Exhibit No. 10.4

 

Confidential Materials omitted and filed separately with the
Securities and Exchange Commission.  Asterisks denote omissions.

 

GENOTYPING SERVICES AGREEMENT

 

This GENOTYPING SERVICES AGREEMENT (the “Agreement”) is made as of the 11 day of
March 2003 (the “Effective Date”), by and between Genaissance Pharmaceuticals,
Inc., with its principal place of business at Five Science Park, New Haven, CT
06511 (“Genaissance”), and Wayne State University, with offices at 5700 Cass
Avenue, Suite 4200, A.A. B., Detroit, MI 48202 (“WSU”).

 

WHEREAS, on December 16, 2002 WSU issued a Request for Proposal for the
provision of Genotyping Services to support its service contract with the
Perinatology Research Branch (PRB) of the National Institute of Child Health and
Human Development (NICHD);

 

WHEREAS, on January 9, 2003 Genaissance submitted a Proposal for Wayne State
University in Response to the RFP – Genotyping Services;

 

NOW THEREFORE, in consideration of the premises and of the covenants herein
contained, the parties mutually agree as follows:

 

1.                                       The documents that are listed in the
attached Table of Contents and that are attached hereto are hereby made part of
the Agreement.

 

2.                                       Genaissance agrees to perform the
Genotyping Services, and WSU agrees to pay for the performance of same, pursuant
to the provisions set forth in the attached documents.

 

IN WITNESS WHEREOF, the parties have caused their duly authorized officer to
execute and deliver this Agreement as of the date first set forth above.

 

GENAISSANCE PHARMACEUTICALS, INC.

 

By:

/s/ Gerald F. Vovis

 

Name:

Gerald F. Vovis, Ph.D.

Title:

Executive Vice President and Chief Technology Officer

 

WAYNE STATE UNIVERSITY

 

By:

/s/ John L. Davis

 

Name:

John L. Davis

 

 

Title:

Senior Vice President for Finance

 

 

and Administration 3/20/03

 

 

1

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Table of Contents

 

Document

 

Originating Party

 

Last Revision
Date/Party

 

 

 

 

 

Wayne State University
Request for Proposal for
Providing Genotyping Services for 2002/2003

 

WSU

 

December 16, 2002

 

 

 

 

 

Addendum One (1) to Request for Proposal for Genotyping Services December 16,
2002

 

WSU

 

December 30, 2002

 

 

 

 

 

Addendum Two (2) to Request for Proposal for Genotyping Services December 16,
2002

 

WSU

 

January 07, 2003

 

 

 

 

 

Proposal for Wayne State University in Response to RFP – Genotyping Services

 

GNSC

 

January 9, 2003

 

 

 

 

 

Addendum to Schedule C of Proposal

 

GNSC

 

March 11, 2003
WSU and GNSC

 

 

 

 

 

Addendum to Addendum 1 (Terms and Conditions) of Proposal

 

WSU

 

February 19,
2003/GNSC

 

 

 

 

 

Replacement of Addendum 2 (License Agreement) of Proposal

 

GNSC

 

March 10, 2003
WSU and GNSC

 

 

 

 

 

Addendum 3 to Proposal, Additional Services
Comparison of Cohorts
Sequence Finishing and Quality Control
Analysis of Candidate Genes

 

GNSC

 

March 10, 2003
WSU and GNSC

 

 

 

 

 

WSU Project Seq Tracking
Time line for sequencing and quality control
analysis of 200 candidate genes

 

GNSC

 

March 7, 2003/GNSC

 

 

 

 

 

WSU Project Tracking
Time line for genotyping 4,000 DNA
samples with an average of [**] SNPs from
each of 200 candidate genes

 

GNSC

 

January 28, 2003/GNSC

 

 

 

 

 

Press Release

 

GNSC

 

March 10, 2003
WSU and GNSC

 

2

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[Attachment 1]

 

 

WAYNE STATE UNIVERSITY

Purchasing Department

Division of Business Operations

Detroit, Michigan 48202

 

(313) 577-3757

 

FAX (313) 577-3747

 

 

 

December 16, 2002

 

Attn:  Jeffrey M. Otto, Ph.D., Director
Geniassance Pharmaceuticals
5 Science Park
New Haven, CT  06511
Dear Mr. Otto:

 

Wayne State University is seeking a Contractor to provide genotyping services. 
The Contractor should have the capability to carry out high-throughput
genotyping for approximately 4,000 DNA samples for polymorphisms in
approximately 200 candidate genes.  We are soliciting information from
organizations that have the capability to provide these services.  This service
is expected to commence on approximately January 24, 2003.  Wayne State
University invites you to participate in the Request for Proposal process.

 

We have enclosed our Request for Proposal and Specifications for your review and
consideration.  If you are interested in participating in this process, please
note the proposal due date and place as follows:

 

Thursday, January 9, 2003 - 4:00 p.m.
Wayne State University
Attn:  Kimberly Tomaszewski, Senior Buyer
RFP - Genotyping Services
5700 Cass Avenue, 4th Floor - Suite 4200 AAB
Detroit, MI 48202

 

Due to the technical and specific nature of the work proposed in this Request
for Proposal, there will be no pre-bid meeting.  Questions that arise as a
result of this RFP should be directed in writing to Kimberly Tomaszewski no
later than Thursday, January 2, 2003.  Should you have any questions or concerns
about this invitation, please contact me at (313) 577-3757 (ac9934@wayne.edu@). 
Thank you for your interest in doing business with Wayne State University.

 

 

Sincerely,

 

 

 

 

 

/s/ Kim

 

 

 

 

Kimberly Tomaszewski

 

Senior Buyer

 

3

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WAYNE STATE UNIVERSITY

 

REQUEST FOR PROPOSAL

 

AND SPECIFICATIONS FOR

 

GENOTYPING SERVICES

 

No part of this publication may be reproduced, transmitted, transcribed,
stored in a retrieval system, or translated into any language in any form
by any means without the written permission of
Wayne State University

 

Wayne State University
Purchasing Department

 

RFP - Genotyping Services

 

December 16, 2002

 

4

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WAYNE STATE UNIVERSITY

 

REQUEST FOR PROPOSAL
FOR GENOTYPING SERVICES

 

 

Note

 

 

I.

INTRODUCTION

II.

INFORMATION FOR VENDOR

III.

GENERAL REQUIREMENTS AND GUIDELINES

IV.

STATEMENT / SCOPE OF WORK

V.

Additional Instructions To VENDORS — Business Proposals

VI.

Vendor Qualifications

VII.

SUMMARY OF GENERAL MANDATORY REQUIREMENTS

 

 

SCHEDULES

 

 

Schedules A1

Proposal Certification

 

 

Schedules A2

Non-Collusion Affidavit

 

 

Schedule B

Insurance Requirements

 

 

Schedule C

Price Schedule

 

 

Schedule D

Summary Questionnaire

 

 

Schedule E

Representations, Certifications and Other Statement of Offerors or Quoters
(vendors)

 

 

 

 

EXHIBITS TO BE SUBMITTED WITH VENDOR PROPOSAL(S)

 

 

 

 

 

Vendor Exhibit 1

Exceptions/Restricted Services

 

Vendor Exhibit 2

Profile/Experience/References

 

Vendor Exhibit 3

Service Plan

 

Vendor Exhibit 4

Vendor Qualifications

 

Vendor Exhibit 5

Small Business Subcontracting Plan

 

5

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NOTE

 

Proposals may be subject to public review after contracts have been awarded. 
Vendors responding to this proposal are cautioned not to include any proprietary
information as part of their proposal unless such proprietary information is
carefully identified as such in writing, and the UNIVERSITY accepts, in writing,
the information as proprietary.

 

6

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I.                                         INTRODUCTION

 

A.                                   WAYNE STATE UNIVERSITY (HEREAFTER REFERRED
TO AS UNIVERSITY OR WSU) IS A COMPREHENSIVE UNIVERSITY WITH APPROXIMATELY 31,000
STUDENTS.  THIS MAKES THE UNIVERSITY THE THIRD LARGEST IN THE STATE.  THE
GRADUATE SCHOOL, WITH NEARLY 13,000 STUDENTS, IS THE LARGEST IN MICHIGAN.  THERE
ARE 14 SCHOOLS AND COLLEGES.  THE UNIVERSITY OFFERS 355 MAJOR SUBJECT AREAS, 128
BACHELOR, 136 MASTER, AND 61 DIFFERENT DOCTORAL DEGREES PLUS 30 DIFFERENT
CERTIFICATE, SPECIALIST AND PROFESSIONAL PROGRAMS.  THERE ARE OVER 202,000
ALUMNI OF THE UNIVERSITY, MANY OF WHOM HAVE ASSUMED LEADERSHIP POSITIONS IN THE
COMMUNITIES OF SOUTHEASTERN MICHIGAN.  MANY SUCCESSFUL DOCTORS AND HEALTH CARE
PROFESSIONALS, LAWYERS, ENGINEERS, EDUCATORS, BUSINESS EXECUTIVES AND MANAGERS,
CIVIC LEADERS, AND COMMUNITY MEMBERS OBTAINED THEIR EDUCATION AT WSU.

 

In fiscal year 2001, the UNIVERSITY had revenues and year end total assets of
approximately $654 million and $1.038 billion, respectively.

 

In 1994, WSU brought the total number of Carnegie “Research I Universities” to
88.  Of the 3,600 accredited universities in the U.S., this select group offers
a broad range of baccalaureate programs while demonstrating a commitment to
graduate education and a significant capacity for research.

 

The Perinatology Research Branch (PRB) was created in response to Sec.  452B of
the Public Health Service Act that was passed by Congress and signed into law by
the President as part of the NIH Revitalization Act of 1993.  Section 452B
states that: “The Director of the National Institute of Child Health and Human
Development (NICHD) shall establish and maintain within the Institute an
intramural laboratory and clinical research program in obstetrics and
gynecology.

 

B.                                     THE PURCHASING (PD) DEPARTMENT OF THE
UNIVERSITY IS SOLICITING PROPOSALS FROM QUALIFIED PROFESSIONAL ORGANIZATIONS,
HEREAFTER REFERRED TO AS VENDOR(S), WHO SPECIALIZE IN PROVIDING GENOTYPING
SERVICES OF SUPERIOR QUALITY AT COMPETITIVE PRICING, UNDER THE DIRECTION OF THE
UNIVERSITY’S PERINATOLOGY RESEARCH BRANCH OF THE NATIONAL INSTITUTE (NICHD), AS
DESCRIBED IN THE STATEMENT OF WORK SECTION OF THE REQUEST FOR PROPOSAL (RFP).

 

The UNIVERSITY reserves the right to select one or several service providers for
the Genotyping Services under consideration.  Make sure to complete the pricing
models as provided on the excel spreadsheets.

 

This RFP outlines basic requirements as specified in the Scope of Work section
of the RFP (Section IV).  Proposals submitted are to be in accordance with the
outline and specifications contained herein and are to remain in effect a
minimum of 120 days from the date of submission, and may be subject to further
extensions

 

7

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as negotiated.  A statement to this effect should be contained in the VENDOR’S
cover letter.

 

VENDOR selected shall have an excellent track record for handling service
programs of our size and scope and shall provide the UNIVERSITY with a top
priority commitment.

 

C.                                     THE UNIVERSITY RESERVES THE RIGHT TO
ACCEPT, REJECT, MODIFY, AND/OR NEGOTIATE ANY AND ALL PROPOSALS RECEIVED IN
CONJUNCTION WITH THE RFP.  IT RESERVES THE RIGHT TO WAIVE ANY DEFECT OR
INFORMALITY IN THE PROPOSALS ON THE BASIS OF WHAT IT CONSIDERS TO BE IN ITS BEST
INTERESTS.  ANY PROPOSAL WHICH THE UNIVERSITY DETERMINES TO BE INCOMPLETE,
CONDITIONAL, OBSCURE, OR HAS IRREGULARITIES OF ANY KIND, MAY BE REJECTED.  THE
UNIVERSITY RESERVES THE RIGHT TO AWARD TO THE FIRM, OR FIRMS, WHICH IN ITS SOLE
JUDGMENT, WILL BEST SERVE ITS LONG-TERM INTEREST.

 

D.                                    THIS RFP IN NO MANNER OBLIGATES THE
UNIVERSITY TO THE EVENTUAL PURCHASE OF ANY PRODUCTS OR SERVICES DESCRIBED,
IMPLIED, OR WHICH MAY BE PROPOSED, UNTIL CONFIRMED BY WRITTEN AGREEMENT, AND MAY
BE TERMINATED BY THE UNIVERSITY WITHOUT PENALTY OR OBLIGATION AT ANY TIME PRIOR
TO THE SIGNING OF AN AGREEMENT.

 

E.                                      EXPENSES FOR DEVELOPING AND PRESENTING
PROPOSALS SHALL BE THE ENTIRE RESPONSIBILITY OF THE VENDOR AND SHALL NOT BE
CHARGEABLE TO THE UNIVERSITY.  ALL SUPPORTING DOCUMENTATION AND MANUALS
SUBMITTED WITH THIS PROPOSAL WILL BECOME THE PROPERTY OF THE UNIVERSITY UNLESS
OTHERWISE REQUESTED BY THE VENDOR, IN WRITING, AT THE TIME OF SUBMISSION, AND
AGREED TO, IN WRITING, BY THE UNIVERSITY.

 

F.                                      ALL QUESTIONS CONCERNING THIS RFP ARE TO
BE DIRECTED TO KIMBERLY TOMASZEWSKI, SENIOR BUYER AT (313) 577-3757, FAX (313)
577-3747 OR EMAIL AC9934@WAYNE.EDU OR IN HER ABSENCE TO KENNETH DOHERTY, C.P.M.,
ASSOCIATE DIRECTOR, AT (313) 577-3756, EMAIL, AC0578@WAYNE.EDU.  UNDER NO
CIRCUMSTANCES MAY A VENDOR CONTACT OTHER INDIVIDUALS AT THE UNIVERSITY, TO
DISCUSS ANY ASPECT OF THIS RFP, UNLESS EXPRESSLY AUTHORIZED BY THE PURCHASING
DEPARTMENT TO DO SO.

 

II.                                     INFORMATION FOR VENDOR

 

A.                                   GENERAL

 

This RFP contains requests for information.  VENDORS, however, in responding to
this RFP, are encouraged to provide any additional information they believe
relevant.

 

VENDORS are encouraged to examine all sections of this RFP carefully, in that
the degree of interrelationship between sections is high.  Clause headings
appearing in this RFP have been inserted for convenience and ready reference.

 

8

--------------------------------------------------------------------------------

 

They do not purport to define, limit or extend the scope of intent of the
respective clauses.

 

Whenever the terms “must” “shall” “will” “is required” or “are required” are
used in the RFP, the subject being referred to is to be a required feature of
this RFP.  In those cases where mandatory requirements are stated, material
failure to meet those requirements could result in disqualification of the
VENDOR’S response.  Any deviation or exception from RFP specifications must be
clearly identified by the VENDOR in its proposal, specifically under the
category “Restricted Services”.  Otherwise, check the box indicating “None” on
the Proposal Certification Schedule A.1.

 

B.                                     CALENDAR OF EVENTS

 

Activity

 

Responsibility

 

Date,

Formal Release of RFP – Genotyping Services 2002/03

 

Purchasing (PD)

 

December 16, 2002

 

 

 

 

 

Deadline for submission of questions in writing

 

PD

 

January 2, 2003

 

 

 

 

 

Delivery of Proposals to Purchasing Department

 

VENDORS.

 

January 9, 2003 by 4:00 p.m.

 

 

 

 

 

Evaluation of Proposals

 

PD/ET

 

January 13, 2003

 

 

 

 

 

Announcement of Selected Vendor

 

PD

 

January 20, 2003

 

 

 

 

 

Readiness for Service/Contract Commencement

 

Vendors

 

January 24, 2003

 

The UNIVERSITY will make every effort to adhere to the above schedule.  It is
subject however, to time extensions.  This would be in the event that further
clarification of responses or terms of contract are in the best interest of the
UNIVERSITY and in the event the UNIVERSITY requires more time to assure that the
selection of the VENDOR is in accordance with its policies, rules and
regulations as well as actual timing needs.

 

C.                                     EXAMINATION OF THE REQUEST FOR PROPOSAL

 

Before submitting proposals, each VENDOR will be held to have examined the
UNIVERSITY requirements outlined in the Statement of Work and Technical
Information sections, and satisfied itself as to the existing conditions under
which it will be obligated to perform in accordance with specifications of this
RFP.

 

No claim for additional compensation will be allowed due to unfamiliarity with
the specifications and/or existing conditions.  It shall be understood that the

 

9

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VENDOR has full knowledge of all of the existing conditions, and accepts them
“as is.”

 

D.                                    DELIVERY OF PROPOSALS:

 

An original (clearly marked as such) plus nine copies (10 total) of concise
proposals in booklet or notebook form with supporting documentation shall be
delivered in a sealed envelope or container to the UNIVERSITY Purchasing
Department.  The specific format for responses is detailed in Section II E
(below).  Proposals and Schedule D, Price Schedule must be signed and the
authority of the individual signing must be stated thereon.  For the VENDOR’S
convenience, the Price Schedule and Appendices will be provided on diskette
using Microsoft Excel version 97.  VENDORS are encouraged to use the disk and
return a completed hard copy with their proposal.  All responses are to be
addressed to:

 

ATTN.: Kimberly Tomaszewski

Wayne State University-RFP Genotyping Services 

Purchasing Department

5700 Cass Avenue, 4th Floor - Suite 4200 AAB

Detroit, MI 48202

 

Deadline for receipt of proposals by the Purchasing Department is 4:00 p.m. on
January 9, 2003.  Date and time will be stamped on the proposals by the
Purchasing Department.  Proposals received after that time will not be
accepted.  VENDORS submitting proposals after the due date and time will be
required to retrieve the unopened proposals.

 

E.                                      PROPOSAL FORMAT

 

Proposals are to be submitted as a booklet or in notebook form with appropriate
indices.  Each proposal should be prepared simply and economically, providing a
straightforward concise description of the VENDOR’S service, approach and
ability to meet the UNIVERSITY’S needs as stated in this RFP.  Schedules and
Exhibits must clearly identify and well define:

 

Schedule Al -

 

Proposal Certification

Schedule A2 -

 

Non Collusion Affidavit

 

 

Schedule B - Insurance Requirements

Schedule C -

 

Price Schedule, Summary of Quoted Rates

Schedule D -

 

Summary Questionnaire

Schedule E -

 

Representations, Certifications and Other Statement of Offerors or Quoters
(Vendors)

Exhibit 1 -

 

Exceptions/Restrictions; if any (Section II F)

Exhibit 2 -

 

Profile/Experience/References (Section II G)

Exhibit 3 -

 

VENDOR Service Plan (Section IV)

Exhibit 4 -

 

Vendor Qualifications

Exhibit 5 -

 

Small Business Subcontracting Plan

 

10

--------------------------------------------------------------------------------

 

Care should be exercised in preparation of the proposals since it is the
UNIVERSITY’S intent to have the final contract documentation consist of the RFP,
VENDOR Proposal, any letters of clarification, and a one or two page enabling
Signatory Document.

 

F.                                      Proposal Evaluation

 

1.                                       Proposals will be evaluated and award
will be based on the VENDOR’S ability to offer the best value (technical
quality, past performance and price), and on anticipated quality of service for
the following principal elements:

 

Primary Considerations

 

•                  Demonstrated ability to perform the genotyping in a
reasonable time frame (45 points);

•                  Experience of the personnel in performing the genotyping (35
points);

•                  Facilities and equipment needed to perform the genotyping (20
points);

 

Additional Considerations

 

•                  Ability to meet all mandatory requirements and specifications
of this RFP;

•                  Cost of Services; Compensation and Fees; (Schedule C);

•                  Financial Strength of the Vendor;

•                  Proposal Documentation / Presentation;

•                  VENDOR’S Experience (Exhibit 2);

•                  VENDOR Profiles/References; (Exhibit 2);

•                  VENDOR Service Plan; (Exhibit 3);

•                  VENDOR Qualifications; (Exhibit 4).

 

NOTE: Additional Considerations are not stated in order of preference.  However,
technical items and past performance will carry greater weight than price.  All
factors listed above will be considered in the final selection of a VENDOR.

 

VENDOR proposals will be evaluated by an evaluation team consisting of members
of the UNIVERSITY’S Purchasing Department and the PRB.  A preliminary screening
will be used to identify competitive VENDORS who have met the mandatory
requirements.  The Purchasing Department may subsequently request selected
VENDORS to make a presentation at a set time and date, to clarify information
provided in the proposals.  Final consideration, evaluation, and recommendation
may be made at this point.  However, the UNIVERSITY reserves the right to take
additional time for reference review, site visits and/or proposal negotiations.

 

11

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2.                                       To qualify for evaluation, a VENDOR’S
proposal must be responsive, must have been submitted on time and must
materially satisfy all mandatory requirements identified throughout the RFP.  To
be considered responsive, a proposal must be reasonable and substantially
conform in the judgment of the UNIVERSITY to all of the specified requirements
in the RFP.  Any deviation from requirements indicated herein must be stated in
the proposal specifically under the category “Restricted Services”, and clearly
identified as Exhibit 1.  Otherwise it will be considered that proposals are in
strict compliance with all requirements, and any successful VENDOR will be held
responsible therefor.

 

3.                                       If there are portions of any proposal
the UNIVERSITY finds unacceptable or otherwise in need of clarification or
revision, the UNIVERSITY reserves the right to negotiate with any or all
VENDORS.  Should the outcome of evaluations result in a recommendation, any
resultant contract shall be subject to the approval of the UNIVERSITY’S General
Counsel and be approved and signed by the appropriate UNIVERSITY representative.

 

4.                                       After notification of acceptance of
proposal and the signing of a resultant agreement and/or Purchase Order, the
successful VENDOR will be expected to establish and be in a position to provide
Genotyping Services commencing on or before January 24, 2003.

 

G.                                     VENDOR PROFILE, EXPERIENCE AND REFERENCES

 

1.                                       Vendor Profile should include:

 

VENDOR is required to provide both financial and organizational data that
demonstrate the size, scope and capability of the Company to handle the
UNIVERSITY’S specific requirements specified in this RFP.

 

VENDOR is required to identify all organizational components and other Companies
or Organizations with which it is affiliated.  Include component and other
company addresses.  Explain any company relationships that could be construed to
be a conflict of interest in doing business with the UNIVERSITY now or in the
future.  Indicate any significant past or pending lawsuits or malpractice claims
against the VENDOR.

 

VENDOR must submit independently audited financial statements (one copy only)
including its statement of statement of revenues and expenses and year-end
balance statements for at least the past three years.  Include most recently
available interim statements.  Such financial information will be treated in
strict confidence.  Financial information should be submitted, under separate
cover, directly to:

 

12

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Joan M. Gossman, C.P.M.

Wayne State University-RFP Genotyping Services

Purchasing Department

5700 Cass Avenue, Suite 4200, A.A.B.

Detroit, MI 48202

 

VENDORS who would like their financial statements returned to them must include
a self addressed envelope marked “Confidential” with their financial statement. 
If VENDOR has already submitted financial statements within 120 days of this
RFP, VENDOR may indicate the RFP date and RFP title in the VENDORS cover letter
instead of resubmitting these statements.

 

2.                                       Experience

 

The successful VENDOR shall be an organization that has an excellent record as a
licensed external provider of the Genotyping Services in the type and scope
detailed in this RFP.  Accordingly, VENDORS are to state in their proposals
their qualifications to meet the RFP specifications in terms of past and current
experience with the same or similar requirements.  VENDORS are to focus on
experiences with organizations having needs similar to that of the UNIVERSITY.

 

3.                                       References

 

VENDORS are to furnish a minimum of three (3) qualified references to support
their proposals.  References are to be from organizations that are not part of
the VENDOR’S organization and that closely parallel the needs stated in this
RFP.  References are to be from organizations that have successfully utilized
the products and services which the VENDOR has offered in its proposal(s) (see
additional reference information required in Section V, item C).

 

The references supplied should include the name and address of the organization,
the name(s), titles, and the telephone numbers of the persons to be contacted
and a general scope of the product or services provided including the
approximate annual aggregate dollar volume involved.

 

III.                                 GENERAL REQUIREMENTS AND GUIDELINES

 

A.                                   TERMS AND CONDITIONS

 

The Proposal response must include a formal copy of any VENDOR’S terms and
conditions applicable to this transaction.  Evaluation and acceptance and/or
modification of these terms and conditions by the University’s General Counsel
is essential prior to the award of the contract.  In the event the VENDOR does
not

 

13

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supply terms and conditions with their proposal, the UNIVERSITY’s terms and
conditions will govern this transaction.

 

B.                                     GOVERNING LAW (MICHIGAN)

 

VENDOR agrees that, in the event of a dispute, laws of the State of Michigan
will prevail.

 

C.                                     NON-DISCRIMINATION

 

The parties agree that in the performance of any contract they shall not
discriminate in any manner on the basis of race, creed, color, national origin,
age, religion, sex, sexual orientation, marital status or handicap protected by
law.  Such action shall include, but is not limited to the following:
employment, upgrading, demotion, transfer, recruitment or recruitment
advertising; layoff or termination; rates of pay or other forms of
compensation.  By submitting a proposal, VENDORS certify that they will conform
to the provisions of the Federal Civil Rights Action of 1964, as amended.

 

D.                                    IMMIGRATION REFORM AND CONTROL ACT OF 1986

 

By submitting a proposal, the VENDORS certify that they do not and will not
during the performance of this contract employ illegal alien workers or
otherwise violate the provisions of the federal Immigration Reform and Control
Act of 1986.

 

E.                                      DEBARMENT STATUS

 

By submitting a proposal, VENDORS certify that they are not currently debarred
from submitting bids on contracts nor are they an agent of any person or entity
that is currently debarred from submitting bids on contracts.

 

F.                                      INDEMNIFICATION AND HOLD HARMLESS

 

The VENDOR shall defend, indemnify and hold harmless the UNIVERSITY, its
officers, employees and agents, against any and all liability of whatever nature
which may arise directly or indirectly by reason of the VENDOR’S performance
under this Agreement.

 

G.                                     (THIS SECTION DELIBERATELY LEFT BLANK)

 

H.                                    EARLY TERMINATION

 

The UNIVERSITY shall have the right to terminate the contract with the VENDOR
without penalty after the UNIVERSITY’S thirty (30) days written notice of
termination to the VENDOR under the following circumstances:

 

14

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1.                                       Default of VENDOR

 

It shall be considered a default whenever the VENDOR shall:

 

a.                                       Disregard or violate material
provisions of the contract documents or UNIVERSITY instructions, or fail to
execute the work according to the agreed upon schedule of completion and/or time
of completion specified, including extensions thereof, or fail to reach agreed
upon performance results.

 

b.                                      Declare bankruptcy, become insolvent, or
assign company assets for the benefit of creditors.

 

2.                                       Convenience of the UNIVERSITY

 

When termination of the contract services is construed by the UNIVERSITY to be
in its best interest for serving the community and its students, faculty, and
staff.

 

Note: Any contract cancellation notice shall not relieve the VENDOR of the
obligation to deliver and/or perform prior to the effective date of
cancellation.

 

I.                                         CANCELLATION OF CONTRACT BY VENDOR

 

VENDOR must provide a minimum of ninety (90) days written notice of cancellation
of contract to the UNIVERSITY regardless of the reason for said termination. 
Such notification must be sent to:

 

Joan M. Gossman, C.P.M.
Wayne State University-RFP Genotyping Services - 2002/03
Purchasing Department
5700 Cass Avenue, Suite 4200, A.A.B.
Detroit, MI 48202

 

J.                                        NON-ASSIGNMENT

 

The agreement shall be between the UNIVERSITY and the VENDOR and the VENDOR
shall neither assign nor delegate the agreement, its rights or obligations, or
any of its terms without the express written permission of the UNIVERSITY.  This
pertains to services performed only.  Financial payments may be assigned at the
VENDOR’s discretion

 

K.                                    PRICE SCHEDULES

 

VENDOR is to quote its rates for the products and services in accordance with
specifications set forth in this RFP.  Rates and other requested data must be
stated on or in the exact format of Schedule C, Price Schedule.  VENDOR shall be
responsible for all errors and omissions.  In the event of a discrepancy between

 

15

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the printed document and diskette version, the printed document will govern and
supercede those of the diskette version.

 

Please Note: VENDORS must respond using Schedule C.  Failure to do so may result
in disqualification of your Proposal.  VENDORS shall be responsible for all
errors and omissions.

 

L.                                      PRICING VARIANCES

 

No changes shall be made, nor invoices for extra changes, alterations,
modifications, deviations, and extra orders be recognized or paid except upon a
written change order from the UNIVERSITY.  The UNIVERSITY will not authorize
payment for changes, alterations, modifications, deviations, etc.  that are a
result of VENDOR error.

 

M.                                 CIVIL RIGHTS REQUIREMENTS

 

All VENDORS must be in compliance with the directives of the Michigan Department
of Civil Rights.  In addition, Vendors are required to comply with all federal
equal opportunity requirements, as stated in Schedule E; Representations,
Certifications and Other Statement of Offerors or Quoters (VENDORS).  Vendors
must complete the Schedule and return it as part of their Proposal.

 

N.                                    NON-COLLUSION CLAUSE

 

The Non-Collusion Affidavit found in Schedules A.1 and A.2 must be executed as a
part of the VENDOR’S proposal.

 

O.                                    VENDOR PAYMENT/BILLING TERMS

 

Payments of invoices will be made thirty (30) days after receipt and approval of
invoice, by the UNIVERSITY Project Manager, for each month completed.

 

P.                                      ENTIRE AGREEMENT

 

An agreement, when fully executed, shall supersede any and all prior and
existing agreements, either oral or in writing, and will contain all the
covenants and agreements between the parties with respect to the subject matter
of this agreement.  Any amendment or modification to this agreement must be in
writing and signed by the parties hereto.

 

Q.                                    SEVERABILITY

 

It is understood and agreed that if any part, term, or provision of this
agreement is by the courts held to be illegal or in conflict with any law of the
State of Michigan, the validity of the remaining portions or provisions shall be
construed and enforced as if the Agreement did not contain the particular part,
term, or provision held to be invalid.

 

16

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R.                                     MODIFICATION OF SERVICE

 

The UNIVERSITY reserves the right to modify the services during the course of
the contract, with concurrence of the VENDOR.  Any changes in pricing and rates
proposed by the VENDOR resulting from such changes are subject to acceptance by
the UNIVERSITY.

 

In the event prices and rates cannot be negotiated to the satisfaction of both
parties, the contract may be subject to competitive bidding based upon the new
specifications.

 

S.                                      PUBLICITY

 

VENDORS must refrain from giving any reference to this project, whether in the
form of press releases, brochures, photographic coverage, or verbal
announcements, without specific written approval from the UNIVERSITY.

 

T.                                     INDEPENDENT CONTRACTOR

 

The VENDOR agrees that in all respects its relationship with the UNIVERSITY will
be that of an independent contractor, and that it will not act or represent that
it is acting as an agent of the UNIVERSITY or incur any obligation on the part
of the UNIVERSITY without written authority of the UNIVERSITY.

 

U.                                    CONFIDENTIALITY

 

Proposals could be subject to public review after the contracts have been
awarded.  VENDORS responding to this proposal are cautioned not to include any
proprietary information as part of their proposal unless such proprietary
information is carefully identified as such in writing, and the UNIVERSITY
accepts, in writing, the information as proprietary.

 

V.                                     INSURANCE REQUIREMENTS

 

VENDORS must provide Certificates of Insurance or other evidence that insurance
is in place.  If awarded a contract, VENDOR must then provide a Certificate of
Insurance naming Wayne State University as the certificate holder.  During the
life of the contract, the VENDOR shall maintain the type of insurance as stated
in Insurance Provisions (Schedule B) attached and any additional requirements as
specified by the UNIVERSITY Office of Risk Management for the VENDOR and
assigned licensed VENDOR professionals.

 

17

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Questions on insurance requirements should be directed to Mr. Homer Isaac,
Director of the UNIVERSITY’S Risk Management Department at (313) 577-3110.

 

W.                                MINORITY BUSINESS

 

Specify in your proposal whether your company is a certified minority firm.  The
University, in accordance with guidelines from the Michigan Minority Business
Development Counsel (MMBDC), considers a minority firm as one that is at least
51% owned, operated, and controlled by a minority, or in case of a
publicly-owned business, at least 51% of the stock must be owned by a minority. 
Such minorities include, but are not limited to:

 

•

African Americans

 

•

Hispanic Americans

•

Asian Americans

 

•

Native Americans

•

Eskimos

 

•

Aleuts

 

If the firm is not a minority firm, describe the firm’s partnering relationships
(if any) with minority firms and how it plans to support the UNIVERSITY’S goal
to award UNIVERSITY business to minority firms.

 

1.                                       Reporting

 

The selected firm will identify and fairly consider minority firms for
subcontracting opportunities when qualified firms are available to perform a
given task in performing for the UNIVERSITY under the resulting agreement.  A
Proposed Small Business Subcontracting Plan (DHHS APPENDIX 6-1) must be approved
by Joan Gossman, University Director of Purchasing, prior to the award of the
contract.  Only the selected VEDNOR will be asked to submit this plan.  The form
can be downloaded at shown on http://www.ogam2000.com/smallbus/6%2D1.htm.  In
addition, the selected VENDOR must submit a quarterly minority business report
to the UNIVERSITY Purchasing Department by the 15th of the month following each
calendar quarter; specifically the months of April, July, October, and January. 
Such reports should be sent directly to:

 

Attn: Joan M.  Gossman, C.P.M.

Wayne State University-RFP -Genotyping Services

Purchasing Department

5700 Cass Avenue, Suite 4200, A.A.B.

Detroit, MI 48202

 

 

18

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2.                                       Report Detail

 

Minority business reports must contain, but are not limited to the following:

•                  Minority firm’s name, address, and phone number with which
the VENDOR has contracted over the-specified quarterly period

•                  Contact person at the minority firm who has knowledge of the
specified information

•                  Type of goods and/or services provided over the specified
period of time

•                  Total amount paid to the minority firm as it relates to the
UNIVERSITY account

 

X.                                    OWNERSHIP OF DOCUMENTS

 

Upon completion or termination of any agreement, all documents prepared by the
VENDOR, including but not limited to: tracings, drawings, estimates,
specifications, field notes, investigations, studies and reports, shall become
the property of the UNIVERSITY.  At the UNIVERSITY’S option, such documents will
be delivered to the UNIVERSITY Purchasing Department.  The UNIVERSITY
acknowledges that the documents are prepared only for the contracted services
specified.  Prior to completion of the contracted services, the UNIVERSITY shall
have a recognized proprietary interest in the work product of the VENDOR.

 

IV.                                 STATEMENT / SCOPE OF WORK

 

A.                                   GENERAL DESCRIPTION OF THE REQUIRED
OBJECTIVES AND DESIRED RESULTS

 

WSU is soliciting genotyping services in support of their service contract with
the PRB of the NICHD.

 

Ongoing research projects conducted by The PRB of the NICHD include studying the
mechanisms of disease responsible for adverse pregnancy outcome and infant
morbidity and mortality.  Priority is given to the understanding of the factors
that predispose to preterm birth, intrauterine growth retardation, preeclampsia,
abruption and other conditions that are collectively referred to as the “Great
Obstetrical Syndromes”.

 

A body of evidence now indicates that several obstetrical syndromes are. 
clustered within families suggesting the presence of heritable risk factors. 
Moreover, recent evidence derived from DNA linkage studies indicates that a
precise genetic locus is linked to pre-eclampsia.  Genetic association studies
of candidate genes also indicate that certain polymorphisms are associated with
a predisposition for these complications and, in some cases, protection.

 

Perinatal morbidity and mortality are largely determined by five major
complications of pregnancy: preterm labor (PTL), preterm premature rupture of
membranes (PROM), small for gestational age (SGA), pre-eclampsia and abruptio
placenta.  The perinatal consequences of these disorders along with congenital
anomalies account for over 95% of infant mortality (death before the age of
one).

 

19

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Although obstetrical complications have been recognized since antiquity, it is
now apparent that they are not discrete disorders and are now collectively
referred by the term “the great obstetrical syndromes”.  The features of these
syndromes are: 1) multiple etiologies; 2) chronicity; 3) the clinical
manifestations (i.e., hypertension, PTL, rupture of membranes or reduced fetal
growth) are adaptive in nature; 4) symptomatic treatment of the specific
syndrome is ineffective in reducing perinatal morbidity; and 5) clinical
presentation depends upon genetic (fetal and/or maternal) and environmental
interactions.

 

The research agenda of the PRB focuses in defining the mechanisms of diseases
responsible for “the great obstetrical syndromes” with the goal of improving the
pathophysiologic understanding of these disorders, developing methods for the
prediction, early diagnosis, and interventions leading to the prevention of
these conditions.  These studies require high-throughput genotyping of large
numbers of samples.  Currently, WSU houses and supports the PRB research
laboratories and PRB investigators undertaking studies on “the great obstetrical
syndromes”.  Therefore, WSU seeks a VENDOR capable of genotyping polymorphisms
in candidate genes that may be involved in determining normal or abnormal
pregnancy outcome.  The VENDOR must have the capability to carry out
high-throughput genotyping for approximately 4,000 DNA samples (that have been
amplified by the “whole genome amplification” protocol) for polymorphisms in
approximately 200 candidate genes.  A successful VENDOR will work closely with
the PRB investigators located at WSU to develop and validate assays for known
and newly identified polymorphisms.  A successful VENDOR will also demonstrate
that the proposed genotyping method(s) can be rapidly and easily adapted to new
polymorphisms and are rapidly scaleable to deal with increasing numbers of new
polymorphisms.

 

The PRB located at WSU has begun to use microarray technology to identify
candidate genes and is now ready to test whether genetic factors predispose to
adverse pregnancy outcome, especially in minority populations.

 

B.                                     TECHNICAL REQUIREMENTS

 

Independently, and not as an agent of the Government, the VENDOR shall furnish
all qualified personnel, materials, facilities, and equipment to provide the
following services to WSU.

 

 

(A)                                  GENERAL REQUIREMENTS:

 

1.                                       The VENDOR shall provide detailed
quality control and quality assurance (QA/QC) plans.  These should cover sample
handling, labeling, and storage, as well as genotyping.  Detail on how the
VENDOR will avoid mislabeling of samples during genotyping is particularly
important.

 

 

20

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2.                                       The VENDOR shall provide an inventory
system for tracking of samples during receipt, storage, processing, and
shipping.  This system shall include but not be limited to the following
information: ID numbers, genotype, results of any quality control tests.  The
Project Officer will assign a unique ID number to each specimen provided to the
VENDOR; this number shall remain with the sample during processing.  The VENDOR
shall provide a list of ID numbers when returning the samples, in both
electronic and paper forms.

 

3.                                       The VENDOR shall provide a plan for
data management, including acquisition, storage, backup, and reporting to WSU. 
The plan should describe methods to handle the large number of samples with
multiple genotypes per sample, including a description of the specific software
packages to be used.  The management of electronic data, computer hardware and
software, and storage of information generated from the contract should be
harmonized with existing WSU information technology capabilities wherever
feasible.

 

(B)                                 THE VENDOR SHALL PROVIDE THE FOLLOWING
SERVICES:

 

1.                                       Provide the PRB investigators
designated by WSU with haplotype and allele frequency information for
polymorphisms in the candidate genes from different ethnic groups, and assist in
identifying suitable polymorphisms for the study.

 

2.             Design genotyping assays for single nucleotide polymorphisms
(SNPs) at specified regions in the human genome.  The VENDOR is required to
submit detailed information about assay design and success rates.

 

3.             Perform the assays on samples provided by WSU.  The samples to be
provided by WSU will be genomic DNA that has been amplified using the whole
genome amplification (also known as the Primer Extension Preamplification; PEP)
method.  The VENDOR should describe in detail the platform or platforms to be
used for genotyping.

 

4.             Input the genotyping data into database tables with a structure
specified by WSU.

 

5.             Perform quality control with negative and positive controls as
well as repeating a random subset (30%) of the assays.

 

6.             Provide WSU with all the raw data (including any gel images or
other electronic data) as hard copies and in electronic format.

 

21

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(C)                                  WSU WILL PROVIDE:

 

1.             Overall technical direction and an outline of the scope of the
specific services required.

 

2.             PEP-products to be used as templates for genotyping (samples will
be assembled in 96-well format and shipped on dry ice; WSU will notify the
VENDOR beforehand about the shipment of samples).

 

3.             Designated WSU appointees, will be available to the VENDOR for
consultations.

 

C.                                     INTELLECTUAL PROPERTY AND PUBLICATIONS

 

(A)                                  THIS IS A SERVICE CONTRACT, NOT A RESEARCH
CONTRACT.  THEREFORE, NO DATA ARE TO BE PUBLISHED WITHOUT THE ADVANCE CONSENT
AND APPROVAL OF WSU, AND THE FUNDING ORGANIZATION, THE NICHD.

 

(B)                                 THE VENDOR SHALL ASSERT NO INTELLECTUAL
PROPERTY RIGHTS WITH REGARD TO GENOTYPING DATA DERIVED FROM THE EXPERIMENTS
DESCRIBED IN THIS DOCUMENT IN SECTION B.  IF THE VENDOR MAKES ADDITIONAL PUBLIC
DOMAIN ASSAYS AVAILABLE DURING THE TERM OF THIS CONTRACT, WSU WILL BE ALLOWED TO
INCLUDE THE USE OF THESE NEW ASSAYS IN THIS CONTRACT

 

D.                                    REPORTING REQUIREMENTS

 

(A)                                  THE VENDOR SHALL INFORM THE DESIGNATED
INVESTIGATORS AT WSU VIA E-MAIL UPON RECEIPT OF SAMPLES VERIFYING NUMBER OF
SAMPLES RECEIVED, ID NUMBERS AND CONDITION

 

(B)                                 THE VENDOR SHALL SEND A REPORT ON RESULTS OF
GENOTYPING, AS SPECIFIED IN THE STATEMENT OF WORK, TO DESIGNATED INVESTIGATORS
AT WSU WITHIN 5 WORKING DAYS OF COMPLETION

 

(C)                                  THE VENDOR SHALL SEND A QUARTERLY DETAILED
PROGRESS REPORT OF THE ANALYSIS FOR EACH SET OF SAMPLES, INCLUDING METHODS USED,
NUMBER OF GENOTYPES ASSAYED, AND THE DATA FOR EACH SAMPLE AS SPECIFIED IN THE
STATEMENT OF WORK

 

(D)                                 THE VENDOR SHALL INFORM WSU ABOUT QUALITY
CONTROL EXPERIMENTS PERFORMED WITH EACH ASSAY.  IF THE QUALITY CONTROL
EXPERIMENTS ARE NOT WITHIN THE VENDOR’S SPECIFICATIONS, THE VENDOR WILL NOTIFY
WSU AND CONSULT WITH THE WSU.  THE VENDOR SHOULD PROVIDE THE RESULTS WITHIN
40-45 WORKING DAYS FROM THE RECEIPT OF PEP-SAMPLES FROM WSU.

 

(E)                                  A COPY OF THE LETTER TRANSMITTING ANY OF
THE ABOVE ITEMS SHOULD BE SENT TO THE PROJECT MANAGER, SERVICES IN SUPPORT OF
THE PERINATOLOGY RESEARCH

 

22

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BRANCH, WAYNE STATE UNIVERSITY, C.S.  MOTT CENTER FOR HUMAN GROWTH AND
DEVELOPMENT, 275 E.  HANCOCK, DETROIT, MI 48201

 

V.                                     Additional Instructions To VENDORS –
Business Proposals

 

The Business Proposal must contain sufficient information to allow WSU to
perform an analysis of the prices offered for the proposed work.

 

A.                                   GENERAL INSTRUCTIONS

 

You must provide the following information on the first page of your pricing
proposal, Schedule C:

 

A.                                       RFP SOLICITATION NAME

 

B.                                      NAME AND ADDRESS OF OFFERER

 

C.                                       NAME AND TELEPHONE NUMBER OF POINT OF
CONTACT

 

D.                                      THE FOLLOWING STATEMENT: BY SUBMITTING
THIS PROPOSAL, WE GRANT WAYNE STATE UNIVERSITY AND AUTHORIZED REPRESENTATIVE(S)
THE RIGHT TO EXAMINE, AT ANY TIME BEFORE AWARD, THOSE RECORDS, WHICH INCLUDE
BOOKS, DOCUMENTS, ACCOUNTING PROCEDURES AND PRACTICES, AND OTHER DATA,
REGARDLESS OF TYPE AND FORM OR WHETHER SUCH SUPPORTING INFORMATION IS
SPECIFICALLY REFERENCED OR INCLUDED IN THE PROPOSAL AS THE BASIS FOR PRICING,
THAT WILL PERMIT AN ADEQUATE EVALUATION OF THE PROPOSED PRICE.

 

E.                                       DATE OF SUBMISSION

 

F.                                         NAME, TITLE AND SIGNATURE OF
AUTHORIZED REPRESENTATIVE

 

As part of the specific information required, you must submit with your
proposal, support for each price proposed.

 

If any of the prices proposed are based on commercial activities or are on the
GSA schedule, please provide us with a catalog price list or GSA schedule
number, showing the cost of the commercial item.  If you provide a discount to
the government, please so indicate.

 

The minimum quantity of samples will be 50, and the maximum quantity will be
10,000 DNA samples.

 

B.                                     PAST PERFORMANCE INFORMATION

 

Officers shall submit the following information as part of their business
proposal a list of the last three (3) contracts completed during the past three
years that are similar in nature to the work required by this solicitation and
all contracts

 

23

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currently in process that are similar in nature to the solicitation.  Include
the following information for each contract:

 

A.                                       NAME OF CONTRACTING ORGANIZATION

 

B.                                      CONTRACT NUMBER

 

C.                                       CONTRACT TYPE

 

D.                                      TOTAL CONTRACT VALUE

 

E.                                       DESCRIPTION OF REQUIREMENT

 

F.                                         CONTRACTING OFFICER’S NAME AND
TELEPHONE NUMBER

 

G.                                      PROGRAM MANAGER’S NAME AND TELEPHONE
NUMBER

 

Each offerer will be evaluated on its performance under existing and prior
contracts for similar products or services.  WSU is not required to contact all
references provided by the offeror.  Also, references other than those
identified by the offeror may be contacted by WSU to obtain additional
information that will be used in the evaluation of the offeror’s past
performance.

 

VI.                                 Vendor Qualifications

 

You are requested to submit a summary of your General Experience, Organizational
Experience Related to this RFP, Performance History.  Pertinent Contracts and
Grants.  This information should be provided in your Proposal under “Vendor
Exhibit 4”, Vendor Qualifications.

 

1.                                       “General experience” is defined as
general background, experience and qualifications of the offeror.  A discussion
of proposed resources which can be devoted to the project may be appropriate.

 

2.             “Organizational experience” is defined as the accomplishment of
work, either past or ongoing, which is comparable or related to the effort
required by this RFP.  This includes overall offeror or corporate experience,
BUT NOT the experience and/or past performance or individuals who are proposed
as personnel involved with the Statement of Work in this RFP.

 

3.             “Performance history” is defined as meeting contract objectives
within DELIVERY and PRICE SCHEDULES on efforts, either past or on-going, which
is comparable or related to the effort required by this RFP.

 

4.             “Pertinent contracts” is defined as a listing of each related
contract completed within the last three years or currently in process.

 

24

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5.                                       “Pertinent grants” - list grants
supported by the Government that involve similar or related work o that called
for in this RFP.  Include the grant number, involved agency, names of the grant
specialist and the Science Administrator, identification of the work, and when
performed.

 

6.             “Facilities” - provide a description of the facilities that the
VENDOR proposes to use, in the performance of this contract.  The description
should include a statement as to whether the facility meets P3 or P4
requirements.

 

VII.                             SUMMARY OF GENERAL MANDATORY REQUIREMENTS

 

A.                                   ORIGINAL CLEARLY MARKED AS SUCH PLUS NINE
COPIES (10 TOTAL) OF THE PROPOSALS ARE REQUIRED.

 

B.                                     PROPOSALS AND SCHEDULES C & D MUST BE
SIGNED AND THE SIGNING AUTHORITY STATED THEREON.

 

C.                                     MEET ABSOLUTE DEADLINE FOR DELIVERY OF
PROPOSALS TO THE PURCHASING DEPARTMENT BY 4:00 P.M., JANUARY 9, 2003.

 

D.                                    PROPOSALS REMAIN IN EFFECT A MINIMUM OF
120 DAYS.  A STATEMENT TO THIS EFFECT MUST BE CONTAINED IN THE VENDOR’S COVER
LETTER.

 

E.                                      ANY DEVIATION FROM THE RFP REQUIREMENTS
MUST BE STATED IN PROPOSAL, UNDER “RESTRICTED SERVICES”.  OTHERWISE, PROPOSAL IS
HELD TO BE IN STRICT COMPLIANCE WITH THIS RFP.

 

F.                                      VENDOR PROFILE, STATEMENT OF EXPERIENCE,
QUALIFICATIONS, COMPARATIVE FINANCIAL STATEMENTS, AND MINIMUM OF THREE QUALIFIED
REFERENCES, ARE REQUIRED INFORMATION FOR THE PURPOSE OF CONSIDERATION IN THIS
RFP PROCESS.

 

G.                                     VENDOR’S QUOTATION, SCHEDULE C, IS TO BE
COMPLETED BY VENDOR, SIGNED AND SUBMITTED WITH PROPOSAL.  VENDORS ARE ENCOURAGED
TO USE THE DISKS PROVIDED, AND RETURN A COMPLETED COPY WITH THEIR PROPOSAL.

 

H.                                    VENDOR AGREES TO ALL TECHNICAL AND GENERAL
REQUIREMENTS AND GUIDELINES, ADDITIONAL GENERAL PROVISIONS, VENDOR SERVICE PLAN
SPECIFICATIONS, AND ALL OTHER SPECIFICATIONS AND TERMS SPECIFIED IN THE RFP.

 

I.                                         VENDOR MUST COMPLETE THE PROPOSAL
CERTIFICATION AND NON-COLLUSION AFFIDAVIT (SCHEDULES AL AND A2) AS SPECIFIED,
SIGN AND SUBMIT AS A PART OF THE PROPOSAL.

 

J.                                        VENDOR MUST COMPLETE SCHEDULE E,
REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS OR QUOTERS
(VENDORS).

 

25

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K.                                    PROVIDE CERTIFICATES OF INSURANCE OR OTHER
EVIDENCE THAT INSURANCE IS IN PLACE, WHICH MEETS OR EXCEEDS REQUIREMENTS
OUTLINED IN SCHEDULE B.

 

L.                                      ABILITY TO COMMENCE FULL SERVICE BY
JANUARY 24, 2003.

 

FAILURE TO MEET THE MANDATORY REQUIREMENTS MAY RESULT IN
DISQUALIFICATION OF YOUR PROPOSAL

 

26

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Schedule A.1

 

PROPOSAL CERTIFICATION

 

VENDOR is to certify its proposal as to its compliance with the Request for
Proposal specifications using the language as stated hereon.

 

RESPONSE TO WAYNE STATE UNIVERSITY

REQUEST FOR PROPOSAL FOR

PROVIDING GENOTYPING SERVICES FOR 2002 / 2003

DATED: December 16, 2002

 

AND TO ANY AMENDMENTS, THERETO

 

The undersigned, duly authorized to represent the persons, firms and
corporations joining and participating in the submission of this Proposal states
that the Proposal contained herein is complete and is in strict compliance with
the requirements of the subject Request for Proposal dated December 16, 2002,
except as noted in Exhibit 1, the “Restricted Services/Exceptions to RFP”
section of the Proposal.  If there are no modifications, deviations or
exceptions, state same as a part of the Proposal Certification Statement:

 

 

oNONE

oIf there are, state YES

 

This proposal remains in effect for 120 days.

 

Any notice required under the Agreement shall be personally delivered or mailed
by first class or certified mail, with proper postage, prepaid, to the Subject
VENDOR at the following address:

 

Company Name:

 

 

 

 

 

Address:

 

 

 

 

 

 

 

 

 

 

 

ATTN:

 

 

 

 

 

 

 

 

Tax Payer ID:

 

 

 

 

 

 

 

 

Submitted by:

 

 

 

 

 

 

 

 

Signature

 

 

 

 

 

 

 

 

Typed Name

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(Title)

 

(Date)

 

27

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NON-COLLUSION AFFIDAVIT

 

The undersigned, duly authorized to represent the persons; firms and
corporations joining and participating in the submission of the foregoing
Proposal (such persons, firms and corporations hereinafter being referred to as
the “VENDOR”), being duly sworn, on his or her oath, states that to the best of
his or her belief and knowledge no person, firm or corporation, nor any person
duly representing the same joining and participating in the submission of the
foregoing Proposal, has directly or indirectly entered into any agreement or
arrangement with any other VENDORS, or with any official of the UNIVERSITY or
any employee thereof, or any person, firm or corporation under contract with the
UNIVERSITY whereby the VENDOR, in order to induce acceptance of the foregoing
Proposal by said UNIVERSITY, has paid or is to pay to any other VENDOR or to any
of the aforementioned persons anything of value whatever, and that the VENDOR
has not, directly or indirectly entered into any arrangement or agreement with
any other VENDOR or VENDORS which tends to or does lessen or destroy free
competition in the letting of the contract sought for by the foregoing Proposal.

 

The VENDOR hereby certifies that neither it, its officers, partners, owners,
providers, representatives, employees and parties in interest, including the
affiant, have in any way colluded, conspired, connived or agreed, directly or
indirectly, with any other proposer, potential proposer, firm or person, in
connection with this solicitation, to submit a collusive or sham bid, to refrain
from bidding, to manipulate or ascertain the price(s) of other proposers or
potential proposers, or to obtain through any unlawful act an advantage over
other proposers or the college.

 

The prices submitted herein have been arrived at in an entirely independent and
lawful manner by the proposer without consultation with other proposers or
potential proposers or foreknowledge of the prices to be submitted in response
to this solicitation by other proposers or potential proposers on the part of
the proposer, its officers, partners, owners, providers, representatives,
employees or parties in interest, including the affiant.

 

CONFLICT OF INTEREST

 

The undersigned proposer and each person signing on behalf of the proposer
certifies, and in the case of a sole proprietorship, partnership or corporation,
each party thereto certifies as to its own organization, under penalty of
perjury, that to the best of their knowledge and belief, no member of the
UNIVERSITY, nor any employee, or person, whose salary is payable in whole or in
part by the UNIVERSITY, has a direct or indirect financial interest in the award
of this Proposal, or in the services to which this Proposal relates, or in any
of the profits, real or potential, thereof, except as noted otherwise herein.

 

Signature

 

 

 

 

 

 

 

Company Name

 

 

 

 

 

 

 

Date

 

 

 

 

 

 

 

 

 

 

 

Subscribed and sworn to before me this

 

 

            day of                   , 2003.

Notary Public in and for the County of                                      ,
State of                                       .

My commission expires:

 

 

 

 

28

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Schedule B

 

INSURANCE REQUIREMENTS

 

                                                                                                   at
its sole expense, shall cause to be issued and maintained in full effect for the
term of this agreement, insurance as set forth hereunder:

 

General Requirements

 

Type of Insurance

 

 

 

Minimum Requirement

1.     Comprehensive General Liability

 

Bodily Injury

 

$500,000 each person

 

 

 

 

$1,000,000 aggregate

 

 

Property Damage

 

$500,000 each occurrence

 

 

 

 

$1,000,000 aggregate

 

 

 

 

Or

 

 

 

 

$3,000,000 Combined Single Limit (CSL)

 

 

 

 

 

2.     Comprehensive Automobile Liability  Bodily Injury (including hired and
non– owned vehicles)

 

$500,000 each person
Property Damage

 

$1,000,000 each accident
$500,000 each accident

or

$3,000,000 Combined Single Limit (CSL)

 

 

 

 

 

3.     Workers’ Compensation (Employers’ Liability)

 

Statutory-Michigan

 

$100,000

 

Maximum Acceptable Deductibles

 

Type of Insurance

 

Deductible

 

 

 

 

 

Comprehensive General Liability

 

$

250

 

Comprehensive Automobile Liability

 

0

 

Workers’ Compensation

 

0

 

 

Coverages

 

1.               All liability policies must be written on an occurrence form.

 

2.               Comprehensive general liability includes, but is not limited
to: consumption or use of products, existence of equipment or machines on
location, and contractual obligations to customers.

 

3.               The Board of Governors, Wayne State University, shall be named
as an additional insured, but only as respects to accidents arising out of said
contact.

 

Certificates of Insurance

 

1.               Certificates of Insurance stating the minimum required
coverages must be forwarded to the Office of Risk Management to be verified and,
authenticated with the agent and/or insurance company.

 

2.               Certificates should contain a statement from the insurer that,
for this contract, the care, custody or control exclusion is waived.

 

3.               Certificates shall be issued on a ACORD form or one containing
the equivalent wording, and require giving WSU a thirty (30) day written notice
of cancellation or material change prior to the normal expiration of coverage.

 

4.               Revised certificates must be forwarded to the Office of Risk
Management thirty (30) days prior to the expiration of any insurance coverage
listed on the original certificate.

 

29

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PRICE SCHEDULE C

 

SUMMARY OF QUOTED RATES

 

30

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SCHEDULE C -Price Schedule
Reply to Wayne State University Request for Proposal
For Genotyping Services

 

NAME OF TEST

 

UNIT PRICE

 

ESTIMATED QUANTITY

 

TOTAL

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Alternate proposals for this solicitation are not acceptable”.

 

The undersigned affirms that the cost of all work is covered by the scope
defined in the RFP dated December 16, 2002.  By submitting this proposal, we
grant Wayne State University and authorized representative(s) the right to
examine, at any time before award, those records, which include books,
documents, accounting procedures and practices, and other data, regardless of
type and form or whether such supporting information is specifically referenced
or included in the proposal as the basis for pricing, that will permit an
adequate evaluation of the proposed price

 

Company Name:

 

 

 

 

 

 

 

 

 

Company Address:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Submitted by:

 

 

 

 

 

 

 

 

 

Signature

 

 

 

 

 

 

 

 

 

Typed Name

 

 

 

 

 

 

(Title)

 

(Date)

 

 

 

 

 

Phone

 

(         )

 

fax (         )

 

31

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Schedule D - Summary Questionnaire

 

 

 

 

YES

 

ALTERNATIVE

1.

Can your company provide services on or before January 24, 2003?

 

 

 

 

 

 

 

 

 

 

2.

Have you provided three (3) references with specific contact names and phone
numbers?’

 

 

 

 

 

 

 

 

 

 

3.

Did your company provide a certificate of insurance to meet or exceed all our
minimum requirements?

 

 

 

 

 

 

 

 

 

 

4.

Did your company provide the required Proposal Certification and Non– Collusion
Affidavit?

 

 

 

 

 

 

 

 

 

 

5.

Did your company complete and provide the Summary Price Schedule C?

 

 

 

 

 

 

 

 

 

 

6.

Did your company complete and provide Schedule E, Statement of Representations
and Certifications?

 

 

 

 

 

 

 

 

 

 

7.

Did your company agree to guarantee to maintain a top priority for the
UNIVERSITY?

 

 

 

 

 

 

 

 

 

 

8.

Please complete the following questions:

 

 

 

 

 

 

 

 

 

 

 

Total number of employees in your company

 

 

 

 

 

 

 

 

 

 

 

Total years in business with this company name

 

 

 

 

 

 

 

 

 

 

9.

Did your company provide financial information under separate cover to the
Director of Purchasing?

 

 

 

 

 

 

 

 

 

 

10.

Are there any conflicts of interest in doing business with the University?

 

 

  Yes

 

 

 

 

 

 

  No

 

 

 

32

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SCHEDULE E

 

REPRESENTATIONS, CERTIFICATIONS
AND OTHER STATEMENTS OF
OFFERORS OR QUOTERS (VENDORS)

 

33

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PART IV - SECTION K
Representations,Certifications, and Other Statements of Offerors or Quoters
(Negotiated).

 

1.  REPRESENTATIONS AND CERTIFICATIONS

 

1.

 

FAR 52.203-2

 

Certification of Independent Price Determination

2.

 

FAR 52.203-11

 

Certification and Disclosure Regarding Payments to Influence Certain Federal
Transactions (DEVIATION)

3.

 

FAR 52.204-3

 

Taxpayer identification

4.

 

FAR 52.204-5

 

Women-Owned Business (Other Than Small Business)

5.

 

FAR 52.204-6

 

Data Universal Numbering System (DUNS) Number

6.

 

FAR 52.209-5

 

Certification Regarding Debarment, Suspension, Proposed Debarment and Other
Responsibility Matters

7.

 

FAR 52.215-6

 

Place of Performance

8.

 

FAR 52.219-1

 

Small Business Program Representations

9.

 

FAR 52.219-19

 

Small Business Concern Representation for the Small Business Competitiveness
Demonstration Program

10.

 

FAR 52.219-21

 

Small Business Size Representation for Targeted Industry Categories Under the
Small Business Competitiveness Demonstration Program

11.

 

FAR 52.219-22

 

Small Disadvantaged Business Status

12.

 

FAR 52.222-18

 

Certification Regarding Knowledge of Child Labor for Listed End Products

13.

 

FAR 52.222-21

 

Certification of Nonsegregated Facilities

14.

 

FAR 52.222-22

 

Previous Contracts and Compliance Reports

15.

 

FAR 52.222-25

 

Affirmative Action Compliance

16.

 

FAR 52.222-38

 

Compliance with veterans’ Employment Reporting Requirements

17.

 

FAR 52.222-48

 

Exemption From Application of Service Contract Act Provisions

18.

 

FAR 52.223-4

 

Recovered Material Certification

19.

 

FAR 52.223-13

 

Certification of Toxic Chemical Release Reporting

20.

 

FAR 52.225-2

 

Buy American Act Certificate

21.

 

FAR 52.225-4

 

Buy American Act-North American Free Trade Agreement—Israeli Trade Act
Certificate

22.

 

FAR 52.225-6

 

Trade Agreements Certificate

23.

 

FAR 52.226-2

 

Historically Black College or University and Minority Institution Representation

24.

 

FAR 52.227-6

 

Royalty Information

25.

 

FAR 52.230-1

 

Cost Accounting Standards Notices and Certification

26.

 

—

 

Certification Regarding Environmental Tobacco Smoke

27.

 

—

 

Certification of Institutional Policy on Conflict of Financial Interest

28.

 

FAR 15.406-2

 

Certificate of Current Cost or Pricing Data

 

To Be Completed by the Offeror: (The Representations and Certifications must be
executed by an individual authorized to bind the offeror.) The offeror makes the
following Representations and Certifications as part of its proposal
(check/complete all appropriate boxes or blanks on the.  following pages).

 

 

 

 

(Name of Offeror)

 

(RFP No.)

 

 

 

 

 

(Signature of Authorized Individual)

(Date)

 

 

(Typed Name of Authorized Individual)

 

 

Note:  The penalty for making false statements in offers is prescribed in 18
U.S.C 1001.

 

34

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29.                               52.203-2 CERTIFICATE OF INDEPENDENT PRICE
DETERMINATION   (APRIL 1985)

 

[NOTE: This provision is applicable when a firm-fixed price or fixed-price with
economic price adjustment contract is contemplated.]

 

(a)                                  The offeror certifies that -

 

(1)                                  The prices in this offer have been arrived
at independently, without, for the purpose of restricting competition, any
consultation, communication, or agreement with any other offeror or competitor
relating to (i) those prices, (ii) the intention to submit an offer, or (iii)
the methods or factors used to calculate the prices offered;

 

(2)                                  The prices in this offer have not been and
will not be knowingly disclosed by the offeror, directly or indirectly, to any
other offeror or competitor before bid opening (in the case of a sealed bid
solicitation) or contract award (in the case of a negotiated solicitation)
unless otherwise required by law; and

 

(3)                                  No attempt has been made or will be made by
the offeror to induce any other concern to submit or not to submit an offer for
the purpose of restricting competition.

 

(b)                                 Each signature on the offer is considered to
be a certification by the signatory that the signatory-

 

(1)                                  Is the person in the offeror’s organization
responsible for determining the prices being offered in this bid or proposal,
and that the signatory has not participated and will not participate in any
action contrary tosubparagraphs (a)(1) through (a)(3) above; or

 

(2)                                                                                 
(i)                                     Has been authorized in writing, to act
as agent for the following principals in certifying that those principals have
not participated, and will not participate in any action contrary to
subparagraphs(a)(1) through (a)(3) above

 

[insert full name of person(s) in the offeror’s organization responsible for
determining the prices offered in this bid or proposal, and the title of his or
her position in the offeror’s organization];

 

(ii)                                  As an authorized agent, does certify that
the principals named in subdivision (b)(2)(i) above have not participated, and
will not participate, in any action contrary to subparagraphs (a)(1) through
(a)(3) above; and

 

(iii)                               As an agent, has not personally
participated, and will not participate, in any action contrary to subparagraphs
(a)(1) through (a)(3) above.

 

(c)                                  If the offeror deletes or modifies
subparagraph (a)(2) above, the offeror must furnish with its offer a signed
statement setting forth in detail the circumstances of the disclosure.

 

30.                               52.203-11 CERTIFICATION AND DISCLOSURE
REGARDING PAYMENTS TO INFLUENCE CERTAIN FEDERAL TRANSACTIONS (DEVIATION)

 

(a)                                  The definitions and prohibitions contained
in the clause, at FAR 52.203-12, Limitations on Payments to Influence Certain
Federal Transactions, included in this solicitation, are hereby incorporated by
reference in paragraph (b) of this certification.

 

(b)                                 The offeror, by signing its offer, hereby
certifies to the best of his or her knowledge and belief that on or after
December 23, 1989 -

 

(1)                                  No Federal appropriated funds have been
paid or will be paid, to any person for influencing or attempting to influence
an officer or employee of any agency, a Member of Congress, an officer or
employee of Congress, or

 

35

--------------------------------------------------------------------------------

 

an employee of a Member of Congress on his or her behalf in connection with the
awarding of a contract resulting from this solicitation.

 

(2)                                  If any funds other than Federal
appropriated funds (including profit or fee received under a covered Federal
transaction) have been paid, or will be paid, to any person for influencing or
attempting to influence an officer or employee of any agency, a Member of
Congress, an officer or employee of Congress, or an employee of a Member of
Congress on his or her behalf in connection with this solicitation, the offeror
shall complete and submit with its offer, OMB Standard Form-LLL, “Disclosure of
Lobbying Activities”, to the Contracting Officer, and

 

(3)                                  He or she will include the language of this
certification in all subcontract awards at any tier and require that all
recipients of subcontract awards in excess of $100,000 shall certify and
disclose accordingly.

 

(c)                                  Submission of this certification and
disclosure is a prerequisite for making or entering into this contract imposed
by section 1352, Title 31, United States Code.  Any person who makes an
expenditure prohibited under this provision or who fails to file or amend the
disclosure form to be filed or amended by this provision, shall be subject to a
civil penalty of not less than $10,000, and not more than $100,000, for each
such failure.

 

31.                               52.204-3 TAXPAYER IDENTIFICATION (OCTOBER
1998) (1)

 

(1)                                  Definitions.

 

Common parent, as used in this provision, means that corporate entity that owns
or controls an affiliated group of corporations that files its Federal income
tax returns on a consolidated basis, and of which the offeror is a member.

 

Taxpayer Identification Number (TIN), as used in this provision, means the
number required by the Internal Revenue Service (IRS) to be used by the offeror
in reporting income tax and other returns.  The TIN may be either a Social
Security Number or an Employer Identification Number.

 

(2)                                  All offerors must submit the information
required in paragraphs (d) through (f) of this provision to comply with debt
collection requirements of 31 U.S.C.  7701(c) and 3325(d), reporting
requirements of 26 U.S.C.  6041, 6041A, and 6050M, and implementing regulations
issued by the IRS.  If the resulting contract is subject to the payment
reporting requirements described in Federal Acquisition Regulation (FAR) 4.904,
the failure or refusal by the offeror to furnish the information may result in a
31 percent reduction of payments otherwise due under the contract.

 

(3)                                  The TIN maybe used by the Government to
collect and report on any delinquent amounts arising out of the offeror’s
relationship with the Government (31 U.S.C.  7701(c)(3)).  If the resulting
contract is subject to the payment reporting requirements described in FAR
4.904, the TIN provided hereunder may be matched with IRS records to verify the
accuracy of the offeror’s TIN.

 

(4)                                  Taxpayer Identification Number (TIN).

 

o                                    TIN:
o                                    TIN has been applied for.
o                                    TIN is not required because:

o                                    Offeror is a nonresident alien, foreign
corporation, or foreign partnership that does not have income effectively
connected with the conduct of a trade or business in the United States and does
not have an office or place of business or a fiscal paying agent in the United
States;

o                                    Offeror is an agency or instrumentality of
a foreign government; [ ] Offeror is an agency or instrumentality of the Federal
Government.

 

36

--------------------------------------------------------------------------------

 

(5)                                  Type of organization.

o Sole proprietorship;

ý Partnership;

o Corporate entity (not tax-exempt);

o Corporate entity (tax-exempt);

o Government entity (Federal, State, or local); o Foreign government;

o International organization per 26 CFR 1.6049-4;

o Other

 

(6)                                  Common parent.

 

o Offeror is not owned or controlled by a common parent as defined in paragraph
(a) of this provision.

o Name and TIN of common parent:

Name

TIN

 

32.                               52.204-5 WOMEN-OWNED BUSINESS (Other-Than
Small Business) (MAY 1999)

 

(a)                                  Definition.  Women-owned business concern,
as used in this provision, means a concern that is at least 51 percent owned by
one or more women; or in the case of any publicly owned business, at least 51
percent of its stock is owned by one or more women; and whose management and
daily business operations are controlled by one or more women.

 

(b)                                 Representation.  (Complete only if the
offeror is a women-owned business concern and has not represented itself as a
small business concern in paragraph (b)(1) of FAR 52.219-1, Small Business
Program Representations, of this solicitation.]

 

The offeror represents that it o is a women-owned business concern.

 

33.                               52.204-.6 DATA UNIVERSAL NUMBERING SYSTEM
(DUNS) NUMBER (JUNE 1999)

 

(a)                                  The offeror shall enter, in the block with
its name and address on the cover page of its offer, the annotation “DUNS”
followed by the DUNS number that identifies the offeror’s name and address
exactly as stated in the offer.  The DUNS number is a nine-digit number assigned
by Dun and Bradstreet Information Services.

 

(b)                                 If the offeror does not have a DUNS number,
it should contact Dun and Bradstreet directly to obtain one.  A DUNS number will
be provided immediately by telephone at no charge to the offeror.  For
information on obtaining a DUNS number, if located within the United States, the
offeror should call Dun and Bradstreet at 1-800-333-0505.  The offeror should be
prepared to provide the following information:

 

(1) Company name.
(2) Company address.
(3) Company telephone number.  (4) Line of business.
(5) Chief executive officer/key manager.
(6) Date the company was started.
(7) Number of people employed by the company.  (8) Company affiliation.

 

(c)                                  Offerors located outside the United States
may obtain the location and phone number of the local Dun and Bradstreet
Information Services office from the Internet home page at
http://www.customerservice@dnb.com.  If an offeror is unable to locate a local
service center, it may send an a-mail to Dun and Bradstreet at
globalinfo@mail.dnb.com.

 

37

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34.          52-.209-5 CERTIFICATION REGARDING DEBARMENT, SUSPENSION, PROPOSED
SUSPENSION, PROPOSED DEBARMENT AND OTHER RESPONSIBILITY MATTERS (DECEMBER 2001)

 

(NOTE: Applies to contracts expected to exceed $100,000.)

 

(a)                                  (1)                                  The
Offeror certifies, to the best of its knowledge and belief, that –

 

(i)                                     The Offeror and/or any of its Principals
-

 

(A)                              Are o, are not o presently debarred, suspended,
proposed for debarment, or declared ineligible for the award of contracts by any
Federal agency;

 

(B)                                Have o, have not o, within a three-year
period preceding this offer, been convicted of or had a civil judgment rendered
against them for: commission of fraud or a criminal offense in connection with
obtaining, attempting to obtain, or performing a public (Federal, state or
local) contract or subcontract; violation of Federal or state antitrust statutes
relating to the submission of offers; or commission of embezzlement, theft,
forgery, bribery, falsification or destruction of records, making false
statements, tax evasion, or receiving stolen property; and

 

(C)                                Are o, are not o presently indicted for, or
otherwise criminally or civilly charged by a governmental entity with,
commission of any of the offenses enumerated in subdivision (a)(1)(i)(B) of this
provision.

 

(ii)                                  The Offeror has o, has not o, within a
three-year period preceding this offer, had one or more contracts terminated for
default by any Federal agency.

 

(2)                                  “Principals” for the purposes of this
certification, means officers; directors; owners; partners; and, persons having
primary management or supervisory responsibilities within a business entity
(e.g., general manager, plant manager, head of a subsidiary, division, or
business segment, and similar positions).

 

THIS CERTIFICATION CONCERNS A MATTER WITHIN THE JURISDICTION OF AN AGENCY OF THE
UNITED STATES AND THE MAKING OF A FALSE, FICTITIOUS, OR FRAUDULENT CERTIFICATION
MAY RENDER THE MAKER SUBJECT TO PROSECUTION UNDER SECTION 1001, TITLE 18, UNITED
STATES CODE.

 

(b)                                 The Offeror shall provide immediate written
notice to the Contracting Officer if, at any time prior to contract award, the
Offeror learns that its certification was erroneous when submitted or has become
erroneous by reason of changed circumstances.

 

(c)                                  A certification that any of the items in
paragraph (a) of this provision exists will not necessarily result in
withholding of an award under this solicitation.  However, the certification
will be considered in connection with a determination of the Offeror’s
responsibility.  Failure of the Offeror to furnish a certification or provide
such additional information as requested by the Contracting Officer may render
the Offeror nonresponsible.

 

(d)                                 Nothing contained in the foregoing shall be
construed to require establishment of a system of records in order to render, in
good faith, the certification required by paragraph (a) of this provision.  The
knowledge and information of an Offeror is not required to exceed that which is
normally possessed by a prudent person in the ordinary course of business
dealings.

 

(e)                                  The certification in paragraph (a) of this
provision is a material representation of fact upon which reliance was placed
when making an award.  If it is later determined that the Offeror knowingly
rendered an erroneous certification, in

 

38

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addition to other remedies available to the Government, the Contracting Officer
may terminate the contract resulting from this solicitation for default.

 

35.                               52.215-6 PLACE OF PERFORMANCE (OCTOBER 1997)

 

(a)                                  The offeror or respondent, in the
performance of any contract resulting from this solicitation, o intends, o does
not intend (check applicable block) to use one or more plants or facilities
located at a different address from the address of the offeror or respondent as
indicated in this proposal or response to request for information.

 

(b)                                 If the offeror or respondent checks
“intends” in paragraph (a) of this provision, it shall insert in the following
spaces the required information:

 

Place of Performance (Street Address
(City, State, County, Zip Code)

 

Name and Address of Owner and Operator of the Plant or Facility if Other than
Offeror or Respondent

 

36.                               52.219-1 SMALL BUSINESS PROGRAM
REPRESENTATIONS (APRIL 2002)

 

(Note: This provision applies to solicitations exceeding the micro-purchase
threshold when the contract is to be performed in the United States, its
territories or possessions, Puerto Rico, the Trust Territory of the Pacific
Islands, or the District of Columbia.)

 

(a)                                  (1)                                  The
North American Industry Classification System (NAICS) code for this acquisition
is [INSERT NAICS CODE).

 

(2)                                  The small business size standard is [INSERT
SIZE STANDARD1 .

 

(3)                                  The small business size standard for a
concern which submits an offer in its own name, other than on a construction or
service contract, but which proposes to furnish a product which it did not
itself manufacture, is 500 employees.

 

(b)                                 Representations.

 

(1)                                  The offeror represents as part of its offer
that it o is, o is not a small business concern.

 

(2)                                  (Complete only if the offeror represented
itself as a small business concern in paragraph (b)(1) of this provision.) The
offeror represents, for general statistical purposes, that it o is, o is not a
small disadvantaged business concern as defined in 13 CFR 124.1002.

 

(3)                                  (Complete only if the offeror represented
itself as a small business concern in paragraph (b)(1) of this provision.) The
offeror represents as part of its offer that it o is, o is not a women-owned
small business concern.

 

(4)                                  (Complete only if the offeror represented
itself as a small business concern in paragraph (b)(1) of this provision.) The
offeror represents as part of its offer that it o is, o is not a veteran-owned
small business concern.

 

(5)                                  (Complete only if the offeror represented
itself as a veteran-owned small business concern in paragraph (b)(4) of this
provision.) The offeror represents as part of its offer that it o is, o is not a
service-disabled veteran-owned small business concern.

 

(1)                                  (Complete only if the offeror represented
itself a small business concern in paragraph (b)(1) of this provision.) The
offeror represents , as a part of its offeror, that

 

39

--------------------------------------------------------------------------------

 

(1)                                  It o is, o is not a HUBZone small business
concern listed, on the date of this representation, on the List of Qualified
HUBZone Small Business Concerns maintained by the Small business Administration,
and no material change in ownership and control, principal office, or HUBZone
employee percentage has occurred since it was certified by the Small Business
Administration in accordance with 13 CFR part 126; and

 

(2)                                  It o is, o is not a joint venture that
complies with the requirements of 13 CFR part 126, and the representation in
paragraph (b) (6) (i) of this provision is accurate for the HUBZone small
business concern or concerns that are participating in the joint venture.  (The
offeror shall enter the name or names of the HUBZone small business concern or
concerns that are participating in the joint venture: ]  Each HUBZone small
business concern participating in the joint venture shall submit a separate
signed copy of the HUBZone representation.

 

(c)                                  Definitions.  As used in this provision-

 

Service-disabled veteran-owned small business concern-

 

(1)                                  Means a small business concern-

 

(i)                                     Not less than 51 percent of which is
owned by one or more service-disabled veterans or, in the case of any publicly
owned business, not less than 51 percent of the stock or which is owned by one
or more service-disabled veterans; and

 

(ii)                                  The Management and daily business
operation of which are controlled by one or more servicedisabled veterans or, in
the case of a veteran with permanent and severe disability, the spouse or
permanent caregiver of such veteran.

 

(2)                                  Service-disabled veteran means a veteran,
as defined in 38 U.S.C.  101(2), with a disability that is service connected, as
defined in 38 U.S.C.  101(16).

 

Small business concern, means a concern, including its affiliates, that is
independently owned and operated, not dominant in the field of operation in
which it is bidding on Government contracts, and qualified as a small business
under the criteria in 13 CFR Part 121 and the size standard in paragraph (a) of
this provision.

 

Women-owned small business concern, means a small business concern-

 

(1)                                  That is at least 51 percent owned by one or
more women; or, in the case of any publicly owned business, at least 51 percent
of the stock of which is owned by one or more women; and

 

(2)                                  Whose management and daily business
operations are controlled by one or more women.

 

Veteran-owned small business concern means a small business concern-

 

(1)                                  Not less than 51 percent of which is owned
by one or more veterans (as defined at 38 U.S.  C.  101(2)) or, in the case of
any publicly owned business, not less than 51 percent of the stock of which is
owned by one or more veterans; and

 

(2)                                  The management and daily business
operations of which are controlled by one or more veterans.

 

40

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(d)                                 Notice.

 

(1)                                  If this solicitation is for supplies and
has been set aside, in whole or in part, for small business concerns, then the
clause in this solicitation providing notice of the set-aside contains
restrictions on the source of the end items to be furnished.

 

(2)                                  Under 15 U.S.C.  645(d), any person who
misrepresents a firm’s status as a small, HUBZone small, small disadvantaged, or
women-owned small business concern in order to obtain a contract to be awarded
under the preference programs established pursuant to section 8(a), 8(d), 9, or
15 of the Small Business Act or any other provision of Federal law that
specifically references section 8(d) for a definition of program eligibility,
shall

 

(i)                                     Be punished by imposition of fine,
imprisonment, or both;

 

(ii)                                  Be subject to administrative remedies,
including suspension and debarment; and

 

(iii)                               Be ineligible for participation in programs
conducted under the authority of the Act.

 

37.                               52.219-19 SMALL BUSINESS CONCERN
REPRESENTATION FOR THE SMALL BUSINESS COMPETITIVENESS DEMONSTRATION PROGRAM
(OCTOBER 2000)

 

(This representation must be completed if the acquisition is for one of the four
designated industry groups of the Small Business Competitiveness Demonstration
Program specified in FAR 19.1005(a) (includes Construction Contracts under NAICS
codes that comprise Industry Subsectors 233, 234 and 235].)

 

(a)                                  Definition

 

“Emerging small business” as used in this solicitation, means a small business
concern whose size is no greater than 50 percent of the numerical size standard
applicable to the North American Industry Classification System (NAICS) code
assigned to a contracting opportunity.

 

(b)                                 (Complete only if offeror has represented
itself under the provision at FAR 52.219-1 as a small business concern under the
size standards of this solicitation.)

 

The Offeror o is, o is not an emerging small business.

 

(c)                                  (Complete only if the Offeror is a small
business or an emerging small business, indicating its size range.)

 

Offeror’s number of employees for the past twelve months (check this column if
size standard stated in solicitation is expressed in terms of number of
employees) or Offeror’s average annual gross revenue for the last 3 fiscal years
(Check this column if size standard stated in solicitation is expressed in terms
of annual receipts).  (Check one of the following.)

 

Number of Employees

 

Average Annual Gross Revenues

 

 

 

o                 50 or fewer

 

o $1 million or less

o                 51-100

 

o $1,000,001 - $2 million

o                 101-250

 

o $2,000,001 - $3.5 million

o                 251- 500

 

o $3,500,001 - $5 million

o                 501 - 750

 

o $5,000,001 - $10 million

o                 751-1,000

 

o $10,000,001 - $17 million

o                 Over 1,000

 

o Over $17 million

 

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38.  52.219-21 SMALL BUSINESS SIZE REPRESENTATION FOR TARGETED INDUSTRY
CATEGORIES UNDER THE SMALL BUSINESS COMPETITIVENESS DEMONSTRATION PROGRAM (MAY
1999)

 

(Complete only if the Offeror has represented itself under the provision
52.219-1 as a small business concern under the size standards of this
solicitation.)

 

(NOTE: This representation must be completed if this solicitation covers one of
the ten targeted industry categories under the Small Business Competitiveness
Demonstration Program and if the offeror has certified itself under the clause
at FAR 52.219-1 to be a small business concern under the size standards of this
solicitation).

 

Offeror’s number of employees for the past twelve months (check this column if
size standard stated in solicitation is expressed in terms of number of
employees) or Offeror’s average annual gross revenue for the last three fiscal
years (check this column if size standard stated in solicitation is expressed in
terms of annual receipts).  (Check one of the following.)

 

Number of Employees

 

Average Annual Gross Revenues

 

 

 

o 50 or fewer

 

o $1 million or less

o 51-100

 

o $1,000,001- $2 million

o 101-250

 

o $2,000,001 - $3.5 million

o 251-500

 

o $3,500,001 - $5 million

o 501-750

 

o $5,000,001 - $10 million

o 751-1,000

 

o $10,000,001 - $17 million

o Over 1,000

 

o Over $17 million

 

The ten targeted industries are as follows:

 

Product Service Code

 

SIC Code

 

Description

 

 

 

 

 

G004

 

8742

 

Counseling/Training/Social Rehabilitation Services

J099

 

7699

 

Maintenance, Repair and Rebuilding of Equipment (Office Machines, Text
Processing Systems & Visible Record Equipment)

K099

 

7699

 

Modification of Equipment (misc.)

Q210

 

8099,8742

 

General Health Care Services

R406

 

8742

 

Policy Review/Development Services

R497

 

7299

 

Personal Services

6505

 

2833,2834

 

Drugs and Biologics

 

 

2835,2836

 

 

7045

 

3572,3695

 

ADP Supplies

 

 

5065

 

 

7110

 

5021

 

Office Furniture

7510

 

5112

 

Office Supplies

 

39.  52.219-22 SMALL DISADVANTAGED BUSINESS STATUS

 

(Note: This applies to competitive solicitations over $100,000 under the SIC
Major Groups for which a price evaluation adjustment is applicable.)

 

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(a)                                  General.  This provision is used to assess
an offeror’s small disadvantaged business status for the purpose of obtaining a
benefit on this solicitation.  Status as a small business and status as a small
disadvantaged business for general statistical purposes is covered by the
provision at FAR 52.219-1, Small Business Program Representation.

 

(b)                                 Representations

 

(1)                                  General.  The offeror represents, as part
of its offer, that it is a small business under the size standard applicable to
this acquisition; and either–

 

o            (i)             It has received certification by the Small Business
Administration as a small disadvantaged business concern consistent with 13 CFR
124, Subpart B; and

 

(A)                              No material change in disadvantaged ownership
and control has occurred since its certification;

 

(B)                                Where the concern is owned by one or more
disadvantaged individuals, the net worth of each individual upon whom the
certification is based does not exceed $750,000 after taking into account the
applicable exclusions set forth at 13 CFR 124.104(c)(2); and

 

(C)                                It is identified, on the date of its
representation, as a certified small disadvantaged business concern in the
database maintained by the Small Business Administration (PRO Net); or

 

o            (ii)          It has submitted a completed application to the Small
Business Administration or a Private Certifier to be certified as a small
disadvantaged business concern in accordance with 13 CFR 124, Subpart B, and a
decision on that application is pending, and that no material change in
disadvantaged ownership and control has occurred since its application was
submitted.

 

(2)                                  o                                    For
Joint Ventures.  The offeror represents, as part of its offer, that it is a
joint venture that complies with the requirements at 13 CFR 124.1002(f) and that
the representation in paragraph (b)(1) of this provision is accurate for the
small disadvantaged business concern that is participating in the joint
venture.  [The offeror shall enter the name of the small disadvantaged business
concern that is participating in the joint venture:                     ]

 

(c)                                  Penalties and Remedies.  Anyone who
misrepresents any aspects of the disadvantaged status of a concern for the
purposes of securing a contract or subcontract shall:

 

(1)                                  Be punished by imposition of a fine,
imprisonment, or both;

 

(2)                                  Be subject to administrative remedies,
including suspension and debarment; and

 

(3)                                  Be ineligible for participation in programs
conducted under the authority of the Small Business Act.

 

Alternate I (OCTOBER 1998)

 

(Note: Applies when price evaluation adjustment for small disadvantaged business
concerns is authorized on a regional basis.  Designated regions by Major SIC
Category can be found at http://www.arnet.pov/Referencestsdbadjustments.htm. 
Currently, this includes SIC Major Industry Groups 15, 16, 17 which are all
construction related groups.)

 

As prescribed in 19.306(b), add the following paragraph (b)(3) to the basic
provision:

 

(3)                                  Address.  The offeror represents that its
address          is,          is not in a region for which a small disadvantaged
business procurement mechanism is authorized and its address has not changed
since its certification as a small disadvantaged business concern or submission
of its application for certification.  The

 

43

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list of authorized small disadvantaged business procurement mechanisms and
regions is posted at http://www.arnet.gov/References/sdbadiustments.htm  The
offeror shall use the list in effect on the date of this solicitation. 
“Address,” as used in this provision, means the address of the offeror as listed
on the Small Business Administration’s register of small disadvantaged business
concerns or the address on the completed application that the concern has
submitted to the Small Business Administration or a Private Certifier in
accordance with 13 CFR part 124, subpart B.  For joint ventures, “address”
refers to the address of the small disadvantaged business concern that is
participating in the joint venture.

 

40.                               52.222-i8 CERTIFICATION REGARDING KNOWLEDGE OF
CHILD LABOR FOR LISTED END PRODUCTS (MAY 2001)

 

(Applies to all contracts for supplies over $2,500.  See FAR 22.1503 for more
information)

 

1.  Definition.

 

Forced or indentured child labor means all work or service-

 

(1)                                  Exacted from any person under the age of 18
under the menace of any penalty for its nonperformance and for which the worker
does not offer himself voluntarily; or

 

(2)                                  Performed by any person under the age of 18
pursuant to a contract the enforcement of which can be accomplished by process
or penalties.

 

2.                                       Listed end products.  The following end
product(s) being acquired under this solicitation is (are) included in the List
of Products Requiring Contractor Certification as to Forced or Indentured Child
Labor, identified by their country of origin.  There is a reasonable basis to
believe that listed end products from the listed countries of origin may have
been mined, produced, or manufactured by forced or indentured child labor.

 

Listed End Product

 

Listed Countries of Origin

 

3.                                       Certification.  The Government will not
make award to an offeror unless the offeror, by checking the appropriate block,
certifies to either paragraph (c) (1) or paragraph (c) (2) of this provision.

 

o            (1)          The offeror will not supply any end product listed in
paragraph (b) of this provision that was mined, produced, or manufactured in a
corresponding country as listed for that end product.

 

o            (2)          The offeror may supply an end product listed in
paragraph (b) of this provision that was mined, produced, or manufactured in the
corresponding country as listed for that product.  The offeror certifies that it
has made a good faith effort to determine whether forced or indentured child
labor was used to mine, produce, or manufacture such end product.  On the basis
of those efforts, the offeror certifies that it is not aware of any such use of
child labor.

 

13.  52.222-21  CERTIFICATION OF NONSEGREGATED FACILITIES (FEBRUARY 1999)

 

(a)                                  Segregated facilities, as used in this
clause, means any waiting rooms, work areas, rest rooms and wash rooms,
restaurants and other eating areas, time clocks, locker rooms and other storage
or dressing areas, parking lots, drinking fountains, recreation or entertainment
areas, transportation, and housing facilities provided for employees, that are
segregated by explicit directive or are in fact segregated on the basis of race,
color, religion, sex, or national origin because of written or oral policies or
employee custom.  The term does not include separate or single-user rest rooms
or necessary dressing or sleeping areas provided to assure privacy between the
sexes.

 

44

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(b)                                 The Contractor agrees that it does not and
will not maintain or provide for its employees any segregated facilities at any
of its establishments, and that it does not and will not permit its employees to
perform their services at any location under its control where segregated
facilities are maintained.  The Contractor agrees that a breach of this clause
is a violation of the Equal Opportunity clause in this contract.

 

(c)                                  The Contractor shall include this clause in
every subcontract and purchase order that is subject to the Equal Opportunity
clause of this contract.

 

14.  52.222-22 PREVIOUS CONTRACTS AND COMPLIANCE REPORTS (FEBRUARY 1999)

 

The offeror represents that -

 

(a)                                  It o has, o has not participated in a
previous contract or subcontract subject to the Equal Opportunity clause of this
solicitation;

 

(b)                                 It o has, o has not, filed all required
compliance reports; and

 

(c)                                  Representations indicating submission of
required compliance reports, signed by proposed subcontractors, will be obtained
before subcontract awards.

 

15.  52.222-25 AFFIRMATIVE ACTION COMPLIANCE (APRIL 1984)

 

The offeror represents that (a) it o has developed and has on file, o has not
developed and does not have on file, at each establishment, affirmative action
programs required by the rules and regulations of the Secretary of Labor (41 CFR
60-1 and 60-2), or (b) it o has not previously had contracts subject to the
written affirmative action programs requirement of the rules and regulations of
the Secretary of Labor.

 

16.  52.222-38 COMPLIANCE WITH VETERANS’ EMPLOYMENT REPORTING REQUIREMENTS
(DECEMBER 2001)

 

By submission of its offer, the offeror represents that, if it is subject to the
reporting requirements of 38 U.S.C.  4212(d) (i.e., if it has any contract
containing Federal Acquisition Regulation clause 52.222-37, Employment Reports
on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible
Veterans), it has submitted the most recent VETS100 Report required by that
clause.

 

17.  52.222-48 EXEMPTION FROM APPLICATION OF SERVICE CONTRACT ACT PROVISIONS FOR
CONTRACTS FOR MAINTENANCE, CALIBRATION, AND/OR REPAIR OF CERTAIN INFORMATION
TECHNOLOGY, SCIENTIFIC AND MEDICAL AND/OR OFFICE AND BUSINESS
EQUIPMENT–CONTRACTOR CERTIFICATION (AUGUST 1996)

 

(NOTE: This clause is applicable to all solicitations and resultant contracts
calling for maintenance, calibration, and/or repair of information technology,
scientific and medical, and office and business equipment if the contracting
officer determines that the resultant contract may be exempt from Service
Contract Act coverage).

 

(a)                                  The following certification shall be
checked:

 

CERTIFICATION

 

The offeror certifies o, does not certify o that: (1) The items of equipment to
be serviced under this contract are commercial items which are used regularly
for other than Government purposes, and are sold or traded by the Contractor in
substantial quantities to the general public in the course of normal business
operations; (2) The contract services are furnished at prices which are, or are
based on, established catalog or market prices for the maintenance, calibration,
and/or repair of certain information technology, scientific and medical, and/or
office and business

 

45

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equipment.  An “established catalog price” is a price (including discount price)
recorded in a catalog, price list schedule, or other verifiable and established
record that is regularly maintained by the manufacturer or the Contractor and is
either published or otherwise available for inspection by customers.  An
“established market price” is a current price, established in the usual course
of ordinary and usual trade between buyers and sellers free to bargain, which
can be substantiated by data from sources independent of the manufacturer or
Contractor; and (3) The Contractor utilizes the same compensation (wage and
fringe benefits) plan for all service employees performing work under the
contract as the Contractor uses for equivalent employees servicing the same
equipment of commercial customers.

 

(b)                                 If a negative certification is made and a
Service Contract Act wage determination is not attached to the solicitation, the
Contractor shall notify the Contracting Officer as soon as possible.

 

(c)                                  Failure to execute the certification in
paragraph (a) of this clause onto contact the Contracting Officer as required in
paragraph (b) of this clause may render the bid or offer nonresponsive.

 

18.  52.223-4  RECOVERED MATERIAL CERTIFICATION (OCTOBER 1997)

 

(This certification is applicable in solicitations that are for, or specify the
use, of recovered materials.)

 

As required by the Resource Conservation and Recovery Act of 1976 (42 U.S.C. 
6962(c)(3)(A)(i)), the offeror certifies, by signing this offer, that the
percentage of recovered materials to be used in the performance of the contract
will be at least the amount required by the applicable contract specifications.

 

19.  52.223-13  CERTIFICATION OF TOXIC CHEMICAL RELEASE REPORTING (OCTOBER 2000)

 

NOTE: This certification is applicable for all solicitations for competitive
contracts expected to exceed $100,000 (including all options) and competitive
8(a) contracts.  It is not applicable to acquisitions of commercial items, or to
contracts where the contractor’s facilities are located outside the United
States (the “United States” includes any state of the United States, the
District of Columbia, the Commonwealth of Puerto Rico, Guam, American Samoa, the
United States Virgin Islands, the Northern Mariana Islands, and any other
territory or possession over which the United States has jurisdiction)

 

(a)                                  Submission of this certification is a
prerequisite for making or entering into this contract imposed by Executive
Order 12969, August 8, 1995.

 

(b)                                 By signing this offer, the offeror certifies
that-

 

(1)                                  As the owner or operator of facilities that
will be used in the performance -of this contract that are subject to the filing
and reporting requirements described in section 313 of the Emergency Planning
and Community Right-to-Know Act of 1986 (EPCRA) (42 U.S.C.  11023) and section
6607 of the Pollution Prevention Act of 1990 (PPA) (42 U.S.C.  13106), the
offeror will file and continue to file for such facilities for the life of the
contract the Toxic Chemical Release Inventory Form (Form R) as described in
sections 313(a) and (g) of EPCRA and section 6607 of PPA; or

 

(2)                                  None of its owned or operated facilities to
be used in the performance of this contract is subject to the Form R filing and
reporting requirements because each such facility is exempt for at least one of
the following reasons: (Check each block that is applicable.)

 

o            (i)                       The facility does not manufacture,
process, or otherwise use any toxic chemicals listed under section 313(c) of
EPCRA, 42 U.S.C.  11023(c);

 

o            (ii)                    The facility does not have 10 or more
full-time employees as specified in section 313(b)(1)(A) of EPCRA, 42 U.S.C. 
11023(b)(1)(A);

 

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o            (iii)                 The facility does not meet the reporting
thresholds of toxic chemicals established under section 313(f) of EPCRA, 42
U.S.C.  11023(f) (including the alternate thresholds at 40 CFR 372.27, provided
an appropriate certification form- has been filed with EPA);

 

o            (iv)                The facility does not fall within Standard
Industrial Classification Code (SIC) major groups 20 through 39 or their
corresponding North American Industry Classification System (NAICS) sectors 31
through 33; or

 

o            (v)                   The facility is not located within any State
of the United States, the District of Columbia, the Commonwealth of Puerto Rico,
Guam, American Samoa, the United States Virgin Islands, the Northern
Mariana-Islands, or any other territory or possession over which the United
States has jurisdiction.

 

20.  52.225-2  BUY AMERICAN ACT CERTIFICATE (MAY 2002)

 

[Note: This provision is applicable for all requirements EXCEPT for 1) foreign
contracts or 2) when one of the following two provisions (52.225-4, Buy American
Act–North American Free Trade Agreement—Israeli Trade Act Certificate, or
52.225-6, Trade Agreements Certificate) apply.

 

(a)                                  The offeror certifies that each end
product, except those listed in paragraph (b) of this provision, is a domestic
end product as defined in the clause of this solicitation entitled `Buy American
Act—Supplies” and that the offeror has considered components of unknown origin
to have been mined, produced, or manufactured outside the United States.  The
offeror shall list as foreign end products those end products manufactured in
the United States that do not qualify as domestic end products.

 

(b)                                 Foreign End Products:

 

Line Item No.:
Country of Origin:
                                                (List as necessary)

 

(c)                                  The Government will evaluate offers in
accordance with the policies and procedures of Part 25 of the Federal
Acquisition Regulation.

 

21.  52.225-4  BUY AMERICAN ACT NORTH AMERICAN FREE TRADE AGREEMENT—ISRAELI
TRADE ACT CERTIFICATE (MAY 2002)

 

[Note: This provision is applicable for requirements with a value of $25,000 or
more but less than $169,000 EXCEPT for 1) foreign acquisitions or 2)
acquisitions that are exempt from NAFTA and the Israeli Trade Act.  (See FAR
25.401).]

 

(a)                                  The offeror certifies that each end
product, except those listed in paragraph (b) or (c) of this provision, is a
domestic end product (as defined in the clause of this solicitation entitled,
`Buy American Act—North American Free Trade Agreement–Israeli Trade Act”) and
that the offeror has considered components of unknown origin to have been mined,
produced, or manufactured outside the United States.

 

(b)                                 The offeror certifies that the following
supplies are NAFTA country end products or Israeli end products as defined in
the clause of this solicitation entitled, `Buy American Act—North American Free
Trade Agreement—Israeli Trade Act”:

 

47

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NAFTA Country or Israeli End Products:

Line Item No.:
Country of Origin:

(List as necessary)

 

(c)                                  The offeror shall list those supplies that
are foreign end products (other than those listed in paragraph (b) of this
provision) as defined in the clause of this solicitation entitled, “Buy American
Act—North American Free Trade Agreement—Israeli Trade Act.” The offeror shall
list as other foreign end products those end products manufactured in the United
States that do not qualify as domestic end products.

 

Other Foreign End Products
Line Item No.:
Country of Origin:

(List as necessary)

 

(d)                                 The Government will evaluate offers in
accordance with the policies and procedures of Part 25 of the Federal
Acquisition Regulation.

 

ALTERNATE I (MAY 2002) As prescribed in 25.1101(b)(2)(ii), substitute the
following paragraph (b) for paragraph (b) of the basic provision:

 

[Note: Applies when the acquisition value is $25,000 or more but is less than
$50,000.]

 

(b)                                 The offeror certifies that the following
supplies are Canadian end products as defined in the clause of this solicitation
entitled `Buy American Act—North American Free Trade Agreement—Israeli Trade
Act”:

 

Canadian End Products:
Line Item No.:

(List as necessary)

 

ALTERNATE II (MAY 2002) As prescribed in 25.1101(b)(2)(iii), substitute the
following paragraph (b) for paragraph (b) of the basic provision:

 

[Note: Applies when the acquisition value is $50,000 or more, but is less than
$56,190.]

 

(b)                                 The offeror certifies that the following
supplies are Canadian end products or Israeli end products as defined in the
clause of this solicitation entitled `Buy American Act-North American Free Trade
Agreement—Israeli Trade Act”:

 

Canadian or Israeli End Products
Line Item No.:
Country of Origin:
                                                (List as necessary)

 

22.  52.225-6  TRADE AGREEMENTS CERTIFICATE - (MAY 2002)

 

(Note: This provision is applicable for acquisitions valued at $169,000 or more,
if the Trade Agreement Act applies.  (See FAR 25.401 and 25.403).]

 

(a)                                  The offeror certifies that each end
product, except those listed in paragraph (b) of this provision, is a U.S.-made,
designated country, Caribbean Basin country, or NAFTA country end product, as
defined in the clause of this solicitation entitled “Trade Agreements.”

 

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(b)                                 The offeror shall list as other end products
those supplies that are not U.S: made, designated country, Caribbean Basin
country, or NAFTA country end products.

 

Other End Products
Line Item No.:
Country of Origin:

(List as necessary)

 

(c)                                  The Government will evaluate offers in
accordance with the policies and procedures of Part 25 of the Federal
Acquisition Regulation.  For line items subject to the Trade Agreements Act, the
Government will evaluate offers of U.S: made, designated country, Caribbean
Basin country, or NAFTA country end products without regard to the restrictions
of the Buy American Act.  The Government will consider for award only offers of
U.S.-made, designated country, Caribbean Basin country, or NAFTA country end
products unless the Contracting Officer determines that there are no offers for
those products or that the offers for those products are insufficient to fulfill
the requirements of this solicitation.

 

23.  52.226-2.  HISTORICALLY BLACK COLLEGE OR UNIVERSITY AND MINORITY
INSTITUTION REPRESENTATION - (MAY 2001)

 

(a)                                  Definitions.  As used in this provision-

 

Historically Black College or University means an institution determined by the
Secretary of Education to meet the requirements of 34 CFR 608.2.  For the
Department of Defense, the National Aeronautics and Space Administration, and
the Coast Guard, the term also includes any nonprofit research institution that
was an integral part of such a college or university before November 14, 1986.

 

Minority Institution means an institution of higher education meeting the
requirements of Section 1046(3) of the Higher Education Act of 1965 (20 U.S.C. 
1067k, including a Hispanic-serving institution of higher education, as defined
in Section 316(b)(1) of the Act (20 U.S.C.  I101a.)).

 

(b)                                 Representation.  The offeror represents that
it-

 

o is o is not a Historically Black College or University;
o is o is not a Minority Institution.

 

24.  52.227-6  ROYALTY INFORMATION - (APRIL 1984)

 

(a)                                  Cost or charges for royalties.  When the
response to this solicitation contains costs or charges for royalties totaling
more than $250, the following information shall be included in the response
relating to each separate item of royalty or license fee:

 

(1)                                  Name and address of licensor.

(2)                                  Date of license agreement.

(3)                                  Patent numbers, patent application serial
numbers or other basis on which the royalty is payable.

(4)                                  Brief description, including any part or
model numbers of each contract item or component on which the royalty is
payable.

(5)                                  Percentage or dollar rate of royalty per
unit.

(6)                                  Unit price of contract item.

(7)                                  Number of units.

(8)                                  Total dollar amount of royalties.

 

(b)                                 Copies of current licenses.  In addition, if
specifically requested by the Contracting officer before execution of the
contract, the offeror shall furnish a copy of the current license agreement and
an identification of applicable claims of specific patents.

 

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(NOTE: Alternate I, below, is applicable for communication services and
facilities by a common carrier.)

 

ALTERNATE I (APRIL 1984), 52.227-6 ROYALTY INFORMATION, (APRIL 1984)

 

Substitute the following for the introductory portion of paragraph (a) of the
basic clause:

 

When the response to this solicitation covers charges for special construction
or special assembly that contain costs or charges for royalties totaling more
than $250, the following information shall be included in the response relating
to each separate item of royalty or license fee:

 

25.  52.230-1  COST ACCOUNTING STANDARDS NOTICES AND CERTIFICATION (JUNE 2000)

 

Note: This notice does not apply to small businesses or foreign governments. 
This notice is in three parts, identified by Roman numerals I through III.

 

Offerors shall examine each part and provide the requested information in order
to determine Cost Accounting Standards (CAS) requirements applicable to any,
resultant contract.

 

If the offeror is an educational institution, Part II does not apply unless the
contemplated contract will be subject to full or modified CAS-coverage pursuant
to 48 CFR 9903.201-2(C)(5) or 9903.2012(c)(6), respectively.

 

I.                                         Disclosure Statement – Cost
Accounting Practices and Certification

 

(a)                                  Any contract in excess of $500,000
resulting from this solicitation will be subject to the requirements of the Cost
Accounting Standards Board (48 CFR Chapter 99), except for those contracts which
are exempt as specified in 9903.201-1.

 

(b)                                 Any offeror submitting a proposal which, if
accepted, will result in a contract subject to the requirements of 48 CFR
Chapter 99 must, as a condition of contracting, submit a Disclosure Statement as
required by 9903.202.  When required, the Disclosure Statement must be submitted
as a part of the offeror’s proposal under this solicitation unless the offeror
has already submitted a Disclosure Statement disclosing the practices used in
connection with the pricing of this proposal.  If an applicable Disclosure
Statement has already been submitted, the offeror may satisfy the requirement
for submission by providing the information requested in paragraph (c) of Part I
of this provision.

 

CAUTION: In the absence of specific regulations or agreement, a practice
disclosed in a Disclosure Statement shall not, by virtue of such disclosure, be
deemed to be a proper, approved, or agreed-to practice for pricing proposals or
accumulating and reporting contract performance cost data.

 

(c)                                  Check the appropriate box below:

 

o            (1)          Certificate of Concurrent Submission of Disclosure
Statement.

 

The offeror hereby certifies that, as part of the offer, copies of the
Disclosure Statement have been submitted as follows:

 

(i)                                     original and one copy to the cognizant
Administrative Contracting Officer (ACO), or cognizant Federal agency official
authorized to act in that capacity (Federal official), as applicable, and;

 

(ii)                                  one copy to the cognizant Federal auditor.

 

(Disclosure must be on Form No.  CASB DS-1 or CASB DS-2, as applicable..  Forms
may be obtained from the cognizant ACO or Federal official and/or from the
looseleaf version of the Federal Acquisition Regulation).

 

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Date of Disclosure Statement:
Name and Address of Cognizant ACO or Federal Official Where Filed:

 

The offeror further certifies that the practices used in estimating costs in
pricing this proposal are consistent with the cost accounting practices
disclosed in the Disclosure Statement.

 

o            (2)          Certificate of Previously Submitted Disclosure
Statement.

 

The offeror hereby certifies that the required Disclosure Statement was filed as
follows:

 

Date of Disclosure Statement:
Name and Address of Cognizant ACO or Federal Official Where Filed:

 

The offeror further certifies that the practices used in estimating costs in
pricing this proposal are consistent with the cost accounting practices
disclosed in the applicable Disclosure Statement.

 

o            (3)          Certificate of Monetary Exemption.

 

The offeror hereby certifies that the offeror together with all divisions,
subsidiaries, and affiliates under common control, did not receive net awards of
negotiated prime contracts and subcontracts subject to CAS totaling more than
$50 million or more in the cost accounting period immediately preceding the
period in which this proposal was submitted.  The offeror further certifies that
if such status changes before an award resulting from this proposal, the offeror
will advise the Contracting Officer immediately.

 

o            (4)          Certificate of Interim Exemption.

 

The offeror hereby certifies that:

 

(I)  the offeror first exceeded the monetary exemption or disclosure, as defined
in (3) of this subsection, in the cost accounting period immediately preceding
the period in which this offer was submitted, and

 

(ii) in accordance with 48 CFR 9903.202-1, the offeror is not yet required to
submit a Disclosure Statement.  The offeror further certifies that if an award
resulting from this proposal has not been made within 90 days after the end of
that period, the offeror will immediately submit a revised certificate to the
Contracting Officer, in the form specified under subparagraph (c)(1) or (c)(2)
of Part I of this provision, ass appropriate, to verify submission of a
completed Disclosure Statement.

 

CAUTION: Offerors currently required to disclose because they were awarded a CAS
covered prime contract or subcontract of $50 million or more in the current cost
accounting period may not claim this exemption (4).  Further, the exemption
applies only in connection with proposals submitted before expiration of the
90-day period following the cost accounting period in which the monetary
exemption was exceeded.

 

o            (5)          Certificate of Disclosure Statement Due Date by
Educational Institution.  (ALTERNATE I - APRIL 1996)

 

If the offeror is an educational institution that, under the transition
provisions of 48 CFR 9903202-1(f), is or will be required to submit a Disclosure
Statement after receipt of this award, the offeror hereby certifies that (check
one and complete):

 

o            (i)             A Disclosure Statement filing Due Date of
                     has been established with the cognizant Federal agency.

 

o            (ii)          The Disclosure Statement will be submitted within the
6-month period ending                      months after receipt of this award.

 

Name and Address of Cognizant ACO or Federal Official Where Disclosure Statement
is to be Filed:

 

51

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II.  Cost Accounting Standards — Eligibility for Modified Contract Coverage

 

If the offeror is eligible to use the modified provisions of 48 CFR
9903.201-2(b) and elects to do so, the offeror shall indicate by checking the
box below.  Checking the box below shall mean that the resultant contract is
subject to the Disclosure and Consistency of Cost Accounting Practices clause in
lieu of the Cost Accounting Standards clause.

 

o                                    The offeror hereby claims an exemption from
the Cost Accounting Standards clause under the provisions of 48 CFR
9903.201-2(b) and certifies that the offeror is eligible for use of the
Disclosure and Consistency of Cost Accounting Practices clause because during
the cost accounting period immediately preceding the period in which this
proposal was submitted, the offeror received less than $50 million in awards of
CAS covered prime contracts and subcontracts.  The offeror further certifies
that if such status changes before an award resulting from this proposal, the
offeror will advise the Contracting Officer immediately.

 

CAUTION: An offeror may not claim the above eligibility for modified contract
coverage if this proposal is expected to result in the award of a CAS-covered
contract of $50 million or more or if, during its current cost accounting
period, the offeror has been awarded a single CAS-covered prime contract or
subcontract of $50 million or more.

 

III.  Additional Cost Accounting Standards Applicable to Existing Contracts

 

The offeror shall indicate below whether award of the contemplated contract
would, in accordance with subparagraph (a)(3) of the Cost Accounting Standards
Clause, require a change in established cost accounting practices affecting
existing contracts and subcontracts.

 

 

o YES

 

o NO

 

26.  CERTIFICATION REGARDING ENVIRONMENTAL TOBACCO SMOKE (DECEMBER 1994)

 

(Note: This certification applies only to those contract which contain
provisions for children’s services.  The offeror’s signature on the face page of
these Representations and Certifications constitutes certification by the
submitting organization of its compliance with the Act.)

 

Public Law 103-227, also known as the Pro-Children Act of 1994 (Act), requires
that smoking not be permitted in any portion of any indoor facility owned or
leased or contracted for by an entity and used routinely or regularly for the
provision of health, day care, early childhood development services, education
or library services to children under the age of 18, if the services are funded
by Federal programs either directly or through State or local governments, by
Federal grant, contract, loan, or loan guarantee.  The law also applies to
children’s services that are provided in indoor facilities that are constructed,
operated, or maintained with such federal funds.  The law does not apply to
children’s services provided in private residences; portions of facilities used
for inpatient drug or alcohol treatment; service providers whose sole source of
applicable federal funds is Medicare or Medicaid; or facilities where WIC
coupons are redeemed.  Failure to comply with the provisions of the law may
result in the imposition of a civil monetary penalty of up to $1,000 for each
violation and/or the imposition of an administrative compliance order on the
responsible entity.

 

By signing this certification, the offeror/contractor (for acquisitions) or
applicant/grantee (for grants) certifies that the submitting organization will
comply with the requirements of the Act and will not allow smoking within any
portion of any indoor facility used for the provision of services for children
as defined by the Act.

 

The submitting organization agrees that it will require that the language of
this certification be included in any subawards which contain provisions for
children’s services and that all subrecipients shall certify accordingly.

 

27.  CERTIFICATION OF INSTITUTIONAL POLICY ON CONFLICT OF FINANCIAL INTEREST
(OCTOBER 1995)

 

(Note: This certification is applicable to Research and Development (R&D)
Contracts.  However, this certification does not apply to SBIR-Phase I
contractors.)

 

52

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By submission of its offer, the offeror certifies that:

 

(1)                                  A written and enforced administrative
process to identify and manage, reduce or eliminate conflicting financial
interest with respect to all research projects for which funding is sought from
the NIH is o, is not o currently in effect.

 

(2)                                  Should a process not be in effect at the
time of the submission of its offer, the offeror certifies that it will, no
later than 30 days subsequent to submission of its offer or prior to award,
whichever is earlier, notify the Contracting Officer of the establishment of a
written and enforced financial conflict of interest policy.

 

28.  15.406-2  CERTIFICATE OF CURRENT COST OR PRICING DATA

 

(When cost or pricing data are required in accordance with FAR 15.406-2, the
Contracting Officer will request that the offeror complete, execute, and submit
to the Contracting Officer a certification in the format shown in the following
Certificate of Current Cost or Pricing Data.  The certification shall be
submitted only at the time negotiations are concluded.  Offerors should complete
the certificate and return it when requested by the Contracting Officer.)

 

This is to certify that, to the best of my knowledge and belief, the cost or
pricing data (as defined in section 15.401 of the Federal Acquisition Regulation
(FAR) and required under FAR subsection 15.403-4) submitted, either actually or
by specific identification in writing, to the Contracting Officer or to the
Contracting Officer’s representative in support of          * are accurate,
complete, and current as of          **.

 

This certification includes the cost or pricing data supporting any advance
agreements and forward pricing rate agreements between the offeror and the
Government that are part of the proposal.

 

Firm

 

Signature Name Title

 

Date of execution***

 

--------------------------------------------------------------------------------

*                                         Identify the proposal, request for
price adjustment, or other submission involved, giving the appropriate
identifying number (e.g., RFP No.)

 

**                                  Insert the day, month, and year when price
negotiations were concluded and price agreement was reached, or, if applicable,
an earlier date agreed upon between the parties that is as close as practicable
to the date of agreement on price.

 

***                           Insert the day, month, and year of signing, which
should be as close as practicable to the date when the price negotiations were
concluded and the contract price was agreed to.

 

(End of Certificate)

 

53

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[Attachment 2]

 

WAYNE STATE UNIVERSITY

 

Purchasing Department

 

 

Detroit, Michigan 48202

 

 

(313) 577-3734

 

 

FAX (313) 577-3747

 

 

 

 

 

December 30, 2002

 

Addendum One (1) To
Request for Proposal
for Genotyping Services
December 16, 2002

 

The following are clarifications resulting from the questions regarding our
Request for Proposal for Genotyping Services.  The individual questions posed
and University Answers / Clarifications are listed below:

 

Question 1                                    Pertaining to Section IV, B, b in
the RFP that states “b) The VENDOR shall provide the following services:  1)
Provide the PRB investigators designated by WSU with haplotype and allele
frequency information for polymorphisms in the candidate genes from different
ethnic groups, and assist in identifying suitable polymorpisms for the study.”,
our questions are as follows: * Is this information expected to be obtained from
the public databases? * If this information is not available in the public
databases, what is expected of the vendor? Should the vendor propose to develop
this information for the public SNPs as part of the contract? * We have
developed proprietary sequence variation information, including frequency and
haplotypes, for over 5,000 genes.  If the investigators wish to gain access to
this information for use in the proposed project, a separate agreement dealing
with intellectual proprietary and confidentiality will have to be negotiated
with us.

 

Answer 1                                             In response to your
question, we would like to suggest that you provide, in your proposal, two
different situations, where: a) only information available in public data bases
will be used, and b) company-generated information would be used.  In addition,
please compare the two options and clarify the IP issues involved.  We would
need as much information as possible to be able to evaluate both options from
many different aspects (legal, intellectual, scientific, cost etc.).

 

Question 2                                    We understand that 200 genes have
been chosen for this study.  What specific information is available on the 200
genes?  Are they in the public domain?  How many polymorphisms are there in the
200 genes?  Are the sequences known and provided?

 

Answer 2                                             We will provide the list of
genes with our response to the public (January 3) with the understanding that
the list is not necessarily final, i.e. possibly subject to change.

 

Yes, the genes are in the public domain.

 

54

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This is one of the tasks that we are asking the VENDOR to help us with.  The
number of polymorphisms to be typed at a specific locus will depend on the
informativeness of the polymorphisms (see below).

 

Gene sequences are in the databases.  These are all well-known genes with known
function.  VENDOR is expected to get gene sequences from databases and evaluate
the usefulness of known polymorphisms for our study.  We expect that something
like 4 polymorphisms per gene would be studied, but this depends on haplotype
information (haplotype blocks) and we expect VENDOR to help us in selecting the
best suited polymorphisms.

 

Question 3                                    For the 4000 specimens, is
pedigree and ethnicity information provided?

 

Answer 3                                             This is a case-control
study.  Ethnicity is available.

 

Question 4                                    Is the PEP-amplified DNA
sufficient in quantity for downstream genotyping?  Can we assume the Vendor is
not responsible for deficiencies in template integrity?

 

Answer 4                                             Yes.  Extensive testing has
been done.

 

Question 5                                    We understand that the proposal is
due Jan. 9.  We find this an unreasonable deadline in view of the amount of
information that must be assembled for the proposal.  Can this date be extended?

 

Answer 5                                             We’re sorry, but we will be
unable to extend the deadline.

 

Question 6                                    What is the time frame for the
project (a one-year or three-year project)?  In other words, when do you expect
to finish the project?

 

Answer 6                                             We hope that this part (200
genes, 4000 samples) could be completed in about 6 months.  Additional work
might come after that.

 

Question 7                                    Is this RFP a small business set
aside (limited to small business only)?

 

Answer 7                                             Our RFP was originally sent
to small businesses, but we are not limiting the applicants or the selected
VENDOR to being a small business.

 

Question 8                                    Do you have preference to the type
of SNP genotyping for this RFP?

 

Answer 8                                             The VENDOR should select
the most efficient and reliable method and justify that.

 

Question 9                                    WSU will provide DNA samples
assembled in 96-well format.  How much DNA at what concentration you will
include in each well?

 

Answer 9                                             The material (as specified
in the RFP) is PEP (Primer Extension Preamplified) DNA.

 

PLEASE NOTE:  In the RFP, we made references to an Excel spreadsheet and disk. 
However, after first drafting the RFP, we decided not to use a complicated
spreadsheet, but rather to allow

 

55

--------------------------------------------------------------------------------

 

each Vendor the latitude to provide pricing using the simple table in Schedule C
as a guideline.  However, we neglected to delete references to the spreadsheet
and disk.  Please disregard them!

 

As a reminder, in order for Proposals to be considered, they must be received by
the University on the due date and place as follows:

 

Thursday, January 9, 2003 - 4:00 p.m.
Wayne State University
Attn: Kimberly Tomaszewski, Senior Buyer
RFP - Genotyping Services
5700 Cass Avenue, Suite 4200 AAB
Detroit, MI 48202

 

If you have questions on this Addendum or on any other aspects of the Request
for Proposal, please call either Kimberly Tomaszewski, Senior Buyer at (313)
577-3757, Fax (313) 577-3747, email ac9934@wayne.edu, or in her absence Kenneth
Doherty, C.P.M., Associate Director, at (313) 577-3756, email ac0578@wayne.edu.

 

Thank you,

 

Kenneth Doherty
Associate Director of Purchasing

 

56

--------------------------------------------------------------------------------

 

[Attachment 3]

 

WAYNE STATE UNIVERSITY

 

Purchasing Department

 

 

Detroit, Michigan 48202

 

 

(313) 577-3734

 

 

FAX (313) 577-3747

 

 

 

 

 

January 07, 2003

 

Addendum Number Two (2) To
Request for Proposal
for Genotyping Services
December 16, 2002

 

The following are additional clarifications resulting from questions regarding
our Request for Proposal for Genotyping Services.  The individual questions
posed and University Answers / Clarifications are listed below.  We number these
as 10 - 14 in order to pick up from Addendum One; which addressed questions 1 -
9.

 

Question 10                             Please clarify the number of SNPs to be
determined and the time-line.  Based on Answer 2 and Answer 6 in the
communication dated December 30, 2002, and information in the RFP, the Vendor
would need to perform approximately 4.16 million SNPs in 6 months (200 genes X 4
SNPs per gene X 4000 DNAs X 30% repeat analyses).  Is this correct?

 

Answer 10                                      Yes, that is correct.

 

Question 11                             Could you please estimate of
approximately how many hours of labor effort (both professional and technical)
would be required for this contract?  This labor effort estimation is commonly
provided in government RFPs.

 

Answer 11                                      Extremely difficult to estimate,
since most of the procedures used by most VENDORS are highly automated.  Depends
on the technology and methodology used for genotyping.

 

Question 12                             It would be difficult for us to estimate
how many professional labor hours would be required for the Vendor to “evalutate
the usefulness of the known polymorphisms for our (WSU) study”.  To do this
properly, the Vendor must become familiar with the current and related
literature in studies which are similar to the WSU study.  Would more details on
the project be provided to the Vendor than the brief background provided on page
13 of the RFP?

 

Answer 12                                      Polymorphisms used in genetic
association studies are usually selected based on their informativeness
(frequency in the population) and known functional consequences.  Since we
provide the list of candidate genes, more deteails on the condition might not be
that useful.  Our samples contain about 250 cases per clinical group.

 

Question 13                             Do you anticipate making one single
award or multiple awards as a result of this RFP?

 

57

--------------------------------------------------------------------------------

 

Answer 13                                      ????????????

 

Question 14                             If a Vendor does not have a propriatory
database with haplotype data, would use of public databases suffice, or would
the Vendor be at a disadvantage compared to another Vendor with this resource?

 

Answer 10                                      Depends on cost associated with
getting such information.  Difficult to answer at this time.

 

As a reminder, in order for Proposals to be considered, they must be received by
the University on the due date and place as follows:

 

Thursday, January 9, 2003 - 4:00 p.m.
Wayne State University
Attn:  Kimberly Tomaszewski, Senior Buyer
RFP - Genotyping Services
5700 Cass Avenue, Suite 4200 AAB
Detroit, MI 48202

 

If you have questions on this Addendum or on any other aspects of the Request
for Proposal, please call either Kimberly Tomaszewski, Senior Buyer at (313)
577-3757, Fax (313) 577-3747, email ac9934@wayne.edu, or in her absence Kenneth
Doherty, C.P.M., Associate Director, at (313) 577-3756, email ac0578@wayne.edu.

 

Thank you,

 

Kenneth Doherty
Associate Director of Purchasing

 

58

--------------------------------------------------------------------------------

 

[Attachment 4]

 

7 January 2003

 

Joan M. Grossman, C.P.M.
Wayne State University
Purchasing Department
4th floor, Suite 4200 AAB
5700 Cass Avenue
Detroit, MI 48202

 

Re:                               RFP Genotyping Services
DUNS number: 78-949-7310

 

Dear Ms. Grossman:

 

We are responding to the above referenced RFP.  As per the instructions in the
Request for Proposal and Specifications for Genotyping Services, we are
submitting the following information:

 

•                  Genaissance’s profile as described in Exhibit 2, which is
part of the proposal being submitted in response to the above referenced RFP.

 

•                  Genaissance’s annual report for 2001, containing
independently audited financial statements of the Company’s revenues and
expenses and year-end balance statements for the last three years.

 

•                  Genaissance’s Third Quarter Form 10-Q for fiscal 2002.

 

Should you have any questions about our financial information, please do not
hesitate to contact us.

 

 

Sincerely,

 

 

/s/ Gerald F. Vovis

 

 

Executive Vice President

 

Chief Technology Officer

 

Enclosures

 

--------------------------------------------------------------------------------

 

7 January 2003

 

Kimberly Tomaszewski
Senior Buyer
Wayne State University
Purchasing Department
4th floor, Suite 4200 AAB
5700 Cass Avenue
Detroit, MI 48202

 

Re:                               RFP Genotyping Services
DUNS number: 78-949-7310

 

Dear Ms. Tomaszewski:

 

Please find enclosed one original (marked as such) and nine copies of our
proposal being submitted in response to the above referenced RFP.  Our proposal
is in accordance with the outline and applications contained therein, except as
detailed in Exhibit 1. The proposal remains in effect for 120 days from 9th
January 2003 and is subject to further extensions as may be negotiated between
Wayne State University (WSU) and Genaissance.

 

We have already generated over three million genotypes in our facility and,
hence, can easily handle the size and scope of the proposed project.  We are
prepared to begin the proposed work on or before 24th January 2003 and will
provide WSU with a top priority commitment.

 

Genaissance is financially strong with over $8 million dollars of revenue
projected for fiscal 2002 and a projected ending year balance of cash, cash
equivalents and marketable securities totaling at least $33 million, which is
sufficient to meet the company’s goal of cash breakeven in 2005.  The Company’s
audited financials for 2002 are scheduled for release in February 2003.

 

Genaissance considers our prices for doing genotyping services to be
confidential and, hence, the prices for the Company’s services that are listed
on Schedule C are proprietary information.

 

Genaissance is not a certified minority firm but it is a small business firm.

 

Should you have any questions about our proposal, please do not hesitate to
contact us.

 

 

Sincerely,

 

 

/s/ Gerald F. Vovis

 

 

Executive Vice President

 

Chief Technology Officer

 

Enclosures

 

59

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Table of Contents

 

Tab

 

Section

 

 

 

Schedule A1

 

Proposal Certification

 

 

 

Schedule A2

 

Non-Collusion Affidavit

 

 

 

Schedule B

 

Insurance Requirements

 

 

 

Schedule C

 

Price Schedule, Summary of Quoted Rates

 

 

 

Schedule D

 

Summary Questionnaire

 

 

 

Schedule E

 

Representations, Certifications and Other Statement of Offerors or Quoters
(Vendors)

 

 

 

Exhibit 1

 

Exceptions/Restrictions

 

 

 

Exhibit 2

 

Profile/Experience/References

 

 

 

Exhibit 3

 

Vendor Service Plan

 

 

 

Exhibit 4

 

Vendor Qualifications

 

 

 

Exhibit 5

 

Small Business Subcontracting Plan

 

 

 

Addendum 1

 

Terms and Conditions

 

 

 

Addendum 2

 

License Agreement

 

60

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Schedule A.2

 

NON-COLLUSION AFFIDAVIT

 

The undersigned, duly authorized to represent the persons; firms and
corporations joining and participating in the submission of the foregoing
Proposal (such persons, firms and corporations hereinafter being referred to as
the “VENDOR”), being duly sworn, on his or her oath, states that to the best of
his or her belief and knowledge no person, firm or corporation, nor any person
duly representing the same joining and participating in the submission of the
foregoing Proposal, has directly or indirectly entered into any agreement or
arrangement with any other VENDORS, or with any official of the UNIVERSITY or
any employee thereof, or any person, firm or corporation under contract with the
UNIVERSITY whereby the VENDOR, in order to induce acceptance of the foregoing
Proposal by said UNIVERSITY, has paid or is to pay to any other VENDOR or to any
of the aforementioned persons anything of value whatever, and that the VENDOR
has not, directly or indirectly entered into any arrangement or agreement with
any other VENDOR or VENDORS which tends to or does lessen or destroy free
competition in the letting of the contract sought for by the foregoing Proposal.

 

The VENDOR hereby certifies that neither it, its officers, partners, owners,
providers, representatives, employees and parties in interest, including the
affiant, have in any way colluded, conspired, connived or agreed, directly or
indirectly, with any other proposer, potential proposer, firm or person, in
connection with this solicitation, to submit a collusive or sham bid, to refrain
from bidding, to manipulate or ascertain the price(s) of other proposers or
potential proposers, or to obtain through any unlawful act an advantage over
other proposers or the college.

 

The prices submitted herein have been arrived at in an entirely independent and
lawful manner by the proposer without consultation with other proposers or
potential proposers or foreknowledge of the prices to be submitted in response
to this solicitation by other proposers or potential proposers on the part of
the proposer, its officers, partners, owners, providers, representatives,
employees or parties in interest, including the affiant.

 

CONFLICT OF INTEREST

 

The undersigned proposer and each person signing on behalf of the proposer
certifies, and in the case of a sole proprietorship, partnership or corporation,
each party thereto certifies as to its own organization, under penalty of
perjury, that to the best of their knowledge and belief, no member of the
UNIVERSITY, nor any employee, or person, whose salary is payable in whole or in
part

 

61

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by the UNIVERSITY, has a direct or indirect financial interest in the award of
this Proposal, or in the services to which this Proposal relates, or in any of
the profits, real or potential, thereof, except as noted otherwise herein.

 

Signature

/s/ Gerald F. Vovis

 

 

Company Name

Genaissance Pharmaceuticals, Inc.

 

 

Date

January 7, 2003

 

 

 

 

 

 

 

 

/s/ [illegible]

 

 

Subscribed and sworn to before me this 7th day of January, 2003.

 

Notary Public in and for the County of New Haven, State of Connecticut.  My
commission expires:  July 31, 2007

 

62

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Schedule A.1

 

PROPOSAL CERTIFICATION

 

VENDOR is to certify its proposal as to its compliance with the Request for
Proposal specifications using the language as stated hereon.

 

RESPONSE TO WAYNE STATE UNIVERSITY
REQUEST FOR PROPOSAL FOR
PROVIDING GENOTYPING SERVICES FOR 2002 / 2003
DATED: December 16, 2002

 

AND TO ANY AMENDMENTS, THERETO

 

The undersigned, duly authorized to represent the persons, firms and
corporations joining and participating in the submission of this Proposal states
that the Proposal contained herein is complete and is in strict compliance with
the requirements of the subject Request for Proposal dated December 16, 2002,
except as noted in Exhibit 1, the “Restricted Services/Exceptions to RFP”
section of the Proposal.  If there are no modifications, deviations or
exceptions, state same as a part of the Proposal Certification Statement:

 

o    NONE        ý    If there are, state YES

 

This proposal remains in effect for 120 days.

 

Any notice required under the Agreement shall be personally delivered or mailed
by first class or certified mail, with proper postage, prepaid, to the Subject
VENDOR at the following address:

 

Company Name:

Genaissance Pharmaceuticals, Inc.

 

 

Address:

5 Science Park

 

 

 

New Haven, CT  06511

 

 

ATTN:

Gerald F. Vovis, Ph.D.

 

 

Tax Payer ID:

06-1338846

 

 

Submitted by:

 

 

 

Signature

/s/ Gerald F. Vovis, Ph.D.

 

 

Typed Name

Gerald F. Vovis, Ph.D.

 

 

 

Title:

Executive Vice President
Chief Technology Officer

 

January 7, 2003

 

(Title)

(Date)

 

63

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INSURANCE REQUIREMENTS

 

Genaissance Pharmaceuticals, Inc., at its sole expense, shall cause to be issued
and maintained in full effect for the term of this agreement, insurance as set
forth hereunder:

 

General Requirements

 

Type of Insurance

 

 

 

Minimum Requirement

 

 

 

 

 

 

 

1.

Comprehensive General Liability

 

Bodily Injury

 

$500,000 each person

 

 

 

 

 

 

$1,000,000 aggregate

 

 

 

 

Property Damage

 

$500,000 each occurrence

 

 

 

 

 

 

$1,000,000 aggregate

 

 

 

 

 

 

Or

 

 

 

 

 

 

$3,000,000 Combined Single Limit (CSL)

 

 

 

 

 

 

 

2.

Comprehensive Automobile Liability Bodily Injury

 

$500,000 each person

 

 

 

 

(including hired and non-owned vehicles)

 

 

 

$1,000,000 each accident

 

 

 

 

Property Damage

 

$500,000 each accident

 

 

 

 

 

 

Or

 

 

 

 

 

 

$3,000,000 Combined Single Limit (CSL)

 

 

 

 

 

 

 

3.

Workers’ Compensation

 

Statutory-Michigan

 

$100,000

 

 

(Employers’ Liability)

 

 

 

 

 

Maximum Acceptable Deductibles

 

Type of Insurance

 

Deductible

 

 

 

 

 

Comprehensive General Liability

 

$

250

 

Comprehensive Automobile Liability

 

0

 

Workers’ Compensation

 

0

 

 

Coverages

 

 

 

 

 

 

 

1.

 

All liability policies must be written on an occurrence form.

 

 

 

2.

 

Comprehensive general liability includes, but is not limited to: consumption or
use of products, existence of equipment or machines on location, and contractual
obligations to customers.

 

 

 

3.

 

The Board of Governors, Wayne State University, shall be named as an additional
insured, but only as respects to accidents arising out of said contact.

 

 

 

Certificates of Insurance

 

 

 

 

 

 

 

1.

 

Certificates of Insurance stating the minimum required coverages must be
forwarded to the Office of Risk Management to be verified and, authenticated
with the agent and/or insurance company.

 

 

 

2.

 

Certificates should contain a statement from the insurer that, for this
contract, the care, custody or control exclusion is waived.

 

 

 

3.

 

Certificates shall be issued on a ACORD form or one containing the equivalent
wording, and require giving WSU a thirty (30) day written notice of cancellation
or material change prior to the normal expiration of  coverage.

 

 

 

4.

 

Revised certificates must be forwarded to the Office of Risk Management thirty
(30) days prior to the expiration of any insurance coverage listed on the
original certificate.

 

64

--------------------------------------------------------------------------------

 

Client #:
765                                                                                                                                                                                                                        
GENAISSANCE

ACORD™                                                                                    
CERTIFICATE OF LIABILITY INSURANCE

DATE (MM/DD/YYYY)
01/07/03

PRODUCER

IA) William Gallagher Assoc.

Insurance Brokers, Inc.

200 State Street, 13th Floor

Boston, MA 02109-2694

THIS CERTIFICATE IS ISSUED AS A MATTER OF INFORMATION ONLY AND CONFERS NO RIGHTS
UPON THE CERTIFICATE HOLDER.  THIS CERTIFICATE DOES NOT AMEND, EXTEND OR ALTER
THE COVERAGE AFFORDED BY THE POLICIES BELOW.

INSURERS AFFORDING COVERAGE

NAIC #

INSURED

Genaissance Pharmaceuticals, Inc.

Five Science Park

New Haven, CT  06511

INSURER A:  Federal Insurance Company

 

INSURER B:  National Fire Insurance of Hartford

 

INSURER C:

 

INSURER D:

 

INSURER E:

 

COVERAGES

THE POLICIES OF INSURANCE LISTED BELOW HAVE BEEN ISSUED TO THE INSURED NAMED
ABOVE FOR THE POLICY PERIOD INDICATED.  NOTWITHSTANDING ANY REQUIREMENT, TERM OR
CONDITION OF ANY CONTRACT OR OTHER DOCUMENT WITH RESPECT TO WHICH THIS
CERTIFICATE MAY BE ISSUED OR MAY PERTAIN, THE INSURANCE AFFORDED BY THE POLICIES
DESCRIBED HEREIN IS SUBJECT TO ALL THE TERMS, EXCLUSIONS AND CONDITIONS OF SUCH
POLICIES.  AGGREGATE LIMITS SHOWN MAY HAVE BEEN REDUCED BY PAID CLAIMS.

 

INSR
LTR

 

ADD’L
INSRD

 

TYPE OF INSURANCE

 

POLICY
NUMBER

 

POLICY
EFFECTIVE
DATE
(MM/DD/YY)

 

POLICY
EXPIRATION
DATE (MM/DD/YY)

 

LIMITS

 

A

 

 

 

GENERAL LIABILITY
ý COMMERCIAL GENERAL
LIABILITY
o o CLAIMS MADE ý OCCUR
o                                            
o                                            
GEN’L AGGREGATE LIMIT
APPLIES PER:
o POLICY  o PROJECT  o LOC

 

35387209

 

01/01/03

 

09/01/03

 

EACH OCCURRENCE

 

$1,000,000

 

DAMAGE TO RENTED PREMISES (Ea occurrence)

$Included

 

MED EXP (Any one person)

$10,000

 

PERSONAL & ADV INJURY

$1,000,000

 

GENERAL AGGREGATE

$2,000,000

 

PRODUCTS – COMP/OP AGG

$Excluded

 

 

 

 

A

 

 

 

AUTOMOBILE LIABILITY
o  ANY AUTO
o  ALL OWNED AUTOS
o  SCHEDULED AUTOS
ý  HIRED AUTOS
ý  NON-OWNED AUTOS
o                                    
o

 

73510560

 

01/01/03

 

09/01/03

 

COMBINED SINGLE LIMIT
(Ea accident)

 

$1,000,000

 

BODILY INJURY
(Per person)

$

 

BODILY INJURY
(Per accident)

$

 

PROPERTY DAMAGE

$

 

PROPERTY DAMAGE

$

 

 

 

 

 

 

 

 

GARAGE LIABILITY
o ANY AUTO
o

 

 

 

 

 

 

 

AUTO ONLY – EA ACCIDENT

 

 

 

OTHER THAN AUTO ONLY:

EA ACC
AGG

$

 

$

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A

 

 

 

EXCESS/UMBRELLA LIABILITY
ý  OCCUR   o  CLAIMS MADE
o  DEDUCTIBLE
o  RETENTION    $

 

79790690

 

01/01/03

 

09/01/03

 

EACH OCCURRENCE

 

$5,000,000

 

AGGREGATE

$5,000,000

 

 

$

 

 

$

 

 

$

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B

 

 

 

WORKERS COMPENSATION AND EMPLOYERS’ LIABILITY ANY PROPRIETOR/PARTNER/ EXECUTIVE
OFFICER/MEMBER EXCLUDED?
If yes, describe under SPECIAL PROVISIONS below

 

WC181880796

 

01/01/03

 

09/01/03

 

ý

WC STATU-TORY LIMITS

OTH-ER

 

 

E.L. EACH ACCIDENT

 

$500,000

 

E.L. DISEASE – EA EMPLOYEE

$500,000

 

E.L. DISEASE – POLICY LIMIT

$500,000

 

 

 

 

 

OTHER

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

DESCRIPTION OF OPERATIONS/LOCATIONS/VEHICLES/EXCLUSIONS ADDED BY
ENDORSEMENT/SPECIAL PROVISIONS
The Board of Governors of Wayne State University and Wayne State University are
additional insured as respects to accidents arising out of contract with
Genaissance Pharmaceuticals, Inc.

 

CERTIFICATE HOLDER

 

CANCELLATION

Wayne State University
Detroit, MI  48202

 

SHOULD ANY OF THE ABOVE DESCRIBED POLICIES BE CANCELLED BEFORE THE EXPIRATION
DATE THEREOF, THE ISSUING INSURER WILL ENDEAVOR TO MAIL 30 DAYS WRITTEN NOTICE
TO THE CERTIFICATE HOLDER NAMED TO THE LEFT, BUT FAILURE TO DO SO SHALL IMPOSE
NO OBLIGATION OR LIABILITY OF ANY KIND UPON THE INSURER, ITS AGENTS OR
REPRESENTATIVES.

AUTHORIZED REPRESENTATIVE

/s/ [illegible]

 

 

65

--------------------------------------------------------------------------------

 

IMPORTANT

 

If the certificate holder is an ADDITIONAL INSURED, the policy(ies) must be
endorsed.  A statement on this certificate does not confer rights to the
certificate holder in lieu of such endorsement(s).

 

If SUBROGATION IS WAIVED, subject to the terms and conditions of the policy,
certain policies may require an endorsement.  A statement on this certificate
does not confer rights to the certificate holder in lieu of such endorsement(s).

 

DISCLAIMER

 

The Certificate of Insurance on the reverse side of this form does not
constitute a contract between the issuing insurer(s), authorized representative
or producer, and the certificate holder, nor does it affirmatively or negatively
amend, extend or alter the coverage afforded by the policies listed thereon.

 

66

--------------------------------------------------------------------------------

 

SCHEDULE C - Price Schedule
Reply to Wayne State University Request for Proposal
For Genotyping Services

 

The following price schedule is based on a project size of 4,000 DNA samples
genotyped with 800 SNP assays (200 genes with 4 SNPs each), with a random
selection of 30% of the assays run a second time and delivery of [**]% of the
total possible data.  Genaissance estimates a turnaround time of 20 weeks to
complete this proposed project.  Changes in either the number of DNA samples or
in the number of SNP assays may necessitate changes in the pricing schedule.

 

Name of Test

 

Unit Price

 

Estimated Quantity

 

Total

 

DNA Plating Fee

 

$

[**]

 

4,000

 

$

[**]

 

DNA QC Fee

 

$

[**]

 

4,000

 

$

[**]

 

Assay Development Fee

 

$

[**]

 

800

 

$

[**]

 

Delivered Genotype Fee

 

$

[**]

 

[**] Million

*

$

[**]

 

Project Total

 

 

 

 

 

$

[**]

†

 

--------------------------------------------------------------------------------

*                                         [**]% of (800 SNP assays x 4,000 DNA
samples) plus an additional [**]% for randomly repeated assays as requested.

 

†                                          This price is an estimate based upon
the anticipated number of genotypes that will be delivered.  The actual project
cost will likely be different, as it will be based on the total number of
genotypes delivered multiplied by the per genotype fee of $[**].

 

The PRB investigators requested haplotype and allele frequency information for
public polymorphisms.  In order to provide such information, all of the
polymorphisms in a candidate gene should be genotyped on the same panel of
individuals of diverse ethnic background.  From such information, haplotypes
could then be built for various diverse populations.  Genaissance has
constructed a reference panel consisting of individuals whose four grandparents
had the same ethnic background.  The panel, which the Company uses to discover
its proprietary polymorphisms and build haplotypes, consists of the following:

 

•             Eighty-two unrelated individuals:

 

•                       21 Caucasians of Western European extraction;

 

•                       20 African-Americans;

 

•                       20 Asians;

 

Confidential and Proprietary

 

1

--------------------------------------------------------------------------------

 

•                       18 Hispanic/Latinos; and

 

•                       3 Native Americans.

 

•             Eleven related individuals:

 

•                       6 Caucasians (4 grandparents) and

 

•                       5 African-Americans (2 parents).

 

•             Three controls:

 

•                       1 chimpanzee;

 

•                       1 gorilla; and

 

•                       1 negative control.

 

The cost to generate a genotype for each individual in the reference panel is
$[**].  Genaissance would then build the haplotypes from the resulting
information using its proprietary HAP™ Builder technology and know-how.

 

Alternate proposals for this solicitation are not acceptable.  As requested in
your Addendum to Request for Proposal for Genotyping Services of December 16,
2002 (Question and Answer 1), we are providing an alternate proposal, in which
Genaissance proprietary SNPs and haplotypes (referred to herein as HAP™ Markers)
would be used in the proposed project.

 

An Alternate Proposal for Genotyping

 

Use of Genaissance’s Proprietary HAP™ Markers.  If WSU decides to use
Genaissance’s proprietary HAP™ Markers, the work would proceed as follows.  The
PRB investigators would identify the candidate genes to be genotyped and supply
Genaissance with the list of candidate genes and the ethnic background of the
patients to be genotyped.  Genaissance would then use its proprietary HAP™
Database to select the minimum number of SNPs (both proprietary to Genaissance
and in the public domain) that are needed to capture 80% to 90% of the haplotype
diversity present in this patient population.  The exact percentage would be
decided upon in discussions between the PRB investigators, WSU and Genaissance. 
In recent large-scale projects, Genaissance has used an average of [**] SNPs per
candidate gene to capture 90% of the haplotype diversity present in the
Caucasian population.

 

Genaissance would then design and validate assays for the selected SNPs.  If
validated assays could not be developed for any of the SNPs, Genaissance would
consult with the PRB investigators regarding whether any replacement SNPs should
be selected to meet the goal of capturing the agreed upon percentage of
haplotype diversity present in the patient population.  Genaissance would design
and validate assays for any replacement SNPs.  Once assays have been designed
and validated for all selected SNPs, Genaissance would genotype each of the

 

2

--------------------------------------------------------------------------------

 

selected SNPs in the patient samples, deduce haplotypes from the resultant
genotypes for each gene and each patient using Genaissance’s proprietary HAP™
Builder technology and know-how, and supply the resultant genotypes and
haplotypes for each patient to WSU.

 

The choice of this alternate proposal would require the execution of a license
agreement between [**] and Genaissance (see tab labeled: Addendum 2, License
Agreement), under which Genaissance would grant [**] a license to use
Genaissance’s [**] in exchange for [**].  In addition, the License Agreement
contains confidentiality obligations [**].

 

Because of the expanded nature of the project in this alternate proposal, 30
weeks would be required for completion of this proposed project.  The price
schedule for this alternate proposal is as follows.

 

Name of Test

 

Unit Price

 

Estimated Quantity

 

Total

 

DNA Plating Fee

 

$

[**]

 

4,000

 

$

[**]

 

DNA QC Fee

 

$

[**]

 

4,000

 

$

[**]

 

SNP Selection Fee

 

$

[**]

 

200

 

$

[**]

 

Assay Development Fee

 

$

[**]

 

800

 

$

[**]

 

Delivered Genotype Fee

 

$

[**]

 

[**] Million

*

$

[**]

 

HAP™ Building of genes

 

$

[**]

 

200

 

$

[**]

 

Project Total

 

 

 

 

 

$

[**]

†

 

--------------------------------------------------------------------------------

*                                         [**]% of ([**] SNP assays ([**] SNPs x
200 genes) x 4,000 DNA samples) plus an additional [**]% for randomly repeated
assays as requested.

 

†                                          This price is an estimate based upon
the anticipated number of genotypes that will be delivered.  The actual project
cost will likely be different, as it will be based on the total number of
genotypes delivered multiplied by the per genotype fee of $[**].

 

The undersigned affirms that the cost of all work is covered by the scope
defined in the RFP dated December 16, 2002.  See Vendor Exhibit 1,
Exceptions/Restrictions for our reason for removing the section authorizing WSU
personnel to determine Genaissance’s costs for doing this proposed project.

 

3

--------------------------------------------------------------------------------

 

Company Name:

Genaissance Pharmaceuticals, Inc.

 

 

 

 

Company Address:

Five Science Park
New Haven, CT 06511

 

 

 

 

Submitted by:

Gerald F. Vovis, Ph.D.

 

 

 

 

Signature:

/s/ Gerald F. Vovis, Ph.D.

 

 

 

 

Typed Name:

Executive Vice President and Chief Technology Officer

 

January 7, 2003

 

 

 

 

 

 

 

(Title)

 

(Date)

 

 

 

 

Phone:

(203) 786-3423

 

Fax

(203) 492-4475

 

 

 

4

--------------------------------------------------------------------------------

 

Schedule D - Summary Questionnaire

 

 

 

 

 

YES

 

ALTERNATIVE

1.

 

Can your company provide services on or before January 24, 2003?

 

ý

 

 

 

 

 

 

 

 

 

2.

 

Have you provided three (3) references with specific contact names and phone
numbers?

 

ý

 

 

 

 

 

 

 

 

 

3.

 

Did your company provide a certificate of insurance to meet or exceed all our
minimum requirements?

 

ý

 

 

 

 

 

 

 

 

 

4.

 

Did your company provide the required Proposal Certification and Non-Collusion
Affidavit?

 

ý

 

 

 

 

 

 

 

 

 

5.

 

Did your company complete and provide the Summary Price Schedule C?

 

ý

 

 

 

 

 

 

 

 

 

6.

 

Did your company complete and provide Schedule E, Statement of Representations
and Certifications?

 

ý

 

 

 

 

 

 

 

 

 

7.

 

Did your company agree to guarantee to maintain a top priority for the
UNIVERSITY?

 

ý

 

 

 

 

 

 

 

 

 

8.

 

Please complete the following questions:

 

ý

 

 

 

 

 

 

 

 

 

 

 

Total number of employees in your company

 

105

 

 

 

 

 

 

 

 

 

 

 

Total years in business with this company name

 

6

 

 

 

 

 

 

 

 

 

9.

 

Did your company provide financial information under separate cover to the
Director of Purchasing?

 

ý

 

 

 

 

 

 

 

 

 

10.

 

Are there any conflicts of interest in doing business with the UNIVERSITY?

 

o Yes
ý No

 

 

 

1

--------------------------------------------------------------------------------

 

SCHEDULE E

 

REPRESENTATIONS, CERTIFICATIONS
AND OTHER STATEMENTS OF
OFFERORS OR QUOTERS (VENDORS)

 

--------------------------------------------------------------------------------

 

PART IV - SECTION K

Representations, Certifications, and Other Statements of Offerors or Quoters
(Negotiated).

 

1.  REPRESENTATIONS AND CERTIFICATIONS

 

1.

FAR 52.203-2

Certification of Independent Price Determination

 

 

 

2.

FAR 52.203-11

Certification and Disclosure Regarding Payments to Influence Certain Federal
Transactions (DEVIATION)

 

 

 

3.

FAR 52.204-3

Taxpayer Ientification

 

 

 

4.

FAR 52.204-5

Women-Owned Business (Other Than Small Business)

 

 

 

5.

FAR 52.204-6

Data Universal Numbering System (DUNS) Number

 

 

 

6.

FAR 52.209-5

Certification Regarding Debarment, Suspension, Proposed Debarment and Other
Responsibility Matters

 

 

 

7.

FAR 52.215-6

Place of Performance

 

 

 

8.

FAR 52.219-1

Small Business Program Representations

 

 

 

9.

FAR 52.219-19

Small Business Concern Representation for the Small Business Competitiveness
Demonstration Program

 

 

 

10.

FAR 52.219-21

Small Business Size Representation for Targeted Industry Categories Under the
Small Business Competitiveness Demonstration Program

 

 

 

11.

FAR 52.219-22

Small Disadvantaged Business Status

 

 

 

12.

FAR 52.222-18

Certification Regarding Knowledge of Child Labor for Listed End Products

 

 

 

13.

FAR 52.222-21

Certification of Nonsegregated Facilities

 

 

 

14.

FAR 52.222-22

Previous Contracts and Compliance Reports

 

 

 

15.

FAR 52.222-25

Affirmative Action Compliance

 

 

 

16.

FAR 52.222-38

Compliance with Veterans’ Employment Reporting Requirements

 

 

 

17.

FAR 52.222-48

Exemption From Application of Service Contract Act Provisions

 

 

 

18.

FAR 52.223-4

Recovered Material Certification

 

2

--------------------------------------------------------------------------------

 

19.

FAR 52.223-13

Certification of Toxic Chemical Release Reporting

 

 

 

20.

FAR 52.225-2

Buy American Act Certificate

 

 

 

21.

FAR 52.225-4

Buy American Act-North American Free Trade Agreement — Israeli Trade Act
Certificate

 

 

 

22.

FAR 52.225-6

Trade Agreements Certificate

 

 

 

23.

FAR 52.226-2

Historically Black College or University and Minority Institution Representation

 

 

 

24.

FAR 52.227-6

Royalty Information

 

 

 

25.

FAR 52.230-1

Cost Accounting Standards Notices and Certification

 

 

 

26.

—

Certification Regarding Environmental Tobacco Smoke

 

 

 

27.

—

Certification of Institutional Policy on Conflict of Financial Interest

 

 

 

28.

FAR 15.406-2

Certificate of Current Cost or Pricing Data

 

To Be Completed by the Offeror: (The Representations and Certifications must be
executed by an individual authorized to bind the offeror.) The offeror makes the
following Representations and Certifications as part of its proposal
(check/complete all appropriate boxes or blanks on the following pages).

 

Genaissance Pharmaceuticals, Inc.

(RFP No.) RFP – Genotyping Services

(Name of Offeror)

 

 

/s/ Gerald F. Vovis, Ph.D.

 

(Date)  January 7, 2003

(Signature of Authorized Individual)

 

 

Gerald F. Vovis, Ph.D.

 

(Typed Name of Authorized Individual)

 

Note:  The penalty for making false statements in offers is prescribed in 18
U.S.C. 1001

 

29.                               52.203-2  CERTIFICATE OF INDEPENDENT PRICE
DETERMINATION  (APRIL 1985)

 

[NOTE: This provision is applicable when a firm-fixed price or fixed-price with
economic price adjustment contract is contemplated.]

 

(a)                                  The offeror certifies that -

 

3

--------------------------------------------------------------------------------

 

(1)                                  The prices in this offer have been arrived
at independently, without, for the purpose of restricting competition, any
consultation, communication, or agreement with any other offeror or competitor
relating to (i) those prices, (ii) the intention to submit an offer, or (iii)
the methods or factors used to calculate the prices offered;

 

(2)                                  The prices in this offer have not been and
will not be knowingly disclosed by the offeror, directly or indirectly, to any
other offeror or competitor before bid opening (in the case of a sealed bid
solicitation) or contract award (in the case of a negotiated solicitation)
unless otherwise required by law; and

 

(3)                                  No attempt has been made or will be made by
the offeror to induce any other concern to submit or not to submit an offer for
the purpose of restricting competition.

 

(b)                                 Each signature on the offer is considered to
be a certification by the signatory that the signatory—

 

(1)                                  Is the person in the offeror’s organization
responsible for determining the prices being offered in this bid or proposal,
and that the signatory has not participated and will not participate in any
action contrary to subparagraphs (a)(1) through (a)(3) above; or

 

(2)                                  (i) Has been authorized in writing, to act
as agent for the following principals in certifying that those principals have
not participated, and will not participate in any action contrary to
subparagraphs (a)(1) through (a)(3) above

Gerald F. Vovis, Ph.D., Executive Vice President and Chief Technology Officer

[insert full name of person(s) in the offeror’s organization responsible for
determining the prices offered in this bid or proposal, and the title of his or
her position in the offeror’s organization];

 

(ii)                                  As an authorized agent, does certify that
the principals named in subdivision (b)(2)(i) above have not participated, and
will not participate, in any action contrary to subparagraphs (a)(1) through
(a)(3) above; and

 

(iii)                               As an agent, has not personally
participated, and will not participate, in any action contrary to subparagraphs
(a)(1) through (a)(3) above.

 

4

--------------------------------------------------------------------------------

 

(c)                                  If the offeror deletes or modifies
subparagraph (a)(2) above, the offeror must furnish with its offer a signed
statement setting forth in detail the circumstances of the disclosure.

 

30.                               52.203-11  CERTIFICATION AND DISCLOSURE
REGARDING PAYMENTS TO INFLUENCE CERTAIN FEDERAL TRANSACTIONS (DEVIATION)

 

(a)                                  The definitions and prohibitions contained
in the clause, at FAR 52.203-12, Limitations on Payments to Influence Certain
Federal Transactions, included in this solicitation, are hereby incorporated by
reference in paragraph (b) of this certification.

 

(b)                                 The offeror, by signing its offer, hereby
certifies to the best of his or her knowledge and belief that on or after
December 23, 1989 -

 

(1)                                  No Federal appropriated funds have been
paid or will be paid, to any person for influencing or attempting to influence
an officer or employee of any agency, a Member of Congress, an officer or
employee of Congress, or an employee of a Member of Congress on his or her
behalf in connection with the awarding of a contract resulting from this
solicitation.

 

(2)                                  If any funds other than Federal
appropriated funds (including profit or fee received under a covered Federal
transaction) have been paid, or will be paid, to any person for influencing or
attempting to influence an officer or employee of any agency, a Member of
Congress, an officer or employee of Congress, or an employee of a Member of
Congress on his or her behalf in connection with this solicitation, the offeror
shall complete and submit with its offer, OMB Standard Form-LLL, “Disclosure of
Lobbying Activities”, to the Contracting Officer, and

 

(3)                                  He or she will include the language of this
certification in all subcontract awards at any tier and require that all
recipients of subcontract awards in excess of $100,000 shall certify and
disclose accordingly.

 

(c)                                  Submission of this certification and
disclosure is a prerequisite for making or entering into this contract imposed
by section 1352, Title 31, United States Code.  Any person who makes an
expenditure prohibited under this provision or who fails to file or amend the
disclosure form to be filed or amended by this provision, shall be subject to a
civil penalty of not less than $10,000, and not more than $100,000, for each
such failure.

 

 

5

--------------------------------------------------------------------------------

 

31.                               52.204-3  TAXPAYER IDENTIFICATION (OCTOBER
1998)

 

(1)                                  Definitions.

 

Common parent, as used in this provision, means that corporate entity that owns
or controls an affiliated group of corporations that files its Federal income
tax returns on a consolidated basis, and of which the offeror is a member.

 

Taxpayer Identification Number (TIN), as used in this provision, means the
number required by the Internal Revenue Service (IRS) to be used by the offeror
in reporting income tax and other returns.  The TIN may be either a Social
Security Number or an Employer Identification Number.

 

(2)                                  All offerors must submit the information
required in paragraphs (d) through (f) of this provision to comply with debt
collection requirements of 31 U.S.C. 7701(c) and 3325(d), reporting requirements
of 26 U.S.C.  6041, 6041A, and 6050M, and implementing regulations issued by the
IRS.  If the resulting contract is subject to the payment reporting requirements
described in Federal Acquisition Regulation (FAR) 4.904, the failure or refusal
by the offeror to furnish the information may result in a 31 percent reduction
of payments otherwise due under the contract.

 

(3)                                  The TIN may be used by the Government to
collect and report on any delinquent amounts arising out of the offeror’s
relationship with the Government (31 U.S.C. 7701(c)(3)).  If the resulting
contract is subject to the payment reporting requirements described in FAR
4.904, the TIN provided hereunder may be matched with IRS records to verify the
accuracy of the offeror’s TIN.

 

(4)                                  Taxpayer Identification Number (TIN).

 

ý

TIN: 06-1338846

o

TIN has been applied for.

o

TIN is not required because:

 

o

Offeror is a nonresident alien, foreign corporation, or foreign partnership that
does not have income effectively connected with the conduct of a trade or
business in the United States and does not have an office or place of business
or a fiscal paying agent in the United States;

 

o

Offeror is an agency or instrumentality of a foreign government;

 

o

Offeror is an agency or instrumentality of the Federal Government.

 

(5)                                  Type of organization.

 

o

Sole proprietorship;

o

Partnership;

ý

Corporate entity (not tax-exempt);

o

Corporate entity (tax-exempt);

o

Government entity (Federal, State, or local);

 

6

--------------------------------------------------------------------------------

 

o

Foreign government;

o

International organization per 26 CFR 1.6049-4;

o

Other

 

(6)                                  Common parent.

 

ý

Offeror is not owned or controlled by a common parent as defined in paragraph
(a) of this provision.

o

Name and TIN of common parent:

 

Name

 

TIN

 

32.                               52.204-5  WOMEN-OWNED BUSINESS (Other Than
Small Business) (MAY 1999)

 

(a)                                  Definition.  Women-owned business concern,
as used in this provision, means a concern that is at least 51 percent owned by
one or more women; or in the case of any publicly owned business, at least 51
percent of its stock is owned by one or more women; and whose management and
daily business operations are controlled by one or more women.

 

(b)                                 Representation.  [Complete only if the
offeror is a women-owned business concern and has not represented itself as a
small business concern in paragraph (b)(1) of FAR 52.219-1, Small Business
Program Representations, of this solicitation.]

 

The offeror represents that it o is a women-owned business concern.

 

33.                               52.204-6  DATA UNIVERSAL NUMBERING SYSTEM
(DUNS) NUMBER (JUNE 1999)

 

(a)                                  The offeror shall enter, in the block with
its name and address on the cover page of its offer, the annotation “DUNS”
followed by the DUNS number that identifies the offeror’s name and address
exactly as stated in the offer.  The DUNS number is a nine-digit number assigned
by Dun and Bradstreet Information Services.

 

(b)                                 If the offeror does not have a DUNS number,
it should contact Dun and Bradstreet directly to obtain one.  A DUNS number will
be provided immediately by telephone at no charge to the offeror.  For
information on obtaining a DUNS number, if located within the United States, the
offeror should call Dun and Bradstreet at 1-800-333-0505.  The offeror should be
prepared to provide the following information:

 

(1)                                  Company name.

 

(2)                                  Company address.

 

(3)                                  Company telephone number.

 

7

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(4)           Line of business.

 

(5)           Chief executive officer/key manager.

 

(6)           Date the company was started.

 

(7)           Number of people employed by the company.

 

(8)                                  Company affiliation.

 

(c)                                  Offerors located outside the United States
may obtain the location and phone number of the local Dun and Bradstreet
Information Services office from the Internet home page at
http://www.customerservice@dnb.com.  If an offeror is unable to locate a local
service center, it may send an e-mail to Dun and Bradstreet at
globalinfo@mail.dnb.com.

 

34.                               52.209-5  CERTIFICATION REGARDING DEBARMENT,
SUSPENSION, PROPOSED AND OTHER RESPONSIBILITY MATTERS (DECEMBER 2001)

 

(NOTE: Applies to contracts expected to exceed $100,000.)

 

(a)                                  (1)                                  The
Offeror certifies, to the best of its knowledge and belief, that –

 

(i)                                     The Offeror and/or any of its Principals
–

 

(A)                              Are o, are not ý presently debarred, suspended,
proposed for debarment, or declared ineligible for the award of contracts by any
Federal agency;

 

(B)                                Have o, have not ý, within a three-year
period preceding this offer, been convicted of or had a civil judgment rendered
against them for: commission of fraud or a criminal offense in connection with
obtaining, attempting to obtain, or performing a public (Federal, state or
local) contract or subcontract; violation of Federal or state antitrust statutes
relating to the submission of offers; or commission of embezzlement, theft,
forgery, bribery, falsification or destruction of records, making false
statements, tax evasion, or receiving stolen property; and

 

(C)                                Are o, are not ý presently indicted for, or
otherwise criminally or civilly charged by a governmental entity with,
commission of any of the offenses enumerated in subdivision (a)(1)(i)(B) of this
provision.

 

8

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(D)                               If the offeror has responded affirmatively,
the offeror shall provide additional information if requested by the Contracting
Officer; and

 

(ii)                                  The Offeror has o, has not ý, within a
three-year period preceding this offer, had one or more contracts terminated for
default by any Federal agency.

 

(2)                                  “Principals” for the purposes of this
certification, means officers; directors; owners; partners; and, persons having
primary management or supervisory responsibilities within a business entity
(e.g., general manager, plant manager, head of a subsidiary, division, or
business segment, and similar positions).

 

THIS CERTIFICATION CONCERNS A MATTER WITHIN THE JURISDICTION OF AN AGENCY OF THE
UNITED STATES AND THE MAKING OF A FALSE, FICTITIOUS, OR FRAUDULENT CERTIFICATION
MAY RENDER THE MAKER SUBJECT TO PROSECUTION UNDER SECTION 1001, TITLE 18, UNITED
STATES CODE.

 

(b)                                 The Offeror shall provide immediate written
notice to the Contracting Officer if, at any time prior to contract award, the
Offeror learns that its certification was erroneous when submitted or has become
erroneous by reason of changed circumstances.

 

(c)                                  A certification that any of the items in
paragraph (a) of this provision exists will not necessarily result in
withholding of an award under this solicitation.  However, the certification
will be considered in connection with a determination of the Offeror’s
responsibility.  Failure of the Offeror to furnish a certification or provide
such additional information as requested by the Contracting Officer may render
the Offeror nonresponsible.

 

(d)                                 Nothing contained in the foregoing shall be
construed to require establishment of a system of records in order to render, in
good faith, the certification required by paragraph (a) of this provision.  The
knowledge and information of an Offeror is not required to exceed that which is
normally possessed by a prudent person in the ordinary course of business
dealings.

 

(e)                                  The certification in paragraph (a) of this
provision is a material representation of fact upon which reliance was placed
when making an award.  If it is later determined that the Offeror knowingly
rendered an erroneous certification, in addition to other remedies available to
the Government, the Contracting Officer may terminate the contract resulting
from this solicitation for default.

 

9

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35.                               52.215-6  PLACE OF PERFORMANCE (OCTOBER 1997)

 

(a)                                  The offeror or respondent, in the
performance of any contract resulting from this solicitation, o intends, ý does
not intend (check applicable block) to use one or more plants or facilities
located at a different addresses from the address of the offeror or respondent
as indicated in this proposal or response to request for information.

 

(b)                                 If the offeror or respondent checks
“intends” in paragraph (a) of this provision, it shall insert in the following
spaces the required information:

 

Place of Performance
(Street Address (City, State, County, Zip Code)

 

Name and Address of Owner and
Operator of the Plant or Facility if
Other than Offeror or Respondent

 

36.                               52.219-1  SMALL BUSINESS PROGRAM
REPRESENTATIONS (APRIL 2002)

 

(Note: This provision applies to solicitations exceeding the micro-purchase
threshold when the contract is to be performed in the United States, its
territories or possessions.  Puerto Rico, the Trust Territory of the Pacific
Islands, or the District of Columbia.)

 

(a)                                  (1)                                  The
North American Industry Classification System (NAICS) code for this acquisition
is [INSERT NAICS CODE].

 

(2)                                  The small business size standard is [INSERT
SIZE; STANDARD]

 

(3)                                  The small business size standard for a
concern which submits an offer in its own name, other than on a construction or
service contract; but which proposes to furnish a product which it did not
itself manufacture, is 500 employees.

 

(b)                                 Representations.

 

(1)                                  The offeror represents as part of its offer
that it ý is, o is not a small business concern.

 

(2)                                  (Complete only if the offeror represented
itself as a small business concern in paragraph (b)(1) of this provision.)  The
offeror represents, for general statistical purposes, that it o is, ý is not a
small disadvantaged business concern as defined in 13 CFR 124.1002.

 

(3)                                  (Complete only if the offeror represented
itself as a small business concern in paragraph (b)(1) of this provision.)  The
offeror represents as part of its offer that it o is, ý is not a women-owned
small business concern.

 

(4)                                  (Complete only if the offeror represented
itself as a small business concern in paragraph (b)(1) of this provision.)  The
offeror represents

 

10

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as part of its offer that it o is, ý is not a veteran-owned small business
concern.

 

(5)                                  (Complete only if the offeror represented
itself as a veteran-owned small business concern in paragraph (b)(4) of this
provision.)  The offeror represents as part of its offer that it o is, ý is not
a service-disabled veteran-owned small business concern.

 

(1)                                  (Complete only if the offeror represented
itself as a small business concern in paragraph (b) (1) of this provision.)  The
offeror represents, as a part of its offeror, that -

 

(1)                                  It o is, ý is not a HUBZone small business
concern listed, on the date of this representation, on the List of Qualified
HUBZone Small Business Concerns maintained by the Small business Administration,
and no material change in ownership and control, principal office, or HUBZone
employee percentage has occurred since it was certified by the Small Business
Administration in accordance with 13 CFR part 126; and

 

(2)                                  It o is, ý is not a joint venture that
complies with the requirements of 13 CFR part 126, and the representation in
paragraph (b)(6)(i) of this provision is accurate for the HUBZone small business
concern or concerns that are participating in the joint venture.  [The offeror
shall enter the name or names of the HUBZone small business concern or concerns
that are participating in the joint venture.]  Each HUBZone small business
concern participating in the joint venture shall submit a separate signed copy
of the HUBZone representation.

 

(c)                                  Definitions.  As used in this provision—

 

Service-disabled veteran-owned small business concern—

 

(1)                                  Means a small business concern—

 

(i)                                     Not less than 51 percent of which is
owned by one or more service-disabled veterans or, in the case of any publicly
owned business, not less than 51 percent of the stock or which is owned by one
or more service-disabled veterans; and

 

(ii)                                  The Management and daily business
operation of which are controlled by one or more service disabled veterans or,
in the case of a veteran with permanent and severe-disability, the spouse or
permanent caregiver of such veteran.

 

11

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(2)                                  Service-disabled veteran means a veteran,
as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as
defined in 38 U.S.C. 101(16).

 

Small business concern, means a concern, including its affiliates, that is
independently owned and operated, not dominant in the field of operation in
which it is bidding on Government contracts, and qualified as a small business
under the criteria in 13 CFR Part 121 and the size standard in paragraph (a) of
this provision.

 

Women-owned small business concern, means a small business concern—

 

(1)                                  That is at least 51 percent owned by one or
more women; or, in the case of any publicly owned business, at least 51 percent
of the stock of which is owned by one or more women; and

 

(2)                                  Whose management and daily business
operations are controlled by one or more women.

 

Veteran-owned small business concern means a small business concern—

 

(1)                                  Not less than 51 percent of which is owned
by one or more veterans (as defined at 38 U.S.C. 101(2)) or, in the case of any
publicly owned business, not less than 51 percent of the stock of which is owned
by one or more veterans; and

 

(2)                                  The management and daily business
operations of which are controlled by one or more veterans.

 

(d)                                 Notice.

 

(1)                                  If this solicitation is for supplies and
has been set aside, in whole or in part, for small business concerns, then the
clause in this solicitation providing notice of the set-aside contains
restrictions on the source of the end items to be furnished.

 

(2)                                  Under 15 U.S.C. 645(d), any person who
misrepresents a firm’s status as a small, HUBZone small, small disadvantaged, or
women-owned small business concern in order to obtain a contract to be awarded
under the preference programs established pursuant to section 8(a), 8(d), 9, or
15 of the Small Business Act or any other provision of Federal law that
specifically references section 8(d) for a definition of program eligibility,
shall—

 

(i)                                     Be punished by imposition of fine,
imprisonment, or both;

 

12

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(ii)                                  Be subject to administrative remedies,
including suspension and debarment; and

 

(iii)                               Be ineligible for participation in programs
conducted under the authority of the Act.

 

37.                               52.219-19  SMALL BUSINESS CONCERN
REPRESENTATION FOR THE SMALL BUSINESS COMPETITIVENESS DEMONSTRATION PROGRAM
(OCTOBER 2000)

 

(This representation must be completed if the acquisition is for one of the four
designated industry groups of the Small Business Competitiveness Demonstration
Program specified in FAR 19.1005(a) (includes Construction Contracts under NAICS
codes that comprise Industry Subsectors 233, 234 and 235].)

 

(a)                                  Definition

 

“Emerging small business” as used in this solicitation, means a small business
concern whose size is no greater than 50 percent of the numerical size standard
applicable to the North American Industry Classification System (NAICS) code
assigned to a contracting opportunity.

 

(b)                                 (Complete only if offeror has represented
itself under the provision at FAR 52.219-1 as a small business concern under the
size standards of this solicitation.)

 

The Offeror o is, o is not an emerging small business.

 

(c)                                  (Complete only if the Offeror is a small
business or an emerging small business, indicating its size range.)

 

Offeror’s number of employees for the past twelve months (check this column if
size standard stated in solicitation is expressed in terms of number of
employees) or Offeror’s average annual gross revenue for the last 3 fiscal years
(Check this column if size standard stated in solicitation is expressed in terms
of annual receipts).  (Check one of the following.)

 

Number of Employees

 

Average Annual Gross Revenues

o 50 or fewer

 

o $1 million or less

 

 

 

o 51-100

 

o $1,000,001 – $2 million

 

 

 

o 101-250

 

o $2,000,001 – $3.5 million

 

 

 

o 251 – 500

 

o $3,500,001 – $5 million

 

 

 

o 501 – 750

 

o $5,000,001 – $10 million

 

 

 

o 751-1,000

 

o $10,000,001 – $17 million

 

 

 

o Over 1,000

 

o Over $17 million

 

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38.                               52.219-21  SMALL BUSINESS SIZE REPRESENTATION
FOR TARGETED INDUSTRY CATEGORIES UNDER THE SMALL BUSINESS COMPETITIVENESS
DEMONSTRATION PROGRAM (MAY 1999)

 

(Complete only if the Offeror has represented itself under the provision
52.219-1 as a small business concern under the size standards of this
solicitation.)

 

(NOTE: This representation must be completed if this solicitation covers one of
the ten targeted industry categories under the Small Business Competitiveness
Demonstration Program and if the offeror has certified itself under the clause
at FAR 52.219-1 to be a small business concern under the size standards of this
solicitation).

 

Offeror’s number of employees for the past twelve months (check this column if
size standard stated in solicitation is expressed in terms of number of
employees) or Offeror’s average annual gross revenue for the last three fiscal
years (check this column if size standard stated in solicitation is expressed in
terms of annual receipts).  (Check one of the following.)

 

Number of Employees

 

Average Annual Gross Revenues

 

 

 

o 50 or fewer

 

o $1 million or less

 

 

 

o 51 – 100

 

o $1,000,001 – $2 million

 

 

 

o 101 – 250

 

o $2,000,001 – $3.5 million

 

 

 

o 251 – 500

 

o $3,500,001 – $5 million

 

 

 

o 501 – 750

 

o $5,000,001 – $10 million

 

 

 

o 751 – 1,000

 

o $10,000,001 – $17 million

 

 

 

o Over 1,000

 

o Over $17 million

 

14

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The ten targeted industries are as follows:

 

Product Service Code

 

SIC Code

 

Description

G004

 

8742

 

Counseling/Training/Social Rehabilitation Services

 

 

 

 

 

J099

 

7699

 

Maintenance, Repair and Rebuilding of Equipment (Office Machines, Text
Processing Systems & Visible Record Equipment)

 

 

 

 

 

K099

 

7699

 

Modification of Equipment (misc.)

 

 

 

 

 

Q210

 

8099, 8742

 

General Health Care Services

 

 

 

 

 

R406

 

8742

 

Policy Review/Development Services

 

 

 

 

 

R497

 

7299

 

Personal Services

 

 

 

 

 

6505

 

2833, 2834, 2835, 2836

 

Drugs and Biologics

 

 

 

 

 

7045

 

3572, 3695

 

ADP Supplies

 

 

 

 

 

7110

 

5065 5021

 

Office Furniture

 

 

 

 

 

7510

 

5112

 

Office Supplies

 

39.                               52.219-22  SMALL DISADVANTAGED BUSINESS STATUS
(OCTOBER 1999)

 

(Note: This applies to competitive solicitations over $100,000 under the SIC
Major Groups for which a price evaluation adjustment is applicable.)

 

(a)                                  General.  This provision is used to assess
an offeror’s small disadvantaged business status for the purpose of obtaining a
benefit on this solicitation.  Status as a small business and status as a small
disadvantaged business for general statistical purposes is covered by the
provision at FAR 52.219-1, Small Business Program Representation.

 

(b)                                 Representations.

 

(1)                                  General.  The offeror represents, as part
of its offer, that it is a small business under the size standard applicable to
this acquisition; and either—

 

o(i)                         It has received certification by the Small Business
Administration as a small disadvantaged business concern consistent with 13 CFR
124, Subpart B; and

 

(A)                              No material change in disadvantaged ownership
and control has occurred since its certification;

 

15

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(B)                                Where the concern is owned by one or more
disadvantaged individuals, the net worth of each individual upon whom the
certification is based does not exceed $750,000 after taking into account the
applicable exclusions set forth at 13 CFR 124.104(c)(2); and

 

(C)                                It is identified, on the date of its
representation, as a certified small disadvantaged business concern in the
database maintained by the Small Business Administration (PRONet); or

 

o(ii)                      It has submitted a completed application to the Small
Business Administration or a Private Certifier to be certified as a small
disadvantaged business concern in accordance with 13 CFR 124, Subpart B, and a
decision on that application is pending, and that no material change in
disadvantaged ownership and control has occurred since its application was
submitted.

 

(2)o                      For Joint Ventures.  The offeror represents, as part
of its offer, that it is a joint venture that complies with the requirements at
13 CFR 124.1002(f) and that the representation in paragraph (b)(1) of this
provision is accurate for the small disadvantaged business concern that is
participating in the joint venture.  [The offeror shall enter the name of the
small disadvantaged business concern that is participating in the joint
venture:                         .]

 

(c)                                  Penalties and Remedies.  Anyone who
misrepresents any aspects of the disadvantaged status of a concern for the
purposes of securing a contract or subcontract shall:

 

(1)                                  Be punished by imposition of a fine,
imprisonment, or both;

 

(2)                                  Be subject to administrative remedies,
including suspension and debarment; and

 

(3)                                  Be ineligible for participation in programs
conducted under the authority of the Small Business Act.

 

Alternate I (OCTOBER 1998)

 

(Note: Applies when price evaluation adjustment for small disadvantaged business
concerns is authorized on a regional basis.  Designated regions by Major SIC
Category can be found at http://www.arnet.gov/References/sdbadjustments.htm. 
Currently, this includes SIC Major Industry Groups 15, 16, 17 which are all
construction related groups.)

 

As prescribed in 19.306(b), add the following paragraph (b)(3) to the basic
provision:

 

16

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(3)                                  Address.  The offeror represents that its
address                     is,                      is not in a region for
which a small disadvantaged business procurement mechanism is authorized and its
address has not changed since its certification as a small disadvantaged
business concern or submission of its application for certification.  The list
of authorized small disadvantaged business procurement mechanisms and regions is
posted at http://www.arnet.gov/References/sdbadjustments.htm  The offeror shall
use the list in effect on the date of this solicitation.  “Address,” as used in
this provision, means the address of the offeror as listed on the Small Business
Administration’s register of small disadvantaged business concerns or the
address on the completed application that the concern has submitted to the Small
Business Administration or a Private Certifier in accordance with 13 CFR part
124, subpart B.  For joint ventures, “address” refers to the address of the
small disadvantaged business concern that is participating in the joint venture.

 

40.                               52.222-18  CERTIFICATION REGARDING KNOWLEDGE
OF CHILD LABOR FOR LISTED END PRODUCTS (MAY 2001)

 

(Applies to all contracts for supplies over $2,500.  See FAR 22.1503 for more
information)

 

1.                                       Definition.

 

Forced or indentured child labor means all work or service—

 

(1)                                  Exacted from any person under the age of 18
under the menace of any penalty for its nonperformance and for which the worker
does not offer himself voluntarily; or

 

(2)                                  Performed by any person under the age of 18
pursuant to a contract the enforcement of which can be accomplished by process
or penalties.

 

2.                                       Listed end products.  The following end
product(s) being acquired under this solicitation is (are) included in the List
of Products Requiring Contractor Certification as to Forced or Indentured Child
Labor, identified by their country of origin.  There is a reasonable basis to
believe that listed end products from the listed countries of origin may have
been mined, produced, or manufactured by forced or indentured child labor.

 

Listed End Product

 

Listed Countries of Origin

 

3.                                       Certification.  The Government will not
make award to an offeror unless the offeror, by checking the appropriate block,
certifies to either paragraph (c)(1) or paragraph (c)(2) of this provision.

 

17

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ý(1)                      The offeror will not supply any end product listed in
paragraph (b) of this provision that was mined, produced, or manufactured in a
corresponding country as listed for that end product.

 

o(2)                      The offeror may supply an end product listed in
paragraph (b) of this provision that was mined, produced, or manufactured in the
corresponding country as listed for that product.  The offeror certifies that it
has made a good faith effort to determine whether forced or indentured child
labor was used to mine, produce, or manufacture such end product.  On the basis
of those efforts, the offeror certifies that it is not aware of any such use of
child labor.

 

13.                               52.222-21  CERTIFICATION OF NONSEGREGATED
FACILITIES (FEBRUARY 1999)

 

(a)                                  Segregated facilities, as used in this
clause, means any waiting rooms, work areas, rest rooms and wash rooms,
restaurants and other eating areas, time clocks, locker rooms and other storage
or dressing areas, parking lots, drinking fountains, recreation or entertainment
areas, transportation, and housing facilities provided for employees, that are
segregated by explicit directive or are in fact segregated on the basis of race,
color, religion, sex, or national origin because of written or oral policies or
employee custom.  The term does not include separate or single-user rest rooms
or necessary dressing or sleeping areas provided to assure privacy between the
sexes.

 

(b)                                 The Contractor agrees that it does not and
will not maintain or provide for its employees any segregated facilities at any
of its establishments, and that it does not and will not permit its employees to
perform their services at any location under its control where segregated
facilities are maintained.  The Contractor agrees that a breach of this clause
is a violation of the Equal Opportunity clause in this contract.

 

(c)                                  The Contractor shall include this clause in
every subcontract and purchase order that is subject to the Equal Opportunity
clause of this contract.

 

14.                               52.222-22  PREVIOUS CONTRACTS AND COMPLIANCE
REPORTS (FEBRUARY 1999)

 

The offeror represents that—

 

(a)                                  It ýhas, o has not participated in a
previous contract or subcontract subject to the Equal Opportunity clause of this
solicitation;

 

(b)                                 It ý has, o has not, filed all required
compliance reports; and

 

18

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(c)                                  Representations indicating submission of
required compliance reports, signed by proposed subcontractors, will be obtained
before subcontract awards.

 

15.                               52.222-25  AFFIRMATIVE ACTION COMPLIANCE
(APRIL 1984)

 

The offeror represents that (a) it ý has developed and has on file, o has not
developed and does not have on file, at each establishment, affirmative action
programs required by the rules and regulations of the Secretary of Labor (41 CFR
60-1 and 60-2), or (b) it o has not previously had contracts subject to the
written affirmative action programs requirement of the rules and regulations of
the Secretary of Labor.

 

16.                               52.222-38  COMPLIANCE WITH VETERANS’
EMPLOYMENT REPORTING REQUIREMENTS (DECEMBER 2001)

 

By submission of its offer, the offeror represents that, if it is subject to the
reporting requirements of 38 U.S.C. 4212(d) (i.e., if it has any contract
containing Federal Acquisition Regulation clause 52.222-37, Employment Reports
on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible
Veterans), it has submitted the most recent VETS-100 Report required by that
clause.

 

17.                               52.222-48  EXEMPTION FROM APPLICATION OF
SERVICE CONTRACT ACT PROVISIONS FOR CONTRACTS FOR MAINTENANCE, CALIBRATION,
AND/OR REPAIR OF CERTAIN INFORMATION TECHNOLOGY, SCIENTIFIC AND MEDICAL AND/OR
OFFICE AND BUSINESS EQUIPMENT—CONTRACTOR CERTIFICATION (AUGUST 1996)

 

(NOTE: This clause is applicable to all solicitations and resultant contracts
calling for maintenance, calibration, and/or repair of information technology,
scientific and medical, and office and business equipment if the contracting
officer determines that the resultant contract may be exempt from Service
Contract Act coverage).

 

(a)                                  The following certification shall be
checked:

 

CERTIFICATION

 

The offeror certifies ý, does not certify o that: (1) The items of equipment to
be serviced under this contract are commercial items which are used regularly
for other than Government purposes, and are sold or traded by the Contractor in
substantial quantities to the general public in the course of normal business
operations; (2) The contract services are furnished at prices which are, or are
based on, established catalog or market prices for the maintenance, calibration,
and/or repair of certain information technology, scientific and medical, and/or
office and business equipment.  An “established catalog price” is a price
(including discount price) recorded in a catalog, price list schedule, or other
verifiable and established record that is regularly maintained by the
manufacturer

 

19

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or the Contractor and is either published or otherwise available for inspection
by customers.  An “established market price” is a current price, established in
the usual course of ordinary and usual trade between buyers and sellers free to
bargain, which can be substantiated by data from sources independent of the
manufacturer or Contractor; and (3) The Contractor utilizes the same
compensation (wage and fringe benefits) plan for all service employees
performing work under the contract as the Contractor uses for equivalent
employees servicing the same equipment of commercial customers.

 

(b)                                 If a negative certification is made and a
Service Contract Act wage determination is not attached to the solicitation, the
Contractor shall notify the Contracting Officer as soon as possible.

 

(c)                                  Failure to execute the certification in
paragraph (a) of this clause or to contact the Contracting Officer as required
in paragraph (b) of this clause may render the bid or offer nonresponsive.

 

18.                               52.223-4  RECOVERED MATERIAL CERTIFICATION
(OCTOBER 1997)

 

(This certification is applicable in solicitations that are for, or specify the
use, of recovered materials.)

 

As required by the Resource Conservation and Recovery Act of 1976 (42 U.S.C. 
6962(c)(3)(A)(i)), the offeror certifies, by signing this offer, that the
percentage of recovered materials to be used in the performance of the contract
will be at least the amount required by the applicable contract specifications.

 

19.                               52.223-13  CERTIFICATION OF TOXIC CHEMICAL
RELEASE REPORTING (OCTOBER 2000)

 

NOTE: This certification is applicable for all solicitations for competitive
contracts expected to exceed $100,000 (including all options) and competitive
8(a) contracts.  It is not applicable to acquisitions of commercial items, or to
contracts where the contractor’s facilities are located outside the United
States (the “United States” includes any state of the United States, the
District of Columbia, the Commonwealth of Puerto Rico, Guam, American Samoa, the
United States Virgin Islands, the Northern Mariana Islands, and any other
territory or possession over which the United States has jurisdiction)

 

(a)                                  Submission of this certification is a
prerequisite for making or entering into this contract imposed by Executive
Order 12969, August 8, 1995.

 

(b)                                 By signing this offer, the offeror certifies
that—

 

(1)                                  As the owner or operator of facilities that
will be used in the performance of this contract that are subject to the filing
and reporting requirements

 

20

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described in section 313 of the Emergency Planning and Community Right-to-Know
Act of 1986 (EPCRA) (42 U.S.C. 11023) and section 6607 of the Pollution
Prevention Act of 1990 (PPA) (42 U.S.C. 13106), the offeror will file and
continue to file for such facilities for the life of the contract the Toxic
Chemical Release Inventory Form (Form R) as described in sections 313(a) and (g)
of EPCRA and section 6607 of PPA; or

 

(2)                                  None of its owned or operated facilities to
be used in the performance of this contract is subject to the Form R filing and
reporting requirements because each such facility is exempt for at least one of
the following reasons: (Check each block that is applicable.)

 

ý(i)                         The facility does not manufacture, process, or
otherwise use any toxic chemicals listed under section 313(c) of EPCRA, 42
U.S.C.  11023(c);

 

o(ii)                      The facility does not have 10 or more full-time
employees as specified in section 313(b)(1)(A) of EPCRA, 42 U.S.C. 
11023(b)(1)(A);

 

o(iii)                   The facility does not meet the reporting thresholds of
toxic chemicals established under section 313(f) of EPCRA, 42 U.S.C.  11023(f)
(including the alternate thresholds at 40 CFR 372.27, provided an appropriate
certification form has been filed with EPA);

 

o(iv)                  The facility does not fall within Standard Industrial
Classification Code (SIC) major groups 20 through 39 or their corresponding
North American Industry Classification System (NAICS) sectors 31 through 33; or

 

o(v)                     The facility is not located within any State of the
United States, the District of Columbia, the Commonwealth of Puerto Rico, Guam,
American Samoa, the United States Virgin Islands, the Northern Mariana Islands,
or any other territory or possession over which the United States has
jurisdiction.

 

20.                               52.225-2  BUY AMERICAN ACT CERTIFICATE (MAY
2002)

 

[Note: This provision is applicable for all requirements EXCEPT for 1) foreign
contracts or 2) when one of the following two provisions (52.225-4, Buy American
Act—North American Free Trade Agreement—Israeli Trade Act Certificate, or
52.225-6, Trade Agreements Certificate) apply.

 

21

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(a)                                  The offeror certifies that each end
product, except those listed in paragraph (b) of this provision, is a domestic
end product as defined in the clause of this solicitation entitled “Buy American
Act—Supplies” and that the offeror has considered components of unknown origin
to have been mined, produced, or manufactured outside the United States.  The
offeror shall list as foreign end products those end products manufactured in
the United States that do not qualify as domestic end products.

 

(b)                                 Foreign End Products:

Line Item No.:
Country of Origin:
                                                (List as necessary)

 

(c)                                  The Government will evaluate offers in
accordance with the policies and procedures of Part 25 of the Federal
Acquisition Regulation.

 

21.                               52.225-4  BUY AMERICAN ACT NORTH AMERICAN FREE
TRADE AGREEMENT—ISRAELI TRADE ACT CERTIFICATE (MAY 2002)

 

[Note: This provision is applicable for requirements with a value of $25,000 or
more but less than $169,000 EXCEPT for 1) foreign acquisitions or 2)
acquisitions that are exempt from NAFTA and the Israeli Trade Act.  (See FAR
25.401).]

 

(a)                                  The offeror certifies that each end
product, except those listed in paragraph (b) or (c) of this provision, is a
domestic end product (as defined in the clause of this solicitation entitled,
“Buy American Act—North American Free Trade Agreement—Israeli Trade Act”) and
that the offeror has considered components of unknown origin to have been mined,
produced, or manufactured outside the United States.

 

(b)                                 The offeror certifies that the following
supplies are NAFTA country end products or Israeli end products as defined in
the clause of this solicitation entitled, “Buy American Act—North American Free
Trade—Agreement—Israeli Trade Act”:

NAFTA Country or Israel:  End Products:
Line Item No.:
Country of Origin:
                (List as necessary)

 

(c)                                  The offeror shall list those supplies that
are foreign end products (other than those listed in paragraph (b) of this
provision) as defined in the clause of this solicitation entitled,  “Buy
American Act—North American Free Trade Agreement—Israeli Trade Act.”  The
offeror shall list as other foreign end products those end products manufactured
in the United States that do not qualify as domestic end products.

 

22

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Other Foreign End Products

Line Item No.:

Country of Origin:
                                                (List as necessary)

 

(d)                                 The Government will evaluate offers in
accordance with the policies and procedures of Part 25 of the Federal
Acquisition Regulation.

 

ALTERNATE I (MAY 2002) As prescribed in 25.1101(b)(2)(ii), substitute the
following paragraph (b) for paragraph (b) of the basic provision:

 

[Note: Applies when the acquisition value is $25,000 or more but is less than
$50,000.]

 

(b)                                 The offeror certifies that the following
supplies are Canadian end products as defined in the clause of this solicitation
entitled “Buy American Act—North American Free Trade Agreement—Israeli Trade
Act”:

Canadian End Products:

Line Item No.:

                                                (List as necessary)

 

ALTERNATE II (MAY 2002) As prescribed in 25.1101(b)(2)(iii), substitute the
following paragraph (b) for paragraph (b) of the basic provision:

 

[Note: Applies when the acquisition value is $50,000 or more, but is less than
$56,190.]

 

(b)                                 The offeror certifies that the following
supplies are Canadian end products or Israeli end products as defined in the
clause of this solicitation entitled “Buy American Act—North American Free Trade
Agreement—Israeli Trade Act”:

 

Canadian or Israeli End Products

Line Item No.:

Country of Origin:

                                                (List as necessary)

 

22.                               52.225-6  TRADE AGREEMENTS CERTIFICATE - (MAY
2002)

 

[Note: This provision is applicable for acquisitions valued at $169,000 or more,
if the Trade Agreement Act applies.  (See FAR 25.401 and 25.403).]

 

(a)                                  The offeror certifies that each end
product, except those listed in paragraph (b) of this provision, is a U.S.-made,
designated country, Caribbean Basin country, or NAFTA country end product, as
defined in the clause of this solicitation entitled “Trade Agreements.”

 

23

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(b)                                 The offeror shall list as other end products
those supplies that are not U.S.-made, designated country, Caribbean Basin
country, or NAFTA country end products.

 

Other End Products

Line Item No.:

Country of Origin:

                                                (List as necessary)

 

(c)                                  The Government will evaluate offers in
accordance with the policies and procedures of Part 25 of the Federal
Acquisition Regulation.  For line items subject to the Trade Agreements Act, the
Government will evaluate offers of U.S.-made, designated country, Caribbean
Basin country, or NAFTA country end products without regard to the restrictions
of the Buy American Act.  The Government will consider for award only offers of
U.S.-made, designated country, Caribbean Basin country, or NAFTA country end
products unless the Contracting Officer determines that there are no offers for
those products or that the offers for those products are insufficient to fulfill
the requirements of this solicitation.

 

23.                               52.226-2  HISTORICALLY BLACK COLLEGE OR
UNIVERSITY AND MINORITY INSTITUTION REPRESENTATION - (MAY 2001)

 

(a)                                  Definitions.  As used in this provision—

 

Historically Black College or University means an institution determined by the
Secretary of Education to meet the requirements of 34 CFR 608.2.  For the
Department of Defense, the National Aeronautics and Space Administration, and
the Coast Guard, the term also includes any nonprofit research institution that
was an integral part of such a college or university before November 14, 1986.

 

Minority Institution means an institution of higher education meeting the
requirements of Section 1046(3) of the Higher Education Act of 1965 (20 U.S.C. 
1067k, including a Hispanic-serving institution of higher education, as defined
in Section 316(b)(1) of the Act (20 U.S.C. 1101a.)).

 

(b)                                 Representation.  The offeror represents that
it—

 

o is ý is not a Historically Black College or University;

o is ý is not a Minority Institution.

 

24.                               52.227-6  ROYALTY INFORMATION - (APRIL 1984)

 

(a)                                  Cost or charges for royalties.  When the
response to this solicitation contains costs or charges for royalties totaling
more than $250, the following information shall be included in the response
relating to each separate item of royalty or license fee:

 

24

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(1)                                  Name and address of licensor.  — See next
page

 

(2)                                  Date of license agreement. — See next page

 

(3)           Patent numbers, patent application serial numbers or other basis
on which the royalty is payable.

 

(4)           Brief description, including any part or model numbers of each
contract item or component on which the royalty is payable.

 

(5)           Percentage or dollar rate of royalty per unit.

 

(6)           Unit price of contract item.

 

(7)           Number of units.

 

(8)           Total dollar amount of royalties.

 

25

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(1)                                  Name and address of licensor

 

[**]

 

(2)                                  Date of license agreement

 

[**]

 

(3)                                  Patent numbers, patent application serial
numbers or other basis on which the royalty is payable. 

 

[**].

 

(4)                                  Brief description, including any part or
model numbers of each contract item or component on which the royalty item is
payable.

 

[**]

 

(5)                                  Percentage or dollar rate of royalty per
unit.

 

[**]

 

(6)                                  Unit price of contract item.

 

$[**]

 

(7)                                  Number of units.

 

[**]

 

(8)                                  Total dollar amount of royalties.

 

$[**]

 

26

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(b)                                 Copies of current licenses.  In addition, if
specifically requested by the Contracting Officer before execution of the
contract, the offeror shall furnish a copy of the current license agreement and
an identification of applicable claims of specific patents.

 

(NOTE: Alternate I, below, is applicable for communication services and
facilities by a common carrier.)

 

ALTERNATE I (APRIL 1984), 52.227-6 ROYALTY INFORMATION (APRIL 1984)

 

Substitute the following for the introductory portion of paragraph (a) of the
basic clause:

 

When the response to this solicitation covers charges for special construction
or special assembly that contain costs or charges for royalties totaling more
than $250, the following information shall be included in the response relating
to each separate item of royalty or license fee:

 

25.                               52.230-1  COST ACCOUNTING STANDARDS NOTICES
AND CERTIFICATION (JUNE 2000)

 

Note:                   This notice does not apply to small businesses or
foreign governments.  This notice is in three parts, identified by Roman
numerals I through III.

 

Offerors shall examine each part and provide the requested information in order
to determine Cost Accounting Standards (CAS) requirements applicable to any
resultant contract.

 

If the offeror is an educational institution, Part II does not apply unless the
contemplated contract will be subject to full or modified CAS-coverage pursuant
to 48 CFR 9903.201-2(C)(5) or 9903.201-2(c)(6), respectively.

 

I.                                         Disclosure Statement — Cost
Accounting Practices and Certification

 

(a)                                  Any contract in excess of $500,000
resulting from this solicitation will be subject to the requirements of the Cost
Accounting Standards Board (48 CFR Chapter 99), except for those contracts which
are exempt as specified in 9903.201-1.

 

(b)                                 Any offeror submitting a proposal which, if
accepted, will result in a contract subject to the requirements of 48 CFR
Chapter 99 must, as a condition of contracting, submit a Disclosure Statement as
required by 9903.202.  When required, the Disclosure Statement must be submitted
as a part of the offeror’s proposal under this solicitation unless the offeror
has already submitted a Disclosure Statement disclosing the practices used in
connection with the pricing of this proposal.  If an applicable Disclosure
Statement has already been submitted, the offeror may satisfy the requirement
for submission by providing the information requested in paragraph (c) of Part I
of this provision.

 

27

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CAUTION: In the absence of specific regulations or agreement, a practice
disclosed in a Disclosure Statement shall not, by virtue of such disclosure, be
deemed to be a proper, approved, or agreed-to practice for pricing proposals or
accumulating and reporting contract performance cost data.

 

(c)                                  Check the appropriate box below:

 

o(1)                      Certificate of Concurrent Submission of Disclosure
Statement.

 

The offeror hereby certifies that, as part of the offer, copies of the
Disclosure Statement have been submitted as follows:

 

(i)                                     original and one copy to the cognizant
Administrative Contracting Officer (ACO), or cognizant Federal agency official
authorized to act in that capacity (Federal official), as applicable, and;

 

(ii)                                  one copy to the cognizant Federal auditor.

 

(Disclosure must be on Form No. CASB DS-1 or CASB DS-2, as applicable.  Forms
may be obtained from the cognizant ACO or Federal official and/or from the
looseleaf version of the Federal Acquisition Regulation).

 

Date of Disclosure Statement:

 

Name and Address of Cognizant ACO or Federal Official Where Filed:

 

The offeror further certifies that the practices used in estimating costs in
pricing this proposal are consistent with the cost accounting practices
disclosed in the Disclosure Statement.

 

o(2)                      Certificate of Previously Submitted Disclosure
Statement.

 

The offeror hereby certifies that the required Disclosure Statement was filed as
follows:

 

Date of Disclosure Statement:

Name and Address of Cognizant ACO or Federal Official Where Filed:

 

The offeror further certifies that the practices used in estimating costs in
pricing this proposal are consistent with the cost accounting practices
disclosed in the applicable Disclosure Statement.

 

28

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o(3)                      Certificate of Monetary Exemption.

 

The offeror hereby certifies that the offeror together with all divisions,
subsidiaries, and affiliates under common control, did not receive net awards of
negotiated prime contracts and subcontracts subject to CAS totaling more than
$50 million or more in the cost accounting period immediately preceding the
period in which this proposal was submitted.  The offeror further certifies that
if such status changes before an award resulting from this proposal, the offeror
will advise the Contracting Officer immediately.

 

o(4)                      Certificate of Interim Exemption.

 

The offeror hereby certifies that:

 

(i)                                     the offeror first exceeded the monetary
exemption for disclosure, as defined in (3) of this subsection, in the cost
accounting period immediately preceding the period in which this offer was
submitted, and

 

(ii)                                  in accordance with 48 CFR 9903.202-1, the
offeror is not yet required to submit a Disclosure Statement.  The offeror
further certifies that if an award resulting from this proposal has not been
made within 90 days after the end of that period, the offeror will immediately
submit a revised certificate to the Contracting Officer, in the form specified
under subparagraph (c)(1) or (c)(2) of Part I of this provision, as appropriate,
to verify submission of a completed Disclosure Statement.

 

CAUTION: Offerors currently required to disclose because they were awarded a
CAS-covered prime contract or subcontract of $50 million or more in the current
cost accounting period may not claim this exemption (4).  Further, the exemption
applies only in connection with proposals submitted before expiration of the
90-day period following the cost accounting period in which the monetary
exemption was exceeded.

 

o                                    (5)                                 
Certificate of Disclosure Statement Due Date by Educational Institution. 
(ALTERNATE I - APRIL 1996)

 

If the offeror is an educational institution that, under the transition
provisions of 48 (CFR 9903.202-1(f), is or will be required to

 

29

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submit a Disclosure Statement after receipt of this award, the offeror hereby
certifies that (check one and complete):

 

o(i)                         A Disclosure Statement filing Due Date of
               has been established with the cognizant Federal agency.

 

o(ii)                      The Disclosure Statement will be submitted within the
6-month period ending                months after receipt of this award.

 

Name and Address of Cognizant ACO or Federal Official Where Disclosure Statement
is to be Filed:

 

II.                                     Cost Accounting Standards — Eligibility
for Modified Contract Coverage

 

If the offeror is eligible to use the modified provisions of 48 CFR
9903.201-2(b) and elects to do so, the offeror shall indicate by checking the
box below.  Checking the box below shall mean that the resultant contract is
subject to the Disclosure and Consistency of Cost Accounting Practices clause in
lieu of the Cost Accounting Standards clause.

 

o                                    The offeror hereby claims an exemption from
the Cost Accounting Standards clause under the provisions of 48 CFR
9903.201-2(b) and certifies that the offeror is eligible for use of the
Disclosure and Consistency of Cost Accounting Practices clause because during
the cost accounting period immediately preceding the period in which this
proposal was submitted, the offeror received less than $50 million in awards of
CAS-covered prime contracts and subcontracts.  The offeror further certifies
that if such status changes before an award resulting from this proposal, the
offeror will advise the Contracting Officer immediately.

 

CAUTION: An offeror may not claim the above eligibility for modified contract
coverage if this proposal is expected to result in the award of a CAS-covered
contract of $50 million or more or if, during its current cost accounting
period, the offeror has been awarded a single CAS-covered prime contract or
subcontract of $50 million or more.

 

III.                                 Additional Cost Accounting Standards
Applicable to Existing Contracts

 

The offeror shall indicate below whether award of the contemplated contract
would, in accordance with subparagraph (a)(3) of the Cost Accounting Standards
Clause, require a change in established cost accounting practices affecting
existing contracts and subcontracts.

 

o YES

 

o NO

 

30

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26.                               CERTIFICATION REGARDING ENVIRONMENTAL TOBACCO
SMOKE (DECEMBER 1994)

 

(Note: This certification applies only to those contract which contain
provisions for children’s services.  The offeror’s signature on the face page of
these Representations and Certifications constitutes certification by the
submitting organization of its compliance with the Act.)

 

Public Law 103-227, also known as the Pro-Children Act of 1994 (Act), requires
that smoking not be permitted in any portion of any indoor facility owned or
leased or contracted for by an entity and used routinely or regularly for the
provision of health, day care, early childhood development services, education
or library services to children under the age of 18, if the services are funded
by Federal programs either directly or through State or local governments, by
Federal grant, contract, loan, or loan guarantee.  The law also applies to
children’s services that are provided in indoor facilities that are constructed,
operated, or maintained with such federal funds.  The law does not apply to
children’s services provided in private residences; portions of facilities used
for inpatient drug or alcohol treatment; service providers whose sole source of
applicable federal funds is Medicare or Medicaid; or facilities where WIC
coupons are redeemed.  Failure to comply with the provisions of the law may
result in the imposition of a civil monetary penalty of up to $1,000 for each
violation and/or the imposition of an administrative compliance order on the
responsible entity.

 

By signing this certification, the offeror/contractor (for acquisitions) or
applicant/grantee (for grants) certifies that the submitting organization will
comply with the requirements of the Act and will not allow smoking within any
portion of any indoor facility used for the provision of services for children
as defined by the Act.

 

The submitting organization agrees that it will require that the language of
this certification be included in any subawards which contain provisions for
children’s services and that all subrecipients shall certify accordingly.

 

27.                               CERTIFICATION OF INSTITUTIONAL POLICY ON
CONFLICT OF FINANCIAL INTEREST (OCTOBER 1995)

 

(Note: This certification is applicable to Research and Development (R&D)
Contracts.  However, this certification does not apply to SBIR-Phase I
contractors.)

 

By submission of its offer, the offeror certifies that:

 

(1)                                  A written and enforced administrative
process to identify and manage, reduce or eliminate conflicting financial
interest with respect to all research projects for which funding is sought from
the NIH is o, is not o currently in effect.

 

(2)                                  Should a process not be in effect at the
time of the submission of its offer, the offeror certifies that it will, no
later than 30 days subsequent to submission of its

 

31

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offer or prior to award, whichever is earlier, notify the Contracting Officer of
the establishment of a written and enforced financial conflict of interest
policy.

 

28.                               15.406-2  CERTIFICATE OF CURRENT COST OR
PRICING DATA

 

(When cost or pricing data are required in accordance with FAR 15.406-2, the
Contracting Officer will request that the offeror complete, execute, and submit
to the Contracting Officer a certification in the format shown in the following
Certificate of Current Cost or Pricing Data.  The certification shall be
submitted only at the time negotiations are concluded.  Offerors should complete
the certificate and return it when requested by the Contracting Officer.)

 

This is to certify that, to the best of my knowledge and belief, the cost or
pricing data (as defined in section 15.401 of the Federal Acquisition Regulation
(FAR) and required under FAR subsection 15.403-4) submitted, either actually or
by specific identification in writing, to the Contracting Officer or to the
Contracting Officer’s representative in support
of                                       * are accurate, complete, and current
as of                                                     **.

 

This certification includes the cost or pricing data supporting any advance
agreements and forward pricing rate agreements between the offeror and the
Government that are part of the proposal.

 

Firm

 

Signature

 

Name

 

Title

 

Date of execution***

 

--------------------------------------------------------------------------------

*                                         Identify the proposal, request for
price adjustment, or other submission involved, giving the appropriate
identifying number (e.g., RFP No.)

 

**                                  Insert the day, month, and year when price
negotiations were concluded and price agreement was reached, or, if applicable,
an earlier date agreed upon between the parties that is as close as practicable
to the date of agreement on price.

 

***                           Insert the day, month, and year of signing, which
should be as close as practicable to the date when the price negotiations were
concluded and the contract price was agreed to.

 

(End of Certificate)

 

32

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Exhibit 1

Exceptions/Restrictions

 

Section II.  Information for Vendor; G.  Vendor Profile, Experience and
References; 3.  References

Genaissance has generated >3 million genotypes in work that the Company has done
for its clients and for its internally funded programs.  However, our contracts
with Biogen, Johnson & Johnson and Sciona prevent us from disclosing
confidential information.  Consequently, Genaissance is prevented from
disclosing details about the genotyping work that the Company has done for these
clients, including the approximate annual aggregate dollar volume involved.

 

Section III.  General Requirements and Guidelines; H.  Early Termination; 2. 
Convenience of the University

If the University exercises its option to terminate the contract services under
the Convenience of the University option, WSU shall pay Genaissance a [**]
dollar ($[**]) cancellation fee in addition to all other costs due under
Schedule C.

 

Section III.  General Requirements and Guidelines; S.  Publicity

If Genaissance receives the contract for the proposed project, the Company would
have to issue a press release announcing the award since the dollar amount of
the contract would have a material impact on the Company.  Genaissance would
provide WSU with an advance copy of any press release at least five (5) business
days prior to the scheduled release.  WSU shall have the right to review
expeditiously and recommend changes to any announcement regarding the award or
the subject of the award.

 

Section III.  General Requirements and Guidelines; W.  Minority Business

Genaissance is a small business but not a minority firm.  However, the Company
was co-founded by Gualberto Ruaño, M.D., Ph.D., who is a Hispanic American.  Dr.
Ruaño was Genaissance’s first Chief Executive Officer and is currently the
Company’s Chief Scientific Officer, one of the four executive officers of the
Company.  Genaissance has developed its proprietary HAP™ Technology, which uses
specific reagents that are provided by a limited number of vendors.  To minimize
costs, the Company does not accept contracts for any work that it cannot do by
itself.  Hence, the Company does not have any partnering relationships with
other firms.  In addition, Genaissance’s HAP™ Typing facility, the Company’s
genotyping facility, is CLIA certified and, as such, is prevented from
outsourcing any of its work.  All of the work in this proposed project would be
done in the Company’s HAP™ Typing facility.  Hence, none of the work that would
be done under this proposed project could be partnered with another company.

 

Section IV.  Statement/Scope of Work; B.  Technical Requirements; b) 6)

Genaissance uses the Sequenom MassARRAY™ platform as its primary high-throughput
genotyping platform.  Because the SNP assays are highly multiplexed, the
resulting MALDI-TOF spectra are highly complex and are not amenable to manual
genotype calling.  Consequently, both Sequenom and Genaissance have written
software to make the initial genotype calls and to perform the analysis of the
data.  Due to the size of this project, while the final genotype data can be
provided both as a hard copy and electronically, the raw spectra

 

1

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cannot be provided.  These spectra, however, would be available for inspection
at Genaissance by the PRB investigators.

 

Section IV.  Statement/Scope of Work.  C.  Intellectual Property and
Publications.

If WSU chooses the Alternate Proposal for Genotyping (Schedule C), then [**] as
outlined in Article 2 of the License Agreement in Addendum 2.

 

Section V.  Additional Instructions to Vendors - Business Proposals.  A. 
General Instructions.  d.

Genaissance does not agree to the statement contained in this section. 
Genaissance would not grant Wayne State University and its authorized
representative(s) the right to examine any records of Genaissance.  The Company
considers its costs to be proprietary information.  There are a number of
companies offering genotyping services.  Genaissance believes that competition
in the market place insures that the proposed price of genotyping will remain
highly competitive for potential customers.

 

Section V.  Additional Instructions to Vendors - Business Proposals.  A. 
General Instructions.

Genaissance considers its costs to be proprietary information.  Consequently,
the Company is not supplying support for each price proposed.  There are a
number of companies offering genotyping services.  Genaissance believes that
competition in the market place insures that the proposed price of genotyping
will remain highly competitive for potential customers.

 

Section V.  Additional Instructions to Vendors - Business Proposals.  A. 
General Instructions

The pricing proposals in Schedule C are based upon the genotyping of a minimum
of 4,000 DNA samples.  If WSU decides to have less than 4,000 DNA samples
genotyped, the cost per genotype would have to be renegotiated.

 

Section V.  Additional Instructions to Vendors - Business Proposals.  B.  Past
Performance Information

Our contracts with Biogen’ Johnson & Johnson and Sciona prevent us from
disclosing confidential information, including d.  Total Contract Value and e. 
Description of Requirement.

 

Schedule B.  Insurance Requirements.  Certificates of Insurance.  2.

Genaissance’s insurer, Chubb, would not waive the care, custody or control
exclusion for this proposed contract.  However, the Company, under its general
liability policy, has coverage for property of other entities while under
Genaissance’s control.

 

2

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Exhibit 2

Profile/Experience/References

 

A.                                    Profile

 

Genaissance Pharmaceuticals, Inc. is seeking to create personalized medicines
through the integration of gene variation into drug development.  The Company
discovers inherited differences, or genomic markers, that exist in human genes. 
Genaissance uses the Company’s technological capabilities and methods as well as
its clinical genetic development skills to identify the genomic markers that
appear to define a patient population that responds best to a medication and has
a superior safety profile.  Genaissance markets its technology and predictive
genomic markers to the pharmaceutical and biotechnology industries as a means to
improve the development, marketing and prescribing of drugs.

 

The Genaissance HAP™ Technology consists of the following components:

 

•                  HAP™ Database, containing proprietary HAP™ Markers (SNPs and
haplotypes) for over 7,000 genes;

 

•                  DecoGen® Informatics System, containing proprietary software
for building haplotypes (HAP™ Builder) and for detecting associations between
gene variation and clinical outcomes;

 

•                  HAP™ Typing Facility, a CLIA licensed genotyping facility
that has generated >3 million genotypes; and

 

•                  Association Expertise, consisting of a high-throughput
statistical analysis pipeline.

 

Genaissance has HAP™ Technology partnerships with six pharmaceutical and
biotechnology companies: AstraZeneca, Biogen, Johnson & Johnson, Millennium,
Pfizer, and Pharmacia.  In these collaborations and the Company’s internally
funded STRENGTH (Statin Response Examined by Genetic HAP™ Markers) clinical
trial, Genaissance has used the Company’s HAPT™ Technology to identify
statistically significant associations (p <0.05) between clinical outcomes and
HAP™ Markers.  The STRENGTH clinical trial was a prospective, multi-center
clinical trial with three parallel arms, each of which used one of three
different statins (atorvastatin, Liptor®; pravastatin, Pravachol®; or
simvastatin, Zōcor®).  Genaissance analyzed 176 candidate genes and identified
HAP™ Markers that defined patient populations, which responded differently to
the three statins.

 

The proposed project would be done in the Company’s HAP™ Typing Facility, which
is headed by [**], Ph.D., Director of the facility.  Dr. [**] reports directly
to Gerald F. Vovis, Ph.D., Executive Vice President and Chief Technology
Officer.

 

Genaissance is not affiliated with any other organizational components,
companies or organizations.  There are no Company relationships that could be
construed to constitute a conflict of interest in doing business with WSU.

 

1

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On December 16, 2002, Genaissance announced that it had received a notice from
General Electric Capital Corporation (GE Capital), claiming an event of default
had occurred under Genaissance’s lease agreement as a result of an alleged
material adverse change in the business of Genaissance.  The GE Capital lease
was entered into on April 10, 1999, prior to the completion of the Company’s
Series B and C pre-IPO rounds of financing.  Because of the alleged default, GE
Capital has declared that all principal, interest and certain fees, which GE
Capital claims to be $3.9 million, are due and payable immediately.  GE Capital
has also filed a complaint in the Superior Court of the State of Connecticut,
demanding payment of all amounts due under the lease agreement.

 

Genaissance does not believe that there has been a material adverse change in
the Company’s business and intends to defend itself vigorously against the GE
Capital claims.

 

Genaissance has and will continue to pay all of the Company’s debt obligations. 
Genaissance currently owes its lease creditors a total of about $10.4 million of
principal and interest, most of which is scheduled for payment in fiscal 2003. 
If Genaissance does not resolve the GE Capital claim, the Company may be
required to pay its lease creditors sooner than was originally scheduled. 
Payment in 2003 of all outstanding principal and interest with its lease
creditors would have the effect of increasing the Company’s cash burn by
approximately $3 million in fiscal 2003, with an offsetting reduction in cash
payments in fiscal 2004.  The Company projects that it will end fiscal 2002 with
a balance of cash, cash equivalents and marketable securities totaling at least
$33 million, which Genaissance believes is sufficient to meet the company’s goal
of cash breakeven in 2005.

 

Genaissance, founded in April 1997, went public in August 2000 and is traded on
the Nasdaq National Market under the symbol GNSC.  Financial revenues for the
Company were $0.753 million, $5.3 million and a projected $8.2 million in 2000,
2001, and 2002, respectively.  Genaissance occupies 78,000 square feet of space
in Science Park in New Haven, Connecticut and currently has 105 employees.

 

B.                                    Experience

 

Genaissance discovers polymorphisms by sequencing genes in a panel consisting of
93 individuals from the Company’s Index Repository, and a chimpanzee and a
gorilla.  The Genaissance HAP™ Factory, the name given to the Company’s
sequencing facility, has 59 ABI Prism® DNA Analyzers.  To date, Genaissance has
generated [**] sequence reads.  During the one-year period from March 31, 2001
through March 30, 2002, the Company generated [**] sequence reads, 83% of which
met the Company’s stringent quality control criteria, i.e. a phred score >30. 
The Company considers a DNA fragment to be completely sequenced if sequence
information is obtained for at least [**]% of the DNA samples.  Information was
successfully generated for [**]% of the DNA fragments sequenced during this
interval of time.  Failures were usually the result of primer pairs that did not
amplify DNA fragments well or primers that yielded a mixture of amplimers.  To
date, Genaissance has examined 7,287 genes in the Company’s HAP™ Factory,
identified 134,142 SNPs and organized these SNPs into 137,208 haplotypes. 
Genaissance recently published a paper describing the genetic diversity that the

 

2

--------------------------------------------------------------------------------

 

Company discovered in 313 genes (Stephens, J.C. et al. 2001.  “Haplotype
Variation and Linkage Disequilibrium in 313 Human Genes.” Science. 293:
489-493).

 

The Genaissance HAP™ Typing Facility, the name given by the Company to its
genotyping facility, principally uses the Sequenom MassARRAY™ platform for
high-throughput genotyping projects.  During the six-month period from October
1, 2001 through March 31, 2002, Genaissance generated >[**] million genotypes. 
During the four most productive weeks in this period of time, more than [**]
genotypes were generated.  During 2002, the facility generated approximately
[**] million genotypes.  To date, the Company has generated a total of more than
3.0 million genotypes.  The current annual capacity of the Genaissance HAP™
Typing Facility is [**] million genotypes.  In the current genotyping process,
generally 75% of the SNPs, for which assays are designed, become validated for
production use.  The remaining 25% of SNPs, which failed a first attempt at
assay development, are recycled for assay development, yielding similar success
rates.  Essential, but recalcitrant SNPs, which fail two attempts for assay
development on the Sequenom platform, are subjected to two additional assay
development cycles on an alternate genotyping platform (Pyrosequencing and/or
TaqMan®).  Using this procedure for assay development, the Company’s assay
conversion rate for essential SNPs approaches 100%.  In a single pass of
genotyping, these production-quality assays generate on average greater than 90%
of the total possible data.  On a per project basis, greater than 95% of the
total possible data is generated.

 

Between these two production facilities, Genaissance has performed
high-throughput genotyping and sequencing projects for both internally and
externally funded projects.  The Company has extensive experience in
simultaneously managing the logistics of multiple large-scale projects,
including sample handling, assay development, production, data collection,
quality control, data analysis, data transmittal and reporting.  The HAP™ Typing
Facility is CLIA licensed and follows GLP and GCP practices (21 CFR part 58),
thus providing assurance for the production of the highest quality genotyping
data.

 

C.                                    References

 

1.                                       [**]

 

Genaissance has provided genotyping services for [**]does not permit Genaissance
to disclose the nature or the magnitude of the genotyping work that has been
performed.

 

2.                                       [**]

 

Genaissance has provided genotyping services for [**] does not permit
Genaissance to disclose the nature or the magnitude of the genotyping work that
has been performed.

 

3.                                       [**]

 

Genaissance has provided genotyping services for [**]does not permit Genaissance
to disclose the nature or the magnitude of the genotyping work that has been
performed.

 

3

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Exhibit 3

Vendor Service Plan

 

A.                                    General Requirements

 

1.                                       Requirement:  The VENDOR shall provide
detailed quality control and quality assurance (QA/QC) plans.  These should
cover sample handling, labeling and storage, as well as genotyping.  Detail on
how the VENDOR will avoid mislabeling of samples during genotyping is
particularly important.

 

Response:

 

a.                                       Sample handling, labeling and storage. 
This proposed genotyping project will be performed in Genaissance
Pharmaceutical’s 8,000 square foot CLIA licensed HAP™ Typing Facility (Centers
for Medicare and Medicaid Services CLIA license: 07D0995237; Connecticut
Department of Public Health CLIA license: CL-0633) and will follow CLIA, GLP and
GCP laboratory standards.  The entire project, starting with sample receipt and
ending with data transmittal, will be performed in accordance with the Company’s
established laboratory protocols and SOPs.  The protocols, SOPs and other
documentation are available for inspection in the HAP™ Typing Facility at
Genaissance Pharmaceuticals.

 

DNA Samples will be received in the Genaissance HAP™ Typing Facility’s receiving
laboratory.  All plates will be labeled with barcodes and accessioned using the
Genaissance HAP™ Typing Facility’s LIMS (Laboratory Information Management
System).  While the laboratory is not 21 CFR part 11 compliant, due to the use
of vendor supplied equipment software originating from multiple sources, the
LIMS that the Company developed was written in a manner consistent with these
regulations.  Each DNA sample is given a unique identifier that will be
associated with all daughter and experimental plates and tracked, using the
LIMS, through all aspects of the genotyping process.  Once the original master
plates have been accessioned, small aliquots will be removed for QC testing,
which includes determination of DNA concentration, OD260/OD280 ratio, DNA
integrity and functional PCR analysis.  Once the DNA concentration has been
determined for each sample, a Tecan GENESIS worklist will be written to create a
master working plate containing the DNA at the appropriate concentration.  The
original barcode labeled master plates will be stored at -70°C and tracked
electronically.  Upon completion of the project, the master plates will be
returned to WSU.  The master working plates will be used to create barcode
labeled single use plates.  The single use plates will be stored at 4°C until
they are used.

 

1

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b.                                      Genotyping.

 

i.                                          Summary.  Genaissance currently
performs high-throughput genotyping on Sequenom’s MassARRAY™ platform using the
homogeneous Mass EXTEND™, process.  Analysis is performed on a 384-spot silicon
chip (SpectroCHIP) with up to [**] SNP assays multiplexed per spot.  Process
improvements and experience now allow the HAP™ Typing Facility to do a single
genotype run and generate, on average, greater than 95% of the total possible
data with >99.8% accuracy.  To manage the large amount of data that the HAP™
Typing Facility is capable of producing, an integrated LIMS monitors all aspects
of the Company’s laboratory operations, starting with sample receipt and
finishing with data transmittal.  Genaissance’s high-throughput genotyping
process is outlined below.

 

ii.                                       Assay Design.  For contract service
work, Genaissance requires the customer to supply the HUGO symbol for the genes
of interest.  Public domain SNPs will be selected from these genes. 
Alternatively (see Schedule C: Alternate Proposal), using the requested gene
list and the Company’s internally identified and validated proprietary SNPs,
Genaissance can select SNPs and design assays to capture ³ 80% of the genetic
diversity for the given gene.  These SNPs were discovered in Genaissance’s HAP™
Factory through gene-based sequence analysis of 82 unrelated individuals.  These
validated SNPs provide the highest quality starting material for assay
development and an internal control for independent validation of genotyping
assays.  Using these validated SNPs and proprietary enhancements to the
MassARRAY™ process, a test is now designed to consist of up to twenty
multiplexed assays using a combination of Sequenom’s SpectroDesigner™ Software
and the Company’s own proprietary assay design software.  Complexity levels are
driven by the number of SNPs queued for assay design.  As the number of SNPs
queued for assay design increases, so does the final complexity level of the
resulting tests.

 

iii.                                    Assay Validation.  For projects
consisting of a large number of DNA samples (>384), Genaissance uses a two-step
validation procedure.  Once oligonucleotides have passed quality control, the
tests are run on a small number of control samples.  [**] controls (ethnically
matched to the experimental DNA samples) from the Company’s Index Repository
serve to validate the assay through a comparison of the results obtained with
the Sequenom platform and the results, if available, obtained previously by
sequencing during the HAP™ Marker discovery process.  If there is a discrepancy
between the results from the two different assay platforms, or if an assay does
not generate a sufficient numbers of

 

2

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genotyping calls, then that under performing assay is removed from the test and
redesigned.  Subsequently, the assays are continuously validated in production. 
This is achieved through maintaining the same control samples on the production
plate.  If the SNP, for which the Company is asked to design an assay, is one
that has not been identified in Genaissance’s HAP™ Marker discovery process, the
Company requires that the client provide Genaissance with a DNA control sample,
i.e. a genomic DNA sample that contains the less frequent SNP allele.  In this
manner, Genaissance can validate the SNP assay.  At the customer’s request,
Genaissance will use an unvalidated assay in production.

 

iv.                                   Production.  [**][**]

 

 

 

 

 

 

 

Average
No.
of Runs
per Sample

 

Table I.

 

Compiled Genotypes

 

Single Pass

 

 

 

 

Average
Calls

 

STD

 

Percent
Calls

 

Average
Calls

 

STD

 

Percent
Calls

Uniplexes (n=12 assays)

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

Duplexes (n=19 tests; 38 assays)

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

Triplexes (n=61 tests; 183 assays)

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

4-plexes (n=32 tests; 128 assays)

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

5-plexes (n=12 tests; 60 assays)

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

Total (avg 3.1 plex; 421 assays)

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

--------------------------------------------------------------------------------

Compiled Genotypes: genotypes assembled from two or more plates.
STD: standard deviation

[**]

 

v.                                      Rules for Genotyping.  Given the above
process changes and improvements, Genaissance now uses the following set of
rules for processing samples in the Company’s HAP™ Typing Facility.

 

•                                          All tests will be designed for
maximum permissible complexity (currently [**]-plexes).

 

•                                          Assay results for positive controls
will be checked for concordance with HAPTM Marker discovery results.  Assays
failing this consistency check will be removed from production and redesigned. 
For assay requests that cannot be mapped to the Company’s database, the customer
must provide a control genomic DNA sample containing the rare

 

3

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allele.  Without such a control, the assay cannot be validated.  However, upon
the request of the client, Genaissance will put an unvalidated assay into
production.

 

•                                          Assay results will be checked for
deviation from Hardy-Weinberg equilibrium.  Assays that produce results that
deviate significantly from the expected distribution will be flagged for review.

 

•                                          Assays that generate ³ [**]% of the
possible data from a single genotype run will be considered to be finished (see
Evaluating the Consequences of Using the Rules below) and the data will be
considered complete.

 

•                                          Assays that generate [**]% of the
total possible data will be requeued for a second genotype run.

 

•                                          Those assays that generate £ [**]% of
the total possible data with a single genotype run or fail to generate ³ [**]%
of the total possible data after combining the results from two genotype runs
will be redesigned.

 

•                                          The second iteration for an assay
will follow the same rules as the first except that assays failing the above
criteria will not be redesigned and the assays will be terminated.  If the
client designates such SNPs to be essential, the assay will be redesigned for an
additional cost on an alternate platform.  Genaissance currently uses
Pyrosequencing and TaqMan® as alternate platforms.

 

vi.                                   Evaluating the Consequences of Using the
Rules.  Genaissance has evaluated this set of rules in silico by applying the
Rules to data already produced under the previous production paradigm.  Below is
a summary of the results from this analysis.

 

[**][**] (Table II).

 

Table II.

 

Average Per SNP

 

Coverage

 

Accuracy

 

Data Coverage after Multiple Genotype Runs

 

[**] Genotypes
(STD of 2.3)

 

[**]% (STD 0.63%)

 

 

 

 

 

 

 

 

 

 

 

Data Coverage after a Single Genotype Run

 

[**] Genotypes
(STD of 6.4)

 

[**]% (STD 1.7%)

 

 

 

 

 

 

 

 

 

 

 

Genotype Differences between Multiple
and Single Genotype Runs

 

[**] Changes
(STD of 0.9)

 

 

 

[**]% (STD 0.25%)

 

--------------------------------------------------------------------------------

Total Number of Subjects: 360
STD: standard deviation

 

4

--------------------------------------------------------------------------------

 

Originally, there were two main reasons for processing samples in duplicate. 
The first reason was to insure accuracy by checking consistency between multiple
runs.  The second reason was to maximize the number of samples for which the
Company would obtain a genotype.  This analysis demonstrates that the fraction
of correct calls obtained with a single genotype run is >[**]% (Table II). 
Also, by following these Rules, Genaissance will obtain results for at least
[**]% of the samples but the average coverage is likely to be significantly
higher (for example, [**]%, Table II).

 

The use of haplotypes is particularly important for obtaining genotyping results
at the lowest possible cost.  During haplotype assignment, missing genotypes are
statistically inferred.  The fraction of correctly inferred genotypes during
haplotype assignment depends only on allele frequencies and the extent of
redundant information found in other SNPs.  This rate ranges, theoretically,
from a worst case of 50% (when there is no redundant information and the two SNP
alleles are equally frequent) to nearly 100% accurate genotype inference.  Based
on the Rule of >[**]% coverage, this means that genotypes represented in
haplotype assignments would be [**]% accurate in the worst case.  However,
because our single genotype coverage is predicted to be very high, in the test
case it was [**]% (Table II), and allele frequencies are usually far from equal,
the effective genotype accuracy after haplotype assignment should average close
to [**]% for the single plate analysis and [**]% with redundancy.  Adjusting for
incorrect genotypes produces a final estimate of average accuracy between [**]%
and [**]%, respectively.  This accuracy is more than sufficient to build
haplotypes and detect significant associations.  An overview of the entire R&D
process is shown in Figure 1.

 

vii.                                Rule Conclusions.  Application of these
Rules does not significantly change the amount of missing genotype data or
potentially erroneous genotype calls and, consequently, does not significantly
impact the Company’s ability to build and assign haplotypes.  This process has
had no impact on the Company’s ability to detect an association between a
phenotype and genetic variation.  Also, because data is generated from a single
production plate, the amount of DNA needed has been effectively cut in half.

 

5

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For clients that require either duplicate data or a higher level of coverage,
this service is still available but at a higher cost.

 

[**]

 

viii.                             Data Transfer.  Upon completion of a project,
the data is copied onto a CD-ROM, along with a report on the project and signed
off by the Laboratory Director.  Some customers have requested that the data and
report also be supplied via email for quicker delivery.

 

6

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For this proposed project, data can be transferred weekly, monthly, or at other
intervals as requested.

 

2.                                       Requirement:  The VENDOR shall provide
an inventory system for tracking of samples during receipt, storage, processing
and shipping.  This system shall include but not be limited to the following
information: ID numbers, genotype, and results of any quality control tests. 
The Project Officer will assign a unique ID number to each specimen provided to
the VENDOR; this sample shall remain with the sample during processing.  The
VENDOR shall provide a list of ID numbers when returning the samples, in both
electronic and paper forms.

 

Response:  All of the information requested above, is part of Genaissance’s
SOP.  Additionally, a DNA sample QC report will be provided.  Typically, this
report is provided upon completion of the QC process and prior to initiation of
genotyping.  However, this report can be transmitted to meet the customer’s
needs.

 

3.                                       Requirement:  The VENDOR shall provide
a plan for data management, including acquisition, storage, backup, and
reporting to WSU.  The plan should describe methods to handle the large number
of samples with multiple genotypes per sample, including a description of the
specific software packages to be used.  The management of electronic data,
computer hardware and software, and storage of information generated from the
contract should be harmonized with existing WSU information technology
capabilities wherever feasible.

 

Response:  This information has been provided in detail in Section A.1 above. 
See below for an example of Genaissance’s LIMS data export.  These exports are
typically transmitted as a standard flat text file.  As many customers require
data in specific formats, Genaissance routinely creates scripts designed to
reformat data to meet the needs of the customer.

 

RpsSnpID

 

15787966

 

6153757

 

6153689

 

5612591

 

5612589

 

3578210

 

3578216

 

4676126

 

Subject/AssayID

 

4735244

 

4735251

 

4735259

 

4735266

 

4735273

 

4735281

 

4735324

 

4735338

 

Sample-01

 

T

 

T

 

G

 

C

 

N/A

 

AG

 

C

 

C

 

Sample-02

 

TC

 

T

 

G

 

C

 

G

 

G

 

C

 

C

 

Sample-03

 

TC

 

T

 

G

 

C

 

G

 

AG

 

CT

 

C

 

Sample-04

 

T

 

T

 

G

 

C

 

AG

 

AG

 

CT

 

C

 

Sample-05

 

T

 

T

 

G

 

C

 

N/A

 

AG

 

CT

 

C

 

Sample-06

 

TC

 

TC

 

G

 

C

 

AG

 

G

 

C

 

C

 

Sample-07

 

T

 

T

 

G

 

C

 

N/A

 

G

 

CT

 

C

 

Sample-08

 

T

 

T

 

G

 

N/A

 

N/A

 

N/A

 

CT

 

C

 

Sample-09

 

T

 

T

 

G

 

C

 

G

 

G

 

C

 

C

 

Sample-10

 

T

 

T

 

G

 

C

 

G

 

AG

 

CT

 

C

 

Sample-11

 

T

 

T

 

G

 

C

 

N/A

 

G

 

CT

 

C

 

Sample-12

 

T

 

T

 

G

 

C

 

G

 

G

 

T

 

C

 

 

7

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B.                                    The VENDOR shall provide the following
services:

 

1.                                       Requirement:  Provide the PRB
investigators designated by WSU with haplotype and allele frequency information
for polymorphisms in the candidate genes from different ethnic groups, and
assist in identifying suitable polymorphisms for the study.

 

Response:  This service will be provided for public domain SNPs as outlined in
Schedule C.  Alternatively, WSU may elect to use Genaissance proprietary SNPs
and haplotypes for the proposed project.  This alternate proposal is also
outlined in Schedule C.

 

2.                                       Requirement:  Design genotyping assays
for single nucleotide polymorphisms (SNPs) at specified regions in the human
genome.  The VENDOR is required to submit detailed information about assay
design and success rates.

 

Response:  Genaissance’s assay design process is outlined in detail in Exhibit
2, Section B, Experience and in Exhibit 3, Section A, General Requirements,
Subsection b, Genotyping.  A flowchart of Genaissance’s genotyping process,
including assay design, is shown in Figure 1.  When using the Company’s
proprietary SNPs, Genaissance has successfully converted >90% of the
polymorphisms to functional validated assays.

 

3.                                       Requirement:  Perform the assays on
samples provided by WSU.  The samples to be provided by WSU will be genomic DNA
that has been amplified using the whole genome amplification (also known as the
Primer Extension Preamplification; PEP) method.  The VENDOR should describe in
detail the platform or platforms to be used for genotyping.

 

Response:  Genaissance has successfully performed genotyping using whole genome
amplified DNA samples.  Genaissance does not expect to encounter difficulties
inusing the WSU DNA samples.  A detailed discussion of the Company’s genotyping
process is provided in Exhibit 2, Section B, Experience and in Exhibit 3,
Section A, General Requirements, Subsection b., Genotyping.

 

4.                                       Requirement:  Input the genotyping data
into database tables with a structure specified by WSU

 

Response:  Genaissance routinely reformats genotyping data to meet the needs of
the customer.

 

8

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5.                                       Requirement:  Perform quality control
with negative and positive controls as well as repeating a random subset (30%)
of the assays.

 

Response:  As part of the Company’s SOPs, Genaissance validates all assays using
a set of control samples, prior to putting the assays into production use.  Many
of these control samples are also used on the production plate along with
negative controls.  The assays to be repeated can either be randomly selected by
Genaissance’s QA/QC officer or by the PRB investigators.

 

6.                                       Requirement:  Provide WSU with all the
raw data (including gel images or other electronic data) as hard copies and in
electronic format.

 

Response:  Genaissance uses the Sequenom MassARRAY™ platform as its primary
high-throughput genotyping platform.  Because the SNP assays are highly
multiplexed, the resulting MALDI-TOF spectra are highly complex and are not
amenable to manual genotype calling.  Consequently, both Sequenom and
Genaissance have written software to make the initial genotype calls and to
perform the analysis of the data.  Due to the size of this project, while the
final genotype data can be provided both as a hard copy and electronically, the
raw spectra cannot be provided.  These spectra, however, would be available for
inspection at Genaissance by the PRB investigators.

 

9

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Exhibit 4

Vendor Qualifications

 

From RFP: “You are requested to submit a summary of your General Experience,
Organizational Experience Related to this RFP, Performance History, Pertinent
Contracts and Grants.  This information should be provided in your Proposal
under “Vendor Exhibit 4”, Vendor Qualifications.

 

1.                                       “General experience” is defined as
general background, experience and qualifications of the offeror.  A discussion
of proposed resources which can be devoted to the project may be appropriate.”

 

Response: Genaissance Pharmaceuticals, Inc. is seeking to create personalized
medicines through the integration of gene variation into drug development.  The
Company discovers inherited differences, or genomic markers, that exist in human
genes.  Genaissance uses the Company’s technological capabilities and methods as
well as its clinical genetic development skills to identify the genomic markers
that appear to define a patient population that responds best to a medication
and has a superior safety profile.  Genaissance markets its technology and
predictive genomic markers to the pharmaceutical and biotechnology industries as
a means to improve the development, marketing and prescribing of drugs.

 

The Genaissance HAP™ Technology consists of the following components:

 

•                  HAP™ Database, containing proprietary HAP™ Markers (SNPs and
haplotypes) for over 7,000 genes;

 

•                  DecoGen® Informatics System, containing proprietary software
for building haplotypes (HAP™ Builder) and for detecting associations between
gene variation and clinical outcomes;

 

•                  HAP™ Typing Facility, a CLIA licensed genotyping facility
that has generated >3 million genotypes; and

 

•                  Association Expertise, consisting of a high-throughput
statistical analysis pipeline.

 

Genaissance has HAP™ Technology partnerships with six pharmaceutical and
biotechnology companies: AstraZeneca, Biogen, Johnson & Johnson, Millennium,
Pfizer, and Pharmacia.  In these collaborations and the Company’s internally
funded STRENGTH (Statin Response Examined by Genetic HAP™ Markers) clinical
trial, Genaissance has used the Company’s HAP™ Technology to identify
statistically significant associations (p <0.05) between clinical outcomes and
HAP™ Markers.  The STRENGTH clinical trial was a prospective, multi-center
clinical trial with three parallel arms, each of which used one of three
different statins (atorvastatin, Liptor®; pravastatin, Pravachol®; or
simvastatin, Zōcor®).  Genaissance analyzed 176 candidate genes and identified
HAP™ Markers that defined patient populations, which responded differently to
the three statins.

 

1

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Genaissance, founded in April 1997, went public in August 2000 and is traded on
the Nasdaq National Market under the symbol GNSC.  Genaissance occupies 78,000
square feet of space in Science Park in New Haven, Connecticut and currently has
105 employees.

 

Based on the proposed size of the project (4,000 DNA samples, 800 SNP assays and
30% repeat genotypes for QC purposes) and the proposed turnaround time of the
project (20 weeks), Genaissance’s HAPTM Typing facility will devote [**]% of its
capacity to the proposed project.

 

“2.                                 “Organizational experience” is defined as
the accomplishment of work, either past or ongoing, which is comparable or
related to the effort required by this RFP.  This includes overall offeror or
corporate experience, BUT NOT the experience and/or past performance or
individuals who are proposed as personnel involved with the Statement of Work in
this RFP.”

 

Response: Genaissance discovers polymorphisms by sequencing genes in a panel
consisting of 93 individuals from the Company’s Index Repository, and a
chimpanzee and a gorilla.  The Genaissance HAP™ Factory, the name given to the
Company’s sequencing facility, has 59 ABI Prism® DNA Analyzers.  To date,
Genaissance has generated [**]sequence reads.  During the one-year period from
March 31, 2001 through March 30, 2002, the Company generated [**] sequence
reads, 83% of which met the Company’s stringent quality control criteria, i.e. a
phred score ³30.  The Company considers a DNA fragment to be completely
sequenced if sequence information is obtained for at least 85% of the DNA
samples.  Information was successfully generated for [**]% of the DNA fragments
sequenced during this interval of time.  Failures were usually the result of
primer pairs that did not amplify DNA fragments well or primers that yielded a
mixture of amplimers.  To date, Genaissance has examined 7,287 genes in the
Company’s HAP™ Factory, identified 134,142 SNPs and organized these SNPs into
137,208 haplotypes.  Genaissance recently published a paper describing the
genetic diversity that the Company discovered in 313 genes (Stephens, J.C. et
al. 2001. “Haplotype Variation and Linkage Disequilbrium in 313 Human Genes.”
Science. 293: 489-493).

 

The Genaissance HAP™ Typing Facility, the name given by the Company to its
genotyping facility, principally uses the Sequenom MassARRAY™ platform for
high-throughput genotyping projects.  During the six-month period from October
1, 2001 through March 31, 2002, Genaissance generated >[**] million genotypes. 
During the four most productive weeks in this period of time, more than [**]
genotypes were generated.  During 2002, the facility generated approximately
[**] million genotypes.  To date, the Company has generated a total of more than
3.0 million genotypes.  The current annual capacity of the Genaissance HAPTM
Typing Facility is [**] million genotypes.  In the current genotyping process,
generally 75% of the SNPs, for which assays are designed, become validated for
production use.  The remaining 25% of SNPs, which failed a first attempt at
assay development, are recycled for assay development, yielding similar success
rates.  Essential, but recalcitrant SNPs, which fail two attempts for assay
development on the Sequenom platform, are subjected to two additional assay
development cycles on an alternate genotyping platform (Pyrosequencing and/or
TaqMan®).  Using this procedure for assay development, the Company’s assay
conversion rate for essential SNPs approaches 100%.  In a single pass of
genotyping, these production-quality assays generate on

 

2

--------------------------------------------------------------------------------

 

average greater than 90% of the total possible data.  On a per project basis,
greater than 95% of the total possible data is generated.

 

Between these two production facilities, Genaissance has performed
high-throughput genotyping and sequencing projects for both internally and
externally funded projects.  The Company has extensive experience in
simultaneously managing the logistics of multiple large-scale projects,
including sample handling, assay development, production, data collection,
quality control, data analysis, data transmittal and reporting.  The HAP™ Typing
Facility is CLIA licensed and follows GLP and GCP practices (21 CFR part 58),
thus providing assurance for the production of the highest quality genotyping
data.

 

“3.                                 “Performance history” is defined as meeting
contract objectives within DELIVERY and PRICE SCHEDULES on efforts, either past
or on-going, which is comparable or related to the efforts required by this
RFP.”

 

Response: Genaissance is not permitted to discuss details of the contracts in
place with AstraZeneca, Biogen, Johnson & Johnson, Millennium, Pfizer,
Pharmacia, and Sciona.

 

“4.                                 “Pertinent contracts” is defined as a
listing of each related contract completed within the last three years or
currently in process.

 

Response: Genaissance currently has ongoing contracts with Biogen, Johnson &
Johnson, Millennium, Pfizer, Pharmacia, and Sciona.  The Company completed the
agreed upon work with AstraZeneca within the specified period of time.

 

“5.                                 “Pertinent grants” - list grants supported
by the Government that involve similar or related work o (sic) that called for
in this RFP.  Include the grant number, involved agency, names of the grant
specialist and the Science Administrator, identification of the work, and when
performed.”

 

Response: Not Applicable.

 

“6.                                 “Facilities” - provide a description of the
facilities that the VENDOR proposes to use, in the performance of this
contract.  The description should include a statement as to whether the facility
meets P3 or P4 requirements.”

 

This proposed genotyping project will be performed in Genaissance’s 8,000 square
foot CLIA licensed HAP™ Typing Facility (Centers for Medicare and Medicaid
Services CLIA license: 07D0995237; Connecticut Department of Public Health CLIA
license: CL-0633) and will follow CLIA, GLP and GCP laboratory standards. 
Because Genaissance uses Epstein-Barr virus to create transformed cell lines,
the Company’s Index Repository meets and follows Biosafety Level 2 guidelines. 
All of Genaissance’s facilities follow applicable state and federal biosafety
guidelines.

 

3

--------------------------------------------------------------------------------

 

Exhibit 5

Small Business Subcontracting Plan

 

Genaissance meets the definition of a small business.  Genaissance has developed
its proprietary HAP™ Technology, which uses specific reagents that are provided
by a limited number of vendors.  To minimize costs, the Company does not accept
contracts for any work that it cannot do by itself.  Hence, the Company does not
have any partnering relationships with other firms.  In addition, Genaissance’s
HAPTM Typing facility, the Company’s genotyping facility, is CLIA certified and,
as such, is prevented from outsourcing any of its work.  All of the work in this
proposed project would be done in the Company’s HAP™ Typing facility.  Hence,
none of the work that would be done under this proposed project could be
partnered with another company.

 

1

--------------------------------------------------------------------------------

 

Genaissance Confidential and Proprietary

 

Terms and Conditions

 

1.                                       General.  For purposes hereof:

 

Assay Data means the genotypes, haplotypes and related data generated by
Genaissance from WSU patient samples as set forth in the “Proposal for Wayne
State University in response to RFP - Genotyping” and dated January 9, 2003
(hereinafter “The Response”).

Client shall mean WSU.

 

Genaissance shall mean Genaissance Pharmaceuticals, Inc.

 

Services shall mean all genotyping and other services to be performed by
Genaissance for Client as set forth in The Response.

 

Research Use means the use of Assay Data for research purposes only and
specifically excludes use of Assay Data by Client to perform services for a
third party other than PRB and any and all diagnostic, therapeutic or clinical
uses.

 

These Terms and Conditions, all attached schedules and exhibits, if any,
(collectively, the “Agreement”), will exclusively govern Genaissance’s provision
of Services to Client.  Client’s acceptance of any quotation for Services is
subject to and expressly limited by these Terms and Conditions.  These Terms and
Conditions cannot be waived, modified or supplemented without the prior, express
written consent of Genaissance.

 

2.                                       Services.  Genaissance will use
reasonable commercial efforts to perform the Services described in The Response
pursuant to the specifications and timeline set forth therein and subject to
these Terms and Conditions and such other conditions as are specified in the
Intellectual Property Addendum.

 

3.                                       Prices, Taxes, and Payment.  [**]

 

4.                                       Limited Warranty.  Other than as
expressly set forth in these Terms and Conditions and the Schedules attached
hereto, Genaissance makes no representations, warranties or guarantees regarding
the Assay Data supplied by Genaissance to Client, or the use of, or the results
of the use of such Assay Data, or the performance of the Services.  GENAISSANCE
AND ITS SUPPLIERS DISCLAIM ALL OTHER WARRANTIES, WHETHER EXPRESSED OR IMPLIED,
INCLUDING, WITHOUT LIMITATION, IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS
FOR A PARTICULAR PURPOSE, TITLE, AND NONINFRINGEMENT.  Client’s exclusive remedy
under Genaissance’s warranty is, at Genaissance’s sole option, a credit for or
re-performance of the Services in question.  IN NO EVENT WILL GENAISSANCE OR ITS
SUPPLIERS BE LIABLE FOR ANY CONSEQUENTIAL, INCIDENTAL, SPECIAL OR INDIRECT
DAMAGES, INCLUDING WITHOUT LIMITATION, DAMAGES FOR LOSS OF PROFITS, BUSINESS
INTERRUPTION, LOSS OF BUSINESS INFORMATION OR PROPERTY DAMAGE SUSTAINED BY
CUSTOMER FROM THE USE OF OR INABILITY TO USE ANY ASSAY DATA, EVEN IF GENAISSANCE
HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH

 

1

--------------------------------------------------------------------------------

 

DAMAGES.  AS TO ANY GENAISSANCE LIABILITY NOT LEGALLY SUBJECT TO THE FOREGOING,
GENAISSANCE’S MAXIMUM LIABILITY WILL NOT EXCEED THE AGGREGATE AMOUNT PAID BY
CLIENT TO GENAISSANCE FOR THE SERVICES IN QUESTION.[**]

 

5.                                       Technical Advice.  At Client’s request,
Genaissance may, but is not obligated to, furnish technical assistance, advice
and information with respect to Assay Data in addition to the technical
assistance, advice and information specified in The Response, if and to the
extent that such advice, assistance and information is conveniently available. 
Such information is provided [**], subject to the warranty disclaimers set forth
in paragraph 6.[**]

 

6.                                       Intellectual Property; Secrecy.  Client
represents and warrants that any information, technology, supplies,
specifications, designs and materials it supplies to Genaissance to enable
Genaissance to provide to Client any Services (collectively, “Client
Information”) will not infringe the intellectual property rights of any third
parties.  All intellectual property rights in the technology used to perform the
Services will at all times remain vested in Genaissance.  Any proprietary
know-how or other information disclosed by Client to Genaissance in connection
with the provision of Services, as well as any Assay Data supplied to Client by
Genaissance, other than HAPTM Markers, will remain the sole property of Client
and will not be used or disclosed by Genaissance to any third party without
Client’s prior written consent, except where such use or disclosure is necessary
to properly carry out the provision of the Services in question or for
Genaissance to practice any research license granted by WSU pursuant to Section
2 of the License Agreement Addendum.  Client will not use or disclose to any
third party any confidential or proprietary information of Genaissance without
Genaissance’s prior written consent, except as expressly authorized in these
Terms and Conditions or the License Agreement Addendum.  The following types of
information will not be subject to the foregoing secrecy provisions: (i)
information which is or becomes publicly available; (ii) information which is
lawfully obtained by the receiving party from a third party; and (iii)
information which is required to be disclosed by a legal or regulatory
authority.  Client acknowledges that Genaissance designs and performs genotyping
assays and other services for third parties.  Client further acknowledges and
agrees that Genaissance intends and is permitted to sell and otherwise
commercialize to third parties such genotyping assays (with no obligation to
Client) that may be utilized or generated as a result of or during the
performance by Genaissance of Services other than the Assay Data.  This
paragraph 6 will survive any termination or expiration of the Agreement.

 

7.                                       Limited License.  All Assay Data
delivered hereunder are solely for research use.  Client is specifically not
authorized to use any Assay Data for diagnostic or therapeutic purposes or as
direct components in the manufacture or use of any diagnostic or therapeutic
product, or to provide any services to any third party other than PRB for
compensation.  No other right is intended or granted through the provision of
any Services to Client by Genaissance.  Purchase by Client of Services does not
include or carry any right of Customer to any Genaissance technology or
intellectual property except as explicitly provided in the Intellectual Property
Addendum.

 

8.                                       Indemnity.  Except where the claim,
loss or liability (collectively, “Losses”) arises as a result of the gross
negligence or willful misconduct of Genaissance, Client indemnifies Genaissance,
its agents, employees, directors, affiliates and representatives (“Genaissance
Indemnified Party”) from and against any Losses which may be incurred by an
Genaissance Indemnified Party as a result of or arising in connection with (i)
Client’s use or transfer to third

 

2

--------------------------------------------------------------------------------

 

parties of any Assay Data and (ii) any alleged infringement by Client of the
proprietary rights of a third party as a result of use of the Assay Data by
Client or by any such transferee of Client.

 

9.                                       Insolvency.  In the event that Client
becomes insolvent, bankrupt under applicable law or otherwise becomes unable to
repay its debts, Genaissance may immediately terminate its provision of Services
under these Terms and Conditions without notice in addition to any other rights
or remedies available to Genaissance.

 

10.                                 Force Majeure.  Genaissance will not be
liable for nonperformance of any of its obligations hereunder or to perform any
Services to the extent that such performance is prevented, prohibited or delayed
by any circumstance for reasons beyond its control including, without
limitation, strikes, lock-outs or labor disputes, fire, flood, natural disaster,
war, blockade, military operations, riot, civil commotion, plant breakdown,
power outage, and computer or other equipment failure, provided that Genaissance
completes the contract within a reasonable time after the circumstances are
resolved.

 

11.                                 Agents.  No agent, employee or other
representative has the right to modify or expand Genaissance’s standard warranty
applicable to Services or to make any representations concerning Services other
than those set forth in Genaissance’s marketing or technical literature.  Any
such affirmation, representation or warranty, if made, should not be relied upon
by Client and does not form a part of The Response or these Terms and
Conditions.

 

12.                                 Modifications, Waiver.  These Terms and
Conditions may be modified and any breach thereunder may be waived only by a
writing signed by both Genaissance and Client.

 

13.                                 Assignment.  Client may not assign these
Terms and Conditions or any of its rights to Services hereunder without the
prior, express written consent of Genaissance.  Any change of control of Client
shall be deemed to be an assignment.  Any assignment in violation hereof is
void.

 

14.                                 Miscellaneous.  In the event that any
provision of these Terms and Conditions or portion thereof is found to be
illegal or unenforceable, it shall be construed without the unenforceable
provision or portion thereof.

 

3

--------------------------------------------------------------------------------

 

[Attachment 5]

 

CONFIDENTIAL

 

ADDENDUM TO SCHEDULE C OF PROPOSAL

 

This Addendum is hereby incorporated by reference and made a part of the
attached Schedule C agreed upon by Wayne State University (“Client”) and
Genaissance Pharmaceuticals, Inc. (“Genaissance”).

 

1.                                      Assay Development Fee:

 

Total Number of Samples

 

Fee per SNP Assay Developed

 

Less than [**]

 

 

$

[**]

 

[**] – [**]

 

 

$

[**]

 

[**] – [**]

 

 

$

[**]

 

[**] – [**]

 

 

$

[**]

 

More than [**]

 

 

[**]

 

 

2.                                      Sample Delivery and Fee per Delivered
Genotype:

 

WSU will send Genaissance DNA samples in 96-well plates or in 384-deep well
plates.  Genaissance will perform the quality control testing described in
Exhibit 3, Vendor Service Plan, Section A.1.a, 2nd paragraph.  Genaissance will
perform genotyping assays on each sample in each plate, regardless of whether
each sample passes the quality control criteria, but shall charge WSU only for
delivered genotypes as follows.

 

If WSU sends Genaissance at least [**] samples, the base genotyping fee is $[**]
per delivered genotype.  If WSU sends Genaissance less than [**] samples, the
base genotyping fee is $[**] per delivered genotype.  These base genotyping fees
are for a combination of certain numbers of DNA samples sent for genotyping with
certain numbers of SNP assays.  In this way, the samples can be processed on
Genaissance’s genotyping platform in the most efficient manner.  Thus,
surcharges will apply if the number of SNP assays is less than [**] or if the
number of DNA samples in any batch of samples (consisting of unique samples and
any duplicates thereof) exceeds [**].  These surcharges are set forth below.

 

SNP Number Surcharge:

 

Total Number
of SNP Assays

 

Surcharge
per Delivered Genotype

 

[**]

 

[**]

 

[**] – [**]

 

$

[**]

 

[**] – [**]

 

$

[**]

 

[**] – [**]

 

$

[**]

 

[**] – [**]

 

$

[**]

 

[**] – [**]

 

$

[**]

 

[**] –[**]

 

$

[**]

 

[**] – [**]

 

$

[**]

 

[**] – [**]

 

$

[**]

 

Under [**]

 

$

[**]

 

 

--------------------------------------------------------------------------------

 

Sample Size Surcharge:  Genaissance uses a 384-position format, in which [**] of
the positions are occupied by samples and [**] of the positions are occupied by
controls.  [**][**].

 

Number of
Samples per Batch

 

Surcharge
per Delivered Genotype

 

[**]

 

[**]

 

Excess of [**]

 

see below

 

 

For any batch of N samples (consisting of unique samples and any duplicate
samples) that is [**], perform the following steps to determine the surcharge to
be applied [**]:

 

•                  [**]

 

Example 1:  WSU requests that Genaissance genotype [**] DNA samples with [**]
SNP assays.

 

•                  [**]

 

Example 2 (For illustrative purposes only):

 

The maximum price that WSU would pay for different numbers of DNA samples is
shown below.  In each instance, the calculation assumed that: [**][**].

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[**])

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Agreed:

 

WAYNE STATE UNIVERSITY

GENAISSANCE PHARMACEUTICALS, INC.

 

 

By:

/s/ John L. Davis

 

By:

/s/Gerald F. Vovis

 

John L. Davis

 

Gerald F. Vovis, Ph.D.

Title:

Senior Vice President for

 

Title:

 Executive VP & CTO

 

 

Finance and Administration

 

Date: 

 

 

Date:

 March 11, 2003

 

 

2

--------------------------------------------------------------------------------

 

[Attachment 6]

 

CONFIDENTIAL

 

ADDENDUM TO ADDENDUM 1 (TERMS AND CONDITIONS) OF PROPOSAL

 

This Addendum is hereby incorporated by reference and made a part of the
attached Terms and Conditions agreed upon by Wayne State University (“Client”)
and Genaissance Pharmaceuticals, Inc. (“Genaissance”).

 

[**]

 

“WSU agrees to pay Genaissance the price of Services as quoted by Genaissance in
the Addendum to Schedule C for each genotype delivered.  Payment terms are
[**].  All payments will be made in United States Dollars.  Client will pay any
tax, duty, custom or other fee of any nature imposed upon this transaction by
any federal, state, local or foreign government authority in addition to the
price quoted or invoiced.  In the event that Genaissance is required to prepay
any such tax or fee, all such fees will be prepaid by Genaissance and added to
the invoice.  The parties acknowledge that Client is tax-exempt.”

 

[**]

 

“Termination.  In the event Client wishes to terminate Services provided by
Genaissance hereunder, Client shall reimburse actual expenditures by Genaissance
for all materials purchased by Genaissance specifically for performing Services,
the results of which were not delivered to Client prior to the effective date of
such termination, but in no event shall Client provide such reimbursement in
excess of $[**].  In order to receive reimbursement under this Section 15,
Genaissance must provide adequate documentation of any expenditure.  Any unused
materials for which Client has provided reimbursement pursuant to this Section
15 shall become Client’s sole property immediately upon payment and shall be
promptly delivered to Client by Genaissance, with due regard to the expiration
of any time-sensitive material.”

 

[**]

 

“Dispute Resolution.  The parties hereby agree that they will attempt in good
faith to resolve any controversy or claim arising out of or relating to this
Agreement promptly by negotiations.  If a controversy or claim should arise
hereunder, the matter shall be referred to an individual designated by the Chief
Executive Officer (or the equivalent position) of Genaissance and an individual
designated by the President (or the equivalent position) of WSU (the
“Representatives”).  If the matter has not been resolved within [**] ([**]) days
of the first meeting of the Representatives of the parties (which period may be
extended by mutual agreement) concerning such matter, each party may pursue
available legal or equitable remedies.”

 

--------------------------------------------------------------------------------

 

Agreed:

 

WAYNE STATE UNIVERSITY

GENAISSANCE PHARMACEUTICALS, INC.

 

 

By:

/s/ John L. Davis

 

By:

/s/ Gerald F. Vovis

 

 

 

 

 

Title:

Senior Vice President for Finance and Administration

Title:

Executive VP & CTO

 

 

 

Date:

3/20/03

Date:  March 11, 2003

 

 

FORM APPROVED:

3/17/03

Office of the General Counsel

 

--------------------------------------------------------------------------------

 

[Attachment 7]

 

LICENSE AGREEMENT

 

This AGREEMENT (the “Agreement”) is made as of the 11 day of March 2003 (the
“Effective Date”), by and between Genaissance Pharmaceuticals, Inc., with its
principal place of business at Five Science Park, New Haven, CT 06511
(“Genaissance”), and Wayne State University, with offices at 5700 Cass Avenue,
Suite 4200, A.A. B., Detroit, MI 48202 (“WSU”).  Genaissance and WSU are
sometimes referred to herein as a party and collectively as the parties.

 

RECITALS

 

WHEREAS, WSU has a service contract with the Perinatology Research Branch (PRB)
of the National Institute of Child Health and Human Development (NICHD) that
includes the identification of genetic variants that predispose individuals to a
normal or abnormal pregnancy outcome (the “PRB Contract”);

 

WHEREAS, Genaissance has expertise in integrating and applying population
genomics and informatics to the identification of correlations between genetic
variants and clinical phenotypes such as disease associations and drug response,
which expertise includes its proprietary HAP™ Database of gene specific variants
(“HAP™ Markers”, as hereinafter defined) and its proprietary DecoGen®
Informatics System (as hereinafter defined), to assemble, process, search,
manipulate, analyze, and correlate gene variants to clinical phenotypes;

 

WHEREAS, in support of the PRB Contract, WSU and Genaissance have concurrently
herewith entered into a contract pursuant to which WSU will gain access to
certain HAP Markers and to the DecoGen Informatics System, and pursuant to which
Genaissance will provide genotyping services (the “Genotyping Contract);

 

WHEREAS, WSU is interested in obtaining a license to use the HAP Markers and
DecoGen® Informatics System for certain research purposes; and Genaissance is
willing to grant this license upon the terms and conditions set forth below.

 

NOW THEREFORE, in consideration of the premises and of the covenants herein
contained, the parties hereto mutually agree as follows.

 

ARTICLE 1
DEFINITIONS

 

1.1                                 “Affiliate” Affiliate shall mean any
corporation or other entity, which directly or indirectly controls, is
controlled by or is under common control with a party to this Agreement.  A
corporation or other entity shall be regarded as in control of another
corporation or entity if it owns or directly or indirectly controls more than
fifty percent (50%) of the outstanding voting stock or other ownership interest
of the other corporation or entity, or if it possesses, directly or indirectly,
the power to manage, direct or cause the direction of the management and
policies of the corporation or other entity or the power to elect or appoint
fifty percent (50%) or more of the members of the governing body of the
corporation or other entity.  Any such other relationship as in fact results in
actual control over the management, business and affairs of a corporation or
other entity shall also be deemed to constitute control.

 

--------------------------------------------------------------------------------

 

1.2                                 “Authorized Users” shall mean [**].

 

1.3                                 “Candidate Gene” shall mean a gene for which
WSU requests Genaissance to provide genotyping services pursuant to the
Genotyping Contract.

 

1.4                                 “Commercial Field of Use” shall mean the
discovery, development, manufacture, marketing and selling of diagnostic
products and therapeutic products.

 

1.5                                 “DecoGen® Informatics System” shall mean
software and components thereof and any associated documentation, whether
existing on the Installation Date or developed by Genaissance during the License
Period, which is owned or controlled by Genaissance, or licensed (with the right
to sublicense) to Genaissance, and which includes the DecoGen® Browser software
and the DecoGen® DataManager software, with the features of these software
products being further described in Exhibit A hereto.  The DecoGen Informatics
System shall not include any Third Party software that WSU has independently of
Genaissance licensed from a Third Party.

 

1.6                                 “Genaissance Know-How” shall mean any and
all proprietary data, information, know-how, inventions, trade secrets,
copyrights, regulatory submissions or other intellectual property of any kind,
other than Genaissance Patent Rights, owned or controlled by Genaissance as of
the effective date or during the term of this Agreement including, but without
limitation, data on the sequence, frequency and distribution of HAP Markers in
the HAP Focus™ Database.

 

1.7                                 “Genaissance Patent Rights” shall mean
Patent Rights that are owned or controlled (with the right to grant licenses) by
Genaissance that are directed to the DecoGen Informatics Platform or to HAP
Markers in the HAP Focus Database, provided that Genaissance Patent Rights shall
not include patents owned or controlled by Genaissance that are directed to an
association between one or more HAP Markers and a specific phenotype, including
but not limited to drug response or disease susceptibility.

 

1.8                                 “Genotype” shall mean an unphased 5’ to 3’
sequence of the two nucleotides found at one or more Polymorphic Sites on a pair
of homologous chromosomes in an individual.

 

1.9                                 “HAP Focus™ Database” shall mean the
database that (a) is initially installed by Genaissance at the WSU site
specified in Exhibit B, and all updates thereof, and (b) contains the following
information generated by Genaissance: (i) a gene structure for each of the
Candidate Genes, (ii) the Polymorphisms identified in the Index Repository for
those Candidate Genes used in the cohort comparison phase of the Genotyping
Contract, (iii) the Genotypes, Haplotypes, and Haplotype Pairs identified in the
PRB Patient Population for each Candidate Gene, and (iv) the frequencies of
Genotypes, Haplotypes and Haplotype Pairs in the Index Repository and PRB
Patient Population.

 

1.10                           “HAP™ Marker Association” shall mean an
association that is (a) between a specific HAP Marker or combination of HAP
Markers and a pregnancy outcome phenotype and (b) discovered solely by employees
of WSU or others acting on behalf of WSU.

 

1.11                           “Haplotype” shall mean any phased 5’ to 3’
sequence of nucleotides present at a set of two or more Polymorphic Sites for a
gene on a single chromosome.

 

2

--------------------------------------------------------------------------------

 

1.12                           “Haplotype Pair” shall mean the two Haplotypes
found in a single individual for a particular set of two or more Polymorphic
Sites.

 

1.13                           “HAP Marker” shall mean (a) any Polymorphism or
Haplotype in the HAP Focus Database that is discovered by Genaissance in the
Index Repository and not publicly known at the time of WSU’s use of such
Polymorphism or Haplotype and (b) any Haplotype determined by Genaissance for a
PRB patient sample that contains at least one Polymorphism that is in the HAP
Focus Database and not publicly known at the time of WSU’s use of such
Haplotype.

 

1.14                           “HAP Marker Data” shall mean any data (a) that
relates to any Polymorphism or Haplotype that is in the HAP Focus Database,
including but not limited to the frequency and ethnic distribution of
Polymorphisms, Haplotypes and Haplotype Pairs in the Index Repository and (b)
that is not publicly known at the time of WSU’s use of such data.

 

1.15                           “Index Repository” shall mean Genaissance’s
proprietary collection of immortalized cell lines established from unrelated
individuals from various geographical origins and from members of extended
families.

 

1.16                           “Installation Date” shall mean the date that
Genaissance installs, at the WSU site specified in Exhibit B, the DecoGen
Informatics System and the initial version of the HAP Focus Database, such date
to be a date mutually agreed upon by the parties after completion by Genaissance
of the sequencing and quality control analysis of the Candidate Genes.

 

1.17                           “Patent Rights” shall mean (i) any United States
or foreign patent application, (ii) any United States patent or foreign patent
issuing from such patent application and (iii) any continuation,
continuation-in-part (to the extent the claims in such continuation-in-part
application are directed to subject matter specifically described in such prior
patent application), divisional, reissue, re-examination, renewal, substitution,
addition, extension, supplementary protection certificate or foreign counterpart
thereof of any of the foregoing.

 

1.18                           “Polymorphic Site” or “PS” shall mean a specific
position within a chromosome at which a Polymorphism is found in a population.

 

1.19                           “Polymorphism” means any alternative nucleotide
or contiguous sequence of nucleotides found at a Polymorphic Site within a
population including, but not limited to: (a) SNPs; (b) insertions and deletions
of one or more nucleotides; (c) repeats of one or more nucleotides; and (d)
restriction fragment length polymorphisms.

 

1.20                           “Positive Scientific Finding” shall mean a (a)
statistically significant correlation (e.g., p <0.05) between a specific
phenotype and one or more HAP Markers in one or more specific genes or (b)
absence of a statistically significant correlation (e.g., p >0.05) between a
specific phenotype and one or more HAP Markers in a specific gene for which a
prior published report concluded that there was a correlation between the same
phenotype and a Polymorphism or Haplotype in the same gene.

 

1.21                           “PRB Patient Population” shall mean the WSU/PRB
patient samples sent to Genaissance for genotyping and haplotyping analysis
pursuant to the Genotyping Contract.

 

3

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1.22                           “Research Field of Use” shall mean the
performance by Authorized Users of research that directly relates to use or
analysis of Genotypes, Haplotypes and HAP Marker Data in the HAP Focus Database
solely for purposes of identifying correlations between genetic variants and
pregnancy outcomes.

 

1.23                           “SNP” means a single nucleotide polymorphism.

 

1.24                           “Third Party” means any entity other than
Genaissance or WSU.

 

ARTICLE 2
INTELLECTUAL PROPERTY

 

2.1                                 Ownership of Intellectual Property.

 

2.1.1                        HAP Markers.  Genaissance shall own all HAP
Markers.

 

2.2                                 License rights granted to WSU by
Genaissance.

 

2.2.1                        Research License to HAP Markers.  Subject to the
terms of this Agreement, Genaissance shall grant WSU a [**]non-exclusive
worldwide license[**] under Genaissance Patent Rights and Genaissance Know-How
to use the HAP Markers in the HAP Focus Database solely in the Research Field of
Use.

 

2.2.2                        Commercial License to HAP Markers in HAP Marker
Associations.  Subject to the terms of this Agreement, Genaissance shall grant
WSU a [**], non-exclusive worldwide license[**] under Genaissance Patent Rights
and Genaissance Know-How to use any HAP Marker in a HAP Marker Association
solely in the Commercial Field of Use.

 

2.2.3                        Research License to the HAP Focus Database and
DecoGen Informatics System.  Subject to the terms of this Agreement, Genaissance
shall grant WSU a [**]non-exclusive, non-transferable license, under Genaissance
Patent Rights and Genaissance Know-How, to use the HAP Focus Database and the
DecoGen Informatics System, each in machine-readable object code only, at the
single site specified in Exhibit B solely in the Research Field of Use.  In
consideration of this license, WSU shall pay Genaissance [**]dollars ($[**]),
which shall be due and payable within [**].

 

2.2.4                        Installation, Training, Support and Updates. 
Genaissance shall install the DecoGen Informatics System and the initial version
of the HAP Focus Database at the site specified in Exhibit B on the Installation
Date.  The installation and timing of the DecoGen license will be initiated no
more than [**] weeks nor less than [**] prior to the time the first set of data
will be delivered pursuant to the Genotyping Contract.  Genaissance will provide
[**] of on-site training, installation documentation and a user manual at that
site.  For a period of [**] after the Installation Date, Genaissance will also
provide (a) technical support via phone and email to Authorized Users between
the hours of 8:30 A.M. and 5:30 P.M. (Eastern Standard Time) Mondays through
Fridays, except when Genaissance is officially closed (e.g., for holidays or
weather emergencies) and (b) any updates to the HAP Focus Database on a monthly
basis and any updates to the DecoGen Informatics System on a quarterly basis. 
After the end of such [**] period, WSU may elect to obtain, on a consecutive
annual basis, the right to receive

 

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technical support and updates to the HAP Focus Database and DecoGen Informatics
System at the same frequency provided to other Genaissance customers by paying
Genaissance the standard commercial price offered by Genaissance for such
support and updates at the time of each such annual election.

 

2.2.5                        For purposes of this subsection 2.2.5, the HAP
Focus Database and the DecoGen Informatics System shall be referred to as the
“Licensed Software”.  WSU’s use of the Licensed Software shall be subject to the
following conditions:

 

(a)                                  To the extent that the Licensed Software
incorporates or requires the use of any commercially available operating system
software that is licensed by Genaissance from a Third Party as described in
Exhibit A and as notified to WSU, as may be supplemented from time to time, WSU
shall be responsible for obtaining any necessary license and paying all fees and
charges associated with WSU’s use of any such Third Party software;

 

(b)                                 WSU agrees to use the Licensed Software in
accordance with the terms and conditions of this Agreement and not to use the
Licensed Software for processing data for Third Parties or to make Licensed
Software available to Third Parties;

 

(c)                                  WSU may make one (1) copy of the Licensed
Software solely for archival or back-up purposes;

 

(d)                                 WSU agrees to allow only Authorized Users to
use or access the Licensed Software and further agrees to establish reasonable
security measures to prevent copies of the software product(s) from being made
available to Third Parties;

 

(e)                                  Except with the express written permission
of Genaissance, WSU agrees that it will not attempt to reverse engineer, reverse
compile or otherwise obtain access to the source code of the Licensed Software;
and

 

(f)                                    WSU may not adapt or modify the Licensed
Software without the express written permission of Genaissance.

 

2.2.6                        Access for Collaborators and Subcontractors.  The
parties agree that WSU may provide access to any Genaissance Know-How and/or
Genaissance Patent Rights licensed to WSU under this Section 2.2 to
collaborators and/or subcontractors of WSU.  Such access shall not be granted
until such collaborator or subcontractor agrees in writing to be bound by the
confidentiality, nondisclosure and publication provisions of Article 3.  WSU
shall promptly provide Genaissance with a copy of the agreement with each such
collaborator or subcontractor.

 

2.3                                 No Grant of Other Technology or Patent
Rights.  Except as otherwise expressly provided in this Agreement, under no
circumstances shall a party hereto, as a result of this Agreement, obtain any
ownership interest in or other right to any technology, know-how, patents,
patent applications, data, products, or biological materials of the other party,
including items owned, controlled or developed by the other party, or
transferred by the other party to said party, at any time pursuant to this
Agreement.

 

5

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ARTICLE 3
CONFIDENTIALITY AND NONDISCLOSURE

 

3.1                                 For purposes of this Agreement, the term
“Confidential Information” will mean any and all data, know-how, technical and
non-technical materials which one party may deliver or disclose in writing to
the other party pursuant to this Agreement, that is marked “Confidential,” and
all oral material which one party declares to be confidential and confirms such
declaration in writing within [**] ([**]) days of disclosure.  Confidential
Information of Genaissance includes but is not limited to HAP Markers and HAP
Marker Data.  Confidential Information of WSU includes but is not limited to the
list of candidate genes and all data and results generated by Genaissance
pursuant to the Genotyping Contract.

 

3.2                                 Confidentiality and Nonuse Obligations. 
Except as otherwise provided in this Section 3, during the term of this
Agreement and for a period of [**] ([**]) years thereafter, each party agrees to
maintain the other party’s Confidential Information in confidence with the same
degree of care it holds its own confidential information and agrees to use the
other party’s Information solely for the purposes specifically authorized under
this Agreement.  Notwithstanding the foregoing [**] ([**]) year period, WSU
shall not disclose to any Third Party any HAP Marker unless and until such HAP
Marker [**]becomes public knowledge [**] (b) [**].

 

3.3                                 Exceptions to Confidentiality.  The
receiving party’s obligation of non-disclosure and the limitations upon the
right to use the disclosing party’s Confidential Information will not apply to
the extent that the receiving party can demonstrate by its written records that
the Confidential Information: (a) was in its possession prior to the time of
disclosure by the disclosing party; (b) is or becomes public knowledge through
no fault or omission of the receiving party; (c) is obtained by the receiving
party from a Third Party under no obligation of confidentiality to the
disclosing party; (d) is required to be disclosed by the receiving party
pursuant to an order or demand issued by a court or governmental agency or as
otherwise required by law; provided, however, that the receiving party notifies
the disclosing party prior to disclosure, giving such disclosing party
sufficient advance notice to permit it to seek a protective order or other
similar order with respect to such Confidential Information and provided,
further, that the receiving party furnishes only that portion of the Information
which it is advised by counsel is legally required whether or not a protective
order or other similar order is obtained by the disclosing party; or (e) where
the receiving party reasonably believes such disclosure is reasonably necessary
or appropriate to fulfill its obligations or exercise its rights under this
Agreement, with such disclosure being limited to (i) consultants, collaborators,
and clinical investigators, on a need-to-know basis and on condition that such
entities or persons agree to keep the Confidential Information confidential for
the same time periods and to the same extent as such party is required to keep
the Confidential Information confidential and (ii) government or other
regulatory authorities to the extent that such disclosure is reasonably
necessary to obtain patents or authorizations to conduct clinical trials of, and
to commercially market, products.

 

3.4                                 Publication.

 

(A)                                  GENERAL RESTRICTIONS.  ANY PARTY MAY
PUBLISH OR PRESENT DATA AND/OR RESULTS GENERATED UTILIZING THE HAP MARKERS OR
HAP FOCUS DATABASE, PROVIDED, THAT IN THE EVENT

 

6

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that a party desires to publish or present any Confidential Information of
another party, then the proposed disclosure shall be subject to the prior review
by the other party solely to determine (i) whether the proposed disclosure
contains the Confidential Information of the other party or (ii) whether the
information contained in the proposed disclosure should be the subject of a
patent application prior to such disclosure.  Each party shall provide the other
party with the opportunity to review any proposed abstract, manuscript or
presentation which discloses Confidential Information of the other party by
delivering a copy thereof to the other party no less than [**] ([**]) days
before its intended submission for publication or presentation.  The other party
shall have [**] ([**]) days from its receipt of any such abstract, manuscript or
presentation in which to notify the party in writing of any specific objections
to the disclosure, based on either the need to seek patent protection or concern
regarding the specific disclosure of the Confidential Information of such
party.  In the event a party objects to the disclosure, the other party agrees
not to submit the publication or make the presentation containing the
objected-to information until the party is given a reasonable additional period
of time (not to exceed an additional [**] ([**]) days) to seek patent protection
for any material in the disclosure which it believes is patentable or, in the
case of Confidential Information, to allow the publishing party to delete any
Confidential Information of the other party from the proposed disclosure.  Each
party agrees to delete from the proposed disclosure any Confidential Information
of the other party upon request.  For the avoidance of doubt, this section shall
not place any restrictions on the freedom of WSU (or collaborators and
subcontractors authorized under section 2.2.6) to publish anything related to
any Polymorphism or Haplotype that is publicly known or discovered by WSU (or
collaborators and subcontractors authorized under section 2.2.6) independently
of use of the HAP Focus Database or the DecoGen Informatics System.

 

(B)                                 EXCEPTIONS TO GENERAL RESTRICTIONS. 
NOTWITHSTANDING SUBSECTION (A) OF THIS SECTION 3.4, GENAISSANCE SHALL NOT
REQUIRE WSU OR COLLABORATORS AND SUBCONTRACTORS AUTHORIZED UNDER SECTION 2.2.6
TO REMOVE HAP MARKERS AND RELATED HAP MARKER DATA FROM ANY PROPOSED DISCLOSURE
IF (A) [**](B) [**] OR (C) THE HAP MARKERS OR RELATED HAP MARKER DATA HAVE
BECOME PUBLICLY KNOWN PRIOR TO THE PROPOSED DISCLOSURE.  IN ADDITION,
GENAISSANCE SHALL NOT REQUIRE WSU OR COLLABORATORS AND SUBCONTRACTORS AUTHORIZED
UNDER SECTION 2.2.6 TO REMOVE FROM ANY PROPOSED DISCLOSURE THE NUMBER AND
POPULATION FREQUENCY OF HAP MARKERS IN THE HAP FOCUS DATABASE THAT WERE ANALYZED
IN GENERATING THE RESULTS DESCRIBED IN SUCH DISCLOSURE.

 

ARTICLE 4
REPRESENTATIONS AND WARRANTIES

 

4.1                                 Representations, Warranties and Covenants of
Genaissance.  Genaissance represents and warrants to and covenants with WSU
that:

 

(a)                                  Genaissance has the legal right, authority
and power to enter into this Agreement, and to extend the rights and licenses
granted to WSU in this Agreement;

 

(b)                                 Genaissance has taken all necessary action
to authorize the execution, delivery and performance of this Agreement;

 

(c)                                  upon the execution and delivery of this
Agreement, this Agreement shall constitute a valid and binding obligation of
Genaissance enforceable in accordance with its

 

7

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terms, except as enforceability may be limited by applicable bankruptcy,
insolvency, reorganization, moratorium or similar laws affecting creditors’ and
contracting parties’ rights generally and except as enforceability may be
subject to general principles of equity (regardless of whether such
enforceability is considered in a proceeding in equity or at law);

 

(d)                                 the performance of its obligations under
this Agreement will not conflict with its charter documents or result in a
breach of any agreements, contracts or other arrangements to which it is a
party; and

 

(e)                                  Genaissance will not after the Effective
Date enter into any agreements, contracts or other arrangements that would be
inconsistent with its obligations under this Agreement.

 

4.2                                 Representations, Warranties and Covenants of
WSU.  WSU represents and warrants to and covenant with Genaissance that:

 

(a)                                  WSU has the legal right, authority and
power to enter into this Agreement;

 

(b)                                 WSU has taken all necessary action to
authorize the execution, delivery and performance of this Agreement;

 

(c)                                  upon the execution and delivery of this
Agreement, this Agreement shall constitute a valid and binding obligation of WSU
enforceable in accordance with its terms, except as enforceability may be
limited by applicable bankruptcy, insolvency, reorganization, moratorium or
similar laws affecting creditors’ and contracting parties’ rights generally and
except as enforceability may be subject to general principles of equity
(regardless of whether such enforceability is considered in a proceeding in
equity or at law);

 

(d)                                 the performance of its obligations under
this Agreement will not conflict with WSU’s charter documents or result in a
breach of any agreements, contracts or other arrangements to which it is a
party; and

 

(e)                                  WSU will not after the Effective Date enter
into any agreements, contracts or other arrangements that would be inconsistent
with its obligations under this Agreement.

 

4.3                                 Warranty Disclaimer.  EXCEPT AS OTHERWISE
EXPRESSLY PROVIDED IN THIS AGREEMENT, GENAISSANCE DOES NOT MAKE ANY WARRANTY
WITH RESPECT TO THE HAP MARKERS, PATENT RIGHTS, GOODS, SERVICES OR OTHER SUBJECT
MATTER OF THIS AGREEMENT AND HEREBY DISCLAIMS WARRANTIES OF MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT WITH RESPECT TO ANY AND ALL
OF THE FOREGOING.  IN ADDITION, WSU ACKNOWLEDGES THAT THE ACQUISITION OR USE OF
THE HAP MARKERS MAY BE COVERED BY PATENT RIGHTS OF THIRD PARTIES.  GENAISSANCE
MAKES NO REPRESENTATION OR WARRANTIES WITH RESPECT TO WSU’S USE OF THE
INFORMATION TO BE PROVIDED TO IT HEREUNDER.

 

8

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4.4                                 Limited Liability.  NOTWITHSTANDING ANYTHING
ELSE IN THIS AGREEMENT OR OTHERWISE TO THE CONTRARY, THE PARTIES SHALL NOT BE
LIABLE TO EACH OTHER WITH RESPECT TO ANY SUBJECT MATTER OF THIS AGREEMENT UNDER
ANY CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY
FOR (I) ANY PUNITIVE, EXEMPLARY, INCIDENTAL OR CONSEQUENTIAL DAMAGES OR LOST
PROFITS OR (II) COST OF PROCUREMENT OF SUBSTITUTE GOODS, TECHNOLOGY OR SERVICES.

 

ARTICLE 5
EXPIRATION AND TERMINATION

 

5.1                                 Term of Agreement.  Unless this Agreement is
sooner terminated in accordance with the provisions of this Article 5, the
“Term” of this Agreement shall commence on the Effective Date and expire three
(3) years after the Effective Date.  Genaissance may terminate this Agreement if
WSU terminates the Genotyping Contract for any reason other than breach of
Genaissance in performing its obligations thereunder.

 

5.2                                 Events of Default.  An Event of Default
shall have occurred upon the occurrence of a material breach of this Agreement
if the breaching party fails to remedy such breach within [**] ([**]) days after
written notice thereof by the non-breaching party.

 

5.3                                 Effect of an Event of Default.

 

5.3.1                        Remedies Available to Genaissance.  In the event
that an Event of Default occurs relating to WSU and WSU fails to cure such
default during any applicable cure period, Genaissance shall have the right, at
its option exercisable in its sole discretion, in addition to any other rights
or remedies available to it at law or in equity, to terminate WSU’s rights under
this Agreement upon notice thereof to WSU, in which case (i) the licenses and
option granted to WSU pursuant to Article 2 shall terminate and (ii) WSU shall
destroy all copies of the HAP Focus Database and DecoGen Informatics Platform
that are in its possession and shall provide Genaissance with written notice of
the completion of such destruction.

 

5.3.2                        Remedies Available to WSU.  In the event that an
Event of Default occurs relating to Genaissance and Genaissance fails to cure
such default within the applicable cure period, then WSU shall have the right,
at its option exercisable in its sole discretion, to seek any rights or remedies
available to it at law or in equity, subject to the limitations set forth in
Section 4.4 hereof or any applicable provisions of the Genotyping Contract.

 

5.4                                 Effect of Expiration or Termination of
Agreement.  The expiration or termination of this Agreement shall not relieve
the parties of any obligation accruing prior to such expiration or termination. 
The provisions of Sections 2.1, 2.2, 2.3, and of Articles 3 and 4 hereof shall
survive the expiration or termination of this Agreement.

 

ARTICLE 6
MISCELLANEOUS

 

6.1                                 Dispute Resolution.  The parties hereby
agree that they will attempt in good faith to resolve any controversy or claim
arising out of or relating to this Agreement promptly by

 

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negotiations.  If a controversy or claim should arise hereunder, the matter
shall be referred to an individual designated by the Chief Executive Officer (or
the equivalent position) of Genaissance and an individual designated by the
President (or the equivalent position) of WSU (the “Representatives”).  If the
matter has not been resolved within [**] ([**]) days of the first meeting of the
Representatives of the parties (which period may be extended by mutual
agreement) concerning such matter, each party may pursue available legal or
equitable remedies.

 

6.2                                 Force Majeure.  Neither party shall be held
liable or responsible to the other party nor be deemed to have defaulted under
or breached this Agreement for failure or delay in fulfilling or performing any
term of this Agreement when such failure or delay is caused by or results from
causes beyond the reasonable control of the affected party, including but not
limited to fire, floods, embargoes, war, acts of war (whether war is declared or
not), insurrections, riots, civil commotions, strikes, lockouts or other labor
disturbances, acts of God or acts, omissions or delays in acting by any
governmental authority or the other party; provided, however, that the party so
affected shall use reasonable commercial efforts to avoid or remove such causes
of nonperformance, and shall continue performance hereunder with reasonable
dispatch whenever such causes are removed.  Either party shall provide the other
party with prompt written notice of any delay or failure to perform that occurs
by reason of force majeure.  The parties shall mutually seek a resolution of the
delay or the failure to perform as noted above.

 

6.3                                 Assignment.  This Agreement may not be
assigned or otherwise transferred by either party without the prior written
consent of the other party, such consent not to be unreasonably withheld or
delayed; provided, however, that Genaissance may, without such consent, assign
its rights and obligations under this Agreement (i) to any Affiliate, or (ii) in
connection with a merger, consolidation or sale of substantially all of its
assets to an unrelated Third Party; provided, however, that Genaissance’s rights
and obligations under this Agreement shall be assumed by its successor in
interest in any such transaction and shall not be transferred separate from all
or substantially all of its other business assets, including those business
assets that are the subject of this Agreement.  Any purported assignment in
violation of the preceding sentence shall be void.  Any permitted assignee shall
assume all obligations of its assignor under this Agreement.

 

6.4                                 Severability.  Each party hereby agrees that
it does not intend to violate any public policy, statutory or common laws,
rules, regulations, treaty or decision of any government agency or executive
body thereof of any country or community or association of countries.  Should
one or more provisions of this Agreement be or become invalid, the parties
hereto shall substitute, by mutual consent, valid provisions for such invalid
provisions which valid provisions in their economic effect are sufficiently
similar to the invalid provisions that it can be reasonably assumed that the
parties would have entered into this Agreement with such valid provisions.  In
case such valid provisions cannot be agreed upon, the invalidity of one or
several provisions of this Agreement shall not affect the validity of this
Agreement as a whole, unless the invalid provisions are of such essential
importance to this Agreement that it is to be reasonably assumed that the
parties would not have entered into this Agreement without the invalid
provisions.

 

6.5                                 Notices.  Any consent, notice or report
required or permitted to be given or made under this Agreement by one of the
parties hereto to the other shall be in writing, delivered personally or by
facsimile (and promptly confirmed by telephone, personal delivery or courier)

 

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or courier, postage prepaid (where applicable), addressed to such other party at
its address indicated below, or to such other address as the addressee shall
have last furnished in writing to the addressor and shall be effective upon
receipt by the addressee.

 

6.6                                 If to
Genaissance:                                                 Genaissance
Pharmaceuticals, Inc.

Five Science Park

New Haven, Connecticut 06511

Attention: Chief Executive Officer

Telephone: (203) 773-1450

Facsimile: (203) 562-9377

 

If to WSU:
                                                                                   
Joan Gossman

Director of Purchasing

5700 Cass Avenue

Suite 4200

Detroit, MI 48202

 

6.7                                 Applicable Law.  This Agreement shall be
governed by and construed in accordance with the laws of the State of Michigan,
without giving effect to the choice of laws provisions thereof.

 

6.8                                 Entire Agreement.  This Agreement, together
with any exhibits hereto, contains the entire understanding of the parties with
respect to the subject matter hereof.  All express or implied agreements and
understandings, either oral or written, heretofore made are expressly merged in
and made a part of this Agreement.  This Agreement may be amended, or any term
hereof modified, only by a written instrument duly executed by both parties
hereto.

 

6.9                                 Publicity.  Except as required by law,
Genaissance and WSU each agree not to disclose the terms or conditions of this
Agreement to any Third Party without the prior written consent of the other
party, which shall not be withheld unreasonably.  Use of each other’s names
requires prior consent.

 

6.10                           Headings.  The captions to the several Articles
and Sections hereof are not a part of this Agreement, but are merely guides or
labels to assist in locating and reading the several Articles and Sections
hereof

 

6.11                           No Partnership.  It is expressly agreed that the
relationship between Genaissance and WSU shall not constitute a partnership,
joint venture or agency.  None of the parties shall have the authority to make
any statements, representations or commitments of any kind, or to take any
action, which shall be binding on any other party, without the prior consent of
such party to do so.

 

6.12                           Waiver.  The waiver by a party hereto of any
right hereunder or the failure to perform or of a breach by one of the other
parties shall not be deemed a waiver of any other right hereunder or of any
other breach or failure by said other party whether of a similar nature or
otherwise.

 

6.13                           Counterparts.  This Agreement may be executed in
two counterparts, each of

 

11

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which shall be deemed an original, but all of which together shall constitute
one and the same instrument.

 

[Remainder of page intentionally left blank.]

 

12

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IN WITNESS WHEREOF, the parties have caused their duly authorized officer to
execute and deliver this Agreement as of the date first set forth above.

 

GENAISSANCE PHARMACEUTICALS, INC.

 

By:

/s/ Gerald F. Vovis

 

 

 

 

Name:  Gerald F. Vovis, Ph.D.

 

Title:  Executive Vice President and Chief Technology Officer

 

WAYNE STATE UNIVERSITY

 

By:

/s/ John L. Davis

 

 

 

 

Name:  John L. Davis

 

Title:  Senior Vice President for Finance and Administration

 

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Exhibit A

 

Deployment Specifications for DecoGen Informatics System

 

1.                                      DATABASE CONFIGURATION

•                                          Software: Oracle[**] Edition, typical
install, and [**] applied.

 

Hardware Requirements: For [**]

 

•                                          Memory: [**]GB, depending on number
of users.  Genaissance has [**]GB to support [**] instances and around [**]
users.

 

•                                          SWAP Space: [**].

 

•                                          CD-ROM Device: [**]s.

 

•                                          CPU: [**]

 

Disk Space Requirements:

 

•                                          Oracle Software: around [**]GB
([**]Edition)

 

•                                          Database: for the data volume of
[**], the database size would be [**]GB.  For best database performance, we
would [**].

 

Operating System Software Requirements

 

•                                          Operating System: [**]

 

•                                          [**]

 

2.                                      APPLICATION (FILE) SERVER CONFIGURATION:

 

•                                          [**]

 

3.                                      SAS SERVER CONFIGURATION:

 

Detailed SAS server requirements:

 

•                                          SAS Version: SAS Software 8.2 release
on NT or Windows 2000 server.

 

•                                          SAS Software 8.2 required
components/modules must include SAS/BASE, SAS/STAT, SAS/CONNECT, SAS/IntraNet.

 

4.                                      End-User Client Computer Configuration:

 

The standard computer configuration we recommend is:

 

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•                                          CPU: [**];

 

•                                          Memory: [**];

 

•                                          Hard disk: [**];

 

•                                          Operating System: Window [**]

 

2

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Exhibit B

 

Installation Site for DecoGen Informatics System and HAP Focus Database

 

Wayne State University

[**]Detroit, MI 48201

 

3

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[Attachment 8]

 

ADDENDUM 3 TO PROPOSAL, ADDITIONAL SERVICES

 

I.              Comparison of Cohorts

 

A.            Description of Service.  The objective of this service is to
confirm that SNPs discovered in Genaissance’s Index Repository are relevant to
the [**]cohort to be studied in the project with Wayne State University. 
[**]Genaissance will sequence [**]DNA fragments from gene regions in [**]
unrelated [**] individuals from the patient cohort that is to be studied in the
genotyping project.  These [**] fragments will be chosen from autosomal genes on
the list of candidate genes.  The criteria for selecting the [**] DNA fragments
will be the following.  The DNA fragment must have [**]SNPs whose minor allele
was seen [**].  In addition, these SNPs must have a minor allele frequency (MAF)
>5[**]in [**].

 

The relevance of [**].  Genaissance has compared different samples of
individuals, such as the patients in the Company’s STRENGTH clinical trial with
the individuals in the Company’s IR.  The results of such comparisons are that
the high frequency SNPs, i.e. those with a MAF >5%, are usually observed in both
samples.  For instance, of 1,027 SNPs observed in the 21 unrelated Caucasians
from the IR, 991 (96%) were also observed in the 590 Caucasians in the STRENGTH
cohort.

 

The [**] fragments to be sequenced should be sufficient to demonstrate that the
SNPs discovered by Genaissance in its IR can be used to capture the haplotype
diversity that is present in the [**]cohort.  Genaissance does expect that the
sequencing of these [**]fragments will identify some novel SNPs that are present
in the [**] cohort.  However, the Company does not expect that a significant
number will be present in the [**] cohort at a high frequency.  In addition, the
[**]autosomal DNA fragments, which should yield at least [**]SNPs genotyped on
[**]individuals, will provide sufficient information to establish a protocol to
select SNPs for the genotyping project.  That is, [**], should be the criterion
used for determining whether to genotype that SNP in the [**] cohort.

 

B.            Service Fee.  [**]

 

II.            Sequence Finishing and Quality Control Analysis of Candidate
Genes

 

A.            Description of Service.  The objective of this service is to
ensure that all candidate genes (approximately 200) in the HAP Database have an
up to date genomic structure and that the sequencing analysis of these genes
meets Genaissance’s standards, as defined in Attachment A to this Addendum 3. 
[**]Genaissance will check the genomic structure recorded in the HAP Database
for each of the candidate genes against the latest publicly available
information and make any necessary adjustments to the genomic structures in the
HAP Database.  Genaissance will then sequence those fragments that are necessary
to bring the genes up to the standards set forth in Attachment A.

 

C.            Service Fee.  [**]

 

--------------------------------------------------------------------------------

 

Attachment A

 

Gene Sequencing Standards

 

The current procedure for discovering HAP Markers for a gene is to sequence,
from the Index Repository, ninety-three (93) individual samples of human genomic
DNA, one sample of chimpanzee genomic DNA and one sample of gorilla genomic
DNA.  The genomic regions of each gene, which are targeted for sequencing, are
as follows.

 

(i)            “Exons” shall mean the genomic DNA segments of a gene whose
sequence information is translated into the protein product of that gene.  The
goal is to obtain sequence information for all Exons of a gene.

 

(ii)           “Exon/Intron Junction” shall mean the junctions between the Exons
and the Introns in genomic DNA.  Beginning with the initiation codon at one end
of a gene and ending with the termination codon at the other end of a gene, the
goal is to obtain sequence information for each Exon/Intron Junction within this
genomic region.

 

(iii)          “Introns” shall mean the genomic DNA segments of a gene, which
are located between Exons.  Beginning with the initiation codon at one end of a
gene and ending with the termination codon at the other end of a gene, the goal
is to obtain a minimum of ten (10) to twenty (20) bases and a maximum of one
hundred (100) bases of sequence information from the Exon/Intron Junction into
the Intron for every Intron within this genomic region.

 

(iv)          “Promoter” shall mean the genomic region that is immediately
upstream of the transcription start site of the gene.  The goal is to obtain
sequence information for up to one (1) thousand bases of the Promoter.

 

(v)           “Three-Prime Untranslated Region” shall mean the genomic region
immediately downstream from the termination codon of a gene.  The goal is to
obtain sequence information for at least one hundred (100) bases of the
Three-Prime Untranslated Region downstream of the termination codon.

 

Specific genomic sequence information is required to meet the goals outlined in
(i) through (v) above.  If genomic sequence information is available for a
majority of these regions, even if the available genomic sequence information is
not sufficient to meet all of the goals in (i) through (v) above, a gene will
still be queued for HAP Marker discovery.

 

Once a gene is completely sequenced, HAP Markers will be constructed for that
gene and placed into the HAP Database.  A gene shall be considered completely
sequenced if sequence information is obtained for at least [**] ([**]) of the
regions targeted for sequencing.  A specific region targeted for sequencing
within a gene shall be considered completely sequenced if sequence information
is obtained for at least [**].

 

If a gene is not completely sequenced after each fragment targeted for
sequencing has been attempted once, each of the failed fragments will be
resequenced using redesigned

 

2

--------------------------------------------------------------------------------

 

amplification/sequencing primers.  However, the presence of runs of guanine and
cytosine, secondary structure or errors in publicly available sequence
information may prevent the generation of sufficient sequence information for
that gene to be considered completely sequenced.  Thus, if the gene does not
meet the completely sequenced criteria after the above resequencing step, HAP
Markers will be constructed for that gene and placed into the HAP Database.

 

3

--------------------------------------------------------------------------------

 

[Attachment 9]

 

WSU PROJECT SEQ TRACKING

Confidential and Proprietary, GPI

 

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[**]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[**]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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[**]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[**]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[**]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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[**] genes done

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[**]

 

 

 

 

 

 

 

[**] genes done

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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[**]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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[**]  genes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[**] genes done

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[**] genes

 

 

 

 

 

 

 

 

 

[**] genes

 

 

 

4

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--------------------------------------------------------------------------------

Project Assumptions:

1.

 

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5

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[Attachment 10]

 

WSU PROJECT TRACKING

 

GENAISSANCE PHARMACEUTICALS, INC.                          Confidential and
Proprietary

 

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Project Assumptions:

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[Attachment 11]

 

Contact:

 

Gerald F. Vovis, Ph.D.

 

Rhonda Chiger (investors)

Executive Vice President & Chief Technology Officer

 

Rx Communications

Genaissance Pharmaceuticals, Inc.

 

917.322.2569

203.786.3423

 

rchiger@RxIR.com

j.vovis@genaissance.com

 

 

 

 

 

 

 

 

 

Not For Immediate Release

 

Genaissance Pharmaceuticals Signs Agreement with Wayne State University to
Support the NIH’s Perinatology Research Branch

 

New Haven, CT, March XX, 2003 - Genaissance Pharmaceuticals, Inc. (Nasdaq: GNSC)
today announced that it has signed an agreement with Wayne State University
(WSU) to support WSU’s research contract with the National Institute of Child
Health and Human Development’s Perinatology Research Branch (PRB), which is
located at the WSU School of Medicine in Detroit, Michigan.  Under the
agreement, WSU will gain access to specific HAP™ Markers and obtain a limited
license to use the Company’s DecoGen® Informatics System.  Genaissance will
develop assays for the selected HAP™ Markers and provide high-throughput
genotyping on clinical samples provided by WSU and the PRB.  Genaissance will
receive a license fee and other payments from WSU.

 

“We are delighted to enter into an agreement with WSU, which is working with the
PRB to address important healthcare issues of adverse pregnancy outcomes,” said
Gerald F. Vovis, Ph.D., Executive Vice President and Chief Technology Officer of
Genaissance Pharmaceuticals.  “This is our first major agreement in the public
sector and reinforces the utility of our HAP™ Technology for helping to detect
associations between clinical outcomes and genetic variation.”

 

About Genaissance:

Genaissance Pharmaceuticals, Inc is a world leader in the discovery and use of
human gene variation for the development of personalized medicines.  The Company
markets its technology and clinical development skills to the pharmaceutical
industry as a complete solution for improving the development, marketing and
prescribing of drugs.  Genaissance has agreements with eight major
pharmaceutical, diagnostic and biotechnology companies:  AstraZeneca, Bayer, BD
(Becton, Dickinson and Company), Biogen, Johnson & Johnson PRD, Millennium,
Pfizer and Pharmacia.  Genaissance is located in Science Park in New Haven,
Connecticut.

 

About Wayne State University:

With more than 1,000 medical students, WSU is among the nation’s largest medical
schools.  Together with its clinical partner the Detroit Medical Center, the
school is a leader in patient care and medical research in a number of areas,
including cancer, genetics, the neurosciences and women’s and children’s health.

 

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This press release contains forward-looking statements, including statements
about the ability of Genaissance to apply its technologies to the development,
marketing and prescribing of drugs and to detect associations between clinical
outcomes and genetic variation.  Such statements are subject to certain factors,
risks and uncertainties that may cause actual results, events and performance to
differ materially from those referred to in such statements, including, but not
limited to, the extent to which genetic markers (haplotypes) are predictive of
clinical outcomes and drug efficacy and safety, the attraction of new business
and strategic partners, the adoption of our technologies by the pharmaceutical
industry, the timing and success of clinical trials, competition from
pharmaceutical, biotechnology and diagnostics companies, the strength of our
intellectual property rights and those risks identified in our Annual Report on
Form 10-K filed with the Securities and Exchange Commission on March  7, 2002
and our Quarterly Reports on Form 10-Q for the quarter ended March 31, 2002,
June 30, 2002 and September 30, 2002 as filed with the Securities and Exchange
Commission on May 14, 2002, August 14, 2002 and November 14, 2002,
respectively.  The forward-looking statements contained herein represent the
judgment of Genaissance as of the date of this release.  Genaissance disclaims
any obligation to update any forward-looking statement.

 

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2

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