Document:

Exhibit 10.3

 

PROMISSORY NOTE

 

	
  $500,000

  	
  San Diego, California

  
	
   

  	
  November 10, 2008

  

 

 

FOR VALUE RECEIVED,
the undersigned (“Borrower”) hereby unconditionally promises to pay to the
order of FAVRILLE, INC., a
Delaware corporation (the “Company”), in lawful money of the United States of
America and in immediately available funds, the principal sum of Five Hundred
Thousand Dollars ($500,000) together with interest accrued from the date hereof
on the unpaid principal at the applicable federal rate of interest per annum,
or the maximum rate permissible by law (which under the laws of the State of
California shall be deemed to be the laws relating to permissible rates of
interest on commercial loans), whichever is less, on the basis of a three
hundred sixty-five (365) day year. 
Interest shall be compounded annually and shall be payable in arrears on
the Maturity Date (as defined below).

 

The outstanding principal amount hereunder and all accrued interest
thereon shall be due and payable in full on March 31, 2009 (“Maturity Date”),
provided that if, prior to the
Maturity Date, Borrower and Company have consummated the merger (the “Merger”)
contemplated by that certain Agreement and Plan of Merger and Reorganization
dated November 8, 2008 (the “Merger Agreement”), by and among the Company,
Montana Merger Sub, Inc., a Delaware corporation and a wholly owned
subsidiary of the Company and Borrower, the principal and interest shall
automatically be treated as a contribution of capital from Company to Borrower
and this Note will be fully discharged. 
Prior to the Maturity Date, if, other than due to a material breach by
Company of the Merger Agreement, the parties terminate the Merger Agreement
without closing the Merger, then this Note shall be accelerated in full and all
unpaid principal and accrued interest hereunder shall become due and payable
effective as of the date of the termination of the Merger Agreement.

 

This Note may be prepaid at any time without penalty.  All money paid toward the satisfaction of
this Note shall be applied first to the payment of interest as required
hereunder and then to the retirement of the principal.

 

Borrower hereby represents and agrees that the amounts due under this
Note are not consumer debt, and are not incurred primarily for personal, family
or household purposes, but are for business and commercial purposes only.

 

Borrower hereby waives presentment, protest and notice of protest,
demand for payment, notice of dishonor and all other notices or demands in
connection with the delivery, acceptance, performance, default or endorsement
of this Note.

 

The holder hereof shall be entitled to recover, and Borrower agrees to
pay when incurred, all costs and expenses of collection of this Note, including
without limitation, reasonable attorneys’ fees.

 

1

 

This Note shall be governed by, and construed, enforced and interpreted
in accordance with, the laws of the State of California, as applied to
agreements among California residents, made and to be performed entirely within
the State of California, without giving effect to conflicts of laws principles.

 

The terms and conditions of this Note shall inure to the benefit of and
be binding upon the respective successors and assigns of the parties hereto. Nothing
in this Note, expressed or implied, is intended to confer upon any third party
any rights, remedies, obligations, or liabilities under or by reason of this
Note, except as expressly provided in this Note.

 

If one or more provisions of this Note are held to be unenforceable
under applicable law, such provision(s) shall be excluded from this Note
and the balance of this Note shall be interpreted as if such provision(s) were
so excluded and shall be enforceable in accordance with its terms.

 

 

	
   

  	
  BORROWER:

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  MYMEDICALRECORDS.COM, INC.

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
   /s/ Robert H. Lorsch

  
	
   

  	
  Name:

  	
  Robert H.
  Lorsch

  
	
   

  	
  Title:

  	
  CEO

  

 

2Exhibit 10.1

 

NON-EXCLUSIVE LICENSE AGREEMENT

 

This NON-EXCLUSIVE LICENSE AGREEMENT (this “Agreement”) is entered into
as of August 12, 2008, by and between Interleukin Genetics, Inc., a
Delaware corporation with an address of 135 Beaver Street, Waltham, MA 02452 (“ILI”),
and Oral DNA Labs, Inc.  214
Overlook Circle, Suite 120, Brentwood, Tennessee 37027 (“Oral DNA”).  Each of ILI and Oral DNA is sometimes
referred to individually herein as a “Party” and collectively as the “Parties.”

 

WHEREAS, ILI is the owner of or otherwise controls certain patents and
technology related to its proprietary DNA-based PST® Genetic Risk Assessment Test that may be used
for the identification of persons at risk for developing periodontis; and

 

WHEREAS, Oral DNA desires to obtain a non-exclusive license from ILI
under such patents and technology to make, distribute, use and sell PST® Genetic Risk Assessment Tests for use in the
Field; and

 

WHEREAS, ILI desires to grant such license to Oral DNA on the terms and
subject to the conditions of this Agreement.

 

NOW, THEREFORE, in consideration of the mutual covenants contained
herein, and for other good and valuable consideration, the Parties hereto,
intending to be legally bound, hereby agree as follows:

 

1.                                      DEFINITIONS

 

Whenever used in this Agreement with an initial capital letter, the
terms defined in this Section 1 shall have the meanings specified.

 

1.1                                 “Affiliate” means, with respect to any
Party, any Person that, directly or through one or more Affiliates, controls,
or is controlled by, or is under common control with, such Party.  For purposes of this definition, “control”
means (a) ownership of more than fifty percent (50%) of the shares of
stock entitled to vote for the election of directors in the case of a
corporation, or more than fifty percent (50%) of the equity interests in the
case of any other type of legal entity, (b) status as a general partner in
any partnership, or (c) any other arrangement whereby a Person controls or
has the right to control the board of directors of a corporation or equivalent
governing body of an entity other than a corporation.

 

1.2                                 “Additional Testing Services” means the
testing services other than the PST®, for which a payment for the
testing services has been received by ILI or its Affiliate on samples sent by
Oral DNA from PST® Patients to ILI or ILI designated subcontractors
pursuant to Section 3.6.

 

1.3                                 “Aggregate Product Sales” means, with
respect to a given period, the aggregate number of Licensed Products sold to a
Patient or any Third Party (including without limitation any Provider) by Oral
DNA over such period.

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.

 

 

1.4                                 “Applicable Laws” means Federal, state,
local, national and supra-national laws, statutes, rules and regulations,
including any rules, regulations, guidance, guidelines or requirements of
Regulatory Authorities, national securities exchanges or securities listing
organizations, that may be in effect from time to time during the Term and
applicable to a particular activity hereunder.

 

1.5                                 “Applicable Measurement Period” means
the four-month period commencing on the first day of Calendar Month 21 (May 2010)
and continuing through the last day of Calendar Month 24 (August 2010).

 

1.6                                 “Applicable Product Payment” means
$[***] for each PST® Genetic Risk Assessment Test.

 

1.7                                 “Approved Patient” means a Patient who
has completed an Informed Consent, submitted an Additional Sample to ILI via
Oral DNA, and whose Additional Testing Services are derived solely from the
Additional Sample sent from Oral DNA.

 

1.8                                 “Business Day” means a day on which
banking institutions in New York, New York are open for business.

 

1.9                                 “Calendar Month” means the period
beginning on the Effective Date and ending on the last day of the calendar
month in which the Effective Date falls, and thereafter each successive
calendar month thereafter.  For purposes
of clarity, the first Calendar Month shall be referred to as “Calendar Month 1”
(August 2008) and each successive Calendar Month shall be sequentially
numbered as “Calendar Month 2”, “Calendar Month 3”, etc.

 

1.10                           “Calendar Quarter” means the period
beginning on the Effective Date and ending on the last day of the calendar
quarter in which the Effective Date falls, and thereafter each successive
period of three (3) consecutive calendar months ending on March 31, June 30,
September 30 or December 31.

 

1.11                           “Calendar Year” means each successive
period of twelve (12) months commencing on January 1 and ending on December 31.

 

1.12                           “Commercially Reasonable Efforts” means,
with respect to Oral DNA, the efforts and resources customarily used by
similarly-sized companies with respect to a product or potential product of
similar nature at a similar stage in its development or product life and of
similar market potential, in view of conditions prevailing at the time, and evaluated
taking into account all relevant factors, including the competitiveness of
alternative products that are in the marketplace or under development, the
patent and other proprietary position of the product, the profitability of the
product and other technical, legal, marketing and competitive factors.

 

1.13                           “Confidential Information” means (a) with
respect to ILI, all tangible embodiments of Licensed Technology and Licensed
Patents; and (b) with respect to each Party, all information and
Technology disclosed or provided by or on behalf of such Party (the “Disclosing
Party”) to the other Party (the “Receiving Party”) or to any of the Receiving
Party’s employees, consultants, Affiliates or sublicensees pursuant to or in
connection with this Agreement; provided, that, none of the foregoing shall be
Confidential Information if:  (i) as
of 

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.

 

2

 

the date of disclosure, it is
known to the Receiving Party or its Affiliates as demonstrated by
contemporaneous written documentation, other than by virtue of a prior
confidential disclosure to such Receiving Party; (ii) as of the date of
disclosure it is in the public domain, or it subsequently enters the public
domain through no fault of the Receiving Party; (iii) it is obtained by
the Receiving Party from a Third Party having a lawful right to make such
disclosure free from any obligation of confidentiality to the Disclosing Party;
or (iv) it is independently developed by or for the Receiving Party
without reference to or use of any Confidential Information of the Disclosing
Party as demonstrated by contemporaneous written documentation.  For purposes of clarity, the terms of this
Agreement shall constitute Confidential Information of each Party.

 

1.14                           “Control” or “Controlled” means with respect to
Technology or Patent Rights, the possession by a Party of the right to grant a
license or sublicense to such Technology or Patent Rights as provided herein
without the payment of additional consideration to, and without violating the terms
of any agreement or arrangement with, any Third Party and without violating any
Applicable Laws.

 

1.15                           “Designated Senior Officer” means, with
respect to a Party, the senior officer designated by such Party to have final
decision making authority over Disputed Matters, which, unless otherwise
specified, shall be each Party’s Chief Executive Officer.

 

1.16                           “Diagnosis” means (a) the
determination or monitoring of (i) the presence or absence of a disease or
genetic predisposition, (ii) the stage, progression or severity of a
disease, (iii) the effect on a disease of a particular treatment, or (iv) the
effect of a genetic predisposition (or lack thereof) on disease progression,
treatment or recurrence; and/or (b) the selection of patients for a
particular treatment with respect to a disease.

 

1.17                           “Effective Date” means the date first
set forth above in the introductory paragraph to this Agreement.

 

1.18                           “Field” means all activities associated
with the Diagnosis of periodontal disease.

 

1.19                           “First Commercial Sale” means, with
respect to a Licensed Product in the Territory, the date on which the Licensed
Product is first provided or performed.

 

1.20                           “Force Majeure Event” means any
occurrence beyond the reasonable control of a Party that (a) prevents or
substantially interferes with the performance by such Party of any of its
obligations hereunder and (b) occurs by reason of any act of God, flood,
fire, explosion, earthquake, strike, lockout, labor dispute, casualty or
accident, or war, revolution, civil commotion, act of terrorism, blockage or
embargo, or any injunction, law, order, proclamation, regulation, ordinance,
demand or requirement of any government or of any subdivision, authority or
representative of any such government.

 

1.21                           “Improvement” means any enhancement,
improvement or modification to the Licensed Technology or the Licensed Patent
Rights that is conceived or reduced to practice by Oral DNA during the Term.

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.

 

3

 

1.22                           “Initial Marketing Activities” means the
initial activities to be conducted by Oral DNA as set forth in the Marketing
Plan, which shall include all training and ramp-up activities to be conducted
with respect to Licensed Products.

 

1.23                           “Licensed Patent Rights” means any of
the patents and patent applications described in Exhibit A attached
hereto, and any divisional, continuation, continuation-in-part (to the extent
that the continuation-in-part is entitled to the priority date of an initial
patent or patent application which is the subject of this Agreement), reissue,
reexamination, confirmation, revalidation, registration, patent of addition,
renewal, extension or substitute thereof, or any patent issuing therefrom or
any supplementary protection certificates related thereto.

 

1.24                           “Licensed Product” means any product
that uses, incorporates, is comprised of, or contains a PST® Genetic
Risk Assessment Test.

 

1.25                           “Licensed Technology” means any
Technology Controlled by ILI at any time during the Term that is related to the
PST® Genetic Risk Assessment Test and is necessary
or useful for Oral DNA to exercise the license granted to it pursuant to Section 2.1.1.

 

1.26                           “Net Sales” means (a) the gross
amount billed or invoiced by ILI or its Affiliates directly from Approved
Patients or their payors in the Territory in connection with the providing by
ILI or its Affiliates of Additional Testing Services, less the following
deductions from such gross amounts absorbed or accrued with respect to such
gross amounts:  (i) trade, cash
and/or quantity discounts allowed and taken directly with respect to such
services, or reflected in the invoiced amount; (ii) excise, sales and
other consumption taxes (excluding taxes based on income) and custom duties
imposed upon and paid directly by ILI with respect to the Additional Testing
Services, to the extent included in the invoice price; (iii) freight,
insurance and other transportation charges, to the extent included in the
invoice price; and (iv) amounts repaid or credited by reason of returns,
rejections, defects or recalls, chargebacks, retroactive price reductions,
refunds and billing errors, or (b) the revenue received by ILI from
Sublicensees in the Territory in connection with such Sublicensees providing
Additional Testing Services.

 

1.27                           “Patent Rights” means all rights and
interests in and to the issued patents and pending patent applications set
forth in Exhibit A (including inventor’s certificates and utility
models) in any country or jurisdiction within the Territory, including all
provisionals, substitutions, continuations, continuations-in-part, divisionals,
supplementary protection certificates, renewals, all letters patent granted
thereon, and all reissues, reexaminations, extensions, confirmations,
revalidations, registrations, patents of addition thereof, applications
pursuant to the Patent Cooperation Treaty and foreign counterparts of any of
the foregoing.

 

1.28                           “Patient” means each individual who
submits to testing using a Licensed Product.

 

1.29                           “Payment Term” means, with respect to
each Licensed Product, the period beginning on the date of First Commercial
Sale of such Licensed Product and continuing for so long as sales of Licensed
Products are made by Oral DNA.

 

1.30                           “Person” means an individual, sole
proprietorship, partnership, limited partnership, limited liability
partnership, corporation, limited liability company, business trust, joint
stock company, trust, incorporated association, joint venture or similar entity
or 

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.

 

4

 

organization, including a government
or political subdivision, department or agency of a government.

 

1.31                           “Promotional Materials” means all
marketing, sales, promotional or other published literature used by Oral DNA in
connection with the marketing, distribution and/or sale of Licensed Products in
the Territory.

 

1.32                           “Provider” means any Third Party that
provides or sells Licensed Products to customers on behalf of Oral DNA.

 

1.33                           “PST® Genetic Risk Assessment Test” means
ILI’s proprietary genetic test covered by one or more Licensed Patent Rights
that detects variations in certain Interleukin-1 genes in order to identify an
individual’s predisposition for over-expression of inflammation and risk for
periodontal disease.

 

1.34                           “Regulatory Approval” means any
approval, license registration or authorization of any Regulatory Authority
required for the manufacture, storage, importation, exportation, transport,
testing or sale of a Licensed Product for use in the Field in the Territory.

 

1.35                           “Regulatory Authority” means any
national, regional, state or local regulatory agency, department, bureau,
commission, council or other governmental entity with authority over the
development, distribution, importation, exportation, manufacture, production,
storage, transport, testing or sale of a Licensed Product in the Territory.

 

1.36                           “Sublicensee” means any Third Party
(other than an Affiliate) to which Oral DNA grants a sublicense pursuant to Section 2.1.2.

 

1.37                           “Technology” means, collectively, all
inventions, discoveries, improvements, trade secrets and proprietary methods,
whether or not patentable, including without limitation, macromolecular
sequences, data, formulations, processes, techniques, know-how and results
(including any negative results).

 

1.38                           “Territory” means metropolitan areas where
Oral DNA maintains a sales representative and markets its primary testing
services within the United States of America (including its territories and
possessions).

 

1.39                           “Third Party” means any Person other
than Oral DNA and ILI and their respective Affiliates.

 

Additional Definitions.  In addition, each of the following
definitions shall have the respective meanings set forth in the section of this
Agreement indicated below:

 

	
  Definition

  	
   

  	
  Section

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Additional Sample

  	
   

  	
  3.5

  	
   

  
	
  Agreement

  	
   

  	
  Recitals

  	
   

  
	
  Claims

  	
   

  	
  9.1

  	
   

  
	
  Disclosing Party

  	
   

  	
  1.13

  	
   

  

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.

 

5

 

	
  Disputed Matters

  	
   

  	
  10.3.1

  	
   

  
	
  ILI

  	
   

  	
  Recitals

  	
   

  
	
  ILI Indemnitees

  	
   

  	
  9.2

  	
   

  
	
  Improvement Patent Rights

  	
   

  	
  6.2.1(a)

  	
   

  
	
  Indemnified Party

  	
   

  	
  9.3

  	
   

  
	
  Indemnifying Party

  	
   

  	
  9.3

  	
   

  
	
  Informed Consent

  	
   

  	
  3.5

  	
   

  
	
  Infringement

  	
   

  	
  6.2.1(a)

  	
   

  
	
  Infringement Notice

  	
   

  	
  6.2.1(a)

  	
   

  
	
  Losses

  	
   

  	
  9.1

  	
   

  
	
  Marketing Plan

  	
   

  	
  3.2

  	
   

  
	
  Oral DNA

  	
   

  	
  Recitals

  	
   

  
	
  Oral DNA Indemnitees

  	
   

  	
  9.1

  	
   

  
	
  Party/Parties

  	
   

  	
  Recitals

  	
   

  
	
  Product Payments

  	
   

  	
  4.1.1

  	
   

  
	
  PST® Result Reports

  	
   

  	
  3.4

  	
   

  
	
  Receiving Party

  	
   

  	
  1.13

  	
   

  
	
  Term

  	
   

  	
  7.1

  	
   

  
	
  Third Party License

  	
   

  	
  4.1.2

  	
   

  
	
  Third Party Product Payment

  	
   

  	
  4.1.2

  	
   

  
	
  Withholding Taxes

  	
   

  	
  4.4

  	
   

  

 

2.                                      LICENSE
GRANTS

 

2.1                                 License to Oral DNA.  Subject to the terms and conditions of this
Agreement, ILI hereby grants to Oral DNA and its Affiliates a non-exclusive
license, without the right to grant sublicenses, under the Licensed Patent
Rights and Licensed Technology to make, distribute, use and sell Licensed
Products within the Field and in the Territory.

 

2.2                                 Retained Rights of ILI.  Subject to the terms and conditions of this
Agreement, ILI hereby retains the right (a) to use the Licensed Technology
and practice the Licensed Patent Rights for any and all uses, including (i) to
perform its obligations under this Agreement; (ii) to develop, have
developed, make, have made, use, have used, sell, have sold, offer for sale,
import, have imported, export and have exported Licensed Products, both within
and outside of the Field; and (b) to grant additional licenses to any
Third Party to do any or all of the foregoing.

 

2.3                                 License to ILI.  Subject to the terms and conditions of this
Agreement, Oral DNA hereby grants to ILI a non-exclusive, worldwide,
fully-paid, irrevocable, royalty-free license under Oral DNA’s interest in any
Improvements Controlled by Oral DNA (a) to develop, make, have made, use,
sell, have sold, offer for sale, import, have imported, export and have
exported Licensed Products; and (b) to otherwise exploit such Improvements
for all uses within the Field and Territory. 
In connection therewith, Oral DNA shall promptly notify ILI of the
conception or reduction to practice of any such Improvement.

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.

 

6

 

3.                                      COMMERCIALIZATION
OF LICENSED PRODUCTS

 

3.1                                Commercialization.

 

3.1.1                        Responsibility.  From and after the Effective Date, Oral DNA
shall have authority over the marketing and commercialization of Licensed
Products in the Field in the Territory, including, without limitation (a) the
conduct of the Initial Marketing Activities; (b) all activities relating
to manufacture and supply of Licensed Products (including any required process
development and scale up work with respect thereto); (c) all marketing,
promotion, sales, marketing, distribution, customer service, import and export
activities relating to Licensed Products; (d) the making and/or obtaining
of required Regulatory Approvals relating to any of the foregoing; and (e) the
processing of DNA samples supplied by Patients for the PST® Genetic Risk Assessment Test included in the
Licensed Product.  Oral DNA shall (a) perform
all such activities (i) at its sole cost and expense and (ii) in
compliance with all Applicable Laws, including without limitation HIPAA, all
applicable CLIA regulations and all regulations of any state agencies within any
state in which Oral DNA is marketing PST® Genetic Risk
Assessment Tests that apply to the conduct of genetic testing and (b) obtain
all Regulatory Approvals required from any applicable Regulatory Authority in
connection with its performance of such activities.  Oral DNA further agrees that all testing of
Licensed Products under this Agreement shall be performed in a CLIA-certified
laboratory in accordance with CLIA-guidelines.

 

3.1.2                       Laboratory Inspection.

 

(a)                                  Access.  Oral DNA shall provide ILI with access to its
testing facility, or any testing facility of a Third Party at which PST® testing is conducted by or on behalf of Oral
DNA, upon at least fifteen (15) days’ prior written notice, for the purposes of
insuring that quality standards are being adhered to and maintained at such
facility to ILI’s reasonable satisfaction and in compliance with this
Agreement.

 

(b)                                 Approval.  Notwithstanding anything to the contrary in
this Agreement, Oral DNA will not begin processing PST® samples until all of the testing facilities
that will be used for processing PST® samples have been approved by ILI (to include
inspection, at ILI’s discretion), such approval not to be unreasonably
withheld.

 

(c)                                  Frequency.  ILI may not request inspection of a given
testing facility under this Section 3.1.2 more frequently than two (2) times
in the first Calendar Year nor more frequently than one (1) time per
Calendar Year after the first Calendar Year.

 

3.1.3                       Diligence.

 

(a)                                  General
Diligence Obligations.  Oral DNA
shall use Commercially Reasonable Efforts in commercializing and marketing
Licensed Products in the Field and in the Territory.

 

(b)                                 Specific
Diligence Obligations.  Without
limiting the generality of the provision of Section 3.1.2 above, Oral DNA
hereby agrees that it will:  (i) complete
the Initial Marketing Activities on or before six (6) months from the
Effective Date; (ii) achieve a First Commercial Sale within one hundred
twenty (120) days from the Effective Date; (iii) 

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.

 

7

 

commencing on the sixth
Calendar Month following the Effective Date and continuing thereafter, make
substantially the same volume of sales calls as made for its primary testing
services; and (iv) conduct at least one (1) lecture per Calendar
Quarter through one or more members of its management team or scientific
advisory board (or such other individual as may be reasonably acceptable to
ILI) that discusses the importance of genetic susceptibility in regard to the
PST® Genetic Risk Assessment Test and periodontal
disease.  In the event that Oral DNA
fails to use Commercially Reasonable Efforts in complying with its diligence
obligations under Sections 3.1.3(a) or (b), then, subject to Section 3.1.3(c),
ILI may terminate this Agreement pursuant to Section 7.2.2.

 

(c)                                  Effect
of Failure to Meet Obligations.  If
Oral DNA fails to meet any of its obligations set forth above in Section 3.1.3(b) by
the applicable deadline, but is otherwise continuously in compliance with the
provisions of Section 3.1.3(a) throughout the entirety of the
diligence period specified above, then ILI and Oral DNA will negotiate in good
faith an extension of these deadlines.

 

3.2                                 Marketing Plan and Information.  As soon as practicable following the
Effective Date, Oral DNA shall submit to ILI for its information a marketing
plan (the “Marketing Plan”) for Licensed Products in the Field and in the
Territory. Thereafter, if requested by ILI, the Parties will have quarterly
conference calls in which (a) the Parties will discuss a non-binding
forecast of the total quantity of Licensed Products estimated to be sold by
Oral DNA during the upcoming Calendar Quarter, (b) Oral DNA will report to
ILI on the number of sales calls for Licensed Products made by Oral DNA during
each Calendar Month of the previous Calendar Quarter, and (c) the Parties
will discuss such other marketing topics as agreed to by the Parties.  In addition to the Marketing Plan, Oral DNA
will submit to ILI in advance all sales, promotional and marketing materials to
be used for Licensed Products.

 

3.3                                 Notice of Certain Events.  Oral DNA shall provide ILI with written
notice within thirty (30) days of the occurrence of the First Commercial Sale
of the first Licensed Product and any other material event related to the
marketing and/or commercialization of Licensed Products, and any adverse event
or product complaint information relating to Licensed Products.

 

3.4                                 Result Reports.  The Parties shall cooperate in good faith in
the preparation of the form of report to be used by Oral DNA to report to
Patients the results of PST® Genetic Risk Assessment Tests conducted by
Oral DNA, which shall be based on a template attached hereto as Exhibit B.
(“PST® Result Reports”).  All such PST® Result Reports shall include the names and
logos of both Parties as well as the PST® logo. Oral DNA
hereby acknowledges ILI’s ownership of all right title and interest in and to
the ILI name and the PST® logo, and agrees that (a) it will do
nothing inconsistent with such ownership, (b) all use of the ILI name and
the PST® logo by Oral DNA shall be in accordance with
any instructions provided in writing by ILI to Oral DNA and (c) in the
event of any inappropriate use of the ILI name and the PST® logo, as determined by ILI, ILI shall have the
right to terminate this Agreement pursuant to Section 7.2.2.

 

3.5                                 Additional Testing Services.  Oral DNA as part of its marketing efforts,
shall communicate to its dental clients information on additional genetic
testing available to Patients from ILI. To the extent Patients consent to
having a duplicate sample sent to ILI, Oral DNA shall seek to have its dental
clients obtain from each Patient an informed consent in accordance with 

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.

 

8

 

21 C.F.R. parts 50 and 56, in a
form acceptable to ILI and containing such information concerning the Patient
as may be reasonably requested by ILI (each, an “Informed Consent”) authorizing
ILI to contact Patient for purposes of offering to provide non-dental related
Additional Testing Services for a fee. 
Subject to the foregoing, (a) Oral DNA shall attempt to have its
dental client obtain from each such Patient and provide to ILI an additional
DNA sample (the “Additional Sample”), together with a copy of the Patient’s
Informed Consent; (b) ILI shall reimburse Oral DNA for the reasonable
costs and expenses incurred by Oral DNA in shipping the Additional Samples to
ILI; and (c) ILI shall have the right to contact each such Patient and
offer to provide non-dental related Additional Testing Services directly to the
Patient.  In the event that Additional
Testing Services are performed by ILI on Approved Patients, ILI shall pay Oral
DNA a royalty of five percent (5%) of Net Sales applicable to the conduct of
such Additional Testing Services. Subject to the above provisions of this Section 3.5,
ILI shall in no event contact directly or indirectly any of the dental clients
of Oral DNA in connection with the Additional Testing Services.

 

3.6                                 Observer Rights.  Oral DNA will permit an authorized
representative of ILI to attend one (1) meeting of Oral DNA’s scientific
advisory board per Calendar Year in a nonvoting observer capacity to enable ILI
to conduct research with respect to the dental industry.

 

4.                                      CONSIDERATION

 

4.1                                Product Payments; Accounting and Records.

 

4.1.1                        Product Payments.  In consideration of the rights and licenses
granted to Oral DNA under this Agreement, commencing on the date of First
Commercial Sale of the first Licensed Product and continuing each Calendar
Quarter thereafter during the Payment Term, Oral DNA shall make payments to ILI
in an amount equal to the result obtained by multiplying the Applicable Product
Payment by the number of Licensed Products sold during such Calendar Quarter
(the “Product Payments”).  Oral DNA shall
have the right to reduce the aggregate amount of Product Payments to be paid to
ILI in each Calendar Quarter by an amount equal to the aggregate Applicable
Payment Amount that is attributable to any Licensed Products the purchase price
of which is refunded or credited to customers by Oral DNA for any reason;
provided, that, in no event shall the amount of such reductions or credits
exceed five percent (5%) of the aggregate amount of Product Payments payable to
ILI over such Calendar Quarter.

 

4.1.2                        Adjustments to Product Payments.  Exhibit C sets forth ILI’s
existing licensees of Licensed Products in the Field and in the Territory (“Existing
Licensees”). If at any time during the Payment Term, ILI grants to a Third
Party a non-exclusive license under the Licensed Patent Rights or the Licensed
Technology to make, use or sell Licensed Products in the Field and in the
Territory (each, a “Third Party License”) that obligates such Third Party
Licensee to make a payment for each Licensed Product in (or reduces the fee for
any Existing Licensee to)  an amount that
is less than the Applicable Product Payment in effect as of such date as
provided under Section 4.1.1 (each, a “Third Party Product Payment”), then
as promptly as possible following the First Commercial Sale of a Licensed
Product at such a fee by such Third Party Licensee or Existing Licensee, (a) ILI
shall give written notice thereof to Oral DNA, which notice shall include the
amount of such other Third Party Product Payment and (b) this Agreement
shall, without any further action by either Party, be deemed to have been
modified as 

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.

 

9

 

of such date by substituting
the amount of the Applicable Product Payment in effect as of such date under Section 4.1.1
by the Third Party Product Payment; provided, that, the Parties shall in good
faith execute an amendment to this Agreement reflecting the foregoing change
effective as of the date of such First Commercial Sale.

 

4.1.3                        Payment Dates and Reports.  All Product Payments shall be made by Oral
DNA within thirty (30) days after the end of each Calendar Quarter commencing
with the Calendar Quarter in which the First Commercial Sale of a Licensed
Product occurs based upon the aggregate Licensed Products that are sold during
such Calendar Quarter.  All payments
shall be made by wire transfer in accordance with instructions given to Oral
DNA in writing from time to time by ILI. 
Oral DNA shall also provide, at the same time each such payment is made,
a report for such Calendar Quarter showing: 
(a) the aggregate volume of sales, by state, of Licensed Products
in the Territory; and (b) a calculation of the aggregate amount of Product
Payments due to ILI.

 

4.1.4                        Records; Audit Rights.  Oral DNA shall keep and maintain, and shall
require its respective Affiliates and Sublicensees to keep and maintain, such
accurate and complete books and records in connection with the sale of Licensed
Products hereunder, as are necessary to allow the accurate calculation
consistent with generally accepted accounting principles of the Product
Payments due to ILI.  ILI shall have the
right to engage an independent certified public accounting firm reasonably
acceptable to Oral DNA, which shall have the right to audit the relevant books
and records of Oral DNA as may be reasonably necessary to determine and/or
verify the amount of Product Payments due hereunder.  Such examination shall be conducted, and Oral
DNA shall make its records available, during normal business hours upon at
least fifteen (15) days prior written notice, which shall take place at the
facility(ies) where such records are maintained.  Such audit rights shall not be exercised by
ILI more than once per Calendar Year. 
Each such audit shall be limited to pertinent books and records for any
year ending not more than thirty six (36) months prior to the date of request;
provided, that, ILI shall not be permitted to audit the same period of time
more than once.  The independent
accounting firm will prepare and provide to each Party a written report stating
whether the reports submitted and Product Payments paid are correct or
incorrect and the specific details concerning any discrepancies and may not
reveal to ILI any information learned in the course of such audit other than
the amount of any such discrepancies. 
ILI agrees to hold in strict confidence all information disclosed to it,
except to the extent necessary for ILI to enforce its rights under this
Agreement or if disclosure is required by Applicable Laws.  In the event there was an underpayment by
Oral DNA hereunder, Oral DNA shall promptly (but in no event later than thirty
(30) days after such Party’s receipt of the independent auditor’s report so
correctly concluding) make payment to ILI of any shortfall.  In the event that there was an overpayment by
Oral DNA hereunder, ILI shall promptly (but in no event later than thirty (30)
days after ILI’s receipt of the independent auditor’s report so correctly
concluding) refund to Oral DNA the excess amount.  ILI shall bear the full cost of such audit
unless such audit discloses an underreporting by Oral DNA of more than five
percent (5%) of the aggregate amount of Product Payments in any twelve (12)
month period, in which case, Oral DNA shall reimburse ILI for all costs
incurred by ILI in connection with such examination and audit.

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.

 

10

 

4.2                                 Payment of Royalties by ILI; Accounting and Records.

 

4.2.1                        Payment of Royalties.  ILI shall pay Oral DNA a royalty equal to
five percent (5%) of the aggregate Net Sales of Additional Testing Services
provided by ILI.

 

4.2.2                        Payment Dates and Reports.  Royalty payments shall be made by ILI within
thirty (30) days after the end of each Calendar Quarter commencing with the
Calendar Quarter in which Additional Testing Services are first provided by
ILI.  All payments shall be made by wire
transfer in accordance with instructions given to ILI in writing from time to
time by Oral DNA.  ILI shall also
provide, at the same time each such payment is made, a report for such Calendar
Quarter showing:  (a) the Net Sales
of Additional Testing Services; (b) the basis for any deductions from
gross amounts billed or invoiced to determine Net Sales; (c) the exchange
rates used in calculating any of the foregoing; and (d) a calculation of
the amount of royalty due to Oral DNA.

 

4.2.3                        Records; Audit Rights.  ILI shall keep and maintain, and shall
require its respective Affiliates and Sublicensees to keep and maintain, such
accurate and complete books and records in connection with the providing of
Additional Testing Services hereunder, as are necessary to allow the accurate
calculation consistent with generally accepted accounting principles of the
royalties due to Oral DNA, including any records required to calculate any
royalty deductions or other adjustments hereunder.  Oral DNA shall have the right to engage an
independent certified public accounting firm reasonably acceptable to ILI,
which shall have the right to audit the relevant books and records of ILI and
its respective Affiliates and Sublicensees as may be reasonably necessary to
determine and/or verify the amount of royalty payments due hereunder.  Such examination shall be conducted, and ILI
shall make its records available, during normal business hours upon at least
fifteen (15) days prior written notice, which shall take place at the
facility(ies) where such records are maintained.  Such audit rights shall not be exercised by
Oral DNA more than once per Calendar Year. 
Each such audit shall be limited to pertinent books and records for any
year ending not more than thirty-six (36) months prior to the date of request;
provided, that, Oral DNA shall not be permitted to audit the same period of
time more than once.  The independent
accounting firm will prepare and provide to each Party a written report stating
whether the royalty reports submitted and royalties paid are correct or
incorrect and the specific details concerning any discrepancies and may not
reveal to Oral DNA any information learned in the course of such audit other
than the amount of any such discrepancies. 
Oral DNA agrees to hold in strict confidence all information disclosed
to it, except to the extent necessary for Oral DNA to enforce its rights under
this Agreement or if disclosure is required by Applicable Laws.  In the event there was an underpayment by ILI
hereunder, ILI shall promptly (but in no event later than thirty (30) days
after such Party’s receipt of the independent auditor’s report so correctly
concluding) make payment to Oral DNA of any shortfall.  In the event that there was an overpayment by
ILI hereunder, Oral DNA shall promptly (but in no event later than thirty (30)
days after Oral DNA’s receipt of the independent auditor’s report so correctly
concluding) refund to ILI the excess amount. 
Oral DNA shall bear the full cost of such audit unless such audit
discloses an underreporting by ILI of more than five percent (5%) of the
aggregate amount of royalties in any twelve (12) month period, in which case,
ILI shall reimburse Oral DNA for all costs incurred by Oral DNA in connection
with such examination and audit.

 

4.3                                 Overdue Payments.  All payments not made by a Party within the
time period set forth in Sections 4.1.3 and/or 4.2.2, as the case may be, shall
bear interest at a rate of one percent 

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.

 

11

 

(1%) per month from the due
date until paid in full or, if less, the maximum interest rate permitted by
Applicable Laws; provided that, in the case of audit adjustments pursuant to
Sections 4.2.1 and 4.2.3, such interest shall only be payable to the extent of
underpayments in excess of five percent (5%). 
Any such overdue royalty payment shall, when made, be accompanied by,
and credited first to, all interest so accrued.

 

4.4                                 Withholding Taxes.  Any payments made by under this Agreement
shall be free and clear of any taxes, duties, levies, fees or charges, and such
amounts shall be reduced by the amount required to be paid or withheld pursuant
to any applicable law, including, but not limited to, United States federal,
state or local tax law (“Withholding Taxes”). 
Upon either Party’s request, the other Party shall submit to the
requesting Party reasonable proof of payment of the Withholding Taxes to the
proper authority, together with an accounting of the calculations of such
taxes, within ten (10) days after such request.  The Parties will cooperate reasonably in
completing and filing documents required under the provisions of any applicable
tax laws or under any other Applicable Laws in connection with the making of
any required tax payment or withholding payment, or in connection with any claim
to a refund of or credit for any such payment.

 

5.                                      TREATMENT
OF CONFIDENTIAL INFORMATION.

 

5.1                                 Confidentiality.

 

5.1.1                        Confidentiality Obligations.  ILI and Oral DNA each recognizes that the
other Party’s Confidential Information constitutes highly valuable assets of
such other Party.  ILI and Oral DNA each
agrees that, subject to Section 4.1.2, (a) during the Term and for an
additional seven (7) years thereafter it will not disclose, and will cause
its Affiliates and Sublicensees not to disclose, any Confidential Information
of the other Party and (b) during and after the Term, it will not use, and
will cause its Affiliates not to use, any Confidential Information of the other
Party, in either case, except as expressly permitted hereunder.  Without limiting the generality of the
foregoing, each Party shall take such action, and shall cause its Affiliates
and sublicensees to take such action, to preserve the confidentiality of the
other Party’s Confidential Information as such Party would customarily take to preserve
the confidentiality of its own Confidential Information and shall, in any
event, use at least reasonable care to preserve the confidentiality of the
other Party’s Confidential Information.

 

5.1.2                        Limited Disclosure.  ILI and Oral DNA each agrees that disclosure
of its Confidential Information may be made by the other Party to any employee,
consultant or Affiliate of such other Party to enable such other Party to
exercise its rights or to carry out its responsibilities under this Agreement;
provided, that, any such disclosure or transfer shall only be made to Persons
who are bound by written obligations as described in Section 4.1.3.  In addition, ILI and Oral DNA each agrees
that the other Party may disclose its Confidential Information (a) on a
need-to-know basis to such other Party’s legal and financial advisors; (b) as
reasonably necessary in connection with an actual or potential (i) permitted
sublicense of such other Party’s rights hereunder, (ii) debt or equity
financing of such other Party or (iii) purchase by any Third Party of all
of the capital stock or all or substantially all of the assets of such other
Party or any merger or consolidation involving such other Party, if, in each
case, the Person receiving such Confidential Information of the other Party
agrees in writing to maintain the 

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.

 

12

 

confidentiality of such
Confidential Information of the other Party with terms at least as restrictive
as those contained in Section 4.1.1; (c) as reasonably necessary to
file, prosecute or maintain patents or patent applications, or to file,
prosecute or defend litigation related to patents or patent applications, in
accordance with this Agreement; or (d) as required by Applicable Laws;
provided, that, in the case of any disclosure under this clause (d), the
Disclosing Party shall (i) if practicable, provide the other Party with
reasonable advance notice of and an opportunity to comment on any such required
disclosure, (ii) if requested by the other Party, cooperate in all
reasonable respects with the other Party’s efforts to obtain confidential
treatment or a protective order with respect to any such disclosure, at the
other Party’s expense and (iii) use good faith efforts to incorporate the
comments of such other Party in any such disclosure or request for confidential
treatment or a protective order.

 

5.1.3                        Employees and Consultants.  ILI and Oral DNA each hereby represents that
all of its employees and consultants, and all of the employees and consultants
of its Affiliates, who participate in the activities contemplated by this
Agreement or have access to Confidential Information of the other Party are or
will, prior to their participation or access, be bound by written obligations
to maintain such Confidential Information in confidence and not to use such
information except as expressly permitted hereunder.  Each Party agrees to use, and to cause its
Affiliates to use, reasonable efforts to enforce such obligations.

 

5.2                                 Publicity.  Neither Party shall issue a press or news
release or make any similar public announcement related to this Agreement
without the prior written consent of the other Party.  Prior to the Effective Date, the Parties
shall agree upon the timing and content of an initial joint press release relating
to the execution of this Agreement and its terms.  Except to the extent already disclosed in
that initial press release, (i) no disclosure of the existence of this
Agreement or its terms may be made by either Party, and (ii) no Party
shall use the name, trademark, trade name or logo of the other Party or its
employees in any publicity, news release or promotional materials relating to
this Agreement or its subject matter, without the prior express written
permission of the other Party, except as permitted by this Agreement or as may
be required by Applicable Laws or judicial order.  The Party desiring to make any such public
announcement shall provide the other Party with a written copy of the proposed
announcement sufficiently in advance of the public release to allow such other
Party to comment upon such announcement, prior to its release.  In addition to the foregoing restrictions on
public disclosure, if either Party concludes that a copy of this Agreement must
be filed with a securities exchange or regulatory or governmental body to which
that Party is subject, wherever situated, such Party shall provide the other
Party with a copy of this Agreement showing any sections as to which the filing
Party proposes to request confidential treatment, will provide the other Party
with an opportunity and a reasonable time period to comment on any such
proposal and to suggest additional portions of the Agreement for confidential
treatment and will take such Party’s comments into consideration before filing
the Agreement.  If the filing Party
disagrees with the other Party’s additional confidential treatment request, the
Parties shall attempt in good faith to discuss the matter before the Agreement
is filed.

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.

 

13

 

6.                                      FILING,
PROSECUTION AND MAINTENANCE OF PATENT RIGHTS

 

6.1                                 Patent Filing, Prosecution and Maintenance.

 

6.1.1                        Licensed Patent Rights.  ILI, acting through patent counsel or agents
of its choice, shall be solely responsible, at its sole cost and expense, for
the preparation, filing, prosecution and maintenance of all Licensed Patent
Rights.  All costs and expenses incurred
by ILI in connection with the preparation, filing, prosecution and maintenance
of Licensed Patent Rights shall be the sole responsibility of ILI.  At ILI’s request and expense, Oral DNA shall
cooperate with ILI in all reasonable respects in connection with such
preparation, filing, prosecution and maintenance of Licensed Patent Rights.

 

6.1.2                        Improvements.  Oral DNA, acting through patent counsel or
agents of its choice, shall be solely responsible, at its sole cost and
expense, for the preparation, filing, prosecution and maintenance of all Patent
Rights that cover Improvements (“Improvement Patent Rights”).  All costs and expenses incurred by Oral DNA
in connection with the preparation, filing, prosecution and maintenance of
Improvement Patent Rights shall be the sole responsibility of Oral DNA.  At Oral DNA’s request and expense, ILI shall
cooperate with Oral DNA in all reasonable respects in connection with such
preparation, filing, prosecution and maintenance of Improvement Patent
Rights.  Nothing in this Agreement shall
obligate Oral DNA to seek or maintain any Improvement Patent Rights.  If Oral DNA decides to cease prosecution or
to allow to lapse of any of the Improvement Patent Rights in any country, Oral
DNA shall inform ILI of such decision promptly and, in any event, so as to
provide ILI a reasonable amount of time to meet any applicable deadline to
establish or preserve such Improvement Patent Rights in such country.  ILI shall have the right to assume
responsibility for continuing the prosecution of such Improvement Patent Rights
in such country and paying any required fees to maintain such Improvement
Patent Rights in such country or defending such Improvement Patent Rights, all
at ILI’s sole expense, through patent counsel or agents of its choice;
provided, that, in the event that ILI assumes such responsibility Oral DNA
shall (a) assign all of its right and interest in and to such Improvement
Patent Rights to ILI, (b) shall promptly deliver to ILI copies of all
necessary files related to the Improvement Patent Rights with respect to which
responsibility has been transferred and (c) shall take all actions and
execute all documents reasonably necessary for ILI to assume such prosecution,
maintenance and defense.

 

6.2                                 Legal Actions.

 

6.2.1                        Third Party Infringement.

 

(a)                                  Infringement
Notice.  In the event either Party
becomes aware of any possible infringement of any Licensed Patent Rights or
Improvement Patent Rights (an “Infringement”), that Party shall promptly notify
the other Party and provide it with all details of such Infringement of which
it is aware (each, an “Infringement Notice”). 
ILI shall have the sole right and option to eliminate any such
Infringement of the Licensed Patent Rights by reasonable steps, which may
include the institution of legal proceedings or other action.  All costs, including without limitation
attorneys’ fees, relating to such legal proceedings or other action shall be
borne by ILI.  Oral DNA shall have the
sole right and option to eliminate any such Infringement of the Improvement
Patent Rights by reasonable steps, which may include the institution of legal
proceedings or other action.  All costs,
including without limitation attorneys’ fees, relating to such legal
proceedings or other action shall be borne by Oral DNA.

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.

 

14

 

(b)                                 Cooperation.  In any action, suit or proceeding instituted
under this Section 6.2.1, each Party shall cooperate with and assist the
other Party in all reasonable respects. 
Upon the reasonable request of a Party, the other Party shall join such
action, suit or legal proceeding and shall be represented using counsel of its
own choice, at the requesting Party’s expense.

 

(c)                                  Recoveries.  Any amounts recovered pursuant to Section 6.2.1(a) with
respect to Licensed Patent Rights, whether by settlement or judgment, shall be
allocated in the following order:  (i) first,
to reimburse ILI and Oral DNA for their reasonable out-of-pocket expenses in
making such recovery (which amounts shall be allocated pro rata according to
such expenses if insufficient to cover the totality of such expenses); and (ii) one
hundred percent (100%) to ILI.  Any
amounts recovered pursuant to Section 6.2.1(a) with respect to
Improvement Patent Rights, whether by settlement or judgment, shall be
allocated in the following order:  (i) first,
to reimburse Oral DNA and ILI for their reasonable out-of-pocket expenses in
making such recovery (which amounts shall be allocated pro rata according to
such expenses if insufficient to cover the totality of such expenses); and (ii) one
hundred percent (100%) to Oral DNA.

 

6.2.2                        Defense of Claims.  In the event that any action, suit or
proceeding is brought against either Party or any Affiliate or Sublicensee of
either Party alleging the infringement of the Technology or Patent Rights of a
Third Party by reason of the use by Oral DNA of the Licensed Technology or
Licensed Patent Rights to manufacture, distribute or sell any Licensed
Product:  (a) ILI shall have the
right to defend such action, suit or proceeding at its sole expense; (b) Oral
DNA shall have the right to separate counsel at its own expense in any such
action, suit or proceeding; and (c) the Parties shall cooperate with each
other in all reasonable respects in any such action, suit or proceeding.  In the event that any action, suit or
proceeding is brought against either Party or any Affiliate or Sublicensee of
either Party alleging the infringement of the Technology or Patent Rights of a
Third Party by reason of the use by ILI of the Improvement Patent Rights:  (a) Oral DNA shall have the right but
not the obligation to defend such action, suit or proceeding at its sole
expense; (b) ILI shall have the right to separate counsel at its own
expense in any such action, suit or proceeding; and (c) the Parties shall
cooperate with each other in all reasonable respects in any such action, suit
or proceeding. Each Party shall provide the other Party with prompt written
notice of the commencement of any such suit, action or proceeding, or of any
allegation of infringement of which such Party becomes aware, and shall
promptly furnish the other Party with a copy of each communication relating to the
alleged infringement that is received by such Party.

 

7.                                      TERM
AND TERMINATION

 

7.1                                 Term. 
This Agreement shall commence on the Effective Date and shall continue
in full force and effect for a period of thirty (30) months; provided, that, if
Aggregate Product Sales over the Applicable Measurement Period are equal to at
least [***] ([***]) Licensed Products, on an annualized basis, the term of this
Agreement shall automatically be extended for an additional period of two (2) years
without any further action of either Party, unless earlier terminated in
accordance with the provisions of this Article 7 (such period, as so
extended, the “Term”).  Upon expiration
of the Term, this Agreement shall terminate without further action of either
Party.

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.

 

15

 

7.2                                 Termination.  This Agreement may be terminated at any time
by either Party as follows:

 

7.2.1                        Right of ILI to Terminate.  ILI may terminate this Agreement by providing
not less than six (6) months’ written notice to Oral DNA in the event that
Aggregate Product Sales over the Applicable Measurement Period are not equal to
at least [***] [***] Licensed Products, on an annualized basis.

 

7.2.2                        Termination for Breach.  Except as set forth herein, either Party may
terminate this Agreement, effective immediately upon written notice to the
other Party, for a breach by the other Party of any material term of this
Agreement that remains uncured ninety (90) days (forty-five (45) days in the
event that the breach is a failure of Oral DNA to make any payment when
required hereunder) after the non-breaching Party first gives written notice of
such breach to the other Party. 
Notwithstanding anything to the contrary set forth herein, (a) if
the asserted breach is cured or shown to be non-existent to the reasonable
satisfaction of both Parties within the applicable cure period, the notice of
breach hereunder shall be deemed automatically withdrawn; and (b) a
material breach by a party shall not give rise to the termination right under
this Section 7.2.2 to the extent such material breach arises from a Force
Majeure event as described in Section 10.11; provided, that, the Party
breaching this Agreement shall have the burden of demonstrating the occurrence
of a Force Majeure, the recognition of which shall not be unreasonably withheld
by the other Party.  Notwithstanding the
foregoing, a Party may not terminate this Agreement pursuant to this Section 7.2.2
at a time when such Party has committed a breach of a material term of this
Agreement which remains uncured.

 

7.2.3                        Termination for Insolvency.  In the event that either Party files for
protection under bankruptcy laws, makes an assignment for the benefit of
creditors, appoints or suffers appointment of a receiver or trustee over its
property, files a petition under any bankruptcy or insolvency act or has any
such petition filed against it which is not discharged within sixty (60) days
of the filing thereof, then the other Party may terminate this Agreement
effective immediately upon written notice to such Party.  In connection therewith, all rights and
licenses granted under this Agreement are, and shall be deemed to be, for
purposes of Section 365(n) of the United States Bankruptcy Code,
licenses of rights to “intellectual property” as defined under Section 101
of the United States Bankruptcy Code.  In
the event that either Party undergoes a voluntary dissolution or winding-up of
its affairs, then the other Party may terminate this Agreement effective
immediately upon written notice to such Party.

 

7.3                                 Consequences of Termination of Agreement.  In the event of the termination of this
Agreement pursuant to Section 7.2, the following provisions shall apply,
as applicable.

 

7.3.1                        Termination by ILI under Section 7.2.1.  If this Agreement is terminated by ILI
pursuant to Section 7.2.1:

 

(a)                                  the
license granted by ILI to Oral DNA pursuant to Section 2.1 shall
immediately terminate; and

 

(b)                                 the
license granted by Oral DNA to ILI pursuant to Section 2.3 shall survive;
and

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.

 

16

 

(c)                                  each
Party shall promptly return or destroy all Confidential Information of the
other Party that are not subject to a continuing license hereunder; provided
that each Party may retain one copy of the Confidential Information of the
other Party in its archives solely for the purpose of establishing the contents
thereof and ensuring compliance with its obligations hereunder.

 

7.3.2                        Termination Pursuant to Section 7.2.2 or Section 7.2.3.  If this Agreement is terminated by Oral DNA
or ILI pursuant to Section 7.2.2 or Section 7.2.3, unless prohibited
by Applicable Laws:

 

(a)                                  the
license set forth in Section 2.1 shall survive solely as applied to
Licensed Products being provided by Oral DNA as of the effective date of
termination, subject to Oral DNA’s continued payment of all payments under and
in accordance with this Agreement with respect thereto;

 

(b)                                 the
license granted by Oral DNA to ILI pursuant to Section 2.3 shall survive;
and

 

(c)                                  each
Party shall promptly return all Confidential Information of the other Party
that are not subject to a continuing license hereunder; provided that each
Party may retain one copy of the Confidential Information of the other Party in
its archives solely for the purpose of establishing the contents thereof and
ensuring compliance with its obligations hereunder.

 

7.4                                 Surviving Provisions.  Termination or expiration of this Agreement
for any reason shall be without prejudice to:

 

(a)                                  the
rights and obligations of the Parties provided in Sections 7.4, 9.1, 9.2, 9.3,
9.4 and 9.5 and Articles 5 and 10 (including all other Sections or Articles
referenced in any such Section or Article and including Article 1),
all of which shall survive such termination;

 

(b)                                 ILI’s
rights to receive Product Payments for the duration of any applicable Product
Payment Term; and

 

(c)                                  any
other rights or remedies provided at law or equity which either Party may
otherwise have.

 

8.                                      REPRESENTATIONS
AND WARRANTIES

 

8.1                                 Mutual Representations and Warranties.  ILI and Oral DNA each represents and warrants
to the other, as of the Effective Date, as follows:

 

8.1.1                        Organization.  It is a corporation duly organized, validly
existing and in good standing under the laws of the jurisdiction of its
organization, and has all requisite power and authority, corporate or
otherwise, to execute, deliver and perform this Agreement.

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.

 

17

 

8.1.2                        Authorization.  The execution and delivery of this Agreement
and the performance by it of the transactions contemplated hereby have been
duly authorized by all necessary corporate action and will not violate (a) such
Party’s certificate or articles of incorporation or bylaws, (b) any
agreement, instrument or contractual obligation to which such Party is bound in
any material respect, (c) any requirement of any Applicable Laws, or (d) any
order, writ, judgment, injunction, decree, determination or award of any court
or governmental agency presently in effect applicable to such Party.

 

8.1.3                        Binding Agreement.  This Agreement is a legal, valid and binding
obligation of such Party enforceable against it in accordance with its terms
and conditions.

 

8.1.4                        No Inconsistent Obligation.  It is not under any obligation, contractual
or otherwise, to any Person that conflicts with or is inconsistent in any
respect with the terms of this Agreement or that would impede the diligent and
complete fulfillment of its obligations hereunder.

 

8.2                                 Additional Representations of ILI.  ILI further represents and warrants to Oral
DNA, as of the Effective Date, as follows:

 

8.2.1                        Licensed Patent Rights.  All Licensed Patent Rights listed on Exhibit A
as of the Effective Date are existing and, to ILI’s knowledge, no such Licensed
Patent Rights are invalid or unenforceable.

 

8.2.2                        Claims or Judgments.  There are no claims, judgment or settlements
against ILI pending, or to ILI’s knowledge, threatened, that invalidate or seek
to invalidate the Licensed Patent Rights listed on Exhibit A as of
the Effective Date.

 

8.2.3                        Right to Technology.  ILI has the right to grant the licenses under
the Licensed Patent Rights pursuant to this Agreement.

 

8.2.4                        No Infringement.  To ILI’s knowledge, no Third Party is
infringing, or threatening to infringe, the Licensed Patent Rights.  The use of Licensed Patent Rights as provided
under this Agreement for the manufacture, distribution or sale of Licensed
Products does not infringe the Patent Rights of any Third Party, nor has ILI
received any written notice alleging such infringement.

 

9.                                      INDEMNIFICATION

 

9.1                                 Indemnification of Oral DNA by ILI.  ILI shall indemnify, defend and hold harmless
Oral DNA, its Affiliates, their respective directors, officers, employees and
agents, and their respective successors, heirs and assigns (collectively, the “Oral
DNA Indemnitees”), against all liabilities, damages, losses and expenses
(including, without limitation, reasonable attorneys’ fees and expenses of
litigation) (collectively, “Losses”) incurred by or imposed upon the Oral DNA
Indemnitees, or any one of them, as a direct result of claims, suits, actions,
demands or judgments of Third Parties, including without limitation personal
injury and product liability claims and claims of suppliers and ILI employees
(collectively, “Claims”), arising out of (a) the material breach by ILI of
this Agreement (including any material breach of any representation of ILI in Section 8.2)
or (b) the conduct by ILI of the Additional Testing Services, except with 

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.

 

18

 

respect to any Claim or Losses
that result from a material breach of this Agreement by, or the gross
negligence or willful misconduct of, Oral DNA; provided, that, with respect to
any Claim for which ILI has an obligation to any Oral DNA Indemnitee pursuant
to this Section 9.1 and Oral DNA has an obligation to any ILI Indemnitee
pursuant to Section 9.2, each Party shall indemnify each of the other
Party’s Indemnitees for its Losses to the extent of its responsibility,
relative to the other Party, for the facts underlying the Claim.

 

9.2                                 Indemnification of ILI by Oral DNA.  Oral DNA shall indemnify, defend and hold
harmless ILI, its Affiliates, their respective directors, officers, employees
and agents, and their respective successors, heirs and assigns (the “ILI
Indemnitees”), against any Losses incurred by or imposed upon the ILI
Indemnitees, or any one of them, as a direct result of Claims arising out of (a) the
material breach by Oral DNA of this Agreement; or (b) the manufacture,
distribution or sale (including, without limitation, the manufacture,
distribution, promotion, import, sale or use by any Person) of any Licensed
Product by Oral DNA or any of its Affiliates, Sublicensees, distributors or
agents, except with respect to any Claim or Losses that result from a breach of
this Agreement by, or the gross negligence or willful misconduct of, ILI;
provided, that, with respect to any Claim for which ILI has an obligation to
any Oral DNA Indemnitee pursuant to Section 9.1 and Oral DNA has an
obligation to any ILI Indemnitee pursuant to this Section 9.2, each Party shall
indemnify each of the other Party’s Indemnitees for its Losses to the extent of
its responsibility, relative to the other Party, for the facts underlying the
Claim.

 

9.3                                 Conditions to Indemnification.  A Person seeking recovery under this Article 9
(the “Indemnified Party”) in respect of a Claim shall give prompt notice of
such Claim to the Party from which recovery is sought (the “Indemnifying Party”)
and; provided that the Indemnifying Party is not contesting its obligation
under this Article 9, shall permit the Indemnifying Party to control any
litigation relating to such Claim and the disposition of such Claim; provided
that the Indemnifying Party shall (a) act reasonably and in good faith
with respect to all matters relating to the settlement or disposition of such
Claim as the settlement or disposition relates to such Indemnified Party and (b) not
settle or otherwise resolve such claim without the prior written consent of
such Indemnified Party (which consent shall not be unreasonably withheld, conditioned
or delayed).  Each Indemnified Party
shall cooperate with the Indemnifying Party in its defense of any such Claim in
all reasonable respects and shall have the right to be present in person or
through counsel at all legal proceedings with respect to such Claim.

 

9.4                                 Warranty Disclaimer.  EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN
THIS AGREEMENT, NEITHER PARTY MAKES ANY WARRANTY WITH RESPECT TO ANY
TECHNOLOGY, GOODS, SERVICES, RIGHTS OR OTHER SUBJECT MATTER OF THIS AGREEMENT
AND EACH PARTY HEREBY DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING
WITHOUT LIMITATION WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE AND NONINFRINGEMENT.

 

9.5                                 Limited Liability.  NOTWITHSTANDING ANYTHING TO THE CONTRARY IN
THIS AGREEMENT, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY OR ANY OF ITS
AFFILIATES FOR (I) ANY SPECIAL, PUNITIVE, INDIRECT, INCIDENTAL OR
CONSEQUENTIAL DAMAGES, INCLUDING WITHOUT LIMITATION 

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.

 

19

 

LOST PROFITS OR LOST REVENUES,
OR (II) COST OF PROCUREMENT OF SUBSTITUTE GOODS, TECHNOLOGY OR SERVICES,
WHETHER UNDER ANY CONTRACT, WARRANTY, NEGLIGENCE, STRICT LIABILITY OR OTHER
LEGAL OR EQUITABLE THEORY.

 

10.                               MISCELLANEOUS

 

10.1                           Notices.  All notices and communications shall be in
writing and delivered personally or by courier or mailed via certified mail,
return receipt requested, addressed as follows, or to such other address as may
be designated from time to time:

 

	
  If to ILI:

  	
  Interleukin Genetics, Inc.

  
	
   

  	
  135 Beaver Street

  
	
   

  	
  Waltham, MA 02452

  
	
   

  	
  Tel: 781-419-4742

  
	
   

  	
  Fax: 781-398-0720

  
	
   

  	
  Attention: Partha Paul

  
	
   

  	
   

  
	
  with a copy to:

  	
  Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

  
	
   

  	
  One Financial Center

  
	
   

  	
  Boston, MA 02111

  
	
   

  	
  Tel.: 617-542-6000

  
	
   

  	
  Fax: 617-542-2241

  
	
   

  	
  Attention: John J. Cheney, Esq.

  
	
   

  	
   

  
	
  If to Oral DNA:

  	
  214 Overlook Circle, Suite 120

  
	
   

  	
  Brentwood, TN 37027

  
	
   

  	
  Tel.: 877-577-9055

  
	
   

  	
  Fax: 615-624-2826

  
	
   

  	
  Attn: Brian Carr

  
	
   

  	
   

  
	
  with a copy to:

  	
  H3GM

  
	
   

  	
  1800 Regions Center

  
	
   

  	
  315 Deaderick Street

  
	
   

  	
  Tel: 615-256-0500

  
	
   

  	
  Fax: 615-251-1056

  
	
   

  	
  Attention: David Cox

  

 

Except as otherwise expressly provided in this Agreement or mutually
agreed by the Parties in writing, any notice, communication or document
(excluding payment) required to be given or made shall be deemed given or made
and effective upon actual receipt or, if earlier, (a) three (3) business
days after deposit with an internationally-recognized overnight express courier
with changes prepaid, or (b) five (5) business days after mailed by
certified, registered or regular mail, postage prepaid, in each case addressed
to a Parties at its address stated above or to such other address as such Party
may designate by written notice given in accordance with this Section 10.1.

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.

 

20

 

10.2                           Governing Law.  This Agreement shall be governed by and
construed in accordance with the laws of the State of Delaware (USA), without
regard to the application of principles of conflicts of law.

 

10.3                           Disputes.

 

10.3.1                  Negotiation.  The Parties recognize that a bona fide
dispute as to certain matters may from time to time arise during the Term of
this Agreement that relates to either Party’s rights and/or obligations
hereunder (“Disputed Matter”).  In the
event of the occurrence of such a Disputed Matter, either Party may, by written
notice to the other Party, have such Disputed Matter referred to their
respective Designated Senior Officers. 
In the event the Designated Senior Officers are not able to resolve such
Disputed Matter within thirty (30) days of the date of such written notice,
either Party may invoke the provisions of Section 10.3.2.

 

10.3.2                  Arbitration.  Subject to Section 10.3.1, any Disputed
Matter initiated by either Party arising out of, resulting from or relating to
this Agreement, or the performance by either Party of its obligations under
this Agreement (other than bona fide Third Party actions or proceedings filed
or instituted in an action or proceeding by a Third Party against a Party),
whether before or after termination of this Agreement, shall be finally
resolved by binding arbitration. 
Whenever a Party shall decide to institute arbitration proceedings, it
shall give written notice to that effect to the other Party.  Any such arbitration shall be conducted under
the Commercial Arbitration Rules of the American Arbitration Association
by a panel of three arbitrators appointed in accordance with such rules.  Any such arbitration shall be held in
Wilmington, Delaware.  The method and
manner of discovery in any such arbitration proceeding shall be governed by the
laws of the State of Delaware.  The
arbitrators shall have the authority to grant injunctions and/or specific
performance and to allocate between the parties the costs of arbitration in
such equitable manner as they determine. 
Judgment upon the award so rendered may be entered in any court having
jurisdiction or application may be made to such court for judicial acceptance
of any award and an order of enforcement, as the case may be.  In no event shall a demand for arbitration be
made after the date when institution of a legal or equitable proceeding based
upon such claim, dispute or other matter in question would be barred by the
applicable statute of limitations.

 

10.4                           Binding Effect.  This Agreement shall be binding upon and
inure to the benefit of the Parties and their respective legal representatives,
successors and permitted assigns.

 

10.5                           Headings.  Section and subsection headings are
inserted for convenience of reference only and do not form a part of this
Agreement.

 

10.6                           Counterparts.  This Agreement may be executed simultaneously
in two or more counterparts, each of which shall be deemed an original and both
of which, together, shall constitute a single agreement.

 

10.7                           Amendment; Waiver.  This Agreement may be amended, modified,
superseded or canceled, and any of the terms of this Agreement may be waived,
only by a written instrument executed by each Party or, in the case of waiver,
by the Party or Parties waiving compliance. 
The delay or failure of either Party at any time or times to require
performance of any provisions 

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.

 

21

 

shall in no manner affect the
rights at a later time to enforce the same. 
No waiver by either Party of any condition or of the breach of any term
contained in this Agreement, whether by conduct, or otherwise, in any one or
more instances, shall be deemed to be, or considered as, a further or
continuing waiver of any such condition or of the breach of such term or any
other term of this Agreement.

 

10.8                           No Third Party Beneficiaries.  Except as set forth in Sections 9.1 and 9.2,
no Third Party (including, without limitation, employees of either Party) shall
have or acquire any rights by reason of this Agreement.

 

10.9                           Purposes and Scope.  The Parties hereto understand and agree that
this License Agreement is limited to the activities, rights and obligations as
set forth in this Agreement. Nothing in this Agreement shall be construed (a) to
create or imply a general partnership between the Parties; (b) to make
either Party the agent of the other for any purpose; (c) to alter, amend,
supersede or vitiate any other arrangements between the Parties with respect to
any subject matters not covered hereunder; (d) to give either Party the
right to bind the other; (e) to create any duties or obligations between
the Parties except as expressly set forth herein; or (f) to grant any
direct or implied licenses or any other right other than as expressly set forth
herein.

 

10.10                     Assignment and Successors.  Neither this Agreement nor any obligation of
a Party hereunder may be assigned by either Party without the consent of the
other which shall not be unreasonably withheld, except that each Party may
assign this Agreement and the rights, obligations and interests of such Party,
in whole or in part, to any of its Affiliates, and to any Third Party purchaser
of all of the capital stock of such Party or all or substantially all of its
assets in the line of business to which this Agreement pertains or to any
successor corporation resulting from any merger or consolidation of such Party
with or into such corporation.

 

10.11                     Force Majeure Event.  Neither Oral DNA nor ILI shall be liable for
failure of or delay in performing obligations set forth in this Agreement, and
neither shall be deemed in breach of its obligations, if such failure or delay
is due to a Force Majeure Event.  In
event of such Force Majeure Event, the Party affected shall use reasonable
efforts to cure or overcome the same and resume performance of its obligations
hereunder.

 

10.12                     Interpretation.  The Parties hereto acknowledge and agree
that: (a) each Party and its counsel reviewed and negotiated the terms and
provisions of this Agreement and have contributed to its revision; (b) the
rule of construction to the effect that any ambiguities are resolved
against the drafting Party shall not be employed in the interpretation of this
Agreement; and (c) the terms and provisions of this Agreement shall be
construed fairly as to each Party and not in a favor of or against either
Party, regardless of which Party was generally responsible for the preparation
of this Agreement.  In addition, unless a
context otherwise requires, wherever used, the singular shall include the
plural, the plural the singular, the use of any gender shall be applicable to
all genders and the word “or” is used in the inclusive sense.

 

10.13                     Integration; Severability.  This Agreement is the entire agreement with
respect to the subject matter hereof and supersede all other agreements and
understandings between the Parties with respect to such subject matter,
including without limitation the confidentiality agreement by and between the
Parties, which is hereby terminated as of the Effective Date.  If 

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.

 

22

 

any provision of this Agreement
is or becomes invalid or is ruled invalid by any court of competent
jurisdiction or is deemed unenforceable, it is the intention of the Parties
that the remainder of this Agreement shall not be affected.

 

10.14                     Further Assurances.  Each of ILI and Oral DNA agrees to duly
execute and deliver, or cause to be duly executed and delivered, such further
instruments and do and cause to be done such further acts and things,
including, without limitation, the filing of such additional assignments,
agreements, documents and instruments, as the other Party may at any time and
from time to time reasonably request in connection with this Agreement or to
carry out more effectively the provisions and purposes of, or to better assure
and confirm unto such other Party its rights and remedies under, this
Agreement.

 

[Remainder of page intentionally left
blank.]

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.

 

23

 

IN WITNESS WHEREOF, the Parties have caused this Agreement to be
executed by their duly authorized representatives.

 

 

	
  INTERLEUKIN GENETICS, INC.

  	
   

  
	
   

  	
   

  
	
  By:

  	
  /s/ Lewis H. Bender

  	
   

  
	
   

  	
   

  
	
  Name:  Lewis H. Bender

  	
   

  
	
   

  	
   

  
	
  Title:  Chief Executive Officer

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  ORAL DNA LABS, INC.

  	
   

  
	
   

  	
   

  
	
  By:

  	
  /s/ Brian C. Carr

  	
   

  
	
   

  	
   

  
	
  Name:  Brian C. Carr

  	
   

  
	
   

  	
   

  
	
  Title:  President/CEO

  	
   

  

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.

 

24

 

Exhibit A

 

Licensed Patent Rights

 

1.                                       Detecting
Genetic Predisposition to Periodontal Disease, US 5,686,246

 

2.                                       Diagnostics and
Therapeutics for Diseases Associated with an IL-1 Inflammatory Haplotype, US
6,268,142 B1

 

3.                                       Diagnostics and
Therapeutics for Diseases Associated with an IL-1 Inflammatory Haplotype, US
6,706,478 B2

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.

 

1

 

Exhibit B

 

PST Result Report Template

 

 

(NEXT TWO PAGES)

 

DRAFT

 

NEED TO BE FINALIZED.

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.

 

2

 

	
  PST® GENETIC TEST

  	
  Company

  
	
  For Susceptibility to Periodontal Disease

  	
  logo

  

 

	
  ·  Ordered By

  	
  ·  Patient Information

  	
  ·  Test Results

  
	
   

  	
   

  	
   

  
	
  Dr. John Johnson

  	
  JOHN L. SMITH

  	
  NEGATIVE

  
	
  Name of Practice

  	
  Gender: Male

  	
  The results of the PST Test indicate that your patient is NEGATIVE
  and does not have an increased risk for periodontal disease due to the
  genetic variations examined in this test. For detailed information about this
  report, read the information below.

  
	
  100 Main Street

  	
  Date of Birth: 25-Mar-1956

  
	
  Anytown, MA 0156

  	
   

  
	
   

  	
   

  
	
  Sample ID: 06-00503

  	
  Date Collected: 01-Feb-2008

  
	
  Sample Type: Buccal Swab

  	
  Date Received: 02-Feb-2008

  
	
  Ordered By: Dr. John Johnson

  	
  Date Reported: 23-Feb-2008

  

 

·  Interpretation

 

This
individual is PST-negative and therefore is not at increased risk for
periodontal disease by overproduction of IL-1 in the presence of bacteria. This
individual’s result does not rule out all risk for periodontal disease.

 

The
PST composite genotype is based on  the combination of the results for
the IL-la and IL-1b genes. Any combination that includes the
presence of a “T” in both IL1a (+4845) and IL1b (+3954) is defined as “PST-positive” and
predisposes an individual to periodontal disease.

 

Most
individuals who do not have major risk factors, including individuals who are
PST-negative and who are non-smokers, should respond favorably to regular
dental hygiene and maintenance care.

 

For
PST-negative patients with periodontal disease who are smokers, more stringent
supportive care and a smoking cessation program may be necessary to control
disease.

 

The
PST test assesses one of multiple risk factors that should be included in an
overall evaluation of periodontal disease. Specific bacteria are associated
with the initiation of the disease, and additional risk factors including
genetic susceptibility, smoking, diabetes, and oral hygiene have an amplifying
effect on disease progression.

 

·   Patient’s Genotype

 

	
  DNA
  Variation Name: 

  	
  IL-la (+4845)

  	
   

  	
  IL1-b (+3954)

  	
   

  
	
  Genotype:

  	
  G/G

  	
   

  	
  C/C

  	
   

  

 

·   Questions?

 

For
an explanation of the test results, please call 800 xxx-xxxx.

 

 

	
  

  	
   

  
	
  Director, DNA Laboratory

  	
   

  

 

 

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.

 

3

 

	
  PST® GENETIC TEST

  	
  Company 

  
	
  For Susceptibility to Periodontal Disease

  	
  logo

  

 

	
  ·   Ordered By

  	
  ·   Patient Information

  	
  ·   Test Results

  
	
   

  	
   

  	
   

  
	
  Dr. John Johnson

  	
  JOHN L. SMITH

  	
  POSITIVE

  
	
  Name of Practice

  	
  Gender: Male

  	
  The results of the PST test indicate that your patient is POSITIVE
  and has an increased risk for periodontal disease due to the genetic
  variations examined in this test. For detailed information about  this
  report, read the information below.

  
	
  100 Main Street

  	
  Date of Birth: 25-Mar-1956

  
	
  Anytown, MA 0156

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  Sample ID: 06-00503

  	
  Date Collected: 01-Feb-2008

  
	
  Sample Type: Buccal Swab

  	
  Date Received: 02-Feb-2008

  
	
  Ordered By: Dr. John Johnson

  	
  Date Reported: 23-Feb-2008

  

 

·   Interpretation

 

This individual has the PST-positive genotype and is therefore at a
3-7-fold increased risk for severe periodontal disease.

 

The PST composite genotype is based on the combination of the results
for the IL-la and IL-1b
genes. Any combination that includes the presence of a “T” in both IL 1a
(+4845) and IL 1b (+3954) is defined as “PST-positive” and
predisposes an individual to more severe periodontal disease.

 

Prevalence of the PST-positive genotype ranges from 30-40% in
populations of European descent. This frequency may be lower in other ethnic
groups. It is important to note that whenever the PST-positive genotype is
present, it is associated with an increased susceptibility to periodontal
disease and overproduction of IL-1.

 

The PST test assesses one of several risk factors that should be
included in an overall evaluation of periodontal disease. Specific bacteria are
associated with the initiation of the disease, and additional risk factors
including genetic susceptibility, smoking, diabetes, and oral hygiene have an
amplifying effect on periodontal disease progression.

 

For PST-positive patients, stringent supportive care, aggressive
treatment and maintenance (which may include medication) to control the
bacterial challenge may be appropriate. This may involve more frequent dental
recalls. For PST-positive patients who smoke, a smoking cessation program is
recommended. PST testing should be considered for first degree relatives of
individuals known to be PST-positive.

 

·   Patient’s Genotype

 

	
  DNA
  Variation Name: 

  	
  IL-la
  (+4845)

  	
   

  	
  IL1-b
  (+3954)

  	
   

  
	
  Genotype:

  	
  G/T

  	
   

  	
  C/T

  	
   

  

 

·   Questions?

 

For an explanation of the test results, please call 800 xxx-xxxx.

 

 

	
  

  	
   

  
	
  Director,
  DNA Laboratory

  	
   

  

 

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.

 

4

 

Exhibit C

 

Existing Licenses

 

Kimball Genetics, Inc.

101 University Boulevard

Suite 350

Denver, CO  80206

 

Hain LifeScience GmBH

Hardwiessenstrasse 1

D-72147 Nehren

GERMANY

 

LabOral International

Peppelkade 56

3992 AK Houten

Nederland

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.

 

5

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