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EXHIBIT 10.17
CONFIDENTIAL TREATMENT REDACTED FOR
REQUESTED CONFIDENTIALITY
The asterisked portions of this document have been
omitted and are filed separately with the Securities and
Exchange Commission
COLLABORATION AND LICENSE AGREEMENT
between and among
SMITHKLINE XXXXXXX plc, SMITHKLINE XXXXXXX corp, INCYTE
PHARMACEUTICALS, INC. and DIADEXUS, LLC
1. DEFINITIONS ..............................................................3
2. DiaDexus STRUCTURE ......................................................15
3. INCYTE ..................................................................15
4. SB ......................................................................20
5. DiaDexus.................................................................24
6. ROYALTIES/MILESTONES/OTHER PAYMENTS .....................................33
7. THIRD PARTY AGREEMENTS ..................................................39
8. BIOINFORMATICS COMMITTEE ................................................40
9. INFORMATION EXCHANGE ....................................................40
10. RESEARCH COMMITTEE ......................................................45
11. RESEARCH PLAN ...........................................................45
12. CONFIDENTIALITY .........................................................45
13. DILIGENCE ...............................................................48
14. PATENT PROSECUTION AND LITIGATION .......................................51
15. STATEMENTS AND REMITTANCES ..............................................53
16. TERM: TERMINATION .......................................................54
17. REPRESENTATIONS AND WARRANTIES; COVENANTS ...............................55
18. INDEMNITY ...............................................................57
19. MISCELLANEOUS PROVISIONS ................................................59
SIGNATURE PAGE ..........................................................64
APPENDICES
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COLLABORATION AND LICENSE AGREEMENT
This Collaboration and License Agreement, made as of the 2nd day of
September 1997, by and among SmithKline Xxxxxxx Corporation, a Pennsylvania
corporation with offices at Xxx Xxxxxxxx Xxxxx, Xxxxxxxxxxxx, Xxxxxxxxxxxx
corporation with offices at Xxx Xxxxxxxx Xxxxx, Xxxxxxxxxxxx, Xxxxxxxxxxxx
00000, X.X.X.; SmithKline Xxxxxxx plc, an English corporation with its
principal offices at Xxx Xxxxxxxx Xxxxx, Xxxxxxxxx, Xxxxxxxxx, XX0 0XX,
Xxxxxxx; Incyte Pharmaceuticals, Inc., a Delaware corporation with offices at
0000 Xxxxxx Xxxxx, Xxxx Xxxx, Xxxxxxxxxx 00000; and diaDexus, a Delaware
limited liability company with offices at 0000 Xxxxx Xxxxxxxxx Xxxxx 000, Xxxxx
Xxxxx, Xxxxxxxxxx 00000;
WITNESSETH:
WHEREAS, Incyte and SB have developed intellectual property with respect
to certain high throughput genomic DNA sequencing and bioinformatics analysis
technologies and to certain DNAs and to proteins they encode;
WHEREAS, Incyte and SB have established DiaDexus for the purpose of
undertaking the research, development and commercialization of certain
diagnostic products;
WHEREAS, Incyte and SB desire to provide technical and financial
assistance to DiaDexus in connection with the research, development and
commercialization of certain diagnostic products, as set forth below;
WHEREAS, Incyte, SB, and DiaDexus desire to grant to each other certain
rights relating to the research, development and commercialization of certain
diagnostic and other products, as set forth below;
NOW, THEREFORE, in consideration of the premises and the mutual covenants
herein contained, the parties hereto agree as follows:
1.0 DEFINITIONS
"Affiliate(s)": shall mean individually and collectively Incyte Affiliates,
DiaDexus Affiliates, and SB Affiliates. For the purposes of this Agreement,
DiaDexus shall not be an Affiliate of either SB or Incyte.
"Bioinformatics": shall mean computer software and know-how each useful for the
analysis, comparison, and curation of nucleic acid and protein sequences, and
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curation of information related to such sequences; and software for the
construction and maintenance of databases for the compilation of such sequences
and their associated information.
"cDx Homebrew(s)"("HB"): shall mean a Clinical Diagnostic performed as a
service by a service provider prior to commercial launch of an RA Approved Kit.
"cDx Kit(s)": shall mean an RA Approved Kit for use in performing a Clinical
Diagnostic.
"Class I Dx Test(s)": shall mean (a) a simultaneous analysis of protein or
peptide analytes representing no greater than twenty (20) Gene Product(s); (b)
analysis of any number of molecules other than proteins (or peptides) or
nucleic acids; and/or (c) nucleic acid probe based analysis performed and
visualized in situ within a cell or tissue to detect specific nucleic acid
sequence(s) representing no more than two (2) Gene Product(s); each of which is
tested for in a human tissue or other human biological sample.
"Class II Dx Test(s)": shall mean (a) simultaneous analysis of nucleic acid
analytes representing up to and including twenty (20) Gene Product(s) (or
single- or multi-based changes therein) which is not performed and visualized
in situ within a cell or tissue; and/or (b) nucleic acid probe based analysis
performed and visualized in situ within a cell or tissue to detect specific
nucleic acid sequences representing three (3) to twenty (20) Gene Product(s);
each of which is tested for in a human tissue or other human biological
sample. The results reported with respect to each such Gene Product included in
a Class II cDx Test must be required for the Test to be valid. More than one
Class II cDx Test may be performed simultaneously using the same reagent(s)
and/or device(s).
"Class III Dx Test(s)": shall mean (a) simultaneous analysis of nucleic acid
analytes representing greater than twenty (20) Gene Product(s) (or single- or
multi-base changes therein); and/or (b) simultaneous analysis of protein
analytes representing greater than twenty (20) Gene Product(s); each of which
is tested for in a human tissue or other human biological sample. The results
reported with respect to each such Gene Product included in a Class III cDx
Test must be required for the Test to be valid. More than one Class III cDx
Test may be performed simultaneously using the same reagent(s) and/or
device(s).
"Clinical Non-genomic DiaDexus Data": shall mean DiaDexus IP which is data
collected on an individual's health or disease status but excluding genomic
data such as DNA sequence analysis and mRNA expression analysis.
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"Clinical Diagnostic(s)" ("cDx"): shall mean test(s) performed on a human tissue
or other human biological sample, the results of which are provided to payors,
providers, or patients for use in the clinical management of individual
patients, which become part of such patient's health record.
"DiaDexus": shall mean diaDexus, a Delaware limited liability company with
offices at 0000 Xxxxx Xxxxxxxxx Xxxxx 000, Xxxxx Xxxxx XX; and any DiaDexus
Affiliate(s) thereof to which any rights and/or obligations shall be assigned
and/or delegated pursuant to this Agreement.
"DiaDexus Affiliate": shall mean any corporation, firm, partnership, or other
legal entity, which is directly or indirectly owned or under common ownership
by DiaDexus to the extent of which the common stock or other equity ownership
thereof is one hundred percent (100%) owned by DiaDexus; provided however, that
where local laws require a minimum percentage of local ownership, the status of
DiaDexus Affiliate will be established if DiaDexus directly or indirectly owns
or controls one hundred percent (100%) of the maximum ownership percentage that
may, under such local laws, be owned or controlled by foreign interests.
"DiaDexus IP": shall mean DiaDexus Know-How and DiaDexus Patents.
"DiaDexus Know-How": shall mean any and all data, substances, processes,
materials, formulae, know-how and inventions which are owned by DiaDexus or with
respect to which DiaDexus has a right to grant a license. DiaDexus Know-How
shall not include Incyte Diagnostic Know-How, SB Diagnostic Know-How, Incyte
Technology Know-How, or SB Technology Know-How.
"DiaDexus Patents": shall mean all patents and patent applications to the
extent they claim DiaDexus Know-How, which are owned by DiaDexus or to which
DiaDexus has the right to grant licenses. Included within the definition of
DiaDexus Patents are all continuations, continuations-in-part, divisions,
patents of addition, reissues, renewals, extensions, registrations,
confirmations, re-examinations thereof and any provisional applications and all
SPCs. DiaDexus Patents shall not include Incyte Diagnostic Patents, SB
Diagnostic Patents, Incyte Technology Patents, or SB Technology Patents.
"Effective Date": shall mean the date first written above.
"Extended License Period": shall mean the period from the Effective Date up to
and including eight (8) years thereafter.
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"Gene Product(s)": shall mean a protein (including peptides and polypeptides) or
nucleic acid analyte representing or encoded by a single gene. Multiple alleiic
forms of a gene and/or multiple splice variants of a gene represent one Gene
Product.
"Healthcare Informatics Product" ("Healthcare-Lx Product(s)"): shall mean a
database product containing data selected by SB and Incyte which is provided on
a commercial basis to healthcare payors, providers, consumers, and/or
healthcare companies for the purpose of (a) making healthcare management or
healthcare delivery decisions for individual patients and healthcare consumers
and/or (b) analysis of healthcare resource utilization and allocation.
"HGS Agreements": shall mean the agreements listed on Appendix A.
"Homebrew Territory": shall mean the countries and territories in which a Party
or its Affiliates has an existing service and/or distribution presence to
feasibly conduct a cDx Homebrew at the time a first right to a license to such
cDx Homebrew is offered to it pursuant to this Agreement. Such cDx Homebrew
service or distribution presence in such country or territory may be indirect
so long as the Party also maintains a direct presence to perform cDx Homebrews
in a Major Market Country. The United States shall be included in the Homebrew
Territory if the relevant Party and/or its Fifty Percent Affiliate has a
service and distribution capability similar to, or competitive with, one of the
major United States clinical diagnostic service laboratories (e.g., SmithKline
Xxxxxxx Clinical Laboratories, LabCorp or Quest) to provide such Homebrew. In
the case of Incyte, such service and distribution capability may be accessed
via partnership with SB, as anticipated by Paragraph 3.5. Fifty Percent
Affiliate for the purposes of this Paragraph and Paragraph 7.1 shall mean any
corporation, firm, partnership or other entity, whether de jure or de facto,
which directly or indirectly owns, is owned by or is under common ownership
with a Party to the extent of at least fifty percent (50%) of the equity (or
such lesser percentage which is the maximum allowed to be owned by a foreign
corporation in a particular jurisdiction) having the power to vote on or direct
the affairs of the entity, and any person, firm, partnership, corporation or
other entity actually controlled by, controlling or under common control with a
Party.
"Incyte": shall mean Incyte Pharmaceuticals, Inc., a Delaware corporation with
offices at 0000 Xxxxxx Xxxxx, Xxxx Xxxx, Xxxxxxxxxx 00000; and any Incyte
Affiliate(s) thereof to which any rights and/or obligations shall be assigned
and/or delegated pursuant to this Agreement.
"Incyte Affiliate": shall mean any corporation, firm, partnership, or other
legal entity, which is directly or indirectly owned or under common ownership
by Incyte to the extent of which the common stock or other equity ownership
thereof is one hundred percent (100%) owned by Incyte; provided however, that
where local laws
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require a minimum percentage of local ownership, the status of Incyte Affiliate
will be established if Incyte directly or indirectly owns or controls one
hundred percent (100%) of the maximum ownership percentage that may, under such
local laws, be owned or controlled by foreign interests.
"Incyte Database Agreements": shall mean the Collaborative LifeSeq(R)
Agreement and the Collaborative PathoSeq(TM) Database Agreement each between
Incyte and DiaDexus relating to Incyte Database Products entered into
contemporaneously herewith.
"Incyte Database Know-How": shall have the same meaning as Database Know-how
and/or Microbial Database Know-How as defined in the Incyte Database
Agreement(s), collectively or singly as applicable.
"Incyte Database Technology": shall have the same meaning as Incyte Database
Technology and/or Incyte Technology as defined in the Incyte Database
Agreements, collectively or singly as applicable.
"Incyte Database Products": shall mean individually and collectively LifeSeq(R),
LifeSeq Atlas(TM), LifeSeq(R)-FL, LifeSeq Arrays(TM) and PathoSeq(TM) as well as
the LifeSeq Gene Album(TM) reagent set each as defined in the Incyte Database
Agreements.
"Incyte Diagnostic IP": shall mean individually and collectively Incyte
Diagnostic Know-How and Incyte Diagnostic Patents.
"Incyte Diagnostic Know-How": shall mean any and all data, substances,
processes, materials, formulae, know-how and inventions with respect to a Gene
Product or set of Gene Product(s) derived from laboratory data resulting from a
prospective study which has been identified by Incyte as having utility as a
potential cDx Homebrew, cDx Kit, or Class I rDx Kit or Class I rDx Service using
standard biology laboratory techniques above and beyond bioinformatics analysis
of data, and is owned by Incyte or with respect to which Incyte has a right to
grant a license, consistent with the terms and conditions of this Agreement and
which are listed on Appendix B (which may be amended from time to time) or is
otherwise expressly provided to DiaDexus in writing by Incyte. Incyte Diagnostic
Know-How shall not include Incyte Database Technology.
"Incyte Diagnostic Patents": shall mean all patents and patent applications to
the extent they claim Incyte Diagnostic Know-How, which are owned by Incyte or
to which Incyte otherwise has the right to grant licenses consistent with the
terms and conditions of this Agreement. Included within the definition of
Incyte Diagnostic Patents, without limitation, are all continuations,
continuations-in-part, divisions,
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patents of addition, reissues, renewals, extensions, registrations,
confirmations, re-examinations thereof and any provisional applications and all
SPCs. Incyte Diagnostics Patents are listed on Appendix C which may be amended
from time to time.
"Incyte IP": shall mean any and all data, substances, processes, materials,
formulae, know-how, patents, patent applications and inventions which are owned
by Incyte or with respect to which Incyte has a right to grant a license
including, but not limited to, all rights under Incyte's database products.
Incyte IP shall not include Incyte Diagnostic IP and Incyte Technology IP.
"Incyte Rx Product": shall mean an Rx Product sold by Incyte or its licensees
of such Rx Product.
"Incyte Technology Know-How": shall mean any and all data, substances,
processes, materials, formulae, know-how and inventions which may be useful for
Making, Having Made, Using, and/or Selling Clinical Diagnostic(s) which are
owned by Incyte or with respect to which Incyte has a right to grant a license
and which are listed on Appendix D (which may be amended from time to time) or
are otherwise expressly provided to DiaDexus in writing by Incyte. Incyte
Technology Know-How includes Bioinformatics, and results of bioinformatics
analysis such as array designs and data mining, and array technology but does
not include Incyte Diagnostic Know-How or Incyte Database Technology.
"Incyte Technology IP": shall mean individually and collectively Incyte
Technology Know-How and Incyte Technology Patents.
"Incyte Technology Patents": shall mean all patents and patent applications to
the extent they claim Incyte Technology Know-How, which are owned by Incyte or
to which Incyte otherwise has the right to grant licenses. Included within the
definition of Incyte Technology Patents, without limitation, are all
continuations, continuations-in-part, divisions, patents of addition, reissues,
renewals, extensions, registrations, confirmations, re-examinations thereof and
any provisional applications and all SPCs. Incyte Technology Patents are listed
on Appendix D which may be amended from time to time.
"IND": shall mean a claimed investigational exemption for a new drug filed with
the United States Food and Drug Administration (FDA) or its successor or its
equivalent in a Major Market.
"Initial License Period": shall mean the period beginning on the Effective Date
and ending four (4) years thereafter.
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"Investigational Trials Informatics Product(s)" ("Investigational-Ix
Product(s)"): shall mean a database product containing and useful for the
analysis of clinical data or data derived from human tissue or other human
biological samples including but not limited to gene expression and/or DNA
sequence information and/or results of Tests, each derived from human patients
selected on the basis of a disease process or a treatment protocol common to all
such patients (along with relevant clinical controls or comparators), which
database is designed for the purpose of determining significance of such
information in that disease process or treatment setting.
"Ix Products": shall mean Investigational-Ix Products, Healthcare-Ix Products,
and Research-Ix Products.
"Kit": shall mean a specific set of reagents and devices, and possibly also
including software and consumable labware, all of which together are sold or
otherwise provided on a commercial basis to an end user for the conduct of a
specific test.
"Licensing Revenues" shall mean, with respect to a license granted by Incyte or
SB in accordance with Paragraph 6.1(f), as the case may be:
(a) All licensing revenues received by Incyte or SB, as the case may
be, from Third Parties solely in consideration of a license to such DiaDexus
Patent or reasonably apportioned thereto; and which are received by Incyte or
SB, as the case may be, in excess of any revenues received for Incyte IP or SB
IP, as the case may be, in the absence of such DiaDexus Patents;
(b) Licensing Revenues shall include non-cash payments received by
Incyte or SB, as the case may be, from Third Parties solely in consideration of
a license to such DiaDexus Patents (including any DiaDexus Patents assigned to
Incyte pursuant to the Incyte Database Agreements) or reasonably apportioned
thereto. Licensing Revenues shall also include consideration received by Incyte
or SB, as the case may be, with respect to an assignment or other conveyance by
Incyte or SB as the case may be of its ownership interests in any DiaDexus
Patent to a Third Party. The cash value of such non-cash payments shall be
determined in good faith by Incyte or SB as the case may be, and shall be
reflected in financial statements prepared on a basis consistent with generally
accepted accounting principles.
(c) Licensing Revenues specifically excludes:
(i) research and development funding, equity investments,
database subscription fees, satellite database fees, fees related to Incyte
intellectual property or SB intellectual property (other than any DiaDexus
Patents assigned to Incyte pursuant to the Incyte Database Agreements) as the
case may be and other fees
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under Incyte's database agreements, each unrelated to a separate license to a
DiaDexus Patent; and
(ii) any royalties, payments (cash or non-cash) or other compensation
made to SB under the HGS Agreements.
"Make, Have Made, Use, and Sell (Making, Having Made, Using, and Selling)":
shall mean all exclusionary rights now or in the future conferred by a patent
or equivalent of a patent (e.g., a SPC), copyright, or trade secret law of each
applicable respective jurisdiction of the world, including but not limited to
the right to practice, make, have made, use, offer to sell, sell, import, copy,
display, license, and distribute.
"Major Market": shall mean the United States, United Kingdom, Germany, France,
Italy, Spain, Switzerland, or Japan.
"Net Ix Revenue": shall mean the revenues received in consideration for the
licenses of an Ix Product by Incyte or SB as the case may be (the Selling
Party), less any of the following charges or expenses, to the extent each is
actually incurred (and not otherwise recovered) and does not exceed the
reasonable and customary amount for such item in the market in which such
license occurred:
(a) credits, allowances and rebates to, and chargebacks from the account
of, such customers for damaged or returned Ix Product;
(b) actual freight and insurance costs incurred by the Selling Party in
transporting the Ix Product to such customers;
(c) trade discounts, cash discounts, quantity discounts, rebates and
other price reduction programs;
(d) sales, value-added and other direct taxes paid by the Selling Party;
(e) customs duties, surcharges and other governmental charges incurred in
connection with the exportation or importation of the Ix Product;
(f) any other similar, reasonable and customary deductions paid or
incurred by the Selling Party which are appropriately deducted from revenues.
If the Ix Product is licensed in combination with other Product(s), the
Net Ix Revenues attributable to the Ix Product shall be determined by prorating
the revenues received from the combination products according to the fees or
values established by the Selling Party for the separate Product(s) contained
in the
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combination product, whether or not such Product(s) are licensed separately,
provided that such fees or values are reasonably related to the fee or value
potentials of the separate Product(s) and are consistent with fees customarily
charged in the industry for comparable products.
"Net Sales": shall mean the gross invoiced sales of a Product by SB or Incyte
or their Affiliates or sublicensees as the case may be ("the Selling Party") to
Third Parties:
(a) in finished product form (i.e., packaged and labeled for sale to the
ultimate consumer); or
(b) in final stage bulk material form with respect to those products sold
in a country which is not a Major Market and where local country legal or
governmental requirements as reasonably determined by the Selling Party,
stipulate that such product be in a form other than finished product form (such
as final stage bulk material ready for conversion to final form, or bulk
tablets, bulk capsules, bulk ampoules or bulk vials) to distributors who
subsequently convert such product into finished product form and sell to Third
Parties, provided that such distributors shall not be considered sublicensees
for purposes of this Net Sales definition;
less deductions actually allowed or specifically allocated and actually
incurred to Product by the Selling Party using generally accepted accounting
standards and reasonable practices with respect to sales of all of such party's
products, consistently applied, for the following:
(i) transportation charges, including insurance, for transporting
Product;
(ii) sales and excise taxes and duties paid or allowed by the Selling
Party and any other governmental charges imposed upon the production,
importation, use or sale of such Product and paid by the Selling Party;
(iii) trade, quantity and cash discounts actually allowed on Product;
(iv) allowances or credits to customers on account of rejection or return
of Product in accordance with SB's or Incyte's (or their sublicensees) returned
goods policy or on account of retroactive price reductions affecting such
Product; and
(v) Product rebates and Product charge backs including those granted to
managed care entities (including Medicaid rebates).
Any accruals for the foregoing deductions shall be reconciled with actual
results on a quarterly basis and any adjustments shall be reflected in the
subsequent quarter's computation of Net Sales.
Sales between a Selling Party and its sublicensees (other than sublicensees
that are end-users) shall be excluded from the computation of Net Sales and no
royalties will be payable on such sales.
Notwithstanding the immediately preceding sentence, it is understood that any
transactions with respect to an Rx Product between a Selling Party or any of
its or
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their Affiliates or sublicensees on the one hand and a PSB on the other hand
shall be on an arms length basis. In the event that any PSB type activity is
within a Party or within any of its Affiliates or its or their sublicensees as
only part of its or their total activities rather than in a separate Affiliate,
a notional Net Sales figure will be calculated on an arms length basis to cover
such activities, in any event not less than the weighted average net sales
price to unaffiliated Third Parties in the same country. The term "PSB" as used
in this definition shall mean any present or future Affiliate of a Party or its
sublicensees which conducts a pharmaceutical service business for or on behalf
of Third Parties, including pharmaceutical benefits management services
(hereinafter "PBM"), wholesaler distribution, pharmacy distribution,
managed-care services, disease-management services, hospital services, or
mail-order prescription pharmacy services. As of the Effective Date, Affiliates
of SB which are included within the definition of PBM are Diversified
Pharmaceutical Services and Diversified Prescription Delivery LLC.
"Operating Agreement": shall mean the Operating Agreement for DiaDexus between
and among SB Corp, Incyte, and DiaDexus entered into of even date herewith.
"Party(ies)": shall mean individually and collectively SB, Incyte, and DiaDexus.
"Phase III Initiation": shall mean the date the first patient is dosed with an
Rx Product by or on behalf of Incyte or SB or their licensees, as the case may
be, in the first phase III clinical trial required for the filing of a new drug
application with the RA for such Rx Product.
"Product(s)": shall mean individually and collectively Tests and Rx Products.
"RA Approved Kit(s)": shall mean a Kit wherein the Regulatory Authority in the
relevant country or territory has granted Regulatory Approval for such Kit for
cDx use, or, in countries and territories where a Kit may be sold for cDx use
without such approval, such Kit is clinically validated to an extent similar to
that which would have been required by a Regulatory Authority in a country or
territory where such approval is required.
"rDx Kit(s)": shall mean any Kit for performing a test on a tissue or
biological sample which test is being conducted as a Research Diagnostic.
"Regulatory Approval": shall mean all the government approvals required to
market a product in a given country, including, but not limited to, product
registration(s) and price and marketing approval(s), as applicable, in such
country.
"Regulatory Authority (RA)": shall mean the FDA or the analogous regulatory
body of any other country or territory where a Test is performed or sold.
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"Research Diagnostic(s)" ("rDx"): shall mean test(s) performed on a commercial
basis on a tissue or other biological sample, the results of which are provided
to any party for any purpose, excluding use as a Clinical Diagnostic.
"Research Diagnostics Service(s)" ("rDx Service(s)"): shall mean a Research
Diagnostic performed as a service.
"Research Informatics Product(s)" ("Research-Ix Product(s)"): shall mean any
database product which is used for any purpose other than as a Investigational
Trials Informatics Product or Healthcare Informatics Product.
"Research Plan": shall mean a research plan for a Test filed by DiaDexus
pursuant to Paragraph 11.1. Appendix F is a Research Plan form.
"Rx/Other": shall mean the field including any products or processes which are
not Tests or Ix Products.
"Rx Product": shall mean a product or service in the field of Rx/Other for the
prevention or treatment of any disease, state or condition by any means in
human or animals, which product was materially based on or materially derived
by SB's or Incyte's, as the case may be, use of DiaDexus IP as licensed under
this Agreement, and which are not Tests or Ix Products.
"SB": shall mean, individually and collectively, SmithKline Xxxxxxx
Corporation; SmithKline Xxxxxxx plc; and any SB Affiliate(s) to which any
rights and/or obligations of either of them shall be assigned and/or delegated
pursuant to this Agreement.
"SB Affiliate": shall mean any corporation, firm, partnership or other entity,
whether de jure or de facto, which directly or indirectly owns, is owned by or
is under common ownership with SB to the extent of at least fifty percent (50%)
of the equity (or such lesser percentage which is the maximum allowed to be
owned by a foreign corporation in a particular jurisdiction) having the power
to vote on or direct the affairs of the entity, and any person, firm,
partnership, corporation or other entity actually controlled by, controlling or
under common control with SB.
"SB Diagnostic IP": shall mean individually or collectively SB Diagnostic
Know-How and SB Diagnostic Patents.
"SB Diagnostic Know-How": shall mean any and all data, substances, processes,
materials, formulae, know-how and inventions with respect to a Gene Product
or set of Gene Product(s) having potential utility as a diagnostic product
which is a cDx
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Homebrew, cDx Kit, or Class I rDx Service or Class I rDx Kit, owned by SB or
with respect to which SB has a right to grant a license consistent with the
terms and conditions of this Agreement and which are listed on Appendix G (which
may be amended from time to time) or is otherwise expressly provided to DiaDexus
in writing by SB.
"SB Diagnostic Patents": shall mean all patents and patent applications to the
extent they claim SB Diagnostic Know-How, which are owned by SB or to which SB
otherwise has the right to grant licenses consistent with the terms and
conditions of this Agreement. Included within the definition of SB Diagnostic
Patents, without limitation, are all continuations, continuations-in-part,
divisions, patents of addition, reissues, renewals, extensions, registrations,
confirmations, re-examinations thereof and any provisional applications and all
SPCs. SB Diagnostic Patents are listed on Appendix H which may be amended from
time to time.
"SB IP": shall mean any and all data, substances, processes, materials,
formulae, know-how, patents, and inventions which are owned by SB or with
respect to which SB has a right to grant a license but shall not include SB
Diagnostic IP and SB Technology IP.
"SB Rx Product": shall mean an Rx Product sold by SB or its licensees of such
Rx Product.
"SB Technology IP": shall mean individually and collectively SB Technology
Know-How and SB Technology Patents.
"SB Technology Know-How": shall mean any and all data, substances, processes,
materials, formulae, know-how and inventions which may be useful for Making,
Having Made, Using, and/or Selling Clinical Diagnostic(s) which are owned by SB
or with respect to which SB has a right to grant a license and which are listed
on Appendix I (which may be amended from time to time) or are otherwise
expressly provided to DiaDexus in writing by SB. SB Technology Know-How includes
Bioinformatics, and results of bioinformatics analysis such as array designs and
data mining, and array technology but does not include SB Diagnostic Know-How.
"SB Technology Patents": shall mean all patents and patent applications to the
extent they claim SB Technology Know-How, which are owned by SB or to which SB
otherwise has the right to grant licenses. Included within the definition of SB
Technology Patents, without limitation, are all continuations,
continuations-in-part, divisions, patents of addition, reissues, renewals,
extensions, registrations, confirmations, re-examinations thereof and any
provisional applications and all SPCs. SB Technology Patents are listed on
Appendix J which may be amended from time to time.
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"SPC": shall mean a right based upon a patent to exclude others from making,
using or selling a product, such as a supplementary protection certificate.
"Test": shall mean individually or collectively a cDx Kit, cDx Homebrew, rDx
Kit, and rDx Service, as applicable.
"Third Party(ies)": means any individual or entity other than SB, Incyte or
DiaDexus.
"Valid Claim" shall mean a claim of an SB Diagnostic Patent, SB Technology
Patent, Incyte Diagnostic Patent, Incyte Technology Patent, or DiaDexus Patent,
as the case may be, which has not been held invalid or unenforceable by final
decision of a court or other governmental agency of competent jurisdiction,
unappealable or unappealed within the time allowed for appeal, and which is not
admitted to be invalid or unenforceable through reissue, disclaimer or
otherwise.
2.0 DiaDexus
2.1 SB and Incyte agree to form DiaDexus pursuant to the Operating Agreement
by and among SB Corp., Incite, and DiaDexus entered into as of even date
herewith.
3.0 Incyte
3.1 General Provisions
3.1.1 Unless expressly granted to DiaDexus pursuant to the terms and
conditions of this Agreement and/or Incyte Database Agreements, Incyte
retains all rights to Incyte Diagnostic IP and Incyte Technology IP.
3.1.2 Notwithstanding any grants conveyed by Incyte under Incyte
Diagnostic IP and Incyte Technology IP, Incyte retains the right to use
such Incyte Diagnostic IP and Incyte Technology IP for its own internal
research purposes.
3.1.3 Notwithstanding anything else to the contrary, Incyte does not xxxxx
XX any rights pursuant to this Agreement under Incyte IP, Incyte Technology
IP, or Incyte Diagnostic IP.
3.1.4 Incyte retains all rights and does not grant DiaDexus any rights
under Incyte IP under this Agreement.
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3.2 Incyte Class I cDx Test(s) Diagnostic IP Grants and Incyte Technology
IP Grants: Subject to all the terms and conditions of this Agreement,
Incyte hereby grants the following rights in the field of Class I Dx
Test(s);
3.2.1 cDx Homebrew
(a) During the Initial License Period, Incyte grants DiaDexus
an exclusive, world-wide, license under Incyte Diagnostic IP,
with the right to sublicense pursuant to Paragraph 3.7, to
Make, Have Made, Use, and Sell cDx Homebrews in the field of
Class I Dx Test(s).
(b) After the Initial License Period, Incyte grants DiaDexus an
exclusive, world-wide, license under Incyte Diagnostic IP, with
the right to sublicense pursuant to Paragraph 3.7, to Make,
Have Made, Use, and Sell cDx Homebrews in the field of Class I
Dx Test(s) with respect to cDx Homebrews for which DiaDexus has
filed a Research Plan pursuant to Section 11.
3.2.2 cDx Kit(s)
(a) During the Initial License Period, Incyte grants DiaDexus an
exclusive, world-wide license under Incyte Diagnostic IP, with
the right to sublicense pursuant to Paragraph 3.7, to Make,
Have Made, Use, and Sell cDx Kit(s) in the field of Class I Dx
Test(s).
(b) After the Initial License Period, Incyte grants DiaDexus an
exclusive, world-wide license under Incyte Diagnostic IP, with
the right to sublicense pursuant to Paragraph 3.7, to Make, Have
Made, Use, and Sell cDx Kit(s) in the field of Class I Dx Test(s)
with respect to cDx Kit(s) for which DiaDexus has filed a
Research Plan pursuant to Section 11.
3.2.3 rDx Kit(s) and rDx Service(s)
(a) During the Initial License Period, Incyte grants DiaDexus a
non-exclusive, world-wide license under Incyte Diagnostic IP,
with the right to sublicense pursuant to Paragraph 3.7, to
Make, Have Made, Use, and Sell rDx Kit(s) and rDx Service(s) in
the field of Class I Dx Test(s); provided that with respect to
nucleic acid based rDx Kit(s) and/or rDx Service(s), DiaDexus
shall also be developing or selling the same nucleic acid based
rDx Kit or rDx Service as a Class I cDx Kit or cDx Homebrew
consistent with the grant to DiaDexus in Paragraphs 3.2.1 or
3.2.2.
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(b) After the Initial License Period, Incyte grants DiaDexus a
non-exclusive, world-wide license under Incyte Diagnostic IP, with
the right to sublicense pursuant to Paragraph 3.7, to Make, Have
Made, Use, and Sell rDx Kit(s) and rDx Service(s) in the field of
Class I Dx Test(s) with respect to rDx Kit(s) and rDx Service(s) for
which DiaDexus has filed a Research Plan pursuant to Section 11,
provided that with respect to nucleic acid based rDx Kit(s) and/or
rDx Service(s), DiaDexus shall also be developing or selling the
same nucleic acid based rDx Kit or rDx Service as a Class I cDx Kit
or cDx Homebrew consistent with the grant to DiaDexus in Paragraphs
3.2.1 or 3.2.2.
3.2.4 Incyte Technology IP: All Class I Dx Test(s) and all Class II &
III Dx Test(s) which are cDx Kit(s)
(a) For all Class I Dx Test(s) and all Class II & III Dx Test(s)
which are cDx Kit(s), Incyte grants DiaDexus a non-exclusive,
world-wide license under Incyte Technology IP provided to DiaDexus
by Incyte during the Initial License Period to Make, Have Made, Use,
and Sell such Tests. This license is sublicensable by DiaDexus
pursuant to Paragraph 3.7 only on a Test by Test basis and only to
the extent that such Incyte Technology IP is required for the
conduct of the specific Test and further provided such Incyte
Technology IP has been listed on Appendix D and/or E as being
sublicenseable.
3.3. Incyte Class II Dx Test(s) Grants: Subject to all the terms and conditions
of this Agreement, Incyte hereby grants the following rights in the field
of Class II DX Test(s);
3.3.1 cDx Kit(s)
(a) During the Initial License Period, Incyte grants DiaDexus an
exclusive, world-wide license under Incyte Diagnostic IP, with the
right to sublicense pursuant to Paragraph 3.7, to Make, Have Made,
Use, and Sell cDx Kit(s) in the field of Class II Dx Test(s).
(b) After the Initial License Period, Incyte grants DiaDexus an
exclusive, world-wide license under Incyte Diagnostic IP, with the
right to sublicense pursuant to Paragraph 3.7, to Make, Have Made,
Use, and Sell cDx Kit(s) in the field of Class II DX Test(s) with
respect to cDx Kit(s) for which DiaDexus has filed a Research Plan
pursuant to Section 11.
3.2.2 cDx Homebrew(s), rDx Kit(s), and rDx Service(s)
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(a) Subject to DiaDexus's right to conduct research only in
furtherance of the rights explicitly granted therein. Incyte retains
all rights under Incyte Diagnostic IP and Incyte Technology IP to
Make, Have Made, Use, and Sell cDx Homebrews, rDx Kit(s), and rDx
Service(s) in the field of Class II Dx Test(s).
3.4 Incyte Class III Dx Test(s) Grants: Subject to all the terms and
conditions of this Agreement, Incyte hereby grants the following rights in
the Field of Class III Dx Test(s):
3.4.1 cDx Kit(s)
(a) During the Initial License Period, Incyte grants DiaDexus an
exclusive, world-wide license under Incyte Diagnostic IP, with the
right to sublicense pursuant to Paragraph 3.7, to Make, Have Made,
Use, and Sell cDx Kit(s) in the field of Class III Dx Test(s).
(b) After the Initial License Period, Incyte grants DiaDexus an
exclusive, world-wide license under Incyte Diagnostic IP, with the
right to sublicense, pursuant to Paragraph 3.7, to Make, Have Made,
Use, and Sell cDx Kit(s) in the field of Class III Dx Test(s) with
respect to cDx Kit(s) for which DiaDexus has filed a Research Plan
pursuant to Section 11.
3.4.2 cDx Homebrew, rDx-Kit(s), and rDx Service(s)
(a) Subject to DiaDexus's right to conduct research only in
furtherance of the rights explicitly granted herein, Incyte retains
all rights under Incyte Diagnostic IP and Incyte Technology IP to
Make, Have Made, Use, and Sell cDx Homebrew(s), rDx-Kit(s) and rDx
Service(s) in the field of Class III Dx Test(s).
3.5 Marketing Agreements
(a) Incyte grants SB a first right in the Homebrew Territory to
enter into a marketing and/or distribution agreement with Incyte for
any Class II or Class III Dx Tests being commercialized by Incyte
which are cDx Homebrew(s) and for which Incyte, in its sole
discretion, seeks a partner for product marketing and/or product
distribution during the Initial License Period. Incyte agrees to
notify SB in writing of such first right and agrees to extend to SB
a six (6) month period in which to negotiate and execute such
marketing and/or distribution agreement for such Tests. SB shall
within thirty (30) days after receipt of such notice either accept
in writing or decline such first right (no notice to Incyte within
such thirty (30) day period shall constitute a waiver of such first
right with respect to such Test). If SB accepts such first right in
writing, SB and Incyte agree to negotiate exclusively with each
other in good faith effort
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to execute such marketing and/or distribution agreement within such six (6)
month period. In the event a marketing and/or distribution agreement is not
entered into during such six (6) month period or a mutually agreed extension
thereof, SB relinquishes any such first right with respect to such Test
leaving Incyte free to pursue marketing and/or distribution agreements with
Third Parties at its own discretion for such Test.
3.6 Bioinformatics
3.6.1 During the Initial License Period, Incyte shall provide DiaDexus
an opportunity to negotiate a commercial non-exclusive license for
Bioinformatics of Incyte made commercially available by Incyte to Third
Parties which Bioinformatics is not otherwise licensed pursuant to this
Agreement or the Incyte Database Agreements.
3.6.2 Except as otherwise expressly provided herein, DiaDexus has no
rights to sublicense Bioinformatics rights it receives from Incyte under
this Agreement or any agreement with Incyte without the prior express
written permission of Incyte.
3.6.3 It is the intent of Incyte, on a collaborative basis, to make
certain Bioinformatics available to DiaDexus which is not otherwise
available pursuant to Paragraph 3.6.1 (e.g., experimental bioinformatics
tools etc.). However, the parties recognize that Incyte is under no
obligation to provide (and may not have the rights to provide) such
Bioinformatics to DiaDexus.
3.7 Sublicensing of Incyte Diagnostic IP and Incyte Technology IP: DiaDexus
agrees that brokerage of Incyte Diagnostic IP or Incyte Technology IP is
not permitted by DiaDexus nor in Incyte's best interests. Therefore:
3.7.1 On an individual Test-by-Test basis, DiaDexus may sublicense to
any Third Party the rights to such Test for which a Research Plan has
been filed in accordance with Section 11 and the Incyte Diagnostic IP
and/or Incyte Technology IP relating thereto, on an exclusive or
non-exclusive basis, as the case may be, in order to Make, Have Made,
Use, and Sell Tests as granted under this Section 3.0; provided,
however, that without the prior express written consent of Incyte, no
sublicense of Incyte Diagnostic IP or Incyte Technology IP will be
granted to any Third Party in the absence of a corresponding license of
rights to a given Test discovered, researched and/or developed by
DiaDexus including the license of patent rights pertaining thereto owned
by, licensed to or controlled by DiaDexus; and further provided that
each sublicense has a grant which is consistent with the terms herein
and DiaDexus shall be responsible for payments and royalties under
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such sublicenses due under Section 6.0 as if such were made by
DiaDexus directly and pursuant to the terms and conditions of this
Agreement.
3.7.2 DiaDexus shall obtain the prior written commitment of any
sublicensee to abide by all applicable terms and conditions of this
Agreement. Promptly upon execution of any permitted sublicense under
3.7.1, DiaDexus shall provide notice thereof to Incyte, and
reasonable satisfactory evidence that such sublicense is in
compliance with this Paragraph 3.7.
3.7.3 Any purported sublicense in violation of this Section 3.7 shall be
void.
3.8 Other Incyte agrees to negotiate with SB in good faith for access to Incyte
Technology IP which is required for the commercially reasonable conduct of
cDx Homebrews licensed to SB by DiaDexus pursuant to Section 5.
4.0 SB
--------
4.1 General Provisions
4.1.1 Any SB Diagnostic IP which is based on the use of or derived from
data or information obtained by SB pursuant to the HGS Agreements
shall only be transferred to DiaDexus on a potential Test-by-
potential Test basis and at DiaDexus's election pursuant to
Paragraph 9.1.2. SB technology intellectual property based on the
use of or derived from data or information obtained by SB pursuant
to the HGS Agreements shall not be transferred to DiaDexus by SB.
4.1.2 Unless expressly granted to DiaDexus pursuant to the terms and
conditions of this Agreement, SB retains all rights to SB
Diagnostic IP and SB Technology IP.
4.1.3 Notwithstanding any grants conveyed by SB under SB Diagnostic IP
and SB Technology IP, SB retains the right to use such SB
Diagnostic IP and SB Technology IP for its own internal research
purposes.
4.1.4 Notwithstanding anything else to the contrary, SB retains all
rights, and does not grant DiaDexus any rights under SB IP under
this Agreement.
4.1.5 Notwithstanding anything else to the contrary, SB does not grant
Incyte any rights pursuant to this Agreement under SB IP, SB
Technology IP, or SB Diagnostic IP.
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4.2 SB cDx Homebrew Grants: Subject to all the terms and conditions of this
Agreement, SB hereby grants the following rights to cDx Homebrew(s) in the
field of Class I Dx Test(s), Class II Dx Test(s), and Class III Dx Test(s):
4.2.1 cDx Homebrews
(a) During the Initial License Period SB grants DiaDexus an
exclusive, world-wide license under SB Diagnostic IP with the right to
sublicense pursuant to Paragraph 4.7, to Make, Have Made, Use, and
Sell cDx Homebrews in the field of Class I Dx Test(s), Class II Dx
Test(s), and Class III Dx Test(s).
(b) After the Initial License Period SB grants DiaDexus an exclusive,
world-wide license under SB Diagnostic IP with the right to sublicense
pursuant to Paragraph 4.7, to Make, Have Made, Use, and Sell cDx
Homebrews in the field of Class I Dx Test(s), Class II Dx Test(s), and
Class III Dx Test(s); provided DiaDexus has filed a Research Plan for
such Homebrew pursuant to Section 11.
4.3 SB cDX Kit Grants: Subject to all the terms and conditions of this
Agreement, SB hereby grants the following rights to cDx Kit(s) in the
field of Class I Dx Test(s), Class II Dx Test(s), and Class III Dx Test(s):
4.3.1 cDx Kit(s)
(a) During the Initial License Period, SB grants DiaDexus an
exclusive, world-wide license under SB Diagnostic IP, with the right
to sublicense pursuant to Paragraph 4.7, to Make, Have Made, Use, and
Sell cDx Kit(s), in the field of Class I Dx Test(s), Class II Dx
Test(s), and Class III Dx Test(s).
(b) After the Initial License Period, SB grants DiaDexus an
exclusive, world-wide license under SB Diagnostic IP, with the right
to sublicense pursuant to Paragraph 4.7, to Make, Have Made, Use, and
Sell cDx Kit(s) in the field of Class I Dx Test(s), Class II Dx
Test(s), and Class III Dx Test(s) with respect to cDx Kit(s) for
which DiaDexus has filed a Research Plan pursuant to Section 11.
4.4 SB Class I Dx Test(s) which are rDx Service or rDx Kit(s) Grants: Subject
to all the terms and conditions of this Agreement, SB hereby grants the
following rights to rDx Service(s) and rDx Kit(s) in the field of Class I
Dx Test(s):
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4.4.1 rDx Service(s) and rDx Kit(s)
(a) During the Initial License Period, SB grants DiaDexus a
non-exclusive, world-wide license under SB Diagnostic IP, with the
right to sublicense pursuant to Paragraph 4.7, to Make, Have Made,
Use, and Sell rDx Service(s) and rDx Kit(s) in the field of Class I
Dx Test(s).
(b) After the Initial License Period, SB grants DiaDexus a
non-exclusive, world-wide license under SB Diagnostic IP, with the
right to sublicense pursuant to Paragraph 4.7, to Make, Have Made,
Use, and Sell rDx Service(s) and rDx Kit(s) in the field of Class I
Dx Test(s) with respect to such rDx Service(s) and rDx Kit(s) for
which DiaDexus has filed a Research Plan pursuant to Section 11.
(c) Subject to DiaDexus's right to conduct research only in
furtherance of the rights explicitly granted herein, SB retains all
rights under SB Diagnostic IP to Make, Have Made, Use, and Sell rDx
Service(s) and rDx Kit(s) in the field of Class II and Class III Dx
Test(s).
4.5 SB Technology IP grants: Subject to all the terms and conditions of this
Agreement. SB hereby grants the following rights under SB Technology IP in
the field of Class I Dx Test(s), Class II Dx Test(s), and Class III Dx
Test(s):
4.5.1 All Class I, Class II and Class III Dx Test(s)
(a) SB grants DiaDexus a non-exclusive, world-wide license under
SB Technology IP provided to DiaDexus by SB during the Initial
License Period, to Make, Have Made, Use, and Sell cDx Kit(s), cDx
Homebrew(s), rDx Kit(s) and rDx Service(s) in the field of Class I
Dx Test(s), Class II Dx Test(s), and Class III Dx Test(s). This
license is sublicensable by DiaDexus pursuant to Paragraph 4.7 on a
Test-by-Test basis and only to the extent such SB Technology IP is
required for the conduct of the specific Test and further provided
such SB Technology IP has been listed on Appendix I or J as being
sublicenseable.
4.6 Bioinformatics/Ix Products:
4.6.1 During the Initial License Period, SB shall provide DiaDexus
an opportunity to negotiate a non-exclusive license for
Bioinformatics of SB made commercially available by SB to Third
Parties which Bioinformatics is not otherwise licensed pursuant to
this Agreement.
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4.6.2 Except as otherwise expressly provided herein, DiaDexus has no rights to
sublicense Bioinformatics rights it receives from SB under this Agreement
or any agreement with SB without the express written permission of SB.
4.6.3 It is the intent of SB, on a collaborative basis, to make certain
Bioinformatics available to DiaDexus which is not otherwise available
under subparagraph 4.6.1 (e.g., experimental bioinformatics tools, etc.).
However, the parties recognize that SB is under no obligation to provide
(and may not have the rights to provide) such Bioinformatics to DiaDexus.
4.6.4 SB grants Incyte a first right of offer to enter into an agreement with
SB for commercialization of SB Bioinformatics platform(s) in the event SB,
in its sole discretion, seeks to commercialize any SB Bioinformatics
platform during the Initial License Period. If SB seeks to commercialize
its Bioinformatics platform(s), SB agrees to provide Incyte promptly in
writing with a description of each such Bioinformatics platform and the
general terms of each such proposed agreement between Incyte and SB to
commercialize such Bioinformatics platform. Incyte shall notify SB within
sixty (60) days after receipt of such terms whether Incyte desires to
proceed into negotiations with respect to each such commercialization
agreement. If Incyte notifies SB in writing that it wishes to proceed, SB
and Incyte agree to negotiate exclusively with each other in good faith to
execute each such agreement within a period of one hundred eighty (180)
days. In the event that Incyte declines in writing to proceed, or if the
Parties cannot reach an agreement within the 180 day period, or a mutually
agreed extension thereof, then during the Initial License Period, SB
agrees not to enter into an agreement to commercialize any such
Bioinformatics platform with any Third Party under more favorable terms
and conditions than the terms and conditions last offered to Incyte unless
such terms have been offered to Incyte in accordance with this Paragraph
4.6.4.
4.6.5 DiaDexus hereby acknowledges that Incyte has ongoing research and
development programs involving material investment by Incyte to produce
and develop Incyte IP independent of that which would constitute Incyte
Diagnostic IP, including Incyte IP which is or shall be provided to third
parties on a non-exclusive commercial basis as Incyte database product(s),
including Lx Product(s). Incyte shall provide SB and DiaDexus with access
on commercial terms to those Ix Product(s), or other Incyte database
products which are made generally available by Incyte to other Third
Parties on a non-exclusive basis.
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4.7 Sublicensing of SB Diagnostic IP and SB Technology IP: DiaDexus agrees that
brokerage of SB Diagnostic IP or SB Technology IP is not permitted by
DiaDexus nor is it in SB's best interests. Therefore:
4.7.1 On an individual Test-by-Test basis, DiaDexus may sublicense to
any Third Party the rights to such Test for which a Research Plan
has been filed in accordance with Section 11 and the SB
Diagnostic IP and/or SB Technology IP relating thereto, on an
exclusive or non-exclusive basis, as the case may be, in order to
Make, Have Made, Use, and Sell Tests as granted under this
Section 4.0; provided, however, that without the prior express
written consent of SB, no sublicense of SB Diagnostic IP or SB
Technology IP will be granted to any Third Party in the absence
of a corresponding license of rights to a given Test discovered,
researched and/or developed by DiaDexus including the license of
patent rights pertaining thereto owned by, licensed to or
controlled by DiaDexus; and further provided that each sublicense
has a grant which is consistent with the terms herein and
DiaDexus shall be responsible for payments and royalties under
such sublicenses due under Section 6.0 as if such were made by
DiaDexus directly and pursuant to the terms and conditions of
this Agreement.
4.7.2 DiaDexus shall obtain the prior written commitment of any
sublicensee to abide by all applicable terms and conditions of
this Agreement. Promptly upon execution of any permitted
sublicense under 4.7.1. DiaDexus shall provide notice thereof to
SB, and reasonable satisfactory evidence that such sublicense is
in compliance with this Paragraph 4.7.
4.7.3 Any purported sublicense in violation of this Section 4.7 shall
be void.
4.8 Tissue
4.8.1 Consistent with the rights granted in this Section 4, SB shall
provide DiaDexus with reasonable access to its tissue collections
for its internal research purposes in the field of Class I Dx
Test(s), Class II Dx Test(s) and Class III Dx Test(s). Such
tissues are SB Technology Know-How.
4.9 Other: SB agrees to negotiate with Incyte in good faith for access to SB
Technology IP which is required for the commercially reasonable conduct of
rDx Service(s) licensed to Incyte by DiaDexus pursuant to Section 5.
5.0 DiaDexus
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5.1 General Provisions
5.1.1 Notwithstanding any exclusive grants conveyed by DiaDexus under
DiaDexus IP, DiaDexus retains the right to use such DiaDexus IP
for its own internal research purposes.
5.1.2 DiaDexus agrees not to intermingle any Incyte Database Know-How,
Incyte Diagnostic Know-How, and/or Incyte Technology Know-How
with any SB Diagnostic Know-How designated by SB as being based
on or derived by its collaboration with HGS pursuant to Paragraph
9.1.5.
5.1.3 DiaDexus retains all rights under DiaDexus IP unless expressly
granted to SB and/or Incyte pursuant to the terms and conditions
of this Agreement.
5.1.4 All rights and licenses granted by DiaDexus to SB and/or Incyte
pursuant to Paragraphs 5.2, 5.3, and 5.4, shall include a
non-exclusive sublicense or exclusive sublicense, as the case may
be, by DiaDexus to any SB Diagnostic IP and/or Incyte Diagnostic
IP each only as may be necessary to exercise such right or
license. Such license shall only be granted exclusively hereunder
to SB or Incyte, if such party had granted the license
exclusively to DiaDexus in Section 3 or 4, as the case may be,
and if not, such sublicense shall only be granted by DiaDexus to
SB or Incyte pursuant to this Paragraph, as the case may be,
non-exclusively.
5.2 DiaDexus Class I DX Test(s) Grants: Subject to all the terms and conditions
of this Agreement, DiaDexus hereby grants the following rights to SB in the
field of Class I DX Test(s):
5.2.1 cDx Homebrew(s)
(a) DiaDexus grants SB a first right to negotiate with DiaDexus to
obtain an exclusive license (with the right to sublicense) under
DiaDexus IP, generated during the Extended License Period to Make, Have
Made, Use, and Sell cDx Homebrew(s) in the field of Class I Dx Test(s)
in the Homebrew Territory. Such license, if agreed to, would include a
royalty and license fee as specified in Paragraph 6.3 and other terms
and conditions mutually acceptable to the Parties and customary in such
licenses, however, no additional payments beyond such royalty and
license fee shall be required for such license.
(b) DiaDexus agrees to notify SB in writing of the commencement of
such first right. SB and DiaDexus shall have a three (3) month period in
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which to negotiate and execute such license for such cDx Homebrew if
the Parties mutually agree thereto. SB shall within thirty (30) days
after receipt of such notice either accept in writing or decline
such first right (no notice to DiaDexus within such thirty (30) day
period shall constitute a waiver of such first right with respect to
such cDx Homebrew). If SB accepts such first right in writing, SB
and DiaDexus agree to negotiate exclusively with each other in good
faith effort to reach mutually acceptable agreement and to execute
such agreement within such three (3) month period. In the event a
license agreement is not entered into during such three (3) month
period or a mutually agreed extension thereof, SB shall have no
further right with respect to such cDx Homebrew leaving DiaDexus
free to pursue agreements with Third Parties or Incyte at its own
discretion for such cDx Homebrew.
5.2.2 rDx Services(s)
(a) DiaDexus grants SB a first right to negotiate with DiaDexus to
obtain a non-exclusive or exclusive (as negotiated), world-wide
license under DiaDexus IP generated during the Extended License
Period to Make, Have Made, Use, and Sell rDx Service(s) in the field
of Class I Dx Test(s).
(b) DiaDexus agrees to notify SB in writing of the commencement of
such first right. SB and DiaDexus shall have a six (6) month period
in which to negotiate and execute such license for such rDx Service,
if the Parties mutually agree thereto. SB shall within thirty (30)
days after receipt of such notice either accept in writing or
decline such first right (no notice to DiaDexus within such thirty
(30) day period shall constitute a waiver of such first right with
respect to such rDx Service). If SB accepts such first right in
writing, SB and DiaDexus agree to negotiate exclusively with each
other in good faith effort to reach mutually acceptable agreement
and to execute such agreement within such six (6) month period. In
the event a license agreement is not entered into during such six
(6) month period or a mutually agreed extension thereof, SB shall
have no further right with respect to such rDx Service leaving
DiaDexus free to pursue agreements with Third Parties or Incyte at
its own discretion for such rDx Service.
5.3 DiaDexus Class II Dx Test(s) Grants: Subject to all the terms and
conditions of this Agreement, DiaDexus hereby grants the following rights
to SB and/or Incyte in the field of Class II Dx Test(s):
5.3.1 cDx Homebrews
(a) DiaDexus grants SB a first right to negotiate with DiaDexus
to obtain an exclusive license under DiaDexus IP generated during
the
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Extended License Period, with the right to sublicense only to Incyte to
Make, Have Made, Use and Sell cDx Homebrews in the field of Class II Dx
Test(s) in the Homebrew Territory.
(b) DiaDexus agrees to notify SB in writing of the commencement of such
first right. SB and DiaDexus shall have a six (6) month period in which to
negotiate and execute such license for such cDx Homebrew if the Parties
mutually agree thereto. SB shall within thirty (30) days after receipt of
such notice either accept in writing or decline such first right (no
notice to DiaDexus within such thirty (30) day period shall constitute a
waiver of such first right with respect to such cDx Homebrew). If SB
accepts such first right in writing, SB and DiaDexus agree to negotiate
exclusively with each other in good faith effort to reach mutually
acceptable agreement and to execute such agreement within such six (6)
month period. In the event a license agreement is not entered into during
such six (6) month period or a mutually agreed extension thereof, SB shall
have no further right with respect to such cDx Homebrew.
(c) In the event SB declines such first right with respect to a cDx
Homebrew, or fails to reach agreement with DiaDexus within the six (6)
month period, DiaDexus grants Incyte the right to negotiate with DiaDexus
to obtain an exclusive license under DiaDexus IP, with the right to
sublicense only to SB, to Make, Have Made, Use, And Sell such cDx Homebrew
in the field of Class II Dx Test(s) in the Homebrew Territory.
(d) DiaDexus agrees to notify Incyte in writing of the commencement of
such right promptly after the earlier of when SB declines such first right
or the expiration of the six (6) month period in which no agreement was
reached with SB. SB and DiaDexus shall have a six (6) month period in
which to negotiate and execute such license for such cDx Homebrew if the
Parties mutually agree thereto. Incyte shall within thirty (30) days after
receipt of such notice either accept in writing or decline such right (no
notice to DiaDexus within such thirty (30) day period shall constitute a
waiver of such right with respect to such cDx Homebrew). If Incyte accepts
such right in writing, Incyte and DiaDexus agree to negotiate exclusively
with each other in good faith effort to reach mutually acceptable
agreement and to execute such agreement within such six (6) month period.
In the event a license agreement is not entered into during such six (6)
month period or a mutually agreed extension thereof, Incyte relinquishes
any such right with respect to such cDx Homebrew and DiaDexus is free to
enter into a license with respect to such cDx Homebrew with Third Parties.
5.3.2 rDx Service(s)
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(a) DiaDexus grants SB and Incyte a first right to negotiate with
DiaDexus to obtain a co-exclusive, world-wide license under DiaDexus
IP generated during the Extended License Period, with the right to
sublicense, to Make, Have Made, Use, and Sell rDx Service(s) in the
field of Class II Dx Test(s).
(b) DiaDexus agrees to notify SB and Incyte in writing of the
commencement of such first right. Each of SB and Incyte shall have a
six (6) month period in which to negotiate with DiaDexus and execute a
license for such rDx Service if such Parties mutually agree thereto.
SB and Incyte shall each within thirty (30) days after receipt of such
notice either accept in writing or decline such first right (no notice
to DiaDexus within such thirty (30) day period shall constitute a
waiver of such first right with respect to such rDx Service with
respect to such Party). If SB and/or Incyte accept such first right in
writing, SB and DiaDexus and/or Incyte and DiaDexus, each agree to
negotiate exclusively with each other in good faith effort to reach
mutually acceptable agreement and to execute such agreement within
such six (6) month period. In the event a license agreement is not
entered into during such six (6) month period or mutually agreed
extension(s) thereof, SB or Incyte, as the case may be, shall have no
further right with respect to such rDx Service.
5.4. DiaDexus Class III Dx Test(s) Grants: Subject to all the terms and
conditions of this Agreement, DiaDexus hereby grants the following rights
to SB and/or Incyte in the field of Class III Dx Test(s):
5.4.1 cDx Homebrew(s)
(a) DiaDexus grants SB a first right to negotiate with DiaDexus to
obtain an exclusive, world-wide license under DiaDexus IP, generated
during the Extended License Period, with the right to sublicense only
to Incyte, to Make, Have Made, Use, and Sell cDx Homebrew in the field
of Class III Dx Test(s) in the Homebrew Territory.
(b) DiaDexus agrees to notify SB in writing of the commencement of
such first right. SB and DiaDexus shall have a six (6) month period in
which to negotiate and execute such license for such cDx Homebrew if
the Parties mutually agree thereto. SB shall within thirty (30) days
after receipt of such notice either accept in writing or decline such
first right (no notice to DiaDexus within such thirty (30) day period
shall constitute a waiver of such first right with respect to such cDx
Homebrew). If SB accepts such first right in writing, SB and DiaDexus
agree to negotiate exclusively with each
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other in good faith effort to reach mutually acceptable agreement and to
execute such agreement within such six (6) month period. In the event a
license agreement is not entered into during such six (6) month period or
a mutually agreed extension thereof, SB shall have no further right with
respect to such cDx Homebrew.
(c) In the event SB declines such first right with respect to a cDx
Homebrew or fails to reach agreement with DiaDexus within a six (6) month
period, DiaDexus grants Incyte the right to an exclusive license under
DiaDexus IP, with the right to sublicense only to SB, to Make, Have Made,
Use, and Sell Clinical Dx Homebrew(s) in the field of Class III Dx Test(s)
in the Homebrew Territory.
(d) DiaDexus agrees to notify Incyte in writing of the commencement of
such right promptly after the earlier of when SB declines such right or
the expiration of the six (6) month period in which no agreement was
reached with SB. Incyte and DiaDexus shall have a six (6) month period in
which to negotiate and execute such license for such cDx Homebrew if the
Parties mutually agree thereto. Incyte shall within thirty (30) days after
receipt of such notice either accept in writing or decline such right (no
notice to DiaDexus within such thirty (30) day period shall constitute a
waiver of such right with respect to such cDx Homebrew). If Incyte accepts
such right in writing, Incyte and DiaDexus agree to negotiate exclusively
with each other in good faith effort to execute such agreement within such
six (6) month period. In the event a license agreement is not entered into
during such six (6) month period or a mutually agreed extension thereof,
Incyte shall have no further right with respect to such cDx Homebrew and
DiaDexus is free to enter into a license with respect to such cDx Homebrew
with Third Parties.
5.4.2 rDx Service(s)
(a) DiaDexus grants Incyte a first right to negotiate with DiaDexus for
an exclusive license under DiaDexus IP generated during the Extended
License Period, with the right to sublicense, to Make, Have Made, Use, and
Sell rDx Service(s) in the field of Class III Dx Test(s).
(b) DiaDexus agrees to notify Incyte in writing of the commencement of
such first right. Incyte and DiaDexus shall have a six (6) month period in
which to negotiate and execute such license for such rDx Service if the
Parties mutually agree thereto. Incyte shall within thirty (30) days after
receipt of such notice either accept in writing or decline such first
right (no notice to DiaDexus within such thirty (30) day period shall
constitute a waiver of such first right with respect to such rDx Service).
If Incyte accepts
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such first right in writing, Incyte and DiaDexus agree to negotiate
exclusively with each other in good faith effort to reach mutually
acceptable agreement and to execute such agreement within such six (6)
month period, provided such agreement contains a provision that such rDx
Service shall be made available to SB on commercial terms. In the event a
license agreement is not entered into during such six (6) month period or
a mutually agreed extension thereof, Incyte shall have no further right
with respect to such rDx Service as the case may be.
(c) In the event Incyte declines such first right with respect to a rDx
Service as the case may be, or fails to reach agreement with DiaDexus
within a six (6) month period, DiaDexus grants SB and Incyte the
co-exclusive right to a license(s) under such DiaDexus IP, with the right
to sublicense, to Make, Have Made, Use, and Sell such rDx Service as the
case may be in the field of Class III Dx Test(s).
(d) DiaDexus agrees to notify SB in writing of the commencement of such
right promptly after the earlier of when Incyte declines such right or
the expiration of the six (6) month period in which no agreement was
reached with Incyte. SB and Incyte and DiaDexus shall have a six (6)
month period in which to negotiate and execute such license(s) for such
rDx Service as the case may be. Incyte and/or SB shall within (30) days
after receipt of such notice either accept in writing or decline such
right (no notice to DiaDexus within such thirty (30) day period shall
constitute a waiver of such right with respect to such rDx Service as the
case may be). If Incyte and/or SB accept such right in writing, Incyte
and/or SB, as the case may be, and DiaDexus agree to negotiate
exclusively with each other in good faith effort to reach mutually
acceptable agreement and to execute such agreement within such six (6)
month period. In the event a license agreement is not entered into during
such six (6) month period or a mutually agreed extension thereof, Incyte
and SB shall have no further right with respect to such rDx Service as
the case may be and DiaDexus is free to enter into a license with respect
to such rDx Service with Third Parties.
5.5 DiaDexus Ix Product Grants: Subject to all the terms and conditions of this
Agreement, DiaDexus hereby grants the following rights to Ix Products:
5.5.1 Healthcare-Ix Products
(a) Subject to subparagraphs (b) and (c), DiaDexus grants SB and
Incyte a world-wide, co-exclusive license, with the right to sublicense,
under DiaDexus IP generated during the Extended License Period to Make,
Have Made, Use, and Sell Healthcare-Ix Products, provided that such
license is
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only sublicenseable by SB and Incyte if SB and Incyte mutually agree in
writing to such sublicense.
(b) Unless DiaDexus otherwise elects at its discretion to accelerate
the effective date of any license grant under Section 5.5.1(a) and
subject to subparagraph (c) below, with respect to DiaDexus IP which is
potentially useful as a Healthcare-Ix Product or portion thereof,
DiaDexus's grant of rights to SB and Incyte under Paragraph 5.5.1(a)
shall be effective upon the expiration of the two (2) year period
following such calendar quarter during which such DiaDexus IP was
generated (the "Proprietary Period").
(c) In the event DiaDexus elects, at its discretion, to grant rights to
SB and Incyte under Paragraph 5.5.1(a) prior to expiration of the
Proprietary Period, such license shall be subject to mutually agreed
field of use restrictions in the field of Clinical Diagnostics.
5.5.2 Research-Ix Products and Investigational-Ix Products
(a) Subject to subparagraphs (b) and (c), DiaDexus grants Incyte an
exclusive, world-wide license, with the right to sublicense, under
DiaDexus IP generated during the Extended License Period to Make, Have
Made, Use, and Sell Research-Ix Products and Investigational-Ix
Products.
(b) Unless at its discretion and subject to subparagraph (c) below,
with respect to DiaDexus IP which is potentially useful as a Research-Ix
Product or Investigational-Ix Product or portion(s) thereof, DiaDexus's
grant of rights to Incyte under Paragraph 5.5.2(a) shall come into
effect upon the expiration of the two (2) year period following such
calendar quarter during which such DiaDexus IP was generated (the
"Proprietary Period").
(c) In the event DiaDexus elects, at its discretion, to grant rights to
Incyte under Paragraph 5.5.2(a) prior to expiration of the Proprietary
Period, such license shall be subject to mutually agreed field of use
restrictions in the field of Clinical Diagnostics.
5.6 Additional DiaDexus grants: Subject to all the terms and conditions of this
Agreement, DiaDexus hereby grants the following additional rights to SB
and/or Incyte:
5.6.1 Improvements to SB Technology IP and Incyte Technology IP
(a) Notwithstanding anything else to the contrary, DiaDexus grants to
Incyte a non-exclusive, paid-up, non-cancellable, royalty-free, license
under
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DiaDexus IP which is an improvement to Incyte Technology IP generated by
or on behalf of DiaDexus during the Extended License Period.
(b) Notwithstanding anything else to the contrary, DiaDexus grants to
SB a non-exclusive, paid-up, non-cancellable, royalty-free, license
under DiaDexus IP which is an improvement to SB Technology IP generated
by or on behalf of DiaDexus during the Extended License Period.
5.6.2 Rx/Other
(a) Subject to subparagraphs (b), (c) and Paragraph 5.6.5(b), DiaDexus
grants Incyte and SB world-wide license(s), with the right to
sublicense, under DiaDexus IP generated during the Extended License
Period to Make, Have Made, Use, and Sell any and all products and
processes in the field of Rx/Other, as follows: such license(s) shall be
co-exclusive to Incyte and SB except as to the license of an Invention
as defined in Section 3.6.3 of the Incyte Collaborative LifeSeq(R)
Database Agreement in the Pharmaceutical Field of Use in order to Make,
Have Made, Use and Sell a Therapeutic Protein Product or Antisense
Product, which such license(s) of DiaDexus IP shall be exclusive to
Incyte.
(b) During the Extended License Period and with respect to all DiaDexus
IP useful in the Rx/Other field, DiaDexus's disclosure of and grant of
rights to SB and Incyte under Paragraph 5.6.2(a) shall only be disclosed
and granted at the time such DiaDexus IP is the subject of a patent
application filed by DiaDexus having a claim in the Rx/Other field and
for which the relevant Gene Product(s) has been tested in diagnostic
validation studies of at least twenty (20) patients.
(c) The parties agree that certain of SB's and Incyte's rights to
DiaDexus IP in the field of Rx/Other are subject to existing obligations
of SB and/or Incyte, as the case may be. For example,
(i) SB's co-exclusive rights in DiaDexus IP derived from Incyte
Database Products are subject to applicable terms and conditions of the
Incyte Database Agreements, including, in particular, the rights and
obligations with respect to disclosure and sublicense of Incyte IP; and
(ii) The obligations of SB to HGS pursuant to Paragraph
5.6.5(b).
5.6.3 Bioinformatics
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DiaDexus hereby grants Incyte and SB a non-exclusive, sublicenseable
license under DiaDexus IP generated during the Initial License Period
in the field of Bioinformatics (which are not improvements to Incyte
Technology IP or SB Technology IP) under reasonable commercial terms
to be negotiated.
5.6.4 Research
DiaDexus hereby grants to SB a non-exclusive license under DiaDexus
IP which is Clinical Non-genomic DiaDexus Data generated by or on
behalf of DiaDexus during the Extended License Period, to use for its
own internal research purposes.
5.6.5 Other
(a) For all Tests to which DiaDexus has lost its licenses to SB
Diagnostic IP or Incyte Diagnostic IP, as the case may be pursuant to
Paragraph 13.5, DiaDexus grants an exclusive, royalty-free,
non-cancellable, world-wide license under DiaDexus IP, with the right
to sublicense, to the extent necessary to Make, Have Made, Use, and
Sell such Tests. Such license shall be granted back to the Party or
Parties who made the original grant of SB Diagnostic IP or Incyte
Diagnostic IP, as the case may be, upon which such Test was based.
(b) Consistent with Paragraph 5.1.2, DiaDexus grants SB an exclusive,
world-wide license, with the right to sublicense, under DiaDexus IP
provided such DiaDexus IP was based on the use of or derived by SB
Diagnostic IP identified by SB pursuant to Paragraphs 4.1.1 and
9.1.5 as HGS Derived to Make, Have Made, Use, and Sell any and all
products and processes other than Tests.
(c) During the Extended License Period and for each cDx Kit
manufactured by DiaDexus, DiaDexus grants SB most favored nation
pricing with respect to the price of such cDx Kit sold to Third
Parties.
(d) During the Extended License Period and for each rDx Kit
manufactured by DiaDexus, DiaDexus grants Incyte most favored nation
pricing with respect to the price of such rDc Kit sold to Third
Parties.
6.0 SCHEDULE OF PAYMENTS; ROYALTIES
6.1 Rx/Other Field of Use; Milestone Payments and Royalties to DiaDexus by SB
and Incyte: Contingent on the following events, and subject to
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Paragraphs 6.5 and 6.6, the following payments and royalties shall be
paid by SB or Incyte or their sublicensees, as the case may be, to
DiaDexus for SB Rx Products and Incyte Rx Products, as the case may
be, to DiaDexus for SB Rx Products and Incyte Rx Products, as the
case may be, under the licenses granted under Paragraph 5.6.2(a) as
applicable:
(a) IND: A payment equal to (1) ******
(b) Phase III Initiation: A payment equal to (1) ******
(c) Regulatory Approval: A payment equal to (1) ******
(d) Single Payment Obligation/Major Market: It is understood
between the Parties that the payments above in subparagraphs
(a)-(c) will not be made more than once with respect to each Rx
Product and shall only be made when such obligation first occurs
in a country of a Major Market.
(e) Royalties on Net Sales: A royalty will be paid on Net Sales
by SB or Incyte or their sublicensees, as the case may be, of
any such Rx Product under the following schedule:
(i) Rx Product subject to Paragraph: 6.5(a) 6.5(b) Rx
Product ********* ********
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
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(ii) In the event an Rx Product is sold in the form of a
combination product containing at least one Rx Product and one
or more other ingredients which are Therapeutically Active
Ingredient(s), Net Sales of such combination product will be
adjusted by multiplying actual Net Sales of such combination
product by the fraction A/(A+B) where A is the average invoice
price of the Rx Product, if sold separately, and B is the
average invoice price of the Therapeutically Active
Ingredient(s), if sold separately. If the Therapeutically Active
Ingredient(s) are not sold separately, Net Sales shall be
calculated by multiplying actual Net Sales of such combination
product by the fraction A/C where A is the average invoice price
of the Rx Product if sold separately, and C is the average
invoice price of the combination product, provide A/C does not
exceed one (1). If, neither the Rx Product nor the
Therapeutically Active Ingredient(s) are sold separately, Net
Sales shall be determined by the Parties in good faith. For the
purposes of this Paragraph, Therapeutically Active Ingredient(s)
shall mean an ingredient which is biologically active in
achieving a clinical therapeutic effect but shall not include
diluents, vehicles, drug delivery systems or specific adjuvants
or any ingredient which does not have any, or only incidental,
therapeutic properties when present alone, but does not include
Rx Product.
(f) Licensing Revenue: SB or Incyte, as the case may be, shall pay
DiaDexus ****** percent of Licensing Revenue for DiaDexus Patents
licensed to Third Parties in the field of Rx/Other, only where such
license is in the absence of the grant of rights to an Rx Product and
payment of royalties and other payments to DiaDexus pursuant to
subparagraphs (a)-(e).
6.2 RX/Other Field of Use; Milestone Payments and Royalties to Incyte by SB:
Contingent on the following events, and subject to Paragraph 6.6, the
following payments and royalties shall be paid for Rx Products under the
licenses granted by DiaDexus to SB under Paragraphs 5.6.2(a) as applicable:
(a) IND: a payment equal to ******
(b) Phase III Initiation: A payment equal to ******
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
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(c) Regulatory Approval: A payment equal to ******
(d) Single Payment Obligation/Major Market: It is understood between the
Parties that the payments above in subparagraphs (a)-(c) will not be made more
than once with respect to each Rx Product and shall only be made when such
obligation first occurs in a country of a Major Market.
(e) Royalties on Net Sales: A ****** percent royalty will be paid by SB to
Incyte on Net Sales of any such SB Rx Product, provided:
(i) The foregoing payments under subparagraphs (a)-(e) will accrue or
become due or payable only with respect to Rx Products which are
materially based on or use materially or are derived by material use of
that which would constitute Incyte Database Know-How at the time of Use
by DiaDexus (as defined in the Incyte Database Agreement(s)), which
such Incyte Database Know-How was sublicensed by DiaDexus to SB as
permitted by Paragraph 3.6.3 of the Incyte Database Agreement(s);
(ii) In the event an Rx Product is sold in the form of a combination product
containing at least one Rx Product and one or more other ingredients
which are Therapeutically Active Ingredient(s), Net Sales of such
combination product will be adjusted by multiplying actual Net Sales of
such combination product by the fraction A/(A+B) where A is the average
invoice price of the Rx Product, if sold separately, and B is the
average invoice price of the Therapeutically Active Ingredient(s), if
sold separately. If the Therapeutically Active Ingredient(s) are not
sold separately, Net Sales shall be calculated by multiplying actual
Net Sales of such combination product by the fraction A/C where A is
the average invoice price of the Rx Product if sold separately, and C
is the average invoice price of the combination product, provide A/C
does not exceed one (1). If, neither the Rx Product nor the
Therapeutically Active Ingredient(s) are sold separately, Net Sales
shall be determined by the Parties in good faith. For the purposes of
this Paragraph, Therapeutically Active Ingredient(s) shall mean an
ingredient which is biologically active in achieving a clinical
therapeutical effect but shall not include
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
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diluents, vehicles, drug delivery systems or specific adjuvants or
any ingredient which does not have any, or only incidental,
therapeutic properties when present alone, but does not include Rx
Product.
6.3 Tests Field of Use; Payments and Royalties to DiaDexus by SB. Contingent
on the following events, and subject to Paragraph 6.5 and 6.6, the
following payments and royalties shall be paid by SB to DiaDexus for Tests
under the licenses granted under Paragraph 5.2.1 as applicable:
(a) Royalties on Net Sales: A royalty will be paid on Net Sales by
SB of any Test under the following schedule:
Test subject to Paragraph 6.5(a) 6.5(b)
cDx Homebrew (Class I) ****** ******
(b) License Fee: Promptly upon the execution of each license
agreement between SB and DiaDexus for each cDx Homebrew entered into
pursuant to Paragraph 5.2.1, SB shall pay to DiaDexus a license fee
of between ****** Such license fee is fully creditable against
future royalties for such cDx Homebrew.
(c) Applicable Royalty Rate/License Fee: The applicable royalty
rate for each such cDx Homebrew within such range specified in
Paragraphs (a) shall be calculated as follows:
(i) If the SB profit margin is ******
(ii) If the SB profit margin is ******
(iii) For profit margins between ******
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
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(d) Other terms: All other terms of such license agreement entered
into pursuant to Paragraph 5.2.1 for such cDx Homebrew to be
negotiated pursuant to the relevant agreement between SB and
DiaDexus with respect to such cDx Homebrew.
(e) Other Tests
SB and/or Incyte shall pay royalties to DiaDexus on Net Sales of
Tests to which SB and/or Incyte has obtained rights from DiaDexus
pursuant to this Agreement. Such royalty and other terms shall be
negotiated pursuant to the relevant agreement negotiated between SB
and/or Incyte and DiaDexus with respect to such Test.
6.4 Ix Product: Net Ix Revenue to DiaDexus by SB and Incyte. Contingent
on the following events, and subject to Paragraph 6.6, the following
payments shall be paid by SB and Incyte to DiaDexus for Ix Products, as
the case may be, under the licenses granted under Paragraph 5.5 as
applicable:
Ix Revenue: SB or Incyte, as the case may be, shall pay DiaDexus
****** percent of Net Ix Revenue for such Ix Product; provided such
Ix Product significantly incorporates DiaDexus data when sold.
6.5 Payment Obligation. The foregoing payment obligations of SB and Incyte to
DiaDexus under Sections 6.1 and 6.3 will accrue or become due or payable
only with respect to Rx Products and Tests:
(a) which but for the patent licenses granted herein would
otherwise infringe a Valid Claim(s) of a DiaDexus Patent(s); or
(b) are covered by a pending claim of a DiaDexus Patent(s) but not
a Valid Claim(s) of a DiaDexus Patent(s).
6.6 Duration of Royalty Payment Obligation.
6.6.1 All Royalty obligations with respect to each Product under any
portion of this Section 6.0 shall terminate on a country-by-country and
product-by-product basis on the later of (i) ten (10) years after the
first country-wide launch of each product in each country or (ii)
expiration of the last-to expire Valid Claim which covers such product in
each country.
6.6.2 Upon termination of the royalty payment obligation, DiaDexus, SB,
and Incyte, as the case may be, shall thereafter have in perpetuity a
royalty-free license to make, use and sell such Product in the specified
field(s) of use.
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
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6.7 Royalties and Other Commitments to Third Parties
6.7.1 DiaDexus acknowledges that SB has certain royalty and other
commitments to Third Parties on certain of the SB Technology IP and/or SB
Diagnostic IP. Where DiaDexus has commercialized or licenses a Test based
on or derived by such SB Technology IP and/or SB Diagnostic IP, DiaDexus
agrees to pay such royalties, either directly to such Third Party or via
pass through payments to SB and to meet all of the other terms and
conditions which such Third Party agreement may impose.
6.7.2 DiaDexus acknowledges that Incyte has certain royalty and other
commitments to Third Parties on certain of the Incyte Technology IP and/or
Incyte Diagnostic IP. Where DiaDexus has commercialized or licenses a Test
based on or derived by such Incyte Technology IP and/or Incyte Diagnostic
IP, DiaDexus agrees to pay such royalties, either directly to such Third
Party or via pass through payments to Incyte and to meet all of the other
terms and conditions which such Third Party agreement may impose.
7.0 THIRD PARTY AGREEMENTS
7.1 Subject to Paragraph 7.2 and during the Initial License Period,
Incyte and SB (including their Fifty Percent Affiliates) agree not to
create new corporate entities formed for the primary purpose of making,
having made, or selling cDx Kit(s).
7.2 During the Initial License Period, any new technology platform which
is reasonably determined to be useful for making cDx Kit(s) to which SB or
Incyte alone have the right to grant, or cause directly or indirectly to be
granted, non-exclusive licenses consistent with the terms and conditions of
this Agreement, SB or Incyte, as the case may be, shall offer DiaDexus a
six (6) month period in which to negotiate and execute a non-exclusive
license for such technology, under commercially reasonable terms. DiaDexus
shall within thirty (30) days of receipt of such notice either accept in
writing or decline such right (no notice to the other Party within such
thirty (30) day period shall constitute a waiver of such right with respect
to such technology license). If DiaDexus accepts such right in writing, the
Parties agree to negotiate exclusively with each other in good faith effort
to execute such agreement within such six (6) month period. In the event a
non-exclusive license agreement is not entered into within such six (6)
month period, SB or Incyte, as the case may be, shall be free to license
such technology, or create a new entity, including joint ventures, which
may utilize such technology in any field of use including cDx Kit(s)
without obligation to DiaDexus. For any other such new technology platform
which SB or Incyte, as the case may be, acquires a partial or restricted
ownership interest during the Initial License Period, and if the partners
in such new technology platform determine at their sole discretion to
license to Third Parties for the purpose of Making, Having Made, Using, or
Selling cDx Kits, SB or Incyte, as the
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case may be, will use commercially reasonable efforts to provide DiaDexus
the opportunity to license such new technology platform non-exclusively.
7.3 Consistent with its obligations described herein, the Parties acknowledge
that Incyte may exchange database access or satellite database services for
cash, technology or equity with Third Party entities including companies
which are involved in business related directly or indirectly to Clinical
Diagnostic(s) without obligation to DiaDexus herein above.
7.4 Notwithstanding the provisions of this Agreement, SB and Incyte retain
the right to undertake research and development programs or establish
collaborations with Third Parties in any research area, including, but not
limited to satellite database services, including areas which are or become
the subject of this Agreement, provided, however that SB and Incyte remain
subject to its confidentiality and license obligations to DiaDexus as set
forth herein.
8.0 BIOINFORMATICS COMMITTEE
8.1 Responsibilities of the Bioinformatics Committee
8.1.1 Promptly following the Effective Date during the Initial License
Period, the parties will form a committee made up of bioinformaticians
from each Party (Bx Committee). The Bx Committee shall have the
following responsibilities:
(a) Arrange for the orderly transfer of Bioinformatics to DiaDexus
from SB and Incyte and to SB and Incyte from DiaDexus in accordance
with the Agreement;
(b) Meet at least quarterly by phone or in person;
(c) Discuss possible collaborative efforts; and
(d) Any other duties as the members may mutually agree upon provided
such duties are consistent with the terms and conditions of this
Agreement.
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9.0 INFORMATION EXCHANGE
9.1 SB
9.1.1 During the Initial License Period, SB shall use reasonable
and ongoing efforts to disclose and supply to DiaDexus with certain
SB Technology Know-How which is reasonably available and
transferable, and has practical application in DiaDexus's research,
development and commercialization activities pursuant to this
Agreement. SB shall specify any prior Third Party obligations with
respect to such SB Technology Know-How.
9.1.2 During the Initial License Period, and consistent with the
scope of applicable licenses granted herein, whenever SB reasonably
determines that a Gene Product or set of Gene Product(s) (which
Gene Product(s) are subject to Third Party obligations) may have
utility as a Test, SB shall offer to DiaDexus any data, substances,
processes, materials, formulae, know-how and inventions which are
reasonably known to it with respect to such Gene Product or set of
Gene Product(s) on a potential Test-by-potential Test basis, to the
extent such data, substances, processes, materials, formulae,
know-how and inventions are owned by SB or for which SB has a right
to grant a license (including intellectual property obtained from
Third Parties) consistent with the terms and conditions of this
Agreement. SB will also notify DiaDexus of any obligations it would
be required to undertake under Paragraph 6.7.1 as a result of
accepting such. If DiaDexus decides to accept any such data,
substances, processes, materials, formulae, know-how and inventions,
such shall become SB Diagnostic Know-How and be listed on Appendix G
and any corresponding SB Diagnostic Patents shall be listed on
Appendix H.
9.1.3 During the Initial License Period and consistent with the
scope of the applicable license grants herein, whenever SB
reasonably determines that a Gene Product or set of Gene Product(s)
(which Gene Product(s) are not subject to Third Party obligations)
may have utility as a Test, such data, substances, processes,
materials, formulae, know-how and inventions which are reasonably
known to it with respect to such Gene Product or set of Gene
Product(s) shall become SB Diagnostic Know-How and be listed on
Appendix G and any corresponding SB Diagnostic Patents shall be
listed on Appendix H.
9.1.4 SB agrees to notify DiaDexus in writing which SB Technology
IP is sublicenseable by DiaDexus under this Agreement, any other SB
Technology IP is not sublicenseable by DiaDexus.
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9.1.5 Prior to transfer to DiaDexus, SB agrees to notify DiaDexus
in writing which SB Diagnostic IP is based on the use of or derived
by the use of information derived from the HGS Agreements or other
Third Party agreements, and to identify the commitments DiaDexus
would be obliged to undertake under 6.7.1.
9.2 Incyte
9.2.1 During the Initial License Period, Incyte shall use
reasonable and ongoing efforts to disclose and supply to DiaDexus
with certain Incyte Technology Know-How which is reasonably
available and transferable, and has practical application in
DiaDexus's research, development and commercialization activities
pursuant to this Agreement. Incyte shall specify any prior Third
Party obligations with respect to such Incyte Technology Know-How.
9.2.2 During the Initial License Period, and consistent with the
scope of the applicable license grants herein, whenever Incyte
reasonably determines that a Gene Product on set of Gene Product(s)
derived from laboratory data resulting from a prospective study
which has been identified by Incyte as having utility as a
potential cDx Homebrew, cDx Kit, or Class I rDx Kit or Class I rDx
Service using standard biology laboratory techniques above and
beyond bioinformatics analysis of data, Incyte shall offer to
DiaDexus any such data, substances, processes, materials,
formulae, know-how and inventions which are reasonably known to it
with respect to such Gene Product or set of Gene Product(s) on a
potential Test-by-potential Test basis, to the extent such data,
substances, processes, materials, formulae, know-how and inventions
are owned by Incyte or for which Incyte has a right to grant a
license (including such intellectual property obtained from Third
Parties) consistent with the terms and conditions of this
Agreement. Incyte will also notify DiaDexus of any obligations it
would be required to undertake under Paragraph 6.7.2 as a result of
accepting such. If DiaDexus decides to accept any such data,
substances, processes, materials, formulae, know-how and
inventions, such shall become Incyte Diagnostic Know-How and be
listed on Appendix B and any corresponding Incyte Diagnostic
Patents shall be listed on Appendix C. DiaDexus acknowledges that
disclosure or transfer of any Database Information as defined in
the Incyte Database Agreement(s) in conjunction with know-how
describing such potential cDx Homebrew, cDx Kit, or Class I rDx Kit
or rDx Service, shall remain Database Information and remains
subject to the terms and conditions of the Incyte Database
Agreement(s).
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9.2.3 Incyte agrees to notify DiaDexus in writing which Incyte
Technology IP is sublicenseable by DiaDexus under this Agreement, any
other Incyte Technology IP is not sublicenseable by DiaDexus.
9.2.4 Incyte agrees to notify SB in writing promptly after Incyte, in
its sole discretion, decides to seek a marketing partner pursuant to
Paragraph 3.5.
9.3 DiaDexus
9.3.1 During the Extended License Period, DiaDexus shall use
reasonable and ongoing efforts to disclose and supply to Incyte,
DiaDexus IP which are improvements to Incyte Technology IP which are
reasonably available and transferable.
9.3.2 During the Extended License Period, DiaDexus shall use reasonable
and ongoing efforts to disclose and supply to SB, DiaDexus IP which are
improvements to SB Technology IP which are reasonably available and
transferable.
9.3.3 cDx Homebrew(s)
During the Extended License Term and to the extent SB and/or Incyte have
a right to a license, DiaDexus shall promptly notify SB (or Incyte as
the case may be) in writing of any DiaDexus IP which is potentially
useful as a specific cDx Homebrew and shall specify any prior Third
Party obligations with respect to such DiaDexus IP.
9.3.4 rDx Service(s)
(a) During the Extended License Term and to the extent SB has a right
to a license, DiaDexus shall promptly notify SB in writing of any
DiaDexus IP which is potentially useful as a rDx Service in the field of
Class I or Class II Dx Test(s) and shall specify any prior Third Party
obligations with respect to such DiaDexus IP.
(b) During the Extended License Term and to the extent Incyte has a
right to a license, DiaDexus shall promptly notify Incyte in writing of
any DiaDexus IP which is potentially useful as a rDx Service in the
field of Class II or Class III Dx Test(s) and shall specify any prior
Third Party obligations with respect to such DiaDexus IP.
9.3.5 Healthcare-Ix Products
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(a) During the Extended License Term, and subject to the provisions of
5.5.1, DiaDexus shall use reasonable and ongoing efforts to promptly and
fully disclose to SB and Incyte all DiaDexus IP which is potentially
useful as a Healthcare Ix Product which is reasonably available and
transferable, and shall specify any prior Third Party obligations with
respect to DiaDexus IP.
(b) During the Extended License Term, whenever SB or Incyte identify a
potential Healthcare-Ix Product opportunity received pursuant to
Paragraph 9.3.5(a), SB or Incyte, as the case may be, shall disclose it
to the others attention. Promptly after such disclosure, the Parties
shall meet and shall mutually agree on the design and content of such
Healthcare Ix Product.
9.3.6 Research-Ix and Investigational-Ix Products
(a) During the Extended License Term, and subject to the provisions of
5.5.2, DiaDexus shall use reasonable and ongoing efforts to promptly and
fully disclose to Incyte and DiaDexus IP which is potentially useful as
a Research-Ix and Investigational-Ix Product which is reasonably
available and transferable, and shall specify any prior Third Party
obligations with respect to DiaDexus IP.
9.3.7 DiaDexus IP which is Rx/Other
(a) During the Extended License Period and subject to Paragraph 5.6.2,
DiaDexus shall use reasonable and ongoing efforts to promptly and fully
disclose to SB and Incyte all DiaDexus IP which is potentially useful in
the Rx/Other field which is reasonably available and transferable, and
shall specify any prior Third Party obligations with respect to DiaDexus
IP.
9.3.8 Bioinformatics
(a) During the Extended License Term, DiaDexus shall promptly and fully
disclose to Incyte and SB any DiaDexus IP which is Bioinformatics and
subject to the provisions of Paragraph 5.6.3 which is reasonably
available and transferable, and shall specify any prior Third Party
obligations with respect to DiaDexus IP.
9.3.9 Other
(a) During the Extended License Period, and with respect to DiaDexus IP
which is subject of any license granted to SB or Incyte under Section 5,
DiaDexus shall use reasonable and ongoing efforts to disclose and supply
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to SB or Incyte, as the case may be, with that certain DiaDexus IP which
is reasonably available and transferable and the subject of such license.
(b) Notwithstanding anything else to the contrary, DiaDexus IP which is
based on the use of or derived by the use of HGS derived SB Diagnostic IP
as provided to DiaDexus pursuant to Paragraph 9.1.2 shall only be
disclosed to SB.
(c) Incyte Database Technology shall only be disclosed to SB by DiaDexus
in accordance with the Incyte Database Agreement(s).
10.0 RESEARCH COMMITTEE
10.1 Research Committee(RC): Promptly after the Effective Date the Parties
shall form an RC and each designate their membership on such committee.
The RC shall meet at least quarterly during the Initial License Period.
10.2 Responsibilities of the RC:
(i) The orderly transfer of DiaDexus IP, SB Diagnostic IP, SB Technology
IP, Incyte Diagnostic IP, and Incyte Technology IP pursuant to the terms
and conditions of this Agreement;
(ii) Receiving Research Plans; and
(iii) Any other responsibilities consistent with the terms and conditions
of this Agreement and which the Parties mutually agree on.
11.0 RESEARCH PLAN
11.1 Filing of Research Plans
(a) A Research Plan may only be submitted to the RC by DiaDexus and only
during the Initial License Period.
(b) Incyte and/or SB may request DiaDexus to submit a Research Plan with
respect to Incyte Diagnostic IP and/or SB Diagnostic IP for which a
Research Plan has not been filed with eighteen (18) months after transfer
to DiaDexus. If six (6) months after such request, DiaDexus has not filed
such Research Plan, such Incyte Diagnostic IP and/or SB Diagnostic IP
shall revert to SB and/or Incyte as the case may be pursuant to Section
13.
11.2 Updating Research Plans
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Within thirty (30) days after the end of June 30 and December 31
respectively, DiaDexus shall provide to the RC in writing
semi-annual reports with respect to work performed by or for it under
each Research Plan which shall consist of updates substantially in
the form of Appendix F.
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12.0 CONFIDENTIALITY AND PUBLICATION
12.1 Confidentiality obligations. Each Party acknowledges that during the
course of this Agreement and pursuant to this Agreement it will
receive information (the "Receiving Party") from another Party or
Parties which is proprietary, confidential and of commercial value to
such Party, the "Disclosing Party". For purposes of this Agreement,
"Confidential Information" shall mean technical and business
information belonging to the Disclosing Party which is disclosed
pursuant to this Agreement, including, where appropriate and without
limitation, any information, business, financial and scientific data,
Gene Product(s), patent disclosures, patent applications, structures,
models, techniques, processes and, compositions, compounds, biological
samples, apparatus, and the like, and bioinformatics methods, hardware
configurations and software in various stages of development or any
software product (source code, object code or otherwise, including
its audiovisual components (menus, screens, structure and
organization) and any human or machine readable form of the program,
and any writing or medium in which the program or information therein
is stored, written or described, including, without limitation,
diagrams, flow charts, designs, drawings, specifications, models,
data, bug reports, and the like. Except to the extent expressly
authorized by this Agreement, the Receiving Party agrees that, for
the Initial License Period and for ten (10) years thereafter, it
shall keep confidential and shall not publish or otherwise disclose
and shall not use for any purpose (except those expressly permitted
under this Agreement) any Confidential Information furnished to it by
a Disclosing Party pursuant to this Agreement, and regardless of the
medium on which it is provided, including know-how, except to the
extent that it can be established by the Receiving Party by competent
proof that such information:
(a) was already known to it, other than under an obligation of
confidentiality, at the time of disclosure by the Disclosing
Party;
(b) was generally known to the public or otherwise part of the
public domain at the time of its disclosure to it;
(c) became generally available to the public or otherwise part
of the public domain after its disclosure other than through any
act or omission of it in breach of this Agreement;
(d) was subsequently lawfully disclosed to it by a Third Party;
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(e) was independently discovered or developed by it without the use
of the Disclosing Party's Confidential Information, as can be
documented by written records created at the time of such independent
discovery or development.
12.2 Disclosure. The Receiving Party may disclose the other's Confidential
Information to the extent such disclosure is reasonably necessary in (i)
filing, prosecuting patent applications and maintaining patents (consistent
with Section 14); (ii) prosecuting or defending litigation; and (iii)
complying with applicable governmental regulations provided, however, that
if it is required to make any disclosure of the Disclosing Party's secret
or Confidential Information it will give reasonable advance notice to the
Disclosing Party of such disclosure requirement and will use its reasonable
efforts to secure confidential treatment of such information required to be
disclosed. The Parties shall cooperate in any patent filing under
subparagraph (i) of this Paragraph.
12.3 Publication; Third Party Access. Except as provided for in Paragraph 12.2,
Confidential Information of a Disclosing Party will not be published by
DiaDexus or disclosed in any form by DiaDexus, except as follows:
(a) DiaDexus and its sublicensees may publish scientific results of
their work within the scope of the licenses granted under this
Agreement, provided, however, that:
(i) any such publication by DiaDexus or its sublicensees that
would disclose Confidential Information of a Disclosing Party
shall require the prior consent of such Party, which consent will
not be unreasonably withheld or delayed, provided that such
disclosure is on a Test-by-Test basis and DiaDexus has taken
necessary steps to provide for diligent review by the Disclosing
Party for removal of, or approval to disclose, Disclosing Party's
Confidential Information; and
(ii) a Research Plan has been filed pursuant to Section 11 with
respect to the Gene Product(s) which are the subject of such
Confidential Information; and
(iii) any such publications will include recognition of the
contributions of the Disclosing Party according to standard
practice for assigning scientific credit, either through
authorship or acknowledgment as may be appropriate.
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(b) Any scientific publications of a Party that would disclose
Confidential Information of another Party on other than an individual
Gene Product basis shall be under reasonable terms and conditions
mutually agreed between the Parties, including the provisions of
subparagraphs (i) to (iii) above.
(c) SB and Incyte recognize that DiaDexus, in the normal course of
business, utilizes consultants and academic collaborators who are bound
by a contractual obligation to DiaDexus, including an obligation of
confidentiality to DiaDexus. DiaDexus may disclose Confidential
Information of a Disclosing Party on a Test-by-Test basis to such
consultants and academic and Third Party collaborators in the context of
the disclosure of DiaDexus's own scientific results or the conduct of
its work within the scope of the licenses granted herein, provided,
however, that:
(i) DiaDexus has obtained a written obligation of confidentiality
and appropriate use restrictions no less restrictive than those set
forth herein and provided that such Third Party shall not further
disclose Confidential Information; and
(ii) any such disclosure of Confidential Information which includes
the transfer of DNA sequence information or biological materials
shall be subject to a written materials transfer agreement which
protects the intellectual property rights of SB, Incyte, and
DiaDexus as set forth herein, such agreement to include customary
provisions regarding scope of work, publication, protection or
proprietary subject matter and ownership of inventions; and
(iii) a Research Plan has been filed pursuant to Section 11 with
respect to the Gene Product(s) which are the subject of such
Confidential Information; and
(iv) DiaDexus has obtained a written obligation from such Third
Party regarding the Disclosing Party's right to review publications
as under the provisions of Paragraph 12.2 herein.
(d) With respect to the transfer of Confidential Information of a Party
on other than a Class I Test basis or an individual Gene Product basis,
the Disclosing Party agrees to obtain the prior
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written consent of the Party who is the source of such Confidential
Information with respect to such Third Party transfer, and the source
Party retains the right to review and approve the relevant sections of
the written materials transfer agreement between the disclosing Party
and such Third Party, with such consent and approval not to be
unreasonably withheld.
12.4 Except as expressly provided for herein, this Section 12 shall not be
construed to allow DiaDexus, its sublicenses, collaborators or consultants
to publish or disclose Incyte Diagnostic IP, Incyte Technology IP, SB
Diagnostic IP, and SB Technology IP at any time without the express written
consent of the Disclosing Party.
12.5 Nothing herein shall be construed as preventing SB or Incyte from
disclosing any DiaDexus information to an Affiliate of a Party or to a
sublicensee, distributor or joint venture or other associated company of
either party for the purpose of developing or commercializing a Product
consistent with the grants herein, provided such Affiliate, sublicensee,
distributor or joint venture or other associated company has undertaken a
similar obligation of confidentiality with respect to the confidential
information.
12.6 All Confidential Information disclosed by one party to the other shall
remain the intellectual property of the disclosing party. In the event that
a court or other legal or administrative tribunal, directly or through an
appointed master, trustee or receiver, assumes partial or complete control
over the assets of a party to this Agreement based on the insolvency or
bankruptcy of such party, the bankrupt or insolvent party shall promptly
notify the court or other tribunal (i) that Confidential Information
received from another Party under this remains the property of the other
party and (ii) of the confidentiality obligations under this Agreement. In
addition, the bankrupt or insolvent Party shall, to the extent permitted by
law, take all steps necessary or desirable to maintain the confidentiality
of the other party's Confidential Information and to insure that the court,
other tribunal or appointee maintains such information in confidence in
accordance with the terms of this Agreement.
13.0 DILIGENCE
13.1 Development, registration, and commercialization: Each Party shall have
full control and authority over development, registration and
commercialization of Products it has rights to develop and commercialize
pursuant to this Agreement.
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13.2 Significant developments: The parties shall keep the other informed of
significant developments in its (and its licensees where relevant)
progress of its efforts to develop and commercialize royalty bearing
Products or Products to which another Party may have rights to under this
Agreement.
13.3 Diligent efforts: Each Party shall use its diligent efforts to develop,
market, promote and sell any Product as to which such Party obtains rights
to under this Agreement. Such diligent efforts shall be equivalent to those
efforts it uses with respect to products of similar value and status.
13.4 cDx/rDx: To the extent permitted by law, in the event one Party is
selling a Test as a cDx Kit or rDx Service and another Party is selling the
same test in the same country or territory in the form of an rDx Kit or rDx
Service, the parties agree to apply consistent and appropriate marketing
and labeling efforts so that such rDx Kit or rDx Service is not used as a
cDx Kit or Homebrew and vice versa.
13.5 Due Diligence/Reversion Exclusive License: Consistent with its
obligations under Paragraph 13.3, in the event DiaDexus and/or its
sublicensees are not selling a given cDx Kit and/or cDx Homebrew or are
not actively researching or developing a given cDx Kit or cDx Homebrew
(each for which DiaDexus has been granted an exclusive license hereunder)
for a period in excess of six (6) months and for which DiaDexus has been
granted a license to Incyte Diagnostic IP or SB Diagnostic IP as the case
may be, such license to such cDx Kit or cDx Homebrew shall immediately
terminate, provided DiaDexus has received written notice from Incyte or SB
promptly after submission to the Research Committee of a Research Plan
with respect to such cDx Kit or cDx Homebrew and further provided that
DiaDexus has not demonstrated in writing within thirty (30) days of such
notice to SB or Incyte, as the case may be, that DiaDexus or its licensees
has been selling such cDx Kit or cDx Homebrew, as the case may be, or has
been actively researching or developing, including reasonable efforts to
sublicense as permitted under this Agreement, any such cDx Kit or cDx
Homebrew, as the case may be.
13.6 DiaDexus Non-Exclusive Licenses
13.6.1 Due Diligence. DiaDexus agrees to use due diligence to pursue the
development, governmental approval and commercial exploitation of Tests
for which DiaDexus has been granted a non-exclusive license to Incyte
Diagnostic IP or SB Diagnostic IP, as the case may be. DiaDexus's
obligation to use due diligence shall require a level of effort consistent
with that applied by DiaDexus towards its other tests with similar
commercial potential.
13.6.2 Reversion. With respect to any Tests for which DiaDexus has been
granted a non-exclusive license to Incyte Diagnostic IP or SB Diagnostic
IP as the case may be, if
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DiaDexus fails, abandons or suspends the development or commercialization of any
such Tests, including reasonable efforts to sublicense, then Incyte or SB, as
the case may be, shall have the right, in its sole discretion upon written
notice to DiaDexus, to terminate such license with respect to such Test.
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14.0 PATENT PROSECUTION AND PATENT LITIGATION
14.1 Ownership: Each Party shall have and retain sole and exclusive title to all
inventions, discoveries and know-how (together with all intellectual
property rights therein and thereto) which are made, conceived, reduced to
practice or generated solely by its employees, agents, or other persons
acting under its authority in the course of or as a result of this
Agreement. A Party shall own an equal and undivided interest with another
Party (or Parties as the case may be) in all inventions, discoveries and
know-how (together with all intellectual property rights therein and
thereto) made, conceived, reduced to practice or generated jointly by
employees, agents, or other persons acting under the authority of another
Party (or Parties) in the course of or as a result of this Agreement, and
such Party shall have the right, subject to the provisions of this
Agreement, to freely exploit, transfer, license or encumber its interest in
such jointly owned intellectual property rights without the consent of, or
payment or accounting to, the other Party(ies).
14.2 Disclosure by SB and Incyte: SB and Incyte shall only be required to
disclose to DiaDexus the complete texts of all patent applications filed
by it which relate to Tests for which DiaDexus has an exclusive license
hereunder as well as all information received concerning the institution or
possible institution of any interference, opposition, re-examination,
reissue, revocation, nullification or any official proceeding involving a
patent covering such Test ("Patents"), provided DiaDexus requests such
information in writing from SB or Incyte, as the case may be. DiaDexus, at
its expense, shall have the right to review all such pending applications
and other proceedings and make recommendations to SB or Incyte, as the case
may be, concerning them and their conduct. SB and Incyte agree to keep
DiaDexus reasonably informed of the course of patent prosecution or other
proceedings of such Patents including by providing DiaDexus with copies of
substantive communications, search reports and Third Party observations
submitted to or received from patent offices. DiaDexus shall provide such
patent consultation at no cost. DiaDexus shall hold all information
disclosed to it under this section as Confidential Information and subject
to the provisions of Section 12.
14.3 Assumption of rights: For Patents for which DiaDexus has been granted an
exclusive license and to the extent possible, DiaDexus shall have the right
to assume responsibility for any Patent or any part of a Patent which SB or
Incyte intends to abandon or otherwise cause or allow to be forfeited for
the limited purpose of obtaining claims which cover Tests to which DiaDexus
retains a license hereunder. SB and Incyte shall give DiaDexus reasonable
written notice prior to abandonment or other forfeiture of any such Patent
or any part of a Patent so as to permit DiaDexus to exercise its rights
under this paragraph.
14.4 DiaDexus Patents: DiaDexus shall have the right within its sole discretion
and at its expense to prepare, file, prosecute and maintain its patents
("DiaDexus Patents") for
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which neither SB nor Incyte are named as inventors. With respect to
DiaDexus Patents as to which SB and/or Incyte retains a license hereunder,
DiaDexus shall keep SB and/or Incyte, as the case may be, reasonably
informed with respect to the filing and prosecution thereof. In the event
that SB or Incyte desires that DiaDexus obtain and maintain patent
protection in any country with respect to DiaDexus IP as to which SB
and/or Incyte, as the case may be, retains a license hereunder, DiaDexus
shall do so at the cost and expense of SB and/or Incyte, as the case may
be.
14.5 Third Party Infringement: A Party will notify the other Parties if it
becomes aware of the activities of any Third Party which are believed to
infringe any of the patent rights licensed exclusively hereunder. DiaDexus
and SB or Incyte as the case may be, as the party licensing the patent at
issue to DiaDexus, including sublicensee(s) as appropriate, shall consult
with each other as to a potential litigation strategy or strategies
against an alleged infringer and may jointly use reasonable commercial
efforts to terminate such alleged infringement without litigation.
15.5.1 If such efforts of DiaDexus and the Party licensing such
patent to DiaDexus are not successful in abating the alleged
infringement:
a) within sixty (60) days of such determination, DiaDexus and
licensor may elect to commence and prosecute a suit jointly, with
litigation strategy and any settlement of such proceedings subject
to the approval of the Party licensing such patent to DiaDexus;
b) DiaDexus, shall have the right to bring and maintain any
appropriate suit or action involving such infringement, at its own
expense provided the Party licensing such patent to DiaDexus has
declined in writing to bring such suit or action;
15.5.2 In the instance in which one Party institutes such
infringement actions, the other Parties agree, to execute all papers
and perform such other acts as may be reasonably required (including
consent to be joined as nominal Party plaintiffs in such action),
such to be at the request and expense of the Party bringing suit.
The other Parties will be provided reasonable opportunities to
advise or comment regarding litigation strategy and settlement of
such proceedings, and may, at their option and expense, be
represented by counsel of their choice. No Party may settle any
action or otherwise consent to an adverse judgment in an action that
diminishes the rights or interests of another Party without the
prior written consent of such other Party.
14.5.3 Any amount recovered in any action or suit, whether by
judgment or settlement, shall first be applied to reimburse pro rata
the costs of litigation to the Party or Parties which paid such
costs. Any remaining amount shall be used to reimburse licensor(s)
which have paid such costs for any royalties which have been
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reduced by virtue of this provision. Any remaining amount shall be
divided in the same proportion as the Parties paid the associated
attorney's fees and Third party litigation expenses.
14.5.4 In the event of the institution of any suit by a Third Party
against DiaDexus, or its sublicenses or distributors for patent
infringement of rights licensed exclusively hereunder and involving
the manufacture, use, sale, distribution or marketing of Test,
DiaDexus shall promptly notify the Licensor in writing. DiaDexus
shall have the right but not the obligation to defend such suit at
its own expense. DiaDexus and Licensor shall assist one another and
cooperate in any such litigation at the other's request without
expense to the requesting Party.
14.6 Freedom From Suit
14.6.1 With respect to composition of matter claims directed to Gene
Products which are materially based on or are derived by material use
of that which would constitute Incyte Diagnostic IP, which are owned
or controlled by DiaDexus, (or DiaDexus Affiliate(s) or
sublicensee(s) as the case may be), DiaDexus (or DiaDexus
Affiliate(s) or sublicensee(s) as the case may be) agrees to xxx or
bring any action in any court or administrative agency or any other
government authority alleging infringement of said claims as a result
of activities or Incyte or Incyte Affiliates or sublicensee(s) with
respect to rDx Service(s) or rDx Kit(s) or Ix Product(s) which would
constitute an infringement of said patents, and further, DiaDexus (or
DiaDexus Affiliate(s) or sublicensee(s) as the case may be) agrees to
extend such freedom from suit or action to further sublicensee(s) of
Incyte, Incyte Affiliates, or licensees with respect to such rDx
Services or rDx Kits or Ix Product(s).
14.6.2 With respect to composition of matter claims directed to Gene
Products which are materially based on or are derived by material use
of that which would constitute SB Diagnostic IP, which are owned or
controlled by DiaDexus (or DiaDexus Affiliate(s) or sublicensee(s) as
the case may be), DiaDexus (or DiaDexus Affiliate(s) or
sublicensee(s) as the case may be) agrees not to xxx or bring any
action in any court or administrative agency or any other government
authority alleging infringement of said claims as a result of
activities of SB or SB Affiliates or sublicensee(s) with respect to
rDx Service(s) or rDx Kit(s) or Ix Product(s) which would constitute
an infringement of said patents, and further, DiaDexus (or DiaDexus
Affiliate(s) or sublicensee(s) as the case may be) agrees to extend
such freedom from suit or action to further sublicensee(s) of SB, SB
Affiliates, or licensees with respect to such rDx Services or rDx
Kits or Ix Product(s).
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15.0 STATEMENTS AND REMITTANCES
15.1 Records: A Party, as the case may be, shall keep and require its licensees
to keep complete and accurate records of all Net Sales, Net Ix Revenues,
and Licensing Revenues subject to royalties and/or payments under the
licenses granted herein. The Party owed such royalties and/or payments
shall have the right, at its expense, through a certified public
accountant or like person reasonably acceptable to the other Party, to
examine such records during regular business hours during the life of this
Agreement and for six (6) months after its termination; provided, however,
that such examination shall not take place more often than once a year and
provided further that such accountant shall report only as to the accuracy
of the royalty statements and payments, including the magnitude and source
of any discrepancy. No Party nor their licensees shall be required to
maintain such records for more than two (2) years with respect to any
given Net Sales, Net Ix Revenues or Licensing Revenues. If such
examination reveals an underpayment of royalties or other payments by ten
percent (10%) or more, the underpaying Party shall pay all costs of such
examination. In the event such accountant concludes that additional
royalties or payments were owed, the additional royalties shall be paid
within thirty (30) days of the date the accounting Party delivers to
underpaying Party such accountant's written report so concluding. If such
examination reveals an underpayment of royalties or other payments by less
than ten percent (10%), the auditing Party shall pay all costs of such
examination.
15.2 Accounting: Within sixty (60) days after the close of each calendar
quarter, each Party shall deliver to the Party owed a royalty and/or
payment hereunder a true accounting of all Products and/or Ix Products
sold or licensed by it and its licensees and distributors during such
quarter for which royalties and/or payments are payable and shall at the
same time pay all royalties due. Such accounting shall show sales on a
country-by-country and product-by-product basis.
15.3 Currency: All royalties due under this Agreement shall be payable in U.S.
dollars. If governmental regulations prevent remittances from a foreign
country with respect to sales made in that country, the obligation to pay
royalties on sales in that country shall be suspended until such
remittances are possible.
15.4 Monetary conversion:
15.4.1 Monetary conversions from the currency of a foreign country,
in which a product is sold, into United States currency shall be made at
the official exchange rate in force in that country for financial
transactions on the last business day of the calendar quarter or half year
for which the royalties are being paid. If there is no such official
exchange rate, the conversation shall be made at the rate for such
remittances on that date as certified by Citibank, N.A., New York, New
York, U.S.A.
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15.4.2 Monetary conversions with respect to payments made by SB from the
currency of a foreign country, in which a product is sold, into United
States currency shall be calculated at the actual average rates of exchange
for the year to date as used by SB in producing its quarterly and annual
accounts, as confirmed by SB's auditors.
15.5 Mode of Payment: Ix Product. For purposes of determining when a license of
a royalty-bearing Ix Product occurs, the license shall be deemed to occur
on the date of the receipt of payments from the Third Party end user of the
Ix Product.
15.6 Mode of Payment. For purposes of determining when a sale of a
royalty-bearing Product occurs, the sale shall be deemed to occur on the
date of the invoice to the purchaser of the Product.
16.0 TERM; TERMINATION
16.1 Term; Termination at Full Term. Unless earlier terminated as provided
herein, this Agreement shall commence as of the Effective Date and shall
remain in full force and effect until the termination of the last to expire
payment obligations of any Party.
16.2 Breach.
16.2.1 Failure by any Party to comply with any of the material obligations
contained in this Agreement shall entitle the other Party(ies) to give to
the Party in default notice specifying the nature of the default and
requiring it to make good such default. If such default is not cured
within ninety (90) days after the receipt of such notice, the notifying
Party(ies) shall be entitled, without prejudice to any of its other rights
conferred on it by this Agreement, in addition to any other remedies
available to it by law or in equity, immediately to terminate this
Agreement by giving written notice to the Party in default provided the
other non-breaching Party agrees in writing to such termination. The right
of a Party to terminate this Agreement, as hereinafter provided, shall not
be affected in any way by its waiver or failure to take action with
respect to any previous default.
16.2.2 In the event a Party fails to make a payment to another with
respect to a Product due under this Agreement when due, in addition to any
other remedy which it may have, such Party may notify the non-paying Party
in writing that all of such Party's rights with respect to such Product
shall terminate as of thirty (30) days after such written notice and such
Party's rights with respect thereto shall terminate unless such payment is
made or such failure is cured, prior to the expiration of such thirty (30)
day period.
16.3 Insolvency or Bankruptcy. To the extent permitted by applicable law, a
Party (Termination Party) may, in addition to any other remedies available
to it by law or in equity, terminate this Agreement, in whole or in part
as the Terminating Party may
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determine, by written notice to the other Party in the event the other
Party shall have become insolvent or bankrupt, or shall have made an
assignment for the benefit of its creditors, or there shall have been
appointed a trustee or receiver of the other Party or for all or a
substantial part of its property, or any case or proceeding shall have
been commenced or other action taken by or against a Party in bankruptcy
or seeking reorganization, liquidation, dissolution, winding-up,
arrangement, composition or readjustment of its debts or any other relief
under any bankruptcy, insolvency, reorganization or other similar act or
law of any jurisdiction now or hereafter in effect.
16.4 Accrued Surviving Obligations. Upon any termination, relinquishing or
expiration of this Agreement, the following provisions will not terminate,
but will continue in full force and effect: Section 6, 12, 13, 14, 15,
18, and 19 and any other terms and conditions of this Agreement clearly
meant to survive termination.
16.5 DiaDexus Test Sublicensees: Upon termination of this Agreement pursuant to
Paragraph 16.2 or Paragraph 16.3 thereof in the event of the bankruptcy or
similar event listed in such Paragraph 16.3 and if a sublicensee of
DiaDexus Test requests, then SB and/or Incyte, as the case may be, shall
grant direct licenses to such sublicensees for such Tests provided that,
(a) the scope of the direct licenses to the Third Party shall be no
greater than the scope of the sublicense granted by DiaDexus for such
Test; (b) SB and/or Incyte shall have no more obligations owing to the
Third Party sublicensee under the direct licenses than their respective
obligations under this Agreement, (c) the sublicensee is in compliance
with all the terms and conditions of the sublicense, and (d) all
consideration for the direct licenses which are not otherwise payable
under the Incyte Database Agreements or subject to Third Party
obligations, shall be retained equally by the non=terminated Parties
granting such direct licenses.
17.0 REPRESENTATIONS AND WARRANTIES; COVENANTS
17.1 Representations and Warranties. Each Party represents and warrants to the
other Parties that:
(a) it has the corporate power and authority and the legal right to
enter into this Agreement and to perform its obligations hereunder.
(b) the execution and delivery of this Agreement and the performance of
the transactions contemplated hereby have been duly authorized by all
necessary corporate action of such Party;
(c) to such Party's knowledge, the execution and delivery of this
Agreement and the performance by such Party of any of its obligations
under this Agreement do not and will not (i) conflict with, or constitute
a breach or violation of, any other contractual obligation to which it is
a Party, any judgment of any court or governmental body
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applicable to such Party or its properties or, any statute, decree,
order, rule or regulation of any court or governmental agency or body
applicable to such Party or its properties, and (ii) with respect to the
execution and delivery of this Agreement, require any consent or
approval of any governmental authority or other person;
(d) there are no material adverse proceedings, claims or actions
pending, or to the best of Incyte's knowledge, threatened, relating to
the Incyte Technology IP and Incyte Diagnostic IP as of the Effective
Date of this Agreement which would materially interfere with Incyte's
performance of its obligations under this Agreement. Further, Incyte
shall to the best of its knowledge without undertaking a special
investigation, disclose to DiaDexus any material adverse proceedings,
claims or action that arise, relating to such Incyte Technology IP and
Incyte Diagnostic IP during the Initial License Period, which would
materially interfere with Incyte's performance of its obligations under
this Agreement.
(e) there are no material adverse proceedings, claims or actions
pending, or to the best of SB's knowledge, threatened, relating to the
SB Technology IP and SB Diagnostic IP as of the Effective Date of this
Agreement which would materially interfere with SB's performance of its
obligations under this Agreement. Further, SB shall to the best of its
knowledge without undertaking a special investigation, disclose to
DiaDexus any material adverse proceedings, claims or action that arise,
relating to such SB Technology IP and SB Diagnostic IP during the
Initial License Period, which would materially interfere with SB's
performance of its obligations under this Agreement.
(e) to the best of its knowledge without undertaking a special
investigation, DiaDexus shall disclose to SB and Incyte any material
adverse proceedings, claims or action that arise, relating to DiaDexus
IP during the Extended License Period, which would materially interfere
with its performance of its obligations under this Agreement.
(f) After the Effective Date and during Initial License Period, it is
the intent of Incyte not to grant licenses to Third Parties in the
diagnostic field of use under future Incyte database agreement(s) beyond
the scope of that which has been previously granted by Incyte pursuant
to Incyte database agreements in effect with Third Parties as of the
Effective Date and further provided that after the Effective Date and
during the Initial License Period it is the intent of Incyte to use
commercially reasonable efforts to grant licenses to Third Parties in
the diagnostic field of use under future Incyte database agreement(s)
which are more restrictive in the field of Class III Tests.
17.2 Compliance with Law. Each Party represents and warrants that it shall
comply with all applicable laws, regulations and guidelines in
connection with that Party's performance of its obligations and rights
pursuant to this Agreement. Without limiting the generality of the
foregoing, each Party shall be responsible for compliance with all
applicable product safety, product testing, product labeling, package
marking, and
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product advertising laws and regulations with respect to its own
activities and products. Further, the Parties shall each comply with
regulations of the United States and any other relevant nation concerning
any export or other transfer of technology, services, or products.
17.3 Disclaimers.
(a) NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION MADE
OR WARRANTY GIVEN BY A PARTY THAT ANY PATENT WILL ISSUE BASED UPON ANY
PENDING PATENT APPLICATION, THAT ANY PATENT THAT HAS ISSUED OR IF IT
ISSUES WILL BE VALID, OR THAT THE USE OF ANY LICENSE GRANTED HEREUNDER OR
THAT THE USE OF ANY PATENT RIGHTS GRANTED HEREUNDER WILL NOT INFRINGE THE
PATENT OR PROPRIETARY RIGHTS OF ANY OTHER PERSON. THE PARTIES MAKE NO
REPRESENTATIONS OR WARRANTIES WITH RESPECT TO DIADEXUS'S USE OF THE
INFORMATION TO BE PROVIDED TO IT HEREUNDER. EXCEPT AS EXPLICITLY STATED
HEREIN, ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF
MERCHANTABILITY, NOVELTY OR FITNESS FOR ANY PARTICULAR PURPOSE, OR
NON-INFRINGEMENT, ARE EXCLUDED. NO PARTY MAKES ANY WARRANTY THAT
INFORMATION PROVIDED HEREUNDER DOES NOT CONTAIN ERRORS.
(b) EXCEPT AS EXPLICITLY STATED HEREIN NO PARTY WILL BE LIABLE FOR
CONSEQUENTIAL OR INCIDENTAL DAMAGES OF ANY NATURE ARISING FROM SUCH
PARTY'S ACTIVITIES UNDER THIS AGREEMENT; PROVIDED, HOWEVER, THAT THIS
LIMITATION SHALL NOT LIMIT THE INDEMNIFICATION OBLIGATION OF SUCH PARTY
UNDER SECTION 18 BELOW FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES RECOVERED
BY A THIRD PARTY.
18.0 INDEMNITY.
18.1 Direct Indemnity. Each Party shall indemnify and hold the other Parties
harmless, and hereby forever releases and discharges the other Parties,
from and against all losses, liabilities, damages and expenses (including
attorney's fees and costs) arising out of a breach of the indemnifying
Party's warranties or out of the negligence, recklessness or intentional
misconduct of the indemnifying Party or its Affiliates in connection with
activities under this Agreement except to the extent such losses,
liabilities, damages and expenses (including attorney's fees and costs)
resulted from the recklessness or intentional misconduct of the other
Party or Parties.
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DiaDexus acknowledges and agrees that with respect to the nature of
Incyte's and SB's Diagnostic IP and Technology IP, there can be no
adequate remedy at law for any breach of DiaDexus obligations under the
security provisions of this Agreement, that any such breach may result in
irreparable harm to Incyte or SB, as the case may be, and therefore, that
upon any such breach Incyte or SB, as the case may be, shall be entitled
to appropriate equitable relief in addition to whatever remedies it might
have at law, including injunctive relief, specific performance or such
other relief as Incyte or SB, as the case may be, may request to enjoin or
otherwise restrain any act prohibited hereby, as well as the recovery of
all costs and expenses, including attorney's fees incurred. Incyte or SB,
as the case may be, shall be entitled to indemnification by DiaDexus from
any losses, liabilities, damages and expenses (including attorney's fees
and costs), in connection with such unauthorized use or release of
Confidential Information of Incyte or SB as the case may be.
18.2 Other Indemnity. Except as otherwise provided below, each Party agrees
to indemnify and hold the other Parties and its Affiliates harmless from
and against any losses, damages and expenses (including attorney's fees
and costs) suffered or incurred, and claims made, in connection with Third
Party claims, demands, actions or other proceedings for personal injuries
or any Product(s) recall to the extent caused by: (a) any and all uses or
other disposition of Gene Product(s) or Product(s) or Ix Products by the
indemnifying Party or its Affiliates, licensees, or sublicensees (other
than the other Parties), (b) any failure to test for or provide adequate
warnings of adverse side effects to the extent such failure arises out of
acts or omissions in connection with a Party's or its Affiliates',
licensees', or sublicensees' (other than the other Parties), preclinical
or clinical testing or marketing of Gene Product(s) or Product(s) or Ix
Products contemplated hereunder, (c) any manufacturing defect in any
product or other material manufactured by a Party or its Affiliates,
licensees, or sublicensees (other than the other Party), or (d) any other
act or omission of Party or its Affiliates, licensees, or sublicensees
(other than the other Party), in connection with the activities
contemplated under this Agreement, except to the extent such losses,
liabilities, damages and expenses (including attorney's fees and costs)
resulted from, recklessness or intentional misconduct of another Party.
18.3 Procedure. A Party (the "Indemnitee") that intends to claim
indemnification under this Section 18 shall promptly notify the other
Party or Parties (the "Indemnitor") of any loss, liability, damage,
expense, claim, demand, action or other proceeding in respect of which the
Indemnitee or any of its Affiliates intend to claim such indemnification,
and the Indemnitor shall have the right to participate in, and, to the
extent the Indemnitor so desires, jointly with any other Indemnitor
similarly noticed, to assume the defense thereof with counsel selected by
the Indemnitor and reasonably satisfactory to the Indemnitee; provided,
however, that an Indemnitee shall have the right to retain its own
counsel, with the fees and expenses to be paid by the Indemnitee, if
representation of such Indemnitee by the counsel retained by the
Indemnitor would be inappropriate due
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to actual or potential differing interests between such Indemnitee and any
other Party represented by such counsel in such proceedings. The indemnity
agreement in this Section 18 shall not apply to amounts paid in settlement
of any loss, liability, damage, expense, claim, demand, action or other
proceeding if such settlement is effected without the consent of the
Indemnitor, which consent shall not be withheld unreasonably. The failure
to deliver notice to the Indemnitor within a reasonable time after the
commencement of any such action, if prejudicial to its ability to defend
such action, shall relieve such Indemnitor of any liability to the
Indemnitee under this Section 18, but the omission so to deliver notice to
the Indemnitor will not relieve it of any liability that it may have to any
Indemnitee otherwise than under this Section 18. The Indemnitor may not
settle the action or otherwise consent to an adverse judgment in action or
other proceeding that materially diminishes the rights or interests of the
Indemnitee without the express written consent of the Indemnitee. The
Indemnitee under this Section 18 and its employee and agents, shall
cooperate fully with the Indemnitor and its legal representatives in the
investigation of any action, claim or liability covered by this
indemnification.
19.0 MISCELLANEOUS PROVISIONS.
19.1 No Party shall incur any debts or make any commitments for the other,
except to the extent, if at all, specifically provided herein.
19.2 Assignment: This Agreement shall be binding upon and inure to the benefit
of the successors in interest of the respective parties. Subject to Paragraph
19.18, neither this Agreement nor any interest hereunder shall be assignable
directly or indirectly assigned or transferred (whether voluntarily, by
operation of law or otherwise) by any party without the prior express written
consent of the other parties; provided, however, that either Incyte or SB may
assign or transfer this Agreement or any of its rights or obligations hereunder
(i) to any Incyte Affiliate or SB Affiliate, respectively, or (ii) to the
extent assignment or transfer is deemed to occur as part of a Change of Control
(as such term is defined in the Master Strategic Relationship Agreement between
and among SB Corp, Incyte, and DiaDexus entered into of even date herewith), or
(iii) to any Third Party with which it may merge or consolidate, or to which it
may transfer all or substantially all of its assets to which this Agreement
relates, in each case without obtaining the consent of the other party, and if
in any such event (including any merger involving Incyte or SB), (i) (A) the
assigning party remains liable under this Agreement, and (ii) (B) the relevant
SB Affiliate or Incyte Affiliate assignee, Third Party assignee or surviving
entity assumes in writing all of the assigning party's obligations under this
Agreement. Any purported assignment or transfer in violation of this Paragraph
shall be void.
19.3 Further Actions. Each Party agrees to execute, acknowledge and deliver
such further instruments, and to do all such other acts, as may be necessary
or appropriate in order to carry out the purposes and intent of this Agreement.
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19.4 No Trademark Rights. Except as otherwise provided herein, no right,
express or implied, is granted by this Agreement to use in any manner the
names "Incyte", "SB", or "DiaDexus", or any other trade name or trademark
of Incyte, SB or DiaDexus or their Affiliates.
19.5 Public Announcements. Notwithstanding Section 12, no Party shall make any
public announcements or issue any press release concerning any aspect of
the business, the relationship of the parties pursuant to this Agreement
or any other matter incidental to the foregoing including any
announcement that references the name of another party except (i) any
disclosure that has been agreed to by the parties, including routine or
recurring disclosures of agreed upon statements: (ii) disclosures
required by applicable law so long as the text of any such disclosure is
provided to the other parties for comment and review at least five (5)
business days in advance of disclosure; and (iii) disclosures of material
financial information in a press release that relates to a party's
earnings or financial performance, so long as the text of any such
disclosure is provided to the other parties for comment and review at
least one (1) business day (business day) in advance of disclosure.
19.6 Entire Agreement of the Parties; Amendments. This Agreement constitutes
and contains the entire understanding and agreement of the Parties and
cancels and supersedes any and all prior negotiations, correspondence,
representations, understandings and agreements, whether verbal or
written, between the Parties respecting the subject matter hereof. No
waiver, modification or amendment of any provision of this Agreement
shall be valid or effective unless made in writing and signed by a duly
authorized officer of each of the Parties.
19.7 Severability. In the event any one or more of the provisions of this
Agreement shall for any reason be held by any court or authority having
jurisdiction over this Agreement or any of the Parties to be invalid,
illegal or unenforceable, such provision or provisions shall be validly
reformed to as nearly as possible approximate the intent of the Parties
and, if unreformable, shall be divisible and deleted in such
jurisdiction; elsewhere, this Agreement shall not be affected so long as
the Parties are still able to realize the principal benefits bargained
for in this Agreement.
19.8 Captions. The captions to this Agreement are for convenience only, and
are to be of no force or effect in construing or interpreting any of the
provisions of this Agreement.
19.9 Applicable Law. This Agreement shall be governed by and interpreted in
accordance with the laws of the State of California, without reference to
the conflicts of law principles thereof.
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19.10 Notices and Deliveries. Any notice, requests, delivery, approval or
consent required or permitted to be given under this Agreement shall be
in writing and shall be deemed to have been sufficiently given if
delivered in person, transmitted by commercial overnight courier, or
transmitted by telex telegram or telecopy to the Party to whom it is
directed as its address shown below or such other address as such Party
shall have last given by notice to the other Party. All notices shall be
effective upon receipt.
If to Incyte, addressed to:
Incyte Pharmaceuticals, Inc.
0000 Xxxxxx Xxxxx
Xxxx Xxxx, XX 00000
Attn: Xxx Xxxxxxxxx, CEO
Tel: (000)-000-0000
Fax: (000)-000-0000
If to DiaDexus, addressed to:
diaDexus
0000 Xxxxx Xxxxxxxxx
Xxxxx 000
Xxxxx Xxxxx, XX 00000
Attention: Xxxxxxx Xxxxxxx
Vice President Corporate Development
Tel: (415)-
Fax: (415)-
If to SB, addressed to:
SmithklineBeecham Corporation
000 Xxxxxxxxx Xxxx
Xxxx xx Xxxxxxx, Xxxxxxxxxxxx 00000
Attention: Director,
Alliance and Technology Group
SmithKline Xxxxxxx Pharmaceuticals
Tel: (000)-000-0000
Fax: (000)-000-0000
copy to: SMITHKLINE XXXXXXX CORPORATION
709 Swedeland Road
X.X. Xxx 0000
Xxxx xx Xxxxxxx, Xxxxxxxxxxxx 00000
Attention: Corporate Law
Tel: (000)-000-0000
Fax: (000)-000-0000
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19.11 Counterparts. This Agreement may be executed in two or more counterparts,
each of which shall be deemed an original, but all of which together
shall constitute one and the same instrument.
19.12 Force Majeure. Force Majeure shall mean an Act of God, flood, fire,
explosion, earthquake, strike, lockout, casualty or accident, war, civil
commotion, act of public enemies, blockage or embargo, or any injunction,
law, order, proclamation, regulation, ordinance, demand or requirement of
any government or any subdivision, authority representative thereof, or
any other cause whatsoever, whether similar or dissimilar to those
enumerated above, which are beyond the reasonable control of such Party,
which the Party affected has used its reasonable best efforts to avoid,
and which prevent, restrict or interfere with the performance by a Party
of its obligations hereunder. The Party affected by Force Majeure shall
give notice to the other Party promptly in writing and whereupon shall be
excused from those obligations hereunder, to the extent of such
prevention, restriction or interference, provided that the affected Party
shall use its commercially reasonable efforts to avoid or remove such
cause(s) of non-performance and shall continue performance whenever such
cause(s) is removed.
19.13 Affiliate Performance. To the extent that any Affiliate of DiaDexus has
the right to receive any other rights or benefits under this Agreement or
otherwise is obligated to perform any obligations under this Agreement,
DiaDexus shall cause such Affiliate to perform in full, when due, all
applicable obligations under this Agreement to the same extent as if such
Affiliate were a Party to this Agreement; provided, however, that nothing
in this Paragraph 19.13 shall expand the rights or benefits of DiaDexus
or its Affiliates, or the obligations of Incyte, or SB beyond those
otherwise expressly set forth in this Agreement. DiaDexus shall guaranty
timely performance in full by such Affiliate of all such obligations. A
breach by such Affiliate of any such obligation shall constitute a breach
by DiaDexus of this Agreement and shall entitle Incyte or SB to exercise
its rights under Section 16.0 (Term and Termination) above, in addition
to any other rights and remedies to which Incyte and/or SB may be
entitled.
19.14 Recording. Any Party shall have the right, at any time, to record,
register, or otherwise notify this Agreement in appropriate governmental
or regulatory offices anywhere in the world, and the other parties shall
provide reasonable assistance to the notifying Party in effecting such
recording, registering or notifying.
19.15 Dispute Resolution. (a) Any controversy or claim arising out of or
relating to this Agreement, or the breach thereof or misrepresentation
thereunder including any disputes regarding rights of the parties to
terminate this Agreement, or whether any such termination has been
wrongfully undertaken, shall first be submitted for resolution to a
committee consisting of the chief executive officer of each of the
parties involved in such dispute, whether they include SB and Incyte or
DiaDexus and either of SB and Incyte, or any combination of the
foregoing. If the committee is
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unable to resolve such controversy or claim within twenty (20) days of the
submission of such matter to the committee, then the parties may have
access to any remedies available under applicable law or otherwise.
(b) The parties agree that termination of this Agreement shall be
available in accordance with the terms of this Agreement, but it is the
intention of the Parties that disputes shall be resolved without
termination of this Agreement to the maximum extent possible.
19.16 No Partnership. Nothing in this Agreement is intended or shall be deemed
to constitute a partnership, agency, distributorship, employer-employee or
joint venture relationship between the Parties. No Party shall incur any
debts or make any commitments for the other, except to the extent, if at
all, specifically provided herein.
19.17 No Implied Licenses. No implied right or license is granted to any Party
to utilize another's intellectual property in a manner not expressly
included within the scope of the licenses granted pursuant to this
Agreement. Other than as expressly granted herein, no licenses either by
estoppel, implication or otherwise are granted herein.
19.18 Certain Research Commitments.
(a) During the Initial License Period, unless this Agreement has been
terminated pursuant to Paragraph 16.2 or 16.3, Incyte shall not materially
reduce the intellectual property that would otherwise have been available
as Incyte Technology IP and Incyte Diagnostic IP pursuant to Sections 3
and 9 of this Agreement by way of assignment of its rights or obligations
as permitted under Paragraph 19.2.
(b) During the Initial License Period, unless this Agreement has been
terminated pursuant to Paragraph 16.2 or 16.3, (1) prior to the occurrence
of a Change of Control (as such term is defined in the Master Strategic
Relationship Agreement between and among SB Corp, Incyte, and DiaDexus
entered into of even date herewith) with respect to SB, SB shall not
materially reduce the intellectual property that would otherwise have been
available as SB Technology IP and SB Diagnostic IP pursuant to Sections 4
and 9 of this Agreement by way of assignment of its rights or obligations
as permitted under Paragraph 19.2; and (2) after the occurrence of a
Change of Control with respect to SB, SB shall perform ethical
pharmaceuticals research and development in entities which are subject to
Sections 4 and 9 at an aggregate level of at least US $700 Million Dollars
per annum.
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66
IN WITNESS WHEREOF, the parties, through their authorized officers, have
executed this Agreement as of the date first written above.
SmithKline Xxxxxxx Corporation
By: [SIGNATURE ILLEGIBLE]
---------------------------
SmithKline Xxxxxxx, plc
By: [SIGNATURE ILLEGIBLE]
---------------------------
Incyte Pharmaceuticals, Inc.
By: [SIGNATURE ILLEGIBLE]
---------------------------
diaDexus, LLC
By: /s/ X. XXXXXXX
---------------------------
67
67
Appendix A
HGS Agreements
Collaboration Agreement: effective as of the 19th day of May, 1993, between
Human Genome Sciences, Inc., a corporation organized under the laws of the
State of Delaware, having a place of business at 0000 Xxxxxxx Xxxxxx Xxxxx,
Xxxxxxxxx, Xxxxxxxx 00000, X.X.X. and SmithKline Xxxxxxx Corporation, a
corporation organized under the laws of the Commonwealth of Pennsylvania,
United States of America, having a principal place of business at Xxx Xxxxxxxx
Xxxxx, Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000, X.X.X.
Amended and Restated License Agreement: effective as of the 31st day of May,
1995, between Human Genome Sciences, Inc., a corporation organized under the
laws of the State of Delaware, having a place of business at 0000 Xxx Xxxx
Xxxxxx, Xxxxxxxxx, Xxxxxxxx 00000, X.X.X. ("HGS"), SmithKline Xxxxxxx
Corporation, a corporation organized under the laws of the Commonwealth of
Pennsylvania, having a place of business at Xxx Xxxxxxxx Xxxxx, Xxxxxxxxxxxx,
Xxxxxxxxxxxx 00000, X.X.X. ("SB corp"), and SmithKline Xxxxxxx Intercredit,
B.V., a corporation organized under the laws of the Netherlands and having a
place of business at Xxxxxxx 0, 0000 XX Hijswijk, the Netherlands ("SBI"), and
their AFFILIATES (individually and collectively "SB").
SB/HGS License Agreement: effective as of the 28th day of June, 1996 between,
on the one hand, SmithKline Xxxxxxx Corporation, a corporation organized under
the laws of the Commonwealth of Pennsylvania, having a place of business at Xxx
Xxxxxxxx Xxxxx, Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000, X.X.X. ("SB corp"),
SmithKline Xxxxxxx p.l.c., a corporation organized under the laws of England
and having a place of business at Xxxxx Xxxx Xxxx, Xxxxxxxxx, Xxxxxxxxx, X.X.
("SB p.l.c.") (individually and collectively "SB"), and, on the other hand,
Human Genome Sciences, Inc., 0000 Xxx Xxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxx 00000
("HGS").
Merck/SB/HGS
Collaboration And License Agreement: effective as of the 10th day of July, 1996
by and among SmithKline Xxxxxxx Corporation, a corporation organized under the
laws of the Commonwealth of Pennsylvania, having a place of business at Xxx
Xxxxxxxx Xxxxx, Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000, X.X.X. ("SB corp"),
SmithKline Xxxxxxx p.l.c., a corporation organized under the laws of England
and having a place of business at Xxxxx Xxxx Xxxx, Xxxxxxxxx, Xxxxxxxxx,
Xxxxxxx ("SB plc") (individually and collectively "SB"), Human Genome
Sciences, Inc. located at 0000 Xxx Xxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxx 00000
("HGS") and Merck XXxX, Xxxxxxxxxxx Xxx. 000, 00000 Xxxxxxxxx, Xxxxxxx
("Merck").
Therapeutic Collaboration And License Agreement: effective as of the 28th of
June, 1996 by and among Human Genome Sciences, Inc., a corporation organized
under the laws of the State of Delaware, United States of America, having a
place of business at 0000 Xxx Xxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxx 00000, for
itself and its Affiliates, as defined below (collectively including such
Affiliates "HGS"), Schering Corporation, a corporation organized under the laws
of the State of New Jersey, United States of America, having a place of
business at 0000 Xxxxxxxxx Xxxx Xxxx,
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68
Xxxxxxxxxx, Xxx Xxxxxx 00000, and Schering Plough Ltd., a Swiss corporation
having its principal place of business at Xxxxxxxxxxxxxx 0, XX-0000 Xxxxxxx,
Xxxxxxxxxxx, each for itself and its Affiliates, as defined below (collectively
including such Affiliates "SP"), and SmithKline Xxxxxxx Corporation, a
corporation organized under the laws of the Commonwealth of Pennsylvania,
United States of America, having a place of business at 000 Xxxxxxxxx Xxxx,
Xxxx xx Xxxxxxx, Xxxxxxxxxxxx, 00000 and SmithKline Xxxxxxx, plc, having a
place of business at Xxxxx Xxxx Xxxx, Xxxxxxxxx, Xxxxxxxxx, X.X.
Synthelabo/SB/HGS
Collaboration And License Agreement: effective as of the 28th day of June, 1996
by and among SmithKline Xxxxxxx Corporation, a corporation organized under the
laws of the Commonwealth of Pennsylvania, having a place of business at Xxx
Xxxxxxxx Xxxxx, Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000, X.X.X. ("SB corp"),
SmithKline Xxxxxxx p.l.c., a corporation organized under the laws of England
and having a place of business at Xxxxx Xxxx Xxxx, Xxxxxxxxx, Xxxxxxxxx,
Xxxxxxx ("SB plc") (individually and collectively "SB"), Human Genome Sciences,
Inc. located at 0000 Xxx Xxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxx 00000 ("HGS") and
Synthelabo, located at 00, xxxxxx Xxxxxxx, 00000 Xx Xxxxxxx-Xxxxxxxx Xxxxx
Xxxxxx ("Synthelabo").
Restated SB-Takeda Collaboration And License Agreement: effective as of the
28th day of June 1996 between, on the one hand, SmithKline Xxxxxxx Corporation,
a corporation organized under the laws of the Commonwealth of Pennsylvania,
having a place of business at Xxx Xxxxxxxx Xxxxx, Xxxxxxxxxxxx, Xxxxxxxxxxxx
00000, X.X.X. ("SB corp"), SmithKline Xxxxxxx p.l.c., a corporation organized
under the laws of England and having a place of business at Xxxxx Xxxx Xxxx,
Xxxxxxxxx, Xxxxxxxxx, X.X. ("SB p.l.c."), (individually and collectively "SB"),
and, on the other hand, Takeda Chemical Industries, Ltd., a corporation
organized under the laws of Japan, having a principal place of business at 0-0,
Xxxxxxxxxx 0-Xxxxx, Xxxx-xx, Xxxxx, 000, Xxxxx, and its Affiliates ("TAKEDA").
SB/HGS DIAGNOSTIC LICENSE AGREEMENT effective July, 1997 between, on the one
hand, SmithKline Xxxxxxx Corporation, a corporation organized under the laws of
the Commonwealth of Pennsylvania, having a place of business at Xxx Xxxxxxxx
Xxxxx, Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000, X.X.X. ("SB corp"), SmithKline Xxxxxxx
p.l.c., a corporation organized under the laws of England and having a place of
business at Xxxxx Xxxx Xxxx, Xxxxxxxxx, Xxxxxxxxx, X.X. ("SB p.l.c."),
(individually and collectively "SB"), and, on the other hand, Human Genome
Sciences, Inc., 0000 Xxx Xxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxx 00000 ("HGS").
69
69
Appendix F
RESEARCH PROGRAM REPORT FORM
I. BACKGROUND
a. briefly describe how diagnostic target/gene was identified
b. briefly describe data regarding potential diagnostic utility
II. KEY MILESTONES
a. list key milestones and anticipated dates for achievement
b. describe current status of project relative to milestones and
associated dates for accomplishments
III. CLINICAL EVALUATION
a. list clinical utility claims desired
b. briefly describe the studies needed for clinical evaluation
IV. PATENT
a. list patents filed by DiaDexus relating to the diagnostic target/gene
70
70
APPENDIX G, II, I, J
APPENDIX CONTENTS
II. SB DIAGNOSTIC PATENTS - COMMITTED
1b. SB DIAGNOSTIC PATENTS - ON OFFER
G. SB DIAGNOSTIC KNOW HOW - COMMITTED
IIb. SB DIAGNOSTIC KNOW HOW - ON OFFER
I. SB TECHNOLOGY KNOW HOW
J. SB TECHNOLOGY PATENTS
71
II. SB DIAGNOSTIC PATENTS - COMMITTED
SUBJECT/
DOCKET NO. TITLE DESCRIPTION SERIAL NO
---------- ----- ----------- ---------
***** ***** ***** HGS
***** ***** ***** HGS
***** ***** ***** HGS
***** ***** ***** HGS
***** ***** ***** HGS
***** ***** ***** HGS
***** ***** *****
***** *****
***** ***** ***** HGS
***** ***** ***** HGS
***** ***** *****
***** ***** *****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
72
***** ***** *****
***** *****
***** ***** *****
***** ***** *****
***** *****
***** *****
***** *****
***** ***** ***
***** *****
***** *****
***** *****
***** *****
***** *****
***** *****
***** *****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
73
*****
***** Novel COMPOUNDS
***** Novel COMPOUNDS
***** Novel COMPOUNDS***** *****
***** Novel COMPOUNDS***** *****
***** *****
***** Novel Compounds***** *****
***** Novel Compounds***** *****
***** Novel Compounds***** *****
***** Novel Compounds***** *****
***** Novel*****
***** *****
***** Novel*****
***** Novel Compounds***** *****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
74
*****
***** Novel Compounds***** *****
***** Novel Compounds(-"-) *****
Novel***** *****
***** Novel***** *****
***** Novel COMPOUNDS *****
***** Novel COMPOUNDS *****
***** ***** *****
***** ***** *****
***** ***** *****
***** Certain information on this page and all of the information on the next
three pages have been omitted and filed separately with the Securities and
Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
75
***** *****
***** *****
***** *****
***** *****
***** *****
***** *****
***** ***** ******
***** Novel*****
***** Novel*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
76
***** Novel*****
***** NOVEL*****
***** NOVEL*****
***** Novel*****
*****
*****
*****
*****
*****
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL*****
***** NOVEL COMPOUNDS
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
77
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
78
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
79
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** NOVEL COMPOUNDS
***** *****
***** *****
***** Certain information on this page and all of the information on the next
three pages have been omitted and filed separately with the Securities and
Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
80
II. SB DIAGNOSTIC TECHNOLOGY - COMMITTED
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ****** MOST RECENT UPDATE: ******
1. BACKGROUND
a. TARGET IDENTIFICATION ******
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
******
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) ******
2) ******
3) ******
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
******
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
81
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
******
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
******
4. PATENT STATUS
******
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
82
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ****** MOST RECENT UPDATE: ******
1. BACKGROUND
a. TARGET IDENTIFICATION ******
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
******
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) ******
2) ******
3) ******
4) ******
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
******
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
83
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
******
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
******
4. PATENT STATUS
******
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
84
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ****** MOST RECENT UPDATE: ******
1. BACKGROUND
a. TARGET IDENTIFICATION ******
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
******
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) ******
2) ******
3) ******
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
******
***** Certain information on this page has been omitted and filed separately
with the securities and exchange commission. confidential treatment has
been requested with respect to the omitted portions.
85
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
******
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
******
PATENT STATUS
******
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
86
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ******* MOST RECENT UPDATE: ******
1. BACKGROUND
a. TARGET IDENTIFICATION *******
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*******
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *******
3) *******
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND ASSOCIATED
DATES FOR ACCOMPLISHMENT.
********
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
87
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED.
*******
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND STATUS OF
THOSE STUDIES.
*******
4. PATENT STATUS
*******
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
88
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ****** MOST RECENT UPDATE: ******
1. BACKGROUND
a. TARGET IDENTIFICATION ********
b. *******
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *******
2) *******
3) ********
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND ASSOCIATED
DATES FOR ACCOMPLISHMENT.
*******
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
89
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
********
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND STATUS OF
THOSE STUDIES.
*******
4. PATENT STATUS
*******
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
90
IIb. SB DIAGNOSTIC TECHNOLOGY-ON OFFER
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ****** MOST RECENT UPDATE: ******
1. BACKGROUND
a. TARGET IDENTIFICATION ******
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
******
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) ******
2) ******
3) ******
4) ******
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
91
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*******
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*******
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND STATUS
OF THOSE STUDIES.
*******
4. PATENT STATUS
*******
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
92
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
93
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
94
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
95
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
96
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
97
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
98
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
99
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
100
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
101
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
102
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
103
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
104
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
105
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
106
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
107
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
108
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
109
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
110
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
111
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
112
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
113
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
114
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
115
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
116
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
117
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
118
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
119
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
120
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
121
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1)
2) *****
3)
4)
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
122
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
123
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
124
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
125
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
126
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
127
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
128
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
129
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
130
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
131
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
132
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
133
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
134
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
135
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
136
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
137
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
138
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
139
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
140
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
141
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
142
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED.
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
143
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
144
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
145
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
146
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
147
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
148
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
149
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
150
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
151
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
152
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
153
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
154
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
155
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
156
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
157
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
158
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
159
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
160
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
161
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
162
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
163
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
164
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
165
RESEARCH PLAN FOR DIAGNOSTIC
PROPOSED DIAGNOSTIC FOR: ***** MOST RECENT UPDATE: *****
1. BACKGROUND
a. TARGET IDENTIFICATION *****
b. BRIEF DESCRIPTION OF DATA REGARDING POTENTIAL DIAGNOSTIC UTILITY
*****
2. KEY MILESTONES
a. LIST KEY MILESTONES AND ANTICIPATED DATES FOR ACHIEVEMENT
1) *****
2) *****
3) *****
4) *****
b. DESCRIBE CURRENT STATUS OF PROJECT RELATIVE TO MILESTONES AND
ASSOCIATED DATES FOR ACCOMPLISHMENT.
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
166
3. CLINICAL EVALUATION
a. LIST CLINICAL UTILITY CLAIMS DESIRED
*****
b. BRIEFLY DESCRIBE THE STUDIES NEEDED FOR CLINICAL EVALUATION AND
STATUS OF THOSE STUDIES.
*****
4. PATENT STATUS
*****
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
167
I. SB TECHNOLOGY KNOW HOW
SB Technology Know How associated with SB Technology Patents
168
Appendix C
INCYTE DIAGNOSTIC PATENTS
------------------------------------------------------------------------------------------------------------
COUNTRY REFERENCES TYPE FILED SERIAL # ISSUED PATENTS STATUS
------------------------------------------------------------------------------------------------------------
AUSTRALIA ****** **** 3/1/93 ******** 12/19/95 ******* ISSUED
CANADA ****** **** 0/0/00 ******** XXXXXXX
XXXXXX ****** **** 3/10/93 ******** PENDING
EUROPEAN PATENT CO ****** **** 7/9/91 ******** PENDING
EUROPEAN PATENT CO ****** **** 3/10/93 ******** PENDING
JAPAN ****** **** 0/0/00 ******** XXXXXXX
XXXXXX XXXXXX ****** **** 7/10/90 ******** ABANDONED
UNITED STATES ****** **** 9/11/92 ******** ABANDONED
UNITED STATES ****** **** 12/18/95 ******** PENDING
UNITED STATES ****** **** 2/28/95 ******** ABANDONED
UNITED STATES ****** **** 6/15/94 ******** 11/28/95 ******** ISSUED
UNITED STATES ****** **** 5/19/94 ******** 12/19/95 ****** ISSUED
WIPO ****** **** 7/9/91 ******** PENDING
WIPO ****** **** 7/8/91 ******** ABANDONED
WIPO ****** **** 9/10/93 ******** PENDING
------------------------------------------------------------------------------------------------------------
AUSTRALIA ****** **** 10/31/90 ******** ABANDONED
[TEXT ILLEGIBLE] ****** **** 10/31/90 ******** PENDING
EUROPEAN PATENT CO ****** **** 00/00/00 ******** XXXXXXX
XXXXXX XXXXXX ****** **** 00/0/00 ******** XXXXXXXXX
XXXXXX XXXXXX ****** **** 7/11/92 ******** PENDING
UNITED STATES ****** **** 8/12/92 ******** ABANDONED
UNITED STATES ****** **** 8/12/92 ******** ABANDONED
WIPO ****** **** 00/00/00 ******** XXXXXXXXX
------------------------------------------------------------------------------------------------------------
XXXXXX XXXXXX ***** **** 00/00/00 ***** XXXXXXXXX
XXXXXX XXXXXX ***** **** 0/00/00 ***** XXXXXXX
XXXXXX XXXXXX ***** **** 4/24/95 ***** ABANDONED
------------------------------------------------------------------------------------------------------------
AUSTRIA ****** ***** 5/25/89 ******** 7/20/94 *** ISSUED
AUSTRALIA ****** ***** 5/26/89 ******** 6/4/93 *** ISSUED
BELGIUM ****** ***** 5/26/89 ******** 7/20/94 *** ISSUED
CANADA ****** ***** 4/25/89 ******** PENDING
SWITZERLAND ****** ***** 5/26/89 ******** 7/20/94 *** ISSUED
GERMANY ****** ***** 5/26/89 ******** 7/20/94 ******** ISSUED
EUROPEAN PATENT CO ****** ***** 5/26/89 ******** 7/20/94 *** ISSUED
FRANCE ****** ***** 5/26/89 ******** 7/20/94 *** ISSUED
UNITED KINGDOM ****** ***** 5/26/89 ******** 7/20/94 *** ISSUED
ITALY ****** ***** 5/26/89 ******** 7/20/94 *** ISSUED
JAPAN ****** ***** 5/26/89 ******** PENDING
LUXEMBOURG ****** ***** 5/26/89 ******** 7/20/94 *** ISSUED
NETHERLANDS ****** ***** 5/26/89 ******** 7/20/94 *** ISSUED
SWEDEN ****** ***** 5/26/89 ******** 7/20/94 *** ISSUED
UNITED STATES ****** ***** 5/26/89 ******** 7/16/91 *** ISSUED
UNITED STATES ****** ***** 7/15/91 ******** 5/11/93 *** ISSUED
UNITED STATES ****** ***** 5/10/93 ******** ABANDONED
WIPO ****** ***** 5/26/89 ******** PENDING
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
169
**************
------------------------------------------------------------------------------------------------------------
AUSTRALIA ***** ** 2/14/90 ***** 7/19/94 ***** ISSUED
AUSTRALIA ***** ** 8/12/91 ***** 6/29/95 ***** ISSUED
AUSTRALIA ***** ** 8/28/92 ***** 2/27/98 ***** ISSUED
AUSTRALIA ***** ** 0/0/00 ***** XXXXXXX
XXXXXXXXX ***** ** 4/29/94 ***** PENDING
CANADA ***** ** 2/14/90 ***** PENDING
CANADA ***** ** 8/13/91 ***** PENDING
CANADA ***** ** 8/29/92 ***** PENDING
CANADA ***** ** 0/0/00 ***** XXXXXXX
XXXXXX ***** ** 4/29/94 ***** PENDING
EUROPEAN PATENT CO ***** ** 2/14/90 ***** PENDING
EUROPEAN PATENT CO ***** ** 8/13/91 ***** PENDING
EUROPEAN PATENT CO ***** ** 9/28/92 ***** PENDING
EUROPEAN PATENT CO ***** ** 7/1/94 ***** PUBLISHED
EUROPEAN PATENT CO ***** ** 4/29/94 ***** PENDING
ISRAEL ***** ** 2/12/90 ***** PENDING
JAPAN ***** ** 2/14/90 ***** PENDING
JAPAN ***** ** 8/13/91 ***** PENDING
JAPAN ***** ** 9/28/92 ***** PENDING
JAPAN ***** ** 7/1/94 ***** PENDING
JAPAN ***** ** 0/00/00 ***** XXXXXXX
XXXXX XXXXX ***** ** 0/00/00 ***** XXXXXXX
XXXXX XXXXX ***** ** 0/00/00 ***** XXXXXXX
XXX XXXXXXX ***** ** 0/00/00 ***** XXXXXXX
XXXXXX XXXXXX ***** ** 0/00/00 ***** XXXXXXXXX
XXXXXX XXXXXX ***** ** 0/00/00 ***** XXXXXXXXX
XXXXXX XXXXXX ***** ** 0/0/00 ***** 00/00/00 ***** XXXXXX
XXXXXX XXXXXX ***** ** 0/0/00 ***** XXXXXXXXX
XXXXXX XXXXXX ***** ** 0/00/00 ***** XXXXXXXXX
XXXXXX XXXXXX ***** ** 0/00/00 ***** XXXXXXX
XXXXXX XXXXXX ***** ** 0/0/00 ***** XXXXXXXXX
XXXXXX XXXXXX ***** ** 00/0/00 ***** XXXXXXXXX
XXXXXX XXXXXX ***** ** 0/00/00 ***** XXXXXXXXX
XXXXXX XXXXXX ***** ** 0/0/00 ***** XXXXXXX
XXXXXX XXXXXX ***** ** 1/22/90 ***** 12/18/92 ***** ISSUED
UNITED STATES ***** ** 12/14/92 ***** 0/0/00 ***** XXXXXX
XXXXXX XXXXXX ***** ** 12/14/92 ***** 0/0/00 ***** XXXXXX
XXXXXX XXXXXX ***** ** 9/27/91 ***** 6/10/93 ***** ISSUED
UNITED STATES ***** ** 00/00/00 ***** XXXXXXX
XXXXXX XXXXXX ***** ** 00/00/00 ***** XXXXXXX
XXXXXX XXXXXX ***** ** 4/18/97 ***** PENDING
WIPO ***** ** 2/14/90 ***** PENDING
WIPO ***** ** 8/13/91 ***** PENDING
WIPO ***** ** 9/23/92 ***** PENDING
WIPO ***** ** 7/1/94 ***** PENDING
WIPO ***** ** 4/28/94 ***** PENDING
WIPO ***** ** 5/1/95 ***** PENDING
14-BETA-GAL MAMMALIAN LECTINS
------------------------------------------------------------------------------------------------------------
AUSTRALIA ***** ** 4/14/89 ***** 5/11/93 ***** ISSUED
BELGIUM ***** ** 4/14/89 ***** 8/7/96 ***** ISSUED
CANADA ***** ** 4/14/89 ***** 1/28/97 ***** ISSUED
GERMANY ***** ** 4/14/89 ***** 8/7/96 ***** ISSUED
EUROPEAN PATENT CO ***** ** 4/14/89 ***** 8/7/96 ***** ISSUED
SPAIN ***** ** 4/14/89 ***** 8/7/96 ***** ISSUED
FRANCE ***** ** 4/14/89 ***** 0/0/00 ***** XXXXXX
XXXXXX XXXXXXX ***** ** 4/14/89 ***** 8/7/96 ***** ISSUED
GREECE ***** ** 4/14/89 ***** 8/7/96 ***** ISSUED
[TEXT ILLEGIBLE] ***** ** 4/14/89 ***** 8/7/96 ***** ISSUED
[TEXT ILLEGIBLE] ***** ** 4/14/89 ***** PENDING
LUXEMBOURG ***** ** 4/14/89 ***** 8/7/96 ***** ISSUED
NETHERLANDS ***** ** 4/14/89 ***** 8/7/96 ***** ISSUED
SWEDEN ***** ** 4/14/89 ***** 8/7/96 ***** ISSUED
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
170
------------------------------------------------------------------------------------------------------------
UNITED STATES ***** ** 0/00/00 ***** XXXXXXXXX
XXXXXX XXXXXX ***** ** 00/00/00 ***** XXXXXXX
XXXXXX XXXXXX ***** ** 0/00/00 ***** XXXXXXXXX
XXXXXX XXXXXX ***** ** 00/00/00 ***** XXXXXXXXX
XXXXXX XXXXXX ***** ** 00/00/00 ***** XXXXXXX
XXXXXX XXXXXX ***** ** 0/00/00 ***** XXXXXXX
XXXXXX XXXXXX ***** ** 0/0/00 ***** 00/00/00 **** XXXXXX
XXXXXX XXXXXX ***** ** 00/0/00 ***** **** XXXXXX
XXXXXX XXXXXX ***** ** 0/00/00 ***** XXXXXXX
XXXXXX XXXXXX ***** ** 0/00/00 ***** XXXXXXX
XXXXXX XXXXXX ***** ** 9/25/96 ***** PENDING
WIPO ***** ** 11/16/93 ***** PENDING
------------------------------------------------------------------------------------------------------------
UNITED STATES MF-0009 US NEW 12/9/90 07/630,976 PENDING
UNITED STATES MF-0009-1 CIP CIP 4/22/94 08/232,859 PENDING
************
------------------------------------------------------------------------------------------------------------
UNITED STATES ***** ** 0/00/00 ***** XXXXXXXXX
XXXXXX XXXXXX ***** ** 0/00/00 ***** XXXXXXXXX
XXXXXX XXXXXX ***** ** 5/16/95 ***** PENDING
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
000
Xxxxxxxx X
Incyte Technology Know-How
Included in this Appendix is all Incyte Technology Know-How associated with
Incyte Technology Patents.
000
Xxxxxxxx X
INCYTE TECHNOLOGY PATENTS
-------------------------------------------------------------------------------------------------------------------
COUNTRY REFERENCES TYPE FILED SERIALS ISSUED PATENTS STATUS
-------------------------------------------------------------------------------------------------------------------
**************
-------------------------------------------------------------------------------------------------------------------
[ILLEGIBLE] ***** ***** 1/27/95 ***** PENDING
AUSTRALIA ***** ***** 1/27/95 ***** PENDING
BULGARIA ***** ***** 1/27/95 ***** PENDING
BRAZIL ***** ***** 1/27/95 ***** PENDING
CANADA ***** ***** 1/27/95 ***** PENDING
CHINA ***** ***** 1/27/95 ***** PENDING
CZECH REPUBLIC ***** ***** 1/27/95 ***** PENDING
ESTONIA ***** ***** 1/27/95 ***** PUBLISHED
EUROPEAN PATENT CO. ***** ***** 1/27/95 ***** ***** ISSUED
ENGLAND ***** ***** 1/27/95 ***** PENDING
GEORGIA ***** ***** 1/27/95 ***** PENDING
HUNGARY ***** ***** 1/27/95 ***** ABANDONED
JAPAN ***** ***** 0/00/00 ***** XXXXXXX
XXXXX XXXXX ***** ***** 0/00/00 ***** XXXXXXX
XXXXX XXXXX ***** ***** 0/00/00 ***** XXXXXXX
XXX XXXXX ***** ***** 1/27/95 ***** PENDING
[ILLEGIBLE] ***** ***** 1/27/95 ***** PENDING
MONGOLIA ***** ***** 1/27/95 ***** PENDING
[ILLEGIBLE] ***** ***** 1/27/95 ***** PENDING
[ILLEGIBLE] ***** ***** 0/00/00 ***** XXXXXXX
XXX XXXXXXX ***** ***** 1/27/95 ***** PENDING
AFRICAN UNION ***** ***** 1/27/95 ***** PENDING
POLAND ***** ***** 1/27/95 ***** PENDING
ROMANIA ***** ***** 1/27/95 ***** PENDING
FEDERATION OF RUSSIA ***** ***** 1/27/95 ***** PENDING
UKRAINE ***** ***** 0/00/00 ***** XXXXXXX
XXXXXX XXXXXX ***** ***** 0/00/00 ***** XXXXXXX
XXXXXX XXXXXX ***** ***** 7/28/94 ***** PENDING
VIETNAM ***** ***** 1/27/95 ***** PENDING
WIPO ***** ***** 1/27/95 ***** ***** ISSUED
**************
-------------------------------------------------------------------------------------------------------------------
XXXXXX XXXXXX XX-0000 XX ***** 0/0/00 ***** XXXXXXX
XXXXXX XXXXXX HP-0001-1 US ***** [ILLEG.] ***** PENDING
WIPO HP-0001-1 PCT ***** 6/3/96 ***** PUBLISHED
**************
-------------------------------------------------------------------------------------------------------------------
XXXXXXXXX XX-0000 XX ***** 0/00/00 ***** XXXXXXX
XXXXXX XX-0000 XX ***** 3/14/95 ***** PENDING
EUROPEAN PATENT CO CM-0001 EP ***** 0/00/00 ***** XXXXXXX
XXXXX XX-0000 XX ***** 3/14/95 ***** PENDING
MEXICO CM-0001 MX ***** 0/00/00 ***** XXXXXXX
XXXXXX XXXXXX CM-0001 US ***** 3/16/94 ***** PENDING
WIPO CM-0001 PCT ***** 3/14/95 ***** PENDING
**************
-------------------------------------------------------------------------------------------------------------------
UNITED STATES CM-0002 US ***** 5/17/96 ***** PENDING
WIPO CM-0002 PCT ***** 5/13/97 ***** PENDING
**************
-------------------------------------------------------------------------------------------------------------------
UNITED STATES CM-0003 US ***** 9/16/96 ***** PENDING
**************
-------------------------------------------------------------------------------------------------------------------
UNITED STATES CM-0004 US ***** 12/13/96 ***** PENDING
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
173
Schedule 1.1(a)
SB R&D - Upper Merion, USA
Date Dep Asset Accum YTD
Description Acquired Met Cost Degree NBV Deprec
--------------------------------------------------------------------------------------------------------
B05911 Optical Storage 6/25/96 01 1,781 -292 1,489 .94
B05912 Optical Storage 6/25/96 01 445 -73 372 .24
B07461 Imaging System 6/25/96 01 84,123 -10,212 73,911 -4,689
B07555 Freezer - Liquid Nitrogen 6/25/96 01 12,432 -1,513 10,919 -693
F08060 Illuminator XX00 Xxxxxxxx 6/25/96 00 000 -000 000 -00
F08061 Misc Lab Equipment 6/25/96 00 000 -000 000 -00
F08074 Centrifuge 6/25/96 00 0,000 -000 000 -00
F08075 Incubator 6/25/96 01 4,034 -1,181 2,853 -204
F08124 Freezer 6/25/96 00 000 -000 000 -00
F41277 Centrifuge 6/25/96 01 8,125 -3,306 4,520 -394
F41835 Electrophoresis Unit 6/25/96 01 6,255 -2,467 3,798 -311
F41837 Incubator 6/25/96 01 20,391 -8,029 12,362 -1,011
F41838 Vacuum 6/25/96 01 3,215 -1,256 1,949 -159
F41866 Centrifuge 6/25/96 01 2,727 -1,095 1,631 -133
F41867 Spectrophetometer 6/25/96 01 4,418 -1,740 2,678 -219
F51868 Balance (Gram) 6/25/96 01 2,535 -1,038 1,597 -131
F41869 Balance (Miligram) 6/25/96 01 1,874 -738 1,136 -93
F41870 Centrifuge 6/25/96 01 1,731 -681 1,050 -86
F41871 Shaker/Mixer/Vortex 6/25/96 01 791 -311 000 -00
X00000 Xxxxxxxx Xxxxxxx - Fixture 6/25/96 01 1,715 -675 1,040 -85
F41875 Centrifuge 6/25/96 01 8,570 -3,374 5,196 -425
F41877 DNA Sequencer 6/25/96 01 117,455 -46,245 71,210 -5,822
F41878 Printer 6/25/96 01 4,889 -1,925 2,954 -242
F41897 Fluorometer 6/25/96 01 2,239 -852 1,387 -113
F41898 Refrigerator 6/25/96 01 6,536 -2,488 4,048 -331
F41899 Centrifuge 6/25/96 01 2,563 -976 1,587 -130
F41900 Centrifuge 6/25/96 01 2,563 -976 1,587 -130
F41901 475 W Ultrasonic Cell Dis 6/25/96 01 2,627 -1,000 1,627 -133
F41902 Centrifuge 6/25/96 01 3,055 -1,153 1,892 -155
F41909 Refrigerator 6/25/96 01 1,761 -670 1,091 -89
F41910 Refrigerator 6/25/96 01 1,761 -670 1,091 -89
F71181 DNA Thermal Cycler 6/25/96 01 6,185 -2,677 3,508 -287
F71182 DNA Thermal Cycler 6/25/96 01 6,185 -2,677 3,508 -287
F71183 Personal Computer 6/25/96 01 5,095 -4,303 000 -000
X00000 Xxxxxxx Ultra Low Temp 6/25/96 01 5,086 -2,135 2,951 -241
F84699 Personal Computer 6/25/96 01 3,047 -1,972 1,075 -315
F84700 Monitor 6/25/96 00 000 -000 000 -00
F94097 Centrifuge 6/25/96 01 1,813 -573 1,240 -89
F94743 Centrifuge 6/25/96 01 5,623 -2,007 3,616 -296
F95220 Water Bath 6/25/96 00 000 -000 000 -00
F95221 Water Bath 6/25/96 00 000 -000 000 -00
F95222 Water Bath 6/25/96 00 000 -000 000 -00
F95223 Water Bath 6/25/96 01 2,858 -969 1,889 -135
F95387 Freezer 6/25/96 01 9,331 -3,358 5,973 -427
F95425 Printer 6/25/96 00 000 -000 000 -00
F95541 Freezer 6/25/96 01 5,005 1,737 3,568 -255
F95686 Pump - Dynamex 6/25/96 01 48,384 -14,520 33,864 -2,420
F96892 Pipettor 6/25/96 00 0,000 -000 000 -00
F98993 Incubator 6/25/96 01 10,229 -3,235 6,994 -500
174
----------------------------------------------------------------------------------------------------
SB R&D - Upper Merion, USA
Date Dep Asset Accum YTD
Description Acquired Met Cost Deprec NBV Deprec
----------------------------------------------------------------------------------------------------
F99172 Water Bath 6/25/96 01 1,864 -402 1,462 -104
F99196 Flucrometer 6/25/96 01 2,456 -662 1,794 -125
F99298 Pipettor 6/25/96 01 1,272 -343 929 -66
038669 EDP Plus Micro 9/17/96 01 1,336 -358 978 -189
038710 Magneto Optical Drive 9/10/96 01 2,476 -663 1,813 -351
038794 Gene AMP PCR System 9/10/96 01 9,609 -1,029 8,580 -545
038796 Multiprobe 204DT Base Uni 9/10/96 01 47,415 -12,689 34,726 -6,718
039031 EDP Plus Micro 11/20/96 01 1,588 -425 1,163 225
039307 PBA Fiery Sys W/Hotel 8/10/97 01 134,547 0 134,547 0
039455 Apex4 - 6GBPC 5/11/97 01 3,266 -58 3,208 -58
039550 HP DeskJet 1600 Printer 10/16/96 01 1,929 -516 1,413 -273
040960 Duo Therm Hybridization O 5/11/97 01 3,885 -28 3,857 -28
040961 Duo Therm Hybridization O 5/11/97 01 3,885 -28 3,857 -28
041485 Micro Centrifuge Model 54 5/11/97 01 1,658 -12 1,646 -12
041486 Micro Centrifuge Model 54 5/11/97 01 1,658 -12 1,646 -12
041487 Micro Centrifuge Model 54 5/11/97 01 1,658 -12 1,646 -12
041561 Silverscanner III W/Photo 5/11/97 01 1,792 -13 1,779 -13
041764 ABI Prism DNA Sequencer 5/11/97 01 130,096 -926 129,172 -926
041901 Centrifuge Refrigerated G 7/13/97 01 10,500 -77 10,723 -77
041902 DU 6408 UV/VIS Scanning 5/11/97 01 11,627 -83 11,544 -83
041903 Auto Microplate Shaking W 5/11/97 01 6,461 -46 6,415 -46
041904 Auto Microplate Shaking W 5/11/97 01 6,461 -46 6,415 -46
041905 Spectramax 250 Windows Sy 5/11/97 01 28,250 -201 28,049 -201
041906 DNA Sequencer 373XLGS 5/11/97 01 17,471 -124 17,347 -124
041907 DNA Sequencer 377XL UPGRA 5/11/97 01 15,025 -107 14,918 -107
041908 Geneamp PCR System 9600 5/11/97 01 9,528 -68 9,460 -68
041909 Geneamp PCR System 9600 5/11/97 01 9,528 -68 9,460 -68
041910 Geneamp PCR System 9600 5/11/97 01 9,528 -68 9,460 -68
041911 Geneamp PCR System 9600 5/11/97 01 9,528 -68 9,460 -68
041912 Eagle Eye Imaging System 5/11/97 01 17,430 -124 17,306 -124
041913 Tekmar Tissue Homogenizer 7/13/97 01 1,788 -13 1,775 -13
041914 Refrigerated Incubator IT 5/11/97 01 4,265 -30 4,235 -30
041915 Micro Centrifuge 20901-05 7/13/97 01 1,658 -12 1,646 -12
041933 Flowcell 4 & .15mm Superp 5/11/97 01 1,808 -13 1,795 -13
041966 Polytron Homogenizer PT31 7/13/97 01 5,092 -36 5,056 -36
042114 DNA Sequencer Model 377 5/11/97 01 124,371 -885 123,486 -885
042222 Compaq Deskpro 5133 M2000 5/11/97 01 2,880 -51 2,829 -51
042233 Screen & Cassette Large 5/11/97 01 1,906 -14 1,892 -14
042234 Screen & Cassette Large 5/11/97 01 1,906 -14 1,892 -14
042235 Screen & Cassette Large 5/11/97 01 1,906 -14 1,892 -14
042236 Screen & Cassette Large 5/11/97 01 1,906 -14 1,892 -14
042240 Sequence Detector Model 7 5/11/97 01 85,488 -609 84,879 -609
042247 HP 1600cm Printer 5/11/97 01 2,600 -19 2,581 -19
042331 Water Bath for DNA Sequen 7/13/97 01 2,771 -20 2,751 -20
042332 Water Bath for DNA Sequen 7/13/97 01 2,771 -20 2,751 -20
042448 Fluorometer Wallac 12345 5/11/97 01 28,700 -204 28,496 -204
042487 Sequencer 3.0 5/11/97 01 2,613 -19 2,594 -19
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175
Schedule 1.1(b) -- SB Employees
NAME TITLE
Xxxxxxx, Xxxx, Dr. Director
Xxxxxx, Xxxxx, Dr. Sr. Investigator
Xxxxxxxxx, Xxxxxx, Dr. Sr. Investigator
Xxxxxx, Xxxxxxx, Dr. Sr. Investigator
Xxxxxxxxx, Xxxxxxx X., Dr. Investigator
Xxxx, Xxx Min Sr. Scientist
Xxxx-Xxxxxxxxxx, Xxxxx Assoc. Investigator
Xxxxxxxx, Xxxx X. Assoc. Investigator
Xxxxxxx, Xxxxxx Scientist
Xxxxx, Xxxxxxx Xxxx Scientist
Ling, Xxxxx X. Scientist
Xx Xx, Xxxxxxxx Scientist
Xxxxxxx, Xxxxxxx Vice President, Business Development