Exhibit 10.3


 


RESEARCH AND LICENSE FOR USE AGREEMENT


 


This Research and License for Use Agreement (this “Agreement”) is made
and effective as of September 16, 2008 (the “Effective
Date”), by and between Geisinger Clinic, a Pennsylvania non-profit corporation
with an address at 100 North Academy Avenue, Weis Center for Research,
Danville, PA 17822 (“Geisinger”), and Interleukin Genetics, Inc., with an
address at 135 Beaver Street, Waltham, MA 02452 (“Interleukin”) (collectively
the “Parties”, and individually a “Party”).


 


WHEREAS, Geisinger, a rural Pennsylvania-based health system, has a
commitment to research and promoting interactions with parties interested in
the research, has access to certain research samples (“Samples”, as more fully
described below) and certain data (“Clinical Content”, as more fully described
below), related to the risks associated with, and the therapeutic monitoring of
certain diseases within the Study Field (as defined below);


 


WHEREAS, Interleukin desires to conduct a study consistent with the
Protocol as a research collaboration using the Samples, Clinical Content and
Geisinger Technology (the “Study”, as more fully described below) to enable it
to investigate the use of single nucleotide polymorphisms (“SNPs”) for the
purpose of developing a genetic test based on Perilipin, interleukin and other
gene variations specifically described herein that would allow physicians to (a) improve
the predictability and maintenance of weight loss for overweight and obese
subjects and (b) predict the inherited tendencies of individuals for
losing weight when placed on a calorie-restricted diet;


 


WHEREAS, Geisinger desires to provide to Interleukin, and Interleukin
desires to receive, a limited license to the Samples and the Clinical Content,
for research purposes, to enable Interleukin and Geisinger to conduct the Study
and develop the genetic tests, all on the terms and subject to the conditions
set forth in this Agreement; and


 


NOW THEREFORE, in consideration of the premises and mutual covenants
herein contained, and intending to be legally bound, the Parties hereto agree
as follows:


 


Article 1 - Definitions


 


1.1                                “Affiliate” means, with respect to any
person or entity, any other person or entity, which controls, is controlled by
or is under common control with such person or entity.  For purposes of this definition, a person or
entity is in “control” of an entity if it owns or controls more than fifty
percent (50%) of the equity securities of the subject entity entitled to vote
in the election of directors (or, in the case of an entity that is not a
corporation, for the election of the corresponding managing authority), or
otherwise has the power to control the management and policies of such other
entity.


 


1.2                                “Applicable Laws and Standards” has the
meaning set forth in Section 2.5 hereof.


 


1.3                                “Clinical Content” means all relevant
medical information associated with each Sample as further defined in the
Protocol and in the attached Appendix 1, Exhibit A; provided, 


 


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.


 

















 


however, that, Clinical Content
will expressly exclude Protected Health Information as defined in 45 C.F.R.
164.501.


 


1.4                                “Confidential Information” means all
confidential or other proprietary information of a Party, whether written, oral
or otherwise, and including, but not limited to, know-how or other information,
whether or not patentable, regarding a Party’s technology, products, business
information or objectives that is designated or marked as “CONFIDENTIAL” or
orally or visually identified as “CONFIDENTIAL” and confirmed as such in writing
within thirty (30) days after such disclosure.


 


1.5                                “Control” or “Controlled” means with respect to ownership of Samples,
Clinical Content, Technology or Patent Rights, the possession by a Party of the
right to grant a license or sublicense to such Samples, Clinical Content,
Technology or Patent Rights as provided herein without violating any Applicable
Laws and Standards.


 


1.6                                “Designated Biomarkers” means individually
or collectively:  (a) [***]; (b) [***],
and (c) [***].


 


1.7                                “Governmental Entity” means any federal,
state, local or foreign government (or political subdivision thereof), agency,
authority (including, without limitation, regulatory authority), commission,
court, tribunal, sovereign body or other governmental or quasi-governmental agency,
entity or body.


 


1.8                                “Patent Rights” means the rights and
interests in and to issued patents and pending patent applications in any
country, including all substitutions, continuations, continuations-in-part,
divisionals, supplementary protection certificates, renewals, all letters
patent granted thereon, and all reissues, reexaminations, extensions,
confirmations, revalidation, registrations and patents of addition thereof.


 


1.9                                “Product” means any diagnostic,
prophylactic, therapeutic or ameliorative product that uses or incorporates the
Designated Biomarkers, or incorporating Approved Restricted Biomarkers only if
the Parties amend the Agreement as described in Section 2.2(b), and that
is validated under the Study through use of the Samples, the Clinical Content
and/or the Study Technology.


 


1.10                          “Protocol” means the manner and methods by
which the Study will be conducted, a copy of which is attached hereto as
Appendix 1.


 


1.11                          “Restricted Biomarkers” means any biomarkers
other than the Designated Biomarkers, unless such biomarkers are included in
this Agreement pursuant to an amendment agreed to in writing by authorized
signers from both Parties according to terms set forth in Section 2.2(b).  If this Agreement is so amended and agreed to
in writing by authorized signers of both Parties according to terms set forth
in Section 2.2(b), then such additional approved biomarkers previously
considered Restricted Biomarkers shall be considered “Approved Restricted Biomarkers”.


 


Confidential and proprietary


Do not disclose without express permission


 


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

















 


1.12                          “Restricted Study Field” means any areas
outside Study Field, which are not permitted in the current Study under the
Samples, Clinical Content and Technology unless this Agreement is amended
pursuant to an amendment agreed to in writing by authorized signers from both
Parties according to terms set forth in Section 2.2(b).


 


1.13                          “Restricted Technology” means any Technology
using or covering Restricted Biomarkers, or using Designated Biomarkers in
Restricted Study Field.


 


1.14                          “Samples” means, as defined in the Protocol,
(a) DNA biological material from 824 individuals to be provided by
Geisinger to Interleukin as described in this Agreement, the exact quantities
and characteristics of which are set forth in the Protocol and (b) any DNA
biological material in addition to the DNA biological material provided by
Geisinger to Interleukin under subsection (a) that is provided by
Geisinger to Interleukin pursuant to Section 3.2(d)(iii) and meets
the criteria established in the Protocol (the “Additional Samples”).  For purposes of clarity, (a) if the
[***] Sample Option and/or the [***] Sample Option is exercised by Interleukin
according to terms set forth in Sections 3.3 and/or 3.4 (whether Partial or
Full Execution), then Samples shall also include the [***] Sample(s) and/or
the [***] Sample(s), as the case may be, covered by such Option and (b) Samples
will not contain any Protected Health Information as defined in 45 C.F.R. 164.501
(2002).


 


1.15                          “Study” means the investigation and use of
the Samples and Clinical Content described in the Protocol.


 


1.16                          “Study Field” means the use of Designated
Biomarkers for genetic screening purposes related to weight loss, obesity, and
metabolic syndrome, as described in the Protocol, including diabetes and
dislipidemia.


 


1.17                          “Study Results” means any and all data and
information produced in the conduct of the Study.


 


1.18                          “Study Technology” means any Technology that
is conceived or first reduced to practice by either Party, or jointly by the
Parties, after the Effective Date and before the Termination Date, as a result
of conducting the Study and identified in written form in the Study Results.


 


1.19                          “Technology” means technical or other information,
whether patentable or not, and whether in written or verbal form, including
know-how, experience, formulae, concepts, discoveries, trade secrets,
inventions, modifications, improvements, data (including all chemical,
preclinical, pharmacological, clinical, pharmacokinetic, toxicological,
analytical and quality control data), results, designs, ideas, analyses,
methods, techniques, assays, research plans, procedures, tests, processes
(including manufacturing processes, specifications and techniques), laboratory
records, reports, summaries, and information contained in submissions to, and
information from, regulatory authorities.


 


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

















 


1.20                          “Term” means the period commencing on the
Effective Date and continuing for a period of twelve (12) months, unless
extended or terminated earlier in accordance with provisions identified in Article 10.


 


1.21                          “Termination Date” means the first
anniversary of the Effective Date, unless extended or terminated earlier in
accordance with provisions identified in Article 10.


 


1.22                          “Third Party” means any entity other than
Geisinger or Interleukin and their respective Affiliates.


 


1.23                          “Usable Sample” means (a) a DNA sample
that can be used to generate a genotype call using a [***], (b) an [***]
tissue preserved in RNAlater or (c) [***] that is not degraded when
examined by agarose gel electrophoresis.


 


Article 2 - Protocol and Research


 


2.1                                Research
Management.  The Study will be
coordinated by Dr. Nazneen Aziz at Interleukin and in collaboration with Dr. Christopher
Still and Dr. Glenn Gerhard at Geisinger (each an “Investigator”).  As described in the Protocol, Dr. Christopher
Still is the Geisinger Principal Investigator. 
Each Investigator will ensure that the Study is performed in accordance
with the Protocol, and will use commercially reasonable efforts to ensure the
accuracy of the Study Results.


 


2.2                                Protocol.  The Parties will perform the Study in
accordance with the Protocol and this Section 2.2 and in accordance with
all Applicable Laws and Standards (as defined in Section 2.5).  The Protocol may be modified from time to
time during the Term by the mutual written consent of both Parties.  Each of Interleukin and Geisinger hereby
undertakes to use reasonable efforts to carry out its respective obligations
under the Protocol, complying with standards of care associated with customary
industry standards.


 


(a)                                  As
part of the Study, Interleukin shall be expressly prohibited from (i) researching
Restricted Biomarkers, (ii) researching Designated Biomarkers in the
Restricted Study Field, (iii) conducting research with or on Restricted
Technology using the Samples and/or Clinical Content conducting research beyond
the scope outlined in the Protocol.


 


(b)                                 If
authorized signers of both Parties agree by means of an amendment to this
Agreement in writing during the Term to conduct collaborative research with
Restricted Biomarkers, then Interleukin and Geisinger shall be permitted as
part of this Study to engage in research activities under this Protocol and use
of Samples and Clinical Content to research those Restricted Biomarkers that
have been designated by the authorized signers as “Approved Restricted
Biomarkers” as defined in Article 1.11.


 


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

















 


2.3                                Study
Results.  Each agent, staff member or
employee of either Party who participates in the conduct of the Study will keep
accurate scientific records relating to the Study, which records will be
sufficient to document all Study Results and all Study Technology discovered
under the Study, and will make such records available to the other Party during
normal business hours upon reasonable written notice.


 


2.4                                Informed
Consent.  To the extent required by
and in accordance with Applicable Laws and Standards:  (a) Geisinger has obtained informed
consent in writing from each individual who provided Samples and/or Clinical
Content prior to the collection of a Sample or Clinical Content from that
individual, which Interleukin agrees is in a form reasonably acceptable to
Interleukin, and (b) each individual that provided Samples and/or Clinical
Content was aware that their samples and associated Clinical Content could be
used for research purposes.


 


2.5                                Compliance
with Laws.  Each Party agrees that it
will comply with any and all laws, rules, regulations, and licensing
requirements that are now or hereafter promulgated by any local, state, and
federal governmental authority or agency that governs or applies to their
respective duties and obligations hereunder and with any and all rules and/or
standards that are now or hereafter promulgated by any accrediting or
administrative body that governs or applies to their respective duties and
obligations hereunder (the “Applicable Laws and Standards”).  The Applicable Laws and Standards will
include, but not be limited to, the Health Insurance Portability and
Accountability Act of 1996 (“HIPAA”), the requirements of the Department of
Health (“DOH”), Joint Commission on the Accreditation of Healthcare
Organizations (“JCAHO”) and the National Committee on Quality Assurance (“NCQA”),
as applicable.  Without limiting the
foregoing, each Party agrees to conform to all laws, rules, regulations and
policies of governing authorities which have jurisdiction over the use and
transfer of patient data.


 


Article 3 - Provision of Samples and Clinical Content


 


3.1                                Supply
of Samples.  As part of the limited
license granted in Section 4.1, Geisinger will provide the Samples and
Clinical Content to Interleukin in accordance with procedures set forth in the
Protocol and within fifteen (15) days after the later of the Effective Date or
receipt by Geisinger of the First Installment of the Overall Payment, as
provided in Section 6.2(a).  Unless
otherwise mutually agreed by the Parties, prior to providing the Samples,
Geisinger shall test, or cause to be tested, such Samples in order to determine
whether such Samples are Usable Samples in the Study as contemplated by the
Protocol.  For each Sample shipment,
Geisinger shall prepare and submit to Interleukin a certificate of analysis, in
form and containing such content as is mutually agreeable to the Parties, that
identifies the test methods and test results used by Geisinger to confirm that
the Samples are Usable Samples (each, a “Certificate of Analysis” identified in
Exhibit 2).


 


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

















 


3.2                                 Contingency
for Usable Samples.


 


(a)                                  Within
thirty (30) days following its receipt of each shipment of Samples and the
applicable Certificate of Analysis, Interleukin shall conduct a review to
confirm whether such Samples are Usable Samples by:  (i) reviewing the Certificate of
Analysis and/or (ii) conducting independent acceptance testing of the
Samples (the “Sample Review”).  Upon
completion of the Sample Review, Interleukin shall notify Geisinger in writing
within fourteen (14) business days of its determination of whether the Samples
are not Usable Samples (such notice, the “Failed Sample Notification”) or are
Usable Samples (such notice, the “Sample Acceptance Notification”).


 


(b)                                 Notwithstanding
anything to the contrary in Section 3.2(a), Interleukin’s use of Samples
in the conduct of the Study, other than for conducting PCR experiments to
determine usability of Samples, shall result in identification of such shipment
of Samples as Usable Samples, and therefore, constitute an implied Sample
Acceptance Notification, even if Interleukin has not provided a written Sample
Acceptance Notification or a Failed Sample Notification to Geisinger.


 


(c)                                  If
Interleukin either (i) provides Geisinger with Sample Acceptance Notice
according to Section 3.2(a), (ii) uses the Samples in the conduct of
the Study according to Section 3.2(b) other than for conducting PCR
experiments to determine usability of Samples, or (iii) does not provide a
Failed Sample Notification according to Section 3.2(a) within the
specified timeframe, then the Parties hereby agree that the Samples are Usable
Samples.


 


(d)                                 In
the event that Interleukin provides Geisinger with a Failed Sample Notification
within the specified timeframe according to Section 3.2(a):


 


(i)                                    If
Interleukin conducts research with the Samples other than for conducting PCR
experiments to determine usability of Samples, then Interleukin will be deemed
to have recognized the Samples as Usable Samples;


 


(ii)                                 If
both Parties agree, which agreement may be based on a Laboratory determination,
that less than ninety percent (90%) of the Samples are Usable Samples (a “Minimum
Supply Failure”), then Geisinger shall have up to forty-five (45) days to
remedy such Minimum Supply Failure such that at least ninety percent (90%) of
the total Samples supplied to Interleukin are Usable Samples as agreed to by
both Parties (the “Remedy Period”) and (B) during the Remedy Period,
Interleukin shall not conduct any research with the Samples according to terms
set forth in Section 3.5(i);


 


(iii)                              If
Geisinger is unable to remedy the above Minimum Supply Failure on or before
expiration of the Remedy Period, then Geisinger will provide Interleukin with
Additional Samples until 


 


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

















 


the earlier of (A) fifteen (15) days
from the date of expiration of the Remedy Period and (B) such date on
which at least ninety percent (90%) of the total Samples supplied by Geisinger
are Usable Samples (the “Additional Sample Supply Period”); or


 


(iv)                             If
Geisinger is unable to remedy the above Minimum Supply Failure on or before
expiration of the Remedy Period and is unable to supply Additional Samples to
Interleukin on or before expiration of the Additional Sample Supply Period,
then the Parties shall attempt to negotiate in good faith a reduction in the
compensation payable to Geisinger under this Agreement for a period of 90 days
(the “Initial Negotiation Period”).  In
the event the Parties are unable to agree to an appropriate reduction in
compensation payable to Geisinger during the Initial Negotiation Period, the
Parties may mutually agree to extend the negotiation period for an additional
thirty (30) days (the “Extended Negotiation Period”). Should the Parties fail
to negotiate an acceptable reduction in compensation during the Initial
Negotiation Period and any Extended Negotiation Period, the Agreement shall
automatically terminate.


 


3.3                                [***]
Tissue Samples.  During the Term,
Geisinger shall set aside for the exclusive use of Interleukin and not license
to any Third Party, [***] sample(s) (at least 400 milligrams each) taken
from [***] and [***] from fifty (50) patients that are represented in the 824
individuals whose DNA will be received under this Agreement for a total of
fifty (50) sample sets, collected and banked from October 2004 through the
Effective Date, and for which Interleukin may license from Geisinger (the “[***]
Sample Option”).  At any time during the
Term, upon written notice to Geisinger, Interleukin may receive quantities of
and a license to all of the [***] sample sets (“Full [***] Execution”) or some
of the sample sets (“Partial [***] Execution”), with a minimum execution of ten
(10) sample sets at a time. The cost of Geisinger providing the license
and samples sets to Interleukin for the Partial [***] Execution or the Full
[***] Execution is $[***] per sample set, payable within thirty (30) days of
Interleukin’s receipt of written invoice from Geisinger. Promptly following
Geisinger’s receipt of the above notice of exercise is given by and payment is
received, Geisinger shall ship the selected number of set-aside [***] samples
to Interleukin for its use, and Interleukin’s rights and restrictions on use of
these [***] samples shall be governed by the same terms set forth in this
Agreement applicable to the use of Samples. Starting six months after the
Effective Date and prior to Full Execution of or termination of the [***]
Sample Option, Interleukin shall pay Geisinger a quarterly maintenance fee of
$[***] per calendar quarter, payable in cash no later than thirty (30) days
after the end of every calendar quarter for which the [***] Sample Option
remains active (the “Phase One [***] Sample Option Maintenance Fee”).  If the [***] Sample Option remains active for
one (1) year, the quarterly maintenance fee shall increase to $[***] per
calendar quarter, payable in cash no later than thirty (30) days after the end
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.


 


7

















 


every calendar quarter for which the [***]
Sample Option remains active (the “Phase Two [***] Sample Option Maintenance
Fee”).  For the first Partial [***]
Execution or Full [***] Execution that occurs at least six (6) months
after the Effective Date, Geisinger shall grant to Interleukin a one-time
discount equal to the price of Partial [***] Execution or Full [***] Execution
minus the amount of the current quarterly [***] Sample Option Maintenance
Fee.  (By way of examples:  If the first Partial [***] Execution is 10
samples, and is executed in month 8 following the Effective Date, the amount
due shall be $[***]; which equals $[***] [10 samples x $[***] per sample] minus
the $[***] Phase One [***] Sample Option Maintenance Fee due for that calendar
quarter. If the first Partial [***] Execution is 20 samples, and is executed in
month 13 following the Effective Date, the amount due shall be $[***]; which
equals $[***] [20 samples x $[***] per sample] minus the $[***] Phase Two [***]
Sample Option Maintenance Fee due for that calendar quarter.)  At any time during the Term, Interleukin may,
at its sole discretion, notify Geisinger in writing that it wishes to terminate
the [***] Sample Option, at which time (a) Geisinger may reintroduce the
set-aside samples back in the general biobank and such samples shall thereafter
be unavailable to Interleukin, (b) the obligation of Interleukin to pay
the ongoing quarterly Phase One [***] Sample Option Maintenance Fee and/or the
Phase Two [***] Sample Option Maintenance Fee shall terminate, and (c) Interleukin
shall pay Geisinger a portion of the quarterly Phase One [***] Sample Option
Maintenance Fee or Phase Two [***] Sample Option Maintenance Fee that would be
otherwise due payable at the end of the then-current calendar quarter,
pro-rated through the date of termination of the option.  [***] Tissue Samples shall be subject to the
same disposal terms as are set forth in Section 3.6.


 


3.4                                [***]
Samples.  During the Term, Geisinger
shall set aside for the exclusive use of Interleukin and not license to any
company, [***] sample(s) (at least 500 nanograms each) taken from [***]
tissue from the same fifty (50) patients that are represented in the 824
individuals who’s DNA will be received under this Agreement and from which the
[***] sample(s) are collected, for a total of fifty (50) [***] Sample(s),
collected and banked from October 2004 through the Effective Date, for
which Interleukin may license from Geisinger (the “[***] Sample Option”).  At any time during the Term, upon written
notice to Geisinger, Interleukin may receive quantities of and a license to all
of the [***] samples (“Full [***] Execution”) or some of the [***] samples (“Partial
[***] Execution”), with a minimum execution of ten (10) sample sets at a
time. The cost of Geisinger providing the license and sample sets to
Interleukin for the Partial [***] Execution or the Full [***] Execution is
$[***] per sample set, payable within thirty (30) days of Interleukin’s receipt
of written invoice from Geisinger. Promptly following Geisinger’s receipt of
the above notice of exercise and payment, Geisinger shall ship the selected
number of set-aside [***] samples to Interleukin for its use, and Interleukin’s
rights and restrictions on use of these [***] samples shall be governed by the
same terms set forth in this Agreement applicable to the use of Samples.
Starting six months after the Effective Date and prior to Full Execution of or
termination of the [***] Sample Option, Interleukin shall pay Geisinger a
quarterly maintenance fee of $[***] per calendar quarter, payable in cash no
later than thirty (30) days after the end of every calendar 


 


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

















 


quarter for which the [***] Sample Option
remains active (the “Phase One [***] Sample Option Maintenance Fee”).  If the [***] Sample Option remains active for
one (1) year, the quarterly maintenance fee shall increase to $[***] per
calendar quarter, payable in cash no later than thirty (30) days after the end
of every calendar quarter for which the [***] Sample Option remains active (the
“Phase Two [***] Sample Option Maintenance Fee”). For the first Partial [***]
Execution or Full [***] Execution that occurs at least six (6) months
after the Effective Date, Geisinger shall grant to Interleukin a one-time
discount equal to the price of Partial [***] Execution or Full [***] Execution
minus the amount of the current quarterly [***] Sample Option Maintenance Fee.
(By way of examples: If the first Partial [***] Execution is 10 samples, and is
executed in month 8 following the Effective Date, the amount due shall be
$[***], which equals $[***] [10 samples x $[***] per sample] minus the $[***]
Phase One [***] Sample Option Maintenance Fee due for that calendar
quarter.  If the first Partial [***]
Execution is 20 samples and is executed in month 13 following the Effective
Date, the amount due shall be $[***], which equals $[***] [20 samples x $[***]
per sample] minus the $[***] Phase Two [***] Sample Option Maintenance
Fee.)  At any time during the Term,
Interleukin may, in its sole discretion, notify Geisinger in writing that it
wishes to terminate the [***] Sample Option, at which time (a) Geisinger
shall reintroduce the set-aside samples back in the general biobank and such
samples shall thereafter be unavailable to Interleukin, (b) the obligation
of Interleukin to pay the Phase One [***] Sample Option Maintenance Fee or
Phase Two [***] Sample Option Maintenance Fee shall terminate and (c) Interleukin
shall pay Geisinger a portion of the quarterly Phase One [***] Sample Option
Maintenance Fee or Phase Two [***] Sample Option Maintenance Fee that would be
otherwise due payable at the end of the then-current calendar quarter,
pro-rated through the date of termination of the option.  All fees associated with this Section 3.4
shall be in addition to any fees applicable to maintenance of the [***] Samples
as described in Section 3.3. [***] Samples shall be subject to the same
disposal terms as are set forth in Section 3.6.


 


3.5                                Disagreements.  In the case of any disagreement between the
Parties as to whether or not any Samples are Usable Samples which remains
unresolved for a period exceeding thirty (30) days, the disputed Sample and all
relevant documentation shall be submitted to an independent testing
organization mutually agreed upon by the Parties (the “Laboratory”) for tests
and final determination.  The agreement
of the appointment of such Laboratory shall not be unreasonably withheld or
delayed by either Party.  The
determination of such Laboratory with respect to whether Samples are Usable Samples
shall be final and binding on the Parties. 
The fees and expenses of the Laboratory incurred in making such
determination shall be paid by the Party against whom the determination is
made.  To the extent the Laboratory
determines that any Samples are Unusable Samples (i) Geisinger shall have
the right to provide a remedy in accordance with Section 3.2(d)(iii), or (ii) the
Compensation shall be adjusted in accordance with terms set forth in Section 3.2(d)(iv) shall
apply.


 


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
















 


3.6                                Return
of Samples.  Interleukin shall use
the Samples solely for the performance of the Study under the Protocol.
Interleukin will not transfer the Samples to any Third Party without the prior
written consent of Geisinger from an authorized signer.  At the expiration of the Term, Interleukin
will return any unused Samples to Geisinger that are not subject to a
continuing commercial license under this Agreement (for the purposes of
validation of Study Results in the Study Field), unless otherwise directed in
writing by an authorized signer of Geisinger.


 


Article 4 - Ownership of Study Results


 


4.1                                Interleukin
shall have sole and exclusive ownership of all right, title and interest in and
to any and all Study Results arising from the conduct of the Study using
Designated Biomarkers (the “Designated Biomarker Study Results”).


 


4.2                                Interleukin
and Geisinger will jointly own any and all Study Results arising from the
conduct of the Study using Approved Restricted Biomarkers (the “Approved
Restricted Biomarker Study Results”).


 


Article 5 - License Rights


 


5.1                                Limited
License to Samples and Clinical Content. 
Geisinger hereby grants to Interleukin a limited, non-exclusive, license
to use the Samples and the Clinical Content for the sole purpose of conducting
the Study in accordance with procedures set forth in this Agreement and the
Protocol.


 


5.2                                Cross-Licenses.  Each Party hereby grants to the other Party a
non-exclusive, non-transferable, royalty-free, paid-up license, without the
right to grant sublicenses, to use Study Technology developed by it as a result
of the conduct of the Study for the sole purpose of enabling such other Parties
to fulfill its obligations under this Agreement and the Protocol.


 


5.3                                Non-Exclusivity.  Interleukin acknowledges and agrees that the
limited licenses provided to Interleukin by Geisinger pursuant to this
Agreement will not and does not restrict Geisinger’s right to conduct research
with, or distribute, biological material that is identical to the Samples
and/or the Clinical Content to any Third Party.


 


5.4                                Commercial
License.


 


(a)                                  Commercial
License Grant.  The Parties recognize
that Interleukin must obtain a commercial license from Geisinger if it wishes
make, use, market or sell, or conduct any commercial activities with the Product.
As of the Effective Date, Geisinger hereby grants to Interleukin an exclusive,
worldwide, royalty-free, fully-paid license, with the right to sublicense to
use Designated Biomarker Study Results in the Study Field to develop, have
developed, make, have made, market, 


 


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

















 


sell, have sold, import and export any
Product that uses or incorporates Designated Biomarker Study Results.


 


(b)                                 Option
to Commercial License for Products using Approved Restricted Biomarkers or
Outside Study Field.  If both Parties
agree to conduct research with Approved Restricted Biomarkers according to Section 2.2(b) and
Interleukin wishes to use the Samples, Clinical Content and Geisinger’s
interest in Study Technology to develop, have developed, make, have made,
market, sell, have sold, import and export any Product that uses or
incorporates Approved Restricted Biomarker Study Results then, during the Term
of this Agreement and for a period of twelve (12) months following the Termination
Date (the “Option Period”), Geisinger hereby grants to Interleukin an option
(the “Commercial License Option”) to obtain an exclusive or non-exclusive
royalty and/or fee-bearing license, to use the Samples, the Clinical Content
and Geisinger’s interest in Study Technology to conduct commercial activities
to develop, have developed, make, have made, use, import, export, market, sell,
have sold, and offer for sale Products that use or incorporate Approved
Restricted Biomarker Study Results and provide services in the Study Field (“Product
and Services Activity”), with the right to grant rights to Third Parties to
exercise some or all of the rights granted as part of the Commercial License
Option (“Sublicensing Activity”) and, together with such Products and Services
Activity (the “Commercial Activity”). 
Interleukin may exercise the Commercial License Option by providing
written notice to Geisinger at any time during the Option Period.  Thereafter, the Parties shall negotiate a
commercial license in good faith and on commercially reasonable terms within
one hundred eighty (180) days following notification by Interleukin or for such
additional time as may be mutually agreed by the Parties.  If the Parties are unable to reach an
agreement within the one hundred eighty (180) day period, the Commercial
License Option shall expire and the Parties shall have no further obligations
with respect thereto; provided, that, if Geisinger enters into negotiations
with a Third Party with respect to the Study Technology Controlled by Geisinger
in the Study Field and covered by the Commercial License Option and the terms
offered to any such Third Party are more favorable to such Third Party than the
terms last offered by Geisinger to Interleukin and rejected by Interleukin, Geisinger
will offer such more favorable terms to Interleukin, and Interleukin will have
ten (10) business days to accept or reject such offer.


 


5.5                                Reservation
of Rights.  Except for the rights
granted to Interleukin under this Agreement, all right, title and interest in
and to the Samples, the Clinical Content and any Technology owned by Geisinger
(“Geisinger IP Rights”) shall at all times remain with and be vested in
Geisinger.  Interleukin shall not use the
Geisinger IP Rights for any purpose other than as expressly granted to
Interleukin under 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.


 


11

















 


Article 6 - Compensation


 


6.1                                Overall
Payment.  In partial consideration of
the costs incurred by Geisinger in performing its obligations under the Protocol
and the grant of license to Interleukin in and to the Samples and Clinical
Content, Interleukin will pay Geisinger a fee in the aggregate amount of USD
$412,000 (the “Overall Payment”), and if selected by Interleukin and agreeable
to Geisinger, Compensation for Optional Samples.


 


6.2                                Payments.  Interleukin will pay Geisinger the Overall
Payment in three (3) installments as follows:


 


(a)                                  First
Installment.  The first installment
of the Overall Payment will be paid within three (3) business days from
the Effective Date and will consist of $150,000 (in cash payable by wire
transfer of immediately available funds to an account identified in writing by
Geisinger, unless otherwise mutually agreed by the Parties).


 


(b)                                 Second
Installment.  The second installment
of the Overall Payment will consist of $131,000 in cash and will be paid (by
wire transfer of immediately available funds to an account identified in
writing by Geisinger, unless mutually agreed by the Parties) within twenty (20)
days after the earlier of (i) the date Interleukin issues the Sample
Acceptance Notification in accordance with Section 3.2, or (ii) to
the extent there is a disagreement between the Parties as to whether any
shipment of Samples are Usable Samples, the date on which such disagreement is
resolved pursuant to Section 3.5.


 


(c)                                  Final
Installment.  The final installment
of the Overall Payment will consist of $131,000 in cash which will be paid (by
wire transfer of immediately available funds to an account identified in
writing by Geisinger, unless mutually agreed by the Parties) on the date that
is twelve months after the Effective Date.


 


(d)                                 Compensation
for Optional Samples.  If either the
[***] Sample Option or [***] Sample Option is selected at the option of
Interleukin according to terms and procedures set forth in Sections 3.3 and
3.4, Geisinger shall receive compensation for [***] Samples and/or [***]
Samples according to such terms and procedures.


 


(e)                                  Reduction
in Payments.  Notwithstanding the
foregoing, the Final Installment may be subject to reduction in accordance with
Section 3.2(d)(iv), and if so reduced, the amount of reduction shall be
determined prior to initiation of the Study.


 


Article 7 - Intellectual Property Ownership and Patent Filings


 


7.1                                Ownership
of Intellectual Property.  Geisinger
shall have sole and exclusive ownership of all right, title and interest on a
worldwide basis in and to any and all Technology owned 


 


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

















 


by Geisinger as of the Effective Date and any
Study Technology, Samples and Clinical Information conceived or reduced to
practice solely by Geisinger in connection with conduct of Study.  Except as specifically provided herein,
Geisinger shall have sole and exclusive ownership of all right, title and
interest on a worldwide basis in and to any and all Samples and Clinical
Content.  Interleukin shall have sole and
exclusive ownership of all right, title and interest on a worldwide basis to
any and all Technology owned by Interleukin as of the Effective Date and any
Study Technology conceived or reduced to practice solely by Interleukin in
connection with the conduct of the Study. 
The Parties shall have joint ownership of all right, title and interest
on a worldwide basis in and to any and all Study Technology that is conceived
or first reduced to practice jointly by the Parties, subject to the terms set
forth in Article 4 and 5.


 


7.2                                Patent
Filings on Study Technology.


 


(a)                                  Interleukin’s
Rights.  Subject to terms set forth
in Article 4, Interleukin will have the sole right and responsibility, at
its sole expense to prepare, file and prosecute all Patent Rights in the Study
Field for (i) Designated Biomarkers without claiming rights to Approved
Restricted Biomarkers that is conceived or first reduced to practice in the
conduct of the Study and (ii) any other Study Technology owned solely by
Interleukin; provided, that, Interleukin will provide Geisinger with a copy of
any such patent applications, in a timely manner for its review and comment
prior to the first filing thereof. 
Geisinger will cooperate with and provide assistance to Interleukin in
connection with such activities, including without unreasonable limitation,
execution of all documents, and performance of all acts reasonably necessary,
to prepare, file, and prosecute such patent applications, and maintain, enforce
and defend such patents.  If Interleukin
elects not to file or thereafter prosecute any Patent Rights claiming such
Designated in any country, Interleukin will promptly notify Geisinger.  In such event, Geisinger, at its expense,
will have the right, but not the obligation, to file and prosecute such
application, and/or maintain such patent, in such country, jointly in its and
Interleukin’s names.


 


(b)                                 Geisinger’s
Rights.  Subject to terms set forth
in Article 4, Geisinger will have the sole right and responsibility, at
its sole expense to prepare, file and prosecute all Patent Rights in the Study
Field for (i) Approved Restricted Biomarkers without claiming rights to
Designated Biomarkers that is conceived or first reduced to practice in the
conduct of the Study, and (ii) any other Study Technology owned solely by
Geisinger; provided, that Geisinger will provide Interleukin with a copy of any
such patent applications, in a timely manner for its review and comment prior
to the first filing thereof.  Interleukin
will cooperate with and provide assistance to Geisinger in connection with such
activities, including without unreasonable limitation, execution of all
documents, and performance of all acts reasonably necessary, to prepare, file,
and prosecute such patent applications, and maintain, enforce and defend such
patents.  If Geisinger elects not to file
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.


 


13

















 


thereafter prosecute any Patent Rights claiming
such Approved Restricted Biomarkers in any country, Geisinger will promptly
notify Interleukin.  In such event,
Interleukin, at its expense, will have the right, but not the obligation, to
file and prosecute such application, and/or maintain such patent, in such
country, jointly in its and Geisinger’s names.


 


(c)                                  Joint
Rights.  The Parties shall agree on
outside counsel to prepare, file and prosecute all Patent Rights claiming
method of use in the Study Field during the course of research under the Protocol
for Study Technology covering both (i) Designated Biomarkers and (ii) Approved
Restricted Biomarkers jointly developed by the Parties subject to terms and
provisions set forth in Articles 4 and 5.


 


Article 8 - Confidential Information and Publication


 


8.1                                Confidential
Information.  Any Confidential
Information disclosed by a Party (the “Disclosing Party”) to another Party (the
“Receiving Party”) pursuant to this Agreement shall be protected by the
Receiving Party using the same degree of care as the Receiving Party uses to
protect its own confidential information of a like nature, but no less than a
reasonable degree of care, to prevent unauthorized use or disclosure of the
Confidential Information.  The Receiving Party
shall not use any Confidential Information of the Disclosing Party, without the
written consent of the Disclosing Party, except as permitted under this
Agreement.  Notwithstanding the
foregoing, the Receiving Party may only disclose and disseminate Confidential
Information of the Disclosing Party to those of its employees or contractors
who have a bona fide need to know
for the purposes of this Agreement, provided such employees or contractors have
been advised of the confidential nature of such information and are bound by an
obligation of confidentiality substantially similar to the confidentiality
obligations in this Agreement.  The
Receiving Party’s obligations of confidentiality will continue from the date of
termination or expiration of this Agreement for a period of five (5) years
unless a longer period is otherwise agreed to by the Parties. In the event of a
breach, the breaching Party shall return all confidential information to the
other Party.  The Receiving Party will
have no obligations under this Section with respect to information which:


 


(a)                                  was
known to it prior to receipt hereunder, as demonstrated by written records; or


 


(b)                                 at
the time of disclosure was generally available to the public, or which after
disclosure becomes generally available to the public through no action or
inaction attributable to the Receiving Party; or


 


(c)                                  is
hereafter made available to the Receiving Party for use or disclosure from any
third party having a right to do so; or


 


(d)                                 is
independently developed by the Receiving Party, as demonstrated by written
records; 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.


 


14

















 


(e)                                  the
Receiving Party is required to divulge either by a court of law or in order to
comply with any federal, national, state, provincial or local law or regulation
(after providing the Disclosing Party with reasonable notice of such
requirement and with an opportunity to oppose or limit such disclosure or to
obtain a protective order).


 


8.2                                Publication.  Geisinger and Interleukin may publish
articles or make presentations concerning the Study Results; provided, that,
each Party shall provide to the other Party the opportunity to review each of
the submitting Party’s proposed abstracts, manuscripts or presentations
(including, without limitation, information to be presented verbally) that
relate to the Study Results at least ninety (90) days prior to its intended
presentation or submission for publication, and such submitting Party agrees,
upon written request from the other Party given within such ninety (90) day
period, not to submit such abstract or manuscript for publication or to make
such presentation until the other Party is given at least sixty (60) days from
the date of such written request to seek appropriate patent protection for any
material in such publication or presentation that it reasonably believes may be
patentable.  Once such abstracts,
manuscripts or presentations have been reviewed and approved by each Party, the
subject matter disclosed in such abstracts, manuscripts or presentations does
not have to be provided again to the other Party for review for a later
submission for publication.  Each Party
also shall have the right to require that any of its Confidential Information
that is disclosed in any such proposed publication or presentation be deleted
prior to such publication or presentation. 
In any permitted publication or presentation by a Party, the other Party’s
contribution shall be duly recognized, and co-authorship shall be determined in
accordance with customary standards.


 


8.3                                Publicity.  The Parties acknowledge and agree that the
terms of this Agreement constitute Confidential Information of each Party and
may only be disclosed (a) as permitted by Section 8.1 (b) for
Geisinger research communication and administration publications including a
published database of titles of grants and contracts, brief description of
research conducted under such grants and contracts, and name of company, and by
way of reference, “Geisinger Research Connections”, and (c) to investment
bankers, investors, and bona fide potential investors, lenders and potential
lenders and other sources and other potential sources of financing, acquirers
or merger partners and potential acquirers or merger partners, but only to the
extent such disclosure is accompanied with confidentiality obligations commensurate
in scope with the confidentiality obligations set forth hereunder.  A copy of this Agreement may be filed by
either Party with the Securities and Exchange Commission if such filing is
required by Applicable Laws and Standards; provided, that in connection with
any such filing, such Party shall endeavor to obtain confidential treatment of
economic and trade secret information, and shall provide the other Party with
the proposed confidential treatment request with reasonable time for such other
Party to provide comments, which comments shall be reasonably considered by the
filing Party. Interleukin, upon the execution of this Agreement, shall issue a
press release with respect to this Agreement as shown in Exhibit 3.  Either Party may make 


 


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

















 


subsequent public disclosure of the contents
of such press release without further approval of the other Party.  After issuance of such press release, except
as required by Applicable Laws and Standards, neither Party shall issue a press
or news release or make any similar public announcement related to the Study
without the prior written consent of the other Party.


 


Article 9 - Representations and Warranties


 


9.1                                Geisinger
Representations and Warranties. 
Geisinger hereby represents and warrants that:


 


(a)                                  the
Samples and Clinical Data provided pursuant to this Agreement were collected in
accordance with all Applicable Laws and Standards, including without
limitation, patient informed consent procedures and protection of human
subjects in effect at the time of collection;


 


(b)                                 it
has access to Samples and Clinical Data, and all necessary right and authority
to transfer the Samples and Clinical Data to Interleukin under the terms of
this Agreement and to grant Interleukin the rights and licenses with respect to
the Samples and Clinical Data as described in this Agreement;


 


(c)                                  it
will not disclose or transfer to Interleukin any Protected Health Information
as defined in 45 C.F.R. 164.501; and


 


(d)                                 it
has taken the appropriate legal and/or contractual steps to ensure that the
employees and/or contractors comply fully with the terms of this Agreement.


 


9.2                                Disclaimer. 
Except for the representations and warranties under Section 9.1,
the Samples are provided “AS IS” and Geisinger hereby disclaims any other
representations or warranties with respect hereto, including warranties of
merchantability or fitness for a particular purpose or any other warranty,
express or implied.  Geisinger makes no
representation or warranty that the use of the Samples will not infringe any
patent or other proprietary right. 
Geisinger makes no representation and extends no warranty that the use
of all or any part of the Samples or Clinical Content will result in successful
Study Results or lead to the development of a commercial product.  UPON INTERLEUKIN’S ACCEPTANCE OF THE SAMPLES,
INTERLEUKIN SHALL BEAR ALL RISK RELATING TO THE USE AND HANDLING OF THE
SAMPLES.  GEISINGER SHALL NOT BE LIABLE
UNDER ANY CONTRACT, NEGLIGENCE, STRICT LIABLITY OR OTHER THEORY FOR ANY DAMAGES
INCLUDING DIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES OR COST OF PROCUREMENT
OF SUBSTITUTE GOODS, SERVICES OR TECHNOLOGY.


 


9.3                                Interleukin
Representations and Warranties. 
Interleukin hereby represents and warrants that:


 


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

















 


(a)                                  It
is duly organized and validly existing under the laws of its jurisdiction of
incorporation, and has the full corporate power and authority to enter into
this Agreement and to carry out the provisions hereof and thereof.


 


(b)                                 It
is duly authorized to execute and deliver this Agreement and to perform its
obligations hereunder and thereunder, and the person executing this Agreement
on its behalf has been duly authorized to do so by all requisite corporate
action.


 


(c)                                  This
Agreement is legally binding upon it and upon its successors, heirs and
permitted assigns, and is enforceable in accordance with its terms.


 


(d)                                 The
execution, delivery and performance of this Agreement and the obligations
hereunder and thereunder by it does not conflict with any agreement, instrument
or understanding, oral or written, now existing or to be entered into during
the term of this Agreement, to which it is a party or by which it is a party or
by which it may be bound, nor violate any material law or regulation of any
court, governmental body or administrative or other agency having jurisdiction
over it.


 


(e)                                  It
will not attempt to utilize the Samples and/or Clinical Data provided by
Geisinger, alone or in combination with any other information or materials, in
any manner which would seek to personally identify the individuals providing
such Samples and/or Clinical Data to Geisinger.


 


Article 10 - Term and Termination


 


10.1                          Period
of Performance.  This Agreement is
effective as of the Effective Date and shall terminate on the Termination Date,
unless terminated earlier in accordance with Section 10.2 and may be
extended or modified only by written agreement signed by both Parties.


 


10.2                          Termination.  This Agreement shall terminate upon the
earliest to occur of:


 


(a)                                  the
natural expiration of the Term;


 


(b)                                 the
mutual written agreement of the Parties;


 


(c)                                  either
Party becoming the subject of any voluntary or involuntary bankruptcy or other
insolvency, liquidation or other similar proceeding, or making any composition
or arrangement for the benefit of its creditors, or having a receiver,
administrative receiver, liquidator or administrator appointed over all or any
part of its assets or business;


 


(d)                                 In
the event of a breach of this Agreement, which remains uncured by the
non-breaching Party for a period of thirty (30) days from receipt of notice to
effect a cure of the breach; 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.


 


17
















 


(e)           In
the event of termination as described in Section 3.2(d)(iv).


 


10.3         Effect of Termination;
Rights and Obligations.  In the event
that this Agreement expires or is terminated by either Party pursuant to Section 10.2,
all further rights and obligations of the Parties under this Agreement,
including without limitation the licenses granted by Geisinger to Interleukin
pursuant to Article 4, shall terminate, without any further action
required by either Party, effective as of such termination date.  Notwithstanding the foregoing, the expiration
or termination of this Agreement by either Party will not affect the rights and
obligations of the Parties accrued prior to the date of such expiration or
earlier termination shall survive. 
Specifically, Articles 2, 4, 7, 8, 11 and 12 and Sections 3.6, 5.3, 5.4
and 10.3 and all other rights and obligations under this Agreement which by
their nature should survive will survive expiration or termination of this
Agreement.  License rights described in
Sections 5.1, 5.2 and 5.5, granted to Interleukin to enable conduct of the
Study, shall expire upon Termination.


 


Article 11
- General Provisions


 


11.1         Nature of Relationship.  The Parties will perform all the work under
this Agreement as independent contractors. 
The Parties are not agents, employees, partners, representatives or
joint venturers.  Nothing in this
Agreement will be construed to give either Party the power or authority to act
or make representations for, or on behalf of, or to bind or commit the other
Party.


 


11.2         Publicity.  Except as permitted under 8.3 above, neither
Party will use the name of the other in connection with any products,
promotion, or advertising without the prior permission of the other Party in
writing.


 


11.3         Governing Law.  This Agreement will be construed in
accordance with, and all the rights, powers and liabilities of the Parties
hereunder will be governed by the laws of the State of Delaware without
reference to its conflict of law rules.


 


11.4         Entire Agreement.  This Agreement sets forth the entire
agreement and understanding of the Parties relating to the subject matter
hereof and thereof and supersedes and merges all prior discussions and
agreements between them prior to the Effective Date.


 


11.5         Modifications and
Amendments.  No modification or
amendment to this Agreement nor any waiver of any rights or obligations under
this Agreement will be effective unless in writing and signed by
representatives of Geisinger and Interleukin.


 


11.6         Assignment.  Neither Geisinger nor Interleukin may assign
any rights or delegate any duties under this Agreement without the other Party’s
prior written consent, not to be unreasonably withheld, and any attempt to
assign or delegate such rights or duties without that consent will be void;
provided, however, that Geisinger may, without such consent, assign any rights
and obligations hereunder to any Affiliate or in connection with the transfer
or sale of all or substantially all of its business relating to the subject 


 


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

















 


matter hereunder, or in the event of its merger or consolidation or
change in control or similar transaction. 
Any permitted assignee will assume all obligations of its assignor under
the corresponding assignment.


 


11.7         Insurance.  Interleukin shall maintain liability
insurance, or a well-maintained program of self insurance (with adequate,
reasonable reserves), with respect to the work it is performing under the
Protocol in such amounts as it customarily maintains with respect to similar
research programs and will provide evidence of such insurance to the other
Party upon request.


 


11.8         Notices.  Any notices given this Agreement will be in
writing and delivered personally, by first-class mail or nationally recognized
overnight courier service, postage prepaid, or by facsimile addressed to the
Parties as follows:


 


	
  To Interleukin:

  	
  Interleukin Genetics, Inc.

  
	
   

  	
  135 Beaver Street

  
	
   

  	
  Waltham, MA 02452

  
	
   

  	
  Attention: Partha Paul

  
	
   

  	
  Facsimile: 781-394-0720

  
	
   

  	
   

  
	
  With a Copy to:

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

  
	
   

  	
  One Financial Center

  
	
   

  	
  Boston, MA 02111

  
	
   

  	
  Attention: John J. Cheney, Esq.

  
	
   

  	
  Facsimile: 617-542-2241

  
	
   

  	
   

  
	
  To Geisinger:

  	
  Dave Felicio, Esquire

  
	
   

  	
  Chief Legal Officer

  
	
   

  	
  Geisinger System Services

  
	
   

  	
  100 North Academy Avenue

  
	
   

  	
  Danville, PA 17822

  
	
   

  	
   

  
	
  With facsimile copies to:

  
	
   

  	
  David Carey, PhD

  
	
   

  	
  Weis Center for Research

  
	
   

  	
  100 North Academy Avenue

  
	
   

  	
  Mail Code 26-00

  
	
   

  	
  Danville, PA 17822

  
	
   

  	
  Facsimile: 570-271-5886

  



 


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

















 


	
   

  	
  Bryan Allinson

  
	
   

  	
  Geisinger Ventures

  
	
   

  	
  100 North Academy Avenue

  
	
   

  	
  Mail Code 30-55

  
	
   

  	
  Danville, PA  17822

  
	
   

  	
  Facsimile: 570-214-5066

  



 


Any notice or other communication or deliveries hereunder shall be
deemed given and effective on the earliest of (a) the date of
transmission, if such notice or communication is delivered via facsimile at the
facsimile telephone number specified in this Section prior to 4:30 p.m.
(Eastern Standard time), (b) the date after the date of transmission, if
such notice or communication is delivered via facsimile at the facsimile
telephone number specified in this Section later than 4:30 p.m.
(Eastern Standard time) on any date and earlier than 11:59 p.m. (Eastern
Standard time) on such date, (c) three (3) Business Days after
deposit in the United States mail, (d) the Business Day following the date
of mailing, if sent by nationally recognized overnight courier service, or (e) upon
actual receipt by the party to whom such notice is required to be given.


 


11.9         Counterparts.  This Agreement may be executed in one or more
counterparts, each of which shall constitute an original and all of which
together shall constitute one and the same instrument.


 


Article 12
- Indemnification


 


12.1         Indemnification by
Geisinger.  Geisinger will indemnify
and hold harmless Interleukin, its Affiliates and their respective directors,
officers, employees and agents (“Interleukin Indemnitees”) from and against all
losses, liabilities, damages and expenses, including reasonable attorneys’ fees
and costs (collectively, “Liabilities”), arising out of (a) the breach of
any representation, warranty or covenant by Geisinger under this Agreement; (b) the
use by Geisinger of any Interleukin Confidential Information not permitted
hereunder; or (c) the gross negligence or willful misconduct of Geisinger.
The obligation to indemnify pursuant to this Section 12.1 will continue so
long as a cause of action giving rise to the right of indemnification may be
brought by the Interleukin Indemnitees.


 


12.2         Indemnification by
Interleukin.  Interleukin will
indemnify and hold harmless Geisinger, its Affiliates and their respective
directors, officers, employees and agents (“Geisinger Indemnitees”) from and
against all Liabilities, arising out of (a) the breach of any
representation, warranty or covenant by Interleukin under this Agreement; (b) the
use by Interleukin of any Geisinger Confidential Information not permitted
hereunder; or (c) the gross negligence or willful misconduct of
Interleukin.  The obligation to indemnify
pursuant to this Section 12.2 will continue so long as a cause of action
giving rise to the right of indemnification may be brought by the Geisinger
Indemnitees.


 


12.3         Procedure for Third
Party Claims.  If an Indemnitee (for
purposes of this Section 12.3, the term “Indemnitee” may refer to either
or both the Interleukin Indemnitees and the Geisinger Indemnitees, as the
context may indicate) intends to claim indemnification 


 


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

















 


under this Section 12.3 for claims,
demands, actions or other proceedings by a third party, it will promptly notify
the other Party (the “Indemnitor”) in writing of any claim, demand, action or
other proceeding for which the Indemnitee intends to claim such
indemnification, and the Indemnitor may participate in, and, to the extent the
Indemnitor so desires, assume the defense of such claim, demand, action or
proceeding with counsel mutually satisfactory to the Parties; provided,
however, that an Indemnitee will have the right to retain its own counsel, with
the fees and expenses to be paid by the Indemnitor, if representation of such
Indemnitee by the counsel retained by the Indemnitor would be inappropriate due
to actual or potential differing interests between the Indemnitee and any other
Party represented by such counsel in such proceeding.  The obligations of this Section 12.3
will not apply to amounts paid in settlement of any claim, demand, action or
other proceeding if such settlement is effected without the consent of the
Indemnitor, which consent will not be unreasonably withheld or delayed.  The failure to deliver written notice to the
Indemnitor within a reasonable time after the commencement of any such action,
if prejudicial to its ability to defend such action, will relieve the
Indemnitor of any obligation to the Indemnitee under this Section 12.3.  The Indemnitee will reasonably cooperate with
the Indemnitor and its legal representatives in the investigation of any claim,
demand, action or other proceeding covered by this Section 12.3.


 


[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.


 


21

















 


IN WITNESS WHEREOF, the Parties have executed this Agreement through
their respective duly authorized officers or agents on the dates first set
forth above.


 


	
  INTERLEUKIN GENETICS, INC.

  	
   

  	
  GEISINGER CLINIC

  
	
   

  	
   

  	
   

  
	
  By:

  	
   /s/ Lewis H. Bender

  	
   

  	
  By:

  	
   /s/ David J. Carey

  
	
   

  	
  Name: Lewis H. Bender

  	
   

  	
   

  	
  Name: David J. Carey

  
	
   

  	
  Title:   Chief Executive
  Officer

  	
   

  	
   

  	
  Title: Assoc. Chief Research Officer

  



 


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.


 

















 


Exhibit 1


 


Protocol


 


Clinical Content:  (See Protocol)


 


SNP Biomarkers:  (See protocol)


 


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.


 
















 


INTERLEUKIN


GENETICS


 


Interleukin Genetics, Inc.


Protocol ILI-08-107 PLIN


 


Clinical Protocol Title:


 


Association of Genetic Variants in Obesity
Genes to Resistance to Weight Loss and Susceptibility to Metabolic Syndrome in
Morbidly Obese Patients


 


A single center, blinded, retrospective
clinical study


 


June 28, 2008


 


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.


 

















 


INTERLEUKIN GENETICS


 


TABLE OF CONTENTS


 


	
  1.

  	
  PROTOCOL SYNOPSIS

  	
  3

  
	
  2.

  	
  INTRODUCTION

  	
  5

  
	
  3.

  	
  STUDY OBJECTIVES

  	
  5

  
	
  3.1

  	
  Primary Outcome Variables

  	
  5

  
	
  3.2

  	
  Secondary Outcome Variables

  	
  5

  
	
  4.

  	
  STUDY ENDPOINT’S

  	
  6

  
	
  4.1

  	
  Primary Endpoint

  	
  6

  
	
  4.2

  	
  Secondary Endpoints

  	
  6

  
	
  5.

  	
  STUDY DESIGN

  	
  7

  
	
  5.1

  	
  Overall Design

  	
  7

  
	
  5.2

  	
  Duration of the Study

  	
  7

  
	
  5.3

  	
  Inclusion Criteria

  	
  7

  
	
  5.4

  	
  Exclusion Criteria

  	
  8

  
	
  6.

  	
  STUDY PROCEDURES

  	
  8

  
	
  6.1

  	
  Study Personnel

  	
  8

  
	
  6.1.1

  	
  Principal Investigator (P1)

  	
  8

  
	
  6.1.2

  	
  Study Examiner

  	
  8

  
	
  6.2

  	
  Study Schedule and Assessments

  	
  8

  
	
  6.2.1

  	
  Demographics, Clinical and
  Laboratory Assessments

  	
  8

  
	
  6.2.2

  	
  Genotyping Method

  	
  10

  
	
  6.3

  	
  STATISTICS

  	
  10

  
	
  7.

  	
  SAMPLE ACCOUNTABILITY AND MANAGEMENT

  	
  11

  
	
  8.

  	
  STUDY MONITORING AND OVERSIGHT

  	
  11

  
	
  9.

  	
  ANALYTICAL PLAN

  	
  11

  
	
  9.1

  	
  Sample Size Calculation

  	
  11

  
	
  9.2

  	
  Statistical Analyses

  	
  11

  
	
  9.2.1

  	
  Outcome Analyses

  	
  11

  
	
  10.

  	
  ETHICAL AND REGULATORY CONSIDERATIONS

  	
  12

  
	
  10.1

  	
  Risk/Benefit Assessment

  	
  12

  
	
  10.2

  	
  Institutional Review Board

  	
  12

  
	
  10.3

  	
  Informed Consent

  	
  12

  
	
  10.4

  	
  Subject Confidentiality

  	
  12

  
	
  10.5

  	
  Withdrawal of Subjects from the
  Study

  	
  12

  
	
  10.6

  	
  General Administration

  	
  12

  
	
  10.7

  	
  Protocol Deviations

  	
  13

  
	
  10.8

  	
  Case Report Forms

  	
  13

  
	
  10.9

  	
  Record Retention

  	
  13

  
	
  10.10

  	
  Termination of Study

  	
  13

  
	
  11.

  	
  REFERENCES

  	
  13

  
	
  12.

  	
  APPENDIX A: ABBREVIATIONS

  	
  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.


 


i

















 


	
  13.

  	
  APPENDIX B: STUDY ASSESSMENTS

  	
  14

  



 


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.


 


ii

















 


INTERLEUKIN GENETICS


 


	
  CONTACT INFORMATION

  
	
   

  
	
  Sponsor

  	
  Interleukin Genetics, Inc.

  
	
   

  	
  135 Beaver Street

  
	
   

  	
  Waltham, Massachusetts 02452, USA

  
	
   

  	
   

  
	
  Sponsor Contacts

  	
  Nazneen Aziz, PhD

  
	
   

  	
  Vice-President, Research and Development

  
	
   

  	
  Tel: 781-419-4728

  
	
   

  	
  FAX: 781-398-0720

  
	
   

  	
  E-mail: Naziz@ilgeneties.com

  
	
   

  	
   

  
	
   

  	
  Karen Shaver, MS

  
	
   

  	
  Director of Clinical Operations

  
	
   

  	
  Tel: 781-419-4722

  
	
   

  	
  FAX: 781-398-0720

  
	
   

  	
  E-mail: kshaver@ilgenetics.com

  
	
   

  	
   

  
	
  Principal Investigator

  	
  Christopher Still, MD

  
	
   

  	
   

  
	
  Co-Principal Investigator

  	
  Glenn S. Gerhard, MD

  
	
   

  	
  Weis Center for Research / Geisinger Clinic

  
	
   

  	
  Tel: 570-271-8669

  
	
   

  	
  E-mail: gsgerhard@geisinger.edu

  
	
   

  	
   

  
	
  Location of Study Site(s)

  	
  Geisinger Clinic

  
	
   

  	
  Weis Center for Research

  
	
   

  	
  100 North Academy Avenue

  
	
   

  	
  Danville, PA 17822

  



 


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

















 


SIGNATURE PAGE


 


I will not initiate this study without approval of the appropriate
Institutional Review Board and I understand that any changes in the protocol
must be approved in writing by the Sponsor and the Institutional Review Board
before they can be implemented, except where necessary to eliminate immediate
hazards to the subjects.


 


By my signature below, I attest that I have read, understood, and agree
to abide by all conditions, instructions and restrictions contained in this
protocol.


 


 


	
  /s/ Christopher Still, MD

  	
   

  	
  /s/ Glenn S. Gerhard, MD

  
	
  Christopher Still, MD

  	
   

  	
  Glenn S. Gerhard, MD

  
	
  Principal Investigator

  	
   

  	
  Co-Principal Investigator

  
	
   

  	
   

  	
   

  
	
  Title: Director, Obesity Institute

  	
   

  	
  Title: Staff Scientist

  
	
   

  	
   

  	
   

  
	
  Date: 9/16/08

  	
   

  	
  Date: 9/16/08

  



 


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

















 


1.                                       PROTOCOL
SYNOPSIS


 


Objectives:


 


The long-term goal of this collaboration between Interleukin Genetics
and the Geisinger Clinic is to [***] in the [***] and [***] would be a [***]
are [***] to [***].  These [***] would
[***] a [***] that will [***] to [***] for [***] and [***] and [***] of
[***].  This information can be used to
[***] of [***] with [***] for [***] which would [***], or other [***] that are
[***] the [***], particularly [***] and [***].


 


The [***] to be [***] is that [***] in the [***] and [***] are [***]
with [***] to [***] for [***] on [***], potentially [***] in the [***].  The [***] from the [***] Geisinger’s Center
for Nutrition and Weight Management [***] for a [***] to [***].  The [***] and the [***] obtained for this
[***] the [***] of the [***], [1] which initially [***] as potentially [***].  However, the [***] in this [***] was
[***].  The [***] of [***] here is [***]
with a [***] of [***] and [***] to [***] from the [***].


 


Primary Goal:


 


·                  The primary goal
of this study is to [***], both [***] and [***], with [***] to [***] in a
[***].


 


In this study, [***] will be [***] based on [***] on [***] to [***],
and if [***] to [***] on a [***].


 


The [***] will be [***] as the [***] and the [***] that [***] will be
[***] as the [***].  [***] will be [***]:


 


(1)                                  [***]:
[***] on the [***] of [***] from [***] and


 


(2)                                  [***]:
[***] to [***] with the [***] for the [***] when [***].


 


[***]


 


Secondary Goal:


 


·                                          The secondary
goals of this study are:


 


·                  To [***] if
[***] [***] that have [***] been [***] or [***] show [***] with [***] to [***]
in [***] on an [***], either [***] or [***].


 


·                  To [***] if
[***], such as [***] or [***], are [***] or [***] in the [***].


 


Number of Subjects


 


Approximately [***] and [***] to [***] to [***].


 


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

















 


Study Population


 


Consists of [***] the [***] and [***], who [***] for [***] the
Geisinger Clinic.


 


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
















 


[***]:


 


A [***] is [***] after the [***] of the [***] are [***].  If [***] are [***] to [***], then [***] will
be [***] in [***] and [***] in a [***].


 


2.                                       INTRODUCTION


 


Background


 


Several [***]
for the [***] and [***] have been [***] including [***] and [***] [2].  In particular, [***] are the [***] which
[***] in [***].  [***] and [***] of these
[***] to [***] or [***].  The [***] to
[***] to [***], which may [***] or [***] and [***] and [***].  [***] at [***] are [***] to [***] for [***].


 


[***], the [***]
[3], has been [***] in [***].  [***]
without the [***] [4] have [***] and an [***] and [***] of [***].  There was also [***] to [***] by a [***] with
[***].  In [***] in [***] was [***]
[5].  A [***] was also [***] with [***]
in [***] to a [***] and a [***] when [***] [6]. 
These data suggest that [***] in the [***] and [***].


 


Methodology Rationale


 


[***] (1) have
previously [***] are [***] and a [***] to [***], however the [***] of [***] was
[***] and the [***] for the [***].  The
[***] of the [***] for the [***], and [***] will be [***] for the [***].  These [***] were [***] in an [***] to
[***].  The [***] also [***] are able to
[***], from those [***] are [***].  The
[***] of [***] to [***].


 


Data
Process Management Overview


 


The [***] to
be [***] will [***] the [***].  The [***]
will be [***] from the [***] on [***]. 
The [***] from [***] will be [***] with a [***] to any [***] will be
[***], in [***] on [***] in the [***] and/or the [***].  A [***] the [***] and [***] will be [***] to
the [***] in this [***].


 


[***] on [***]
will [***] be [***] into a [***] with the [***] with the [***].  The [***] and [***] will then be [***] for
[***].


 


3.                                       STUDY OBJECTIVES


 


3.1                                 Primary Outcome Variables


 


The primary
goal of this study is to [***] the [***], both [***] and [***], with [***] are
[***] in a [***].


 


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

















 


3.2                                 Secondary Outcome Variables


 


Secondary:


 


·                  The secondary
goals of this study are:


 


·                  To [***], or
[***] with [***] to [***] in [***] on an [***], either [***] or [***].


 


·                  To [***] such as
[***] or [***], or [***] or [***] are [***] with [***] or [***], or [***].


 


4.                                       STUDY ENDPOINT’S


 


4.1                                 Primary Endpoint


 


[***] from [***] will be [***] for the [***][***]:


 


	
   

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  



 


4.2                                 Secondary Endpoints


 


[***] from [***] will be [***] 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.


 


6

















 


	
   

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  



 


5.                                       STUDY DESIGN


 


5.1                                 Overall Design


 


[***] will be [***] for [***].


 


A [***] and [***] will be [***] with [***].  [***] will also have been [***].


 


The [***] will be [***] to [***]. 
[***] has the [***] and [***] to [***]. 
[***] will also be [***] to [***]. 
[***] will be [***] by both [***] and [***], and the [***].


 


5.2                                 Duration of the Study.


 


The [***] is [***] to be [***]r. 
Any [***] will be [***] to [***] at that time.


 


5.3                                 Inclusion Criteria


 


[***] will be [***] from the [***] from [***] upon the [***]:


 


[***]


 


[***] in [***]


 


[***] who are [***] for [***]:


 


·                  [***]


 


·                  [***]


 


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

















 


·                  [***] with [***]
such as [***], or [***].


 


·                  [***] with [***]


 


5.4                                 Exclusion Criteria


 


[***] not [***] in [***]


 


[***] do not [***] for [***] on [***]


 


[***] with [***]


 


[***] not [***] to be [***] with [***]


 


[***] than [***]


 


[***] than [***]


 


[***] do not [***] for [***] on [***] for [***].


 


[***] are [***].


 


[***]


 


[***]


 


6.                                       STUDY PROCEDURES


 


6.1                                 Study Personnel


 


6.1.1                        [***]


 


The [***] will be [***] for the [***] of this [***].


 


6.1.2                        [***]


 


The [***]s at [***]  will [***]
as this [***]


 


6.2                                 Study Schedule and Assessments


 


6.2.1                        Demographics, Clinical and Laboratory Assessments


 


[***]


 


	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  



 


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

















 


	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  



 


6.2.1.1     Clinical
and Biochemical markers


 


	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  



 


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

















 


	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  



 


6.2.2                        Genotyping Method


 


Genotyping will be accomplished by [***] specifically [***] the [***]
for each [***].  All [***] from an [***]
will be [***] with [***] and [***], and then [***] with [***].  A [***] will then be [***], the [***], and a
[***].


 


The [***] a [***] to the [***] of the [***].  [***] subsequently [***] the [***] after
[***] within the [***].  The [***] will
be [***] by the [***] and [***] as [***]; each [***] a [***].  [***] of [***] will [***] a [***], while
[***] of [***] will [***] a [***].


 


[***] will be [***] a [***] that is [***] as a [***].  A [***] and a [***] are also [***] with [***]
of [***] as a [***] of [***].


 


Laboratory Accreditation


 


The diagnostic laboratory at Interleukin Genetics has been certified
under the Clinical Laboratory Improvement Amendments (CLIA) by the Centers for
Medicare and Medicade Services (CMS), a division of the United States
Department of Health and Human Services.


 


6.3                                 STATISTICS


 


[***]


 


[***]


 


[***] in the [***] of [***] were from the [***], which [***] in the
[***] and [***] in the [***].  The [***]
in this [***] was [***] between [***]. 
For our [***], we used [***], and [***] for [***] a [***] in the [***].  [***], [***] of those [***] in the
[***].  The [***] on [***] and [***], is the
[***] to have [***] to [***].  However,
to [***] with [***], up to [***].  Since 


 


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

















 


[***] will be [***], there is a [***] of [***].  However, [***] of [***] for this [***], the
[***] will be [***] for [***] of [***]. 
If [***] than [***], then the [***], may be [***].


 


7.                                       SAMPLE ACCOUNTABILITY AND MANAGEMENT


 


[***] and [***]


 


[***] in a [***] at [***] will be [***] and [***] for [***] to
[***].  At [***], a [***] will be
[***].  For [***], an [***] into the [***]
shall be [***] to [***] and [***].  [***]
is [***] on the [***], and then all [***] are [***].


 


8.                                       STUDY MONITORING AND OVERSIGHT


 


[***] from [***]:


 


[***] of a
[***] of [***] for the [***]


 


[***]s of [***] in the [***].


 


[***] of [***].


 


[***] for all [***] in the [***].


 


[***] or [***] to [***] are [***] this is a [***].


 


9.                                       ANALYTICAL PLAN


 


9.1                                 Sample Size Calculation


 


For this [***] is [***] by the [***] of [***], which is [***] in [***]
with a [***] and [***], which are [***] and [***], which [***] to [***].


 


9.2                                 Statistical Analyses


 


9.2.1                        Outcome Analyses


 


Data Analysis for Primary Objectives


 


The primary aim of the study will be [***] whether [***] at [***] of
the [***] and [***].  Thus, a [***] will
be [***] if the [***] not [***] the [***]. 
For each [***], the [***] of the [***] will also be [***] and [***] to
the [***].  A [***] will be [***] if the
[***] of the [***] is at [***] and [***] if the [***] of the [***] the [***].  In the [***] will also be [***].  (The [***]).


 


The [***] will further be [***] by [***] of [***] of the [***].  This will [***] and [***] 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.


 


11

















 


Data Analysis for Secondary Objectives


 


The same [***] will be [***] the [***] to [***] in the [***].  [***] these [***] will be [***] to a [***].


 


In addition to the [***] to the [***] of [***] or [***] will be [***]
to [***] if [***] an [***] or [***] with any of the [***] in the [***] in [***]
of the [***].


 


10.                                 ETHICAL AND REGULATORY CONSIDERATIONS


 


10.1                           Risk/Benefit Assessment


 


The [***] in this [***] are [***].


 


10.2                           Institutional Review Board


 


Ethical Review and Communications


 


This is a [***], however, [***] at the [***] will [***] of the [***]
and [***] have been [***] from the [***] or its [***] to [***].  Any [***] to the [***] in [***] by the [***]
and [***] and [***] to [***].  [***] of
the [***] will be [***] to [***] for [***] before [***] of the [***] will be
[***].


 


10.3                           Informed Consent


 


[***] will have [***] a [***] that [***] to [***] of [***] and the
[***].  A [***] of the [***] will be
[***] to [***] to [***] of the [***]. 
[***] will have also been [***] will be [***], and that [***] in the
[***] will not [***] or [***].


 


[***] and the [***] the [***] and [***] are [***] and [***] by a [***]
to [***]. The [***] of all [***] and of [***] the [***], which are [***] the
[***] of the [***] or the [***] of the [***].


 


[***] must be [***] of the [***]. 
The [***] will [***] the [***] on [***] in a [***].


 


10.4                           Subject Confidentiality


 


[***] will be [***] that [***] will have [***] and [***] of the [***].


 


The [***] are [***] that [***] will be [***].


 


10.5                           Withdrawal of Subjects from the Study


 


[***] may be [***] at [***].  In
the [***] a [***] is [***] from [***], the [***] the [***] will be [***].


 


10.6                           General Administration


 


[***] to the [***] will be [***] to the [***] the [***].  If the [***] a [***] to the [***], it will be
[***] to 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
















 


10.7                           Protocol Deviations


 


[***] from
[***] will be [***] and the [***].


 


10.8                           Case Report Forms


 


[***] by the [***] in the [***] will be [***].


 


10.9                           Record Retention


 


[***] will [***] in a [***] for [***] the [***] of an [***] or [***].


 


10.10                     Termination
of Study


 


[***] the [***] the [***] with [***] to the [***].  In [***] the [***] will [***] is [***] to the
[***] of the [***].


 


11.                                 REFERENCES


 


1.                                       [***] [***].


 


2.                                       [***].


 


3.                                       [***].


 


4.                                       [***].


 


5.                                       [***].


 


6.                                       [***].


 


12.                                 APPENDIX A: ABBREVIATIONS


 


	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
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  [***]

  	
   

  	
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  [***]

  	
   

  	
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  [***]

  	
   

  	
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  [***]

  	
   

  	
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  [***]

  	
   

  	
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  [***]

  	
   

  	
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  [***]

  	
   

  	
  [***]

  



 


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

















 


	
  [***]

  	
   

  	
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  [***]

  	
   

  	
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  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  



 


13.                                 APPENDIX B: STUDY ASSESSMENTS


 


Demographics and Family History


 


	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
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  [***]

  	
   

  	
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  [***]

  	
   

  	
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  [***]

  	
   

  	
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  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  



 


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

















 


Clinical Endpoints and Biochemical markers


 


	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  



 


Genotyping


 


[***] will be [***] for 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.


 


15

















 


	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  



 


	
  [***]

  	
   

  
	
  [***]

  	
   

  	
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  [***]

  	
   

  	
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  [***]

  	
   

  	
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  [***]

  	
   

  	
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  [***]

  	
   

  	
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  [***]

  	
   

  	
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  [***]

  	
   

  	
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  [***]

  	
   

  	
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  [***]

  	
   

  	
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  [***]

  	
   

  	
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  [***]

  	
   

  	
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  [***]

  	
   

  	
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  [***]

  	
   

  	
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  [***]

  	
   

  	
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  [***]

  	
   

  	
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  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  



 


Exhibit 2


 


Certificate of Analysis


 


[***] Samples


 


	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  



 


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

















 


	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
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  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  



 


[***] Tissue


 


	
  [***]

  	
   

  	
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  [***] 

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  



 






* [***] is a [***] with a [***].


 


	
  [***]

  	
   

  	
  [***]

  	
   

  	
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  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  



 


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

















 


	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
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  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***] 

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  



 






* [***] is a [***] with a [***].


 


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

















 


Exhibit 3


 


Draft Press Release


 


Interleukin Genetics and Geisinger to collaborate genetic tests to
predict weight loss success


 


WALTHAM, MA and DANVILLE, PA - September 2008.  Interleukin (AMEX:ILI) and Geisinger Health
System today announced a research collaboration to explore the role of genetics
in obesity.  The goal of the
collaboration is to develop a series of genetic tests that will help physicians
better understand an individual’s inherited resistance to weight loss and, more
specifically, gauge a patient’s success with diet and other weight loss
techniques.


 


Geisinger and Interleukin will engage in a case-control retrospective
study involving the analysis of DNA to better understand its genetic link to
obesity.  The study will focus
exclusively on variations of perilipin, interleukin 1 and a select number of
other genes.  “We are pleased to be
working with Geisinger to develop an accurate and affordable genetic test as a
determinant for weight loss success,” commented Interleukin’s Chief Executive
Officer, Lewis H. Bender.  “This
relationship allows our scientists to build on Geisinger’s extensive clinical
expertise and biobank.”


 


“We are excited to be working with Interleukin Genetics and view our
collaboration with them as a way to capitalize on our integrated health system
and electronic infrastructure to conduct research in new ways,” said Geisinger’s
Associate Chief Research Officer David Carey, PhD.


 


About Interleukin Genetics


 


Interleukin Genetics, Inc. (AMEX:ILI) is a genetics-focused
personalized health company that develops preventive consumer products and
genetic tests for sale to the emerging personalized health market.  Focused on the future of health and medicine,
Interleukin uses its leading genetics research and scientific capabilities to
develop and test innovative preventive and therapeutic products.  Interleukin is headquartered in Waltham,
MA.  For more information about
Interleukin, its products and ongoing programs, please visit www.ilgenetics.com.


 


About Geisinger Health System


 


Founded in 1915, Geisinger Health System (Danville, PA) is one of the
nation’s largest integrated health services organizations.  Serving more than two million residents
throughout central and northeastern Pennsylvania, the physician-led
organization is at the forefront of the country’s rapidly emerging electronic
health records movement.  Geisinger is
comprised of three medical center campuses, a 700-member group practice, a
not-for-profit health insurance company and the Center for Health
Research-dedicated to creating innovative new models for patient care,
satisfaction and clinical outcomes.  For
more information, visit www.geisingenorg


 


About Obesity & Weight Management


 


Obesity has been defined by the National Institutes of Health (the NIH)
as a BMI of 30 and above.  (A BMI of 30
is about 30 pounds overweight.) Obesity is often multi-factorial, based on both
genetic and behavioral factors. 
Accordingly, treatment of obesity usually requires more than just
dietary changes.  Exercise, counseling
and support, and sometimes medication can 


 


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

















 


supplement diet to help patients conquer weight problems.  Being Overweight is a significant contributor
to health problems.  It increases the
risk of developing a number of diseases. 
Because obesity is associated with increased risk for a range of chronic
conditions, health care costs are higher for obese than for normal weight
individuals.  Annual medical expenditures
are $732 higher on average for obese individuals than for normal weight
individuals.  The annual cost of managing
obesity in the United States alone amounts to approximately $100 billion of
which approximately $52 billion are direct costs of healthcare.  These costs amount to approximately 5.7% of
all US health expenditure.  The cost of
lost productivity due to obesity is approximately $3.9 billion, and another $33
billion is spent annually on weight-loss products and services.


 


Certain statements contained herein are forward-looking” statements
including statements regarding our ability to develop diagnostic, personalized
nutritional and therapeutic products to prevent or treat diseases of
inflammation and other genetic variations, our ability to screen nutritional
compounds for their effects on inflammatory responses and other genetic
variations, given specific genetic patterns and our ability to make progress in
advancing our core technologies.  Because
such statements include risks and uncertainties, actual results may differ
materially from those expressed or implied by such forward-looking statements.  Factors that could cause actual results to
differ materially from those expressed or implied by such forward-looking
statements include, but are not limited to, the risk of market acceptance of
our products, the risk of technology and product obsolescence, delays in
product development, the performance of our commercial partners, the
availability of adequate capital, the actions of our competitors and other
competitive risks, and those risks and uncertainties described in our annual
reports on Form 10-K, our quarterly reports on Form 10-Q and other
documents we file with, or furnish to, the Securities and Exchange
Commission.  We disclaim any obligation
or intention to update these forward-looking statements.


 


# # #


Contacts:


Media (LI):


Catherine Cloft


LaVoie Group


978-745-4200 x107


ccloft@lavoiegroup.com


 


Investor Relations (ILI):


Melanie Friedman


Stern Investor Relations


212-362-1200


Melanie@sternir.com


 


Media (Geisinger)


Patti Urosevich


Geisinger Health System


570-271-6435


purosevich@geisinger.edu


 


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.


 


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