSE RISKS IDENTIFIED IN OUR
REGISTRATION STATEMENT ON FORM S-3 FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION ON OCTOBER 18, 2001 AND OUR ANNUAL REPORT ON FORM 10-K FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION ON APRIL 2, 2001. THE FORWARD-LOOKING
STATEMENTS CONTAINED HEREIN REPRESENT THE JUDGMENT OF GENAISSANCE AS OF THE DATE
OF THIS RELEASE. GENAISSANCE DISCLAIMS ANY OBLIGATION TO UPDATE ANY
FORWARD-LOOKING STATEMENT.
