Document:

Exhibit
10.3

 

January 27, 2003

 

 

Dr. Krishnan
Nandabalan

Vice President,
Alliances

Genaissance
Pharmaceuticals, Inc.

5 Science Park

New Haven, CT
06511

 

 

Dear Dr. Nandabalan,

 

Further to our recent discussions regarding the Agreement between
Pfizer Inc and Genaissance Pharmaceuticals, Inc. dated August 31, 2001 (“2001
Agreement”); Pfizer Inc (“Pfizer”) and Genaissance Pharmaceuticals, Inc.
(“Genaissance”) will amend the 2001 Agreement as follows:

 

Section 3 is replaced in its entirety with the
following text:

 

Section 3    
Term:  The term of this Agreement
is three (3) years from August 31, 2001.

 

All other terms and conditions of the 2001 Agreement shall remain
unchanged and in full force.

 

Please have the appropriate official of Genaissance Pharmaceuticals,
Inc. sign both copies of this Agreement and return one original to Kelly P.
Longo at the above address.

 

 

Sincerely,

	
                  

  /s/ Mark P. DellaPorta

  
	
  Mark P. DellaPorta

  
	
  Site Director

  
	
  Strategic Alliances

  

 

 

Agreed:

 

Genaissance
Pharmaceuticals, Inc.

 

 

	
  By:

  	
  /s/ Krishnan Nandabalan

  

 

 

Date: February 6, 2003Exhibit
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

 

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

 

	
   

  	
  [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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

(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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

PRICE
SCHEDULE C

 

SUMMARY
OF QUOTED RATES

 

30

 

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

 

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

 

SCHEDULE E

 

REPRESENTATIONS, CERTIFICATIONS

AND OTHER STATEMENTS OF

OFFERORS OR QUOTERS (VENDORS)

 

33

 

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

 

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

 

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

 

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

 

(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

  

 

41

 

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.)

 

42

 

(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

 

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

 

(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

 

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);

 

46

 

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

 

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.”

 

48

 

(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.

 

49

 

(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).

 

50

 

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

 

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

 

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

 

[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

 

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

 

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

 

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

 

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

 

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

 

 

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

	
  ACORDTM                                                                                     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 HAPTM 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 HAPTM
Markers) would be used in the proposed project.

 

An Alternate Proposal for Genotyping

 

Use
of Genaissance’s Proprietary HAPTM
Markers.  If WSU
decides to use Genaissance’s proprietary HAPTM
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 HAPTM 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 HAPTM 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

  	
  *

  	
  $

  	
  [**]

  	
   

  
	
  HAPTM
  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

 

(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

 

(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

 

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

 

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

 

(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

 

(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

  

 

13

 

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

 

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

 

(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

 

(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

 

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

 

(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

 

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

 

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

 

(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

 

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

 

(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

 

(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

 

(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

 

(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

 

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

 

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

 

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

 

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

 

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

 

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 HAPTM 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 HAPTM 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 MassARRAYTM 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

 

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

 

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 HAPTM
Technology consists of the following components:

 

•                  HAPTM
Database, containing proprietary HAPTM
Markers (SNPs and haplotypes) for over 7,000 genes;

 

•                  DecoGen® Informatics System, containing
proprietary software for building haplotypes (HAPTM
Builder) and for detecting associations between gene variation and clinical
outcomes;

 

•                  HAPTM
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 HAPTM
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
HAPTM Markers) clinical trial,
Genaissance has used the Company’s HAPTTM
Technology to identify statistically significant associations (p <0.05)
between clinical outcomes and HAPTM
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 HAPTM Markers that
defined patient populations, which responded differently to the three statins.

 

The proposed project would be done in the Company’s HAPTM 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

 

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 HAPTM 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 HAPTM
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 HAPTM
Typing Facility, the name given by the Company to its genotyping facility,
principally uses the Sequenom MassARRAYTM 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 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 HAPTM 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

 

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 HAPTM 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 HAPTM
Typing Facility at Genaissance Pharmaceuticals.

 

DNA Samples will be received in the Genaissance HAPTM
Typing Facility’s receiving laboratory. 
All plates will be labeled with barcodes and accessioned using the
Genaissance HAPTM
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

 

b.                                      Genotyping.

 

i.                                          Summary. 
Genaissance currently performs high-throughput genotyping on Sequenom’s
MassARRAYTM platform using the
homogeneous Mass EXTENDTM, 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 HAPTM 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 HAPTM
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 HAPTM 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 MassARRAYTM process, a test is now designed to
consist of up to twenty multiplexed assays using a combination of Sequenom’s
SpectroDesignerTM 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 HAPTM 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

 

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 HAPTM
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 HAPTM
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

 

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

 

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

 

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

 

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

 

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 MassARRAYTM 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

 

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 HAPTM
Technology consists of the following components:

 

•                  HAPTM
Database, containing proprietary HAPTM
Markers (SNPs and haplotypes) for over 7,000 genes;

 

•                  DecoGen® Informatics System, containing
proprietary software for building haplotypes (HAPTM
Builder) and for detecting associations between gene variation and clinical
outcomes;

 

•                  HAPTM 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 HAPTM
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
HAPTM Markers) clinical trial, Genaissance
has used the Company’s HAPTM Technology to identify statistically
significant associations (p <0.05) between clinical outcomes and HAPTM 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 HAPTM
Markers that defined patient populations, which responded differently to the
three statins.

 

1

 

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 HAPTM 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 HAPTM 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 HAPTM
Typing Facility, the name given by the Company to its genotyping facility,
principally uses the Sequenom MassARRAYTM
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 HAPTM 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 HAPTM
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 HAPTM 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 HAPTM
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 HAPTM Database of gene specific variants (“HAPTM 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  FocusTM
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  FocusTM
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                           “HAPTM
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.

 

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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

 

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

 

4

 

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

 

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

 

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

 

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

 

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

 

9

 

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)

 

10

 

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

 

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

 

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

  
				

 

13

 

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:

 

1

 

•                                          CPU: [**];

 

•                                          Memory: [**];

 

•                                          Hard disk:
[**];

 

•                                          Operating
System: Window [**]

 

2

 

Exhibit
B

 

Installation
Site for DecoGen Informatics
System and HAP  Focus Database

 

Wayne State University

[**]Detroit, MI 48201

 

3

 

[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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  [**] genes done

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [**] genes

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [**] genes

  	
   

  	
   

  

 

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  Project Assumptions:

  	
  1.

  	
   

  	
  [**]

  
	
   

  	
  2.

  	
   

  	
  [**]

  
	
   

  	
  3.

  	
   

  	
  [**]

  
	
   

  	
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  [**]

  
	
   

  	
  5.

  	
   

  	
  [**]

  
	
   

  	
  6.

  	
   

  	
  [**]

  

 

5

 

[Attachment 10]

 

WSU
PROJECT TRACKING

 

GENAISSANCE PHARMACEUTICALS, INC.                          Confidential
and Proprietary

 

	
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  Project Assumptions:

  	
  1.

  	
   

  	
  [**]

  
	
   

  	
  2.

  	
   

  	
  [**]

  
	
   

  	
  3.

  	
   

  	
  [**]

  
	
   

  	
  4.

  	
   

  	
  [**]

  
	
   

  	
  5.

  	
   

  	
  [**]

  

 

6

 

[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 HAPTM Markers and obtain
a limited license to use the Company’s DecoGen®
Informatics System.  Genaissance will
develop assays for the selected HAPTM
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 HAPTM
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.

 

 

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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