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EXHIBIT 10.39
Portions of Exhibit 10.39 have been redacted and are the subject of a
confidential treatment request filed with the Secretary of the Securities and
Exchange Commission.
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COLLABORATIVE
RESEARCH AND LICENSE AGREEMENT
BY AND BETWEEN
TANABE SEIYAKU CO., LTD.
AND
OSI PHARMACEUTICALS, INC.
EFFECTIVE AS OF OCTOBER 1, 1999
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TABLE OF CONTENTS
PAGE
1. Definitions...........................................................2
1.1 "Affiliate"...................................................2
1.2 "Assay Materials".............................................2
1.3 "Budget"......................................................2
1.4 "Budgeted Amount".............................................2
1.5 "Clinical Development and Marketing Phase"....................2
1.6 "Compound"....................................................3
1.7 "Confidential Information"....................................3
1.8 "Contract Period".............................................3
1.9 "Dispute".....................................................3
1.10 "Drug Discovery Phase"........................................3
1.11 "Early Development Phase".....................................3
1.12 "Early Termination"...........................................3
1.13 "Effective Date"..............................................3
1.14 "Event of Default"............................................3
1.15 "FDA".........................................................3
1.16 "Field".......................................................4
1.17 "Fourth Year FTE Rate"........................................4
1.18 "FTE".........................................................4
1.19 "FTE Rate"....................................................4
1.20 "Funding Amount"..............................................4
1.21 "Improvements"................................................4
1.22 "IND".........................................................4
1.23 "Joint Management Committee"..................................4
1.24 "Joint Patents"...............................................4
1.25 "Lead Compound"...............................................5
1.26 "Materials"...................................................5
1.27 "NDA".........................................................5
1.28 "Net Sales"...................................................5
1.29 "Option Period"...............................................6
1.30 "Option Payment"..............................................7
1.31 "OSI Compound"................................................7
1.32 "OSI Confidential Information"................................7
1.33 "OSI Patents".................................................7
1.34 "OSI Product".................................................7
1.35 "OSI Technology"..............................................7
1.36 "Pharmaceutical Partner"......................................8
1.37 "Products"....................................................8
1.38 "Remaining Right Period"......................................8
1.39 "Research Plan"...............................................8
1.40 "Research Program"............................................9
1.41 "Royalty-Receiving Party".....................................9
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1.42 "Seed Compound"..................................................................................9
1.43 "Selling Party"..................................................................................9
1.44 "Steering Committee".............................................................................9
1.45 "Tanabe Compound"................................................................................9
1.46 "Tanabe Confidential Information"................................................................9
1.47 "Tanabe Patents"................................................................................10
1.48 "Tanabe Product"................................................................................10
1.49 "Tanabe Technology".............................................................................10
1.50 "Targets".......................................................................................10
1.51 "Technology"....................................................................................10
1.52 "Term"..........................................................................................11
1.53 "Third Party"...................................................................................11
1.54 "Third Year FTE Rate"...........................................................................11
1.55 "Two Year Minimum Requirements".................................................................11
1.56 "Two Year Report"...............................................................................11
1.57 "Valid Claim"...................................................................................12
1.58 "Withholding Tax"...............................................................................12
2. Collaboration Between the Parties.......................................................................12
2.1 Research Plan...................................................................................12
2.2 Allocation of Responsibilities for the Research Program.........................................12
2.2.1 Responsibility of OSI.:...............................................................12
2.2.2 Compound Withdrawal...................................................................14
(a) Compound Exchange............................................................14
(b) Withdrawal of Seed Compound..................................................14
2.2.3 Commencement of Early Development Phase...............................................15
(a) OSI Participation...........................................................16
(b) Tanabe's Designation as Lead Compound........................................16
(c) Tanabe's Responsibility for Clinical Development and Marketing Phase.........17
2.3 Exclusivity.....................................................................................17
2.3.1 ** .:..............................................................................17
(a) ** .......................................................................17
(b) ** .......................................................................17
2.3.2 ** ................................................................................17
2.3.3 Development Of Other Products Directed Towards Targets................................17
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** This portion has been redacted pursuant to a request for confidential
treatment.
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2.4. Committees..........................................................................18
2.4.1 Steering Committee........................................................18
(a) Activities.:.....................................................18
(b) Membership.......................................................18
(c) Chairs...........................................................19
(d) Meetings.........................................................19
(e) Minutes..........................................................19
(f) Decisions........................................................19
(g) Expenses.........................................................20
2.4.2 Joint Management Committee................................................20
(a) Activities.......................................................20
(b) Membership.......................................................21
(c) Co-Chairs........................................................21
(d) Meetings.........................................................21
(e) Minutes..........................................................22
(f) Decisions........................................................22
(g) Expenses.........................................................22
2.4.3 Subcommittees.............................................................22
2.4.4 Future Committees.........................................................23
2.5 Reports and Materials...............................................................23
2.5.1 Disclosure of Technology and Improvements.................................23
2.5.2 Reports...................................................................23
2.5.3 Materials.................................................................24
2.6 Laboratory Facilities and Personnel.................................................24
2.7 Tanabe Visiting Scientist...........................................................25
2.8 Ownership of Improvements...........................................................26
3. Funding of the Research Program.............................................................27
3.1 Contract Period Funding.............................................................27
3.1.1 Budgeted Amount...........................................................27
3.1.2 Adjustments...............................................................28
3.1.3 Progress Pursuant to the Research Plan....................................28
3.1.4 Inspection of Funding Amount..............................................28
3.1.5 Minimization of Expenditures..............................................30
3.2 Sharing of Responsibilities in the Early Development Phase..........................30
3.3 Technology Access Fee and Milestone Payments........................................30
3.3.1 Technology Access Fee.....................................................30
3.3.2 Early Development Phase Milestones........................................30
3.3.3 Clinical Development and Marketing Phase Milestones.......................31
4. Treatment of Confidential Information.......................................................31
4.1 Confidentiality.....................................................................31
4.1.1 Confidentiality and Non-Use Obligations...................................31
4.1.2 Disclosure of Confidential Information....................................32
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4.1.3 Employees and Consultants.................................................33
4.2 Publication.........................................................................33
4.3 Press Release.......................................................................33
4.4 Restrictions on Transferring Materials..............................................34
4.5 Permitted Use of Confidential Information...........................................35
5. Licenses and Royalties......................................................................36
5.1. Grant of Licenses...................................................................36
5.1.1 Option to Tanabe..........................................................36
5.1.2 License to OSI............................................................36
5.2 Paid-Up License.....................................................................37
5.3 Obligations to Exploit the Products.................................................38
5.4 Sublicenses.........................................................................38
5.5 Royalty Payments, Accounting for Royalties, Records and Withholding Tax.............38
5.5.1 Royalty Payments by Tanabe................................................38
5.5.2 Royalty Payments by OSI...................................................39
5.5.3 Payment Dates.............................................................39
5.5.4 Accounting................................................................39
5.5.5 Records...................................................................40
5.5.6 Withholding Taxes.........................................................41
(a) ** ...........................................................41
(b) Withholding to be Borne by Royalty-Receiving Party...............41
5.6 Payment to Vanderbilt...............................................................42
6. Provisions Concerning the Filing, Prosecution and Maintenance of Patent Rights..............42
6.1 OSI Filing, Prosecution and Maintenance.............................................42
6.2 Tanabe Filing, Prosecution and Maintenance..........................................42
6.3 Legal Action........................................................................43
6.3.1 Actual or Threatened Disclosure or Infringement...........................43
6.3.2 Defense of Infringement Claims............................................45
6.3.3 Third Party Licenses......................................................46
6.3.4 No Selling Party..........................................................47
6.3.5 Acquisition of Rights from Third Parties..................................47
7. Hold Harmless...............................................................................48
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** This portion has been redacted pursuant to a request for confidential
treatment.
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8. Term, Termination and Disengagement.........................................................48
8.1 Term................................................................................48
8.1.1 Term of Contract Period...................................................48
8.1.2 Two-Year Review...........................................................49
8.1.3 Renewal...................................................................49
8.1.4 Term of Agreement.........................................................50
8.2 Tanabe's Right to Early Termination.................................................50
8.3 Termination Upon an Event of Default................................................50
8.3.1 Incorrect Representation or Warranty......................................51
8.3.2 Failure to Perform........................................................51
8.3.3 Bankruptcy................................................................51
8.4 Effect of Expiration or Termination of the Contract Period..........................51
8.4.1 Expiration................................................................52
(a) Tanabe License to OSI...........................................52
(b) OSI License to Tanabe...........................................52
(c) Option Payment...................................................52
(d) Royalty Obligation...............................................54
(e) Milestone Obligation.............................................54
(f) Transfer of Assay................................................55
8.4.2 Early Termination if Two Year Minimum Requirements Are Not Met............55
(a) Tanabe License to OSI...........................................55
(b) OSI License to Tanabe...........................................55
(c) Royalty Obligation...............................................55
(d) Milestone Obligation.............................................56
(e) Tanabe's Option..................................................56
(f) Transfer of Assay................................................56
8.4.3 Termination Upon an Event of Default......................................56
8.5 Survival............................................................................57
9. Representations and Warranties..............................................................58
9.1 Representations and Warranties Made by Tanabe and OSI...............................58
9.1.1 Status....................................................................58
9.1.2 Authority.................................................................58
9.1.3 Binding Obligation........................................................58
9.1.4 No Conflicting Obligations................................................58
9.1.5 Good Title................................................................59
9.1.6 Right to Grant Licenses...................................................59
9.2 Representations and Warranties Made by OSI..........................................59
9.2.1 Vanderbilt Agreement......................................................59
9.2.2 No Litigation.............................................................59
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10. Dispute Resolution..........................................................................59
10.1 ** ..............................................................................59
10.2. Arbitration.........................................................................59
11. Notices.....................................................................................60
12. Governing Law...............................................................................61
13. Force Majeure...............................................................................61
14. Miscellaneous...............................................................................61
14.1 Binding Effect......................................................................61
14.2 Headings............................................................................61
14.3 Interpretation......................................................................61
14.4 Counterparts........................................................................61
14.5 Amendment; Waiver; etc..............................................................62
14.6 No Third Party Beneficiaries........................................................62
14.7 Assignment and Successors...........................................................62
14.7.1 Affiliates................................................................62
14.7.2 Assignment................................................................62
14.8 Entire Agreement....................................................................63
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** This portion has been redacted pursuant to a request for confidential
treatment.
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COLLABORATIVE RESEARCH AND LICENSE AGREEMENT
This COLLABORATIVE RESEARCH AND LICENSE AGREEMENT (this "Agreement")
effective as of October 1, 1999, by and between TANABE SEIYAKU CO., LTD.
("Tanabe"), a corporation organized under the laws of Japan, with offices at
0-00 Xxxxx-Xxxxx 0-xxxxx, Xxxx-xx, Xxxxx, Xxxxx, and OSI PHARMACEUTICALS, INC.
("OSI"), a Delaware corporation, with its principal office at 000 Xxxxxxx
Xxxxxxxxx Xxxxxxxxx, Xxxxxxxxx, Xxx Xxxx 00000 X.X.X.
W I T N E S S E T H :
WHEREAS, OSI is a leading drug discovery company which has assembled a
strong platform of technologies for drug discovery;
WHEREAS, OSI and Vanderbilt University, through its Vanderbilt
University Medical Center and Vanderbilt Diabetes Center (collectively
"Vanderbilt"), are jointly conducting a research program in the area of
diabetes, pursuant to an Amended and Restated Collaborative Research, License
and Alliance Agreement between OSI and Vanderbilt (and Tanabe for certain
sections therein) dated as of even date herewith (the "Vanderbilt Agreement");
WHEREAS, Tanabe is a leading pharmaceutical company and has the
capability for preclinical and clinical development, manufacturing and marketing
of pharmaceutical products for the prevention, treatment and management of human
diseases, including agents directed to diabetes;
WHEREAS, Tanabe wishes to collaborate with OSI, and OSI wishes to
collaborate with Tanabe, in the research and development of pharmaceutical
products directed toward the prevention, treatment and management of diabetes on
the terms and conditions set forth herein; and
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WHEREAS, OSI wishes to contribute to, and provide for the benefit of,
the collaboration between OSI and Tanabe certain results from OSI's
collaboration with Vanderbilt pursuant to the Vanderbilt Agreement.
NOW, THEREFORE, in consideration of the foregoing premises and the
mutual covenants and agreements contained in this Agreement and intending to be
legally bound, the parties agree as follows:
1. Definitions.
Whenever used in this Agreement, the terms defined in this
Section 1 shall have the meanings specified.
1.1 "Affiliate" shall mean any corporation or other legal
entity owning, directly or indirectly, more than fifty percent (50%) of the
voting capital shares or voting rights of Tanabe or OSI; any corporation or
other legal entity more than fifty percent (50%) of the voting capital shares or
voting rights of which is owned, directly or indirectly, by Tanabe or OSI; or
any corporation or other legal entity more than fifty percent (50%) of the
voting capital shares or voting rights of which is owned, directly or
indirectly, by a corporation or other legal entity which owns, directly or
indirectly, more than fifty percent (50%) of the voting capital shares or voting
rights of Tanabe or OSI.
1.2 "Assay Materials" shall mean any reagents, cell
lines, antibodies, antigens and other substances relating to the assays provided
by OSI to Tanabe pursuant to Section 2.2.1 hereof.
1.3 "Budget" shall have the meaning set forth in Section
3.1.1.
1.4 "Budgeted Amount" shall have the meaning set forth in
Section 3.1.1
1.5 "Clinical Development and Marketing Phase" shall
mean, on a Compound-by-Compound basis, the period commencing with Phase III
clinical trials and shall
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continue through the marketing of a Product.
1.6 "Compound" shall mean any OSI Compound or Tanabe
Compound, either collectively or separately, as applicable.
1.7 "Confidential Information" shall mean Tanabe
Confidential Information and OSI Confidential Information, either separately or
collectively, as may be applicable.
1.8 "Contract Period" shall mean the period during which
OSI is conducting the Research Program jointly with Tanabe. The initial term and
the extension thereof is set forth in Section 8.1 hereof.
1.9 "Dispute" shall have the meaning set forth in Section
10.2.
1.10 "Drug Discovery Phase" shall mean, on a
Compound-by-Compound basis, the period commencing with initial research and
development of a Compound aimed at a Product and shall conclude upon the
transfer of the Materials of a Lead Compound after the identification thereof.
The Drug Discovery Phase shall include identification of the Targets, assay
development, screening, identification of Seed Compounds, optimization of Seed
Compounds and identification of Lead Compounds.
1.11 "Early Development Phase" shall mean, on a
Compound-by-Compound basis, the period commencing upon the determination by
Tanabe to initiate the optimization of a Lead Compound pursuant to Section
2.4.1(f) hereof and concluding upon the completion of all of the Phase II
clinical trials. The Early Development Phase shall include the identification of
an IND candidate.
1.12 "Early Termination" shall have the meaning set forth
in Section 8.2.
1.13 "Effective Date" shall mean October 1, 1999.
1.14 "Event of Default" shall have the meaning set forth
in Section 8.3 hereof.
1.15 "FDA" shall mean the United States Food and Drug
Administration.
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1.16 "Field" shall mean the discovery, development,
manufacture and marketing of human therapeutic products for the treatment,
prevention or management of diabetes.
1.17 "Fourth Year FTE Rate" shall have the meaning set
forth in Section 3.1.
1.18 "FTE" shall have the meaning set forth in Section 2.6
hereof.
1.19 "FTE Rate" shall have the meaning set forth in
Section 3.1 hereof.
1.20 "Funding Amount" shall have the meaning set forth in
Section 3.1 hereof.
1.21 "Improvements" shall mean any and all inventions and
patents, discoveries, methods, ideas, works of authorship, know-how, data,
clinical and preclinical results, information, and any physical, chemical or
biological material, including any replication or any part of such material,
techniques and Technology, whether or not patentable or subject to other forms
of protection, which (i) are made, created, developed, written, conceived, or
reduced to practice, or which are licensed or otherwise acquired from Third
Parties (to the extent the disclosing party is legally enabled to disclose and
use the same in the Research Program), in the course of, arising out of, or as a
result of conducting the Research Program, and (ii) are related to the Targets.
Improvements include all rights relating to the protection of trade secrets and
Confidential Information, and any right analogous to those set forth in this
Section 1.21, which relate to, are embodied in or are appurtenant to such
discoveries, methods, ideas, etc.
1.22 "IND" shall mean an Investigational New Drug
application filed with the FDA and any equivalent foreign filing.
1.23 "Joint Management Committee" has the meaning
specified in Section 2.4.2 hereof.
1.24 "Joint Patents" shall mean the patents and patent
applications owned or filed jointly in the name of Tanabe and OSI (and
Vanderbilt, where applicable), both inside and
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outside the United States, arising in the course of conducting the Research
Program, including patents and patent applications arising from Improvements,
which relate to the research, development, manufacture, composition, derivative,
use or sale of Compounds or Products, including, without limitation, all
substitutions, extensions, Supplementary Protection Certificates, reissues,
renewals, divisions, continuations, continuations in part, utility models and
certificates of invention thereof, all of which shall be from time to time
identified to the Joint Management Committee.
1.25 "Lead Compound" shall mean a Compound and its
derivatives (i) which meets all of the criteria set forth on Exhibit B attached
hereto, or (ii) which Tanabe has designated in writing as a Lead Compound as set
forth in Section 2.2.3(b).
1.26 "Materials" shall have the meaning set forth in
Section 2.5.3 hereof.
1.27 "NDA" shall mean any and all applications (New Drug
Applications) submitted to the FDA under Sections 505, 507 or 512 of the Food,
Drug & Cosmetic Act and applicable regulations related to a Product, and any
equivalent foreign filing.
1.28 "Net Sales" shall mean the gross revenues from the
first sales of a Product by the Selling Party, its Affiliates and/or its
sublicensees to Third Parties, less deductions for:
(a) standard transportation charges,
including insurance, consistent with custom in the industry;
(b) import, export, sales, use and
excise taxes, tariffs and duties paid or allowed by the Selling Party, its
Affiliates and/or its sublicensees, and any other governmental charges imposed
upon the production, importation, use or sale of a Product;
(c) discounts (including retroactive
price reductions or a statutorily required reimbursement) mandated by or granted
in response to state, provincial or federal law or regulation;
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(d) allowances or credits to customers
on account of recalls, rejection or return (including for spoiled, damaged and
outdated goods) in the ordinary course of business;
(e) rebates paid or credited to any
government or agency or any Third Party payor, administrator or contractee; and
(f) customary discounts and rebates
paid or credited by the Selling Party, its Affiliates and/or its sublicensees.
The computation of Net Sales shall not include sales between
or among the Selling Party and its Affiliates or sublicensees, except where such
Affiliates or sublicensees are end users.
1.29 "Option Period" shall mean the ** period following
the expiration of the Contract Period on the fourth anniversary of the Effective
Date or such later date if the
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** This portion has been redacted pursuant to a request for confidential
treatment.
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Contract Period is renewed pursuant to Section 8.1.3 hereof.
1.30 "Option Payment" shall have the meaning set forth in
Section 8.4.1(c).
1.31 "OSI Compound" shall mean (a) any compound and
derivative thereof from OSI's compound library and (b) any product and
derivative thereof from OSI's natural products library, in each case, which is
selected by OSI in its sole discretion.
1.32 "OSI Confidential Information" shall mean all
information about any element of OSI Technology which is disclosed by OSI to
Tanabe, and designated "Confidential" in writing by OSI at the time of such
disclosure (or, if disclosed orally, within ** thereafter), subject to the
exceptions set forth in Section 4.5 hereof.
1.33 "OSI Patents" shall mean the patents and patent
applications owned by, filed by or licensed to OSI, its Affiliates and/or
Vanderbilt, both inside and outside the United States, which are not Joint
Patents, and the Valid Claims of which patents and patent applications cover the
research, development, manufacture, use or sale of the Compounds or the
Products, including, without limitation, all substitutions, extensions,
Supplementary Protection Certificates, reissues, renewals, divisions,
continuations, continuations in part, utility models and certificates of
invention thereof, all of which shall be, from time to time, identified to the
Joint Management Committee.
1.34 "OSI Product" shall mean a pharmaceutical product
containing a Lead Compound derived from an OSI Compound which is directed to a
Target and which is sold for the prevention, treatment or management of any
disease state in a human patient or any other human therapeutic indication.
1.35 "OSI Technology" shall mean Technology (a) which is
not an
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** This portion has been redacted pursuant to a request for confidential
treatment.
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Improvement and (b) which is owned by or licensed to OSI, its Affiliates and/or
Vanderbilt as of the Effective Date or during the Contract Period (including any
VU Technology (as defined in the Vanderbilt Agreement) licensed to OSI by
Vanderbilt pursuant to the Vanderbilt Agreement), that may be useful or
necessary for work on any of the Targets and that may be applicable to the
objectives of this Agreement, but only to the extent that either OSI, its
Affiliates or Vanderbilt is legally entitled to disclose such acquired
Technology and use it to achieve the objectives of this Agreement.
1.36 "Pharmaceutical Partner" shall mean any entity (other
than an academic institution or an entity which provides research services for a
fee) which is in the business of drug discovery and/or marketing. Pharmaceutical
Partner shall specifically not include Tanabe.
1.37 "Products" shall mean the OSI Products and the Tanabe
Products, collectively or separately, as may be applicable.
1.38 "Remaining Right Period" shall mean the ** period
following the expiration of the Contract Period on the fourth anniversary of the
Effective Date or such later date if the Contract Period is renewed pursuant to
Section 8.1.3 hereof.
1.39 "Research Plan" shall mean the written research plan
to be carried out during the Contract Period by Tanabe and OSI together with
Vanderbilt as described in Section 2.1 hereof and the first year Research Plan
is attached hereto as Exhibit E.
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** This portion has been redacted pursuant to a request for confidential
treatment.
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1.40 "Research Program" shall mean the collaborative
research program to be carried out during the Contract Period by Tanabe and OSI
together with Vanderbilt pursuant to Section 2 hereof and attached hereto as
Exhibit D.
1.41 "Royalty-Receiving Party" shall mean the party which
has granted a license under Section 5.1.1 or Section 5.1.2.
1.42 "Seed Compound" shall mean (a) a Compound and its
derivatives which meets all of the criteria set forth on Exhibit A attached
hereto or (b) a Compound which has been designated by the Joint Management
Committee as a Seed Compound.
1.43 "Selling Party" shall mean the party holding a
license under Section 5.1.1 or 5.1.2.
1.44 "Steering Committee" shall have the meaning set forth
in Section 2.4.1 hereof.
1.45 "Tanabe Compound" shall mean (a) any compound and
derivative thereof from Tanabe's compound library, and (b) any product and
derivative thereof from Tanabe's natural products library, in each case, which
is selected by Tanabe at its sole discretion.
1.46 "Tanabe Confidential Information" shall mean all
information about any element of Tanabe Technology which is disclosed by Tanabe
to OSI and designated "Confidential" in writing at the time of such disclosure
(of, if disclosed orally, within ** thereafter), subject to the exceptions set
forth in Section 4.5 hereof.
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** This portion has been redacted pursuant to a request for confidential
treatment.
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1.47 "Tanabe Patents" shall mean the patents and patent
applications owned by, filed by or licensed to Tanabe and/or its Affiliates,
both inside and outside the United States, which are not Joint Patents, and the
Valid Claims of which patents and patent applications cover the research,
development, manufacture, use or sale of the Compounds or the Products,
including, without limitation, all substitutions, extensions, Supplementary
Protection Certificates, reissues, renewals, divisions, continuations,
continuations in part, utility models and certificates of invention thereof, all
of which shall be, from time to time, identified to the Joint Management
Committee.
1.48 "Tanabe Product" shall mean a pharmaceutical product
containing a Lead Compound derived from a Tanabe Compound which is directed to a
Target and which is sold for the prevention, treatment or management of any
disease state in a human patient or any other human therapeutic indication.
1.49 "Tanabe Technology" shall mean Technology (a) which
is not an Improvement and (b) which is owned by or licensed to Tanabe and/or its
Affiliates as of the Effective Date or during the Contract Period, that may be
useful or necessary for work on the Targets and that may be applicable to the
objectives of this Agreement, but only to the extent that Tanabe or its
Affiliates is legally entitled to disclose such acquired Technology and use it
to achieve the objectives of this Agreement.
1.50 "Targets" shall mean the targets which have been
identified as the subject of the research carried out under the Research Program
as listed on Exhibit C, which list may be supplemented or amended from time to
time as provided in Section 2.4.1(f) hereof.
1.51 "Technology" shall mean and include all tangible or
intangible know-how, trade secrets, inventions (whether or not patentable),
data, clinical and preclinical results and any
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physical, chemical or biological material that pertain to the development of
human therapeutic products, including all laboratory notebooks, research plans,
cultures, strains, vectors, genes and gene fragments and their sequences, cell
lines, hybridoma cell lines, monoclonal and polyclonal antibodies, proteins and
protein fragments, non-protein chemical structures and methods for synthesis,
structure-activity relationships, computer models of chemical structures,
computer software, assay methodology, processes, materials and methods for
production, recovery and purification of nature products, formulas, plans,
specifications, characteristics, equipment and equipment designs, marketing
surveys and plans, business plans and experience.
1.52 "Term" shall have the meaning set forth in Section
8.1.4 hereof.
1.53 "Third Party" shall mean any individual, estate,
trust, partnership, joint venture, association, firm, corporation, company or
other entity, other than the parties hereto and their respective Affiliates,
sublicensees and successors. Third Party shall include, without limitation,
Vanderbilt.
1.54 "Third Year FTE Rate" shall have the meaning set
forth in Section 3.1.
1.55 "Two Year Minimum Requirements" shall mean (a)
completion of high throughput screening of a minimum of ** and up to ** (the
number of Tanabe Compounds shall be decided by Tanabe at its discretion) against
each of ** Targets; and (b) identification of ** from different Targets.
1.56 "Two Year Report" shall have the meaning set forth in
Section 8.1.2.
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** This portion has been redacted pursuant to a request for confidential
treatment.
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1.57 "Valid Claim" shall mean a claim of an issued patent
so long as such claim shall not have been disclaimed by the party(s) owning such
patent, or shall not have been held invalid or unenforceable in a final decision
rendered by a tribunal of competent jurisdiction from which no appeal has been
or can be taken.
1.58 "Withholding Tax" shall mean the withholding of tax
at the source of income.
2. Collaboration Between the Parties.
2.1 Research Plan. During the first year of the Contract
Period, the Research Program will be conducted pursuant to the Research Plan
annexed hereto as Exhibit E. Thereafter, the Research Plan for each succeeding
year during the Contract Period shall be prepared and approved by the Steering
Committee at a meeting of the Steering Committee held prior to the end of each
year until the end of the Contract Period and shall be set forth within the
minutes of such meeting. The Research Plan shall be in line with the Research
Program annexed hereto as Exhibit D.
2.2 Allocation of Responsibilities for the Research
Program.
2.2.1 Responsibility of OSI. As between OSI and
Tanabe, the Drug Discovery Phase shall be the sole responsibility of OSI,
subject to the last three sentences of this Section 2.2.1, and shall be funded
in accordance with Section 3.1 hereof. Pursuant to the Research Program and the
Vanderbilt Agreement, OSI shall work together with Vanderbilt to fulfill its
responsibilities during the Drug Discovery Phase. OSI will use its commercially
reasonable and diligent efforts, and shall undertake to ensure that Vanderbilt
uses its commercially reasonable and diligent efforts, to achieve the objectives
of the Research Program. OSI's responsibilities shall include:
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(a) identification of Targets;
(b) assay development;
(c) screening of the OSI Compounds and
the Tanabe Compounds against the Targets;
(d) identification of Seed Compounds
which meet the criteria set forth on Exhibit A, attached hereto;
(e) optimization of Seed Compounds; and
(f) identification of Lead Compounds
which meet the criteria set forth on Exhibit B, attached hereto.
OSI shall fulfill its responsibilities in the Drug Discovery Phase by
using its own, its Affiliates' and/or Vanderbilt's (i) drug discovery resources
(e.g., compound libraries, library design, automation, building blocks,
informatics, computation tools, high throughput screening capacity, medicinal
chemistry, high speed analoging, combinatorial chemistry, automated synthesis,
automated determination of pharmaceutical parameters, in vivo pharmacology,
array assays), (ii) transcription technology, and (iii) any assay high
throughput screening formatted for the Target.
As part of the Drug Discovery Phase, OSI will provide to Tanabe, at
Tanabe's request and at ** Technology for any assays developed by OSI, its
Affiliates and/or Vanderbilt for purposes of the Research Program. OSI shall
supply to Tanabe, at Tanabe's request, bulk Assay Materials, the cost of which
shall be ** . Tanabe will screen its natural products library against the
Targets
---------------------
** This portion has been redacted pursuant to a request for confidential
treatment.
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using such assay technology and bulk Assay Materials and will provide the
results of such screening to OSI for use in the Research Program.
2.2.2 Compound Withdrawal.
(a) Compound Exchange. Tanabe may
supply Tanabe Compounds to other Pharmaceutical Partners for screening against
such Pharmaceutical Partners' targets. If any activity of such Tanabe Compounds
is identified in such other Pharmaceutical Partner's screening, Tanabe may
withdraw such Tanabe Compound from the Research Program provided that such
Compound has not met the criteria set forth on Exhibit A for a Seed Compound.
Notwithstanding anything to the contrary set forth in this Agreement, each party
understands and agrees that the supply of Compounds to Pharmaceutical Partners
by Tanabe for screening against targets of such Pharmaceutical Partners may
unknowingly result in overlap between such targets and the Targets hereunder and
Tanabe shall be entitled to engage in such Pharmaceutical Partners' research
program even after such overlap becomes known to Tanabe upon the activity
identification of such Compound in any such other Pharmaceutical Partner's
screening and such Compound shall not be subject to milestone/royalty payments
hereunder. In no event shall Tanabe, in connection with any such Compound supply
or exchange, disclose Confidential Information, Technology, or Patents of OSI or
knowingly permit any such Pharmaceutical Partner to screen Compounds against
targets which are Targets hereunder.
(b) Withdrawal of Seed Compound. During
the Contract Period, OSI and Tanabe shall not (i) withdraw any Compound which
meets the criteria of or is otherwise identified as a Seed Compound from the
Research Program, or (ii) include any Compound which meets the criteria of or is
otherwise identified as a Seed Compound in a collaboration research program with
any Third Party (except Vanderbilt under the Vanderbilt
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Agreement).
2.2.3 Commencement of Early Development Phase. The
Early Development Phase with respect to a Lead Compound shall be the
responsibility of Tanabe, subject to the provisions set forth in subsection (a)
below. Tanabe shall use commercially reasonable and diligent efforts to achieve
the objectives of the Research Program. To achieve the objectives of the Early
Development Phase and the Clinical Development and Marketing Phase, Tanabe will
use commercially reasonable and diligent efforts and standard procedures
consistent with those used with Tanabe's own internal compounds and products of
like potential to (i) assess safety and efficacy of the selected Lead Compounds
in animals and in human patients under conditions designed to yield data
suitable for inclusion in submission(s) necessary to obtain market
authorization, (ii) develop manufacturing methods and pharmaceutical
formulations for those selected Lead Compounds, and (iii) develop strategies
and/or enter into appropriate partnering arrangements in order to effectively
commercialize Products on a worldwide basis. In connection with the foregoing,
Tanabe agrees to hold at least one meeting per year of its product development
team at which the progress of the Early Development Phase and/or the Clinical
Development and Marketing Phase, as the case may be, shall be reported. OSI
shall be provided with 60 days prior written notice of such team meetings and
shall have the right to attend such meetings at OSI's cost.
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(a) OSI Participation. Promptly after
the identification of a Lead Compound by OSI and/or Vanderbilt pursuant to
Section 2.2.1, OSI shall transfer the Materials of the Lead Compound to Tanabe,
and Tanabe shall determine, within ** following such transfer of Materials,
whether to initiate the Early Development Phase with respect to such Lead
Compound. Thereafter, OSI and Tanabe shall discuss the extent of OSI's
participation, or OSI's participation together with Vanderbilt, in the Early
Development Phase with respect to such Lead Compounds. Tanabe shall have the
option to assume sole responsibility for the Early Development Phase or to share
responsibility with OSI or OSI together with Vanderbilt. If Tanabe determines
that OSI or OSI together with Vanderbilt shall assume certain responsibilities,
such responsibilities shall be funded in accordance with Section 3.2 hereof.
(b) Tanabe's Designation as Lead
Compound. Tanabe may, upon written notice to OSI, designate any Compound as a
Lead Compound at any time during the Contract Period and, subject to the
provisions of Section 8.4.1(c), the Remaining-Right Period, provided that such
Compound has resulted from the Drug Discovery Phase. In such case, OSI shall
transfer the Materials of the Lead Compound to Tanabe and Tanabe shall initiate
the Early Development Phase with respect to such Lead Compound within ** after
such transfer, which initiation shall be deemed to be an exercise by Tanabe of
the option granted to it in Section 5.1.1.
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** This portion has been redacted pursuant to a request for confidential
treatment.
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(c) Tanabe's Responsibility for
Clinical Development and Marketing Phase. The Clinical Development and Marketing
Phase with respect to a Lead Compound shall be the sole responsibility of
Tanabe, subject to the provisions regarding reversion of the exclusive
option/exclusive license set forth in Section 5.1.2 hereof.
2.3 Exclusivity.
2.3.1 **
(a) **
(b) **
2.3.2 **
2.3.3 Development Of Other Products Directed
Towards Targets. If (i) a product is derived as a result of the exercise of a
non-exclusive license with respect to VU Technology or VU Patents (as such terms
are defined in the Vanderbilt Agreement) granted by Vanderbilt to not-for-profit
entities or the U.S. Federal Government under Sections 2.1.4 and 5.3 of the
Vanderbilt Agreement, and (ii) such a product is directed toward the same Target
as a Product developed hereunder, and (iii) as a result of the development and
commercial sale of such product the commercial viability of the Product
developed hereunder is jeopardized or negatively affected, then OSI and Tanabe
will negotiate in good faith the modification of the milestone and royalty
payments set forth in Sections 3.3.2, 3.3.3 and 5.5 with respect to such
Product.
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** This portion has been redacted pursuant to a request for confidential
treatment.
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2.4 Committees.
2.4.1 Steering Committee.
(a) Activities. The parties shall
establish a Steering Committee (the "Steering Committee"), which shall remain in
existence for the Contract Period and which may co-exist with any other
committees which may be formed pursuant to Sections 2.4.2, 2.4.3 and 2.4.4
hereof, for the following purposes:
(i) to prepare and approve the
Research Plan for each year in advance of the beginning of such year during the
Contract Period in accordance with the provisions of Section 2.1 hereof; and
(ii) to prepare and approve the
Budget for each year during the Contract Period.
(b) Membership. Tanabe and OSI each
shall appoint, in its sole discretion, ** from either its own or its Affiliates'
directors, officers, or employees to the Steering Committee. Substitutes may be
appointed at any time with the prior written approval of the other party, which
approval shall not be unreasonably withheld or delayed. The members initially
shall be:
Tanabe Appointees OSI Appointees
----------------- --------------
** **
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** This portion has been redacted pursuant to a request for confidential
treatment.
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(c) Chairs. The Steering Committee
shall be chaired by one of the members appointed by Tanabe. The chair shall
establish the agenda for meetings and coordinate follow-up actions.
(d) Meetings. The Steering Committee
shall meet at least ** per year, at places and on dates selected by each party
in turn. In addition to members of the Steering Committee, representatives of
Tanabe and OSI, and their respective Affiliates, and Vanderbilt may attend such
meetings at the invitation of either party; however, such invitees shall not be
entitled to vote in any matter which comes before the Steering Committee.
(e) Minutes. The Steering Committee
shall keep accurate minutes of its deliberations and shall record all proposed
decisions and all actions recommended or taken. The minutes shall be delivered
in draft form to all Steering Committee members within 10 working days after
each meeting. The party hosting the meeting shall be responsible for the
preparation of the minutes. Draft minutes shall be edited by the chair and shall
be issued in final form only with the chair's approval and agreement. The
minutes for the final meeting of each year shall include the approved Research
Plan for the next succeeding year and, from time to time as provided for herein,
reports on progress under the Research Plan then in effect.
(f) Decisions. All decisions or actions
of the Steering Committee shall be made by majority of the members (including
the chair), subject to the last sentence of this Section 2.4.1(f). ** .
Notwithstanding the foregoing, only the Tanabe
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** This portion has been redacted pursuant to a request for confidential
treatment.
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representatives on the Steering Committee shall have the right to make decisions
and actions with respect to the following issues:
(i) **
(ii) **
(g) Expenses. Tanabe and OSI shall each
bear all expenses of their respective members related to the participation on
the Steering Committee.
2.4.2 Joint Management Committee.
(a) Activities. The parties shall
establish a Joint Management Committee (the "Joint Management Committee") which
shall remain in existence for the Contract Period for the following purposes:
(i) to direct the
implementation of the Research Plans;
(ii) to modify the Research
Plans as appropriate;
(iii) to coordinate and monitor
publication of research results obtained from the exchange of information and
Materials that relate to the Research Programs;
(iv) to coordinate and monitor
patent applications with respect to Tanabe Patents and OSI Patents to be filed
during the Contract Period; and
(v) to determine which party
is responsible for the following activities relating to Improvements and/or
Joint Patents: (a) filing applications for letters patent on any patentable
invention included in Improvements; (b) prosecuting all
-------------------
** This portion has been redacted pursuant to a request for confidential
treatment.
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pending and new patent applications involving Improvements, and responding to
oppositions filed by Third Parties against the grant of letters patent for such
applications, provided that the prosecuting party shall also provide to the
other party copies of all documents relating to prosecution of all patent
applications and/or oppositions filed by Third Parties; and (c) maintaining in
force any letters patent included in Joint Patents by duly filing all necessary
papers and paying any fees required by the patent laws of the particular country
in which such letters patent were granted.
(b) Membership. Tanabe and OSI each
shall appoint, in its sole discretion, ** from either its own or its Affiliates'
directors, officers or employees to the Joint Management Committee. Substitutes
may be appointed at any time with the prior written approval of the other party,
which approval shall not be unreasonably withheld or delayed. The members
initially shall be:
Tanabe Appointees OSI Appointees
----------------- --------------
** **
(c) Co-Chairs. The Joint Management
Committee shall be co-chaired by one of the Tanabe appointees and one of the OSI
appointees. The co-chairs shall together establish the agenda for meetings and
coordinate follow-up actions.
(d) Meetings. The Joint Management
Committee shall meet at least ** per year, at places and on dates selected by
each party in turn. In addition to the members of the Joint Management
Committee, representatives of Tanabe and OSI, and their
-------------------
** This portion has been redacted pursuant to a request for confidential
treatment.
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respective Affiliates, and Vanderbilt may attend such meetings at the invitation
of either party; however, such invitees shall not be entitled to vote in any
matter which comes before the Joint Management Committee. In addition to such
meetings, the members of the Joint Management Committee shall exchange
information as frequently as possible, by means of telephone, facsimile, e-mail
or other method of communication.
(e) Minutes. The Joint Management
Committee shall keep accurate minutes of its deliberations and shall record all
proposed decisions and all actions recommended or taken. The minutes shall be
delivered in draft form to all Joint Management Committee members within ten
working days after each meeting. The party hosting the meeting shall be
responsible for the preparation of the minutes. Draft minutes shall be edited by
the co-chairs and shall be issued in final form only with the co-chairs'
approval and agreement.
(f) Decisions. **
(g) Expenses. Tanabe and OSI shall each
bear all expenses of their respective members related to the participation on
the Joint Management Committee.
2.4.3 Subcommittees. The Steering Committee shall
have authority to appoint subcommittees (in addition to the Joint Management
Committee provided for in Section 2.4.2 hereof) and delegate to such
subcommittees powers and duties determined by the Steering Committee. Such
subcommittees may include persons who are not members of the Joint Management
Committee. A subcommittee meeting (face-to-face, telephone conference or video
conference) shall be held as agreed by the parties.
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** This portion has been redacted pursuant to a request for confidential
treatment.
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2.4.4 Future Committees. During the Contract
Period, the parties will discuss the necessity for and composition of other
future committees.
2.5 Reports and Materials.
2.5.1 Disclosure of Technology and Improvements.
Promptly following the Effective Date, OSI shall provide to Tanabe any OSI
Technology related to the Targets which is in the possession of OSI, its
Affiliates and/or Vanderbilt as of the Effective Date, subject to, in the case
of Vanderbilt, the consent of the Investigators (as such term is defined in the
Vanderbilt Agreement). OSI shall continue to provide additional OSI Technology
to Tanabe from time to time during the Contract Period promptly upon becoming
aware of the existence of such additional OSI Technology. Each party shall
promptly inform the other party of all Improvements concerning the Targets that
are conceived, made or developed in the course of carrying out the Research
Program solely by employees of, or consultants to, that party or jointly with
employees of, or consultants to, the other party. OSI shall likewise promptly
inform Tanabe of all Improvements concerning the Targets that are conceived,
made or developed in the course of carrying out the Research Program solely by
employees of, or consultants to, Vanderbilt or jointly with employees of, or
consultants to OSI, subject to the consent of the Vanderbilt Investigators. This
Agreement shall not be construed to obligate a party to disclose to the other
party any Technology which does not concern the Targets or potential Targets
except to the extent necessary or useful for Tanabe's evaluation in acquiring
the license for OSI's potential product pursuant to Section 2.3.1.
2.5.2 Reports. During the Contract Period, OSI
shall furnish to the Joint Management Committee summary written reports within
15 days after the end of each calendar month, commencing on the Effective Date,
describing the progress of OSI and Vanderbilt under
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the Research Program. During the Research Program, Tanabe shall furnish to the
Joint Management Committee quarterly summary written reports within 15 days
after the end of each calendar quarter, commencing on the Effective Date,
describing its progress under the Research Program. The Joint Management
Committee shall provide to the Steering Committee a summary written report of
the progress of the Research Program prior to each meeting of the Steering
Committee.
2.5.3 Materials. OSI and Tanabe shall, during the
Contract Period, whether in accordance with the Research Plans or upon the
written request of a party, furnish to the requesting party samples of
biochemical, biological or synthetic chemical materials ("Materials") which are
part of the Improvements, OSI Technology or Tanabe Technology, and which are
useful or necessary for such party to carry out its rights and responsibilities
under the Research Plans and this Agreement.
2.6 Laboratory Facilities and Personnel. OSI and Tanabe
shall each provide suitable laboratory facilities, equipment and personnel for
the work to be done by each of them to diligently carry out their respective
activities under the Research Program and OSI shall undertake that Vanderbilt
shall provide the same. During the Contract Period, OSI will assign duties under
the Research Plans to the full-time equivalent ("FTE") of ** scientists during
the first year, ** scientists during the second year, and ** scientists during
each of the third and fourth years of the Contract Period. Immediately upon
assignment of any Ph.D. scientists to the Research Program, OSI shall provide to
Tanabe the resume/curricula vitae of all such
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** This portion has been redacted pursuant to a request for confidential
treatment.
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Ph.D. scientists who will be engaged in the Research Program as FTEs, ** . In
principle, ** of the total personnel time of FTEs allocated to the Research
Program shall be performed by such Ph.D. scientists. OSI itself shall employ, in
addition to those personnel employed at Vanderbilt, ** biologists or
pharmacologists in the Field for the purpose of evaluation of Seed Compounds and
Lead Compounds.
2.7 Tanabe Visiting Scientist. OSI shall undertake that
Tanabe may dispatch ** Tanabe scientists to the Vanderbilt Diabetes Center as
staff members at any time during the Contract Period. The length of stay for
such visiting scientists shall not be less than ** . In addition, during all
phases of the Contract Period, including without limitation, target
identification, assay development, screening and chemistry for the
identification of the Lead Compounds, OSI shall accept, at its research
facilities in Uniondale, New York and at its Affiliate's research facilities in
Aston, England, ** Tanabe visiting scientist(s) to participate in the work for
the Research Program under OSI's direction upon mutually agreed confidentiality
terms and conditions. With respect to the OSI facility located in Uniondale, New
York, Tanabe visiting scientists may visit such facility for up to ** during
each calendar year and ** Tanabe visiting scientists may be present at any one
visit. Notwithstanding the foregoing, OSI shall accept the additional visit of
Tanabe visiting scientists when any assay related to the Targets is transferred
to Tanabe. With respect to OSI's Affiliate's facility located in Aston, England,
OSI shall accept Tanabe visiting scientists to visit such facility for up to **
during any one calendar year. The detailed scheduling of such visits and the
number of visiting scientists to be included in any such visits shall be
reasonably mutually determined
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** This portion has been redacted pursuant to a request for confidential
treatment.
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by OSI and Tanabe. Tanabe shall be responsible for all expenses relating to
visas, transportation, lodging, salaries and benefits of such Tanabe visiting
scientist(s) and OSI shall be responsible for all such expenses as laboratory
space, office space, instruments, equipment and materials, necessary to allow
such Tanabe visiting scientist to engage in the work for the Research Program.
The Tanabe visiting scientist(s) shall be required to execute all
confidentiality agreements as are used from time to time by OSI. The Tanabe
visiting scientist(s) shall have access to all information, OSI Technology, OSI
Confidential Information and Improvements which are necessary or useful in order
to achieve the objectives of this Agreement or which may concern the Targets;
provided, however, that due to the fact that OSI is and will continue to be
conducting other research and development activities sponsored by Third Parties
other than the Research Program, OSI shall have sole and unfettered discretion
to exclude such Tanabe visiting scientist(s) from participation in any
activities in order to protect the confidentiality of such other activities.
2.8 Ownership of Improvements. OSI and Tanabe shall own
jointly all Improvements made or discovered either solely or jointly by Tanabe
and/or OSI and/or their respective employees during the Research Program. Any
Improvements which are Joint Technology under the Vanderbilt Agreement shall be
owned jointly by OSI, Tanabe and Vanderbilt. Each party represents and agrees
that all employees and other persons acting on its behalf in performing its
obligations under this Agreement shall be obligated to assign to such party or
as such party shall direct (to the extent such party is legally enabled to
disclose and use the same in the Research Program), all Improvements made or
developed by such employee or other person. OSI and Tanabe each agrees to
undertake to enforce such obligations (to the extent each party is legally
enabled to disclose and use the same in the Research Program), including, where
appropriate, by legal action, considering, among other things, the commercial
value of
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such Improvements. OSI shall undertake to have Vanderbilt agree to such
obligations with respect to Joint Technology under the Vanderbilt Agreement to
the same extent OSI is obligated hereunder.
3. Funding of the Research Program.
3.1 Contract Period Funding. During the Contract Period,
Tanabe shall pay to OSI its total actual research costs in carrying out the
Research Plans (the "Funding Amounts") at the rate (the "FTE Rate") of ** per
FTE during the first year of the Contract Period, ** per FTE during the second
year of the Contract Period, ** per FTE during the third year of the Contract
Period (the "Third Year FTE Rate"), and ** per FTE during the fourth year of the
Contract Period (the "Fourth Year FTE Rate"). The Funding Amounts for any given
period shall be calculated by ** . The aggregate Funding Amounts which Tanabe
shall be obligated to pay hereunder during each year during the Contract Period
shall not exceed ** during the first year of the Contract Period, ** during the
second year of the Contract Period, ** during the third year of the Contract
Period, and ** during the fourth year of the Contract Period. If the aggregate
Funding Amounts for a year exceed the Budgeted Amount for such year, OSI shall
bear such excess unless such excess had been approved by the Steering Committee.
3.1.1 Budgeted Amount. Prior to the beginning of
each year (or part thereof) during the Contract Period, the Steering Committee
shall approve a budget (the "Budget") of the Funding Amounts by OSI and
Vanderbilt necessary to fulfill the duties
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** This portion has been redacted pursuant to a request for confidential
treatment.
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assigned under the Research Plan for such year (the "Budgeted Amount"). The
Budgeted Amount shall not be less than ** for the first year of the Contract
Period, ** for the second year of the Contract Period, ** for the third year of
the Contract Period, and ** for the fourth year of the Contract Period. The
Budget for each year shall be consistent with the provisions of Section 2.6 and
Section 3.1 hereof. The Budget will be in form and detail as the Steering
Committee shall determine and shall be delivered to both parties in time to be
included in each party internal budgeting process.
3.1.2 Adjustments. Tanabe shall make prepayments
to OSI of the Budgeted Amount quarterly in advance for work scheduled to be
performed by OSI and/or Vanderbilt during any calendar quarter. Adjustments as
necessary to reflect the work actually performed by OSI and Vanderbilt shall be
made at the end of each quarter. Within 30 days of the close of a calendar
quarter, OSI shall invoice Tanabe for an amount equal to the Funding Amount for
such quarter. ** If the aggregate Funding Amount for a year exceeds the Budgeted
Amount and if the Steering Committee approved such excess in writing, ** .
3.1.3 Progress Pursuant to the Research Plan. The
amount of the Funding Amount for each quarter shall be based on the work in
progress pursuant to the Research Plan and the associated annual Budget.
3.1.4 Inspection of Funding Amount. OSI shall
keep, and shall undertake to have Vanderbilt keep, for seven years from the
expiration of the Contract Period complete and accurate records of OSI's and
Vanderbilt's expenditures of the Funding
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** This portion has been redacted pursuant to a request for confidential
treatment.
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Amounts received by OSI. The records shall conform to generally accepted
accounting principles as applied to a similar company similarly situated. Tanabe
shall have the right at its own expense during the Contract Period and during
the subsequent seven-year period to obtain from an independent certified public
accountant selected by Tanabe, an audit of said records to verify the accuracy
of such expenditures, pursuant to the Research Plan. OSI shall make, and shall
undertake to have Vanderbilt make, its records available for inspection by the
independent certified public accountant during regular business hours at the
place or places where such records are customarily kept, upon reasonable notice
from Tanabe, to the extent reasonably necessary to verify the accuracy of the
expenditures and required reports. This right of inspection shall not be
exercised more than once in any calendar year and not more than once with
respect to records covering any specific period of time, unless a subsequent
inspection reveals discrepancies which may have also occurred during such prior
period of time. Tanabe agrees to hold in strict confidence all information
concerning such expenditures, other than their total amounts, and all
information learned in the course of any audit or inspection, except to the
extent that it is necessary for Tanabe to reveal the information in order to
enforce any rights it may have pursuant to this Agreement or if disclosure is
required by law or competent authorities. The failure of Tanabe to request
verification of any expenditures before the expiration of the seven-year period
referred to above shall be considered acceptance of the accuracy of the invoices
for such expenditures, and OSI and Vanderbilt shall have no obligation to
maintain any records pertaining to such expenditures beyond the seven-year
period. The results of the inspection shall be binding on both parties. **
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** This portion has been redacted pursuant to a request for confidential
treatment.
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3.1.5 Minimization of Expenditures. OSI agrees to
use good faith efforts to conduct and to have Vanderbilt conduct the research
contemplated under this Agreement efficiently so as to minimize the Funding
Amounts made under this Agreement.
3.2 Sharing of Responsibilities in the Early Development
Phase. If, pursuant to Section 2.2.3, Tanabe determines that OSI or OSI together
with Vanderbilt shall share in the responsibilities of the Early Development
Phase, the parties shall mutually determine the number of additional FTEs which
shall be allocated to such responsibilities and Tanabe shall fund such
additional FTEs at the applicable FTE Rate in accordance with Section 3.1
hereof.
3.3 Technology Access Fee and Milestone Payments.
3.3.1 Technology Access Fee. Tanabe will pay to
OSI a technology access fee of ** in cash on the Effective Date.
3.3.2 Early Development Phase Milestones. Upon a
determination by Tanabe to initiate the Early Development Phase with respect
only to the first Lead Compound among all the Compounds within the same Target,
Tanabe shall make a cash milestone payment to OSI of ** . Upon IND approval in
the first country among the U.S., Japan and any of the countries in the European
Union (i.e., Austria, Belgium, Denmark, Finland, France, Germany, Greece,
Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden and the
United Kingdom of Great Britain and Northern Ireland (the "European Union
Countries")), with respect only to the first Lead Compound among all the
Compounds within the same Target, Tanabe shall make an additional cash milestone
payment to OSI of ** .
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** This portion has been redacted pursuant to a request for confidential
treatment.
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3.3.3 Clinical Development and Marketing Phase
Milestones. With respect to each Lead Compound, (i) upon the initiation of the
first Phase III clinical trials for the first indication in the first country
among the U.S., Japan and the European Union Countries, Tanabe shall make a
one-time cash milestone payment to OSI of ** (ii) upon filing of the first NDA
for the first indication in the first country among the U.S., Japan and any of
the European Union Countries, Tanabe shall make a one-time cash milestone
payment to OSI of ** and (iii) upon approval of the NDA for the first indication
in the first country among the U.S., Japan and in the European Union Countries,
Tanabe shall make a one-time cash milestone payment to OSI of ** . For each
Product for which Net Sales by Tanabe, its Affiliates and sublicensees in a
given year exceed ** worldwide, Tanabe shall pay OSI a one-time cash milestone
payment of **
4. Treatment of Confidential Information
4.1 Confidentiality.
4.1.1 Confidentiality and Non-Use Obligations.
Subject to the disclosure obligations set forth in Sections 2.5.1 and 4.3 hereof
and publication rights set forth in Section 4.2 hereof, (i) Tanabe agrees that
during the Contract Period and for five years thereafter, it will keep
confidential, and will cause its Affiliates to keep confidential, all OSI
Confidential Information, and neither Tanabe nor any of its Affiliates shall use
OSI Confidential Information except as expressly permitted in this Agreement and
(ii) OSI agrees
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** This portion has been redacted pursuant to a request for confidential
treatment.
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that during the Contract Period and for five years thereafter, it will keep
confidential, and will cause its Affiliates to keep confidential, all Tanabe
Confidential Information, and neither OSI nor any of its Affiliates shall use
Tanabe Confidential Information except as expressly permitted in this Agreement.
4.1.2 Disclosure of Confidential Information.
Tanabe and OSI acknowledge that the OSI Confidential Information and Tanabe
Confidential Information constitute highly valuable, proprietary, confidential
information, and each party agrees that any disclosure of the other party's
Confidential Information to any officer, employee or agent of such party or of
any of its Affiliates shall be made only if and to the extent necessary to carry
out its responsibilities under this Agreement and shall be limited to the
greatest extent possible consistent with such responsibilities. Subject to
Section 4.5 hereof, each party agrees not to disclose the other party's
Confidential Information to any Third Parties under any circumstance without
written permission of the other party; provided, however, that OSI may disclose
Tanabe Confidential Information to Vanderbilt, to the extent necessary in order
for OSI to perform its obligations under this Agreement and to the extent
Vanderbilt is obligated at least under the same degree of confidentiality and
non-use obligation as OSI is obligated hereunder. Each party shall take such
action and shall cause its Affiliates to take such action, and OSI will cause
Vanderbilt to make such action, to preserve the confidentiality of each other
party's Confidential Information as they would customarily take to preserve the
confidentiality of their own confidential information. Notwithstanding the
foregoing, the party that is granted the right to sublicense pursuant to Section
5.1 hereof shall be permitted to disclose any Improvement or the other party's
Confidential Information to any sublicensees of the Products (including
potential sublicensees) to the extent necessary or useful to exercise the
sublicense rights granted to it under Section 5.1.
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4.1.3 Employees and Consultants. Each party
represents that all of its employees and consultants participating in the
Research Program who shall have access to the other party's Confidential
Information are bound by agreement to maintain such information in confidence.
4.2 Publication. Section 4.1 hereof to the contrary
notwithstanding, the results obtained in the course of the Research Program
(including, without limitation, such results obtained by Vanderbilt under the
Vanderbilt Agreement) may be submitted for publication following scientific
review by the Joint Management Committee or any other committee charged with
such review and subsequent approval by OSI's and Tanabe's management. After
receipt of the proposed publication by Tanabe's and OSI's management, written
approval or disapproval shall be provided within 30 days for a manuscript,
within 30 days for an abstract for presentation at, or inclusion in the
proceedings of, a scientific meeting, and within 30 days for a transcript of an
oral presentation to be given at a scientific meeting. If any patentable
Technology is included in such publication or scientific meeting, the disclosure
thereof shall be delayed up to 90 additional days from the scheduled publication
date for the purpose of filing a patent application. The contribution of each
party shall be noted in all publications or presentations by acknowledgment or
co-authorship, whichever is appropriate. OSI shall undertake that Vanderbilt's
publication rights are restricted to the same extent as OSI is obligated
hereunder.
4.3 Press Release. Except as required by law, no party
may disclose the existence of this Agreement nor the research described in it
except with the written consent of the other party, which consent shall not be
unreasonably withheld or delayed. Neither party will issue a press release with
regard to matters relating to this Agreement without the other party's consent,
which consent shall not be unreasonably withheld. The party desiring to make any
such press release or other disclosure shall provide the other party with a
written copy of the proposed
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announcement or disclosure in sufficient time prior to the proposed press
release to allow such other party to comment upon the nature, text and timing of
such announcement or disclosure prior to the proposed press release.
Notwithstanding the foregoing, OSI may disclose the existence or the content of
this Agreement to Vanderbilt in order to enter into the Vanderbilt Agreement;
provided, however, that OSI shall obligate Vanderbilt at least under the same
degree of confidentiality and non-use obligation as OSI is obligated hereunder.
4.4 Restrictions on Transferring Materials. Tanabe and
OSI recognize that the Materials which are part of OSI Technology, Tanabe
Technology or Improvements represent valuable commercial assets. Therefore,
throughout the Contract Period and for ** thereafter (unless the other party
consents thereto, which consent shall not be unreasonably withheld or delayed),
each of OSI and Tanabe agrees not to transfer to any Third Party any such
Materials which constitute Technology owned solely by the other party to this
Agreement; provided, however, that OSI may transfer any such Materials to
Vanderbilt to the extent necessary in order for OSI to perform its obligations
under this Agreement and to the extent Vanderbilt is obligated at least under
the same degree of confidentiality and non-use obligation as OSI is obligated
hereunder. Additionally, throughout the Contract Period and for ** thereafter,
OSI and Tanabe agree not to transfer to any Third Party any Materials which are
part of the Improvements (except that OSI may transfer any such Materials to
Vanderbilt to
-------------------
** This portion has been redacted pursuant to a request for confidential
treatment.
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the extent necessary in order for OSI to perform its obligations under this
Agreement), unless prior consent for any such transfer is obtained from the
other party, which consent shall not be unreasonably withheld or delayed, and
unless such Third Party agrees as a condition of any such transfer not to
transfer the Materials further and to use the Materials only for academic
purposes not directed toward the development of compounds or products.
Notwithstanding the foregoing, the party granted the right to sublicense
pursuant to Section 5.1 hereof shall be permitted to supply Materials to any
sublicensees of the Products (including potential sublicensees) to the extent
necessary or useful to exercise the sublicense rights granted to it under
Section 5.1.
4.5 Permitted Use of Confidential Information. Nothing
contained herein will in any way restrict or impair any party's right to use,
disclose or otherwise deal with any Confidential Information which:
(a) at the time of disclosure is
properly in the public domain or thereafter becomes part of the public domain by
publication or otherwise through no breach of this Agreement by the party
receiving such information;
(b) the party receiving such
information can establish by competent evidence that such information was
properly in its possession prior to the time of the disclosure;
(c) is independently and properly made
available as a matter of right to the party receiving such information by a
Third Party (including, for purposes of this subsection sublicensees) who is not
thereby in violation of a confidential relationship;
(d) is information which is required to
be included in patent applications filed hereunder or required to be provided to
a government agency in order to obtain approvals to market Products; provided,
however, that Tanabe Confidential Information or OSI Confidential Information
shall not be disclosed in any such patent application or otherwise
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without the prior written consent of Tanabe or OSI, respectively, which consent
shall not be unreasonably withheld or delayed;
(e) is information which is required to
be disclosed to customers, users and prescribers of a Product, or which is
reasonably necessary to disclose in connection with the marketing of a Product;
or
(f) is information required to be
disclosed by law or by a court order or by competent authorities, in each of
which cases the disclosing party shall timely inform the other and use its best
efforts to limit the disclosure and maintain confidentiality to the extent
possible and will permit the other party to limit such disclosure.
5. Licenses and Royalties
5.1 Grant of Licenses.
5.1.1 Option to Tanabe. OSI hereby grants to
Tanabe an exclusive option, exercisable at any time during the Contract Period
and the Remaining Right Period, prior to commencement of the Early Development
Phase, to acquire, with respect to a Lead Compound, a worldwide exclusive
license, including the right to sublicense, under the OSI Technology, the OSI
Patents and OSI and/or Vanderbilt's rights in the Improvements and Joint Patents
to develop, have developed, make, have made, use, sell and have sold Products,
which license shall be exclusive (even as to OSI) (a) for so long as Tanabe is
obligated to pay a royalty under Section 5.5.1 hereof and (b) thereafter in
accordance with Section 5.2 hereof. The terms of any such license are set forth
in Sections 5.2 through 5.5 hereof. The option granted by OSI under this Section
5.1.1 shall automatically be deemed to be exercised by Tanabe by its decision to
initiate the Early Development Phase with respect to a Lead Compound.
5.1.2 License to OSI. In the event that (a) a Seed
Compound meets the criteria of a Lead Compound as set forth on Exhibit B and
Tanabe does not determine to initiate,
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directly or through its Affiliates or sublicensees, the Early Development Phase
with respect to such Lead Compound within ** following the transfer of the
Materials of the Lead Compound after the identification thereof by OSI and/or
Vanderbilt, or (b) Tanabe fails to commence, directly or through its Affiliates
or sublicensees, the Clinical Development and Marketing Phase with respect to a
Lead Compound within ** following completion of all of the Phase II clinical
trials for such Lead Compound unless such failure is beyond the reasonable
control of Tanabe, the exclusive option or exclusive license, as the case may
be, with respect to such Lead Compound, including, without limitation, the right
to complete development and the right to market a Product, shall revert to OSI
and Tanabe shall grant to OSI a worldwide exclusive license, including the right
to sublicense, under the Tanabe Technology, the Tanabe Patents and the Tanabe
rights in the Improvements and Joint Patents to develop, have developed, make,
have made, use, sell and have sold Products, which such license shall be
exclusive (even as to Tanabe) (a) for so long as OSI is obligated to pay a
royalty under Section 5.5.2 hereof and (b) thereafter in accordance with Section
5.2 hereof. The terms of any such license are set forth in Sections 5.2 through
5.5 hereof.
5.2 Paid-Up License. Provided that Tanabe or OSI, as the
case may be, has satisfied all of its obligations to pay royalties hereunder
with respect to a Product, such party shall have a paid-up exclusive
royalty-free license to manufacture, have manufactured, use, sell
-------------------
** This portion has been redacted pursuant to a request for confidential
treatment.
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and have sold such Product in each country after the expiration of such party's
last obligation to pay royalties on its Net Sales of such Product in such
country.
5.3 Obligations to Exploit the Products. Either Tanabe or
OSI, as the case may be, shall use commercially reasonable and diligent efforts
to exploit the Products. This requirement shall be deemed satisfied if such
party uses substantially the same degree of diligence it uses with respect to
products of similar commercial potential developed by such party outside of this
Agreement.
5.4 Sublicenses. If either Tanabe or OSI grants a
sublicense pursuant to Section 5, such party shall guarantee that any
sublicensee fulfills all of its obligations under this Agreement. In the event
Tanabe or OSI grants sublicenses under Section 5 to others to develop, have
developed, make, have made, use, sell or have sold Products, such sublicenses
shall include an obligation of the sublicensees to account for and report all
Net Sales of Products on the same basis as if such sales were Net Sales of
Products by such party, and such party shall pay royalties to the other party
under this Agreement as if the Net Sales of the sublicensee were Net Sales of
the sublicensor.
5.5 Royalty Payments, Accounting for Royalties, Records
and Withholding Tax.
5.5.1 Royalty Payments by Tanabe. Tanabe shall pay
to OSI a royalty of (a) ** of the Net Sales made by Tanabe, its Affiliates and
sublicensees of each Tanabe Product, and (b) ** of the Net Sales made by Tanabe,
its Affiliates and sublicensees of each OSI Product. Tanabe shall continue to
pay royalties on Net Sales of each Product on a country-
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** This portion has been redacted pursuant to a request for confidential
treatment.
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by-country basis so long as the manufacture, use and/or sale of such Product
would infringe a Valid Claim of an OSI Patent or a Joint Patent with respect to
such Product in such country or for ** following the date of first commercial
sale of such Product, whichever is longer. Upon the request of OSI, Tanabe will,
at its option, identify OSI on the packaging of all Products on which Tanabe is
obligated to pay royalties, subject to legal and commercial requirements on a
country-by-country basis and in a manner in accordance with such legal and
commercial requirements.
5.5.2 Royalty Payments by OSI. In the event that
the exclusive option or the exclusive license, as the case may be, with respect
to a Lead Compound revert to OSI and OSI is granted the license set forth in
Section 5.1.2 hereof, OSI shall pay to Tanabe a royalty of ** of Net Sales by
OSI, its Affiliates or sublicensees of each such Product. OSI shall continue to
pay such royalty on Net Sales of each Product commercialized by OSI, its
Affiliates or sublicensees on a country-by-country basis so long as the
manufacture, use and/or sale of such Product would infringe a Valid Claim of a
Tanabe Patent or a Joint Patent with respect to such Product in such country or
for ** following the date of first commercial sale of such Product, whichever is
longer.
5.5.3 Payment Dates. Royalties shall be paid by
Tanabe or OSI, as the case may be, on Net Sales within 90 days after the end of
each calendar quarter in which such Net Sales are made. Such payments shall be
accompanied by a statement showing the Net Sales of each Product in each country
and a calculation of the amount of royalty due.
5.5.4 Accounting. The Net Sales used for computing
the royalties payable to OSI by Tanabe, or to Tanabe by OSI, as the case may be,
shall be computed and
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** This portion has been redacted pursuant to a request for confidential
treatment.
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paid in U.S. Dollars. For purposes of determining the amount of royalties due
with respect to Net Sales in any foreign currency, the amount shall be computed
generally by converting the foreign currency amount into U.S. Dollars using for
each quarter's calculation the foreign currency exchange rate on the last day of
such quarter or such other method as is consistent with internal foreign
currency translation procedures of the Selling Party, as actually used by the
Selling Party on a consistent basis in preparing its audited financial
statements.
5.5.5 Records. Tanabe or OSI, as the case may be,
shall keep for seven years from the date of each payment of royalties complete
and accurate records of Net Sales made by such party, its Affiliates and
sublicensees of each Product in sufficient detail to allow the accruing
royalties to be determined accurately. The Royalty-Receiving Party shall have
the right for a period of seven years after receiving any report or statement
with respect to royalties due and payable to obtain, at its expense, from the
independent certified public accountant selected by the Royalty-Receiving Party,
an audit of the relevant records of the Selling Party to verify such report or
statement. The Selling Party shall make its records available for inspection by
such independent certified public accountant during regular business hours at
such place or places where such records are customarily kept, upon reasonable
notice from the Royalty-Receiving Party, to the extent reasonably necessary to
verify the accuracy of the reports and payments. Such inspection right shall not
be exercised more than once in any calendar year nor more than once with respect
to sales in any given period, unless a subsequent inspection reveals
discrepancies which may have also occurred during such period. Such independent
certified public accountant shall report to the Royalty-Receiving Party only as
to the accuracy of the Net Sales computation and royalty payments. The
Royalty-Receiving Party agrees to hold in strict confidence all information
concerning royalty payments and reports, and all information learned in the
course of any audit or inspection, except to the extent necessary for such party
to reveal
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such information in order to enforce its rights under this Agreement or
disclosure is required by law or by the competent authorities. The failure of
the Royalty-Receiving Party to request verification of any report or statement
during the seven-year period shall be considered acceptance of the accuracy of
such report, and the Selling Party shall have no obligation to maintain records
pertaining to such report or statement beyond the seven-year period. The results
of the inspection shall be binding on both parties.
5.5.6 Withholding Taxes.
(a) **
(b) Withholding to be Borne by
Royalty-Receiving Party. Any Withholding Tax imposed on any amounts under
Section 5.5 hereof shall be deducted from the amount otherwise due. The Selling
Party will assist the Royalty-Receiving Party in minimizing the Withholding Tax
applicable to any payment made by the Selling Party hereunder and in claiming
tax refunds at the Royalty-Receiving Party's request by providing such documents
and providing such other reasonable cooperation as may be necessary to assist
the Royalty-Receiving Party in receiving a tax refund or in claiming a foreign
tax credit and shall, upon the Royalty-Receiving Party's request, give proper
evidence from time to time as to the payment of such Withholding Tax.
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** This portion has been redacted pursuant to a request for confidential
treatment.
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5.6 Payment to Vanderbilt. OSI shall be responsible for
any payment which will be made to Vanderbilt for Vanderbilt's participation in
the Research Program, including, without limitation, any payment necessary to
obtain a license from Vanderbilt, and Tanabe shall not be obliged to make any
payment other than specifically set forth herein.
6. Provisions Concerning the Filing, Prosecution and Maintenance
of Patent Rights.
The following provisions relate to the filing, prosecution and
maintenance of OSI Patents and Tanabe Patents:
6.1 OSI Filing, Prosecution and Maintenance. OSI shall
have the exclusive right and obligation:
(a) to file applications on any
patentable invention relating to OSI Technology;
(b) to prosecute all pending and new
patent applications with respect to OSI Patents, and to respond to oppositions
filed by Third Parties against the grant of OSI Patents; and
(c) to maintain in force all OSI
Patents by duly filing all necessary papers and paying any fees required by the
patent laws of the particular country in which such OSI Patents were granted.
6.2 Tanabe Filing, Prosecution and Maintenance. Tanabe
shall have the exclusive right and obligation:
(a) to file applications on any
patentable invention relating to Tanabe Technology;
(b) to prosecute all pending and new
patent applications with respect to Tanabe Patents, and to respond to
oppositions filed by Third Parties against the grant
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of Tanabe Patents; and
(c) to maintain in force all Tanabe
Patents by duly filing all necessary papers and paying any fees required by the
patent laws of the particular country in which such Tanabe Patents were granted.
6.3 Legal Action.
6.3.1 Actual or Threatened Disclosure or
Infringement. When information comes to the attention of either Tanabe or OSI to
the effect that a Tanabe Patent, OSI Patent or Joint Patent or Improvement
relating to a Compound or Product have been or are threatened to be unlawfully
disclosed or that any of the rights granted by this Agreement have been or are
threatened to be unlawfully infringed, such party shall notify the other party
in writing and the Selling Party shall have the right at its expense to take
such action as it may deem necessary to prosecute or prevent such unlawful
disclosure or infringement, including the right to bring or defend any suit,
action or proceeding involving any such disclosure or infringement. The Selling
Party shall notify the Royalty-Receiving Party promptly of the receipt of any
such information and of the commencement of any such suit, action or proceeding.
If the Selling Party determines that it is necessary or desirable for the
Royalty-Receiving Party to join any such suit, action, or proceeding, the
Royalty-Receiving Party shall execute all papers and perform such other acts as
may be reasonably required to permit the Selling Party to act in the
Royalty-Receiving Party's name. If Tanabe is the Selling Party, and Tanabe
determines that it is necessary or desirable for Vanderbilt to join any such
suit, action, or proceeding, OSI shall undertake to have Vanderbilt execute all
papers and perform such
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other acts as may be reasonably required to permit Tanabe to act in Vanderbilt's
name but at no cost to OSI or Vanderbilt ** . In the event that the Selling
Party brings a suit, it shall have the right first to reimburse itself out of
any sums recovered in such suit or in its settlement for all reasonable costs
and expenses of every kind and character, including reasonable attorneys' fees,
involved in the prosecution of any suit, and ** of any funds that shall remain
from said recovery shall be distributed to the Royalty-Receiving Party and ** of
such funds shall be retained by the Selling Party.
If the Selling Party does not, within ** days after giving
notice to the Royalty-Receiving Party of the above-described information, notify
the Royalty-Receiving Party of the intent of the Selling Party to bring suit
against any infringer, the Royalty-Receiving Party shall have the right to bring
suit for such alleged infringement, but it shall not be obligated to do so, and
may cause the Selling Party to be joined as a party plaintiff, if appropriate,
in which event the Royalty-Receiving Party shall hold the Selling Party free,
clear, and harmless from any and all costs and expenses of such litigation,
including attorneys' fees, and any sums recovered in any such suit or in its
settlement shall belong to the Royalty-Receiving Party. However, ** of any such
sums received by the Royalty-Receiving Party, after deduction of the costs and
expenses of litigation, including attorneys' fees paid, shall be paid to the
Selling Party and ** of such sums shall be retained by the Royalty-Receiving
Party. Each party shall always have the right to be represented by counsel of
its own selection and at its own expense in any suit instituted by the other for
infringement, under the terms of this Section. If the Selling Party lacks
standing to bring any such suit, action, or proceeding, then the
Royalty-Receiving Party shall do so at the request of the Selling Party and at
the Selling Party's expense.
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** This portion has been redacted pursuant to a request for confidential
treatment.
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6.3.2 Defense of Infringement Claims. If OSI or
Tanabe, or any of their respective Affiliates or sublicensees or their
customers, is sued by a Third Party for infringement of a patent because of the
research, development, manufacture, use or sale of a Compound or Product, the
party which has been sued shall promptly notify the other in writing of the
institution of such suit. The Selling Party shall have the right (including the
right to exclusive control of the defense of any such suit, action, or
proceeding and the exclusive right to compromise, litigate, settle, or otherwise
dispose of any such suit, action, or proceeding), but not the obligation, to
control the defense or settlement of any such suit, action, or proceeding and
the Royalty-Receiving Party shall furnish to the Selling Party all necessary
information and assistance in connection therewith. The Selling Party shall bear
** of the expense (including, without limitation, any sums paid to such Third
Party as damages), and the Royalty-Receiving Party shall bear ** of the expense
(including, without limitation, any sums paid to such Third Party as damages);
provided that the sole obligation of the Royalty-Receiving Party will be paid by
a ** reduction of all royalties then payable and payable thereafter to the
Royalty-Receiving Party until the Royalty Receiving Party's ** share of the
expenses of such suit are deducted on a global basis, and not on a
patent-by-patent basis nor country-by-country basis. If such suit results in any
award or settlement paid in favor of Tanabe or OSI, such amount shall be shared
in the same proportion as the expenses of such suit have been actually borne by
such parties. The share of the expenses of any suit of the Royalty-Receiving
Party shall be limited to the foregoing royalty reduction and ** . It is agreed
that if one party conducts the defense, the other shall have the right to be
represented
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** This portion has been redacted pursuant to a request for confidential
treatment.
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by advisory counsel of its own selection, at its own expense, and shall
cooperate fully in the defense of such suit and furnish to the other all
evidence and assistance in its control.
6.3.3 Third Party Licenses. If Tanabe and OSI
agree that the development, manufacture, use, or sale by Tanabe or OSI, as the
case may be, of a Product in any country would infringe a patent owned by a
Third Party, the Selling Party shall attempt to obtain a license under such
patent. If the Selling Party obtains a license under such patent, ** of any
payments made by the Selling Party to such Third Party shall be deductible from
royalty payments due from the Selling Party to the Royalty-Receiving Party;
provided, however, that in no event shall royalties payable to the
Royalty-Receiving Party be reduced by more than ** as a result of all such
deductions. All such computations, payments, and adjustments of ** shall be made
on a country-by-country and patent-by-patent basis. If either Tanabe or OSI is
of the opinion that such development, manufacture, use, or sale would not
infringe such patent owned by a Third Party, the Selling Party may, at its
election and expense, bring suit against such Third Party seeking a declaration
that such Third Party patent is invalid or not infringed by such party's
development, manufacture, use or sale of such Product, or may bring opposition,
nullity, or other proceedings against such patent, as appropriate. If the
Selling Party chooses not to bring such a suit or is successful in such suit,
the Selling Party shall continue to pay royalties in such country as provided in
Section 5. If the Selling Party is unsuccessful in such suit, it shall join the
Royalty-Receiving Party in an attempt to obtain a license under such patent to
the extent that the terms and conditions to obtain such license from
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** This portion has been redacted pursuant to a request for confidential
treatment.
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such Third Party are commercially feasible, and royalty payments made to such
Third Party for such license shall be as provided in this Section.
6.3.4 No Selling Party. For purposes of this
Section 6.3, if there is no Selling Party (because no license has yet been
granted under Section 5.1.1 or Section 5.1.2), all references to "Selling Party"
shall be deemed to be references to OSI and all references to "Royalty-Receiving
Party" shall be deemed to be references to Tanabe except that if the actual or
threatened unlawful disclosure or infringement solely relates to a Tanabe
Patent, then all references in this Section 6.3 to "Selling Party" shall be
deemed to be references to Tanabe and all references to "Royalty-Receiving
Party" shall be deemed to be references to OSI.
6.3.5 Acquisition of Rights from Third Parties.
Subject to OSI's rights with respect to potential pharmaceutical products in the
Field licensed-in by OSI during the Contract Period as set forth in Section
2.3.1 hereof, OSI and Tanabe shall, during the Contract Period, promptly notify
the Joint Management Committee in writing of any and all opportunities to
acquire in any manner from Third Parties (except Vanderbilt under the Vanderbilt
Agreement) enabling technologies or patents relating to the Targets which may be
used in the Research Program and which were not theretofore available to the
Research Program from either Tanabe or OSI. Such opportunities shall include,
without limitation, a research collaboration with a Third Party which relates to
any of the Targets. If OSI and Tanabe mutually determine that such rights should
be acquired or a research collaboration with a Third Party should be entered
into, the notifying party shall negotiate with such Third Party to make the
acquisition or enter into the research collaboration. If such rights are
acquired or a research collaboration is entered into, such rights acquired or
resulting from such research collaboration shall be deemed part of the
Technology of the party making the acquisition or entering into the research
collaboration. Upon
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such acquisition or entering into the research collaboration, OSI and Tanabe
shall negotiate in good faith the modification (if any) of the milestone and
royalty payments set forth in Sections 3.3.2, 3.3.3 and 5.5 with respect to
Products directly resulting from such acquired technology or patents or from
such research collaboration.
7. Hold Harmless. If Tanabe grants to OSI a license hereunder,
OSI agrees to defend, protect, indemnify and hold harmless Tanabe from and
against any liability, claim, loss, cost or expense arising from any claim for
product liability based upon OSI's, its Affiliates' and/or its sublicensees'
development, manufacture, use, or sale of any Product, except to the extent such
liability, claim, loss, or expense also results from the negligence or willful
misconduct of Tanabe, its Affiliates and/or its sublicensees or their respective
employees and agents. If OSI grants to Tanabe a license hereunder, Tanabe agrees
to defend, protect, indemnify, and hold harmless OSI from and against any
liability, claim, loss, cost, or expense arising from any claim for product
liability based upon Tanabe's, its Affiliates' and/or its sublicensees'
development, manufacture, use, or sale of any Product, except to the extent such
liability, claim, loss, cost or expense also results from the negligence or
willful misconduct of OSI, its Affiliates, its sublicensees and/or Vanderbilt or
their respective employees and agents.
8. Term, Termination and Disengagement
8.1 Term.
8.1.1 Term of Contract Period. The term of the
Contract Period shall commence on the Effective Date and shall expire on the
fourth anniversary of the Effective Date, unless extended by mutual written
agreement of the parties pursuant to Section 8.1.3, terminated by Tanabe
pursuant to Section 8.1.2 hereof or as otherwise provided in this Agreement, and
shall mean the period during which Tanabe is providing Funding Amounts pursuant
to Section 3
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hereof.
8.1.2 Two-Year Review. On or before the second
anniversary of the Effective Date, OSI shall deliver to Tanabe a written report
indicating whether the Two-Year Minimum Requirements have been met (the "Two
Year Report"). If the Two-Year Minimum Requirements have been met, the Contract
Period will remain in effect for the remainder of the 4-year period from the
Effective Date. If the Two-Year Minimum Requirements have not been met, within
** following receipt of such report, Tanabe shall notify OSI in writing whether
it intends to terminate the Contract Period in accordance with the provisions of
Section 8.2 hereof or whether the Contract Period shall remain in effect for the
remainder of the 4-year period from the Effective Date. If the Two Year Report
indicates that the Two Year Minimum Requirements have not been met but Tanabe
nonetheless determines not to exercise its right to Early Termination, Tanabe
shall make the quarterly Funding Amount for the first quarter of the third year
of the Contract Period on the later of the first day of such quarter or the day
on which Tanabe provides OSI with notice of its intent not to terminate the
Contract Period.
8.1.3 Renewal. Tanabe may renew the Contract
Period for an additional period of at ** by providing written notice of its
intent to renew to OSI within four months prior to the expiration of the
Contract Period. Following delivery and receipt of such written notice, the
parties will negotiate in good faith the level of funding during the renewal
period; provided, however, that such funding, on an annual basis, shall be equal
to or greater
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** This portion has been redacted pursuant to a request for confidential
treatment.
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than the aggregate Funding Amounts during the fourth year of the Contract
Period. The "Contract Period" shall be deemed to include any renewal period.
Notwithstanding the foregoing, at Tanabe's request, OSI shall, for a period of
one year following the expiration of the Contract Period (i.e., all four years
or more if extended hereby), provide to Tanabe ongoing services to be mutually
determined by the parties on a Compound-by-Compound basis or a Target-by-Target
basis. Tanabe shall pay OSI for such services an additional Funding Amount equal
** .
8.1.4 Term of Agreement. The term of this
Agreement ("Term") shall continue until the expiration or termination of the
last obligation of either party to pay royalties on a country-by-country basis
and shall include the Contract Period as well as the Drug Discovery Phase, Early
Development Phase and Clinical Development and Marketing Phase, any or all of
which may be coexistent with the Contract Period.
8.2 Tanabe's Right to Early Termination. Tanabe shall
have the right to terminate the Contract Period following its receipt of the Two
Year Report, in accordance with the provisions set forth in Section 8.1.2
hereof, if the Two-Year Minimum Requirements have not been met ("Early
Termination"). If there is an Early Termination, there shall be no Remaining
Right Period.
8.3 Termination Upon an Event of Default. Upon the
occurrence of any of the following events ("Events of Default"), the party not
responsible may, by notice to the other party, terminate this Agreement subject
to compliance with the terms of Section 10
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** This portion has been redacted pursuant to a request for confidential
treatment.
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(Dispute Resolution), and without prejudice to any remedy or claims it may have
against the other party.
8.3.1 Incorrect Representation or Warranty. Any
material representation or warranty by OSI or Tanabe, or any of their officers,
under or in connection with this Agreement, proves to have been incorrect in any
material respect when made.
8.3.2 Failure to Perform. OSI or Tanabe fails in
any material respect to perform or observe any material term, covenant or
understanding contained in this Agreement or in any of the other documents or
instruments delivered pursuant to, or concurrently with, this Agreement, and any
such failure shall remain unremedied for 60 days after written notice to the
failing party.
8.3.3 Bankruptcy. OSI or Tanabe makes an
assignment for the benefit of its creditors, becomes insolvent, files a petition
in bankruptcy, petitions or applies to any tribunal for the appointment of a
custodian, receiver or any trustee for it or a substantial part of its assets,
or commences any proceeding under any bankruptcy, reorganization, arrangement,
readjustment of debt, dissolution or liquidation law or statute of any
jurisdiction, whether now or hereafter in effect; or if there has been filed any
such petition or application against OSI or Tanabe, or any such proceeding has
been commenced against it, in which an order for relief is entered or which
remains undismissed for a period of 60 days or more; or OSI or Tanabe by any act
or omission indicates its consent to, approval of or acquiescence in, any such
petition, application or proceeding or order for relief or the appointment of a
custodian, receiver or any trustee for it or any substantial part of any of its
properties, or is the subject to any such custodianship, receivership or
trusteeship that continues undischarged for a period of 60 days or more.
8.4 Effect of Expiration or Termination of the Contract
Period.
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8.4.1 Expiration. Upon expiration of the Contract
Period as provided in Section 8.1.1 (including the renewal period, if any,
provided for in Section 8.1.3):
(a) Tanabe License to OSI. Tanabe shall
grant to OSI a royalty-free, worldwide, perpetual, non-exclusive license,
including the right to grant sublicenses, under Tanabe Technology and Tanabe's
rights in Improvements and Joint Patents, to research, develop, have developed,
make, have made, use, sell, have sold and commercialize pharmaceutical products;
(b) OSI License to Tanabe. OSI shall
grant to Tanabe a royalty-free, worldwide, perpetual, non-exclusive license,
including the right to grant sublicenses, under OSI Technology and OSI's rights
in Improvements and Joint Patents, to research, develop, have developed, make,
have made, use, sell, have sold and commercialize pharmaceutical products;
(c) Option Payment. Following the
expiration of the Contract Period, each of Tanabe and OSI shall have the right
to independently continue development with respect to a Target with no
obligation to the other Party except as follows in subsections (c)(i) and
(c)(ii):
(i) Seed Compounds after
Contract Period. If, during the Remaining Right Period, a Seed Compound on which
OSI has continued development meets the criteria of a Lead Compound as set forth
on Exhibit B hereto, OSI shall so notify Tanabe in writing and, together with
such notice, shall supply to Tanabe any Materials with
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respect to the Lead Compound which OSI reasonably determines would be useful for
Tanabe's evaluation of such Lead Compound. OSI shall include in such written
notice ** by OSI in connection with the development of such Seed Compound during
the period between the expiration of the Contract Period and the date of such
notice. ** . Such written notice shall constitute an offer by OSI to Tanabe of
an exclusive option to commence the Early Development Phase with respect to such
Lead Compound, and, accordingly, take a license to such Lead Compound consistent
with Section 5.1.1. As consideration for such option, Tanabe shall pay OSI the
amount of its ** (the "Option Payment"). Tanabe shall exercise such option by
sending OSI written notice of such exercise within ** following the date of
OSI's notice to Tanabe and transfer of the Materials from OSI to Tanabe.
Tanabe's notice to OSI shall be accompanied by the Option Payment. If Tanabe
determines not to exercise such option, OSI may continue development of such
Seed Compound may commercialize any product resulting from such Seed Compound
with no further obligation to Tanabe.
(ii) Competitive Compound
Directed Toward a Tanabe Target. If, during the ** period after the Contract
Period, any compound which OSI has continued to develop by itself or with any
Third Party meets the criteria of a Lead Compound as set forth on Exhibit B
hereto and such compound is directed toward the same target as a Target for
which Tanabe has paid the milestone of ** for the first Lead Compound pursuant
to Section 3.3.2, and Tanabe is continuing the development or commercialization
of any Lead Compound directed to such Target, OSI shall notify Tanabe in writing
that such compound has met the criteria of a Lead Compound and, together with
such notice, shall supply to Tanabe
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** This portion has been redacted pursuant to a request for confidential
treatment.
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any Materials with respect to such Lead Compound identified by it which OSI
reasonably determines would be useful for Tanabe's evaluation of such Lead
Compound. OSI shall include in such written notice the ** in connection with the
development of such compound during the period between the expiration of the
Contract Period and the date of such notice. ** Such written notice shall
constitute an offer by OSI to Tanabe of an exclusive option to commence the
Early Development Phase with respect to such Lead Compound and, accordingly,
take a license to such Lead Compound consistent with Section 5.1.1. As
consideration for such option, Tanabe shall pay OSI the amount of its ** (the
"Option Payment"). Tanabe shall exercise such option by sending OSI written
notice of such exercise within ** following the date of OSI's notice to Tanabe
and transfer of the Materials from OSI to Tanabe. Tanabe's notice to OSI shall
be accompanied by the Option Payment. If Tanabe determines not to exercise such
option, OSI may continue development of such compound and may commercialize any
product resulting from such compound with no further obligation to Tanabe.
(d) Royalty Obligation. Notwithstanding
anything herein to the contrary, any licenses under Section 5.1.1 for which
Tanabe has exercised its option, and the concurrent obligation to pay royalties
as provided in Section 5.5.1, shall continue, and any license under Section
5.1.2 (if in effect at such time), and the concurrent obligation to pay
royalties as provided in Section 5.5.2, shall continue;
(e) Milestone Obligation. Tanabe's
obligations to pay milestones under Sections 3.3.2 and 3.3.3 shall continue; and
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** This portion has been redacted pursuant to a request for confidential
treatment.
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(f) Transfer of Assay. OSI will
transfer to Tanabe, at Tanabe's request and ** technology for any assay
developed for a Target by OSI, its Affiliates and/or Vanderbilt under the
Research Program which has not yet been transferred to Tanabe under Section
2.2.1.
8.4.2 Early Termination if Two Year Minimum
Requirements Are Not Met. If the Two Year Report indicates that the Two Year
Minimum Requirements have not been met, and Tanabe exercises its right to Early
Termination:
(a) Tanabe License to OSI. Tanabe shall
grant to OSI a royalty-free, worldwide, perpetual, non-exclusive license,
including the right to grant sublicenses, under Tanabe Technology and Tanabe's
rights in Improvements and Joint Patents, to research, develop, have developed,
make, have made, use, sell, have sold and commercialize pharmaceutical products;
(b) OSI License to Tanabe. OSI shall
grant to Tanabe a royalty-free, worldwide, perpetual, non-exclusive license,
including the right to grant sublicenses, under OSI Technology and OSI's rights
in Improvements and Joint Patents, to research, develop, have developed, make,
have made, use, sell, have sold and commercialize pharmaceutical products;
(c) Royalty Obligation. Notwithstanding
anything herein to the contrary, any licenses under Section 5.1.1 for which
Tanabe has exercised its option, and the concurrent obligation to pay royalties
as provided in Section 5.5.1, shall continue, and any
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** This portion has been redacted pursuant to a request for confidential
treatment.
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license under Section 5.1.2 (if in effect at such time), and the concurrent
obligation to pay royalties as provided in Section 5.5.2, shall continue;
(d) Milestone Obligation. Tanabe's
obligations to pay milestones under Sections 3.3.2 and 3.3.3 shall continue;
(e) Tanabe's Option. Tanabe's option to
acquire any license(s) under Section 5.1.1 shall remain in effect; and
(f) Transfer of Assay. OSI will provide
to Tanabe, at Tanabe's request and ** technology for any assay developed for a
Target by OSI , its Affiliates and/or Vanderbilt during the Research Program and
which has not yet been transferred to Tanabe under Section 2.2.1.
8.4.3 Termination Upon an Event of Default. If
this Agreement is terminated due to an Event of Default as set forth in Section
8.3, (a) if Tanabe is the terminating party, (i) Tanabe shall have the right to
have the option set forth in Section 5.1.1 and all licenses already granted
under Section 5.1.1 remain in effect, in which case, Tanabe's obligations to
make the milestone payments set forth in Sections 3.3.2 and 3.3.3 and the
royalty obligations set forth in Section 5.5.1 shall also remain in effect, and
(ii) the licenses granted by Tanabe in Section 5.1.2 shall terminate and (b) if
OSI is the terminating party, (i) the licenses granted by Tanabe in Section
5.1.2 shall remain in effect, (ii) Tanabe's option in Section 5.1.1 shall
terminate, and (iii) OSI shall have the right to determine whether any licenses
granted by OSI under Section 5.1.1 remain in effect or are terminated. If such
licenses granted by OSI remain in effect, Tanabe's obligations under Sections
3.3.2, 3.3.3 and
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** This portion has been redacted pursuant to a request for confidential
treatment.
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5.5.1 shall also remain in effect. If such licenses are terminated, then all of
Tanabe's rights with respect to the Lead Compound(s) which are the subject of
such terminated licenses (except Tanabe's ownership interest in Improvements and
Tanabe Technology) shall revert to OSI and OSI shall be granted the license set
forth in Section 5.1.2 with respect to such Lead Compounds and the royalty
obligations set forth in Section 5.5.2 shall also remain in effect. The
terminating party shall also be granted by the defaulting party a royalty-free,
worldwide, perpetual, non-exclusive license, including the right to grant
sublicenses, under OSI Technology (if OSI is the defaulting party) or Tanabe
Technology (if Tanabe is the defaulting party) and under the defaulting party's
rights in Improvements and Joint Patents, to research, develop, have developed,
make, have made, use sell, have sold and commercialize pharmaceutical products.
8.5 Survival. Upon expiration pursuant to Section 8.1.4
hereof, the following sections of this Agreement shall survive such termination:
Sections 1, 2.8, 4, 5.2, 5.5.5, 5.5.6, 7, 10, 11 and 12 hereof. Upon termination
pursuant to Section 8.2 or 8.3 hereof, the following sections of this Agreement
shall survive such termination if OSI has a worldwide license as provided in
Section 5.1.2 hereof: Sections 1, 2.8, 3.1.4, 4, 5.1.2, 5.2, 5.3, 5.4, 5.5.2,
5.5.3, 5.5.4, 5.5.5, 5.5.6, 5.6, 6, 7, 10, 11 and 12 hereof. Upon termination
pursuant to Section 8.2 or 8.3 hereof, the following sections of this Agreement
shall survive such termination if Tanabe has a worldwide license as provided in
Section 5.1.1 hereof: Sections 1, 2.8, 3.1.4, 3.3.2, 3.3.3, 4, 5.1.1, 5.2, 5.3,
5.4, 5.5.1, 5.5.3, 5.5.4, 5.5.5, 5.5.6, 5.6, 6, 7, 10, 11 and 12 hereof. Upon
termination pursuant to Section 8.2 or 8.3 hereof, if neither party has (or
exercises its option to obtain) a worldwide license as provided in Section 5.1
hereof, the following sections of this Agreement shall survive: 1, 2.8, 3.1.4,
4, 5.5.5, 5.5.6, 6, 10, 11 and 12 hereof.
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9. Representations and Warranties.
9.1 Representations and Warranties Made by Tanabe and
OSI. OSI and Tanabe each represents and warrants as follows:
9.1.1 Status. It is a corporation, validly
existing and in good standing under the laws of the jurisdiction where it has
been organized, and has all requisite power and authority, corporate or
otherwise, to conduct its business as now being conducted, to own, lease and
operate its properties and to execute, deliver and perform this Agreement.
9.1.2 Authority. The execution, delivery and
performance by it of this Agreement has been duly authorized by all necessary
corporate action and the execution, delivery and performance by either party do
not and will not (a) require any consent or approval of its stockholders, (b)
violate any provision of any law, rule, regulation, order, writ, judgment,
injunction, decree, determination or award presently in effect having
applicability to it or any provision of its charter or by-laws or (c) result in
a breach of or constitute a default under any material agreement, mortgage,
lease, license, permit or other instrument or obligation to which it is a party
or by which it or its properties may be bound or affected.
9.1.3 Binding Obligation. This Agreement is a
legal, valid and binding obligation of it enforceable against it in accordance
with its terms and conditions, except as such enforceability may be limited by
applicable bankruptcy, insolvency, moratorium, reorganization or similar laws,
from time to time in effect, affecting creditor's rights generally.
9.1.4 No Conflicting Obligations. It is not under
any obligation to any Third Party, contractual or otherwise, that is conflicting
or inconsistent in any respect with the terms of this Agreement or that would
impede the diligent and complete fulfillment of its obligations.
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9.1.5 Good Title. It has good and marketable title
to or valid leases or licenses for, all of its properties, rights and assets
necessary for the fulfillment of its responsibilities hereunder and the Research
Program, subject to no claim of any Third Party other than the relevant lessors
or licensors.
9.1.6 Right to Grant Licenses. It has the right to
grant to the other the licenses granted pursuant to this Agreement, and that the
licenses so granted do not conflict with or violate the terms of any agreement
between either of them and any Third Party.
9.2 Representations and Warranties Made by OSI. OSI
represents and warrants as follows:
9.2.1 Vanderbilt Agreement. OSI and Vanderbilt
have entered into the Vanderbilt Agreement. The Vanderbilt Agreement is not
conflicting or inconsistent with the terms of this Agreement and contains all
provisions necessary for OSI to diligently fulfill its obligations hereunder.
9.2.2 No Litigation. There is no interference
action or litigation pending with any Third Party, or to the best of OSI's
knowledge, any threatened interference action or litigation with any Third
Party, before any court or other governmental entity of competent jurisdiction
in regard to the OSI Technology.
10. Dispute Resolution.
10.1 **
10.2 Arbitration. Any dispute, controversy or claim
arising out of, relating to, or in connection with this Agreement or for the
breach, termination or validity thereof (a
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** This portion has been redacted pursuant to a request for confidential
treatment.
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"Dispute"), except for matters which shall be determined by the Steering
Committee or the Joint Management Committee as set forth in Section 2.4, shall
be finally settled by arbitration in accordance with the rules of the
International Chamber of Commerce; provided, however, that during the period of
arbitration on any Dispute the parties shall continue to fulfill their
obligations as set forth in this Agreement. The parties agree that discovery
proceedings shall be limited to: (a) the Dispute; (b) depositions of those
persons having direct knowledge of the Dispute; and (c) submission of all
documents which relate to the Dispute. The arbitration hearing shall be held in
Osaka, Japan in the English language before three arbitrators unless otherwise
mutually agreed. This Agreement shall be interpreted and construed in accordance
with the laws of the State of New York. The decision of the arbitrator shall be
binding on both parties and non-appealable. Judgment upon the award rendered by
the arbitrator shall be enforceable in any court of competent jurisdiction. Each
party agrees to submit to the personal jurisdiction of that court for purposes
of the enforcement of any such award. All fees of the arbitrator and the court
stenographer shall be paid by the party who does not prevail in the arbitration
as determined by the arbitrator. All other arbitration-related expenses shall be
borne by the party incurring such expenses.
11. Notices. All notices shall be mailed via certified mail,
return receipt requested, or telecopy or courier with confirmation of receipt,
and which shall be addressed as follows, or to such other address as may be
designated from time to time:
If to Tanabe: At its address as set forth at the beginning
of this Agreement.
Attention: President
Telecopy: 00-0-0000-0000
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If to OSI: At its address as set forth at the beginning
of this Agreement
Attention: Chief Executive Officer
Telecopy: 000-000-0000
with a copy to: Squadron, Ellenoff, Plesent & Xxxxxxxxx, LLP
000 Xxxxx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000
Telecopy: (000) 000-0000
Attention: Xxxxxxx X. Xxxx, Esq.
Notices shall be deemed given as of the date of receipt.
12. Governing Law. This Agreement shall be construed in accordance
with the laws of the State of New York.
13. Force Majeure. Neither party shall be responsible for a
failure or delay in performance of any of its obligations hereunder due to force
majeure such as war, insurrection, strikes, acts of God, governmental action, or
any other contingency beyond its control. However, the party which is affected
by any force majeure shall contact the other party for discussion of possible
emergency measures.
14. Miscellaneous.
14.1 Binding Effect. This Agreement shall be binding upon
and inure to the benefit of the parties and their respective legal
representatives, successors and permitted assigns.
14.2 Headings. Section headings are inserted for
convenience of reference only and do not form a part of this Agreement.
14.3 Interpretation. Unless expressly set forth, the use
of the singular form of terms herein shall include the plural and the use of the
plural form of terms herein shall include the singular.
14.4 Counterparts. This Agreement may be executed
simultaneously in two
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counterparts, each of which shall be deemed an original.
14.5 Amendment; Waiver; etc. This Agreement may be
amended, modified, superseded or canceled, only by a written instrument executed
by both parties, and any of the terms may be waived, by the written instrument
executed by the party waiving the claim for the other party compliance. The
delay or failure of any party at any time or times to require performance of any
provision shall in no manner affect the rights at a later time to enforce the
same.
14.6 No Third Party Beneficiaries. No person not a party
to this Agreement, including any employee of any party to this Agreement, shall
have or acquire any rights by reason of this Agreement. Both parties hereto are
independent contractors and nothing contained in this Agreement shall be deemed
to constitute either party as a partner, principal, agent or employee of the
other party or any Third Party (including sublicensees).
14.7 Assignment and Successors.
14.7.1 Affiliates. Either party may, at its sole
discretion, but with reasonable prior notice to the other party, designate and
cause its Affiliate to perform all or part of its obligations under this
Agreement or to have the benefit of all or part of its rights under this
Agreement. In any such event, the name "OSI" or "Tanabe" appearing herein shall
be deemed to be the name of such Affiliate to the extent necessary to carry out
the intent of this Section, and the performance of the obligations of such
Affiliate shall be deemed guaranteed by the party which has made such
designation.
14.7.2 Assignment. This Agreement may not be
assigned by either party without the prior written approval of the other party,
except that either party may assign this Agreement and its rights, in whole or
in part, to any of its Affiliates, or any purchaser of all or
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substantially all of its assets or to any successor corporation resulting from
any merger or consolidation with or into such corporation, provided that such
assigning party shall remain primarily liable for its obligations hereunder.
14.8 Entire Agreement. This Agreement supersedes all prior
agreements, oral or written, between the parties hereto with respect to the
subject matter hereof and contains the entire and only agreement between the
parties regarding the subject matter hereof (except as otherwise expressly
provided herein), and any representation, terms or conditions relating thereto
or in connection therewith, oral or in writing, not incorporated herein will not
be binding upon either party.
IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed by their duly authorized representatives.
TANABE SEIYAKU CO., LTD.
By: /s/ Shoei Nakashima
--------------------------------------------
Name: Shoei Nakashima
Title: Managing Director of the Board
OSI PHARMACEUTICALS, INC.
By: /s/ Xxxxx Xxxxxxx
--------------------------------------------
Name: Xxxxx Xxxxxxx
Title: Chief Executive Officer and President
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EXHIBIT A
CRITERIA FOR SEED COMPOUND
**
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** This portion has been redacted pursuant to a request for confidential
treatment.
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EXHIBIT B
CRITERIA FOR LEAD COMPOUND
**
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** This portion has been redacted pursuant to a request for confidential
treatment.
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EXHIBIT C
TARGETS
**
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** This portion has been redacted pursuant to a request for confidential
treatment.
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EXHIBIT D
RESEARCH PROGRAM
**
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** This portion has been redacted pursuant to a request for confidential
treatment.
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EXHIBIT E
RESEARCH PLAN
JULY 1999
**
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** This portion has been redacted pursuant to a request for confidential
treatment.
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